0001213900-17-009468.txt : 20170907 0001213900-17-009468.hdr.sgml : 20170907 20170906174140 ACCESSION NUMBER: 0001213900-17-009468 CONFORMED SUBMISSION TYPE: S-1 PUBLIC DOCUMENT COUNT: 63 FILED AS OF DATE: 20170907 DATE AS OF CHANGE: 20170906 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADial Pharmaceuticals, L.L.C. CENTRAL INDEX KEY: 0001513525 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 800667150 STATE OF INCORPORATION: VA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: S-1 SEC ACT: 1933 Act SEC FILE NUMBER: 333-220368 FILM NUMBER: 171072263 BUSINESS ADDRESS: STREET 1: 1180 SEMINOLE TRAIL STREET 2: SUITE 495 CITY: CHARLOTTESVILLE STATE: VA ZIP: 22902 BUSINESS PHONE: 434-422-9800 MAIL ADDRESS: STREET 1: 1180 SEMINOLE TRAIL STREET 2: SUITE 495 CITY: CHARLOTTESVILLE STATE: VA ZIP: 22902 FORMER COMPANY: FORMER CONFORMED NAME: Adial Pharmaceuticals, L.L.C. DATE OF NAME CHANGE: 20110218 S-1 1 fs12017_adialpharma.htm REGISTRATION STATEMENT

As filed with the Securities and Exchange Commission on September 6, 2017

Registration No. 333-       

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

_________________________________

FORM S-1
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933

_________________________________

ADIAL PHARMACEUTICALS, L.L.C.

(to be converted as described herein to a corporation named)

ADIAL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

_________________________________

Delaware

 

8071

 

[   ]

(State or other jurisdiction of
incorporation or organization)

 

(Primary Standard Industrial
Classification Code Number)

 

(I.R.S. Employer
Identification No.)

Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
(434) 422-9800

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive office)

_________________________________

William B. Stilley, III
President and Chief Executive Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
(434) 422-9800

(Name, address, including zip code, and telephone number, including area code, of agent for service)

_________________________________

Copies to:

Leslie Marlow, Esq.
Hank Gracin, Esq.
Patrick J. Egan, Esq.
Gracin & Marlow, LLP
The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, NY 10174
Telephone: (212) 907-6457
Facsimile: (212) 208-4657

 

Brad L. Shiffman, Esq.
Megan C. Filoon, Esq.
Blank Rome LLP
The Chrysler Building
405 Lexington Avenue
New York, NY 10174
Telephone: (212) 885-5000
Facsimile: (212) 885-5001

_________________________________

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.

If any of the Securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box: x

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act Registration Statement number of the earlier effective Registration Statement for the same offering: ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, please check the following box and list the Securities Act Registration Statement number of the earlier effective Registration Statement for the same offering: ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act Registration Statement number of the earlier effective Registration Statement for the same offering: ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ¨

 

Accelerated filer ¨

Non-accelerated filer ¨

 

Smaller reporting company x

 

 

Emerging Growth Company x

If an emerging growth company, indicate by checkmark if the registrant has not elected to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ¨

 

CALCULATION OF REGISTRATION FEE

Title of each class of securities to be registered

 

Proposed
maximum
aggregate
offering price
(1)

 

Amount of
registration
fee
(2)

Common Stock, $0.001 par value(2)(3)

 

$

16,100,000

 

$

1,8665.99

Representative’s Warrants(4)

 

 

 

 

Shares of Common Stock underlying Representative’s Warrants(2)(5)

 

$

700,000

 

$

81.13

Total

 

$

16,800,000

 

$

1,947.12

____________

(1)      Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rule 457(o) of the Securities Act of 1933, as amended (the “Securities Act”).

(2)      Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions.

(3)      Includes shares of common stock the underwriters have the option to purchase to cover over-allotments, if any.

(4)      No fee pursuant to Rule 457(g) under the Securities Act.

(5)      Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act. The representative’s warrants are exercisable at a per share exercise price equal to 125% of the public offering price per share. As estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act, the proposed maximum aggregate offering price of the representative’s warrants is $700,000, which is equal to 125% of $560,000 (4% of $14,000,000).

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

 

SUBJECT TO COMPLETION

 

DATED SEPTEMBER 6, 2017

      Shares

Common Stock

This is a firm commitment initial public offering of 1,400,000 shares of common stock of Adial Pharmaceuticals, Inc. No public market currently exists for our shares. We anticipate that the initial public offering price will be between $9.00 and $11.00.

Prior to this offering, there has been no public market for our common stock. We have applied to list our shares of common stock for trading on The Nasdaq Capital Market under the symbol “ADIL.” No assurance can be given that our application will be approved.

We are an “emerging growth company” under applicable Securities and Exchange Commission (the “SEC”) rules and will be eligible for reduced public company disclosure requirements. See “Summary — Implications of Being an Emerging Growth Company.”

Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 14 of this prospectus for a discussion of information that you should consider before investing in our securities.

Neither the SEC nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

 

Per Share

 

Total

Public offering price

 

$

 

 

$

 

Underwriting discounts and commissions(1)

 

$

 

 

$

 

Proceeds, before expenses, to us

 

$

 

 

$

 

______________

(1)      The underwriters will receive compensation in addition to the discounts and commissions. See “Underwriting” for a description of compensation payable to the underwriters.

We have granted the representative of the underwriters an option to purchase up to an additional 210,000 shares of common stock from us at the public offering price, less the underwriting discounts and commissions, within 45 days from the date of this prospectus to cover over-allotments, if any. If the representative of the underwriters exercises the option in full the total underwriting discounts and commissions payable will be $     , and the total proceeds to us, before expenses, will be $     .

The underwriters expect to deliver the shares to purchasers in the offering on or about         , 2017.

Aegis Capital Corp

The date of this prospectus is         , 2017

 

TABLE OF CONTENTS

 

 

Page

PROSPECTUS SUMMARY

 

1

THE OFFERING

 

9

SUMMARY FINANCIAL INFORMATION

 

12

RISK FACTORS

 

14

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

47

USE OF PROCEEDS

 

49

DIVIDEND POLICY

 

50

CORPORATE CONVERSION/REINCORPORATION

 

50

CAPITALIZATION

 

51

DILUTION

 

53

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

55

BUSINESS

 

68

MANAGEMENT

 

96

EXECUTIVE COMPENSATION

 

103

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

 

109

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

 

112

SHARES ELIGIBLE FOR FUTURE SALE

 

113

MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS OF OUR COMMON STOCK

 

115

DESCRIPTION OF SECURITIES

 

119

UNDERWRITING

 

126

LEGAL MATTERS

 

134

EXPERTS

 

134

WHERE YOU CAN FIND ADDITIONAL INFORMATION

 

134

INDEX TO FINANCIAL STATEMENTS

 

F-1

You should rely only on the information contained in this prospectus or in any free writing prospectus that we may specifically authorize to be delivered or made available to you. We have not, and the underwriters have not, authorized anyone to provide you with any information other than that contained in this prospectus or in any free writing prospectus we may authorize to be delivered or made available to you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus may only be used where it is legal to offer and sell our securities. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date. We are not, and the underwriters are not, making an offer of these securities in any jurisdiction where the offer is not permitted.

For investors outside the United States: We have not and the underwriters have not done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside must inform themselves about, and observe any restrictions relating to, the offering of securities and the distribution of this prospectus outside the United States.

This prospectus includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We believe that the data obtained from these industry publications and third-party research, surveys and studies are reliable. The Company is ultimately responsible for all disclosure included in this prospectus.

i

PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before investing in our securities, you should carefully read this entire prospectus, including our financial statements and the related notes and the information set forth under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in each case included elsewhere in this prospectus. In this prospectus, unless the context otherwise requires, the terms “we,” “us,” “our,” “ADial” and the “Company” refer to ADial Pharmaceuticals, L.L.C. for the periods prior to the consummation of the corporate conversion/reincorporation (as described below), and such terms refer to Adial Pharmaceuticals, Inc. for the periods after the consummation of the corporate conversion/reincorporation. Except as disclosed in the prospectus, the financial statements and selected historical financial data and other financial information included in this registration statement are those of ADial Pharmaceuticals, L.L.C. and do not give effect to the corporate conversion/reincorporation.

Immediately prior to the effective date of the registration statement of which this prospectus is a part, we will complete a number of transactions pursuant to which Adial Pharmaceuticals, Inc. will succeed to the business of ADial Pharmaceuticals, L.L.C. and the members of ADial Pharmaceuticals, L.L.C. will become stockholders of Adial Pharmaceuticals, Inc. In this prospectus, we refer to such transactions as the corporate conversion/reincorporation.

Overview

We are a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use disorder (“AUD”) using our lead investigational new drug product, AD04, a selective serotonin-3 antagonist (i.e., a “5-HT3 antagonist”). The active ingredient in AD04 is ondansetron, which is also the active ingredient in Zofran®, an approved drug for treating nausea and emesis. AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption. We intend to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes. We believe our approach is unique in that it targets the serotonin system and individualizes the treatment of AUD, through the use of genetic screening. We have created an investigational companion diagnostic biomarker test for the genetic screening of patients with certain biomarkers that, as reported in the American Journal of Psychiatry (Johnson, et. al. 2011 & 2013), we believe will benefit from treatment with AD04. Our strategy is to integrate the pre-treatment genetic screening into AD04’s label to create a patient-specific treatment in one integrated therapeutic offering. Our goal is to develop a genetically targeted, effective and safe product candidate to treat AUD that does not require abstinence as part of the treatment.

We have a worldwide, exclusive license from the University of Virginia Patent Foundation (d.b.a the Licensing & Venture Group) (“UVA LVG”), which is the licensing arm of the University of Virginia, to commercialize our investigational drug candidate, AD04, subject to Food and Drug Administration (“FDA”) approval of the product, based upon three separate patents and patent application families, with patents issued in over 40 jurisdictions, including three issued patents in the U.S. Our investigational agent has been used in several investigator-sponsored trials and we possess or have rights to use toxicology, pharmacokinetic and other preclinical and clinical data that supports our Phase 3 clinical trial. Our therapeutic agent was the product candidate used in a University of Virginia investigator sponsored Phase 2b clinical trial of 283 patients. In this Phase 2b clinical trial, ultra-low dose ondansetron, the active pharmaceutical agent in AD04, showed a statistically significant difference between ondansetron and placebo for both the primary endpoint and secondary endpoint, which were reduction in severity of drinking measured in drinks per drinking day (1.71 drinks/drinking day; p=0.0042), and reduction in frequency of drinking measured in days of abstinence/no drinking (11.56%; p=0.0352), respectively. Additionally, and importantly, the Phase 2b results showed a significant decrease in the percentage of heavy drinking days (11.08%; p=0.0445) with a “heavy drinking day” defined as a day with four (4) or more alcoholic drinks for women or five (5) or more alcoholic drinks for men consumed in the same day.

The active pharmaceutical agent in AD04, our lead investigational new drug product, is ondansetron (the active ingredient in Zofran®), which was granted FDA approval in 1991 for nausea and vomiting post-operatively and after chemotherapy or radiation treatment and is now commercially available in generic form. In studies of Zofran® conducted as part of its FDA review process, ondansetron was given acutely at dosages up to almost 100 times the dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously (“i.v.”), which results in almost twice the exposure level as oral dosing. Even at high doses given i.v. the studies found that ondansetron is well-tolerated and results in few adverse side effects at the currently marketed doses, which reach more than 70 times the AD04 dose and are given i.v. The formulation dosage of ondansetron used in our drug

1

candidate (and expected to be used by us in our Phase 3 clinical trials) has the potential advantage that it contains a much lower concentration of ondansetron than the generic formulation/dosage that has been used in prior clinical trials, is dosed orally, and is available with use of a companion diagnostic biomarker. Our development plan for AD04 is designed to demonstrate both the efficacy of AD04 in the genetically targeted population and the safety of ondansetron when administered chronically at the AD04 dosage. However, to the best of our knowledge, no comprehensive clinical study has been performed to date that has evaluated the safety profile of ondansetron for long-term use as anticipated at any dosage.

According to the National Institute of Alcohol Abuse and Alcoholism (the “NIAAA”) and the Journal of the American Medical Association (“JAMA”), in the United States alone, approximately 35 million people each year have AUD (such number is based upon the 2012 data provided in Grant et. al. the JAMA 2015 and has been adjusted to reflect a compound annual growth rate of 1.13%, which is the growth rate reported by U.S. Census Bureau for the general adult population from 2012-2017), resulting in significant health, social and financial costs with excessive alcohol use being the fourth leading cause of preventable death and is responsible for 31% of driving fatalities in the United States (NIAAA Alcohol Facts & Statistics). AUD contributes to over 200 different diseases and 10% of children live with a person that has an alcohol problem. The Centers for Disease Control (the “CDC”) has reported that AUD costs the U.S. economy about $250 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. Despite this, according to the article in the JAMA 2015 publication, only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only 3.6% by a physician (i.e., approximately 1.3 million people). In addition, according to the NIAAA, the problem in the United States appears to be growing with almost a 50% increase in AUD prevalence between 2002 and 2013.

Disease Targets and Markets

Limitations of Current AUD Therapies

Today the most common treatments for AUD are directed at achieving abstinence and typical treatments include psychological and social interventions. Most therapies actually require abstinence prior to initiating therapy. Abstinence requires dramatic lifestyle changes often with serious work and social consequences. Frequently, patients cannot attend family and social events in order to ensure compliance with abstinence, and patients often must suffer from the stigma of having been labelled an alcoholic. Significant side effects of current pharmacologic therapies include mental side effects such as psychiatric disorders and depressive symptoms and physical side effect such as nausea, dizziness, vomiting, abdominal pain, arthritis and joint fitness. In fact, according to peer reviewed studies referenced in The Sober Truth: Debunking the Bad Science Behind 12-Step Programs and the Rehab Industry, L. Dodes and Z. Dodes, 2014 by Dr. Lance Dodes, the former Director of the substance abuse treatment unit of Harvard’s McLean Hospital, 90% or more of patients that use current therapy solutions, such as Alcoholics Anonymous, do not achieve long-term abstinence.

There are four drugs approved by the FDA and marketed in the United States for the treatment of alcohol addiction, Antabuse® (disulfram) Vivitrol® (naltrexone), Revia® (naltrexone) and Campral® (acomprosate) and one drug, Selincro® (nalmefene) is marketed outside of the United States. All of the approved drugs, other than Selincro®, require abstinence prior to commencing treatment with the drug, and all five drugs are known to have significant side effects.

Antabuse® was approved for the treatment of alcohol dependence more than 50 years ago, making it the oldest such drug on the market. It works by interfering with the body’s ability to process alcohol. Its method of action and purpose is to cause patients that drink alcohol while taking Antabuse® to experience numerous and extremely unpleasant adverse effects, including, among others, flushing, nausea, and palpitations, with the goal that patients will continue the medication but refrain from drinking in order to avoid these effects.

Naltrexone, which can be taken as a once-daily pill (Revia®) or in an approved once-monthly injectable form (Vivitrol®) that requires a doctor to administer is often associated with gastrointestinal complaints and has been reported to cause liver damage when given at certain high doses. As a result, it carries an FDA boxed warning, a special emphasized warning, for this side effect.

Campral®, taken by mouth three times daily, acts on chemical messenger systems in the brain.

Selincro® has not been approved for sale in the United States.

2

Our Proposed Solution

Our goal is to develop an effective and safe product to treat AUD that does not require abstinence as part of the treatment and does not have the negative side effects of the current drugs on the market. Our product candidate is designed for patients who desire to control their drinking but cannot or do not want to completely abstain from drinking. By removing the difficulties associated with abstinence and the side effects associated with the other current products on the market, we believe that we may be able to remove barriers to patient adoption that inhibit adoption of current therapies and can attract a greater portion of the many millions of patients with AUD that remain untreated. Unlike other therapies, our investigational product, AD04, uses a novel mode of action that involves genetic screening with a companion diagnostic genetic test prior to treatment and is designed to reduce cravings for alcohol to effectively curb alcohol intake, without the requirement of abstinence prior to or during treatment. Our product candidate is intended to be easy to use since it is administered orally, currently on a twice daily basis and with a once-a-day tablet planned as part of the product’s life cycle management. To date, clinical testing of AD04 has shown it to have a positive safety and tolerability profile with side effects similar to placebo.

The companion diagnostic genetic test to be used to identify patients that are most likely to benefit from treatment with AD04 may potentially enhance the likelihood of a successful outcome for those undergoing treatment. Additionally, it may provide doctors with the opportunity to have a non-threatening conversation about alcohol with their patients and may provide the patient an acceptable path to help them determine if they might be a candidate for help with their alcohol use. If the test results are positive, they would have a science based rationale for their treatment, which reduces some of the stigma patients might otherwise endure, and allows them to be treated in the confidence of their doctor, potentially with a simple, oral tablet.

Strengths and Competitive Advantages

Large Market Opportunity for an Effective Solution

As stated above, in the United States alone, it is estimated that approximately 35 million people have AUD in 2017. Based on data from the Phase 2b trial of AD04 and our analysis of publicly available genetic databases, we preliminarily estimate that about one in three patients with AUD in the U.S. will have the genetic markers to indicate possible treatment with AD04. At this time, we are not aware of any oral pharmaceutical treatment approved in the U.S. that addresses the needs of patients who desire to control their drinking but cannot or do not want to abstain from drinking. The current abstinence-based treatments have limitations. The limited side effects expected for our investigational new drug, based on clinical data so far, are also believed to be an important factor in the expected market acceptance of AD04. Our approach, if approved by FDA, may allow for social drinking to continue and is aimed at reducing dangerous, heavy drinking. This would allow patients to live the life they want without the stigma associated with complete abstention and currently endured by those seeking help for their excessive drinking. Assuming that one-third of AUD patients are genotype positive for treatment with AD04 and a $235 price for a one month supply of the drug (assumed pricing based on an average of prices published by Blue Cross Blue Shield in June 2017 for tier-3 oral, on-patent, chronic maintenance drugs, discounted by 16.6%, to reflect the average difference between retail and wholesale pricing for branded drugs as reported by drugs.com), and that all such patients are treated with AD04, the total potential market for AD04 would be approximately $36 billion in the United States alone.

Beyond the United States, alcohol consumption worldwide is a serious health issue. The 2014 Global Status Report on Alcohol and Health published by the World Health Organization (the “WHO”) states that 5.9% of all deaths (about 3.3 million per year) and 5.1% of disease worldwide are attributable to alcohol consumption. Europe consumes over 25% of the total alcohol consumed worldwide despite only having 14.7% of the world’s population. The WHO estimates that about 55 million people in Europe have AUD and, within Europe, Eastern Europe has a particularly acute problem with Russia estimated to have about 21 million people with AUD. The WHO further estimates that 17.4% of adult Russians and 31% of adult Russian males have AUD, and Organization for Economic Cooperation and Development data indicates that 30% of all deaths in Russia are alcohol related as reported by Quartz Media.

Prior Work of Universities Creates Cost Efficiencies

We have a worldwide, exclusive license to intellectual property developed at the University of Virginia by a member of our board of directors, Dr. Bankole A. Johnson, who was Chairman of the Department of Psychiatry & Neurobehavioral Sciences at the University of Virginia (and prior to that the Chief of the Division of Alcohol and

3

Drug Addiction at the University of Texas) and is now Chair, Department of Psychiatry and Director of the Brain Science Research Consortium Unit at the University of Maryland. Dr. Johnson has spent almost three decades researching the underlying subject matter. Significant portions of the supporting research were also funded under grants from the National Institute of Health to the University of Virginia and the University of Texas.

By leveraging the prior work of universities and their researchers, including their pre-clinical studies and accumulated data, we believe we have developed a significant drug development opportunity. Because of the licensing approach taken to secure intellectual property, including, without limitation, patents and rights to clinical trial data, and our collaborations with the University of Virginia, we have not had to incur the significant costs that would normally be required to develop therapeutic treatments to the point of being ready to commence a Phase 3 clinical trial, which often amount to tens of millions of dollars or more. Based upon current information, and depending on the regulatory authorities requirements to secure marketing authorization, we estimate that we will require approximately $6.5 million for the initial Phase 3 clinical trial (not including company overhead) and an additional $30 million of additional capital to complete our second Phase 3 program (which includes any necessary Phase 1 clinical trials) as currently contemplated in order to achieve regulatory approval for the use of AD04 to treat AUD in the United States and Europe.

Known, Well-Tested Agent Has Shown Favorable Results in Non-AUD Uses

Ondansetron, the principal active pharmaceutical agent in AD04 has been approved by the FDA to treat nausea and vomiting but is administered at much higher doses than we intend to use and has shown limited side effects even at the higher dosages currently on the market. However, it has not been approved in our anticipated dosage or for our anticipated uses. Consequently, we expect to submit a new drug application, pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for U.S. marketing authorization. Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act allows the FDA to rely, for approval of an NDA, on data not developed by the applicant. Such an NDA contains full reports of investigations of safety and effectiveness, but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Such applications permit approval of applications other than those for duplicate products and permits reliance for such approvals on literature or an FDA finding of safety and/or effectiveness for an approved drug product. A Phase 2b University of Virginia investigator sponsored clinical trial of AD04 for the treatment of AUD showed promising results and no overt safety concerns (there were no statistically significant serious adverse events reported). Not only did the trial show no statistically significant, serious adverse side effects, but both of the pre-specified endpoints, reduction in severity of drinking measured in drinks per day of drinking day and reduction in frequency of drinking measured in days of abstinence, were met with statistical significance as shown in the graph below:

Phase 2b Clinical Trial Results– Analysis of Primary and Secondary Efficacy Endpoints for Target Genotypes

A 12-week, randomized, two-center, parallel-group, double-blind, placebo-controlled, two-arm (four cell) clinical trial of oral ondansetron (n=283) conducted by University of Virginia

 

4

Planned Phase 3 Clinical Program

The FDA has indicated that we may proceed with a single-arm, two-cell Phase 3 clinical trial design for the testing of AD04 as a treatment for AUD in patients that are genotype positive when tested against the AD04 genetic panel using our companion diagnostic test (i.e., a negative genetic test result will be an exclusion criterion). The initial Phase 3 trial is planned to be conducted in 294 patients in Scandinavia and Central and Eastern Europe where the prevalence of genotype positive people appears to be higher than in the U.S. and Western Europe. The primary analysis is expected to use the primary endpoints previously accepted by the European Medicines Authority (“EMA”) with the reduction from baseline of heavy drinking and reduction from baseline in total alcohol consumed being the co-primary endpoints, and an alternative analysis is expected to be conducted for filing in the United States using the FDA specified endpoint of reduction in percentage of patients with heavy drinking during the efficacy observation period as compared to placebo (FDA Feb. 2015 Draft Guidance Alcoholism: Developing Drugs for Treatment Guidance for Industry) and which the FDA has indicated will be acceptable. Under this guidance, the FDA appears to now define a heavy drinking day as more than three drinks in a day for a woman and more than four drinks in a day for a man. We intend to seek clarification from the FDA on the definition of a heavy drinking day prior to our submission to them and do not believe a minor change to the definition of a heavy drinking day will be material to our plans. To conduct this initial trial, we plan to file a Clinical Trial Authorization (“CTA”) with the EMA and not file with the FDA since the trial is intended to be run exclusively in Europe. We have placed our investigational new drug (“IND”) application with the FDA on inactive status, which is a voluntary decision that reflects our strategic decision not to pursue clinical trials in the United States at this time. If we should choose to conduct clinical trials in the future in the United States we will be required to reactivate our IND in the United States prior to commencing any such clinical trials.

Our Substantial Proprietary Estate and Protection from Competition

We currently hold a worldwide, exclusive license to three patent families that provide us with the ability to exclude potential competitors from practicing the claimed inventions, such as the use of ondansetron to treat any of the four specified genotypes for AUD. Our licensed patent estate is expected to provide us patent protection through 2032 plus possible extensions. Ondansetron, the active ingredient in AD04, has never been approved in a low dosage near the AD04 dose of 0.33mg per tablet, and we believe our licensed patents will protect AD04 from any competitor that attempts to bring to market an ondansetron dose at or near the AD04 dose for treatment of patients having one or more of the four target genotypes.

We believe use of the currently marketed doses “off-label” will not be significant due to (i) the lack of demonstrated efficacy at currently marketed doses, (ii) potential safety concerns if the currently marketed doses are used chronically as is expected to be necessary for treating AUD, and (iii) cutting the smallest currently marketed dose into the 12 pieces that would be necessary to achieve the AD04 dose is deemed by us to be impractical and likely to result in inaccurate dosing.

Companion Genetic Bio-Marker Aimed at Identifying Patients Most Likely to Respond To Treatment, Potentially Results in Increased Use of AD04

We believe our drug is unique in that it is designed to treat individuals with certain genotypes. We are pursuing a strategy that aims to integrate pre-treatment screening with the companion diagnostic genetic test into the drug label, essentially combining the test and treatment into one integrated therapeutic offering that has combined intellectual property protections. This companion diagnostic testing approach may be a useful genetic screening tool to predict those most likely to respond to the drug and to have minimal side effects. Based on the clinical experience to date and publicly available databases, we believe the genetic prevalence of genotype positive people is about 33% of the population in the United States and that the prevalence in certain areas of Eastern Europe and in Scandinavia may be greater than 50%. The FDA has agreed that the Phase 3 trials of AD04 can proceed only enrolling patients that are genotype positive, which greatly reduces, the cost, time and risk relative to a trial that also enrolled patients that are genotype negative for treatment with AD04. Our plan to conduct our first Phase 3 trial in geographic areas with expected higher prevalence of genotype positive patients should further reduce the cost, time and risk to achieve Phase 3 results. The FDA has indicated that any approval based on a trial only in genotype positive patients would result in labeling restricted to treating genotype positive patients.

5

We believe that the companion diagnostic genetic test enables physicians to more easily have an initial conversation with their patients about alcohol use and, for the patient, provides a less threatening and obtrusive first step toward treatment because the conversation will include the topic of genetic testing and not be solely about behavior. Patients that then test positive against the AD04 genetic panel would be expected to be more likely to then receive a prescription for AD04 (based on an external quantitative market study of 156 primary care physicians and psychiatrists that was conducted by Ipsos-Insight LLC, who we commissioned, and that concluded a majority of genetically targeted patients currently receiving pharmacologic treatment would be switched to a drug with the characteristics expected for AD04).

Experienced Leadership

Our management, advisors and board of directors have extensive experience in pharmaceutical development, the clinical trial and regulatory approval processes, drug commercialization, financing capital-intensive projects, and developing new markets for pharmaceutical agents. Members of our team have previously worked in senior management and senior officer positions, or led significant research initiatives at Clinical Data, Inc., Adenosine Therapeutics, and the University of Virginia in a broad range of therapeutic areas. Our management and board members have particular expertise in the science and development of addictions related drugs.

Our Strategy

We develop pharmaceutical treatments for addictions and addictive disorders. The focus of our business strategy is to advance AD04, our lead investigational drug candidate, toward regulatory approval for alcohol addiction in the United States, the European Union, and then eventually other territories. We subsequently plan to develop label expansions into other indications (e.g., drug addiction, obesity, smoking cessation, eating disorders and anxiety).

Our goals in executing this strategy are to keep capital requirements to a minimum, expedite product development, gain access to clinical research and manufacturing expertise that will advance product development, approval and eventual market uptake of our product, and rely on a well-defined and carefully executed intellectual property strategy in order to position AD04 with long-term, defensible, competitive advantages.

Our near-term strategy includes:

         Obtaining regulatory approval for our lead product in the United States and Europe. We intend to commence Phase 3 clinical trials for the treatment of AUD. The first Phase 3 trial is planned to be conducted in Scandinavia and Central and Eastern Europe, where the genetic prevalence of the target genotypes appear to be higher. If our initial Phase 3 clinical trial is successful we expect to conduct a second, and possibly a third, Phase 3 clinical trial in the same areas but with additional clinical sites in the United States and Western Europe.

         Prosecuting and expanding our intellectual property and product portfolio. We have acquired rights to a promising drug candidate and made a significant investment in the development of our licensed patent portfolio to protect our technologies and programs, and we intend to continue to do so. We have obtained exclusive rights to three different patent families directed to therapeutic methods related to our AD04 platform. These families include 3 issued U.S. patents, and at least one foreign equivalent patent covering AD04 issued in over 40 jurisdictions, including most of Europe and Eurasia. Divisional and continuation applications to expand the coverage have also been filed in certain jurisdictions. We intend that product portfolio expansions will be focused on promising addiction therapies and/or late-stage clinical assets.

         Evaluating the additional use of our product candidate in other indications. In addition to alcohol addiction, we plan to conduct exploratory work to investigate using AD04 as a potential treatment for opioid addiction, gambling addiction, smoking cessation, obesity, and other addiction related disorders in which 5-HT3 antagonism may have a treatment effect. We believe we will be able to undertake this initial exploratory effort with minimal additional cash cost to our company through the use of academic partnerships, grants, human laboratory studies and/or non-clinical studies. We believe that, due to its hypothesized mechanism of action (i.e., the modulation of the serotonin system in patients that are genetically targeted based on the apparent sensitivity to such modulation, where the modulation appears to reduce cravings), AD04 has the potential to be used for the treatment of such other addictive disorders. To date, we have not discussed these potential uses with the FDA or any other regulatory bodies.

6

         Maximizing commercial opportunity for our technology. Our lead product candidate targets large markets with significant unmet medical need. We intend to develop an extended release, once-a-day formulation of AD04 to enhance patient compliance and market appeal.

         Managing our business with efficiency and discipline. We believe we have efficiently utilized our capital and human resources to develop and acquire our product candidate and programs, and create a broad intellectual property portfolio. We operate cross-functionally and are led by an experienced management team with backgrounds in developing product candidates. We use project management techniques to assist us in making disciplined strategic program decisions and to attempt to limit the risk profile of our product pipeline.

Risks

Our business and our ability to execute our business strategy are subject to a number of risks of which you should be aware of before you decide to buy our common stock. In particular, you should carefully consider following risks, which are discussed more fully in “Risk Factors” beginning on page 14 of this prospectus:

         our ability to implement our business plan;

         our ability to raise additional capital to meet our liquidity needs;

         our ability to generate product revenues;

         our ability to achieve profitability;

         our ability to satisfy U.S. (including FDA) and international regulatory requirements;

         our ability to obtain market acceptance of our technology and lead product;

         our ability to compete in the market;

         our ability to advance our clinical trials;

         our ability to fund, design and implement clinical trials;

         our ability to demonstrate that our lead product candidate is safe for human use and effective for indicated uses;

         our ability to gain acceptance of physicians and patients for use of our lead product;

         our dependency on third-party researchers, manufacturers and payors;

         our ability to establish and maintain strategic partnerships, including for the distribution of our lead product;

         our ability to attract and retain sufficient, qualified personnel;

         our ability to obtain or maintain patents or other appropriate protection for the intellectual property;

         our dependency on the intellectual property licensed to us or possessed by third parties;

         our ability to adequately support future growth; and

         potential product liability or intellectual property infringement claims.

Implications of Being an Emerging Growth Company

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and therefore we intend to take advantage of certain exemptions from various public company reporting requirements, including not being required to have our internal controls over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments. We may take advantage of these exemptions until we are no

7

longer an “emerging growth company.” In addition, the JOBS Act provides that an “emerging growth company” can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to use the extended transition period for complying with new or revised accounting standards under the JOBS Act. This election allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates. We will remain an “emerging growth company” until the earlier of (1) the last day of the fiscal year: (a) following the fifth anniversary of the completion of this offering; (b) in which we have total annual gross revenue of at least $1.0 billion; or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeded $700.0 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. References herein to “emerging growth company” have the meaning associated with that term in the JOBS Act.

Corporate Information

ADial Pharmaceuticals, L.L.C. was formed as a Virginia limited liability company in November 2010. Prior to the effective date of the registration statement of which this prospectus, ADial Pharmaceuticals, L.L.C. will convert from a Virginia limited liability company into a Virginia corporation, and then reincorporate in Delaware by merging with Adial Pharmaceuticals, Inc., a Delaware corporation and wholly owned subsidiary of ADial Pharmaceuticals, L.L.C. We refer to this as the corporate conversion/reincorporation. In connection with the corporate conversion/reincorporation, each unit of ADial Pharmaceuticals, L.L.C. will be converted into shares of common stock of the Virginia corporation and then ultimately into shares of common stock of Adial Pharmaceuticals, Inc., the members of ADial Pharmaceuticals, L.L.C. will ultimately become stockholders of Adial Pharmaceuticals, Inc. and Adial Pharmaceuticals, Inc. will ultimately succeed to the business of ADial Pharmaceuticals, L.L.C. See “Corporate Conversion/Reincorporation” for further information regarding the corporate conversion/reincorporation.

Our principal executive offices are located at 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901, and our telephone number is (434) 422-9800. Our website address is www.adialpharma.com. Information contained in our website does not form part of the prospectus and is intended for informational purposes only.

This prospectus contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

8

THE OFFERING

Issuer

 

Adial Pharmaceuticals, Inc.

 

 

 

Common stock offered by us

 

1,400,000 shares (or 1,610,000 shares if the underwriters exercise their over-allotment option in full).

 

 

 

Over-allotment option

 

The underwriters have an option for a period of 45 days to purchase up to 210,000 additional shares of our common stock to cover over-allotments, if any.

 

 

 

Common stock to be outstanding immediately after this offering

 


5,468,504 shares. If the underwriters’ over-allotment option is exercised in full, the total number of shares of common stock outstanding immediately after this offering would be 5,678,504.

 

 

 

Use of Proceeds

 

We currently intend to use the net proceeds from this offering as follows:

 

 

 

 

 

approximately $6,500,000 to fund our Phase 3 clinical trial for the use of AD04 to treat AUD;

 

 

 

 

 

approximately $331,000 (which includes a redemption payment of 115% of the principal amount) to repay a loan that is due November 1, 2017 but subject to mandatory redemption upon consummation of a financing in the amount of $250,000.

 

 

 

 

 

approximately $257,250 for cash payments to be made to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer in accordance with the terms of our Performance Bonus Plan;

 

 

 

 

 

approximately $210,000 for development, set up and authorization of the AD04 companion diagnostic test;

 

 

 

 

 

approximately $240,000 for payments under the license agreement for the patents covering AD04, including the prosecution and maintenance of the AD04 patent estate;

 

 

 

 

 

approximately $2,700,000 for personnel costs, including enhancing our executive team to manage and grow our business with the hire of a Chief Financial Officer with public company experience and a Chief Development Officer to oversee the clinical trials of AD04;

 

 

 

 

 

approximately $560,000 for research and development, including without limitation, potentially developing a once a day formulation of AD04; and

 

 

 

 

 

  the balance for working capital and general corporate purposes.

 

 

 

 

 

Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment grade, interest bearing instruments and U.S. government securities. See “Use of Proceeds” on page 49.

9

Representative’s Warrants

 

The registration statement of which this prospectus is a part also registers for sale warrants to purchase 56,000 shares of our common stock to the representative of the underwriters as a portion of the underwriting compensation payable to the underwriters in connection with this offering. The warrants will be exercisable for a four-year period commencing one year following the closing of this offering at an exercise price equal to 125% of the initial public offering price of the common stock. Please see “Underwriting — Representative’s Warrants” for a description of these warrants.

 

 

 

Risk Factors

 

See “Risk Factors” beginning on page 14 and the other information included in this prospectus for a discussion of factors you should carefully consider before investing in our securities.

 

 

 

Proposed symbol and listing

 

We have applied to list our common stock on The NASDAQ Capital Market under the symbol “ADIL.” No assurance can be given that our application will be approved.

Unless we indicate otherwise, the number of shares of our common stock outstanding after this offering is based on the following:

         the conversion of approximately $273,563 of debt (including principal and interest through September 30, 2017) into an aggregate of 536,845 shares of our common stock (the “debt conversion”);

         the consummation of the corporate conversion/reincorporation, pursuant to which all of the outstanding Class A units, Class B units, and Profits Interest Units of ADial Pharmaceuticals, LLC (collectively, the “LLC Units”) will be automatically converted into an aggregate of 3,268,005 shares of our common stock;

         the issuance of an additional 215,879 shares of common stock that we have agreed to issue to consultants, employees, and one debtholder upon consummation of this offering;

         the issuance of an additional 47,775 shares of common stock having a value of $477,750 that we have agreed to issue to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer in accordance with the terms of our Performance Bonus Plan (assuming an initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus);

         excludes an additional 482,555 shares of our common stock issuable upon the exercise of outstanding warrants at a weighted average exercise price of $5.51 per share;

         excludes an additional 320,352 shares of our common stock issuable upon the exercise of warrants to be issued upon consummation of this offering at an exercise price equal to the initial offering price of the common stock;

         excludes and additional 56,000 shares of our common stock issuable upon the exercise of warrants to be issued upon consummation of this offering at an exercise price equal to 125% of the initial offering price of the common stock;

         excludes an additional 174,282 shares of our common stock issuable upon outstanding options to purchase shares of common stock; and

         excludes an additional 1,750,000 shares of our common stock reserved for future issuance under the 2017 equity incentive plan we intend to adopt immediately prior to the closing of this initial public offering.

Unless specifically stated otherwise, the information in this prospectus:

         assumes completion of the corporate conversion/reincorporation and debt conversion;

         assumes no exercise by the underwriters of their option to purchase up to an additional 210,000 shares of common stock to cover over-allotments, if any;

10

         assumes no exercise of the representative’s warrants granted to Aegis Capital Corp. upon completion of this offering; and

         assumes an initial public offering price of $10.00 per share, which is the mid-point of the range set forth on the front cover of this prospectus.

To the extent additional principal and interest on the outstanding debt is incurred after the date of this prospectus and prior to the closing of this offering, the number of shares to be issued in connection with the debt conversion and for future issuance under the 2017 equity incentive plan shall be adjusted accordingly.

11

SUMMARY FINANCIAL INFORMATION

The following table presents summary financial data for Adial Pharmaceuticals, LLC for the periods and at the dates indicated. The selected statements of operations data for the years ended December 31, 2015 and 2016 are derived from the audited financial statements appearing elsewhere in this prospectus. The selected statements of operations data for the six months ended June 30, 2017 and 2016 and the summary balance sheet data as of June 30, 2017 were derived from our unaudited financial statements appearing elsewhere in this prospectus. The unaudited financial statements have been prepared on a basis consistent with our audited financial statements included in this prospectus and include, in our opinion, all adjustments, consisting only of normal recurring adjustments, necessary for the fair presentation of the financial information in those statements. You should read this data together with our audited and unaudited financial statements and related notes appearing elsewhere in this prospectus and the information under the captions “Capitalization” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Our historical results are not necessarily indicative of our future results or any other period. The summary financial data included in this section are not intended to replace the financial statements and the related notes included elsewhere in this prospectus.

(Rounded to nearest thousand, except

 

For the Years Ended
December 31,

 

For the Six Months
Ended June 30,

share and per share amounts)

 

2016

 

2015

 

2017

 

2016

Operating Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

146,000

 

 

$

322,000

 

 

$

102,000

 

 

77,000

 

General and administrative expenses

 

 

265,000

 

 

 

497,000

 

 

 

309,000

 

 

144,000

 

Total Operating Expenses

 

 

411,000

 

 

 

819,000

 

 

 

411,000

 

 

221,000

 

Loss From Operations

 

 

(411,000

)

 

 

(819,000

)

 

 

(411,000

)

 

(221,000

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(421,000

)

 

$

(818,000

)

 

$

(443,000

)

 

(221,000

)

Net loss per unit, basic and diluted

 

 

(0.02

)

 

 

(0.05

)

 

 

(0.02

)

 

(0.01

)

Weighted average units outstanding

 

 

18,166,550

 

 

 

17,876,277

 

 

 

18,187,484

 

 

18,123,943

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unaudited pro forma net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted(1)

 

 

(0.13

)

 

 

(0.25

)

 

 

(0.14

)

 

(0.07

)

Weighted average shares, basic and diluted(1)

 

 

3,258,002

 

 

 

3,216,009

 

 

 

3,261,112

 

 

3,251,838

 

Pro forma net loss per share, basic and diluted(2)

 

 

(1.11

)

 

 

 

 

 

 

(0.11

)

 

 

 

Shares used to calculate pro forma net loss per common share, basic and diluted(2)

 

 

4,062,011

 

 

 

 

 

 

 

4,065,121

 

 

 

 

 

 

 

As of June 30, 2017

 

 

Balance sheet data:

 

Actual

 

Pro
Forma
(2)

 

Pro Forma
As Adjusted
(3)(4)

Cash and cash equivalents

 

$

137,000

 

 

$

157,000

 

 

$

11,849,000

 

Total assets

 

$

196,000

 

 

$

216,000

 

 

$

11,907,000

 

Total liabilities

 

$

661,000

 

 

$

398,000

 

 

$

134,000

 

Accumulated deficit

 

$

(10,381,000

)

 

$

(14,451,000

)

 

$

(14,776,000

)

Total members’/stockholders’ deficit/equity

 

$

(465,000

)

 

$

(182,000

)

 

$

11,773,000

 

____________

(1)      See Note 2 of our notes to our audited financial statements appearing elsewhere in this prospectus for an explanation of the method used to calculate the basic and diluted net loss per unit and weighted average units and the number of units used in the computation of the per unit amounts. Weighted average shares are calculated by multiplying the weighted average units by the ratios of units to shares in the corporate conversion/reincorporation.

(2)      The pro forma gives effect to (i) the corporate conversion/reincorporation (including the conversion of the Class B Units issued in July and August 2017); (ii) the debt and accrued interest conversion; (iii) the issuance of 215,879 shares of our common stock to a debt holder, consultants, and employees upon consummation of the offering; (iv) the issuance of warrants to purchase 320,352 shares of our common stock to one consultant and one debtholder upon consummation of the offering; (v) the issuance of 47,775 shares of common stock having a value of $477,750 upon consummation of the offering to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer in accordance with

12

the terms of our Performance Bonus Plan; (vi) the receipt of $10,000 in cash proceeds from the sale of 9,434 Series B Units (1,755 shares of common stock post-corporate conversion/reincorporation) in July 2017 and the issuance of such Class B Units; and (vii) the receipt of $10,000 in cash proceeds from the sale of 9,434 Series B Units (1,755 shares of common stock post-corporate conversion/reincorporation) in August 2017 and the issuance of such Class B Units.

(3)      The pro forma, as adjusted balance sheet data reflects the items described in footnote (2) above and gives effect to (i) our receipt of estimated net proceeds from the sale of shares of common stock that we are offering at an assumed initial public offering price of the common stock of $10.00 per share, the mid-point of the price range on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us; (ii) repayment of a bridge loan in the amount of $331,000, as required on consummation of the offering; and (iii) payment of the cash portion of our Performance Bonus Plan in the amount of $257,250, as required on consummation of the offering.

(4)      The pro forma as adjusted data is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing.

A $1.00 increase (decrease) in the assumed initial public offering price of $10.00 per share of common stock, the mid-point of the estimated price range on the cover of this prospectus, would increase (decrease) each of cash and cash equivalents, total assets and total stockholders’ equity by $1,288,000 assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable.

13

RISK FACTORS

Investors should carefully consider the risks described below before deciding whether to invest in our securities. If any of the following risks actually occurs, our business, financial condition or results of operations could be adversely affected. In such case, the trading price of our common stock could decline and you could lose all or part of your investment. Our actual results could differ materially from those anticipated in the forward-looking statements made throughout this prospectus as a result of different factors, including the risks we face described below.

Risks Relating to our Company

We have incurred net losses every year since our inception and anticipate that we will continue to incur net losses in the future.

We are a clinical stage biotechnology pharmaceutical company that is focused on the discovery and development of medications for the treatment of addictions and related disorders of AUD in patients with certain targeted genotypes. We have a limited operating history. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. To date, we have not generated positive cash flow, revenues, or profitable operations, nor do we expect to in the foreseeable future. Through June 30, 2017, we had an accumulated deficit of approximately $10.4 million and through December 31, 2016, we had an accumulated deficit of approximately $10.0 million. Our net loss for the six months ended June 30, 2017 and June 30, 2016 was approximately $0.4 million and $0.2 million, respectively. Our net loss for the years and the years ended December 31, 2016 and December 31, 2015 was approximately $0.4 million and $0.8 million, respectively. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase significantly as we continue our research and development of, and seek regulatory approvals for our lead product candidate, AD04, and future product candidates.

Even if we succeed in commercializing our product candidate or any future product candidates, we expect that the commercialization of our product will not begin until 2023 or later, we will continue to incur substantial research and development and other expenditures to develop and market additional product candidates and will continue to incur substantial losses and negative operating cash flow. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

We currently have no product revenues and may not generate revenue at any time in the near future, if at all. Currently, we have no products approved for commercial sale.

We currently have no products for sale and we cannot guarantee that we will ever have any drug products approved for sale. We and our product candidate are subject to extensive regulation by the FDA, and comparable regulatory authorities in other countries governing, among other things, research, testing, clinical trials, manufacturing, labeling, promotion, marketing, adverse event reporting and recordkeeping of our product candidates. Until, and unless, we receive approval from the FDA or other regulatory authorities for our product candidates, we cannot commercialize product candidates and will not have product revenues. Even if we successfully develop products, achieve regulatory approval, and then commercialize our products, we may be unable to generate revenue for many years, if at all. We do not anticipate that we will generate revenue for at least several years, if at all. If we are unable to generate revenue, we will not become profitable, and we may be unable to continue our operations. For the foreseeable future, we will have to fund all of our operations from equity and debt offerings, cash on hand and grants. In addition, changes may occur that would consume our available capital at a faster pace than expected, including changes in and progress of our development activities, acquisitions of additional candidates and changes in regulation. Moreover, preclinical and clinical testing may not start or be completed as we forecast and may not achieve the desired results. Therefore, we expect to seek additional sources of funding, such as additional financing or grant funding, and additional financing may not be available on favorable terms, if at all.

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We have had limited operations to date and there can be no assurance that we will be able to execute on our business strategy.

We are a clinical stage company and have had limited operations to date. We have yet to demonstrate our ability to overcome the risks frequently encountered in our industry and are still subject to many of the risks common to such enterprises, including our ability to implement our business plan, market acceptance of our proposed business and lead product, under-capitalization, cash shortages, limitations with respect to personnel, financing and other resources, competition from better funded and experienced companies, and uncertainty of our ability to generate revenues. In fact, though individual team members have experience running clinical trials, as a company we have yet to prove that we can successfully run a clinical trial. There is no assurance that our activities will be successful or will result in any revenues or profit, and the likelihood of our success must be considered in light of the stage of our development. In addition, no assurance can be given that we will be able to consummate our business strategy and plans, or that financial, technological, market, or other limitations may force us to modify, alter, significantly delay, or significantly impede the implementation of such plans. We have insufficient results for investors to use to identify historical trends. Investors should consider our prospects in light of the risk, expenses and difficulties we will encounter as an early stage company. Our revenue and income potential is unproven and our business model is continually evolving. We are subject to the risks inherent to the operation of a new business enterprise, and cannot assure you that we will be able to successfully address these risks.

Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.

As described in Note 2 of our accompanying audited financial statements, our auditors have issued a going concern opinion on our December 31, 2016 financial statements, expressing substantial doubt that we can continue as an ongoing business for the next twelve months after issuance of their report based on our current development plans and our operating requirements and us having suffered recurring losses from operations and having a net capital deficiency. Our financial statements do not include any adjustments that may result from the outcome of this uncertainty. If we cannot raise the necessary capital to continue as a viable entity, we could experience a material adverse effect on our business and our stockholders may lose some or all of their investment in us.

We will need to secure additional financing in order to support our operations. We can provide no assurances that any additional sources of financing will be available to us on favorable terms, if at all. Our forecast of the period of time through which our current financial resources will be adequate to support our operations and the costs to support our general and administrative, selling and marketing and research and development activities are forward-looking statements and involve risks and uncertainties.

If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete planned preclinical and clinical trials or obtain approval of our product candidate from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities.

We will also need to raise additional capital to expand our business to meet our long-term business objectives.

Additional financing, which is not in place at this time, may be from the sale of equity or convertible or other debt securities in a public or private offering, from a credit facility or strategic partnership coupled with an investment in us or a combination of both. Our ability to raise capital through the sale of equity may be limited by the various rules of the Securities and Exchange Commission (the “SEC”) and the NASDAQ Capital Market (“NASDAQ”), which place limits on the number of shares of stock that may be sold. Equity issuances would have a dilutive effect on our stockholders. We may be unable to raise sufficient additional financing on terms that are acceptable to us, if at all. Our failure to raise additional capital and in sufficient amounts may significantly impact our ability to expand our business. For further discussion of our liquidity requirements as they relate to our long-term plans, see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”

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We rely on licenses to use various technologies that are material to our business and if the agreements were to be terminated or if other rights that may be necessary or we deem advisable for commercializing our intended products cannot be obtained, it would halt our ability to market our products and technology, as well as have an immediate material adverse effect on our business, operating results and financial condition.

Our prospects are significantly dependent upon the UVA LVG License. The UVA LVG License grants us exclusive, worldwide rights to certain existing patents and related intellectual property that covers AD04, our lead and currently only product candidate. If we breach the terms of the UVA LVG License, including any failure to make minimum royalty payments required thereunder or failure to reach certain developmental milestones and completion of deadlines, including, initiating Phase 3 clinical trials by December 31, 2018, submitting an NDA by December 31, 2023 and commencing commercialization of an FDA approved product by December 31, 2024, or other factors, including but not limited to, the failure to comply with material terms of the Agreement, the licensor has the right to terminate the license. If we were to lose or otherwise be unable to maintain these licenses on acceptable terms, or find that it is necessary or appropriate to secure new licenses from other third parties, we would not be able to market our products and technology, which would likely require us to cease our current operations which would have an immediate material adverse effect on our business, operating results and financial condition.

Our business is dependent upon the success of our lead product candidate, AD04, which requires significant additional clinical testing before we can seek regulatory approval and potentially launch commercial sales. We do not have any other products in clinical development.

Our business and future success depends upon our ability to obtain regulatory approval of and then successfully commercialize our lead investigational product candidate, AD04. AD04 is in clinical stage development. To date, our main focus and the investment of a significant portion of our efforts and financial resources has been in the development of our lead and only investigational product candidate, AD04, for which we are currently planning a Phase 3 clinical trial with approximately 300 patients in Scandinavia and Central and Eastern Europe, which will target the reduction of risk drinking (heavy drinking of alcohol) in subjects that possess selected genetics of the serotonin transporter and/or 5-HT3 receptor gene. We expect that at least one additional Phase 3 clinical trial will be required for approval, as well as, one or more Phase 1 supportive studies. Even though we are pursuing a registration pathway based on specific FDA input and guidance and the EMA precedents and guidance, there are many uncertainties known and unknown that may affect the outcome of the trial. These include adequate patient enrollment, adequate supply of our product candidate, potential changes in the regulatory landscape, and the results of the trial being successful.

All of our future product candidates, as well as AD04, will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. We expect AD04 will need at least two Phase 3 trials (including the Phase 3 trial we plan to conduct in Scandinavia and Central and Eastern Europe) and one or more Phase 1 supportive studies to gain approval in either the U.S. or Europe. In addition, because AD04 is our most advanced product candidate and there is limited history information on long-term effects of our proposed dosage, there is always a chance of developmental delays or regulatory issues or other problems arising, with our development plans and depending on their magnitude, our business could be significantly harmed.

Our future success depends heavily on our ability to successfully manufacture, develop, obtain regulatory approval, and commercialize AD04, which may never occur. We currently generate no revenues from our product candidate, and we may never be able to develop or commercialize a marketable drug.

The active ingredient of our product candidate, ondansetron, is currently available in generic form.

Ondansetron, the active pharmaceutical ingredient (“API”) of our current drug treatment, was granted FDA approval as Zofran® in January 1991 and is approved in many foreign markets. Ondansetron, is commercially available in generic form, but not available: (i) at the formulation/dosage levels expected to be marketed by us, or (ii) with a requirement to use a diagnostic biomarker, as we expect to be the case with AD04. Although ondansetron has been approved to treat nausea and emesis it has not been approved to treat AUD and it has not been approved for daily long-term use as planned by us. Clinical testing to date of ondansetron at the higher doses used to treat nausea/emesis have not shown effectiveness in treating AUD or any other addictive disorder; however, if a third party

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conducted a Phase 3 clinical program and showed success treating AUD at those doses, we could not prevent such third party from marketing ondansetron for AUD at those doses.

Results from clinical studies suggest that high intravenous doses of ondansetron may affect the electrical activity of the heart. As part of the FDA’s most recent safety review of approved ondansetron doses, the FDA stated that: “A 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.” In addition: “No single intravenous dose should exceed 16 mg.” There are also several recent lawsuits claiming that Zofran® used for the unapproved use of morning sickness causes birth defects. Although we do not believe that our dosage will cause such adverse event there can be no assurance that the negative side effects of the generic drug that have been found in higher dosages will not occur in our dosage or otherwise deter potential users of our product candidate and adversely impact sales of our product candidate. If we were to be required to have such a warning on our drug label, patients may be deterred from using our product candidates.

In addition, we also face the risk, that doctors will prescribe off label, the generic form of ondansetron to treat AUD despite the different dosage of ondansetron in the generic form from that in AD04, the lack of demonstrated clinical efficacy against AUD at the currently available doses (i.e., the Zofran® and approved generics), and the potential safety concerns if the currently available/higher doses are taken chronically as would be needed for AUD or other addictions. Physicians, or their patients, could divide the lowest dose existing oral tablet into more than ten parts to equal the necessary AD04 dosage.

Although we believe that any attempt by competitors to reformulate and market ondansetron at our intended dosage levels, while technically feasible, infringes on our intellectual property rights, and should, accordingly, be actionable, we cannot give assurances that we would be successful in defending our rights or that we will have access to sufficient funds necessary to successfully prosecute any such violations of, or infringements on, our intellectual property rights. Additionally, we cannot ensure investors that other companies will not discover and seek to commercialize low doses of ondansetron, not currently available, for other indications.

While there exists a large body of evidence supporting the safety of our primary API, ondansetron, under short-term use, there are currently no long-term use clinical safety data available.

We intend to market our products, particularly AD04, for long-term use by patients seeking to reduce their number of days of heavy drinking, and we assume future sales volumes reflecting such extended use.

Studies of Zofran® conducted as part of its FDA and other regulatory agencies review process found that the drug is well-tolerated and results in few adverse side effects at dosages almost 100 times the dosage expected to be formulated in AD04. However, to the best of our knowledge, no comprehensive clinical study has been performed to date that has evaluated the safety profile of ondansetron for long-term use. We expect the FDA will require us to provide safety data in at least 100 patients for 12 months, and can offer no assurances that safety results of these long term use studies will lead to any subsequent approval for long-term use. There can be no assurance that long-term usage of ondansetron, at dosages anticipated by us, will be safe. Though the FDA has stated it will not require additional non-clinical testing nor will it require a QT interval prolongation clinical study, such statements by the FDA are not legally binding on the agency.

All of our current data for our lead product candidate are the result of Phase 2 clinical trials conducted by third parties and do not necessarily provide sufficient evidence that our products are viable as potential pharmaceutical products.

Through our proprietary access to relevant laboratory and clinical trial results of the University of Virginia’s research program, and through our reliance on publicly available third party research, we possess toxicology, pharmacokinetic, and other preclinical data and clinical data on AD04. As of now, AD04 has completed only Phase 2 clinical trials and is now in preparations to enter Phase 3 trials. There is no guarantee that Phase 2 results can or will be replicated by pivotal Phase 3 studies.

To date, long-term safety and efficacy have not yet been demonstrated in clinical trials for our investigational product candidate. Favorable results in early studies or trials may not be repeated in later studies or trials. Even if our clinical trials are initiated and completed as planned, we cannot be certain that the results will support our product candidate claims. Success in preclinical testing and early clinical trials does not ensure that

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later clinical trials will be successful. We cannot be sure that the results of later clinical trials would replicate the results of prior clinical trials and preclinical testing, nor that they would satisfy the requirements of the FDA or other regulatory agencies. Clinical trials may fail to demonstrate that our product candidate is safe for humans and effective for indicated uses. Preclinical and clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or commercialization. Any delay in, or termination of, our clinical trials would delay our obtaining FDA or EMA approval for the affected product candidate and, ultimately, our ability to commercialize that product candidate.

Previous clinical trials using ondansetron have had different trial designs, doses, parameters and endpoints than the planned Phase 3 clinical trial that is expected to serve as a basis for approval of AD04. Though various doses of ondansetron have been tested as treatments for alcohol addiction (Johnson, BA et al., 2011; Johnson, BA et al., 2000; Kranzler et al, 2003; Sellers, EM et al., 1994), the 283-patient Phase 2b clinical trial on which the Company is largely basing its clinical expectations only tested one dosing regimen, which was weight-based (Johnson, BA et al., 2011). We plan to use a fixed dose in future clinical trials that we believe provides good coverage given the dose ranges tested clinically; however, it is possible that the dose selected will not be the optimal dose and so drug effects may be limited or not be demonstrated sufficiently in clinical testing. Additionally, only one genotype in the genetic panel that will be used to define patients that are genotype positive for treatment with AD04 was used in primary analyses of the Phase 2b trial and three of the genotypes were added to the panel after a retrospective exploratory analysis of the Phase 2b data. The genotype in the panel related to the 5-HTT, that was included in the primary analysis (Johnson, BA et al., 2011) appears to make up about half of the patients that are genotype positive. The three genotypes related to modulation of the 5-HT3 receptor were selected based on a retrospective analysis that was constrained to 18 single-nucleotide polymorphism (“SNPs”) identified for analysis (Johnson, BA et al., 2013). Therefore, confidence in the effects of the 5-HT3 genetics is less than that for the 5-HTT genetics, and this could negatively impact the treatment effect of AD04 in the Phase 3 for a segment of the patients identified as genotype positive, which could dilute the overall demonstrated effect of AD04 in the trial.

The endpoints for the Phase 2b clinical trial of AD04 were reduction in the severity of drinking, measured as drinks per day of drinking alcohol and reduction frequency of drinking, measured by days of total abstinence from alcohol. These are surrogate endpoints for the endpoints expected to be required for approval, which, for Europe, are expected to be reduction of heavy drinking days (defined herein), measured in percentage of heavy drinking days per month, and total average alcohol consumed per month, and, for the United States, is expected to be the percentage of patients that have no heavy drinking days in the final 2 months of a six month treatment regimen of AD04. Though the Phase 2b trial showed a statistically significant effect against both pre-specified endpoints and when analyzed for reducing heavy drinking days, all when compared against the placebo group, it is possible that AD04 could affect the endpoints of the Phase 2b trial while not demonstrating a strong enough effect to gain approval.

The Phase 2b clinical trial was 12 weeks in duration, including a one week placebo run-in period, and the Phase 3 trials expected to be required for approval will be 24 weeks. Though the effect of AD04 against AUD in the Phase 2b trial appeared to begin in the first month of the trial and appeared durable throughout the trial, we cannot be sure the effect will extend for the duration of the Phase 3 trials.

The FDA and/or EMA may not accept our planned Phase 3 endpoints for final approval of AD04 and may determine additional clinical trials are required for approval of AD04.

The FDA has indicated to us that a comparison of the percent of patients with no heavy drinking days in the last two months of a six month clinical trial between the drug and placebo groups will be a satisfactory endpoint for determination of a successful Phase 3 trial of AD04 and has published the draft guidance Alcoholism: Developing Drugs for Treatment Guidance for Industry dated February 2015 indicating this endpoint for the development of drugs for AUD. Similarly, the EMA has in the past accepted the co-primary endpoints of reduction from baseline in days of heavy drinking and reduction total grams of alcohol consumed per month and has published the Guideline on the development of medicinal products for the treatment of alcohol dependence on February 18, 2010 stating these endpoints as approvable endpoints for alcohol addiction treatment. Despite these indications, neither the FDA nor the EMA is bound to accept the stated endpoint if a new drug application for AD04 is submitted and their definitions of a heavy drinking day may change. We, however, can offer no assurance that the FDA or EMA will approve our primary endpoints, that we can achieve success at the any endpoints they do approve, or that these potential benefits will subsequently be realized.

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We will incur additional costs and our approvals could be delayed if the FDA or EMA requires additional clinical trials in patients that are negative for the genotypes targeted by AD04. In addition, clinical trials conducted with only genotype positive subjects will likely result in labeling restricted to treating patients that are genotype positive.

Although the FDA has indicated that it sees little evidence of positive effects for the use of AD04 in subjects that are negative for the genotypes targeted by AD04 and has stated that it would not object to the AD04 Phase 3 clinical trials going forward without including these additional subjects, the FDA has indicated that some research in this area may be required prior to approval of AD04 for AUD within the target population. We believe the data supports our hypothesis that no further studies in genotype negative patients need be conducted. However, the FDA has indicated that any approval based on a trial only in genotype positive subjects would result in labeling restricted to treating patients that are genotype positive. If further studies are required, we will incur additional costs not anticipated, and it could delay approval of AD04 or, if the results of such studies are not positive for AD04, it may result in AD04 not being approved or it may result in AD04’s patents failing to protect AD04 against generic competition.

Under the Pediatric Research Equity Act (“PREA”), NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. We do not plan to test AD04 in pediatric patients as part of our next Phase 3 trial. The FDA may grant full or partial waivers, or deferrals, for submission of data in pediatric subjects, and we intend to apply for such a waiver. If the FDA requires data in pediatric patients, the required studies could delay approval of AD04, requiring significantly more capital be invested, and, if the results of such studies are not positive for AD04 it may result in AD04 not being approved.

Our lead investigational product, AD04, is dependent on a successful development, approval, and commercialization of a genetic test, which is expected to be classified as a companion diagnostic.

Treatment with AD04 will be dependent on identification of patients with a genetic test (i.e., a companion diagnostic). Companion diagnostics and complementary diagnostics are regulated as medical devices by the FDA and, as such, require either clearance or approval prior to commercialization. While the technology for the test we plan to use is well established, it cannot be certain the testing laboratory we set up will be able to conduct the test with the selectivity and sensitivity that will be required or that the genetic test will be approved by FDA for such use, which could increase the time and cost to develop AD04 and possibly prevent marketing approval. While we have been party to a joint meeting with the Center for Drug Evaluation and Research (“CDER”, the FDA division responsible for drug approvals) and the Center for Devices and Radiological Health (“CDRH”, the FDA division responsible for device approvals, including genetic tests) at which agreement was reached as to the development path for the genetic test, neither CDER nor CDRH is bound to accept our planned submission package even if the data is positive. We have been instructed by CDER and CDRH that we need to obtain a separate approval or marketing authorization for the companion diagnostic genetic test from CDRH. We plan to collect and store additional blood samples from all patients enrolled in the Phase 3 trial in the event of any difficulties, however, we cannot be certain we can overcome all of the technological, logistical or regulatory hurdles related to the genetic testing, which include, without limitation, technical validation of the test (e.g. specificity, sensitivity, reproducibility, robustness of methods), clinical validation acceptable to CDER and CDRH, all of which are needed for approval of AD04 and its companion diagnostic genetic test. Failure in any of these areas could delay approval of AD04, increase the cost necessary to achieve approval of AD04 or prevent approval of AD04.

If we obtain approval of AD04 and its genetic test, we currently plan to distribute the genetic test as widely as possible to third party testing companies with limited attention to capitalizing on the revenue potential of the genetic test itself in order to achieve wider availability of the genetic test to drive market uptake of AD04. However, we cannot be sure that third party testing companies will be willing to provide the test, that reimbursement for the test will be available to make such business profitable, or that taking a genetic test will be acceptable to patients or physicians. Additionally, our plans may change so that we attempt to make the test a material business of our own. In this event, the availability of the genetic test in the market could be reduced, limiting market uptake of AD04, the testing business could fail, and we could be in a position where it never reaches profitability. As one of our products/services, the genetic test will be subject to all of the risks stated elsewhere herein related to reimbursement of our products and failure to achieve adequate reimbursement could limit the potential sales of both the genetic test and AD04, and there is no assurance that the diagnostic will be approved or authorized for marketing.

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We have limited experience as a company conducting clinical trials.

We are a clinical stage company and our success is dependent upon our ability to obtain regulatory approval for and commercialization of our investigational products, and we have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any product candidates. The successful commercialization of any product candidates may require us to perform a variety of functions, including:

         continuing to undertake preclinical development and successfully enroll patients in clinical trials;

         participating in regulatory approval processes;

         formulating and manufacturing products; and

         conducting sales and marketing activities.

We have limited experience conducting and enrolling patients in clinical trials. While certain members of our management and staff have significant experience in conducting clinical trials, to date, we have not successfully completed any clinical trials as a company. Until recently, our operations have been limited primarily to organizing and staffing our company, acquiring, developing and securing our proprietary technology and preparing for clinical trials of our product candidate. These operations provide a limited basis to assess our ability to develop and commercialize our product candidate and the advisability of investing in our securities.

All of the preclinical and clinical trials relating to our product candidate have been conducted by third parties. Although we have recruited a team that has significant experience with managing clinical trials, we have no experience as a company in conducting our own clinical trials. In part because of this lack of experience, we cannot guarantee that planned clinical trials will be completed on time, if at all. Large-scale trials require significant additional financial and management resources, monitoring and oversight, and reliance on third-party clinical investigators, contract research organizations (“CROs”), or consultants. Relying on third-party clinical investigators, CROs and manufacturers, which are all also subject to governmental oversight and regulations, may also cause us to encounter delays that are outside of our control.

Our product candidate is in early stages of development.

Because our product candidate is in early stages of development it will require extensive clinical and other testing. Although our lead product candidate has completed a 283-patient Phase 2b clinical trial, we cannot predict with any certainty if or when we might submit an application for regulatory approval for any of our product candidates or whether any such application will be accepted for review by the FDA or EMA, or whether any application will be approved upon review.

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our proposed indications. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and preclinical testing. Results from earlier clinical trials may not be repeated in later clinical trials. The clinical trial process may fail to demonstrate that our product candidate is safe and effective for their proposed uses. This failure could cause us to abandon our product candidate and may delay development of other product candidates. Any delay in, or termination of, our clinical trials will delay and possibly preclude the filing of any NDAs with the FDA or EMA and, ultimately, our ability to commercialize our product candidate and generate product revenues.

Our clinical trials may fail to demonstrate adequately the safety and efficacy of AD04 or any future product candidates, which would likely prevent or delay regulatory approval and commercialization.

Before obtaining regulatory approvals for the commercial sale of AD04 or any future product candidates, including AD04, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that product candidates are both safe and effective for use in each target indication. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of product candidates may not be predictive of the results of later-stage clinical trials. Results from subsequent clinical trials may not be the same as the results from the Phase 2b clinical trial that was conducted by the University of Virginia. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product

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candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. We can make no assurances that, should our Phase 3 studies provide statistically significant and clinical meaningful results evidencing that treatment with AD04 results in reduced days of heavy drinking or abstinence, these same results will also provide evidence of greater patient efficacy rates and or patient benefit ratios vis-à-vis currently marketed drug treatments. Most product candidates that commence clinical trials are never approved as products.

In addition, even if the trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of product candidates.

If we experience delays in the enrollment of patients in our clinical trials or our CMC clinical hold is not promptly lifted, our receipt of necessary regulatory approvals could be delayed or prevented.

A Phase 2b clinical trial for our lead product candidate AD04 was completed by the University of Virginia in 2008. Although we intend to commence our Phase 3 clinical trial shortly after consummation of this offering, our inability to locate and enroll a sufficient number of eligible patients in our future Phase 3 clinical trials would result in significant delays or may require us to abandon one or more clinical trials. Retention of subjects in clinical trials related to AUD can be challenging relative to trials in some other indications due to the nature of the target population. Our ability to enroll patients in trials is affected by many factors out of our control including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, the prevalence and successful recruiting of patients that are genotype positive, competing clinical trials, and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating. Due to the use of a biomarker to determine enrollment in our Phase 3 clinical trial, we will have a limited population of patients to draw from for our Phase 3 clinical trials.

The FDA had agreed to review our IND filing prior to completion of the development of our manufacturing plan and production of our clinical supply so that we could proceed more quickly once our Chemistry, Manufacturing, and Controls (“CMC”) submission was ready but with the understanding that we would be on clinical hold pending a satisfactory CMC submission. We then filed our IND without a complete CMC submission, placing a voluntary clinical hold on our program as part of our IND filing pending the filing of a satisfactory CMC submission. The clinical hold was confirmed by the FDA pending receipt of a satisfactory CMC submission. We have since completed our CMC development and manufactured clinical supply for the planned Phase 3 trial, and believe we currently have the capability to file a satisfactory CMC submission to remove the clinical hold. However, the CMC submission has not yet been made. No assurance can be given that the CMC plan developed by us will be satisfactory to the FDA or that the clinical supply produced for use in clinical trials of AD04 will be approved for use in the trials by the FDA, either of which could result in delay of the clinical trial program and a requirement for increased investment prior to commencement of clinical trials.

Our success will be dependent upon adoption by physicians and others.

Even if the FDA and/or EMA approves our product candidate or any future product candidates we may develop or acquire, the product will require acceptance among physicians, healthcare payers, patients, and the medical community. Our products are to be used in combination with a genetic test targeted at patients with certain specified genotypes. It is anticipated that physicians will recommend patients for screening prior to administration of AD04 or future product candidates. Therefore, our business will be substantially dependent upon our ability to communicate with and obtain support from physicians regarding the benefits of our products relative to alternative treatments available at that time.

Rapid technological change and substantial competition may impair the business.

The pharmaceutical industry is subject to rapid and substantial technological change. Technological competition in the industry from pharmaceutical and biotechnology companies, universities, governmental entities, and others diversifying into the field is intense and is expected to increase. Many of these entities have significantly

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greater research and development capabilities, as well as substantially more marketing, financial, and managerial resources than we do, and represent significant competition. Acquisitions of, or investments in, competing biotechnology companies by large pharmaceutical companies could increase these competitors’ financial, marketing, and other resources. We cannot assure you that developments by others will not render our products or technologies noncompetitive or that we will be able to keep pace with technological developments. Competitors have developed, or are in the process of developing, technologies that are, or in the future may be, the basis for competitive products. Some of these products may have an entirely different approach or means of accomplishing similar therapeutic endpoints than products we are currently developing. These competing products may be more effective and less costly than the products that we are developing. In addition, conventional behavioral therapies and other treatment approaches currently in use today may continue to be used instead of, rather than in conjunction with, our products.

Any product that we successfully develop, and for which we gain regulatory approval, must compete for market acceptance and market share. Accordingly, important competitive factors, in addition to completion of clinical testing and the receipt of regulatory approval, will include product efficacy, safety, timing, and scope of regulatory approvals, availability of supply, marketing and sales capability, reimbursement coverage, pricing, and patent protection. Existing or future competing products may provide greater therapeutic convenience or clinical or other benefits for a specific indication than our products, or may offer comparable performance at a lower cost. If our products fail to capture and maintain market share, we may not achieve sufficient product revenues and our business will suffer.

We will compete against fully integrated pharmaceutical companies such as Alkermes and Indivior and smaller companies that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. Many of these competitors have drugs already approved or in development. In addition, many of these competitors, either alone or together with their collaborative partners, operate larger research and development programs or have substantially greater financial resources than we do, as well as significantly greater experience in:

         developing drugs, and other therapies;

         undertaking preclinical testing and clinical trials;

         obtaining FDA and other regulatory approvals of drugs, biologics and other therapies;

         formulating and manufacturing drugs, biologics and other therapies; and

         launching, marketing and selling drugs, and other therapies.

If we fail to develop additional product candidates, our commercial opportunity will be limited.

We expect to initially develop our lead product candidate, AD04. However, we may pursue clinical development of additional product candidates and development of AD04 for additional indications. Developing, obtaining regulatory approval for and commercializing additional product candidates, will require substantial additional funding beyond the net proceeds of this offering and is prone to the risks of failure inherent in medical product development. We cannot provide you any assurance that we will attempt to advance or that we will be able to successfully advance any of these additional product candidates through the development process.

Even if we receive FDA approval or approval in another jurisdiction to market additional product candidates or AD04 for the treatment of various indications (such as, obesity, drug addiction, and smoking cessation), we cannot assure you that any such product candidates will be successfully commercialized, widely accepted in the marketplace or be more effective than other commercially available alternatives. If we are unable to successfully develop and commercialize additional product candidates, our commercial opportunity will be limited. Moreover, a failure in obtaining regulatory approval of additional product candidates may have a negative effect on the approval process of any other, or result in losing approval of any approved, product candidate.

Risks Relating to Our Business and Industry

If we do not obtain the necessary regulatory approvals in the United States and/or other countries, we will not be able to sell our product candidates.

We cannot assure you that we will receive the approvals necessary to commercialize AD04 or any future product candidates we acquire or develop in the future. We will need FDA approval to commercialize our product candidates

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in the United States and approvals from the FDA-equivalent regulatory authorities in foreign jurisdictions to commercialize our product candidates in those jurisdictions. In order to obtain FDA approval of any product candidate, we must submit to the FDA an NDA, demonstrating that the product candidate is safe, pure and potent, and effective for its intended use. This demonstration requires significant research including preclinical studies, as well as clinical trials. Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing. We cannot predict whether our clinical trials will demonstrate the safety and efficacy of our product candidates or if the results of any clinical trials will be sufficient to advance to the next phase of development or for approval from the FDA. We also cannot predict whether our research and clinical approaches will result in drugs or therapeutics that the FDA considers safe and effective for the proposed indications. The FDA has substantial discretion in the approval process.

The approval process may be delayed by changes in government regulation, future legislation or administrative action, or changes in FDA policy that occur prior to or during our regulatory review. Factors that might lead to a suspension or termination of a clinical trial include, but are not limited to:

         failure to conduct the clinical trial in accordance with U.S., international and or local regulatory requirements;

         failure of medical investigators to follow clinical trial protocols;

         unforeseen safety issues; and/or

         lack of adequate funding to continue the clinical trial.

Delays in obtaining regulatory approvals may:

         prevent or delay commercialization of, and our ability to derive product revenues from, product candidates; and

         diminish any competitive advantages that we may otherwise believe that we hold.

Even if we comply with all FDA requests, the FDA may ultimately reject one or more of our applications. We may never obtain regulatory clearance for any product candidates. Failure to obtain FDA approval of any of product candidates will severely undermine our business by leaving us without a saleable product, and therefore without any source of revenues, until another product candidate can be developed. There is no guarantee that we will ever be able to develop or acquire another product candidate.

In addition, the FDA may require us to conduct additional preclinical and clinical testing or to perform post-marketing studies, as a condition to granting marketing approval of a product. Initial acceptance by the FDA of clinical trial protocols is subject to constant review and any process control failures could result in additional required testing. Regulatory approval of products often requires that subjects in clinical trials be followed for long periods to assess their overall survival. The results generated after approval could result in loss of marketing approval, changes in product labeling, and/or new or increased concerns about the side effects or efficacy of a product. The FDA has significant post-market authority, including the explicit authority to require post-market studies and clinical trials, labeling changes based on new safety information, and compliance with FDA-approved risk evaluation and mitigation strategies. The FDA’s exercise of its authority has in some cases resulted, and in the future could result, in delays or increased costs during product development, clinical trials and regulatory review, increased costs to comply with additional post-approval regulatory requirements and potential restrictions on sales of approved products based on labeling or other requirements.

In foreign jurisdictions, we must also receive approval from the appropriate regulatory authorities before we can commercialize any candidate products. Foreign regulatory approval processes generally include all of the risks associated with the FDA approval procedures described above. There can be no assurance that we will receive the approvals necessary to commercialize our product candidate for sale outside the United States.

Changes in regulatory requirements and guidance may occur, and we may need to amend clinical trial protocols or our development plan to reflect these changes. Amendments may require resubmitting clinical trial

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protocols to FDA and institutional review boards for reexamination, which may impact the costs, timing or successful completion of a clinical trial. If we experience delays in completion of, or if we terminate any clinical trials, the commercial prospects for product candidates may be harmed, and the ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of product candidates.

Obtaining and maintaining regulatory approval of product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, and a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials, as clinical studies conducted in one jurisdiction may not be accepted by or sufficient for regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our candidate products is also subject to approval. Additionally, some foreign jurisdictions require participation of subjects from their country in the Phase 3 trial in order to gain approval in their country.

We intend to also submit marketing applications in other jurisdictions, including European countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of AD04 or any future product candidates will be harmed.

Even if we receive regulatory approval of AD04 or any future product candidates, we will be subject to ongoing regulatory obligations, such as post market surveillance and current good manufacturing practice (“GMP”) requirements, and continued regulatory review, which may result in significant additional expense. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with product candidates. In addition, third parties on whom we rely must comply with regulatory requirements, and any non-compliance on their part may negatively impact our business, assuming we obtain regulatory authorization at all.

Any regulatory approvals that we receive for product candidates will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a Risk Evaluation and Mitigation Strategy (“REMS”) program in order to approve product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA could also require a boxed warning, sometimes referred to as a Black Box Warning on the product label to identify a particular safety risk, which could affect commercial efforts to promote and sell the product. In addition, if the FDA or a comparable foreign regulatory authority approves product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current GMPs and current good clinical practices (“GCPs”) for any clinical trials that we conduct post-approval. We are also subject to certain user fees imposed by the regulatory agencies. Later discovery of previously unknown problems with product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

         restrictions on the marketing or manufacturing of product candidates, withdrawal of the product from the market, or product recalls;

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         fines, warning letters or holds on clinical trials;

         refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals;

         product seizure or detention, or refusal to permit the import or export of product candidates; and

         injunctions or the imposition of civil or criminal penalties.

The FDA’s and other regulatory authorities’ policies may change, such as those required by the 21st Century Cures Act, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of AD04 or any future product candidates. In addition, it is unclear what changes, if any, the new presidential administration may bring. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

Clinical trials are very expensive, time-consuming and difficult to design and implement.

As part of the regulatory process, we must conduct clinical trials for each product candidate to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities. As we advance AD04 or any future product candidates we expect that our expenses will increase. The number and design of the clinical trials that will be required varies depending upon product candidate, the condition being evaluated, current medical strategies and the trial results themselves. Therefore, it is difficult to accurately estimate the cost of the clinical trials. Clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming. We estimate that clinical trials of product candidates including AD04, will take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be delayed or prevented by several factors, including:

         unforeseen safety issues;

         failure to determine appropriate dosing;

         greater than anticipated cost of our clinical trials;

         failure to demonstrate effectiveness during clinical trials;

         slower than expected rates of subject recruitment or difficulty obtaining investigators;

         subject drop-out or discontinuation;

         inability to monitor subjects adequately during or after treatment;

         third party contractors, including, without limitation, CRO’s and manufacturers, failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;

         reaching agreements with prospective CROs, and trial sites, both of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

         insufficient or inadequate supply or quality of product candidates or other necessary materials to conduct our trials;

         potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;

         problems engaging Institutional Review Boards (“IRBs”), to oversee trials or in obtaining and maintaining IRB approval of studies;

         imposition of clinical hold or suspension of our clinical trials by regulatory authorities; and

         inability or unwillingness of medical investigators to follow our clinical protocols.

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In addition, we or the FDA may suspend or terminate our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our Investigational New Drug, or IND, submissions or the conduct of these trials. Therefore, we cannot predict with any certainty when, if ever, future clinical trials will commence or be completed.

There is uncertainty as to market acceptance of our technology and product candidates.

Even if the FDA approves our current product candidate, or any future product candidates we may develop or acquire, the products may not gain broad market acceptance among physicians, healthcare payers, patients, and the medical community. We have conducted our own research into the markets for our product candidates; however, we cannot guarantee market acceptance of our product candidates, if approved, and have somewhat limited information on which to estimate our anticipated level of sales. Product candidates, if approved, will require patients, healthcare providers and doctors to adopt our technology. Our industry is susceptible to rapid technological developments and there can be no assurance that we will be able to match any new technological advances. If we are unable to match the technological changes in the needs of our customers the demand for our products will be reduced. Acceptance and use of any products we market, assuming market authorization approval at all, will depend upon a number of factors including:

         perceptions by members of the health care community, including physicians, about the safety and effectiveness of our products;

         limitation on use or warnings required by FDA in our product labeling;

         cost-effectiveness of our products relative to competing products;

         convenience and ease of administration;

         potential advantages of alternative treatment methods;

         availability of reimbursement for our products from government or other healthcare payers; and

         effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

Because we expect virtually all of our product revenues for the foreseeable future to be generated from sales of AD04, if approved, the failure of this product to find market acceptance would substantially harm our business and would adversely affect our revenue.

Even if we are able to obtain regulatory approval for our product candidate or any product candidates we develop or acquire, we will continue to be subject to ongoing and extensive regulatory requirements, and our failure, or the failure of our contract manufacturers, to comply with these requirements could substantially harm our business.

If the FDA approves our product candidate or any product candidates we develop or acquire, the labeling, manufacturing, packaging, adverse events reporting, storage, advertising, promotion and record-keeping for our products will be subject to ongoing FDA requirements and continued regulatory oversight and review. We may also be subject to additional FDA post-marketing obligations. If we are not able to maintain regulatory compliance, we may not be permitted to market product candidates and/or may be subject to product recalls or seizures. The subsequent discovery of previously unknown problems with any marketed product, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the product, and could include withdrawal of the product from the market.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to: (i) comply with the laws of the FDA and other similar foreign regulatory bodies; (ii) provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; (iii) comply with manufacturing standards we have established; (iv) comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or (v) report financial information or data accurately or to disclose unauthorized activities to us. Any such misconduct or noncompliance could negatively affect the FDA’s review of our regulatory submission, including delaying approval or disallowance

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of certain information to support the submission, and/or delay a federal or state healthcare program’s or a commercial insurer’s determination regarding the availability of future reimbursement for product candidates. If we obtain FDA approval of any product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials. The laws that may affect our ability to operate or may require us to modify certain programs include, but are not limited to:

         the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs;

         federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other third-party payors (both governmental and private) that are false or fraudulent or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to a federal or state healthcare program or private payor;

         the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which, among other things, created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

         HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which, among other things, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of such individually identifiable health information;

         the federal Physician Payment Sunshine Act, created under the Healthcare Reform Act (as defined herein), and its implementing regulations, which require certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services (“HHS”), information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;

         federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and

         the Foreign Corrupt Practices Act (the “FCPA”) and similar antibribery and anticorruption laws in other countries that, for example, prevent improper payments or transfers of anything of value to foreign officials for the purpose of gaining commercial advantage, obtaining or retaining business, or to enhancing clinical trials.

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Additionally, we are subject to state and foreign equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply regardless of the payor.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of any product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

We have no experience selling, marketing or distributing products and have no internal capability to do so.

We currently have no sales, marketing or distribution capabilities, including, without limitation, capabilities to market AD04 or its companion genetic test. We do not anticipate having the resources in the foreseeable future to allocate to the sales and marketing of our proposed products, if approved. Our future success depends, in part, on our ability to enter into and maintain collaborative relationships for such capabilities, the collaborator’s strategic interest in the products under development and such collaborator’s ability to successfully market and sell any such products. We intend to pursue collaborative arrangements regarding the sales and marketing of our products, however, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or if able to do so, that our collaborators will have effective sales forces. To the extent that we decide not to, or are unable to, enter into collaborative arrangements with respect to the sales and marketing of our proposed products, significant capital expenditures, management resources and time will be required to establish and develop an in-house marketing and sales force with technical expertise. There can also be no assurance that we will be able to establish or maintain relationships with third party collaborators or develop in-house sales and distribution capabilities. To the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third parties over whom we have no control, and there can be no assurance that such efforts will be successful. In addition, there can also be no assurance that we will be able to successfully market and sell our products in the United States or overseas on our own.

We may not be successful in establishing and maintaining strategic partnerships, which could adversely affect our ability to develop and commercialize products.

We may seek to enter into strategic partnerships in the future, including alliances with other biotechnology or pharmaceutical companies, to enhance and accelerate the development and commercialization of our products, such as a third party drug development company. We face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex and can be costly. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for any future product candidates and programs because our research and development pipeline may be insufficient, our product candidates and programs may be deemed to be at too early of a stage of development for collaborative effort and/or third parties may not view our product candidates and programs as having the requisite potential to demonstrate safety and efficacy or return on investment. Even if we are successful in our efforts to establish strategic partnerships, the terms that we agree upon may not be favorable to us and we may not be able to maintain such strategic partnerships if, for example, development or approval of a product candidate is delayed or sales of an approved product are disappointing.

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If we ultimately determine that entering into strategic partnerships is in our best interest but either fail to enter into, are delayed in entering into or fail to maintain such strategic partnerships:

         the development of our current product candidate or certain future product candidates may be terminated or delayed;

         our planned clinical trials may be restructured or terminated;

         our cash expenditures related to development of our current product candidate or certain future product candidates may increase significantly and we may need to seek additional financing;

         we may be required to hire additional employees or otherwise develop expertise, such as sales and marketing expertise, for which we have not budgeted;

         we will bear all of the risk related to the development of any such product candidates; and

         the competitiveness of any product candidate that is commercialized could be reduced.

To the extent we elect to enter into licensing or collaboration agreements to partner AD04 or any future product candidates, our dependence on such relationships may adversely affect our business.

Our commercialization strategy for certain product candidates may depend on our ability to enter into agreements with collaborators to obtain assistance and funding for the development and potential commercialization of these investigational product candidates. Supporting diligence activities conducted by potential collaborators and negotiating the financial and other terms of a collaboration agreement are long and complex processes with uncertain results. Even if we are successful in entering into one or more collaboration agreements, collaborations may involve greater uncertainty for us, as we have less control over certain aspects of our collaborative programs than we do over our proprietary development and commercialization programs. Our collaborators could delay or terminate their agreements, and our product candidates subject to collaborative arrangements may never be successfully developed or commercialized.

Further, our future collaborators may develop alternative products or pursue alternative technologies either on their own or in collaboration with others, including our competitors, and the priorities or focus of our collaborators may shift such that our programs receive less attention or fewer resources than we would like, or they may be terminated altogether. Any such actions by our collaborators may adversely affect our business prospects and ability to earn revenues. In addition, we could have disputes with our future collaborators, such as the interpretation of terms in our agreements. Any such disagreements could lead to delays in the development or commercialization of any potential products or could result in time-consuming and expensive litigation or arbitration, which may not be resolved in our favor.

Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or suffer security breaches.

Despite the implementation of security measures, our internal computer systems and those of our future CROs and other contractors and consultants are vulnerable to damage from computer viruses and unauthorized access. While we have not experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Since we rely on third parties for research and development of AD04, and expect do so for future product candidates and for the manufacture of product candidates and to conduct clinical trials, similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of product candidates could be delayed.

We have limited protection for our intellectual property. Our licensed patents and proprietary rights may not prevent us from infringing on the rights of others, or prohibit potential competitors from commercializing products.

We intend to rely on a combination of common law copyright, patent, trademark, and trade secret laws and measures to protect our proprietary information. We have licensed patents to protect certain of our proprietary

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intellectual property and have obtained exclusive rights to license certain of the technology for which patent protection has been obtained; however, such protection does not prevent unauthorized use of such technology. Trademark and copyright protections may be limited, and enforcement could be too costly to be effective. It may also be possible for unauthorized third parties to copy aspects of, or otherwise obtain and use, our proprietary information without authorization, including, but not limited to, product design, software, customer and prospective customer lists, trade secrets, copyrights, patents and other proprietary rights and materials. Other parties can use and register confusingly similar business, product and service names, as well as domain names, which could divert customers, resulting in a material adverse effect on our business, operating results and financial condition.

We have not conducted an exhaustive patent search and cannot assure you that patents do not exist or could not be filed that would negatively affect our ability to market our products or maintain our competitive position with respect to our products. Additionally, our licensed patents may not prevent others from developing competitive products using related technology. Furthermore, other companies that obtain patents claiming products or processes useful to us may bring infringement actions against us. As a result, we may be required to obtain licenses from others to develop, manufacture or market our products. We cannot assure you that we will be able to obtain any such licenses on commercially reasonable terms, if at all.

We also rely on trade secrets and proprietary know-how that we seek to protect, in part, by confidentiality agreements with our employees, consultants, suppliers, and licensees. We cannot give any assurance that these third parties will not breach these agreements, that we would have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently developed by competitors.

We cannot assure you that the U.S. Patent and Trademark Office (“USPTO”) will approve pending patent applications for intellectual property for which we are currently the exclusive worldwide licensee, or that any patent issued to, or licensed by, us will provide protection that has commercial significance. In this regard, the patent position of pharmaceutical compounds and compositions is particularly uncertain. Even issued patents may later be modified or revoked by the USPTO in proceedings instituted by others or by us. In addition, we cannot assure you that our licensed patents will afford protection against competitors with similar compounds or technologies, that others will not obtain patents with claims similar to those covered by our licensed patents or applications, or that the patents of others will not adversely affect our ability to conduct our business.

Despite licensing patents issued in more than 40 jurisdictions around the world, we know that receiving, maintaining and defending foreign patents may be more difficult than defending domestic patents because of differences in patent laws, and recognize that our licensed patent position therefore may be stronger in the United States than abroad. In addition, the protection provided by foreign patents, once they are obtained, may be weaker than that provided in the United States.

If we fail to successfully enforce our intellectual property rights, our competitive position could suffer, which could harm our operating results. Competitors may challenge the validity or scope of our licensed patents or future patents we may obtain or license. In addition, our licensed patents may not provide us with a meaningful competitive advantage. We may be required to spend significant resources to monitor and police our licensed intellectual property rights. We may not be able to detect infringement and our competitive position may be harmed. In addition, competitors may design around our technology or develop competing technologies. Intellectual property rights may also be unavailable or limited in some foreign countries, which could make it easier for competitors to capture market share.

The technology we license, our products or our development efforts may be found to infringe upon third-party intellectual property rights.

Our commercial success depends in part on us avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference and reexamination proceedings before the USPTO, or oppositions and other comparable proceedings in other jurisdictions. Recently, under the American Invents Act (“AIA”), new procedures including inter parties review and post grant review have been implemented. These procedures are relatively new and the manner in which they are being implemented continues to evolve, which brings additional uncertainty to our licensed patents and pending applications. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing product candidates. As the biotechnology

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and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others.

Third parties may, in the future, assert claims or initiate litigation related to their patent, copyright, trademark and other intellectual property rights in technology that is important to us. The asserted claims and/or litigation could include claims against us, our licensors or our suppliers alleging infringement of intellectual property rights with respect to our products or components of those products. Regardless of the merit of the claims, they could be time consuming, result in costly litigation and diversion of technical and management personnel, or require us to develop a non-infringing technology or enter into license agreements. We have not undertaken an exhaustive search to discover any third party intellectual patent rights which might be infringed by commercialization of the product candidates described herein. Although we are not currently aware of any such third party intellectual patent rights, it is possible that such rights currently exist or might be obtained in the future. In the event that a third party controls such rights and we are unable to obtain a license to such rights on commercially reasonable terms, we may not be able to sell or continue to develop our products, and may be liable for damages for such infringement. We cannot assure you that licenses will be available on acceptable terms, if at all. Furthermore, because of the potential for significant damage awards, which are not necessarily predictable, it is not unusual to find even arguably unmeritorious claims resulting in large settlements. If any infringement or other intellectual property claim made against us by any third party is successful, or if we fail to develop non-infringing technology or license the proprietary rights on commercially reasonable terms and conditions, our business, operating results and financial condition could be materially adversely affected.

If our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial costs and we may have to:

         obtain licenses, which may not be available on commercially reasonable terms, if at all;

         abandon an infringing drug or therapy candidate;

         redesign our products or processes to avoid infringement;

         stop using the subject matter claimed in the patents held by others;

         pay damages; or

         defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize product candidates, which could harm our business significantly.

We may be involved in lawsuits to protect or enforce the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of our licensed patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our licensed patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our licensed patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our licensed

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patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.

Interference proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to some of our licensed patents or patent applications subject to pre-AIA or those of our licensors. An unfavorable outcome could result in a loss of our current licensed patent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or interference proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.

A derivation proceeding is a trial proceeding conducted at the Patent Trial and Appeal Board to determine whether (i) an inventor named in an earlier application derived the claimed invention from an inventor named in the petitioner’s application; and (ii) the earlier application claiming such invention was filed without authorization. An applicant subject to the first-inventor-to-file provisions may file a petition to institute a derivation proceeding only within one year of the first publication of a claim to an invention that is the same or substantially the same as the earlier application’s claim to the invention. The petition must be supported by substantial evidence that the claimed invention was derived from an inventor named in the petitioner’s application. Derivation proceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our shares of common stock.

Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

Patents are subject to changing legal interpretation by the USPTO and the Courts.

If the U.S. Supreme Court, other federal courts, or the USPTO were to change the standards of patentability such changes could have a negative impact on our business. Recent court cases have made it more difficult to protect certain types of inventions. For instance, on October 30, 2008, the Court of Appeals for the Federal Circuit issued a decision that methods or processes cannot be patented unless they are tied to a machine or involve a physical transformation. On March 20, 2012, in the case Mayo v. Prometheus, the U.S. Supreme Court invalidated a patent focused on a diagnostic process because the patent claim embodied a law of nature. On July 3, 2012, the USPTO

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issued its Interim Guidelines for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature in view of the Prometheus decision. It remains to be seen how these guidelines will play out in the actual prosecution of diagnostic claims. Similarly, it remains to be seen how lower courts will interpret the Prometheus decision. Some aspects of our technology involve processes that may be subject to this evolving standard and we cannot guarantee that any of our pending process claims will be patentable as a result of such evolving standards.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

Our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.

Our ability to commercialize our products, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from:

         government and health administration authorities;

         private health maintenance organizations and health insurers; and

         other healthcare payers.

Patients generally expect that products such as ours are covered and reimbursed by third-party payors for all or part of the costs and fees associated with their use. If such products are not covered and reimbursed then patients may be responsible for the entire cost of the product, which can be substantial. Therefore, health care providers generally do not prescribe products that are not covered and reimbursed by third-party payors in order to avoid subjecting their patients to such financial liability. The existence of adequate coverage and reimbursement for the products by government and private insurance plans is central to the acceptance of AD04 and any future products we provide.

During the past several years, third-party payors have undertaken cost-containment initiatives including different payment methods, monitoring health care expenditures, and anti-fraud initiatives. For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state, and some state Medicaid programs may not pay an adequate amount for AD04 or any of our other products or may make no payment at all. Furthermore, the health care industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control health care costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Therefore, we cannot be certain that our services will be reimbursed at a level that is sufficient to meet our costs.

Obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Patients are unlikely to use AD04 or any future product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of AD04 or any future product candidates.

We intend to seek approval to market AD04 and future product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for AD04 or any future product candidates, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in the European Union, the pricing of drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales of product candidates will depend significantly on

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the availability of adequate coverage and reimbursement from third-party payors for product candidates and may be affected by existing and future health care reform measures.

Third-party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. In particular, in 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “Healthcare Reform Act”), was enacted. The Healthcare Reform Act and its implementing regulations, among other things, revised the methodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs, including product candidates, under the Medicaid Drug Rebate Program are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research.

Other legislative changes have been proposed and adopted in the United States since the Healthcare Reform Act was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012 (the “ATRA”) which delayed for another two months the budget cuts mandated by these sequestration provisions of the Budget Control Act of 2011. In March 2013, the President signed an executive order implementing sequestration, and in April 2013, the 2% Medicare payment reductions went into effect. The ATRA also, among other things, reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future, particularly in light of the new presidential administration in the United States, and any proposed changes to healthcare laws that could potentially affect our clinical development or regulatory strategy. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

         the demand for AD04, or future product candidates, if we obtain regulatory approval;

         our ability to set a price that we believe is fair for our products;

         our ability to generate revenue and achieve or maintain profitability;

         the level of taxes that we are required to pay; and

         the availability of capital.

Any reduction in reimbursement from Medicare, Medicaid or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.

If we are unable to obtain adequate coverage and reimbursement for our tests, it is unlikely that our tests will gain widespread acceptance.

Use of our product candidate will require pre-treatment screening. Our strategy for AD04 aims to integrate pre-treatment screening into the drug label, effectively creating a patient-specific or “precision” treatment into one integrated therapeutic offering. Our ability to generate revenue will depend upon the availability of adequate coverage and reimbursement for our tests from third-party payors, including government programs such as Medicare and Medicaid, private insurance plans and managed care programs. Health care providers that order diagnostic services generally expect that those diagnostic services are covered and reimbursed by third-party payors for all or

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part of the costs and fees associated with the diagnostic tests they order. If such diagnostic tests are not covered and reimbursed then their patients may be responsible for the entire cost of the test, which can be substantial. Therefore, health care providers generally do not order tests that are not covered and reimbursed by third-party payors in order to avoid subjecting their patients to such financial liability. The existence of adequate coverage and reimbursement for the procedures performed by us by government and private insurance plans is central to the acceptance of our product candidate. During the past several years, third-party payors have undertaken cost-containment initiatives including different payment methods, monitoring health care expenditures, and anti-fraud initiatives. In addition, the Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare program, has taken the position that the algorithm portion of multi-analyst algorithmic assays, or MAAAs, is not a clinical laboratory test and is therefore not reimbursable under the Medicare program. Although this position is only applicable to tests with a CMS determined national payment amount, it is possible that the local MACs, who make coverage and payment determinations for tests such as ours may adopt this policy and reduce payment for such test. If that were to happen, reimbursement for our pre-screening tests would be uncertain. We may not be able to achieve or maintain profitability if third-party payors deny coverage or reduce their current levels of payment, or if our costs of production increase faster than increases in reimbursement levels. Further, many private payors use coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies. Future action by CMS or other government agencies may diminish payments to clinical laboratories, physicians, outpatient centers and/or hospitals. Those private payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for us and coverage and the amount of reimbursement under those polices is uncertain. For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state, and some state Medicaid programs may not pay an adequate amount for MyPRS® or may make no payment at all. As the portion of the U.S. population over the age of 65 and eligible for Medicare continues to grow, we may be more vulnerable to coverage and reimbursement limitations imposed by CMS. Furthermore, the health care industry in the United States has experienced a general trend toward cost containment as government and private insurers seek to control health care costs through various mechanisms, including imposing limitations on payment rates and negotiating reduced contract rates with service providers, among other things. Therefore, we cannot be certain that our services will be reimbursed at a level that is sufficient to meet our costs.

A variety of risks associated with marketing AD04 or any future product candidates internationally could materially adversely affect our business.

We plan to seek regulatory approval of AD04 and any future product candidates outside of the United States, in particular in European markets, and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:

         differing regulatory and reimbursement requirements in foreign countries;

         unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

         economic weakness, including inflation, or political instability in particular foreign economies and markets;

         compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

         foreign taxes, including withholding of payroll taxes;

         foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

         compliance with U.S. and foreign export control regulations, including economic sanctions and embargo programs, each of which may be subject to unexpected changes;

         difficulties staffing and managing foreign operations;

         workforce uncertainty in countries where labor unrest is more common than in the United States;

         potential liability under the FCPA or comparable foreign regulations;

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         challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;

         production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

         business interruptions resulting from geo-political actions, including war and terrorism; and

         potential difficulties that may arise with pharmaceutical company partners under license or other agreement to jointly develop, seek regulatory approval, and commercialize our products.

These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations.

We may not successfully effect our intended expansion.

Our success will depend upon the expansion of our operations and the effective management of our growth, which will place a significant strain on our management and on our administrative, operational and financial resources. To manage this growth, we must expand our facilities, augment our operational, financial and management systems and hire additional qualified personnel, including a Chief Development Officer. We will need to hire additional qualified personnel with expertise in preclinical and clinical research, government regulation, formulation and manufacturing, sales and marketing and accounting and financing. In particular, over the next 12 months, we expect to hire additional new employees. We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions. Competition for such individuals is intense, and we cannot be certain that our search for such personnel will be successful. Attracting and retaining qualified personnel will be critical to our success. If we are unable to manage our growth effectively, our business would be harmed.

We rely on key executive officers and scientific, regulatory and medical advisors, and their knowledge of our business and technical expertise would be difficult to replace.

Because of the specialized nature of our business, our ability to maintain a competitive position depends on our ability to attract and retain qualified management and other personnel. We cannot assure you that we will be able to continue to attract or retain such persons.

We are highly dependent on our principal scientific, regulatory and medical advisors and our chief executive officer. We do not have an insurance policy on the life of our chief executive officer, William B. Stilley; and we do not have “key person” life insurance policies for any of our other officers or advisors. The loss of the technical knowledge and management and industry expertise of any of our key personnel could result in delays in product development, loss of customers and sales and diversion of management resources, which could adversely affect our operating results.

Certain of our officers may have a conflict of interest.

Certain of our officers are currently working for our company on a part-time basis and we expect that they will continue to do so after this offering. Our employment agreements with our Chief Financial Officer/Chief Operating Officer and with our Chief Development Officer provide that they will devote 50% and 70% of each of their business time to our matters, respectively, with their remaining business time devoted to other matters including, without limitation, employment at other companies that are non-competitive with us, which may result in a lack of availability when needed due to responsibilities with other requirements.

AD04 and any future product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

Undesirable side effects caused by AD04 or any future product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory

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approval by the FDA or other comparable foreign regulatory authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects or other unexpected characteristics.

If unacceptable safety concerns or other adverse events arise in the development of a product candidate, our clinical trials could be suspended or terminated or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of such product candidate for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Inadequate training in recognizing or managing the potential side effects of a product candidate could result in patient deaths. Any of these occurrences may harm our business, financial condition and prospects significantly.

We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

The testing and marketing of drug product candidates entail an inherent risk of product liability. Product liability claims might be brought against us by consumers, health care providers or others selling or otherwise coming into contact with our products. Clinical trial liability claims may be filed against us for damages suffered by clinical trial subjects or their families. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products which could impact our ability to continue as a going concern. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with collaborators. In addition, regardless of merit or eventual outcome, product liability claims may result in:

         decreased demand for any approved product candidates;

         impairment of our business reputation;

         withdrawal of clinical trial participants;

         costs of related litigation;

         distraction of management’s attention;

         substantial monetary awards to patients or other claimants;

         loss of revenues; and

         the inability to successfully commercialize any approved drug candidates.

We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

As part of our business strategy, we may pursue acquisitions of businesses and assets. We also may pursue strategic alliances and joint ventures that leverage our technology and industry experience to expand our offerings or other capabilities. Though certain company personnel have business development and corporate transaction experience, including with licensing, mergers and acquisitions, and strategic partnering, as a company we have no experience with acquiring other companies and limited experience with forming strategic alliances and joint ventures. We may not be able to find suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could have a material adverse effect on our financial condition, results of operations and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing business. We may experience losses related to investments in other companies, which could have a material negative effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.

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To finance any acquisitions or joint ventures, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of our stockholders. If the price of our common stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our stock as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all.

Declining general economic or business conditions may have a negative impact on our business.

Continuing concerns over U.S. health care reform legislation and energy costs, geopolitical issues, the availability and cost of credit and government stimulus programs in the United States and other countries have contributed to increased volatility and diminished expectations for the global economy. These factors, combined with low business and consumer confidence and high unemployment, precipitated an economic slowdown and recession and stagnant economy for more than a decade. Additionally, political changes in the U.S. and elsewhere in the world have created a level of uncertainty in the markets. If the economic climate does not improve or deteriorate, our business, as well as the financial condition of our suppliers and our third-party payors, could be adversely affected, resulting in a negative impact on our business, financial condition and results of operations.

Health care policy changes, including legislation reforming the U.S. health care system and other legislative initiatives, may have a material adverse effect on our financial condition, results of operations and cash flows.

Government payors, such as Medicare and Medicaid, have taken steps and can be expected to continue to take steps to control the cost, utilization and delivery of health care services, including clinical laboratory test services.

In March 2010, U.S. President Barack Obama signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, which made a number of substantial changes in the way health care is financed by both governmental and private insurers. It is unclear what, if any, changes the new administration will make to the health care system. We cannot predict whether future health care initiatives will be implemented at the federal or state level, or how any future legislation or regulation may affect us.

Risks Related to this Offering

Certain of our shareholders have sufficient voting power to make corporate governance decisions that could have a significant influence on us and the other stockholders.

Our two largest shareholders, Bankole Johnson, our Chairman of the Board of Directors, and Becker Specialty Corporation, will control approximately 30.62% of our outstanding voting power on a fully diluted basis after consummation of this offering assuming the issuance of all 1,400,000 common stock offered in this offering. Mr. Stilley will control approximately 6.62% of our outstanding common stock on a fully diluted basis after consummation of this offering assuming the issuance of all 1,400,000 common stock offered in this offering. As a result, Bankole Johnson and Becker Specialty Corporation together with Mr. Stilley will be able to exert a significant degree of influence over our management and affairs and over matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions. In addition, this concentration of ownership may delay or prevent a change in our control and might affect the market price of our common stock, even when a change in control may be in the best interest of all stockholders. Furthermore, the interests of this concentration of ownership may not always coincide with our interests or the interests of other stockholders. Accordingly, these stockholders could cause us to enter into transactions or agreements that we would not otherwise consider.

Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans and outstanding warrants could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.

We expect that significant additional capital may be needed in the future to continue our planned operations, including conducting clinical trials, commercialization efforts, expanded research and development activities and costs associated with operating a public company. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to the holders of our common stock, including shares of common stock sold in this offering. Pursuant to our 2017 equity incentive plan, which will become effective on the business

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day prior to the public trading date of our common stock, our management will be authorized to grant equity awards to our employees, officers, directors and consultants.

Initially, the aggregate number of shares of our common stock that may be issued pursuant to stock awards under our 2017 equity incentive plan is 1,750,000 shares. Increases in the number of shares available for future grant or purchase may result in additional dilution, which could cause our stock price to decline.

We currently have warrants to purchase 482,555 shares of common stock outstanding at exercise prices ranging from $0.005 to $7.634 and options to purchase 174,282 shares of common stock outstanding, all at an exercise price of $5.700. We have also agreed to issue upon consummation of this offering warrants to purchase 320,352 shares of our common stock at the offer price, and to issue warrants to purchase 56,000 shares of our common stock at 125% of the initial public offering price of the common stock. The issuance of the shares of common stock underlying the warrants will have a dilutive effect on the percentage ownership held by holders of our common stock.

We have agreed to issue to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer shares of our common stock having a maximum value of $477,750 upon consummation of the offering in accordance with the terms of our Performance Bonus Plan.

We have additional securities available for issuance, which, if issued, could adversely affect the rights of the holders of our common stock.

Our Certificate of Incorporation authorizes the issuance of 50,000,000 shares of common stock and 5,000,000 shares of preferred stock. The common stock and preferred stock, as well as the awards available for issuance under our 2017 equity incentive plan, can be issued by our board of directors, without stockholder approval. Any future issuances of such stock would further dilute the percentage ownership in us held by holders of our common stock and may be issued at prices below the initial price offering. In addition, the issuance of preferred stock may be used as an “anti-takeover” device without further action on the part of our stockholders, and may adversely affect the holders of the common stock.

If we issue preferred stock with superior rights than the common stock offered hereby, it could result in a decrease in the value of our common stock and delay or prevent a change in control of us.

Our board of directors is authorized to issue 5,000,000 shares of preferred stock in series. The issuance of any preferred stock having rights superior to those of the common stock may result in a decrease in the value or market price of the common stock. Holders of preferred stock may have the right to receive dividends, certain preferences in liquidation and conversion rights and rights to elect directors. The issuance of preferred stock could, under certain circumstances, have the effect of delaying, deferring or preventing a change in control of us without further vote or action by the stockholders and may adversely affect the voting and other rights of the holders of common stock.

We have never paid dividends and have no plans to pay dividends in the future.

Holders of our common stock are entitled to receive such dividends as may be declared by our board of directors. To date, we have paid no cash dividends on our preferred or common stock and we do not expect to pay cash dividends in the foreseeable future. We intend to retain future earnings, if any, to provide funds for operations of our business. Therefore, any return investors in our preferred or common stock may have will be in the form of appreciation, if any, in the market value of their common stock. See “Dividend Policy.”

Our failure to meet the continued listing requirements of the NASDAQ could result in a de-listing of our common stock.

If after listing we fail to satisfy the continued listing requirements of the NASDAQ such as the corporate governance requirements, the stockholder’s equity requirement or the minimum closing bid price requirement, the NASDAQ may take steps to de-list our common stock. Such a de-listing or even notification of failure to comply with such requirements would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a de-listing, we would take actions to restore our compliance with the NASDAQ’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the NASDAQ minimum bid price requirement or prevent future non-compliance with the NASDAQ’s listing requirements.

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The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Because we expect that our common stock will be listed on the NASDAQ, our common stock will be covered securities. Although the states are preempted from regulating the sale of covered securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case. Further, if we were to be delisted from the NASDAQ, our common stock would cease to be recognized as covered securities and we would be subject to regulation in each state in which we offer our securities.

Shareholders purchasing shares of common stock in this offering will experience immediate and substantial dilution, causing their investment to immediately be worth less than their purchase price.

If you purchase shares of common stock in this offering, you will experience an immediate and substantial dilution in the projected book value of the common stock from the price you pay in this offering.

After consummation of this offering and assuming the consummation of this offering and conversion of all of the outstanding convertible notes exclusive of the underwriters’ over-allotment option, you will have an immediate dilution of $7.85 per common share and an immediate increase in net tangible book value to our present shareholders from $(0.05) to $2.15 per share will occur.

We are an “emerging growth company,” and any decision on our part to comply with certain reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

We are an “emerging growth company” as defined in the JOBS Act, and, for as long as we continue to be an emerging growth company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, not being required to comply with any new requirements adopted by the Public Company Accounting Oversight Board (the “PCAOB”), requiring mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer, not being required to comply with any new audit rules adopted by the PCAOB after April 5, 2012 unless the SEC determines otherwise, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could remain an emerging growth company until the earlier of: (i) the last day of the fiscal year in which we have total annual gross revenues of US$1 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of our first sale of common equity securities pursuant to an effective registration statement; (iii) the date on which we have issued more than US$1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer. We cannot predict if investors will find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as a result of any choices to reduce future disclosure, there may be a less active trading market for our common stock and our stock price may be more volatile. Further, as a result of these scaled regulatory requirements, our disclosure may be more limited than that of other public companies and you may not have the same protections afforded to shareholders of such companies.

Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (the “Securities Act”), for complying with new or revised accounting standards. We have opted for taking advantage of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the Jobs Act.

As a result of our becoming a public company, we will become subject to additional reporting and corporate governance requirements that will require additional management time, resources and expense.

As a public company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the NASDAQ and other applicable securities rules and regulations impose various requirements on public companies, including the obligation to file with the SEC annual and quarterly information and other reports that are specified in the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and to establish and maintain effective disclosure and

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financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.

We are evaluating these rules and regulations, and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

We have identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in the future.

As a public company, we will be subject to the reporting requirements of the Exchange Act, and the Sarbanes-Oxley Act. We expect that the requirements of these rules and regulations will continue to increase our legal, accounting and financial compliance costs, make some activities more difficult, time consuming and costly, and place significant strain on our personnel, systems and resources.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures, and internal control over financial reporting.

We do not yet have effective disclosure controls and procedures, or internal controls over all aspects of our financial reporting. We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we will file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Our management has deemed certain conditions to be material weaknesses and significant deficiencies in our internal controls. For example, we failed to employ a sufficient number of staff to maintain optimal segregation of duties and to provide optimal levels of oversight. Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a-15(f) under the Exchange Act. We will be required to expend time and resources to further improve our internal controls over financial reporting, including by expanding our staff. However, we cannot assure you that our internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future.

Our current controls and any new controls that we develop may become inadequate because of changes in conditions in our business, including increased complexity resulting from our international expansion. Further, weaknesses in our disclosure controls or our internal control over financial reporting may be discovered in the future. Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods. Any failure to implement and maintain effective internal control over financial reporting could also adversely affect the results of management reports and independent registered public accounting firm audits of our internal control over financial reporting that we will eventually be required to include in our periodic reports that will be filed with the SEC. Ineffective disclosure controls and procedures, and internal control over financial reporting could also cause investors to lose confidence in our reported financial and other information, which would likely have a negative effect on the market price of our common stock.

We are not currently required to comply with the SEC rules that implement Section 404 of the Sarbanes-Oxley Act, and are therefore not required to make a formal assessment of the effectiveness of our internal control over financial reporting for that purpose. As a public company, we will be required to provide an annual management report on the effectiveness of our internal control over financial reporting commencing with our second annual report on Form 10-K. Our independent registered public accounting firm is not required to audit the effectiveness of our internal control over financial reporting until after we are no longer an “emerging growth company” as defined in the JOBS Act. At such time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control over financial reporting is documented, designed or operating.

Any failure to maintain effective disclosure controls and internal control over financial reporting could have a material and adverse effect on our business and operating results, and cause a decline in the market price of our common stock.

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Future sales of a substantial number of our common stock by our existing shareholders could cause our stock price to decline.

We will have a significant number of restricted common stock that will become eligible for sale shortly after this registration statement is declared effective. Prior to the consummation of this offering we will have 3,268,005 shares of our common stock outstanding, convertible notes outstanding that convert to 536,845 shares of common stock (based in interest calculated through September 30, 2017) and upon consummation of this offering we have agreed to issue 263,654 shares of our common stock upon consummation of this offering. All of the shares sold in this offering will be eligible for sale immediately upon effectiveness of this registration statement. All of the remaining shares will be eligible for sale in the public market upon expiration of lock-up agreements 180 days after the date, of this prospectus, subject, in certain circumstances to the volume, manner of sale and other limitations under Rule 144 or 701 promulgated under the Securities Act. It is conceivable that following the holding period, many shareholders may wish to sell some or all of their shares. If our shareholders sell substantial amounts of our common stock in the public market at the same time, the market price of our common stock could decrease significantly due to an imbalance in the supply and demand of our common stock. Even if they do not actually sell the common stock, the perception in the public market that our shareholders might sell significant common stock could also depress the market price of our common stock.

A decline in the price of our common stock might impede our ability to raise capital through the issuance of additional common stock or other equity securities, and may cause you to lose part or all of your investment in our common stock.

Our common stock may be thinly traded, so you may be unable to sell at or near ask prices or at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares.

Prior to this offering, you could not buy or sell our common stock publicly. We cannot predict the extent to which investors’ interests will lead to an active trading market for our common stock or whether the market price of our common stock will be volatile following this offering. If an active trading market does not develop, investors may have difficulty selling any of our common stock that they buy. There may be limited market activity in our stock and we are likely to be too small to attract the interest of many brokerage firms and analysts. We cannot give you any assurance that a public trading market for our common stock will develop or be sustained. The market price of our common stock could be subject to wide fluctuations in response to quarterly variations in our revenues and operating expenses, announcements of new products or services by us, significant sales of our common stock, including “short” sales, the operating and stock price performance of other companies that investors may deem comparable to us, and news reports relating to trends in our markets or general economic conditions.

The price of our common stock may be volatile, and you could lose all or part of your investment.

The trading price of our common stock following this offering is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this prospectus, these factors include:

         the commencement, enrollment or results of the planned clinical trials of AD04 or any future clinical trials we may conduct, or changes in the development status of AD04 or any product candidates;

         any delay in our regulatory filings for our product candidate and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

         adverse results or delays in clinical trials;

         our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;

         adverse regulatory decisions, including failure to receive regulatory approval of our product candidate;

         changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals;

42

         adverse developments concerning our manufacturers;

         our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;

         our inability to establish collaborations if needed;

         our failure to commercialize AD04;

         additions or departures of key scientific or management personnel;

         unanticipated serious safety concerns related to the use of AD04;

         introduction of new products or services offered by us or our competitors;

         announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

         our ability to effectively manage our growth;

         the size and growth of our initial target markets;

         our ability to successfully treat additional types of indications or at different stages;

         actual or anticipated variations in quarterly operating results;

         our cash position;

         our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

         publication of research reports about us or our industry, or positive or negative recommendations or withdrawal of research coverage by securities analysts;

         changes in the market valuations of similar companies;

         overall performance of the equity markets;

         sales of our common stock by us or our stockholders in the future;

         trading volume of our common stock;

         changes in accounting practices;

         ineffectiveness of our internal controls;

         disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our or our licensee’s technologies;

         significant lawsuits, including patent or stockholder litigation;

         general political and economic conditions; and

         other events or factors, many of which are beyond our control.

In addition, the stock market in general, and the NASDAQ and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. If the market price of our common stock after this offering does not exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment. In the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results or financial condition.

43

The offering price of the common stock may not be indicative of the value of our assets or the price at which shares can be resold.

The offering price of the common stock may not be an indication of our actual value. Prior to this offering, there has been no public market for our securities. The offering price of per share was determined based upon negotiations between the underwriters and us. Factors considered in determining such price in addition to prevailing market conditions include an assessment of our future prospects, an increase in value of our stock due to becoming a public company and prior valuations of our shares prepared for us. Such price does not have any relationship to any established criteria of value, such as book value or earnings per share. Such price may not be indicative of the current market value of our assets. No assurance can be given that the shares can be resold at the public offering price.

Our need for future financing may result in the issuance of additional securities which will cause investors to experience dilution.

Our cash requirements may vary from those now planned depending upon numerous factors, including the result of future research and development activities. We believe that the proceeds derived from the sale of the shares in this offering will provide us with sufficient working capital to fund completion of our first Phase 3 clinical trial with AD04 conducted in Scandinavia and Central and Eastern Europe. Thereafter, we expect to require additional funds in the future to conduct additional clinical trials even if the maximum amount is raised in this offering. There are no other commitments by any person for future financing. Though we believe a successful Phase 3 trial will be a significant value creation event for us, our securities may be offered to other investors at a price lower than the price per share offered to the investors in the offering, or upon terms which may be deemed more favorable than offered hereunder. In addition, the issuance of securities in this offering as well as any future financing using our securities may dilute an investor’s equity ownership. Moreover, we may issue derivative securities, including options and/or warrants, from time to time, to procure qualified personnel or for other business reasons. The issuance of any such derivative securities, which is at the discretion of our board of directors, may further dilute the equity ownership of our stockholders, including the investors in this offering. No assurance can be given as to our ability to procure additional financing, if required, and on terms deemed favorable to us. To the extent additional capital is required and cannot be raised successfully, we may then have to limit our then current operations and/or may have to curtail certain, if not all, of our business objectives and plans.

Our management will have broad discretion over the use of the proceeds we receive in this offering, and may not apply the proceeds in ways that increase the value of your investment.

If the representative of the underwriter exercises their option to purchase additional shares in this offering in full, we estimate that net proceeds of the sale of the common stock that we are offering will be approximately $14,233,000. Our management will have broad discretion to use the net proceeds from this offering, and you will be relying on the judgment of our management regarding the application of these proceeds. Although we intend to use a portion of the net proceeds from this offering for research, development and commercialization of our products, because of the number and variability of factors that will determine our use of the net proceeds from this offering, we cannot specify with certainty the particular use of the net proceeds that we will receive from this offering, and we cannot assure you that we will use the proceeds in a manner that will increase the value of your investment or of which you would approve. Moreover, you will not have the opportunity to influence our decision on how to use the proceeds from this offering. We may use the proceeds for corporate purposes that do not immediately enhance our prospects for the future or increase the value of your investment. See the Section entitled “Use of Proceeds.”

The application of the “penny stock” rules to our common stock could limit the trading and liquidity of the common stock, adversely affect the market price of our common stock and increase your transaction costs to sell those shares.

If our common stock become traded on a securities market or exchange, as long as the trading price of our common stock is below US$5 per share, the open-market trading of our common stock will be subject to the “penny stock” rules, unless we otherwise qualify for an exemption from the “penny stock” definition. The “penny stock” rules impose additional sales practice requirements on certain broker-dealers who sell securities to persons other than established customers and accredited investors (generally those with assets in excess of US$1.0 million or annual income exceeding US$200,000 or US$300,000 together with their spouse). These regulations, if they apply, require

44

the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the associated risks. Under these regulations, certain brokers who recommend such securities to persons other than established customers or certain accredited investors must make a special written suitability determination regarding such a purchaser and receive such purchaser’s written agreement to a transaction prior to sale. These regulations may have the effect of limiting the trading activity of our common stock, reducing the liquidity of an investment in our common stock and increasing the transaction costs for sales and purchases of our common stock as compared to other securities. The stock market in general and the market prices for penny stock companies in particular, have experienced volatility that often has been unrelated to the operating performance of such companies. These broad market and industry fluctuations may adversely affect the price of our stock, regardless of our operating performance. Stockholders should be aware that, according to SEC Release No. 34-29093, the market for penny stocks has suffered in recent years from patterns of fraud and abuse. Such patterns include: (i) control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (iii) boiler room practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (iv) excessive and undisclosed bid-ask differential and markups by selling broker-dealers; and (v) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, along with the resulting inevitable collapse of those prices and with consequent investor losses. The occurrence of these patterns or practices could increase the volatility of our share price.

Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our corporate charter and our bylaws that will become effective upon the closing of this offering may discourage, delay or prevent a merger, acquisition or other change in control of our company that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, these provisions:

         our board of directors is divided into three classes, one class of which is elected each year by our stockholders with the directors in each class to serve for a three-year term;

         the authorized number of directors can be changed only by resolution of our board of directors;

         directors may be removed only by the affirmative vote of the holders of at least sixty percent (60%) of our voting stock, whether for cause or without cause;

         our bylaws may be amended or repealed by our board of directors or by the affirmative vote of sixty-six and two-thirds percent (66 2/3%) of our stockholders;

         stockholders may not call special meetings of the stockholders or fill vacancies on the board of directors;

         our board of directors will be authorized to issue, without stockholder approval, preferred stock, the rights of which will be determined at the discretion of the board of directors and that, if issued, could operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that our board of directors does not approve;

         our stockholders do not have cumulative voting rights, and therefore our stockholders holding a majority of the shares of common stock outstanding will be able to elect all of our directors; and

         our stockholders must comply with advance notice provisions to bring business before or nominate directors for election at a stockholder meeting.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the

45

person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on our Company. If no securities or industry analysts commence coverage of our Company, the trading price for our stock would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price may decline. If one or more of these analysts ceases coverage of our Company or fails to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

46

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements. Such forward-looking statements include those that express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These forward-looking statements are based on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown that could cause actual results and developments to differ materially from those expressed or implied in such statements. Those risks and uncertainties include, among others:

         our ability to implement our business plan;

         our ability to raise additional capital to meet our liquidity needs;

         our ability to generate product revenues;

         our ability to achieve profitability;

         our ability to satisfy U.S. (including FDA) and international regulatory requirements;

         our ability to obtain market acceptance of our technology and products;

         our ability to compete in the market;

         our ability to advance our clinical trials;

         our ability to fund, design and implement clinical trials;

         our ability to demonstrate that our lead product candidate is safe for human use and effective for indicated uses;

         our ability to gain acceptance of physicians and patients for use of our lead product;

         our dependency on third-party researchers, manufacturers and payors;

         our ability to establish and maintain strategic partnerships, including for the distribution of our lead product and any future products that we may acquire;

         our ability to attract and retain a sufficient qualified personnel;

         our ability our ability to obtain or maintain patents or other appropriate protection for the intellectual property;

         our dependency on the intellectual property licensed to us or possessed by third parties;

         our ability to adequately support future growth; and

         potential product liability or intellectual property infringement claims.

In some cases, you can identify forward-looking statements by terminology, such as “expects,” “anticipates,” “intends,” “estimates,” “plans,” “believes,” “seeks,” “may,” “should,” “could,” “would,” “will”, “future,” “likely,” “goal,” “continue,” “appears,” “suggests,” “ongoing,” or the negative of such terms or other similar expressions. Accordingly, these statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this prospectus.

You should read this prospectus and the documents that we reference herein and therein and have filed as exhibits to the registration statement, of which this prospectus is part, completely and with the understanding that our actual future results may be materially different from what we expect. You should assume that the information appearing in this prospectus is accurate as of the date on the front cover of this prospectus only. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. These risks and uncertainties, along with others, are described above under the heading

47

“Risk Factors.” Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We qualify all of the information presented in this prospectus, and particularly our forward-looking statements, by these cautionary statements.

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USE OF PROCEEDS

We estimate that the net proceeds from our issuance and sale of shares of our common stock in this offering will be approximately $12.3 million, (or approximately $14.2 million if the underwriters exercise their over-allotment option in full), assuming an initial public offering price of $10.00 per share, which is the mid-point of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

A $1.00 increase (decrease) in the assumed initial public offering price of $10.00 per share, would increase (decrease) the net proceeds from this offering by approximately $1.3 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

We currently intend to use the net proceeds from this offering as follows:

         approximately $6.5 million to fund our initial Phase 3 clinical trial for the use of AD04 to treat AUD;

         approximately $331,000 (which includes a redemption payment of 115% of the principal amount) to repay the loan that is subject to mandatory redemption upon consummation of a financing in the amount of $250,000. The loan, which was for working capital purposes, matures on November 1, 2017, is in the principal amount of $287,500, accrues interest at a rate of 2% per annum, and is subject to mandatory redemption upon consummation of this offering;

         approximately $75,950, $147,000, and $34,300 for cash payments to be made to our Chairman of the Board, Chief Executive officer and Chief Operating Officer/Chief Financial Officer, respectively in accordance with the terms of our Performance Bonus Plan. Under the Performance Bonus Plan, 5.25% of a strategic transaction  up to a maximum of $14.7 million (one or more transactions that provide funds to us and/or our members that enable the commencement of the clinical development of AD04) will be set aside for our personnel, with 1.25% of funds to be awarded to the Chairman of the Board and the remainder to be awarded at the Chief Executive Officer’s discretion, with no more than 3.15% payout to the Chief Executive Officer. The maximum bonus amount to be paid out of the Performance Bonus Plan is $771,750 (contingent upon us raising $14.7 million, or such pro rata lesser amount to the extent the gross proceeds from this offering are less) and we have the right to pay up to 65% of the amounts due with our equity; the $257,250 cash payment assumes that we pay 65% of the amount due under the Performance Bonus Plan in equity;

         approximately $210,000 for development, set up and authorization of the AD04 companion diagnostic test;

         approximately $240,000 for payments under the license agreement for the patents covering AD04, including the prosecution and maintenance of the AD04 patent estate;

         approximately $2.7 million for personnel costs, including enhancing our executive team to manage and grow our business, including hiring a Chief Financial Officer with public company experience and a Chief Development Officer to oversee the clinical trials of AD04;

         approximately $560,000 for research and development, including without limitation, potentially developing a once a day formulation of AD04; and

         the balance for working capital and general corporate purposes.

This expected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to be received from this offering. The amounts and timing of our actual expenditures will depend on numerous factors including the progress in, and costs of, our clinical trials and other preclinical development programs and the amount of funding, if any, received from grants. Accordingly, our management will have broad discretion in the application of the net proceeds, and investors will be relying on the judgment of management regarding the application of the net proceeds from the offering. We may find it necessary or advisable to reallocate the net proceeds of this offering; however, any such reallocation would be substantially limited to the categories set forth above as we do not intend to use the net proceeds for other purposes.

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Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment grade, interest bearing instruments and U.S. government securities.

DIVIDEND POLICY

We do not anticipate paying dividends on our common stock. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. We are not subject to any legal restrictions respecting the payment of dividends, except that we may not pay dividends if the payment would render us insolvent. Any future determination as to the payment of cash dividends on our common stock will be at our board of directors’ discretion and will depend on our financial condition, operating results, capital requirements and other factors that our board of directors considers to be relevant.

CORPORATE CONVERSION/REINCORPORATION

In connection with this offering, our board of directors and the holders of a majority of our outstanding units will elect to convert ADial Pharmaceuticals, L.L.C. from a Virginia limited liability company into a Virginia corporation, and then reincorporate in Delaware by merging with Adial Pharmaceuticals, Inc., a Delaware corporation and wholly owned subsidiary of ADial Pharmaceuticals, L.L.C. In order to consummate such a conversion, a certificate of conversion will be filed with the Secretary of State of the State of Virginia and certificates of merger will be filed with the Secretary of State of the States of Delaware and Virginia prior to the effective date of the registration statement of which this prospectus is a part. In connection with the corporate conversion/reincorporation, all outstanding LLC Units will be automatically converted into shares of common stock of the Virginia corporation and then ultimately into an aggregate of 3,268,005 shares of common stock of Adial Pharmaceuticals, Inc. No U.S. federal taxable income or taxable gain is expected to be recognized by Adial Pharmaceuticals, Inc. as a result of our conversion from a limited liability company into a Virginia corporation and our subsequent reincorporation merger into Delaware.

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CAPITALIZATION

The following table sets forth our capitalization, as of June 30, 2017:

         on an actual basis;

         on a pro forma basis to give effect to the (i) corporate conversion/reincorporation (including the conversion of the Class B Units issued in July and August 2017), (ii) the debt conversion, (iii) the issuance of 215,879 shares of our common stock to consultants, employees and one debtholder upon consummation of the offering, (iv) the issuance of an aggregate of 47,775 shares of common stock having a value of $477,750 that we have agreed to issue to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer upon consummation of this offering in accordance with the terms of our Performance Bonus Plan (at an assumed offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus); (v) the receipt of $10,000 in cash proceeds from the sale of 9,434 Class B Units in July 2017 and the issuance of such Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) as if the issuance and sale had occurred on June 30, 2017; (vi) the receipt of $10,000 in cash proceeds from the sale of 9,434 Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) in August 2017 and the issuance of such Class B Units as if the issuance and sale had occurred on June 30, 2017; and (vii) the expense of the issuance of warrants to purchase 376,352 shares of common stock to a debt holder and consultants; and

         on a pro forma as adjusted basis after giving effect to the (i) corporate conversion/reincorporation (including the conversion of the Class B Units issued in July and August 2017); (ii) the debt conversion; (iii) the issuance of 215,879 shares of common stock to consultants, employees and one debtholder upon consummation of this offering; (iv) the issuance of 47,775 shares of common stock having a value of $477,750 that we have agreed to issue to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer upon consummation of this offering in accordance with the terms of our Performance Bonus Plan (at an assumed offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus); (v) the receipt of $10,000 in cash proceeds from the sale of 9,434 Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) in July 2017 and the issuance of such Class B Units as if the issuance and sale had occurred on June 30, 2017; (vi) the receipt of $10,000 in cash proceeds from the sale of 9,434 Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) in August 2017 and the issuance of such Class B Units, as if the issuance and sale had occurred on June 30, 2017; (vii) the sale of the shares of our common stock in this offering at the assumed public offering price of $10.00 per share, which is the mid-point of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us; (viii) the expense of the issuance of warrants to purchase 376,352 shares of common stock to a debt holder and consultants; (ix) the cash repayment of our bridge loan with $331,000; and (x) cash payment of $257,250 to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer upon consummation of this offering in accordance with the terms of our Performance Bonus Plan.

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You should consider this table in conjunction with “Use of Proceeds,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes thereto included elsewhere in this prospectus.

 

 

As of June 30, 2017

 

 

(unaudited)

 

 

ADial
Pharmaceuticals,
LLC Actual

 

ADial
Pharmaceuticals,
Inc. Pro Forma

 

ADial
Pharmaceuticals,
Inc. Pro Forma,
As
Adjusted
(1)

Cash

 

$

137,134

 

 

157,134

 

 

11,848,884

 

Total Indebtedness

 

$

496,512

 

 

262,228

 

 

 

Members’/stockholders’ equity

 

 

9,915,570

 

 

 

 

 

Common Stock, $0.001 par value, 50,000,000 shares authorized, pro forma and pro forma as adjusted; 4,068,504 shares issued and outstanding, pro forma; 5,468,504 shares issued and outstanding, pro forma, as adjusted.

 

 

 

 

4,069

 

 

5,469

 

Additional paid in capital/cost of offering

 

 

 

 

14,265,097

 

 

26,543,697

 

Accumulated deficit

 

 

(10,381,083

)

 

(14,451,087

)

 

(14,776,167

)

Total members’ deficiency/stockholders’ equity (deficit)

 

 

(465,513

)

 

(181,921

)

 

11,772,999

 

Total capitalization

 

$

30,999

 

 

80,307

 

 

11,772,999

 

__________

(1)      A $1.00 increase or decrease in the assumed initial public offering price of $10.00 per share would increase or decrease total stockholders’ equity and total capitalization on a pro forma as adjusted basis by approximately $1,288,000, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions.

The number of shares of common stock that will be outstanding immediately after this offering is based on the number of shares of common stock outstanding immediately prior to this offering after giving effect to the debt conversion, and the corporate conversion/reincorporation. The number excludes:

         1,750,000 shares of our common stock reserved for future issuance under our 2017 equity incentive plan we intend to adopt immediately prior to the closing of this offering;

         56,000 shares of our common stock issuable upon exercise of the warrants granted to Aegis Capital Corp. upon completion of this offering;

         482,555 shares of our common stock issuable upon the exercise of outstanding warrants, at a weighted average exercise price of $5.51 per shares;

         174,282 shares of our common stock issuable upon outstanding options to purchase shares of common stock; and

         excludes an additional 320,352 shares of our common stock to be issued upon the exercise of outstanding warrants to be issued upon consummation of this offering at an exercise price equal to the initial offering price of the common stock.

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DILUTION

If you invest in our common stock in this offering, your interest will be immediately and substantially diluted to the extent of the difference between the public offering price per share of our common stock and the pro forma net tangible book value per share of our common stock after giving effect to this offering.

Our historical net tangible book value as June 30, 2017 was $(473,000). Historical net tangible book value per share as of June 30, 2017 has not been provided due to the fact that at June 30, 2017 we were a limited liability company and did not have shares of common stock outstanding.

Our pro forma net tangible book value as of June 30, 2017 was $(190,000), or $(0.05) per share of our common stock. Pro forma net tangible book value per share represents the amount of our total tangible assets (as adjusted to take into account $10,000 in cash proceeds from the sale of 9,434 of our Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) in July 2017, $10,000 in cash proceeds from the sale of 9,434 of our Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) in August 2017, and the issuance of such Class B Units as if the issuances and sales had occurred on June 30, 2017) less our total liabilities, adjusted to give effect to the debt conversion, divided by the pro forma number of shares of our common stock outstanding as of June 30, 2017, which includes 3,268,005 shares after giving effect to the corporate conversion/reincorporation (including the conversion of the Class B Units issued in July and August 2017), 536,845 shares after giving effect to the debt conversion, the issuance of an additional 215,879 shares of common stock that we have agreed to issue to consultants, employees and one debt holder upon consummation of this offering and the issuance of 47,775 shares of common stock having a value of $477,750 that we have agreed to issue to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer upon consummation of this offering in accordance with the terms of our Performance Bonus Plan (at an assumed offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus).

After giving effect to the sale of the shares in this offering at the assumed initial public offering price of $10.00 per share, which is the mid-point of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us, our pro forma as adjusted net tangible book value at June 30, 2017 would have been approximately $11,765,418, or $2.15 per share. This represents an immediate increase in pro forma net tangible book value of approximately $2.20 per share to our existing stockholders, and an immediate dilution of $7.85 per share to investors purchasing shares of common stock in this offering.

Dilution in pro forma net tangible book value per share represents the difference between the amount per share paid by purchasers of our common stock in this offering and the pro forma net tangible book value per share of our common stock immediately after this offering.

The following table illustrates the per share dilution to investors purchasing shares in the offering:

Assumed initial public offering price per share

 

$

 

 

10.00

 

Pro forma net tangible book value per share as of June 30, 2017

 

$

 

 

(0.05

)

Increase in pro forma net tangible book value per share attributable to consummation of offering

 

$

 

 

2.20

 

Pro forma as adjusted net tangible book value per share after this offering

 

 

 

 

2.15

 

Dilution per share to new investors

 

 

 

 

7.85

 

If the underwriters exercise their over-allotment option in full, the pro forma as adjusted net tangible book value will increase to $2.42 per share, representing an immediate dilution of $7.58 per share to new investors, assuming that the initial public offering price will be $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus.

A $1.00 increase (decrease) in the assumed initial public offering price of $10.00 per share would increase (decrease) the pro forma as adjusted net tangible book value by approximately $1,288,00, and increase (decrease) the pro forma as adjusted net tangible book value per share by $0.24 per share, and the dilution in pro forma as adjusted net tangible book value per share to investors in this offering by $(0.76) per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

53

The following table summarizes, on a pro forma as adjusted basis as of June 30, 2017, the differences between the number of shares of common stock purchased from us, the total consideration and the average price per share paid by existing stockholders and by investors participating in this offering, after deducting estimated underwriting discounts and commissions and estimated offering expenses, at an assumed public offering price of $10.00 per share, the mid-point of the estimated price range of this prospectus.

 

 

Shares
Purchased

 

Total
Consideration

 

Average
Price Per

 

 

Number

 

%

 

Amount

 

%

 

Share

Existing stockholders

 

4,068,504

 

74

%

 

$

11,537,226

 

45

%

 

$

2.84

New investors

 

1,400,000

 

26

%

 

$

14,000,000

 

55

%

 

$

10.00

Total/Weighted Average

 

5,468,504

 

100

%

 

$

25,537,226

 

100

%

 

$

4.67

The number of shares of common stock that will be outstanding immediately after this offering is based on 4,068,504 shares of common stock outstanding immediately prior to this offering after giving effect to the debt conversion and the corporate conversion/reincorporation, the issuance of an additional 215,879 shares of common stock that we have agreed to issue to consultants and employees upon consummation of this offering the receipt of $10,000 in cash proceeds from the sale of 9,434 Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) in July 2017, the receipt of $10,000 in cash proceeds from the sale of 9,434 Class B Units (1,755 shares of common stock post corporate conversion/reincorporation) in August 2017, and the issuance of such Class B Units and the issuance of 47,775 shares of common stock having a value of $477,750 that we have agreed to issue to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer upon consummation of this offering in accordance with the terms of our Performance Bonus Plan. The number excludes:

         1,750,000 shares of our common stock reserved for future issuance under our 2017 equity incentive plan we intend to adopt immediately prior to the closing of this offering;

         56,000 shares of our common stock issuable upon exercise of the warrants granted to Aegis Capital Corp. upon completion of this offering;

         482,555 shares of our common stock issuable upon the exercise of outstanding warrants at a weighted average exercise price of $5.51 per shares;

         174,282 shares of our common stock issuable upon outstanding options to purchase shares of common stock; and

         excludes an additional 320,352 shares of our common stock to be issued upon the exercise of outstanding warrants to be issued upon consummation of this offering at an exercise price equal to the initial offering price of the common stock.

If the underwriters exercise their over-allotment option in full, the number of shares held by new investors will increase to 1,610,000, or 28% of the total number of shares of common stock outstanding after this offering and the shares held by existing stockholders will be 4,068,504 but the percentage of shares held by existing stockholders will decrease to 72% of the total shares outstanding.

To the extent that the underwriters’ over-allotment option is exercised or any warrants or options are exercised, there will be further dilution to new investors.

54

MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis should be read together with our financial statements and the related notes appearing elsewhere in this prospectus. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this prospectus.

Overview

We are a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use disorder (“AUD”) using our lead investigational new drug product, AD04, a selective serotonin-3 antagonist (i.e., a “5-HT3 antagonist”). The active ingredient in AD04 is ondansetron, which is also the active ingredient in Zofran®, an approved drug for treating nausea and emesis. AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption. We intend to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes. We believe our approach is unique in that it targets the serotonin system and individualizes the treatment of AUD, through the use of genetic screening. We have created an investigational companion diagnostic biomarker test for the genetic screening of patients with certain biomarkers that, as reported in the American Journal of Psychiatry (Johnson, et. al. 2011 & 2013), we believe will benefit from treatment with AD04. Our strategy is to integrate the pre-treatment genetic screening into AD04’s label to create a patient-specific treatment in one integrated therapeutic offering. Our goal is to develop a genetically targeted, effective and safe product candidate to treat AUD that does not require abstinence as part of the treatment.

We have a worldwide, exclusive license from the University of Virginia Patent Foundation (d.b.a the Licensing & Venture Group) (“UVA LVG”), which is the licensing arm of the University of Virginia, to commercialize our investigational drug candidate, AD04, subject to Food and Drug Administration (“FDA”) approval of the product, based upon three separate patents and patent application families, with patents issued in over 40 jurisdictions, including three issued patents in the U.S. Our investigational agent has been used in several investigator-sponsored trials and we possess or have rights to use toxicology, pharmacokinetic and other preclinical and clinical data that supports our Phase 3 clinical trial. Our therapeutic agent was the product candidate used in a University of Virginia investigator sponsored Phase 2b clinical trial of 283 patients. In this Phase 2b clinical trial, ultra-low dose ondansetron, the active pharmaceutical agent in AD04, showed a statistically significant difference between ondansetron and placebo for both the primary endpoint and secondary endpoint, which were reduction in severity of drinking measured in drinks per drinking day (1.71 drinks/drinking day; p=0.0042), and reduction in frequency of drinking measured in days of abstinence/no drinking (11.56%; p=0.0352), respectively. Additionally, and importantly, the Phase 2b results showed a significant decrease in the percentage of heavy drinking days (11.08%; p=0.0445) with a “heavy drinking day” defined as a day with four (4) or more alcoholic drinks for women or five (5) or more alcoholic drinks for men consumed in the same day.

The active pharmaceutical agent in AD04, our lead investigational new drug product, is ondansetron (the active ingredient in Zofran®), which was granted FDA approval in 1991 for nausea and vomiting post-operatively and after chemotherapy or radiation treatment and is now commercially available in generic form. In studies of Zofran® conducted as part of its FDA review process, ondansetron was given acutely at dosages up to almost 100 times the dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously (“i.v.”), which results in almost twice the exposure level as oral dosing. Even at high doses given i.v. the studies found that ondansetron is well-tolerated and results in few adverse side effects at the currently marketed doses, which reach more than 70 times the AD04 dose and are given i.v. The formulation dosage of ondansetron used in our drug candidate (and expected to be used by us in our Phase 3 clinical trials) has the potential advantage that it contains a much lower concentration of ondansetron than the generic formulation/dosage that has been used in prior clinical trials, is dosed orally, and is available with use of a companion diagnostic biomarker. Our development plan for AD04 is designed to demonstrate both the efficacy of AD04 in the genetically targeted population and the safety of ondansetron when administered chronically at the AD04 dosage. However, to the best of our knowledge, no comprehensive clinical study has been performed to date that has evaluated the safety profile of ondansetron for long-term use as anticipated at any dosage.

55

According to the National Institute of Alcohol Abuse and Alcoholism (the “NIAAA”) and the Journal of the American Medical Association (“JAMA”), in the United States alone, approximately 35 million people each year have AUD (such number is based upon the 2012 data provided in Grant et. al. the JAMA 2015 and has been adjusted to reflect a compound annual growth rate of 1.13%, which is the growth rate reported by U.S. Census Bureau for the general adult population from 2012-2017), resulting in significant health, social and financial costs with excessive alcohol use being the fourth leading cause of preventable death and is responsible for 31% of driving fatalities in the United States (NIAAA Alcohol Facts & Statistics). AUD contributes to over 200 different diseases and 10% of children live with a person that has an alcohol problem. The Centers for Disease Control (the “CDC”) has reported that AUD costs the U.S. economy about $250 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. Despite this, according to the article in the JAMA 2015 publication, only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only 3.6% by a physician (i.e., approximately 1.3 million people). In addition, according to the NIAAA, the problem in the United States appears to be growing with almost a 50% increase in AUD prevalence between 2002 and 2013.

We have devoted substantially all of our resources to development efforts relating to AD04, including preparation for conducting clinical trials, providing general and administrative support for these operations and protecting our intellectual property. We currently do not have any products approved for sale and we have not generated any significant revenue from product sales since our inception. From our inception through the date of this prospectus, we have funded our operations primarily through the private placement of Class A and Class B units, the convertible debt and the bridge note debt.

We have incurred net losses in each year since our inception, including net losses of approximately $0.4 million and $0.8 million for the years ended December 31, 2016 and 2015, respectively, and $0.4 million and $0.2 million for the six months ended June 30, 2017 and 2016, respectively. We had an accumulated deficit of approximately $10.4 million as of June 30, 2017. Substantially all our operating losses resulted from costs incurred in connection with our research and development programs, and from general and administrative costs associated with our operations.

We expect to continue to incur significant expenses and to incur increasing operating losses for at least the next several years. We anticipate that our expenses and operating losses will increase substantially following this offering as we:

         complete the planned Phase 3 trials of our lead product candidate, AD04 for the treatment of AUD;

         hire internal staff to coordinate and manage the overall drug development process;

         further develop the companion diagnostic genetic test;

         maintain, expand and protect our intellectual property portfolio;

         seek to obtain regulatory approvals for AD04;

         continue our research and development efforts, including without limitation, potentially developing a once a day formulation of AD04;

         add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts; and

         operate as a public company.

We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain marketing approval for AD04, which we expect will take a number of years and is subject to significant uncertainty. Although we believe the proceeds from this offering will be sufficient in order to enable us to complete our first Phase 3 clinical trial, we anticipate the need for at least a second Phase 3 clinical trial, and possibly a third, in order to receive FDA approval for commercialization of AD04 for the treatment of AUD. Accordingly, we anticipate that we will need to raise additional capital in addition to the net proceeds of this offering prior to the commercialization of and to complete the clinical trials for AD04. Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our operating activities through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and

56

distribution arrangements and other collaborations, strategic alliances and licensing arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop AD04.

Clinical Trials — Research and Development Schedule

We currently anticipate that we, working in collaboration with our vendors, upon execution of collaborative research and development agreements with them, will be able to execute the following timeline:

AD04 — Two-Stage Clinical Development Strategy — Conduct the Phase 3 clinical trials sequentially

* Even if the 1st Phase 3 trial is not accepted by the FDA due to the study not being well-powered for the FDA’s currently stated end point, we still expect that the EMA will require only one additional trial. In this case, however, a 3rd trial might be required by the FDA (i.e., three Phase 3 trials in total). If two additional trials are required for FDA approval after an initial Phase 3 trial conducted in the EMA, we would expect to run the 2nd and 3rd trials in parallel (i.e., at the same time) so as not to increase the expected time to approval. The 2nd additional trial (i.e., the 3rd Phase 3 trial) would be expected to require an additional $20 million in expenditures.

We expect to incur R&D expenses of approximately $7.2 million over the next 12-18 months. We estimate the cost to complete our initial Phase 3 clinical trial of AD04 for the treatment of AUD to be $6,500,000, all of which is expected to be derived from the net proceeds of this offering and is subject to many factors, some of which are beyond our control. These factors include, but are not limited to, the following:

         the progress and cost of our research and development activities;

         the number and scope of our research and development programs;

         the progress and cost of our preclinical and clinical development activities;

         our ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements;

         our ability to achieve our milestones under licensing arrangements;

         the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and

         the costs and timing of regulatory approvals.

57

Results of operations for the six months ended June 30, 2017 and 2016 (rounded to nearest thousand)

The following table sets forth the components of our statements of operations in dollars for the periods presented:

 

 

For the Six Months Ended
June 30,

 

Change

 

 

2017

 

2016

 

(Decrease)

Research and development expenses

 

$

102,000

 

 

77,000

 

 

25,000

 

General and administrative expenses

 

 

309,000

 

 

144,000

 

 

164,000

 

Total Operating Expenses

 

 

411,000

 

 

221,000

 

 

189,000

 

 

 

 

 

 

 

 

 

 

 

 

Loss From Operations

 

 

(411,000

)

 

(221,000

)

 

189,000

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

32,000

 

 

 

 

32,000

 

Total other income (expenses)

 

 

(32,000

)

 

 

 

(32,000

)

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(443,000

)

 

(221,000

)

 

221,000

 

Research and development (“R&D”) expenses

R&D expenses increased by approximately $25,000 (32%) during the six months ended June 30, 2017 as compared to the six months ended June 30, 2016. The increase was primarily attributable to the offset of decreased costs in 2016 due to the completion of the AD04 accelerated stability testing program ($3,940) by the increased costs in 2017 due to the accrual of $20,000 minimum royalty expense related to a payment due under the UVA license at the end of 2017.

General and administrative expenses

General and administrative expenses increased by approximately $164,000 (114%) during the during the six months ended June 30, 2017 as compared to the six months ended June 30, 2016. The increase was attributable to added part-time headcount and contracting of consultants in the first half of 2017, largely in preparation for an initial public offering.

Other income (expenses)

Other expense increased by approximately $32,000 during the six months ended June 30, 2017. The increase was attributable to an increase in interest expense due to increased debt.

Results of operations for the three months ended June 30, 2017 and 2016 (rounded to nearest thousand)

The following table sets forth the components of our statements of operations in dollars for the periods presented:

 

 

For the Three Months Ended
June 30,

 

Change

 

 

2017

 

2016

 

(Decrease)

Research and development expenses

 

$

58,000

 

 

38,000

 

 

20,000

General and administrative expenses

 

 

183,000

 

 

58,000

 

 

125,000

Total Operating Expenses

 

 

241,000

 

 

96,000

 

 

145,000

 

 

 

 

 

 

 

 

 

 

Loss From Operations

 

 

(241,000

)

 

(96,000

)

 

145,000

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(23,000

)

 

 

 

23,000

Total other income (expenses)

 

 

(23,000

)

 

 

 

23,000

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(264,000

)

 

(96,000

)

 

168,000

58

Research and development (“R&D”) expenses

R&D expenses increased by approximately $20,000 (53%) during the three months ended June 30, 2017 as compared to the three months ended June 30, 2016. The increase was primarily attributable by added contract labor costs of about $6,000 and the accrual of $10,000 minimum royalty expense related to a payment due under the UVA license at the end of 2017.

General and administrative expenses

General and administrative expenses increased by approximately $125,000 (216%) during the three months ended June 30, 2017 as compared to the three months ended June 30, 2016. The increase was attributable to added part-time headcount and contracting of consultants in 2017, largely in preparation for an initial public offering.

Other income (expenses)

Other expense increased by approximately $23,000 during the three months ended June 30, 2017. The increase was attributable to an increase in interest expense due to increased debt.

Results of operations for the years ended December 31, 2016 and 2015 (rounded to nearest thousand)

The following table sets forth the components of our statements of operations in dollars for the periods presented:

 

 

For the Years Ended
December 31,

 

Change

 

 

2016

 

2015

 

(Decrease)

Research and development expenses

 

$

146,000

 

 

322,000

 

 

176,000

 

General and administrative expenses

 

 

265,000

 

 

497,000

 

 

232,000

 

Total Operating Expenses

 

 

411,000

 

 

819,000

 

 

408,000

 

 

 

 

 

 

 

 

 

 

 

 

Loss From Operations

 

 

(411,000

)

 

(819,000

)

 

(408,000

)

 

 

 

 

 

 

 

 

 

 

 

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

 

 

1,000

 

 

1,000

 

Change in fair value of derivative liability

 

 

 

 

 

 

 

Interest expense

 

 

(10,000

)

 

 

 

10,000

 

Total other income (expenses)

 

 

(10,000

)

 

1,000

 

 

11,000

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(421,000

)

 

(818,000

)

 

(397,000

)

Research and development (“R&D”) expenses

R&D expenses decreased by approximately $176,000 (55%) during the fiscal year ended December 31, 2016 as compared to the fiscal year ended December 31, 2015. The decrease was primarily attributable to the completion of manufacturing our clinical trial material for our planned initial Phase 3 trial, completion of the technical validation of our genetic testing laboratory, and completion of the clinical study report for the Phase 2b trial of AD04.

General and administrative expenses

General and administrative expenses decreased by approximately $232,000 (47%) during the fiscal year ended December 31, 2016 as compared to the fiscal year ended December 31, 2015. The decrease was attributable to a decrease in equity based compensation of approximately $97,000 due to the decrease in personnel and the expiration of the rights of repurchase on certain equity grants; a decrease in litigation expense of approximately $46,000 due to the settlement of the one litigation matter, and a decrease in other general and administrative expenses of $89,000 due to reduced operations.

59

Other income (expenses)

Other (income) expense decreased by approximately $11,000 during the fiscal year ended December 31, 2016. The increase was attributable to an increase in interest expense due to increased debt.

Liquidity and capital resources for the six months ended June 30, 2017 and 2016

Overview

Our principal liquidity needs have historically been working capital, R&D, patent costs and personnel costs. We expect these needs to continue as we develop and eventually commercialize our compound. Over the next several years, we expect to increase our R&D expenses as we undergo clinical trials to demonstrate the safety and efficacy of the product. To date, we have funded our operations primarily with equity financings.

As of June 30, 2017, we had approximately $137,000 in cash and cash equivalents and ($473,000) of negative working capital, compared to approximately $88,000 in cash and cash equivalents and $(114,000) of negative working capital as of December 31, 2016. As of December 31, 2016, we had outstanding convertible notes payable, net of debt discount, of approximately $234,000. Pursuant to the terms of the convertible notes, the principal and interest will be due in 2029, bear an interest rate of 15% per annum. The notes will automatically convert to equity in the event that we close a financing round of $2,000,000 or more, excluding the value of the conversion of these notes.

In May 2017, we issued an additional note in the principal amount of $287,500 and received proceeds of $250,000 from said loan. The note bears interest of 2% annually and matures on November 1, 2017. The note is to be mandatorily redeemed by us upon the closing of our next financing in excess of $250,000 at a redemption premium of 115% of the principal amount of the note.

Cash flows

(rounded to nearest thousand)

 

For the Six Months Ended
June 30,

Provided by (used in)

 

 

2017

 

 

 

2016

 

Operating activities

 

$

(236,000

)

 

$

(126,000

)

Investing activities

 

 

35,000

 

 

 

 

Financing activities

 

 

250,000

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

$

49,000

 

 

$

(126,000

)

We used cash during the six months ended June 30, 2017 primarily to fund our general and administrative expenses and for research and development

Our current cash and cash equivalents at June 30, 2017 will not be sufficient to fund operations for at least the next twelve months. However, we believe that our existing cash and cash equivalents and the anticipated net proceeds from this offering will be sufficient in the aggregate to meet our anticipated cash requirements for at least the next 12 months. We may, however, require additional liquidity as we continue to execute our business strategy, including additional funds in order to commence a second Phase 3 trial of AD04 as planned after completion of the first Phase 3 trial funded through this financing. Our liquidity may be negatively impacted as a result of a research and development cost increases in addition to general economic and industry factors. We anticipate that, to the extent that we require additional liquidity, it will be funded through the incurrence of other indebtedness, additional equity financings or a combination of these potential sources of liquidity. In addition, we may raise additional funds to finance future cash needs through corporate collaboration and licensing arrangements. If we raise additional funds by issuing equity securities or convertible debt, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our products, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us. The covenants under future credit facilities may limit our ability to obtain additional debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Any failure to raise capital in the future could have a negative impact on our financial condition and our ability to pursue our business strategies.

60

Off-balance sheet arrangements

We do not have any off-balance sheet arrangements.

Liquidity and capital resources for the years ended December 31, 2016 and 2015

Overview

Our principal liquidity needs have historically been working capital, R&D and personnel costs. We expect these needs to continue as we develop and eventually commercialize our compound. Over the next several years, we expect to increase our R&D expenses as we undergo clinical trials to demonstrate the safety and efficacy of the product. To date, we have funded our operations primarily with equity financings.

As of December 31, 2016, we had approximately $88,000 in cash and cash equivalents and ($114,000) of negative working capital, compared to approximately $162,000 in cash and cash equivalents and $153,000 of positive working capital on December 31, 2015. As of December 31, 2016, we had outstanding convertible notes indebtedness of approximately $235,000. Pursuant to the terms of the convertible notes, the principal and interest will be due in 2029, bear an interest rate of 15% per annum. The notes will automatically convert to equity in the event that we close a financing round of $2,000,000 or more, excluding the value of the conversion of these notes.

In September and December 2016, we issued convertible notes (the “notes”) with an outstanding principal amount of $235,000 to its members. The principal and interest is due in 2029, and the notes bear interest at a rate of 15% per annum. The principal and interest is due in 2029, and the notes bear interest at a rate of 15% per annum. The notes will automatically convert to such equity units in the event we issue and sell either common or preferred units of $2,000,000 or more, excluding the value of the conversion of these notes. The conversion price will be either one third the price offered during the financing round that triggers the conversion, or the price obtained by dividing $2,000,000 by our fully-diluted capitalization at the time of the financing round that triggers the conversion, whichever is lower.

Our current cash and cash equivalents at December 31, 2016 will not be sufficient to fund operations for at least the next twelve months. However, we believe that our existing cash and cash equivalents and the anticipated net proceeds from this offering will be sufficient in the aggregate to meet our anticipated cash requirements for at least the next twenty-four months. We may, however, require additional liquidity as we continue to execute our business strategy, including that we will require additional funds in order to commence the second Phase 3 trial of AD04 that is planned after completion of the first Phase 3 trial, which is the primary use of funds in this financing. Our liquidity may be negatively impacted as a result of a research and development cost increases in addition to general economic and industry factors. We anticipate that, to the extent that we require additional liquidity, it will be funded through the incurrence of other indebtedness, additional equity financings or a combination of these potential sources of liquidity. In addition, we may raise additional funds to finance future cash needs through corporate collaboration and licensing arrangements. If we raise additional funds by issuing equity securities or convertible debt, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our products, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us. The covenants under future credit facilities may limit our ability to obtain additional debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Any failure to raise capital in the future could have a negative impact on our financial condition and our ability to pursue our business strategies.

Cash flows

(rounded to nearest thousand)

 

For the Year Ended
December 31,

Provided by (used In)

 

2016

 

2015

Operating activities

 

$

(274,000

)

 

$

(465,000

)

Investing activities

 

 

 

 

 

 

Financing activities

 

 

200,000

 

 

 

 

Net decrease in cash and cash equivalents

 

$

(74,000

)

 

$

(465,000

)

61

Net cash used in operating activities

Net cash provided by operating activities consists primarily of net loss adjusted for certain non-cash items (including amortization, change in fair value of derivative liability, profits interest compensation and amortization of debt discount), and the effect of changes in working capital and other activities. The decrease in cash used in operating activities is primarily due to the decrease in net loss in 2016.

Net cash provided by financing activities

Net cash provided by financing activities primarily consists of capital raising activities through debt financing. Net cash provided by financing activities increased $200,000 during the year ended December 31, 2016, the increase in cash provided by financing activities was attributable to the increase in proceeds from the convertible notes.

Off-balance sheet arrangements

We do not have any off-balance sheet arrangements.

Recent Accounting Pronouncements

Statement of Cash Flows — In 2016 the FASB issued ASU 2016-15, “Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments” and ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”. ASU 2016-15 addresses the presentation and classification of certain cash receipts and payments in the statement of cash flows. ASU 2016-18 is intended to reduce diversity in the presentation of restricted cash and restricted cash equivalents in the cash flows statement. The statement requires that restricted cash and restricted cash equivalents to be included as components of total cash and cash equivalents as presented on the statement of cash flows. These pronouncements go into effect for periods beginning after December 15, 2017. We do not believe the adoption of these pronouncements will have a material effect on the Company’s financial statements.

Leases — In February 2016, the FASB issued ASU 2016-02 which amends existing lease accounting guidance, and requires recognition of most lease arrangements on the balance sheet. The adoption of this standard will result in the Company recognizing a right-of-use asset representing its rights to use the underlying asset for the lease term with an offsetting lease liability. ASU 2016-02 will be effective for fiscal years beginning after December 15, 2018. We are currently evaluating the potential impact of the adoption of this accounting pronouncement to its financial statements.

Going Concern — In August 2014, FASB issued guidance that requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued. An entity must provide certain disclosures if conditions or events raise substantial doubt about the entity’s ability to continue as a going concern. The updated accounting guidance was effective for us on December 31, 2016, and early adoption was permitted. We have implemented this guidance on December 31, 2016.

Stock Compensation — In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which will simplify the income tax consequences, accounting for forfeitures and classification on the Statement of Consolidated Cash Flows. This standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016, with early adoption permitted. This new pronouncement is not expected to have a material effect on our financial position, results of operations or cash flows.

Internal control over financial reporting

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP. Prior to this offering, we were a private company and we are currently in the process of reviewing, documenting and testing our internal control over financial reporting. During our internal reviews, we have identified material weaknesses in our internal control over financial reporting. See “Risk Factors — We have identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in the future.” If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired. If we are unable to remediate these material weaknesses, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal

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controls, we may not be able to accurately or timely report our financial condition or results of operations, or comply with the accounting and reporting requirements applicable to public companies, which may adversely affect investor confidence in us and, as a result, the value of our common stock.

We have not performed an evaluation of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act, nor have we engaged an independent registered accounting firm to perform an audit of our internal control over financial reporting as of any balance sheet date or for any period reported in our financial statements. Presently, we are not an accelerated filer, as such term is defined by Rule 12b-2 of the Exchange Act, and therefore, our management is not presently required to perform an annual assessment of the effectiveness of our internal control over financial reporting. This requirement will first apply to our second Annual Report on Form 10-K. Our independent public registered accounting firm will first be required to attest to the effectiveness of our internal control over financial reporting for our Annual Report on Form 10-K for the first year we are no longer an “emerging growth company.”

Critical accounting policies and estimates

The preparation of the financial statements requires us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of sales and expenses during the reporting periods. Certain of our more critical accounting policies require the application of significant judgment by management in selecting the appropriate assumptions for calculating financial estimates. By their nature, these judgments are subject to an inherent degree of uncertainty. On an ongoing basis, we evaluate our judgments, including those related to prepaid and other current assets, recoverability of long-lived assets and the fair value of our membership units. We use historical experience and other assumptions as the basis for our judgments and making these estimates. Because future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Any changes in those estimates will be reflected in our financial statements as they occur. While our significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this prospectus, we believe that the following accounting policies and estimates are most critical to a full understanding and evaluation of our reported financial results. The critical accounting policies addressed below reflect our most significant judgments and estimates used in the preparation of our financial statements.

Significant items subject to such estimates and assumptions include the valuation of outstanding profits interest units, derivative liabilities, intangible assets useful life, contingent liabilities and income taxes. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes.

Fair Value of Financial Instruments and Fair Value Measurements

Our financial instruments consist primarily of cash, receivables, accounts payable and accrued liabilities, debt instruments and derivative liabilities.

FASB Accounting Standards Codification (“ASC”) Topic 820, “Fair Value Measurements and Disclosures,” requires disclosure of the fair value of financial instruments held by us. ASC Topic 825, “Financial Instruments,” defines fair value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The carrying amounts reported in the balance sheets for receivables, current liabilities and convertible notes payable each qualify as financial instruments and are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments and their expected realization and their current market rate of interest.

The three levels of valuation hierarchy are defined as follows:

         Level 1: Observable inputs such as quoted prices in active markets;

         Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

         Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. As of December 31, 2016, the significant inputs to our derivative liabilities recorded at fair value were considered level 3 inputs.

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Profits Interest Units

The Operating Agreement also creates and authorizes the issuance of Profits Interest Units (“PIU’s”). PIU’s are identical to Class A units except that the amount of cash distributions to be received by the holder of a PIU will be reduced by Distribution Reduction. PIU’s awarded as incentives to personnel are usually subject to our right of repurchase, at the nominal amount, in the event the awardee’s employment with us is terminated. The right of repurchase usually expires over time on a straight-line, monthly basis with the length of expiration of the right of repurchase being 6-48 months depending on the circumstances.

We estimate the fair value of PIU’s granted using the Black Scholes Merton model. We estimate when and if performance-based awards will be earned. If an award is not considered probable of being earned, no amount of equity-based compensation expense is recognized. If the award is deemed probable of being earned, related equity-based compensation expense is recorded. The fair value of an award ultimately expected to vest is recognized as an expense, net of forfeitures, over the requisite service periods in our statements of operations, which is generally the vesting period of the award.

The Black Scholes Merton model requires the input of certain subjective assumptions and the application of judgment in determining the fair value of the awards. The most significant assumptions and judgments include the expected volatility, risk-free interest rate, the expected dividend yield, and the expected term of the awards. In addition, the recognition of equity-based compensation expense is impacted by our estimated forfeiture rates, which is based on an analysis of historical forfeitures. We will continue to evaluate our forfeiture rate, considering our actual forfeiture experience, analysis of employee turnover and other factors.

The assumptions used in our option pricing model represent management’s best estimates. If factors change and different assumptions are used, our equity-based compensation expense could be materially different in the future. The key assumptions included in the model are as follows:

         Expected volatility — We determine the expected price volatility based on the historical volatilities of our peer group as we do not have a sufficient trading history for our units. Industry peers consist of several public companies in the bio-tech industry similar to us in size, stage of life cycle and financial leverage. We intend to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information regarding the volatility of our own stock price becomes available, or unless circumstances change such that the identified companies are no longer similar to us, in which case, more suitable companies whose share prices are publicly available would be utilized in the calculation.

         Risk-free interest rate — The risk free rate was determined based on yields of U.S. Treasury Bonds of comparable terms. The volatility is based on analyzing the stock price and implied volatility of guideline companies.

         Expected dividend yield — We have not previously issued dividends and do not anticipate paying dividends in the foreseeable future. Therefore, we used a dividend rate of zero based on our expectation of additional dividends.

         Expected term — The expected term of the awards is based on an estimated service period of 1.62 years for 2016 and between 2.42 years and 2.58 years for 2015.

The weighted average assumptions used in the Black Scholes Merton model related to profits interest units, for the years ended December 31, 2016 and 2015, are as follows:

 

 

2016

 

2015

Fair Value of Class A unit

 

$0.81 to $0.92

 

$0.63 to $0.76

Risk-free rate

 

0.57%

 

0.51% to 0.70%

Volatility

 

80% to 92%

 

92 to 98%

Dividend yield

 

0%

 

0%

Expected term (years)

 

1.62 years

 

2.42 to 2.58 years

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The Fair Value of the underlying Class A units were valued based on our security offerings, increased for our annual weighted average cost of capital for PIU’s issued in subsequent years from the security offerings. The underlying Class A units were valued using an Option Pricing Model (OPM) using an iterative approach at various total equity values, such that the value of the equity instruments issued was equal to the consideration paid (given the equity structure at the time).

Prior to our initial public offering, in the absence of a public trading market, our board of directors determined a reasonable estimate of the then-current fair value of our equity awards for purposes of granting equity-based compensation based on input from management. We determined the fair value of our PIU utilizing methodologies, approaches and assumptions from a third party valuation firm. In addition, we exercised judgment in evaluating and assessing the foregoing based on several factors including:

         the nature and history of our business;

         our historical operating and financial results;

         the market value of companies that are engaged in a similar business to ours;

         the lack of marketability of our common stock;

         the price at which shares of our equity instruments have been sold;

         the overall inherent risks associated with our business at the time stock option grants or warrants were approved; and

         the overall equity market conditions and general economic trends.

We will continue to accumulate additional data and use judgment in evaluating each assumption on a prospective basis. As of June 30, 2017 and December 31, 2016, we had $8,689 and $69,506, respectively, of unrecognized equity-based compensation expense, net of estimated forfeitures, related to profits interest units that is expected to be recognized in 2017.

Embedded Derivative Liability — Convertible Notes

We have convertible notes outstanding at June 30, 2017 and December 31, 2016 with default payment provisions (default provision that requires payment of three times the outstanding principal amount plus accrued interest). We determined that the default provision is an embedded component that qualifies as a derivative which should be bifurcated from the Convertible Notes and separately accounted for in accordance with FASB ASC 815, “Derivatives and Hedging”. ASC 815 – 15 – 25 – 42 establishes criteria to determine whether puts are closely and clearly related to a debt host should the debt contain a substantial premium or default provision (one that is greater than 10% of the principal resulting from puts that require payoff for more than 110% of principal amount outstanding). The embedded derivative is recorded at fair value on the date of issuance and marked-to-market at each balance sheet date with the change in the fair value recorded as income or expense in the statement of operations.

We used the Monte-Carlo valuation model to determine the fair value of the derivatives liability, using the following key assumptions for the year ended December 31, 2016. The change in the fair value of the derivative liability at June 30, 2017 was not material.

Underlying asset

 

Class A Unit

Class A Expected term (years)

 

5 years

Class A Volatility

 

90-92%

Risk free rate

 

1.67-2.45%

Event of default trigger

 

Starts at 0%, then rises 0.5% per year to a maximum of 5%

Probability of Company Sale

 

45% by 12/31/17

 

 

25% by 12/31/18

 

 

25% by 12/31/19

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Impairment of Long-Lived Assets

Our long-lived assets (consisting of the trademarks) are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the undiscounted future net cash flows expected to be generated by that asset. If the carrying amount of an asset exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Through June 30, 2017, we had not experienced impairment losses on its long-lived assets.

Commitments and Contingencies

The Company follows subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment.

If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company’s financial statements. If the assessment indicates that a potentially material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, and an estimate of the range of possible losses, if determinable and material, would be disclosed.

Loss contingencies considered remote are generally not disclosed unless they involve guarantees, in which case the guarantees would be disclosed. The Company’s legal costs associated with contingent liabilities are recorded to expense as incurred.

Income taxes

We are currently a partnership for U.S. federal income tax purposes. As a partnership, taxable income or loss is includable in the income tax returns of its members. After consummation of this offering, we will become subject to U.S. federal, state and local income taxes and will be taxed at the prevailing corporate tax rates. We recognize the effect of income tax positions only if these positions are more likely than not to be sustained. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The pro forma financial statements included in this prospectus do not include a provision for federal income taxes since each of our pro forma statements of operations have a pro forma net loss. In the future, if redemption or exchange of ADial Pharmaceuticals, L.L.C Units for shares of our common stock or cash occurs and if we determine that such tax benefits are likely to be realized by us, we will record a deferred tax asset based on the step-up in basis resulting from the exchange and the then effective income tax rate.

JOBS Act

We qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financial statements in Management’s discussion and analysis of financial condition and results of operations and exemptions from the requirements of holding advisory “say-on-pay” votes on executive compensation and shareholder advisory votes on golden parachute compensation. We have availed ourselves of the reduced reporting obligations and executive compensation disclosure in this prospectus, and expect to continue to avail ourselves of the reduced reporting obligations available to emerging growth companies in future filings.

In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies. However, we are choosing to take advantage of such extended transition period, and as a result, we may not comply with any new or revised accounting standards on the relevant dates on which non-emerging growth companies must adopt such standards.

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We will continue to qualify as an emerging growth company until the earliest of:

         The last day of our fiscal year following the fifth anniversary of the date of our IPO;

         The last day of our fiscal year in which have annual gross revenues of $1.0 billion or more;

         The date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt;

         The date on which we are deemed to be a “large accelerated filer”, which will occur at such time as we (1) have an aggregate worldwide market value of common equity securities held by non-affiliates of $700 million or more as of the last business day of our most recently completed second quarter, (2) have been required to file annual and quarterly reports under the Exchange Act for a period of at least 12 months and (3) have filed at least one annual report pursuant to the Exchange Act.

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BUSINESS

Overview

We are a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use disorder (“AUD”) using our lead investigational new drug product, AD04, a selective serotonin-3 antagonist (i.e., a “5-HT3 antagonist”). The active ingredient in AD04 is ondansetron, which is also the active ingredient in Zofran®, an approved drug for treating nausea and emesis. AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption. We intend to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes. We believe our approach is unique in that it targets the serotonin system and individualizes the treatment of AUD, through the use of genetic screening. We have created an investigational companion diagnostic biomarker test for the genetic screening of patients with certain biomarkers that, as reported in the American Journal of Psychiatry (Johnson, et. al. 2011 & 2013), we believe will benefit from treatment with AD04. Our strategy is to integrate the pre-treatment genetic screening into AD04’s label to create a patient-specific treatment in one integrated therapeutic offering. Our goal is to develop a genetically targeted, effective and safe product candidate to treat AUD that does not require abstinence as part of the treatment.

We have a worldwide, exclusive license from the University of Virginia Patent Foundation (d.b.a the Licensing & Venture Group) (“UVA LVG”), which is the licensing arm of the University of Virginia, to commercialize our investigational drug candidate, AD04, subject to Food and Drug Administration (“FDA”) approval of the product, based upon three separate patents and patent application families, with patents issued in over 40 jurisdictions, including three issued patents in the U.S. Our investigational agent has been used in several investigator-sponsored trials and we possess or have rights to use toxicology, pharmacokinetic and other preclinical and clinical data that supports our Phase 3 clinical trial. Our therapeutic agent was the product candidate used in a University of Virginia investigator sponsored Phase 2b clinical trial of 283 patients. In this Phase 2b clinical trial, ultra-low dose ondansetron, the active pharmaceutical agent in AD04, showed a statistically significant difference between ondansetron and placebo for both the primary endpoint and secondary endpoint, which were reduction in severity of drinking measured in drinks per drinking day (1.71 drinks/drinking day; p=0.0042), and reduction in frequency of drinking measured in days of abstinence/no drinking (11.56%; p=0.0352), respectively. Additionally, and importantly, the Phase 2b results showed a significant decrease in the percentage of heavy drinking days (11.08%; p=0.0445) with a “heavy drinking day” defined as a day with four (4) or more alcoholic drinks for women or five (5) or more alcoholic drinks for men consumed in the same day.

The active pharmaceutical agent in AD04, our lead investigational new drug product, is ondansetron (the active ingredient in Zofran®), which was granted FDA approval in 1991 for nausea and vomiting post-operatively and after chemotherapy or radiation treatment and is now commercially available in generic form. In studies of Zofran® conducted as part of its FDA review process, ondansetron was given acutely at dosages up to almost 100 times the dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously (“i.v.”), which results in almost twice the exposure level as oral dosing. Even at high doses given i.v. the studies found that ondansetron is well-tolerated and results in few adverse side effects at the currently marketed doses, which reach more than 70 times the AD04 dose and are given i.v. The formulation dosage of ondansetron used in our drug candidate (and expected to be used by us in our Phase 3 clinical trials) has the potential advantage that it contains a much lower concentration of ondansetron than the generic formulation/dosage that has been used in prior clinical trials, is dosed orally, and is available with use of a companion diagnostic biomarker. Our development plan for AD04 is designed to demonstrate both the efficacy of AD04 in the genetically targeted population and the safety of ondansetron when administered chronically at the AD04 dosage. However, to the best of our knowledge, no comprehensive clinical study has been performed to date that has evaluated the safety profile of ondansetron for long-term use as anticipated at any dosage.

According to the National Institute of Alcohol Abuse and Alcoholism (the “NIAAA”) and the Journal of the American Medical Association (“JAMA”), in the United States alone, approximately 35 million people each year have AUD (such number is based upon the 2012 data provided in Grant et. al. the JAMA 2015 and has been adjusted to reflect a compound annual growth rate of 1.13%, which is the growth rate reported by U.S. Census Bureau for the general adult population from 2012-2017), resulting in significant health, social and financial costs with excessive alcohol use being the fourth leading cause of preventable death and is responsible for 31% of driving fatalities in the United States (NIAAA Alcohol Facts & Statistics). AUD contributes to over 200 different diseases and 10% of

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children live with a person that has an alcohol problem. The Centers for Disease Control (the “CDC”) has reported that AUD costs the U.S. economy about $250 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. Despite this, according to the article in the JAMA 2015 publication, only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only 3.6% by a physician (i.e., approximately 1.3 million people). In addition, according to the NIAAA, the problem in the United States appears to be growing with almost a 50% increase in AUD prevalence between 2002 and 2013.

AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption. Until the publication of the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders in 2013 (the “DSM-5”), AUD was broken into “alcohol dependence” and “alcohol abuse”. More broadly, overdrinking due to the inability to moderate drinking is called alcohol addiction and is often called “alcoholism”, sometimes pejoratively.

Since ondansetron is already manufactured for generic sale, the active ingredient for AD04 is readily available from several manufacturers, and we have contracted with a U.S. manufacturer to acquire ondansetron at a cost expected to be under $0.01 per dose. Clinical trial material (“CTM”) has already been manufactured for the initial Phase 3 trial. The CTM has demonstrated good stability after three years with the stability studies still ongoing to potentially demonstrate longer stability and shelf life. We have entered into a Secrecy and Supply Agreement on December 1, 2011 with Cambrex Charles City, Inc. (“Cambex”) for the supply of the active ingredient for AD04. The agreement has an initial term of eight (8) years and may be terminated by either party upon a material breach that is not cured within sixty (60) days of receipt of written notice or certain bankruptcy events. Cambrex has the right to terminate the agreement if we do not cure a payment failure within thirty (30) days of notice thereof and we have the right to terminate the agreement if a regulatory authority prohibits or restricts manufacture and sale of the active ingredient in a way that would have an adverse effect on the sale price or volume of the product. Pursuant to the terms of the agreement with Cambrex, Cambrex cannot decline a purchase order of 50kg of product or less and we are required to purchase 66.67% of our requirements of the active ingredient sold in the United States and the European Union from Cambrex for a period of five (5) years from submission of our NDA.

We have also developed the manufacturing process at a third-party vendor to produce tablets at what we expect will serve for commercial scale production, also at a cost of less than $0.01 per dose. A proprietary packaging process has been developed, which appears to extend the stability of the drug product. Packaging costs are expected to be less than $0.05 per dose. We do not have a written commitment for supply of either the tablets or the packaging and believe that alternative suppliers are available to whom we can transfer the processes that have been developed.

Methods for the companion diagnostic genetic test have been developed as a blood test, and we established the test with a U.S. third-party vendor capable of supporting a Phase 3 clinical trial. Additionally, we have built validation and possible approval of the companion diagnostic into the Phase 3 program, including that we plan to store blood samples for all patients in the event additional genetic testing is required by regulatory authorities. Methods are intended to be transferred to third-party vendors in Europe for conduct of the planned initial Phase 3 trial.

Disease Targets and Markets

Limitations of Current AUD Therapies

Today the most common treatments for AUD are directed at achieving abstinence and typical treatments include psychological and social interventions. Most therapies actually require abstinence prior to initiating therapy. Abstinence requires dramatic lifestyle changes often with serious work and social consequences. Frequently, patients cannot attend family and social events in order to ensure compliance with abstinence, and patients often must suffer from the stigma of having been labelled an alcoholic. Significant side effects of current pharmacologic therapies include mental side effects such as psychiatric disorders and depressive symptoms and physical side effect such as nausea, dizziness, vomiting, abdominal pain, arthritis and joint fitness. In fact, according to peer reviewed studies referenced in The Sober Truth: Debunking the Bad Science Behind 12-Step Programs and the Rehab Industry, L. Dodes and Z. Dodes, 2014 by Dr. Lance Dodes, the former Director of the substance abuse treatment unit of Harvard’s McLean Hospital, 90% or more of patients that use current therapy solutions, such as Alcoholics Anonymous, do not achieve long-term abstinence.

There are four drugs approved by the FDA and marketed in the United States for the treatment of alcohol addiction, Antabuse® (disulfram) Vivitrol® (naltrexone), Revia® (naltrexone) and Campral® (acomprosate) and one drug, Selincro® (nalmefene) is marketed outside of the United States. All of the approved drugs, other than

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Selincro®, require abstinence prior to commencing treatment with the drug, and all five drugs are known to have significant side effects.

Antabuse® was approved for the treatment of alcohol dependence more than 50 years ago, making it the oldest such drug on the market. It works by interfering with the body’s ability to process alcohol. Its method of action and purpose is to cause patients that drink alcohol while taking Antabuse® to experience numerous and extremely unpleasant adverse effects, including, among others, flushing, nausea, and palpitations, with the goal that patients will continue the medication but refrain from drinking in order to avoid these effects.

Naltrexone, which can be taken as a once-daily pill (Revia®) or in an approved once-monthly injectable form (Vivitrol®) that requires a doctor to administer is often associated with gastrointestinal complaints and has been reported to cause liver damage when given at certain high doses. As a result, it carries an FDA boxed warning, a special emphasized warning, for this side effect.

Campral®, taken by mouth three times daily, acts on chemical messenger systems in the brain.

Selincro® has not been approved for sale in the United States.

Our Proposed Solution

Our goal is to develop an effective and safe product to treat AUD that does not require abstinence as part of the treatment and does not have the negative side effects of the current drugs on the market. Our product candidate is designed for patients who desire to control their drinking but cannot or do not want to completely abstain from drinking. By removing the difficulties associated with abstinence and the side effects associated with the other current products on the market, we believe that we may be able to remove barriers to patient adoption that inhibit adoption of current therapies and can attract a greater portion of the many millions of patients with AUD that remain untreated. Unlike other therapies, our investigational product, AD04, uses a novel mode of action that involves genetic screening with a companion diagnostic genetic test prior to treatment and is designed to reduce cravings for alcohol to effectively curb alcohol intake, without the requirement of abstinence prior to or during treatment. Our product candidate is intended to be easy to use since it is administered orally, currently on a twice daily basis and with a once-a-day tablet planned as part of the product’s life cycle management. To date, clinical testing of AD04 has shown it to have a positive safety and tolerability profile with side effects similar to placebo.

The companion diagnostic genetic test to be used to identify patients that are most likely to benefit from treatment with AD04 may potentially enhance the likelihood of a successful outcome for those undergoing treatment. Additionally, it may provide doctors with the opportunity to have a non-threatening conversation about alcohol with their patients and may provide the patient an acceptable path to help them determine if they might be a candidate for help with their alcohol use. If the test results are positive, they would have a science based rationale for their treatment, which reduces some of the stigma patients might otherwise endure, and allows them to be treated in the confidence of their doctor, potentially with a simple, oral tablet.

Strengths and Competitive Advantages

Large Market Opportunity for an Effective Solution

In the United States alone, approximately 35 million people each year have AUD. Based on data from the Phase 2b trial of AD04 and our analysis of publicly available genetic databases, we preliminarily estimate that about one in three patients with AUD in the U.S. will have the genetic markers to indicate possible treatment with AD04. At this time, we are not aware of any oral pharmaceutical treatment approved in the U.S. that addresses the needs of patients who desire to control their drinking but cannot or do not want to abstain from drinking. The current abstinence-based treatments have limitations. The limited side effects expected for our investigational new drug, based on clinical data so far, are also believed to be an important factor in the expected rapid uptake of AD04 in the market. Our approach, if approved by FDA, may allow for social drinking to continue and is aimed at reducing the dangerous, heavy drinking. This would allow patients to live the life they want without the stigma associated with complete abstention and currently endured by those seeking help for their excessive drinking. Assuming that one-third of AUD patients are genotype positive for treatment with AD04 and a $235 price for a one month supply of the drug (assumed pricing based on an average of prices published by Blue Cross Blue Shield in June 2017 for tier-3 oral, on-patent, chronic maintenance drugs, discounted by 16.6% , to reflect the average difference between retail and wholesale pricing for

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branded drugs as reported by drugs.com), the total potential market for AD04 would be approximately $36 billion in the United States alone.

Beyond the United States, alcohol consumption worldwide is a serious health issue. The 2014 Global Status Report on Alcohol and Health published by the World Health Organization (the “WHO”) states that 5.9% of all deaths (about 3.3 million per year) and 5.1% of disease worldwide are attributable to alcohol consumption. Europe consumes over 25% of the total alcohol consumed worldwide despite only having 14.7% of the world’s population. The WHO estimates that about 55 million people in Europe have AUD and, within Europe, Eastern Europe has a particularly acute problem with Russia estimated to have about 21 million people with AUD. The WHO further estimates that 17.4% of adult Russians and 31% of adult Russian males have AUD, and Organization for Economic Cooperation and Development data indicates that 30% of all deaths in Russia are alcohol related as reported by Quartz Media.

Prior Work of Universities Creates Cost Efficiencies

We have a worldwide, exclusive license to intellectual property developed at the University of Virginia by a member of our board of directors, Dr. Bankole A. Johnson, who was Chairman of the Department of Psychiatry & Neurobehavioral Sciences at the University of Virginia (and prior to that the Chief of the Division of Alcohol and Drug Addiction at the University of Texas) and is now Chair, Department of Psychiatry and Director of the Brain Science Research Consortium Unit at the University of Maryland. Dr. Johnson has spent almost three decades researching the underlying subject matter. Significant portions of the supporting research were also funded under grants from the National Institute of Health to the University of Virginia and the University of Texas.

By leveraging the prior work of universities and their researchers, including their pre-clinical studies and accumulated data, we believe we have developed a significant drug development opportunity. Because of the licensing approach taken to secure intellectual property, including, without limitation, patents and rights to clinical trial data, and our collaborations with the University of Virginia, we have not had to incur the significant costs that would normally be required to develop therapeutic treatments to the point of being ready to commence a Phase 3 clinical trial, which often amount to tens of millions of dollars or more. In fact, based upon current information, and depending on what the regulatory authorities may require to secure marketing authorization, we estimate that we will only require approximately $30 million of additional capital to complete our second Phase 3 program (which includes any necessary Phase 1 clinical trials) as currently contemplated in order to achieve regulatory approval for the use of AD04 to treat AUD in the United States and Europe.

Known, Well-Tested Agent Has Shown Favorable Results in Non-AUD Uses

Ondansetron, the principal active pharmaceutical agent in AD04 has been approved by the FDA to treat nausea and vomiting but is administered at much higher doses than we intend to use and has shown limited side effects even at the higher dosages currently on the market. However, it has not been approved in our anticipated dosage or for our anticipated uses. Consequently, we expect to submit a new drug application, pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for U.S. marketing authorization. Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act allows the FDA to rely, for approval of an NDA, on data not developed by the applicant. Such an NDA contains full reports of investigations of safety and effectiveness, but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Such applications permit approval of applications other than those for duplicate products and permits reliance for such approvals on literature or an FDA finding of safety and/or effectiveness for an approved drug product. A Phase 2b University of Virginia investigator sponsored clinical trial of AD04 for the treatment of AUD showed promising results and no overt safety concerns (there were no statistically significant serious adverse events reported). Not only did the trial show no statistically significant, serious adverse side effects, but both of the pre-specified endpoints, reduction in severity of drinking measured in drinks per day of drinking day and reduction in frequency of drinking measured in days of abstinence, were met with statistical significance as shown in the graph below:

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Our Substantial Proprietary Estate and Protection from Competition

We currently hold a worldwide, exclusive license to three (3) patent families that provide us with the ability to exclude potential competitors from practicing the claimed inventions, such as the use of ondansetron to treat any of the four (4) specified genotypes for AUD. Our licensed patent estate is expected to provide us patent protection through 2032 plus possible extensions. Ondansetron, the active ingredient in AD04, has never been approved in a low dosage near the AD04 dose of 0.33mg per tablet, and we believe our licensed patents will protect AD04 from any competitor that attempts to bring to market an ondansetron dose at or near the AD04 dose for treatment of patients having one or more of the four target genotypes.

We believe use of the currently marketed doses “off-label” will not be significant due to (i) the lack of demonstrated efficacy at currently marketed doses, (ii) potential safety concerns if the currently marketed doses are used chronically as is expected to be necessary for treating AUD, and (iii) cutting the smallest currently marketed dose into the 12 pieces that would be necessary to achieve the AD04 dose is deemed by us to be impractical and likely to result in inaccurate dosing.

Companion Genetic Bio-Marker Aimed at Identifying Patients Most Likely to Respond To Treatment, Potentially Results in Increased Use of AD04

We believe our drug is unique in that it is designed to treat individuals with certain genotypes. We are pursuing a strategy that aims to integrate pre-treatment screening with the companion diagnostic genetic test into the drug label, essentially combining the test and treatment into one integrated therapeutic offering that has combined intellectual property protections. This companion diagnostic testing approach may be a useful genetic screening tool to predict those most likely to respond to the drug and to have minimal side effects. Based on the clinical experience to date and publicly available databases, we believe the genetic prevalence of genotype positive people is about 33% of the population in the United States and that the prevalence in certain areas of Eastern Europe and in Scandinavia may be greater than 50%. The FDA has agreed that the Phase 3 trials of AD04 can proceed only enrolling patients that are genotype positive, which greatly reduces, the cost, time and risk relative to a trial that also enrolled patients that are genotype negative for treatment with AD04. Our plan to conduct our first Phase 3 trial in geographic areas with expected higher prevalence of genotype positive patients should further reduce the cost, time and risk to achieve Phase 3 results. The FDA has indicated that any approval based on a trial only in genotype positive patients would result in labeling restricted to treating genotype positive patients.

We believe that the companion diagnostic genetic test enables physicians to more easily have an initial conversation with their patients about alcohol use and, for the patient, provides a less threatening and obtrusive first step toward treatment because the conversation will include the topic of genetic testing and not be solely about behavior. Patients that then test positive against the AD04 genetic panel would be expected to be more likely to then receive a prescription for AD04 (based on an external quantitative market study of 156 primary care physicians and psychiatrists that was conducted by Ipsos-Insight LLC, who we commissioned, and that concluded a majority of genetically targeted patients currently receiving pharmacologic treatment would be switched to a drug with the characteristics expected for AD04).

Experienced Leadership

Our management, advisors and board of directors have extensive experience in pharmaceutical development, the clinical trial and regulatory approval processes, drug commercialization, financing capital-intensive projects, and developing new markets for pharmaceutical agents. Members of our team have previously worked in senior management and senior officer positions, or led significant research initiatives at Clinical Data, Inc., Adenosine Therapeutics, and the University of Virginia in a broad range of therapeutic areas. Our management and board members have particular expertise in the science and development of addictions related drugs.

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Our Strategy

We develop pharmaceutical treatments for addictions and addictive disorders. The focus of our business strategy is to advance AD04, our lead investigational drug candidate, toward regulatory approval for alcohol addiction in the United States, the European Union, and then eventually other territories. We subsequently plan to develop label expansions into other indications (e.g., drug addiction, obesity, smoking cessation, eating disorders and anxiety).

Our goals in executing this strategy are to keep capital requirements to a minimum, expedite product development, gain access to clinical research and manufacturing expertise that will advance product development, approval and eventual market uptake of our product, and rely on a well-defined and carefully executed intellectual property strategy in order to position AD04 with long-term, defensible, competitive advantages.

Our near-term strategy includes:

         Obtaining regulatory approval for our lead product in the United States and Europe. We intend to commence Phase 3 clinical trials for the treatment of AUD. The first Phase 3 trial is planned for conduct in Scandinavia and Central and Eastern Europe, where the genetic prevalence of the target genotypes appear to be higher. If our initial Phase 3 clinical trial is successful we expect to conduct a second, and possibly a third, Phase 3 clinical trial in the same areas but with additional clinical sites in the United States and Western Europe.

         Prosecuting and expanding our intellectual property and product portfolio. We have acquired rights to a promising drug candidate and made a significant investment in the development of our licensed patent portfolio to protect our technologies and programs, and we intend to continue to do so. We have obtained exclusive rights to three different patent families directed to therapeutic methods related to our AD04 platform. These families include 3 issued U.S. patents, and at least one foreign equivalent patent covering AD04 issued in over 40 national jurisdictions, including most of Europe and Eurasia. Divisional and continuation applications to expand the coverage have also been filed in certain jurisdictions. We intend that product portfolio expansions will be focused on promising addiction therapies and/or late-stage clinical assets.

         Evaluating the additional use of our product candidate in other indications. In addition to alcohol addiction, we plan to conduct exploratory work to investigate using AD04 as a potential treatment for opioid addiction, gambling addiction, smoking cessation, obesity, and other addiction related disorders in which 5-HT3 antagonism may have a treatment effect. We believe we will be able to undertake this initial exploratory effort with minimal additional cash cost to our company through the use of academic partnerships, grants, human laboratory studies and/or non-clinical studies. We believe that, due to its hypothesized mechanism of action (i.e., the modulation of the serotonin system in patients that are genetically targeted based on the apparent sensitivity to such modulation, where the modulation appears to reduce cravings), AD04 has the potential to be used for the treatment of such other addictive disorders. To date, we have not discussed these potential uses with the FDA or any other regulatory bodies.

         Maximizing commercial opportunity for our technology. AD04 targets large markets with significant unmet medical need. We intend to develop an extended release, once-a-day formulation of AD04 to enhance compliance and market appeal.

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         Managing our business with efficiency and discipline. We believe we have efficiently utilized our capital and human resources to develop and acquire our product candidate and programs, and create a broad intellectual property portfolio. We operate cross-functionally and are led by an experienced management team with backgrounds in developing product candidates. We use project management techniques to assist us in making disciplined strategic program decisions and to attempt to limit the risk profile of our product pipeline.

The clinical development plan for AD04 can be described as a two-stage development strategy in which we expend limited resources to achieve the significant value inflection point of Phase 3 data in our primary indication of AUD. With a successful trial and the risk reduction associated with that success, we would then be ready to conduct the final trials to seek approval in the U.S. and Europe as shown below:

AD04 — Two-Stage Clinical Development Strategy — Conduct the Phase 3 clinical trials sequentially

*Even if the 1st Phase 3 trial is not accepted by the FDA due to the study not being well-powered for the FDA’s currently stated end point, we expect that the EMA will require only one additional trial. In this case, however, a 3rd trial might be required by the FDA (i.e., three Phase 3 trials in total). If two additional trials are required for FDA approval after an initial Phase 3 trial conducted in the EMA, we would expect to run the 2nd and 3rd trials in parallel (i.e., at the same time) so as not to increase the expected time to approval. The 2nd additional trial (i.e., the 3rd Phase 3 trial) would be expected to require an additional $20 million in expenditures.

After approval, we plan to execute a two-stage commercialization plan. With psychiatrists and addiction specialists treating a majority of the current AUD patients today and with psychiatrists most likely to be familiar with the mechanism of action of AD04, we believe that a relatively small psychiatry-targeted, specialty sales force could successfully sell AD04 into the market. This plan creates the opportunity for us to develop into a commercial enterprise with an initial niche-market sales force at a relatively low cost for market entry. It also expands the universe of potential acquirers of our company or AD04 to smaller and mid-size pharmaceutical companies. Once success is shown in the niche market and the thought leaders and early adopters are prescribing AD04, market adoption risk will have been greatly reduced and we would expect to be able to sell or partner with a large pharmaceutical partner to develop AD04 as a blockbuster product. This commercialization plan is shown below:

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AD04 — Two-Stage Commercialization Strategy — Initial launch with a specialty sales force to build the market, then partner or sell to a large pharmaceutical partner to capture market share and optimize the market

Ondansetron History and Foundation for Treating AUD

Ondansetron is a 5-HT3 receptor antagonist. Preclinical and pharmacobehavioral studies suggest that blockade of serotonin-3 receptors will influence the dopamine reward system activated by alcohol, decreasing dopamine release and attenuating craving for alcohol (Dawes, MA et al., 2005b; Johnson, BA et al., 2002; Lovinger, DM, 1999a). Early clinical studies found that the efficacy of ondansetron is limited to certain subgroups of the alcohol-dependent population and suggested the differential effect could be predicted based on age of onset of alcoholism, an indistinct concept likely confounded by genetic, regional and ethnic differences (Johnson, BA et al., 2000; Kranzler, HR et al., 2003). Recent research suggests the variable effect may be predictable based on molecular mechanism of ondansetron action and individual subject genotype of key genes in the serotonin system (Enoch, MA et al., 2010; Johnson, BA et al., 2011; Kenna, GA et al., 2009).

We are pursuing development of ondansetron in the alcohol-dependent population. Clinical studies will initially focus on the use of a low dose, oral tablet (0.33 mg administered twice daily) to reduce alcohol consumption in subjects with genotypes that have been correlated with a responsive to treatment with ondansetron.

Ondansetron was first approved by the FDA in 1991 as a solution for injection. Subsequent approvals were obtained for oral tablets in dosage forms and an oral solution. It is marketed as Zofran® and is also available in generic formulations, and it has been used widely for the approved indications – prevention of nausea and vomiting associated with certain cancer chemotherapies and radiotherapies and for the prevention of postoperative nausea or vomiting — at adult doses of 8–24 mg/day with manageable side effects.

Ondansetron has been administered to dogs‚ rats‚ and mice as part of a preclinical toxicology program which included single-dose acute‚ repeated-dose studies. Ondansetron was not mutagenic in the standard battery of microbial tests for mutagenicity and no carcinogenic effects were seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 and 30 mg/kg/day, respectively. In studies of rats and rabbits there was no evidence

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of reproductive toxicity seen on fertility, early embryonic development, perinatal/postnatal development or fetal development of the F2 generation. Based on these studies, as well as over 20 years of human use in clinical trials and the post-marketing environment, ondansetron is considered to be a well-tolerated drug with a generally mild safety profile.

Ondansetron, by blocking the 5-HT3 receptor, is known to affect dopaminergic signaling in the brain; and the scientific rational for use of a 5-HT3 antagonist in the treatment of alcohol dependence is well established (Johnson, BA, 2004). Briefly, studies suggest that: the rewarding effects of alcohol involve activation of the 5-HT3 receptors leading to release of dopamine within the mesolimbic system of the brain (McBride, WJ et al., 2004). Thus, by blocking activation of the 5-HT3 receptor, ondansetron may reduce the ethanol-stimulated release of dopamine leading to reduced feelings of pleasure or reward and consequently, reduced consumption (Carboni, E et al., 1989; Costall, B et al., 1987; Hagan, RM et al., 1990; Imperato, A and Angelucci, L, 1989; Lovinger, DM, 1999b; McBride, WJ et al., 2004; Minabe, Y et al., 1991; Rasmussen, K et al., 1991; Wozniak, KM et al., 1990; Yoshimoto, K et al., 1996).

Preclinical studies have demonstrated that alcohol stimulates the release of both serotonin (5-hydroxytryptamine or 5-HT) and dopamine within the cortio-mesolimbic system (Campbell, AD et al., 1996; Campbell, AD and McBride, WJ, 1995; Di Chiara, G and Imperato, A, 1988; Imperato, A and Angelucci, L, 1989; Yoshimoto, K et al., 1992; Yoshimoto, K et al., 1996; Zazpe, A et al., 1994). Other studies have shown that alcohol potentiates the effects of 5-HT at the 5-HT3 receptor, leading to augmented release of dopamine, and that ondansetron and the selective antagonists of the 5-HT3 receptor inhibit dopaminergic firing and release of dopamine in response to alcohol and serotonin (Costall, B et al., 1987; Lovinger, DM, 1991; Minabe, Y et al., 1991; Rasmussen, K et al., 1991; Yoshimoto, K et al., 1996; Zazpe, A et al., 1994; Zhou, Q et al., 1998). Finally, numerous in vivo studies in rats and mice have shown that ondansetron and other selective antagonist of the 5-HT3 receptor reduce volitional intake of alcohol in models selectively bred for alcohol preference (Fadda, F et al., 1991; Hodge, CW et al., 1993; McBride, WJ and Li, TK, 1998; Meert, TF, 1993; Tomkins, DM et al., 1995).

The aforementioned nonclinical studies have shown that 5-HT3 and dopamine interactions in the cortico-mesolimbic system appear to mediate many of the reinforcing effects of alcohol. Collectively the available nonclinical studies suggest that, by inhibiting the 5-HT3 receptor and reducing the release of dopamine in the cortico-mesolimbic area, ondansetron can interfere with the dopamine reward system activated by alcohol and lead to reduced alcohol intake (Barnes, NM and Sharp, T, 1999; Dawes, MA et al., 2005b; Johnson, BA et al., 1993; Johnson, BA and Cowen, PJ, 1993; Lovinger, DM, 1991, 1999a; Swift, RM et al., 1996; Tomkins, DM et al., 1995).

Five clinical studies have been conducted that demonstrate ondansetron is a promising treatment for alcohol-dependent individuals (Johnson, BA et al., 2011; Johnson, BA et al., 2000; Kenna, GA et al., 2009; Kranzler, HR et al., 2003; Sellers, EM et al., 1994). Several important findings in these studies guide the design of future clinical studies, including:

(1)      Ondansetron’s efficacy in alcohol-dependent individuals is associated optimally with a small dose of the compound (0.25-0.33 mg twice daily), a dose that is <1/10 of the dose used for adults for the currently approved indications.

(2)      In clinical studies in over 600 subjects, ondansetron was well-tolerated and safe, with a mild side-effect profile when administered to currently drinking alcohol-dependent individuals. Overall, the types of adverse events reported during multi-week clinical studies in alcohol dependence appear similar to those outlined in the package insert for the approved indications and to those reported in the literature for treatment in chronic liver disease, chronic fatigue syndrome and schizophrenia.

(3)      The extent of benefit with ondansetron treatment varies among different subtypes of alcohol-dependent subjects. Prior studies found that ondansetron benefited subjects with early-onset alcoholism (EOA) but not late-onset alcoholism (LOA). The pharmacological reason for this was not known, but it was presumed that the differential effect was due to a higher degree of serotonergic dysfunction in EOA (Johnson, BA et al., 2000; Kranzler, HR et al., 2003).

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The below table summarizes the five clinical studies demonstrating ondansetron is a promising treatment for alcohol-dependent individuals

Study type (Reference)

 

Number of
Subjects

 

Dosing (Duration)

 

Summary Results

Phase 2

(Sellers, EM et al., Clinical Efficacy of the 5-HT3 Antagonist Ondansetron in Alcohol Abuse and Dependence, Alcohol Clin Exp Res, 18 (1994) 879-885.)

 

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0.25 mg, 2 mg, and placebo b.i.d.

(6 weeks)

 

The 0.25 mg dose showed a near significant effect in reducing severity of drinking measured in DDD (p=0.06 ) while the 2 mg dose was similar to placebo.

Phase 2

(Johnson, BA et al., Ondansetron for Reduction of Drinking among Biologically Predisposed Alcoholic Patients: A Randomized Controlled Trial, JAMA, 284 (2000) 963-971)

 

321

 

1, 4, and 16 ug/kg b.i.d.

(11 weeks)

 

Ondansetron treatment at doses of 1, 4, and 16 µg/kg bid resulted in significant reductions in DDD in EOA subjects, but only the 4 µg/kg dose showed such a reduction in frequency of drinking measured in PDA and the maximal effect was shown at the µg/kg does. Only the 4 µg/kg bid showed significant improvements in PDA in the LOA group.

Phase 2

(Kranzler, HR et al., A within-Group Design of Nontreatment Seeking 5-HTTLPR Genotyped Alcohol-Dependent Subjects Receiving Ondansetron and Sertraline, Alcohol Clin Exp Res, 33 (2009) 315-323)

 

40

 

4 ug/kg bid for 8 weeks

 

EOA subjects showed significant improvement over LOA subjects in DDD.

Phase 2

(Kenna, GA et al., Pharmacogenetic Approach at the Serotonin Transporter Gene as a Method of Reducing the Severity of Alcohol Drinking, Am J Psychiatry, 168 (2011) 265-275)

 

21

 

..5 mg/day for 3 weeks

 

LL genotype subject showed significant improvement in DDD.

Phase 2b

(Johnson, BA et al., Determination of Genotype Combinations That Can Predict the Outcome of the Treatment of Alcohol Dependence Using the 5-HT3 Antagonist Ondansetron, Am J Psychiatry (2013)

 

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4 ug/kg bid

(12 weeks, including 1 week placebo run-in)

 

The target genotype group showed significant improvement in DDD and PDA against both the placebo groups and other genotypes on drug.

Additional detail with respect to four of the clinical studies referenced in the chart above is provided below with the fifth being the Phase 2b clinical trial upon which we are basing the development of AD04 and which is described more fully in the following section titled “Phase 2b Investigator Initiated Clinical Trial of AD04 for Alcohol Use Disorder Conducted by the University of Virginia.”

A Dose-Ranging, Placebo-Controlled, 6-Week Study of Ondansetron in Alcoholic-Dependent Subjects

In 1994, Sellers et al. reported on the effects of administration of 0.25 mg bid ondansetron (N=23), 2 mg bid ondansetron (N=25), or placebo (N=23) for 6 weeks in alcohol-dependent males (Sellers, EM et al., 1994). Endpoints included change in drinks per drinking day (“DDD”) and proportion of responders, where a responder was defined as a subject with a Reliable Change score > 1.96, representing an improvement of at least 2 standard deviations. The Reliable Change score was calculated as the difference between pre- and post-test DDD divided by the standard error. Analyses were conducted comparing pre-treatment with the Week 6 visit, representing the end-of-study medication administration, and pre-treatment with the Week 7 visit, after completion of a 1-week follow-up period.

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In the 71 subjects who completed the study, the on-treatment changes in DDD were approximately -1.9 (0.25 mg bid), -1.2 (2 mg bid), and -1.3 (placebo), with neither ondansetron effect being statistically different from the placebo effect. The corresponding changes from pre-treatment to Week 7 (after 6 weeks of treatment and a 1-week follow-up) were approximately -2.7 (0.25 mg bid), -1.1 (2 mg bid), and -1.6 (placebo), with the difference between low-dose ondansetron and placebo approaching statistical significance (p=0.06). By Week 6, nearly twice as many subjects on low-dose ondansetron compared with those on either high-dose ondansetron or placebo showed significant improvement according to the Reliable Change score. Lower baseline drinking and higher level of education were significant predictors of reduction in drinking while on treatment.

A Dose-Ranging, Placebo-Controlled, 11-Week Study of Ondansetron in Alcoholic-Dependent Subjects

In 2000, Johnson et al. reported on the co-administration of weekly cognitive behavioral therapy and either placebo or ondansetron at doses of 1, 4, and 16 µg/kg bid for 11 weeks (after a 1-week, single-blind, placebo lead-in) in 321 alcohol-dependent subjects (Johnson, BA et al., 2000). Endpoints included drinks per day, DDD, percentage of days abstinent (“PDA”), total days abstinent, and plasma carbohydrate deficient transferrin (CDT) level, an objective measure of drinking. Analyses were conducted comparing each dose group with placebo, with drinking response variables analyzed as means of data collected from Weeks 3 through 12.

The table below sets forth treatment results. Ondansetron treatment at doses of 1, 4, and 16 µg/kg bid resulted in statistically significant reductions in DDD and drinks per day compared with placebo for EOA (age of onset ≤25 years). The maximum clinical effect was observed at the middle dose (4 µg/kg bid), though the differences between doses were not statistically significant. At 4 µg/kg bid (but not at 1 or 16 µg/kg bid), significant improvements in days and PDA were also achieved. LOA (age of onset ≥26 years) did not benefit from ondansetron treatment at any dose studied.

Treatment Effect Size in EOA Subjects and Statistical Comparison to Placebo Effect

Variable

 

1 µg/kg bid

 

4 µg/kg bid

 

16 µg/kg bid

Drinks/drinking day

 

0.25 (p≤0.05)

 

0.41 (p≤0.01)

 

0.23 (p≤0.05)

Drinks/day

 

0.26 (p≤0.05)

 

0.37 (p≤0.01)

 

0.22 (p≤0.05)

Days abstinent (%)

 

0.13 (ns)

 

0.26 (p≤0.01)

 

0.17 (ns)

Days abstinent

 

0.06 (ns)

 

0.24 (p≤0.05)

 

0.18 (ns)

The findings in this study support the earlier evidence that the dose-response effect of ondansetron in reduction of alcohol consumption is not linear. Of the doses used in this study, only 4 µg/kg (0.28 mg for a 70 kg person) bid exhibited clinically and statistically meaningful improvements in all efficacy endpoints. This study also suggested that ondansetron may be an appropriate therapy for EOA, but not LOA.

An Open-Label, 8-Week Study Comparing Ondansetron Effect in Early-Onset and Late-Onset Alcoholic Subjects

In 2003, Kranzler et al. reported on the co-administration of weekly cognitive behavioral therapy and ondansetron at 4 µg/kg bid for 8 weeks to 40 alcohol-dependent subjects (Kranzler, HR et al., 2003). The subjects were evenly divided between early-onset alcoholism (EOA; age of onset of the disorder <25 years) and late-onset alcoholism (LOA; age of onset of the disorder ≥25 years). Endpoints included drinks per day, DDD, PDA, Drinker Inventory of Consequences (DrInC) score, and percentage of heavy-drinking days, where heavy drinking was defined as ≥5 drinks in a day for a male subject or ≥4 drinks in a day for a female subject. Analyses were conducted comparing pre-treatment with 8-week values within onset category (EOA or LOA) and comparing treatment effects between categories.

The table below sets forth treatment results. All efficacy parameters improved significantly on treatment in both groups. EOA subjects reported significantly greater improvements in drinks per day, DDD, and DrInC score than LOA subjects. These findings, as noted earlier by Johnson et al., suggest that ondansetron shows promise for treatment of EOA by improving drinking outcomes.

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Results of Study Comparing Effects of Ondansetron in EOA versus LOA

 

 

EOA

 

LOA

 

EOA v LOA

 

 

change mean
(SD)

 

p-value

 

change mean
(SD)

 

p-value

 

p-value

Drinks/drinking day

 

5.78 (8.9)

 

0.009

 

1.55 (2.0)

 

0.004

 

0.032

Drinks/day

 

4.53 (4.5)

 

<0.001

 

1.98 (2.1)

 

0.001

 

0.013

Days abstinent (%)

 

30.2 (29.4)

 

<0.001

 

24.8 (21.2)

 

<0.001

 

0.373

Heavy-drinking days (%)

 

35.1 (24.7)

 

<0.001

 

26.7 (27.4)

 

<0.001

 

0.139

DrInC total score

 

30.3 (27.7)

 

<0.001

 

11.4 (11.2)

 

<0.001

 

0.013

A 3-Period Study of Ondansetron Effect and Sertraline Effect in Subgroups of Alcoholics Constructed Based on Genotypes of the Serotonin Transporter Gene

In 2009, Kenna et al. reported on a placebo-controlled cross-over study in which 21 alcohol-dependent subjects received 0.5 mg/day ondansetron or 200 mg/day sertraline for 3 weeks, placebo for 3 weeks and the alternative active medication for 3 weeks (Kenna, GA et al., 2009). An alcohol self-administration experiment was conducted at the end of each treatment period. The primary endpoint was DDD during the final week of each treatment period.

During the first 3-week treatment period, ondansetron-treated subjects carrying L/L genotype (n = 3), compared to the L/S and S/S carriers (n = 4), had a significantly fewer DDD (3.66 vs. 8.40, p = 0.02). Within L/S and S/S group, there was no significant effect of ondansetron. A pronounced order effect confounded analyses after the third 3-week treatment period.

Our clinical development program is designed to demonstrate the safety and efficacy of ondansetron in the alcohol-dependent population in low dosages for long periods of time, while targeting genotypes that have been shown to benefit from ondansetron treatment. Ultimately, this development program aims to establish a scientific link between the biology of alcohol addiction and the therapeutic mechanism of ondansetron action, permitting genetically-based prediction of ondansetron effectiveness.

Phase 2b Investigator Initiated Clinical Trial of AD04 for Alcohol Use Disorder Conducted by the University of Virginia

In various studies, it has been shown that alcohol dependent individuals with the LL genotype of the 5’-HTT and the TT genotype in the 3’-UTR LL and TT genotype have lower B-CIT neuronal binding to 5-HTT. It is hypothesized that individuals with the LL or TT genotype, 5-HTT gene expression is suppressed by increased alcohol consumption, and therefore, ondansetron, which causes 5-HTT gene expression would have the greatest effect upon individuals that possess both the LL genotype of the 5’-HTT and the TT genotype in the 3’-UTR. A subsequent Phase 2b study (N = 283), conducted by the University of Virginia for which we have acquired rights to the data, showed that a prospectively identified subgroup of alcohol-dependent individuals with these specific polymorphisms of the serotonin transporter protein responded therapeutically to ondansetron administration (Johnson, BA et al., 2011). Further analysis of this same data set against 18 additional polymorphisms located on the genes for the A and B subunits of the serotonin 5-HT3 receptor revealed polymorphisms that were also associated with a therapeutic response to ondansetron. Collectively, the genotypes from the two aforementioned analyses comprise the genotypes selected for testing in Phase 3 trials for AD04. The Phase 3 studies will test ondansetron’s efficacy compared with placebo based on its ability to decrease the frequency and amount of heavy drinking among alcohol dependent individuals with the selected genotypes.

Study Design

The Phase 2b clinical trial conducted by the University of Virginia was a 283-patient, 12-week, randomized, two-center, parallel-group, placebo-controlled study. Following a 1 week placebo run in (single-blind), alcohol-dependent subjects were randomized to receive either 4 µg/kg ondansetron or placebo, orally, twice daily (double-blind) for 11 additional weeks. In addition to study treatment, all subjects received weekly, standardized, manual-driven, cognitive behavioral therapy.

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Eligible subjects were classified to one of twelve groups described by the 2×2 x 3 factorial combinations and randomized to placebo or ondansetron (4 mcg/kg twice daily [b.i.d.]) using a computed blocks randomization procedure that balances the twelve treatment groups on drinks/day ≤ 7.99 vs ≥8.00), age of onset (early vs. late), and genotype (LL, SS, SL).

Genotyping and analysis of the study subjects for the SNP rs1042173 (TT, TG or GG) in the 3´-UTR of the 5-SLC6A4 gene that codes for the serotonin transporter was performed following randomization but prior to database lock. Genotyping and analysis of the study subjects for SNPs located on genes that govern expression of the 5-HT3A and 5-HT3B subunits of the 5-HT3 receptor was performed after database lock.

During treatment, subjects were evaluated weekly at the study center for efficacy, safety, and tolerability. Alcohol consumption was collected via the self-reported Timeline Follow-Back (TLFB) method (Sobell and Sobell, Psychosocial & Biochem. Meth., 1992).

Efficacy measures were based on self-reported drinking outcomes with drinks per drinking day (“DDD”), with a standard drink equal to 14 grams of alcohol, and the percentage of days abstinent (“PDA”) being the pre-specified efficacy end points. Withdrawal symptoms, social functioning, and motivation to use alcohol were assessed using standard questionnaires and scales. Subject safety was monitored through periodic electrocardiograms (EKGs), physical exams, safety laboratories and collection of adverse events, concomitant medications, and vital signs. Additionally, a post hoc analysis was conducted using the endpoint of percentage of heavy drinking days (“PDHD”), which is the number of days of heavy drinking days in a month as a percentage of days in the month, because it is widely recognized as a clinically meaningful endpoint and is expected to be an end point in a pivotal/Phase 3 trials. The PDHD end point requires that each day be determined to be a heavy drinking day (i.e., a day in which a female drinks 4 or more drinks or a male drinks 5 or more drinks) or not, making each day binary and requiring an increased sample size to ensure statistical power. Therefore, the goal of the PDHD analysis was to determine if the was a trend toward and effect with PDHD without necessary achieving statistical significance.

The study objectives were to evaluate the safety of AD04 and to test the hypotheses that: (i) ondansetron will have a greater effect of reducing the severity of alcohol drinking and of increasing the percentage of days abstinent among alcohol-dependent subjects with the LL genotype as compared with S carriers (SS or SL) of the 5´-HTTLPR; and (ii) ondansetron’s therapeutic effect will be greatest among alcohol-dependent subjects who possess both the LL genotype of the 5´-HTTLPR and the TT genotype of rs1042173 in the 3´-UTR of the 5´-HTT. After completion of the study, a planned additional analysis of the correlation between genotype and drinking outcomes was conducted considering 18 SNPs located on the 5-HT3A and 5-HT3B subunit genes that were selected based on their minor allele frequency (≥ 0.05) in different ethnic populations, to obtain uniform physical coverage of the two genes, and on results from previous genetic association studies. This latter analysis identified three SNPs as having an apparent beneficial effect.

The primary analytic procedure used mixed-effects linear regression models and a sensitivity analysis using repeated measures models.

Additionally, based on the expectation that subjects with the LL and LL/TT variants of the SLC6A4 gene would respond to ondansetron treatment while others do not, the possibility that SNPs in the 5-HT3A and 5-HT3B subunits of the 5-HT3AB receptor complex may also influence the response to ondansetron was planned as a post hoc analysis. The possible role of SNPs on the HTR3A and HTR3B genes in the response to ondansetron is logical since the 5-HT3A receptor subunit is the primary target for ondansetron’s actions, and the 5-HT3B receptor subunit may be associated with the availability and externalization of the 5-HT3AB receptor complex. Thus, alterations in post-synaptic receptors, such as the 5-HT3AB receptor complex, could have a large impact on signal transduction along post-synaptic neurons. For these analyses, a total of 18 SNPs on the genes for the 5-HT3A and 5-HT3B subunits were examined. SNPs were selected based on their minor allele frequency (≥ 0.05) in different ethnic populations, to obtain uniform physical coverage of the two genes, and on results from previous genetic association studies.

Summary Results — Safety:

Overall, 95% of the subjects in the ondansetron group and 96% in the placebo group reported a treatment-emergent AE (TEAE) during the study. TEAEs occurred most frequently in the SOCs of gastrointestinal

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disorders (ondansetron 65%, placebo 61%), metabolism and nutritional disorders (38%, 43%), and nervous system disorders (60%, 58%). The incidence of TEAEs by preferred term was similar between the ondansetron and placebo groups. TEAEs that occurred at a frequency ≥ 5% in the ondansetron group compared with the placebo group included constipation (32%, 21%), fatigue (39%, 25%), and dizziness (21%, 12%). There was one death during the study; Subject #218 committed suicide on Study Day 40. The event was considered not related to study drug. Treatment-emergent SAEs were reported in 3 (2.1%) ondansetron-treated subjects and 6 (3.8%) placebo-treated subjects. No SAE was considered related to study drug, and detoxification was the only SAE that was reported for more than 1 subject (2 ondansetron subjects). No clinically meaningful changes in clinical laboratory results, vital sign measurements, ECGs or physical examinations were observed for subjects during the course of the study.

Summary Results — Primary Analysis of Efficacy of LL and LL/TT

Analysis of the LL genotype of the 5´-HTTLPR as compared to the non-LL genotypes showed a significant reduction in DDD and PDA (Johnson, et.al, Am. Jrnl. Psych., 2011). However, the demonstrated effect of the LL/TT vs. other patients was more pronounced, and carriers of LL/TT genotype who received ondansetron showed a greater reduction in drinking compared to LL/TT. Carriers who received placebo showed a difference in DDD (difference of 2.05 drinks/drinking day; 95% CI, -3.72 to -0.39; p=0.0158); compared to LL/Gx carriers who received ondansetron (difference of 2.29 drinks/drinking day; 95% CI, -3.99 to -0.72; p=0.0048) and compared to all other genotypes who received ondansetron treatment (difference of 2.58 drinks/drinking day; 95% CI, -3.94 to 1.22; p<0.0001); and a greater PDA compared with: 1) the LL/TT genotype group treated with placebo (mean difference=12.38%; 95% CI= -1.57 to 26.33; p= 0.0819); 2) LL/Gx carriers treated with ondansetron (mean difference=15.14%; 95% CI= 1.41 to 28.87; p= 0.0307); and 3) all other genotypes treated with ondansetron (difference= 16.82%; 95% CI= 6.15 to 27.48; p=0.0020). The post hoc analysis of the PDHD endpoint show that ondansetron treatment of subjects with the LL/TT genotype was associated with a larger (but not statistically significant) reduction in PDHD compared to changes in PDHD in subjects with all other genotypes who received treatment with ondansetron (mean difference= -8.49%; 95% CI= 20.34 to 3.367; p= 0.1601). Similar trends (i.e., augmented reductions in PDHD) were observed for the LL/TT group treated with ondansetron versus the LL/Gx genotype group treated with ondansetron and versus the LL/TT group treated with placebo (mean difference=-2.54% 95% CI= 17.74 to 12.66, p=0.7431; and mean difference= 5.72% 95% CI= 21.20 to 9.75, p=0.4684; respectively).

Identification of Modulators of the 5-HT3 Receptor and Selection of the Phase 3 Genetic Panel for AD04

As stated above, a total of 18 SNPs on the genes for the 5-HT3A and 5-HT3B subunits were examined with SNPs selected based on frequency and on results from previous genetic association studies.

These analyses identified 3 SNPs (three in the gene for the 5-HT3A subunit and one in the gene for the 5-HT3B subunit) that were significantly associated with a positive response to ondansetron based on reductions in DDD and PDA. Thus, the genotype profile targeted for Phase 3 development is defined as those subjects who carry the LL/TT genotype and/or one of three 5-HT3 SNPs of interest (i.e., rs1150226-AG and rs1176713-GG in the gene that encodes the 5-HT3A receptor subunit and rs17614942-AC in the gene that encodes the 5-HT3B receptor subunit). The hypothesis that subjects who are carriers of the genotype panel targeted for study in Phase 3 (“P3-genotype”, with such patients “genotype positive” or “marker positive”) preferentially respond to treatment with ondansetron compared to subjects who do not carry any of the genotypes targeted for study in Phase 3 were assessed using the drinking endpoints of DDD, PDA, and PDHD.

Carriers of the P3-genotype who received ondansetron showed a greater reduction in DDD compared to P3-genotype carriers who received placebo (difference of 1.71 drinks/drinking day; 95% CI= -2.88 to -0.54; p=0.0042), and compared to subjects treated with ondansetron who were not carriers of the P3-genotype (All Other-OND; difference of 2.05 drinks/drinking day; 95% CI= -3.11 to -1.00, p=0.0001). In contrast, no difference was observed between non-P3-genotypes who received ondansetron (All Other-OND) versus non-P3-genotypes who received placebo (All Other-Placebo; difference of 0.40 drinks/drinking day; 95% CI= -0.43 to 1.23; p=0.3445). Carriers of the P3-genotype who received ondansetron (P3-OND) had a greater increase in PDA compared to P3-genotype carriers who received placebo (P3-Placebo; difference of 11.56%; 95% CI= 0.80 to 22.31; p=0.0352) and compared to non-P3-genotype carriers who received ondansetron (All Other-OND; difference of 11.52%; 95% CI= 1.76 to 21.28; p=0.0208). In contrast, no differences were observed for the PDA endpoint between non-P3-genotypes treated with ondansetron versus non P3-genotypes treated with placebo (All Other-OND versus All Other-Placebo; difference of -0.96%; 95% CI= -8.61 to 6.69; p=0.8055).

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The results are summarized in the below graphs.

Phase 2b Clinical Trial Results — Analysis of Primary and Secondary Efficacy Endpoints for Target Genotypes

A 12- week, randomized, two-center, parallel-group, double-blind, placebo-controlled, two-arm (four cell) clinical trial of oral ondansetron (n=283)

 

As stated, above, the study was not powered to achieve statistical significance against the binary-by-day end point of PDHD, however, carriers of the P3-genotype who received ondansetron (P3-OND) showed a significantly greater reduction in PDHD compared to P3-genotype carriers who received placebo (P3-Placebo; difference of -11.08%; 95% CI= -21.90 to 0.27; p=0.0445), and compared to non-P3-genotype carriers who received ondansetron (All Other-OND; difference of -10.35%; 95% CI= -20.11 to -0.58; p=0.0378). In contrast, no difference was observed between non-P3-genotypes who received ondansetron (All Other-OND) versus non-P3-genotypes who received Placebo (All Other-Placebo; difference of 2.88%; 95% CI= -4.80 to 10.56; p=0.4625).

The results are summarized in the below graphs.

Phase 2b Clinical Study – Analysis of Reduction of Heavy Drinking for Target Genotypes

Definition of Heavy Drinking Day

As stated above, for the PDHD post hoc analysis of the Phase 2b clinical trial data, a heavy drinking day was defined as a day when a female drank 4 or more drinks in a day, with a drink being defined as containing 14 grams of alcohol, or when a man drank 5 or more drinks in a day, which was the definition the FDA indicated to us was required. It is also currently the definition of “high-risk drinking” in Dietary Guidelines for Americans 2015-2020 (U.S. Departments of HHS and Agriculture), the NIAAA’s definition of “binge drinking”, and has historically been the definition for a heavy drinking day (Neal, D., & Carey, K., 2007). The Substance Abuse and Mental Health Services Administration (SAMHSA) defines heavy drinking “as drinking 5 or more alcoholic drinks on the same occasion.” Subsequent to our analysis of the Phase 2b data and agreement with the FDA on the definition of a heavy drinking day as 4/5 or more drinks in a day for females/males, the FDA published a draft guidance, in which it states, “Those drinking 4 plus/5 plus [drinks for females and males, respectively] even on occasion have significantly higher risks (10 to 20 percent) of meeting criteria for AUD.” The FDA’s draft guidance then states that the NIAAA defines a heavy drinking day as more than 3 drinks in a day for a woman and more than 4 drinks in a day for a man, which is currently only part of the NIAAA’s definition for “low-risk drinking”, and which is very similar but not necessarily identical to what the FDA indicated to us was required and the criteria we used when generating our study report on the Phase 2b. So, it is unclear which definition of a heavy drinking day the FDA will accept at this time. However, under this different definition of a heavy drinking day as more than 3/4 for females/males, the Phase 2b trial data support the effect of AD04 on reducing heavy drinking and showed a greater reduction in PDHD compared to P3-genotype carriers who received placebo (P3-Placebo; difference of -10.24%; 95% CI= -21.18 to 0.70; p=0.0665), and compared to non-P3-genotype carriers who received ondansetron (All Other-OND; difference of -11.65%; 95% CI= -21.54 to -1.77; p=0.0209). In contrast, no difference was observed between non-P3-genotypes who received

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ondansetron (All Other-OND) versus non-P3-genotypes who received Placebo (All Other-Placebo; difference of 4.09%; 95% CI= -3.70 to 11.88; p=0.3033). We do not expect a small change to the definition of a heavy drinking day to dramatically change our plans or probability of success. We intend to discuss the definition of a heavy drinking day with the FDA and EMA prior to our relevant submissions.

 

Planned Phase 3 Clinical Program

The FDA has indicated that we can proceed with a single-arm, two-cell Phase 3 clinical trial design for the testing of AD04 as a treatment for AUD in patients that are genotype positive when tested against the AD04 genetic panel using our companion diagnostic test (i.e., a negative genetic test result will be an exclusion criterion). The initial Phase 3 trial is planned to be conducted in 294 patients in Scandinavia and Central and Eastern Europe where the prevalence of genotype positive people appears to be higher than in the U.S. and Western Europe. The primary analysis is expected to use the primary endpoints previously accepted by the European Medicines Authority (“EMA”) with the reduction from baseline of heavy drinking and reduction from baseline in total alcohol consumed being the co-primary endpoints, and an alternative analysis is expected to be conducted for filing in the United States using the FDA specified endpoint of reduction in percentage of patients with heavy drinking during the efficacy observation period as compared to placebo (FDA Feb. 2015 Draft Guidance Alcoholism: Developing Drugs for Treatment Guidance for Industry) and which the FDA has indicated will be acceptable. Under this guidance, the FDA appears to now define a heavy drinking as more than three drinks in a day for a woman and more than four drinks in a day for a man. We intend to seek clarification from the FDA on the definition of a heavy drinking day prior to our submission to them and do not believe a minor change to the definition of a heavy drinking day will be material to our plans. To conduct this initial trial, we plan to file a Clinical Trial Authorization (“CTA”) with the EMA and not file with the FDA since the trial is intended to be run exclusively in Europe. We have placed our investigational new drug (“IND”) application with the FDA on inactive status, which is a voluntary decision that reflects our strategic decision not to pursue clinical trials in the United States at this time. If we should choose to conduct clinical trials in the future in the United States we will be required to reactivate our IND in the United States prior to commencing any such clinical trials.

If the initial Phase 3 trial is successful, we intend to consult with the FDA and EMA, and assuming agreement from the agencies, conduct a second Phase 3 clinical trial in a broader geography that includes the United States. The trial design is expected to be the same as the first Phase 3 trial but is expected to include 580 patients in order provide increased exposure data to demonstrate the safety and tolerability of AD04 and increase the statistical power of the study. Depending on the results of the initial Phase 3 trial, which will not be fully powered for the FDA endpoint, it is also possible that the FDA may require a third Phase 3 trial. If a third Phase 3 trial is required, we would expect to conduct it in parallel with the second Phase 3 trial with a goal of not delaying approval of AD04, though this would require additional funds and investment in the clinical trials.

We have had a joint meeting with the Center for Drug Evaluation and Review (“CDER”) and the Center for Devices and Radiological Health (“CDRH”), the two divisions of the FDA responsible for drug approvals and test approvals, respectively. At the meeting the divisions agreed that clinical validation of our companion diagnostic test

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for AD04 will be evaluated by CDER and the technical validation of our companion diagnostic will be evaluated by CDRH. We already developed the methods for the companion diagnostic as a blood test and established the test with a U.S. third-party vendor capable of supporting a Phase 3 clinical trial, and have built validation and possible approval of the companion diagnostic into the Phase 3 program, including that we plan to store blood samples for all patients in the event additional genetic testing is required by regulatory authorities.

We do not plan to test AD04 in pediatric patients as part of our next Phase 3 trial. The FDA may grant full or partial waivers, or deferrals, for submission of data in pediatric subjects. We intend to apply for such a waiver, and the FDA has currently indicated it will grant a waiver for initial approval of AD04 for AUD.

In parallel with the second Phase 3 trial, we expect to conduct any standard Phase 1 studies required by the regulatory agencies. Studies that have been discussed with the FDA as potentially being required might assess food effects, potentiation of the central nervous system effects of alcohol, and pharmacodynamic impact of certain cytochrome P450 enzyme variants.

License with University of Virginia Patent Foundation

In January 2011, we entered into an exclusive, worldwide license agreement with UVA LVG for rights to make, use or sell licensed products in the United States based upon the patents and patent applications made and held by UVA LVG (the “UVA LVG License”). Three patent and patent application families are included in the UVA LVG License, with patents issued in over 40 countries, including, without limitation, in the U.S. and Europe. The licensed patents and patent applications currently include the below listed U.S. patents and patent application and any divisional patents, continuation patents and foreign equivalents.

1.       U.S. Patent Number 8,697,361, filed 1/11/11

“Serotonin Transporter Gene and Treatment of Alcoholism”

2.       U.S. Patent Number 8,753,815, filed 8/20/12

“Molecular genetic approach to treatment and diagnosis of alcohol and drug dependence”

3.       U.S. Patent Number 9,539,242, filed 4/30/14

“Molecular genetic approach to treatment and diagnosis of alcohol and drug dependence”

4.       PCT/US2012/054090, filed 9/7/2012

“Molecular genetic approach to treatment and diagnosis of alcohol and drug dependence”

Additionally, the UVA LVG License grants rights to data and know-how developed by the University of Virginia related to AD04, including, without limitation, to the data from the Phase 2b study described above.

As consideration for the rights granted in the license agreement, we are obligated to pay UVA LVG yearly license fees and milestone payments, and a royalty based on net sales of products covered by the patent-related rights set forth above. More specifically, upon commencement of the license we issued to UVA LVG Class A Units (which was equal to four percent (4%) of our equity on the date of issuance) as a license issue. We are obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product or the partnering of the licensed or sale of our company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; and (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, we are obligated to pay royalties to UVA LVG equal to a percentage of what we would have been required to pay to UVA LVG had we sold the products under sublicense ourselves. In addition, we are required to pay to UVA LVG 15% of any sublicensing income. The license agreement sets forth specific milestones completion deadlines including initiate Phase 3 clinical trials by December 31, 2018, submit an NDA by December 31, 2023 and commercialization of an FDA approved product by December 31, 2024. The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if we breach our obligations thereunder, including failing to make any milestone, the most immediate being initiating Phase 3 clinical trials by December 31, 2018, failing to make other required payments, or the failure to exercise diligence to bring licensed products to market. In the event of a termination, we will be obligated to pay all amounts that accrued prior to such termination. The license agreement also contains other customary clauses and terms as are common in similar agreements between industry and academia, including agreements to indemnify UVA

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LVG for any liabilities arising out of or related to the licensee’s exercise of its rights under the license agreement, making the license grant subject to the Bayh-Dole Act (35 U.S.C. 200 et seq.), the reservation of the licensor of the right to use the licensed intellectual property rights for its internal, non-commercial purposes, limitations/disclaimers of various warranties and representations, reporting and record-keeping requirements, and licensee liability insurance requirements.

The term of the license continues until the expiration, abandonment or invalidation of the licensed patents, and following any such expiration, abandonment or invalidation will continue in perpetuity on a royalty-free, fully-paid basis.

The UVA LVG currently has a policy under which a certain percentage of payments made to the UVA LVG under a license may be distributed to inventor of the licensed technology, therefor the Chairman of the Board in his capacity as inventor of the patents licensed by us from the UVA LVG may be eligible to receive such payments from the UVA LVG.

Protection from Generic Competition

Since our inception, we have focused on taking action geared toward ensuring AD04 will have market exclusivity for at least 10 years after it is launched with particular focus on the U.S. and Europe. Ondansetron, the active pharmaceutical ingredient (“API”) of AD04 was granted FDA approval as Zofran® for the treatment of post-operative and post-chemotherapy nausea and emesis in January 1991 and is now commercially available in generic form at doses from more than 12 times the AD04 dose to over 70 times the AD04 dose with the highest doses being administered intravenously (“i.v.”), which provides almost twice the drug exposure levels as oral dosing. With generic ondansetron available, the following threats have been addressed: (i) the potential use of currently available ondansetron products (i.e., Zofran®) “off-label”, and (ii) the potential manufacturing and launching of a generic version AD04 by a competitor.

Limited Threat of “Off-label” Use of Zofran®

The lowest doses of Zofran® tablets (and its generic equivalents) on the market are a 4 mg and 8 mg tablet as compared to AD04, which is currently formulated as a 0.33 mg tablet (12.2 times less than the 4 mg tablet). Thus, in order for a patient to use tablets already on the market and get the AD04 dose, a patient would have to cut the 4 mg tablet into 12 parts (or the 8 mg tablet into 24 parts), which we do not believe is reasonably possible; and, even with precise sectioning into 12 pieces, the dose may still not be accurate because tablets at the Zofran® dose have not been manufactured to ensure uniformity of distribution of the active ingredient across the tablet. Therefore, we believe that the risk of a large number of patients attempting to cut the currently marketed tablet to achieve the AD04 dose to be extremely low.

Since we do not believe that Zofran® tablets can be used as a substitute for AD04, the main question related to the potential for off-label use of the current products for treating addictions then becomes whether doctors and patients will believe it is possible to use the currently available, higher doses of ondansetron to treat addictions, including AUD. We believe doctors are extremely unlikely to prescribe currently available high dose versions of ondansetron and that any such prescribing that dose will likely be limited and immaterial to the sales of AD04 for two reasons — (1) we believe the high doses are unlikely to be efficacious as a treatment for AUD, and (2) we believe the high doses would likely raise significant safety concerns.

1.       Lack of Efficacy. The high doses of ondansetron found in Zofran® have been tested in clinical trials for treating AUD and have not shown efficacy against AUD (Sellers, et. al. 1994). At best, existing trial results do not suggest that the high Zofran®-level doses of ondansetron currently on the market and approved for nausea and emesis will be effective.

2.       Safety Concerns. While high-dose ondansetron is safe and tolerable at the doses on the market if administered acutely (i.e., dosed for a few hours i.v. or a few days orally) as is done for post-operative and post-chemotherapy nausea and emesis, the drug is known to have cardiovascular side effects at higher doses, and results from clinical studies suggest that high doses of ondansetron may affect the electrical activity of the heart. In fact, the FDA withdrew approval of the 32 mg i.v. Zofran® product that was

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previously on the market. As part of the FDA’s on-going safety review of currently available ondansetron doses, the FDA has stated that: “Ondansetron at currently marketed levels may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal or potentially fatal heart rhythm.” There are also several recent lawsuits claiming that Zofran® used for off label for morning sickness causes birth defects. Thus, if the currently available high-dose ondansetron was used chronically as would be needed for treating addiction there could potentially be significant safety concerns without additional clinical studies related to the chronic dosing of currently available ondansetron. At the lower dose of ondansetron in AD04, our product is almost as low as one one-hundredth of the dose of i.v. ondansetron that was removed from the market. The FDA has stated that we can commence chronic dosing of patients with AD04 without any further safety or non-clinical studies.

Therefore, we do not expect physicians to prescribe current ondansetron doses for currently unapproved use for treating AUD because there is no evidence those doses would work for treating AUD and there may be safety concerns associated with the chronic administration of currently available doses.

There is also a liquid, pediatric formulation of Zofran® on the market. It is offered in a 50 mL bottle that is available for a little over $100 online and would provide a 2-month supply of AD04 if dosed at the 0.4 mL required to achieve the 0.33 mg AD04 dose. Our risk assessment is that, though it would be possible to use the liquid formulation for administering a dose of ondansetron equivalent to AD04, it is not expected to be a practice that would materially impact the sales of AD04, and the risk from the liquid formulation is low for the following reasons:

1.       Compliance concerns. In the field of addiction, patient compliance is one of the biggest concerns for both the physicians and the patients themselves. A treatment not appropriately administered is a treatment that will not work. Oral tablets have been shown to have one of the highest compliance rates over other dosage forms. It is likely that both physicians and patients will demand the tablet in order to improve compliance and, thus, treatment success rates.

2.       Inconvenient, complicated delivery. A major driver of compliance is the convenience of appropriately administering the drug. Appropriate delivery of the liquid formulation would require patients to measure each dose into a graduated dropper or syringe (administration of such a small amount (0.4 mL) by graduated cup would not be practical). Cleanup of the sticky product would be inconvenient as would transportation and storage, and an opened bottle would need to be used within 4 weeks (per UKPAR). Therefore, we expect that AD04’s convenient tablet would increase patient compliance relative to the liquid formulation. Bottle breakage and spillage will also be a concern.

3.       Dosing Accuracy. Dosing accuracy is particularly important when using ondansetron to treat alcoholism due to the limitations of the therapeutic window and the cardiovascular side effects at high doses. With the liquid formulation, measuring the small (0.4 mL) dose will be difficult with great opportunity for misdosing even if a graduated syringe is used. In real-world practice, many patients would use other methods such as estimated pouring into cups and drinking directly from the bottle. Misdosing could significantly affect the safety and/or efficacy of the treatment.

4.       Lack of physician motivation to prescribe the liquid formulation. Given the known compliance advantages of oral tablets vs. liquid formulations, the heightened need for compliance in this particular patient population, and the concerns around dosing accuracy with a liquid formulation, we believe it is likely physicians would recognize the risk of prescribing the liquid formulation off-label and so be unwilling to prescribe it. For insured patients, any differential in co-payments would create little incentive to use the liquid formulation relative to the compliance and inconvenience problems.

5.       Lack of competitive marketing. Manufacturers of liquid ondansetron are not allowed to market for reduction in alcohol use disorder because reduction in alcohol use disorder is not an approved indication for their product. Furthermore, most generic companies do not have marketing efforts of any kind.

6.       Litigation risk to large prescribers. If a large clinic (such as a rehabilitation clinic) prescribes or provides the liquid formulation off-label, the institution could be liable for inducing infringement of our licensed patents.

In summary, we do not expect off-label use of currently available ondansetron to meaningfully impact the sales of AD04.

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Protection from a Competitor Launching a Generic Version of AD04.

We believe that we license the patent protection necessary to protect us against the launch by a competitor of a generic version of AD04. The label being sought for AD04 will be:

The use of AD04 (i.e., ondansetron) for the treatment of patients that are positive for the specified genetic markers.

The only use for the AD04 dose of ondansetron will be under this label.

Our licensed patents cover the following:

The use of AD04 (i.e., ondansetron) for the treatment of patients that are positive for the specified genetic markers.

We believe that any attempt by competitors to reformulate and market ondansetron at our intended dosage levels, while technically feasible, can be interpreted under current case law as inducement to infringe on our intellectual property rights, which should, accordingly, be actionable. Additionally, there will be no unpatented use for the AD04 dose of ondansetron. So, a competitor that sells a product containing the AD04 dose of ondansetron will indirectly infringe our licensed patents, which should, accordingly, be actionable.

A competitor could sell a dose equal to that of AD04 and avoid our licensed patents if they conduct a Phase 3 program using the AD04 dose to treat a different label indication, and achieved successful results and approval. We do not know of any clinical development programs of ondansetron underway at this time and so consider this risk to be negligible.

Implications of Being an Emerging Growth Company

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and therefore we intend to take advantage of certain exemptions from various public company reporting requirements, including not being required to have our internal controls over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments. We may take advantage of these exemptions until we are no longer an “emerging growth company.” In addition, the JOBS Act provides that an “emerging growth company” can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to use the extended transition period for complying with new or revised accounting standards under the JOBS Act. This election allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates. We will remain an “emerging growth company” until the earlier of (1) the last day of the fiscal year: (a) following the fifth anniversary of the completion of this offering; (b) in which we have total annual gross revenue of at least $1.0 billion; or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeded $700.0 million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. References herein to “emerging growth company” have the meaning associated with that term in the JOBS Act.

Corporate Information

ADial Pharmaceuticals, L.L.C. was formed as a Virginia limited liability company in November 2010. Prior to the closing of this offering, ADial Pharmaceuticals, L.L.C. will convert from a Virginia limited liability company into a Virginia corporation, and then reincorporate in Delaware by merging with Adial Pharmaceuticals, Inc., a Delaware corporation and wholly owned subsidiary of ADial Pharmaceuticals, L.L.C. We refer to this as the corporate conversion/reincorporation. In connection with the corporate conversion/reincorporation, each unit of ADial Pharmaceuticals, L.L.C. will be converted into shares of common stock of a Virginia corporation and the ultimately shares of common stock of Adial Pharmaceuticals, Inc., the members of ADial Pharmaceuticals, L.L.C. will ultimately become stockholders of Adial Pharmaceuticals, Inc. and Adial Pharmaceuticals, Inc. will ultimately

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succeed to the business of ADial Pharmaceuticals, L.L.C. See “Corporate Conversion/Reincorporation” for further information regarding the corporate conversion/reincorporation.

Our principal executive offices are located at 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901, and our telephone number is (434) 422-9800. Our website address is www.adialpharma.com. Information contained in our website does not form part of the prospectus and is intended for informational purposes only.

This prospectus contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Governmental Regulation

Our business is subject to extensive laws and regulations, the most significant of which are summarized below.

FDA Approval Process

In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act (the “FDC Act”), and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. In the United States, pharmaceutical products used for the prevention, treatment, or cure of a disease or condition of a human being are subject to extensive regulation under the FDC Act. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending NDAs, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.

Pharmaceutical product development for a new product or certain changes to an approved product in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA of an investigational new drug application (“IND”), which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product or disease.

Preclinical tests include laboratory evaluation of product chemistry, formulation, and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin. However, the FDA can impose a clinical hold after 30 days if it has safety or compliance-related concerns.

Clinical trials involve the administration of the investigational new drug or biologic to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice (“GCP”), an international standard meant to protect the rights and health of subjects and to define the roles of clinical trial sponsors, administrators, and monitors; as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. subjects and subsequent protocol amendments must be submitted to the FDA as part of the IND.

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As noted, the FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The study protocol and informed consent information for subjects in clinical trials must also be submitted to an institutional review board (“IRB”), for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, for safety or other concerns, or may impose other conditions.

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase 1, the initial introduction of the drug or biologic into healthy human subjects or patients, the product is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence of effectiveness. Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug or biologic for a particular indication, dosage tolerance, and optimum dosage, and to identify common adverse effects and safety risks. If preliminary evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug or biologic and to provide adequate information for the labeling of the product. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug or biologic.

After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States. The NDA must include the results of all preclinical, clinical, and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and control. The cost of preparing and submitting an NDA is substantial. The submission of most NDAs is additionally subject to a substantial application user fee, currently exceeding $2,335,200 (although a waiver is possible in certain cases), and the manufacturer and/or sponsor under an approved new drug application are also subject to annual product and establishment user fees, currently exceeding $110,370 per product and $569,200 per establishment. These fees are typically increased annually.

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of NDAs. Most such applications for standard review drug or biologic products are reviewed within ten to twelve months; most applications for priority review drugs or biologics are reviewed in six to eight months. The FDA can extend these reviews by three months. The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission.

The FDA may also refer applications for novel drug or biologic products, or drug or biologic products that present difficult questions of safety or efficacy, to an advisory committee — typically a panel that includes clinicians and other experts — for review, evaluation, and a recommendation on questions raised by an application, including whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with current good manufacturing practice (“cGMP”) is satisfactory and the NDA contains data that provide substantial evidence that the drug or biologic is safe and effective in the indication studied.

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a Complete Response Letter (“CRL”). A CRL generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.

An approval letter authorizes commercial marketing of the drug or biologic with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use

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(“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the product. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the product’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing. The FDA could also impose a boxed warning (sometimes referred to as a Black Box Warning) in the product label if it identifies a specific risk that requires particular attention. This imposition of a Black Box Warning limits certain types of promotions.

Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented.

Enacted in 2016, the 21st Century Cures Act (the “Cures Act”), in part, revises the drug and device review and approval processes at the FDA. The Cures Act, which was signed into law on December 13, 2016, among other things, requires the manufacturer of an investigational drug for a serious disease or condition to make available, such as by posting on its website, its policy on evaluating and responding to requests for individual patient access to such investigational drug. This requirement applies on the later of 60 calendar days after the date of enactment of the Cures Act or the first initiation of a Phase 2 or Phase 3 trial of the investigational drug.

Post-Approval Requirements

Once an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of drugs and biologics, including standards and regulations for direct-to-consumer advertising, industry-sponsored scientific and educational activities and promotional activities involving the internet. Drugs and biologics may be marketed only for the approved indications and in accordance with the provisions of the approved labeling.

Adverse event reporting and submission of periodic reports is required following FDA approval of an NDA. The FDA also may require post-marketing testing, known as Phase 4 testing, REMS, and special surveillance to monitor the effects of an approved product, or the FDA may place other conditions on an approval that could restrict the distribution or use of the product. In addition, quality control, drug manufacture, packaging, and labeling procedures must continue to conform to cGMPs after approval. Drug and biologic manufacturers must list the product with the FDA, and they and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing and other facilities to assess compliance with cGMPs and other requirements. Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality-control to maintain compliance with cGMPs. Regulatory authorities may withdraw product approvals, issue warning or other letters, suspend production activities, or request product recalls if a company fails to comply with regulatory standards, or take other regulatory or enforcement action if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered. Significant expenses are required to correct deficiencies.

Companion diagnostics and complementary diagnostics

We believe that the success of our product candidates may depend, in part, on the development and commercialization of either a companion diagnostic or complementary diagnostic. Companion diagnostics and complementary diagnostics can identify patients who are most likely to benefit from a particular therapeutic product; identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; or monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness. Companion diagnostics and complementary diagnostics are regulated as medical devices by the FDA and, as such, require either clearance or approval prior to commercialization. The level of risk combined with available controls to mitigate risk determines whether a companion diagnostic device requires Premarket Approval Application, or PMA, approval or is cleared through the 510(k) premarket notification process. For a novel therapeutic product for which a companion diagnostic device is essential for the safe and effective use of the product, the companion diagnostic device should be developed and approved or 510(k)-cleared contemporaneously with the therapeutic. The use of the companion diagnostic device will be stipulated in the labeling of the therapeutic product. This is also true for a complementary diagnostic, although it is not a prerequisite for receiving the therapeutic.

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Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act

Under certain circumstances, an approved application may be eligible for three years of non-patent market exclusivity provided by the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. The FDA might grant such exclusivity, (which would be separate from any patent protection to which an approved drug might be entitled) if the applicant conducted new clinical investigations (other than bioavailability studies) that are new and essential to the application’s approval. Among the types of exclusivity are those for a “new chemical entity” and those for a new formulation or indication for a previously-approved drug. If granted, marketing exclusivity for the types of products that include only drugs with innovative changes to previously-approved products using the same active ingredient, might prohibit the FDA from approving an application for a competitor product, such as an abbreviated new drug application or a 505(b)(2) NDA relying on the finding of safety and efficacy for three years. This three-year exclusivity, however, covers only the innovation associated with the original NDA. It does not prohibit the FDA from approving applications for drugs with the same active ingredient but without the new innovative change. These marketing exclusivity protections do not prohibit the FDA from approving a full NDA, even if it contains the innovative change. There is no guarantee that the FDA will grant such exclusivity and competitors can try to seek approval of competitive products, notwithstanding the exclusivity. However, if three years of exclusivity is afforded, it offers us one more barrier to competitor entry for a few years.

505(b)(2) NDA

We intend to submit a 505(b)(2) NDA. A 505(b)(2) NDA provided by Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, allows the FDA to rely, for approval of an NDA, on data not developed by the applicant. Such an NDA, referred to as a 505(b)(2) application contains full reports of investigations of safety and effectiveness, but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Such applications permit approval of applications other than those for duplicate products and permit reliance for such approvals on scientific literature or an FDA finding of safety and/or effectiveness for a previously approved drug product. While each application is different, these types of applications will typically require bridging studies (to support the change or modification from the listed drug) and could require clinical data to support the modification of the already-approved drug product.

In addition, a 505(b)(2) NDA requires the applicant to certify as to any patents that claim the drug for which a claim of patent infringement could be made. In certain cases, the applicant of the NDA with a patent certification must provide notice to the patent holder, which can lead to a patent infringement lawsuit, thereby delaying the FDA approval of the competitor product for up to 30 months, separate from any traditional patent infringement litigation delay. Similarly, if the competitor has its own market exclusivity, this can delay approval of the product. However, if a product obtains exclusivity or patent protection, it can delay entry of competitors for several years.

Pediatric Information

Under the PREA, NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data.

Fraud and Abuse and Other Healthcare Regulation

We are subject to various federal and state healthcare laws, including, but not limited to, anti-kickback laws. Penalties for violations of these healthcare laws include, but are not limited to, criminal, civil and/or administrative penalties, damages, fines, disgorgement, individual imprisonment, possible exclusion from Medicare, Medicaid and other federal and state healthcare programs, and the curtailment or restructuring of operations.

Anti-Kickback Statute

The federal Anti-Kickback Statute prohibits persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in exchange for or to induce either the referral of an individual, or the furnishing, arranging for or recommending a good or service, or for the purchasing, leasing, ordering, or arranging for or recommending, any good, facility, service or item for which payment may be made in whole or in part under federal healthcare programs, such as the

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Medicare and Medicaid programs. The federal Anti-Kickback Statute is broad and prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. The term “remuneration” expressly includes kickbacks, bribes, or rebates and also has been broadly interpreted to include anything of value, including for example, gifts, discounts, meals, entertainment, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value.

There are a number of statutory exceptions and regulatory safe harbors protecting certain business arrangements from prosecution under the federal Anti-Kickback Statute. These statutory exceptions and safe harbors set forth provisions that, if all their applicable requirements are met, will assure healthcare providers and other parties that they may not be prosecuted under the federal Anti-Kickback Statute. The failure of a transaction or arrangement to fit precisely within one or more applicable statutory exceptions or safe harbors does not necessarily mean that it is per se illegal or that prosecution will be pursued. However, conduct and business arrangements that do not fully satisfy all requirements of an applicable safe harbor may result in increased scrutiny by government enforcement authorities and will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Additionally, the intent standard under the federal Anti-Kickback Statute was amended under the Affordable Care Act, to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. The Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act, which is discussed below.

Federal Civil False Claims Act

The federal civil False Claims Act prohibits, among other things, persons or entities from knowingly presenting or causing to be presented a false or fraudulent claim to, or the knowing use of false statements to obtain payment from or approval by, the federal government. Suits filed under the federal civil False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government. These individuals, sometimes known as “relators” or, more commonly, as “whistleblowers”, may share in any amounts paid by the entity to the government in fines or settlement. The number of filings of qui tam actions has increased significantly in recent years, causing more healthcare companies to have to defend a case brought under the federal civil False Claim Act. If an entity is determined to have violated the federal civil False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Many comparable state laws are broader in scope and apply to all payors, and therefore, are not limited to only those claims submitted to the federal government.

Federal Physician Self-Referral Prohibition

We may also be subject to the federal physician self-referral prohibitions, commonly known as the Stark Law, which prohibits, among other things, physicians who have a financial relationship, including an investment, ownership or compensation relationship with an entity, from referring Medicare and Medicaid patients for designated health services (which include clinical laboratory services) to such entity, unless an exception applies. Similarly, entities may not bill Medicare, Medicaid or any other party for services furnished pursuant to a prohibited referral. Many states have their own self-referral laws as well, which in some cases apply to all third-party payors, not just Medicare and Medicaid.

Federal Civil Monetary Penalties Statute

The federal Civil Monetary Penalties Statute, among other things, imposes fines against any person or entity who is determined to have presented, or caused to be presented, claims to a federal healthcare program that the person knows, or should know, is for an item or service that was not provided as claimed or is false or fraudulent.

Health Insurance Portability and Accountability Act of 1996

The federal Health Insurance Portability and Accountability Act (“HIPAA”) created several new federal crimes, including healthcare fraud and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering

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up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations established uniform standards for certain covered entities, which are healthcare providers, health plans and healthcare clearinghouses, as well as their business associates, governing the conduct of specified electronic healthcare transactions and protecting the security and privacy of protected health information. Among other things, HITECH also created four new tiers of civil monetary penalties and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

The Federal Physician Payments Sunshine Act

The federal Physician Payment Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with certain exceptions, to report annually to CMS, information related to “payments or other transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and to report annually to CMS ownership and investment interests held by physicians, as defined above, and their immediate family members. Failure to submit timely, accurately and completely the required information for all payments, transfers of value and ownership or investment interests may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1.0 million per year for “knowing failures.”

State Law Equivalents

Many states have also adopted laws similar to each of the above federal laws, such as anti-kickback and false claims laws, which may be broader in scope and apply to items or services reimbursed by any third-party payor, including commercial insurers, as well as laws that restrict our marketing activities with health care professionals and entities, and require us to track and report payments and other transfers of value, including consulting fees, provided to certain healthcare professionals and entities. Some states mandate implementation of compliance programs to ensure compliance with these laws. We also are subject to foreign fraud and abuse laws, which vary by country.

Healthcare Reform

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), which has the potential to substantially change healthcare financing and delivery by both governmental and private insurers, and significantly impact the drug and medical device industries. The ACA will impact existing government healthcare programs and will result in the development of new programs. The ACA’s provisions of importance include, but are not limited to, a deductible 2.3% excise tax on any entity that manufactures or imports medical devices offered for sale in the Unites States, with limited exceptions, effective January 1, 2013.

In addition, the ACA and its implementing regulations, among other things, revised the methodology for calculation of rebates owed by manufacturers to the state and federal government for covered outpatient drugs and certain biologics, including AD04 or any future product candidates, under the Medicaid Drug Rebate Program, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research.

Other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year. In January 2013, President Obama signed into law

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the American Taxpayer Relief Act of 2012 (the “ATRA”) which delayed for another two months the budget cuts mandated by these sequestration provisions of the Budget Control Act of 2011. In March 2013, the President signed an executive order implementing sequestration, and in April 2013, the 2% Medicare payment reductions went into effect. The ATRA also, among other things, reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

In addition, Congress often uses the Medicare program for pay for legislation. For example, on April 16, 2015, President Obama signed into law the “Medicare Access and CHIP Reauthorization Act of 2015” (“MACRA”). MACRA repealed the Medicare sustainable growth rate formula that had been used to determine payment levels under the Medicare physician fee schedule (“PFS”), and established a new method to update payments for physicians and other providers paid under the PFS. Congress reduced Medicare payments for several categories of providers and made changes to Medicare policies to offset the cost of the bill. It is possible that future legislation and regulations may include Medicare payment reductions or policy changes that result in reduced payments, increased burdens or increased operating costs.

The full impact of the ACA, as well as other laws and reform measures that may be proposed and adopted in the future, remains uncertain, but may continue the downward pressure on medical device pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs, which could have a material adverse effect on our business operations. Efforts to significantly amend or repeal the ACA continue and if passed could have a significant impact on important aspects of our business including medical device and drug pricing, Medicare payment reductions or policy changes that result in reduced payments, or increased burdens or operating costs.

The Foreign Corrupt Practices Act

The Foreign Corrupt Practices Act (“FCPA”), prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of such foreign official in her or her official capacity or to secure any other improper advantage in order to obtain or retain business. In addition to the antibribery provisions, the FCPA also obligates “issuers,” companies whose securities are registered pursuant to Section 12 of the Exchange Act or is required to file periodic and other reports with SEC under Section 15(d) of the Exchange Act to comply with the FCPA’s record keeping and internal controls provisions; the accounting provisions require a listed company to maintain books and records that, in reasonable detail, accurately and fairly reflect all transactions of the corporation, including international affiliates, and to devise and maintain an adequate system of internal accounting controls to assure management’s control authority, and responsibility over the company’s assets.

Export Controls and Economic Sanctions

Several U.S. statutes and regulations regulate the export from the United States of pharmaceutical products. Pursuant to the Export Administration Regulations, (“EAR”) the export (including re-exports and “deemed exports”) of commercial and “dual-use” products may require a license or be prohibited. A listing of the types of goods and services controlled for export by the EAR is on the Commerce Control List (“CCL”), which includes essentially all civilian science, technology, and engineering dual use items. For products listed on the CCL, a license will be required as a condition to export, unless an exclusion or license exception applies. Those items not explicitly included on the CCL are included in a broad category known as “EAR99.” Although a license may not generally be required for EAR99 designated items, a license will be required if the item will be shipped or otherwise transferred to a comprehensively embargoed country or for a potentially prohibited purpose.

The Commerce Department’s Office of Antiboycott Compliance and the Treasury Department’s Internal Revenue Service enforce anti-boycott compliance regulations that prohibit U.S. persons such as the Company from participating directly or indirectly with an economic boycott that is not recognized by the United States. The regulations include reporting requirements, prohibitions, and tax liabilities that may be incurred if the Company supports, even inadvertently, an economic boycott in which the U.S. does not participate.

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Pursuant to the Trading With the Enemy Act, the International Emergency Economic Powers Act, and other related statutes, regulations, and Executive Orders, the Treasury Department’s Office of Foreign Assets Control (“OFAC”), administers and enforces economic and trade sanctions that prohibit or restrict certain activities with embargoed countries, sanctioned entities, and sanctioned individuals for particular foreign policy and national security reasons. The scope of the sanctions varies significantly, but may include comprehensive restrictions on imports, exports, investment, and facilitation of foreign transactions involving a sanctioned jurisdiction, entity or person, as well as non-sanctioned persons and entities acting on behalf of sanctioned jurisdictions, entities or people. OFAC’s programs also prohibit U.S. persons, such as the Company, from transacting with any person or entity that is deemed to be a Foreign Sanctions Evader (foreign individuals and entities determined to have violated, attempted to violate, conspired to violate, or caused a violation of U.S. sanctions).

Other U.S. government agencies, including the U.S. Department of State, may maintain regulations that impact the Company’s ability to export pharmaceutical products from the United States. These broad range of U.S. export control laws and regulations obligate U.S. businesses to develop, maintain, and enforce an adequate system of internal controls to ensure compliance with such laws and regulations.

Employees

As of the date of this prospectus, we have 3 full and part-time employees. None of our employees is represented by a labor union, and we consider our relationship with our employees to be good.

Description of Property

On August 16, 2017, we entered into a sublease for two furnished offices (approximately 440 square feet) located at 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901. Pursuant to the sublease we have agreed to pay rent in the amount of $300 per month while we are a private company with the rent increasing to $1,300 per month beginning on the first day of the month that we are a public company. Either party may terminate the sublease upon written notice to the other party specifying the date of termination as long as such date of termination is not earlier than the last day of the month following the month in which such notice is given. Other company personnel work remotely.

Prior to the entry into our current sublease, we occupied approximately 300 square feet of office space that was provided to us at no cost by one of our members.

Legal Proceedings

We are subject to claims and legal actions that arise in the ordinary course of business from time to time. However, we are not currently subject to any claims or actions that we believe would have a material adverse effect on our financial position or results of operations.

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MANAGEMENT

Board of Directors, Executive Officers and Key Employee

Our business and affairs are organized under the direction of our board of directors, which currently consists of eight members.

In accordance with the terms of our certificate of incorporation that will go into effect immediately prior to the closing of this offering, we will divide our board of directors into three classes, as follows:

         Class I, which will consist of Bankole A. Johnson, William B. Stilley, III and Kevin Schuyler, whose term will expire at our annual meeting of stockholders to be held in 2018;

         Class II, which will consist of Tony Goodman and Robertson H. Gilliland, whose terms will expire at our annual meeting of stockholders to be held in 2019; and

         Class III, which will consist of J. Kermit Anderson and James W. Newman, Jr., whose terms will expire at our annual meeting of stockholders to be held in 2020.

At each annual meeting of stockholders to be held after the initial classification, the successors to directors whose terms then expire will serve until the third annual meeting following their election and until their successors are duly elected and qualified. The authorized number of directors may be changed only by resolution of the board of directors. Any additional directorships resulting from an increase in the number of directors will be distributed between the three classes so that, as nearly as possible, each class will consist of one-third of the directors.

Set forth below are our directors and executive officers and their respective ages and positions as of the date of this prospectus:

Executive Officers and Directors

 

Age

 

Position(s) Held

William B. Stilley, III, MBA

 

49

 

Chief Executive Officer, President and Director

Joseph Truluck, MBA

 

39

 

Chief Operating Officer and Chief Financial Officer

J. Kermit Anderson

 

67

 

Director

Robertson H. Gilliland, MBA

 

37

 

Director

Tony Goodman

 

53

 

Director

Bankole A. Johnson, DSc, MD

 

57

 

Director, Chairman of the Board

James W. Newman, Jr.

 

74

 

Director

Kevin Schuyler, MBA, CFA

 

48

 

Director, Vice Chairman of the Board, Lead Independent Director

There are no family relationships among any of our directors or executive officers. The executive officers and directors named above may act as authorized officers of the Company when so deemed by resolutions of the Company. Set forth below is a summary of the business experience of each of our directors and executive officers identified above and our key employee:

William B. Stilley, III, Chief Executive Officer, President and Director

William B. Stilley has served as our Chief Executive Officer since December 2010, our Secretary and Treasurer since April 2012 and as a director since April 2011. Prior to joining ADial Pharmaceuticals, LLC, from August 2008 until December 2010 he was the Vice President, Business Development & Strategic Projects at Clinical Data, Inc. (NASDQ CLDA). At Clinical Data, Inc., Mr. Stilley worked on licensing and M&A transactions and was involved in management of Phase 3 clinical trials, production of Viibryd® for initial commercial launch of the product, and sourcing drug product and drug substance for the Phase 3 clinical trials of the company’s vasodilator drug for myocardial stress imaging. From February 2002, Mr. Stilley was the COO and CFO of Adenosine Therapeutics, LLC where he ran the internal operations of the company, including research and development, and all financing activity, until the sale of its principal assets Adenosine Therapeutics were acquired by Clinical Data, Inc. in August 2008. Mr. Stilley has served as an advisor of Adenosine Therapeutics since the sale of its assets to clinical data and its subsequent acquisition of new assets. Mr. Stilley has advised both public and private companies on financing and M&A transactions, has been the interim CFO of a public company, the interim Chief Business Officer of Diffusion Pharmaceuticals from September 2015 through December 2015, and the COO and CFO of a number of private companies. Before entering the business community, Mr. Stilley served as Captain in the U.S. Marine Corps.

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Mr. Stilley has an MBA with honors from the Darden School of Business and a B.S. in Commerce/Marketing from the McIntire School of Commerce at the University of Virginia. Until recently, he guest lectured at the Darden School of Business in two courses on the management of life science companies and serves on the Board of Virginia BIO, the statewide biotechnology organization. He also holds patents for Stedivaze®, which is currently in Phase 3 clinical development.

We selected Mr. Stilley to serve on our board because he brings to the board extensive knowledge of the biotechnology industry. Having served in senior corporate positions in several biomedical companies, he has a vast knowledge of the industry and brings to the board significant executive leadership and operational experience as well as knowledge and experience of financing and M&A transactions. His business experience provides him with a broad understanding of the operational, financial and strategic issues facing public companies and his extensive knowledge financing and M&A will serve our company well in the future.

Joseph Truluck, Chief Operating Officer and Chief Financial Officer

Joseph Truluck has served as our Chief Operating officer since April 2017, our Chief Financial Officer since June 2017 and since May 2016 as our VP Operations and Finance. Since January 2013, Mr. Truluck has served as the VP Operations and Finance at Adenosine Therapeutics, LLC after the company reacquired its major drug development program. As VP Operations and Finance, at Adenosine Therapeutics, Mr. Truluck has overseen the operations of the business, including seeing to completion a project to merge and analyze two partially completed Phase 3 trials to constitute a single trial. From April 2005 to July 2019, Mr. Truluck served as the Operations Manager of Adenosine Therapeutics’ until its purchase in August 2008 by Clinical Data. After the purchase of Adenosine Therapeutics’ operations by Clinical Data, Mr. Truluck went on to gain an MBA from Tulane University with a concentration in Finance. After graduation, from July 2011 until March 2012, he co-founded and served as the VP Operations and Finance for Beonten, Inc., a software development company. Beonten’s goal was the creation of a software platform for knowledge management and sharing. Beonten was a Semi-Finalist in the prestigious MIT 100K business plan competition. In addition to his MBA at Tulane, Mr. Truluck earned an MA in Philosophy at the University of Virginia, with a thesis in the area of modal semantics.

J. Kermit Anderson, Director

J. Kermit Anderson has served as a director since February 2015. He has served as the VP and Chief Financial Officer at Cumberland Development Co. since 2007. Cumberland is a privately held company which evaluates and oversees investments in minerals exploration, life sciences, and real estate for a family office. Mr. Anderson has over forty years of experience in financial and development roles for a number of companies. He holds widely diversified experience in financial planning and reporting, accounting, forecasting, pricing, GAAP reporting and contract negotiations including benefits and compensation. His career is split almost equally between public and private companies including major sales and acquisitions. He has held various positions in energy businesses including Massey Energy, AMVEST and Cumberland Resources Corporation working on the sale of the companies for the last two roles. Mr. Anderson has worked extensively on startups for Massey and AMVEST including the move to a new business area with AMVEST. He received his BS-BA from West Virginia University in 1972.

We selected Mr. Anderson to serve on our board because he brings extensive industry experience in corporate development and finance. His prior service with other public companies provides experience related to good corporate governance practices.

Robertson H. Gilliland, MBA, Director

Mr. Gilliland has served as a director since June 2014. Since July 2013, he has been a Principal at Keller Enterprises, LLC, a family office that invests and manages private capital. As a principal, Mr. Gilliland is responsible for sourcing, vetting and managing a variety of private direct investments and spearheading internal initiatives. Prior to joining Keller Enterprises, Mr. Gilliland attended business school beginning in 2011 and was previously a Director at the Brunswick Group, where he specialized in strategic communications and investor relations around mergers and acquisitions. During his tenure at Brunswick, Mr. Gilliland worked on over 35 multi-billion dollar M&A transactions. He has his MBA from the University of Michigan’s Ross School of Business, where he graduated with honors.

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We selected Mr. Gilliland to serve on our board because he brings extensive knowledge of the financial markets. Mr. Gilliland’s business background provides him with a broad understanding of the financial markets and the financing opportunities available to us.

Tony Goodman, Director

Tony Goodman has served as a director since July 2017. Mr. Goodman’s career spans over 23 years in Pharma and Biotech. Mr. Goodman is the Founder/Managing Director of Keswick Group, LLC, a Biotech Strategic Commercial and Business Development Advisory Firm. From October 2014 until February 2017, he served as the Chief Business Development Officer of Indivior PLC (INDV, FTSE 500) and a member of the executive team which brought Indivior public as a demerger from Reckitt Benckiser Pharmaceuticals, Inc. Mr. Goodman held many leadership positions at Reckitt Benckiser Pharmaceuticals from October 2009 until October 2014 that include: Global Director, Strategy and Commercial Development; Global Head, Category Development; and Director of US Commercial Managed Care. Mr. Goodman has also served as the Director of Strategic Marketing and Business Development at PRA International and Group Product Manager, Marketing and Director of the Managed Health Strategies Group at Purdue Pharmaceuticals L.P. Mr. Goodman graduated from Marshall University, with a degree in Business Administration and is currently a Full Board Executive with the National Association of Corporate Directors (“NACD”).

We selected Mr. Goodman to serve on our board because he brings extensive knowledge of the addiction and pharmaceuticals industry and his significant strategic development experience. Mr. Goodman’s position at the NACD provides him with a broad understanding of the role of directors and corporate governance issues facing public companies.

Bankole A. Johnson, Director and Chairman of the Board

Professor Bankole Johnson has served as the Chairman of our Board since November 2010. Dr. Johnson is a world-leading neuroscientist and a pioneer in the development of medications for the treatment of alcohol abuse and is the inventor of all patents covering AD04. In August 2013 he was appointed Chair of the Department of Psychiatry at the University of Maryland School of Medicine and also leads the new Brain Science Research Consortium Unit at the University of Maryland. Previously, from 2004 until August 2013, he served as Alumni Professor and Chairman of the Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia.

Professor Johnson graduated in Medicine from Glasgow University in 1982 and trained in Psychiatry at the Royal London and Maudsley and Bethlem Royal Hospitals. Additional to his medical degree, he trained in research at the Institute of Psychiatry (University of London) and conducted studies in neuropsychopharmacology for his doctoral thesis (degree from Glasgow University) on the Medical Research Council unit at Oxford University. More recently, in 2004, Professor Johnson earned his Doctor of Science degree in Medicine from Glasgow University — the highest degree that can be granted in science by a British university. His primary area of research expertise is the psychopharmacology of medications for treating addictions.

Professor Johnson is a licensed physician and board-certified psychiatrist throughout Europe and in the U.S. He is the Principal Investigator on National Institutes of Health (NIH)-funded research studies utilizing neuroimaging, neuropharmacology, and molecular genetics techniques. Professor Johnson’s clinical expertise is in the fields of addiction, biological, and forensic psychiatry. Honors include service on numerous NIH review and other committees including special panels.

Professor Johnson was the 2001 recipient of the Dan Anderson Research Award for his “distinguished contribution as a researcher who has advanced the scientific knowledge of addiction recovery.” He received the Distinguished Senior Scholar of Distinction Award in 2002 from the National Medical Association. Professor Johnson also was an inductee of the Texas Hall of Fame in 2003 for contributions to science, mathematics, and technology, and in 2006 he received the American Psychiatric Association’s (APA’s) Distinguished Psychiatrist Lecturer Award. In 2007, he was named as a Fellow in the Royal College of Psychiatrists, and in 2008 he was elected to the status of Distinguished Fellow of the APA. In 2009, he received the APA’s Solomon Carter Fuller Award, honoring an individual who has pioneered in an area that has benefited significantly the quality of life for Black people. In 2010, he was named as a Fellow in the American College of Neuropsychopharmacology. Professor Johnson is Field Editor-in-Chief of Frontiers in Psychiatry, serves on the Editorial Board of The American Journal of Psychiatry, and reviews for over 30 journals in pharmacology, neuroscience, and the addictions. He has over

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200 publications. Professor Johnson also has edited three books: Drug Addiction and Its Treatment: Nexus of Neuroscience and Behavior, Handbook of Clinical Alcoholism Treatment, and Addiction Medicine: Science and Practice, one of the foremost reference textbooks in the field.

Bankole Johnson has served as a consultant to Johnson & Johnson (Ortho-McNeil Janssen Scientific Affairs, LLC), Transcept Pharmaceuticals, Inc., D&A Pharma, Organon, ADial Corporation, Psychological Education Publishing Company (PEPCo LLC), and Eli Lilly and Company. He also has served on the Extramural Advisory Board for NIAAA (2004-present), the National Advisory Council for NIDA (2004-2007), the Medications Development Subcommittee of NIDA’s Advisory Council on Drug Abuse (2004-2007), and the Medications Development Scientific Advisory Board for NIDA (2005-2009). In addition, he has been the recipient of research grant support from both NIAAA and NIDA.

We selected Professor Johnson to serve on our Board as our Chairman because he brings extensive knowledge of neuropsychopharmacology and psychopharmacology of medications for treating addictions. Having significant clinical expertise in the fields of addiction, biological, and forensic psychiatry, he has a vast knowledge of and contacts throughout the industry.

James W. Newman, Jr., Director

James W. Newman, Jr. has served as a director since December 2015. Since April 2013, he served as the Founder, Chairman, and President of Medical Predictive Science Corporation (“MPSC”), a medical device company that translates ICU research discoveries to the patient’s bedside and develops predictive technology that detects imminent, catastrophic illness. MPSC’s HeRO sold in over 20 countries and is a pioneering monitoring system for premature infants which detects early signs of distress commonly caused by infection and other potentially life-threatening illnesses. He has also served as part of the management team of Newman Company, a real estate company, since 1980, for which he still works and is the sole owner. In the mid-1990s he began making capital investments in several “start-up” companies, including Charlottesville-based Medical Automation Systems, a major provider of information management systems for point-of-care testing, which was acquired by Massachusetts-based Alere Inc. in 2011. His investments have covered a wide range of fields, encompassing everything from biotechnology, bio-informatics, education, and telecommunications, as well as mechanical inventions. He is particularly interested in investments in the medical field that improve healthcare, but do so at a reduced cost to consumers. Mr. Newman received a B.A. degree from Upsala College in 1968.

We selected Mr. Newman to serve on our board because he brings a strong business background to our company and adds significant strategic, business and financial experience. Mr. Newman’s business and finance background provides him with a broad understanding of the issues faced by companies similar to us.

Kevin Schuyler, CFA – Director, Vice Chairman of the Board, Lead Independent Director

Kevin Schuyler has served as a director since April 2016 and is our Vice Chairman of the Board and Lead Independent Director. Since 2006 he has served as a senior managing director at CornerStone Partners LLC, a full service CIO and investment office located in Charlottesville, VA. Prior to joining CornerStone Partners in 2006, he was chief investment officer, vice president, and director of finance and investments for The Nature Conservancy, the world’s largest not-for-profit conservation organization. Before The Nature Conservancy, he was a commodity trader and manager for Louis Dreyfus Corporation, a management consultant with McKinsey & Company, and an entrepreneur. Kevin serves on various boards and committees of Sentara Martha Jefferson Hospital and Stone Barns Center. He is a member of the investment committee of the Margaret A. Cargill Philanthropies. Kevin graduated with honors from Harvard College and received his MBA from The Darden Graduate School of Business at the University of Virginia. He is a member of the Chartered Financial Analyst Society of Washington, DC.

We selected Mr. Schuyler to serve on our board because he brings extensive knowledge of the financial markets. Mr. Schuyler’s business background provides him with a broad understanding of the financial markets and the financing opportunities available to us.

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Key Employee

Tomasz Zastawny, Chief Development Officer

Dr. Zastawny has served as our Chief Development Officer since July 2017. Dr. Zastawny has over 25 years of experience in all aspects of pharmaceutical product development, including regulatory and regulatory strategy, managing, planning, designing and conducting domestic and international clinical studies compliance, and preparation of products for commercial launch. He has led or otherwise participated in more than 150 clinical trials, both domestic and internationally. Recently, he has been the CEO of ECRC, LLC, which he founded in 2008 and which provides consulting services to a number of US and international biopharmaceutical companies, with a focus on the development of strategy and the commercialization of pharmaceuticals and medical devices. He is also a partner in Quark Ventures, a life sciences VC fund, since August 2015. During his career Dr. Zastawny has served in numerous senior positions with responsibility for drug development, most recently serving as VP of Drug Development at Amrita Therapeutics from August 2015 to September 2016 and as a VP of R&D for Boston Therapeutics from September 2012 to May 2015. He began his career in the contract research industry, including serving as the President, Central & Eastern European Units at PRA International, a global CRO, where he was responsible for the all clinical trials in the region.

Dr. Zastawny is a frequent speaker at numerous domestic and international conferences, is the author and co-author of over 80 articles and publications and co-author of the book on clinical aspects of drug development. He received his Ph.D. in Medical Sciences at Nicolaus Copernicus University in Bydgoszcz, Poland and his D.Sc. in Biochemistry at the Polish Academy of Science in Warsaw, Poland.

Dr. Zastawny currently serves as our consultant on a part-time basis; however, upon the closing of this offering he will devote no less than 70% of his business time to our company.

Board Composition and Election of Directors

Our board of directors consists of seven members: Messrs. Kermit Anderson, Robertson Gilliland, Tony Goodman, Bankole Johnson, James Newman, Kevin Schuyler, and William Stilley. Our board of directors has undertaken a review of its composition and its committees and the independence of each director. Based upon information requested from and provided by each director concerning his or her background, employment and affiliations, including family relationships, our board of directors has determined that each of Messrs. Kermit Anderson, Robertson Gilliland, Tony Goodman, James Newman, and Kevin Schuyler is “independent” under the applicable rules of the SEC and NASDAQ and that neither Messrs. Stilley, nor Dr. Johnson is “independent” as defined under the such rules. In making such determination, our board of directors considered the relationship that each such non-employee director has with our company and all other facts and circumstances that our board of directors deemed relevant in determining his independence, including the beneficial ownership of our capital stock by each non-employee director. Mr. Stilley is not an independent director under these rules because he is our Chief Executive Officer and President and Dr. Johnson is not an independent director under these rules because of the payments that have been made by us to Dr. Johnson in 2014 for his employment by the Company as a consultant and Chairman with executive powers.

Corporate Governance

Board Committees

Our board of directors has established an Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee.

Audit Committee

The members of our Audit Committee are Messrs. Schuyler, Newman, and Goodman each of whom has been determined by our board of directors to be independent under applicable NASDAQ and SEC rules and regulations. Mr. Schuyler is the chair of the Audit Committee. Our Audit Committee’s responsibilities include, among others:

         appointing, approving the compensation of, and assessing the independence of our registered public accounting firm;

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         overseeing the work of our independent registered public accounting firm, including through the receipt and consideration of reports from that firm;

         reviewing and discussing with management and our independent registered public accounting firm our annual and quarterly financial statements and related disclosures;

         monitoring our internal control over financial reporting, disclosure controls and procedures;

         overseeing our internal audit function;

         discussing our risk management policies;

         establishing policies regarding hiring employees from our independent registered public accounting firm and procedures for the receipt and retention of accounting related complaints and concerns;

         meeting independently with our internal auditing staff, if any, our independent registered public accounting firm and management;

         reviewing and approving or ratifying any related person transactions; and

         preparing the Audit Committee report required by Securities and Exchange Commission, or SEC, rules.

All audit and non-audit services, other than de minimis non-audit services, to be provided to us by our independent registered public accounting firm must be approved in advance by our Audit Committee.

Our board of directors has determined that Mr. Schuyler is an “audit committee financial expert” as defined in applicable SEC rules.

Compensation Committee

The members of our Compensation Committee are Messrs. Anderson and Newman, each of whom has been determined by our board of directors to be independent under current NASDAQ rules and regulations. Mr. Anderson is the chair of the Compensation Committee. Our Compensation Committee’s responsibilities include, among others:

         reviewing and approving annually the corporate goals and objectives applicable to the compensation of the Chief Executive Officer, evaluating at least annually the Chief Executive Officer’s performance in light of those goals and objectives, and determining and approving the Chief Executive Officer’s compensation level based on this evaluation;

         reviewing and approving the compensation of all other executive officers;

         reviewing and approving and, when appropriate, recommending to the board of directors for approval, incentive compensation plans and equity-based plans, and where appropriate or required, recommending for approval by the stockholders of the Company, the adoption, amendment or termination of such plans; and administering such plans;

         reviewing and approving the executive compensation information included in the Company’s annual report on Form 10-K and proxy statement;

         reviewing and approving or providing recommendations with respect to any employment agreements or severance arrangements or plans; and

         reviewing director compensation and recommending any changes to the board of directors.

Nominating and Corporate Governance Committee

The members of our Nominating and Corporate Governance Committee are Messrs. Gilliland, and Goodman, each of whom has been determined by our board of directors to be independent under current NASDAQ rules. Mr. Newman is the chair of the Nominating and Corporate Governance Committee. Our Nominating and Corporate Governance Committee’s responsibilities include, among others:

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         identifying and recommending candidates to fill vacancies on the board of directors and for election by the stockholders;

         recommending committee and chairperson assignments for directors to the board of directors;

         developing, subject to the board of directors’ approval, a process for an annual evaluation of the board of directors and its committees and to oversee the conduct of this annual evaluation;

         overseeing the Company’s corporate governance practices, including reviewing and recommending to the board of directors for approval any changes to the documents and policies in the Company’s corporate governance framework, including its certificate of incorporation and bylaws; and

         monitoring compliance with the Company’s Code of Business Conduct and Ethics, investigating alleged breaches or violations thereof and enforcing its provisions.

Board of Directors Leadership Structure

Our largest stockholder also serves as the Chairman of our board of directors. We currently have a separate lead independent director. Our lead independent director is Kevin Schuyler. In that role, he presides over the executive sessions of the board of directors, during which our independent directors meet without management, and he serves as the principle liaison between management and the independent directors of the board of directors. We do not have a formal policy regarding having a separate lead independent director. Our board of directors has determined its leadership structure is appropriate and effective for us, given our stage of development.

Risk Oversight

Our board of directors monitors our exposure to a variety of risks through our Audit Committee. Our Audit Committee charter gives the Audit Committee responsibilities and duties that include discussing with management, the internal audit department and the independent auditors our major financial risk exposures and the steps management has taken to monitor and control such exposures, including our risk assessment and risk management policies.

Code of Business Conduct and Ethics

We have adopted a code of business conduct and ethics that applies to all of our employees, officers, and directors, including those officers responsible for financial reporting. These standards are designed to deter wrongdoing and to promote honest and ethical conduct. The code of business conduct and ethics and the written charter for the audit committee, compensation committee and nominating and corporate governance committee are be available on our website. The information that appears on our website is not part of, and is not incorporated into, this prospectus.

None of our directors or executive officers, nor any associate of such individual, is involved in a legal proceeding adverse to us.

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EXECUTIVE COMPENSATION

Summary Compensation Table (2016 and 2015)

The following table sets forth the information as to compensation paid to or earned by our executive officers whose total compensation did exceed $100,000. The person listed in the following table is referred to herein as the “named executive officer.”

Name and Principal Position

 

Fiscal
Year

 

Salary

 

Profits
Interest
Unit
Award(s)

 

All Other
Compensation

 

Total

William B. Stilley
Chief Executive Officer

 

2016

 

$

35,773

 

$

62,909

(1)

 

$

24,164

(3)

 

$

122,846

and Member of the Board Directors

 

2015

 

 

87,950

 

 

125,422

(1,2)

 

 

28,711

(3)

 

 

242,083

____________

(1)      Related to issuance on April 17, 2015 of 487,600 Profits Interest Units with a Distribution Reduction to $0.50 per unit and with a right of repurchase expiring on August 16, 2017 ratably per month over 26 months. Represents the aggregate fair value of awards computed in accordance with FASB ASC topic 718.

(2)      Related to modification of the Distribution Reduction of 170,500 previously issued Profits Interest Units from $1.42 per unit to $0.50 per unit.

(3)      The all other compensation column is comprised of (i) a contribution by our company to an HSA ($3,000 for 2016 and $6,000 for 2015); (ii) the payment by our company of insurance premiums including life, dental, vision ($19,524 for 2016 and $21,219 for 2015); and (iii) cell phone payments ($1,640 for 2016 and $1,492 for 2015).

Employment and Consulting Agreements

We are currently a party to an employment agreement with Mr. Stilley and a consulting agreement with Mr. Truluck. Effective upon the closing of this offering, we will enter into new employment agreements with each of Messrs. Stilley and Truluck and Dr. Zastawny.

Current Employment Agreement with William Stilley

Effective December 6, 2010, we entered into an Executive Employment Agreement (“EEA”) with William Stilley (“Stilley”), our Chief Executive Officer. The agreement was for a term of one year and renews annually unless notice is provided 30 days prior to the renewal date. The agreement provides for an annual base salary of $210,000 and for one year of severance. On August 17, 2016, we and Mr. Stilley entered into a Salary Forbearance Agreement with the following key terms:

         Mr. Stilley forgave past and future salary and severance owed under the EEA in order to facilitate fundraising activities and in return for a general release from us and subject to the following:

         We would pay Mr. Stilley a salary that is reasonable given our financial position (as negotiated in good faith by the parties, and which amount for the next few months will be $5,000 per month).

         Upon receipt by us of $1 million or more in funding, Mr. Stilley’s full salary and other provisions of the EEA would be reinstated from that point forward and paid in cash with the waiver terminating.

         The full amount forgiven could be used to offset any claims by us against Mr. Stilley if we take action against him (except for criminal activities).

         If Dr. Johnson gains control of our company by either controlling the Board or controlling 50% of the voting interests, the full amount forgiven would be once more be due and payable to Mr. Stilley. This creates a risk to us that the amount becomes due, but we believe the deterrent effect is a benefit to a majority of our current Members/stockholders of the Company.

         Additionally, Mr. Stilley has agreed that any such liability due to this provision would be subordinate to our outstanding convertible notes.

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         Mr. Stilley may perform work for third parties as long as he continues to reasonably perform his duties for us. The Board has granted such dispensation previously, and believes Mr. Stilley’s consultancy to third parties has been beneficial to us due to the connections Mr. Stilley makes during such activities.

Current Consulting Agreement with Joseph Truluck

Mr. Truluck is currently serving as an independent contractor and receives compensation of $2,200 per month for his services. However, upon consummation of the initial public offering, this agreement will be superseded by the employment agreement described below.

Options Granted to Tomasz Zastawny

Dr. Zastawny is currently serving as an independent contractor and has been issued options to purchase units in the Company as his compensation. Upon the closing of this offering, the employment agreement with Dr. Zastawny described below will become effective.

Employment Agreements with William B. Stilley, Joseph Truluck and Tomasz H. Zastawny to be Effective Upon the Closing of this Offering

Effective upon the closing of this offering, we intend to enter into a five-year employment agreement with Mr. Stilley to continue to serve as our Chief Executive Officer (the “Stilley EA”). Under the Stilley EA, Mr. Stilley will receive an annual salary of $350,000 and has a target bonus opportunity equal to 30% of his salary. Mr. Stilley’s annual salary will be subject to increase at the discretion of our board of directors. Our board of directors may, in its discretion, pay a portion of Mr. Stilley’s annual bonus in the form of equity or equity-based compensation, provided that commencing with the year following the year in which a Change of Control (as defined in the Stilley EA) occurs, Mr. Stilley’s annual bonus will be paid in cash. Mr. Stilley will also subject to certain restrictive covenants, including a non-competition (applicable during employment and for 24 months thereafter), customer non-solicitation and employee and independent contractor non-solicitation (each applicable during employment and for 12 months thereafter), as well as confidentiality (applicable during employment and 7 years thereafter) and non-disparagement restrictions (applicable during employment and at all times thereafter).

Effective upon the closing of this offering, we intend to enter into a three-year employment agreement with Joseph Truluck to serve as our Chief Operating Officer and Chief Financial Officer (the “Truluck EA”). Under the Truluck EA, Mr. Truluck will devote no less than 50% of his business time to the affairs of our company. He will receive an annual salary of $143,000 and has a target bonus opportunity equal 20% of his salary. Mr. Truluck’s annual salary is subject to increase at the discretion of our board of directors. Our board of directors may, in its discretion, pay a portion of Mr. Truluck’s annual bonus in the form of equity or equity-based compensation. Mr. Truluck is also subject to certain restrictive covenants, including a non-competition (applicable during employment and for 24 months thereafter), customer non-solicitation and employee and independent contractor non-solicitation (each applicable during employment and for 12 months thereafter), as well as confidentiality (applicable during employment and 7 years thereafter) and non-disparagement restrictions (applicable during employment and at all times thereafter).

Effective upon the closing of this offering, we intend to enter into a three-year employment agreement with Tomasz H. Zastawny to serve as our Chief Development Officer (the “Zastawny EA”). Under the Zastawny EA, Dr. Zastawny will devote no less than 70% of his business time to the affairs of our company. He will receive an annual salary of $260,000 and has a target bonus opportunity equal to 20% of his base salary. Dr. Zastawny’s annual salary is subject to increase at the discretion of our board of directors. Our board of directors may, in its discretion, pay a portion of Dr. Zastawny’s annual bonus in the form of equity or equity-based compensation. Dr. Zastawny is also subject to certain restrictive covenants, including a non-competition (applicable during employment and for 24 months thereafter), customer non-solicitation and employee and independent contractor non-solicitation (each applicable during employment and for 12 months thereafter), as well as confidentiality (applicable during employment and 7 years thereafter) and non-disparagement restrictions (each applicable during employment and all times thereafter).

In the event that Mr. Stilley’s, Mr. Truluck’s or Dr. Zastawny’s (each an “Executive”) employment is terminated by us other than for Cause, or upon his resignation for Good Reason (as such terms are defined in the Employment Agreement), the Executive will be entitled to any unpaid bonus earned in the year prior to the termination, a pro-rata portion of the bonus earned during the year of termination, continuation of base salary for 12 months for Mr. Stilley

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and 6 months in the cases of Mr. Truluck and Dr. Zastawny, plus 12 months of COBRA premium reimbursement. If Mr. Stilley’s termination occurs within 60 days before or within 24 months following a Change of Control, then Mr. Stilley will be entitled to receive the same severance benefits as provided above except he will receive (a) a payment equal to two times the sum of his base salary and the higher of his target annual bonus opportunity and the bonus payment he received for the year immediately preceding the year in which the termination occurred instead of 12 months of base salary continuation and (b) 24 times the monthly COBRA premium for himself and his eligible dependents instead of 12 months of COBRA reimbursements (the payments in clauses (a) and (b) are paid in a lump sum in some cases and partly in a lump sum and partly in installments over 12 months in other cases). In addition, if Mr. Stilley’s employment is terminated by the Company without Cause or by the Executive for Good Reason, in either case, upon or within 24 months following a Change of Control, then the Executive will be entitled to full vesting of all equity awards received by the Executive from the Company (with any equity awards that are subject to the satisfaction of performance goals deemed earned at not less than target performance).

In the event that the Executive’s employment is terminated due to his death or Disability, the Executive (or his estate) will be entitled to any unpaid bonus earned in the year prior to the termination, a pro-rata portion of the bonus earned during the year of termination, 12 months of COBRA premium reimbursement and accelerated vesting of (a) all equity awards received in payment of base salary or an annual bonus and (b) with respect to any other equity award, the greater of the portion of the unvested equity award that would have become vested within 12 months after the termination date had no termination occurred and the portion of the unvested equity award that is subject to accelerated vesting (if any) upon such termination under the applicable equity plan or award agreement (with performance goals deemed earned at not less than target performance, and with any equity award that is in the form of a stock option or stock appreciation right to remain outstanding and exercisable for 12 months following the termination date or, if longer, such period as provided under the applicable equity plan or award agreement (but in no event beyond the expiration date of the applicable option or stock appreciation right).

All severance payments to the Executives will be subject to the execution and non-revocation of a release of claims by the Executive or his estate, as applicable.

For purpose of each of the 2017 Stilley EA, Truluck EA and Zastawny EA, “Good Reason” is defined as the occurrence of any of the following events without the respective Executive’s consent: (i) a material reduction in the Executive’s duties, responsibilities or authority; (ii) a reduction of the Executive’s base salary; (iii) failure or refusal of a successor to the Company to either materially assume the Company’s obligations under the employment agreement or enter into a new employment agreement with the Executive on terms that are materially similar to those provided under this Agreement, in any case, in the event of a Change of Control; (iv) relocation of the Executive’s primary work location that results in an increase in the Executive’s one-way driving distance by more than twenty-five (25) miles from the Executive’s then-current principal residence; or (v) a material breach of the employment agreement by the Company.

For purposes of the 2017 Stilley EA, Truluck EA, and Zastawny EA, “Cause” is defined as that the Executive shall have engaged in any of the following acts or that any of the following events shall have occurred, all as determined by the board of directors in its sole and absolute discretion: (i) conviction for, or entering of a plea of guilty or nolo contendere (or its equivalent under any applicable legal system) with respect to (A) a felony or (B) any crime involving moral turpitude; (ii) commission of fraud, misrepresentation, embezzlement or theft against any person; (iii) engaging in any intentional activity that injures or would reasonably be expected to injure (monetarily or otherwise), in any material respect, the reputation, the business or a business relationship of the Company or any of its affiliates; (iv) gross negligence or willful misconduct in the performance of the Executive’s duties to the Company or its affiliates under this Agreement, or willful refusal or failure to carry out the lawful instructions of the Board that are consistent with the Executive’s title and position; (v) violation of any fiduciary duty owed to the Company or any of its affiliates; or (vi) breach of any restrictive covenant (as defined) or material breach or violation of any other provision of the employment agreement, of a written policy or code of conduct of the Company or any of its affiliates (as in effect from time to time) or any other agreement between the Executive and the Company or any of its affiliates. Except when such acts constituting Cause which, by their nature, cannot reasonably be expected to be cured, the Executive will have twenty (20) days following the delivery of written notice by the Company of its intention to terminate the Executive’s employment for Cause within which to cure any acts constituting Cause. Following such twenty (20) day cure period, and if the reason stated in the notice is not cured, the Executive shall be given five (5) business days prior written notice to appear (with or without counsel) before the full Board for the opportunity to present information regarding his views on the alleged Cause event.

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After we provide the original notice of our intent to terminate Executive’s employment for Cause, we may suspend the Executive, with pay, from all his duties and responsibilities and prevent him from accessing our or our affiliates premises or contacting any of our personal or any of our affiliates until a final determination on the hearing is made. The Executive will not be terminated for Cause until a majority of the independent directors approve such termination following the hearing.

For the purposes of each of the Stilley EA, Truluck EA and Zastawny EA, “Change in Control” is defined as: (i) the accumulation over a twelve (12) month period, whether directly or indirectly, by any individual, entity or group of our securities representing over fifty (50%) percent of the total voting power of all our then outstanding voting securities; (ii) a merger or consolidation of us in which our voting securities immediately prior to the merger or consolidation do not represent, or are not converted into securities that represent, a majority of the voting power of all voting securities of the surviving entity immediately after the merger or consolidation; (iii) a sale of substantially all of our assets; or (iv) during any period of twelve (12) consecutive months, our current directors, together with any new director whose election by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the directors then still in office, cease for any reason to constitute at least a majority of the Board.

Equity Compensation Grants

On July 1, 2017, as compensation for services as executive officers, we granted to each of Mr. Stilley and Mr. Truluck an option to purchase 279,000 and 162,000 Class A Units, respectively, at an exercise price of $1.06 per unit, vesting as to 1/6th of the Class A Units on the six month anniversary of the date of the grant and the remaining Class A Units vesting as to 1/36th of the Class A Units over the remaining 30 months. The options have a term of ten years. As a result of the conversion/reincorporation, these options will become options to purchase 51,894 shares and 30,132 of common stock at an exercise price of $5.70 per share.

On July 26, 2017, we granted to Dr. Zastawny an option to purchase 186,000 Class A Units at an exercise price of $1.06 per unit. These options vest over three years, the first 1/6th vesting only after 6 months, then 1/36th vesting each month for the remaining 30 months. The options have a term of ten years. As a result of the conversion/reincorporation, these options will become options to purchase 34,596 shares of common stock at an exercise price of $5.70 per share.

2017 Equity Incentive Plan

Prior to the closing of this offering, we intend to adopt the Adial Pharmaceuticals, Inc. 2017 Equity Incentive Plan (the “2017 equity incentive plan”). Initially, the aggregate number of shares of our common stock that may be issued pursuant to stock awards under the 2017 equity incentive plan is 1,750,000 shares.

The principal provisions of the 2017 equity incentive plan are summarized below.

Administration

The 2017 equity incentive plan generally will be administered by our Compensation Committee, which has been appointed by the board of directors to administer the 2017 equity incentive plan. The Compensation Committee will have full authority to establish rules and regulations for the proper administration of the 2017 equity incentive plan, to select the employees, directors and consultants to whom awards are granted, and to set the date of grant, the type of award and the other terms and conditions of the awards, consistent with the terms of the 2017 equity incentive plan. As of the date of this prospectus, no awards have been made under this plan.

Eligibility

Persons eligible to participate in the 2017 equity incentive plan include all of our officers, employees, directors and consultants.

Awards

The 2017 equity incentive plan provides for the grant of: (i) incentive stock options; (ii) nonstatutory stock options; (iii) stock appreciation rights; (iv) restricted stock; and (v) other stock-based and cash-based awards to

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eligible individuals. The terms of the awards will be set forth in an award agreement, consistent with the terms of the 2017 equity incentive plan. No stock option will be exercisable later than ten years after the date it is granted.

The 2017 equity incentive plan permits the grant of awards intended to qualify as “performance-based compensation” under Section 162(m) of the Internal Revenue Code of 1986, as amended.

Stock Options

The Compensation Committee may grant incentive stock options as defined in Section 422 of the Code, and nonstatutory stock options. Options shall be exercisable for such prices, shall expire at such times, and shall have such other terms and conditions as the Compensation Committee may determine at the time of grant and as set forth in the award agreement; however, the exercise price must be at least equal to 100% of the fair market value at the date of grant. The option price is payable in cash or other consideration acceptable to us.

Stock Appreciation Rights

The Compensation Committee may grant stock appreciation rights with such terms and conditions as the Compensation Committee may determine at the time of grant and as set forth in the award agreement. The grant price of a stock appreciation right shall be determined by the Compensation Committee and shall be specified in the award agreement; however, the grant price must be at least equal to 100% of the fair market value of a share on the date of grant. Stock appreciation rights may be exercised upon such terms and conditions as are imposed by the Compensation Committee and as set forth in the stock appreciation right award agreement.

Restricted Stock

Restricted stock may be granted in such amounts and subject to the terms and conditions as determined by the Compensation Committee at the time of grant and as set forth in the award agreement. The Compensation Committee may impose performance goals for restricted stock. The Compensation Committee may authorize the payment of dividends on the restricted stock during the restricted period.

Other Awards

The Compensation Committee may grant other types of equity-based or equity-related awards not otherwise described by the terms of the 2017 equity incentive plan, in such amounts and subject to such terms and conditions, as the Compensation Committee shall determine. Such awards may be based upon attainment of performance goals established by the Compensation Committee and may involve the transfer of actual shares to participants, or payment in cash or otherwise of amounts based on the value of shares.

Amendment and Termination

Our board of directors may amend the 2017 equity incentive plan at any time, subject to stockholder approval to the extent required by applicable law or regulation or the listing standards of the NASDAQ or any other market or stock exchange on which the common stock is at the time primarily traded or the provisions of the Code.

Our board of directors may terminate the 2017 equity incentive plan at any time provided all shareholder approval has been received to the extent required by the Code, applicable law or the listing standards of Nasdaq or any other market or stock exchange which the common stock is at the time primarily traded. Unless sooner terminated by the Board, the 2017 equity incentive plan will terminate on the close of business on August 30, 2027.

Miscellaneous

The 2017 equity incentive plan also contains provisions with respect to payment of exercise prices, vesting and expiration of awards, treatment of awards upon the sale of our company, transferability of awards, and tax withholding requirements. Various other terms, conditions, and limitations apply, as further described in the 2017 equity incentive plan.

Performance Bonus Plan

On February 17, 2015, we adopted a Performance Bonus Plan (“PBP”) to provide incentive for our personnel, which was then modified on January 25, 2016 and April 15, 2017. Under the PBP, 5.25% of the first $14.7 million

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of a strategic transaction (one or more transactions that provide funds to us and/or our members that enable the commencement of the clinical development of AD04) will be set aside for our personnel with 1.25% of funds to be awarded to the Chairman of the Board and the remainder to be awarded at the Chief Executive Officer’s discretion, with no more than 3.15% payout to the Chief Executive Officer. The maximum bonus amount to be paid out of the PBP is $735,000 (assuming the underwriters’ over-allotment option is not exercised). If the underwriters’ over-allotment option is exercised, the maximum bonus amount to be paid out of the PBP will be $771,750. We have the right to pay up to 65% of the amounts due under the PBP with our equity valued upon consummation of the offering; and we intend to issue 14,105, 27,300, and 6,370 shares of common stock having a value of $141,050, 273,000, and 63,700, respectively, to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer, upon consummation of this offering in accordance with the terms of BPB (or such pro rata lesser amount to the extent the gross proceeds from this offering are less than $14.7 million). If the underwriters’ over-allotment option is exercised and additional $36,750 will be available under the PBP, of which 65% will be able to be paid in our common stock through the issuance of an aggregate of 2,389 shares (at an assumed initial public offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus).

Indemnification Agreements

In connection with this offering, we intend to enter into agreements with each Executive and each director under which we will be required to indemnify them against expenses, judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement and other amounts actually and reasonably incurred in connection with an actual or threatened proceeding if any of them may be made a party because the Executive or director is or was one of our executive officers. We will be obligated to pay these amounts only if the Executive or director acted in good faith and in a manner that he or she reasonably believed to be in or not opposed to our best interests. With respect to any criminal proceeding, we will be obligated to pay these amounts only if the Executive or director had no reasonable cause to believe his/her conduct was unlawful. The indemnification agreements also set forth procedures that will apply in the event of a claim for indemnification.

Director Compensation

2016 Compensation of Directors

Since 2014, our directors have not received any compensation for their service as directors. Commencing upon this offering, directors who are not employees will receive cash compensation for their service as directors, including service as members of each committee on which they serve.

On June 30, 2017, the board of directors approved a plan for the annual cash compensation of directors, to commence upon the completion of this offering, as follows:

 

 

Board

 

Audit
Committee

 

Compensation
Committee

 

Nominating &
Governance
Committee

Chair

 

$

23,750

 

$

15,000

 

$

10,000

 

$

7,000

Member

 

$

20,000

 

$

6,000

 

$

5,000

 

$

3,000

In addition, on July 1, 2017, we issued to each director, other than Mr. Goodman who received the grant described below, an option to purchase 30,000 Class A Units at an exercise price of $1.06 per unit with vesting of the options over three years. The first 1/6th of the options vest 6 months after the date of the grant, then 1/36th vests each month for the remaining 30 months. The options have a term of ten years. As a result of the conversion/reincorporation, each option will become an option to purchase 5,580 shares of common stock at an exercise price of $5.70 per share.

On July 1, 2017, Mr. Goodman was issued an option to purchase 60,000 Class A Units at an exercise price of $1.06 per unit, vesting monthly over a thirty-six (36) month period, subject to accelerated vesting upon (i) any transaction or series of related transactions by us or our equity holders in which a majority of the voting power of the members is transferred to one or more persons who were not previously equity holders, (ii) any merger or consolidation of us with or into any other entity, after which our members do not hold, either directly or indirectly, a majority of the voting equity of the surviving entity, or (iii) a sale of all or substantially all of our operating assets. The option terminates to the extent not exercised upon the earlier of June 30, 2027 and ninety days after Mr. Goodman is no longer serving as a director. As a result of the conversion/reincorporation, these options will become options to purchase 11,160 shares of common stock at an exercise price of $5.70 per share.

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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table sets forth certain information with respect to the beneficial ownership of our common stock immediately prior to and immediately following the offering:

         each person who is known by us to be the beneficial owner of more than 5% of our outstanding common stock;

         each of our directors;

         each of our named executive officers; and

         all of our directors and executive officers as a group.

The pre-offering percentage ownership information shown in the table is based upon 4,068,504 shares of common stock outstanding immediately prior to the offering (assuming that the 14,100,394 outstanding Class A units convert to 2,622,673 shares of common stock; the 2,216,308 outstanding profits interest units convert to 290,405 shares of common stock; the 1,898,771 outstanding Class B units convert to 354,927 shares of common stock; the convertible promissory notes convert to 536,845 shares of common stock debt (at an assumed initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus, and interest calculated through September 30, 2017); the issuance of 215,879 shares to consultants, employees, and one debt holder upon consummation of the offering; and the issuance of 47,775 shares of common stock having a value of $477,750 that we have agreed to issue to our Chairman of the Board, Chief Executive Officer and Chief Operating Officer/Chief Financial Officer upon consummation of this offering in accordance with the terms of our Performance Bonus Plan (at an assumed initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus). The post-offering percentage is based upon 5,468,504 shares of common stock outstanding after completion of this offering, assuming no exercise of the underwriters’ over-allotment option.

We have determined beneficial ownership in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities. In addition, the rules include shares of common stock issuable pursuant to the exercise of profits interest units, warrants or other rights that are either immediately exercisable or exercisable on or before November 7, 2017, which is 60 days after the date of this prospectus. These shares are deemed to be outstanding and beneficially owned by the person holding those options or warrants for the purpose of computing the percentage ownership of that person, but they are not treated as outstanding for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the persons or entities identified in this table have sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to applicable community property laws.

Except as otherwise noted below, the address for each of the individuals and entities listed in this table is c/o Adial Pharmaceuticals, Inc., 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901.

 

 

Number of
shares
(pro forma)

 

Percentage of shares
beneficially owned

Name and address of beneficial owner

 

beneficially
owned

 

Before
offering

 

After
offering

Directors and named executive officers

 

 

 

 

 

 

 

 

William B. Stilley, III (Chief Executive Officer, President and
Director
)(1)

 

363,553

 

8.88

%

 

6.62

%

Joseph Truluck (Chief Operating Officer and Chief Financial
Officer
)(2)

 

40,910

 

1.01

%

 

*

%

J. Kermit Anderson (Director)(3)

 

 

 

 

 

Robertson H. Gilliland, MBA (Director)(4)

 

153,954

 

3.72

%

 

2.78

%

Bankole Johnson, DSc, MD (Chairman of the Board and Director)(5)

 

1,169,517

 

28.72

%

 

21.37

%

James W. Newman, Jr. (Director)(6)

 

122,231

 

2.99

%

 

2.23

%

Kevin Schuyler, CFA (Director)(7)

 

130,043

 

3.19

%

 

2.37

%

Tony Goodman (Director)(8)

 

2,685

 

*

%

 

*

%

All current executive officers and directors as a group (8 persons)

 

1,982,893

 

47.28

%

 

35.45

%

 

 

 

 

 

 

 

 

 

5% or greater stockholders

 

 

 

 

 

 

 

 

En Fideicomiso De Mi Vida 11/23/2010 (Trust)(5)

 

850,896

 

20.91

%

 

15.56

%

Becker Specialty Corporation(9)

 

519,640

 

12.31

%

 

9.25

%

109

____________

*         less than 1%

(1)      Includes (i) 137,929 shares of common stock and warrants to acquire 16,281 shares of common stock; (ii) 132,141 shares of common stock and warrants to acquire 9,824 shares of common stock owned by Mr. Stilley and his wife Anne T. Stilley. The number of shares also includes 40,078 shares of common stock to be issued upon consummation of this offering upon automatic conversion of a convertible note in the principal amount of $17,449 at a conversion price of $0.51 per share. The number of shares also includes 27,300 shares to be issued upon consummation of this offering in accordance with the terms of the Performance Bonus Plan (at an assumed initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus). Does not include (x) 5,580 shares of our common stock owned by the Meredith A. Stilley Trust dtd 11/23/2010;  (y) 5,580 shares of our common stock owned by the Morgan J. Stilley Trust dtd 11/23/2010; and (z) 5,580 shares of our common stock owned by the Blair E. Stilley Trust dtd 11/23/2010. The trusts are for the benefit of Mr. Stilley’s children and Mr. Stilley is not the trustee. Mr. Stilley disclaims beneficial ownership of these shares except to the extent of any pecuniary interest he may have in such shares. The number of shares reported for Mr. Stilley represents the number of shares he and the trusts will receive in connection with the corporate conversion/reincorporation. Does not include an option to purchase 57,474 shares of our common stock, none of which will vest within 60 days of the date of this prospectus, or an additional 1,365 shares of our common stock to be issued in accordance with the terms of the Performance Bonus Plan if the proceeds from this offering are at least $14,700,000.

(2)      Comprised of 29,992 shares of our common stock. The number of shares also includes 4,548 shares to be issued upon consummation of this offering upon automatic conversion of a convertible note in the principal amount of $1,980 at a conversion price of $0.51 per share. The number of shares also includes 6,370 shares to be issued upon consummation of this offering in accordance with the terms of the Performance Bonus Plan (at an assumed initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus). Does not include an option to purchase 30,132 shares of our common stock, none of which will vest within 60 days of the date of this prospectus, or an additional 319 shares of our common stock to be issued in accordance with the terms of the Performance Bonus Plan if the proceeds from this offering are at least $14,700,000.

(3)      Does not include an option to purchase 5,580 shares of our common stock, none of which will vest within 60 days of the date of this prospectus.

(4)      Includes 65,493 shares of common stock and warrants to acquire 65,493 shares of common stock owned by Keller Enterprises. The number of shares also includes 22,968 shares to be issued to Keller Enterprises upon consummation of this offering upon automatic conversion of a convertible note in the principal amount of $10,000 at a conversion price of $0.51 per share. Mr. Gilliland is the principal of Keller Enterprises. The number of shares reported for Mr. Gilliland represents the number of shares Keller Enterprises will receive in connection with the corporate conversion/reincorporation. Does not include an option to purchase 5,580 shares of our common stock, none of which will vest within 60 days of the date of this prospectus.

(5)      Includes (i) 850,896 shares of our common stock owned by En Fideicomiso De Mi Vida 11/23/2010 (Trust); (ii) 93,000 shares of our common stock owned by En Fidecomiso de Todos Mis Suenos Grantor Retained Annuity Trust dated June 27, 2017; (iii) 52,654 shares of our common stock and warrants to purchase 3,275 shares of our common stock owned by Bankole A. Johnson, who also owns convertible debt in the Company in the principal amount of $52,000; (iv) 22,320 shares of our common stock owned by En Fideicomiso De Mis Suenos 11/23/2010 (Trust); (v) 7,440 shares of our common stock owned by De Mi Amor 11/23/2010 (Trust); and (vi) an aggregate of 9,300 shares of our common stock owned by each of Efunbowale Johnson, Ade Johnson, Lola Johnson, Lina Tiouririne, and Aida Tiouririne from whom Dr. Johnson has an voting proxy. The number of shares also includes 116,527 shares to be issued upon consummation of this offering upon automatic conversion of a convertible note in the principal amount of $52,000 at a conversion price of $0.51 per. The number of shares also includes 14,105 shares to be issued upon consummation of this offering in accordance with the terms of the Performance Bonus Plan (at an assumed initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus). Dr. Johnson is the Trustee of each Trust. Does not include an option to purchase 5,580 shares of our common stock, none of which will vest within 60 days of the date of this prospectus, or an additional 705 shares of our common stock to be issued in accordance with the terms of the Prformance Bonus Plan if the proceeds from this offering are at least $14,700,000.

(6)      Includes (i) 36,704 shares of common stock and warrants to purchase 10,389 shares of common stock owned by Virga Ventures, LLC, which also owns convertible debt in the Company in the principal amount of $7,255; (ii) 11,229 shares of our common stock, warrants to purchase 2,372 shares of our common stock owned by Newman GST Trust FBO James W. Newman Jr., which also owns convertible debt in the Company in the principal amount of $10,000; (iii) 10,043 shares of our common stock and warrants to purchase 1,186 shares of our common stock owned by Ivy Cottage Group, LLC.; and (iv) 3,288 shares of our common stock and warrants to purchase 3,415 shares of our common stock owned by Rountop Limited Partnership, LLP. Mr. Newman is the sole member of Virga Ventures, LLC and

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Ivy Cottage Group, LLC, the general partner of Rountop Limited Partnership, LLP and Trustee of the Newman GST Trust. The number of shares also includes 3,973, 16,664 and 22,968 shares to be issued to Ivy Cottage Group, LLC, Virga Ventures, LLC and Newman GST Trust FBO James W. Newman Jr , respectively upon consummation of this offering upon automatic conversion of a convertible note in the principal amount of $1,729.95, $7255.02 and $10,000, each at a conversion price of $0.51 per share. Does not include an option to purchase 5,580 shares of our common stock, none of which will vest within 60 days of the date of this prospectus.

(7)      Includes (i) 50,929 shares of common stock and warrants to purchase 9,659 shares of common stock and (ii) 3,042 shares of our common stock warrants to purchase 3,135 shares of our common stock owned by Carolyn M. Schuyler, his wife. The number of shares also includes 63,278 shares to be issued to upon consummation of this offering upon automatic conversion of a convertible note in the principal amount of $27,550, at a conversion price of 0.51 per share. Does not include an option to purchase 5,580 shares of our common stock none of which will vest within 60 days of the date of this prospectus.

(8)      Includes 1,755 shares of our common stock our common stock. Mr. Goodman has also been granted an option to purchase 11,160 shares of our common stock, of which 930 are vested and exercisable within 60 days of the date of this prospectus.

(9)      Includes (i) 368,092 shares of our common stock and warrants to purchase 151,548 shares of our common stock. Joacim Diaz Bjork is a former director of the Corporation and an officer of Lindéngruppen, AB, the owner of Becker Specialty Corporation of 2526 Delta Lane, Elk Grove Village, IL 60007.

111

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

The following is a summary of transactions since January 1, 2015 to which we have been a party in which the amount involved exceeded the lesser of $120,000 or one percent of the average of our total assets at the end of the last two recent fiscal years and in which any of our executive officers, directors, director nominees or beneficial holders of more than five percent of our capital stock had or will have a direct or indirect material interest, other than compensation arrangements which are described under the section of this prospectus entitled “Management — Non-Employee Director Compensation” and “Executive Compensation.”

Dr. Bankole Johnson Agreement

We entered into a Settlement Agreement and Release Of Claims with Dr. Bankole Johnson, Chairman of the Board, on January 25, 2016 related to a dispute between us and Dr. Johnson. Under this agreement, Dr. Johnson agreed to provide occasional consultation by e-mail or phone outside of Board meetings upon our request and subject to Dr. Johnson’s reasonable availability. In return for such services, the agreement provides that Dr. Johnson shall receive up to $183,750 under Adial’s Performance Bonus Plan, in cash and shares upon consummation of a significant transaction by ADial. In 2014 and 2015, we withheld a total of $31,352 due to Dr. Johnson in escrow pending the outcome of legal action against Mr. Johnson. In December 2015, we recorded the settlement and on January 25, 2016, $15,596 was released to Mr. Johnson and the balance was retained by us. The gain on settlement of the legal action of $15,756 was recorded for the year ended December 31, 2015.

On November 24, 2016, in consideration for acceptance of his subscription to invest in our convertible note offering, we accepted a promissory note from Dr. Bankole A. Johnson with the principal amount of $35,000 and an interest rate of 5% per annum. This promissory note was paid in full on June 13, 2017.

In September 2016, we issued in our private placement in which we issued an aggregate principal amount of $235,000 promissory notes including (i) $17,449 to William Stilley, our Chief Executive Officer and a board member; (ii) $1,980 to Joseph Truluck, our Chief Operating Officer and Chief Financial Officer; (iii) $10,000 to Keller Enterprises, an entity of which Mr. Gilliland, our board member, is the principal; (iv) $4,889 to Ming D. Li, a board member at the time; (v) $1,730 and $7,255 to Ivy Cottage Group, LLC and Virga Ventures, LLC, respectively, entities for which Mr. Newman, a board member, is the sole member, and $10,000 to Newman GST Trust FBO James W. Newman Jr, a trust for which Mr. Newman is a trustee; (vi) $52,000 to Bankole Johnson, a board member and Chairman of the Board, and (vii) $27,550 to Mr. Schuyler, a board member. The notes will automatically convert into shares of our common stock upon consummation of this offering. See “Description of Securities — Convertible Promissory Notes.”

Under the UVA LVG License, we are required to pay compensation to the UVA LVG as described under “Business — License with the University of Virginia Patent Foundation.” Up to 35% of payments to the UVA LVG under the UVA LVG license may then be distributed to Dr. Johnson in his capacity as the inventor of the patents licensed by us under the UVA LVG License, all in accordance with the UVA LVG policy.

Simultaneous with his appointment as a director on July 1, 2017, Tony Goodman purchased 9,434 Class B units at $1.06 per unit for $10,000. The Class B units will convert into 1,755 shares of our common stock as a result of the corporate conversion/reorganization.

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SHARES ELIGIBLE FOR FUTURE SALE

Before this offering, there was no public market for our securities and a significant public market for our securities may not develop or be sustained after this offering. As described below, the approximately 4,068,504 shares outstanding immediately prior to the offering will not be available for sale immediately after this offering due to certain contractual and securities law restrictions on resale. Sales of substantial amounts of our common stock in the public market after these restrictions lapse could cause the prevailing market price to decline and limit our ability to raise equity capital in the future.

Upon completion of this offering, we will have outstanding an aggregate of 5,468,504 shares of common stock (5,678,504 shares if the underwriters exercise their over-allotment option in full). In addition, we have reserved:

         1,750,000 shares for future issuance under our 2017 equity incentive plan we intend to adopt immediately prior to the closing of this offering.

Of these shares, the 1,400,000 shares sold in this offering (1,610,00 shares if the underwriters exercise their over-allotment option in full) will be freely transferable without restriction or further registration under the Securities Act, except for any shares that are acquired by affiliates as that term is defined in Rule 144 under the Securities Act (“Rule 144”).

As a result of contractual restrictions described below and the provisions of Rule 144 and/or Rule 701, the shares sold in this offering and the restricted securities will be available for sale in the public market as follows:

         the 1,400,000 shares sold in this offering (1,610,000 shares if the underwriters exercise their over-allotment option in full) will be eligible for immediate sale upon the completion of this offering;

         approximately 4,068,504 restricted shares will be eligible for sale in the public market upon expiration of lock-up agreements 180 days after the date of this prospectus, which date may be extended in specified circumstances, subject to the volume, manner of sale and other limitations of Rule 144.

Rule 144

In general, under Rule 144 as currently in effect, once we have been subject to the reporting requirements under the Exchange Act for at least 90 days a person (or persons whose shares are aggregated) who is not deemed to have been an affiliate of ours at any time during the three months preceding a sale, and who has beneficially owned restricted securities within the meaning of Rule 144 for at least six months, would be entitled to sell those shares, subject only to the availability of current public information about us. A non-affiliated person who has beneficially owned restricted securities within the meaning of Rule 144 for at least one year would be entitled to sell those shares without regard to the availability of current public information about us.

An affiliate of ours who has beneficially owned restricted shares of our common stock for at least twelve months (or six months, provided that such sale occurs after we have been subject to the reporting requirements under the Exchange Act for at least 90 days) would be entitled to sell, within any three-month period, a number of shares that does not exceed the greater of (i) 1% of shares of our common stock then outstanding and (ii) the average weekly trading volume of our common stock on The NASDAQ Capital Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale.

Sales under Rule 144 by our affiliates or persons selling shares on behalf of our affiliates are also subject to manner of sale provisions, notice requirements and the availability of current public information about us.

Rule 701

Under Rule 701, common stock acquired pursuant to other awards granted under a written compensatory benefit plan (or written compensation contract) established by the issuer may be resold, to the extent not subject to lock-up agreements, (a) by persons other than affiliates, beginning 90 days after the effective date of this offering, and (b) by affiliates, subject to the manner-of-sale, volume limitations, current public information and filing requirements of Rule 144, in each case, without compliance with the holding period requirement of Rule 144.

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Lock-Up Agreements

In connection with this offering, our directors and officers and all other holders of one percent (1%) or more of our outstanding equity securities, on an as converted basis, will agree not to sell or otherwise dispose of any securities, without the prior written consent of Aegis Capital Corp., for a period of 180 days after the date of this prospectus, subject to certain exceptions. See the section entitled “Underwriting”. The underwriters may release all or any portion of the securities subject to lock-up agreements.

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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES
TO NON-U.S. HOLDERS OF OUR COMMON STOCK

The following discussion describes the material U.S. federal income tax consequences to non-U.S. holders (as defined below) of the acquisition, ownership and disposition of our common stock issued pursuant to the initial public offering. This discussion is not a complete analysis of all potential U.S. federal income tax consequences and does not address any tax consequences arising under any state, local or foreign tax laws, any income tax treaties, or any other U.S. federal tax laws, including U.S. federal estate and gift tax laws (except as specifically addressed herein with respect to U.S. federal estate taxes). This discussion is based on the Internal Revenue Code of 1986, as amended (“Code”), U.S. Treasury Regulations promulgated thereunder, judicial decisions and published rulings and administrative pronouncements of the Internal Revenue Service (“IRS”), all as in effect on the date of the initial public offering. These authorities may change, possibly retroactively, resulting in tax consequences different from those discussed below. No rulings have been or will be sought from the IRS with respect to the matters discussed below, and there can be no assurance that the IRS will not take a different position regarding the tax consequences of a non-U.S. holder’s acquisition, ownership or disposition of our common stock or that any such position would not be sustained by a court.

This discussion is limited to non-U.S. holders who purchase our common stock pursuant to this offering and who hold our common stock as “capital assets” within the meaning of Code Section 1221 (generally, property held for investment). This discussion does not address all U.S. federal income tax consequences that may be relevant to a non-U.S. holder in light of the holder’s particular circumstances. It also does not consider any specific facts or circumstances that may be relevant to non-U.S. holders subject to special rules under the U.S. federal income tax laws, including, without limitation, U.S. expatriates, banks, financial institutions, insurance companies, regulated investment companies, real estate investment trusts, “controlled foreign corporations,” “passive foreign investment companies,” corporations that accumulate earnings to avoid U.S. federal income tax, brokers, dealers or traders in securities, commodities or currencies, partnerships or other pass-through entities (or investors in such entities), tax-exempt organizations, tax-qualified retirement plans, persons subject to the alternative minimum tax or the unearned income Medicare contribution tax, and persons holding our common stock as part of a straddle, hedge or other risk reduction strategy or as part of a conversion transaction or other integrated investment.

WE RECOMMEND THAT PROSPECTIVE INVESTORS CONSULT THEIR TAX ADVISORS REGARDING THE PARTICULAR U.S. FEDERAL INCOME TAX CONSEQUENCES TO THEM OF THE ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK, AS WELL AS ANY TAX CONSEQUENCES ARISING UNDER ANY STATE, LOCAL OR FOREIGN TAX LAWS, ANY APPLICABLE INCOME TAX TREATIES, OR ANY OTHER U.S. FEDERAL TAX LAWS (INCLUDING ESTATE AND GIFT TAX LAWS).

Definition of Non-U.S. Holder

As used in this discussion, a non-U.S. holder is any beneficial owner of our common stock who is not treated as a partnership for U.S. federal income tax purposes and is not:

         an individual citizen or resident of the United States;

         a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized under the laws of the United States, any state thereof or the District of Columbia;

         an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

         a trust if (i) a U.S. court is able to exercise primary supervision over its administration and one or more U.S. persons have authority to control all its substantial decisions or (ii) the trust was in existence on August 20, 1996, was treated as a U.S. person prior to that date and validly elected to continue to be so treated.

If any entity treated as a partnership for U.S. federal income tax purposes holds our common stock, the tax treatment of a partner generally will depend on the status of the partner and the activities of the partnership. Partnerships and their partners should consult their tax advisors as to the tax consequences to them of the acquisition, ownership and disposition of our common stock.

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Distributions on Our Common Stock

As described in the section entitled, “Dividend Policy,” we do not anticipate paying dividends on our common stock in the foreseeable future. If we make a distribution of cash or other property with respect to our common stock, the distribution generally will constitute a dividend for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return of capital and will first be applied against and reduce a holder’s adjusted tax basis in its common stock, but not below zero. Any remaining excess will be treated as capital gain from the sale of property.

Dividends paid to a non-U.S. holder of our common stock that are not effectively connected to the holder’s conduct of a U.S. trade or business generally will be subject to U.S. federal withholding tax at a rate of 30% of the gross amount of the dividends, or a lower rate specified by an applicable tax treaty. To receive the benefit of a reduced treaty rate, a non-U.S. holder must furnish to us or our paying agent a valid IRS Form W-8BEN (or applicable successor form) certifying the holder’s qualification for the reduced rate. A non-U.S. holder may be required to obtain a U.S. taxpayer identification number to claim treaty benefits. This certification must be provided to us or our paying agent prior to the payment of dividends and may be required to be updated periodically. Non-U.S. holders that do not timely provide us or our paying agent with the required certification, but which qualify for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS. Non-U.S. holders should consult their tax advisors regarding their entitlement to benefits under a relevant income tax treaty.

If a non-U.S. holder holds our common stock in connection with the conduct of a trade or business in the United States, and dividends paid on the common stock are effectively connected with the holder’s U.S. trade or business and, if an income tax treaty applies, the non-U.S. holder maintains a “permanent establishment” in the United States to which the dividends are attributable, the non-U.S. holder will be exempt from U.S. federal withholding tax, if the appropriate certification is provided. To claim the exemption for effectively connected income, the non-U.S. holder must furnish to us or our paying agent a properly executed IRS Form W-8ECI (or applicable successor form) prior to the payment of the dividends. Any dividends paid on our common stock that are effectively connected with a non-U.S. holder’s U.S. trade or business generally will be subject to U.S. federal income tax on a net income basis at the regular graduated U.S. federal income tax rates in the same manner as if the holder were a resident of the United States, unless the holder is entitled to the benefits of a tax treaty that provides otherwise. A non-U.S. holder that is a foreign corporation also may be subject to a branch profits tax equal to 30% (or a lower rate specified by an applicable tax treaty) of its effectively connected earnings and profits for the taxable year that are attributable to such dividends. Non-U.S. holders should consult any applicable tax treaties that may provide for different rules.

Gain on Disposition of Our Common Stock

Subject to the discussions below regarding backup withholding and foreign accounts, a non-U.S. holder generally will not be subject to U.S. federal income tax on any gain realized upon the sale or other disposition of our common stock unless:

         the gain is effectively connected with the non-U.S. holder’s conduct of a trade or business in the United States;

         the non-U.S. holder is a nonresident alien individual present in the United States for 183 days or more during the taxable year of the disposition and certain other requirements are met; or

         our common stock constitutes a U.S. real property interest by reason of our status as a U.S. real property holding corporation at any time within the shorter of the five-year period preceding the disposition or the non-U.S. holder’s holding period for our common stock and certain other requirements are met.

Unless an applicable tax treaty provides otherwise, gain described in the first bullet point above will be subject to U.S. federal income tax on a net income basis at the regular graduated U.S. federal income tax rates in the same manner as if the holder were a resident of the United States. Non-U.S. holders that are foreign corporations also may be subject to a branch profits tax equal to 30% (or a lower rate specified by an applicable tax treaty) of its effectively connected earnings and profits for the taxable year that are attributable to such gain. Non-U.S. holders should consult any applicable tax treaties that may provide for different rules.

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Gains described in the second bullet point above will be subject to U.S. federal income tax at a flat 30% rate (or a lower rate specified by an applicable income tax treaty), but may be offset by U.S. source capital losses.

With respect to the third bullet point above, we believe we currently are not and will not become a U.S. real property holding corporation. However, because the determination of whether we are a U.S. real property holding corporation generally depends on whether the fair market value of our U.S. real property interests equals or exceeds 50% of the sum of the fair market value of our other trade or business assets and our worldwide real property interests, there can be no assurance that we will not become a U.S. real property holding corporation in the future. In the event we do become a U.S. real property holding corporation, as long as our common stock is regularly traded on an established securities market, our common stock will constitute a U.S. real property interest only with respect to a non-U.S. holder that actually or constructively holds more than five percent of our common stock at some time during the shorter of the five-year period preceding the disposition or the non-U.S. holder’s holding period for our common stock. Any taxable gain generally will be taxed in the same manner as gain that is effectively connected with the conduct of a U.S. trade or business, except that the branch profits tax will not apply.

Information Reporting and Backup Withholding

We must report annually to the IRS and to each non-U.S. holder the amount of dividends on our common stock paid to the holder and the amount of any tax withheld with respect to those dividends. These information reporting requirements apply even if no withholding was required because the dividends were effectively connected with the holder’s conduct of a U.S. trade or business, or withholding was reduced or eliminated by an applicable tax treaty. This information also may be made available under a specific treaty or agreement with the tax authorities in the country in which the non-U.S. holder resides or is established.

Backup withholding, currently at a rate of 28%, generally will not apply to payments of dividends to a non-U.S. holder of our common stock provided the non-U.S. holder furnishes to us or our paying agent the required certification as to its non-U.S. status (typically, by providing a valid IRS Form W-8BEN or W-8ECI) or an exemption is otherwise established.

Payment of the proceeds from a non-U.S. holder’s disposition of our common stock made by or through a foreign office of a broker will not be subject to information reporting or backup withholding, except that information reporting (but generally not backup withholding) may apply to those payments if the broker does not have documentary evidence that the beneficial owner is a non-U.S. holder, an exemption is not otherwise established and the broker is:

         a U.S. person, as defined in the Code;

         a controlled foreign corporation for U.S. federal income tax purposes;

         a foreign person 50% or more of whose gross income is effectively connected with a U.S. trade or business for a specified three-year period; or

         a foreign partnership if at any time during its tax year (1) one or more of its partners are U.S. persons who hold in the aggregate more than 50% of the income or capital interest in the partnership or (2) it is engaged in the conduct of a U.S. trade or business.

Payment of the proceeds from a non-U.S. holder’s disposition of our common stock made by or through the U.S. office of a broker generally will be subject to information reporting and backup withholding unless the non-U.S. holder certifies as to its non-U.S. status (such as by providing a valid IRS Form W-8BEN or W-8ECI) or otherwise establishes an exemption from information reporting and backup withholding.

Backup withholding is not an additional tax. Taxpayers may use amounts withheld as a credit against their U.S. federal income tax liability or may claim a refund if they timely provide certain information to the IRS.

U.S. Federal Estate Tax

Shares of common stock held (or deemed held) by an individual who is a non-U.S. holder at the time of his or her death will be included in such non-U.S. holder’s gross estate for U.S. federal estate tax purposes, unless an applicable estate tax treaty provides otherwise, and thus may be subject to U.S. federal estate tax.

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Additional Withholding Tax Relating to Foreign Accounts

Legislation enacted in 2010 will generally impose a U.S. federal withholding tax of 30% on dividends and the gross proceeds of a disposition of our common stock paid after December 31, 2012 to a foreign financial institution (whether holding stock for its own account or on behalf of its account holders/investors) unless such institution enters into an agreement with the U.S. government to withhold on certain payments and to collect and provide to the U.S. tax authorities substantial information regarding U.S. account holders of such institution (which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners). The legislation will also generally impose a U.S. federal withholding tax of 30% on dividends and the gross proceeds of a disposition of our common stock paid after December 31, 2012 to any other foreign entity unless such entity provides the withholding agent with a certification identifying the direct and indirect U.S. owners of the entity.

Recent administrative guidance provides, however, that such withholding would generally apply only to dividends paid on or after January 1, 2014, and to other “withholdable payments” (including payments of gross proceeds from a sale or other disposition of our common stock) made on or after January 1, 2017. Under certain circumstances, a holder might be eligible for refunds or credits of such taxes. Prospective investors are encouraged to consult with their own tax advisors regarding the possible impact of these rules on their investment in our common stock.

WE RECOMMEND THAT PROSPECTIVE INVESTORS CONSULT THEIR TAX ADVISORS REGARDING THE PARTICULAR U.S. FEDERAL INCOME TAX CONSEQUENCES TO THEM OF THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR COMMON STOCK, AS WELL AS ANY TAX CONSEQUENCES ARISING UNDER ANY STATE, LOCAL OR FOREIGN TAX LAWS, ANY APPLICABLE INCOME TAX TREATIES, OR ANY OTHER U.S. FEDERAL TAX LAWS (INCLUDING ESTATE AND GIFT TAX LAWS).

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DESCRIPTION OF SECURITIES

The following description of our capital stock and the provisions of our certificate of incorporation and our bylaws are summaries and are qualified by reference to the certificate of incorporation and the bylaws that will be in effect upon the closing of this offering. We have filed copies of these documents with the SEC as exhibits to our registration statement of which this prospectus forms a part. The descriptions of the common stock and preferred stock reflect changes to our capital structure that will occur prior to and upon the closing of this offering.

General

Upon the closing of this offering, our authorized capital stock will consist of 50,000,000 shares of common stock, par value $0.001 per share, and 5,000,000 shares of preferred stock, par value $0.001 per share.

As of the date of this prospectus and prior to conversion/reincorporation, ADial Pharmaceuticals, L.L.C. had issued and outstanding 14,100,394 Class A units. 2,216,308 Profits Interest Units, and 1,870,469 Class B units held by 103 holders of record. As part of the corporate conversion/reincorporation, the outstanding Class A units, Profits Interest Units and Class B were automatically converted into 2,622,673 shares, 290,405 shares and 354,927 shares, respectively, for an aggregate of 3,268,005 shares of common stock of Adial Pharmaceuticals, Inc.

The following description summarizes the terms of our capital stock after the corporate conversion/reincorporation. Because it is only a summary, it does not contain all the information that may be important to you. For a complete description, you should refer to our certificate of incorporation and bylaws, as in effect immediately following the closing of this offering, copies of which have been filed as exhibits to the registration statement of which this prospectus is a part.

Common Stock

Common stock outstanding. Assuming the debt conversion and corporate conversion/reincorporation are consummated, all shares common stock to be issued upon consummation of this offering are issued and assuming an initial public offering price of $10.00 per share, there will be 5,468,504 shares of our common stock outstanding, immediately following the consummation of this offering, but assuming no exercise of the underwriters’ over-allotment option and no exercise of outstanding options or warrants.

Voting rights. The holders of common stock are entitled to one vote per share on all matters to be voted upon by the stockholders, except on matters relating solely to terms of preferred stock.

Dividend rights. Subject to preferences that may be applicable to any outstanding preferred stock, the holders of common stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by the board of directors out of funds legally available therefor. See “Dividend Policy.”

Rights upon liquidation. In the event of our liquidation, dissolution or winding up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities, subject to prior distribution rights of preferred stock, if any, then outstanding.

Other rights. The holders of our common stock have no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions applicable to our common stock.

Preferred Stock

Our board of directors has the authority to issue preferred stock in one or more classes or series and to fix the designations, powers, preferences and rights, and the qualifications, limitations or restrictions thereof, including dividend rights, conversion right, voting rights, terms of redemption, liquidation preferences and the number of shares constituting any class or series, without further vote or action by the stockholders. Although we have no present plans to issue any other shares of preferred stock, the issuance of shares of preferred stock, or the issuance of rights to purchase such shares, could decrease the amount of earnings and assets available for distribution to the holders of common stock, could adversely affect the rights and powers, including voting rights, of the common stock, and could have the effect of delaying, deterring or preventing a change of control of us or an unsolicited acquisition proposal.

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Representative’s Warrants

Please see “Underwriting — Representative’s Warrants” for a description of the warrants we have agreed to issue to the representative of the underwriters in this offering, subject to the completion of the offering. We expect to enter into a warrant agreement in respect of the Representative’s Warrants prior to the closing of this offering.

Convertible Promissory Notes

On September 10, 2016 and November 24, 2016, we issued convertible promissory notes in the aggregate principal amount of $200,000 and $35,000, respectively, (the “Notes”). The Notes bear interest at a rate of 15% per annum and mature on August 31, 2029 unless earlier converted or prepaid. The Notes are a general unsecured obligation of the Company and is not guaranteed by any other person or entity or secured by any assets of the Company.

Prepayment

The Notes may be prepaid by a cash payment of an amount equal to the outstanding principal balance of the Note, and any accrued but unpaid interest thereon at such time (the “Outstanding Balance”), plus an additional payment equal to 200% of the Outstanding Balance and by additionally issuing Class A units to the holder with the number of units to be issued being equal to the Outstanding Balance divided by the Conversion Cap Price (i.e., the number of Class A units shall be equal to the quotient of the Outstanding Balance divided by the Conversion Cap Price).

The “Conversion Cap Price” is, at the time the Note is converted to Equity Securities per the terms hereunder, the price per unit shall be equal to the quotient of $2,000,000 divided by the aggregate number of the Company’s outstanding units as of the date immediately prior to the initial closing of the Qualified Financing (assuming full conversion or exercise of all convertible and exercisable securities then outstanding other than the Notes).

Conversion of the Notes

(i) Conversion Upon a Qualified Financing. In the event that the Company issues and sells an interest (“Equity Securities”) in the Company to investors (the “Investors”) resulting in gross proceeds to the Company of at least $2,000,000 (not including the conversion of the Note and other notes) (a “Qualified Financing”), then the Outstanding Balance of a Note automatically converts in whole without any further action by a holder into such Equity Securities at a conversion price equal to the lesser of: (i) one third (1/3) of the per unit price paid by the Investor in such Equity Securities in the Qualified Financing; or (ii) the Conversion Cap Price.

(ii) Conversion Upon Sale of Company. If the Notes have not been previously converted to Equity Securities and we elect to consummate a Sale of the Company, then notwithstanding any provision of the Note to the contrary, the Outstanding Balance of a Note automatically converts in whole without any further action by a holder into a newly created class of units (the “Class XX Units”) at a conversion price equal to the Conversion Cap Price. Class XX Units will be a newly created class of LLC Units (defined in the LLC Operating Agreement) representing Membership Interests (defined in the LLC Operating Agreement) that are identical to Class A Units (defined in the LLC Operating Agreement) except as follows: (i) Class XX Units will receive cumulative distributions in preference to all other LLC Units in an amount equal to three (3) times the Outstanding Balance at the time of conversion (the “Preferential Distribution”), and (ii) after receiving the Preferential Distribution, Class XX Units will then receive distributions at least to the extent as any distributions are received by Class A Units with an associated Contributed Capital (defined in the LLC Operating Agreement) of less than $0.01 per Unit.

“Sale of the Company” means (i) any consolidation or merger of the Company with or into any other corporation or other entity or person, or any other corporate reorganization, other than any such consolidation, merger or reorganization in which the members of the Company immediately prior to such consolidation, merger or reorganization, continue to hold at least a majority of the voting power of the surviving entity in substantially the same proportions (or, if the surviving entity is a wholly owned subsidiary, its parent) immediately after such consolidation, merger or reorganization; (ii) any transaction or series of related transactions to which the Company is a party in which in excess of 50% of the Company’s voting power is transferred; provided, however, that a Sale of the Company shall not include any transaction or series of transactions principally for bona fide equity financing

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purposes in which cash is received by the Company or any successor or indebtedness of the Company is cancelled or converted or a combination thereof; or (iii) a sale or other disposition of all or substantially all of the assets of the Company.

(iii) Conversion at Maturity. If the Notes have not been previously converted to Equity Securities effective upon the Maturity Date, a holder may elect to convert each of the Notes into Class XX Units as if a Sale of the Company had occurred by delivery of written notice to the Company at least thirty (30) days prior to the Maturity Date of the intent to make such election to convert.

Default

If there shall be any Event of Default hereunder, at the option and upon the declaration of the Holder and upon written notice to us (which election and notice shall not be required in the case of an Event of Default under Section (ii) or (iii)), the Notes shall accelerate and three (3) times the Outstanding Balance shall become due and payable. The occurrence of any one or more of the following shall constitute an Event of Default:

(i)       we fail to pay timely any of the principal amount, accrued interest or other amounts due under the Notes on the date the same becomes due and payable;

(ii)      we default in our performance of any covenant in the Notes;

(iii)     we file any petition or action for relief under any bankruptcy, reorganization, insolvency or moratorium law or any other law for the relief of, or relating to, debtors, now or hereafter in effect, or makes any assignment for the benefit of creditors or takes any corporate action in furtherance of any of the foregoing; or

(iv)     an involuntary petition is filed against us (unless such petition is dismissed or discharged within 60 days under any bankruptcy statute now or hereafter in effect, or a custodian, receiver, trustee, assignee for the benefit of creditors (or other similar official) is appointed to take possession, custody or control of any of our property.

The Notes provide that if we convert to a corporation that all references to units shall be interpreted to be references to shares with terms and preference practically similar to such membership units.

The notes and accrued interest will automatically convert into 536,845 shares of our common stock upon consummation of this offering (assuming interest calculated through September 30, 2017).

2017 Bridge Note and Warrant

In May 2017, we issued to one lender in consideration of our receipt of $250,000, a senior secured note in the principal amount of $287,500 together with a warrant with a cashless exercise feature exercisable to purchase shares of common stock equal to $287,500 divided by the initial offering price of our common stock in our initial public offering (28,750 shares of common stock at an assumed initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus ) at an exercise price of equal to the price of common stock sold in our next financing of $250,000 or more. In addition, we agreed to issue upon consummation of this offering such number of shares of common stock having a value equal to $29,000 based upon the initial public offering price or 2,900 shares of our common stock (at an assumed initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus). The note matures six (6) months from its date of issuance, is secured by our assets (other than our licenses), bears interest at a rate of 2% per annum and provides that we must redeem the note at 115% of the principal amount upon consummation of a financing with proceeds in the amount of $250,000.

CRO Option

We issued an option which expires on the earlier of either March 14, 2021  or consummation of our next financing of $3,000,000 or more, to a service provider to acquire up to $100,000 of securities issued in our next financing of $3,000,000 or more at a purchase price equal to a 15% discount to the lowest price paid by a majority of the other investors in the financing. This option will become exercisable to acquire up to 11,765 shares of our common stock in this offering at a purchase price equal to $8.50 per share.

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Class A Warrants

The investors that purchased Class A units in the financing that occurred in the fourth quarter of 2011 were also issued warrants to purchase 723,916 Class A Units at an exercise price of $0.001 per unit, expiring December 31, 2021. As a result of this offering, the warrants will become exercisable to purchase 134,648 shares of our common stock at an exercise price of $0.0054 per share.

Class B Warrants

The investors that purchased Class B units were also issued warrants to purchase 1,870,469 Class B Units at an exercise price of $1.41 per unit, expiring December 31, 2031. The warrants contain adjustments in the case of stock splits, stock dividends, reorganizations and others similar transactions. As a result of this offering, the warrants will become exercisable to purchase 347,907 shares of our common stock at an exercise price of $7.63 per share.

Other Warrants

We have agreed to issue immediately following the date hereof a five year warrant to a consultant to purchase 4.9% of our common stock on a fully diluted basis (291,602 shares of common stock) with an exercise price equal to the initial offering price of our common stock. The warrant provides that it may not be exercised if such exercise would result in the holder being the beneficial owner of in excess of 4.99% of our securities.

We have agreed to issue immediately following the date hereof a four year warrant to the representative of the underwriters, as a portion of the underwriting compensation payable to the underwriters in connection with this offering, to purchase 56,000 shares of our common stock with an exercise price of 125% of the initial offering price.

Other Options

We currently have outstanding options to purchase a total of 937,000 Class A Units to directors, officers, and consultants at an exercise price of $1.06 per unit, vesting monthly over 3 years and with certain options delaying the vesting of the first 1/6 of the total grant until 4 to 6 months after the date the options were granted. The options have a term of ten years. As a result of the conversion/reincorporation, the currently outstanding options will become options to purchase 174,282 shares of common stock at an exercise price of $5.70 per share. 

Anti-Takeover Effects of Delaware Law

The provisions of Delaware law, our certificate of incorporation and our bylaws described below may have the effect of delaying, deferring or discouraging another party from acquiring control of us.

Section 203 of the Delaware General Corporation Law

We are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder, with the following exceptions:

         before such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;

         upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or

         on or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least sixty-six and two-thirds percent (66 2/3%) of the outstanding voting stock that is not owned by the interested stockholder.

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In general, Section 203 defines business combination to include the following:

         any merger or consolidation involving the corporation and the interested stockholder;

         any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;

         subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

         any transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; or

         the receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits by or through the corporation.

Certificate of Incorporation and Bylaws

Our certificate of incorporation and bylaws provide that:

         our board of directors is divided into three classes, one class of which is elected each year by our stockholders with the directors in each class to serve for a three-year term;

         the authorized number of directors can be changed only by resolution of our board of directors;

         directors may be removed only by the affirmative vote of the holders of at least 60% of our voting stock, whether for cause or without cause;

         our bylaws may be amended or repealed by our board of directors or by the affirmative vote of sixty-six and two-thirds percent (66 2/3%) of our stockholders;

         stockholders may not call special meetings of the stockholders or fill vacancies on the board of directors;

         our board of directors will be authorized to issue, without stockholder approval, preferred stock, the rights of which will be determined at the discretion of the board of directors and that, if issued, could operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that our board of directors does not approve;

         our stockholders do not have cumulative voting rights, and therefore our stockholders holding a majority of the shares of common stock outstanding will be able to elect all of our directors; and

         our stockholders must comply with advance notice provisions to bring business before or nominate directors for election at a stockholder meeting.

Board Classification

Our board of directors is divided into three classes, one class of which is elected each year by our stockholders. The directors in each class will serve for a three-year term. For more information on the classified board, see “Management—Board of Directors and Executive Officers.” The classification of our board of directors and the limitations on the ability of our stockholders to remove directors could make it more difficult for a third-party to acquire, or discourage a third-party from seeking to acquire, control of us.

Potential Effects of Authorized but Unissued Stock

We have shares of common stock and preferred stock available for future issuance without stockholder approval. We may utilize these additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate corporate acquisitions or payment as a dividend on the capital stock.

The existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons friendly to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management. In addition, the board of

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directors has the discretion to determine designations, rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock, all to the fullest extent permissible under the Delaware General Corporation Law and subject to any limitations set forth in our certificate of incorporation. The purpose of authorizing the board of directors to issue preferred stock and to determine the rights and preferences applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible financings, acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from acquiring, a majority of our outstanding voting stock.

Limitations of Director Liability and Indemnification of Directors, Officers and Employees

Our certificate of incorporation, which will become effective upon the closing of this offering, limits the liability of directors to the maximum extent permitted by Delaware law. Delaware law provides that directors of a corporation will not be personally liable for monetary damages for breach of their fiduciary duties as directors, except for liability for any:

         breach of their duty of loyalty to us or our stockholders;

         act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

         unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the Delaware General Corporation Law; or

         transaction from which the directors derived an improper personal benefit.

These limitations of liability do not apply to liabilities arising under the federal or state securities laws and do not affect the availability of equitable remedies such as injunctive relief or rescission.

Our bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by law, and may indemnify employees and other agents. Our bylaws also provide that we are obligated to advance expenses incurred by a director or officer in advance of the final disposition of any action or proceeding.

We have obtained a policy of directors’ and officers’ liability insurance.

We plan to enter into separate indemnification agreements with our directors and officers. These agreements, among other things, require us to indemnify our directors and officers for any and all expenses (including reasonable attorneys’ fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees) judgments, fines and amounts paid in settlement actually and reasonably incurred by such directors or officers or on his or her behalf in connection with any action or proceeding arising out of their services as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request provided that such person follows the procedures for determining entitlement to indemnification and advancement of expenses set forth in the indemnification agreement. We believe that these bylaw provisions and indemnification agreements are necessary to attract and retain qualified persons as directors and officers.

The limitation of liability and indemnification provisions in our certificate of incorporation and bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful, might provide a benefit to us and our stockholders. Our results of operations and financial condition may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling us, we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

At present, there is no pending litigation or proceeding involving any of our directors or officers as to which indemnification is required or permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification.

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Requirements for Advance Notification of Stockholder Nominations and Proposals

Our Bylaws establish advance notice procedures with respect to stockholder proposals and nomination of candidates for election as directors.

Limits on Special Meetings

Special meetings of the stockholders may be called at any time only by the board of directors, Chairman or our Chief Executive Officer, subject to the rights of the holders of any series of preferred stock.

Election and Removal of Directors

Directors are elected by a plurality of the votes of shares present in person or represented by proxy at a meeting and entitled to vote generally on the election of directors. Our stockholders may remove directors only with the vote of sixty percent (60%) of the stockholders, whether for cause or without cause. Our board of directors may appoint a director to fill a vacancy, including vacancies created by the expansion of the board of directors. This system of electing and removing directors may discourage a third party from making a tender offer or otherwise attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of our directors. Our certificate of incorporation and bylaws do not provide for cumulative voting in the election of directors.

Amendments to Our Governing Documents

Generally, the amendment of our certificate of incorporation requires approval by our board of directors and a majority vote of stockholders. Any amendment to our bylaws requires the approval of either a majority of our board of directors or approval of at least sixty-six and two-thirds (66 2/3%) of the votes entitled to be cast by the holders of our outstanding capital stock in elections of our board of directors.

Listing

We have applied to list our common stock on The NASDAQ Capital Market under the symbol “ADIL.” No assurance can be given that our application will be approved.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is VSTOCK Transfer, LLC.

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UNDERWRITING

Aegis Capital Corp. is acting as the representative of the underwriters of the offering (the “Representative”). We have entered into an underwriting agreement dated       , 2017 with the representative. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to each underwriter named below and each underwriter named below has severally and not jointly agreed to purchase from us, at the public offering price per share less the underwriting discounts set forth on the cover page of this prospectus, the number of shares of common stock listed next to its name in the following table:

Underwriters

 

Number of
Shares

Aegis Capital Corp.

 

 

Total

 

1,400,000

The underwriters are committed to purchase all the shares of common stock offered by us other than those covered by the option to purchase additional shares described below, if they purchase any shares. The obligations of the underwriters may be terminated upon the occurrence of certain events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement, the underwriters’ obligations are subject to customary conditions, representations and warranties contained in the underwriting agreement, such as receipt by the underwriters of officers’ certificates and legal opinions.

We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act of 1933, and to contribute to payments the underwriters may be required to make in respect thereof.

The underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions specified in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

Over-allotment Option. We have granted the underwriters an over-allotment option. This option, which is exercisable for up to 45 days after the date of this prospectus, permits the underwriters to purchase a maximum of 210,000 additional shares (15% of the shares sold in this offering) from us to cover over-allotments, if any. If the underwriters exercise all or part of this option, they will purchase shares covered by the option at the public offering price per share that appears on the cover page of this prospectus, less the underwriting discount. If this option is exercised in full, the total offering price to the public will be $16,100,000 and the total net proceeds, before expenses, to us will be $14,973,000.

Discount. The following table shows the public offering price, underwriting discount and proceeds, before expenses, to us. The information assumes either no exercise or full exercise by the underwriters of their over-allotment option.

 

 

Per Share

 

Total Without
Over-allotment
Option

 

Total With
Over-allotment
Option

Public offering price

 

$

 

 

$

 

 

$

 

Underwriting discount (7%)(1)

 

$

 

 

$

 

 

$

 

Proceeds, before expenses, to us

 

$

 

 

$

 

 

$

 

Non-accountable expense allowance (1%)(2)

 

$

 

 

$

 

 

$

 

____________

(1)      We and the underwriters have agreed to a commission of 3.5% on an aggregate of      shares and sold to certain investors, including members of our board of directors and/or our executive officers.

(2)      The expense allowance of 1% is not payable with respect to the shares sold upon exercise of the underwriters’ over-allotment option.

The underwriters propose to offer the shares offered by us to the public at the public offering price per share set forth on the cover of this prospectus. In addition, the underwriters may offer some of the shares to other securities dealers at such price less a concession of $[  ] per share. After the initial offering, the public offering price and concession to dealers may be changed.

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We have paid an expense deposit of $20,000 to the Representative, which will be applied against the accountable expenses that will be paid by us to the Representative in connection with this offering. The $20,000 expense deposit will be returned to us to the extent not actually incurred. The underwriting agreement also provides that in the event the offering is terminated, the $20,000 expense deposit paid to the Representative will be returned to us to the extent that offering expenses are not actually incurred by the Representative in accordance with FINRA Rule 15110(f)(2)(C).

We have also agreed to pay the underwriters’ expenses relating to the offering, including (a) all Public Offering Systems filing fees associated with the review of the offering by FINRA; (b) all fees, expenses and disbursements relating to background checks of our officers and directors in an amount not to exceed $5,000 per individual, but no more than $15,000 in the aggregate; (c) all fees, expenses and disbursements relating to the registration, or qualification or exemption of the securities in the offering under the “blue sky” securities laws (including all filing and registration fees and the reasonable fees and disbursements of “blue sky” counsel up to $2,500; (d) the costs of all mailing and printing of the underwriting documents (including, without limitation, the Underwriting Agreement, any blue sky surveys and, if appropriate, any agreement among underwriters, selected dealers’ agreement, underwriters’ questionnaire and power of attorney), registration statements, prospectuses and all amendments, supplements and exhibits thereto and as many preliminary and final prospectuses as the representative may reasonably deem necessary; (e) the costs (up to $5,000) associated with bound volumes of the public offering materials as well as commemorative mementos and lucite tombstones; (f) all fees, expenses and disbursements relating to the registration, qualification or exemption of securities offered under the securities laws of foreign jurisdictions designated by the underwriters; (g) the fees and expenses of underwriter’s legal counsel up to $65,000; (h) the $29,500 cost associated with the use of Ipreo’s book-building, prospectus tracking and compliance software for this offering; (i) upon successful completion of this offering, and (j) up to $20,000 of the representative’s actual accountable “road show” expenses for the offering.

We estimate that the total expenses of the offering payable by us, excluding the total underwriting discount and non-accountable expense allowance, will be approximately $600,000.

Discretionary Accounts. The underwriters do not intend to confirm sales of the securities offered hereby to any accounts over which they have discretionary authority.

Lock-Up Agreements. We, our directors and executive officers and substantially all of our other stockholders expect to enter into lock up agreements with the representative prior to the commencement of this offering pursuant to which each of these persons or entities, for a period of six months from the effective date of the registration statement of which this prospectus is a part without the prior written consent of the representative, agree not to (1) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares of our securities or any securities convertible into or exercisable or exchangeable for shares of our common stock owned or acquired on or prior to the closing date of this offering (including any shares of common stock acquired after the closing date of this offering upon the conversion, exercise or exchange of such securities); (2) file or caused to be filed any registration statement relating to the offering of any shares of our capital stock; or (3) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the common stock, whether any such transaction described in clause (1), (2) or (3) above is to be settled by delivery of common stock or such other securities, in cash or otherwise, except for certain exceptions and limitations.

Representative’s Warrants. We have agreed to issue to the representative warrants to purchase up to a total of 56,000 shares of common stock (4% of the shares of common stock sold in this offering, excluding the over-allotment). The warrants will be exercisable at any time, and from time to time, in whole or in part, during the four-year period commencing one year from the effective date of the offering, which period shall not extend further than five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(i). The warrants are exercisable at a per share price equal to $12.50 per share, or 125% of the public offering price per share in the offering (assuming an initial offering price of $10.00 per share, which is the mid-point of the range set forth on the cover page of this prospectus). The warrants have been deemed compensation by FINRA and are therefore subject to a 180 day lock-up pursuant to Rule 5110(g)(1) of FINRA. The representative (or permitted assignees under Rule 5110(g)(1)) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will they engage in any hedging, short sale, derivative, put, or call transaction that would result

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in the effective economic disposition of the warrants or the underlying securities for a period of 180 days from the effective date of the offering. In addition, the warrants provide for registration rights upon request, in certain cases. In addition, the warrants provide for registration rights upon request, in certain cases. The demand registration right provided will not be greater than five years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(iv). The piggyback registration right provided will not be greater than seven years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G)(v). We will bear all fees and expenses attendant to registering the securities issuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The exercise price and number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, extraordinary cash dividend or our recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or underlying shares will not be adjusted for issuances of shares of common stock at a price below the warrant exercise price.

Right of First Refusal. Subject to the closing of this offering and certain conditions set forth in the underwriting agreement, until eighteen (18) months from the date of effectiveness of the registration statement of which this prospectus forms a part, the Representative shall have a right of first refusal to act as lead investment banker, lead book-runner and/or lead placement agent, at the Representative’s sole discretion, for each and every of our future public equity offerings for us, or any of our successors or subsidiaries, on terms customary to the Representative. The Representative, in conjunction with us, shall have the sole right to determine whether or not any other broker-dealer shall have the right to participate in any such offering and the economic terms of any such participation.

NASDAQ Capital Market Listing. We have applied to list our common stock on The NASDAQ Capital Market under the symbol “ADIL.” No assurance can be given that our application will be approved.

Electronic Offer, Sale and Distribution of Securities. A prospectus in electronic format may be made available on the websites maintained by one or more of the underwriters or selling group members, if any, participating in this offering and one or more of the underwriters participating in this offering may distribute prospectuses electronically. The representative may agree to allocate a number of shares and warrants to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the underwriters and selling group members that will make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part of, nor incorporated by reference into, this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or any underwriter in its capacity as underwriter, and should not be relied upon by investors.

Determination of the Initial Public Offering Price. Prior to this offering, there has been no public market for our common stock. The initial public offering price was determined through negotiations between us and the representative of the underwriters. In addition to prevailing market conditions, the factors considered in determining the initial public offering price included the following:

         the information included in this prospectus and otherwise available to the representative;

         the valuation multiples of publicly traded companies that the representative believes to be comparable to us;

         our financial information;

         our prospects and the history and the prospects of the industry in which we compete;

         an assessment of our management, its past and present operations, and the prospects for, and timing of, our future revenues;

         the present state of our development; and

         the above factors in relation to market values and various valuation measures of other companies engaged in activities similar to ours.

An active trading market for our common stock may not develop. It is also possible that, after the offering, the shares will not trade in the public market at or above the initial public offering price.

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         Stabilization.In connection with this offering, the underwriters may engage in stabilizing transactions, over-allotment transactions, syndicate-covering transactions, penalty bids and purchases to cover positions created by short sales.

         Stabilizing transactions permit bids to purchase shares so long as the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose of preventing or retarding a decline in the market price of the shares while the offering is in progress.

         Over-allotment transactions involve sales by the underwriters of shares in excess of the number of shares the underwriters are obligated to purchase. This creates a syndicate short position that may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the over-allotment option. In a naked short position, the number of shares involved is greater than the number of shares in the over-allotment option. The underwriters may close out any short position by exercising their over-allotment option and/or purchasing shares in the open market.

         Syndicate covering transactions involve purchases of shares in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared with the price at which they may purchase shares through exercise of the over-allotment option. If the underwriters sell more shares than could be covered by exercise of the over-allotment option and, therefore, have a naked short position, the position can be closed out only by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the shares in the open market that could adversely affect investors who purchase in the offering.

         Penalty bids permit the representative to reclaim a selling concession from a syndicate member when the shares originally sold by that syndicate member are purchased in stabilizing or syndicate covering transactions to cover syndicate short positions.

These stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our shares or common stock or preventing or retarding a decline in the market price of our shares or common stock. As a result, the price of our common stock in the open market may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the price of our common stock. These transactions may be effected on The NASDAQ Capital Market, in the over-the-counter market or otherwise and, if commenced, may be discontinued at any time.

Passive market making. In connection with this offering, underwriters and selling group members may engage in passive market making transactions in our common stock on The NASDAQ Capital Market in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the shares and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, then that bid must then be lowered when specified purchase limits are exceeded.

Offer Restrictions Outside the United States

Other than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.

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Australia

This prospectus is not a disclosure document under Chapter 6D of the Australian Corporations Act, has not been lodged with the Australian Securities and Investments Commission and does not purport to include the information required of a disclosure document under Chapter 6D of the Australian Corporations Act. Accordingly, (i) the offer of the securities under this prospectus is only made to persons to whom it is lawful to offer the securities without disclosure under Chapter 6D of the Australian Corporations Act under one or more exemptions set out in section 708 of the Australian Corporations Act, (ii) this prospectus is made available in Australia only to those persons as set forth in clause (i) above, and (iii) the offeree must be sent a notice stating in substance that by accepting this offer, the offeree represents that the offeree is such a person as set forth in clause (i) above, and, unless permitted under the Australian Corporations Act, agrees not to sell or offer for sale within Australia any of the securities sold to the offeree within 12 months after its transfer for the offeree under this prospectus.

China

The information in this document does not constitute a public offer of the securities, whether by way of sale or subscription, in the People’s Republic of China (excluding, for purposes of this paragraph, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan). The securities may not be offered or sold directly or indirectly in the PRC to legal or natural persons other than directly to “qualified domestic institutional investors.”

European Economic Area — Belgium, Germany, Luxembourg and the Netherlands

The information in this document has been prepared on the basis that all offers of common stock will be made pursuant to an exemption under the Directive 2003/71/EC (“Prospectus Directive”), as implemented in Member States of the European Economic Area (each, a “Relevant Member State”), from the requirement to produce a prospectus for offers of securities.

An offer to the public of common stock has not been made, and may not be made, in a Relevant Member State except pursuant to one of the following exemptions under the Prospectus Directive as implemented in that Relevant Member State:

         to legal entities that are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;

         to any legal entity that has two or more of (i) an average of at least 250 employees during its last fiscal year; (ii) a total balance sheet of more than €43,000,000 (as shown on its last annual unconsolidated or consolidated financial statements) and (iii) an annual net turnover of more than €50,000,000 (as shown on its last annual unconsolidated or consolidated financial statement);

         to fewer than 100 natural or legal persons (other than qualified investors within the meaning of Article 2(1)I of the Prospectus Directive) subject to obtaining the prior consent of the company or any underwriter for any such offer; or

         in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of common stock shall result in a requirement for the publication by the company of a prospectus pursuant to Article 3 of the Prospectus Directive.

France

This document is not being distributed in the context of a public offering of financial securities (offre au public de titres financiers) in France within the meaning of Article L.411-1 of the French Monetary and Financial Code (Code monétaire et financier) and Articles 211-1 et seq. of the General Regulation of the French Autorité des marchés financiers (“AMF”). The common stock has not been offered or sold and will not be offered or sold, directly or indirectly, to the public in France.

This document and any other offering material relating to the common stock has not been, and will not be, submitted to the AMF for approval in France and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in France.

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Such offers, sales and distributions have been and shall only be made in France to (i) qualified investors (investisseurs qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-1 to D.411-3, D. 744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation and/or (ii) a restricted number of non-qualified investors (cercle restreint d’investisseurs non-qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-4, D.744-1, D.754-1 and D.764-1 of the French Monetary and Financial Code and any implementing regulation.

Pursuant to Article 211-3 of the General Regulation of the AMF, investors in France are informed that the common stock cannot be distributed (directly or indirectly) to the public by the investors otherwise than in accordance with Articles L.411-1, L.411-2, L.412-1 and L.621-8 to L.621-8-3 of the French Monetary and Financial Code.

Ireland

The information in this document does not constitute a prospectus under any Irish laws or regulations and this document has not been filed with or approved by any Irish regulatory authority as the information has not been prepared in the context of a public offering of securities in Ireland within the meaning of the Irish Prospectus (Directive 2003/71/EC) Regulations 2005 (the “Prospectus Regulations”). The common stock has not been offered or sold, and will not be offered, sold or delivered directly or indirectly in Ireland by way of a public offering, except to (i) qualified investors as defined in Regulation 2(l) of the Prospectus Regulations and (ii) fewer than 100 natural or legal persons who are not qualified investors.

Israel

The common stock offered by this prospectus have not been approved or disapproved by the Israeli Securities Authority (the ISA), or ISA, nor have such common stock been registered for sale in Israel. The shares and warrants may not be offered or sold, directly or indirectly, to the public in Israel, absent the publication of a prospectus. The ISA has not issued permits, approvals or licenses in connection with the offering or publishing the prospectus; nor has it authenticated the details included herein, confirmed their reliability or completeness, or rendered an opinion as to the quality of the common stock being offered. Any resale in Israel, directly or indirectly, to the public of the common stock offered by this prospectus is subject to restrictions on transferability and must be effected only in compliance with the Israeli securities laws and regulations.

Italy

The offering of the common stock in the Republic of Italy has not been authorized by the Italian Securities and Exchange Commission (Commissione Nazionale per le Società e la Borsa, “CONSOB” pursuant to the Italian securities legislation and, accordingly, no offering material relating to the common stock may be distributed in Italy and such securities may not be offered or sold in Italy in a public offer within the meaning of Article 1.1(t) of Legislative Decree No. 58 of 24 February 1998 (“Decree No. 58”), other than:

         to Italian qualified investors, as defined in Article 100 of Decree no. 58 by reference to Article 34-ter of CONSOB Regulation no. 11971 of 14 May 1999 (“Regulation no. 1197l”) as amended (“Qualified Investors”); and

         in other circumstances that are exempt from the rules on public offer pursuant to Article 100 of Decree No. 58 and Article 34-ter of Regulation No. 11971 as amended.

Any offer, sale or delivery of the common stock or distribution of any offer document relating to the common stock in Italy (excluding placements where a Qualified Investor solicits an offer from the issuer) under the paragraphs above must be:

         made by investment firms, banks or financial intermediaries permitted to conduct such activities in Italy in accordance with Legislative Decree No. 385 of 1 September 1993 (as amended), Decree No. 58, CONSOB Regulation No. 16190 of 29 October 2007 and any other applicable laws; and

         in compliance with all relevant Italian securities, tax and exchange controls and any other applicable laws.

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Any subsequent distribution of the common stock in Italy must be made in compliance with the public offer and prospectus requirement rules provided under Decree No. 58 and the Regulation No. 11971 as amended, unless an exception from those rules applies. Failure to comply with such rules may result in the sale of such common stock being declared null and void and in the liability of the entity transferring the common stock for any damages suffered by the investors.

Japan

The common stock has not been and will not be registered under Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948), as amended (the “FIEL”) pursuant to an exemption from the registration requirements applicable to a private placement of securities to Qualified Institutional Investors (as defined in and in accordance with Article 2, paragraph 3 of the FIEL and the regulations promulgated thereunder). Accordingly, the common stock may not be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan other than Qualified Institutional Investors. Any Qualified Institutional Investor who acquires common stock may not resell them to any person in Japan that is not a Qualified Institutional Investor, and acquisition by any such person of common stock is conditional upon the execution of an agreement to that effect.

Portugal

This document is not being distributed in the context of a public offer of financial securities (oferta pública de valores mobiliários) in Portugal, within the meaning of Article 109 of the Portuguese Securities Code (Código dos Valores Mobiliários). The common stock has not been offered or sold and will not be offered or sold, directly or indirectly, to the public in Portugal. This document and any other offering material relating to the common stock has not been, and will not be, submitted to the Portuguese Securities Market Commission (Comissão do Mercado de Valores Mobiliários) for approval in Portugal and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in Portugal, other than under circumstances that are deemed not to qualify as a public offer under the Portuguese Securities Code. Such offers, sales and distributions of common stock in Portugal are limited to persons who are “qualified investors” (as defined in the Portuguese Securities Code). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

Sweden

This document has not been, and will not be, registered with or approved by Finansinspektionen (the Swedish Financial Supervisory Authority). Accordingly, this document may not be made available, nor may the common stock be offered for sale in Sweden, other than under circumstances that are deemed not to require a prospectus under the Swedish Financial Instruments Trading Act (1991:980) (Sw. lag (1991:980) om handel med finansiella instrument). Any offering of common stock in Sweden is limited to persons who are “qualified investors” (as defined in the Financial Instruments Trading Act). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

Switzerland

The common stock may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange (“SIX”) or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering material relating to the common stock may be publicly distributed or otherwise made publicly available in Switzerland.

Neither this document nor any other offering material relating to the common stock has been or will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of common stock will not be supervised by, the Swiss Financial Market Supervisory Authority (FINMA).

This document is personal to the recipient only and not for general circulation in Switzerland.

132

United Arab Emirates

Neither this document nor the common stock have been approved, disapproved or passed on in any way by the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab Emirates, nor have we received authorization or licensing from the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab Emirates to market or sell the common stock within the United Arab Emirates. This document does not constitute and may not be used for the purpose of an offer or invitation. No services relating to the common stock, including the receipt of applications and/or the allotment or redemption of such shares, may be rendered within the United Arab Emirates by us.

No offer or invitation to subscribe for common stock is valid or permitted in the Dubai International Financial Centre.

United Kingdom

Neither the information in this document nor any other document relating to the offer has been delivered for approval to the Financial Services Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 2000, as amended (“FSMA”)) has been published or is intended to be published in respect of the common stock. This document is issued on a confidential basis to “qualified investors” (within the meaning of section 86(7) of FSMA) in the United Kingdom, and the common stock may not be offered or sold in the United Kingdom by means of this document, any accompanying letter or any other document, except in circumstances that do not require the publication of a prospectus pursuant to section 86(1) FSMA. This document should not be distributed, published or reproduced, in whole or in part, nor may its contents be disclosed by recipients to any other person in the United Kingdom.

Any invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) received in connection with the issue or sale of the common stock has only been communicated or caused to be communicated and will only be communicated or caused to be communicated in the United Kingdom in circumstances in which section 21(1) of FSMA does not apply to us.

In the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (together “relevant persons”). The investments to which this document relates are available only to, and any invitation, offer or agreement to purchase will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

133

LEGAL MATTERS

The validity of the securities being offered by this prospectus have been passed upon for us by Gracin & Marlow, LLP, New York, New York. Certain legal matters in connection with this offering will be passed upon for the underwriters by Blank Rome LLP, New York, New York.

EXPERTS

The financial statements as of December 31, 2016 and 2015 and for each of the two years in the period ended December 31, 2016 included in the Registration Statement have been so included in reliance on the report of Friedman LLP, an independent registered public accounting firm, (the report on the financial statements contains an explanatory paragraph regarding the Company’s ability to continue as a going concern) appearing in the Registration Statement, given on the authority of said firm as experts in auditing and accounting.

WHERE YOU CAN FIND ADDITIONAL INFORMATION

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock we are offering to sell. This prospectus, which constitutes part of the registration statement, does not include all of the information contained in the registration statement and the exhibits, schedules and amendments to the registration statement. For further information with respect to us and our common stock, we refer you to the registration statement and to the exhibits and schedules to the registration statement. Statements contained in this prospectus about the contents of any contract, agreement or other document are not necessarily complete, and, in each instance, we refer you to the copy of the contract, agreement or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference.

You may read and copy the registration statement of which this prospectus is a part at the SEC’s public reference room, which is located at 100 F Street, N.E., Room 1580, Washington, DC 20549. You can request copies of the registration statement by writing to the SEC and paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for more information about the operation of the SEC’s public reference room. In addition, the SEC maintains an Internet website, which is located at http://www.sec.gov, that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC. You may access the registration statement of which this prospectus is a part at the SEC’s Internet website. Upon completion of this offering, we will be subject to the information reporting requirements of the Securities Exchange Act of 1934, and we will file reports, proxy statements and other information with the SEC.

134

ADIAL PHARMACEUTICALS, LLC

FINANCIAL STATEMENTS

Contents

 

 

Page

Report of Independent Registered Public Accounting Firm

 

F-2

Balance Sheets as of December 31, 2016 and 2015

 

F-3

Statements of Operations for each of the years ended December 31, 2016 and 2015

 

F-4

Statements of Changes in Members’ Equity (Deficit) for each of the years ended December 31, 2016 and 2015

 

F-5

Statements of Cash Flows for each of the years ended December 31, 2016 and 2015

 

F-6

Notes to Financial Statements

 

F-7

Six month periods ended June 30, 2017 and 2016 (unaudited)

 

 

Page

Condensed Balance Sheets as of June 30, 2017 (unaudited) and December 31, 2016 (unaudited)

 

F-19

Condensed Statements of Operations for the three months and six months ended June 30, 2017 and 2016 (unaudited)

 

F-20

Condensed Statement of Changes in Members’ Deficit for the year ended December 31, 2016
and the six months ended June 30, 2017 (unaudited)

 

F-21

Condensed Statements of Cash Flows for the six months ended June 30, 2017 and 2016 (unaudited)

 

F-22

Notes to Condensed Financial Statements (unaudited)

 

F-23

F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and

Members of ADial Pharmaceuticals, LLC

We have audited the accompanying balance sheets of ADial Pharmaceuticals, LLC (the “Company”) as of December 31, 2016 and 2015, and the related statements of operations, members’ equity (deficit), and cash flows for each of the years in the two-year period ended December 31, 2016. The Company’s management is responsible for these financial statements. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2016 and 2015, and the results of its operations, and its cash flows for each of the years in the two-year period ended December 31, 2016, in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has recurring losses, negative cash flows from operations and an accumulated deficit. These conditions, among others, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to obtain financing, there could be a material adverse effect on the Company.

/s/ Friedman LLP

East Hanover, New Jersey

May 11, 2017

F-2

ADIAL PHARMACEUTICALS, LLC

BALANCE SHEETS

 

 

December 31,

 

 

2016

 

2015

ASSETS

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

87,993

 

 

$

162,377

 

Prepaid expenses and other current assets

 

 

18,303

 

 

 

43,170

 

Note receivable – related party

 

 

35,117

 

 

 

 

Total Current Assets

 

 

141,413

 

 

 

205,547

 

 

 

 

 

 

 

 

 

 

Intangible assets – net

 

 

7,863

 

 

 

8,428

 

Other Assets

 

 

2,250

 

 

 

2,250

 

Total Other Assets

 

 

10,113

 

 

 

10,678

 

 

 

 

 

 

 

 

 

 

Total Assets

 

$

151,526

 

 

$

216,225

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND MEMBERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

20,012

 

 

$

37,484

 

Due to related party

 

 

 

 

 

15,596

 

Convertible notes payable, net of discount of $745 – related party

 

 

234,255

 

 

 

 

Derivative liability

 

 

752

 

 

 

 

Total Current Liabilities

 

 

255,019

 

 

 

53,080

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MEMBERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

Members’ equity

 

 

9,834,752

 

 

 

9,681,190

 

Accumulated deficit

 

 

(9,938,245

)

 

 

(9,518,045

)

Total Members’ Equity (Deficit)

 

 

(103,493

)

 

 

163,145

 

 

 

 

 

 

 

 

 

 

Total Liabilities and Members’ Equity (Deficit)

 

$

151,526

 

 

$

216,225

 

The accompanying notes are an integral part of these financial statements.

F-3

ADIAL PHARMACEUTICALS, LLC

STATEMENTS OF OPERATIONS

 

 

For the Years Ended
December 31,

 

 

2016

 

2015

Operating Expenses:

 

 

 

 

 

 

 

 

Research and development expenses

 

$

146,143

 

 

$

322,107

 

General and administrative expenses

 

 

264,664

 

 

 

497,150

 

Total Operating Expenses

 

 

410,807

 

 

 

819,257

 

 

 

 

 

 

 

 

 

 

Loss From Operations

 

 

(410,807

)

 

 

(819,257

)

 

 

 

 

 

 

 

 

 

Other Income (Expenses)

 

 

 

 

 

 

 

 

Interest income

 

 

240

 

 

 

1,264

 

Change in fair value of derivative liability

 

 

10

 

 

 

 

Interest expense

 

 

(9,643

)

 

 

 

Total other income (expenses)

 

 

(9,393

)

 

 

1,264

 

 

 

 

 

 

 

 

 

 

Loss Before Provision For Income Taxes

 

 

(420,200

)

 

 

(817,993

)

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(420,200

)

 

$

(817,993

)

 

 

 

 

 

 

 

 

 

Net loss per unit, basic and diluted

 

$

(0.02

)

 

$

(0.05

)

 

 

 

 

 

 

 

 

 

Weighted average units outstanding, basic and diluted

 

 

18,166,550

 

 

 

17,876,277

 

The accompanying notes are an integral part of these financial statements.

F-4

ADIAL PHARMACEUTICALS, LLC

STATEMENTS OF CHANGES IN MEMBERS’ EQUITY (DEFICIT)

 

 

Class A Units

 

Class B Units

 

Profits Interest Units

 

Total
Members’

 

Accumulated

 

 

 

 

Units

 

Amount

 

Units

 

Amount

 

Units

 

Amount

 

Equity

 

Deficit

 

Total

Balance,
January 1,
2015

 

14,100,394

 

$

6,248,402

 

1,870,469

 

$

2,656,042

 

1,359,391

 

 

$

525,923

 

 

$

9,430,367

 

$

(8,700,052

)

 

$

730,315

 

Equity-based compensation

 

 

 

 

 

 

 

722,600

 

 

 

250,823

 

 

 

250,823

 

 

 

 

 

250,823

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(817,993

)

 

 

(817,993

)

Balance,
December 31, 2015

 

14,100,394

 

$

6,248,402

 

1,870,469

 

$

2,656,042

 

2,081,991

 

 

$

776,746

 

 

$

9,681,190

 

$

(9,518,045

)

 

$

163,145

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity-based compensation

 

 

 

 

 

 

 

207,319

 

 

 

153,563

 

 

 

153,563

 

 

 

 

 

153,563

 

Repurchased Profits Interest Units

 

 

 

 

 

 

 

(73,002

)

 

 

(1

)

 

 

 

 

 

 

 

(1

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(420,200

)

 

 

(420,200

)

Balance,
December 31, 2016

 

14,100,394

 

$

6,248,402

 

1,870,469

 

$

2,656,042

 

2,216,308

 

 

$

930,308

 

 

$

9,834,753

 

 

(9,938,245

)

 

$

(103,493

)

The accompanying notes are an integral part of these financial statements

F-5

ADIAL PHARMACEUTICALS, LLC

STATEMENTS OF CASH FLOWS

 

 

For the Years Ended
December 31,

 

 

2016

 

2015

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(420,200

)

 

$

(817,993

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Equity-based compensation for services

 

 

153,563

 

 

 

250,823

 

Loss on write off of assets

 

 

 

 

 

1,091

 

Amortization of intangible assets

 

 

565

 

 

 

565

 

Amortization of discount to convertible note

 

 

17

 

 

 

 

Change in fair value of derivative liability

 

 

(10

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

24,867

 

 

 

60,014

 

Note receivable – related party

 

 

(117

)

 

 

 

Other assets

 

 

 

 

 

13,665

 

Accounts payable and accrued expenses

 

 

(17,473

)

 

 

15,840

 

Due to related party

 

 

(15,596

)

 

 

10,773

 

Net cash used in operating activities

 

 

(274,384

)

 

 

(465,222

)

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from issuance of convertible notes

 

 

200,000

 

 

 

 

Net cash provided by financing activities

 

 

200,000

 

 

 

 

 

 

 

 

 

 

 

 

 

NET DECREASE IN CASH AND CASH EQUIVALENTS

 

 

(74,384

)

 

 

(465,222

)

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS-BEGINNING OF YEAR 162,377

 

 

 

 

 

 

627,599

 

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS-END OF YEAR

 

$

87,993

 

 

$

162,377

 

 

 

 

 

 

 

 

 

 

Supplemental Disclosure of Cash Flow Information:

 

 

 

 

 

 

 

 

Cash paid during the year:

 

 

 

 

 

 

 

 

Interest paid

 

$

 

 

$

 

Income taxes paid

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

Non-cash Investing and Financing Activities:

 

 

 

 

 

 

 

 

Debt discount from the recognition of a derivative liability

 

$

762

 

 

$

 

Note receivable – subscription for convertible notes

 

$

35,000

 

 

$

 

The accompanying notes are an integral part of these financial statements.

F-6

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

1 — DESCRIPTION OF BUSINESS

Adial Pharmaceuticals, LLC (the “Company” or “Adial”) was formed on November 23, 2010 in the Commonwealth of Virginia. Adial is presently engaged in the development and commercializing of medications for the treatment of addictions and related disorders.

The Company is planning to commence its first Phase 3 clinical trial of its lead compound ADO4 (“AD04”) for the treatment of alcohol use disorder. Both the U.S. Food and Drug Administration (“FDA”) and the European Medicines Authority (“EMA”) have indicated they will accept to heavy-drinking-based endpoints as a basis approval for the treatment of alcohol use disorder rather than the previously required abstinence-based endpoints. Key patents have been issued in the United States, the European Union, and other jurisdictions for which the Company has worldwide, exclusive license rights. The active ingredient in AD04 is ondansetron, a serotonin-3 antagonist. Due to its mechanism of action, AD04 has the potential to be used for the treatment of other addictive disorders, such as obesity, smoking, and drug addiction.

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Liquidity, Going Concern and Uncertainties

The financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated revenues to enable profitability. As of December 31, 2016, the Company had an accumulated deficit of approximately $10 million, and has incurred net losses of approximately $0.4 million and approximately $0.8 million for the years ended December 31, 2016 and 2015, respectively. Based on the current development plans for AD04 in both the U.S. and foreign markets and the Company’s other operating requirements, management believes that the existing cash at December 31, 2016 will not be sufficient to fund operations for at least the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

The Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products in order to complete its ongoing research and development efforts and the planned Phase 3 clinical trial. Management is actively pursuing financing, but can provide no assurances that such financing will be available on acceptable terms, or at all. Without this funding, the Company could be required to delay, scale back or eliminate some or all of its research and development programs which would likely have a material adverse effect on the Company.

The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern.

Generally, the Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; the ability to manufacture the Company’s products successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the ability to raise capital to support its operations.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

F-7

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

Significant items subject to such estimates and assumptions include the valuation of outstanding PIU’s (defined in Note 9), derivative liabilities, intangible assets useful life, and contingent liabilities. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes.

Basic and Diluted Earnings (Loss) per Unit

Basic and diluted earnings (loss) per unit are computed based on the weighted-average outstanding Class A and Class B member units, which are all voting units and member unit equivalents outstanding during the year. The weighted average PIU’s outstanding are also included in the basic and diluted loss per unit calculations.

Member unit equivalents consist of outstanding warrants and outstanding convertible notes payable (see Note 6). Member unit equivalents of approximately 2.6 million warrants and future member equity units to be authorized and issued upon the conversion of the convertible notes to equity, were both excluded from the computation of diluted earnings (loss) per unit for the years ended December 31, 2016 and 2015, because their effect on the loss per unit is anti-dilutive.

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. At times, the Company’s cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. There were no accounts that exceeded federally insured limits at December 31, 2016 and 2015.

Intangible Assets

Intangible assets consist primarily of the trademarks and copyrights. The trademarks and copyrights will be amortized using the straight-line method based on an estimated useful life of 20 years.

Impairment of Long-Lived Assets

The Company’s long-lived assets (consisting of the trademarks) are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the undiscounted future net cash flows expected to be generated by that asset. If the carrying amount of an asset exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Through December 31, 2016, the Company had not experienced impairment losses on its long-lived assets.

Income Taxes

As a limited liability company, the Company is not a taxpaying entity for federal and state income tax purposes. Accordingly, the Company’s taxable income or loss is allocated to its members in accordance with their respective percentage ownership. Therefore, no provision or liability for income taxes has been included in the accompanying financial statements. The Company may be subject to examination by IRS for calendar years 2013 through 2016.

Research and Development

Research and development costs are charged to expense as incurred. Research and development includes fees associated with consultants supporting our research and development endeavors and the acquisition of technology rights and patents costs for which development work is still in process. These costs are charged to operations as incurred as research and development expense.

F-8

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

Embedded Derivative Liability — Convertible Notes

The Company has convertible notes outstanding at December 31, 2016 with default payment provisions (default provision that requires payment of three times the outstanding principal amount plus accrued interest). The Company determined that the default provision is an embedded component that qualifies as a derivative which should be bifurcated from the Convertible Notes and separately accounted for in accordance with FASB ASC 815, “Derivatives and Hedging”. ASC 815 – 15 – 25 – 42 establishes criteria to determine whether puts are closely and clearly related to a debt host should the debt contain a substantial premium or default provision (one that is greater than 10% of the principal resulting from puts that require payoff for more than 110% of principal amount outstanding). The embedded derivative is recorded at fair value on the date of issuance and marked-to-market at each balance sheet date with the change in the fair value recorded as income or expense in the statement of operations (see Note 6).

Equity-Based Compensation

The Company treats the PIU’s it issues in the form of Class A membership Units as compensation in a manner consistent with how stock-based compensation of a C-corporation would be treated if the membership units were shares of a C corporation. Because the arrangement is primarily based on the price of the Company’s equity instruments and there are no substantive repurchase provisions, the arrangement in accounted for under FASB ASC 718 “Compensation — Stock Compensation” (“ASC 718”). The Company measures the cost of these equity awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the employee is required to provide service in exchange for the entire award. The fair value of the PIU’s on the date of grant is calculated using the Black Scholes option pricing model, based on key assumptions such as the fair value of Class A units, expected volatility and expected term. The Company’s estimates of these important assumptions are primarily based on third-party valuations, historical data, peer company data and the judgement of management regarding future trends.

The Company accounts for equity-based compensation issued to non-employees and consultants in accordance with the provisions of FASB ASC 505-50 “Equity – Based Payments to Non-employees”. The non-cash charge to operations for non-employee PIU’s with time based vesting provisions is based on the fair value of the PIU’s re-measured each reporting period and amortized to expense over the remaining vesting period.

Recent Accounting Pronouncements

Statement of Cash Flows — In 2016 the FASB issued ASU 2016-15, “Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments” and ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”. ASU 2016-15 addresses the presentation and classification of certain cash receipts and payments in the statement of cash flows. ASU 2016-18 is intended to reduce diversity in the presentation of restricted cash and restricted cash equivalents in the cash flows statement. The statement requires that restricted cash and restricted cash equivalents to be included as components of total cash and cash equivalents as presented on the statement of cash flows. These pronouncements go into effect for periods beginning after December 15, 2017. The Company does not believe the adoption of these pronouncements will have a material effect on the Company’s financial statements.

Leases — In February 2016, the FASB issued ASU 2016-02 which amends existing lease accounting guidance, and requires recognition of most lease arrangements on the balance sheet. The adoption of this standard will result in the Company recognizing a right-of-use asset representing its rights to use the underlying asset for the lease term with an offsetting lease liability. ASU 2016-02 will be effective for fiscal years beginning after December 15, 2018. The Company is currently evaluating the potential impact of the adoption of this accounting pronouncement to its financial statements.

Going Concern — In August 2014, FASB issued guidance that requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued. An entity must provide certain disclosures if conditions or events raise substantial doubt about the entity’s ability to continue as a going concern. The updated accounting guidance was effective for the

F-9

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

Company on December 31, 2016, and early adoption was permitted. The Company has implemented this guidance on December 31, 2016.

Stock Compensation — In March 2016, the FASB issued ASU 2016-09, Compensation — Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which will simplify the income tax consequences, accounting for forfeitures and classification on the Statement of Consolidated Cash Flows. This standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016, with early adoption permitted. This new pronouncement is not expected to have a material effect on the Company’s financial position, results of operations or cash flows.

3 —NOTES RECEIVABLE – RELATED PARTY

On November 24, 2016, the Chairman of the Board issued a promissory note to the Company in the amount of $35,000, payable with interest on or before June 6, 2017. Interest is calculated at a 5% interest rate per annum and shall be added to the principal balance of this note receivable. The Chairman subscribed to $35,000 of the Company convertible notes issued which generated this note receivable (see Note 6).

4 — INTANGIBLE ASSETS, NET

Intangible assets, net consist of the following:

 

 

Useful
life

 

December 31,
2016

 

December 31,
2015

Trademarks and Copyrights

 

20 years

 

$

11,300

 

 

$

11,300

 

Less: Accumulated amortization

 

 

 

 

(3,437

)

 

 

(2,872

)

Intangible Assets, net

 

 

 

$

7,863

 

 

$

8,428

 

Amortization of trademarks and copyrights amounted to $565 for each of the years ended December 31, 2016 and 2015. At December 31, 2016, the future remaining amortization periods for trademarks and copyrights are approximately 14 years.

5 — DUE TO RELATED PARTY

At December 31, 2015 the balance due to the Chairman of the Board was $15,596. In 2015, the Company withheld a total of $31,352 due to the Chairman of the Board in a segregated checking account, pending the outcome of legal action against the Chairman of the Board. In December 2015 the Company settled this legal action and recorded the gain on settlement of $15,756 as a reduction of general and administrative expenses for the year ended December 31, 2015.

6 — CONVERTIBLE NOTES — RELATED PARTIES AND DERIVATIVE LIABILITIES

In September and December, 2016, the Company issued convertible notes (the “notes”) with an outstanding unsecured principal amount of $235,000 to its members, including Directors and Officers, ($35,000 of which was purchased with a note receivable — see Note 3). The principal and interest is due in 2029, and the notes bear interest at a rate of 15% per annum.

The notes will automatically convert to such equity units in the event the Company issues and sells either common or preferred units of $2,000,000 or more, excluding the value of the conversion of these notes. The conversion price will be either one third the price offered during the financing round that triggers the conversion, or the price obtained by dividing $2,000,000 by the Company’s fully-diluted capitalization at the time of the financing round that triggers the conversion (the “Conversion Cap Price”), whichever is lower. In the event that the Company or its assets are acquired prior to the closing of a financing round of $2,000,000 or more, the outstanding principal and accrued interest of the notes will automatically convert to a new class of equity units in the Company with rights similar to the Class A units. The conversion will be equal to the Conversion Cap Price at the time of the event. This

F-10

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

6 — CONVERTIBLE NOTES — RELATED PARTIES AND DERIVATIVE LIABILITIES (cont.)

new class of equity units is entitled to receive cumulative distributions in preference to all other units of three times the outstanding balance at the time of conversion and would also receive distributions to the extent distributions are received by Class A Units of the founders. Upon maturity of the notes, the holder may elect to convert the notes into the new class of equity securities as if a sale of the Company had occurred on the maturity date. A default is defined as non-payment, default in a covenant of the note, bankruptcy or involuntary petition for bankruptcy against the Company.

In addition, repayment of the notes due to an event of default, as defined above and in the convertible promissory note agreement, requires an accelerated payment of three times the outstanding principal and accrued interest. These default payment provisions were determined to be a derivative instrument. A derivative liability and an associated discount to the convertible notes of $762 at the date of issuance, was recognized. On December 31, 2016 the Company revalued the fair value of this derivative liability which resulted in $10 gain on the derivative liability for the year ended December 31, 2016.

The Company used the Monte-Carlo valuation model to determine the fair value of the derivatives liability, using the following key assumptions for the year ended December 31, 2016.

Underlying asset

 

Class A Unit

Class A Expected term (years)

 

5 years

Class A Volatility

 

90-92%

Risk free rate

 

1.67-2.45%

Event of default trigger

 

Starts at 0%, then rises 0.5% per year to a maximum of 5%

Probability of Company Sale

 

45% by 12/31/17 25% by 12/31/18 25% by 12/31/19

The following table sets forth a reconciliation of change in the fair value of financial liabilities, classified as Level 3 in the fair value hierarchy:

 

 

Derivative
Liability

Balance at December 31, 2015

 

$

 

Issuance of derivative liability – convertible notes payable

 

 

762

 

Change in fair value of derivative liability

 

 

(10

)

Balance at December 31, 2016

 

$

752

 

7 — Fair Value of Financial Instruments and Fair Value Measurements

The Company’s financial instruments consists primarily of cash, receivables, accounts payable and accrued liabilities, debt instruments and derivative liabilities.

FASB Accounting Standards Codification (“ASC”) Topic 820, “Fair Value Measurements and Disclosures,” requires disclosure of the fair value of financial instruments held by the Company. ASC Topic 825, “Financial Instruments,” defines fair value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The carrying amounts reported in the balance sheets for receivables, current liabilities and convertible notes payable each qualify as financial instruments and are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments and their expected realization and their current market rate of interest.

The three levels of valuation hierarchy are defined as follows:

         Level 1: Observable inputs such as quoted prices in active markets;

         Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

         Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

F-11

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

7 — Fair Value of Financial Instruments and Fair Value Measurements (cont.)

As of December 31, 2016, the significant inputs to the Company’s derivative liability recorded at fair value were considered level 3 inputs.

 

 

Fair value measurement using

 

 

Quoted prices
in
active markets
(Level 1)

 

Significant
other
observable
inputs
(Level 2)

 

Significant
unobservable
inputs
(Level 3)

 

Total

Balance at December 31, 2016

 

 

 

 

 

 

 

 

 

 

 

Derivative liability

 

$

 

$

 

$

752

 

752

8 — RELATED PARTY TRANSACTIONS

In January 2011, the Company entered into an exclusive, worldwide license agreement with The University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group (the “UVA LVG”) for rights to make, use or sell licensed products in the United States based upon patents and patent applications made and held by UVA LVG (the “UVA LVG License”). The Company is required to pay compensation, as described Note 10. The Company is required to pay compensation to the UVA LVG, as described Note 10. A certain percentage of these payments by the Company to the UVA LVG may then be distributed to the Chairman of the Board in his capacity as inventor of the patents by the UVA LVG in accordance with their policies at the time.

As part of the settlement agreement, described in Note 5 — Due to Related Party, the Chairman of the Board will provide consulting services for the Company on an ongoing, open-ended basis in return for participation in the Company’s Performance Bonus Plan.

In September and December, 2016, the Company issued convertible notes, with a total outstanding unsecured principal amount of $235,000 to its members, including its Directors and Officers, refer to Note 6 — Convertible notes — related parties and derivative liabilities. Convertible notes payable, held by Directors and Officers of the Company, totaled $132,854 in principal at December 31, 2016.

The Company issued 7,054,735 Class A units, 554,330 Class B units, 117,872 warrants to purchase Class A units, 554,330 warrants to purchase Class B units, and 1,494,725 PIU’s to its Directors and Officers as of December 31, 2016, their direct relatives, or related entities (see Note 9).

9 — MEMBERS’ EQUITY

Classes of Membership Units

The Operating Agreement of the Company creates membership units “units” that are designed to largely mimic shares in a C corporation with the class and characteristics of the units determining the voting rights and share of cash distributions to be received by holders of the units, all as defined in the Operating Agreement.

As of December 31, 2016, the Company had two classes of units — Class A units and Class B units. The only difference between the two classes of units is the priority of distributions to the unit holders as further described under Distributions to Members described below. Under the Operating Agreement, the Company is authorized to issue either voting or non-voting units when issuing either Class A or Class B units. At December 31, 2016 and 2015 there were 14,100,394 Class A units outstanding and 1,870,469 Class B units outstanding and these outstanding units are all voting units.

Distributions to Members

The Operating Agreement provides for the relative distribution priority for all the members, for any regular distributions made by the Company to its members, which will be made at the discretion of the Company’s board of

F-12

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

9 — MEMBERS’ EQUITY (cont.)

directors, based first on the class of the units, then on the invested capital paid for the unit, and then on whether there is a reduction in distribution due to the unit being a PIU, with the priority for distributions being in the order shown below:

First, Class B units will receive an amount equal to their invested capital prior to distributions to Class A units.

Second, Class A units will receive an amount equal to their invested capital with investors receiving the same percentage of their invested capital across the class of units if there is not enough funds to return the full amount of the invested capital.

Third, once all investors have received their invested capital, then distributions will be made to units of any class that have received the smallest amount on a per unit basis until all units have received the same amount of distributions on a per unit basis.

In addition to regular distributions, to the extent the Company has the financial capacity, it will make distributions to its members for the payment of the personal income taxes of its members in which such distributions will be due to profits allocations from the Company. Such tax related distributions will not be subject to the distribution priorities described above.

For the purpose of determining distributions only, PIU’s are effectively deemed to have already received a distribution equal to the fair value of a Class A unit at the time of issuance of the PIU (the “Distribution Reduction”). For instance, if a PIU was issued with a Class A unit having a value of $1.00, then all Class A units will received distributions of $1.00 before any distributions are made to the PIU, and once $1.00 has been distributed to all other Class A units, then the PIU will receive distributions pari passu to such Class A units thereafter.

Profits Interest Units (“PIU’s”)

The Operating Agreement also creates and authorizes the issuance of PIU’s. PIU’s are identical to Class A units except that the amount of cash distributions to be received by the holder of a PIU will be reduced by Distribution Reduction. In practice this makes the amount of cash to be received by the holder of a PIU, effectively identical to the amount that would be received for an equity stock option holder in a C corporation that received the option with an exercise price equal to the value of the underlying equity at the time of issuance (i.e., priced “at the money”).

PIU’s awarded as incentives to personnel are usually subject to Company right of repurchase, at the nominal amount, in the event the awardee’s employment with the Company is terminated. The right of repurchase usually expires over time on a straight-line, monthly basis with the length of expiration of the right of repurchase being 6-48 months depending on the circumstances.

Equity Issuances/Repurchases

Upon formation of the Company on November 23, 2010, the Company issued 9,151,141 Class A units shares to the Company’s founding members for a total price of $92.

From 2011 through 2014, the Company issued and repurchased Class A Units and Class B Units and warrants to purchase units as follows:

         Issued 5,159,131 Class A units and warrants to purchase 723,916 Class A units for $0.001 per unit for total cash, net of financing cost $15,908, aggregating $6,392,110;

         Issued 1,870,469 Class B units and warrants to purchase 1,870,469 Class B units for $1.42 per unit for cash aggregating $2,656,042;

         Issued a certain warrant to third-party contract research organization (“CRO”) related to funding contract research work for clinical development of AD04 (the “CRO Contracts”). This warrant was later terminated in relation to termination of the CRO Contract;

F-13

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

9 — MEMBERS’ EQUITY (cont.)

         Issued 1,456,056 PIU’s for Company personnel incentives with a Distribution Reduction at time of issue of between $0.50 and $1.42 per unit;

         Repurchased 209,878 Class A units for cash aggregating $143,800 from members;

         Repurchased 96,665 PIU’s due to personnel leaving employment with the Company.

In 2015, the Company issued and re-valued PIU’s and canceled a warrant as follows:

         Issued 722,600 PIU’s for Company personnel incentives with a Distribution Reduction at time of issue of $0.50 per unit, with fair value of $281,827;

         Reduced the Distribution Reduction for 515,250 PIU’s to $0.50 for Company personnel incentives. Of these PIU’s 183,500 of the PIU’s previously had a Distribution Reduction of $1.05 per unit and 331,750 of the PIU’s previously had a Distribution Reduction of $1.42 per unit. The expense recorded due to the modification of the PIU’s was $65,795, $59,835 of which was recognized as an expense in 2015 and $5,961 of which was amortized over the remaining life of the corresponding PIU grants.

In 2016, the Company issued and repurchased PIU’s as follows:

         Issued 207,319 PIU’s for Company personnel incentives with a Distribution Reduction at time of issue of $0.50 per unit, with fair value of $90,698;

         Repurchased 73,002 PIU’s for cash aggregating approximately $1 due to personnel leaving employment with the Company.

The following table provides the activity in PIU’s for the years ended December 31, 2016 and 2015.

 

 

Total PIU’s
Outstanding

 

Weighted
Average
Distribution
Reduction

Outstanding December 31, 2014

 

1,359,391

 

 

$

1.07

Granted

 

722,600

 

 

$

0.50

Outstanding December 31, 2015

 

2,081,991

 

 

$

0.68

 

 

 

 

 

 

 

Granted

 

207,319

 

 

$

0.50

Re-purchased

 

(73,002

)

 

$

0.50

Outstanding December 31, 2016

 

2,216,308

 

 

$

0.66

At December 31, 2016 and 2015, the numbers of vested PIU’s were 2,044,993 and 1,669,705, respectively. Of these total vested PIU’s, 446,806 were non-voting.

At December 31, 2016 and 2015, the intrinsic value totals of the outstanding PIU’s were $591,897 and $169,523 respectively.

The weighted average assumptions used in the Black Scholes Merton model related to PIU’s, for the years ended December 31, 2016 and 2015, are as follows:

 

 

2016

 

2015

Fair Value of Class A unit

 

$

0.81 to $0.92

 

 

$

0.63 to $0.76

 

Risk-free rate

 

 

0.57

%

 

 

0.51% to 0.70

%

Volatility

 

 

80% to 92

%

 

 

92 to 98

%

Dividend yield

 

 

0

%

 

 

0

%

Expected term (years)

 

 

1.62 years

 

 

 

2.42 to 2.58 years

 

F-14

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

9 — MEMBERS’ EQUITY (cont.)

The Fair Value of the underlying Class A units were valued based on security offerings of the Company, increased for the Company’s annual weighted average cost of capital for PIU’s issued in subsequent years from the security offerings. The underlying Class A units were valued using an Option Pricing Model (OPM) using an iterative approach at various total equity values, such that the value of the equity instruments issued was equal to the consideration paid (given the equity structure at the time).

The risk free rate was determined based on the U.S. Treasury Bond Yield. The volatility is based on analyzing the stock price and implied volatility of guideline companies. The expected term of the awards is based on an estimated service period of 1.62 years for 2016 and between 2.42 years and 2.58 years for 2015. Compensation expense was recognized using the straight line method over the requisite service period, which is the implied service period. During the years ended December 31, 2016 and 2015, total equity-based compensation expense from the PIU’s issued was $153,562 and $250,823, respectively. The total future unrecognized compensation expense of $69,506 will be recognized in 2017.

The following is a summary of Warrants

 

 

December 31,

Warrants outstanding:

 

2016

 

2015

Issued to investors in 2011 to purchase non-voting Class A units for $0.001 per unit exercise price, expiring on December 31, 2021

 

723,916

 

723,916

 

 

 

 

 

Issued to investors in 2013 to purchase Class B units for $1.42 per unit exercise price, expiring on December 31, 2031

 

1,870,469

 

1,870,469

 

 

 

 

 

Total Warrants Outstanding

 

2,594,385

 

2,594,385

There were no warrants issued, exercised or expired for the years ended December 31, 2016 and 2015.

10 — COMMITMENTS AND CONTINGENCIES

License with University of Virginia Patent Foundation

In January 2011, the Company entered into an exclusive, worldwide license agreement with (the “UVA LVG”) for rights to make, use or sell licensed products in the United States based upon the ten separate patents and patent applications made and held by UVA LVG.

As consideration for the rights granted in the UVA LVG License, the Company is obligated to pay UVA LVG yearly license fees and milestone payments, as well as a royalty based on net sales of products covered by the patent-related rights. More specifically, the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense ourselves. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income. The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if we breach our obligations thereunder, including failing to make any milestone, deadline, the most immediate being initiating Phase 3 clinical trials by December 31, 2018, required payments or the failure to exercise diligence to bring licensed products to market. In the event of a termination, the Company will be obligated to pay all amounts that accrued prior to such termination.

F-15

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

10 — COMMITMENTS AND CONTINGENCIES (cont.)

The term of the license continues until the expiration, abandonment or invalidation of all licensed patents and patent applications, and following any such expiration, abandonment or invalidation will continue in perpetuity on a royalty-free, fully-paid basis.

Lease Commitments

On December 31, 2014, the Company signed a lease agreement for offices at 414 East Water Street, Charlottesville, VA 22902. The lease requires monthly payments of $2,250 and terminated on January 31, 2017. As of the date of these statements, the lease had terminated and the full security deposit of $2,250 has been returned to the Company. Rent expense under this operating lease agreement was approximately $27,000 and $32,000 for the years ended December 31, 2016 and 2015, respectively. The Company currently occupies approximately 300 square feet of office space in Charlottesville, Virginia that is provided at no cost by one of its members.

On June 1, 2016, the Company signed a sublease agreement under which to sublet the Company’s offices. The lease expires January 31, 2017 and requires monthly payments of $1,500. As of the date of these statements, the sublease had terminated and the full security deposit of $1,500 has been returned by the Company. Payments under sublease agreement were recorded as an offset to rent expense and were approximately $10,000 for the year ended December 31, 2016.

Performance Bonus Plan

On February 17, 2015, the Company adopted a Performance Bonus Plan (“PBP”) to provide incentive for Company personnel, which was then modified on January 25, 2016 and April 15, 2017. Under the PBP, 5.25% of the first $14.7 million of a strategic transaction (one or more transactions that provide funds to the Company and/or its members that enable the commencement of the clinical development of AD04) will be set aside for Company’s personnel with 1.25% of funds to be awarded to the Chairman of the Board and the remainder to be awarded at the CEO’s discretion, with no more than 3.15% payout to the CEO of the Company. The maximum bonus amount to be paid out of the PBP is $771,750. The Company has the right to pay up to 65% of the amounts due under the PBP with equity of the Company valued at a future investors round equity price.

Consulting Agreements

On March 22, 2016, the Company entered into an agreement with a third party consultant to explore transactions with a specific set of international pharmaceutical companies. This consultant was paid $1,740 (1,500 euros) in cash as an engagement fee. Additionally, if a transaction is consummated with one of the listed companies before March 21, 2018, when this agreement expires, this consultant will receive the greater of $91,000 (payable — 85,000 Euros) or 4% of the consideration received by the Company under the transaction.

On April 25, 2016, the Company entered into a Consulting Agreement with a consultant, who now serves as Chief Operating Officer at a compensation rate of $2,200 per month.

This consultant was granted 207,319 PIU’s in the Company and will be awarded 0.5% of a transaction, as defined by and under the terms of the Company’s PBP as stated in the above paragraph. The 0.5% of a transaction is equal to 9.5% of the Pool. For the year ended December 31, 2016, total fees charged by this consultant was $8,000.

On October 27, 2016, the Company entered into a Consulting Agreement to provide implementation of the Company’s investor relations program through September 30, 2018.

The consultant will receive equity, which will be in the form of restricted common stock at the completion of an offering of common stock securities (“Offering”), which would take place after the future reorganization of the Company into a corporation, in an amount equal to 4.8% of the common stock outstanding immediately prior to the Offering. Shares shall vest 50% upon issuance and 50% on December 31, 2017. If the Company does not conduct an Offering no shares will be received by the consultant. In addition, immediately following an Offering, the Company shall issue the consultant 5-year warrants to purchase such number of shares of common equity of the Company,

F-16

ADIAL PHARMACEUTICALS, LLC

NOTES TO FINANCIAL STATEMENTS

10 — COMMITMENTS AND CONTINGENCIES (cont.)

equal to 4.9% of the then total fully diluted outstanding shares with an exercise price equal to the price of the shares issued in the Offering.

Employment Agreement

The Company has entered into an employment agreement with the Chief Executive Officer and Board Director (the “CEO”) effective December 6, 2010. The term of the agreement is 1 year and renews annually unless notice is provided 30 days prior to the renewal date. The annual base salary is $210,000 and the agreement provides for one year of severance upon termination by the Company. On August 17, 2016, the employment agreement was modified and the CEO would receive $5,000 per month until the Company raises additional funds, as defined, at which time the salary is to increase back to the annual base salary of $210,000, on a prospective basis. Additionally, if a single member gains control of the Company, as defined, the Company may be liable for payment of the full salary on a retroactive basis.

Litigation

The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash flows. For the year ended December 31, 2016 and 2015, the Company did not have any pending legal actions.

CRO Option

As part of the termination of the CRO Contracts, the Company issued the CRO an option to invest $100,000 in the Company’s next financing of $3,000,000 on terms equal to those received by investors but at a 15% discount to the lowest price paid by such investors. In the event the Company is acquired prior to such a financing, the CRO also has the option to purchase 70,423 Class B units at a price of $1.42 per unit (i.e., $100,000 total purchase price). This option expires on March 14, 2021.

11 — SUBSEQUENT EVENTS

Effective May 1 2017, the Company entered into a senior secured bridge note financing with a third party investment fund (“Holder”), for the principal sum of $287,500 of which $250,000 was received as proceeds and $37,500 was recorded as original issue discount (the “OID”). The interest on the principal amount is at the rate of two percent per annum until the principal amount becomes due and payable, whether at maturity or upon acceleration or by prepayment or otherwise. The maturity date will be November 1, 2017, at which time the principal and accrued and unpaid interest and other fees herein, will be due and payable. This note is secured by all the assets held by the Company.

Holder has the right to require repayment of 115% of the outstanding principal amount plus interest upon the Company receiving proceeds of $250,000 or more from the sale of its equity (or equivalent securities) or the issuance of debt (the “Financing”). In the future, Holder is also entitled to receive warrants, which amounts are based on the above principal sum of $287,500 divided by the equity price sold to investors in the Financing. The number of warrants to be issued to the Holder also depends on the type of Financing the Company completes in the future. There are also commitment shares, as defined in the agreement, that are due to the Holder in the amount of $29,000 upon the closing of the Financing.

During the first quarter of 2017, the Company entered into consulting and service agreements with various personnel and third parties in exchange for cash and future equity interests, based on the Company completing its future Offering.

F-17

ADIAL PHARMACEUTICALS, LLC

UNAUDITED CONDENSED FINANCIAL STATEMENTS

JUNE 30, 2017 AND 2016

Contents

 

 

Page

Condensed Balance Sheets as of June 30, 2017 (unaudited) and December 31, 2016 (unaudited)

 

F-19

Condensed Statements of Operations for the three months and six months ended June 30, 2017
and 2016 (unaudited)

 

F-20

Condensed Statements of Changes in Members’ Deficit for the year ended December 31, 2016
and the six months ended June 30, 2017 (unaudited)

 

F-21

Condensed Statements of Cash Flows for the six months ended June 30, 2017 and 2016 (unaudited)

 

F-22

Notes to Condensed Financial Statements (unaudited)

 

F-23

F-18

ADIAL PHARMACEUTICALS, LLC

CONDENSED BALANCE SHEETS (UNAUDITED)

 

 

June 30,
2017

 

December 31,
2016

ASSETS

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

137,134

 

 

$

87,993

 

Prepaid expenses and other current assets

 

 

51,000

 

 

 

18,303

 

Note receivable – related party

 

 

 

 

 

35,117

 

Total Current Assets

 

 

188,134

 

 

 

141,413

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangible assets – net

 

 

7,581

 

 

 

7,863

 

Other assets

 

 

 

 

 

2,250

 

Total Other Assets

 

 

7,581

 

 

 

10,113

 

 

 

 

 

 

 

 

 

 

Total Assets

 

$

195,715

 

 

$

151,526

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND MEMBERS’ DEFICIT

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

163,964

 

 

$

20,012

 

Senior bridge note payable, net of discount of $25,272 at June 30, 2017

 

 

262,228

 

 

 

 

Convertible notes payable, net of discount of $716 and $745 at June 30, 2017 and Dec. 31, 2016 respectively

 

 

234,284

 

 

 

234,255

 

Derivative liability

 

 

752

 

 

 

752

 

Total Current Liabilities

 

 

661,228

 

 

 

255,019

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MEMBERS’ DEFICIT

 

 

 

 

 

 

 

 

Members’ equity

 

 

9,915,570

 

 

 

9,834,752

 

Accumulated deficit

 

 

(10,381,083

)

 

 

(9,938,245

)

Total Members’ Deficit

 

 

(465,513

)

 

 

(103,493

)

 

 

 

 

 

 

 

 

 

Total Liabilities and Members’ Deficit

 

$

195,715

 

 

$

151,526

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

F-19

ADIAL PHARMACEUTICALS, LLC

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

For the Three Months Ended
June 30,

 

For the Six Months Ended
June 30,

 

 

2017

 

2016

 

2017

 

2016

Operating Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

57,863

 

 

$

38,160

 

 

$

102,339

 

 

$

77,267

 

General and administrative expenses

 

 

183,622

 

 

 

57,534

 

 

 

308,746

 

 

 

144,136

 

Total Operating Expenses

 

 

241,485

 

 

 

95,694

 

 

 

411,085

 

 

 

221,403

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss From Operations

 

 

(241,485

)

 

 

(95,694

)

 

 

(411,085

)

 

 

(221,403

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

38

 

 

 

14

 

 

 

376

 

 

 

116

 

Interest expense

 

 

(22,826

)

 

 

 

 

 

(32,129

)

 

 

 

Total other income (expense)

 

 

(22,788

)

 

 

14

 

 

 

(31,753

)

 

 

116

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss Before Provision For Income Taxes

 

 

(264,273

)

 

 

(95,680

)

 

 

(442,838

)

 

 

(221,287

)

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(264,273

)

 

$

(95,680

)

 

$

(442,838

)

 

$

(221,287

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per unit, basic and diluted

 

$

(0.01

)

 

$

(0.01

)

 

$

(0.02

)

 

$

(0.01

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average units, basic and diluted

 

 

18,187,807

 

 

 

18,195,032

 

 

 

18,187,484

 

 

 

18,123,943

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

F-20

ADIAL PHARMACEUTICALS, LLC

CONDENSED STATEMENT OF CHANGES IN MEMBERS’ DEFICIT (UNAUDITED)

FOR THE SIX MONTHS ENDED JUNE 30, 2017 AND YEAR ENDED DECEMBER 31, 2016

 

 

Class A Units

 

Class B Units

 

Profits Interest Units

 

Total
Members’

 

Accumulated

 

 

 

 

Units

 

Amount

 

Units

 

Amount

 

Units

 

Amount

 

Equity

 

Deficit

 

Total

Balance,
December 31,
2015

 

14,100,394

 

$

6,248,402

 

1,870,469

 

$

2,656,042

 

2,081,991

 

 

$

776,746

 

 

$

9,681,190

 

 

$

(9,518,045

)

 

$

163,145

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity-based compensation

 

 

 

 

 

 

 

207,319

 

 

 

153,563

 

 

 

153,563

 

 

 

 

 

 

153,563

 

Repurchased Profit Interest Units

 

 

 

 

 

 

 

(73,002

)

 

 

(1

)

 

 

(1

)

 

 

 

 

 

(1

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(420,200

)

 

 

(420,200

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2016

 

14,100,394

 

$

6,248,402

 

1,870,469

 

$

2,656,042

 

2,216,308

 

 

$

930,308

 

 

$

9,834,752

 

 

 

(9,938,245

)

 

$

(103,493

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Units Sold

 

 

 

 

18,868

 

 

20,000

 

 

 

 

 

 

 

20,000

 

 

 

 

 

 

20,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity-based compensation

 

 

 

 

 

 

 

 

 

 

60,818

 

 

 

60,818

 

 

 

 

 

 

60,818

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(442,838

)

 

 

(442,838

)

Balance at June 30, 2017

 

14,100,394

 

$

6,248,402

 

1,889,337

 

$

2,676,042

 

2,216,308

 

 

$

991,126

 

 

$

9,915,570

 

 

 

(10,381,083

)

 

$

(465,513

)

The accompanying notes are an integral part of these unaudited condensed financial statements.

F-21

ADIAL PHARMACEUTICALS, LLC

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

For the Six Months Ended
June 30,

 

 

2017

 

2016

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(442,838

)

 

$

(221,287

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Equity-based compensation for services

 

 

60,818

 

 

 

79,189

 

Amortization of intangible assets

 

 

282

 

 

 

282

 

Amortization of discount to senior and convertible notes

 

 

12,257

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(12,697

)

 

 

43,170

 

Other assets

 

 

2,250

 

 

 

 

Accounts payable and accrued expenses

 

 

143,952

 

 

 

(12,340

)

Due to related party

 

 

 

 

 

(15,596

)

Net cash used in operating activities

 

 

(235,976

)

 

 

(126,582

)

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Note receivable – related party

 

 

35,117

 

 

 

 

Net cash provided by investing activities

 

 

35,117

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from Bridge Note Payable

 

 

250,000

 

 

 

 

Net cash provided by financing activities

 

 

250,000

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

49,141

 

 

 

(126,582

)

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS-BEGINNING OF PERIOD

 

 

87,993

 

 

 

162,377

 

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS-END OF PERIOD

 

$

137,134

 

 

$

35,795

 

 

 

 

 

 

 

 

 

 

Supplemental Disclosure of Cash Flow Information:

 

 

 

 

 

 

 

 

Interest paid

 

$

 

 

$

 

Income taxes paid

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

Non-Cash Financing Activities:

 

 

 

 

 

 

 

 

Class B Units Issued for subscription receivable

 

$

20,000

 

 

$

 

The accompanying notes are an integral part of these unaudited condensed financial statements.

F-22

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

1 — DESCRIPTION OF BUSINESS

Adial Pharmaceuticals, LLC (the “Company” or “Adial”) was formed on November 23, 2010 in the Commonwealth of Virginia. Adial is presently engaged in the development and commercializing of medications for the treatment of addictions and related disorders.

The Company is planning to commence its first Phase 3 clinical trial of its lead compound AD04 (“AD04”) for the treatment of alcohol use disorder when the necessary funding becomes available (Note 2). Both the U.S. Food and Drug Administration (“FDA”) and the European Medicines Authority (“EMA”) have indicated they will accept to heavy-drinking-based endpoints as a basis for approval for the treatment of alcohol use disorder rather than the previously required abstinence-based endpoints. Key patents have been issued in the United States, the European Union, and other jurisdictions for which the Company has exclusive license rights. The active ingredient in AD04 is ondansetron, a serotonin-3 antagonist. Due to its mechanism of action, AD04 has the potential to be used for the treatment of other addictive disorders, such as obesity, smoking, and drug addiction.

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions for Form 10-Q and Article 8 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2017 or for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the accompanying Form S-1/A.

Liquidity, Going Concern and Uncertainties

The financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated revenues to enable profitability. As of June 30, 2017, the Company had an accumulated deficit of approximately $10.4 million, and has incurred net losses of approximately $0.4 million and $0.2 million for the six months ended June 30, 2017 and 2016, respectively. Based on the current development plans for AD04 in both the U.S. and foreign markets and the Company’s other operating requirements, management believes that the existing cash at June 30, 2017 will not be sufficient to fund operations for at least the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

The Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products in order to complete its ongoing research and development efforts and the planned Phase 3 clinical trial. Management is actively pursuing financing, but can provide no assurances that such financing will be available on acceptable terms, or at all. Without this funding, the Company could be required to delay, scale back or eliminate some or all of its research and development programs which would likely have a material adverse effect on the Company.

The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern.

Generally, the Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products;

F-23

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

the ability to manufacture the Company’s products successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the ability to raise capital to support its operations.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Significant items subject to such estimates and assumptions include the valuation of outstanding PIU’s (defined in Note 9), derivative liabilities, intangible assets useful life, and contingent liabilities. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes.

Basic and Diluted Earnings (Loss) per Unit

Basic and diluted earnings (loss) per unit are computed based on the weighted-average outstanding Class A and Class B member units, which are all voting units and member unit equivalents outstanding during the year. The weighted average PIU’s outstanding are also included in the basic and diluted loss per unit calculations.

Member unit equivalents consist of outstanding warrants and outstanding convertible notes payable (see Note 6). Member unit equivalents of approximately 2.6 million warrants and future member equity units to be authorized and issued upon the conversion of the convertible notes to equity (Note 6), were both excluded from the computation of diluted earnings (loss) per unit for the three and six months ended June 30, 2017 and 2016, because their effect on the loss per unit is anti-dilutive.

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. At times, the Company’s cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. There were no accounts that exceeded federally insured limits at June 30, 2017 and December 31, 2016.

Intangible Assets

Intangible assets consist primarily of the trademarks and copyrights. The trademarks and copyrights will be amortized using the straight-line method based on an estimated useful life of 20 years.

Impairment of Long-Lived Assets

The Company’s long-lived assets (consisting of the trademarks) are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the undiscounted future net cash flows expected to be generated by that asset. If the carrying amount of an asset exceeds its estimated future undiscounted cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Through June 30, 2017, the Company had not experienced impairment losses on its long-lived assets.

F-24

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

Income Taxes

As a limited liability company, the Company is not a taxpaying entity for federal and state income tax purposes. Accordingly, the Company’s taxable income or loss is allocated to its members in accordance with their respective percentage ownership. Therefore, no provision or liability for income taxes has been included in the accompanying financial statements. The Company may be subject to examination by IRS for calendar years 2013 through 2016.

Research and Development

Research and development costs are charged to expense as incurred. Research and development includes fees associated with consultants supporting our research and development endeavors and the acquisition of technology rights and patents costs for which development work is still in process. These costs are charged to operations as incurred as research and development expense.

Embedded Derivative Liability — Convertible Notes

The Company has convertible notes outstanding at June 30, 2017 and December 31, 2016 with default payment provisions (default provision that requires payment of three times the outstanding principal amount plus accrued interest). The Company determined that the default provision is an embedded component that qualifies as a derivative which should be bifurcated from the Convertible Notes and separately accounted for in accordance with FASB ASC 815, “Derivatives and Hedging”. ASC 815 – 15 – 25 – 42 establishes criteria to determine whether puts are closely and clearly related to a debt host should the debt contain a substantial premium or default provision (one that is greater than 10% of the principal resulting from puts that require payoff for more than 110% of principal amount outstanding). The embedded derivative is recorded at fair value on the date of issuance and marked-to-market at each balance sheet date with the change in the fair value recorded as income or expense in the statement of operations (see Note 6).

Equity-Based Compensation

The Company treats the PIU’s it issues in the form of Class A membership Units as compensation in a manner consistent with how stock-based compensation of a C-corporation would be treated if the membership units were shares of a C corporation. Because the arrangement is primarily based on the price of the Company’s equity instruments and there are no substantive repurchase provisions, the arrangement in accounted for under FASB ASC 718 “Compensation — Stock Compensation” (“ASC 718”). The Company measures the cost of these equity awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the employee is required to provide service in exchange for the entire award. The fair value of the PIU’s on the date of grant is calculated using the Black Scholes option pricing model, based on key assumptions such as the fair value of Class A units, expected volatility and expected term. The Company’s estimates of these assumptions are primarily based on third-party valuations, historical data, peer company data and the judgment of management regarding future trends.

The Company accounts for equity-based compensation issued to non-employees and consultants in accordance with the provisions of FASB ASC 505-50 “Equity – Based Payments to Non-employees”. The non-cash charge to operations for non-employee PIU’s with time based vesting provisions is based on the fair value of the PIU’s re-measured each reporting period and amortized to expense over the remaining vesting period.

Recent Accounting Pronouncements

Statement of Cash Flows — In 2016 the FASB issued ASU 2016-15, “Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments” and ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”. ASU 2016-15 addresses the presentation and classification of certain cash receipts and payments in the

F-25

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)

statement of cash flows. ASU 2016-18 is intended to reduce diversity in the presentation of restricted cash and restricted cash equivalents in the cash flows statement. The statement requires that restricted cash and restricted cash equivalents to be included as components of total cash and cash equivalents as presented on the statement of cash flows. These pronouncements go into effect for periods beginning after December 15, 2017. The Company does not believe the adoption of these pronouncements will have a material effect on the Company’s financial statements.

Leases — In February 2016, the FASB issued ASU 2016-02 which amends existing lease accounting guidance, and requires recognition of most lease arrangements on the balance sheet. The adoption of this standard will result in the Company recognizing a right-of-use asset representing its rights to use the underlying asset for the lease term with an offsetting lease liability. ASU 2016-02 will be effective for fiscal years beginning after December 15, 2018. The Company is currently evaluating the potential impact of the adoption of this accounting pronouncement to its financial statements.

Stock Compensation — In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which will simplify the income tax consequences, accounting for forfeitures and classification on the Statement of Cash Flows. This standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016, with early adoption permitted. The adoption of Topic 718 did not have a material impact to our financial statements, including the presentation of equity-based compensation in our Statements of Operations.

3 — NOTES RECEIVABLE — RELATED PARTY

On November 24, 2016, the Chairman of the Board issued a promissory note to the Company in the amount of $35,000, payable with interest on or before June 6, 2017. Interest was calculated at a 5% interest rate per annum and shall be added to the principal balance of this note receivable. The Chairman subscribed to $35,000 of the Company convertible notes issued which generated this note receivable (see Note 6).

During the six months ended June 30, 2017, the Company received approximately $35,500 from this related party for this note receivable, and the Company accrued interest of $367 on this note for the six months ended June 30, 2017. As of June 30, 2017, this note has been paid in full.

4 — INTANGIBLE ASSETS, NET

Intangible assets, net consist of the following:

 

 

Useful
life

 

June 30,
2017

 

December 31,
2016

Trademarks and Copyrights

 

20 years

 

$

11,300

 

 

$

11,300

 

Less: Accumulated amortization

 

 

 

 

(3,719

)

 

 

(3,437

)

Intangible Assets, net

 

 

 

$

7,581

 

 

$

7,863

 

Amortization of trademarks and copyrights amounted to $282 for each of the six months ended June, 2017 and 2016. At June 30, 2017, the future remaining amortization periods for trademarks and copyrights are approximately 14 years.

5 — SENIOR BRIDGE NOTE

Effective May 1 2017, the Company entered into a senior secured bridge note financing with a third party investment fund (“Holder”) for the principal sum of $287,500 of which $250,000 was received as proceeds and $37,500 was recorded as original issue discount. The interest on the principal amount is at the rate of two percent per annum until the principal amount becomes due and payable, whether at maturity or upon acceleration or by prepayment or otherwise. The maturity date is November 1, 2017, at which time the principal and accrued and unpaid interest and other fees herein, is due and payable. This note is secured by all the assets held by the Company

F-26

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

5 — SENIOR BRIDGE NOTE (cont.)

which cannot be sold or otherwise disposed of without the Holder’s written consent. At June 30, 2017, the Company had accrued $942 in interest and amortized $12,228 of the original discount, with $25,272 in discount remaining. Both interest accrual and discount amortization were recorded as interest expense.

Holder has the right to require repayment of 115% of the outstanding principal amount plus interest upon the Company receiving proceeds of $250,000 or more from the sale of its equity (or equivalent securities) or the issuance of debt. In the future, Holder is also entitled to receive warrants, which amounts are based on the above principal sum of $287,500 divided by the equity price sold to investors in the contemplated IPO, as defined with the exercise price equal to the offering price. The number of warrants to be issued to the Holder also depends on the type of financing the Company completes in the future. There are also commitment shares, as defined in the agreement, that are due to the Holder in the amount of $29,000 and shall be paid on consummation of the contemplated IPO. In the event of default, the full principal amount of $287,500 plus accrued interest will be immediately due and payable to the Holder; in addition, $25,000 will be due and payable to Holder for every calendar month the note is in default until full payment is made.

6 — CONVERTIBLE NOTES — RELATED PARTIES AND DERIVATIVE LIABILITIES

In September and December, 2016, the Company issued convertible notes (the “notes”) with an outstanding unsecured principal amount of $235,000 to its members, including Directors and Officers, ($35,000 of which was purchased with a note receivable — see Note 3). The principal and interest is due in 2029, and the notes bear interest at a rate of 15% per annum.

The notes will automatically convert to such equity units in the event the Company issues and sells either common or preferred units of $2,000,000 or more, excluding the value of the conversion of these notes. The conversion price will be either one third the price offered during the financing round that triggers the conversion, or the price obtained by dividing $2,000,000 by the Company’s fully-diluted capitalization at the time of the financing round that triggers the conversion (the “Conversion Cap Price”), whichever is lower. In the event that the Company or its assets are acquired prior to the closing of a financing round of $2,000,000 or more, the outstanding principal and accrued interest of the notes will automatically convert to a new class of equity units in the Company with rights similar to the Class A units. The conversion will be equal to the Conversion Cap Price at the time of the event. This new class of equity units will be entitled to receive cumulative distributions in preference to all other units of three times the outstanding balance at the time of conversion and would also receive distributions to the extent distributions are received by Class A Units of the founders. Upon maturity of the notes, the holder may elect to convert the notes into the new class of equity securities as if a sale of the company had occurred on the maturity date. A default is defined as non-payment, default in a covenant of the note, bankruptcy or involuntary petition for bankruptcy against the Company.

In addition, repayment of the notes due to an event of default, as defined above and in the convertible promissory note agreement, requires an accelerated payment of three times the outstanding principal and accrued interest. These default payment provisions were determined to be a derivative instrument. A derivative liability and an associated discount to the convertible notes of $762 at the date of issuance, was recognized. On December 31, 2016 the Company revalued the fair value of this derivative liability which resulted in $10 gain on the derivative liability for the year ended December 31, 2016. The change in the fair value of the derivative liability for the six months ended June 30, 2017 was not significant and therefore no gain or loss was recognized for the six months ended June 30, 2017.

F-27

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

6 — CONVERTIBLE NOTES — RELATED PARTIES AND DERIVATIVE LIABILITIES (cont.)

The Company used the Monte-Carlo valuation model to determine the fair value of the derivative liability, using the following key assumptions for the year ended December 31, 2016 and six months ended June 30, 2017.

Underlying asset

 

Class A Unit

Class A Expected term (years)

 

5 years

Class A Volatility

 

90-92%

Risk free rate

 

1.67-2.45%

Event of default trigger

 

Starts at 0%, then rises 0.5% per year to a maximum of 5%

Probability of Company Sale

 

45% by 12/31/17 25% by 12/31/18 25% by 12/31/19

The following table sets forth a reconciliation of change in the fair value of financial liabilities, classified as Level 3 in the fair value hierarchy:

 

 

Derivative
Liability

Balance at December 31, 2015

 

$

 

Issuance of derivative liability – convertible notes payable

 

 

762

 

Change in fair value of derivative liability

 

 

(10

)

Balance at December 31, 2016

 

$

752

 

Change in fair value of derivative liability

 

 

 

Balance at June 30, 2017

 

$

752

 

7 — Fair Value of Financial Instruments and Fair Value Measurements

The Company’s financial instruments consists primarily of cash, receivables, accounts payable and accrued liabilities, debt instruments and derivative liabilities.

FASB Accounting Standards Codification (“ASC”) Topic 820, “Fair Value Measurements and Disclosures,” requires disclosure of the fair value of financial instruments held by the Company. ASC Topic 825, “Financial Instruments,” defines fair value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The carrying amounts reported in the balance sheets for receivables, current liabilities and convertible notes payable each qualify as financial instruments and are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments and their expected realization and their current market rate of interest.

The three levels of valuation hierarchy are defined as follows:

         Level 1: Observable inputs such as quoted prices in active markets;

         Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

         Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

As of June 30, 2017 and December 31, 2016, the significant inputs to the Company’s derivative liability recorded at fair value were considered level 3 inputs.

F-28

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

7 — Fair Value of Financial Instruments and Fair Value Measurements (cont.)

 

 

Fair value measurement using

 

 

Quoted prices
in
active markets
(Level 1)

 

Significant
other
observable
inputs
(Level 2)

 

Significant
unobservable
inputs
(Level 3)

 

Total

Balance at June 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

Derivative liability

 

$

 

$

 

$

752

 

$

752

 

 

 

Fair value measurement using

 

 

Quoted prices
in
active markets
(Level 1)

 

Significant
other
observable
inputs
(Level 2)

 

Significant
unobservable
inputs
(Level 3)

 

Total

Balance at December 31, 2016

 

 

 

 

 

 

 

 

 

 

 

 

Derivative liability

 

$

 

$

 

$

752

 

$

752

8 — RELATED PARTY TRANSACTIONS

In January 2011, the Company entered into an exclusive, worldwide license agreement with The University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group (the “UVA LVG”) for rights to make, use or sell licensed products in the United States based upon patents and patent applications made and held by UVA LVG (the “UVA LVG License”). The Company is required to pay compensation to the UVA LVG, as described Note 10. A certain percentage of these payments by the Company to the UVA LVG may then be distributed to the Chairman of the Board in his capacity as inventor of the patents by the UVA LVG in accordance with their policies at the time.

The Chairman of the Board will provide consulting services for the Company on an ongoing, open-ended basis in return for participation in the Company’s Performance Bonus Plan.

In September and December, 2016, the Company issued convertible notes, with a total outstanding unsecured principal amount of $235,000 to its members, including its Directors and Officers, refer to Note 6 — Convertible notes – related parties and derivative liabilities. Convertible notes payable, held by Directors and Officers of the Company, totaled $132,854 in principal at June 30, 2017 and December 31, 2016.

The Company issued 7,054,735 Class A units, 554,330 Class B units, 117,872 warrants to purchase Class A units, 554,330 warrants to purchase Class B units, and 1,494,725 PIU’s to its Directors and Officers, their direct relatives or related entities (see Note 9) as of June 30, 2017 and December 31, 2016.

9 — MEMBERS’ EQUITY

Classes of Membership Units

The Operating Agreement of the Company creates membership “units” that are designed to largely mimic shares in a C corporation with the class and characteristics of the units determining the voting rights and share of cash distributions to be received by holders of the units, all as defined in the Operating Agreement.

As of June 30, 2017 and December 31, 2016, the Company had two classes of units — Class A units and Class B units. The only difference between the two classes of units is the priority of distributions to the unit holders as further described under Distributions to Members described below. Under the Operating Agreement, the Company is authorized to issue either voting or non-voting units when issuing either Class A or Class B units. On June 28, 2017, the Company accepted a subscription for 18,868 Class B units at $1.06 per unit. At June 30, 2017 there were

F-29

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

9 — MEMBERS’ EQUITY (cont.)

14,100,394 Class A units outstanding and 1,889,337 Class B units outstanding. At December 31, 2016, there were 14,100,394 Class A units outstanding and 1,870,469 Class B units outstanding. These outstanding units are all voting units.

Distributions to Members

The Operating Agreement provides for the relative distribution priority for all the members, for any regular distributions made by the Company to its members, which will be made at the discretion of the Company’s board of directors, based first on the class of the units, then on the invested capital paid for the unit, and then on whether there is a reduction in distribution due to the unit being a PIU, with the priority for distributions being in the order shown below:

First, Class B units will receive an amount equal to their invested capital prior to distributions to Class A units.

Second, Class A units will receive an amount equal to their invested capital with investors receiving the same percentage of their invested capital across the class of units if there are not enough funds to return the full amount of the invested capital.

Third, once all investors have received their invested capital, then distributions will be made to units of any class that have received the smallest amount on a per unit basis until all units have received the same amount of distributions on a per unit basis.

In addition to regular distributions, to the extent the Company has the financial capacity, it will make distributions to its members for the payment of the personal income taxes of its members in which such distributions will be due to profits allocations from the Company. Such tax related distributions will not be subject to the distribution priorities described above.

For the purpose of determining distributions only, PIU’s are effectively deemed to have already received a distribution equal to the fair value of a Class A unit at the time of issuance of the PIU (the “Distribution Reduction”). For instance, if a PIU was issued with a Class A unit having a value of $1.00, then all Class A units will receive distributions of $1.00 before any distributions are made to the PIU, and once $1.00 has been distributed to all other Class A units, then the PIU will receive distributions pari passu to such Class A units thereafter.

Profits Interest Units (“PIU’s”)

The Operating Agreement authorized the issuance of PIU’s. PIU’s are identical to Class A units except that the amount of cash distributions to be received by the holder of a PIU will be reduced by Distribution Reduction. In practice this makes the amount of cash to be received by the holder of a PIU, effectively identical to the amount that would be received for an equity stock option holder in a C corporation that received the option with an exercise price equal to the value of the underlying equity at the time of issuance (i.e., priced “at the money”).

PIU’s awarded as incentives to personnel are usually subject to Company right of repurchase, at the nominal amount, in the event the awardee’s employment with the Company is terminated. The right of repurchase usually expires over time on a straight-line, monthly basis with the length of expiration of the right of repurchase being 6-48 months depending on the circumstances.

Equity Issuances/Repurchases

Upon formation of the Company on November 23, 2010, the Company issued 9,151,141 Class A units shares to the Company’s founding members for a total price of $92.

F-30

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

9 — MEMBERS’ EQUITY (cont.)

From 2011 through 2014, the Company issued and repurchased Class A Units and Class B Units and warrants to purchase units as follows:

         Issued 5,159,131 Class A units and warrants to purchase 723,916 Class A units for $0.001 per unit for total cash, net of financing cost $15,908, aggregating $6,392,110;

         Issued 1,870,469 Class B units and warrants to purchase 1,870,469 Class B units for $1.42 per unit for cash aggregating $2,656,042;

         Issued a certain warrant to a third party contract research organization (“CRO”) related to funding contract research work for clinical development of AD04 (the “CRO Contracts”). This warrant was later terminated in relation to termination of the CRO Contract;

         Issued 1,456,056 PIU’s for Company personnel incentives with a Distribution Reduction at time of issue of between $0.50 and $1.42 per unit;

         Repurchased 209,878 Class A units for cash aggregating $143,800 from members; and

         Repurchased 96,665 PIU’s due to personnel leaving employment with the Company.

In 2015, the Company issued and re-valued PIU’s and canceled a warrant as follows:

         Issued 722,600 PIU’s for Company personnel incentives with a Distribution Reduction at time of issue of $0.50 per unit, with fair value of $281,827; and

         Reduced the Distribution Reduction for 515,250 PIU’s to $0.50 for Company personnel incentives. Of these PIU’s 183,500 of the PIU’s previously had a Distribution Reduction of $1.05 per unit and 331,750 of the PIU’s previously had a Distribution Reduction of $1.42 per unit. The expense recorded due to the modification of the PIU’s was $65,795, $59,835 of which was recognized as an expense in 2015 and $5,961 of which was amortized over the remaining life of the corresponding PIU grants.

In 2016, the Company issued and repurchased PIU’s as follows:

         Issued 207,319 PIU’s for Company personnel incentives with a Distribution Reduction at time of issue of $0.50 per unit, with fair value of $90,698; and

         Repurchased 73,002 PIU’s for cash aggregating approximately $1 due to personnel leaving employment with the Company.

During the six months ended June 30, 2017, there were no PIU’s granted or repurchased.

The following table provides the activity in PIU’s for the three months ended June 30, 2017.

 

 

Total PIU Units
Outstanding

 

Weighted
Average
Distribution
Reduction

Outstanding December 31, 2016

 

2,216,308

 

$

0.66

Granted

 

 

 

 

Re-purchased

 

 

 

 

Outstanding June 30, 2017

 

2,216,308

 

$

0.66

At June 30, 2017 and December 31, 2016, the numbers of vested PIU’s were 2,193,803 and 2,044,993, respectively. Of these total vested PIU units, 446,806 were non-voting.

F-31

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

9 — MEMBERS’ EQUITY (cont.)

At June 30, 2017 and December 31, 2016, the intrinsic value totals of the outstanding PIU’s were $820,117 and $591,897 respectively.

Compensation expense was recognized using the straight line method over the requisite service period, which is the implied service period. During the six months ended June 30, 2017 and 2016, total equity-based compensation expense from the PIU’s issued was $60,818 and $79,189, respectively. The total future unrecognized compensation expense of $8,689 will be recognized in 2017.

The following is a summary of Warrants outstanding:

 

 

June 30,
2017

 

December 31,
2016

Issued to investors in 2011 to purchase non-voting Class A units for $0.001 per unit exercise price, expiring on December 31, 2021

 

723,916

 

723,916

 

 

 

 

 

Issued to investors in 2013 to purchase Class B units for $1.42 per unit exercise price, expiring on December 31, 2031

 

1,870,469

 

1,870,469

 

 

 

 

 

Total Warrants Outstanding

 

2,594,385

 

2,594,385

There were no warrants issued, exercised or expired for the six months ended June 30, 2017 and 2016.

10 — COMMITMENTS AND CONTINGENCIES

License with University of Virginia Patent Foundation

In January 2011, the Company entered into an exclusive, worldwide license agreement with (the “UVA LVG”) for rights to make, use or sell licensed products in the United States based upon the ten separate patents and patent applications made and held by UVA LVG.

As consideration for the rights granted in the UVA LVG License, the Company is obligated to pay UVA LVG yearly license fees and milestone payments, as well as a royalty based on net sales of products covered by the patent-related rights. More specifically, the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense ourselves. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income. The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if we breach our obligations thereunder, including failing to make any milestone, the most immediate being initiating Phase 3 clinical trials by December 31, 2018, making required payments or the failure to exercise diligence to bring licensed products to market. In the event of a termination, the Company will be obligated to pay all amounts that accrued prior to such termination.

The term of the license continues until the expiration, abandonment or invalidation of all licensed patents and patent applications, and following any such expiration, abandonment or invalidation will continue in perpetuity on a royalty-free, fully-paid basis.

F-32

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

10 — COMMITMENTS AND CONTINGENCIES (cont.)

Lease Commitments

On December 31, 2014, the Company signed a lease agreement for office at 414 East Water Street, Charlottesville, VA 22902. The lease requires monthly payments of $2,250 and terminated on January 31, 2017. As of the date of these statements, the lease had terminated and the full security deposit of $2,250 has been returned to the Company. Rent expense under this operating lease agreement was approximately $750 and $12,600 for the six months ended June 30, 2017 and 2016, respectively. The Company currently occupies approximately 300 square feet of office space in Charlottesville, Virginia that is provided at no cost by one of its members.

Performance Bonus Plan

On February 17, 2015, the Company adopted a Performance Bonus Plan (“PBP”) to provide incentive for Company personnel, which was then modified on January 25, 2016 and April 15, 2017. Under the PBP, 5.25% of the first $14.7 million of a strategic transaction (one or more transactions that provide funds to the Company and/or its members that enable the commencement of the clinical development of AD04) will be set aside for Company’s personnel with 1.25% of funds to be awarded to the Chairman of the Board and the remainder to be awarded at the CEO’s discretion, with no more than 3.15% payout to the CEO of the Company. The maximum bonus amount to be paid out of the PBP is $771,750. The Company has the right to pay up to 65% of the amounts due under the PBP with equity of the Company, valued at a future investors round equity price.

Consulting Agreements

On March 22, 2016, the Company entered into an agreement with a third party consultant to explore transactions with a specific set of international pharmaceutical companies. This consultant was paid $1,740 (1,500 euros) in cash as an engagement fee. Additionally, if a transaction is consummated with one of the listed companies before March 21, 2018, when this agreement expires, this consultant will receive the greater of $91,000 (payable — 85,000 Euros) or 4% of the consideration received by the Company under the transaction.

On April 25, 2016, the Company entered into a Consulting Agreement with a consultant, who now serves as Chief Operating Officer and Chief Financial Officer, at a compensation rate of $2,000 per month. This amount was raised to $2,200 per month on June 1, 2017. This consultant was granted 207,319 PIU’s in the Company and will be awarded 0.5% of a transaction, as defined by and under the terms of the Company’s PBP as stated in the above paragraph. The 0.5% of a transaction is equal to 9.5% of the Pool. For the six months ended June 30, 2017, total fees charged by this consultant were $12,200.

On October 27, 2016, the Company entered into a Consulting Agreement to provide implementation of the Company’s investor relations program through September 30, 2018. The consultant will receive equity, which will be in the form of restricted common stock at the completion of an offering of common stock securities (“Offering”), which would take place after the future reorganization of the Company into a corporation, in an amount equal to 4.8% of the common stock outstanding immediately prior to the Offering. Shares shall vest 50% upon issuance and 50% on December 31, 2017. If the Company does not conduct an Offering, no shares will be received by the consultant. In addition, immediately following an Offering, the Company shall issue the consultant 5-year warrants to purchase such number of shares of common equity of the Company equal to 4.9% of the then total fully diluted outstanding shares with an exercise price equal to the price of the shares issued in the Offering.

Employment Agreement

The Company has entered into an employment agreement with the Chief Executive Officer and Board Director (the “CEO”) effective December 6, 2010. The term of the agreement is 1 year and renews annually unless notice is provided 30 days prior to the renewal date. The annual base salary is $210,000 and the agreement provides for

F-33

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

10 — COMMITMENTS AND CONTINGENCIES (cont.)

one year of severance upon termination by the Company. On August 17, 2016, the employment agreement was modified and the CEO would receive $5,000 per month until the Company raises additional funds, as defined, at which time the salary is to increase back to the annual base salary of $210,000 on a prospective basis. Additionally, if a single member gains control of the Company, as defined, the Company may be liable for payment of the full salary on a retroactive basis.

Litigation

The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash flows. At June 30, 2017 and December 31, 2016, the Company did not have any pending legal actions.

CRO Option

As part of the termination of the CRO Contracts, the Company issued the CRO an option to invest $100,000 in the Company’s next financing of $3,000,000 on terms equal to those received by investors but at a 15% discount to the lowest price paid by such investors. In the event the Company is acquired prior to such a financing, the CRO also has the option to purchase 70,423 Class B units at a price of $1.42 per unit (i.e. $100,000 total purchase price). This option expires on March 14, 2021.

Other Agreements

During the six months ended June 30, 2017, the Company entered into consulting and service agreements with various personnel and third parties in exchange for cash and future equity interests, contingent on the Company completing its contemplated initial public offering.

11 — SUBSEQUENT EVENTS

Adoption of Board Compensation Plan & Director Option Grant

Effective July 1, 2017, the board of directors approved a plan for the annual compensation of Directors, to commence on the completion of an initial public offing, as follows:

 

 

Board

 

Audit
Committee

 

Compensation
Committee

 

Nominating &
Governance
Committee

Chair

 

$

23,750

 

$

15,000

 

$

10,000

 

$

7,000

Member

 

$

20,000

 

$

6,000

 

$

5,000

 

$

3,000

Additionally, effective July 1, 2017, the board of director granted each of the then serving nine Directors 30,000 options for the purchase of Class A units at a price of $1.06 per unit with vesting of the options over three years and with a term of ten years, the first 1/6th vesting only after 6 months (“the Cliff”), then 1/36th vesting each month for the remaining 30 months. Two of these Directors no longer serve on the board of directors, and the entirety of their option grants were forfeited.

Appointment of New Director with Approval of Additional Compensation

Effective July 1, 2017, the board of directors appointed an additional Director. In addition to receipt of the Director compensation described above, this Director was granted and additional 30,000 options on the same terms, and the entirety of his grant of 60,000 options was exempted from the Cliff.

F-34

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

11 — SUBSEQUENT EVENTS (cont.)

Acceptance of Unit Subscription from Director

Simultaneous with his appointment on July 1, 2017, the Company accepted a subscription from the new Director for purchase of 9,434 Class B units at $1.06 per unit, $10,000 in total, payable in cash.

Adoption of Compensation Plan for Officers & Execution of Employment Agreements

Effective July 1, 2017, the board of directors approved a plan for the annual compensation of Officers, to commence on the completion of an initial public offing, as follows:

 

 

Annual
Salary

 

Target Annual
Bonus2

 

One-time
Option Award

CEO

 

$

350,000

 

30

%

 

279,000

3

COO/CFO1

 

$

143,000

 

20

%

 

162,000

3

CDO

 

$

260,000

 

20

%

 

186,000

4

____________

1        Annual salary is for 50% of full time, on a full-time equivalent basis of $286,000 annually.

2        As a percentage of Annual Salary. The target annual bonus will be awarded for meeting performance goals set by the board of directors, with the potential for an additional award not to exceed a third of the target annual bonus for exemplary performance awarded at the discretion of the board of directors.

3        Options issued July 1, 2017. Options are to purchase Class A units at a price of $1.06 per unit, the options vesting over three years and with a term of ten years, the first 1/6th vesting only after 6 months, then 1/36th vesting each month for the remaining 30 months.

4        186,000 Options issued July 25, 2017. Options are to purchase Class A units at a price of $1.06 per unit and have a term of ten years. These options vest over three years, the first 1/6th vesting only after 6 months, then 1/36th vesting each month for the remaining 30 months.

On July 25, 2017, these terms were memorialized in employment agreements concluded by the Company and the executives referred to above for terms of five, three, and three years, respectively, with customary terms of severance.

Furthermore, the Company intends, on the completion of the initial public offering, to adopt the Adial Pharmaceuticals, Inc. 2017 Equity Incentive Plan (the “2017 equity incentive plan”). Initially, the aggregate number of shares of our common stock that may be issued pursuant to stock awards under the 2017 equity incentive plan is 1,750,000 shares. The executives referred to above would be eligible to participate in that plan, once adopted.

Receipt of Investment Receivable & Additional Pre-Paid Investment

Payment of $20,000 cash for the subscription for 18,868 Class B units accepted on June 28, 2017 was received on July 18, 2017, simultaneous with a pre-paid investment of $10,000 toward purchase of an additional 9,434 Class B units on substantially the same terms as the previously accepted investment. The pre-paid subscription for the additional 9,434 Class B units was accepted by the Company August 1, 2017.

Amendment of Goldman Agreement & Option Grant

The services agreement with Goldman Accounting Services CPA, PLLC dated January 25, 2017 was amended August 1, 2017, changing the title used by Larry Goldman in his service role from VP, Finance to Controller and granting Larry Goldman 40,000 options for the purchase of Class A units at a price of $1.06 per unit with vesting of the options over three years and with a term of ten years, the first 1/6th vesting only after 6 months (“the Cliff”), then 1/36th vesting each month for the remaining 30 months. The terms of the option grant were confirmed in a separately concluded option agreement, also dated August 1, 2017.

F-35

ADIAL PHARMACEUTICALS, LLC

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

11 — SUBSEQUENT EVENTS (cont.)

Fourth Amendment to UVALVG License Agreement

The Company executed an amendment, dated August 15, 2017, to the license agreement with the University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group dated January 21, 2011 (see Note 10). This fourth amendment changed the dates by which the Company, using commercially reasonable efforts, was to achieve the goals of submitting a New Drug Application to the FDA for a licensed product to December 31, 2023 (from December 31, 2021) and commencing commercialization of an FDA approved product by December 31, 2024 (from December 31, 2022). If the company were to fail to use commercially reasonable effort and fail to meet either goal, the licensor would have the right to terminate the license.

Lease of Office Space

On August 16, 2017, the Company entered into a sublease with Inspyr Therapeutics, Inc. for two furnished offices located at 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901. Pursuant to the sublease, the Company has agreed to pay rent in the amount of $300 per month while it is a private company with the rent increasing to $1,300 per month beginning on the first day of the month after it is a public company. Either party may terminate the sublease upon written notice to the other party specifying the date of termination as long as such date of termination is not earlier than the last day of the month following the month in which such notice is given.

Consultant Option Grant

On September 1, 2017, we granted a consultant an option to purchase 30,000 Class A Units at an exercise price of $1.06 per unit, with the option vesting over three years, the first 1/6th vesting four months after the grant date, then 1/36th vesting each month for the remaining 30 months. The option has a term of ten years.

F-36

         Shares

Common Stock

________________________

PROSPECTUS

_________________________

Aegis Capital Corp

Through and including       , 2017 (25 days after commencement of this offering), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

 

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth all expenses to be paid by the registrant, other than estimated underwriting discounts and commissions, in connection with our public offering. All amounts shown are estimates except for the SEC registration fee, the FINRA filing fee and the NASDAQ listing fee:

SEC registration fee

 

$

1,947

FINRA filing fee

 

 

2,915

Nasdaq Listing fee

 

 

50,000

Legal fees and expenses

 

 

350,000

Accounting fees and expenses

 

 

100,000

Transfer agent and registrar’s fees and expenses

 

 

10,000

Printing and engraving expenses

 

 

6,000

Non-Accountable Expense Allowance

 

 

140,000

Miscellaneous expenses

 

 

79,138

Total

 

$

740,000

Item 14. Indemnification of Directors and Officers.

The Registrant is incorporated under the laws of the State of Delaware. Section 145 of the Delaware General Corporation Law provides that a Delaware corporation may indemnify any persons who were, are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person is or was an officer, director, employee or agent of such corporation, or is or was serving at the request of such corporation as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who were, are, or are threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person is or was a director, officer, employee or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’\ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit provided such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the expenses (including attorneys’ fees) actually and reasonably incurred.

The Registrant’s certificate of incorporation and amended and restated bylaws, each of which will become effective immediately prior to the closing of this offering, provide for the indemnification of its directors and officers to the fullest extent permitted under the Delaware General Corporation Law.

Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability for any:

         transaction from which the director derives an improper personal benefit;

         act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

         unlawful payment of dividends or redemption of shares; or

         breach of a director’s duty of loyalty to the corporation or its stockholders.

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The Registrant’s certificate of incorporation includes such a provision. Expenses incurred by any officer or director in defending any such action, suit or proceeding in advance of its final disposition shall be paid by the Registrant upon delivery to it of an undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified by the Registrant.

Section 174 of the Delaware General Corporation Law provides, among other things, that a director who willfully or negligently approves of an unlawful payment of dividends or an unlawful stock purchase or redemption, may be held liable for such actions. A director who was either absent when the unlawful actions were approved or dissented at the time may avoid liability by causing his or her dissent to such actions to be entered in the books containing minutes of the meetings of the board of directors at the time such action occurred or immediately after such absent director receives notice of the unlawful acts.

As permitted by the Delaware General Corporation Law, the Registrant has entered into indemnity agreements with each of its directors and executive officers, that require the Registrant to indemnify such persons against any and all costs and expenses (including attorneys’, witness or other professional fees) actually and reasonably incurred by such persons in connection with any action, suit or proceeding (including derivative actions), whether actual or threatened, to which any such person may be made a party by reason of the fact that such person is or was a director or officer or is or was acting or serving as an officer, director, employee or agent of the Registrant or any of its affiliated enterprises. Under these agreements, the Registrant is not required to provide indemnification for certain matters, including:

         indemnification beyond that permitted by the Delaware General Corporation Law;

         indemnification for any proceeding with respect to the unlawful payment of remuneration to the director or officer;

         indemnification for certain proceedings involving a final judgment that the director or officer is required to disgorge profits from the purchase or sale of the Registrant’s stock;

         indemnification for proceedings involving a final judgment that the director’s or officer’s conduct was in bad faith, knowingly fraudulent or deliberately dishonest or constituted willful misconduct or a breach of his or her duty of loyalty, but only to the extent of such specific determination;

         indemnification for proceedings or claims brought by an officer or director against us or any of the Registrant’s directors, officers, employees or agents, except for claims to establish a right of indemnification or proceedings or claims approved by the Registrant’s board of directors or required by law;

         indemnification for settlements the director or officer enters into without the Registrant’s consent; or

         indemnification in violation of any undertaking required by the Securities Act or in any registration statement filed by the Registrant.

The indemnification agreements also set forth certain procedures that will apply in the event of a claim for indemnification thereunder.

Except as otherwise disclosed under the heading “Legal Proceedings” in the “Business” section of this registration statement, there is at present no pending litigation or proceeding involving any of the Registrant’s directors or executive officers as to which indemnification is required or permitted, and the Registrant is not aware of any threatened litigation or proceeding that may result in a claim for indemnification.

The Registrant has an insurance policy in place that covers its officers and directors with respect to certain liabilities, including liabilities arising under the Securities Act or otherwise.

The Registrant plans to enter into an underwriting agreement which provides that the underwriters are obligated, under some circumstances, to indemnify the Registrant’s directors, officers and controlling persons against specified liabilities, including liabilities under the Securities Act.

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Item 15. Recent Sales of Unregistered Securities.

During the last three years, we have issued unregistered securities to the persons described below. None of these transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe that each transaction was exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering. The recipients both had access, through their relationship with us, to information about us.

During the year ended December 31, 2014, we issued 446,806 nonvoting profits interest units to our personnel as compensation for services. The profits interest units had an exercise price of $0.50 per unit.

During the year ended December 31, 2015, we issued 722,600 profits interest units to our personnel as compensation for services. The profits interest units had an exercise price of $0.50 per unit.

During the year ended December 31, 2015, we issued an option to a service provider to invest in our next financing of $3,000,000 or more at a purchase price equal to a 15% discount to the lowest price paid by the investors in the financing.

During the year ended December 31, 2016, we issued 207,319 profits interest units to our personnel as compensation for services. The profits interest units had an exercise price of $0.50 per unit.

In September and December 2016, we issued convertible notes in the aggregate principal amount of $235,000 to 34 investors that were members, some of whom were officers and directors.

In the first quarter of 2017, we agreed to issue certain personnel and third parties upon consummation of this offering, shares of common stock having a value equal to $2,129,790.

In May 2017, we issued to one lender in consideration of our receipt of $250,000, a senior secured note in the principal amount of $287,500 together with a warrant with a cashless exercise feature exercisable to purchase shares of common stock equal to $287,500 divided by the initial offering price of our common stock in our initial public offering at an exercise price of equal to the price of common stock sold in our next financing of $250,000 or more. In addition, we agreed to issue upon consummation of this offering such number of shares of common stock having a value equal to $29,000 based upon the initial public offering price.

On June 29, 2017, we issued 18,868 Class B Units to one (1) investor in consideration of the investor’s investment of $20,000.

On July 1, 2017, we issued Tony Goodman an option to purchase 60,000 Class A Units at an exercise price of $1.06 per Unit in consideration of his services as a director. Simultaneous with his appointment as a director on July 1, 2017, Mr. Goodman purchased from us 9,434 Class B Units for an aggregate of $10,000 (or $1.06 per unit).

On July 1, 2017, we issued to nine (9) directors an option for each director to purchase 30,000 Class A Units (for an aggregate of 270,000 Class A Units) at an exercise price of $1.06 per unit, with the options vesting over three years, the first 1/6th vesting 6 months after the grant date, then 1/36th vesting each month for the remaining 30 months. The options have a term of ten years.

On July 1, 2017, we granted to each of Mr. Stilley and Mr. Truluck an option to purchase 279,000 and 162,000 Class A Units, respectively, at an exercise price of $1.06 per unit, vesting as to 1/6th of the Class A Units on the six month anniversary of the date of the grant and the remaining Class A Units vesting as to 1/36th of the Class A Units over the remaining 30 months. The options have a term of ten years.

On July 26, 2017, we granted to each of Dr. Zastawny an option to purchase 186,000 Class A Units at an exercise price of $1.06 per unit, with these options vesting over three years, the first 1/6th vesting after 6 months, then 1/36th vesting each month for the remaining 30 months. The options have a term of ten years.

II-3

On August 1, 2017, we granted Larry Goldman options to purchase 40,000 Class A units at an exercise price of $1.06 per Unit in consideration of his services to the Company. The options vest over three years, the first 1/6th vest after 6 months, then 1/36th vest each month for the remaining 30 months. The options have a term of ten years.

On August 1, 2017, we issued 18,868 Class B Units to one investor in consideration for his investment of $20,000 (or $1.06 per unit).

On September 1, 2017, we granted a consultant an option to purchase 30,000 Class A Units at an exercise price of $1.06 per unit, with the option vesting over three years, the first 1/6th vesting four months after the grant date, then 1/36th vesting each month for the remaining 30 months. The option has a term of ten years.

Prior to the effectiveness of the registration statement, we will convert from a Virginia limited liability company into a Virginia corporation and thereafter reincorporate in Delaware by merging with Adial Pharmaceuticals, Inc., a wholly owned subsidiary of ADial Pharmaceuticals, L.L.C. (We refer to this as the corporate conversion/reincorporation.) At the time of the corporate conversion/reincorporation, all of the outstanding Class A and Class B Units and Profit Interest Units of ADial Pharmaceuticals, L.L.C will be automatically converted into an aggregate of 3,268,005 shares of our common stock. The issuance of common stock to our members in the corporate conversion/reincorporation will be exempt from registration under the Securities Act by virtue of the exemption provided under Section 3(a)(9) thereof as the common stock will be exchanged by us with our existing security holders exclusively and no commission or other remuneration will be paid or given directly or indirectly for soliciting such exchange. The issuance of common stock by Adial Pharmaceuticals, Inc will also be exempt from registration under the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

Item 16. Exhibits and Financial Statement Schedules.

The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this registration statement.

Item 17. Undertakings.

(a)      The undersigned registrant hereby undertakes:

(1)      To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(i)       To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

(ii)      To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) (§230.424(b) of this Chapter) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.

(iii)     To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

(2)      That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-4

(3)      To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4)      That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(i)       Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424 (§230.424 of this chapter);

(ii)      Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

(iii)     The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

(iv)     Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

(f)      The undersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreements certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

(h)      Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer, or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

(i)       The undersigned Registrant hereby undertakes that:

(1)      For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

(2)      For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-5

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Charlottesville, State of Virginia, on the 6th of September, 2017.

 

 

ADIAL PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

By:

 

/s/ William B. Stilley

 

 

Name:

 

William B. Stilley

 

 

Title:

 

President and Chief Executive Officer

POWER OF ATTORNEY

KNOW ALL BY THESE PRESENT, that each person whose signature appears below constitutes and appoints William B. Stilley and Joseph Truluck, and each of them, as his or her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or her and in his or her name, place or stead, in any and all capacities, to sign any and all amendments to this registration statement (including post-effective amendments), and to sign any registration statement for the same offering covered by this registration statement that is to be effective upon filing pursuant to Rule 462(b) promulgated under the Securities Act, and all post-effective amendments thereto, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

Signature

 

Title

 

Date

/s/ William B. Stilley

 

Chief Executive Officer and President

 

 

William B. Stilley

 

(Principal Executive Officer)

 

September 6, 2017

 

 

 

 

 

/s/ Joseph M. Truluck

 

Chief Operating Officer and Chief Financial Officer

 

 

Joseph M. Truluck

 

(Principal Financial and Accounting Officer)

 

September 6, 2017

 

 

 

 

 

/s/ J. Kermit Anderson

 

 

 

 

J. Kermit Anderson

 

Member of the Board of Directors

 

September 6, 2017

 

 

 

 

 

/s/ Robertson H. Gilliland

 

 

 

 

Robertson H. Gilliland

 

Member of the Board of Directors

 

September 6, 2017

 

 

 

 

 

/s/ Tony Goodman

 

 

 

 

Tony Goodman

 

Member of the Board of Directors

 

September 6, 2017

 

 

 

 

 

/s/ Bankole A. Johnson

 

 

 

 

Bankole A. Johnson

 

Member of the Board of Directors

 

September 6, 2017

 

 

 

 

 

/s/ James W. Newman, Jr.

 

 

 

 

James W. Newman, Jr

 

Member of the Board of Directors

 

September 6, 2017

 

 

 

 

 

/s/ Kevin Schuyler, CFA

 

 

 

 

Kevin Schuyler, CFA

 

Member of the Board of Directors

 

September 6, 2017

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EXHIBIT INDEX

Exhibit Number

 

Description of Exhibit

1.1

 

Form of Underwriting Agreement

3.1

 

Articles of Organization of ADial Pharmaceuticals L.L.C.

3.2

 

Second Amended and Restated Operating Agreement of ADial Pharmaceuticals, L.L.C., dated as of February 3, 2014

3.3

 

Form of Certificate of Incorporation of Adial Pharmaceuticals, Inc.

3.4

 

Form of Bylaws of Adial Pharmaceuticals, Inc.

3.5

 

Form of Articles of Incorporation of APL Conversion Corp., a Virginia Stock Corporation

3.6

 

Form of Bylaws of APL Conversion Corp.

3.7

 

Form of Entity Conversion to be filed with the Virginia Secretary of State

3.8

 

Form of Terms and Conditions of the Plan of Entity Conversion

3.9

 

Form of Certificate of Merger to be Filed with the Delaware Secretary of State

3.10

 

Form of Articles of Merger to be filed with the Virginia Secretary of State

3.11

 

Form of Agreement and Plan of Reorganization

4.1*

 

Specimen Common Stock Certificate

4.2

 

Form of Representative’s Warrant Agreement

4.3

 

Form of Warrant to Purchase Membership Units (2011 Offering)

4.4

 

Form of Warrant to Purchase Membership Units (2013 Offering)

4.5

 

Form of Common Stock Purchase Warrant by and between ADial Pharmaceuticals, LLC and FirstFire Global Opportunities Fund, LLC

4.6

 

Form of 2016 Convertible Promissory Note (2016 Offering)

4.7

 

Senior Secured Promissory Note dated as of May 1, 2017 by and between ADial Pharmaceuticals, LLC and FirstFire Global Opportunities Fund, LLC

4.8

 

Form of Membership Unit Award (Profits Interest) Agreement

4.9+

 

Option Agreement between ADial Pharmaceuticals, LLC and Tony Goodman, effective July 1, 2017

4.10+

 

Performance Bonus Plan dated April 15, 2017

4.11+

 

Form of Adial Pharmaceuticals, Inc. 2017 Equity Incentive Plan

4.12+

 

Form of Stock Option Grant Notice, Option Agreement (Incentive Stock Option or Nonstatutory Stock Option) and Notice of Exercise under the 2017 Equity Incentive Plan

4.13+

 

Form of ADial Pharmaceuticals, LLC Option Agreement

5.1*

 

Opinion of Gracin & Marlow, LLP

10.1

 

License Agreement between the University of Virginia Patent Foundation and ADial Pharmaceuticals, L.L.C. effective January 21, 2011

10.2

 

Amendment #1 to License Agreement between University of Virginia Patent Foundation and ADial Pharmaceuticals, LLC effective October 21, 2013

10.3

 

Amendment #2 to License Agreement between University of Virginia Patent Foundation and ADial Pharmaceuticals, LLC effective May 18, 2016

10.4

 

Amendment #3 to License Agreement between University of Virginia Patent Foundation and ADial Pharmaceuticals, LLC effective March 27, 2017

10.5+

 

Executive Employment Agreement with William B. Stilley, III dated December 6, 2010

10.6+

 

Salary Forbearance Agreement with William B. Stilley, III dated August 17, 2016

10.7+

 

Consulting Agreement with Joseph Truluck dated April 25, 2016

10.8

 

Termination Agreement with Cato Holding Company dated March 14, 2016

10.9

 

Securities Purchase Agreement dated as of May 1, 2017 by and between ADial Pharmaceuticals, LLC and FirstFire Global Opportunities Fund, LLC

10.10

 

Security Agreement dated May 1, 2017 by and between ADial Pharmaceuticals, LLC and FirstFire Global Opportunities Fund, LLC

10.11

 

Settlement Agreement and Release of Claims entered into as of January 25, 2016 by and between Bankole Johnson and ADial Pharmaceuticals, LLC

10.12

 

Promissory Note issued to ADial Pharmaceuticals, L.L.C. by Bankole A. Johnson in the principal amount of $35,000, dated November 24, 2016

II-7

Exhibit Number

 

Description of Exhibit

10.13+

 

Form of Subscription Agreement to the Offering of Class B Units

10.14+

 

Consulting Agreement between ADial Pharmaceuticals, LLC and Crescendo Communications, LLC Agreed to and approved June 30, 2017

10.15+

 

Form of Employment Agreement to be entered into with William B. Stilley, III

10.16+

 

Form of Employment Agreement to be entered into with Joseph A. M. Truluck

10.17+

 

Form of Employment Agreement to be entered into with Tomasz H. Zastawny, Ph.D.

10.18

 

Form of Indemnification Agreement

10.19

 

Sublease Agreement with Inspyr Therapeutics, Inc. dated August 16, 2017

10.20

 

Amendment #4 to License Agreement between University of Virginia Patent Foundation and ADial Pharmaceuticals, LLC effective August 15, 2017

23.1

 

Consent of Friedman LLP

23.2*

 

Consent of Gracin & Marlow, LLP (See Exhibit 5.1 above)

23.3

 

Consent of Ipsos-Insight, LLC

24.1

 

Power of Attorney (Included in the signature page of this Registration Statement)

____________

*        To be filed by amendment.

+        Indicates management contract or compensatory plan.

II-8

EX-1.1 2 fs12017ex1-1_adailpharma.htm FORM OF UNDERWRITING AGREEMENT

Exhibit 1.1

 

UNDERWRITING AGREEMENT

 

between

  

ADIAL PHARMACEUTICALS, INC.,

 

and

  

AEGIS CAPITAL CORP.,

  

as Representative of the Several Underwriters

 

 

 

 

ADIAL PHARMACEUTICALS, INC.

 

UNDERWRITING AGREEMENT

 

New York, New York

[●], 2017

 

Aegis Capital Corp.

As Representative of the several Underwriters named on Schedule 1 attached hereto

810 Seventh Avenue, 18th Floor

New York, New York 10019

 

Ladies and Gentlemen:

 

The undersigned, Adial Pharmaceuticals, Inc., a corporation formed under the laws of the State of Delaware (the “Company” and, together with Adial Pharmaceuticals, L.L.C., a Virginia limited liability company, and APL Conversion Corp., a Virginia corporation, the “Company Parties”), hereby confirms its agreement (this “Agreement”) with Aegis Capital Corp. (hereinafter referred to as “you” (including its correlatives) or the “Representative”) and with the other underwriters named on Schedule 1 hereto for which the Representative is acting as representative (the Representative and such other underwriters being collectively called the “Underwriters” or, individually, an “Underwriter”) as follows:

 

1.      Purchase and Sale of Shares.

 

1.1       Firm Shares.

 

1.1.1        Nature and Purchase of Firm Shares

 

(i)        On the basis of the representations and warranties herein contained, but subject to the terms and conditions herein set forth, the Company agrees to issue and sell to the several Underwriters, an aggregate of [●] shares (the “Firm Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”).

 

(ii)       The Underwriters, severally and not jointly, agree to purchase from the Company the number of Firm Shares set forth opposite their respective names on Schedule 1 attached hereto and made a part hereof at a purchase price of $[●] per Firm Share [●]% of the per Firm Share offering price). The Firm Shares are to be offered initially to the public at the offering price set forth on the cover page of the Prospectus (as defined in Section 2.1.1 hereof).

 

1.1.2        Firm Shares Payment and Delivery.

 

(i)       Delivery and payment for the Firm Shares shall be made at 10:00 a.m., Eastern time, on the third (3rd) Business Day following the effective date (the “Effective Date”) of the Registration Statement (as defined in Section 2.1.1 below) (or the fourth (4th) Business Day following the Effective Date if the Registration Statement is declared effective after 4:01 p.m., Eastern time) or at such earlier time as shall be agreed upon by the Representative and the Company, at the offices of Blank Rome LLP, 405 Lexington Avenue, New York, NY 10174 (“Representative’s Counsel”), or at such other place (or remotely by facsimile or other electronic transmission) as shall be agreed upon by the Representative and the Company. The hour and date of delivery of and payment for the Firm Shares is called the “Closing Date.”

 

(ii)       Payment for the Firm Shares shall be made on the Closing Date by wire transfer in federal (same day) funds, payable to the order of the Company upon delivery of the certificates (in form and substance satisfactory to the Underwriters) representing the Firm Shares (or through the facilities of the Depository Trust Company (“DTC”)) for the respective accounts of the Underwriters. The Firm Shares shall be registered in such name or names and in such authorized denominations as the Representative may request in writing at least two (2) full Business Days prior to the Closing Date. The Company shall not be obligated to sell or deliver the Firm Shares except upon tender of payment by the Representative for all of the Firm Shares. The term “Business Day” means any day other than a Saturday, a Sunday or a legal holiday or a day on which banking institutions are authorized or obligated by law to close in New York, New York.

 

 -1- 

 

 

1.2       Over-allotment Option.

 

1.2.1        Additional Shares. The Company hereby grants to the Underwriters an option (the “Over-allotment Option”) to purchase up to an additional [●] shares of Common Stock, representing up to 15% of the Firm Shares sold in the Offering (the “Additional Shares”), for the purpose of covering over-allotment of such securities, if any. The purchase price to be paid per Additional Share shall be equal to the price per Firm Share set forth in Section 1.1.1 hereof. The Firm Shares and the Additional Shares are hereinafter referred to together as the “Public Securities.” The offering and sale of the Public Securities is herein referred to as the “Offering”.

 

1.2.2        Exercise of Option. The Over-allotment Option granted pursuant to Section 1.2.1 hereof may be exercised by the Representative as to all (at any time) or any part (from time to time) of the Additional Shares within 45 days after the Effective Date. The Underwriters shall not be under any obligation to purchase any Additional Shares prior to the exercise of the Over-allotment Option. The Over-allotment Option granted hereby may be exercised by the giving of oral notice to the Company from the Representative, which shall be confirmed in writing by overnight mail or facsimile or other electronic transmission, setting forth the number of Additional Shares to be purchased and the date and time for delivery of and payment for the Additional Shares (the “Option Closing Date”), which shall not be later than five (5) full Business Days after the date of the notice or such other time as shall be agreed upon by the Company and the Representative, at the offices of Representative’s Counsel or at such other place (including remotely by facsimile or other electronic transmission) as shall be agreed upon by the Company and the Representative. If such delivery and payment for the Additional Shares does not occur on the Closing Date, the Option Closing Date will be as set forth in the notice. Upon exercise of the Over-allotment Option with respect to all or any portion of the Additional Shares, subject to the terms and conditions set forth herein, (i) the Company shall become obligated to sell to the Underwriters the number of Additional Shares specified in such notice and (ii) each of the Underwriters, acting severally and not jointly, shall purchase that portion of the total number of Additional Shares then being purchased that the number of Firm Shares as set forth in Schedule 1 opposite the name of such Underwriter bears to the total number of Firm Shares, subject, in each case, to such adjustments as the Representative, in its sole discretion, shall determine.

 

1.2.3        Payment and Delivery. Payment for the Additional Shares shall be made on the Option Closing Date by wire transfer in federal (same day) funds, payable to the order of the Company upon delivery to you of certificates (in form and substance satisfactory to the Underwriters) representing the Additional Shares (or through the facilities of DTC for the account of the Underwriters). The Additional Shares shall be registered in such name or names and in such authorized denominations as the Representative may request in writing at least two (2) full Business Days prior to the Option Closing Date. The Company shall not be obligated to sell or deliver the Additional Shares except upon tender of payment by the Representative for applicable Additional Shares. The Option Closing Date may be simultaneous with, but not earlier than, the Closing Date; and in the event that such time and date are simultaneous with the Closing Date, the term “Closing Date” shall refer to the time and date of delivery of the Firm Shares and Additional Shares.

 

1.3       Representative’s Warrants.

 

1.3.1        Purchase Warrants. The Company hereby agrees to issue and sell to the Representative (and/or its designees) on the Closing Date an option (“Representative’s Warrant”) for the purchase of an aggregate of [●] shares of Common Stock (which is equal to an aggregate of 4% of the Firm Shares sold in the Offering), for an aggregate purchase price of $100.00. The Representative’s Warrant agreement, in the form attached hereto as Exhibit A (the “Representative’s Warrant Agreement”), shall be exercisable, in whole or in part, commencing on a date which is one (1) year after the Effective Date and expiring on the five-year anniversary of the Effective Date at an initial exercise price per share of Common Stock of $[●], which is equal to 125% of the public offering price of each Firm Share. The Representative’s Warrant Agreement and the shares of Common Stock issuable upon exercise thereof are sometimes hereinafter referred to together as the “Representative’s Securities.” The Representative understands and agrees that there are significant restrictions pursuant to FINRA Rule 5110 against transferring the Representative’s Warrant and the underlying shares of Common Stock during the one hundred eighty (180) days after the Effective Date and by its acceptance thereof shall agree that it will not sell, transfer, assign, pledge or hypothecate the Representative’s Warrant Agreement, or any portion thereof, or be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of such securities for a period of one hundred eighty (180) days following the Effective Date to anyone other than (i) an Underwriter or a selected dealer in connection with the Offering, or (ii) a bona fide officer or partner of the Representative or of any such Underwriter or selected dealer; and only if any such transferee agrees to the foregoing lock-up restrictions.

 

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1.3.2        Delivery. Delivery of the Representative’s Warrant Agreement shall be made on the Closing Date and shall be issued in the name or names and in such authorized denominations as the Representative may request.

 

2.       Representations and Warranties of the Company. The Company, represents and warrants to the Underwriters as of the Applicable Time (as defined below), as of the Closing Date and as of the Option Closing Date, if any, as follows:

 

2.1       Filing of Registration Statement.

 

2.1.1        Pursuant to the Securities Act.

 

(i)        The Company has prepared and filed with the Securities and Exchange Commission (the “Commission”) a registration statement, including the related preliminary prospectus or prospectuses, relating to the Public Securities under the Securities Act of 1933, as amended (the “Securities Act”), on Form S-1 (No. 333-[●]) (the “Initial Registration Statement”); and such Initial Registration Statement, and any post-effective amendment thereto, each in the form previously delivered to you, have been declared effective by the Commission, in such form. Other than a registration statement, if any, increasing the size of the Offering (a “Rule 462(b) Registration Statement”) filed pursuant to Rule 462(b) under the Securities Act, which will become effective upon filing, no other document with respect to the Initial Registration Statement has heretofore been filed with the Commission. The various parts of the Initial Registration Statement and the 462(b) Registration Statement, if any, including all exhibits thereto and including the information contained in the form of final prospectus filed with the Commission pursuant to Rule 424(b) under the Securities Act and deemed by virtue of Rule 430A under the Securities Act to be part of the Initial Registration Statement at the time it became effective under the Securities Act, each as amended at the time such part of the Initial Registration Statement or Rule 462(b) Registration Statement, if any, became or hereafter becomes effective under the Securities Act, are hereafter collectively referred to as the “Registration Statement.”

 

All references in this agreement (this “Agreement”) to the Registration Statement, the Rule 462(b) Registration Statement, any Preliminary Prospectus, Issuer Free Writing Prospectus or the Prospectus, or any amendments or supplements to any of the foregoing, shall be deemed to include any copy thereof filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval System (“EDGAR”). For purposes of this Agreement, “Applicable Time” is [●][●].m. (New York City time) on the date of this Agreement.

 

(ii)       The prospectus relating to the Public Securities and the Representative’s Securities, in the form first filed with the Commission pursuant to Rule 424(b) under the Securities Act, is hereafter referred to as the “Prospectus.” Any preliminary prospectus included in the Initial Registration Statement or filed with the Commission pursuant to Rule 424 under the Securities Act is hereafter referred to as a “Preliminary Prospectus”; and the Preliminary Prospectus relating to the Public Securities, if any, as amended or supplemented immediately prior to the Applicable Time, is hereafter referred to as the “Pricing Prospectus.” Any “issuer free writing prospectus” (as defined in Rule 433 under the Securities Act) relating to the Public Securities is hereafter referred to as an “Issuer Free Writing Prospectus”; and the Pricing Prospectus, as supplemented by the Issuer Free Writing Prospectuses, if any, listed in Schedule 2-B hereto, and the information included on Schedule 2A hereto, taken together, are hereafter referred to collectively as the “Pricing Disclosure Package.” As used herein “Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act and “Written Testing-the-Waters Communication” means any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Securities Act.

 

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(iii)      At the time of filing the Registration Statement and any post-effective amendment thereto, at the earliest time thereafter that the Company or another offering participant made a bona fide offer (within the meaning of Rule 164(h)(2) of the Securities Act) of the Public Securities and at the date hereof, the Company was not and is not an “ineligible issuer,” as defined in Rule 405.

 

(iv)      Each Issuer Free Writing Prospectus conformed or will conform in all material respects to the requirements of the Securities Act and the regulations promulgated thereunder on the date of first use, and the Company has complied with the requirements of Rule 433 under the Securities Act with respect to each Issuer Free Writing Prospectus including, without limitation, all prospectus delivery, filing, record retention and legending requirements applicable to any such Issuer Free Writing Prospectus. The Company has not (i) distributed any offering material in connection with the Offering other than any Preliminary Prospectus, the Prospectus, and any Issuer Free Writing Prospectus set forth on Schedule II hereto, or (ii) filed, referred to, approved, used or authorized the use of any “free writing prospectus” as defined in Rule 405 under the Securities Act with respect to the Offering or the Public Securities, except for any Issuer Free Writing Prospectus set forth in Schedule 2-B hereto and any electronic road show previously approved by the Representative. The Company has retained in accordance with the Securities Act and the rules and regulations promulgated thereunder all Issuer Free Writing Prospectuses that were not required to be filed pursuant to the Securities Act and the rules and regulations promulgated thereunder. The Company has taken all actions necessary so that any “road show” (as defined in Rule 433 under the Securities Act) in connection with the offering of the Stock will not be required to be filed pursuant to the Securities Act and the rules and regulations thereunder.

 

2.1.2        Pursuant to the Exchange Act. The Company has filed with the Commission a Form 8-A (Accession No. 001-[●]) providing for the registration pursuant to Section 12(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of the shares of Common Stock; and such Form 8-A has become effective under the Exchange Act. The Company has taken no action designed to, or likely to have the effect of, terminating the registration of the shares of Common Stock under the Exchange Act, nor has the Company received any notification that the Commission is contemplating terminating such registration.

 

2.1.3        Testing the Waters Communications

 

(i)        Each Written Testing-the-Waters Communications did not, as of the Applicable Time, and at all times through the completion of the public offer and sale of the Public Securities will not, include any information that conflicted, conflicts or will conflict with the information contained in the Registration Statement, the Pricing Disclosure Package or the Prospectus. Each Written Testing-the-Waters Communication did not, as of the Applicable Time, when taken together with the Pricing Disclosure Package, contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided that no representation or warranty is made as to the Underwriters’ Information (as defined in Section 2.4.1 below).

 

(ii)       No Company Party (a) has engaged in any Testing-the-Waters Communication other than Testing-the-Waters Communications with the consent of the Representative with entities that are qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act and (b) has authorized any third party to engage in Testing-the-Waters Communications. The Company reconfirms that the Representative has been authorized to act on its behalf in undertaking Testing-the-Waters Communications. No Company Party has distributed any Written Testing-the-Waters Communications other than those listed on Schedule 2-C hereto.

 

(iii)      From the time of the initial confidential submission of the Registration Statement to the Commission (or, if earlier, the first date on which the Company Parties engaged directly or through any person authorized to act on its behalf in any Testing-the-Waters Communication) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”).

 

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2.1.4        Road Show. The Company has filed publicly on EDGAR at least 15 calendar days prior to any “road show” (as defined in Rule 433 under the Securities Act), any confidentially submitted registration statement and registration statement amendments relating to the offer and sale of the Public Securities.

 

2.2       Stock Exchange Listing. The shares of Common Stock have been approved for listing on The NASDAQ Capital Market (the “NasdaqCM”), subject only to official notice of issuance.

 

2.3       No Stop Orders, etc. No stop order suspending the effectiveness of the Initial Registration Statement, any post-effective amendment thereto or the Rule 462(b) Registration Statement, if any, has been issued and no proceeding for that purpose has been initiated or, to the Company’s knowledge, threatened by the Commission. No order preventing or suspending the use of any Preliminary Prospectus or the Prospectus has been issued and no proceeding for that purpose has been initiated or, to the Company’s knowledge, threatened by the Commission. The Company has complied in all material respects with each request (if any) from the Commission for additional information.

 

2.4       Disclosures in Registration Statement.

 

2.4.1        Compliance with Securities Act and 10b-5 Representation.

 

(i)        Each of the Registration Statement and any post-effective amendment thereto, at the time it became effective, complied in all material respects with the requirements of the Securities Act and the rules and regulations of the Commission thereunder (the “Securities Act Regulations”). Each Preliminary Prospectus, the Prospectus and any amendment or supplement thereto, at the time each was filed with the Commission, complied in all material respects with the requirements of the Securities Act and the Securities Act Regulations. Each Preliminary Prospectus delivered to the Underwriters for use in connection with this offering and the Prospectus was or will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

 

(ii)       The Registration Statement, when it became effective, did not contain and, as amended or supplemented, if applicable, will not contain, as of the date of such amendment or supplement, an untrue statement of a material fact or omitted or will omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; provided, however, that this representation and warranty shall not apply to any information contained in or omitted from the Registration Statement or any amendment thereto in reliance upon and in conformity with information furnished in writing to the Company by or on behalf of any Underwriter through the Representative specifically for use therein. The parties acknowledge and agree that such information provided by or on behalf of any Underwriter consists solely of the following disclosure contained in the “Underwriting” section of the Prospectus: (a) the second sentence of the second paragraph under the heading “Discounts”, (b) the first sentence under the heading “Stabilization” and (collectively, the “Underwriters’ Information”).

 

(iii)      The Pricing Disclosure Package, as of the Applicable Time, did not contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Prospectus will not, as of its date, as of the Closing Date or as of any Option Closing Date, contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. Each Issuer Free Writing Prospectus complies in all material respects with the applicable provisions of the Securities Act and the Securities Act Regulations, and does not conflict with the information contained in the Registration Statement, the Pricing Prospectus or the Prospectus, and each Issuer Free Writing Prospectus listed in Schedule 2-B hereto, as supplemented by and taken together with the Pricing Disclosure Package did not, as of the Applicable Time, contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. No representation and warranty is made in this Section 1(d) with respect to the Underwriters’ Information.

 

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2.4.2        Disclosure of Agreements. The agreements and documents described in the Registration Statement, the Pricing Disclosure Package and the Prospectus conform in all material respects to the descriptions thereof contained therein and there are no agreements or other documents required by the Securities Act and the Securities Act Regulations to be described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or to be filed with the Commission as exhibits to the Registration Statement, that have not been so described or filed. Each agreement or other instrument (however characterized or described) to which either the Company or the LLC is a party or by which the Company or LLC is or may be bound or affected and (i) that is referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or (ii) is material to the Company’s or the LLC’s business, has been duly authorized and validly executed by the Company or the LLC, as the case may be, is in full force and effect in all material respects and is enforceable against the Company or the LLC, or as the case may be, and, to the Company’s knowledge, the other parties thereto, in accordance with its terms, except (x) as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors’ rights generally, (y) as enforceability of any indemnification or contribution provision may be limited under the federal and state securities laws, and (z) that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. None of such agreements or instruments has been assigned by the Company or LLC, and neither the Company, the LLC nor, to the Company’s knowledge, any other party is in default thereunder and no event has occurred that, with the lapse of time or the giving of notice, or both, would constitute a default thereunder. To the best of the Company’s knowledge, performance by the Company Party which is a party thereto of the material provisions of such agreements or instruments will not result in a violation of any existing applicable law, rule, regulation, judgment, order or decree of any governmental, judicial, regulatory or administrative agency, body or court, domestic or foreign, having jurisdiction over the Company Parties or any of their assets or business (each, a “Governmental Entity”), including, without limitation, those relating to environmental laws and regulations.

 

2.4.3        Prior Securities Transactions. Since inception, no securities of any Company Party have been sold by the Company Parties or by or on behalf of, or for the benefit of, any person or persons controlling, controlled by or under common control with a Company Party, except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Preliminary Prospectus.

 

2.4.4        Regulations. The statements set forth in the Pricing Prospectus and Prospectus under the caption “Description of Securities”, insofar as it purports to constitute a summary of the terms of the Common Stock, and under the captions “Shares Eligible for Future Sale,” “Material U.S. Federal Income Tax Consequences to Non-U.S. Holders of Our Common Stock,” “Certain Relationships and Related Transactions,” “Business—Implications of Being an Emerging Growth Company”, “Business—Government Regulation,” “Business—Legal Proceedings,” “Business—Intellectual Property,” “Underwriting,” “Risk Factors, and the statements in the Registration Statement under Item 14 thereof, insofar as they purport to describe the provisions of the laws and documents referred to therein, are accurate, complete and fair in all material respects.

 

2.4.5        No Other Distribution of Offering Materials. The Company Parties have not, directly or indirectly, distributed and will not distribute any offering material in connection with the Offering other than any Preliminary Prospectus, the Prospectus and other materials, if any, permitted under the Securities Act and consistent with Section 3.2 below.

 

2.5       Changes After Dates in Registration Statement. Subsequent to the respective dates as of which information is given in the Registration Statement, the Pricing Disclosure Package or the Prospectus, except as disclosed or contemplated therein and giving effect to the conversion/reincorporation transactions (the “Reorganization”) contemplated by the Terms and Conditions of the Plan of Entity Conversion Adial Pharmaceuticals L.L.C. into APL Conversion Corp in the form filed as Exhibit 3.8 to the Registration Statement (the “Plan of Conversion”) and the Agreement and Plan of Reorganization between APL Conversion Corp. and the Company in the form filed as Exhibit 3.11 to the Registration Statement (the “Merger Agreement”), (i) no Company Party has declared or paid any dividends, or made any other distribution of any kind, on or in respect of its capital stock, (ii) there has not been any material change in the capital stock or long-term or short-term debt of the Company, (iii) there have been no transactions entered into by a Company Party, other than in the ordinary course of business, which are material with respect to the Company Parties, individually or taken as a whole, (iv) neither Company Party has sustained any material loss or interference with its business or properties from fire, explosion, flood, earthquake, hurricane, accident or other calamity, whether or not covered by insurance, or from any labor dispute or any legal or governmental proceeding, and (v) there has not been any material adverse change or any development involving a prospective material adverse change, whether or not arising from transactions in the ordinary course of business, in or affecting the business, general affairs, management, condition (financial or otherwise), results of operations, stockholders’ equity, properties or prospects of the Company, individually or taken as a whole (a “Material Adverse Change”). Since the date of the latest balance sheet included in the Registration Statement, the Pricing Disclosure Package or the Prospectus, no Company Party has incurred or undertaken any liabilities or obligations, whether direct or indirect, liquidated or contingent, matured or unmatured, or entered into any transactions, including any acquisition or disposition of any business or asset, which are material to the Company Parties, individually or taken as a whole, except for liabilities, obligations and transactions which are disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

 

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2.6       Independent Accountants. Friedman LLP (the “Auditor”), who has certified the financial statements and supporting schedules and information of the Company Parties that are included in the Registration Statement, the Pricing Disclosure Package or the Prospectus are independent public accountants as required by the Securities Act, the Securities Act Regulations and the rules of the Public Company Accounting Oversight Board (“PCAOB”). The Auditor has not, during the periods covered by the financial statements included in the Registration Statement, the Pricing Disclosure Package and the Prospectus, provided to the Company Parties any non-audit services, as such term is used in Section 10A(g) of the Exchange Act.

 

2.7       Financial Statements, etc. The financial statements, including the notes thereto, and the supporting schedules included in the Registration Statement, the Pricing Disclosure Package and the Prospectus present fairly in all material respects the consolidated financial position as of the dates indicated and the cash flows and results of operations for the periods specified of the Company Parties; except as otherwise stated in the Registration Statement, the Pricing Disclosure Package and the Prospectus, said financial statements have been prepared in conformity with United States generally accepted accounting principles (“GAAP”) applied on a consistent basis throughout the periods involved; and the supporting schedules, if any, included in the Registration Statement, the Pricing Disclosure Package and the Prospectus present fairly in all material respects in accordance with GAAP the information required to be stated therein. No other historical or pro forma financial statements or supporting schedules are required to be included in the Registration Statement, the Pricing Disclosure Package or the Prospectus by the Securities Act or the Securities Act Regulations. The other financial and statistical information included in the Registration Statement, the Pricing Disclosure Package and the Prospectus present fairly in all material respects the information included therein and have been prepared on a basis consistent with that of the financial statements that are included in the Registration Statement, the Pricing Disclosure Package and the Prospectus and the books and records of the respective entities presented therein. The pro forma financial statements included in the Registration Statement, Pricing Disclosure Package and the Prospectus have been properly compiled and prepared in accordance with the applicable requirements of the Securities Act and the Securities Act Regulations and include all adjustments necessary to present fairly in all material respects in accordance with GAAP the pro forma financial position of the respective entity or entities presented therein at the respective dates indicated and their cash flows and the results of operations for the respective periods specified. All disclosures contained in the Registration Statement, the Pricing Disclosure Package or the Prospectus regarding “non-GAAP financial measures” (as such term is defined by the rules and regulations of the Commission), if any, comply with Regulation G of the Exchange Act and Item 10 of Regulation S-K of the Securities Act, to the extent applicable. Each of the Registration Statement, the Pricing Disclosure Package and the Prospectus discloses all material off-balance sheet transactions, arrangements, obligations (including contingent obligations), and other relationships of the Company Parties with unconsolidated entities or other persons that may have a material current or future effect on the Company’s financial condition, changes in financial condition, results of operations, liquidity, capital expenditures, capital resources, or significant components of revenues or expenses. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (a) the Company has not incurred any material liabilities or obligations, direct or contingent, or entered into any material transactions other than in the ordinary course of business, (b) the Company Parties have not declared or paid any dividends or made any distribution of any kind with respect to its capital stock, (c) after giving effect to the Reorganization, there has not been any change in the capital stock of the Company, (d) other than in the ordinary course of business and consistent with the Company’s prior policies, made any grants under any stock compensation plan, and (e) there has not been any material adverse change in the Company’s long-term or short-term debt.

 

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2.8       Authorized Capital; Options, etc. The Company had, at the date or dates indicated in the Registration Statement, the Pricing Disclosure Package and the Prospectus and after giving effect to the Reorganization, the duly authorized, issued and outstanding capitalization as set forth therein. Based on the assumptions stated in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company will have on the Closing Date the adjusted stock capitalization set forth therein. Except as set forth in, or contemplated by, the Registration Statement, the Pricing Disclosure Package and the Prospectus, on the Applicable Time, as of the Applicable Time and on the Closing Date and any Option Closing Date, there will be no stock options, warrants, or other rights to purchase or otherwise acquire any authorized but unissued shares of Common Stock of the Company or any security convertible or exercisable into shares of Common Stock of the Company, or any contracts or commitments to issue or sell shares of Common Stock or any such options, warrants, rights or convertible securities.

 

2.9       Valid Issuance of Securities, etc.

 

2.9.1        Outstanding Securities. All issued and outstanding securities of the Company Parties issued prior to the transactions contemplated by this Agreement have been duly authorized and validly issued and are fully paid and non-assessable; the holders thereof have no contractual rights of rescission or put rights with respect thereto, and are not subject to personal liability by reason of being such holders; and none of such securities were issued in violation of the preemptive rights, rights of first refusal or rights of participation of any holders of any security of the Company Parties or similar contractual rights granted by the Company Parties, except for such rights as may have been fully satisfied or waived prior to the Effective Date. The authorized shares of Common Stock conform in all material respects to all statements relating thereto contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus. The offers and sales of the outstanding shares of membership interests of Common Stock, options, warrants and other rights to purchase or exchange such securities for shares of the Common Stock of other Company and membership interests of the LLC, as the case may be, were at all relevant times either registered under the Securities Act and the applicable state securities or “blue sky” laws or, based in part on the representations and warranties of the purchasers of such shares of Common Stock, and or holders of membership interests exempt from such registration requirements.

 

2.9.2        Securities Sold Pursuant to this Agreement. The Public Securities and Representative’s Securities have been duly authorized for issuance and sale and, when issued and paid for, will be validly issued, fully paid and non-assessable; the holders thereof are not and will not be subject to personal liability by reason of being such holders; the Public Securities and Representative’s Securities are not and will not be subject to the preemptive rights of any holders of any security of the Company or similar contractual rights granted by a Company Party; and all corporate action required to be taken for the authorization, issuance and sale of the Public Securities and Representative’s Securities has been duly and validly taken. The Public Securities and Representative’s Securities conform in all material respects to all statements with respect thereto contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus. All corporate action required to be taken for the authorization, issuance and sale of the Representative’s Warrant has been duly and validly taken; the shares of Common Stock issuable upon exercise of the Representative’s Warrant have been duly authorized and reserved for issuance by all necessary corporate action on the part of the Company and, when paid for and issued in accordance with the Representative’s Warrant and the Representative’s Warrant Agreement, such underlying shares of Common Stock will be validly issued, fully paid and non-assessable; the holders thereof are not and will not be subject to personal liability by reason of being such holders; and such shares of Common Stock are not and will not be subject to the preemptive rights of any holders of any security of the Company or similar contractual rights granted by a Company Party.

 

2.10     Registration Rights of Third Parties. Except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus, no holders of any securities of the Company Parties or any options, warrants, rights or other securities exercisable for or convertible or exchangeable into securities of the Company have the right to require the Company to register any such securities of Company Party under the Securities Act or to include any such securities in the Registration Statement or any other registration statement to be filed by the Company, except for any such rights so disclosed that have either been fully complied with by the Company or effectively waived by the holders thereof.

 

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2.11     Validity and Binding Effect of Agreements. The execution, delivery and performance of this Agreement, the Plan of Conversion, the Merger Agreement, the Representative’s Warrant and the Representative’s Warrant Agreement have been duly and validly authorized by the Company, and, this Agreement, the Plan of Conversion and Merger Agreement, constitute, and the Representative’s Warrant and the Representative’s Warrant Agreement, when executed and delivered, will constitute, the valid and binding agreements of the Company, in each case, enforceable against the Company in accordance with their respective terms, except: (i) as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors’ rights generally; (ii) as enforceability of any indemnification or contribution provision may be limited under the federal and state securities laws; and (iii) that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion of the court before which any proceeding therefor may be brought.

 

2.12     No Conflicts, etc. The execution, delivery and performance by the Company Parties of this Agreement, the Plan of Conversion, the Merger Agreement, the Representative’s Warrant and the Representative’s Warrant Agreement and all ancillary documents, the consummation by the Company Parties of the transactions herein and therein contemplated and the compliance by the Company Parties with the terms hereof and thereof, as the case may be, do not and will not, with or without the giving of notice or the lapse of time or both: (i) result in a material breach of, or conflict with any of the terms and provisions of, or constitute a material default under, or result in the creation, modification, termination or imposition of any lien, charge, mortgage, pledge, security interest, claim, equity, trust or other encumbrance, preferential arrangement, defect or restriction of any kind whatsoever (any “Lien”) upon any property or assets of the Company Parties pursuant to the terms of any indenture, mortgage, deed of trust, note, lease, loan agreement or any other agreement or instrument, franchise, license or permit to which the Company is a party or as to which any property of the Company is a party; (ii) result in any violation of the provisions of the Company’s Certificate of Incorporation (as the same have been amended or restated from time to time, the “Charter”), the by-laws of the Company Parties (as the same may be amended or restated from time to time) or (iii) violate any existing applicable law, rule, regulation, ordinance, directive, judgment, writ, order or decree of any Governmental Entity as of the date hereof (including, without limitation, those promulgated by the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or by any foreign, state or local Governmental Entity performing functions similar to those performed by the FDA), except in the cases of clauses (i) and (iii) for such breaches, conflicts or violations which could not reasonably be expected to have a Material Adverse Change.

 

2.13     No Defaults; Violations. The Company is not (i) in violation of its Charter, by-laws, or other organizational documents, (ii) in default under, and no event has occurred which, with notice or lapse of time or both, would constitute a default under or result in the creation or imposition of any Lien upon any property or assets of the Company pursuant to any indenture, mortgage, deed of trust, note, lease, loan agreement or other agreement or instrument to which it is a party or by which it is bound or to which any of its property or assets is subject, or (iii) in violation of any statute, law, rule, regulation, ordinance, directive, judgment, writ, decree or order of any court or judicial, regulatory or other legal or Governmental Entity, except (in the case of clauses (ii) and (iii) above) for violations or defaults that could not (individually or in the aggregate) reasonably be expected to have a Material Adverse Effect.

 

2.14     Corporate Power; Licenses; Authorizations.

 

2.14.1      Conduct of Business. The Company has all requisite power and authority, and all necessary consents, approvals, authorizations, orders, registrations, qualifications, licenses, filings and permits of, with and from all Governmental Entities and all third parties, foreign and domestic (collectively, the “Authorizations”), to own, lease and operate its properties and conduct its business as it is now being conducted and as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, and each such Authorization is valid and in full force and effect, except in each case as could not reasonably be expected to have a Material Adverse Effect. Neither Company Party has received notice of any investigation or proceedings which, if decided adversely to the Company, could reasonably be expected to result in, the revocation of, or imposition of a materially burdensome restriction on, any such Authorization.

 

2.14.2      Transactions Contemplated Herein. Each of the Company Parties has or, at the time of execution, had all corporate power and authority to enter into this Agreement the Plan of Conversion, the Merger Agreement, the Representative’s Warrant and the Representative’s Warrant Agreement to which it is a party and to carry out the provisions and conditions hereof, and all Authorizations required in connection therewith have been obtained. No Authorization of, and no filing with, Governmental Entity is required for the valid issuance, sale and delivery of the Public Securities and the consummation of the transactions and agreements contemplated by this Agreement, the Plan of Conversion, the Merger Agreement and the Representative’s Warrant Agreement and as contemplated by the Registration Statement, the Pricing Disclosure Package and the Prospectus, except as may be required under state securities or blue sky laws or the by-laws the rules and regulations of the Financial Industry Regulatory Authority, Inc. (“FINRA”) in connection with the purchase and distribution of the Public Securities by the Underwriters, each of which has been obtained and is in full force and effect.

 

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2.15     D&O Questionnaires. To the Company’s knowledge, all information contained in the questionnaires (the “Questionnaires”) completed by each of the Company’s directors, officers and principal stockholders immediately prior to the Offering (the “Insiders”) as supplemented by all information concerning the Company’s directors, officers and principal stockholders as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, provided to the Underwriters is true and correct in all material respects and the Company has not become aware of any information which would cause the information disclosed in the Questionnaires to become inaccurate and incorrect in any material respect.

 

2.16     Litigation; Governmental Proceedings. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there is no judicial, regulatory, arbitral or other legal or governmental proceeding or other litigation or arbitration, domestic or foreign, pending to which the Company is a party or of which any property, operations or assets of the Company Parties is the subject which, individually or in the aggregate, if determined adversely to the Company, could reasonably be expected to have a Material Adverse Effect, or which might materially and adversely affect the consummation of the transactions contemplated in this Agreement or the performance by the Company of its respective obligations hereunder; to the Company Parties’ knowledge, no such proceeding, litigation or arbitration is threatened or contemplated; and the defense of all such proceedings, litigation and arbitration against or involving the Company Party could not reasonably be expected to have a Material Adverse Effect.

 

2.17     Good Standing. The Company has been duly organized and is validly existing as a corporation and is in good standing under the laws of its jurisdiction of incorporation. The Company is duly qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the character or location of its properties (owned, leased or licensed) or the nature or conduct of its business makes such qualification necessary, except for those failures to be so qualified or in good standing which (individually and in the aggregate) could not reasonably be expected to have a material adverse effect on (i) the business, general affairs, management, condition (financial or otherwise), results of operations, stockholders’ equity, properties or prospects of the Company; or (ii) the ability of the Company Parties to consummate the Offering or any other transaction contemplated by this Agreement or the Registration Statement, the Pricing Disclosure Package and the Prospectus (a “Material Adverse Effect”). The Charter, and by-laws, or other constitutive and organizational documents of the Company comply with the requirements of applicable law and are in full force and effect.

 

2.18     Insurance. The Company maintains insurance in such amounts and covering such risks as the Company reasonably considers adequate for the conduct of its business and the value of its properties and as is customary for companies engaged in similar businesses in similar industries, all of which insurance is in full force and effect, except where the failure to maintain such insurance could not reasonably be expected to have a Material Adverse Effect. There are no material claims by the Company under any such policy or instrument as to which any insurance company is denying liability or defending under a reservation of rights clause. The Company reasonably believes that it will be able to renew its existing insurance as and when such coverage expires or will be able to obtain replacement insurance adequate for the conduct of the business and the value of its properties at a cost that would not have a Material Adverse Effect.

 

2.19     Transactions Affecting Disclosure to FINRA.

 

2.19.1      Finder’s Fees. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there are no claims, payments, contracts, arrangements, agreements or understandings between a Company Party and any person that would give rise to a valid claim against the Company or any Underwriter for a brokerage commission, finder’s fee or other like payment in connection with the transactions contemplated by this Agreement or, to the Company’s knowledge, any arrangements, agreements, understandings, payments or issuance with respect to the Company or any of its officers, directors, stockholders, partners, employees or affiliates that may affect the Underwriters’ compensation as determined by FINRA.

 

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2.19.2      Payments Within Six (6) Months. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, none of the Company Parties has made any direct or indirect payments (in cash, securities or otherwise) to: (i) any person, as a finder’s fee, consulting fee or otherwise, in consideration of such person raising capital for a Company Party or introducing to a Company Party persons who raised or provided capital to the Company; (ii) any FINRA member; or (iii)  any person or entity that has any direct or indirect affiliation or association with any FINRA member, within the six (6) months prior to the initial filing of the Registration Statement, other than the payment to the Underwriters as provided hereunder in connection with the Offering.

 

2.19.3      Use of Proceeds. None of the net proceeds of the Offering will be paid by the Company to any participating FINRA member or its affiliates, except as specifically described in the Registration Statement.

 

2.19.4      FINRA Affiliation. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there is no (i) officer or director of the Company, (ii) beneficial owner of 5% or more of any class of the Company’s securities after giving effect to the Reorganization or (iii) beneficial owner of the Company’s unregistered equity securities which were acquired during the 180-day period immediately preceding the filing of the Registration Statement that is an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA). Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company (i) does not have any material lending or other relationship with any bank or lending affiliate of any Underwriter and (ii) does not intend to use any of the proceeds from the sale of the Public Securities to repay any outstanding debt owed to any affiliate of any Underwriter.

 

2.19.5      Information. All information provided by the Company Parties in the FINRA questionnaire to Representative’s Counsel specifically for use by Representative’s Counsel in connection with its Public Offering System filings (and related disclosure) with FINRA is true, correct and complete in all material respects.

 

2.20     Foreign Corrupt Practices Act. None of the Company Parties, any director or officer of a Company Party, or, to the knowledge of the Company Parties, any agent, employee, affiliate or other person acting on behalf of the Company, has (i) made any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any domestic governmental official, “foreign official” (as defined in the U.S. Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (collectively, the “FCPA”) or employee; (iii) violated or is in violation of any provision of the FCPA or any applicable non-U.S. anti-bribery statute or regulation; (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment; and (v) received notice of any investigation, proceeding or inquiry by any Governmental Entity regarding any of the matters in clauses (i)-(iv) above; and a Company Party and, to the knowledge of the Company Parties, the Company Parties’ affiliates have conducted their respective businesses in compliance with the FCPA and have instituted and maintain policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith.

 

2.21     Compliance with OFAC. None of the Company Parties, any director or officer of a Company Party, or, to the knowledge of the Company Parties, any agent, employee, affiliate or other person acting on behalf of a Company Party, is currently the subject or target of any sanctions administered or enforced by the United States Government, including, without limitation, the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), the U.S. Department of State, the United Nations Security Council, the European Union, Her Majesty’s Treasury, or other relevant sanctions authority (collectively, “Sanctions”), nor is a Company Party located, organized or resident in a country or territory that is the subject of Sanctions; and the Company will not directly or indirectly use the proceeds of the offering, or lend, contribute or otherwise make available such proceeds to any joint venture partner or other person or entity, for the purpose of financing the activities of or business with any person, or in any country or territory, that currently is the subject or target of any U.S. sanctions administered by OFAC or in any other manner that will result in a violation by any person (including any person participating in the transaction whether as underwriter, advisor, investor or otherwise) of Sanctions.

 

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2.22     Money Laundering Laws. The operations of the Company are and the obligations of the Company Parties have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines issued, administered or enforced by any Governmental Entity (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any Governmental Entity or any arbitrator involving a Company Party with respect to the Money Laundering Laws is pending or, to the best knowledge of the Company Parties, threatened.

 

2.23     Forward-Looking Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) contained in either the Registration Statement, Pricing Disclosure Package or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith.

 

2.24     Officers’ Certificate. Any certificate signed by any duly authorized officer of a Company Party and delivered to you or to Representative’s Counsel shall be deemed a representation and warranty by the Company to the Underwriters as to the matters covered thereby.

 

2.25     Lock-Up AgreementsSchedule 3 hereto contains a complete and accurate list of each of the Company’s officers, directors and each owner of 1% of the Company’s outstanding shares of Common Stock (or securities convertible into or exercisable for shares of Common Stock) often giving effect to the Reorganization (collectively, the “Lock-Up Parties”). The Company has caused each of the Lock-Up Parties to deliver to the Representative an executed Lock-Up Agreement, in the form attached hereto as Exhibit B (the “Lock-Up Agreement”), prior to the execution of this Agreement. 

 

2.26     Subsidiaries. The Company has no “subsidiaries” (within the meaning of Rule 405 under the Securities Act). After giving effect to the Reorganization, the Company does not own, directly or indirectly, any shares of stock or any other equity or long-term debt securities of any other corporation or have any equity interest in any other corporation, partnership, joint venture, association, trust or other entity.

 

2.27     Related Party Transactions.

 

2.27.1      Business Relationships. There are no business relationships or related party transactions involving a Company Party or any other person required to be described in the Pricing Disclosure Package and the Prospectus that have not been described. Without limiting the generality of the immediately preceding sentence, no relationship, direct or indirect, exists between or among the Company on the one hand, and the directors, officers, stockholders managers or members of a Company Party on the other hand, that is required to be described in the Pricing Disclosure Package and the Prospectus and that is not so described. Except as described in the Registration Statement, Pricing Disclosure Package and the Prospectus, since inception, none of the Company Parties, has directly or indirectly, extended or maintained credit, arranged to extend credit, or renewed any extension of credit, in the form of a personal loan, to or for any director, executive officer of the Company Party, or to or for any family member or affiliate of any director, executive officer or Manager of a Company Party.

 

2.27.2      No Unconsolidated Entities. There are no transactions, arrangements or other relationships between and/or among a Company Party, any of its affiliates (as such term is defined in Rule 405 of the Securities Act) and any unconsolidated entity, including, but not limited to, any structure finance, special purpose or limited purpose entity that could reasonably be expected to materially affect the Company Parties’ liquidity or the availability of or requirements for its capital resources required to be described in the Pricing Disclosure Package and the Prospectus or a document incorporated by reference therein which have not been described as required.

 

2.28     Board of Directors. The Board of Directors of the Company is, and on the Closing Date, will be comprised of the persons set forth under the heading of the Pricing Prospectus and the Prospectus captioned “Management.” The qualifications of the persons serving as board members and the overall composition of the board comply with the Exchange Act and the rules and regulations of the Commission promulgated thereunder (the “Exchange Act Regulations”), the Sarbanes-Oxley Act of 2002 and the rules promulgated thereunder (the “Sarbanes-Oxley Act”) applicable to the Company and the listing rules of the NASDAQ Stock Market LLC. At least one member of the Audit Committee of the Board of Directors of the Company qualifies, and at the Closing Date, will qualify as an “audit committee financial expert,” as such term is defined under Regulation S-K and the listing rules of the NASDAQ Stock Market LLC. In addition, at least a majority of the persons serving on the Board of Directors qualify as “independent,” as defined under the listing rules of the NASDAQ Stock Market LLC.

 

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2.29     Sarbanes-Oxley Compliance.

 

2.29.1      Disclosure Controls. Except as set forth in the Registration Statement, Pricing Disclosure Package and the Prospectus, the Company has developed and currently maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) under the Exchange Act Regulations) that comply with the requirements of the Exchange Act; such disclosure controls and procedures have been designed to ensure that material information relating to the Company is made known to the Company’s principal executive officer and principal financial officer by others within those entities; and such disclosure controls and procedures are effective.

 

2.29.2      Compliance. Except as set forth in the Registration Statement, Pricing Disclosure Package and the Prospectus, the Company has taken all necessary actions to ensure that, upon the effectiveness of the Registration Statement, it will be in compliance with all provisions of the Sarbanes-Oxley Act with which the Company is required to comply as of the effectiveness of the Registration Statement, and is taking all steps necessary to ensure that it will at all times be in compliance with other provisions of the Sarbanes-Oxley Act as and when the same become applicable to the Company after the effectiveness of the Registration Statement.

 

2.30     Accounting Controls. Except as set forth in the Registration Statement, Pricing Disclosure Package and the Prospectus, the Company maintains a system of “internal control over financial reporting” (as defined under Rules 13a-15(f) under the Exchange Act Regulations) that complies with the requirements of the Exchange Act and have been designed by, or under the supervision of, their respective principal executive and principal financial officers, or persons performing similar functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including, but not limited to, internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any material weaknesses in its internal controls. The Company’s auditors and the Audit Committee of the Board of Directors of the Company have been advised of: (i) all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are known to the Company’s management and that have adversely affected or are reasonably likely to adversely affect the ability of the Company to record, process, summarize and report financial information; and (ii) any fraud known to the Company’s management, whether or not material, that involves management or other employees who have a significant role in the Company’s internal controls over financial reporting. Since the date of the latest audited financial statements included in the Pricing Disclosure Package, there has been no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

2.31     No Investment Company Status. The Company is not and, at all times up to and including consummation of the transactions contemplated by this Agreement, and after giving effect to application of the net proceeds of the Offering as described in the Pricing Disclosure Package and the Prospectus, will not be, required to register as an “investment company” under the Investment Company Act of 1940, as amended, and is not and will not be an entity “controlled” by an “investment company” within the meaning of such act.

 

2.32     No Labor Disputes. No labor disturbance by the employees of the Company exists or, to the best of the Company’s knowledge, is imminent and the Company is not aware of any existing or imminent labor disturbances by the employees of any of its principal suppliers, manufacturers’ customers or contractors, which, in either case (individually or in the aggregate), could reasonably be expected to have a Material Adverse Effect.

 

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2.33     Intellectual Property Rights.

 

(i)        Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company (i) owns or possesses the right to use all patents, patent applications, trademarks, service marks, domain names, trade names, trademark registrations, service mark registrations, copyrights, formulae, customer lists, and know-how and other intellectual property (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures) (collectively, “Intellectual Property”) necessary for the conduct of its business substantially as presently conducted and as currently proposed to be conducted as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, and (ii) has no reason to believe that the conduct of its business does or will conflict with any Intellectual Property of any third party in any material respect; and neither Company Party has received any notice of any claim of material conflict with any such Intellectual Property of others. To the Company’s knowledge, all material technical information developed by and belonging to the Company Parties that has not been patented has been kept confidential. To the Company’s knowledge, there is no infringement, misappropriation, or other violation by third parties of any such Intellectual Property; there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others challenging the Company Parties’ rights in or to such Intellectual Property, and the Company is are unaware of any facts that would form a reasonable basis for any such claim; and there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others that a Company Party infringes, misappropriates, or otherwise violates any patent, trademark, copyright, trade secret or other proprietary rights of others, and the Company is are unaware of any other fact that would form a reasonable basis for any such claim. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (x) no Company Party has granted, licensed or assigned to any other person or entity any right to manufacture, have manufactured, assemble or sell the current products of the Company Parties or those products or product candidates described in the Registration Statement, the Pricing Disclosure Package and the Prospectus and (y) to the Company’s knowledge, there are no rights of third parties, including liens, security interests or other encumbrances, to the Intellectual Property necessary for the conduct of its business substantially as presently conducted or as currently proposed to be conducted as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

 

(ii)       All licenses for the use of the Intellectual Property described in the Registration Statement, the Pricing Disclosure Package and the Prospectus are in full force and effect in all material respects and are enforceable by the Company Party which is a party thereto and, to the Company’s knowledge, the other parties thereto, in accordance with their terms, except (x) as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors’ rights generally, (y) as enforceability of any indemnification or contribution provision may be limited under the federal and state securities laws, and (z) that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. None of such agreements or instruments has been assigned by a Company Party, and none of the Company Parties, nor, to the Company’s knowledge, any other party is in default thereunder and, to the Company’s knowledge, no event has occurred that, with the lapse of time or the giving of notice, or both, would constitute a default thereunder.

 

2.34     Taxes. Each Company Party has accurately prepared and timely filed all federal, state, foreign and other tax returns that are required to be filed by it and has paid or made provision for the payment of all taxes, assessments, governmental or other similar charges, including without limitation, all sales and use taxes and all taxes which such Company Party is obligated to withhold from amounts owing to employees, creditors and third parties, with respect to the periods covered by such tax returns (whether or not such amounts are shown as due on any tax return), except where the failure to timely file any such tax return or pay any such tax would not result in a Material Adverse Effect. No deficiency assessment with respect to a proposed adjustment of a Company Parties’ federal, state, local or foreign taxes is pending or, to the best of the Company’s knowledge, threatened. The accruals and reserves on the books and records of the Company Parties’ in respect of tax liabilities for any taxable period not finally determined are adequate to meet any assessments and related liabilities for any such period and, since the date of most recent audited financial statements, none of the Company Parties has incurred any liability for taxes other than in the ordinary course of its business. There is no tax lien, whether imposed by any federal, state, foreign or other taxing authority, outstanding against the assets, properties or business of a Company Party.

 

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2.35     Compliance with Environmental Laws. There has been no storage, generation, transportation, handling, use, treatment, disposal, discharge, emission, contamination, release or other activity involving any kind of hazardous, toxic or other wastes, pollutants, contaminants, petroleum products or other hazardous or toxic substances, chemicals or materials (“Hazardous Substances”) by, due to, on behalf of, or caused by a Company Party (or, to the Company’s knowledge, any other entity for whose acts or omissions a Company Party is or may be liable) upon any property now or previously owned, operated, used or leased by the Company, or upon any other property, which would be a violation of or give rise to any liability under any applicable law, rule, regulation, order, judgment, decree or permit, common law provision or other legally binding standard relating to pollution or protection of human health and the environment (“Environmental Law”), except for violations and liabilities which, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. There has been no disposal, discharge, emission contamination or other release of any kind at, onto or from any such property or into the environment surrounding any such property of any Hazardous Substances with respect to which the Company has knowledge, except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. None of the Company Parties has agreed to assume, undertake or provide indemnification for any liability of any other person under any Environmental Law, including any obligation for cleanup or remedial action, except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. There is no pending or, to the best of the Company’s knowledge, threatened administrative, regulatory or judicial action, claim or notice of noncompliance or violation, investigation or proceedings relating to any Environmental Law against a Company Party. No property of any Company is subject to any Lien under any Environmental Law. No Company Party is subject to any order, decree, agreement or other individualized legal requirement related to any Environmental Law.

 

2.36     ERISA Compliance. (i) Each “employee benefit plan” (within the meaning of Section 3(3) of the Employee Retirement Security Act of 1974, as amended (“ERISA”)) for which a Company Party or any member of its “Controlled Group” (defined as any organization which is a member of a controlled group of corporations within the meaning of Section 414 of the Internal Revenue Code of 1986, as amended (the “Code”)) would have any liability (each a “Plan”) has been maintained in compliance with its terms and with the requirements of all applicable statutes, rules and regulations including ERISA and the Code; (ii) no prohibited transaction, within the meaning of Section 406 of ERISA or Section 4975 of the Code, has occurred with respect to any Plan excluding transactions effected pursuant to a statutory or administrative exemption; (iii) with respect to each Plan subject to Title IV of ERISA (A) no “reportable event” (within the meaning of Section 4043(c) of ERISA) has occurred or is reasonably expected to occur, (B) no “accumulated funding deficiency” (within the meaning of Section 302 of ERISA or Section 412 of the Code), whether or not waived, has occurred or is reasonably expected to occur, (C) the fair market value of the assets under each Plan exceeds the present value of all benefits accrued under such Plan (determined based on those assumptions used to fund such Plan), and (D) neither the Company, the LLC or any member of its Controlled Group has incurred, or reasonably expects to incur, any liability under Title IV of ERISA (other than contributions to the Plan or premiums to the Pension Benefit Guaranty Corporation in the ordinary course and without default) in respect of a Plan (including a “multiemployer plan,” within the meaning of Section 4001(c)(3) of ERISA); and (iv) each Plan that is intended to be qualified under Section 401(a) of the Code is so qualified and nothing has occurred, whether by action or by failure to act, which would cause the loss of such qualification.

 

2.37     Compliance with Laws. Each Company Party: (A) is and at all times has been in compliance with all statutes, rules, or regulations applicable to the ownership, testing, development, manufacture, packaging, processing use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by Company or the LLC (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (B) has not received any written notices, statements or other correspondence or notice from the FDA or any foreign, state or local Governmental Entity performing functions similar to the FDA or any other Governmental Entity alleging or asserting noncompliance with any Applicable Laws or any Authorizations; (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental Entity or third party alleging that any product operation or activity is in violation of any applicable Laws or Authorizations and has no knowledge that any such governmental authority is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims submissions and supplements or amendments as required by any applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

 

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2.38     Smaller Reporting Company.  As of the time of filing of the Registration Statement, the Company was a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act Regulations.

 

2.39     Industry Data.  The statistical, industry related and market-related data included in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus are based on or derived from sources that the Company Parties reasonably and in good faith believes are reliable and accurate or represent the Company Parties’ good faith estimates that are made on the basis of data derived from such sources, and such data agree with the sources from which they are derived.

 

2.40     Margin Securities. The Company does not own any “margin securities” as that term is defined in Regulation U of the Board of Governors of the Federal Reserve System (the “Federal Reserve Board”), and none of the proceeds of the Offering will be used, directly or indirectly, for the purpose of purchasing or carrying any margin security, for the purpose of reducing or retiring any indebtedness which was originally incurred to purchase or carry any margin security or for any other purpose which might cause any of the shares of Common Stock to be considered a “purpose credit” within the meanings of Regulation T, U or X of the Federal Reserve Board.

 

2.41     Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Pricing Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the pricing Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of a Company Party that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, no Company Party has received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of a Company Party is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of a Company Party has been, will be or may be suspended, revoked, modified or limited.

 

2.42     Integration. No Company Party nor any of their affiliates, nor any person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause the Offering to be integrated with prior offerings by the Company Parties for purposes of the Securities Act that would require the registration of any such securities under the Securities Act.

 

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2.43     Title to Real and Personal Property. The Company owns or leases all such properties as are necessary to the conduct of its business as presently operated and as proposed to be operated as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus. The Company has good and marketable title in fee simple to all real property and good and marketable title to all personal property owned by it, in each case free and clear of any and all Liens except such as are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or such as do not (individually or in the aggregate) materially affect the value of such property or materially interfere with the use made or proposed to be made of such property by the Company; and any real property and buildings held under lease or sublease by the Company are held by them under valid, subsisting and enforceable leases with such exceptions as are not material to, and do not materially interfere with, the use made and proposed to be made of such property and buildings by the Company. No Company Party has received any notice of any claim adverse to its ownership of any real or personal property or of any claim against the continued possession of any real property, whether owned or held under lease or sublease by a Company Party.

 

2.44     Confidentiality and Non-Competitions. To the Company’s knowledge, no director, officer, key employee or consultant of a Company Party is subject to any confidentiality, non-disclosure, non-competition agreement or non-solicitation agreement with any employer or prior employer that could materially affect his ability to be and act in his respective capacity of a Company Party or be expected to result in a Material Adverse Change. Each officer, key employee or consultant of the Company has entered into a confidentiality agreement in favor of the Company relating to the protection of the proprietary information and confidential information of the Company.

 

2.45     Corporate Records. The minute books of the Company and the LLC have been made available to the Underwriters and counsel for the Underwriters, and such books (i) contain minutes of all material meetings and actions of the board of directors (including each board committee) and stockholders of the Company, and (ii) reflect all material transactions referred to in such minutes.

 

2.46     No Stabilization. Neither the Company, the LLC nor any of its affiliates (within the meaning of Rule 144 under the Securities Act) has taken, directly or indirectly, any action which constitutes or is designed to cause or result in, or which could reasonably be expected to constitute, cause or result in, the stabilization or manipulation of the price of any security to facilitate the sale or resale of the Public Securities or to result in a violation of Regulation M under the Exchange Act.

 

3.       Covenants of the Company. The Company covenants and agrees as follows:

 

3.1       Amendments to Registration Statement. The Company shall deliver to the Representative, prior to filing, any amendment or supplement to the Registration Statement or Prospectus proposed to be filed after the Effective Date and not file any such amendment or supplement to which the Representative shall reasonably object in writing.

 

3.2       Federal Securities Laws.

 

3.2.1        Compliance. The Company, subject to Section 3.2.2, shall comply with the requirements of Rule 430A of the Securities Act Regulations, and will notify the Representative promptly, and confirm the notice in writing, (i) when any post-effective amendment to the Registration Statement shall become effective or any amendment or supplement to the Prospectus shall have been filed; (ii) of the receipt of any comments from the Commission; (iii) of any request by the Commission for any amendment to the Registration Statement or any amendment or supplement to the Prospectus or for additional information; (iv) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment or of any order preventing or suspending the use of any Preliminary Prospectus or the Prospectus, or of the suspension of the qualification of the Public Securities and Representative’s Securities for offering or sale in any jurisdiction, or of the initiation or threatening of any proceedings for any of such purposes or of any examination pursuant to Section 8(d) or 8(e) of the Securities Act concerning the Registration Statement; and (v) if the Company becomes the subject of a proceeding under Section 8A of the Securities Act in connection with the Offering of the Public Securities and Representative’s Securities. The Company shall effect all filings required under Rule 424(b) of the Securities Act Regulations, in the manner and within the time period required by Rule 424(b) (without reliance on Rule 424(b) (8)), and shall take such steps as it deems necessary to ascertain promptly whether the form of prospectus transmitted for filing under Rule 424(b) was received for filing by the Commission and, in the event that it was not, it will promptly file such prospectus. The Company shall use its best efforts to prevent the issuance of any stop order, prevention or suspension and, if any such order is issued, to obtain the lifting thereof at the earliest possible moment.

 

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3.2.2        Continued Compliance. The Company shall comply with the Securities Act, the Securities Act Regulations, the Exchange Act and the Exchange Act Regulations so as to permit the completion of the distribution of the Public Securities as contemplated in this Agreement and in the Registration Statement, the Pricing Disclosure Package and the Prospectus. If at any time when a prospectus relating to the Public Securities is (or, but for the exception afforded by Rule 172 of the Securities Act Regulations (“Rule 172”), would be) required by the Securities Act to be delivered in connection with sales of the Public Securities, any event shall occur or condition shall exist as a result of which it is necessary, in the opinion of counsel for the Underwriters or for the Company, to (i) amend the Registration Statement in order that the Registration Statement will not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; (ii) amend or supplement the Pricing Disclosure Package or the Prospectus in order that the Pricing Disclosure Package or the Prospectus, as the case may be, will not include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in the light of the circumstances existing at the time it is delivered to a purchaser or (iii) amend the Registration Statement or amend or supplement the Pricing Disclosure Package or the Prospectus, as the case may be, in order to comply with the requirements of the Securities Act or the Securities Act Regulations, the Company will promptly (A) give the Representative notice of such event; (B) prepare any amendment or supplement as may be necessary to correct such statement or omission or to make the Registration Statement, the Pricing Disclosure Package or the Prospectus comply with such requirements and, a reasonable amount of time prior to any proposed filing or use, furnish the Representative with copies of any such amendment or supplement and (C) file with the Commission any such amendment or supplement; provided that the Company shall not file or use any such amendment or supplement to which the Representative or counsel for the Underwriters shall reasonably object. The Company will furnish to the Underwriters such number of copies of such amendment or supplement as the Underwriters may reasonably request. The Company has given the Representative notice of any filings made pursuant to the Exchange Act or the Exchange Act Regulations within 48 hours prior to the Applicable Time; the Company will give the Representative notice of its intention to make any such filing from the Applicable Time to the Closing Date and will furnish the Representative with copies of any such documents a reasonable amount of time prior to such proposed filing, as the case may be, and will not file or use any such document to which the Representative or counsel for the Underwriters shall reasonably object.

 

3.2.3        Exchanged Act Registration. For a period of three (3) years after the date of this Agreement, the Company shall use its reasonable best efforts to maintain the registration of the Common Stock under the Exchange Act, provided that such provision shall not prevent a sale, merger or similar transaction involving the Company. The Company shall not deregister any of the Common Stock under the Exchange Act without the prior written consent of the Representative, which consent shall not be unreasonably withheld, provided that such provision shall not prevent a sale, merger or similar transaction involving the Company.

 

3.2.4        Free Writing Prospectuses. The Company will not, without the prior consent of the Representative, (i) make any offer relating to the Public Securities that would constitute a “free writing prospectus” as defined in Rule 405 under the Securities Act, except for any Issuer Free Writing Prospectus set forth in Schedule    2-B hereto and any electronic road show previously approved by the Representative, or (ii) file, refer to, approve, use or authorize the use of any “free writing prospectus” as defined in Rule 405 under the Securities Act with respect to the Offering or the Public Securities. If at any time any event shall have occurred as a result of which any Issuer Free Writing Prospectus as then amended or supplemented would, in the judgment of the Underwriters or the Company, conflict with the information in the Registration Statement, the Pricing Prospectus or the Prospectus as then amended or supplemented or would, in the judgment of the Underwriters or the Company, include an untrue statement of a material fact or omit to state any material necessary in order to make the statements therein, in the light of the circumstances existing at the time of delivery to the purchaser, not misleading, or if to comply with the Securities Act or the Securities Act Regulations it shall be necessary at any time to amend or supplement any Issuer Free Writing Prospectus, the Company will notify the Representative promptly and, if requested by the Representative, prepare and furnish without charge to each Underwriter an appropriate amendment or supplement (in form and substance satisfactory to the Representative) that will correct such statement, omission or conflict or effect such compliance. The Company has complied and will comply with the requirements of Rule 433 with respect to each Issuer Free Writing Prospectus including, without limitation, all prospectus delivery, filing, record retention and legending requirements applicable to each such Issuer Free Writing Prospectus.

 

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3.2.5        Testing-the-Waters Communications. If at any time following the distribution of any Written Testing-the-Waters Communication there occurred or occurs an event or development as a result of which such Written Testing-the-Waters Communication included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company shall promptly notify the Representative and shall promptly amend or supplement, at its own expense, such Written Testing-the-Waters Communication to eliminate or correct such untrue statement or omission. The Company will promptly notify the Representative of (i) any distribution by the Company of Written Testing-the-Waters Communications and (ii) any request by the Commission for information concerning the Written Testing-the-Waters Communications

 

3.3       Delivery to the Underwriters of Registration Statements. The Company has delivered or made available or shall deliver or make available to the Representative and counsel for the Representative, without charge, signed copies of the Registration Statement as originally filed and each amendment thereto (including exhibits filed therewith) and signed copies of all consents and certificates of experts, and will also deliver to the Underwriters, without charge, a conformed copy of the Registration Statement as originally filed and each amendment thereto (without exhibits) for each of the Underwriters. The copies of the Registration Statement and each amendment thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

 

3.4       Delivery to the Underwriters of Prospectuses. The Company has delivered or made available or will deliver or make available to each Underwriter, without charge, as many copies of each Preliminary Prospectus as such Underwriter reasonably requested, and the Company hereby consents to the use of such copies for purposes permitted by the Securities Act. The Company will furnish to each Underwriter, without charge, during the period when a prospectus relating to the Public Securities is (or, but for the exception afforded by Rule 172 of the Securities Act Regulations, would be) required to be delivered under the Securities Act, such number of copies of the Prospectus (as amended or supplemented) as such Underwriter may reasonably request. The Prospectus and any amendments or supplements thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

 

3.5       Effectiveness and Events Requiring Notice to the Representative. The Company use its best efforts to cause the Registration Statement to remain effective with a current prospectus for at least same (9) nine months after the Applicable Time, and shall notify the Representative immediately and confirm the notice in writing: (i) of the effectiveness of the Registration Statement and any amendment thereto; (ii) of the issuance by the Commission of any stop order or of the initiation, or the threatening, of any proceeding for that purpose; (iii) of the issuance by any state securities commission of any proceedings for the suspension of the qualification of the Public Securities for offering or sale in any jurisdiction or of the initiation, or the threatening, of any proceeding for that purpose; (iv) of the mailing and delivery to the Commission for filing of any amendment or supplement to the Registration Statement or Prospectus; (v) of the receipt of any comments or request for any additional information from the Commission; and (vi) of the happening of any event during the period described in this Section 3.5 that, in the judgment of the Company, makes any statement of a material fact made in the Registration Statement, the Pricing Disclosure Package or the Prospectus untrue or that requires the making of any changes in (a) the Registration Statement in order to make the statements therein not misleading, or (b) in the Pricing Disclosure Package or the Prospectus in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. If the Commission or any state securities commission shall enter a stop order or suspend such qualification at any time, the Company shall make every reasonable effort to obtain promptly the lifting of such order.

 

3.6       Review of Financial Statements. For a period of five (5) years after the date of this Agreement, the company, at its expense, shall cause its regularly engaged independent registered public accounting firm to review (but not audit) the Company’s financial statements for each of the three (3) fiscal quarters immediately preceding the announcement of any quarterly financial information, provided that such provision shall not prevent a sale, merger or similar transaction involving the Company.

 

3.7       Listing. The Company shall use its reasonable best efforts to maintain the listing of the Common Stock (including the Public Securities) on the NasdaqCM for at least three (3) years from the date of this Agreement; provided that such provision shall not prevent a sale, merger or similar transaction involving the Company.

 

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3.8       Financial Public Relations Firm. As of the Effective Date, the Company shall have retained a financial public relations firm reasonably acceptable to the Representative and the Company, which shall initially be Crescendo Communications, which firm shall be experienced in assisting issuers in initial public offerings of securities and in their relations with their security holders, and shall retain such firm or another firm reasonably acceptable to the Representative for a period of not less than two (2) years after the Effective Date; provided that such provision shall not prevent a sale, merger or similar transaction involving the Company.

 

3.9       Reports to the Representative.

 

3.9.1        Periodic Reports, etc. For a period of three (3) years after the Effective Date, at the Representative’s request, the Company shall furnish to the Representative copies of such financial statements and other periodic and special reports as the Company from time to time furnishes generally to holders of any class of its securities and also promptly furnish to the Representative: (i) a copy of each periodic report the Company shall be required to file with the Commission under the Exchange Act and the Exchange Act Regulations; (ii) a copy of every press release and every news item and article with respect to the Company or its affairs which was released by the Company; (iii) a copy of each Form 8-K prepared and filed by the Company; (iv) five copies of each registration statement filed by the Company under the Securities Act; (v) a copy of each report or other communication furnished to stockholders and (vi) such additional documents and information with respect to the Company and the affairs of any future subsidiaries of the Company as the Representative may from time to time reasonably request; provided the Representative shall sign, if requested by the Company, a Regulation FD compliant confidentiality agreement which is reasonably acceptable to the Representative and Representative’s Counsel in connection with the Representative’s receipt of such information. Documents filed with the Commission pursuant to its EDGAR system or otherwise publicly filed or made available shall be deemed to have been delivered to the Representative pursuant to this Section 3.7.1.

 

3.9.2        Transfer Agent; Transfer Sheets. For a period of three (3) years after the Effective Date, the Company shall retain a transfer agent and registrar acceptable to the Representative (the “Transfer Agent”) and shall furnish to the Representative at the Company’s sole cost and expense such transfer sheets of the Company’s securities as the Representative may reasonably request, including the daily and monthly consolidated transfer sheets of the Transfer Agent and DTC; provided that such provision shall not prevent a sale, merger or similar transaction involving the Company. VStock Transfer LLC is acceptable to the Representative to act as Transfer Agent for the shares of Common Stock.

 

3.9.3        Trading Reports. For a period of three (3) years after the date of this Agreement, the Company shall provide to the Representative, at the Company’s expense, such reports published by NasdaqCM relating to price trading of the Public Securities, as the Representative shall reasonably request; provided that such provision shall not prevent a sale, merger or similar transaction involving the Company.

 

3.10     Payment of Expenses

 

3.10.1      General Expenses Related to the Offering. The Company hereby agrees to pay on each of the Closing Date and the Option Closing Date, if any, to the extent not paid at the Closing Date, all expenses incident to the performance of the obligations of the Company under this Agreement, including, but not limited to: (a) all filing fees and communication expenses relating to the registration of Public Securities to be issued and sold in the Offering with the Commission; (b) all filing fees associated with the review of the Offering by FINRA; (c) all fees and expenses relating to the listing of such Common Stock on the NasdaqCM; (d) all fees, expenses and disbursements relating to background checks of the Company’s officers and directors in an amount not to exceed $5,000 per individual and $15,000 in the aggregate; (e) all fees, expenses and disbursements relating to the registration or qualification of the Public Securities under the “blue sky” securities laws of such states and other jurisdictions as the Representative may reasonably designate (including, without limitation, all filing and registration fees, and the reasonable fees and disbursements of “blue sky” counsel), it being agreed that such fees and expenses will be limited if the offering is commenced on the NasdaqCM to make a payment of $2,500 to such counsel on the Closing Date; (f) all fees, expenses and disbursements relating to the registration, qualification or exemption of the Public Securities under the securities laws of such foreign jurisdictions as the Representative may reasonably designate; (g) the costs of all mailing and printing of the underwriting documents (including, without limitation, this Agreement, any blue sky surveys and, if appropriate, any agreement among underwriters, selected dealers’ agreement, underwriters’ questionnaire and power of attorney), Registration Statements, Prospectuses and all amendments, supplements and exhibits thereto and as many preliminary and final Prospectuses as the Representative may reasonably deem necessary; (h) the costs and expenses of the public relations firm referred to in Section 3.8 hereof; (i) the costs of preparing, printing and delivering certificates representing the Public Securities; (j) fees and expenses of the Transfer Agent for the shares of Common Stock; (k) stock transfer and/or stamp taxes, if any, payable upon the transfer of securities from the Company to the Underwriters; (l) to the extent approved by the Company in writing, the costs associated with post-Closing advertising of the Offering in the national editions of The Wall Street Journal and The New York Times; (m) the costs associated with bound volumes of the public offering materials as well as commemorative mementos and lucite tombstones in an aggregate amount not to exceed $5,000, each of which the Company or its designee will provide, including to the Representative, within a reasonable time after the Closing in such quantities as the Representative may reasonably request; (n) the fees and expenses of the Company’s accountants; (o) the fees and expenses of the Company’s legal counsel and other agents and representatives; (p) the reasonable and documented fees and expenses of Underwriter’s legal counsel not to exceed $65,000; (q) the $29,500 cost associated with the Underwriters’ use of Ipreo’s book building, prospectus tracking and compliance software for the Offering; and (r) upon successful completion of the Offering, up to $20,000 of the Underwriters’ actual accountable “road show” expenses for the offering. The Representative may deduct from the net proceeds of the Offering payable to the Company on the Closing Date, or the Option Closing Date, if any, the expenses set forth herein to be paid by the Company to the Underwriters, provided, however, that in the event that the Offering is terminated, the Company agrees to reimburse the Underwriters pursuant to Section 8.3 hereof.

 

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3.10.2      Non-accountable Expenses. The Company further agrees that, in addition to the expenses payable pursuant to Section 3.10.1, on the Closing Date it shall pay to the Representative, by deduction from the net proceeds of the Offering contemplated herein, a non-accountable expense allowance equal to one percent (1%) of the gross proceeds received by the Company from the sale of the Firm Shares.

 

3.11     Application of Net Proceeds. The Company shall apply the net proceeds from the Offering received by it in a manner consistent with the application thereof described under the caption “Use of Proceeds” in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

 

3.12     Delivery of Earnings Statements to Security Holders. The Company shall make generally available to its security holders as soon as practicable, but not later than the first day of the fifteenth (15th) full calendar month following the Effective Date, an earnings statement (which need not be certified by an independent registered public accounting firm unless required by the Securities Act or the Securities Act Regulations, but which shall satisfy the provisions of Rule 158(a) under Section 11(a) of the Securities Act) covering a period of at least twelve (12) consecutive months beginning after the Effective Date.

 

3.13     Stabilization. Neither Company Party nor, to their knowledge, any of their employees, directors or stockholders (without the consent of the Representative) has taken or shall take, directly or indirectly, any action designed to or that has constituted or that might reasonably be expected to cause or result in, under Regulation M of the Exchange Act, or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Public Securities.

 

3.14     Internal Controls. The Company shall maintain a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary in order to permit preparation of financial statements in accordance with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

 

3.15     Accountants. As of the Effective Date, the Company shall have retained an independent registered public accounting firm, as required by the Securities Act and the Regulations and the PCAOB, reasonably acceptable to the Representative and the Company shall retain a nationally recognized independent public accounting firm for a period of at least three (3) years after the Effective Date. The Representative acknowledges that the Auditor is acceptable to the Representative.

 

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3.16     FINRA. For a period of 90 days from the later of the Closing Date or the Option Closing Date, the Company shall advise the Representative (who shall make an appropriate filing with FINRA) if it is or becomes aware that (i) any officer or director of the Company, (ii) any beneficial owner of 5% or more of any class of the Company’s securities or (iii) any beneficial owner of the Company’s unregistered equity securities which were acquired during the 180 days immediately preceding the filing of the Registration Statement is or becomes an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA).

 

3.17     No Fiduciary Duties. The Company acknowledges and agrees that the Underwriters’ responsibility to the Company s is solely contractual in nature and that none of the Underwriters or their affiliates or any selling agent shall be deemed to be acting in a fiduciary capacity, or otherwise owes any fiduciary duty to the Company or any of their affiliates in connection with the Offering and the other transactions contemplated by this Agreement.

 

3.18      Company Lock-Up Agreements

 

3.18.1      Restrictions on Sales of Capital Stock. The Company, on behalf of itself and any successor entity of the Company, agrees that, without the prior written consent of the Representative, it will not, during the period commencing on the date of this Agreement and ending on the six (6) month anniversary thereof (the “Lock-Up Period”), (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock of the Company (other than the Additional Shares and Common Stock issued pursuant to employee benefit plans, qualified stock option plans or other employee compensation plans existing on the date hereof or pursuant to currently outstanding options, warrants or rights) provided that either (a) such shares shall not vest during the Lock-Up Period or (b) the grantee of such shares will execute a Lock-Up Agreement; (ii) file or cause to be filed any registration statement with the Commission relating to the offering of any shares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock of the Company other than a registration statement on Form S-4 or S-8; or (iii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of capital stock of the Company, whether any such transaction described in clause (i), (ii) or (iii) above is to be settled by delivery of shares of capital stock of the Company or such other securities, in cash or otherwise.

 

The restrictions contained in this Section 3.16 shall not apply to (i) the Public Securities to be sold hereunder, (ii) the issuance by the Company of shares of Common Stock upon the exercise of a stock option or warrant or the conversion of a security outstanding on the date hereof, which is disclosed in the Registration Statement, Pricing Disclosure Package and Prospectus, (iii) the issuance by the Company of any security under any equity compensation plan of the Company, (iv) the issuance by the Company of shares of Common Stock in the connection with mergers, acquisitions or joint ventures, and (v) the issuance by the Company of shares of Common Stock to consultants in the Company’s ordinary course of business and not for capital raising transactions.

 

3.18.2      Restriction on Continuous Offerings. Notwithstanding the restrictions contained in Section 3.18.1, the Company, on behalf of itself and any successor entity, agrees that, without the prior written consent of the Representative, it will not, for a period of 12 months after the date of this Agreement, directly or indirectly in any “at-the-market”, or continuous equity transaction, offer to sell, sell, contract to sell, grant any option to sell or otherwise dispose of shares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock of the Company.

 

3.19     Release of D&O Lock-up Period. If the Representative, in its sole discretion, agrees to release or waive the restrictions set forth in the Lock-Up Agreements described in Section 2.25 hereof for an officer or director of the Company and provide the Company with notice of the impending release or waiver at least three (3) Business Days before the effective date of the release or waiver, the Company agrees if required by applicable law to announce the impending release or waiver by a press release substantially in the form of Exhibit C hereto through a major news service at least two (2) Business Days before the effective date of the release or waiver.

 

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3.20     Blue Sky Qualifications. The Company shall use its best efforts, in cooperation with the Underwriters, if necessary, to qualify the Public Securities for offering and sale under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Representative may designate and to maintain such qualifications in effect so long as required to complete the distribution of the Public Securities; provided, however, that the Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject.

 

3.21     Reporting Requirements. The Company, during the period when a prospectus relating to the Public Securities is (or, but for the exception afforded by Rule 172, would be) required to be delivered under the Securities Act, will file all documents required to be filed with the Commission pursuant to the Exchange Act within the time periods required by the Exchange Act and Exchange Act Regulations. Additionally, the Company shall report the use of proceeds from the issuance of the Public Securities as may be required under Rule 463 under the Securities Act Regulations.

 

3.22     Emerging Growth Company Status. The Company shall promptly notify the Representative if the Company ceases to be an Emerging Growth Company at any time prior to the later of (i) completion of the distribution of the Public Securities within the meaning of the Securities Act and (ii) fifteen (15) days following the completion of the Lock-Up Period.

 

3.23     Press Releases. Prior to the Closing Date and any Option Closing Date, the Company shall not issue any press release or other communication directly or indirectly or hold any press conference with respect to the Company, its condition, financial or otherwise, or earnings, business affairs or business prospects (except for routine oral marketing communications in the ordinary course of business and consistent with the past practices of the Company and of which the Representative is notified), without the prior written consent of the Representative, which consent shall not be unreasonably withheld, unless in the judgment of the Company and its counsel, and after notification to the Representative, such press release or communication is required by law.

 

3.24     Sarbanes-Oxley. The Company shall at all times comply with all applicable provisions of the Sarbanes-Oxley Act in effect from time to time and applicable to the Company, provided that such provision shall not prevent a sale, merger or similar transaction involving the Company.

 

3.25     IRS Forms. If requested by the Representative, the Company shall deliver to each Underwriter (or its agent), prior to or at the Closing Date, a properly completed and executed Internal Revenue Service (“IRS”) Form W-9 or an IRS Form W-8, as appropriate, together with all required attachments to such form.

 

4.       Conditions of Underwriters’ Obligations. The obligations of the Underwriters to purchase and pay for the Public Securities, as provided herein, shall be subject to (i) the continuing accuracy of the representations and warranties of the Company as of the date hereof and as of each of the Closing Date and the Option Closing Date, if any; (ii) the accuracy of the statements of officers of the Company made pursuant to the provisions hereof; (iii) the performance by the Company of its obligations hereunder; and (iv) the following conditions:

 

4.1       Regulatory Matters.

 

4.1.1        Effectiveness of Registration Statement; Rule 430A Information. The Registration Statement shall have become effective not later than 5:30 p.m., Eastern time, on the date of this Agreement or such later date and time as shall be consented to in writing by you, and, at each of the Closing Date and any Option Closing Date, no stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto shall have been issued under the Securities Act, no order preventing or suspending the use of any Preliminary Prospectus or the Prospectus shall have been issued and no proceedings for any of those purposes shall have been instituted or are pending or, to the Company’s knowledge, contemplated by the Commission. The Company has complied with each request (if any) from the Commission for additional information. A prospectus containing the Rule 430A Information shall have been filed with the Commission in the manner and within the time frame required by Rule 424(b) under the Securities Act Regulations (without reliance on Rule 424(b)(8)) or a post-effective amendment providing such information shall have been filed with, and declared effective by, the Commission in accordance with the requirements of Rule 430A under the Securities Act Regulations.

 

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4.1.2        FINRA Clearance. On or before the Effective Date, the Representative shall have received clearance from FINRA as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

 

4.1.3        NasdaqCM Stock Market Clearance. On the Closing Date, the Company’s Common Stock (including the shares of Common Stock underlying the Additional Shares) shall have been approved for listing on the NasdaqCM. On the first Option Closing Date (if any), the Company’s Common Stock (including the Common Stock underlying the Additional Shares) shall have been approved for listing on the NasdaqCM, subject only to official notice of issuance.

 

4.2       Company Counsel Matters.

 

4.2.1        Closing Date Opinion of Counsel to the Company. On the Closing Date, the Representative shall have received the favorable opinions of Gracin & Marlow LLP and Virginia, special counsel to the Company, and a written statement providing certain “10b-5” negative assurances, dated the Closing Date and addressed to the Representative, substantially in a form acceptable to the Representative.

 

4.2.2        Closing Date Opinion of Regulatory Counsel to the Company. On the Closing Date, the Representative shall have received the favorable opinion of [●], regulatory counsel to the Company, and a written statement providing certain “10b-5” negative assurances, dated the Closing Date and addressed to the Representative, substantially in a form acceptable to the Representative.

 

4.2.3        Closing Date Opinion of Intellectual Property Counsel to the Company. On the Closing Date, the Representative shall have received the favorable opinion of [●], intellectual property counsel to the Company, and a written statement providing certain “10b-5” negative assurances, dated the Closing Date and addressed to the Representative, substantially in a form acceptable to the Representative.

 

4.2.4        Option Closing Date Opinions of Counsel. On the Option Closing Date, if any, the Representative shall have received the favorable opinions of each counsel listed in Sections 4.2.1, 4.2.2 and 4.2.3, dated the Option Closing Date, addressed to the Representative and in form and substance reasonably satisfactory to the Representative, confirming as of the Option Closing Date, the statements made by such counsels in their respective opinions delivered on the Closing Date.

 

4.2.5        Reliance. In rendering such opinions, such counsel may rely: (i) as to matters involving the application of laws other than the laws of the United States and jurisdictions in which they are admitted, to the extent such counsel deems proper and to the extent specified in such opinion, if at all, upon an opinion or opinions (in form and substance reasonably satisfactory to the Representative) of other counsel reasonably acceptable to the Representative, familiar with the applicable laws; and (ii) as to matters of fact, to the extent they deem proper, on certificates or other written statements of officers of the Company and officers of departments of various jurisdictions having custody of documents respecting the corporate existence or good standing of the Company, provided that copies of any such statements or certificates shall be delivered to Representative’s Counsel if requested.

 

4.3       Comfort Letters.

 

4.3.1        Cold Comfort Letter. At the time this Agreement is executed you shall have received a cold comfort letter containing statements and information of the type customarily included in accountants’ comfort letters with respect to the financial statements and certain financial information contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus, addressed to the Representative and in form and substance satisfactory in all respects to you and to Representative’s Counsel from the Auditor, dated as of the date of this Agreement.

 

4.3.2        Bring-down Comfort Letter. At each of the Closing Date and the Option Closing Date, if any, the Representative shall have received from the Auditor a letter, dated as of the Closing Date or the Option Closing Date, as applicable, to the effect that the Auditor reaffirms the statements made in the letter furnished pursuant to Section 4.3.1, except that the specified date referred to shall be a date not more than three (3) Business Days prior to the Closing Date or the Option Closing Date, as applicable.

 

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4.4       Officers’ Certificates.

 

4.4.1        Officers’ Certificate. The Company shall have furnished to the Representative a certificate, dated the Closing Date and any Option Closing Date (if such date is other than the Closing Date), of its Chief Executive Officer and its Chief Financial Officer stating that (i) such officers have carefully examined the Registration Statement, the Pricing Disclosure Package, any Issuer Free Writing Prospectus and the Prospectus and, in their opinion, the Registration Statement and each amendment thereto, as of the Applicable Time and as of the date of this Agreement and as of the Closing Date (or any Option Closing Date if such date is other than the Closing Date) did not include any untrue statement of a material fact and did not omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and the Pricing Disclosure Package, as of the Applicable Time and as of the Closing Date (or any Option Closing Date if such date is other than the Closing Date), any Issuer Free Writing Prospectus as of its date and as of the Closing Date (or any Option Closing Date if such date is other than the Closing Date), the Prospectus and each amendment or supplement thereto, as of the respective date thereof and as of the Closing Date, did not include any untrue statement of a material fact and did not omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances in which they were made, not misleading, (ii) since the effective date of the Registration Statement, no event has occurred which should have been set forth in a supplement or amendment to the Registration Statement, the Pricing Disclosure Package or the Prospectus, (iii) to the best of their knowledge, as of the Closing Date (or any Option Closing Date if such date is other than the Closing Date), the representations and warranties of the Company in this Agreement are true and correct in all material respects (except for those representations and warranties qualified as to materiality, which shall be true and correct in all respects and except for those representations and warranties which refer to facts existing at a specific date, which shall be true and correct as of such date) and the Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied hereunder at or prior to the Closing Date (or any Option Closing Date if such date is other than the Closing Date), and (iv) there has not been, subsequent to the date of the most recent audited financial statements included or incorporated by reference in the Pricing Disclosure Package, any material adverse change in the financial position or results of operations of the Company, or any change or development that, singularly or in the aggregate, would involve a material adverse change, in or affecting the condition (financial or otherwise), results of operations, business, assets or prospects of the Company, except as set forth in the Prospectus.

 

4.4.2        Secretary’s Certificate. At each of the Closing Date and the Option Closing Date, if any, the Representative shall have received a certificate of the Company signed by the Secretary of the Company, dated the Closing Date or the Option Date, as the case may be, respectively, certifying: (i) that each of the Charter and by-laws is true and complete, has not been modified and is in full force and effect; (ii) that the resolutions of the Company’s Board of Directors relating to the Offering are in full force and effect and have not been modified; (iii) as to the accuracy and completeness of all correspondence between the Company or its counsel and the Commission; and (iv) as to the incumbency of the officers of the Company. The documents referred to in such certificate shall be attached to such certificate.

 

4.5       No Material Changes. Prior to and on each of the Closing Date and each Option Closing Date, if any: (i) there shall have been no Material Adverse Change and no material change in the capital stock or debt of the Company from the latest dates as of which such information is set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus, except as set forth in the Registration Statement, Pricing Disclosure and the Prospectus; (ii) no action, suit or proceeding, at law or in equity, shall have been pending or threatened against the Company or any Insider before or by any court or federal or state commission, board or other administrative agency wherein an unfavorable decision, ruling or finding may result in a Material Adverse Change, except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iii) no stop order shall have been issued under the Securities Act and no proceedings therefore shall have been initiated or threatened by the Commission; (iv) no action shall have been taken and no law, statute, rule, regulation or order shall have been enacted, adopted or issued by any Governmental Entity which would prevent the issuance or sale of the Public Securities or materially and adversely affect or potentially materially and adversely affect the business or operations of the Company; (v) no injunction, restraining order or order of any other nature by any federal or state court of competent jurisdiction shall have been issued which would prevent the issuance or sale of the Public Securities or materially and adversely affect or potentially materially and adversely affect the business or operations of the Company; and (vi) the Registration Statement, the Pricing Disclosure Package and the Prospectus and any amendments or supplements thereto shall contain all material statements which are required to be stated therein in accordance with the Securities Act and the Securities Act Regulations and shall conform in all material respects to the requirements of the Securities Act and the Securities Act Regulations, and neither the Registration Statement, the Pricing Disclosure Package, the Prospectus nor any Issuer Free Writing Prospectus nor any amendment or supplement thereto shall contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.

 

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4.6       No Material Misstatement or Omission. The Underwriters shall not have discovered and disclosed to the Company on or prior to the Closing Date and any Option Closing Date that the Registration Statement or any amendment or supplement thereto contains an untrue statement of a fact which, in the opinion of counsel for the Underwriters, is material or omits to state any fact which, in the opinion of such counsel, is material and is required to be stated therein or is necessary to make the statements therein not misleading, or that the Registration Statement, Pricing Disclosure Package, any Issuer Free Writing Prospectus or the Prospectus or any amendment or supplement thereto contains an untrue statement of fact which, in the opinion of such counsel, is material or omits to state any fact which, in the opinion of such counsel, is material and is necessary in order to make the statements, in the light of the circumstances under which they were made, not misleading.

 

4.7       Corporate Proceedings. All corporate proceedings and other legal matters incident to the authorization, form and validity of each of this Agreement, the Plan of Conversion, the Merger Agreement, the Representative’s Warrant, the Representative’s Warrant Agreement, the Public Securities, the Registration Statement, the Pricing Disclosure Package, each Issuer Free Writing Prospectus, if any, and the Prospectus and all other legal matters relating to this Agreement, the Plan of Conversion, the Merger Agreement, the Representative’s Warrant, the Representative’s Warrant Agreement and the transactions contemplated hereby and thereby shall be reasonably satisfactory in all material respects to counsel for the Underwriters, and the Company Parties shall have furnished to such counsel all documents and information that they may reasonably request to enable them to pass upon such matters.

 

4.8       Delivery of Agreements.

 

4.8.1        Effective Date Deliveries. On or before the Effective Date, the Company shall have delivered to the Representative executed copies of the Lock-Up Agreements from each of the persons listed in Schedule 3 hereto.

 

4.8.2        Closing Date Deliveries. On the Closing Date, the Company shall have delivered to the Representative an executed copy of the Representative’s Warrant Agreement.

 

4.9       Completion of Reorganization. The Company shall have been completed the Reorganization on the terms described in the Registration Statement.

 

4.10     Additional Documents. At the Closing Date and at each Option Closing Date (if any), Representative’s Counsel shall have been furnished with such documents and opinions as they may require for the purpose of enabling Representative’s Counsel to deliver an opinion to the Underwriters, or in order to evidence the accuracy of any of the representations or warranties, or the fulfillment of any of the conditions, herein contained; and all proceedings taken by the Company in connection with the issuance and sale of the Public Securities and the Representative’s Securities as herein contemplated shall be satisfactory in form and substance to the Representative and Representative’s Counsel.

 

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5.       Indemnification.

 

5.1       Indemnification by the Company Parties. The Company, shall indemnify and hold harmless each Underwriter, its affiliates and each of its and their respective directors, officers, members, employees, representatives and agents and each person, if any, who controls any Underwriter within the meaning of Section 15 of the Securities Act of or Section 20 of the Exchange Act (collectively the “Underwriter Indemnified Parties,” and each a “Underwriter Indemnified Party”) against any loss, claim, damage, expense or liability whatsoever (or any action, investigation or proceeding in respect thereof), to which such Underwriter Indemnified Party may become subject, under the Securities Act or otherwise, insofar as such loss, claim, damage, expense, liability, action, investigation or proceeding arises out of or is based upon (A) any untrue statement or alleged untrue statement of a material fact contained in any Preliminary Prospectus, any Issuer Free Writing Prospectus, any “issuer information” filed or required to be filed pursuant to Rule 433(d) of the Securities Act Regulations, any Registration Statement or the Prospectus, or in any amendment or supplement thereto or document incorporated by reference therein, or (B) the omission or alleged omission to state in any Preliminary Prospectus, any Issuer Free Writing Prospectus, any “issuer information” filed or required to be filed pursuant to Rule 433(d) of the Securities Act Regulations, any Registration Statement or the Prospectus, or in any amendment or supplement thereto or document incorporated by reference therein, a material fact required to be stated therein or necessary to make the statements therein in the light of the circumstances under which they were made not misleading, and shall reimburse the Underwriter Indemnified Party promptly upon demand for any legal fees or other expenses reasonably incurred by that Underwriter Indemnified Party in connection with investigating, or preparing to defend, or defending against, or appearing as a third party witness in respect of, or otherwise incurred in connection with, any such loss, claim, damage, expense, liability, action, investigation or proceeding, as such fees and expenses are incurred; provided, however, that the Company shall not be liable in any such case to the extent that any such loss, claim, damage, expense or liability arises out of or is based solely upon an untrue statement in, or omission from any Preliminary Prospectus, any Registration Statement or the Prospectus, or any such amendment or supplement thereto, or any Issuer Free Writing Prospectus made in reliance upon and in conformity with written information furnished to the Company through the Representative by or on behalf of any Underwriter specifically for use therein, which information the parties hereto agree is limited to the Underwriters’ Information. This indemnity agreement is not exclusive and will be in addition to any liability, which the Company might otherwise have and shall not limit any rights or remedies which may otherwise be available at law or in equity to each Underwriter Indemnified Party.

 

5.2       Indemnification by the Underwriter. Each Underwriter, severally and not jointly, shall indemnify and hold harmless the Company, the Company’s directors, its officers who signed the Registration Statement and each person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (collectively the “Company Indemnified Parties” and each a “Company Indemnified Party”) against any loss, claim, damage, expense or liability whatsoever (or any action, investigation or proceeding in respect thereof), to which such Company Indemnified Party may become subject, under the Securities Act or otherwise, insofar as such loss, claim, damage, expense, liability, action, investigation or proceeding arises out of or is based upon (i) any untrue statement of a material fact contained in any Preliminary Prospectus, any Issuer Free Writing Prospectus, any “issuer information” filed or required to be filed pursuant to Rule 433(d) of the Securities Act Regulations, any Registration Statement or the Prospectus, or in any amendment or supplement thereto, or (ii) the omission to state in any Preliminary Prospectus, any Issuer Free Writing Prospectus, any “issuer information” filed or required to be filed pursuant to Rule 433(d) of the Securities Act Regulations, any Registration Statement or the Prospectus, or in any amendment or supplement thereto, a material fact required to be stated therein or necessary to make the statements therein in the light of the circumstances under which they were made not misleading, but in each case only to the extent that the untrue statement or omission was made in reliance upon and in conformity with written information furnished to the Company through the Representative by or on behalf of any Underwriter specifically for use therein, which information the parties hereto agree is limited to the Underwriters’ Information and shall reimburse the Company for any legal or other expenses reasonably incurred by such party in connection with investigating or preparing to defend or defending against or appearing as third party witness in connection with any such loss, claim, damage, liability, action, investigation or proceeding, as such fees and expenses are incurred. Notwithstanding the provisions of this Section 5.2, in no event shall any indemnity by an Underwriter under this Section 5.2 exceed the total discount and commission received by such Underwriter in connection with the Offering.

 

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5.3       Procedure. Promptly after receipt by an indemnified party under this Section 5 of notice of the commencement of any action, the indemnified party shall, if a claim in respect thereof is to be made against an indemnifying party under this Section 5, notify such indemnifying party in writing of the commencement of that action; provided, however, that the failure to notify the indemnifying party shall not relieve it from any liability which it may have under this Section 5 except to the extent it has been materially adversely prejudiced by such failure; and, provided, further, that the failure to notify an indemnifying party shall not relieve it from any liability which it may have to an indemnified party otherwise than under this Section 5. If any such action shall be brought against an indemnified party, and it shall notify the indemnifying party thereof, the indemnifying party shall be entitled to participate therein and, to the extent that it wishes, jointly with any other similarly notified indemnifying party, to assume the defense of such action with counsel reasonably satisfactory to the indemnified party (which counsel shall not, except with the written consent of the indemnified party, be counsel to the indemnifying party). After notice from the indemnifying party to the indemnified party of its election to assume the defense of such action, except as provided herein, the indemnifying party shall not be liable to the indemnified party under Section 5 for any legal or other expenses subsequently incurred by the indemnified party in connection with the defense of such action other than reasonable costs of investigation; provided, however, that any indemnified party shall have the right to employ separate counsel in any such action and to participate in the defense of such action but the fees and expenses of such counsel (other than reasonable costs of investigation) shall be at the expense of such indemnified party unless (i) the employment thereof has been specifically authorized in writing by the Company in the case of a claim for indemnification under 5.1 or the Representative in the case of a claim for indemnification under Section 5.2, (ii) such indemnified party shall have been advised by its counsel that there may be one or more legal defenses available to it which are different from or additional to those available to the indemnifying party, or (iii) the indemnifying party has failed to assume the defense of such action and employ counsel reasonably satisfactory to the indemnified party within a reasonable period of time after notice of the commencement of the action or the indemnifying party does not diligently defend the action after assumption of the defense, in which case, if such indemnified party notifies the indemnifying party in writing that it elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of (or, in the case of a failure to diligently defend the action after assumption of the defense, to continue to defend) such action on behalf of such indemnified party and the indemnifying party shall be responsible for legal or other expenses subsequently incurred by such indemnified party in connection with the defense of such action; provided, however, that the indemnifying party shall not, in connection with any one such action or separate but substantially similar or related actions in the same jurisdiction arising out of the same general allegations or circumstances, be liable for the reasonable fees and expenses of more than one separate firm of attorneys at any time any such indemnified party (in addition to any local counsel), which firm shall be designated in writing by the Representative if the indemnified party under this Section 5 is an Underwriter Indemnified Party or by the Company if an indemnified party under this Section 5 is a Company Indemnified Party. Subject to this Section 5.3, the amount payable by an indemnifying party under Section 5 shall include, but not be limited to, (x) reasonable legal fees and expenses of counsel to the indemnified party and any other expenses in investigating, or preparing to defend or defending against, or appearing as a third party witness in respect of, or otherwise incurred in connection with, any action, investigation, proceeding or claim, and (y) all amounts paid in settlement of any of the foregoing. No indemnifying party shall, without the prior written consent of the indemnified parties, settle or compromise or consent to the entry of judgment with respect to any pending or threatened action or any claim whatsoever, in respect of which indemnification or contribution could be sought under this Section 5 (whether or not the indemnified parties are actual or potential parties thereto), unless such settlement, compromise or consent (i) includes an unconditional release of each indemnified party in form and substance reasonably satisfactory to such indemnified party from all liability arising out of such action or claim and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of any indemnified party. Subject to the provisions of the following sentence, no indemnifying party shall be liable for settlement of any pending or threatened action or any claim whatsoever that is effected without its written consent (which consent shall not be unreasonably withheld or delayed), but if settled with its written consent, if its consent has been unreasonably withheld or delayed or if there be a judgment for the plaintiff in any such matter, the indemnifying party agrees to indemnify and hold harmless any indemnified party from and against any loss or liability by reason of such settlement or judgment. In addition, if at any time an indemnified party shall have requested that an indemnifying party reimburse the indemnified party for fees and expenses of counsel, such indemnifying party agrees that it shall be liable for any settlement of the nature contemplated herein effected without its written consent if (i) such settlement is entered into more than forty-five (45) days after receipt by such indemnifying party of the request for reimbursement, (ii) such indemnifying party shall have received notice of the terms of such settlement at least thirty (30) days prior to such settlement being entered into and (iii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.

 

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5.4       Contribution. If the indemnification provided for in this Section 5 is unavailable or insufficient to hold harmless an indemnified party under Section 5.1 or Section 5.2, then each indemnifying party shall, in lieu of indemnifying such indemnified party, contribute to the amount paid, payable or otherwise incurred by such indemnified party as a result of such loss, claim, damage, expense or liability (or any action, investigation or proceeding in respect thereof), as incurred, (i) in such proportion as shall be appropriate to reflect the relative benefits received by the Company on the one hand and each of the Underwriters on the other hand from the Offering, or (ii) if the allocation provided by clause (i) of this Section 5.4 is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) of this Section 5.4 but also the relative fault of the Company on the one hand and the Underwriters on the other with respect to the statements, omissions, acts or failures to act which resulted in such loss, claim, damage, expense or liability (or any action, investigation or proceeding in respect thereof) as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriters on the other with respect to such offering shall be deemed to be in the same proportion as the total proceeds from the Offering (before deducting expenses) received by the Company bear to the total underwriting discount and commissions received by the Underwriters in connection with the Offering, in each case as set forth in the table on the cover page of the Prospectus. The relative fault of the Company on the one hand and the Underwriters on the other shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company on the one hand or the Underwriters on the other, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such untrue statement, omission, act or failure to act; provided that the parties hereto agree that the written information furnished to the Company through the Representative by or on behalf of any Underwriter for use in any Preliminary Prospectus, any Registration Statement or the Prospectus, or in any amendment or supplement thereto, consists solely of the Underwriters’ Information. The Company and the Underwriters agree that it would not be just and equitable if contributions pursuant to this Section 5.4 be determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, damage, expense, liability, action, investigation or proceeding referred to above in this Section 5.4 shall be deemed to include, for purposes of this Section 5.4, any legal or other expenses reasonably incurred by such indemnified party in connection with investigating, preparing to defend or defending against or appearing as a third party witness in respect of, or otherwise incurred in connection with, any such loss, claim, damage, expense, liability, action, investigation or proceeding. Notwithstanding the provisions of this Section 5.4, no Underwriter shall be required to contribute any amount in excess of the total discount and commission received by such Underwriter in connection with the Offering less the amount of any damages which such Underwriter has otherwise paid or become liable to pay by reason of any untrue or alleged untrue statement, omission or alleged omission, act or alleged act or failure to act or alleged failure to act. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Underwriters’ obligation to contribute as provided in this Section 5.4 are several and in proportion to their respective underwriting obligation, and not joint.

 

6.       Default by an Underwriter.

 

6.1       Default Not Exceeding 10% of Firm Shares or Additional Shares. If any Underwriter or Underwriters shall default in its or their obligations to purchase the Firm Shares or the Additional Shares, if the Over-allotment Option is exercised hereunder, and if the number of the Firm Shares or Additional Shares with respect to which such default relates does not exceed in the aggregate 10% of the number of Firm Shares or Additional Shares that all Underwriters have agreed to purchase hereunder, then such Firm Shares or Additional Shares to which the default relates shall be purchased by the non-defaulting Underwriters in proportion to their respective commitments hereunder.

 

6.2       Default Exceeding 10% of Firm Shares or Additional Shares. In the event that the default addressed in Section 6.1 relates to more than 10% of the Firm Shares or Additional Shares, the Representative may in its discretion arrange for it or for another party or parties to purchase such Firm Shares or Additional Shares to which such default relates on the terms contained herein. If, within one (1) Business Day after such default relating to more than 10% of the Firm Shares or Additional Shares, the Representative does not arrange for the purchase of such Firm Shares or Additional Shares, then the Company shall be entitled to a further period of one (1) Business Day within which to procure another party or parties satisfactory to the Representative to purchase said Firm Shares or Additional Shares on such terms. In the event that neither the Representative nor the Company arrange for the purchase of the Firm Shares or Additional Shares to which a default relates as provided in this Section 6, this Agreement will automatically be terminated by the Representative or the Company without liability on the part of the Company (except as provided in Sections 3.10 and 5 hereof) or the several Underwriters (except as provided in Section 5 hereof); provided, however, that if such default occurs with respect to the Additional Shares, this Agreement will not terminate as to the Firm Shares; and provided, further, that nothing herein shall relieve a defaulting Underwriter of its liability, if any, to the other Underwriters and to the Company for damages occasioned by its default hereunder.

 

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6.3       Postponement of Closing Date. In the event that the Firm Shares or Additional Shares to which the default relates are to be purchased by the non-defaulting Underwriters, or are to be purchased by another party or parties as aforesaid, the Representative or the Company shall have the right to postpone the Closing Date or Option Closing Date for a reasonable period, but not in any event exceeding five (5) Business Days, in order to effect whatever changes may thereby be made necessary in the Registration Statement, the Pricing Disclosure Package or the Prospectus or in any other documents and arrangements, and the Company agrees to file promptly any amendment to the Registration Statement, the Pricing Disclosure Package or the Prospectus that in the opinion of counsel for the Underwriter may thereby be made necessary. The term “Underwriter” as used in this Agreement shall include any party substituted under this Section 6 with like effect as if it had originally been a party to this Agreement with respect to such shares of Common Stock.

 

7.       Additional Covenants.

 

7.1       Board Composition and Board Designations. The Company shall ensure that: (i) the qualifications of the persons serving as members of the Board of Directors and the overall composition of the Board comply with the Sarbanes-Oxley Act, the Exchange Act and the listing rules of the NasdaqCM or any other national securities exchange, as the case may be, in the event the Company seeks to have any of its securities listed on another exchange or quoted on an automated quotation system, and (ii) if applicable, at least one member of the Audit Committee of the Board of Directors qualifies as an “audit committee financial expert,” as such term is defined under Regulation S-K and the listing rules of the NasdaqCM.

 

7.2       Prohibition on Press Releases and Public Announcements. The Company shall not issue press releases or engage in any other publicity, without the Representative’s prior written consent, for a period ending at 5:00 p.m., Eastern time, on the first (1st) Business Day following the fortieth (40th) day after the Closing Date, other than normal and customary releases issued in the ordinary course of the Company’s business.

 

7.3       Right of First Refusal. Provided that the gross proceeds to the Company from the Securities are sold in accordance with the terms of this Agreement are at least $18,500,000, the Representative shall have an irrevocable right of first refusal (the “Right of First Refusal”), for a period of eighteen (18) months after the Effective Date to act as lead investment banker, lead bookrunner and/or lead placement agent, at the Representative’s sole discretion, on the Representative’s customary terms and conditions, for each and every public equity offering (each, a “Subject Transaction”). The Representative shall, together with the Company, determine whether or not any other broker dealer shall have the right to participate in any Subject Transaction and the economic terms of such participation. The Company shall notify the Representative of its intention to pursue a Subject Transaction, including the material terms thereof, by providing written notice thereof by registered mail or overnight courier service addressed to the Representative.  If the Representative fails to exercise its Right of First Refusal with respect to any Subject Transaction within ten (10) Business Days after the mailing of such written notice, then the Representative shall have no further claim or right with respect to the Subject Transaction. The Representative may elect, in its sole and absolute discretion, not to exercise its Right of First Refusal with respect to any Subject Transaction; provided that any such election by the Representative shall not adversely affect the Representative’s Right of First Refusal with respect to any other Subject Transaction.   The terms and conditions of any such engagements shall be set forth in separate agreements and may be subject to, among other things, satisfactory completion of due diligence by the Representative, market conditions, the absence of a material adverse change to the Company’s business, financial condition and prospects, approval of the Representative’s internal committee and any other conditions that the Representative may deem appropriate for transactions of such nature.

 

8.       Effectiveness of this Agreement and Termination Thereof.

 

8.1       Effectiveness of the Agreement. This Agreement shall become effective when the Company Parties and the Representative have executed the same and delivered counterparts of such signatures to the other party.

 

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8.2       Termination. The Representative shall have the right to terminate this Agreement at any time prior to any Closing Date, (i) if any domestic or international event or act or occurrence has materially disrupted, or in your opinion will in the immediate future materially disrupt, general securities markets in the United States; or (ii) if trading on the New York Stock Exchange or the NASDAQ Stock Market LLC shall have been suspended or materially limited, or minimum or maximum prices for trading shall have been fixed, or maximum ranges for prices for securities shall have been required by FINRA or by order of the Commission or any other Governmental Entity having jurisdiction; or (iii) if the United States shall have become involved in a new war or an increase in major hostilities; or (iv) if a banking moratorium has been declared by a New York State or federal authority; or (v) if a moratorium on foreign exchange trading has been declared which materially adversely impacts the United States securities markets; or (vi) if the Company shall have sustained a material loss by fire, flood, accident, hurricane, earthquake, theft, sabotage or other calamity or malicious act which, whether or not such loss shall have been insured, will, in your opinion, make it inadvisable to proceed with the delivery of the Firm Shares or Additional Shares; or (vii) if the Company is in material breach of any of its representations, warranties or covenants hereunder; or (viii) if the Representative shall have become aware after the date hereof of a material adverse change in the conditions or prospects of the Company, or a material adverse change in general market conditions as in the Representative’s reasonable judgment would make it impracticable to proceed with the offering, sale and/or delivery of the Public Securities or to enforce contracts made by the Underwriters for the sale of the Public Securities.

 

8.3       Expenses. Notwithstanding anything to the contrary in this Agreement, except in the case of a default by the Underwriters, pursuant to Section 6.2 above, in the event that this Agreement shall not be carried out for any reason whatsoever, within the time specified herein or any extensions thereof pursuant to the terms herein, the Company Parties shall be obligated to pay to the Underwriters their actual and accountable out-of-pocket expenses related to the transactions contemplated herein then due and payable (including the fees and disbursements of Representative’s Counsel) up to $100,000 (inclusive of the $20,000 advance previously paid by the Company to the Representative) for out-of-pocket accountable expenses, and upon demand the Company Parties shall pay the full amount thereof to the Representative on behalf of the Underwriters; provided, however, that such expense cap in no way limits or impairs the indemnification and contribution provisions of this Agreement. Notwithstanding the foregoing, any advance received by the Representative will be reimbursed to the Company to the extent not actually incurred in compliance with FINRA Rule 5110(f)(2)(C).

 

8.4       Survival of Indemnification. Notwithstanding any contrary provision contained in this Agreement, any election hereunder or any termination of this Agreement, and whether or not this Agreement is otherwise carried out, the provisions of Section 5 shall remain in full force and effect and shall not be in any way affected by, such election or termination or failure to carry out the terms of this Agreement or any part hereof.

 

8.5       Representations, Warranties, Agreements to Survive. All representations, warranties and agreements contained in this Agreement or in certificates of officers of the Company submitted pursuant hereto, shall remain operative and in full force and effect regardless of (i) any investigation made by or on behalf of any Underwriter or its Affiliates or selling agents, any person controlling any Underwriter, its officers or directors or any person controlling the Company or (ii) delivery of and payment for the Public Securities.

 

9.       Miscellaneous.

 

9.1       Notices. All communications hereunder, except as herein otherwise specifically provided, shall be in writing and shall be mailed (registered or certified mail, return receipt requested), personally delivered or sent by facsimile transmission and confirmed and shall be deemed given when so delivered or faxed and confirmed or if mailed, two (2) days after such mailing.

 

If to the Representative:

 

Aegis Capital Corp.

810 Seventh Avenue, 18th Floor

New York, New York 10019

Attn: Mr. David Bocchi, Managing Director of Investment Banking

Fax No.: (212) 813-1047

 

with a copy (which shall not constitute notice) to:

 

Blank Rome LLP

405 Lexington Avenue

New York, New York 10174

Attn: Brad L. Shiffman, Esq.

Fax No.:  (917) 332-3725

 

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If to the Company:

 

Adial Pharmaceuticals, Inc.

1180 Seminole Trail, Suite 495

Charlottesville, Virginia 22901

Attn: William B. Stilley, Chief Executive Officer

Fax No.: (434) 422-9797

 

with a copy (which shall not constitute notice), in each case, to:

 

Gracin & Marlow, LLP

465 Lexington Avenue, 26th Floor

New York, New York 10174

Attention: Leslie Marlow, Esq.

Fax No: (212) 208-4657

 

9.2       Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of this Agreement.

 

9.3       Absence of Fiduciary Relationship. Each Company Party acknowledges and agrees that:

 

(i)        each Underwriter’s responsibility to the Company is solely contractual in nature, each Underwriter has been retained solely to act as an underwriter in connection with the Offering and no fiduciary, advisory or agency relationship between the Company and the Underwriters has been created in respect of any of the transactions contemplated by this Agreement, irrespective of whether either the Representative has advised or is advising the Company on other matters;

 

(ii)       the price of the Public Securities set forth in this Agreement was established by the Company following discussions and arm’s-length negotiations with the Representative, and the Company are capable of evaluating and understanding, and understands and accepts, the terms, risks and conditions of the transactions contemplated by this Agreement; and

 

(iii)      it has been advised that the Representative and their respective affiliates are engaged in a broad range of transactions which may involve interests that differ from those of the Company Parties and that the Underwriters have no obligation to disclose such interests and transactions to the Company Parties by virtue of any fiduciary, advisory or agency relationship.

 

9.4       Research Analyst Independence. The Company acknowledges that each Underwriter’s research analysts and research departments are required to be independent from its investment banking division and are subject to certain regulations and internal policies, and that such Underwriter’s research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the Offering that differ from the views of their investment banking division. The Company acknowledges that each Underwriter is a full service securities firm and as such from time to time, subject to applicable securities laws, rules and regulations, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the Company; provided, however, that nothing in this Section 9.4 shall relieve the Underwriter of any responsibility or liability it may otherwise bear in connection with activities in violation of applicable securities laws, rules or regulations.

 

9.5       Amendment. This Agreement may only be amended by a written instrument executed by each of the parties hereto.

 

9.6       Entire Agreement. This Agreement (together with the other agreements and documents being delivered pursuant to or in connection with this Agreement) constitutes the entire agreement of the parties hereto with respect to the subject matter hereof and thereof, and supersedes all prior agreements and understandings of the parties, oral and written, with respect to the subject matter hereof.

 

 -32- 

 

 

9.7       Binding Effect. This Agreement shall inure solely to the benefit of and shall be binding upon the Representative, the Underwriters, the Company, and the controlling persons, directors and officers referred to in Section 5.2 hereof, and their respective successors, legal representatives, heirs and assigns, and no other person shall have or be construed to have any legal or equitable right, remedy or claim under or in respect of or by virtue of this Agreement or any provisions herein contained. The term “successors and assigns” shall not include a purchaser, in its capacity as such, of securities from any of the Underwriters.

 

9.8       Governing Law; Consent to Jurisdiction; Trial by Jury. This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of New York, without giving effect to conflict of laws principles thereof. The Company hereby agrees that any action, proceeding or claim against it arising out of, or relating in any way to this Agreement shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum. Any such process or summons to be served upon the Company may be served by transmitting a copy thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in Section 9.1 hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any action, proceeding or claim. The Company agrees that the prevailing party(ies) in any such action shall be entitled to recover from the other party(ies) all of its reasonable attorneys’ fees and expenses relating to such action or proceeding and/or incurred in connection with the preparation therefor. The Company (on its own behalf and, to the extent permitted by applicable law, on behalf of its stockholders and affiliates) and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.

 

9.9       Execution in Counterparts. This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which shall be deemed to be an original, but all of which taken together shall constitute one and the same agreement, and shall become effective when one or more counterparts has been signed by each of the parties hereto and delivered to each of the other parties hereto. Delivery of a signed counterpart of this Agreement by facsimile or email/pdf transmission shall constitute valid and sufficient delivery thereof.

 

9.10      Waiver, etc. The failure of any of the parties hereto to at any time enforce any of the provisions of this Agreement shall not be deemed or construed to be a waiver of any such provision, nor to in any way effect the validity of this Agreement or any provision hereof or the right of any of the parties hereto to thereafter enforce each and every provision of this Agreement. No waiver of any breach, non-compliance or non-fulfillment of any of the provisions of this Agreement shall be effective unless set forth in a written instrument executed by the party or parties against whom or which enforcement of such waiver is sought; and no waiver of any such breach, non-compliance or non-fulfillment shall be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.

 

[Signature Page Follows]

 

 -33- 

 

  

If the foregoing correctly sets forth the understanding between the Underwriters and the Company, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement between us.

 

  Very truly yours,
   
  ADIAL PHARMACEUTICALS, INC.

 

  By:                    
  Name:  
  Title:  

 

Confirmed as of the date first written

above, on behalf of itself and as

Representative of the several Underwriters

named on Schedule 1 hereto:

 

AEGIS CAPITAL CORP.  
     
By:                                     
Name:    
Title:    

 

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SCHEDULE 1

 

Underwriter

Total Number of

Firm Shares to be

Purchased

Number of Additional
Shares to be Purchased if
Over-Allotment Option is
Fully Exercised
Aegis Capital Corp    
     
     

 

S-1

 

 

SCHEDULE 2-A

 

Pricing Information

 

Number of Firm Shares:

 

Number of Additional Shares:

 

Public Offering Price per Share:    $

 

Underwriting Discount per Share:    $ *

 

Proceeds to Company per Share (before expenses and credit):   $

 

Underwriting non-accountable expense allowance per Share:  $

 

* The Company shall be credited $[●] at closing, which will reduce the aggregate Underwriting Discount

 

S-2A

 

 

SCHEDULE 2-B

 

Issuer General Use Free Writing Prospectuses

 

Free writing prospectus filed with the SEC on [●], 2017

  

S-2B

 

 

SCHEDULE 2-C

 

Written Testing-the-Waters Communications

 

[●]

 

S-2C

 

 

SCHEDULE 3

 

List of Lock-Up Parties

 

S-3

 

 

EXHIBIT A

 

Form of Representative’s Warrant Agreement

 

Reference is made to Exhibit 4.2 to the Registration Statement on Form S-1 (File Number 333- [●]) of the Company, which is incorporated by reference.

  

Exhibit A

 

 

EXHIBIT B

 

Lock-Up Agreement

 

Exhibit B

 

 

EXHIBIT C

 

Form of Press Release

 

Adial Pharmaceuticals, Inc.

 

[Date]

 

Adial Pharmaceuticals, Inc. (the “Company”) announced today that Aegis Capital Corp., acting as representative for the underwriters in the Company’s recent public offering of the Company’s common stock, is [waiving] [releasing] a lock-up restriction with respect to _________ shares of the Company’s common stock held by [certain officers, directors or other security holders] [an officer, director or security holder] of the Company.  The [waiver] [release] will take effect on _________, 20___, and the shares may be sold on or after such date.  

 

This press release is not an offer or sale of the securities in the United States or in any other jurisdiction where such offer or sale is prohibited, and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act of 1933, as amended.

 

 

Exhibit C

 

EX-3.1 3 fs12017ex3-1_adialpharma.htm ARTICLES OF ORGANIZATION

Exhibit 3.1

 

ARTICLES OF ORGANIZATION

OF

ADIAL PHARMACEUTICALS, L.L.C.

 

The undersigned, desiring to organize a limited liability company (the “Company”) under the provisions of Chapter 12 of Title 13.1 of the Code of Virginia, sets forth the following:

 

ARTICLE I

Name

 

The name of the limited liability company is ADial Pharmaceuticals, L.L.C.

 

ARTICLE II

Registered Office and Agent

 

The post-office address of the initial registered office in Virginia is 321 East Main Street, Suite 400, Charlottesville, Virginia 22902 located in the City of Charlottesville. The registered agent of the Company is David L. Dallas, Jr. who is a resident of Virginia and a member of the Virginia State Bar. His business address is identical with that of the registered office.

 

ARTICLE III

Principal Office

 

The post office address of the principal office where the records will be maintained pursuant to Virginia Code Section 13.1-1028 shall be 321 East Main Street, Suite 400, Charlottesville, Virginia 22902.

 

ARTICLE IV

Manager-Managed Company

 

The Company shall be manager managed. The initial number of managers shall be one (1) until the adoption of an Operating Agreement by the members, and such initial manager shall be Bankole A. Johnson.

 

Given under my hand this 19th day of November, 2010.

 

  ORGANIZER:
   
  /s/ David L. Dallas, Jr.
  David L. Dallas, Jr.

 

 

 

EX-3.2 4 fs12017ex3-2_adialpharma.htm SECOND AMENDED AND RESTATED OPERATING AGREEMENT

Exhibit 3.2

 

SECOND AMENDED & RESTATED

 

OPERATING AGREEMENT

 

OF

 

ADIAL PHARMACEUTICALS, L.L.C.

 

 
 

 

TABLE OF CONTENTS

 

1 DEFINITIONS 1
     
2 GENERAL PROVISIONS 3
     
3 MEMBERS 4
     
4 ACTIONS BY THE MEMBERS; MEETINGS; QUORUM. 6
     
5 CLASSES OF MANAGERS, GENERAL POWERS 7
     
6 DIRECTORS 9
     
7 OFFICERS 11
     
8 CAPITAL STRUCTURE 13
     
9 ALLOCATIONS AND DISTRIBUTIONS 14
     
10 TRANSFERS OF UNITS 15
     
11 DISSOLUTION OF THE LLC 19
     
12 EXCULPATION OF LIABILITY; INDEMNIFICATION 20
     
13 MISCELLANEOUS 21

 

i
 

 

SECOND AMENDED AND RESTATED OPERATING AGREEMENT OF ADIAL PHARMACEUTICALS, L.L.C.

 

Upon due authorization and approval hereof by the Board of Directors of ADial Pharmaceuticals, L.L.C., a limited liability company organized under the laws of the Commonwealth of Virginia (hereinafter referred to as “the Company” or “the LLC”), the Company hereby enters into this Second Amended and Restated Limited Liability Company Operating Agreement (this “Agreement” or this “Operating Agreement”):

 

1. DEFINITIONS

 

As used in this Operating Agreement, the following terms are to have the meaning as stated below:

 

1.1Act” shall mean the Virginia Limited Liability Company Act, Va. Code Section 13.1-1000 et seq., as amended and in force from time to time.

 

1.2Additional Member” shall mean any Person who, after the execution of this Operating Agreement or a Member Signature Page substantially in the form attached hereto as Exhibit A, is admitted to the LLC as a Member.

 

1.3Affiliate” means, with respect to any Member, Manager or employee of the LLC, any Person that directly or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, such Member, Manager or employee and shall include any relative or spouse of such Member, Manager or employee or any relative of such Member’s, Manager’s or employee’s spouse. As used in the foregoing sentence, the term “control” means possession, directly or indirectly, of the power to direct or cause a direction of the management or policies of a Person, whether through the ownership of voting securities, by contract, or otherwise.

 

1.4Articles of Organization” or “Articles” mean the Articles of Organization of the Company filed with the Commonwealth of Virginia effective November 23, 2010, as amended from time to time.

 

1.5Board of Directors” shall mean the class of Managers whose rights, powers and authority are specified in the Board of Directors section.

 

1.6Capital Account” as of any given date shall mean the account calculated and maintained by the LLC for each Member as specified in Section 8.6 below.

 

1.7Capital Account Per Unit” shall mean the Capital Account for a Member divided by the number of Units held by the Member.

 

1.8Cause” shall mean (i) conduct (or a pattern of conduct) relating to the business or affairs of the LLC that amounts to gross negligence or willful misconduct or (ii) conviction of a crime involving fraud or dishonesty.

 

1.9Chairman” shall have the meaning set forth in Section 6.1 below.

 

 
 

 

1.10Class A Members” shall mean holders of Class A Units who shall have been admitted as Members pursuant to the provisions of this Agreement.

 

1.11Class A Units” shall have the meaning as set forth is Section 1.16. All Units outstanding as of April 8, 2013, as well as all rights to acquire Units outstanding as of April 8, 2013, are hereby denominated Class A Units or rights to acquire Class A Units, as applicable.

 

1.12Class B Members” shall mean holders of Class B Units who shall have been admitted as Members pursuant to the provisions of this Agreement.

 

1.13Class B Units” shall have the meaning as set forth is Section 1.19.

 

1.14Code” shall mean the Internal Revenue Code, viz., Title 26 of the United States Code.

 

1.15Director” shall mean a Manager who is a member of the Board of Directors.

 

1.16Executive Committee” shall have the meaning set forth in Section 6.14.2.

 

1.17LLC” means “Limited Liability Company” and “the LLC” or “the Company” means ADial Pharmaceuticals, L.L.C.

 

1.18LLC Units” or “Units” means the two classes of ownership interests in the LLC designated “Class A Units” and “Class B Units”, respectively. Each class of LLC Units shall consist of voting and nonvoting LLC Units. All LLC Units shall have equal rights, except with respect to (i) voting matters, in the case of voting versus non-voting Units as provided in Section 8.1 below, and (ii) certain preferences on distribution and liquidation, in the case of Class B Units versus other Units and related to Unreturned Capital of units of the same class, both as provided in Section 9.4 below, for all purposes under this Operating Agreement. For the avoidance of doubt, unless otherwise specified, references herein to “LLC Units” or “Units” shall mean both voting and non-voting LLC Units or Units, taken together.

 

1.19LLC Unit Percentage” means, with respect to a Member, the percentage derived from the following fraction: number of LLC Units held by such Member divided by the total number of LLC Units held by all Members (and, thereafter, multiplying said fraction by 100 to arrive at a percentage).

 

1.20       “Manager” shall mean a manager as defined in the Act.

 

1.21Member” shall mean each of the parties who executes a counterpart of this Agreement as a member of the LLC and each of the parties who may hereafter become an Additional Member or Substitute Member, so long as any such party continues to hold a Membership Interest.

 

1.22Membership Interest” shall mean the LLC Unit Percentage of a Member (or a Successor in Interest thereof).

 

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1.23Officers” shall mean the class of Managers whose respective rights, powers and duties are specified in Officers section.

 

1.24Person” shall mean any natural person or Entity, and the heirs, executors, administrators, legal representatives, successors and assigns of such Person where the context so admits.

 

1.25Profits Interest Units” means LLC Units or Units which have been identified as Profits Interests in the award agreement granting such Units to a holder thereof.

 

1.26Regulations” shall refer to all Treasury Regulations, viz., Title 26 of the Code of Treasury Regulations.

 

1.27       “State Law” means the laws of the Commonwealth of Virginia.

 

1.28Substitute Member” shall mean a Successor in Interest who is admitted to the LLC as a Member.

 

1.29Successor in Interest” shall mean a Person other than a Member who is an assignee, transferee, successor or legatee of, or who otherwise succeeds to an ownership interest in, all or any portion of a Member’s Membership Interest and who has not been admitted as a Substitute Member.

 

1.30Unreturned Capital” shall mean with respect to a Member the excess, if any, of (i) the aggregate capital contributions of such Member, over (ii) the aggregate distributions to such Member pursuant to Section 9.4 hereof.

 

2.            GENERAL PROVISIONS

 

2.1          Formation. Articles of Organization have been filed with the appropriate State office. As authorized by the Members or Directors, the Members or Managers shall execute or cause to be executed all other instruments, certificates, notices and documents as may now or hereafter be required for the formation, valid existence and, when appropriate, termination of the LLC as a limited liability company under the laws of the Commonwealth of Virginia.

 

2.2          LLC Name. The name of the LLC is “ADial Pharmaceuticals, L.L.C.” or such other name or names as may be selected by the Members from time to time, and its business shall be carried on in such name with such variations and changes as the Members deem prudent.

 

2.3          Purpose of the LLC. The purpose of the LLC is to engage in any lawful act or activity for which a limited liability company may be organized under the laws of the Commonwealth of Virginia including, but not limited to, conduct as a for profit business in the Commonwealth of Virginia.

 

2.4          Place of Business. The business address of the LLC shall be determined by the Board of Directors. The LLC may from time to time have such other place or places of business, within or without the Commonwealth of Virginia, as the Board of Directors may decide.

 

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2.5          Registered Agent. The registered agent of the LLC shall be determined by the Board of Directors, which shall also possess the power to remove or replace a currently serving LLC registered agent.

 

2.6          Business Transactions of a Member with the LLC. A Member may lend money to, borrow money from, act as surety, guarantor or endorser for, guarantee or assume one or more obligations of, provide collateral for, and transact other business with, the LLC and, subject to applicable law, shall have the same rights and obligations with respect to any such matter as a Person who is not a Member; provided, however, that such a transaction shall be on terms not less favorable to the Company than as would be generally available from an unaffiliated third party in an arms-length transaction, as determined by the Board of Directors in its sole discretion with any conflicted parties recusing themselves from the discussion and abstaining in the vote.

 

2.7          Interested Party Transactions. Pursuant to Sections 2.6 or 5.6 hereof, as applicable, an otherwise valid contract between the LLC and a Member or Manager is valid notwithstanding the fact that the Member or Manager approves of the contract on behalf of the LLC if (i) all material facts as to the contract are disclosed to or known by the Board of Directors, (ii) the contract is approved by the Board of Directors or the Executive Committee as being in the best interests of the Company and the Members as a whole and (iii) any Members or Managers that are conflicted in the transaction recuse themselves from the discussion and abstain in the vote.

 

2.8          LLC Property. No real or other property of the LLC shall be deemed to be owned by any Member individually, but shall be owned by and title shall be vested solely in the LLC.

 

2.9          No Term To Existence. The LLC’s existence shall be deemed to have commenced on the date of the filing of the Articles of Organization with the appropriate state office and, thereafter, the LLC’s existence shall be perpetual without term.

 

2.10        Accounting Period. The close of the LLC’s year for financial statement and federal income tax purposes shall be as determined by the Board of Directors.

 

3.           MEMBERS

 

3.1         Members. Those Persons holding Units, as reflected on the Company capitalization table attached hereto as Exhibit B, are all of the Members as of the date hereof. A record of the Members and the LLC Units and LLC Unit Percentage of the Members will be maintained by the LLC.

 

3.2         Admission of New Members. New Members may be admitted to the LLC by the Board of Directors.

 

3.3         No Liability of Members. All debts, obligations and liabilities of the LLC, whether arising in contract, tort or otherwise, shall be solely the debts, obligations and liabilities of the LLC, including a debt, obligation or liability under a judgment, decree or order of a court, and no Member shall be obligated personally for any such debt, obligation or liability of the LLC solely by reason of being a Member. This Section 3.3 does not prevent a Member, should he, she or it so choose, from separately agreeing to guaranty or otherwise become liable for a debt that is also one of the LLC.

 

 4 

 

 

3.4         Access to Books and Records of LLC. Each Member shall have the right to inspect the books and records of the LLC during normal business hours after the giving of reasonable notice of this intent to the LLC custodian of said documents and information; however, each Member gaining access to the books and records of the LLC shall hold this information in confidence and use such information only for the furtherance of LLC business and interests or for making investment decisions regarding the Member’s LLC interest. Upon withdrawal or departure of a Member, such Member shall deliver all LLC books and records in his, her or its possession to the Board of Directors or its designee.

 

3.5         Members Who Are Not Individuals. Each Member who is an artificial entity or otherwise not an individual hereby represents and warrants to the LLC and each other Member of the LLC that such Member: (a) is duly incorporated or formed (as the case may be), (b) is validly existing and in good standing under the laws of the jurisdiction of its incorporation or formation, and (c) has full power and authority to execute and deliver this Agreement and to perform its obligations hereunder.

 

3.6          Additional Terms Applicable to Profits Interest Units.

 

3.6.1The Board of Directors may, in its sole discretion, issue Profits Interest Units to employees, consultants or advisors of the Company. The issuance of Profits Interest Units shall be made pursuant to this Operating Agreement, and such issuance may also be governed by the terms and conditions set forth in an award agreement or subscription agreement.

 

3.6.2Each Profits Interest Unit is intended to be a “profits interest” within the meaning of IRS Revenue Procedures 93-27 and 2001-43 and is issued with the intention, but without the assurance, guarantee or liability on the part of the Company or any Member, that under current interpretations of the Code and Regulations the recipient will not recognize income upon the issuance or vesting of the Profits Interest Units and that neither the Company nor any Member is entitled to any deduction either immediately or through depreciation or amortization as a result of the issuance or vesting of such Profits Interest Units.

 

3.6.3As a condition precedent to the receipt of Profits Interest Units and admission as a Member, each grantee of one or more Profits Interest Units shall: (i) execute and deliver a counterpart to this Operating Agreement; and (ii) make a timely protective election under Section 83(b) of the Code.

 

3.6.4       Holders of Profits Interest Units shall not be credited with any capital contribution.

 

3.6.5Notwithstanding any provisions of this Agreement to the contrary, holders of Profits Interest Units may not transfer such Profits Interest Units for a period of two years from the date of grant.

 

3.6.6On the date of grant of any Profits Interest Units, the Board of Directors shall establish the current value of each then-outstanding LLC Unit and such value shall be set forth in the award agreement with respect to the Profits Interest Units. Unless otherwise determined by the Board of Directors, the current value of each outstanding Unit shall be equal to the per-Unit amount that would be available to distribute to the Company’s Members in a hypothetical transaction in which the Company sold all of its assets for fair market value and distributed the proceeds therefrom in liquidation of the Company pursuant to Section 11.2 of this Operating Agreement (as determined immediately prior to the issuance of the Profits Interest Units). It is intended that the current value with respect to each grant of a Profits Interest Unit hereunder shall be established in such a manner that the amount distributed to the grantee with respect to each grant of a Profits Interest Unit hereunder, in a hypothetical liquidation of the Company as of the date of grant thereof, would be equal to $0.00.

 

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4.           ACTIONS BY THE MEMBERS; MEETINGS; QUORUM.

 

4.1         Annual Meeting. The annual meeting of Members shall be called by the Chairman or by resolution of the Board of Directors for the purpose of electing Directors and transacting such other business as may properly come before the meeting.

 

4.2         Special Meetings. Special meetings of the Members, for any purpose or purposes, unless otherwise prescribed by statute, shall be called by the Secretary at the request of (a) a majority of the Directors or (b) any Member or combination of Members holding a majority of the Units entitled to vote. At a special meeting, any business of the Members may be transacted, but only as stated in the notice of the meeting.

 

4.3         Place of Meetings. The Board of Directors may designate any place within or outside of the Commonwealth of Virginia as the place of meeting for any meeting of the Members. If no designation is made, the place of meeting shall be the principal office of the LLC.

 

4.4         Notice of Meetings. Written notice stating the place, day and hour of the meeting and the purpose or purposes for which the meeting is called shall be delivered to each Member entitled to vote at such meeting no fewer than ten (10) nor more than sixty (60) days before the day of the meeting, by either personal delivery, facsimile machine, electronic mail or U.S. mail, as determined by the Board of Directors or the Person(s) calling the meeting.

 

4.5         Meeting of All Members. If all the Members entitled to vote shall meet at any time and place, either within or outside of the Commonwealth of Virginia, and consent is given to the holding of a meeting at such time and place, such meeting shall be valid without call or notice, and at such a meeting any lawful action may be taken.

 

4.6         Record Date. For the purpose of determining Members entitled to receive notice of any meeting of Members or any adjournment thereof, to vote at any such Meeting or to receive payment of any distribution—or for the purpose of determining Members for any other reason—the date on which notice of the meeting is mailed or the date on which the resolution declaring such distribution or taking such other action is adopted, as the case may be, shall be the record date for such determination of Members. When a determination of Members entitled to vote at any meeting of Members has been made as provided in this Section 4.6, such determination shall apply to any adjournment thereof.

 

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4.7         Quorum; Manner of Acting. Members holding at least a majority of all Units entitled to vote at a meeting of the Members, represented in person or by proxy, shall constitute a quorum at any meeting of Members. At any duly noticed meeting at which a quorum is present, the affirmative vote of the majority of all Units present and entitled to vote shall constitute the act of the Members unless a greater number is required herein or by law. In the absence of a quorum at any meeting of the Members, those voting a majority of the Units present and entitled to vote at such meeting may adjourn the meeting from time to time for a period not to exceed sixty (60) days without further notice other than the announcement at the meeting of the new date, time, and place. However, if the adjournment is for more than sixty (60) days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each Member of record entitled to vote at the meeting. At such adjourned meeting at which a quorum shall be present or represented, any business may be transacted which might have been transacted at the meeting as originally noticed.

 

4.8          Proxies. At all meetings of Members, a Member may vote such Member’s Units entitled to be voted in person or by proxy executed in writing by the Member or by a duly authorized attorney-in-fact. Such proxy shall be filed with the Secretary before or at the time of the meeting. No proxy shall be valid after eleven (11) months from the date of its execution, unless otherwise provided in the proxy.

 

4.9          Action by Members Without a Meeting. Any action required or permitted to be taken at a meeting of Members may be taken without a meeting if one or more written consents to such action are signed by Members holding more than fifty percent (50%) of the Units entitled to vote and such consent or consents are filed with the minutes of the proceedings of the Members. Action taken under this Section 4.9 becomes effective when Members holding more than fifty percent (50%) of the Units entitled to vote have signed the consent or consents, unless the consent or consents specify a different effective date. The record date for determining Members entitled to take action without a meeting shall be the date the first Member signs a written consent.

 

4.10        Waiver of Notice. When any notice is required to be given to any Member, a waiver thereof in writing signed by the Member entitled to such notice, whenever signed, shall be equivalent to the giving of such notice.

 

4.11        Voting Rights of Members. Except as otherwise provided herein or as required by law, each Member shall be entitled to vote based on the number of voting Units held by such Member (at a rate of one vote per voting Unit) immediately after the close of business on the record date fixed for any meeting of Members or action by written consent without a meeting, as provided in this Article 4. The holders of nonvoting Units shall not have the right to vote such nonvoting Units except as may be otherwise expressly required by law.

 

5.            CLASSES OF MANAGERS, GENERAL POWERS

 

5.1          Classes of Managers. The LLC shall have two classes of Managers – Directors and Officers.

 

5.2          General Powers of Board of the Directors. All powers of the LLC shall be exercised by or under the authority of, and the business and affairs of the LLC shall be managed under the direction of the Directors constituting the Board of Directors of the LLC, to the extent not inconsistent with the Act, the Articles or the express provisions of this Operating Agreement.

 

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5.3          General Powers of the Officers. The Officers of the LLC shall carry out the policies, directions, orders and resolutions of the Board of Directors in the manner described in this Operating Agreement and as authorized and directed by the Board of Directors from time to time, to the extent not inconsistent with the Act, the Articles or the express provisions of this Operating Agreement.

 

5.4          Limited Authority. Unless authorized to do so by this Operating Agreement or by the Board of Directors of the LLC, no Member, Manager, agent, or employee of the LLC shall have any power or authority to bind the LLC in any way.

 

5.5          Managers Have No Exclusive Duty to LLC. A Manager shall not be required to manage the LLC as his sole and exclusive function, and subject to Section 5.7 below, he may have other business interests and consultancies and may engage in other activities in addition to those relating to the LLC. Neither the LLC nor any Member shall have any right, solely by virtue of this Agreement, to share or participate in such other investments or activities of any Manager or to the income or proceeds derived therefrom.

 

5.6         Transactions with Managers. The Board of Directors (a) may appoint, employ, contract or otherwise deal with any Person, including a Manager or an Affiliate thereof, and with Persons in which a Manager has a financial interest, for the purpose of transacting the LLC’s business, including the performance of any and all services or purchases of goods or other property which may at any time be necessary, proper, convenient or advisable in carrying on the business and affairs of the LLC or in disposing of some or all of its assets; and (b) may otherwise enter into business transactions (including but not limited to the sale, merger, or other disposition of the LLC or all or substantially all of its assets) with any such Persons. Notwithstanding the foregoing, such relationships or transactions shall be on terms not less favorable to the LLC than as would be generally available from an unaffiliated third party in an arms-length relationship or transaction, as determined by the Executive Committee acting in good faith and in its sole discretion.

 

5.7          Competitive Activities by Managers. If a Manager is involved in an activity that is directly or indirectly competitive with the business of the LLC, such Manager shall promptly disclose any such activity to the Board of Directors, including the scope and extent to which such activity may be competitive with the business of the LLC. Consultancy agreements between full-time Officers and other parties require the approval of the Board of Directors. No Manager shall knowingly and willfully subvert, undermine, or interfere with any business relationship or business initiative of the LLC. Furthermore, no Manager may disclose any confidential information, trade secret, or anything else that the LLC considers proprietary, unless such disclosure is required in the ordinary course of performing his duties as a Manager.

 

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6.            DIRECTORS

 

6.1          Initial Director; Chairman of the Board of Directors. The Initial Director shall be Bankole A. Johnson, whose term as a Director shall be perpetual until his death, resignation or removal pursuant to Section 6.5. Bankole A. Johnson also shall serve as the Chairman of the Board of Directors (the “Chairman”) so long as he is serving as a Director and desires to hold such position. The Chairman shall preside over all meetings of the Board of Directors at which he is present and (except as expressly provided herein) shall have a vote on all matters brought before or subject to the authority of the Board. Except as may be expressly assigned or delegated to him by the Board, the Chairman shall not have any executive or supervisory authority over the LLC’s business affairs or officers (other than through the Board in his capacity as Chairman). In the event Bankole A. Johnson shall no longer be serving as Chairman (whether by reason of his death, resignation or removal), a successor Chairman may be appointed by majority vote of the other Directors then serving.

 

6.2          Number of Directors. The Board of Directors shall at all times consist of a number of Directors no fewer than five (5) and no more than nine (9), which number shall be set from time to time by resolution of the Members; provided that the Board of Directors shall consist of nine (9) Directors unless and until otherwise determined by resolution of the Members.

 

6.3          Tenure; Qualifications; Election. Directors shall be elected by the Members and (other than Bankole A. Johnson) shall serve for a term of two (2) years or, if later, until their successor has been duly elected or appointed. Directors shall be natural persons over the age of eighteen (18) and need not be Members or Officers of the Company.

 

6.4          Vacancies. Any vacancy occurring in the Board of Directors for any reason may be filled either by action of a majority of the remaining Directors or by action of a Member or Members holding at least a majority of LLC Units entitled to be voted. A Director elected to fill a vacancy (other than a vacancy resulting from the expiration of a term or due to the increase in the number of members of the Board of Directors, for which Section 6.3 would apply) shall hold office until the remainder of the term of his predecessor is completed, unless otherwise specified by action of the Members or the Board of Directors. On proper notice, any Member is entitled to cumulate such Member’s votes for purposes of electing Directors, and if any Member has given such notice, all other Members shall also be entitled to cumulate their votes in such election.

 

6.5          Removal. Directors may be removed prior to the expiration of their term (i) for Cause by the vote of all other Directors then serving less one (i.e., if there are nine Directors including the Director whose removal is at issue, the vote of seven Directors would be required to remove the subject Director for Cause); or (ii) with or without Cause by the affirmative vote of a Member or Members holding at least sixty percent (60%) of all Units entitled to be voted. Cause shall be determined in good faith by the Board of Directors or Members, as applicable, by the same vote as is required for the removal of the Director.

 

6.6          Resignation. Any Director may resign at any time by giving written notice to the Chairman or the Board of Directors. Unless otherwise specified in such written notice, a resignation shall take effect upon delivery thereof to the Chairman or the Board of Directors. It shall not be necessary for a resignation to be accepted before it becomes effective.

 

6.7          Place of Meetings. The Board of Directors may hold meetings, annual, regular or special at any place or time inside or outside the Commonwealth of Virginia.

 

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6.8          Regular Meetings. Regular meetings of the Board of Directors may be held with informal notice to the members of the Board of Directors, at such time and place as may from time to time be determined by the Board of Directors.

 

6.9          Special Meetings. Any Director may call a special meeting of the Board of Directors with at least five (5) business days’ notice to each Director given by U.S. mail, personal delivery, facsimile machine or electronic mail. Such notice must state the purpose or purposes of such meeting. The initial Director (Bankole A. Johnson) must be notified of any such meeting in writing, the purpose of such a meeting must be expressed, and he must be provided with reasonable notice (no less than 5 business days) to attend or be represented by counsel at any such meeting. The Chairman may call a special meeting of the Board of Directors at any time with such notice to the Board of Directors as is reasonable under the circumstances.

 

6.10        Quorum; Manner of Acting; Adjournments. Unless otherwise expressly provided herein, at all meetings of the Board of Directors, two-thirds (2/3) of the number of Directors then in office shall constitute a quorum for the transaction of business. Unless otherwise provided herein or in the Act, the act of a majority of the Directors present at a meeting at which a quorum is present shall be the act of the Board of Directors. If a quorum is not present at any meeting of the Board of Directors, the Directors present may adjourn the meeting from time to time—without notice other than announcement at the meeting of the date, time, and place of the next meeting—until a quorum shall be present.

 

6.11        Compensation and Reimbursement of Directors. The compensation of Directors, if any, will be on such basis as is determined by the Board of Directors. Directors shall be entitled to reimbursement for any reasonable expenses incurred in attending Directors’ meetings as may from time to time be fixed by the Board of Directors. Any Director may waive compensation or reimbursement for any meeting. Any Director receiving compensation or reimbursement under these provisions shall not be barred from serving the LLC in any other capacity and receiving compensation and reimbursement for reasonable expenses for such other services.

 

6.12        Action by Written Consent. Any action required or permitted to be taken at any meeting of the Board of Directors may be taken without a meeting if a written consent to such action is presented to each Director for possible approval, and, if approved, such written consent or consents are filed with the minutes of the proceedings of the Board of Directors. Action taken under this Section 6.12 is effective when two-thirds (2/3) or more of the total number of Directors entitled to vote on such matter have signed the consent or consents, unless the consent or consents shall specify a different effective date, in which case the action shall be effective as of such date; provided that if a vote of a greater number of Directors is otherwise required (e.g., for the removal of the Initial Director), then action on written consent with respect thereto shall require such greater number of Directors; and provided further that the written consent of three-fourths (3/4) of the Directors then serving shall be required for an action involving the sale of all or substantially all the assets of the Company, its merger with or into another entity, its winding up, or the filing of any petition for relief or restructuring of under applicable bankruptcy rules.

 

6.13        Meetings by Telephone or Similar Communications. The Board of Directors (or any individual Director) may participate in a meeting by means of a telephone conference or similar communications equipment by means of which all Directors participating in the meeting can hear each other at the same time, and participation by such means shall be conclusively deemed to constitute presence in person at such meeting.

 

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6.14         Committees.

 

6.14.1Executive Committee. An “Executive Committee” of the Board of Directors is hereby established, to be comprised of two (2) or more Directors who are not Officers. The Executive Committee shall have the authority to function as an audit committee and to investigate and make recommendations to the full Board of Directors regarding any conflicts of interest (so long as no members of the Executive Committee are interested parties), internal controversies or complaints. The Board of Directors may from time to time delegate other authority to the Executive Committee. Should a member of the Executive Committee be an interested party with respect to a potential conflict of interest, determination of the existence or non-existence of a conflict shall be made by the majority of the other disinterested Directors. The initial members of the Executive Committee shall be Erik Urnes and Mark Giles. The appointment or removal of members of the Executive Committee shall be by the vote of at least sixty percent (60%) of the full Board of Directors.

 

6.14.2Committee Formation. The Board of Directors may establish such other standing or special committees or subcommittees of the Board of Directors as it may deem advisable for the efficient operation of the LLC – each committee or subcommittee consisting of not fewer than two Directors; and the members, terms and authority of such committees or subcommittees shall be as set forth in the resolutions establishing the same.

 

6.14.3Quorum and Manner of Acting. A majority of the members of any Committee serving at the time of any meeting thereof shall constitute a quorum for the transaction of business at such meeting. The action of a majority of those members present at a Committee meeting at which a quorum is present shall constitute the act of the Committee.

 

7.            OFFICERS

 

7.1          Designations. The required Officers shall be a CEO, a Secretary and a Treasurer. The Members or the Board of Directors may also establish other Officers, such as one or more Chief Officers, Vice Presidents, Assistant Secretaries and/or Assistant Treasurers and such other Officers and/or agents as they shall deem necessary or appropriate, who also shall be elected by the Board of Directors. All Officers and agents shall exercise such powers and perform such duties as shall from time to time be determined by and pursuant to the direction of the Board of Directors. Any number of offices may be held by the same person, but no person shall execute, acknowledge or verify any instrument in more than one capacity, if such instrument is required by law, the Articles or this Operating Agreement to be executed, acknowledged or verified by two (2) or more Officers.

 

7.2          Election; Term of Office; Removal. Officers shall be elected by the Board of Directors. The Officers shall hold office until their successors are chosen and shall qualify, or until their earlier death, resignation or removal. Any Officer may be removed by the Board of Directors when, in the judgment of the Board of Directors, the best interests of the LLC will be served thereby. Such removal shall be without prejudice to the contractual rights, if any, of the person so removed. The Board of Directors may fill any vacancy occurring in any office of the LLC for the unexpired portion of the applicable term.

 

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7.3          Duties. The officers of the LLC shall have such duties as generally pertain to their offices, respectively, as well as such powers and duties as are hereinafter provided or as from time to time shall be conferred by the Board of Directors. The Board of Directors may require any officer to give such bond for the faithful performance of his duties as the Board of Directors may see fit.

 

7.4          Compensation. The Board of Directors shall fix the salaries of all Officers, if any, and other compensation, from time to time, and no Officer shall be prevented from receiving such compensation by reason of the fact that he is also a Director.

 

7.5          [Not Used]

 

7.6          The Chief Executive Officer (the “CEO”). The CEO shall report to the Board of Directors. The CEO shall be the chief executive officer of the LLC, shall be responsible for the direction of the business and affairs of the LLC and oversight of the Officers and employees, and shall be primarily responsible for the implementation of policies of the Board of Directors. The CEO may execute in the name of the LLC Unit certificates, deeds, mortgages, bonds, contracts or other instruments except in cases where the signing and the execution thereof shall be required by law to be otherwise signed or executed. In addition, he shall perform all duties incident to the office of the CEO and such other duties as from time to time may be assigned to him by the Board of Directors.

 

7.7          The Secretary. The Secretary shall attend, when possible, all meetings of the Board of Directors and Members and record all votes and the proceedings of such meetings in a book to be kept for that purpose. He shall give, or cause to be given, notice of all meetings of Members and special meetings of the Board of Directors, and shall perform such other duties as may from time to time be prescribed by the Board of Directors, the CEO or other Officer as designated by the Board of Directors. He shall have custody of the seal of the LLC, and he, or an Assistant Secretary, shall have authority to affix the same to any instrument requiring it, and, when so affixed, the seal may be attested by his signature or by the signature of such Assistant Secretary. The Board of Directors may also, or instead, give general authority to any other Officer to affix the seal of the LLC and to attest the affixing thereof by his signature.

 

7.8          The Treasurer. The Treasurer shall have the information related to all LLC funds and other valuable effects, including securities, and shall keep full and accurate accounts of receipts and disbursements in books belonging to the LLC, shall deposit all moneys and other valuable effects in the name and to the credit of the LLC in such depositories as may from time to time be designated by the Board of Directors, taking proper vouchers for such disbursements, and shall render to the Board of Directors, the CEO or other Officer as designated by the Board of Directors, at regular meetings of the Board of Directors, or whenever the Board of Directors may require it, an account of the financial condition of the LLC.

 

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8.            CAPITAL STRUCTURE

 

8.1          Capital Structure. Except to the extent set forth in Section 3.6, the capital structure of the LLC shall consist of voting and nonvoting LLC Units, with all such LLC Units having equal rights (except with respect to voting matters and certain preferences on distribution and liquidation) under all provisions of this Operating Agreement. The subscription agreement and/or other instruments evidencing LLC Units (or rights to acquire LLC Units) shall designate whether such LLC Units are to be voting or nonvoting (provided that if LLC Units or instruments have been issued without express designation, such LLC Units shall be presumed to be voting).

 

8.2          LLC Units. LLC Units may be issued by either the Board of Directors or one or more Members holding a majority of the outstanding Units entitled to be voted. The Board of Directors shall determine, as permitted in this Operating Agreement, the class, voting and other rights, terms and conditions of all such LLC Units and any options, warrants or other rights to acquire LLC Units.

 

8.3          Additional Capital Contributions. Members may make additional capital contributions but shall not be required to do so.

 

8.4          Raising Additional Capital. Additional capital may be raised by the LLC through sales of new LLC Units at the election of the Board of Directors. The Directors shall determine, as permitted in this Operating Agreement, the voting and other rights, terms and conditions of all such LLC Units and any options, warrants or other rights to acquire LLC Units issued in connection therewith.

 

8.5          No Withdrawal of Capital Contributions. Except upon the dissolution and liquidation of the LLC as set forth herein, no Member shall have the right to withdraw its capital contributions. Furthermore, no interest shall be paid upon any Member’s Capital Account.

 

8.6          Maintenance of Capital Accounts. An individual Capital Account shall be maintained for each Member consisting of the Member’s capital contributions as (1) increased by that Member’s share of LLC profits, (2) decreased by that Member’s share of LLC losses, and (3) further adjusted as required or allowed by the Code or the Regulations, or both. In all cases, the Capital Accounts of the Members shall be accounted for in accordance with the Code and the Regulations.

 

8.7          No Pay to Play. The Company shall not, without the affirmative vote of holders of Class A Units and Class B Units holding a majority of the outstanding Class A Units and Class B Units entitled to vote thereon, perform any action which imposes any penalty (including, but not limited to, forfeiture of any rights) on holders of Class A Units or Class B Units by virtue of their holding of Class A Units or Class B Units and refusal or failure to purchase any other security of the Company.

 

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9.           ALLOCATIONS AND DISTRIBUTIONS

 

9.1         Allocations of Profits to Capital Accounts. Except as may be otherwise required by the Code or the Regulations, net profits and other items of net income and gain shall be allocated as follows:

 

(i)           First, in each year ratably to the Class B Members to the extent of all losses previously allocated to them pursuant to the provisions of Section 9.2 below, up to the amount of each such Class B Member’s Unreturned Capital as of the end of the immediately prior calendar year;

 

(ii)          Second, in each year ratably to the Class A Members to the extent of all losses previously allocated to them pursuant to the provisions of Section 9.2 below, up to the amount of each such Class A Member’s Unreturned Capital as of the end of the immediately prior calendar year;

 

(iii)         Third, to the Members with the lowest Capital Account Per Unit until all Members have the same Capital Account Per Unit; then

 

(iv)         Fourth, ratably in proportion to each Member’s LLC Unit Percentage.

 

9.2         Allocations of Losses to Capital Accounts. Except as may be otherwise required by the Code or the Regulations, net losses and other items of net loss shall be allocated as follows:

 

(i)           First, to the Members with the highest Capital Account Per Unit until all Members have the same Capital Account Per Unit; then

 

(ii)          Second, ratably in proportion to each Member’s LLC Unit Percentage.

 

9.3         Tax Allocations. In the case of any special tax allocations allowed or required under the Code or the Regulations, the method of allocation and formula determined by the Treasurer shall be followed so long as it complies with State Law, the Code, the Regulations, and fairly treats each Member. The method of tax allocation selected by the Treasurer shall be presumed to be “fair to all the members” and any Member or party challenging said allocation on these grounds shall bear the burden of proof.

 

9.4          Distributions.

 

9.4.1Subject to the provisions of Section 9.4.2, the LLC, by resolution of the Board of Directors or Members issued pursuant to this Agreement, may make distributions to the Members from time to time in amounts deemed appropriate. Such distributions shall be made:

 

(i)           First, to the Class B Members pro rata in proportion to, but no more than, the amount of their Unreturned Capital;

 

(ii)          Second, to the Class A Members pro rata in proportion to, but no more than, the amount of their Unreturned Capital;

 

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(iii)         Third, to all Members pro rata, in proportion to and in the amount necessary to cause each Member to be distributed an aggregate amount per Unit until all Members have received an equal amount of aggregate distributions on a per Unit basis after accounting for the distributions contemplated under subsection (i) above, subsection (ii) above and this subsection (iii) with Units having received the lowest amount in aggregate distributions receiving distributions first; provided, however, that to achieve the intent of the parties under this subsection (iii), it shall be assumed (for distribution accounting purposes only) that each Profit Interest holder was previously distributed the award price per unit for each Profit Interest Unit held by such holder. For sake of clarity, the Members agree that it is the intent of this subsection (iii) that amounts distributed to Members under this subsection should be to equalize on a per Unit basis the aggregate amount distributed per Unit starting with all distributions going to Units that have received the least amount in aggregate distributions until those Units are not the Units that have received the least amount in aggregate distributions and continuing in this manner until all Units have received an equal amount in aggregate distributions.

 

(iv)          Thereafter, the balance to all Members pro rata in accordance with their respective Membership Interests.

 

9.4.2Tax Distributions. Notwithstanding Section 9.4.1, to the extent the LLC has available cash, the LLC will distribute to each Member taking into account the specific tax situation of each Member to the extent known to the Board of Directors (including, but in no way limiting, net operating losses, passive losses, capital losses and carryovers of such losses from prior years) within ninety (90) days of the end of each of the LLC’s fiscal years, an amount estimated by the Board of Directors, at its reasonable discretion, to be necessary to assist with the payment of income taxes assuming each Member is a Virginia resident and in the highest marginal federal tax bracket. Distributions made under this Section 9.4.2 need not be made in accordance with Section 9.4.1, but amounts otherwise distributable to a Member pursuant to Section 9.4.1 shall be reduced by distributions made to such Member pursuant to this Section 9.4.2.

 

9.5          Family Partnership Savings Provision. Notwithstanding anything in this Operating Agreement to the contrary, should any provision of this Operating Agreement, or any act of the parties, result in violation of the family partnership provisions of Code Sec. 704(e) (as amended) or the regulations and cases thereunder, the Members may amend this Agreement, or take any other actions reasonably necessary to prevent or correct such violation.

 

10.          TRANSFERS OF UNITS

 

10.1        Transfer Generally. No holder of any Unit shall, directly or indirectly, transfer, sell, give, encumber, assign, or otherwise deal with or dispose of all or any part of his LLC Units now owned or subsequently acquired, other than as permitted by this Agreement. Any transfer in violation of and without full compliance with this Agreement shall be void ab initio and without legal effect.

 

10.2        Permitted Transfers. A Member (but not a Successor in Interest) may transfer all or a portion of his LLC Units to (i) a spouse, ancestor, lineal descendant or trust or entity solely for the benefit of one or more of the foregoing persons or the Member, (ii) another Member or an Affiliate of a Member, or (iii) one or more other transferees in connection with the Member’s exercise of his Co-Sale Rights provided in Section 10.7 below. In the event of a Member’s death, the Member’s LLC Units will be transferred to such Member’s heirs and/or beneficiaries. A transfer pursuant to this Section 10.2 (a “Permitted Transfer”) will not be subject to Section 10.3 below, but will be subject to all other sections except as otherwise provided in this Agreement.

 

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10.3 Right of First Opportunity.

 

10.3.1If a holder of any Unit wishes to transfer all or any portion of his LLC Units (an “Offering Holder”), the Offering Holder shall, before making any such disposition, first give the LLC a selling notice, specifying in writing the identity of the proposed buyer and the price, conditions and terms upon which he is willing to sell such LLC Units. The LLC shall have the option to purchase all of the offered LLC Units at the price and upon the conditions and terms set forth in such notice in the manner described herein.

 

10.3.2The LLC shall have thirty (30) days from the date of the selling notice within which to elect to purchase all of the offered LLC Units. The closing of the purchase shall be not more than sixty (60) days from the date of the selling notice.

 

10.3.3If the LLC does not elect to purchase all of the offered LLC Units, then the Offering Holder may, subject to Sections 10.4 and 10.5 below, sell to the identified buyer such LLC Units at a price not below nor upon terms more advantageous than those contained in the selling notice. If such sale is not made and consummated within ninety (90) days after the date of the selling notice, the Offering Holder may not thereafter sell or otherwise dispose of any of his LLC Units without again complying with Sections 10.3.1 and 10.3.2.

 

10.4 Rights of Successor in Interest; Admittance as Substitute Member.

 

10.4.1No Successor in Interest of the whole or any portion of any LLC Units shall have the right to participate in the management of the business and affairs of the LLC or to become a Substitute Member in place of his predecessor in interest with respect to the whole or any portion of said LLC Units without the prior consent of at least two thirds (2/3) of the Directors then in office or any Member or combination of Members holding a majority of the Units entitled to vote, which consent shall be in the Members’ respective sole discretion and be binding and conclusive on all parties. A Successor in Interest shall be bound by, and shall take such LLC Units subject to, the terms and conditions of this Agreement as apply to Members and their LLC Units, but a Successor in Interest shall not have any right to vote the Units or any other rights or privileges of a Member hereunder (including but not limited to the right to participate in the Members’ right of first opportunity set forth in Section 10.3 above) other than to share in the allocations and distributions to which the transferor of the LLC Units would be entitled in respect of the transferred LLC Units unless and until such Successor in Interest is admitted as a Substitute Member in accordance with the provisions of this Section 10.4 and Section 10.5 hereof. Notwithstanding the provisions of this Section 10.4, any transferee who acquires his LLC Units in a transaction subject to the provisions of Section 10.6 or 10.7 shall immediately become a Substitute Member upon compliance with the provisions of Section 10.5 below and shall not be required to obtain the prior written consent of the Members.

 

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10.4.2Notwithstanding anything herein to the contrary, any Successor in Interest of the whole or any portion of any LLC Units as a result a Member’s death (pursuant to a Permitted Transfer under Section 10.2) shall become a Substitute Member without further action and will be bound by this Agreement and all of its terms.

 

10.5        Requirements for Substitute Members. As a condition to the admission as a Substitute Member with respect to the whole or any portion of any LLC Units, a Successor in Interest shall execute and acknowledge such instruments in form and substance as the Board of Directors reasonably deems necessary or desirable to effect such admission and to confirm the agreement of such Person being admitted as a Substitute Member to be bound by all of the terms of this Operating Agreement, as the same may have been amended and then in force. Such Successor in Interest shall pay all reasonable expenses of the LLC in connection with such admission as a Substitute Member, including, but not limited to, legal fees and the cost of preparing, filing and publishing any amendment to the Articles if deemed by the Board of Directors to be necessary or desirable in connection therewith.

 

10.6        Drag Along Rights. Subject to the right of first opportunity described in Section 10.3 above, if one or more Members holding at least two thirds (2/3) of the LLC Units entitled to be voted determine by affirmative vote to transfer all (but not less than all) of their LLC Units (for purposes of this Section 10.6, “Selling Members”) to a third party, the other holders of any LLC Units hereunder shall, upon written demand by the Selling Members to all such holders and to the LLC, be obligated to sell all of their LLC Units, at the same price, and upon the same terms and conditions as are to be paid and given to the Selling Members. In the event that the Selling Members exercise their rights under this Section 10.6, the Chairman or other designee of the Board of Directors shall have the Power of Attorney as set forth in Section 13.3 below to transfer the LLC Units of all the holders of any LLC Units subject to the proposed transfer. Consideration for such LLC Units may be held in trust by the Board of Directors pending such action by the holders as the Board of Directors may reasonably require.

 

10.7        Co-Sale Rights. Subject to the right of first opportunity described in Section 10.3 above, if the holder or holders of a majority of the LLC Units shall determine to transfer a majority of the outstanding LLC Units to a third party (the “Offered Interest”) other than in accordance with Section 10.2 above (for purposes of this Section 10.7, “Selling Members”), the other Members (the “Non-selling Members”) shall have the right to offer and sell a pro rata portion of the Offered Interest determined by multiplying the Offered Interest by such Non-selling Member’s Membership Interest at the time of the proposed sale (the “Co-Sale Interest”); provided that each Non-selling Member agrees to make substantially the same representations, warranties, covenants and indemnities and other similar agreements relating to title to their LLC Units as the Selling Members agree to make in connection with the proposed transfer of their LLC Units. If not all of the Non-selling Members wish to exercise their Co-Sale Rights, then each Non-selling Member exercising his Co-Sale Rights shall have the right to sell an additional number of his LLC Units equal to (i) the Offered Interest times (ii) the number of his LLC Units divided by the aggregate number of LLC Units owned by the Selling Members and the other Members exercising their Co-Sale Rights expressed as a percentage. The Co-Sale Interest exercised under the Members’ Co-Sale Rights shall reduce the percentage of the Selling Members’ LLC Units included in the Offered Interest pari passu. Prior to any sale under this Section 10.7, however, the Selling Members shall give notice to the other Members of their Co-Sale Rights, and the Non-selling Members shall have fifteen (15) days after receipt of such notice to determine if they desire to offer their LLC Units to the third party acquiring the Selling Members’ LLC Units. In the event the Selling Members fail to give the Non-selling Members the notice required hereunder, the Selling Members hereby agree, jointly and severally, to purchase, upon request, for cash, payable immediately, that portion of the Non-selling Members’ LLC Units that they would have been entitled to sell pursuant to the terms hereof, at a purchase price equal to the aggregate consideration received by the Selling Members for an equivalent number of LLC Units.

 

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10.8        IPO. In connection with an initial public offering, the LLC may be converted to or merged into a corporation and the LLC Units may or may not be converted into shares of stock or other securities (in any event, for purposes of this Section 10.8, “Securities”). In such event, the Members hereunder, as Security holders, agree that each shall have the right and opportunity to participate on a pro rata basis in accordance with their Membership Interest (or comparable Securities’ interest) in any public offering of Securities in which previously outstanding Securities are included for sale pursuant to a registration statement for any of such Securities. In the event of an initial public offering of Securities by the LLC or its successor, each holder of Securities further agrees that in connection with any registration of Securities by the LLC and upon request of the Board of Directors or underwriters managing any underwritten offering, such holder will not sell long, sell short, grant any purchase option, loan, pledge or otherwise hypothecate, encumber, or dispose of any Securities (other than those included in the registration) without the prior written consent of the LLC or such underwriters, as the case may be, for such period of time (not to exceed one hundred eighty (180) days after the effective date of the registration statement for such registered public offering) as the underwriters or the Board of Directors may specify.

 

10.9        Tax Reporting. Each holder of any LLC Units agrees that if he transfers or assigns all or part of his LLC Units as specified herein, such holder shall keep a list containing the transferee’s name, address, social security number or taxpayer identification number, as the case may be, the date on which such transfer occurred and the name, address and tax shelter registration number of the LLC. If a holder of any LLC Units does not want to maintain such list, such holder shall (a) send the aforementioned information to the Secretary of the LLC who shall keep a list of transferees of LLC Units and (b) give a copy of this Section 10.9 to the transferee.

 

10.10       Absolute Prohibition. Notwithstanding the above, (a) LLC Units shall not be assigned, transferred or otherwise disposed of and (b) the respective rights of any holders of any LLC Units to distributions hereunder, in whole or in part shall not be pledged, encumbered or assigned under any circumstances if, as a result of (a) or (b), the LLC would be terminated for federal income tax purposes in the opinion of counsel for the LLC. Any such attempted assignment, transfer or other disposition shall be void ab initio and shall be of no force and effect whatsoever.

 

10.11       Admission of New Member. With the approval of the Board of Directors, any Person may become an Additional Member by the issuance of new LLC Units in exchange for such consideration as the Board of Directors shall determine appropriate; provided, that such Person executes such instruments as the Board of Directors deems necessary or desirable to effect its admission as a Member and to confirm its agreement to be bound by all the terms and conditions of this Operating Agreement.

 

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10.12       Allocations to New Members. No Additional Member or Substitute Member or Successor in Interest shall be entitled to any retroactive allocation of items of taxable income, gain, loss, deductions or credits of the LLC. The Board of Directors may, at its option, at the time an Additional Member or Substitute Member is admitted, or a Successor in Interest receives a Membership Interest, close the LLC books (as though the LLC’s tax year had ended) or make pro rata allocations of income, gain, loss, deductions or credits to an Additional Member or Substitute Member or Successor in Interest for that portion of the LLC’s tax year in which an Additional Member or Substitute Member was admitted or Successor in Interest received his Membership Interest, in accordance with the provisions of Section 706(d) of the Code and the regulations promulgated thereunder.

 

11.          DISSOLUTION OF THE LLC

 

11.1        Dissolution. The LLC shall be dissolved only upon the occurrence of one of the following events (each separately, a “Liquidation Event”):

 

11.1.1     A vote to dissolve the LLC by a group of one or more Members together holding a majority of the Units entitled to vote;

 

11.1.2     The death of all Members;

 

11.1.3     The final, non-appealable order of a court order of competent jurisdiction that the LLC be dissolved.

 

11.2         Liquidation.

 

11.2.1      Should a Liquidation Event occur, the LLC shall then be liquidated and its affairs shall be wound up—including preparation of final financial statements and an accounting—by (or at the direction of) the Members. All proceeds from the liquidation shall be distributed in accordance with State Law, and all LLC Units shall, thereafter, be canceled. The LLC’s assets (including any cash on hand) shall be distributed to the Members on a pro rata basis in accordance with their respective Capital Accounts after giving effect to all contributions, allocations and distributions for all periods; provided, however, in the event that, upon liquidation, there would otherwise be any conflict between a distribution pursuant to the Members’ respective Capital Account balances and the intent of the Members with respect to the distribution of proceeds as provided in Section 9.4.1, the Board of Directors (or the person or persons carrying out the liquidation) shall, notwithstanding the provisions of the other sub-sections of this Section 11, allocate to Members gains, profits and losses (including items thereof) in a manner that will, as nearly as possible, cause the distribution of liquidation proceeds to the Members to be in accordance both with the Members’ economic expectations as set forth in Section 9.4.1 and their respective Capital Account balances. If the LLC’s gains, profits and losses are insufficient to cause the Members’ Capital Accounts to be in such amounts as will permit liquidation proceeds to be distributed both in accordance with the Members’ respective Capital Account balances and Section 9.4.1, then the liquidation proceeds shall be distributed in accordance with the Members’ respective Capital Account balances after the allocations described herein have been made. Notwithstanding the foregoing provisions to the contrary, no distributions shall be made hereunder to each respective holder of a Profits Interest Unit unless and until an aggregate amount equal to the current value of each outstanding LLC Unit on the date of grant of such Profits Interest Unit has been distributed without such holder of Profits Interest Units participating (directly or indirectly) in such distributions. For purposes of clarity, if there were 100,000 LLC Units outstanding on the date of grant of the Profits Interest Unit, each having a current value of $1.00, the holder of such Profits Interest Unit would not be entitled to share in the first $100,000 of distributions pursuant to this Section 11.2.1. In addition to the modifications of the allocation provisions described above with respect to complying with the intent of Section 9.4.1, all allocations of gains, profits and losses (including items thereof) on liquidation shall be allocated among the Members so as to nearly as possible reflect the intent of the preceding provisions of this Section 11.2.1 and 9.4.1 as modified by the immediately preceding two sentences. Notwithstanding anything else in this Agreement to the contrary, the Members hereby agree that in the event of any sale of the Company as a whole (pursuant to a merger of sale of all or substantially all of the Membership Interests), they shall allocate the proceeds of such sale among themselves so to reflect, as nearly as possible, the intent of this Section 11.2.1 in its entirety.

 

 19 

 

 

11.2.2      Final distributions to Members shall not be made until all liabilities have been satisfied and any known contingent claims against the LLC have been resolved.

 

11.2.3      Upon the completion of the liquidation and distribution of the LLC’s assets, the LLC shall be terminated and the Managers shall cause the LLC to execute and file a certificate of cancellation in accordance with State Law.

 

12. EXCULPATION OF LIABILITY; INDEMNIFICATION

 

12.1        Exculpation of Liability. Unless otherwise provided by law or expressly assumed, a Person who is a Member or Manager, or both, shall not be liable for the acts, debts or liabilities of the LLC to third-parties--i.e., Persons other than the LLC or the Members.

 

12.2        Indemnification. Except as otherwise provided in this Section 12.2, the LLC shall indemnify any Member or Manager (and may indemnify any employee or agent) of the LLC who was or is a party or is threatened to be made a party to a potential, pending or completed action, suit or proceeding, whether civil, criminal, administrative, or investigative, and whether formal or informal, including, without limitation, an action by one or more Members—other than an action by or in the right of the LLC itself—by reason of the fact that such Person is or was a Member, Manager, employee or agent of the LLC. Indemnification shall be limited to expenses, including attorney’s fees, judgments, penalties, fines, and amounts paid in settlement actually and reasonably incurred by such Person in connection with the action, suit or proceeding, unless the misconduct for which such Person is found liable was intentional or malicious. For Persons other than Members or Managers of the LLC, indemnification shall be made only after an affirmative vote of a majority of the Directors.

 

 20 

 

 

13.          MISCELLANEOUS

 

13.1        Amendment.

 

13.1.1By the Board of Directors. Except as otherwise provided herein, by law, or in the Articles of Organization, this Agreement may be amended or altered by majority vote of the full Board of Directors.

 

13.1.2By the Members. Except as otherwise provided herein, by law, or in the Articles of Organization, this Agreement may be amended or altered by vote of one or more Members holding a majority of the outstanding Units entitled to vote.

 

13.1.3Amendment Limitation. Notwithstanding the foregoing provisions of this Section 13.1, no amendment to this Operating Agreement shall alter or change the rights and privileges, including without limitation as to allocations of profits and losses and distributions, of the Class B Units as compared to the Class A Units so as to adversely affect such Class B Units without the vote or written consent of the holders of not less than a majority of the then outstanding Class B Units, voting as a separate class, including as outstanding, solely for the purpose of such vote or consent, the number of Class B Units directly issuable, at the time of such vote or consent, upon exercise of that certain Warrant dated October 26, 2013 issued to Cato BioVentures (the “Cato Warrant”) as though the Cato Warrant were exercised at such date with respect to such Class B Units; provided, however, for avoidance of doubt, no such voting right shall be attributable to any warrant to purchase Class B Units that is issuable upon the exercise of the Cato Warrant (each, a “Secondary Warrant”) and no holder of any such Secondary Warrant shall be entitled to vote with respect to such Secondary Warrant for this or any other purpose until such Secondary Warrant shall have been duly exercised in accordance with its respective terms; and provided further, however, that notwithstanding the foregoing provisions of this Section 13.1.3, nothing in this Section 13.1.3 shall prevent the Company from authorizing and issuing, without the requirement of any vote or consent of the Class B Units issued or deemed issued under the Cato Warrant pursuant to this Section 13.1.3, a new class of Units (or rights to acquire Units) with rights and privileges that are senior to or on parity with the Class B Units, including without limitation as to allocations of profits and losses and distributions.

 

13.2        Execution of Additional Instruments. Each Member hereby agrees to execute such other and further statements of interest and holdings, designations, powers of attorney and other instruments as necessary to comply with any laws, rules or regulations.

 

13.3        Power of Attorney.

 

13.3.1     Each Member hereby makes, constitutes and appoints the LLC’s CEO or other designee of the Board of Directors and any successor to any of them, its true and lawful attorney for it and in its name, place and stead to make, execute, sign, acknowledge, and swear to, any instruments on behalf of the Member with respect to any and all matters upon which a sufficient vote has been achieved pursuant to the terms of the Agreement, notwithstanding the Member’s vote on the matter.

 

13.3.2     The foregoing grant of authority is hereby declared irrevocable and the power coupled with an interest and shall survive the death or incapacity of any Member and the assignment by any Member of his LLC Units; provided that in the event of such assignment, the power of attorney of such Member shall survive such assignment

 

 21 

 

 

13.4         Construction. Whenever the singular number is used in this Agreement and when required by the context, the same shall include the plural, and the masculine gender shall include the feminine and neuter genders, and vice versa. All pronouns and all variations thereof shall be deemed to refer to the masculine, feminine, or neuter, singular or plural, as the context in which they are used may require.

 

13.5        Headings. The headings in this Agreement are inserted for convenience only and are in no way intended to describe, interpret, define, or limit the scope, extent or intent of this Operating Agreement or any provision hereof.

 

13.6        Waivers. The failure of any party to seek redress for violation of or to insist upon the strict performance of any covenant or condition of this Operating Agreement shall not prevent a subsequent act, which would have originally constituted a violation, from having the effect of an original violation.

 

13.7        Rights and Remedies Cumulative. The rights and remedies provided by this Operating Agreement are cumulative and the use of any one right or remedy by any party shall not preclude or waive the right to use any or all other remedies. Said rights and remedies are given in addition to any other rights the parties may have by law, statute, ordinance or otherwise.

 

13.8        Heirs, Successors and Assigns. Each and all of the covenants, terms, provisions and agreements herein contained shall be binding upon and inure to the benefit of the parties hereto and, to the extent permitted by this Operating Agreement, their respective heirs, legal representatives, successors and assigns.

 

13.9        Counterparts. This Agreement may be executed in several counterparts with the same effect as if the parties executing the several counterparts had all executed one single document.

 

13.10      Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Virginia, except that area known as “Choice of Law.” Each Member, by signing this agreement, hereby submits to personal and subject matter jurisdiction to the state courts in the Commonwealth of Virginia, and waives any claim of inconvenient forum, for any dispute between or among the Members, the LLC, and/or the Managers connected to or regarding the business of, or investment in, the LLC.

 

13.11      Severability; Standard for Interpretation. If it shall be determined by a court or other competent body that any provision or wording of this Agreement shall be invalid or unenforceable under state or other applicable law, such invalidity or unenforceability shall not invalidate the entire Agreement. Whenever two or more interpretations of the provisions or wording of this Agreement shall be possible, the interpretation or construction which leads to the enforcement and validity of any provision of this Agreement shall be favored and deemed to be the intended interpretation of the parties to this Agreement. To the extent that this Agreement is in conflict with the Act or the Articles, the Act shall control, then the Articles, then this Agreement; provided, however, that only that portion in conflict shall be made consistent, and the rest of the Agreement shall remain in full force and effect as if the conflict had not existed.

 

13.12      Entire Agreement. This Agreement (and any Exhibits or other documents herein referenced) constitutes the entire agreement and understanding among the LLC, its Members and its Managers with respect to the subject matter hereof and supersedes any and all prior agreements or understandings, whether oral or written, with respect to the subject matter hereof.

 

[Signature page follows]

 

 22 

 

 

IN WITNESS WHEREOF, the Company, by its undersigned duly authorized officer, hereby executes this Agreement effective as of the date first above written.

 

ADIAL PHARMACEUTICALS, L.L.C.  
   
/s/ William B. Stilley, III  
By: William B. Stilley, III  
Title: Chief Executive Officer  

 

 23 

 

 

EXHIBIT A

ADIAL PHARMACEUTICALS, L.L.C.

MEMBER SIGNATURE PAGE

 

In consideration for the sale of LLC Units in ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “LLC”), to the undersigned, the undersigned hereby approves and consents to, and agrees to be bound by, the terms of that certain Amended and Restated Operating Agreement of the LLC effective __________ __, 201_, as may be amended and/or restated from time to time (the “Operating Agreement”), and concurrently herewith enters into the Operating Agreement by executing and delivering to the LLC this Member Signature Page.

 

Upon the undersigned’s execution and delivery of this Member Signature Page, the undersigned’s delivery of any monies and/or other items required by management of the LLC, and acceptance of this Member Signature Page by the LLC, the undersigned shall become a Member of the LLC.

 

Date: ________________, 20____

 

  [Name(s) of Purchaser(s)/Transferee(s)] *
   
  (Signature)     
     
  Name(s):  
     
     
     
  Social Security #:  
     
  Social Security #:  
     
  MAILING ADDRESS:  
     
     
     
     
     
     
     
  Email Address:  

 

Accepted on behalf of

ADial Pharmaceuticals, L.L.C.

 

By:    
     
Name:    
     
Title:    

 

* If the signatory is purchasing LLC Units jointly with another, all such joint owners must execute this Member Signature Page.

 

A-1

EX-3.3 5 fs12017ex3-3_adialpharma.htm FORM OF CERTIFICATE OF INCORPORATION

Exhibit 3.3

 

CERTIFICATE OF INCORPORATION

 
OF

 
ADIAL PHARMACEUTICALS, INC.

 

 

 

The undersigned, a natural person (the “Sole Incorporator”), for the purpose of organizing a corporation to conduct the business and promote the purposes hereinafter stated, under the provisions and subject to the requirements of the laws of the State of Delaware hereby certifies that:

 

ARTICLE I

NAME

 

The name of this Corporation is Adial Pharmaceuticals, Inc. (the “Corporation”).

 

ARTICLE II

REGISTERED OFFICE AND AGENT

 

The registered office of the Corporation in the State of Delaware shall be established and maintained at the office of The Corporation Trust Company, 1209 Orange Street, Wilmington, Delaware 19801, County of New Castle, and The Corporation Trust Company shall be the registered agent of the Corporation in charge thereof.

 

ARTICLE III

PURPOSE

 

The purpose of this Corporation is to engage in any lawful act or activity for which a Corporation may be organized under the General Corporation Law of the State of Delaware or any applicable successor act thereto, as the same may be amended from time to time (“DGCL”).

 

ARTICLE IV

CAPITAL STOCK

 

A.       This Corporation is authorized to issue two classes of stock to be designated, respectively, “Common Stock” and “Preferred Stock.” The total number of shares which the Corporation is authorized to issue is Fifty-Five Million (55,000,000) shares. Fifty Million (50,000,000) shares shall be Common Stock, each having a par value of one-tenth of one cent ($0.001). Five Million (5,000,000) shares shall be Preferred Stock, each having a par value of one-tenth of one cent ($0.001).

 

 

 

B.       The Preferred Stock may be issued from time to time in one or more series. The Board of Directors is hereby expressly authorized to provide for the issue of all of any of the shares of the Preferred Stock in one or more series, and to fix the number of shares and to determine or alter for each such series, such voting powers, full or limited, or no voting powers, and such designation, preferences, and relative, participating, optional, or other rights and such qualifications, limitations, or restrictions thereof, as shall be stated and expressed in the resolution or resolutions adopted by the Board of Directors providing for the issuance of such shares and as may be permitted by the DGCL. The Board of Directors is also expressly authorized to increase or decrease the number of shares of any series subsequent to the issuance of shares of that series, but not below the number of shares of such series then outstanding. In case the number of shares of any series shall be decreased in accordance with the foregoing sentence, the shares constituting such decrease shall resume the status that they had prior to the adoption of the resolution originally fixing the number of shares of such series. The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the voting power of the stock of the Corporation entitled to vote thereon, without a separate vote of the holders of the Preferred Stock, or of any series thereof, unless a vote of any such holders is required pursuant to the terms of any certificate of designation filed with respect to any series of Preferred Stock.

 

ARTICLE V

BOARD OF DIRECTORS

 

For the management of the business and for the conduct of the affairs of the Corporation, and in further definition, limitation and regulation of the powers of the Corporation, of its directors and of its stockholders or any class thereof, as the case may be, it is further provided that:

 

A.       Board of Directors. The management of the business and the conduct of the affairs of the Corporation shall be vested in its Board of Directors. The number of directors which shall constitute the Board of Directors shall be fixed exclusively by resolutions adopted by a majority of the authorized number of directors constituting the Board of Directors. In no event shall the number of directors be less than the minimum prescribed by law. The directors of the Corporation need not be elected by written ballot unless the Bylaws so provide. Directors need not be stockholders of the Corporation.

 

B.        Election of Board of Directors. Subject to the rights of the holders of any series of Preferred Stock to elect directors under specified circumstances, the Board of Directors shall be and is divided into three classes, designated Class I, Class II and Class III. Each class shall consist, as nearly as may be possible, of one third of the total number of directors constituting the entire Board of Directors. The Board of Directors is authorized to assign members of the Board of Directors already in office to Class I, Class II or Class III at the time such classification becomes effective.

 

Subject to the rights of holders of any series of Preferred Stock to elect directors under specified circumstances, each director shall serve for a term ending on the date of the third annual meeting of stockholders following the annual meeting of stockholders at which such director was elected; provided that each director initially assigned to Class I shall serve for a term expiring at the Corporation’s first annual meeting of stockholders held after the effectiveness of this Certificate of Incorporation; each director initially assigned to Class II shall serve for a term expiring at the Corporation’s second annual meeting of stockholders held after the effectiveness of this Certificate of Incorporation; and each director initially assigned to Class III shall serve for a term expiring at the Corporation’s third annual meeting of stockholders held after the effectiveness of this Certificate of Incorporation; provided further, that the term of each director shall continue until the election and qualification of his or her successor and be subject to his or her earlier death, disqualification, resignation or removal.

 

2

 

 

C.       Removal of Directors. The Board of Directors or any individual director may be removed from office at any time (1) with cause by the affirmative vote of the holders of at least Sixty Percent (60%) of the voting power of all the then-outstanding shares of capital stock of the Corporation, entitled to vote at an election of directors; or (2) without cause by the affirmative vote of the holders of at least Sixty Percent (60%) of the voting power of all the then-outstanding shares of the capital stock of the Corporation entitled to vote generally at an election of directors.

 

D.       Vacancies. Subject to any limitations imposed by applicable law and subject to the rights of the holders of any series of Preferred Stock, any vacancies on the Board of Directors resulting from death, resignation, disqualification, removal or other causes and any newly created directorships resulting from any increase in the number of directors, shall, unless the Board of Directors determines by resolution that any such vacancies or newly created directorships shall be filled by the stockholders and except as otherwise provided by applicable law, be filled only by the affirmative vote of a majority of the directors then in office, even though less than a quorum of the Board of Directors, and not by the stockholders. Any director elected in accordance with the preceding sentence shall hold office for the remainder of the full term of the director for which the vacancy was created or occurred and until such director’s successor shall have been elected and qualified.

 

E.       Bylaw Amendments. The Board of Directors is expressly empowered to adopt, amend or repeal the Bylaws of the Corporation. Any adoption, amendment or repeal of the Bylaws of the Corporation by the Board of Directors shall require the approval of a majority of the authorized number of directors. The stockholders shall also have power to adopt, amend or repeal the Bylaws of the Corporation; provided, however, that, in addition to any vote of the holders of any class or series of stock of the Corporation required by law or by this Certificate of Incorporation, such action by stockholders shall require the affirmative vote of the holders of at least sixty-six and two-thirds percent (66 2/3%) of the voting power of all of the then-outstanding shares of the capital stock of the Corporation entitled to vote generally in the election or directors, voting together as a single class.

 

F.       Director Election. The directors of the Corporation need not be elected by written ballot unless the Bylaws so provide.

 

G.       Stockholder Action. No action shall be taken by the stockholders of the Corporation except at an annual or special meeting of stockholders called in accordance with the Bylaws. Advance notice of stockholder nominations for the election of directors and of business to be brought by stockholders before any meeting of the stockholders of the Corporation shall be given in the manner provided in the Bylaws of the Corporation.

 

H.       Committees of the Board. Pursuant to the Bylaws the Board may establish one or more committees of the Board to which may be delegated any or all of the powers and duties of the Board to the full extent permitted by law.

 

3

 

 

ARTICLE VI

LIMITATION OF LIABILITY AND INDEMNIFICATION

 

A.       Liability of Directors. The liability of the directors for monetary damages shall be eliminated to the fullest extent under applicable law.

 

B.       Indemnification. To the fullest extent permitted by applicable law, the Corporation is authorized to provide indemnification of (and advancement of expenses to) directors, officers and agents of the Corporation (and any other persons to which applicable law permits the Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise in excess of the indemnification and advancement otherwise permitted by such applicable law. If applicable law is amended after approval by the stockholders of this Article VI to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director to the Corporation shall be eliminated or limited to the fullest extent permitted by applicable law as so amended.

 

C.       Repeal or Modification. Any repeal or modification of this Article VI shall only be prospective and shall not affect the rights or protections or increase the liability of any director under this Article VI in effect at the time of the alleged occurrence of any act or omission to act giving rise to liability or indemnification.

 

ARTICLE VII

FORUM FOR ADJUDICATION OF DISPUTES

 

Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall, to the fullest extent permitted by law, be the sole and exclusive forum for (1) any derivative action or proceeding brought on behalf of the Corporation; (2) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders; (3) any action asserting a claim against the Corporation or any director or officer or other employee of the Corporation arising pursuant to any provision of the DGCL, the Corporation’s Certificate of Incorporation or the Bylaws of the Corporation; or (4) any action asserting a claim against the Corporation or any director or officer or other employee of the Corporation governed by the internal affairs doctrine. Any person or entity purchasing or otherwise acquiring or holding any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to the provisions of this Article VII.

 

ARTICLE VIII

AMENDMENT

 

The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by statute, and all rights conferred upon the stockholders herein are granted subject to this reservation.

 

ARTICLE IX

SOLE INCORPORATOR

 

The name and mailing address of the Sole Incorporator are as follows: William B. Stilley, III, 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901.

 

[Signature page follows]

 

4

 

 

IN WITNESS WHEREOF, I, the undersigned Sole Incorporator, for the purpose of forming a corporation under the laws of the State of Delaware, do make, file and record this Certificate of Incorporation, and do certify that the facts herein stated are true, and I have accordingly hereunto set my hand this [__] day of [ ], 2017.

 

  By:  
     
  Name:

William B. Stilley

Sole Incorporator

  

[Signature page to Adial Pharmaceutical, Inc. Certification of Incorporation]

 

 

5

 

 

EX-3.4 6 fs12017ex3-4_adialpharma.htm FORM OF BYLAWS

Exhibit 3.4

   

BYLAWS

OF

Adial Pharmaceuticals, inc.

 

  (A DELAWARE CORPORATION)

  

 

 

 

TABLE OF CONTENTS

 

  Page
     
ARTICLE I OFFICES 1
     
Section 1. Registered Office 1
     
Section 2. Other Offices 1
     
ARTICLE II CORPORATE SEAL 1
     
Section 3. Corporate Seal 1
     
ARTICLE III STOCKHOLDERS’ MEETINGS 1
     
Section 4. Place of Meetings 1
     
Section 5. Annual Meetings 2
     
Section 6. Special Meetings 6
     
Section 7. Notice of Meetings 7
     
Section 8. Quorum 7
     
Section 9. Adjournment and Notice of Adjourned Meetings 8
     
Section 10. Voting Rights 8
     
Section 11. Joint Owners of Stock 8
     
Section 12. List of Stockholders 8
     
Section 13. Action Without Meeting 9
     
Section 14. Organization 9
     
ARTICLE IV DIRECTORS 9
     
Section 15. Number and Term of Office 9
     
Section 16. Powers 9
     
Section 17. Election of Directors 9
     
Section 18. Vacancies 10
     
Section 19. Resignation 10
     
Section 20. Removal 10
     
Section 21. Meetings 10
     
Section 22. Quorum and Voting 11
     
Section 23. Action Without Meeting 12
     
Section 24. Fees and Compensation 12
     
Section 25. Committees 12
     
Section 26. Lead Independent Director 13
     
Section 27. Chairman 13
     
Section 28 Organization 13

  

i

 

 

Table Of Contents Continued

  

    Page
     
ARTICLE V OFFICERS 14
     
Section 29. Officers Designated 14
     
Section 30. Tenure and Duties of Officers 14
     
Section 31. Delegation of Authority 16
     
Section 32. Resignations 16
     
Section 33. Removal 16
     
ARTICLE VI EXECUTION OF CORPORATE INSTRUMENTS AND VOTING OF SECURITIES OWNED BY THE CORPORATION 16
     
Section 34. Execution of Corporate Instruments 16
     
Section 35. Voting of Securities Owned by the Corporation 17
     
ARTICLE VII SHARES OF STOCK 17
     
Section 36. Form and Execution of Certificates 17
     
Section 37. Lost Certificates 17
     
Section 38. Transfers 17
     
Section 39. Fixing Record Dates 18
     
Section 40. Registered Stockholders 18
     
ARTICLE VIII OTHER SECURITIES OF THE CORPORATION 18
     
Section 41. Execution of Other Securities 18
     
ARTICLE IX DIVIDENDS 19
     
Section 42. Declaration of Dividends 19
     
Section 43. Dividend Reserve 19
     
ARTICLE X FISCAL YEAR 19
     
Section 44. Fiscal Year 19
     
ARTICLE XI INDEMNIFICATION 19
     
Section 45. Indemnification of Directors, Executive Officers, Other Officers, Employees and Other Agents 19
     
ARTICLE XII NOTICES 22
     
Section 46. Notices 22
     
ARTICLE XIII AMENDMENTS 23
     
Section 47. Amendments 23
     
ARTICLE XIV FORUM FOR ADJUDICATION OF DISPUTES 24
     
Section 48. Forum 24

 

ii

 

 

BYLAWS

OF

ADIAL PHARMACEUTICALS, INC.
(A DELAWARE CORPORATION)

 

ARTICLE I

Offices

 

Section 1. Registered Office. The registered office of Adial Pharmaceuticals, Inc. (the “Corporation”) in the State of Delaware shall be established and maintained at the office of The Corporation Trust Company, 1209 Orange Street, Wilmington, Delaware 19801, County of New Castle, and The Corporation Trust Company shall be the registered agent of the Corporation in charge thereof.

 

Section 2. Other Offices. The Corporation shall also have and maintain an office or principal place of business at such place as may be fixed by the Board of Directors, and may also have offices at such other places, both within and without the State of Delaware as the Board of Directors may from time to time determine or the business of the Corporation may require.

 

ARTICLE II

Corporate Seal

 

Section 3. Corporate Seal. The Board of Directors may adopt a corporate seal. The corporate seal shall consist of a die bearing the name of the Corporation and the inscription, “Corporate Seal-Delaware.” Said seal may be used by causing it or a facsimile thereof to be impressed or affixed or reproduced or otherwise.

 

ARTICLE III

Stockholders’ Meetings

 

Section 4. Place of Meetings. Meetings of the stockholders of the Corporation may be held at such place, either within or without the State of Delaware, as may be determined from time to time by the Board of Directors. The Board of Directors may, in its sole discretion, determine that the meeting shall not be held at any place, but may instead be held solely by means of remote communication as provided under the Delaware General Corporation Law (“DGCL”).

 

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Section 5. Annual Meetings.

 

(a)       The annual meeting of the stockholders of the Corporation, for the purpose of election of directors and for such other business as may properly come before it, shall be held on such date and at such time as may be designated from time to time by the Board of Directors. Nominations of persons for election to the Board of Directors of the Corporation and the proposal of business to be considered by the stockholders may be made at an annual meeting of stockholders: (i) pursuant to the Corporation’s notice of meeting of stockholders (with respect to business other than nominations); (ii) brought specifically by or at the direction of the Board of Directors; or (iii) by any stockholder of the Corporation who was a stockholder of record at the time of giving the stockholder’s notice provided for in Section 5(b) below, who is entitled to vote at the meeting and who complied with the notice procedures set forth in Section 5. For the avoidance of doubt, clause (iii) above shall be the exclusive means for a stockholder to make nominations and submit other business (other than matters properly included in the Corporation’s notice of meeting of stockholders and proxy statement under Rule 14a-8 under the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder (the “Exchange Act”)) before an annual meeting of stockholders.

 

(b)       At an annual meeting of the stockholders, only such business shall be conducted as is a proper matter for stockholder action under Delaware law and as shall have been properly brought before the meeting.

 

(i)       For nominations for the election to the Board of Directors to be properly brought before an annual meeting by a stockholder pursuant to clause (iii) of Section 5(a) of these Bylaws, the stockholder must deliver written notice to the Secretary at the principal executive offices of the Corporation on a timely basis as set forth in Section 5(b)(iii) and must update and supplement such written notice on a timely basis as set forth in Section 5(c). Such stockholder’s notice shall set forth: (A) as to each nominee such stockholder proposes to nominate at the meeting: (1) the name, age, business address and residence address of such nominee; (2) the principal occupation or employment of such nominee; (3) the class and number of shares of each class of capital stock of the Corporation which are owned of record and beneficially by such nominee; (4) the date or dates on which such shares were acquired and the investment intent of such acquisition; (5) with respect to each nominee for election or re-election to the Board of Directors, include a completed and signed questionnaire, representation and agreement required by Section 5(e) of these Bylaws; and (6) such other information concerning such nominee as would be required to be disclosed in a proxy statement soliciting proxies for the election of such nominee as a director in an election contest (even if an election contest is not involved), or that is otherwise required to be disclosed pursuant to Section 14 of the Exchange Act and the rules and regulations promulgated thereunder (including such person’s written consent to being named as a nominee and to serving as a director if elected); and (B) the information required by Section 5(b)(iv). The Corporation may require any proposed nominee to furnish such other information as it may reasonably require to determine the eligibility of such proposed nominee to serve as an independent director of the Corporation or that could be material to a reasonable stockholder’s understanding of the independence, or lack thereof, of such proposed nominee.

 

(ii)       Other than proposals sought to be included in the Corporation’s proxy materials pursuant to Rule 14a-8 under the Exchange Act, for business other than nominations for the election to the Board of Directors to be properly brought before an annual meeting by a stockholder pursuant to clause (iii) of Section 5(a) of these Bylaws, the stockholder must deliver written notice to the Secretary at the principal executive offices of the Corporation on a timely basis as set forth in Section 5(b)(iii), and must update and supplement such written notice on a timely basis as set forth in Section 5(c). Such stockholder’s notice shall set forth: (A) as to each matter such stockholder proposes to bring before the meeting, a brief description of the business desired to be brought before the meeting, the reasons for conducting such business at the meeting, and any material interest (including any anticipated benefit of such business to any Proponent (as defined below) other than solely as a result of its ownership of the Corporation’s capital stock, that is material to any Proponent individually, or to the Proponents in the aggregate) in such business of any Proponent; and (B) the information required by Section 5(b)(iv).

 

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(iii)       To be timely, the written notice required by Section 5(b)(i) or 5(b)(ii) must be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the ninetieth (90th) day nor earlier than the close of business on the one hundred twentieth (120th) day prior to the first anniversary of the preceding year’s annual meeting; provided, however, that, subject to the last sentence of this Section 5(b)(iii), in the event that the date of the annual meeting is advanced more than thirty (30) days prior to or delayed by more than thirty (30) days after the anniversary of the preceding year’s annual meeting, notice by the stockholder to be timely must be so received not earlier than the close of business on the one hundred twentieth (120th) day prior to such annual meeting and not later than the close of business on the later of the ninetieth (90th) day prior to such annual meeting or the tenth (10th) day following the day on which public announcement of the date of such meeting is first made. In no event shall an adjournment or a postponement of an annual meeting for which notice has been given, or the public announcement thereof has been made, commence a new time period for the giving of a stockholder’s notice as described above.

 

(iv)       The written notice required by Section 5(b)(i) or 5(b)(ii) shall also set forth, as of the date of the notice and as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the nomination or proposal is made (each, a “Proponent” and collectively, the “Proponents”): (A) the name and address of each Proponent, as they appear on the Corporation’s books; (B) the class, series and number of shares of the Corporation that are owned beneficially and of record by each Proponent; (C) a description of any agreement, arrangement or understanding (whether oral or in writing) with respect to such nomination or proposal between or among any Proponent and any of its affiliates or associates, and any others (including their names) acting in concert, or otherwise under the agreement, arrangement or understanding, with any of the foregoing; (D) a representation that the Proponents are holders of record or beneficial owners, as the case may be, of shares of the Corporation entitled to vote at the meeting and intend to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice (with respect to a notice under Section 5(b)(i)) or to propose the business that is specified in the notice (with respect to a notice under Section 5(b)(ii)); (E) a representation as to whether the Proponents intend to deliver a proxy statement and form of proxy to holders of a sufficient number of holders of the Corporation’s voting shares to elect such nominee or nominees (with respect to a notice under Section 5(b)(i)) or to carry such proposal (with respect to a notice under Section 5(b)(ii)); (F) to the extent known by any Proponent, the name and address of any other stockholder supporting the proposal on the date of such stockholder’s notice; and (G) a description of all Derivative Transactions (as defined below) by each Proponent during the previous twelve (12) month period, including the date of the transactions and the class, series and number of securities involved in, and the material economic terms of, such Derivative Transactions.

 

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For purposes of Sections 5 and 6, a “Derivative Transaction” means any agreement, arrangement, interest or understanding entered into by, or on behalf or for the benefit of, any Proponent or any of its affiliates or associates, whether record or beneficial:

 

(w)       the value of which is derived in whole or in part from the value of any class or series of shares or other securities of the Corporation,

 

(x)        which otherwise provides any direct or indirect opportunity to gain or share in any gain derived from a change in the value of securities of the Corporation,

 

(y)        the effect or intent of which is to mitigate loss, manage risk or benefit of security value or price changes, or

 

(z)        which provides the right to vote or increase or decrease the voting power of, such Proponent, or any of its affiliates or associates, with respect to any securities of the Corporation,

 

which agreement, arrangement, interest or understanding may include, without limitation, any option, warrant, debt position, note, bond, convertible security, swap, stock appreciation right, short position, profit interest, hedge, right to dividends, voting agreement, performance-related fee or arrangement to borrow or lend shares (whether or not subject to payment, settlement, exercise or conversion in any such class or series), and any proportionate interest of such Proponent in the securities of the Corporation held by any general or limited partnership, or any limited liability company, of which such Proponent is, directly or indirectly, a general partner or managing member.

 

(c)       A stockholder providing written notice required by Section 5(b)(i) or (ii) shall update and supplement such notice in writing, if necessary, so that the information provided or required to be provided in such notice is true and correct in all material respects as of (i) the record date for the meeting and (ii) the date that is five (5) business days prior to the meeting and, in the event of any adjournment or postponement thereof, five (5) business days prior to such adjourned or postponed meeting. In the case of an update and supplement pursuant to clause (i) of this Section 5(c), such update and supplement shall be received by the Secretary at the principal executive offices of the Corporation not later than five (5) business days after the record date for the meeting. In the case of an update and supplement pursuant to clause (ii) of this Section 5(c), such update and supplement shall be received by the Secretary at the principal executive offices of the Corporation not later than two (2) business days prior to the date for the meeting, and, in the event of any adjournment or postponement thereof, two (2) business days prior to such adjourned or postponed meeting.

 

(d)       Notwithstanding anything in Section 5(b)(iii) to the contrary, in the event that the number of directors of the Board of Directors of the Corporation is increased and there is no public announcement of the appointment of a director, or, if no appointment was made, of the vacancy, made by the Corporation at least ten (10) days before the last day a stockholder may deliver a notice of nomination in accordance with Section 5(b)(iii), a stockholder’s notice required by this Section 5 and which complies with the requirements in Section 5(b)(i), other than the timing requirements in Section 5(b)(iii), shall also be considered timely, but only with respect to nominees for any new positions created by such increase, if it shall be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the tenth (10th) day following the day on which such public announcement is first made by the Corporation.

 

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(e)       To be eligible to be a nominee for election or re-election as a director of the Corporation pursuant to a nomination under clause (iii) of Section 5(a), such proposed nominee or a person on such proposed nominee’s behalf must deliver (in accordance with the time periods prescribed for delivery of notice under Section 5(b)(iii) or 5(d), as applicable) to the Secretary at the principal executive offices of the Corporation a written questionnaire with respect to the background and qualification of such proposed nominee and the background of any other person or entity on whose behalf the nomination is being made (which questionnaire shall be provided by the Secretary upon written request) and a written representation and agreement (in the form provided by the Secretary upon written request) that such person (i) is not and will not become a party to (A) any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or entity as to how such person, if elected as a director of the Corporation, will act or vote on any issue or question (a “Voting Commitment”) that has not been disclosed to the Corporation in the questionnaire or (B) any Voting Commitment that could limit or interfere with such person’s ability to comply, if elected as a director of the Corporation, with such person’s fiduciary duties under applicable law; (ii) is not and will not become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director of the Corporation that has not been disclosed therein; and (iii) in such person’s individual capacity and on behalf of any person or entity on whose behalf the nomination is being made, would be in compliance, if elected as a director of the Corporation, and will comply with, all applicable publicly disclosed corporate governance, conflict of interest, confidentiality and stock ownership and trading policies and guidelines of the Corporation.

 

(f)       A person shall not be eligible for election or re-election as a director unless the person is nominated either in accordance with clause (ii) of Section 5(a), or in accordance with clause (iii) of Section 5(a). Except as otherwise required by law, the chairman of the meeting shall have the power and duty to determine whether a nomination or any business proposed to be brought before the meeting was made, or proposed, as the case may be, in accordance with the procedures set forth in these Bylaws and, if any proposed nomination or business is not in compliance with these Bylaws, or the Proponent does not act in accordance with the representations in Sections 5(b)(iv)(D) and 5(b)(iv)(E), to declare that such proposal or nomination shall not be presented for stockholder action at the meeting and shall be disregarded, notwithstanding that proxies in respect of such nominations or such business may have been solicited or received.

 

(g)       Notwithstanding the foregoing provisions of this Section 5, in order to include information with respect to a stockholder proposal in the proxy statement and form of proxy for a stockholders’ meeting, a stockholder must also comply with all applicable requirements of the Exchange Act and the rules and regulations thereunder. Nothing in these Bylaws shall be deemed to affect any rights of stockholders to request inclusion of proposals in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Exchange Act; provided, however, that any references in these Bylaws to the Exchange Act or the rules and regulations thereunder are not intended to and shall not limit the requirements applicable to proposals and/or nominations to be considered pursuant to Section 5(a)(iii) of these Bylaws.

 

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(h)       For purposes of Sections 5 and 6,

 

(i)       public announcement” shall mean disclosure in a press release reported by the Dow Jones News Service, Associated Press or comparable national news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission (the “SEC”) pursuant to Section 13, 14 or 15(d) of the Exchange Act; and

 

(ii)       affiliates” and “associates” shall have the meanings set forth in Rule 405 under the Securities Act of 1933, as amended.

 

Section 6. Special Meetings.

 

(a)       Special meetings of the stockholders of the Corporation may be called, for any purpose as is a proper matter for stockholder action under Delaware law, by (i) the Chairman of the Board of Directors; (ii) the Chief Executive Officer; or (iii) the Board of Directors pursuant to a resolution adopted by a majority of the total number of authorized directors (whether or not there exist any vacancies in previously authorized directorships at the time any such resolution is presented to the Board of Directors for adoption).

 

(b)       The Board of Directors shall determine the time and place, if any, of such special meeting. Upon determination of the time and place, if any, of the meeting, the Secretary shall cause a notice of meeting to be given to the stockholders entitled to vote, in accordance with the provisions of Section 7 of these Bylaws. No business may be transacted at such special meeting otherwise than specified in the notice of meeting.

 

(c)       Nominations of persons for election to the Board of Directors may be made at a special meeting of stockholders at which directors are to be elected (i) by or at the direction of the Board of Directors or (ii) by any stockholder of the Corporation who is a stockholder of record at the time of giving notice provided for in this paragraph, who shall be entitled to vote at the meeting and who delivers written notice to the Secretary of the Corporation setting forth the information required by Section 5(b)(i). In the event the Corporation calls a special meeting of stockholders for the purpose of electing one or more directors to the Board of Directors, any such stockholder of record may nominate a person or persons (as the case may be), for election to such position(s) as specified in the Corporation’s notice of meeting, if written notice setting forth the information required by Section 5(b)(i) of these Bylaws shall be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the later of the ninetieth (90th) day prior to such meeting or the tenth (10th) day following the day on which public announcement is first made of the date of the special meeting and of the nominees proposed by the Board of Directors to be elected at such meeting. The stockholder shall also update and supplement such information as required under Section 5(c). In no event shall an adjournment or a postponement of a special meeting for which notice has been given, or the public announcement thereof has been made, commence a new time period for the giving of a stockholder’s notice as described above.

 

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(d)       Notwithstanding the foregoing provisions of this Section 6, a stockholder must also comply with all applicable requirements of the Exchange Act and the rules and regulations thereunder with respect to matters set forth in this Section 6. Nothing in these Bylaws shall be deemed to affect any rights of stockholders to request inclusion of proposals in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Exchange Act; provided, however, that any references in these Bylaws to the Exchange Act or the rules and regulations thereunder are not intended to and shall not limit the requirements applicable to nominations for the election to the Board of Directors to be considered pursuant to Section 6(c) of these Bylaws.

 

Section 7. Notice of Meetings. Except as otherwise provided by law, notice, given in writing or by electronic transmission, of each meeting of stockholders shall be given not less than ten (10) nor more than sixty (60) days before the date of the meeting to each stockholder entitled to vote at such meeting, such notice to specify the place, if any, date and hour, in the case of special meetings, the purpose or purposes of the meeting, and the means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at any such meeting. If mailed, notice is given when deposited in the United States mail, postage prepaid, directed to the stockholder at such stockholder’s address as it appears on the records of the Corporation. Notice of the time, place, if any, and purpose of any meeting of stockholders may be waived in writing, signed by the person entitled to notice thereof, or by electronic transmission by such person, either before or after such meeting, and will be waived by any stockholder by his attendance thereat in person, by remote communication, if applicable, or by proxy, except when the stockholder attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Any stockholder so waiving notice of such meeting shall be bound by the proceedings of any such meeting in all respects as if due notice thereof had been given.

 

Section 8. Quorum. At all meetings of stockholders, except where otherwise provided by statute or by the Certificate of Incorporation, or by these Bylaws, the presence, in person, by remote communication, if applicable, or by proxy duly authorized, of the holders of a majority of the outstanding shares of stock entitled to vote shall constitute a quorum for the transaction of business. In the absence of a quorum, any meeting of stockholders may be adjourned, from time to time, either by the chairman of the meeting or by vote of the holders of a majority of the shares represented thereat, but no other business shall be transacted at such meeting. The stockholders present at a duly called or convened meeting, at which a quorum is present, may continue to transact business until adjournment, notwithstanding the withdrawal of enough stockholders to leave less than a quorum. Except as otherwise provided by statute or by applicable stock exchange rules, or by the Certificate of Incorporation or these Bylaws, in all matters other than the election of directors, the affirmative vote of the majority of shares present in person, by remote communication, if applicable, or represented by proxy at the meeting and entitled to vote generally on the subject matter shall be the act of the stockholders. Except as otherwise provided by statute, the Certificate of Incorporation or these Bylaws, directors shall be elected by a plurality of the votes of the shares present in person, by remote communication, if applicable, or represented by proxy at the meeting and entitled to vote generally on the election of directors. Where a separate vote by a class or classes or series is required, except where otherwise provided by the statute or by the Certificate of Incorporation or these Bylaws, a majority of the outstanding shares of such class or classes or series, present in person, by remote communication, if applicable, or represented by proxy duly authorized, shall constitute a quorum entitled to take action with respect to that vote on that matter. Except where otherwise provided by statute or by the Certificate of Incorporation or these Bylaws, the affirmative vote of the majority (plurality, in the case of the election of directors) of shares of such class or classes or series present in person, by remote communication, if applicable, or represented by proxy at the meeting shall be the act of such class or classes or series.

 

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Section 9. Adjournment and Notice of Adjourned Meetings. Any meeting of stockholders, whether annual or special, may be adjourned from time to time either by the chairman of the meeting or by the vote of a majority of the shares present in person, by remote communication, if applicable, or represented by proxy at the meeting. When a meeting is adjourned to another time or place, if any, notice need not be given of the adjourned meeting if the time and place, if any, thereof are announced at the meeting at which the adjournment is taken. At the adjourned meeting, the Corporation may transact any business which might have been transacted at the original meeting. If the adjournment is for more than thirty (30) days or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.

 

Section 10. Voting Rights. For the purpose of determining those stockholders entitled to vote at any meeting of the stockholders, except as otherwise provided by law, only persons in whose names shares stand on the stock records of the Corporation on the record date, as provided in Section 12 of these Bylaws, shall be entitled to vote at any meeting of stockholders. Every person entitled to vote shall have the right to do so either in person, by remote communication, if applicable, or by an agent or agents authorized by a proxy granted in accordance with Delaware law. An agent so appointed need not be a stockholder. No proxy shall be voted after three (3) years from its date of creation unless the proxy provides for a longer period.

 

Section 11. Joint Owners of Stock. If shares or other securities having voting power stand of record in the names of two (2) or more persons, whether fiduciaries, members of a partnership, joint tenants, tenants in common, tenants by the entirety, or otherwise, or if two (2) or more persons have the same fiduciary relationship respecting the same shares, unless the Secretary is given written notice to the contrary and is furnished with a copy of the instrument or order appointing them or creating the relationship wherein it is so provided, their acts with respect to voting shall have the following effect: (a) if only one (1) votes, his act binds all; (b) if more than one (1) votes, the act of the majority so voting binds all; (c) if more than one (1) votes, but the vote is evenly split on any particular matter, each faction may vote the securities in question proportionally, or may apply to the Delaware Court of Chancery for relief as provided in the DGCL, Section 217(b). If the instrument filed with the Secretary shows that any such tenancy is held in unequal interests, a majority or even-split for the purpose of subsection (c) shall be a majority or even-split in interest.

 

Section 12. List of Stockholders. The Secretary shall prepare and make, at least ten (10) days before every meeting of stockholders, a complete list of the stockholders entitled to vote at said meeting, arranged in alphabetical order, showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, (a) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (b) during ordinary business hours, at the principal place of business of the Corporation. In the event that the Corporation determines to make the list available on an electronic network, the Corporation may take reasonable steps to ensure that such information is available only to stockholders of the Corporation. The list shall be open to examination of any stockholder during the time of the meeting as provided by law.

 

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Section 13. Action Without Meeting. No action shall be taken by the stockholders except at an annual or special meeting of stockholders called in accordance with these Bylaws, and no action shall be taken by the stockholders by written consent or by electronic transmission.

 

Section 14. Organization.

 

(a)       Unless otherwise proscribed by the Board of Directors, the Chairman of the Board of Directors shall preside as chairman at all meetings of the stockholders. If the Chairman of the Board of Directors has not been appointed or is absent, then the Lead Independent Director (if any) shall preside as chairman of the meeting. If a Lead Independent Director has not been appointed or is absent, then the Chief Executive Officer shall preside as chairman of the meeting. If the Chief Executive Officer is absent, a chairman of the meeting chosen by a majority in interest of the stockholders entitled to vote, present in person or by proxy, shall preside as chairman of such meeting. The Secretary, or, in his or her absence, an Assistant Secretary directed to do so by the Chairman of the Board, or the Lead Independent Director (if any) if the Chairman of the Board is absent, or by the Chief Executive Officer if the Lead Independent Director is absent, and if the Chief Executive Officer is absent, then the President, shall act as secretary of the meeting.

 

(b)       The Board of Directors of the Corporation shall be entitled to make such rules or regulations for the conduct of meetings of stockholders as it shall deem necessary, appropriate or convenient. Subject to such rules and regulations of the Board of Directors, if any, the chairman of the meeting shall have the right and authority to prescribe such rules, regulations and procedures and to do all such acts as, in the judgment of such chairman, are necessary, appropriate or convenient for the proper conduct of the meeting.

 

ARTICLE IV

Directors

 

Section 15. Number and Term of Office. The authorized number of directors of the Corporation shall be fixed in accordance with the Certificate of Incorporation. Directors need not be stockholders unless so required by the Certificate of Incorporation. If for any cause, the directors shall not have been elected at an annual meeting, they may be elected as soon thereafter as convenient at a special meeting of the stockholders called for that purpose in the manner provided in these Bylaws.

 

Section 16. Powers. The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors, except as may be otherwise provided by statute or by the Certificate of Incorporation.

 

Section 17. Election of Directors. Subject to the rights of the holders of any series of Preferred Stock to elect additional directors under specified circumstances, directors shall be elected at each annual meeting of stockholders to serve until the next annual meeting of stockholders. Each director shall serve until his successor is duly elected and qualified or until his death, resignation or removal. No stockholder entitled to vote at an election for directors may cumulate votes to which such stockholder is entitled. No decrease in the number of directors constituting the Board of Directors shall shorten the term of any incumbent director.

 

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Section 18. Vacancies. Unless otherwise provided in the Certificate of Incorporation, and subject to the rights of the holders of any series of Preferred Stock, any vacancies on the Board of Directors resulting from death, resignation, disqualification, removal or other causes and any newly created directorships resulting from any increase in the number of directors shall, unless the Board of Directors determines by resolution that any such vacancies or newly created directorships shall be filled by stockholders, be filled only by the affirmative vote of a majority of the directors then in office, even though less than a quorum of the Board of Directors, or by a sole remaining director, and not by the stockholders, provided, however, that whenever the holders of any class or classes of stock or series thereof are entitled to elect one or more directors by the provisions of the Certificate of Incorporation, vacancies and newly created directorships of such class or classes or series shall, unless the Board of Directors determines by resolution that any such vacancies or newly created directorships shall be filled by stockholders, be filled by a majority of the directors elected by such class or classes or series thereof then in office, or by a sole remaining director so elected, and not by the stockholders. Any director elected in accordance with the preceding sentence shall hold office for the remainder of the full term of the director for which the vacancy was created or occurred and until such director’s successor shall have been elected and qualified. A vacancy in the Board of Directors shall be deemed to exist under this Bylaw in the case of the death, removal or resignation of any director.

 

Section 19. Resignation. Any director may resign at any time by delivering his or her notice in writing or by electronic transmission to the Secretary, such resignation to specify whether it will be effective at a particular time. If no such specification is made, it shall be deemed effective at the time of delivery to the Secretary. When one or more directors shall resign from the Board of Directors, effective at a future date, a majority of the directors then in office, including those who have so resigned, shall have power to fill such vacancy or vacancies, the vote thereon to take effect when such resignation or resignations shall become effective, and each Director so chosen shall hold office for the unexpired portion of the term of the Director whose place shall be vacated and until his successor shall have been duly elected and qualified.

 

Section 20. Removal. The Board of Directors or any individual director may be removed from office at any time (a) with cause by the affirmative vote of the holders of at least Sixty Percent (60%) of the voting power of all the then-outstanding shares of capital stock of the Corporation, entitled to vote generally at an election of directors; or (b) without cause by the affirmative vote of the holders of at least Sixty Percent (60%) of the voting power of all the then-outstanding shares of the capital stock of the Corporation entitled to vote generally at an election of directors.

 

Section 21. Meetings.

 

(a)       Regular Meetings. Unless otherwise restricted by the Certificate of Incorporation, regular meetings of the Board of Directors may be held at any time or date and at any place within or without the State of Delaware which has been designated by the Board of Directors and publicized among all directors, either orally or in writing, by telephone, including a voice-messaging system or other system designed to record and communicate messages, facsimile, telegraph or telex, or by electronic mail or other electronic means. No further notice shall be required for regular meetings of the Board of Directors.

 

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(b)       Special Meetings. Unless otherwise restricted by the Certificate of Incorporation, special meetings of the Board of Directors may be held at any time and place within or without the State of Delaware whenever called by at least one-third (1/3) of the authorized number of Directors.

 

(c)       Meetings by Electronic Communications Equipment. Any member of the Board of Directors, or of any committee thereof, may participate in a meeting by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and participation in a meeting by such means shall constitute presence in person at such meeting.

 

(d)       Notice of Special Meetings. Notice of the time and place of all special meetings of the Board of Directors shall be orally or in writing, by telephone, including a voice messaging system or other system or technology designed to record and communicate messages, facsimile, telegraph or telex, or by electronic mail or other electronic means, during normal business hours, at least twenty-four (24) hours before the date and time of the meeting. If notice is sent by US mail, it shall be sent by first class mail, charges prepaid, at least three (3) days before the date of the meeting. Notice of any meeting may be waived in writing, or by electronic transmission, at any time before or after the meeting and will be waived by any director by attendance thereat, except when the director attends the meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened.

 

(e)       Waiver of Notice. The transaction of all business at any meeting of the Board of Directors, or any committee thereof, however called or noticed, or wherever held, shall be as valid as though it had been transacted at a meeting duly held after regular call and notice, if a quorum be present and if, either before or after the meeting, each of the directors not present who did not receive notice shall sign a written waiver of notice or shall waive notice, by electronic transmission. All such waivers shall be filed with the corporate records or made a part of the minutes of the meeting.

 

Section 22. Quorum and Voting.

 

(a)       Unless the Certificate of Incorporation requires a greater number, and except with respect to questions related to indemnification arising under these Bylaws for which a quorum shall be one-third of the exact number of directors fixed from time to time, a quorum of the Board of Directors shall consist of a majority of the exact number of directors fixed from time to time by the Board of Directors in accordance with the Certificate of Incorporation; provided, however, at any meeting whether a quorum be present or otherwise, a majority of the directors present may adjourn from time to time until the time fixed for the next regular meeting of the Board of Directors, without notice other than by announcement at the meeting.

 

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(b)       At each meeting of the Board of Directors at which a quorum is present, all questions and business shall be determined by the affirmative vote of a majority of the directors present, unless a different vote be required by law, the Certificate of Incorporation or these Bylaws.

 

Section 23. Action Without Meeting. Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a meeting, if all members of the Board of Directors or committee, as the case may be, consent thereto in writing or by electronic transmission, and such writing or writings or transmission or transmissions are filed with the minutes of proceedings of the Board of Directors or committee. Such filing shall be in paper form if the minutes are maintained in paper form and shall be in electronic form if the minutes are maintained in electronic form.

 

Section 24. Fees and Compensation. Directors shall be entitled to such compensation for their services as may be approved by the Board of Directors, including, if so approved, by resolution of the Board of Directors, a fixed sum and expenses of attendance, if any, for attendance at each regular or special meeting of the Board of Directors and at any meeting of a committee of the Board of Directors. Nothing herein contained shall be construed to preclude any director from serving the Corporation in any other capacity as an officer, agent, employee, or otherwise and receiving compensation therefor.

 

Section 25. Committees.

 

(a)       Executive Committee. The Board of Directors may appoint an Executive Committee to consist of one (1) or more members of the Board of Directors. The Executive Committee, to the extent permitted by law and provided in the resolution of the Board of Directors shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the Corporation, and may authorize the seal of the Corporation to be affixed to all papers which may require it; but no such committee shall have the power or authority in reference to (i) approving or adopting, or recommending to the stockholders, any action or matter (other than the election or removal of directors) expressly required by the DGCL to be submitted to stockholders for approval, or (ii) adopting, amending or repealing any Bylaw of the Corporation.

 

(b)       Other Committees. The Board of Directors may, from time to time, appoint such other committees as may be permitted by law. Such other committees appointed by the Board of Directors shall consist of one (1) or more members of the Board of Directors and shall have such powers and perform such duties as may be prescribed by the resolution or resolutions creating such committees, but in no event shall any such committee have the powers denied to the Executive Committee in these Bylaws.

 

(c)       Term. The Board of Directors, subject to any requirements of any outstanding series of Preferred Stock and the provisions of subsections (a) or (b) of this Section 25, may at any time increase or decrease the number of members of a committee or terminate the existence of a committee. The membership of a committee member shall terminate on the date of his death or voluntary resignation from the committee or from the Board of Directors. The Board of Directors may at any time for any reason remove any individual committee member and the Board of Directors may fill any committee vacancy created by death, resignation, removal or increase in the number of members of the committee. The Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee, and, in addition, in the absence or disqualification of any member of a committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not he or they constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in the place of any such absent or disqualified member.

 

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(d)       Meetings. Unless the Board of Directors shall otherwise provide, regular meetings of the Executive Committee or any other committee appointed pursuant to this Section 25 shall be held at such times and places as are determined by the Board of Directors, or by any such committee, and when notice thereof has been given to each member of such committee, no further notice of such regular meetings need be given thereafter. Special meetings of any such committee may be held at any place which has been determined from time to time by such committee, and may be called by any director who is a member of such committee, upon notice to the members of such committee of the time and place of such special meeting given in the manner provided for the giving of notice to members of the Board of Directors of the time and place of special meetings of the Board of Directors. Notice of any special meeting of any committee may be waived in writing or by electronic transmission at any time before or after the meeting and will be waived by any director by attendance thereat, except when the director attends such special meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Unless otherwise provided by the Board of Directors in the resolutions authorizing the creation of the committee, a majority of the authorized number of members of any such committee shall constitute a quorum for the transaction of business, and the act of a majority of those present at any meeting at which a quorum is present shall be the act of such committee.

 

Section 26. Lead Independent Director. One of the Corporation’s independent directors may be designated by the Board of Directors as lead independent director to serve until replaced by the Board of Directors (the “Lead Independent Director”). The Lead Independent Director (if any) will establish the agenda for meetings of the independent directors; coordinate with the committee chairs regarding meeting agendas and informational requirements; preside over meetings of the independent directors; preside over any portions of meetings of the Board of Directors at which the performance of the Board of Directors is presented or discussed; and perform such other duties as may be established or delegated by the Chairman of the Board of Directors.

 

Section 27. Chairman. The Chairman of the Board of Directors, when present, shall preside at all meetings of the stockholders and the Board of Directors. The Chairman of the Board of Directors and shall also perform such other duties and have such other powers, as the Board of Directors shall designate from time to time.

 

Section 28. Organization. At every meeting of the directors, the Chairman of the Board of Directors, or, if a Chairman has not been appointed or is absent, the Lead Independent Director (if any), or if the Lead Independent Director is absent, the Chief Executive Officer (if a director), or, if a Chief Executive Officer is absent, the President (if a director), or if the President is absent, the most senior Vice President (if a director), or, in the absence of any such person, a chairman of the meeting chosen by a majority of the directors present, shall preside over the meeting. The Secretary, or in his absence, any Assistant Secretary or other officer or director directed to do so by the President or, in the absence of the President, a majority of the directors in attendance, shall act as secretary of the meeting.

 

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ARTICLE V

Officers

 

Section 29. Officers Designated. The officers of the Corporation shall include, if and when designated by the Board of Directors, the Chairman of the Board of Directors, the Chief Executive Officer, the President, one or more Vice Presidents, the Secretary, the Chief Financial Officer and the Treasurer. In addition, a Principal Executive Officer (in almost every case, the Chief Executive Officer) and the Principal Financial Officer and Principal Accounting Officer shall be designated pursuant to applicable SEC rules and regulations. The Board of Directors may also appoint one or more Assistant Secretaries and Assistant Treasurers and such other officers and agents with such powers and duties as it shall deem necessary. The Board of Directors may assign such additional titles to one or more of the officers as it shall deem appropriate. Any one person may hold any number of offices of the Corporation at any one time unless specifically prohibited therefrom by law. The salaries and other compensation of the officers of the Corporation shall be fixed by or in the manner designated by the Board of Directors.

 

Section 30. Tenure and Duties of Officers.

 

(a)       General. All officers shall hold office at the pleasure of the Board of Directors and until their successors shall have been duly elected and qualified, unless sooner removed. Any officer elected or appointed by the Board of Directors may be removed at any time by the Board of Directors. If the office of any officer becomes vacant for any reason, the vacancy may be filled by the Board of Directors.

 

(b)       Duties of Chief Executive Officer. The Chief Executive Officer shall preside at all meetings of the stockholders, unless the Chairman of the Board of Directors or the Lead Independent Director (if any) has been appointed and is present. Unless an officer has been appointed Chief Executive Officer of the Corporation, the President shall be the chief executive officer of the Corporation and shall, subject to the control of the Board of Directors, have general supervision, direction and control of the business and officers of the Corporation. To the extent that a Chief Executive Officer has been appointed and no President has been appointed, all references in these Bylaws to the President shall be deemed references to the Chief Executive Officer. The Chief Executive Officer shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers, as the Board of Directors shall designate from time to time, including, but not limited to, the authority for the Chief Executive Officer or his or her designees to bind the Corporation by executing contracts or other agreements and/or entering into other arrangements, all of which are in the ordinary course of the Corporation’s business.

 

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(c)       Duties of President. The President shall preside at all meetings of the stockholders, unless the Chairman of the Board of Directors, the Lead Independent Director, or the Chief Executive Officer has been appointed and is present. Unless another officer has been appointed Chief Executive Officer of the Corporation, the President shall be the Chief Executive Officer of the Corporation and shall, subject to the control of the Board of Directors, have general supervision, direction and control of the business and officers of the Corporation. The President shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers, as the Board of Directors shall designate from time to time.

 

(d)       Duties of Vice Presidents. The Vice Presidents may assume and perform the duties of the President in the absence or disability of the President or whenever the office of President is vacant. The Vice Presidents shall perform other duties commonly incident to their office and shall also perform such other duties and have such other powers as the Board of Directors or the Chief Executive Officer, or, if the Chief Executive Officer has not been appointed or is absent, the President shall designate from time to time.

 

(e)       Duties of Secretary. The Secretary shall attend all meetings of the stockholders and of the Board of Directors and shall record all acts and proceedings thereof in the minute book of the Corporation. The Secretary shall give notice in conformity with these Bylaws of all meetings of the stockholders and of all meetings of the Board of Directors and any committee thereof requiring notice. The Secretary shall perform all other duties provided for in these Bylaws and other duties commonly incident to the office and shall also perform such other duties and have such other powers, as the Board of Directors shall designate from time to time. The President may direct any Assistant Secretary or other officer to assume and perform the duties of the Secretary in the absence or disability of the Secretary, and each Assistant Secretary shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board of Directors or the President shall designate from time to time.

 

(f)       Duties of Chief Financial Officer. The Chief Financial Officer shall keep or cause to be kept the books of account of the Corporation in a thorough and proper manner and shall render statements of the financial affairs of the Corporation in such form and as often as required by the Board of Directors or the President. The Chief Financial Officer, subject to the order of the Board of Directors, shall have the custody of all funds and securities of the Corporation. The Chief Financial Officer shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board of Directors or the President shall designate from time to time. To the extent that a Chief Financial Officer has been appointed and no Treasurer has been appointed, all references in these Bylaws to the Treasurer shall be deemed references to the Chief Financial Officer. The President may direct the Treasurer, if any, or any Assistant Treasurer, or the Controller or any Assistant Controller to assume and perform the duties of the Chief Financial Officer in the absence or disability of the Chief Financial Officer, and each Treasurer and Assistant Treasurer and each Controller and Assistant Controller shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board of Directors or the President shall designate from time to time.

 

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(g)       Duties of Treasurer. Unless another officer has been appointed Chief Financial Officer of the Corporation, the Treasurer shall be the chief financial officer of the Corporation and shall keep or cause to be kept the books of account of the Corporation in a thorough and proper manner and shall render statements of the financial affairs of the Corporation in such form and as often as required by the Board of Directors or the President, and, subject to the order of the Board of Directors, shall have the custody of all funds and securities of the Corporation. The Treasurer shall perform other duties commonly incident to the office and shall also perform such other duties and have such other powers as the Board of Directors or the President shall designate from time to time.

 

Section 31. Delegation of Authority. The Board of Directors may from time to time delegate the powers or duties of any officer to any other officer or agent, notwithstanding any provision hereof.

 

Section 32. Resignations. Any officer may resign at any time by giving notice in writing or by electronic transmission to the Board of Directors or to the President or to the Secretary. Any such resignation shall be effective when received by the person or persons to whom such notice is given, unless a later time is specified therein, in which event the resignation shall become effective at such later time. Unless otherwise specified in such notice, the acceptance of any such resignation shall not be necessary to make it effective. Any resignation shall be without prejudice to the rights, if any, of the Corporation under any contract with the resigning officer.

 

Section 33. Removal. Subject to the rights, if any, of an officer under contract of employment, any officer may be removed from office at any time, either with or without cause, by the affirmative vote of a majority of the directors in office at the time, by the unanimous written consent of the directors in office at the time, by the Chief Executive Officer, or by other superior officer or officers upon whom such power of removal may have been conferred by the Board of Directors or the Chief Executive Officer.

 

ARTICLE VI

Execution Of Corporate Instruments And Voting Of Securities

Owned By The Corporation

 

Section 34. Execution of Corporate Instruments. The Board of Directors may, in its discretion, determine the method and designate the signatory officer or officers, or other person or persons, to execute on behalf of the Corporation any corporate instrument or document, or to sign on behalf of the Corporation the corporate name without limitation, or to enter into contracts on behalf of the Corporation, except where otherwise provided by law or these Bylaws, and such execution or signature shall be binding upon the Corporation.

 

All checks and drafts drawn on banks or other depositaries on funds to the credit of the Corporation or in special accounts of the Corporation shall be signed by such person or persons as the Board of Directors shall authorize so to do.

 

Unless authorized or ratified by the Board of Directors or within the agency power of an officer, including, but not limited to, Section 30(b) of these Bylaws, no officer, agent or employee shall have any power or authority to bind the Corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or for any amount.

 

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Section 35. Voting of Securities Owned by the Corporation. All stock and other securities of other corporations owned or held by the Corporation for itself, or for other parties in any capacity, shall be voted, and all proxies with respect thereto shall be executed, by the person authorized so to do by resolution of the Board of Directors, or, in the absence of such authorization, by the Chief Executive Officer, the President, or any Vice President.

 

ARTICLE VII

Shares Of Stock

 

Section 36. Form and Execution of Certificates. The shares of the Corporation shall be represented by certificates, provided that the Board may provide by resolution or resolutions that some or all of any classes or series of its stock shall be uncertificated. Certificates for the shares of stock, if any, shall be in such form as is consistent with the Certificate of Incorporation and applicable law. Every holder of stock represented by certificate in the Corporation shall be entitled to have a certificate signed by or in the name of the Corporation by the Chairman of the Board of Directors, or the President or any Vice President and by the Treasurer or Assistant Treasurer or the Secretary or Assistant Secretary, certifying the number of shares owned by him in the Corporation. Any or all of the signatures on the certificate may be facsimiles. In case any officer, transfer agent, or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent, or registrar before such certificate is issued, it may be issued with the same effect as if he were such officer, transfer agent, or registrar at the date of issue.

 

Section 37. Lost Certificates. A new certificate or certificates shall be issued in place of any certificate or certificates theretofore issued by the Corporation alleged to have been lost, stolen, or destroyed, upon the making of an affidavit of that fact by the person claiming the certificate of stock to be lost, stolen, or destroyed. The Corporation may require, as a condition precedent to the issuance of a new certificate or certificates, the owner of such lost, stolen, or destroyed certificate or certificates, or the owner’s legal representative, to agree to indemnify the Corporation in such manner as it shall require or to give the Corporation a surety bond in such form and amount as it may direct as indemnity against any claim that may be made against the Corporation with respect to the certificate alleged to have been lost, stolen, or destroyed.

 

Section 38. Transfers.

 

(a)       Transfers of record of shares of stock of the Corporation shall be made only upon its books by the holders thereof, in person or by attorney duly authorized, and, in the case of stock represented by certificate, upon the surrender of a properly endorsed certificate or certificates for a like number of shares.

 

(b)       The Corporation shall have power to enter into and perform any agreement with any number of stockholders of any one or more classes of stock of the Corporation to restrict the transfer of shares of stock of the Corporation of any one or more classes owned by such stockholders in any manner not prohibited by the DGCL.

 

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Section 39. Fixing Record Dates. In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which record date shall, subject to applicable law, not be more than sixty (60) nor less than ten (10) days before the date of such meeting. If no record date is fixed by the Board of Directors, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or if notice is waived, at the close of business on the day next preceding the day on which the meeting is held. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.

 

Section 40. Registered Stockholders. The Corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends, and to vote as such owner, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of Delaware.

 

ARTICLE VIII

Other Securities Of The Corporation

 

Section 41. Execution of Other Securities. All bonds, debentures and other corporate securities of the Corporation, other than stock certificates (covered in Section 36), may be signed by the Chief Executive Officer, the President or any Vice President, or such other person as may be authorized by the Board of Directors, and the corporate seal impressed thereon or a facsimile of such seal imprinted thereon and attested by the signature of the Secretary or an Assistant Secretary, or the Chief Financial Officer or Treasurer or an Assistant Treasurer; provided, however, that where any such bond, debenture or other corporate security shall be authenticated by the manual signature, or where permissible facsimile signature, of a trustee under an indenture pursuant to which such bond, debenture or other corporate security shall be issued, the signatures of the persons signing and attesting the corporate seal on such bond, debenture or other corporate security may be the imprinted facsimile of the signatures of such persons. Interest coupons appertaining to any such bond, debenture or other corporate security, authenticated by a trustee as aforesaid, shall be signed by the Treasurer or an Assistant Treasurer of the Corporation or such other person as may be authorized by the Board of Directors, or bear imprinted thereon the facsimile signature of such person. In case any officer who shall have signed or attested any bond, debenture or other corporate security, or whose facsimile signature shall appear thereon or on any such interest coupon, shall have ceased to be such officer before the bond, debenture or other corporate security so signed or attested shall have been delivered, such bond, debenture or other corporate security nevertheless may be adopted by the Corporation and issued and delivered as though the person who signed the same or whose facsimile signature shall have been used thereon had not ceased to be such officer of the Corporation.

 

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ARTICLE IX

Dividends

 

Section 42. Declaration of Dividends. Dividends upon the capital stock of the Corporation, subject to the provisions of the Certificate of Incorporation and applicable law, if any, may be declared by the Board of Directors pursuant to law at any regular or special meeting. Dividends may be paid in cash, in property, or in shares of the capital stock, subject to the provisions of the Certificate of Incorporation and applicable law.

 

Section 43. Dividend Reserve. Before payment of any dividend, there may be set aside out of any funds of the Corporation available for dividends such sum or sums as the Board of Directors from time to time, in their absolute discretion, think proper as a reserve or reserves to meet contingencies, or for equalizing dividends, or for repairing or maintaining any property of the Corporation, for maintaining insurance policies or for such other purpose as the Board of Directors shall think conducive to the interests of the Corporation, and the Board of Directors may modify or abolish any such reserve in the manner in which it was created.

 

ARTICLE X

Fiscal Year

 

Section 44. Fiscal Year. Except as from time to time otherwise designated by the Board of Directors, the fiscal year of the Corporation shall begin on the first day of January of each year and end on the last day of December in each year.

 

ARTICLE XI

Indemnification

 

Section 45. Indemnification of Directors, Executive Officers, Other Officers, Employees and Other Agents.

 

(a)       Directors and Executive Officers. The Corporation shall indemnify its directors, executive officers (for the purposes of this Article XI, “executive officers” shall have the meaning defined in Rule 3b-7 promulgated under the Exchange Act) and officers to the extent not prohibited by the DGCL or any other applicable law; provided, however, that the Corporation may modify the extent of such indemnification by individual contracts with its directors and executive officers; and, provided, further, that the Corporation shall not be required to indemnify any director or executive officer in connection with any proceeding (or part thereof) initiated by such person unless (i) such indemnification is expressly required to be made by law, (ii) the proceeding was authorized by the Board of Directors of the Corporation, (iii) such indemnification is provided by the Corporation, in its sole discretion, pursuant to the powers vested in the Corporation under the DGCL or any other applicable law or (iv) such indemnification is required to be made under subsection (d).

 

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(b)       Expenses. The Corporation shall advance to any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he is or was a director or executive officer, of the Corporation, or is or was serving at the request of the Corporation as a director or executive officer of another corporation, partnership, joint venture, trust or other enterprise, prior to the final disposition of the proceeding, promptly following request therefor, all expenses incurred by any director or executive officer in connection with such proceeding provided, however, that if the DGCL requires, an advancement of expenses incurred by a director or executive officer in his or her capacity as a director or executive officer (and not in any other capacity in which service was or is rendered by such indemnitee, including, without limitation, service to an employee benefit plan) shall be made only upon delivery to the Corporation of an undertaking (hereinafter an “undertaking”), by or on behalf of such indemnitee, to repay all amounts so advanced if it shall ultimately be determined by final judicial decision from which there is no further right to appeal (hereinafter a “final adjudication”) that such indemnitee is not entitled to be indemnified for such expenses under this section or otherwise.

 

Notwithstanding the foregoing, unless otherwise determined pursuant to paragraph (d) of this section, no advance shall be made by the Corporation to an officer of the Corporation (except by reason of the fact that such officer is or was a director of the Corporation in which event this paragraph shall not apply) in any action, suit or proceeding, whether civil, criminal, administrative or investigative, if a determination is reasonably and promptly made (i) by a majority vote of directors who were not parties to the proceeding, even if not a quorum, or (ii) by a committee of such directors designated by a majority vote of such directors, even though less than a quorum, or (iii) if there are no such directors, or such directors so direct, by independent legal counsel in a written opinion, that the facts known to the decision-making party at the time such determination is made demonstrate clearly and convincingly that such person acted in bad faith or in a manner that such person did not believe to be in or not opposed to the best interests of the Corporation.

 

(c)       Enforcement. Without the necessity of entering into an express contract, all rights to indemnification and advances to directors and officers under this Bylaw shall be deemed to be contractual rights and be effective to the same extent and as if provided for in a contract between the Corporation and the director or officer. Any right to indemnification or advances granted by this section to a director or officer shall be enforceable by or on behalf of the person holding such right in any court of competent jurisdiction if (i) the claim for indemnification or advances is denied, in whole or in part, or (ii) no disposition of such claim is made within ninety (90) days of request therefor. To the extent permitted by law, the claimant in such enforcement action, if successful in whole or in part, shall be entitled to be paid also the expense of prosecuting the claim. In connection with any claim for indemnification, the Corporation shall be entitled to raise as a defense to any such action that the claimant has not met the standards of conduct that make it permissible under the DGCL or any other applicable law for the Corporation to indemnify the claimant for the amount claimed. In connection with any claim by an officer of the Corporation (except in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that such executive officer is or was a director or officer of the Corporation) for advances, the Corporation shall be entitled to raise a defense as to any such action clear and convincing evidence that such person acted in bad faith or in a manner that such person did not believe to be in or not opposed to the best interests of the Corporation, or with respect to any criminal action or proceeding that such person acted without reasonable cause to believe that his conduct was lawful. Neither the failure of the Corporation (including its Board of Directors, independent legal counsel or its stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant is proper in the circumstances because he has met the applicable standard of conduct set forth in the DGCL or any other applicable law, nor an actual determination by the Corporation (including its Board of Directors, independent legal counsel or its stockholders) that the claimant has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that claimant has not met the applicable standard of conduct. In any suit brought by a director or officer to enforce a right to indemnification or to an advancement of expenses hereunder, the burden of proving that the director or officer is not entitled to be indemnified, or to such advancement of expenses, under this section or otherwise shall be on the Corporation.

 

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(d)       Non-Exclusivity of Rights. The rights conferred on any person by this Bylaw shall not be exclusive of any other right which such person may have or hereafter acquire under any applicable statute, provision of the Certificate of Incorporation, Bylaws, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in his official capacity and as to action in another capacity while holding office. The Corporation is specifically authorized to enter into individual contracts with any or all of its directors, officers, employees or agents respecting indemnification and advances, to the fullest extent not prohibited by the DGCL, or by any other applicable law.

 

(e)       Survival of Rights. The rights conferred on any person by this Bylaw shall continue as to a person who has ceased to be a director or officer, employee or other agent and shall inure to the benefit of the heirs, executors and administrators of such a person.

 

(f)       Insurance. To the fullest extent permitted by the DGCL or any other applicable law, the Corporation, upon approval by the Board of Directors, may purchase insurance on behalf of any person required or permitted to be indemnified pursuant to this section.

 

(g)       Amendments. Any repeal or modification of this section shall only be prospective and shall not affect the rights under this Bylaw in effect at the time of the alleged occurrence of any action or omission to act that is the cause of any proceeding against any agent of the Corporation.

 

(h)       Saving Clause. If this Bylaw or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each director and officer to the full extent not prohibited by any applicable portion of this section that shall not have been invalidated, or by any other applicable law. If this section shall be invalid due to the application of the indemnification provisions of another jurisdiction, then the Corporation shall indemnify each director and officer to the full extent under any other applicable law.

 

(i)       Certain Definitions. For the purposes of this Bylaw, the following definitions shall apply:

 

(i)       The term “proceeding” shall be broadly construed and shall include, without limitation, the investigation, preparation, prosecution, defense, settlement, arbitration and appeal of, and the giving of testimony in, any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative.

 

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(ii)       The term “expenses” shall be broadly construed and shall include, without limitation, court costs, attorneys’ fees, witness fees, fines, amounts paid in settlement or judgment and any other costs and expenses of any nature or kind incurred in connection with any proceeding.

 

(iii)       The term the “corporation” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers, and employees or agents, so that any person who is or was a director, officer, employee or agent of such constituent corporation, or is or was serving at the request of such constituent corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, shall stand in the same position under the provisions of this section with respect to the resulting or surviving corporation as he would have with respect to such constituent corporation if its separate existence had continued.

 

(iv)       References to a “director,” “executive officer,” “officer,” “employee,” or “agent” of the Corporation shall include, without limitation, situations where such person is serving at the request of the Corporation as, respectively, a director, executive officer, officer, employee, trustee or agent of another corporation, partnership, joint venture, trust or other enterprise.

 

(v)       References to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxes assessed on a person with respect to an employee benefit plan; and references to “serving at the request of the Corporation” shall include any service as a director, officer, employee or agent of the Corporation which imposes duties on, or involves services by, such director, officer, employee, or agent with respect to an employee benefit plan, its participants, or beneficiaries; and a person who acted in good faith and in a manner he reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the Corporation” as referred to in this section.

 

ARTICLE XII

Notices

 

Section 46. Notices.

 

(a)       Notice to Stockholders. Written notice to stockholders of stockholder meetings shall be given as provided in Section 7 herein. Without limiting the manner by which notice may otherwise be given effectively to stockholders under any agreement or contract with such stockholder, and except as otherwise required by law, written notice to stockholders for purposes other than stockholder meetings may be sent by US mail or nationally recognized overnight courier, or by facsimile, telegraph or telex or by electronic mail or other electronic means.

 

(b)       Notice to Directors. Any notice required to be given to any director may be given by the method stated in subsection (a), as otherwise provided in these Bylaws, or by overnight delivery service, facsimile, telex or telegram, except that such notice other than one which is delivered personally shall be sent to such address as such director shall have filed in writing with the Secretary, or, in the absence of such filing, to the last known post office address of such director.

 

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(c)       Affidavit of Mailing. An affidavit of mailing, executed by a duly authorized and competent employee of the Corporation or its transfer agent appointed with respect to the class of stock affected, or other agent, specifying the name and address or the names and addresses of the stockholder or stockholders, or director or directors, to whom any such notice or notices was or were given, and the time and method of giving the same, shall in the absence of fraud, be prima facie evidence of the facts therein contained.

 

(d)       Methods of Notice. It shall not be necessary that the same method of giving notice be employed in respect of all recipients of notice, but one permissible method may be employed in respect of any one or more, and any other permissible method or methods may be employed in respect of any other or others.

 

(e)       Notice to Person with Whom Communication is Unlawful. Whenever notice is required to be given, under any provision of law or of the Certificate of Incorporation or Bylaws of the Corporation, to any person with whom communication is unlawful, the giving of such notice to such person shall not be required and there shall be no duty to apply to any governmental authority or agency for a license or permit to give such notice to such person. Any action or meeting which shall be taken or held without notice to any such person with whom communication is unlawful shall have the same force and effect as if such notice had been duly given. In the event that the action taken by the Corporation is such as to require the filing of a certificate under any provision of the DGCL, the certificate shall state, if such is the fact and if notice is required, that notice was given to all persons entitled to receive notice except such persons with whom communication is unlawful.

 

(f)       Notice to Stockholders Sharing an Address. Except as otherwise prohibited under DGCL, any notice given under the provisions of DGCL, the Certificate of Incorporation or the Bylaws shall be effective if given by a single written notice to stockholders who share an address if consented to by the stockholders at that address to whom such notice is given. Such consent shall have been deemed to have been given if such stockholder fails to object in writing to the Corporation within sixty (60) days of having been given notice by the Corporation of its intention to send the single notice. Any consent shall be revocable by the stockholder by written notice to the Corporation.

 

ARTICLE XIII

Amendments

 

Section 47. Amendments. Subject to the limitations set forth in Section 45(g) of these Bylaws or the provisions of the Certificate of Incorporation, the Board of Directors is expressly empowered to adopt, amend or repeal the Bylaws of the Corporation. Any adoption, amendment or repeal of the Bylaws of the Corporation by the Board of Directors shall require the approval of a majority of the authorized number of directors. The stockholders also shall have power to adopt, amend or repeal the Bylaws of the Corporation; provided, however, that, in addition to any vote of the holders of any class or series of stock of the Corporation required by law or by the Certificate of Incorporation, such action by stockholders shall require the affirmative vote of the holders of at least sixty-six and two-thirds percent (66-2/3%) of the voting power of all of the then-outstanding shares of the capital stock of the Corporation entitled to vote generally in the election of directors, voting together as a single class.

 

23

 

 

article xiv

FORUM FOR ADJUDICATION OF DISPUTES

 

Section 48. Forum. Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Corporation; (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders; (iii) any action asserting a claim against the Corporation or any director or officer or other employee of the Corporation arising pursuant to any provision of the DGCL, the certificate of incorporation or the Bylaws of the Corporation; or (iv) any action asserting a claim against the Corporation or any director or officer or other employee of the Corporation governed by the internal affairs doctrine. Any person or entity purchasing or otherwise acquiring or holding any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to the provisions of this Article XIV.

 

Adoption

 

These Bylaws were duly approved and adopted by the Corporation’s Board of Directors as of the [  ] day of [  ], 2017 and the Corporation’s stockholders on the [  ] day of [  ], 2017 and shall become effective immediately upon the closing of the Corporation’s initial public offering.

 

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EX-3.5 7 fs12017ex3-5_adialpharma.htm FORM OF ARTICLES OF INCORPORATION OF APL CONVERSION CORP

Exhibit 3.5

 

ARTICLES OF INCORPORATION

OF

APL CONVERSION CORP.

A VIRGINIA STOCK CORPORATION

 

1.The name of the corporation is APL Conversion Corp. (the “Corporation”).

 

2.The total number of shares of capital stock which the Corporation shall have authority to issue is 25,000 consisting of 18,000 shares of common stock, each share having a par value of one-tenth of one cent ($0.001) (the “Common Stock”), and 7,000 shares of preferred stock, each share having a par value of one-tenth of one cent ($0.001) (the “Preferred Stock”).

 

a.Common Stock.

 

i.There will be four series of Common Stock—Series 1, 2, 3, and 4—authorized for issuance with the series designated at time of issuance. The number of authorized shares for each series is set forth below.

 

Common Stock Series  Authorized Shares 
1   15,000 
2   300 
3   1,350 
4   1,350 

 

ii.The series of Common Stock are identical in all respects except as to voting rights as stated below.

 

Common Stock Series  Votes Per Share 
1   1 
2   2.7109 
3   1.2857 
4   No voting rights 

 

i.In the event of a merger, acquisition, reorganization or conversion of the Corporation in order to effect a public listing of the Corporation’s securities, each series of Common Stock will be treated identically on a per share basis as is each share of Common Stock Series 1.

 

 

 

 

b.Preferred Stock.

 

i.There shall be two series of Preferred Stock—Series 1 and 2— authorized for issuance with the series designated at time of issuance. The number of authorized shares for each series is set forth below.

 

Preferred Stock Series  Authorized Shares 
1   6,000 
2   1,000 

 

The Preferred Stock is identical to Common Stock Series 1 in all respects except as specifically stated in this Section 2.b:

 

ii.The Preferred Stock shall rank, with respect to dividend rights and rights on liquidation, winding up and dissolution senior to the Common Stock such that each share of Preferred Stock shall receive the amount per share as set forth below (the “Preference Amount”) prior to any dividends or other cash payments to Common Stock, which amount, when paid in full, shall fully redeem and retire the Preferred Stock. In the event there is not enough distributed to pay the full Preference Amount of both series of Preferred Stock, then such partial payments will be made pro-rata and in proportion to the Preference Amount.

 

Preferred Stock Series  Preferred Amount 
1  $4,733.3333 
2  $3,533.3333 

 

iii.Any holder of Preferred Stock may, upon written notice to the Corporation, convert their shares of Preferred Stock into shares of Common Stock Series 1 on a 1:1 basis adjusted downward pro rata with the percentage of the Preference Amount already paid to the holders of Preferred Stock.

 

iv.The terms and preferences of the Preferred Stock may be amended with the vote or written consent of the holders of not less than a majority of the then outstanding shares of Preferred Stock, voting as a separate class.

 

v.In the event of a merger, acquisition, reorganization or conversion of the Corporation in order to effect a public listing of the Corporation’s securities, each share of Preferred Stock will be treated identically as each share of Common Stock Series 1.

 

c.Fractional Shares.

 

Fractional shares of capital stock may be issued and will have the rights and privileges equal to the fraction of the respective share so issued as a fractional share (e.g., 0.33 of a share of Common Stock Series 1 will have 0.33 votes).

 

3.No Preemptive Rights.

 

No share of capital stock shall have any rights of preemption whatsoever as to any securities of the Corporation, or any warrants, rights or options issued or granted with respect thereto, regardless of how such securities, or such warrants, rights or options, may be designated, issued or granted.

 

4.Actions Without a Meeting.

 

Any action that is otherwise permitted to be taken at a meeting of the shareholders of the Corporation may take action without a meeting if (i) a written consent (which may be electronic), setting forth the action to be taken, shall be provided to all of the shareholders entitled to vote with respect to the subject matter thereof, (ii) the written consent is approved (which may be electronically) by holders of not less than the minimum number of outstanding shares of each voting group entitled to vote on the action that would be required to adopt or take the action at a shareholders' meeting at which all shares of each voting group entitled to vote on the action were present and voted shall have signed written consents setting forth the action to be adopted or taken, (iii) the corporation's secretary shall have received a copy of the form of written consent setting forth the action to be adopted or taken, and (iv) such consent complies with all requirements of the laws of the Commonwealth of Virginia.

 

The written consent shall bear the date on which each shareholder signed the consent and be delivered to the corporation for inclusion in the minutes or filing with the corporate records.

 

5.Registered Agent.

 

a.The name of the corporation's initial registered agent is William B. Stilley.

 

b.The corporation’s initial registered agent is an individual who is a resident of Virginia and an initial director of the corporation.

 

2

 

 

6.The corporation's initial registered office address, which is identical to the business office of the initial registered agent, is 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901.

 

7.The initial director is William B. Stilley.

 

Incorporator:

 

   

William B. Stilley, Incorporator

 

 

3

 

 

EX-3.6 8 fs12017ex3-6_adialpharma.htm FORM OF BYLAWS OF APL CONVERSION CORP

Exhibit 3.6

 

BYLAWS

OF

APL CONVERSION CORP.

 

ARTICLE I

Meetings of Shareholders

 

1.1       Place of Meetings. All meetings of the shareholders shall be held at such place, either within or without the Commonwealth of Virginia, as from time to time may be fixed by the Board of Directors.

 

1.2       Annual Meetings. The annual meeting of the shareholders, for the election of Directors and transaction of such other business as may come before the meeting, shall be held in each year on the first Tuesday in February each year, or on such other day as the Board of Directors shall determine if that day is not a legal holiday. If that day is a legal holiday, the annual meeting shall be held on the next succeeding day not a legal holiday.

 

1.3       Special Meetings. A special meeting of the shareholders for any purpose or purposes may be called at any time by the a majority of the Board of Directors, or by shareholders together holding at least 40% of the number of shares of the Corporation at the time outstanding and entitled to vote with respect to the business to be transacted at such meeting. At a special meeting no business shall be transacted and no corporate action shall be taken other than that stated in the notice of the meeting.

 

1.4       Notice of Meetings. Written or printed notice stating the place, day and hour of every meeting of the shareholders and, in case of a special meeting, the purpose or purposes for which the meeting is called, shall be mailed (notice sent by email to an email address provided by the shareholder is sufficient) not less than ten nor more than sixty days before the date of the meeting to each shareholder of record entitled to vote at such meeting, at his address which appears in the stock transfer books of the Corporation. Such further notice shall be given as may be required by law, but such meetings may be held without notice if all of the shareholders entitled to vote at the meeting are present in person or by proxy or if notice is waived in writing by those not present, either before or after the meeting.

 

1.5       Quorum. Any number of shareholders together holding at least a majority of the outstanding shares of capital stock entitled to vote with respect to the business to be transacted, who shall be present in person or represented by proxy at any meeting duly called, shall constitute a quorum for the transaction of business. If less than a quorum shall be in attendance at the time for which a meeting shall have been called, the meeting may be adjourned from time to time by a majority vote of the shareholders present or represented by proxy without notice other than by announcement at the meeting.

 

1.6       Voting. At any meeting of the shareholders, each shareholder of a class entitled to vote on any matter coming before the meeting shall, as to such matter, have one vote, in person or by proxy, for each share of capital stock of such class standing in his name on the books of the Corporation on the date, not more than seventy days prior to such meeting, fixed by the Board of Directors as the record date for the purpose of determining shareholders entitled to vote. Each proxy shall be in writing, dated and signed by the shareholder entitled to vote or his duly authorized attorney-in-fact.

 

1.7       Inspectors. An appropriate number of inspectors for any meeting of shareholders may be appointed by the chairman of such meeting. Inspectors so appointed will open and close the polls, will receive and take charge of proxies and ballots, and will decide all questions as to the qualifications of voters, validity of proxies and ballots, and the number of votes properly cast.

 

 

 

ARTICLE II

Directors

 

2.1       General Powers. The property, affairs and business of the Corporation shall be under the direction of the Board of Directors, and, except as otherwise expressly provided by law, the Corporation’s Articles of Incorporation or these Bylaws, all of the powers of the Corporation shall be vested in such Board.

 

2.2       Number of Directors. The number of Directors constituting the Board of Directors shall be at least one (1) and no more than nine (9).

 

2.3       Election and Removal of Directors; Quorum.

 

a.       Directors shall be elected at each annual meeting of shareholders to succeed those Directors whose terms have expired and to fill any vacancies then existing.

 

b.       Directors shall hold their offices for terms of one year and until their successors are elected. Any Director may be removed from office at a meeting called expressly for that purpose by the vote of shareholders holding not less than a majority of the shares entitled to vote at an election of Directors.

 

c.       Any vacancy occurring in the Board of Directors may be filled by the affirmative vote of the majority of the remaining Directors though less than a quorum of the Board, and the term of office of any Director so elected shall expire at the next shareholders’ meeting at which Directors are elected.

 

d.       A majority of the number of Directors elected and serving at the time of any meeting shall constitute a quorum for the transaction of business. The act of a majority of Directors present at a meeting at which a quorum is present shall be the act of the Board of Directors. Less than a quorum may adjourn any meeting.

 

2.4       Meetings of Directors. An annual meeting of the Board of Directors shall be held as soon as practicable after the adjournment of the annual meeting of shareholders at such place as the Board may designate. Other meetings of the Board of Directors shall be held at places within or without the State of Virginia and at times fixed by resolution of the Board. The Secretary or officer performing the Secretary’s duties shall give not less then twenty-four hours’ notice by letter, email, facsimile or telephone (or in person) of all meetings of the Board of Directors, provided that notice need not be given of the annual meeting or of regular meetings held at times and places fixed by resolution of the Board. Meetings may be held at any time without notice if all of the Directors are present, or if those not present waive notice in writing before or after the meeting. The notice of meetings of the Board need not state the purpose of the meeting.

 

2.5       Compensation. By resolution of the Board, Directors may be compensated for services as Directors. Nothing herein shall preclude Directors from serving the Corporation in other capacities and receiving compensation for such other services.

 

2

 

 

ARTICLE III

Officers

 

4.1       Election of Officers; Terms. The officers of the Corporation shall consist of a President, a Secretary, and a Treasurer. Other officers, including a Chairman of the Board, Chief Operating Officer and one or more Vice-Presidents (whose seniority and title, including Executive Vice-Presidents and Senior Vice-Presidents, may be specified by the Board of Directors), and assistant and subordinate officers, may from time to time be elected by the Board of Directors. All officers shall hold office until the next annual meeting of the Board of Directors and until their successors are elected. The President shall be chosen from among the Directors. Any offices may be combined in the same person as the Board of Directors may determine.

 

4.2       Removal of Officers; Vacancies. Any officer of the Corporation may be removed summarily with or without cause, at any time, by the Board of Directors. Vacancies may be filled by the Board of Directors.

 

4.3       Duties. The officers of the Corporation shall have such duties as generally pertain to their offices, respectively, as well as such powers and duties as are prescribed by law or are hereinafter provided or as from time to time shall be conferred by the Board of Directors. The Board of Directors may require any officer to give such bond for the faithful performance of his duties as the Board may see fit.

 

4.4       Duties of the President. The President shall be the chief executive officer of the Corporation and shall be primarily responsible for the implementation of the policies of the Board of Directors. He shall have authority over the general management and direction of the business and operations of the Corporation and its divisions, if any, subject only to the ultimate authority of the Board of Directors. He shall be a Director and, except as otherwise provided by these Bylaws or in the resolutions of establishing such committees, he shall be ex officio a member of all Committees of the Board. In the absence of the Chairman and the Vice-Chairman of the Board, or if there are no such officers, the President shall preside at all corporate meetings. He may sign and execute in the name of the Corporation share certificates, deeds, mortgages, bonds, contracts or other instruments except in cases where the signing and the execution thereof shall be expressly delegated by the Board of Directors or by these Bylaws to some other officer or agent of the Corporation or shall be required by law otherwise to be signed or executed. In addition, he shall perform all duties incident to the office of the President and such other duties as from time to time may be assigned to him by the Board of Directors.

 

4.5       Duties of the Vice-Presidents. Each Vice-President, if any, shall have such powers and duties as may from time to time be assigned to him by the President or the Board of Directors. Any Vice-President may sign and execute in the name of the Corporation deeds, mortgages, bonds, contracts or other instruments except where the signing and execution of such documents shall be expressly delegated by the Board of Directors or the President to some other officer or agent of the Corporation or shall be required by law otherwise to be signed or executed.

 

3

 

 

4.6       Duties of the Treasurer. The Treasurer shall have charge of and be responsible for all funds, securities, receipts and disbursements of the Corporation, and shall deposit all monies and securities of the Corporation in such banks and depositories as shall be designated by the Board of Directors. He shall be responsible (a) for maintaining adequate financial accounts and records in accordance with generally accepted accounting practices; (b) for the preparation of appropriate operating budgets and financial statements; (c) for the preparation and filing of all tax returns required by law; and (d) for the performance of all duties incident to the office of Treasurer and such other duties as from time to time may be assigned to him by the Board of Directors, the Finance Committee or the President. The Treasurer may sign and execute in the name of the Corporation share certificates, deeds, mortgages, bonds, contracts or other instruments, except in cases where the signing and execution thereof shall be expressly delegated by the Board of Directors or by these Bylaws to some other officer or agent of the Corporation or shall be required by law or otherwise to be signed or executed.

 

4.7       Duties of Secretary. The Secretary shall act as secretary of all meetings of the Board of Directors and shareholders of the Corporation. When requested, he also shall act as secretary of the meetings of the committees of the Board. He shall keep and preserve the minutes of all such meetings in permanent books. He shall be responsible for (a) seeing that all notices required to be given by the Corporation are duly given and served; (b) having custody of the seal of the Corporation and shall affix the seal or cause to be affixed to all share certificates of the Corporation and to all documents the execution of which on behalf of the Corporation under its corporate seal is duly authorized in accordance with law or the provisions of these Bylaws; (c) having custody of all deeds, leases, contracts and other important corporate documents; (d) having charge of the books, records and papers of the Corporation relating to its organization and management as a Corporation; (e) seeing that all reports, statements and other documents required by law (except tax returns) are properly filed; and (f) in general, performing all the duties incident to the office of Secretary and such other duties as from time to time be assigned to him by the Board of Directors or the President.

 

4.8       Compensation. Officers will not be compensated.

 

4

 

 

ARTICLE IV

Capital Stock

 

5.1       Certificates. The holdings of shares of capital stock of the Corporation shall be maintained by the Corporation.

 

5.2       Transfer of Shares. The shares of the Corporation shall be transferable or assignable only on the books of the Corporation by the holder in person or by attorney on surrender of the certificate for such shares duly endorsed and, if sought to be transferred by attorney or stock power, accompanied by a written power of attorney or stock power to have the same transferred on the books of the Corporation. The Corporation will recognize, however, the exclusive right of the person registered on its books as the owner of shares to receive dividends and to vote as such owner.

 

5.3       Fixing Record Date. For the purposes of determining shareholders entitled to notice of or to vote at any meeting of shareholders or any adjournment thereof, or entitled to receive payment of any dividend, or in order to make a determination of shareholders for any other proper purpose, the Board of Directors may fix in advance a date as the record date for any such determination of shareholders, such date in any case to be not more than seventy days prior to the date on which the particular action requiring such determination of shareholders is to be taken. If no record date is fixed for the determination of shareholders entitled to notice of or to vote at a meeting of shareholders, or shareholders entitled to receive payment of a dividend, the date on which notices of the meeting are mailed or the date on which the resolution of the Board of Directors declaring such dividend is adopted, as the case may be, shall be the record date for such determination of shareholders. When a determination of shareholders entitled to vote at any meeting of shareholders has been made as provided in this Section, such determination shall apply to any adjournment thereof unless the Board of Directors fixes a new record date, which it shall do if the meeting is adjourned to a date not than more than 120 days after the date fixed for the original meeting.

 

ARTICLE V

Miscellaneous Provisions

 

6.1       Fiscal Year. The fiscal year of the Corporation shall end on such date and shall consist of such accounting periods as may be fixed by the Board of Directors.

 

6.2       Checks, Notes and Drafts. Checks, notes, drafts and other orders for the payment of money shall be signed by such persons as the Board of Directors from time to time may authorize. When the Board of Directors so authorizes, however, the signature of any such person may be a facsimile.

 

6.3       Amendment of Bylaws. Unless otherwise prescribed by the Articles of Incorporation, these Bylaws may be amended or altered at any meeting of the Board of Directors by affirmative vote of a majority of the number of Directors fixed by these Bylaws. The shareholders entitled to vote in respect of the election of Directors, however, shall have the power to rescind, amend, alter or repeal any Bylaws and to enact Bylaws which, if expressly so provided, may not be amended, altered or repealed by the Board of Directors.

 

6.5       Voting of Shares Held. Unless otherwise provided by resolution of the Board of Directors, the President may from time to time appoint an attorney or attorneys or agent or agents of the Corporation, in the name and on behalf of the Corporation, to cast the vote which the Corporation may be entitled to cast as a shareholder or otherwise in any other corporation, any of whose securities may be held by the Corporation, at meetings of the holders of the shares or other securities of such other corporation, or to consent in writing to any action by any such other corporation; and the President shall instruct the person or persons so appointed as to the manner of casting such votes or giving such consent and may execute or cause to be executed on behalf of the Corporation, and under its corporate seal or otherwise, such written proxies, consents, waivers or other instruments as may be necessary or proper in the premises. In lieu of such appointment, the President may himself attend any meetings of the holders of shares or other securities of any such other corporation and there vote or exercise any or all power of the Corporation as the holder of such shares or other securities of such other corporation.

 

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ARTICLE VI

Emergency Bylaws

 

The Emergency Bylaws provided in this Article VII shall be operative during any emergency, notwithstanding any different provision in the preceding Articles of these Bylaws or in the Articles of Incorporation of the Corporation or in the Virginia Stock Corporation Act (other than those provisions relating to emergency by-laws). An emergency exists if a quorum of the Corporation’s Board of Directors cannot readily be assembled because of some catastrophic event. To the extent not inconsistent with these Emergency Bylaws, the Bylaws provided in the preceding Articles shall remain in effect during such emergency and upon the termination of such emergency these Emergency Bylaws shall cease to be operative unless and until another such emergency shall occur.

 

During any such emergency:

 

a.       Any meeting of the Board of Directors may be called by any officer of the Corporation or by any Director. The notice thereof shall specify the time and place of the meeting. To the extent feasible, notice shall be given in accordance with Section 2.4 above, but notice may be given only to such of the Directors as it may be feasible to reach at the time, by such means as may be feasible at the time, including publication or radio, and at a time less than twenty-four hours before the meeting if deemed necessary by the person giving such notice. Notice shall be similarly given, to the extent feasible, to the other persons referred to in (b) below.

 

b.       At any meeting of the Board of Directors, a quorum shall consist of a majority of the number of Directors fixed at the time by Article II of these Bylaws. If the Directors present at any particular meeting shall be fewer than the number required for such quorum, other persons present as required for such quorum, other persons present as referred to below, to the number necessary to make up such quorum, shall be deemed Directors for such particular meeting as determined by the following provisions and in the following order or priority:

 

(i)       Vice-Presidents not already serving as Directors, in the order of their seniority of first election to such offices, or if two or more shall have been first elected to such offices on the same day, in the order of their seniority in age;

 

(ii)       All other officers of the Corporation in the order of their seniority of first election to such offices, or if two or more shall have been first elected to such offices on the same day, in the order of their seniority in age; and

 

(iii)       Any other persons that are designated on a list that shall have been approved by the Board of Directors before the emergency, such persons to be taken in such order of priority and subject to such conditions as may be provided in the resolution approving the list.

 

c.       The Board of Directors, during as well as before any such emergency, may provide, and from time to time modify, lines of succession in the event that during such emergency any or all officers or agents of the Corporation shall for any reason be rendered incapable of discharging their duties.

 

d.       The Board of Directors, during as well as before any such emergency, may, effective in the emergency, change the principal office or designate several alternative offices, or authorize the officers to do so.

 

No officer, Director or employee shall be liable for action taken in good faith in accordance with these Emergency Bylaws.

 

These Emergency Bylaws shall be subject to repeal or change by further action of the Board of Directors or by action of the shareholders, except that no such repeal or change shall modify the provisions of the next preceding paragraph with regard to action or inaction prior to the time of such repeal or change.

 

Any such amendment of these Emergency Bylaws may make any further or different provision that may be practical and necessary for the circumstances of the emergency.

 

 

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EX-3.7 9 fs12017ex3-7_adialpharma.htm FORM OF ARTICLES OF CONVERSION

Exhibit 3.7

 

ARTICLES OF ENTITY CONVERSION OF

ADIAL PHARMACEUTICALS, L.L.C.

 

The undersigned, on behalf of the limited liability company set forth below, pursuant to Title 13.1, Chapter 12, Article 15 of the Code of Virginia, states as follows:

 

1.The name of the Virginia limited liability company immediately before the filing of these articles of entity conversion is ADial Pharmaceuticals, L.L.C. The limited liability company shall convert to a Virginia stock corporation and its name shall be

 

APL Conversion Corp.

 

2.The converting limited liability company was originally organized on November 23, 2010 as a Virginia limited liability company with the name ADial Pharmaceuticals, L.L.C.

 

3. The plan of entity conversion, pursuant to § 13.1-1083 of the Code of Virginia, is attached hereto as Exhibit A.

 

4.The plan of entity conversion was adopted by the limited liability company in accordance with § 13.1-1084 of the Code of Virginia on _______________, 2017.

 

Signed in the name of the limited liability company by:

  

                    (date)

William B. Stilley

Company Secretary

 

SCC ID Number: S345366-1 

 

The person signing the articles has been delegated the right and power to manage the business and affairs of the limited liability company.

EX-3.8 10 fs12017ex3-8_adialpharma.htm FORM OF PLAN OF CONVERSION

Exhibit 3.8

 

TERMS AND CONDITIONS OF THE

PLAN OF ENTITY CONVERSION

ADIAL PHARMACEUTICALS, L.L.C.

INTO

APL CONVERSION CORP.

 

__________, 2017

 

Pursuant to Title 13.1, Chapter 12, Article 15 of the Code of Virginia (the “Code”), this Plan of Entity Conversion (this “Plan”) sets forth the manner and basis of converting the membership interests of ADial Pharmaceuticals, L.L.C., a Virginia limited liability company, (the “LLC”) into APL Conversion Corp., a Virginia corporation (the “Corporation”). Capitalized terms not otherwise defined herein shall have the meaning ascribed in the Second Amended and Restated Operating Agreement of the LLC dated February 3, 2014 (the “Operating Agreement”).

 

WHEREAS, the LLC plans to convert into a domestic stock corporation, subject to approval therefor by the Members of the LLC and the filing of Articles of Entity Conversion (the “Certificates”) with the Commonwealth of Virginia State Corporation Commission in connection with the listing of the securities of the Corporation or a successor entity on a public stock exchange (a “public listing”); and

 

WHEREAS, the Code requires the LLC to adopt a plan of entity conversion; and

 

WHEREAS, the LLC has issued Class A and Class B Units, which together represent all of the outstanding Membership Interests in the Company, and has designated certain Class A Units as Profits Interest Units, which units have a liquidation value equal to a fraction of the Class A Units based on the value of the then outstanding Class A Units at the time of issuance of the Profits Interest Units, and whereas, the Members of the LLC desires to convert all such Units into stock in the Corporation in a manner that retains the relative value of the Units to each other on the date of such conversion; and

 

WHEREAS, the LLC has issued certain options and warrants to purchase Units to certain Members, and the LLC intends to convert such options and warrants into options and warrants for stock in the Corporation; and

 

 

 

WHEREAS, the Section 13 of the Operating Agreement permits the amendment of the Operating Agreement by Members holding a majority of the outstanding Units entitled to vote and a majority of the then outstanding Class B Units, voting as a separate class, to amend the Operating Agreement, which under the Code is thus the threshold for approving this Plan; and

 

WHEREAS, the Corporation will have the following capital stock: Common Stock Series 1, Common Stock Series 2, Common Stock Series 3, Common Stock Series 4, Preferred Stock Series 1 and Preferred Stock Series 2; all as further described in the attached Articles of Incorporation of the Corporation;

 

NOW. THEREFORE, the LLC hereby sets forth the details for such conversion into the Corporation in this Plan as follows:

 

1.The LLC hereby agrees to convert the LLC into the Corporation (the “Conversion") to be and to perform such acts and execute such documents as may be necessary and/or convenient to effect the Conversion, including, but not limited to, the execution of the Certificates and the By-laws of the Corporation (the "By-laws”) substantially in the form submitted to the Members.

 

2.Conversion. Upon the filing of the Certificates with the Virginia Secretary of State, the LLC shall be converted into the Corporation pursuant to the Code and, in connection therewith, as follows:

 

a.Holders of LLC Units will receive shares of the capital stock of the Corporation as for each Unit held as set forth below:

 

  LLC Unit Converted Corporation Capital Stock Received for Each LLC Unit Converted
  Voting Class A Units 0.00030000 shares of Common Stock Series 1
  Voting Class A Profits Interest Units with and issue value of $1.42 0.00011067 shares of Common Stock Series 2
  Voting Class A Profits Interest Units with and issue value of $0.50 0.00023333 shares of Common Stock Series 3
  Nonvoting Class A Units 0.00030000 shares of Common Stock Series 4
  Nonvoting Class A Profits Interest Units with and issue value of $0.50 0.00023333 shares of Common Stock Series 4
  Class B Units with Unreturned Capital of $1.42 per unit 0.00030000 shares of Preferred Stock Series 1
  Class B Units with Unreturned Capital of $1.06 per unit 0.00030000 shares of Preferred Stock Series 2

  

b.Holders of options and/or warrants to purchase Units in the LLC will, upon Conversion, hold options and/or warrants to purchase shares in a number and type equal to the number and type of shares they would have received if their options and/or warrants had been exercised prior to the Conversion with the aggregate exercise price to be paid for their options and/or warrants being the same as that prior to the Conversion.

 

2

 

  

3.Amendment. This Plan may be amended prior to filing the Certificates (but subsequent to approval of this Plan) by the shareholders of the Corporation or the Board of Directors of the LLC, except that this Plan may not be amended to change:

 

a.the amount or kind of shares or other securities, interests, obligations, rights to acquire shares, other securities or interests, cash, or other property to be received by the shareholders or Members under this Plan.

 

b.any of the other terms or conditions of this Plan if the change would adversely affect any of the shareholders or Members in any material respect.

 

4.Business of LLC. The business of the LLC shall continue to be carried on after the Conversion by the Corporation in accordance with the provisions of Virginia Law, the Articles of Entity Conversion, and the By-laws.

 

5.Articles of Incorporation. Pursuant to Section 13.1-1083.A.1.c of the Code, attached hereto are the Articles of Incorporation of the Corporation.

 

6.Limitation. Notwithstanding anything else herein, the Conversion is only authorized in connection with the merger with and subsequent public listing of Adial Pharmaceuticals, Inc., a Delaware corporation, and if no such merger and public listing has occurred prior to January 31, 2018, then this Plan is withdrawn and any approvals of this Plan are null and void.

 

3

 

 

IN WTINESS WHEREOF, the undersigned has executed this Agreement as of the date first set forth above.

 

ADial Pharmaceuticals, L.L.C.  
a Virginia limited liability company  
     
By:    
  William B. Stilley  
  Company Secretary  

 

[Articles of Incorporation]

 

 

4

 

 

EX-3.9 11 fs12017ex3-9_adialpharma.htm FORM OF CERTIFICATE OF MERGER - DELAWARE

Exhibit 3.9

 

STATE OF DELAWARE
CERTIFICATE OF MERGER OF
FOREIGN CORPORATION INTO
DOMESTIC CORPORATION

 

Pursuant to Title 8, Section 252 of the Delaware General Corporation Law, the undersigned corporation executed the following Certificate of Merger:

 

FIRST: The name of the surviving corporation is Adial Pharmaceuticals, Inc., a Delaware corporation, and the name of the corporation being merged into the surviving corporation is APL Conversion Corp., a Virginia corporation.

 

SECOND: The Agreement and Plan of Reorganization has been approved, adopted, certified, executed and acknowledged by each of the constituent corporations pursuant to Title 8, Section 252 of the General Corporation Law of the State of Delaware.

 

THIRD: The name of the surviving corporation is Adial Pharmaceuticals, Inc., a Delaware corporation.

 

FOURTH: The Certificate of Incorporation of the surviving corporation shall be its Certificate of Incorporation.

 

FIFTH: The authorized stock and par value of the non-Delaware corporation is 50,000,000 shares of common stock, $0.001 par value, and 5,000,000 shares of preferred stock, $0.001 par value.

 

SIXTH: The merger is to become effective on September      , 2017.

 

SEVENTH: The Agreement of Merger is on file at the place of business of the surviving corporation.

 

EIGHTH: A copy of the Agreement and Plan of Reorganization will be furnished by the surviving corporation on request, without cost, to any stockholder of the constituent corporations.

 

IN WITNESS WHEREOF, said surviving corporation has caused this certificate to be signed by an authorized officer, the       day of September, 2017.

 

  ADIAL PHARMACEUTICALS, INC.
     
  By:    
  Name: William B. Stilley
  Title: Chief Executive Officer

 

EX-3.10 12 fs12017ex3-10_adialpharma.htm FORM OF ARTICLES OF MERGER - VIRGINIA

Exhibit 3.10

 

ARTICLES OF MERGER

OF

APL CONVERSION CORP.

INTO

ADIAL PHARMACEUTICALS, INC.

 

The undersigned corporations, pursuant to Title 13.1, Chapter 9 Article 12 of the Code of Virginia, titled the Virginia Stock Corporation Act (hereinafter the “VSCA”), hereby execute the following articles of merger and set forth:

 

FIRST: The name and state or jurisdiction of incorporation of each of the constituent corporations proposing to merge is as follows:

 

Name of Corporation


 

State of Incorporation


APL CONVERSION CORP.   Virginia
     
ADIAL PHARMACEUTICALS, INC.   Delaware

 

SECOND: The laws of the state under which Adial Pharmaceuticals, Inc. (hereinafter “API”) is organized permit the proposed merger and API has complied with all of the requisite merger provisions of the Delaware General Corporation Law in effecting the merger.

 

THIRD: APL Conversion Corp. (hereinafter “ACC”) has complied with all of the requisite merger provisions of the VSCA in effecting the merger, including Sections 13.1 – 716, 718, 720-722.

 

FOURTH: The Agreement and Plan of Merger, by and between ACC and API, dated September , 2017 (the “Merger Agreement”) has been approved, adopted and certified, executed and acknowledged by each of the constituent corporations and the terms of the Merger Agreement are as follows:

 

ACC shall merge with and into API, whereby the separate corporate existence of ACC shall thereupon cease (the “Merger”) and API shall continue as the surviving corporation. API shall continue to be governed by the laws of the State of Delaware, and all of the assets, and interests of every description, wherever located, and all rights, privileges, immunities, powers, franchises and authority of ACC shall be vested in API as the surviving corporation, without further act or deed and all liabilities and obligations of ACC shall be allocated to API as the surviving corporation.

 

The Certificate of Incorporation and Bylaws of API shall be the Certificate of Incorporation and Bylaws of the surviving corporation.

 

Each share of common stock, par value $0.01 per share, of API issued and outstanding immediately prior to the Merger shall be canceled, retired and cease to be outstanding or exist.

 

Each outstanding share of ACC common stock issued and outstanding immediately prior to the Merger shall convert into the right to receive merger consideration, subject to the terms and conditions of the Merger Agreement, without interest, upon surrender of the certificate representing such shares and all shares of ACC common stock shall be canceled, retired and cease to be outstanding or exist. Each holder of a certificate representing shares of ACC common stock and ACC preferred stock shall thereafter cease to have any rights with respect to the same.

 

 

 

ARTICLES OF MERGER — Page 2


  

  

The Merger shall have the effects as specified in Section 259 of the Delaware General Corporation Law and Section 13.1 – 721 of the VSCA.

 

FIFTH: The Merger Agreement was submitted to the shareholders of ACC by the board of directors of ACC in accordance with the provisions of Section 13.1 – 718 of the VSCA, and:

 

The designation, number of outstanding shares, and number of votes entitled to be cast by each voting group entitled to vote separately on the Merger Agreement were as follows:

 

Designation


   

No. of Outstanding Shares


 

No. of Votes


Common Stock          

Preferred Stock

 

         
Grand Total          

 

The total number of votes cast for and against the Merger Agreement by each voting group entitled to vote separately thereon was:

 

Voting Group


 

Total No. of Votes

Cast for the Merger


 

Total No. of Votes Cast

Against the Merger


Common Stock Stockholders        

Preferred Stock Stockholders

 

       
Grand Total        

 

The number of votes cast in favor of the Merger Agreement by each voting group was sufficient for approval by that voting group.

 

SIXTH: The effective date of the Merger shall be the date that the Articles of Merger are filed with State Corporation Commission of the Commonwealth of Virginia and the Certificate of Merger is filed with the Secretary of State of the State of Delaware.

 

SEVENTH: The terms and conditions of the Merger Agreement were adopted by (i) the board of directors of ACC on September , 2017 and by the shareholders of ACC on September , 2017, and (ii) the board of directors of API on September , 2017 and by the shareholders of API, the surviving corporation, on September , 2017.

 

 

[SIGNATURES ON NEXT PAGE]

 

 

 

ARTICLES OF MERGER — Page 3


  

 

    Signed this      day of September, 2017
         
    APL CONVERSION CORP.
         
         
      By:  
      Name:  
      Title:  
    ADIAL PHARMACEUTICALS, INC.
         
         
      By:  
      Name:  
      Title:  

 

 

 

 

 

ARTICLES OF MERGER — Signature Page

 

 

EX-3.11 13 fs12017ex3-11_adialpharma.htm FORM OF AGREEMENT AND PLAN OF REORGANIZATION

Exhibit 3.11

 

AGREEMENT AND PLAN OF REORGANIZATION

 

THIS AGREEMENT AND PLAN OF REORGANIZATION is dated ________________, 2017 (this “Agreement”), and is between APL Conversion Corp., a Virginia corporation (“ACC”), and Adial Pharmaceuticals, Inc., a Delaware corporation (“Adial”).

 

WHEREAS, the Board of Directors of ACC and Adial have approved and deem it in the best interest of their respective shareholders to consummate the business combination transaction provided for herein in which ACC will merge with and into Adial for the purpose of reincorporating in Delaware, with Adial being the surviving entity, all on the terms and subject to the conditions set forth in this Agreement;

 

WHEREAS, such merger shall take place pursuant to a plan of merger in the form set forth in the Certificates of Merger attached hereto as Exhibit A, (the “Merger”);

 

WHEREAS, the Board of Directors and the shareholders of ACC and Adial have approved the Merger and the execution of the Certificates of Merger;

 

WHEREAS, the laws of the States of Virginia and Delaware permit the Merger and the parties hereto wish to merge under and pursuant to the provisions of such laws; and

 

WHEREAS, for Federal income tax purposes it is intended that the Merger qualify as a reorganization within the meaning of Section 368 of the Internal Revenue Code of 1986, as amended (the “Code”), and this Agreement be a “plan of reorganization” within the meaning of the regulations promulgated under Section 368 of the Code.

 

NOW, THEREFORE, in consideration of the foregoing premises and the respective representations, warranties, covenants and agreements contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound hereby, the parties agree as follows:

 

ARTICLE I
THE MERGER

 

1.1       The Merger. At the Effective Time, as defined in Section 1.2, the Merger shall be effected by merging ACC with and into Adial, upon the terms and subject to the conditions set forth in this Agreement and in accordance with the Delaware General Corporation Law (the “DGCL”) and the Virginia Stock Corporation Act (“the “VSCA”), whereupon: (i) the separate corporate existence of ACC shall cease and (ii) Adial shall continue as the surviving company.

 

1.2       Effective Time. On the Closing Date, as defined in Article IV, the parties shall file a Certificate of Merger with the Secretary of State of the States of Delaware and Virginia, make all other filings or recordings required by the DGCL and VSCA in connection with the Merger. The Merger shall become effective at the time as the Certificates of Merger are duly filed and accepted with the Secretary of States of Delaware and Virginia, or at such later time as the parties agree and specify in the Certificates of Merger (the time the Mergers become effective being the “Effective Time”).

 

 

 

 

1.3       Effects of the Mergers. At the Effective Time, the Merger shall have the effects set forth in this Agreement, the DGCL and, as applicable, the VSCA. Without limiting the foregoing, and subject thereto, at the Effective Time: (i) all of the property, rights, powers, privileges and franchises of ACC shall be vested in Adial, and (ii) all of the debts, liabilities and duties of ACC shall become the debts, liabilities and duties of Adial.

 

1.4       Certificate of Incorporation and By-Laws. The certificate of incorporation and the by-laws of Adial as in effect immediately prior to the Effective Time shall remain the certificate of incorporation and by-laws of Adial until thereafter amended as provided therein or by applicable law

 

1.5       Officers and Directors. The officers and directors of Adial immediately prior to the Effective Time shall remain the officers and directors of Adial, and shall hold office in accordance with the certificate of incorporation and by-laws of Adial until the earlier of the applicable officer’s or director’s resignation or removal or until his or her respective successor is duly elected and qualified, as the case may be.

 

1.6       Conversion of Shares. At the Effective Time, by virtue of the Merger and without any action on the part of the shareholders of ACC or Adial: (i) each issued and outstanding share of Series 1 common stock, without par value, of ACC shall be converted into and become Six Hundred Twenty (620) shares of common stock $.001 par value, of Adial; (ii) each issued and outstanding share of Series 2 common stock, without par value, of ACC shall be converted into and become Six Hundred Twenty (620) shares of common stock $.001 par value, of Adial; (iii) each issued and outstanding share of Series 3 common stock, without par value, of ACC shall be converted into and become Six Hundred Twenty (620) shares of common stock $.001 par value, of Adial; (iv) each issued and outstanding share of Series 4 common stock, without par value, of ACC shall be converted into and become Six Hundred Twenty (620) shares of common stock $.001 par value, of Adial; (v) each issued and outstanding share of Series 1 preferred stock, without par value, of ACC shall be converted into and become Six Hundred Twenty (620) shares of common stock $.001 par value, of Adial; (vi) each issued and outstanding share of Series 2 preferred stock, without par value, of ACC shall be converted into and become Six Hundred Twenty (620) shares of common stock $.001 par value, of Adial; and (vii) the Outstanding Shares (defined in Section 3.6 below) shall be canceled, retired and cease to be outstanding or existing. For share calculations under (i)-(v) in this Section 1.6, the number of shares to be issued will be the number calculated and rounded to the nearest whole share.

 

1.7       Options and Warrants Effective as of the Effective Time, all outstanding options and warrants that have been issued by ACC will be assumed by Adial, and the holders thereof shall be entitled to exercise such options and warrants until their stated expiration date for an equivalent amount of securities at proportionately adjusted exercise price to give effect to the Merger, as determined by the board of directors of Adial in good faith.

 

1.8       No Further Ownership Rights in Shares. From and after the Effective Time, the holders of certificates evidencing ownership of ACC shares of common stock outstanding immediately prior to the Effective Time shall cease to have any rights with respect to such ACC shares, and as such will automatically be cancelled.

 

1.9       Board and Shareholders. (i) ACC’s Board of Directors shall approve this Agreement and the Merger and obtain shareholder approval and (ii) Adial’s Board of Directors shall approve this Agreement and the Merger and obtain shareholder approval.

 

2

 

 

ARTICLE II
ACC Representations

 

ACC represents to Adial as of the date of this Agreement and as of the Closing Date as follows:

 

2.1       Organization and Good Standing. ACC is an entity duly organized, validly existing, and in good standing under the laws of the State of Virginia, with all power and authority necessary to own or use its assets and conduct its business as it is now being conducted. ACC is duly qualified to do business as a foreign corporation in, and is in good standing under the laws of, each state or other jurisdiction in which the failure to be so qualified or in good standing would have a material adverse effect on: (i) its ability to perform its obligations under this Agreement or (ii) the assets, financial position, or results of operations of ACC.

 

2.2       Authority. ACC has full power and authority to execute and deliver this Agreement and to perform its obligations hereunder. Execution and delivery of this Agreement and performance by ACC of its obligations hereunder have been duly authorized by the shareholders and the board of directors of ACC and no other proceedings on the part of ACC is necessary with respect thereto.

 

2.3       Enforceability. This Agreement constitutes the valid and binding obligation of ACC, enforceable in accordance with its terms, except as enforceability is limited by: (i) any applicable bankruptcy, insolvency, reorganization, moratorium, or similar law affecting creditors’ rights generally or (ii) general principles of equity, whether considered in a proceeding in equity or at law.

 

2.4       Consents. ACC is not required to obtain the consent of any person, including the consent of any party to any contract to which ACC is party, in connection with execution and delivery of this Agreement and performance of its obligations hereunder.

 

2.5       No Violations. The execution and delivery of the agreement by ACC and the performance of its obligations hereunder do not: (i) violate any provision of ACC’s organizational documents as currently in effect; (ii) conflict with, result in a breach of, constitute a default under (or an event that, with notice or lapse of time or both, would constitute a default under), accelerate the performance required by, result in the creation of any lien on any of the properties or assets of ACC under, or create in any party the right to accelerate, terminate, modify, or cancel, or require any notice under, any contract to which ACC is a party or by which any properties or assets of ACC are bound; or (iii) to ACC’s knowledge, contravene, conflict with, or violate any law or order to which it is subject.

 

2.6        Accredited Investors. To ACC’s knowledge, all of ACC’s shareholders are “accredited investors” as that term is defined by Rule 501(a) of Regulation D, as promulgated under the Securities Act of 1933, as amended.

 

3

 

 

ARTICLE III
ADIAL representations

 

Adial represents to ACC as of the date of this Agreement and as of the Closing Date as follows:

 

3.1       Organization and Good Standing. Adial is validly existing, and in good standing under the laws of the State of Delaware, with all power and authority necessary to own or use its assets and conduct its businesses as it is now being conducted. Adial is duly qualified to do business as a foreign corporation in, and is in good standing under the laws of, each state or other jurisdiction in which the failure to be so qualified or in good standing would have a material adverse effect on: (i) its ability to perform its obligations under this Agreement or (ii) its assets, financial position, or results of operations.

 

3.2       Authority. Adial has full power and authority to execute and deliver this Agreement and to perform its obligations hereunder. Execution and delivery of this Agreement and performance by Adial of its obligations hereunder have been duly authorized by the shareholders and board of directors of Adial and no other proceedings on the part of either is necessary with respect thereto.

 

3.3       Enforceability. This Agreement constitutes the valid and binding obligation of Adial, enforceable in accordance with its terms, except as enforceability is limited by: (i) any applicable bankruptcy, insolvency, reorganization, moratorium, or similar law affecting creditors’ rights generally or (ii) general principles of equity, whether considered in a proceeding in equity or at law.

 

3.4       Consents. Adial is not required to obtain the consent of any person, including the consent of any party to any contract to which either is party, in connection with execution and delivery of this Agreement and performance of its obligations hereunder.

 

3.5       No Violations. The execution and delivery of the agreement by Adial and the performance of its obligations hereunder does not: (i) violate any provision of its organizational documents as currently in effect; (ii) conflict with, result in a breach of, constitute a default under (or an event that, with notice or lapse of time or both, would constitute a default under), accelerate the performance required by, result in the creation of any lien on any of the properties or assets of either under, or create in any party the right to accelerate, terminate, modify, or cancel, or require any notice under, any contract to which either is a party or by which any properties or assets of either is bound; or (iii) to Adial’s knowledge, contravene, conflict with, or violate any law or order to which it is subject.

 

3.6       Capitalization. The authorized capital stock of Adial consists of 55,000,000 shares of common stock, $0.001 par value, of which 100 shares are issued and outstanding (the “Outstanding Shares”) and 5,000,000 shares of preferred stock, $0.0001 par value, of which no shares are issued and outstanding. All of the shares of common stock outstanding of Adial have been duly authorized and validly issued and are fully paid and non-assessable. There are no securities of Adial outstanding that contain anti-dilution or similar provisions that will be triggered by the Merger. There are no outstanding preemptive, conversion or other rights, options, warrants or agreements granted or issued by or binding upon Adial for the purchase or acquisition of any shares of its capital stock of either. There are no agreements for the registration of any outstanding shares of capital stock of Adial.

 

3.7       Liabilities.  Adial has no debts, liabilities or obligations and there are no outstanding guaranties, performance or payment bonds, letters of credit or other contingent contractual obligations that have been undertaken by Adial or otherwise related to its business that may survive the Merger.

 

3.8        Litigation. There are no actions, suits, proceedings or investigations (including any purportedly on behalf of the ) pending or threatened against or affecting the businesses or properties of Adial whether at law or in equity or admiralty or before or by any governmental department, commission, board, agency, court or instrumentality, domestic or foreign; nor is the operating under, subject to, in violation of or in default with respect to, any judgment, order, writ, injunction or degree of any court or other governmental department, commission, board, agency or instrumentality, domestic or foreign. No written inquiries or oral inquiries have been made directly to Adial by any governmental agency which might form the basis of any such action, suit, proceeding or investigation, or which might require Adial to undertake a course of action which would involve any expense. No filings have been made by any present or former employee of any of Adial with the Equal Employment Opportunity Commission or any governmental agency, asserting any claim based on alleged race, gender (including, without limitation, sexual harassment), age or other type of discrimination on the part of Adial.

 

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3.9        Enforceability. This Agreement constitutes the valid and binding agreement of Adial, enforceable against Adial in accordance with its terms, except to the extent that its enforceability may be subject to applicable bankruptcy, insolvency, reorganization, moratorium and similar laws affecting the enforcement of creditors' rights generally and by general equitable principles.

 

ARTICLE IV

the closing

 

4.1       Closing. The parties shall hold the closing of the transactions contemplated by this Agreement (the “Closing”) at Gracin & Marlow, LLP in New York, New York at 10:00 A.M. on _______, 2017 or at such other time and place as the parties agree (the date of the Closing, the “Closing Date”).

 

ARTICLE V
Miscellaneous

 

5.1       Reasonable Efforts. Subject to the conditions of this Agreement, each of the parties shall use the efforts that a reasonable person would make so as to achieve that goal as expeditiously as possible to take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary or advisable under applicable laws to consummate the transactions contemplated by this Agreement as promptly as practicable including but not limited to: (i) taking such actions as are necessary to obtain any required approval, consent, ratification, filing, declaration, registration, waiver, or other authorization and (ii) satisfying all conditions to Closing at the earliest possible time.

 

5.2       Transaction Costs. Each party shall pay its own fees and expenses (including without limitation the fees and expenses of its representatives, attorneys, and accountants) incurred in connection with negotiation, drafting, execution, and delivery of this Agreement.

 

5.3       Assignment. No party may assign any of its rights or delegate any performance under this Agreement except with the prior written consent of the other party.

 

5.4       Binding. This Agreement binds, and inures to the benefit of, the parties and their respective permitted successors and assigns.

 

5.5       Governing Law. The laws of the State of Delaware (without giving effect to its conflict of laws principles) govern all matters arising out of this Agreement, including without limitation tort claims.

 

5.6       Entirety of Agreement. This Agreement constitute the entire agreement of the parties concerning the subject matter hereof and supersedes all prior agreements, if any.

 

5.7       Further Assurances. Each of ACC and Adial shall execute and deliver such additional documents and instruments and perform such additional acts as the other party may reasonably request to effectuate or carry out and perform all the terms of this Agreement and the transactions contemplated hereby, and to effectuate the intent of this Agreement.

 

5

 

 

5.8       References to Time. All references to a time of day in this Agreement are references to the time in the State of New York.

 

5.9       Amendment. This Agreement may not be amended except by an instrument in writing signed on behalf of each of the parties.

 

5.10     Counterparts. This Agreement may be executed in several counterparts, each of which is an original and all of which together constitute one and the same instrument.

 

5.11     No Third-Party Rights. Nothing expressed or referred to in this Agreement gives any Person other than the parties to this Agreement any legal or equitable right, remedy, or claim under or with respect to this Agreement or any provision of this Agreement, and this Agreement and all of its provisions are for the sole and exclusive benefit of the parties to this Agreement and their successors and permitted assigns. The undersigned are signing this Agreement on the date stated in the introductory clause.

 

  APL CONVERSION CORP.,
          a Virginia corporation
       
  By:  
    Name: William Stilley
    Title: President
       
  ADIAL PHARMACEUTICALS, INC.,
           a Delaware corporation
       
  By:  
    Name: William Stilley
    Title: President

 

6

 

 

EXHIBIT A

 

Certificates of Merger

 

 

 

 

 

EX-4.2 14 fs12017ex4-2_adialpharma.htm FORM OF REPRESENTATIVE'S WARRANT

Exhibit 4.2

 

Form of Representative’s Warrant Agreement

 

THE REGISTERED HOLDER OF THIS PURCHASE WARRANT BY ITS ACCEPTANCE HEREOF, AGREES THAT IT WILL NOT SELL, TRANSFER OR ASSIGN THIS PURCHASE WARRANT EXCEPT AS HEREIN PROVIDED AND THE REGISTERED HOLDER OF THIS PURCHASE WARRANT AGREES THAT IT WILL NOT SELL, TRANSFER, ASSIGN, PLEDGE OR HYPOTHECATE THIS PURCHASE WARRANT FOR A PERIOD OF 180 DAYS FOLLOWING THE EFFECTIVE DATE OF THE REGISTRATION STATEMENT (DEFINED BELOW) TO ANYONE OTHER THAN (I) AEGIS CAPITAL CORP. OR AN UNDERWRITER OR A SELECTED DEALER IN CONNECTION WITH THE OFFERING, OR (II) A BONA FIDE OFFICER OR PARTNER OF AEGIS CAPITAL CORP. OR OF ANY SUCH UNDERWRITER OR SELECTED DEALER.

 

THIS PURCHASE WARRANT IS NOT EXERCISABLE PRIOR TO [·], 2018. VOID AFTER 5:00 P.M., EASTERN TIME, [·], 2022.

 

PURCHASE WARRANT

 

For the Purchase of [·] Shares of Common Stock

 

of

 

ADIAL PHARMACEUTICALS, INC.

 

1.       Purchase Warrant. THIS CERTIFIES THAT, in consideration of funds duly paid by or on behalf of Aegis Capital Corp. or its assigns (“Holder”), as registered owner of this Purchase Warrant, to Adial Pharmaceuticals, Inc., a Delaware corporation (the “Company”), Holder is entitled, at any time or from time to time from [·], 2018 (the one-year anniversary of the effective date of the Offering, the “Commencement Date”), and at or before 5:00 p.m., Eastern time, [·], 2022 (the five-year anniversary of the effective date of the Offering, the “Expiration Date”), but not thereafter, to subscribe for, purchase and receive, in whole or in part, up to [·] shares of common stock of the Company, par value $0.001 per share (the “Shares”), subject to adjustment as provided in Section 6 hereof. If the Expiration Date is a day on which banking institutions are authorized by law to close, then this Purchase Warrant may be exercised on the next succeeding day which is not such a day in accordance with the terms herein. During the period ending on the Expiration Date, the Company agrees not to take any action that would terminate the Purchase Warrant. This Purchase Warrant is initially exercisable at $[·] per Share (125% of the price of the Shares sold in the Offering); provided, however, that upon the occurrence of any of the events specified in Section 6 hereof, the rights granted by this Purchase Warrant, including the exercise price per Share and the number of Shares to be received upon such exercise, shall be adjusted as therein specified. The term “Exercise Price” shall mean the initial exercise price or the adjusted exercise price, depending on the context.

 

2.       Exercise.

 

2.1       Exercise Form. In order to exercise this Purchase Warrant, the exercise form attached hereto must be duly executed and completed and delivered to the Company, together with this Purchase Warrant and payment of the Exercise Price for the Shares being purchased payable in cash by wire transfer of immediately available funds to an account designated by the Company or by certified check or official bank check. If the subscription rights represented hereby shall not be exercised at or before 5:00 p.m., Eastern time, on the Expiration Date, this Purchase Warrant shall become and be void without further force or effect, and all rights represented hereby shall cease and expire.

 

2.2       Cashless Exercise.  If at any time after the Commencement Date there is no effective registration statement registering, or no current prospectus available for, the resale of the Shares by the Holder, then in lieu of exercising this Purchase Warrant by payment of cash or check payable to the order of the Company pursuant to Section 2.1 above, Holder may elect to receive the number of Shares equal to the value of this Purchase Warrant (or the portion thereof being exercised), by surrender of this Purchase Warrant to the Company, together with the exercise form attached hereto, in which event the Company shall issue to Holder, Shares in accordance with the following formula:

 

X = Y(A-B)  
A  
Where, X = The number of Shares to be issued to Holder;
  Y = The number of Shares for which the Purchase Warrant is being exercised;
  A = The fair market value of one Share; and
  B = The Exercise Price.

 

 

 

 

            For purposes of this Section 2.2, the fair market value of a Share is defined as follows:

 

(i)       if the Company’s common stock is traded on a securities exchange, the value shall be deemed to be the closing price on such exchange on the trading date immediately prior to the date on which the exercise form in connection with the exercise of the Purchase Warrant is submitted to the Company; or

 

(ii)       if the Company’s common stock is traded over-the-counter, the value shall be deemed to be the closing bid price on the trading date immediately prior to the date on which the exercise form in connection with the exercise of the Purchase Warrant is submitted to the Company; if there is no public market, the value shall be the fair market value thereof, as determined in good faith by the Company’s Board of Directors.

 

2.3        Legend. Each certificate for the securities purchased under this Purchase Warrant shall bear a legend as follows unless such securities have been registered under the Securities Act of 1933, as amended (the “Act”):

 

“The securities represented by this certificate have not been registered under the Securities Act of 1933, as amended (the “Act”), or applicable state law. Neither the securities nor any interest therein may be offered for sale, sold or otherwise transferred except pursuant to an effective registration statement under the Act, or pursuant to an exemption from registration under the Act and applicable state law which, in the opinion of counsel to the Company, is available.”

 

3.       Transfer.

 

3.1       General Restrictions. The registered Holder of this Purchase Warrant agrees by his, her or its acceptance hereof, that such Holder will not: (a) sell, transfer, assign, pledge or hypothecate this Purchase Warrant for a period of 180 days following the effective date of the registration statement on Form S-1 (Registration No. 333-[·]) of the Company (the “Registration Statement”) to anyone other than: (i) Aegis Capital Corp. (“Aegis”) or an underwriter or a selected dealer participating in the Offering, or (ii) a bona fide officer or partner of Aegis or of any such underwriter or selected dealer, in each case in accordance with FINRA Conduct Rule 5110(g)(1), or (b) cause this Purchase Warrant or the securities issuable hereunder to be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of this Purchase Warrant or the securities hereunder, except as provided for in FINRA Rule 5110(g)(2). On and after that date that is 180 days after the effective date of the Registration Statement, transfers to others may be made subject to compliance with or exemptions from applicable securities laws. In order to make any permitted assignment, the Holder must deliver to the Company the assignment form attached hereto duly executed and completed, together with the Purchase Warrant and payment of all transfer taxes, if any, payable in connection therewith. The Company shall within five (5) Business Days transfer this Purchase Warrant on the books of the Company and shall execute and deliver a new Purchase Warrant or Purchase Warrants of like tenor to the appropriate assignee(s) expressly evidencing the right to purchase the aggregate number of Shares purchasable hereunder or such portion of such number as shall be contemplated by any such assignment.

 

3.2        Restrictions Imposed by the Act. The securities evidenced by this Purchase Warrant shall not be transferred unless and until: (i) the Company has received the opinion of counsel for the Holder that the securities may be transferred pursuant to an exemption from registration under the Act and applicable state securities laws, the availability of which is established to the reasonable satisfaction of the Company, or (ii) a registration statement or a post-effective amendment to the Registration Statement relating to the offer and sale of such securities has been filed by the Company and declared effective by the U.S. Securities and Exchange Commission (the “Commission”) and compliance with applicable state securities law has been established.

 

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4.       Registration Rights. The Holder shall only be entitled to the rights set forth in this Section 4 at such time as the Registration Statement is not effective or the prospectus included in the Registration Statement covering the Registrable Securities (as defined below) is not available for use by the Holders thereof.

 

4.1       Demand Registration.

 

4.1.1       Grant of Right. The Company, upon written demand (a “Demand Notice”) of the Holder(s) of at least 51% of the Purchase Warrants and/or the underlying Shares (“Majority Holders”), agrees to register, on one occasion, all or any portion of the Shares underlying the Purchase Warrants (collectively, the “Registrable Securities”). On such occasion, the Company will file a registration statement with the Commission covering the Registrable Securities within sixty (60) days after receipt of a Demand Notice and use its commercially reasonable efforts to have the registration statement declared effective promptly thereafter, subject to compliance with review by the Commission; provided, however, that the Company shall not be required to comply with a Demand Notice if the Company has filed a registration statement with respect to which the Holder is entitled to piggyback registration rights pursuant to Section 4.2 hereof and either: (i) the Holder has elected to participate in the offering covered by such registration statement or (ii) if such registration statement relates to an underwritten primary offering of securities of the Company, until the offering covered by such registration statement has been withdrawn or until thirty (30) days after such offering is consummated. The demand for registration may be made at any time during a period of four (4) years beginning one year after the effective date of the Registration Statement. The Company covenants and agrees to give written notice of its receipt of any Demand Notice by any Holder(s) to all other registered Holders of the Purchase Warrants and/or the Registrable Securities within ten (10) days after the date of the receipt of any such Demand Notice.

 

4.1.2        Terms. The Company shall bear all fees and expenses attendant to the registration of the Registrable Securities pursuant to Section 4.1.1, but the Holders shall pay any and all underwriting commissions and the expenses of any legal counsel selected by the Holders to represent them in connection with the sale of the Registrable Securities. The Company agrees to use its commercially reasonable efforts to cause the filing required herein to become effective promptly and to qualify or register the Registrable Securities in such States as are reasonably requested by the Holder(s); provided, however, that in no event shall the Company be required to register the Registrable Securities in a State in which such registration would cause: (i) the Company to be obligated to register or license to do business in such State or submit to general service of process in such State, or (ii) the principal shareholders of the Company to be obligated to escrow their shares of capital stock of the Company. The Company shall cause any registration statement filed pursuant to the demand right granted under Section 4.1.1 to remain effective for a period of at least twelve (12) consecutive months after the date that the Holders of the Registrable Securities covered by such registration statement are first given the opportunity to sell all of such securities. The Holders shall only use the prospectuses provided by the Company to sell the shares covered by such registration statement, and will immediately cease to use any prospectus furnished by the Company if the Company advises the Holder that such prospectus may no longer be used due to a material misstatement or omission. Notwithstanding the provisions of this Section 4.1.2, the Holder shall be entitled to a demand registration under this Section 4.1.2 on only one (1) occasion and such demand registration right shall terminate on the fifth anniversary of the effective date of the Registration Statement in accordance with FINRA Rule 5110(f)(2)(G)(iv).

 

4.2       “Piggy-Back” Registration.

 

4.2.1       Grant of Right. In addition to the demand right of registration described in Section 4.1 hereof, the Holder shall have the right, for a period of six (6) years commencing one year after the effective date of the Registration Statement, to include the Registrable Securities as part of any other registration of securities filed by the Company (other than in connection with a transaction contemplated by Rule 145 promulgated under the Act or pursuant to Form S-8 or any equivalent form); provided, however, that if, solely in connection with any primary underwritten public offering for the account of the Company, the managing underwriter(s) thereof shall, in its reasonable discretion, impose a limitation on the number of shares of common stock which may be included in the Registration Statement because, in such underwriter(s)’ judgment, marketing or other factors dictate such limitation is necessary to facilitate public distribution, then the Company shall be obligated to include in such Registration Statement only such limited portion of the Registrable Securities with respect to which the Holder requested inclusion hereunder as the underwriter shall reasonably permit. Any exclusion of Registrable Securities shall be made pro rata among the Holders seeking to include Registrable Securities in proportion to the number of Registrable Securities sought to be included by such Holders; provided, however, that the Company shall not exclude any Registrable Securities unless the Company has first excluded all outstanding securities, the holders of which are not entitled to inclusion of such securities in such Registration Statement or are not entitled to pro rata inclusion with the Registrable Securities.

 

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4.2.2        Terms. The Company shall bear all fees and expenses attendant to registering the Registrable Securities pursuant to Section 4.2.1 hereof, but the Holders shall pay any and all underwriting commissions and the expenses of any legal counsel selected by the Holders to represent them in connection with the sale of the Registrable Securities. In the event of such a proposed registration, the Company shall furnish the then Holders of outstanding Registrable Securities with not less than thirty (30) days written notice prior to the proposed date of filing of such registration statement. Such notice to the Holders shall continue to be given for each registration statement filed by the Company until such time as all of the Registrable Securities have been sold by the Holder. The holders of the Registrable Securities shall exercise the “piggy-back” rights provided for herein by giving written notice, within ten (10) days of the receipt of the Company’s notice of its intention to file a registration statement. Except as otherwise provided in this Purchase Warrant, there shall be no limit on the number of times the Holder may request registration under this Section 4.2.2; provided, however, that such registration rights shall terminate on the seventh anniversary of the effective date of the Registration Statement.

 

4.3       General Terms.

 

4.3.1       Indemnification. The Company shall indemnify the Holder(s) of the Registrable Securities to be sold pursuant to any registration statement hereunder and each person, if any, who controls such Holders within the meaning of Section 15 of the Act or Section 20(a) of the Securities Exchange Act of 1934, as amended (“Exchange Act”), against all loss, claim, damage, expense or liability (including all reasonable attorneys’ fees and other expenses reasonably incurred in investigating, preparing or defending against any claim whatsoever) to which any of them may become subject under the Act, the Exchange Act or otherwise, arising from such registration statement but only to the same extent and with the same effect as the provisions pursuant to which the Company has agreed to indemnify the Underwriters contained in Section 5 of the Underwriting Agreement between the Underwriters and the Company, dated as of [·], 2017. The Holder(s) of the Registrable Securities to be sold pursuant to such registration statement, and their successors and assigns, shall severally, and not jointly, indemnify the Company, against all loss, claim, damage, expense or liability (including all reasonable attorneys’ fees and other expenses reasonably incurred in investigating, preparing or defending against any claim whatsoever) to which they may become subject under the Act, the Exchange Act or otherwise, arising from information furnished by or on behalf of such Holders, or their successors or assigns, in writing, for specific inclusion in such registration statement to the same extent and with the same effect as the provisions contained in Section 5 of the Underwriting Agreement pursuant to which the Underwriters have agreed to indemnify the Company.

 

4.3.2        Exercise of Purchase Warrants. Nothing contained in this Purchase Warrant shall be construed as requiring the Holder(s) to exercise their Purchase Warrants prior to or after the initial filing of any registration statement or the effectiveness thereof.

 

4.3.3        Documents Delivered to Holders. The Company shall furnish to each Holder participating in any of the foregoing offerings and to each underwriter of any such offering, if any, a signed counterpart, addressed to such Holder or underwriter, of: (i) an opinion of counsel to the Company, dated the effective date of such registration statement (and, if such registration includes an underwritten public offering, an opinion dated the date of the closing under any underwriting agreement related thereto), and (ii) a “cold comfort” letter dated the effective date of such registration statement (and, if such registration includes an underwritten public offering, a letter dated the date of the closing under the underwriting agreement) signed by the independent registered public accounting firm which has issued a report on the Company’s financial statements included in such registration statement, in each case covering substantially the same matters with respect to such registration statement (and the prospectus included therein) and, in the case of such accountants’ letter, with respect to events subsequent to the date of such financial statements, as are customarily covered in opinions of issuer’s counsel and in accountants’ letters delivered to underwriters in underwritten public offerings of securities. The Company shall also deliver promptly to each Holder participating in the offering requesting the correspondence and memoranda described below and to the managing underwriter, if any, copies of all correspondence between the Commission and the Company, its counsel or auditors and all memoranda relating to discussions with the Commission or its staff with respect to the registration statement and permit each Holder and underwriter to do such investigation, upon reasonable advance notice, with respect to information contained in or omitted from the registration statement as it deems reasonably necessary to comply with applicable securities laws or rules of FINRA. Such investigation shall include access to books, records and properties and opportunities to discuss the business of the Company with its officers and independent auditors, all to such reasonable extent and at such reasonable times as any such Holder shall reasonably request.

 

 4 

 

 

4.3.4        Underwriting Agreement. The Company shall enter into an underwriting agreement with the managing underwriter(s), if any, selected by any Holders whose Registrable Securities are being registered pursuant to this Section 4, which managing underwriter shall be reasonably satisfactory to the Company. Such agreement shall be reasonably satisfactory in form and substance to the Company, each Holder and such managing underwriters, and shall contain such representations, warranties and covenants by the Company and such other terms as are customarily contained in agreements of that type used by the managing underwriter. The Holders shall be parties to any underwriting agreement relating to an underwritten sale of their Registrable Securities and may, at their option, require that any or all the representations, warranties and covenants of the Company to or for the benefit of such underwriters shall also be made to and for the benefit of such Holders. Such Holders shall not be required to make any representations or warranties to or agreements with the Company or the underwriters except as they may relate to such Holders, their Shares and their intended methods of distribution.

 

4.3.5        Documents to be Delivered by Holder(s). Each of the Holder(s) participating in any of the foregoing offerings shall furnish to the Company a completed and executed questionnaire provided by the Company requesting information customarily sought of selling security holders.

 

4.3.6        Damages. Should the registration or the effectiveness thereof required by Section 4.1 and Section 4.2 hereof be delayed by the Company or the Company otherwise fails to comply with such provisions, the Holder(s) shall, in addition to any other legal or other relief available to the Holder(s), be entitled to obtain specific performance or other equitable (including injunctive) relief against the threatened breach of such provisions or the continuation of any such breach, without the necessity of proving actual damages and without the necessity of posting bond or other security.

 

5.       New Purchase Warrants to be Issued.

 

5.1       Partial Exercise or Transfer. Subject to the restrictions in Section 3 hereof, this Purchase Warrant may be exercised or assigned in whole or in part. In the event of the exercise or assignment hereof in part only, upon surrender of this Purchase Warrant for cancellation, together with the duly executed exercise or assignment form and funds sufficient to pay any Exercise Price and/or transfer tax if exercised pursuant to Section 2.1 hereof, the Company shall cause to be delivered to the Holder without charge a new Purchase Warrant of like tenor to this Purchase Warrant in the name of the Holder evidencing the right of the Holder to purchase the number of Shares purchasable hereunder as to which this Purchase Warrant has not been exercised or assigned.

 

5.2        Lost Certificate. Upon receipt by the Company of evidence satisfactory to it of the loss, theft, destruction or mutilation of this Purchase Warrant and of reasonably satisfactory indemnification or the posting of a bond, the Company shall execute and deliver a new Purchase Warrant of like tenor and date. Any such new Purchase Warrant executed and delivered as a result of such loss, theft, mutilation or destruction shall constitute a substitute contractual obligation on the part of the Company.

 

6.       Adjustments.

 

6.1       Adjustments to Exercise Price and Number of Securities. The Exercise Price and the number of Shares underlying the Purchase Warrant shall be subject to adjustment from time to time as hereinafter set forth:

 

6.1.1       Share Dividends; Split Ups. If, after the date hereof, and subject to the provisions of Section 6.3 below, the number of outstanding Shares is increased by a stock dividend payable in Shares or by a split up of Shares or other similar event, then, on the effective day thereof, the number of Shares purchasable hereunder shall be increased in proportion to such increase in outstanding shares, and the Exercise Price shall be proportionately decreased.

 

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6.1.2        Aggregation of Shares. If, after the date hereof, and subject to the provisions of Section 6.3 below, the number of outstanding Shares is decreased by a consolidation, combination or reclassification of Shares or other similar event, then, on the effective date thereof, the number of Shares purchasable hereunder shall be decreased in proportion to such decrease in outstanding shares, and the Exercise Price shall be proportionately increased.

 

6.1.3        Replacement of Securities upon Reorganization, etc. In case of any reclassification or reorganization of the outstanding Shares other than a change covered by Section 6.1.1 or Section 6.1.2 hereof or that solely affects the par value of such Shares, or in the case of any share reconstruction or amalgamation or consolidation of the Company with or into another corporation (other than a consolidation or share reconstruction or amalgamation in which the Company is the continuing corporation and that does not result in any reclassification or reorganization of the outstanding Shares), or in the case of any sale or conveyance to another corporation or entity of the property of the Company as an entirety or substantially as an entirety in connection with which the Company is dissolved, the Holder of this Purchase Warrant shall have the right to receive upon the exercise hereof (until the Expiration Date), for the same aggregate Exercise Price payable hereunder immediately prior to such event, the kind and amount of shares of stock or other securities or property (including cash) receivable upon such reclassification, reorganization, share reconstruction or amalgamation, or consolidation, or upon a dissolution following any such sale or transfer, by a Holder of the number of Shares of the Company obtainable upon exercise of this Purchase Warrant immediately prior to such event; and if any reclassification also results in a change in Shares covered by Section 6.1.1 or Section 6.1.2, then such adjustment shall be made pursuant to Section 6.1.1, Section 6.1.2 and this Section 6.1.3. The provisions of this Section 6.1.3 shall similarly apply to successive reclassifications, reorganizations, share reconstructions or amalgamations, or consolidations, sales or other transfers.

 

6.1.4        Changes in Form of Purchase Warrant. This form of Purchase Warrant need not be changed because of any change pursuant to this Section 6.1, and Purchase Warrants issued after such change may state the same Exercise Price and the same number of Shares as are stated in the Purchase Warrants initially issued pursuant to this Agreement. The acceptance by any Holder of the issuance of new Purchase Warrants reflecting a required or permissive change shall not be deemed to waive any rights to an adjustment occurring after the Commencement Date or the computation thereof.

 

6.2        Substitute Purchase Warrant. In case of any consolidation of the Company with, or share reconstruction or amalgamation of the Company with or into, another corporation (other than a consolidation or share reconstruction or amalgamation which does not result in any reclassification or change of the outstanding Shares), the corporation formed by such consolidation or share reconstruction or amalgamation shall execute and deliver to the Holder a supplemental Purchase Warrant providing that the holder of each Purchase Warrant then outstanding or to be outstanding shall have the right thereafter (until the stated expiration of such Purchase Warrant) to receive, upon exercise of such Purchase Warrant, the kind and amount of shares of stock and other securities and property receivable upon such consolidation or share reconstruction or amalgamation, by a holder of the number of Shares of the Company for which such Purchase Warrant might have been exercised immediately prior to such consolidation, share reconstruction or amalgamation, sale or transfer. Such supplemental Purchase Warrant shall provide for adjustments which shall be identical to the adjustments provided for in this Section 6. The above provision of this Section 6 shall similarly apply to successive consolidations or share reconstructions or amalgamations.

 

6.3        Elimination of Fractional Interests. The Company shall not be required to issue certificates representing fractions of Shares upon the exercise of the Purchase Warrant, nor shall it be required to issue scrip or pay cash in lieu of any fractional interests, it being the intent of the parties that all fractional interests shall be eliminated by rounding any fraction up or down, as the case may be, to the nearest whole number of Shares or other securities, properties or rights.

 

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7.        Reservation and Listing. The Company shall at all times reserve and keep available out of its authorized Shares, solely for the purpose of issuance upon exercise of the Purchase Warrants, such number of Shares or other securities, properties or rights as shall be issuable upon the exercise thereof. The Company covenants and agrees that, upon exercise of the Purchase Warrants and payment of the Exercise Price therefor, in accordance with the terms hereby, all Shares and other securities issuable upon such exercise shall be duly and validly issued, fully paid and non-assessable and not subject to preemptive rights of any shareholder. The Company further covenants and agrees that upon exercise of the Purchase Warrants and payment of the exercise price therefor, all Shares and other securities issuable upon such exercise shall be duly and validly issued, fully paid and non-assessable and not subject to preemptive rights of any shareholder. As long as the Purchase Warrants shall be outstanding, the Company shall use its commercially reasonable efforts to cause all Shares issuable upon exercise of the Purchase Warrants to be listed (subject to official notice of issuance) on all national securities exchanges (or, if applicable, on the OTC Bulletin Board or any successor trading market) on which the Shares issued to the public in the Offering may then be listed and/or quoted.

 

8.       Certain Notice Requirements.

 

8.1       Holder’s Right to Receive Notice. Nothing herein shall be construed as conferring upon the Holders the right to vote or consent or to receive notice as a shareholder for the election of directors or any other matter, or as having any rights whatsoever as a shareholder of the Company. If, however, at any time prior to the expiration of the Purchase Warrants and their exercise, any of the events described in Section 8.2 shall occur, then, in one or more of said events, the Company shall give written notice of such event at least fifteen days prior to the date fixed as a record date or the date of closing the transfer books (the “Notice Date”) for the determination of the shareholders entitled to such dividend, distribution, conversion or exchange of securities or subscription rights, or entitled to vote on such proposed dissolution, liquidation, winding up or sale. Such notice shall specify such record date or the date of the closing of the transfer books, as the case may be. Notwithstanding the foregoing, the Company shall deliver to each Holder a copy of each notice given to the other shareholders of the Company at the same time and in the same manner that such notice is given to the shareholders.

 

8.2        Events Requiring Notice. The Company shall be required to give the notice described in this Section 8 upon one or more of the following events: (i) if the Company shall take a record of the holders of its Shares for the purpose of entitling them to receive a dividend or distribution payable otherwise than in cash, or a cash dividend or distribution payable otherwise than out of retained earnings, as indicated by the accounting treatment of such dividend or distribution on the books of the Company, (ii) the Company shall offer to all the holders of its Shares any additional shares of capital stock of the Company or securities convertible into or exchangeable for shares of capital stock of the Company, or any option, right or warrant to subscribe therefor, or (iii) a dissolution, liquidation or winding up of the Company (other than in connection with a consolidation or share reconstruction or amalgamation) or a sale of all or substantially all of its property, assets and business shall be proposed.

 

8.3        Notice of Change in Exercise Price. The Company shall, promptly after an event requiring a change in the Exercise Price pursuant to Section 6 hereof, send notice to the Holders of such event and change (“Price Notice”). The Price Notice shall describe the event causing the change and the method of calculating same and shall be certified as being true and accurate by the Company’s Chief Financial Officer.

 

8.4        Transmittal of Notices. All notices, requests, consents and other communications under this Purchase Warrant shall be in writing and shall be deemed to have been duly made (1) when hand delivered, (2) when mailed by express mail, electronic mail or private courier service or (3) when the event requiring notice is disclosed in all material respects and filed in a current report on Form 8-K or in a definitive proxy statement on Schedule 14A prior to the Notice Date: (i) if to the registered Holder of the Purchase Warrant, to the address of such Holder as shown on the books of the Company, or (ii) if to the Company, to the following address or to such other address as the Company may designate by notice to the Holders:

 

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If to the Holder:

 

Aegis Capital Corp.
810 Seventh Avenue, 11th Floor
New York, New York 10019
Attn: Mr. David Bocchi, Managing Director of

Investment Banking

Fax No.: (212) 813-1047

Email: dbocchi@aegiscap.com

 

With a copy (which shall not constitute notice) to:

 

Blank Rome LLP

405 Lexington Avenue

New York, New York 10174

Attn: Brad L. Shiffman, Esq.

Fax: (917) 332-3725

Email: bshiffman@blankrome.com

 

If to the Company:

 

Adial Pharmaceuticals, Inc.

1180 Seminole Trail, Suite 495
Charlottesville, Virginia 22901

Attention: William B. Stilley, III, President and Chief Executive Officer

Fax No: (434) 422-9797

Email: wstilley@adialpharma.com

 

with a copy (which shall not constitute notice) to:

 

Gracin & Marlow, LLP

405 Lexington Avenue, 26th Floor

New York, New York 10174

Attention: Leslie Marlow, Esq.

Fax No: (212) 208-4657

Email: lmarlow@gracinmarlow.com

 

9.       Miscellaneous.

 

9.1       Amendments. The Company and Aegis may from time to time supplement or amend this Purchase Warrant without the approval of any of the Holders in order to cure any ambiguity, to correct or supplement any provision contained herein that may be defective or inconsistent with any other provisions herein, or to make any other provisions in regard to matters or questions arising hereunder that the Company and Aegis may deem necessary or desirable and that the Company and Aegis deem shall not adversely affect the interest of the Holders. All other modifications or amendments shall require the written consent of and be signed by the party against whom enforcement of the modification or amendment is sought.

 

9.2        Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of this Purchase Warrant.

 

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9.3.        Entire Agreement. This Purchase Warrant (together with the other agreements and documents being delivered pursuant to or in connection with this Purchase Warrant) constitutes the entire agreement of the parties hereto with respect to the subject matter hereof, and supersedes all prior agreements and understandings of the parties, oral and written, with respect to the subject matter hereof.

 

9.4        Binding Effect. This Purchase Warrant shall inure solely to the benefit of and shall be binding upon, the Holder and the Company and their permitted assignees, respective successors, legal representative and assigns, and no other person shall have or be construed to have any legal or equitable right, remedy or claim under or in respect of or by virtue of this Purchase Warrant or any provisions herein contained.

 

9.5        Governing Law; Submission to Jurisdiction. This Purchase Warrant shall be governed by and construed and enforced in accordance with the laws of the State of New York, without giving effect to conflict of laws principles thereof. The Company hereby agrees that any action, proceeding or claim against it arising out of, or relating in any way to this Purchase Warrant shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum. Any process or summons to be served upon the Company may be served by transmitting a copy thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in Section 8 hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any action, proceeding or claim. The Company and the Holder agree that the prevailing party(ies) in any such action shall be entitled to recover from the other party(ies) all of its reasonable attorneys’ fees and expenses relating to such action or proceeding and/or incurred in connection with the preparation therefor. The Company (on its behalf and, to the extent permitted by applicable law, on behalf of its stockholders and affiliates) and the Holder hereby irrevocably waive, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this agreement or the transactions contemplated hereby.

 

9.6        Waiver, etc. The failure of the Company or the Holder to at any time enforce any of the provisions of this Purchase Warrant shall not be deemed or construed to be a waiver of any such provision, nor to in any way affect the validity of this Purchase Warrant or any provision hereof or the right of the Company or any Holder to thereafter enforce each and every provision of this Purchase Warrant. No waiver of any breach, non-compliance or non-fulfillment of any of the provisions of this Purchase Warrant shall be effective unless set forth in a written instrument executed by the party or parties against whom or which enforcement of such waiver is sought; and no waiver of any such breach, non-compliance or non-fulfillment shall be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.

 

9.7        Execution in Counterparts. This Purchase Warrant may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which shall be deemed to be an original, but all of which taken together shall constitute one and the same agreement, and shall become effective when one or more counterparts has been signed by each of the parties hereto and delivered to each of the other parties hereto. Such counterparts may be delivered by facsimile transmission or other electronic transmission.

 

9.8        Exchange Agreement. As a condition of the Holder’s receipt and acceptance of this Purchase Warrant, Holder agrees that, at any time prior to the complete exercise of this Purchase Warrant by Holder, if the Company and Aegis enter into an agreement (“Exchange Agreement”) pursuant to which they agree that all outstanding Purchase Warrants will be exchanged for securities or cash or a combination of both, then Holder shall agree to such exchange and become a party to the Exchange Agreement.

 

[Remainder of page intentionally left blank.]

 

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IN WITNESS WHEREOF, the Company has caused this Purchase Warrant to be signed by its duly authorized officer as of the __th day of _____________, 2017.

 

ADIAL PHARMACEUTICALS, INC.  
     
By:                                  
Name:    
Title:    

 

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Form to be used to exercise Purchase Warrant:

 

Date: __________, 20___

 

The undersigned hereby elects irrevocably to exercise the Purchase Warrant for ______ Shares of Adial Pharmaceuticals, Inc., a Delaware corporation (the “Company”) and hereby makes payment of $____ (at the rate of $____ per Share) in payment of the Exercise Price pursuant thereto. Please issue the Shares as to which this Purchase Warrant is exercised in accordance with the instructions given below and, if applicable, a new Purchase Warrant representing the number of Shares for which this Purchase Warrant has not been exercised.

 

or

 

The undersigned hereby elects irrevocably to convert its right to purchase ___ Shares under the Purchase Warrant for ______ Shares, as determined in accordance with the following formula:

 

  X = Y(A-B)
A
Where, X = The number of Shares to be issued to Holder;
  Y = The number of Shares for which the Purchase Warrant is being exercised;
  A = The fair market value of one Share which is equal to $_____; and
  B = The Exercise Price which is equal to $______ per share

 

The undersigned agrees and acknowledges that the calculation set forth above is subject to confirmation by the Company and any disagreement with respect to the calculation shall be resolved by the Company in its sole discretion.

 

Please issue the Shares as to which this Purchase Warrant is exercised in accordance with the instructions given below and, if applicable, a new Purchase Warrant representing the number of Shares for which this Purchase Warrant has not been converted.

 

Signature

 

Signature Guaranteed

 

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INSTRUCTIONS FOR REGISTRATION OF SECURITIES

 

Name:

(Print in Block Letters)

Address:

 

NOTICE: The signature to this form must correspond with the name as written upon the face of the Purchase Warrant without alteration or enlargement or any change whatsoever, and must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered national securities exchange.

 

 12 

 

 

Form to be used to assign Purchase Warrant:

ASSIGNMENT

 

(To be executed by the registered Holder to effect a transfer of the within Purchase Warrant):

 

FOR VALUE RECEIVED, __________________ does hereby sell, assign and transfer unto ______________ the right to purchase shares of Adial Pharmaceuticals, Inc., a Delaware corporation (the “Company”), evidenced by the Purchase Warrant and does hereby authorize the Company to transfer such right on the books of the Company.

 

Dated: __________, 20__

 

Signature

 

Signature Guaranteed

 

NOTICE: The signature to this form must correspond with the name as written upon the face of the within Purchase Warrant without alteration or enlargement or any change whatsoever, and must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered national securities exchange.

 

 

13

 

 

EX-4.3 15 fs12017ex4-3_adialpharma.htm FORM OF WARRANT TO PURCHASE MEMBERSHIP UNITS (2011 OFFERING)

Exhibit 4.3

 

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED, QUALIFIED, APPROVED OR DISAPPROVED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR THE SECURITIES LAWS OF ANY STATE AND MAY NOT BE SOLD OR OTHERWISE DISPOSED OF EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT AND APPLICABLE STATE SECURITIES LAWS OR AN APPLICABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER SUCH ACT OR LAWS AND NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY OTHER FEDERAL OR STATE REGULATORY AUTHORITY HAS PASSED ON OR ENDORSED THE MERITS OF THESE SECURITIES.

 

December 31, 2011

 

WARRANT TO PURCHASE MEMBERSHIP UNITS

 

OF

 

ADIAL PHARMACEUTICALS, L.L.C.

 

THIS IS TO CERTIFY THAT «LegalName» or its assigns (the “Holder”), is the owner of the right to subscribe for and to purchase from ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (including any successor entities) (the “Company”) «RoundedWarrants» nonvoting units (the “Warrant Units”), at a price per unit equal to $0.001 (the “Exercise Price”) and during the period ending at 5:00 p.m. Eastern Time on December 31, 2021 (the “Expiration Date”), all on the terms and subject to the conditions hereinafter set forth (the “Warrants”).

 

The Number Issuable is subject to further adjustment from time to time pursuant to the provisions of Section 2 of this Warrant Agreement.

 

Capitalized terms used herein but not otherwise defined shall have the meanings given to them in Section 12 hereof.

 

“Unit” or “units” shall mean the measure of ownership in the Company as defined the Operating Agreement.

 

This Warrant Agreement issued in connection with the Subscription Agreement between the parties dated December 31, 2011 in which «LegalName» invested «RoundedInvestment» to purchase «RoundedUnits» units.

 

Section 1.           Exercise of Warrants.

 

(a)          The Warrants evidenced hereby may be exercised for units of Warrant Units, in whole but not in part, by the Holder hereof, on or after the date hereof and prior to the Expiration Date and upon the occurrence of an event triggering the delivery by the Company of a notice as described in Section 4 hereof. Holder shall exercise via the delivery to the Company, at the principal executive office of the Company, of (A) this Warrant Agreement, (B) a written notice stating that such Holder elects to exercise the Warrants evidenced hereby in accordance with the provisions of this Section 1 and specifying the number of Warrants being exercised and the name in which the Holder wishes the certificate or certificates for units of Warrant Units to be issued, (C) payment of the Exercise Price for such Warrants, which shall be payable by any one or any combination of the following: (i) cash; or, (ii) certified or official bank check payable to the order of the Company, and (D) an executed Member Signature Page of the Operating Agreement binding Holder to the terms of the Operating Agreement. The documentation and consideration, if any, delivered in accordance with subsections (A), (B) and (C) are collectively referred to herein as the “Warrant Exercise Documentation.”

 

 Page 1 of 8

 

(b)       As promptly as practicable, and in any event within ten (10) Business Days after receipt of the duly executed Warrant Exercise Documentation, the Company will deliver or cause to be delivered (A) acknowledgment of the receipt and acceptance of the Warrant Exercise Documents, (B) if applicable, cash in lieu of any fraction of a unit, as hereinafter provided. Such exercise shall be deemed to have been made at the close of business on the date of delivery of the Warrant Exercise Documentation so that the Person entitled to receive units of Warrant Units upon such exercise shall be treated for all purposes as having become the record holder of such units of Warrant Units at such time.

 

(c)       The Company shall pay all expenses incurred by the Company in connection with and taxes and other governmental charges (other than income taxes of the Holder) that may be imposed in respect of, the issue or delivery of any units of Warrant Units issuable upon the exercise of the Warrants evidenced hereby. The Company shall not be required, however, to pay any tax or other charge imposed in connection with any transfer involved in the issue of any certificate for units of Warrant Units, as the case may be, in any name other than that of the registered holder of the Warrant evidenced hereby.

 

(d)       In connection with the exercise of any Warrants evidenced hereby, the Company may elect that no fractions of units of Warrant Units shall be issued, but in lieu thereof the Company shall pay a cash adjustment in respect of such fractional interest in an amount equal to such fractional interest multiplied by the Fair Market Value for one Unit of Warrant Units on the Business Day which immediately precedes the day of exercise. If more than one (1) such Warrant shall be exercised by the holder thereof at the same time, the number of full units of Warrant Units issuable on such exercise shall be computed on the basis of the total number of Warrants so exercised.

 

Section 2.           Certain Adjustments.

 

(a)       The number of units of Warrant Units purchasable upon the exercise of this Warrant and the Exercise Price shall be subject to adjustment as follows:

 

(i)          Split or Reverse Split. In the event that Company completes a split or reverse split of its Warrant Units, or any class of security into which such Warrant Units are convertible (the “Reverse Split”), the number and kind of units to be delivered upon exercise of this Warrant will be adjusted so that the Holder will be entitled to receive the number and kind of units that such Holder would have owned or been entitled to receive upon or by reason of such event had this Warrant been exercised immediately prior thereto, and the Exercise Price will be adjusted as provided below.

 

 Page 2 of 8

 

(ii)         Distributions; Subdivision; Combination or Reclassification of Units. If at any time after the date of the issuance of this Warrant the Company shall (A) pay a distribution to holders on the Warrant Units or on any class of security into which the Warrant Units are convertible, in units, (B) combine its outstanding units of the Warrant Units, or any class of security into which the Warrant Units are convertible into, a smaller number of units, (C) subdivide its outstanding units of the Warrant Units, or any class of security into which the Warrant Units are convertible, or (D) issue by reclassification of its units of the Warrant Units, or any class of security into which the Warrant Units are convertible, any units of the Company, then, on the record date for such distribution or the effective date of such subdivision or split-up, combination or reclassification as the case may be the number and kind of units to be delivered upon exercise of this Warrant will be adjusted so that the Holder will be entitled to receive the number and kind of units that such Holder would have owned or been entitled to receive upon or by reason of such event had this Warrant been exercised immediately prior thereto, and the Exercise Price will be adjusted as provided below in paragraph 2(a)(v).

 

(iii)        Reorganization. etc. If at any time after the date of issuance of this Warrant any consolidation of the Company with or merger of the Company with or into any other Person (other than a merger or consolidation in which the Company is the surviving or continuing business entity and which does not result in any reclassification of, or change in, outstanding units of either the Warrant Units, or any class of security into which the Warrant Units are convertible) or any sale, lease or other transfer of all or substantially all of the assets of the Company to any other person (each, a “Reorganization Event”) shall be effected in such a way that the holders of the Warrant Units or any class of security into which the Warrant Units are convertible shall be entitled to receive cash, units, other securities or assets (whether such cash, units, other securities or assets are issued or distributed by the Company or another Person) with respect to or in exchange for the Warrant Units, or any class of security into which the Warrant Units are convertible, then, upon exercise of this Warrant, the Holder shall have the right to receive the kind and amount of cash, units, other securities or assets receivable upon such Reorganization Event by a holder of the number of units of the Warrant Units that such holder would have been entitled to receive upon exercise of this Warrant had this Warrant been exercised immediately before such Reorganization Event, subject to adjustments that shall be as nearly equivalent as may be practicable to the adjustments provided for in this Section 2(a). The Company shall not enter into any of the transactions referred to in this Section 2(a)(iii) unless effective provision shall be made so as to give effect to the provisions set forth in this Section 2(a)(iii).

 

(iv)       Carryover. Notwithstanding any other provision of this Section 2(a), no adjustment shall be made to the number of units of Warrant Units to be delivered to the Holder (or to the Exercise Price) if such adjustment represents less than .05% of the number of units to be so delivered, but any lesser adjustment shall be carried forward and shall be made at the time and together with the next subsequent adjustment that together with any adjustments so carried forward shall amount to .05% or more of the number of units to be so delivered.

 

 Page 3 of 8

 

(v)        Exercise Price Adjustment. Whenever the Number Issuable upon the exercise of the Warrant is adjusted as provided pursuant to this Section 2(a), the Exercise Price per unit payable upon the exercise of this Warrant shall be adjusted by multiplying such Exercise Price immediately prior to such adjustment by a fraction, of which the numerator shall be the Number Issuable upon the exercise of the Warrant immediately prior to such adjustment, and of which the denominator shall be the Number Issuable immediately thereafter.

 

(b)       Notice of Adjustment. Whenever the Number Issuable or the Exercise Price is adjusted, as herein provided, the Company shall promptly mail by first class mail, postage prepaid, to the Holder, notice of such adjustment or adjustments setting forth the Number Issuable and the Exercise Price after such adjustment, setting forth a brief statement of the facts requiring such adjustment and setting forth the computation by which such adjustment was made.

 

Section 3.          No Redemption. The Company shall not have any right to redeem any of the Warrants evidenced hereby.

 

Section 4.          Notice of Certain Events. In the event at any time or from time to time that (i) the Company shall make any other distribution to the holders of the Warrant Units, or any class of security into which the Warrant Units are convertible, (ii) the Company shall authorize the granting to the holders of the Warrant Units, or any class of security into which the Warrant Units are convertible, of rights or Warrants to subscribe for or purchase any additional units of any class or any other right, (iii) the Company shall authorize the issuance or sale of any other units or rights which would result in an adjustment to the Number Issuable pursuant to Section 2(a)(i), (ii), or (iii), or (iv) there shall be any capital reorganization or reclassification of the Warrant Units, or any class of security into which the Warrant Units are convertible, of the Company or consolidation or merger of the Company with or into another Person, or any sale or other disposition of all or substantially all the assets of the Company, or (v) there shall be a voluntary or involuntary dissolution, liquidation or winding up of the Company, then, in any one or more of such cases the Company shall mail to the Holder at such Holder’s address as it appears on the transfer books of the Company, as promptly as practicable but in any event at least 10 days prior to the date on which the transactions contemplated in Section 2(a)(i), (ii), or (iii), a notice stating (a) the date on which a record is to be taken for the purpose of such distribution, rights or Warrants or, if a record is not to be taken, the date as of which the holders of record of either the Warrant Units, or any class of security into which the Warrant Units are convertible, to be entitled to such distribution, rights or Warrants are to be determined, or (b) the date on which such reclassification, consolidation, merger, sale, conveyance, dissolution, liquidation or winding up is expected to become effective. Such notice also shall specify the date as of which it is expected that the holders of record of the Warrant Units, or any class of security into which the Warrant Units are convertible, shall be entitled to exchange the Warrant Units, or any class of security into which the Warrant Units are convertible, for units or other securities or property or cash deliverable upon such reorganization, reclassification, consolidation, merger, sale, conveyance, dissolution, liquidation or winding up.

 

Section 5.          Certain Covenants. The Company covenants and agrees that all units of the Company which may be issued upon the exercise of the Warrants evidenced hereby will be duly authorized, validly issued and fully paid and nonassessable. The Company covenants and agrees that all of the terms and conditions of this Warrant shall be fully binding on any successor entity.

 

 Page 4 of 8

 

Section 6.          Registered Holder. The persons in whose names this Warrant Agreement is registered shall be deemed the owner hereof and of the Warrants evidenced hereby for all purposes. The registered Holder of this Warrant Agreement, in their capacity as such, shall not be entitled to any rights whatsoever as a member of the Company.

 

Section 7.          Transfer of Warrants. The Holder may transfer one time all but not part of this Warrant Agreement without the consent of the Company to any one (1), but only one (1), individual or entity (the “Transferee”) as long as such entity or individual is an “Accredited Investor,” as that term is defined in Regulation D (“Regulation D”) promulgated under the Securities Act of 1933 as amended; provided, however, the Transferee provides the Company with an executed Member Signature Page of the Operating Agreement binding the Transferee to the terms of the Operating Agreement. Any transfer of the rights represented by this Warrant Agreement shall be effected by the surrender of this Warrant Agreement, along with the form of assignment attached hereto, properly completed and executed by the registered Holder hereof, at the principal executive office of the Company in the United States of America, together with an appropriate investment letter and opinion of counsel, if deemed reasonably necessary by counsel to the Company to assure compliance with applicable securities laws. Thereupon, the Company shall issue in the name of the Transferee specified by the registered Holder hereof, a new Warrant Agreement identical to this agreement as it exists at the time but in the name of the Transferee.

 

Section 8.           Replacement of Warrants. Upon receipt of evidence satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant Agreement and, in the case of loss, theft or destruction, upon delivery of an indemnity reasonably satisfactory to the Company (in the case of an insurance company or other institutional investor, its own unsecured indemnity agreement shall be deemed to be reasonably satisfactory), or, in the case of mutilation, upon surrender and cancellation thereof, the Company will issue a new Warrant Agreement of like tenor for a number of Warrants equal to the number of Warrants evidenced by this Warrant Agreement.

 

Section 9.         Governing Law. THIS WARRANT AGREEMENT SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH, AND THE RIGHTS OF THE PARTIES SHALL BE GOVERNED BY, THE LAWS OF THE STATE OF VIRGINIA APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED ENTIRELY WITHIN SUCH STATE.

 

Section 10.        Rights Inure to Registered Holder. The Warrants evidenced by this Warrant Agreement will inure to the benefit of and be binding upon the registered Holder thereof and the Company and their respective successors and permitted assigns. Nothing in this Warrant Agreement shall be construed to give to any Person other than the Company and the registered Holder thereof any legal or equitable right, remedy or claim under this Warrant Agreement, and this Warrant Agreement shall be for the sole and exclusive benefit of the Company and such registered Holder. Nothing in this Warrant Agreement shall be construed to give the registered Holder hereof any rights as a Holder of units until such time, if any, as the Warrants evidenced by this Warrant Agreement are exercised in accordance with the provisions hereof.

 

 Page 5 of 8

 

Section 11.        Exercise if a Corporation. In the event of exercise of this Warrant per Section 1 at a time at which the Company is a corporation, then all references in this Warrant to “units” or “equity” of any kind in the Company shall be interpreted to mean “shares” or “stock” in the Company and all references to the Operating Agreement shall be interpreted to mean any stockholders’ agreement of the corporation.

 

Section 12.        Definitions. For the purposes of this Warrant Agreement, the following terms shall have the meanings indicated below:

 

Business Day” means any day other than a Saturday, Sunday or other day on which commercial banks in the Commonwealth of Virginia are authorized or required by law or executive order to close.

 

“Fair Market Value” shall mean, per unit of Warrant Units, on any date specified herein: (a) if the Warrant Units are not then listed or admitted to trading on any national securities exchange but is designated as a national market system security, the average of the closing bid and ask price of the Warrant Units on such date; or (b) if there shall have been no trading on such date or if the Warrant Units are not so designated, the average of the reported closing bid and asked price of the Warrant Units, on such date as shown by NASDAQ and reported by any member firm of the NYSE selected by the Company; or (c) if neither (a) nor (b) is applicable, the value per unit determined in good faith by the Board of Directors of the Company which shall be deemed to be Fair Market Value.

 

Person” shall mean any individual, corporation, limited liability company, partnership, trust, incorporated or unincorporatcd association, joint venture, joint stock company, government (or an agency or political subdivision thereof) or other entity of any kind.

 

Operating Agreement” means the Operating Agreement of the Company dated November 23, 2010, as amended from time to time.

 

Section 13.        Notice. Any notice election, communication, request or other document or demand required or permitted under this Note shall be in writing and shall be deemed delivered on the earlier to occur of (i) receipt or (ii) three days after depositing such notice with the United States postal service, postage prepaid first class certified or registered mail, return receipt requested, addressed to Company or Holder as the case may be at the following locations:

 

  If to Company

ADial Pharmaceuticals, L.L.C.

1001 Research Park Blvd.

Suite 100

Charlottesville, VA 22911

 

  With a copy to: «LegalName»
«Address1» «Address2»
«City», «State» «Zipcode» «Country»

 

  If to Holder:

«LegalName»

«Address1» «Address2»

«City», «State» «Zipcode» «Country»

 

 Page 6 of 8

 

Either party may, from time to time, change the address at which such written notices or elections, communications, requests, or other documents or demands are to be mailed, by giving the other party ten (10) days’ written notice of such changed address in the manner hereinabove provided.

 

Section 14.         Registration of Units. The Holder understands and acknowledges that the units of Warrant Units that will be issued upon exercise of this Warrant will not be registered under the Securities Act.

 

IN WITNESS WHEREOF, the Company has caused this Warrant Agreement to be duly executed as the Issue Date.

 

  ADIAL PHARMACEUTICALS, L.L.C.
     
  By:    
    Bankole A. Johnson
    Chairman

 

 Page 7 of 8

 

[Form of Assignment Form]

 

[To be executed upon assignment of Warrants]

 

The undersigned hereby assigns and transfer this Warrant Agreement to ________ whose Social Security Number or Tax ID Number is ____________________ and whose record address is _________________________, and irrevocably appoints _____________________ as agent to transfer this security on the books of the Company. Such agent may substitute another to act for such agent.

 

  Signature:
   
                    
  Signature Guarantee:

 

Date:    

 

 

 Page 8 of 8

 

 

EX-4.4 16 fs12017ex4-4_adialpharma.htm FORM OF WARRANT TO PURCHASE MEMBERSHIP UNITS (2013 OFFERING)

Exhibit 4.4

 

Exhibit A

 

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED, QUALIFIED, APPROVED OR DISAPPROVED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT“), OR THE SECURITIES LAWS OF ANY STATE OR JURISDICTION AND MAY NOT BE SOLD OR OTHERWISE DISPOSED OF EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT AND/OR THE SECURITIES LAWS OF ANY APPLICABLE JURISDICTIONS OR AN APPLICABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER SUCH ACT OR LAWS AND NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY OTHER FEDERAL, STATE OR OTHER APPLICABLE REGULATORY AUTHORITY HAS PASSED ON OR ENDORSED THE MERITS OF THESE SECURITIES.

  

________ ____, 2013

 

WARRANT TO PURCHASE MEMBERSHIP UNITS

 

OF

 

ADIAL PHARMACEUTICALS, L.L.C.

 

THIS IS TO CERTIFY THAT ________________________ or its assigns (the “Holder”), is the owner of the right to subscribe for and to purchase from ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (including any successor entities) (the “Company”), _______ Class B Units (the “Warrant Units”) at a price per unit equal to $1.42 (the “Exercise Price”) during the period starting on the date hereof and ending at 5:00 p.m. Eastern Time on December 31, 2031 (the “Expiration Date”) all on the terms and subject to the conditions hereinafter set forth (“Warrants”). The number of Warrant Units stated above shall be the “Number Issuable”.

 

The Number Issuable is subject to further adjustment from time to time pursuant to the provisions of Section 2 of this Warrant Agreement.

 

Capitalized terms used herein but not otherwise defined shall have the meanings given to them in Section 12 hereof.

 

This Warrant Agreement is entered into pursuant to and in connection with the Subscription Agreement of even date herewith (“Subscription Agreement”) between the parties in which Holder invested $______________ to purchase ___________ Class B Units from the Company. Therefore, for the avoidance of doubt, the parties hereto acknowledge that the obligation of the Company to deliver the Warrant Units hereunder is contingent upon Holder fully performing its obligations under the Subscription Agreement up to and on the date on which Holder seeks to exercise the Warrants.

 

 Page 1 of 9

 

Exhibit A

 

Section 1.          Exercise of Warrants.

 

(a)          The Warrants evidenced hereby may be exercised, in whole but not in part, by the Holder hereof, on or after the date hereof and prior to the Expiration Date and upon the occurrence of an event triggering the delivery by the Company of a notice as described in Section 4 hereof. Holder shall exercise via the delivery to the Company, at the principal executive office of the Company, of (A) an executed form of this Warrant Agreement, (B) a written notice stating that such Holder elects to exercise the Warrants evidenced hereby in accordance with the provisions of this Section 1 and specifying the number of Warrants being exercised and the name in which the Holder wishes the certificate or certificates for Warrant Units to be issued, (C) payment of the Exercise Price for such Warrants, which shall be payable, in immediately available funds, by any one or any combination of the following: (i) cash; or, (ii) certified or official bank check payable to the order of the Company, and (D) an executed Member Signature Page to the Operating Agreement binding Holder to the terms of the Operating Agreement. The documentation and consideration, if any, delivered in accordance with subsections (A), (B), (C) and (D) are collectively referred to herein as the “Warrant Exercise Documentation.”

 

(b)          As promptly as practicable, and in any event within ten (10) Business Days after receipt of the duly executed Warrant Exercise Documentation, the Company will deliver or cause to be delivered (A) acknowledgment of the receipt and acceptance of the Warrant Exercise Documents, (B) if applicable, cash in lieu of any fraction of a unit, as hereinafter provided. Such exercise shall be deemed to have been made at the close of business on the date of delivery of the Warrant Exercise Documentation so that the Person entitled to receive the Warrant Units upon such exercise shall be treated for all purposes as having become the record holder of such Warrant Units on such date.

 

(c)          The Company shall pay all expenses incurred by the Company in connection with, and taxes and other governmental charges (other than income taxes of the Holder) imposed in respect of, the issue or delivery of any Warrant Units issuable upon the exercise of the Warrants evidenced hereby. The Company shall not be required, however, to pay any tax or other charges imposed in connection with any transfer involved in the issue of any certificate for Warrant Units, as the case may be, in any name other than that of the registered holder of the Warrant evidenced hereby.

 

(d)          In connection with the exercise of any Warrants evidenced hereby, the Company may elect that no fractions of Warrant Units shall be issued, but in lieu thereof the Company shall pay a cash adjustment in respect of such fractional interest in an amount equal to such fractional interest multiplied by the Fair Market Value of one Warrant Unit on the Business Day which immediately precedes the day of exercise. If more than one (1) such Warrant shall be exercised by the holder thereof at the same time, the number of full Warrant Units issuable on such exercise shall be computed on the basis of the total number of Warrants so exercised.

 

 Page 2 of 9

 

Exhibit A

 

Section 2.          Certain Adjustments.

 

(a)          The number of Warrant Units purchasable upon the exercise of this Warrant and the Exercise Price shall be subject to adjustment as follows:

 

(i)         Split or Reverse Split. In the event that Company completes a split or reverse split of its Warrant Units, or any class of security into which such Warrant Units are convertible (the “Reverse Split”), the number and kind of units to be delivered upon exercise of this Warrant will be adjusted so that the Holder will be entitled to receive the number and kind of units that such Holder would have owned or been entitled to receive upon or by reason of such event had this Warrant been exercised immediately prior thereto, and the Exercise Price will be adjusted as provided below.

 

(ii)        Distributions; Subdivision; Combination or Reclassification of Units. If at any time after the date of the issuance of this Warrant the Company shall (A) pay a distribution to holders on the Warrant Units or on any class of security into which the Warrant Units are convertible, in any equity security of the Company, (B) combine its outstanding units of the Warrant Units, or any class of security into which the Warrant Units are convertible into, a smaller number of units, (C) subdivide its outstanding units of the Warrant Units, or any class of security into which the Warrant Units are convertible, or (D) issue by reclassification of its units of the Warrant Units, or any class of security into which the Warrant Units are convertible, any units of the Company, then, on the record date for such distribution or the effective date of such subdivision or split-up, combination or reclassification, as the case may be, the number and kind of units to be delivered upon exercise of this Warrant will be adjusted so that the Holder will be entitled to receive the number and kind of units that such Holder would have owned or been entitled to receive upon or by reason of such event had the Warrants been exercised immediately prior thereto, and the Exercise Price will be adjusted as provided below in paragraph 2(a)(v).

 

(iii)       Reorganization. etc. If at any time after the date of issuance of this Warrant any consolidation of the Company with or merger of the Company with or into any other Person (other than a merger or consolidation in which the Company is the surviving or continuing business entity and which does not result in any reclassification of, or change in, outstanding units of either the Warrant Units, or any class of security into which the Warrant Units are convertible) or any sale, lease or other transfer of all or substantially all of the assets of the Company to any other person (each, a “Reorganization Event”) shall be effected in such a way that the holders of the Warrant Units or any class of security into which the Warrant Units are convertible shall be entitled to receive cash, units, other securities or assets (whether such cash, units, other securities or assets are issued or distributed by the Company or another Person) with respect to or in exchange for the Warrant Units, or any class of security into which the Warrant Units are convertible, then, upon exercise of this Warrant, the Holder shall have the right to receive the kind and amount of cash, units, other securities or assets receivable upon such Reorganization Event by a holder of the number of units of the Warrant Units that such holder would have been entitled to receive upon exercise of this Warrant had this Warrant been exercised immediately before such Reorganization Event, subject to adjustments that shall be as nearly equivalent as may be practicable to the adjustments provided for in this Section 2(a). The Company shall not enter into any of the transactions referred to in this Section 2(a)(iii) unless effective provision shall be made so as to give effect to the provisions set forth in this Section 2(a)(iii).

 

(iv)       Carryover. Notwithstanding any other provision of this Section 2(a), no adjustment shall be made to the number of units of Warrant Units to be delivered to the Holder (or to the Exercise Price) if such adjustment represents less than .05% of the number of units to be so delivered, but any lesser adjustment shall be carried forward and shall be made at the time and together with the next subsequent adjustment that together with any adjustments so carried forward shall amount to .05% or more of the number of units to be so delivered.

 

 Page 3 of 9

 

Exhibit A

 

(v)        Exercise Price Adjustment. Whenever the Number Issuable upon the exercise of the Warrant is adjusted as provided pursuant to this Section 2(a), the Exercise Price per unit payable upon the exercise of this Warrant shall be adjusted by multiplying such Exercise Price immediately prior to such adjustment by a fraction, the numerator of which shall be the Number Issuable upon the exercise of the Warrant immediately prior to such adjustment, and the denominator of which shall be the Number Issuable immediately thereafter.

 

(b)          Notice of Adjustment. Whenever the Number Issuable or the Exercise Price is adjusted, as herein provided, the Company shall promptly mail by first class mail, postage prepaid, to the Holder, notice of such adjustment or adjustments setting forth (i) the Number Issuable and the Exercise Price after such adjustment, (ii) a brief statement of the facts requiring such adjustment and (iii) the computation by which such adjustment was made.

 

Section 3.         No Redemption. The Company shall not have any right to redeem any of the Warrants evidenced hereby.

 

Section 4.        Notice of Certain Events. In the event at any time or from time to time that (i) the Company shall make any other distribution to the holders of the Warrant Units, or any class of security into which the Warrant Units are convertible, (ii) the Company shall authorize the granting to the holders of the Warrant Units, or any class of security into which the Warrant Units are convertible, of rights or Warrants to subscribe for or purchase any additional units of any class or any other right, (iii) the Company shall authorize the issuance or sale of any other units or rights which would result in an adjustment to the Number Issuable pursuant to Section 2(a)(i), (ii), or (iii), or (iv) there shall be any capital reorganization or reclassification of the Warrant Units, or any class of security into which the Warrant Units are convertible, of the Company or consolidation or merger of the Company with or into another Person, or any sale or other disposition of all or substantially all the assets of the Company, or (v) there shall be a voluntary or involuntary dissolution, liquidation or winding up of the Company, then, in any one or more of such cases the Company shall mail to the Holder at such Holder’s address as it appears on the transfer books of the Company, as promptly as practicable but in any event at least 10 days prior to the date on which the transactions contemplated in Section 2(a)(i), (ii), or (iii), a notice stating (a) the date on which a record is to be taken for the purpose of such distribution, rights or Warrants or, if a record is not to be taken, the date as of which the holders of record of either the Warrant Units, or any class of security into which the Warrant Units are convertible, to be entitled to such distribution, rights or Warrants are to be determined, or (b) the date on which such reclassification, consolidation, merger, sale, conveyance, dissolution, liquidation or winding up is expected to become effective. Such notice also shall specify the date as of which it is expected that the holders of record of the Warrant Units, or any class of security into which the Warrant Units are convertible, shall be entitled to exchange the Warrant Units, or any class of security into which the Warrant Units are convertible, for units or other securities or property or cash deliverable upon such reorganization, reclassification, consolidation, merger, sale, conveyance, dissolution, liquidation or winding up.

 

 Page 4 of 9

 

Exhibit A

 

Section 5.          Certain Covenants. The Company covenants and agrees that all units of the Company which may be issued upon the exercise of the Warrants evidenced hereby will be duly authorized, validly issued and fully paid and nonassessable. The Company covenants and agrees that all of the terms and conditions of this Warrant shall be fully binding on any successor entity.

 

Section 6.          Registered Holder. The persons in whose names this Warrant Agreement is registered shall be deemed the owner hereof and of the Warrants evidenced hereby for all purposes. The registered Holder of this Warrant Agreement, in their capacity as such, shall not be entitled to any rights whatsoever as a member of the Company.

 

Section 7.          Transfer of Warrants. The Holder may transfer at one time all but not part of this Warrant Agreement without the consent of the Company to any one (1), but only one (1), individual or entity (the “Transferee”) as long as such individual or entity is an “Accredited Investor,” as that term is defined in Regulation D (“Regulation D”) promulgated under the Securities Act of 1933, as amended; provided, however, that the Transferee must provide the Company with an executed Member Signature Page of the Operating Agreement binding the Transferee to the terms of the Operating Agreement before the transfer could be valid. Any transfer of the rights represented by this Warrant Agreement shall be effected by the surrender of this Warrant Agreement, along with the form of assignment attached hereto, properly completed and executed by the registered Holder hereof, at the principal executive office of the Company in the United States of America, together with an appropriate investment letter and opinion of counsel, if deemed reasonably necessary by counsel to the Company to assure compliance with applicable securities laws. Thereupon, the Company shall issue in the name of the Transferee specified by the registered Holder hereof, a new Warrant Agreement, mutatis mutandis, in the name of the Transferee.

 

Section 8.          Replacement of Warrants. Upon receipt of evidence satisfactory to the Company of the loss, theft, destruction or mutilation of this Warrant Agreement and, in the case of loss, theft or destruction, upon delivery of an indemnity reasonably satisfactory to the Company (in the case of an insurance company or other institutional investor, its own unsecured indemnity agreement shall be deemed to be reasonably satisfactory), or, in the case of mutilation, upon surrender and cancellation thereof, the Company will issue a new Warrant Agreement of like tenor for a number of Warrants equal to the number of Warrants evidenced by this Warrant Agreement.

 

Section 9.         Governing Law. THIS WARRANT AGREEMENT SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH, AND THE RIGHTS OF THE PARTIES SHALL BE GOVERNED BY, THE LAWS OF THE STATE OF VIRGINIA APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED ENTIRELY WITHIN SUCH STATE.

 

Section 10.        Rights Inure to Registered Holder. The Warrants evidenced by this Warrant Agreement will inure to the benefit of and be binding upon the registered Holder thereof and the Company and their respective successors and permitted assigns. Nothing in this Warrant Agreement shall be construed to give to any Person other than the Company and the registered Holder thereof any legal or equitable right, remedy or claim under this Warrant Agreement, and this Warrant Agreement shall be for the sole and exclusive benefit of the Company and such registered Holder. Nothing in this Warrant Agreement shall be construed to give the registered Holder hereof any rights as a Holder of units until such time, if any, as the Warrants evidenced by this Warrant Agreement are exercised in accordance with the provisions hereof.

 

 Page 5 of 9

 

Exhibit A

 

Section 11.       Exercise if a Corporation. In the event of exercise of this Warrant in accordance with Section 1 at a time at which the Company is a corporation, then all references in this Warrant to “units” or “equity” of any kind in the Company shall be interpreted to mean “shares” or “stock” in the Company and all references to the Operating Agreement shall be interpreted to mean any stockholders’ agreement of such corporation.

 

Section 12.        Definitions. For the purposes of this Warrant Agreement, the following terms shall have the meanings indicated below:

 

Business Day” means any day other than a Saturday, Sunday or other day on which commercial banks in the Commonwealth of Virginia are authorized or required by law or executive order to close.

 

Class A Unit” shall mean the Class A Membership Unit of the Company as defined the Operating Agreement.

 

Class B Unit” shall mean the Class B Membership Unit of the Company as defined the Operating Agreement.

 

“Fair Market Value” shall mean, per unit of Warrant Units, on any date specified herein: (a) if the Warrant Units are not then listed or admitted to trading on any national securities exchange but is designated as a national market system security, the average of the closing bid and ask price of the Warrant Units on such date; or (b) if there shall have been no trading on such date or if the Warrant Units are not so designated, the average of the reported closing bid and asked price of the Warrant Units, on such date as shown by NASDAQ and reported by any member firm of the NYSE selected by the Company; or (c) if neither (a) nor (b) is applicable, the value per unit determined in good faith by the Board of Directors of the Company.

 

Person” shall mean any individual, corporation, limited liability company, partnership, trust, incorporated or unincorporatcd association, joint venture, joint stock company, government (or an agency or political subdivision thereof) or other entity of any kind.

 

Operating Agreement” means the Operating Agreement of the Company dated April 8, 2013 , as may be amended from time to time.

 

 Page 6 of 9

 

Exhibit A

 

Section 13.       Notice. Any notice election, communication, request or other document or demand required or permitted under this Note shall be in writing and shall be deemed delivered on the earlier to occur of (i) receipt or (ii) three days after depositing such notice with the United States postal service, postage prepaid first class certified or registered mail, return receipt requested, addressed to Company or Holder as the case may be at the following locations:

 

  If to Company

ADial Pharmaceuticals, L.L.C.

1001 Research Park Blvd.

Suite 100

Charlottesville, VA 22911

     
  With a copy to:

________________________________________

________________________________________

________________________________________

 

  If to Holder:

________________________________________

________________________________________

________________________________________

 

  With a copy to:

________________________________________

________________________________________

________________________________________

 

Either party may, from time to time, change the address at which such written notices or elections, communications, requests, or other documents or demands are to be mailed, by giving the other party ten (10) days’ written notice of such changed address in the manner hereinabove provided.

 

Section 14.       Registration of Units. The Holder understands and acknowledges that the units of Warrant Units that will be issued upon exercise of this Warrant will not be registered under the Securities Act.

 

 

 

[Signature Page Follows]

 

 Page 7 of 9

 

Exhibit A

 

IN WITNESS WHEREOF, the Company has caused this Warrant Agreement to be duly executed as of the date first written above.

 

  ADIAL PHARMACEUTICALS, L.L.C.
     
  By:                           
    Name:
    Title

 

 

 Page 8 of 9

 

Exhibit A

 

[Form of Assignment Form]

 

[To be executed upon assignment of Warrants]

 

The undersigned hereby assigns and transfer this Warrant Agreement to ________ whose Social Security Number or Federal Tax ID Number is ____________________ and whose record address is ________________, and irrevocably appoints ________________, as agent to transfer this security on the books of the Company. Such agent may substitute another to act for such agent.

 

  Signature:
   
   
  Signature Guarantee:

 

Date:    

 

 

Page 9 of 9

 

EX-4.5 17 fs12017ex4-5_adialpharma.htm FORM OF COMMON STOCK PURCHASE WARRANT

Exhibit 4.5

 

NEITHER THIS SECURITY NOR THE SECURITIES AS TO WHICH THIS SECURITY MAY BE EXERCISED HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE SUBSTANCE OF WHICH SHALL BE REASONABLY ACCEPTABLE TO THE COMPANY. THIS SECURITY AND THE SECURITIES ISSUABLE UPON EXERCISE OF THIS SECURITY MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN SECURED BY SUCH SECURITIES.

 

COMMON STOCK PURCHASE WARRANT

 

ADIAL PHARMACEUTICALS, LLC

Warrant Shares: ___________

Date of Issuance: _____________, 2017 (“Issuance Date”)

 

This COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received (in connection with the issuance of the $287,500.00 senior secured promissory note to the Holder (as defined below) of even date) (the “Note”), FirstFire Global Opportunities Fund, LLC, a Delaware limited liability company (including any permitted and registered assigns, the “Holder”), is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date of issuance hereof, to purchase from ADial Pharmaceuticals, LLC, a Virginia limited liability company (the “Company”), _______________ shares of Common Stock (as defined below) (the “Warrant Shares”) (whereby such number may be adjusted from time to time pursuant to the terms and conditions of this Warrant) at the exercise price per share of ____________ (the “Exercise Price”). This Warrant is issued by the Company as of the date hereof in connection with that certain securities purchase agreement dated May 1, 2017, by and among the Company and the Holder (the “Purchase Agreement”).

 

Capitalized terms used in this Warrant shall have the meanings set forth in the Purchase Agreement unless otherwise defined in the body of this Warrant or in Section 12 below. The term “Exercise Period” shall mean the period commencing on the Issuance Date and ending on 5:00 p.m. eastern standard time on the two-year anniversary of the later of (i) the consummation of the Next Financing (as defined in the Purchase Agreement) and (ii) the end of the Lock-Up Period (as defined in the Purchase Agreement).

 

1. EXERCISE OF WARRANT.

 

(a) Mechanics of Exercise. Subject to the terms and conditions hereof, the rights represented by this Warrant may be exercised in whole or in part at any time or times during the Exercise Period by delivery of a written notice, in the form attached hereto as Exhibit A (the “Exercise Notice”), of the Holder’s election to exercise this Warrant. The Holder shall not be required to deliver the original Warrant in order to effect an exercise hereunder. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. On or before the third Trading Day (the “Warrant Share Delivery Date”) following the date on which the Company shall have received the Exercise Notice, and upon receipt by the Company on or prior to the second Trading Day following the date on which the Company shall have received the Exercise Notice of payment to the Company of an amount equal to the applicable Exercise Price multiplied by the number of Warrant Shares as to which all or a portion of this Warrant is being exercised (the “Aggregate Exercise Price” and together with the Exercise Notice, the “Exercise Delivery Documents”) in cash or by wire transfer of immediately available funds (or by cashless exercise, in which case there shall be no Aggregate Exercise Price provided), the Company shall (or direct its transfer agent to) issue and dispatch by overnight courier to the address as specified in the Exercise Notice, a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of shares of Common Stock to which the Holder is entitled pursuant to such exercise. Upon delivery of the Exercise Delivery Documents, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised, irrespective of the date of delivery of the certificates evidencing such Warrant Shares. If this Warrant is submitted in connection with any exercise and the number of Warrant Shares represented by this Warrant submitted for exercise is greater than the number of Warrant Shares being acquired upon an exercise, then the Company shall as soon as practicable and in no event later than three Business Days after any exercise and at its own expense, issue a new Warrant (in accordance with Section 6) representing the right to purchase the number of Warrant Shares purchasable immediately prior to such exercise under this Warrant, less the number of Warrant Shares with respect to which this Warrant is exercised.

 

 1 

 

 

If the Company fails to cause its transfer agent to transmit to the Holder the respective shares of Common Stock by the respective Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise in Holder’s sole discretion, and such failure shall be deemed an event of default under the Note.

 

If at any time the Company does not have an effective registration statement registering the shares of Common Stock underlying the Warrant and the Market Price of one share of Common Stock is greater than the Exercise Price, the Holder may elect to receive Warrant Shares pursuant to a cashless exercise, in lieu of a cash exercise, equal to the value of this Warrant determined in the manner described below (or of any portion thereof remaining unexercised) by surrender of this Warrant and a Notice of Exercise, in which event the Company shall issue to Holder a number of Common Stock computed using the following formula:

 

X = Y (A-B)

      A

 

  Where X = the number of Shares to be issued to Holder.
       
    Y =   the number of Warrant Shares that the Holder elects to purchase under this Warrant (at the date of such calculation).
       
    A =    the average of the VWAP for the five days prior to the date of the Notice.
      “VWAP” on a trading day means the volume weighted average price of the Common Stock for such trading day on the principal market on which the Common Stock then trades as reported by Bloomberg Financial Markets or, if Bloomberg Financial Markets is not then reporting such prices, by a comparable reporting service of national reputation selected by the Company and reasonably satisfactory to the Holder
       
    B =   Exercise Price (as adjusted to the date of such calculation).

 

(b) No Fractional Shares. No fractional shares shall be issued upon the exercise of this Warrant as a consequence of any adjustment pursuant hereto. All Warrant Shares (including fractions) issuable upon exercise of this Warrant may be aggregated for purposes of determining whether the exercise would result in the issuance of any fractional share. If, after aggregation, the exercise would result in the issuance of a fractional share, the Company shall, in lieu of issuance of any fractional share, pay the Holder otherwise entitled to such fraction a sum in cash equal to the product resulting from multiplying the then-current fair market value of a Warrant Share by such fraction.

 

 2 

 

 

(c) Holder’s Exercise Limitations. The Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, to the extent that after giving effect to issuance of Warrant Shares upon exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other persons acting as a group together with the Holder or any of the Holder’s Affiliates), would beneficially own in excess of the Beneficial Ownership Limitation, as defined below. For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates shall include the number of shares of Common Stock issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, non-exercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates and (ii) exercise or conversion of the unexercised or non-converted portion of any other securities of the Company (including without limitation any other Common Stock Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates. Except as set forth in the preceding sentence, for purposes of this paragraph (d), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this paragraph applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any affiliates) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination.

 

For purposes of this paragraph, in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or its transfer agent setting forth the number of shares of Common Stock outstanding. Upon the request of a Holder, the Company shall within two Trading Days confirm to the Holder the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its affiliates since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon exercise of this Warrant. Upon no fewer than 61 days’ prior notice to the Company, a Holder may increase or decrease the Beneficial Ownership Limitation provisions of this paragraph, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon exercise of this Warrant held by the Holder and the provisions of this paragraph shall continue to apply. Any such increase or decrease will not be effective until the 61st day after such notice is delivered to the Company and shall only apply to such Holder and no other Holder. The limitations contained in this paragraph shall apply to a successor Holder of this Warrant.

 

2.  ADJUSTMENTS. The Exercise Price and the number of Warrant Shares shall be adjusted from time to time as follows:

 

(a)  Distribution of Assets. If the Company shall make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including without limitation any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall for ten (10) days after receipt of notice of a Distribution have the right to exercise this Warrant and after such exercise will be entitled to participate in such Distribution with respect to the number of Warrant Shares acquired upon complete exercise of this Warrant immediately before the date on which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution.

 

 3 

 

 

(b)  Splits and Reverse Splits. In the event that Company completes a split or reverse split of its Common Stock (the “Split”), the number of Warrant Shares to be delivered upon exercise of this Warrant will be adjusted so that the Holder will be entitled to receive the number of shares that the Holder would have owned or been entitled to receive upon or by reason of such event had this Warrant been exercised immediately prior to the Split and the Exercise Price will be adjusted so that the total amount required to exercise the purchase of all the Warrant Shares under this Warrant shall be the same as it was prior to the adjustment of the number of Warrant Shares for the Split.

 

3. FUNDAMENTAL TRANSACTIONS. If, at any time while this Warrant is outstanding, (i) the Company effects any merger of the Company with or into another entity and the Company is not the surviving entity (such surviving entity, the “Successor Entity”), (ii) the Company effects any sale of all or substantially all of its assets in one or a series of related transactions, (iii) any tender offer or exchange offer (whether by the Company or by another individual or entity, and approved by the Company) is completed pursuant to which holders of Common Stock are permitted to tender or exchange their shares of Common Stock for other securities, cash or property and the holders of at least 50% of the Common Stock accept such offer, or (iv) the Company effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (other than as a result of a subdivision or combination of shares of Common Stock) (in any such case, a “Fundamental Transaction”), then, at least ten (10) days prior to the consummation of each Fundamental Transaction pursuant to which holders of shares of Common Stock are entitled to receive securities or other assets with respect to or in exchange for shares of Common Stock (a “Corporate Event”), the Company shall provide notice of the Corporate Event and make appropriate provision to insure that the Holder will have an opportunity to exercise this Warrant prior to the Corporate Event and receive the number of shares of Common Stock of the Successor Entity or of the Company and any additional consideration (the “Alternate Consideration”) receivable upon or as a result of such reorganization, reclassification, merger, consolidation or disposition of assets by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such event (disregarding any limitation on exercise contained herein solely for the purpose of such determination). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. To the extent necessary to effectuate the foregoing provisions, any Successor Entity in such Fundamental Transaction shall issue to the Holder a new warrant consistent with the foregoing provisions and evidencing the Holder’s right to exercise such warrant into Alternate Consideration.

 

4. NON-CIRCUMVENTION. The Company covenants and agrees that it will not, by amendment of its certificate of incorporation, bylaws or through any reorganization, transfer of assets, consolidation, merger, scheme of arrangement, dissolution, issue or sale of securities, or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, and will at all times in good faith carry out all the provisions of this Warrant and take all action as may be required to protect the rights of the Holder. Without limiting the generality of the foregoing, the Company (i) shall not increase the par value of any shares of Common Stock receivable upon the exercise of this Warrant above the Exercise Price then in effect, (ii) shall take all such actions as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and non-assessable shares of Common Stock upon the exercise of this Warrant, and (iii) shall, for so long as this Warrant is outstanding, have authorized and reserved, free from preemptive rights, thirty five (35) times the number of shares of Common Stock into which the Warrants are then exercisable into to provide for the exercise of the rights represented by this Warrant (without regard to any limitations on exercise).

 

 4 

 

 

5. WARRANT HOLDER NOT DEEMED A STOCKHOLDER. Except as otherwise specifically provided herein, this Warrant, in and of itself, shall not entitle the Holder to any voting rights or other rights as a stockholder of the Company. In addition, nothing contained in this Warrant shall be construed as imposing any liabilities on the Holder to purchase any securities (upon exercise of this Warrant or otherwise) or as a stockholder of the Company, whether such liabilities are asserted by the Company or by creditors of the Company.

 

6. REISSUANCE.

 

(a) Lost, Stolen or Mutilated Warrant. If this Warrant is lost, stolen, mutilated or destroyed, the Company will, on such terms as to indemnity or otherwise as it may reasonably impose (which shall, in the case of a mutilated Warrant, include the surrender thereof), issue a new Warrant of like denomination and tenor as this Warrant so lost, stolen, mutilated or destroyed.

 

(b) Issuance of New Warrants. Whenever the Company is required to issue a new Warrant pursuant to the terms of this Warrant, such new Warrant shall be of like tenor with this Warrant, and shall have an issuance date, as indicated on the face of such new Warrant which is the same as the Issuance Date.

 

7. TRANSFER.

 

(a) Notice of Transfer. The Holder agrees to give written notice to the Company before transferring this Warrant or transferring any Warrant Shares of such Holder’s intention to do so, describing briefly the manner of any proposed transfer. Promptly upon receiving such written notice, the Company shall present copies thereof to the Company’s counsel. If the proposed transfer may be effected without registration or qualification (under any federal or state securities laws), the Company, as promptly as practicable, shall notify the Holder thereof, whereupon the Holder shall be entitled to transfer this Warrant or to dispose of Warrant Shares received upon the previous exercise of this Warrant, all in accordance with the terms of the notice delivered by the Holder to the Company; provided, however, that an appropriate legend may be endorsed on this Warrant or the certificates for such Warrant Shares respecting restrictions upon transfer thereof necessary or advisable in the opinion of counsel and satisfactory to the Company to prevent further transfers which would be in violation of Section 5 of the Securities Act and applicable state securities laws; and provided further that the prospective transferee or purchaser shall execute the Assignment of Warrant attached hereto as Exhibit B and such other documents and make such representations, warranties, and agreements as may be required solely to comply with the exemptions relied upon by the Company for the transfer or disposition of the Warrant or Warrant Shares.

 

(b) If the proposed transfer or disposition of this Warrant or such Warrant Shares described in the written notice given pursuant to this Section 7 may not be effected without registration or qualification of this Warrant or such Warrant Shares, the Holder will limit its activities in respect to such transfer or disposition as are permitted by law.

 

(c) Any transferee of all or a portion of this Warrant shall succeed to the rights and benefits of the initial Holder of this Warrant.

 

8. NOTICES. Whenever notice is required to be given under this Warrant, unless otherwise provided herein, such notice shall be given in accordance with the notice provisions contained in the Purchase Agreement. The Company shall provide the Holder with prompt written notice (i) immediately upon any adjustment of the Exercise Price, setting forth in reasonable detail, the calculation of such adjustment and (ii) at least 20 days prior to the date on which the Company closes its books or takes a record (A) with respect to any dividend or distribution upon the shares of Common Stock, (B) with respect to any grants, issuances or sales of any stock or other securities directly or indirectly convertible into or exercisable or exchangeable for shares of Common Stock or other property, pro rata to the holders of shares of Common Stock or (C) for determining rights to vote with respect to any Fundamental Transaction, dissolution or liquidation, provided in each case that such information shall be made known to the public prior to or in conjunction with such notice being provided to the Holder.

 

9. AMENDMENT AND WAIVER. The terms of this Warrant may be amended or waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the Company and the Holder.

 

 5 

 

 

10. GOVERNING LAW. This Warrant shall be governed by and construed in accordance with the laws of the State of New York without regard to principles of conflicts of laws. Any action brought by either party against the other concerning the transactions contemplated by this Warrant shall be brought only in the state courts or federal courts located in New York. The parties to this Warrant hereby irrevocably waive any objection to jurisdiction and venue of any action instituted hereunder and shall not assert any defense based on lack of jurisdiction or venue or based upon forum non conveniens. EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT IT MAY HAVE TO, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR UNDER ANY OTHER TRANSACTION DOCUMENT ENTERED INTO IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT, ANY OTHER TRANSACTION DOCUMENT OR ANY TRANSACTION CONTEMPLATED HEREBY OR THEREBY. The prevailing party shall be entitled to recover from the other party its reasonable attorney's fees and costs. In the event that any provision of this Warrant or any other agreement delivered in connection herewith is invalid or unenforceable under any applicable statute or rule of law, then such provision shall be deemed inoperative to the extent that it may conflict therewith and shall be deemed modified to conform with such statute or rule of law. Any such provision which may prove invalid or unenforceable under any law shall not affect the validity or enforceability of any other provision of any agreement. Each party hereby irrevocably waives personal service of process and consents to process being served in any suit, action or proceeding in connection with this Agreement or any other Transaction Document by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law.

 

11. ACCEPTANCE. Receipt of this Warrant by the Holder shall constitute acceptance of and agreement to all of the terms and conditions contained herein.

 

12. CERTAIN DEFINITIONS. For purposes of this Warrant, the following terms shall have the following meanings:

 

(a) “Nasdaq” means www.Nasdaq.com.

 

(c) “Common Stock” means the Company’s common stock, and any other class of securities into which such securities may hereafter be reclassified or changed.

 

(d) “Common Stock Equivalents” means any securities of the Company that would entitle the holder thereof to acquire at any time Common Stock, including without limitation any debt, preferred stock, rights, options, warrants or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

 

(e) This section intentionally left blank.

 

(f) “Exempt Issuance” means the issuance of (i) shares of Common Stock or options to employees, officers, or directors of the Company pursuant to any stock or option plan duly adopted by a majority of the non-employee members of the Board of Directors of the Company or a majority of the members of a committee of non-employee directors established for such purpose, (ii) securities issued pursuant to acquisitions approved by a majority of the disinterested directors of the Company, and (iii) shares of Common Stock issued pursuant to any real property leasing arrangement or debt financing from a bank approved by the Board of Directors of the Company.

 

(g) “Principal Market” means the primary national securities exchange on which the Common Stock is then traded.

 

(h) “Market Price” means the highest traded price of the Common Stock during the thirty (30) Trading Days prior to the date of the respective Exercise Notice.

 

(i) “Trading Day” means (i) any day on which the Common Stock is listed or quoted and traded on its Principal Market, (ii) if the Common Stock is not then listed or quoted and traded on any national securities exchange, then a day on which trading occurs on any over-the-counter markets, or (iii) if trading does not occur on the over-the-counter markets, any Business Day.

 

* * * * * * *

 6 

 

 

IN WITNESS WHEREOF, the Company has caused this Warrant to be duly executed as of the Issuance Date set forth above.

 

  ADIAL PHARMACEUTICALS, LLC
   
   
  Name: William Stilley
  Title:  Chief Executive Officer

 

 

 

 

EXHIBIT A

 

EXERCISE NOTICE

 

(To be executed by the registered holder to exercise this Common Stock Purchase Warrant)

  

The undersigned holder hereby exercises the right to purchase ____________________of the shares of Common Stock (“Warrant Shares”) of ADial Pharmaceuticals, LLC, a Virginia limited liability company (the “Company”), evidenced by the attached copy of the Common Stock Purchase Warrant (the “Warrant”). Capitalized terms used herein and not otherwise defined shall have the respective meanings set forth in the Warrant.

 

1. Form of Exercise Price. The Holder intends that payment of the Exercise Price shall be made as (check one):

 

☐ a cash exercise with respect to ___________________ Warrant Shares; or

☐ by cashless exercise pursuant to the Warrant.

 

2. Payment of Exercise Price. If cash exercise is selected above, the holder shall pay the applicable Aggregate Exercise Price in the sum of $ ________________ to the Company in accordance with the terms of the Warrant.

 

3. Delivery of Warrant Shares. The Company shall deliver to the holder ____________________ Warrant Shares in accordance with the terms of the Warrant.

 

Date: _____________________

 

   
  (Print Name of Registered Holder)
     
  By:    
  Name:   
  Title:   

  

 

 

 

EXHIBIT B

 

ASSIGNMENT OF WARRANT

 

(To be signed only upon authorized transfer of the Warrant)

 

FOR VALUE RECEIVED, the undersigned hereby sells, assigns, and transfers unto the right to purchase shares of common stock of ADial Pharmaceuticals, LLC, to which the within Common Stock Purchase Warrant relates and appoints , as attorney-in-fact, to transfer said right on the books of ADial Pharmaceuticals, LLC with full power of substitution and re-substitution in the premises. By accepting such transfer, the transferee has agreed to be bound in all respects by the terms and conditions of the within Warrant.

 

Dated: _____________________  
   
  (Signature) *
   
   
  (Name)
   
   
  (Address)
   
   
  (Social Security or Tax Identification No.)

 

* The signature on this Assignment of Warrant must correspond to the name as written upon the face of the Common Stock Purchase Warrant in every particular without alteration or enlargement or any change whatsoever. When signing on behalf of a corporation, partnership, trust or other entity, please indicate your position(s) and title(s) with such entity.

 

 

 

 

 

EX-4.6 18 fs12017ex4-6_adialpharma.htm FORM OF 2016 CONVERTIBLE PROMISSORY NOTE

Exhibit 4.6

 

Exhibit A

Form of Convertible Note

 

THIS CONVERTIBLE PROMISSORY NOTE HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. NO SALE OR DISPOSITION MAY BE EFFECTED EXCEPT IN COMPLIANCE WITH RULE 144 UNDER SAID ACT OR AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL FOR THE HOLDER SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE ACT OR RECEIPT OF A NO-ACTION LETTER FROM THE SECURITIES AND EXCHANGE COMMISSION.

 

CONVERTIBLE PROMISSORY NOTE

 

$_________ August __, 2016
  Charlottesville, VA

 

For value received, ADIAL PHARMACEUTICALS, LLC, a Virginia Limited Liability Company (the “Company”), promises to pay to ___________________or their assigns (“Holder”) the principal sum of $______________ together with accrued and unpaid interest thereon, each due and payable on the date and in the manner set forth below. This “Note” is one of a series of convertible promissory notes identical in substance to this Note (collectively, the “Notes”) except as to the Holder, date, and principal amount. The Notes are being sold by the Company pursuant to an offering (“Offering”) under Rule 504 of Regulation D.

 

1.       Definitions. As used in this Note, the following terms are to have the meaning as stated below.

 

(a)       The “Conversion Cap Price” is, at the time this Note is converted to membership units in the Company per the terms hereunder, the price per Unit equal to the quotient of $2,000,000 divided by the aggregate number of the Company’s outstanding Units as of the date immediately prior to the initial closing of the Qualified Financing (assuming full conversion or exercise of all convertible and exercisable securities then outstanding other than the Notes).

 

(b)       Class XX Units” shall have the meaning defined in Section 5(b) below.

 

(c)       The “Maturity Date” is August 31, 2029.

 

(d)       Operating Agreement” means the Second Amended & Restated Operating Agreement of ADial Pharmaceuticals, L.L.C. dated February 3, 2016 as amended from time to time.

 

(e)       The “Outstanding Balance” at any time is the outstanding principal balance of this Note, and any accrued but unpaid interest thereon at such time.

 

(f)       Qualified Financing” is the sale of equity securities of the Company resulting in gross proceeds to the Company of at least $2,000,000 (not including the conversion of this Note and other notes).

 

 1 

 

 

(g)       Sale of the Company” shall mean (i) any consolidation or merger of the Company with or into any other corporation or other entity or person, or any other corporate reorganization, other than any such consolidation, merger or reorganization in which the Members of the Company immediately prior to such consolidation, merger or reorganization, continue to hold at least a majority of the voting power of the surviving entity in substantially the same proportions (or, if the surviving entity is a wholly owned subsidiary, its parent) immediately after such consolidation, merger or reorganization; (ii) any transaction or series of related transactions to which the Company is a party in which in excess of 50% of the Company’s voting power is transferred; provided, however, that a Sale of the Company shall not include any transaction or series of transactions principally for bona fide equity financing purposes in which cash is received by the Company or any successor or indebtedness of the Company is cancelled or converted or a combination thereof; or (iii) a sale or other disposition of all or substantially all of the assets of the Company.

 

(h)       Units” and “Members” shall have the meaning set forth in the Operating Agreement.

 

2.       Interest Rate. The Company promises to pay interest on the outstanding principal amount hereof from the date hereof until payment in full or conversion under the terms hereunder at an annual rate of 15% or the maximum rate permissible by law, whichever is less. Interest shall be due and payable on the Maturity Date and shall be calculated on a 30/360 basis, compounded monthly.

 

3.       Maturity. Unless this Note has been previously converted in accordance with the terms hereunder, the entire Outstanding Balance shall become fully due and payable on the Maturity Date.

 

4.       Prepayment. The Notes may be prepaid by cash payment of an amount equal to Outstanding Balance, plus an additional payment equal to 200% of the Outstanding Balance and by additionally issuing Class A Units (defined in the Operating Agreement) to Holder with the number of Class A Units to be issued being equal to the Outstanding Balance divided by the Conversion Cap Price (i.e., the number of Class A Units shall be equal to the quotient of the Outstanding Balance divided by the Conversion Cap Price) and such Class A Units shall have a basis of $0.00 per unit (i.e. $0.00 Contributed Capital (defined in the Operating Agreement)).

 

5.       Conversion.

 

(a)       Conversion Upon a Qualified Financing. In the event that the Company issues and sells either common or preferred Units (“Equity Securities”) in the Company to investors (the “Investors”) in a Qualified Financing, then the Outstanding Balance of this Note shall automatically convert in whole without any further action by the Holder into such Equity Securities at a conversion price equal to the lesser of: (i) one third (1/3) of the per Unit price paid by the Investor in such Equity Securities in the Qualified Financing or (ii) the Conversion Cap Price.

 

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(b)       Conversion Upon Sale of Company. If the Note has not been previously converted to Equity Securities and the Company elects to consummate a Sale of the Company, then notwithstanding any provision of the Note to the contrary, the Outstanding Balance of this Note shall automatically convert in whole without any further action by the Holder into Class XX Units (defined below) at a conversion price equal to the Conversion Cap Price. “Class XX Units” will be a newly created class of LLC Units (defined in the Operating Agreement) representing Membership Interests (defined in the Operating Agreement) that are identical to Class A Units (defined in the Operating Agreement) except as follows: (i) Class XX Units will receive cumulative distributions in preference to all other LLC Units in an amount equal to three (3) times the Outstanding Balance at the time of conversion (the “Preferential Distribution”), and (ii) after receiving the Preferential Distribution, Class XX Units will then receive distributions at least to the extent as any distributions are received by Class A Units with an associated Contributed Capital (defined in the Operating Agreement) of less than $0.01 per Unit.

 

(c)       Conversion at Maturity. If the Note has not been previously converted to Equity Securities effective upon the Maturity Date, the Holder may elect to convert each of the Notes into Class XX Units as if a Sale of the Company had occurred by delivery of written notice to the Company at least thirty (30) days prior to the Maturity Date of the intent to make such election to convert.

 

(d)       Fractional Units. If the conversion of this Note would result in the issuance of a fractional Unit, the Company shall, at the Company’s sole option, (i) issue fractional units, (ii) round the number of units issued up to the nearest whole unit, or (iii) in lieu of issuance of any fractional Unit, pay the Holder otherwise entitled to such fraction a sum in cash equal to the product resulting from multiplying the then current fair market value of one Unit into which this Note has converted by such fraction.

 

6.       Expenses. In the event of any default hereunder, the Company shall pay all reasonable attorneys’ fees and court costs incurred by Holder in enforcing and collecting this Note.

 

7.       Default. If there shall be any Event of Default hereunder, at the option and upon the declaration of the Holder and upon written notice to the Company (which election and notice shall not be required in the case of an Event of Default under Section 7(c) or 7(d)), this Note shall accelerate and three (3) times the Outstanding Balance shall become due and payable. The occurrence of any one or more of the following shall constitute an Event of Default:

 

(a)       The Company fails to pay timely any of the principal amount, accrued interest or other amounts due under this Note on the date the same becomes due and payable;

 

(b)       The Company defaults in its performance of any covenant in this Note;

 

(c)       The Company files any petition or action for relief under any bankruptcy, reorganization, insolvency or moratorium law or any other law for the relief of, or relating to, debtors, now or hereafter in effect, or makes any assignment for the benefit of creditors or takes any corporate action in furtherance of any of the foregoing; or

 

(d)       An involuntary petition is filed against the Company (unless such petition is dismissed or discharged within 60 days under any bankruptcy statute now or hereafter in effect, or a custodian, receiver, trustee, assignee for the benefit of creditors (or other similar official) is appointed to take possession, custody or control of any property of the Company.

 

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8.       Security; Subordination.

 

(a)       Security. This Note is a general unsecured obligation of the Company and is not guaranteed by any other person or entity or secured by any assets of the Company.

 

(b)       Senior Indebtedness. The indebtedness evidenced by this Note, including principal and interest, shall be subordinate and subject in right of payment to the prior payment in full of all Senior Indebtedness (as defined below), whether now outstanding or hereafter incurred, and any holder of this Note, by acceptance hereof, agrees to and shall be bound by the provisions of this section. “Senior Indebtedness” shall mean the principal and interest on indebtedness of the Company whether now outstanding or hereafter incurred for money borrowed from or guaranteed to banks, trust companies, insurance companies, governmental agencies and other recognized financing institutions, as evidenced by notes or similar obligations unless, in each case, by the terms of the instrument creating or evidencing such indebtedness it is provided that such indebtedness is not superior in the right of payment to this Note.

 

(c)       Distribution of Assets. Upon any payment or distribution of the assets of the Company of any kind or character, whether in cash, property or securities, to creditors upon any dissolution or winding-up or total or partial liquidation or reorganization of the Company, whether voluntary or involuntary, or in bankruptcy, insolvency, receivership or other proceedings, all principal and interest due upon all Senior Indebtedness shall first be paid in full, or payment thereof provided for before the holder of this Note shall be entitled to be paid in cash or receive any assets.

 

(d)       Obligation of Company. Nothing contained in this Section 8 is intended to or shall impair the obligation of the Company, which is absolute and unconditional, to pay to Holder and others holding similar Notes the Outstanding Balance on such Notes, as and when the same shall become due and payable in accordance with their terms, or to affect the relative rights of Holder and creditors of the Company other than the holders of the Senior Indebtedness, nor shall anything herein or therein prevent Holder from exercising all remedies otherwise permitted by applicable law upon default of this Note, subject to the rights, if any, under this section of the holders of Senior Indebtedness in respect of cash, property or securities of the Company otherwise payable or delivered to such holder upon the exercise of any such remedy.

 

9.       Repayments. All payments of interest and principal shall be in lawful money of the United States of America. All payments shall be applied first to accrued interest and thereafter to principal.

 

10.     Waiver. The Company hereby waives demand, notice, presentment, protest and notice of dishonor.

 

11.     Governing Law. This Note shall be governed by and construed under the laws of the Commonwealth of Virginia, as applied to agreements among Virginia residents, made and to be performed entirely within the Commonwealth of Virginia, without giving effect to conflicts of laws principles.

 

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12.       Parity with Other Notes. The Company’s repayment obligation to Holder under this Note shall be on parity with the Company’s obligation to repay the Notes issued to other holders pursuant the Offering by the Company. In the event that the Company is obligated to repay the Note and does not have sufficient funds to repay all the holders of the Notes in full, payment shall be made to the Holder of this Note and the holders of the other Notes on a pro rata basis but in all cases subordinate to the holders of Senior Indebtedness.

 

13.       No Distributions. No distributions may be made to Members (as defined in the Operating Agreement) based on their ownership of Membership Interests unless and until this Note has been repaid in full or converted under the terms hereunder, except that the Board of Directors may make distributions to Members solely for the purpose of assisting with the payment of income taxes as per Section 9.4.2 of the Operating Agreement.

 

14.       Required Actions of the Company. If necessary, the Company’s Board of Directors will make any amendments to the Operating Agreement in order to comply with the terms herein, including, without limitation, the creation of a Class XX Units upon conversion under Sections 5(b) or 5(c) above.

 

15.       Conversion to Corporation. In the event the Company converts to a corporation, then all references to membership units in this Note shall automatically be deemed to refer to shares of stock with terms and preference practically similar to such membership units.

 

16.       Modification; Waiver. Any term of this Note may be amended, or any term thereof waived, upon the written consent of the Company and the approval in writing by holders of Notes whose aggregate principal amount represents fifty percent (50%) of the outstanding principal amount of all then-outstanding Notes.

 

17.       Assignment. This Note may be transferred only upon its surrender to the Company for registration of transfer, duly endorsed, or accompanied by a duly executed written instrument of transfer in form satisfactory to the Company. Thereupon, this Note shall be reissued to, and registered in the name of, the transferee, or a new Note for like principal amount and interest shall be issued to, and registered in the name of, the transferee. Interest and principal shall be paid solely to the registered holder of this Note. Such payment shall constitute full discharge of the Company’s obligation to pay such interest and principal. Notwithstanding the above, any transferee of this Note will, upon request, execute a subscription agreement with terms similar to that used for issuance of this Note and any other documentation reasonably requested by the Company.

 

18.       Operating Agreement. This Note will be subject to the terms and conditions of the Operating Agreement. Prior to receiving Units in the Company the Holder will execute a signature page to the Operating Agreement agreeing to be bound by the terms and conditions of the Operating Agreement.

 

ADIAL PHARMACEUTICALS, LLC   Holder:                                                                             
                                                                                
By:                                  Principal Amount of Note: $                                          
Name:     Date of Note:                                                                   
Title:      

 

 

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EX-4.7 19 fs12017ex4-7_adialpharma.htm SENIOR SECURED PROMISSORY NOTE

Exhibit 4.7

 

THE ISSUANCE AND SALE OF THE SECURITIES REPRESENTED BY THIS NOTE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR APPLICABLE STATE SECURITIES LAWS. THE SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD, TRANSFERRED OR ASSIGNED (I) IN THE ABSENCE OF (A) AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR (B) AN OPINION OF COUNSEL (WHICH MAY BE THE LEGAL COUNSEL OPINION (AS DEFINED IN THE PURCHASE AGREEMENT)), IN A GENERALLY ACCEPTABLE FORM, THAT REGISTRATION IS NOT REQUIRED UNDER SAID ACT. NOTWITHSTANDING THE FOREGOING, THE SECURITIES MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN OR FINANCING ARRANGEMENT SECURED BY THE SECURITIES.

 

Principal Amount: $287,500.00 Issue Date: May 1, 2017

Actual Amount of Purchase Price: $250,000.00

 

SENIOR SECURED PROMISSORY NOTE

 

FOR VALUE RECEIVED, ADIAL PHARMACEUTICALS, LLC, a Virginia limited liability company (hereinafter called the “Borrower” or the “Company”), hereby promises to pay to the order of FIRSTFIRE GLOBAL OPPORTUNITIES FUND LLC, a Delaware limited liability company, or registered assigns (the “Holder”), in the form of lawful money of the United States of America, the principal sum of $287,500.00, which amount is the $250,000.00 actual amount of the purchase price (the “Consideration”) hereof plus a prorated 15% original issue discount (the “OID”) (subject to adjustment pursuant to Section 3) (the “Principal Amount”) and to pay interest on the unpaid Principal Amount hereof at the rate of two percent (2%) (the “Interest Rate”) per annum from the date hereof (the “Issue Date”) until the same becomes due and payable, whether at maturity or upon acceleration or by prepayment or otherwise, as further provided herein. The maturity date shall be six (6) months from the Issue Date (the “Maturity Date”), and is the date upon which the principal sum, the applicable portion of the OID, as well as any accrued and unpaid interest and other fees herein, shall be due and payable.

 

This Note may be prepaid or repaid in whole or in part at any time as provided herein. This Note shall be a senior secured obligation of the Company, with priority over all future Indebtedness (as defined below) of the Company as provided for herein. The obligations of the Company under this Note are secured pursuant to the terms of the security agreement of even date (the “Security Agreement) by and among the Borrower, its Subsidiaries, and the Secured Parties (as defined therein), and such security interest includes but is not limited to all of the assets of the Company and its Subsidiaries.

 

Interest shall commence accruing on the date that the Note is fully funded and shall be computed on the basis of a 365-day year and the actual number of days elapsed. Any Principal Amount or interest on this Note which is not paid when due shall bear interest at the rate of fifteen percent (15%) per annum from the due date thereof until the same is paid (“Default Interest”).

 

All payments due hereunder shall be made in lawful money of the United States of America. All payments shall be made at such address as the Holder shall hereafter give to the Borrower by written notice made in accordance with the provisions of this Note. Whenever any amount expressed to be due by the terms of this Note is due on any day which is not a business day, the same shall instead be due on the next succeeding day which is a business day and, in the case of any interest payment date which is not the date on which this Note is paid in full, the extension of the due date thereof shall not be taken into account for purposes of determining the amount of interest due on such date.

 

1

 

 

Each capitalized term used herein, and not otherwise defined, shall have the meaning ascribed thereto in that certain securities purchase agreement dated as of the Issue Date (the “Purchase Agreement”), pursuant to which this Note was originally issued. As used in this Note, the term “business day” shall mean any day other than a Saturday, Sunday or a day on which commercial banks in the city of New York, New York are authorized or required by law or executive order to remain closed. As used herein, the term “Trading Day” means any day that shares of Common Stock are listed for trading or quotation on the OTCBB (as defined in the Purchase Agreement), any tier of the NASDAQ Stock Market, the New York Stock Exchange or the NYSE MKT. As used in this Note. The term “Common Stock” shall include limited liability company membership interests of the Company until such time as the Company converts into a corporation.

 

This Note is free from all taxes, liens, claims and encumbrances with respect to the issue thereof and shall not be subject to preemptive rights or other similar rights of shareholders of the Borrower and will not impose personal liability upon the holder thereof.

 

The following terms shall apply to this Note:

 

ARTICLE I. REPAYMENT RIGHTS

 

1.1 Effect of Certain Events.

 

(a) Effect of Merger, Consolidation, Etc. At the option of the Holder, the sale, conveyance or disposition of all or substantially all of the assets of the Borrower, or the consolidation, merger or other business combination (other than a reincorporation merger or a reorganization to convert to a corporation) of the Borrower with or into any other Person (as defined below) or Persons when the Borrower is not the survivor or where the majority owners of Borrower prior to the transaction are not the majority owners of the surviving entity shall be deemed to be an Event of Default (as defined in Article III) pursuant to which the Borrower shall be required to pay to the Holder upon the consummation of and as a condition to such transaction until this Note is paid in full an amount equal to the Default Amount (as defined herein). “Person” shall mean any individual, corporation, limited liability company, partnership, association, trust or other entity or organization. The Borrower shall not effectuate any transaction described in this Section 1.1(a), including but not limited to a reincorporation merger or a reorganization to convert to a corporation, unless (a) it first gives, to the extent practicable, at least thirty (30) days prior written notice (but in any event at least fifteen (15) days prior written notice of the record date of the special meeting of shareholders to approve, or if there is no such record date, the consummation of, such merger, consolidation, exchange of shares, recapitalization, reorganization or other similar event or sale of assets, and (b) the resulting successor or acquiring entity (if not the Borrower) assumes by written instrument the obligations of this Note. The above provisions shall similarly apply to successive consolidations, mergers, sales, transfers or share exchanges.

 

(b) Adjustment Due to Distribution. If the Borrower shall declare or make any distribution of its assets (or rights to acquire its assets) to holders of Common Stock as a dividend, stock repurchase, by way of return of capital or otherwise (including any dividend or distribution to the Borrower’s shareholders in cash or shares (or rights to acquire shares) of capital stock of a subsidiary (i.e., a spin-off)) (a “Distribution”), then the Borrower shall be required to pay to the Holder the Default Amount within one (1) business day.

 

(c) If the Company enters into a Variable Rate Transaction, despite the prohibition set forth in the Purchase Agreement, then the Borrower shall be required to pay to the Holder the Default Amount within one (1) business day.

 

1.3 Prepayment. Notwithstanding anything to the contrary contained in this Note, at any time or prior to (but not following) the earlier of the (i) the close of business three (3) days after the date that an Event of Default occurs hereunder and (ii) Maturity Date, the Borrower shall have the right to prepay the outstanding Principal Amount and interest (including any Default Interest) then due under this Note, in whole or in part, in accordance with this Section 1.3. Any prepayment must be delivered with notice and such notice of prepayment hereunder (an “Optional Prepayment Notice”) shall be delivered to the Holder of the Note at its registered addresses and shall state: (1) that the Borrower is exercising its right to prepay the Note, and (2) the date of prepayment which shall be not more than three (3) business days after the date of the Optional Prepayment Notice. On the date fixed for prepayment (the “Optional Prepayment Date”), the Borrower shall make payment of an amount in cash equal to the sum of: (w) 115% multiplied by the Principal Amount then outstanding plus (x) accrued and unpaid interest on the Principal Amount to the Optional Prepayment Date plus (y) Default Interest, if any, on the amounts referred to in clauses (w) and (x).

 

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1.4 Repayment from Proceeds. While any portion of the outstanding Principal Amount and interest (including Default Interest) under this Note are due and owing, if the Company receives net cash proceeds from any source or series of related or unrelated sources, including but not limited to, from the issuance of equity or debt, the conversion of outstanding warrants of the Borrower, the issuance of securities pursuant to an equity line of credit of the Borrower or the sale of assets, in the aggregate amount of more than $250,000.00, the Borrower shall, within three (3) business days of Borrower’s receipt of such proceeds, inform the Holder of such receipt, following which the Holder shall have the right in its sole discretion to require the Borrower to immediately apply all or any portion of such proceeds to repay all or any portion of the outstanding Principal Amount and interest (including any Default Interest) then due under this Note. Failure of the Borrower to comply with this provision shall constitute an Event of Default. In the event that such proceeds are received by the Holder prior to the Maturity Date, the required prepayment shall be subject to the terms of Section 1.3 herein.

 

ARTICLE II. RANKING AND CERTAIN COVENANTS

 

2.1 Ranking and Security. The obligations of the Borrower under this Note shall rank senior with respect to any and all Indebtedness incurred as of or following the Issue Date. The obligations of the Borrower under this Note are secured pursuant to that certain Security Agreement of even date. The obligations of the Company under this Note are secured pursuant to the terms of the Security Agreement by and among the Borrower, its Subsidiaries, and the Secured Parties, and such security interest includes but is not limited to all of the assets of the Company and its Subsidiaries.

 

2.2 Other Indebtedness. So long as the Borrower shall have any obligation under this Note, the Borrower shall not (directly or indirectly through any Subsidiary or affiliate) incur or suffer to exist or guarantee any Indebtedness that is senior to or pari passu with (in priority of payment and performance) the Borrower’s obligations hereunder. As used in this Section 2.2, the term “Borrower” means the Borrower and any Subsidiary of the Borrower. As used herein, the term “Indebtedness” means (a) all indebtedness of the Borrower for borrowed money or for the deferred purchase price of property or services, including any type of letters of credit, but not including deferred purchase price obligations in place as of the Issue Date or obligations to trade creditors incurred in the ordinary course of business, (b) all obligations of the Borrower evidenced by notes, bonds, debentures or other similar instruments, (c) all guarantee obligations of the Borrower in respect of obligations of the kind referred to in clauses (a) through (b) above that the Borrower would not be permitted to incur or enter into, and (d) all obligations of the kind referred to in clauses (a) through cd) above that the Borrower is not permitted to incur or enter into that are secured and/or unsecured by (or for which the holder of such obligation has an existing right, contingent or otherwise, to be secured and/or unsecured by) any lien or encumbrance on property (including accounts and contract rights) owned by the Borrower, whether or not the Borrower has assumed or become liable for the payment of such obligation.

 

2.3 Distributions on Capital Stock. So long as the Borrower shall have any obligation under this Note, the Borrower shall not without the Holder’s written consent (a) pay, declare or set apart for such payment, any dividend or other distribution (whether in cash, property or other securities) on shares of capital stock other than dividends on shares of Common Stock solely in the form of additional shares of Common Stock or (b) directly or indirectly or through any subsidiary make any other payment or distribution in respect of its capital stock except for distributions pursuant to any shareholders’ rights plan which is approved by a majority of the Borrower’s disinterested directors.

 

2.4 Restriction on Stock Repurchases and Debt Repayments. So long as the Borrower shall have any obligation under this Note, the Borrower shall not without the Holder’s written consent redeem, repurchase or otherwise acquire (whether for cash or in exchange for property or other securities or otherwise) in any one transaction or series of related transactions any shares of capital stock of the Borrower or any warrants, rights or options to purchase or acquire any such shares, or repay any pari passu or subordinated indebtedness of Borrower.

 

2.5 Sale of Assets. So long as the Borrower shall have any obligation under this Note, the Borrower shall not, without the Holder’s written consent, sell, lease or otherwise dispose of any significant portion of its assets outside the ordinary course of business. Any consent to the disposition of any assets may be conditioned on a specified use of the proceeds of disposition.

 

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2.6 Advances and Loans; Affiliate Transactions. So long as the Borrower shall have any obligation under this Note, the Borrower shall not, without the Holder’s written consent, lend money, give credit, make advances to or enter into any transaction with any person, firm, joint venture or corporation, including, without limitation, officers, directors, employees, subsidiaries and affiliates of the Borrower, except loans, credits or advances (a) in existence or committed on the Issue Date and which the Borrower has informed Holder in writing prior to the Issue Date, (b) in regard to transactions with unaffiliated third parties, made in the ordinary course of business or (c) in regard to transactions with unaffiliated third parties, not in excess of $50,000. So long as the Borrower shall have any obligation under this Note, the Borrower shall not, without the Holder’s written consent, repay any affiliate (as defined in Rule 144) of the Borrower in connection with any indebtedness or accrued amounts owed to any such party.

 

2.7 Preservation of Business and Existence, etc. So long as the Borrower shall have any obligation under this Note, the Borrower shall not, without the Holder’s written consent, change the nature of its business. In addition, so long as the Borrower shall have any obligation under this Note, the Borrower shall maintain and preserve, and cause each of its Subsidiaries to maintain and preserve, its existence, rights and privileges, and become or remain, and cause each of its Subsidiaries (other than dormant Subsidiaries that have no or minimum assets) to become or remain, duly qualified and in good standing in each jurisdiction in which the character of the properties owned or leased by it or in which the transaction of its business makes such qualification necessary. Furthermore, so long as the Borrower shall have any obligation under this Note, the Borrower shall not, without the Holder’s written consent, solicit any offers for, respond to any unsolicited offers for, or conduct any negotiations with, any other person or entity with respect to any Variable Rate Transaction or investment.

 

2.8 Noncircumvention. The Company hereby covenants and agrees that the Company will not, by amendment of its Certificate or Articles of Organization or Operating Agreement, or through any reorganization, transfer of assets, consolidation, merger, scheme of arrangement, dissolution, issue or sale of securities (other than a reincorporation merger or reorganization to convert to a corporation), or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Note, and will at all times in good faith carry out all the provisions of this Note and take all action as may be required to protect the rights of the Holder.

 

2.9 Lost, Stolen or Mutilated Note. Upon receipt by the Company of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Note, and, in the case of loss, theft or destruction, of any indemnification undertaking by the Holder to the Company in customary form and, in the case of mutilation, upon surrender and cancellation of this Note, the Company shall execute and deliver to the Holder a new Note.

 

ARTICLE III. EVENTS OF DEFAULT

 

It shall be considered an event of default if any of the following events listed in this Article III (each, an “Event of Default”) shall occur; provided, however, that, except in the case of the Events of Default listed in Sections 3.1, 3.2, 3.7, 3.9, 3.10, 3.16, 3.18, 3.19 or 3.20 below, the Borrower shall have five (5) business days to cure such Event of Default unless a lesser number of days is required pursuant to the provisions of this Article III:

 

3.1 Failure to Pay Principal or Interest. The Borrower fails to pay the Principal Amount hereof or interest thereon when due on this Note, whether at maturity, upon acceleration or otherwise, and has failed to cure such default within three (3) days of notice thereof.

 

3.2 This section intentionally left blank.

 

3.3 Breach of Agreements and Covenants. The Borrower breaches any material agreement, covenant or other material term or condition contained in the Purchase Agreement, this Note, the Warrant described in the Purchase Agreement, the Irrevocable Transfer Agent Instructions or in any agreement, statement or certificate given in writing pursuant hereto or in connection herewith or therewith.

 

3.4 Breach of Representations and Warranties. Any material representation or warranty of the Borrower made in the Purchase Agreement, this Note, the Warrant described in the Purchase Agreement, the Irrevocable Transfer Agent Instructions or in any agreement, statement or certificate given in writing pursuant hereto or in connection herewith or therewith shall be false or misleading in any material respect when made and the breach of which has (or with the passage of time will have) a material adverse effect on the rights of the Holder with respect to this Note or the Purchase Agreement.

 

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3.5 Receiver or Trustee. The Borrower or any subsidiary of the Borrower shall make an assignment for the benefit of creditors, or apply for or consent to the appointment of a receiver or trustee for it or for a substantial part of its property or business, or such a receiver or trustee shall otherwise be appointed.

 

3.6 Judgments. Any money judgment, writ or similar process shall be entered or filed against the Borrower or any subsidiary of the Borrower or any of its property or other assets for more than $50,000, and shall remain unvacated, unbonded or unstayed for a period of sixty (60) days unless otherwise consented to by the Holder, which consent will not be unreasonably withheld.

 

3.7 Bankruptcy. Bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for relief under any bankruptcy law or any law for the relief of debtors shall be instituted by or against the Borrower or any subsidiary of the Borrower.

 

3.8 Delisting of Common Stock. If at any time after the listing of the Common Stock on at least one of the Over the Counter Bulletin Board, the OTCQB Market, any level of the OTC Markets, or any level of the Nasdaq Stock Market or the New York Stock Exchange (including the NYSE MKT), the Borrower shall fail to maintain the listing of the Common Stock on at least one of the Over the Counter Bulletin Board, the OTCQB Market, any level of the OTC Markets, or any level of the Nasdaq Stock Market or the New York Stock Exchange (including the NYSE MKT).

 

3.9 Failure to Comply with the 1934 Act. If at any time after the Borrower becomes subject to the reporting requirements of the 1934 Act, the Borrower shall fail to comply with the reporting requirements of the

1934 Act and/or the Borrower shall cease to be subject to the reporting requirements of the 1934 Act, including but not limited to the Borrower’s filing of any Notification of Late Filing on Form 12b-25 with the SEC.

 

3.10 Liquidation. Any dissolution, liquidation, or winding up of Borrower or any substantial portion of its business.

 

3.11 Cessation of Operations. Any cessation of operations by Borrower or Borrower admits it is otherwise generally unable to pay its debts as such debts become due, provided, however, that any disclosure of the Borrower’s ability to continue as a “going concern” shall not be an admission that the Borrower cannot pay its debts as they become due.

 

3.12 Maintenance of Assets. The failure by Borrower to maintain any material intellectual property rights, personal, real property or other assets which are necessary to conduct its business (whether now or in the future).

 

3.14 Reverse Splits. The Borrower effectuates a reverse split of its Common Stock without twenty (20) days prior written notice to the Holder.

 

3.15 Replacement of Transfer Agent. In the event that terms for conversion are incorporated into this Note, pursuant to Section 1.1(e) of this Note, and the Borrower fails to provide, prior to the effective date of the replacement of its transfer agent, a fully executed irrevocable transfer agent instructions (including but not limited to the provision to irrevocably reserve shares of Common Stock in the Reserved Amount) signed by the successor transfer agent to Borrower and the Borrower.

 

3.16 DTC “Chill”. The DTC places a “chill” (i.e. a restriction placed by DTC on one or more of DTC’s services, such as limiting a DTC participant’s ability to make a deposit or withdrawal of the security at DTC) on any of the Borrower’s securities.

 

3.17 Illegality. Any court of competent jurisdiction issues an order declaring this Note, the Purchase Agreement or any provision hereunder or thereunder to be illegal.

 

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3.18. DWAC Eligibility. In addition to the Event of Default in Section 3.16, if at any time after the listing of the Common Stock on at least one of the Over the Counter Bulletin Board, the OTCQB Market, any level of the OTC Markets, or any level of the Nasdaq Stock Market or the New York Stock Exchange (including the NYSE MKT), the Common Stock is otherwise not eligible for trading through the DTC’s Fast Automated Securities Transfer or Deposit/Withdrawal at Custodian programs.

 

3.19 Cross-Default. The declaration of an event of default by any lender or other extender of credit to the Company under any notes, loans, agreements or other instruments of the Company evidencing any Indebtedness of the Company (including those filed as exhibits to or described in the Company’s filings with the SEC), after the passage of all applicable notice and cure or grace periods.

 

3.20 Variable Rate Transactions. The Borrower (i) issues shares of Common Stock (or convertible securities) pursuant to an equity line of credit of the Company or otherwise in connection with a Variable Rate Transaction (whether now existing or entered into in the future) or (ii) adjusts downward the “floor price” at which shares of Common Stock (or convertible securities) may be issued under an equity line of credit or otherwise in connection with a Variable Rate Transaction (whether now existing or entered into in the future).

 

3.21 Rights and Remedies Upon an Event of Default. Subject to applicable cure periods specifically provided for herein, upon the occurrence and during the continuation of any Event of Default specified in this Article III, exercisable through the delivery of written notice to the Borrower by the Holder (the “Default Notice”) (provided, however, that no Default Notice need be provided by the Holder and no notice and no cure period shall apply in the case of the Events of Default specified in Sections 3.1, 3.2, 3.7, 3.9, 3.10, 3.16, 3.18, 3.19 or 3.20 above), this Note shall become immediately due and payable and the Borrower shall pay to the Holder, in full satisfaction of its obligations hereunder, an amount (the “Default Amount”) equal to the Principal Amount then outstanding plus accrued interest (including any Default Interest) through the date of full repayment plus an additional $25,000.00 per each calendar month that the Note has been in default until payment in full. Upon an uncured Event of Default, all amounts payable hereunder shall immediately become due and payable, all without demand, presentment or notice, all of which hereby are expressly waived by the Borrower, together with all costs, including, without limitation, legal fees and expenses, of collection, and the Holder shall be entitled to exercise all other rights and remedies available at law or in equity, including, without limitation, those set forth in Section 3.22 below.

 

3.22 Holder’s Right to Confession of Judgment. Upon the occurrence and during the continuation of any Event of Default, and in addition to any other right or remedy of the Holder hereunder, under the Purchase Agreement or otherwise at law or in equity, the Borrower hereby irrevocably authorizes and empowers Holder or its legal counsel, each as the Borrower’s attorney-in-fact, to appear ex parte and without notice to the Borrower to confess judgment against the Borrower for the unpaid amount of this Note as evidenced by the Affidavit of Confession of Judgment signed by the Borrower as of the Issue Date and to be completed by the Holder or its counsel pursuant to the foregoing power of attorney (which power is coupled with an interest), a copy of which is attached as Exhibit A hereto (the “Affidavit”). The Affidavit shall set forth the amount then due hereunder, plus attorney’s fees and cost of suit, and to release all errors, and waive all rights of appeal. The Borrower waives the right to contest Holder’s rights under this Section 3.22, including without limitation the right to any stay of execution and the benefit of all exemption laws now or hereafter in effect. No single exercise of the foregoing right and power to confess judgment will be deemed to exhaust such power, whether or not any such exercise shall be held by any court to be invalid, voidable, or void, and such power shall continue undiminished and may be exercised from time to time as the Holder may elect until all amounts owing on this Note have been paid in full.

 

3.23 Failure to Issue. If the Borrower fails to issue the Commitment Shares (as defined in the Purchase Agreement), Warrant (as defined in the Purchase Agreement), or Warrant Shares (as defined in the Purchase Agreement) within the required timeframe as provided therein.

 

ARTICLE IV. MISCELLANEOUS

 

4.1 Failure or Indulgence Not Waiver. No failure or delay on the part of the Holder in the exercise of any power, right or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such power, right or privilege preclude other or further exercise thereof or of any other right, power or privileges. All rights and remedies of the Holder existing hereunder are cumulative to, and not exclusive of, any rights or remedies otherwise available.

 

6

 

 

4.2 Notices. All notices, demands, requests, consents, approvals, and other communications required or permitted hereunder shall be in writing and, unless otherwise specified herein, shall be (i) personally served, (ii) deposited in the mail, registered or certified, return receipt requested, postage prepaid, (iii) delivered by reputable air courier service with charges prepaid, or (iv) transmitted by hand delivery, telegram, e-mail or facsimile, addressed as set forth below or to such other address as such party shall have specified most recently by written notice. Any notice or other communication required or permitted to be given hereunder shall be deemed effective (a) upon hand delivery or delivery by e-mail or facsimile, with accurate confirmation generated by the transmitting facsimile machine, at the address or number designated below (if delivered on a business day during normal business hours where such notice is to be received), or the first business day following such delivery (if delivered other than on a business day during normal business hours where such notice is to be received) or (b) on the second business day following the date of mailing by express courier service, fully prepaid, addressed to such address, or upon actual receipt of such mailing, whichever shall first occur. The addresses for such communications shall be:

 

If to the Borrower, to:

 

ADIAL PHARMACEUTICALS, LLC

204 E. High Street

Charlottesville, VA 22902

Attention: William Stilley

e-mail: wstilley@adialpharma.com

 

With a copy by e-mail only to (which copy shall not constitute notice):

 

GRACIN & MARLOW, LLP

405 Lexington Avenue

26th Floor

New York, New York 10174

Attn: Leslie Marlow, Esq.

e-mail: lmarlow@gracinmarlow.com

 

If to the Holder:

 

FIRSTFIRE GLOBAL OPPORTUNITIES FUND LLC

1040 First Avenue, Suite 190

New York, NY 10022

Attention: Eli Fireman

e-mail: eli@firstfirecapital.com

 

With a copy by e-mail only to (which copy shall not constitute notice):

 

LEGAL & COMPLIANCE, LLC

330 Clematis Street, Suite 217

West Palm Beach, FL 33401

Attn: Chad Friend, Esq., LL.M.

e-mail: CFriend@LegalandCompliance.com

 

4.3 Amendments. This Note and any provision hereof may only be amended by an instrument in writing signed by the Borrower and the Holder. The term “Note” and all reference thereto, as used throughout this instrument, shall mean this instrument as originally executed, or if later amended or supplemented, then as so amended or supplemented.

 

4.4 Assignability. This Note shall be binding upon the Borrower and its successors and assigns, and shall inure to be the benefit of the Holder and its successors and assigns. Each transferee of this Note must be an “Accredited Investor” (as defined in the Purchase Agreement).

 

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4.5 Cost of Collection. If default is made in the payment of this Note, the Borrower shall pay the Holder hereof costs of collection, including reasonable attorneys’ fees.

 

4.6 Governing Law; Venue; Attorney’s Fees. This Note shall be governed by and construed in accordance with the laws of the State of New York without regard to principles of conflicts of laws. Any action brought by either party against the other concerning the transactions contemplated by this Note or any other agreement, certificate, instrument or document contemplated hereby shall be brought only in the state courts of New York or in the federal courts located in the state and county of New York. The Borrower hereby irrevocably waives any objection to jurisdiction and venue of any action instituted hereunder and shall not assert any defense based on lack of jurisdiction or venue or based upon forum non conveniens. THE BORROWER HEREBY IRREVOCABLY WAIVES ANY RIGHT IT MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION WITH OR ARISING OUT OF THIS NOTE OR ANY TRANSACTIONS CONTEMPLATED HEREBY. Each party hereby irrevocably waives personal service of process and consents to process being served in any suit, action or proceeding in connection with this Note or any other agreement, certificate, instrument or document contemplated hereby or thereby by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Note and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. The prevailing party in any action or dispute brought in connection with this the Note or any other agreement, certificate, instrument or document contemplated hereby or thereby shall be entitled to recover from the other party its reasonable attorney’s fees and costs.

 

4.7 Certain Amounts. Whenever pursuant to this Note the Borrower is required to pay an amount in excess of the outstanding Principal Amount (or the portion thereof required to be paid at that time) plus accrued and unpaid interest plus Default Interest on such interest, the Borrower and the Holder agree that the actual damages to the Holder from the receipt of cash payment on this Note may be difficult to determine and the amount to be so paid by the Borrower represents stipulated damages and not a penalty and is intended to compensate the Holder in part for its loss. The Borrower and the Holder hereby agree that such amount of stipulated damages is not plainly disproportionate to the possible loss to the Holder.

 

4.8 Purchase Agreement. The Company and the Holder shall be bound by the applicable terms of the Purchase Agreement and the documents entered into in connection herewith and therewith.

 

4.9 This section intentionally left blank.

 

4.10 Remedies. The Borrower acknowledges that a breach by it of its obligations hereunder will cause irreparable harm to the Holder, by vitiating the intent and purpose of the transaction contemplated hereby. Accordingly, the Borrower acknowledges that the remedy at law for a breach of its obligations under this Note will be inadequate and agrees, in the event of a breach or threatened breach by the Borrower of the provisions of this Note, that the Holder shall be entitled, in addition to all other available remedies at law or in equity, and in addition to the penalties assessable herein, to an injunction or injunctions restraining, preventing or curing any breach of this Note and to enforce specifically the terms and provisions thereof, without the necessity of showing economic loss and without any bond or other security being required.

 

4.11 Construction; Headings. This Note shall be deemed to be jointly drafted by the Company and all the Holder and shall not be construed against any person as the drafter hereof. The headings of this Note are for convenience of reference and shall not form part of, or affect the interpretation of, this Note.

 

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4.12 Usury. To the extent it may lawfully do so, the Company hereby agrees not to insist upon or plead or in any manner whatsoever claim, and will resist any and all efforts to be compelled to take the benefit or advantage of, usury laws wherever enacted, now or at any time hereafter in force, in connection with any action or proceeding that may be brought by the Holder in order to enforce any right or remedy under this Note. Notwithstanding any provision to the contrary contained in this Note, it is expressly agreed and provided that the total liability of the Company under this Note for payments which under New York law are in the nature of interest shall not exceed the maximum lawful rate authorized under applicable law (the “Maximum Rate”), and, without limiting the foregoing, in no event shall any rate of interest or default interest, or both of them, when aggregated with any other sums which under New York law in the nature of interest that the Company may be obligated to pay under this Note exceed such Maximum Rate. It is agreed that if the maximum contract rate of interest allowed by New York law and applicable to this Note is increased or decreased by statute or any official governmental action subsequent to the Issue Date, the new maximum contract rate of interest allowed by law will be the Maximum Rate applicable to this Note from the effective date thereof forward, unless such application is precluded by applicable law. If under any circumstances whatsoever, interest in excess of the Maximum Rate is paid by the Company to the Holder with respect to indebtedness evidenced by this the Note, such excess shall be applied by the Holder to the unpaid principal balance of any such indebtedness or be refunded to the Company, the manner of handling such excess to be at the Holder’s election.

 

4.13 Severability. In the event that any provision of this Note is invalid or unenforceable under any applicable statute or rule of law (including any judicial ruling), then such provision shall be deemed inoperative to the extent that it may conflict therewith and shall be deemed modified to conform with such statute or rule of law. Any such provision which may prove invalid or unenforceable under any law shall not affect the validity or enforceability of any other provision of this Note.

 

4.14 Most Favored Nation. While the Note or any principal amount, interest or fees or expenses due thereunder remain outstanding and unpaid, the Company shall not enter into any public or private offering of its securities (including securities convertible into shares of Common Stock) with any individual or entity (an “Other Investor”) that has the effect of establishing rights or otherwise benefiting such Other Investor in a manner more favorable in any material respect to such Other Investor than the rights and benefits established in favor of the Buyer by this Agreement or the Note unless, in any such case, the Buyer has been provided with written notice (the “Company Notice”) and no less than 10 days to exercise the right, but not the obligation, to exchange its rights and obligations hereunder (i.e. to the Securities) for the rights and obligations established with the Other Investor, except that Buyer shall retain a senior position to the Other Investor . In order to exercise such right, Buyer shall send the Company a written notice of its exercise (the “Buyer Notice”). If the Buyer Notice is not received by the Company within ten (10) days of Buyer’s receipt of the Company Notice, the rights under this Section 4.14 shall terminate only with respect to such offering of the Company’s securities as identified in the respective Company Notice, and not with respect to any future public or private offering by the Company of its securities (including securities convertible into shares of Common Stock).

 

4.15 Notwithstanding anything to the contrary contained herein, the reincorporation of Borrower in another state or the conversion of Borrower into a corporation or any other similar transaction intended to effectuate the change to an entity appropriate for an initial public offering shall have not trigger an adjustment or other action under this Note and shall not be an Event of Default, provided, however, that the resulting successor or acquiring entity (if not the Borrower) assumes by written instrument or operation by law the obligations of this Note.

 

[signature page follows]

 

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IN WITNESS WHEREOF, Borrower has caused this Note to be signed in its name by its duly authorized officer on May 1, 2017.

 

ADIAL PHARMACEUTICALS, LLC
     
By: /s/ William Stilley  
Name: William Stilley  
Title: Chief Executive Officer  

 

10

 

 

EXHIBIT A

 

Affidavit of Confession of Judgment

 

SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK    
  X  
FIRSTFIRE GLOBAL OPPORTUNITIES FUND, LLC,    
   

Index No.

 

Plaintiff,

 

   
    AFFIDAVIT OF
    CONFESSION OF
    JUDGMENT 
- against -

 

ADIAL PHARMACEUTICALS, LLC, 

   

Defendant.

  X  
   
     
STATE OF NEW YORK            )    
                                                     )          ss.:    
COUNTY OF NEW YORK        )    

 

William Stilley, being duly sworn, hereby deposes and says:

 

1. I am the Chief Executive Officer of defendant ADIAL PHARMACEUTICALS, LLC (“Borrower”). As such, I am fully familiar with all the facts and circumstances recited herein on personal knowledge. Borrower has its principal place of business at 204 E. High Street, Charlottesville, VA 22902. On behalf of the Borrower, I hereby confess judgment in favor of FirstFire Global Opportunities Fund, LLC (“FirstFire”), residing at 1040 First Avenue, Suite 190, New York, New York, 10022, in the amount of the Default Amount (as defined in the senior secured promissory note between of the parties, dated May 1, 2017 (the “Note”)), less any payments made on or after the date of this affidavit of confession of judgment, plus interest a default interest rate of fifteen percent (15%) percent per annum on said amount. In no event shall interest payable hereunder exceed the maximum permissible under applicable law.

 

 

 

2. I hereby authorize the Supreme Court of the State of New York to enter judgment against Borrower in the amount of in the amount of the Default Amount plus a default interest rate of fifteen percent (15%) per annum on said amount from the date of any default, plus the costs and attorneys’ fees that are set forth below, less any payments made on or after the date of this affidavit of confession of judgment, upon Borrower’s failure for any reason to timely make any payment to FirstFire called for by the Note, due to Borrower’s breach of Section 3.1 of the Note (failure to pay Principal or Interest) or due to Borrower’s breach of its obligations that it owes to FirstFire pursuant to Sections 3.2-3.20 of the Note.

 

3. In order to secure these obligations, Borrower agreed to simultaneously deliver with the execution of the Note this Affidavit of Confession of Judgment.

 

4. The sums confessed pursuant to this affidavit of confession of judgment are justly due and owing to FirstFire under the following circumstances: Borrower entered into the Note pursuant to which Borrower promised to pay to the order of FirstFire the Default Amount plus interest as provided for therein. The amounts confessed by this affidavit represent a convertible note investment by FirstFire in Borrower and arise out of Borrower’s breach of its obligations under the Note.

 

5. Borrower agrees to pay any and all costs and expenses incurred by FirstFire in enforcing the terms of this affidavit of confession of judgment, including reasonable attorneys’ fees and expenses at the rate of $475.00 per hour that FirstFire incurs or is billed for in connection with enforcing the terms of the affidavit of confession of judgment, entering any Judgment, collecting upon said Judgment, and defending or prosecuting any appeals.

 

 

 

  ADIAL PHARMACEUTICALS, LLC
     
  By:  /s/ William Stilley
  Name: William Stilley
  Title: Chief Executive Officer

 

 

 

STATE OF Virginia      )
   
  ss.:
   
COUNTY OF Albemarle      )

 

ACKNOWLEDGMENT

 

On April 29, 2017 before me personally came William Stilley, to me known, who, by me duly sworn, did depose and say that deponent is an officer of ADIAL PHARMACEUTICALS, LLC, the limited liability company described in, and which executed the foregoing affidavit of confession of judgment, that deponent knows the seal of the corporation, that the seal affixed to the affidavit of confession of judgment is the corporation’s seal, that it was affixed by order of the board of directors of the corporation and that deponent signed deponent’s name by like order.

 

/s/ Sarah Hipple  

Notary Public

 

SEAL: Sarah Hipple

Notary Republic

Commonwealth of Virginia

7383264

My Commission Expirers Sep 30, 2019

 

[Signature Page to Affidavit of Confession of Judgment]

 

 

 

 

EX-4.8 20 fs12017ex4-8_adialpharma.htm FORM OF MEMBERSHIP UNIT AWARD (PROFITS INTEREST) AGREEMENT

Exhibit 4.8

 

ADIAL PHARMACEUTICALS, L.L.C.

Membership Unit Award (Profits Interest) Agreement

 

“Recipient”: ___________________
“Date of Award”: ___________________
“Units”: ___________________
“Current Unit Valuation”: $__________________

 

This Membership Unit Award Agreement (this “Agreement”) is made as of the Date of Award set forth above, between ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (“Company”), and the Recipient named above, subject to the following terms and conditions:

 

1.         Award of Membership Units. In exchange for the services and other consideration set forth on Exhibit A attached hereto and incorporated herein (the “Services”), Company hereby awards to Recipient the number of the Company’s Membership Units set forth above (the “Units”), which shall have all voting, profits, losses and other interests afforded Membership Units of Company pursuant to the Operating Agreement of Company, as amended from time to time (the “Operating Agreement”). Such award is contingent upon Recipient’s execution and delivery of the Operating Agreement, which condition may be satisfied by Recipient executing and delivering the Member Signature Page attached hereto as Exhibit B. Nothing in this Agreement shall confer upon Recipient any right to continue providing the Services. The capital account balances for the Units will be held so that profits and losses allocations and/or other adjustments are made to maintain the differential to the capital accounts of membership units existing on the Date of Award based on the Current Unit Valuation set forth above.

 

2.         Units Subject to Right of Repurchase. The Units awarded hereby are subject to a Right of Repurchase by the Company as set forth and defined in Exhibit. A. In the event of repurchase of some or all of the Units, Recipient shall have no right to the benefit of any capital account associated with the repurchased Units, nor any profit or loss allocation in the year of repurchase; provided, however, nothing shall prohibit Company from allocating profits or losses to such Units prior to the date of repurchase.

 

3.         Non-Transferability During Restrictive Period. Notwithstanding anything set forth in the Operating Agreement, during the period when any of the Units are subject to forfeiture, Recipient shall not transfer to any person or entity any right, title or interest in or to the Units awarded hereunder, and, in the event such Units are represented by certificates, Company shall hold the certificates representing the Units in escrow until all risks of forfeiture lapse, whereupon, Company will deliver such certificate or certificates to Recipient free and clear of such restrictions unless the Units represented by such certificates have been previously forfeited to Company. When delivered to Recipient such Units and certificates, as applicable, will be validly issued, fully paid, and non-assessable and will be free of any liens of encumbrances other than the applicable transfer restriction set forth in the Operating Agreement.

 

4.         Investment Representation. Recipient hereby makes the representations warranties, and covenants set forth in the Membership Unit Recipient Investment Letter attached hereto and incorporated herein as Exhibit C.

 

  Page 1 of 7

 

 

5.       Binding Effect. Subject to the limitations stated above, this Agreement shall be binding upon and inure to the benefit of the legatees, distributees, and personal representatives of Recipient and the successors and assigns of Company. Recipient may not assign his or her rights or obligations under this Agreement, and any attempt by Recipient to do so shall be deemed a breach of this Agreement and shall be void and of no effect.

 

6.       Entire Agreement. This Agreement, along with the Exhibits attached hereto, constitutes the entire Agreement between the parties with respect to the subject matter hereof and supersedes all prior or contemporaneous, written or oral agreements or understandings with respect to the subject matter hereof. This Agreement may only be amended by a writing signed by the party to be charged.

 

7.       Governing Law. This Agreement shall be interpreted, governed, and enforced in accordance with the laws of Commonwealth of Virginia, notwithstanding its choice of law principles. The invalidity or unenforceability of any portion hereof shall in no way affect the validity or enforceability of any other portion of this Agreement, and any portion held to be invalid or unenforceable shall be deemed modified, restricted, or omitted to the extent necessary to make this Agreement enforceable.

 

8.       Legal Counsel. Recipient has reviewed the contents of this Agreement and fully understands its terms. Recipient acknowledges that he or she is fully aware of his or her right to the advice of counsel independent from that of Company, that the Company has advised Recipient of such right and disclosed to Recipient the risk in not seeking such independent advice, and that Recipient understands the potentially adverse interest of the parties with respect to this Agreement. Recipient further acknowledges that no representations have been made with respect to the income or state tax or other consequences of this Agreement to Recipient and that Recipient has been advised of the importance of seeking independent advice of counsel with respect to such consequences. RECIPIENT IS URGED TO CONSULT INDEPENDENT TAX ADVISERS WITH RESPECT TO THE FEDERAL AND STATE TAX CONSEQUENCES ARISING FROM THE AWARD AND OWNERSHIP OF UNITS OF COMPANY.

 

9.       Definitions. All capitalized terms not defined herein shall have the meanings ascribed to such terms in the Operating Agreement

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the Date of Award.

 

ADIAL PHARMACEUTICALS, L.L.C.     RECIPIENT:
     
By:      
  William B. Stilley, CEO    [NAME]

 

  Page 2 of 7

 

 

Exhibit A

 

SERVICES AND FORFEITURE PROVISIONS

 

1.       Services. Recipient shall serve as Vice President, Operations & Finance or such other position(s) as shall be designated by the Chief Executive Officer and shall perform such duties as may be reasonably requested of him or her from time to time by the Chief Executive Officer.

 

2.       “Right of Repurchase”. The Units shall be subject to a right of repurchase by the Company as set forth below.

 

(a)The Right of Repurchase shall lapse according to the following schedule: _____________th of are fully released from the Right of Repurchase immediately and the remainder of the Units shall become fully released from the Right of Repurchase at the rate of 1/30th of such Units per month commencing on the Date of Award, such that all of the Units shall be released from the Right of Repurchase on _____________.
(b)Notwithstanding the above, the Right of Repurchase shall immediately lapse as to 100% of the Units upon the occurrence of a Material Transaction or upon a liquidation or dissolution of the Company. “Material Transaction” means the occurrence of any of the following: (A) any transaction or series of related transactions by the Company or its equity holders in which a majority of the Company’s voting power is transferred to one or more persons or entities who were not equity holders of the Company prior to such transaction or series of transactions; (B) any merger or consolidation of the Company with or into any other entity, after which the Members of the Company do not hold, either directly or indirectly, a majority of the voting equity of the surviving entity; (C) the sale, conveyance, exclusive license or other disposition of a material portion of the business and/or assets of the Company to a non-affiliated entity (it being agreed, by way of illustration and not limitation, that the sale, conveyance, exclusive license or other disposition of the Company’s drug candidate currently designated as AD/04 to a non-affiliated entity shall constitute a Material Transaction); or (D) any transaction, or series of transactions, the effect of which is substantially the same as the effect of the transactions contemplated under subsections (A), (B), and (C) of this Section 2(b).
(c)If Recipient’s employment to perform the Services is terminated for any reason prior to the expiration of the Right of Repurchase, the Company shall have the right to repurchase such of the Units as are subject to the Right of Repurchase as of the date of termination for a price of one-thousandth of one dollar ($0.001) per Unit for such Units to be repurchased, which Right of Repurchase shall be automatically exercised by the Company without notice and the repurchase price paid within thirty (30) of written request for payment by Recipient.

 

 

  Initials _____/______

 

  Page 3 of 7

 

 

Exhibit B

 

ADIAL PHARMACEUTICALS, L.L.C. OPERATING AGREEMENT

MEMBER SIGNATURE PAGE

 

In consideration for the sale of Membership Units in ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “Company”), by the Company to the undersigned, the undersigned hereby approves and consents to, and agrees to be bound by, the terms of that certain Second Amended & Restated Operating Agreement of the Company dated as of February 3, 2014, as amended (the “Operating Agreement”), and concurrently herewith enters into the Operating Agreement with all existing members of the Company by executing and delivering to the Company this Member Signature Page.

 

Upon the undersigned’s execution and delivery of this Signature Page, the undersigned’s delivery of all monies and other items required by management of the Company, and acceptance of this Member Signature Page by the Company, the undersigned shall become a Member of the Company.

 

If the undersigned is purchasing Membership Units jointly with another, all such joint owners must execute this Member Signature Page.

 

Date: _____________

 

By:    
  [NAME]  

 

MAILING ADDRESS:

 

  _____________  
  _____________  

 

Accepted on behalf of ADial Pharmaceuticals, L.L.C.

 

By:    
  William B. Stilley  
  CEO  

 

  Page 4 of 7

 

 

Exhibit C

 

Membership Unit Recipient Investment Letter

 

[DATE]

 

ADial Pharmaceuticals, L.L.C.

204 E. High St.

Charlottesville, VA 22902

 

Attention: William Stilley, CEO

 

Dear _____________:

 

This letter will confirm my acceptance of Membership Units (“Units”) of, and accordingly, a profits interest in ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “Company”), pursuant and subject to the terms and conditions of a certain Membership Unit Award Agreement (the “Award Agreement”), and subject to the Company’s right to repurchase the Units thereunder.

 

Unless otherwise defined herein, capitalized terms used herein shall have the same meanings ascribed to them in the Company’s Operating Agreement of February 3, 2014 (as hereafter amended from time to time, the “Operating Agreement”), a copy of which I acknowledge receiving.

 

In connection with my acquisition of Units in the Company, I represent and warrant the following:

 

(1)       I have sufficient knowledge and experience in financial and business matters to be capable of evaluating the merits and risks of this investment and understand and acknowledge that my rights and privileges with respect to the Units, including, without limitation, any rights to transfer the Units, are all subject to the provisions of the Articles of Organization and the Operating Agreement of the Company, as the same may be amended from time to time.

 

(2)       I understand that this investment involves a high degree of risk because the Company has a limited operating history and that there is no guarantee of profitability or continued operation of the Company.

 

(3)       I am acquiring the Units pursuant to the terms of a written contract relating to my compensation, and I am able to bear the economic risk of this investment. I acknowledge that I might have to hold the Units for an indefinite period of time, since the Units have not been registered, and I might have to bear a complete economic loss, in the event that the business does not succeed.

 

  Page 5 of 7

 

 

(4)       In making my decision to acquire Units of the Company, I have relied upon independent investigations made by me. I have taken the opportunity to examine any and all documents and, to the extent I have deemed necessary, to ask pertinent questions and receive answers, concerning the terms and conditions of my acquisition of such Units or any other matter pertaining to such investment, and to obtain any additional information necessary to verify the accuracy of the information given to me.

 

(5)       I understand that the Units will not be registered under the Securities Act of 1933, as amended (the “Act”), and that the Units that I acquire cannot be sold to any person except pursuant to the terms of the Operating Agreement.

 

(6)       I am acquiring the Units for my own investment account and have no intention, agreement or arrangement to redistribute, divide, assign, transfer the Units or to sell it to any other person.

 

(7)       I have reviewed with my own tax advisors the immediate and prospective federal, state, local and foreign tax consequences of this investment, and I am relying solely on the statements of such advisors and not on the statements or representations of the Company or any of its agents with respect to such tax consequences or any other matter. I have not relied on any advice given by the Company’s legal counsel.

 

(8)       I have adequate net worth and means of providing for my current and future needs and possible contingencies and have no need for liquidity in this investment. My commitment to investments that are not readily marketable is not disproportionate to my net worth and my investment in the Units covered by this letter and will not cause my overall commitment to become excessive.

 

(9)       I understand that under Section 83 of the Internal Revenue Code of 1986, as amended (the “Code”), the difference between the price paid for the Units and the fair market value on the date that a risk of forfeiture lapses (as set forth in the Award Agreement) may be reportable as ordinary income at that time. I understand that I may elect to be taxed at the time the Units are acquired hereunder to the extent the fair market of the Units differs from the price paid rather than when and as such Units cease to be subject to risks of forfeiture, by filing an election under Section 83(b) of the Code with the IRS within thirty (30) days after the date of acquisition hereunder. If the fair market value of the Units at the date of purchase equals the price paid (and thus no tax is payable), the election should be made to avoid adverse tax consequences in the future. The form for making this election is attached hereto. I understand that failure to make this filing within the thirty (30) day period may result in the recognition of ordinary income by me as the risks of forfeiture lapse. I ACKNOWLEDGE THAT IT IS MY SOLE RESPONSIBILITY, and not THE Company’s to file a timely election under Section 83(b), even if I request THE Company to make this filing on my behalf. I am relying solely on my advisors with respect to the decision as to whether or not to file an 83(b) election.

 

(10)      The foregoing representations and warranties shall survive my acquisition of the Units in the Company, and I agree to indemnify and hold harmless the Company and its directors, officers, agents and representatives, for and from any and all losses, liabilities, claims, damages and expenses, including, without limitation, attorney fees and dispute costs, caused by my breach of any agreement, representation or warranty contained herein or as a result of the reliance of the Company or any other indemnities on such agreement, representation or warranty.

 

  Sincerely,
   
   
  [NAME]

 

  Page 6 of 7

 

 

Form 83(b) Election

 

This statement is being made under Section 83(b) of the Internal Revenue Code, pursuant to Treasury Regulation Section 1.83-2.

 

(1)       The person who performed the services (“Recipient”) is:

 

  Name:  _____________
     
  Address:  _____________
   _____________
     

 

  Taxpayer Identification No.:   _____________

 

(2)       The property with respect to which the election is being made is _____________ Class A Membership Units (Profits Interest) in ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (“Issuer”).

 

(3)       The property was transferred on _____________. The tax year of Recipient for which this election is made is calendar year _____________.

 

(4)       The property is subject to risks of forfeiture, the last of which expires on _____________.

 

(5)       The fair market value of the property at the time of transfer (determined without regard to any restriction other than a restriction which by its terms will never lapse) is $0.00 per unit for a total of $0.00.

 

(6)       The amount paid for such property is $0.00

 

(7)       A copy of this statement was furnished to Issuer, for whom Recipient will render the service or payment underlying the transfer of property.

 

(8)       This statement is executed as of _____________.

 

   
  [NAME]

 

 

Page 7 of 7

 

EX-4.9 21 fs12017ex4-9_adialpharma.htm OPTION AGREEMENT

Exhibit 4.9

 

ADial Pharmaceuticals, LLC

Option Agreement

  

Recipient: Tony Goodman (“Recipient”)
Effective Date: July 1, 2017 (“Effective Date”)
Option for: 60,000 Class A Units (the “Units”)
Exercise Price: $1.06 per Unit (“Exercise Price”)
Expiration Date: June 30, 2027 (“Expiration Date”)

 

THIS OPTION AGREEMENT (this “Agreement”) is made and entered into effective as the Effective Date by and between ADial Pharmaceuticals, LLC, a limited liability company organized under the laws of the Commonwealth of Virginia (the "Company"), and Recipient. Any and all other Option Agreements, if any, issued to Recipient and effective on or before the Effective Date are hereby canceled and of no further effect whatsoever.

 

All capitalized terms used herein shall have the same meaning that they have in the Company’s Second Amended and Restated Operating Agreement dated February 3, 2014 (the “Operating Agreement”), unless otherwise indicated or unless the context otherwise requires. As used herein, the terms “employ”, “employed”, “employment” refer to and mean the obligation to provide services to the Company or the holding of office in the Company as a director, officer, employee or consultant, as applicable. For clarity, if Recipient is a non-employee director, a non-employee officer or a consultant, use of these terms herein does not confer or imply an employee relationship between the Company and Recipient as that term is used in the context of labor applications.

  

WITNESSETH:

 

WHEREAS the Company desires to give its directors, officers, employees and consultants an added incentive to promote the growth of the Company through the participation in the equity of the Company;

 

WHEREAS, the Company desires to grant to Recipient an option to purchase the Units, on the terms and conditions hereinafter set forth;

 

NOW, THEREFORE, for and in consideration of the premises and the mutual agreements and covenants hereinafter set forth and of other good and valuable consideration, the receipt, adequacy and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

1.             GRANT OF OPTION. Subject to the terms and conditions of this Agreement, including the vesting provisions of Section 3 below, the Company hereby grants to Recipient the right and option (the "Option") to purchase the Units, subject to the terms herein, including, without limitation, the vesting provisions set forth in Section 3 herein.

 

 

 

 

The Units which are subject to the Option are sometimes referred to herein as the “Option Units.”

 

2.             OPTION.

 

(a)       Option Price. The price to purchase each Option Unit shall be the Exercise Price.

 

(b)       Exercise of Option. Subject to subparagraph (f) hereof, Recipient may exercise this Option with respect to all or any portion of his vested Option Units at any time prior to the Expiration Date.

 

(c)       Manner of Exercise. This Option may be exercised by delivering written notice of exercise in the form of the Exercise Letter, a form of which is at Exhibit A, paying the purchase price set forth herein, and by delivering a completed Member Signature Page, a form of which is attached as Exhibit B, binding Recipient into the Operating Agreement to the Chief Executive Officer of the Company, in person, or by mail, postage prepaid, addressed to the attention of the Chief Executive Officer at the location at which the Company then maintains its principal office, and if so mailed, the date of mailing will be considered the date of exercise.

 

(d)       Person Who May Exercise Option. During the lifetime of Recipient, this Option shall be exercisable only by Recipient, or if Recipient is disabled, by his duly appointed guardian or legal representative.

 

(e)       Operating Agreement. In accordance with the Company’s Operating Agreement, all Units of the Company are subject to certain restrictions. Upon the exercise of an Option, Recipient (or his or her guardian, legal representative or personal representative, as applicable) agrees to execute and be bound by the terms and conditions of such Operating Agreement, as a precondition of being issued any Units.

 

(f)       Termination of Option. Notwithstanding any other provisions to the contrary, this Option, to the extent that it has not previously been exercised or that Recipient’s employment has been terminated for any reason, including termination by resignation or by reason of death or disability, prior to vesting (which will terminate this Option), will terminate upon the Expiration Date hereof.

 

3.             VESTING. The Option granted hereunder will vest monthly in equal 1/36th increments during the three years from the date of this agreement and while Recipient is a Director of the Company so that on the 1st day of the first month after the Effective Date (i.e. August 1, 2017), the Option may only be exercised in relation to 1/36th of the Units, after the 2nd month the Option may only be exercised in relation to 2/36th of the Units, and so forth so that all Units subject to the Option will be fully vested on July 1 of the third year. In the event of a Liquidity Event (defined below), the Option shall fully vest simultaneously with such Liquidity Event unless such Liquidity Event is as part of an Adjusting Event (defined in Section 5 below) with the intent of facilitating a public offering of securities of the Company. For purposes of this Agreement a “Liquidity Event” means (i) any transaction or series of related transactions by the Company or its equity holders in which a majority of the voting power of the members is transferred to one or more persons who were not previously equity holders of the Company, (ii) any merger or consolidation of the Company with or into any other entity, after which the members of the Company do not hold, either directly or indirectly, a majority of the voting equity of the surviving entity, or (iii) a sale of all or substantially all of the operating assets of the Company.

 

 2 

 

 

4.             TRANSFERABILITY. This Agreement and any rights hereunder shall be nontransferable and nonassignable by Recipient, except that it may be transferred in the event of Recipient’s death to Recipient’s heirs.

 

5.             ADJUSTMENT OF UNITS. In the event of any recapitalization, reclassification, split-up or consolidation of, or other change in, the Units, or an exchange of the outstanding Units of the Company, in connection with a merger, consolidation, reincorporation or other reorganization of the Company for a different number of Units or for shares of stock or other securities of the Company or for Units or other securities of the other company (an “Adjusting Event”), then the Board of Directors shall, in such manner as they shall determine in their sole discretion, appropriately adjust the number of the Option Units or the number of Units or other securities that shall then be subject to this Option and/or the Exercise Price per Unit or share that must be paid thereafter upon exercise of this Option and may, in such manner as they shall determine in their sole discretion, modify this agreement to take into account the new structure and entity, including, without limitation, potentially binding the Option under an option plan as then approved or placing restrictions on the sale and/or registration of securities acquired under this Agreement.

 

6.             INVESTMENT REPRESENTATION. Recipient hereby represents, warrants and agrees that:

 

(a)       He understands the offer of Units under this Agreement is made pursuant to a claim of exemption from the registration provisions of the Securities Act of 1933, as amended (the “Act”) and applicable state securities law;

 

(b)       The Company is not obligated to issue Units upon exercise of this Option until there has been compliance with any Federal or state laws or regulations that the Company may deem applicable;

 

(c)       The Option Units will be purchased for his own account for investment purposes only and not with a view to resale or distribution thereof;

 

(d)       The Option Units may be unregistered and, if so, will be required to be held indefinitely, unless such Units are subsequently registered or an exemption from registration is then available; and

 

(e)       The Company is under no obligation to register the Option Units, to comply with any such exemption or to supply Recipient with any information necessary to enable him to make routine sales of such Units under Rule 144 or any other rule or regulation of the Securities and Exchange Commission.

 

7.             NO RIGHTS AS MEMBER OR TO EMPLOYMENT. The Recipient shall not have any interest in or membership rights with respect to any Units that are subject to this Option until such Units have been issued and delivered to Recipient pursuant to the exercise of this Option. Furthermore, this Option does not confer upon Recipient any rights of employment with the Company, including without limitation any right to continue in the employ of the Company, nor does it affect the right of the Company to terminate the services provided by Recipient as a Director of the Company at any time, with or without cause, or to continue or alter the terms of such services.

 

 3 

 

 

8.             DRAG-ALONG PROVISIONS. The Company shall have the right, but not the obligation, to “call”, effective immediately prior to a Liquidity Event (defined below), any and all unexercised portions of the Option, as fully vested in accordance with Section 3 above, and to issue, subject to all terms and conditions of the Operating Agreement, to Recipient such Units to which Recipient would be entitled upon Recipient’s exercise of the fully vested Option. Upon the Company’s exercise of such call right, the Exercise Price under this Agreement for such Units shall be immediately due and payable to the Company, and the Company shall be entitled (i) to deduct such price from any amounts due to Recipient or (ii) to effect a redemption of such number of Units at fair market value (reasonably determined in the discretion of the Board of Directors) as shall be necessary to pay such purchase price. Notwithstanding any other provision of this Agreement, the purchase price of Units issued upon exercise of the Company’s call right shall be no greater than the fair market value of such Units. The Recipient agrees to execute such documentation as is reasonably requested to document the issuance of Units to Recipient, including, but not limited to, the Operating Agreement then in effect.

 

9.             WITHHOLDING TAXES. As a condition of exercise of this Option, the Company may, in its sole discretion, withhold or require Recipient to pay or reimburse the Company for any taxes which the Company determines are required to be withheld in connection with the grant or any exercise of this Option. The Recipient understands that the Option granted hereunder does not qualify for favorable tax treatment under Section 422 of the Internal Revenue Code as an “incentive stock option.”

 

10.           HEIRS AND SUCCESSORS. This Agreement and all terms and conditions hereof shall be binding upon the Company and its successors and assigns, and upon Recipient and his or her heirs, legatees and legal representatives.

 

11.           GOVERNING LAW. This Agreement shall be interpreted, governed, and enforced in accordance with the laws of the Commonwealth of Virginia, notwithstanding its choice of law principles. The invalidity or unenforceability of any portion hereof shall in no way affect the validity or enforceability of any other portion of this Agreement, and any portion held to be invalid or unenforceable shall be deemed modified, restricted, or omitted to the extent necessary to make this Agreement enforceable.

 

IN WITNESS WHEREOF, the Company has caused this Agreement to be executed by its duly authorized representative and Recipient has executed this Agreement, all as of the date and year first above written.

 

ADial Pharmaceuticals, LLC   Recipient
     
By: /s/ William B. Stilley   By: /s/ Tony Goodman
  William B. Stilley, CEO     Tony Goodman

  

 4 

 

 

Exhibit A

 

Option Exercise Letter

  

_____________, 20__

  

ADial Pharmaceuticals, L.L.C.

204 E. High St.

Charlottesville, VA 22902

Attention: CEO

 

Gentlemen:

 

In connection with my purchase of ______________ membership units (the “Units”) of ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “Company”) pursuant and subject to the terms and conditions of the option agreement between me and the Company dated __________________, (the “Option Agreement”) and the Company’s Operating Agreement of __________________, as amended (the “Operating Agreement”), I am delivering this investment letter. Unless otherwise defined herein, capitalized terms used in this investment letter shall have the same meanings ascribed to them in the Operating Agreement.

 

In connection with my acquisition of Units in the Company, I represent and warrant the following:

 

(1)       I understand that by virtue of this investment, I will have acquired a Membership Interest in the Company. Furthermore, I acknowledge that I have received a copy of the Operating Agreement and agree to be bound by the terms and conditions therein.

 

(2)       I have sufficient knowledge and experience in financial and business matters to be capable of evaluating the merits and risks of this investment and understand and acknowledge that my rights and privileges with respect to the Units, including, without limitation, any rights to transfer the Units, are all subject to the provisions of the Articles of Organization and the Operating Agreement of the Company, as the same may be amended from time to time.

 

(3)       I understand that this investment involves a high degree of risk because the Company has a limited operating history and that there is no guarantee of profitability or continued operation of the Company.

 

(4)       I am acquiring the Units pursuant to the terms of the Option Agreement entered into in connection with my serving as a Director of the Company. I acknowledge that I am able to bear the economic risk of this investment, and that I might have to hold the Units for an indefinite period of time, since the Units have not been registered. Furthermore, I acknowledge that I might have to bear a complete economic loss, in the event that the business does not succeed.

 

(5)       In making my decision to acquire Units of the Company, I have relied upon independent investigations made by me. I have taken the opportunity to examine any and all documents and, to the extent I have deemed necessary, to ask pertinent questions and receive answers, concerning the terms and conditions of my acquisition of such Units or any other matter pertaining to such investment, and to obtain any additional information necessary to verify the accuracy of the information given to me.

  

 5 

 

 

Exhibit A

 

(6)       I understand that the Units will not be registered under the Securities Act of 1933, as amended (the “Act”), and that the Units that I acquire cannot be sold to any person except pursuant to the terms of the Operating Agreement and in full compliance with all applicable federal and state securities laws.

 

(7)       I understand that no federal or state agency has passed upon the Units or made any finding or determination concerning the fairness of this investment.

 

(8)       I am acquiring the Units for my own investment account and have no intention, agreement or arrangement to redistribute, divide, assign or transfer the Units or to sell them to any other person.

 

(9)       I have reviewed with my own tax advisors the immediate and prospective federal, state, local and foreign tax consequences of this investment, and I am relying solely on the statements of such advisors and not on the statements or representations of the Company or any of its agents with respect to such tax consequences or any other matter. I have not relied on any advice given by the Company’s legal counsel.

 

(10)       I have adequate net worth and means of providing for my current and future needs and possible contingencies and have no need for liquidity in this investment. My commitment to investments that are not readily marketable is not disproportionate to my net worth and my investment in the Units covered by this letter and will not cause my overall commitment to become excessive.

 

(11)       The foregoing representations and warranties shall survive my acquisition of the Units in the Company, and I agree to indemnify and hold harmless the Company and its directors, officers, agents and representatives, for and from any and all losses, liabilities, claims, damages and expenses, including, without limitation, attorneys fees and dispute costs, caused by my breach of any agreement, representation or warranty contained herein or as a result of the reliance of the Company or any other indemnities on such agreement, representation or warranty.

 

  Sincerely,
   
   
  Signature:  
   
  Printed Name:  

 

 6 

 

 

Exhibit B

 

ADIAL PHARMACEUTICALS, L.L.C.

MEMBER SIGNATURE PAGE

 

In consideration for the sale of LLC Units in ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “LLC”), by the LLC to the undersigned, the undersigned hereby approves and consents to, and agrees to be bound by, the terms of that certain operating agreement of the ADial Pharmaceuticals, L.L.C. effective _________________, as may be amended and/or restated from time to time (the “Operating Agreement”) and concurrently herewith enters into the Operating Agreement with all existing members of the LLC by executing and delivering to the LLC this Member Signature Page.

 

Upon the undersigned’s execution and delivery of this Member Signature Page, the undersigned’s delivery of all monies and/or other items required by management of the LLC, and acceptance of this Member Signature Page by the LLC, the undersigned shall become a Member of the LLC.

 

If the undersigned is purchasing LLC Units jointly with another, all such joint owners must execute this Member Signature Page.

 

Effective Date: ________________, 2017.

  

Member Name:

 

______________________________________

 

Signed:________________________________

Print: _________________________________

Title (if required): ________________________

 

____________________________________

Fed. Tax ID/Social Security Number

 

Address:

 ____________________________________

 ____________________________________

 ____________________________________

 

Email Address:

 

___________________________________

Co-Member Name (if applicable):

 

______________________________________

 

Signed: ________________________________

Print: __________________________________

Title (if required): _________________________

 

____________________________________

Fed. Tax ID/Social Security Number

 

Address:

 ______________________________________

 ______________________________________

 ______________________________________

Email Address:

 

 ______________________________________

 

  Accepted on behalf of ADial Pharmaceuticals, L.L.C.
     
  By:
    William B. Stilley
    CEO

 

 

7

 

EX-4.10 22 fs12017ex4-10_adialpharma.htm PERFORMANCE BONUS PLAN

Exhibit 4.10

 

CONFIDENTIAL

 

Performance Bonus Plan

Dated April 15, 2017

 

The Company hereby modifies the bonus plan (the “Plan”) as described herein.

 

Purpose:

 

To provide incentive for Company personnel and motivate Company personnel to achieve the goals of the Company, which are to bring in the resources to develop AD04 or create a liquidity event for the Company through a Transaction (defined below). The purpose includes, without limitation, to create motivation to position the Company to achieve future Transactions and Transactions that have the possibility of contingent future payments.

 

Definition:

 

A “Transaction” is defined as one or more transactions (A) that enable clinical development of AD04 by either (i) bringing in sufficient funds to the Company to enable it to proceed toward conducting such clinical development or (ii) partnering with or selling to a third party that will enable proceeding toward conducting such clinical development; or (B) that provided liquidity for the members of the Company. For clarity, financings that provide funds to sustain Company operations, but do not provide sufficient resources to proceed with clinical development are not considered a Transaction.

 

Bonus Pool:

 

A bonus pool (the “Pool”) will be created as follows:

 

5.25% of funds received related to any Transaction will be set aside as the Pool for payment as bonuses.

 

Once a total of $771,750 has been paid in bonuses under the Plan (i.e. $14,700 million has been received from Transactions), no more bonuses will be paid and the Plan will terminate.

 

Bonuses under the Plan will be awarded from the Pool at the discretion of the CEO subject to the following:

 

1.23.8% of the Pool will be awarded to Bankole Johnson (i.e. 1.25% of funds received related to any Transaction).

 

2.No more than 60% of the Pool may be awarded to the CEO.

 

3.Subject to the above, the award percentages will be determined by the CEO at the time of any Transaction and will carry forward if any funds related to Transaction (including follow-on Transactions deriving from an original Transaction) are received in the future, even if the personnel have left the Company at the time of actual receipt of the funds (i.e. they will be “residuals” due the personnel).

 

4.There will be a 12 month “tail” for transactions for the current CEO if he is terminated without cause (defined as gross negligence or material willful misconduct) by the Company equal to 60% of the Pool for transactions in first 6 months following termination and equal to 30% of the Pool for transactions that occur 7-12 months out from termination.

 

5.There will be a 12 month “tail” for transactions for Bankole Johnson if he is terminated as chairman without cause (defined as a pattern of severe gross negligence or material willful misconduct) by the Company equal to 23.8% of the Pool for transactions in first 6 months following termination and equal to 11.9% of the Pool for transactions that occur 7-12 months out from termination.

 

It is understood that the Plan is being approved as part of the contract with current Company personnel in order to retain them and may not be adversely modified without the permission of any affected persons.

 

The term “funds” herein includes cash and non-cash consideration of any kind, with any award hereunder awarded in-kind.

 

Notwithstanding the above, in the event the Company completes an initial public offering of its stock for trading on a public stock exchange, then the Company may, at its option, pay amounts due under this PBP by awarding stock having a total value equal to the amount due with such stock valued on a per share basis at the price of such offering. However, if such award of stock will be a taxable transaction, then at least 35% of the amount due hereunder will be paid in cash and 65% may be paid by awarding stock as stated in the preceding sentence.

EX-4.11 23 fs12017ex4-11_adialpharma.htm FORM OF 2017 EQUITY INCENTIVE PLAN

Exhibit 4.11

 

FORM OF

ADIAL PHARMACEUTICALS, INC.

2017 EQUITY INCENTIVE PLAN

 

Adopted by the Board of Directors: [  ], 2017

Approved by the Stockholders: [  ], 2017

IPO Date: _________

 

1.  Establishment and Purpose.

 

The purpose of the Adial Pharmaceuticals, Inc. 2017 Equity Incentive Plan (the “Plan”) is to promote the interests of Adial Pharmaceuticals, Inc. (the “Company”) and the stockholders of the Company by providing officers, directors, employees and consultants of the Company with appropriate incentives and rewards to encourage them to enter into and continue in the employ or service of the Company, to acquire a proprietary interest in the long-term success of the Company and to reward the performance of individuals in fulfilling long-term corporate objectives.

 

2.  Definitions. For purposes of the Plan, the following terms shall be defined as set forth below.

 

  (a) Administrator” means the Board of Directors or a Committee appointed by the Board of Directors that will be administering the Plan, in accordance with Section 3 hereof.

 

  (b) Agreement” shall mean the written agreement between the Company and a Participant evidencing an Award.

 

  (c) Annual Incentive Award” shall mean an Award described in Section 6(g) hereof that is based upon a period of one year or less.

 

  (d) Award” shall mean any Option, Restricted Stock, Stock Bonus award, Stock Appreciation Right, Performance Award, Other Cash-Based Award or Other Stock-Based Award granted pursuant to the terms of the Plan.

 

  (e) Award Agreement” shall mean either (i) a written or electronic agreement entered into between the Company and a Participant setting forth the terms and conditions of an Award including any amendment or modification thereof; or (ii) a written or electronic statement issued by the Company to a Participant describing the terms and provisions of such Award, including any amendment or modification thereof. The Administrator may provide for the use of electronic, internet or other non-paper Award Agreements, and the use of electronic, internet or other non-paper means for the acceptance thereof and actions thereunder by a Participant. Each Award Agreement shall be subject to the terms and conditions of the Plan and need not be identical.

 

  (f) Beneficiary” and “Beneficiaries” means the person, persons, trust or trusts which have been designated by a Participant in his or her most recent written beneficiary designation submitted to the Administrator to receive the benefits specified under the Plan upon such Participant’s death or, if there is no designated Beneficiary or surviving designated Beneficiary, then the person, persons, trust or trusts entitled by will or the laws of descent and distribution to receive such benefits.

 

  (g) Board of Directors” shall mean the Board of Directors of the Company.

 

  (h) Capital Stock” means each and every class (if more than one) of common stock of the Company, regardless of the number of votes per share.

 

     
 1 

 

 

  (i) Cause” shall mean a termination of a Participant’s employment by the Company or any of its Subsidiaries due to (i) the continued failure, after written notice, by such Participant substantially to perform his or her duties with the Company or any of its Subsidiaries (other than any such failure resulting from incapacity due to reasonably documented physical illness or injury or mental illness); (ii) the Participant’s indictment or conviction of, or entering a plea of guilty or nolo contendere to, a crime constituting a felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any state thereof; or (iii) the material breach by the Participant of any agreement between such Participant, on the one hand, and the Company, on the other hand. Notwithstanding the above, with respect to any Participant who is a party to an employment agreement with the Company, Cause shall have the meaning set forth in such employment agreement. The determination that a termination of the Participant’s service is either for Cause or without Cause shall be made by the Company, in its sole discretion.

 

  (j) A “Change in Control” shall be deemed to have occurred if the event set forth in any one of the following paragraphs shall have occurred:

 

  (i) any Person is or becomes the “Beneficial Owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company (not including in the securities Beneficially Owned by such Person any securities acquired directly from the Company) representing 50% or more of the Company’s then outstanding securities; or

 

  (ii) the following individuals cease for any reason to constitute a majority of the number of directors then serving: individuals who, on the Effective Date, constitute the Board of Directors and any new director (other than a director whose initial assumption of office is in connection with an actual or threatened election contest, including but not limited to a consent solicitation, relating to the election of directors of the Company) whose appointment or election by the Board of Directors or nomination for election by the Company’s stockholders was approved or recommended by a vote of at least a two-thirds of the directors then still in office who either were directors on the Effective Date or whose appointment, election or nomination for election was previously so approved or recommended; or

 

  (iii) there is consummated a merger or consolidation of the Company with any other corporation other than (A) a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof) at least 50% of the combined voting power of the voting securities of the Company or such surviving entity or any parent thereof outstanding immediately after such merger or consolidation, or (B) a merger or consolidation effected to implement a re-capitalization of the Company (or similar transaction) in which no Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company (not including in the securities Beneficially Owned by such Person any securities acquired directly from the Company) representing 50% or more of the combined voting power of the Company’s then outstanding securities; or

 

  (iv) the stockholders of the Company approve a plan of complete liquidation or dissolution of the Company or there is consummated an agreement for the sale or disposition by the Company of all or substantially all of the Company’s assets, other than a sale or disposition by the Company of all or substantially all of the Company’s assets to an entity at least 75% of the combined voting power of the voting securities of which are owned by Persons in substantially the same proportions as their ownership of the Company immediately prior to such sale.

 

  (k) Code” shall mean the Internal Revenue Code of 1986, as amended from time to time, and any regulations promulgated thereunder. References in the Plan to specific sections of the Code shall be deemed to include any successor provisions thereto.

 

 2 

 

 

  (l) Committee” shall mean the committee of the Board of Directors delegated with the authority to administer the Plan, or the full Board of Directors, as provided in Section 3 hereof. With respect to any decision involving an Award intended to satisfy the requirements of Section 162(m) of the Code, the Committee shall consist of two or more directors of the Company who are “outside directors” within the meaning of Section 162(m) of the Code. With respect to any decision involving an Award intended to satisfy the requirements of Rule 16b-3, the Committee shall consist solely of two or more “non-employee directors” within the meaning of Rule 16b-3. The fact that a Committee member shall fail to qualify under any of these requirements shall not invalidate an Award if the Award is otherwise validly made under the Plan. The Board of Directors may at any time appoint additional members to the Committee, remove and replace members of the Committee with or without Cause, and fill vacancies on the Committee however caused.

 

  (m) Company” shall mean Adial Pharmaceuticals, Inc., a Delaware corporation, or any successor thereto, and, where appropriate, each of its Subsidiaries.
     
  (n) Company Stock” shall mean the common stock of the Company, par value $0.001 per share.
     
  (o) Disability” shall mean total and permanent disability as defined in Section 22(e)(3) of the Code, provided that in the case of Awards other than Incentive Stock Options, the Administrator in its discretion may determine whether a permanent and total disability exists in accordance with uniform and non-discriminatory standards adopted by the Administrator from time to time.
     
  (p) Effective Date” shall mean the IPO Date, provided that this Plan has been adopted by the Board of Directors and approved by the stockholders of the Company.
     
  (q) Exchange Act” shall mean the Securities Exchange Act of 1934, as amended from time to time.
     
  (r) The “Fair Market Value” of a share of Company Stock, as of a date of determination, shall mean (i) the closing sales price per share of Company Stock on the principal national securities exchange on which such Company Stock is listed on the date of the grant of such Award; (ii) if the shares of Company Stock are not listed or admitted to trading on any such exchange, the closing price of the shares of Company Stock on the principal securities market on which the shares trade as reported for the last preceding date on which there was a sale of such stock on such market; or (iii) if the shares of Company Stock are not then listed on a national securities exchange or traded on a securities market or in an over-the-counter market or the value of such shares is not otherwise determinable, such value as determined by the Administrator in good faith upon the advice of a qualified valuation expert. In no event shall the Fair Market Value of any share of Company Stock, the Option exercise price of any Option, the appreciation base per share of Company Stock under any Stock Appreciation Right, or the amount payable per share of Company Stock under any other Award, be less than the par value per share of Company Stock.
     
  (s) Full Value Award” shall mean any Award, other than an Option or a Stock Appreciation Right, which Award is settled in Company Stock.
     
  (t) Incentive Stock Option” shall mean an Option that is an “incentive stock option” within the meaning of Section 422 of the Code, or any successor provision, and that is designated by the Administrator as an Incentive Stock Option.
     
  (u) IPO Date” means the date on which the underwriting agreement between the Company and the underwriter(s) managing the initial public offering of the Company Stock, pursuant to which the Company Stock is priced for the initial public offering, is executed.
     
  (v) Long-Term Incentive Award” shall mean an Award that is based upon a period in excess of one year.
     
  (w) Nonemployee Director” shall mean a member of the Board of Directors who is not an employee of the Company.
     
  (x) Nonstatutory Stock Option” shall mean an Option other than an Incentive Stock Option.

 

 3 

 

 

  (y) Option” shall mean an option to purchase shares of Company Stock granted pursuant to Section 6(b).

 

  (z) Other Cash-Based Award” shall mean a right or other interest granted to a Participant pursuant to Section 6(g) hereof other than an Other Stock-Based Award entitling such Participant to receive a cash payment at such times, and subject to such conditions, as are set forth in the Plan and the applicable Award Agreement.

 

  (aa) Other Stock-Based Award” shall mean a right or other interest granted to a Participant, valued in whole or in part by reference to, or otherwise based on, or related to, Company Stock pursuant to Section 6(g) hereof, including but not limited to: (i) unrestricted Company Stock awarded as a bonus or upon the attainment of performance goals or otherwise as permitted under the Plan; and (ii) a right granted to a Participant to acquire Company Stock from the Company containing terms and conditions prescribed by the Administrator.

 

  (bb) Participant” shall mean an officer, director, employee or consultant of the Company to whom an Award is granted pursuant to the Plan, and, upon the death of the officer, director, employee or consultant, his or her successors, heirs, executors and administrators, as the case may be.

 

  (cc) Performance Award” shall mean an Award granted to a Participant pursuant to Section 6(f) hereof.

 

  (dd) Person” shall have the meaning set forth in Section 3(a)(9) of the Exchange Act, except that such term shall not include: (i) the Company; (ii) a trustee or other fiduciary holding securities under an employee benefit plan of the Company; (iii) an underwriter temporarily holding securities pursuant to an offering of such securities; or (iv) a corporation owned, directly or indirectly, by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company.

 

  (ee) Restricted Stock” shall mean a share of Company Stock that is granted pursuant to the terms of Section 6(e) hereof.

 

  (ff) Retirement” shall mean, in the case of employees, the termination of employment with the Company (other than for Cause) during or after the calendar year in which a Participant has or will reach (i) age 55 with ten years of service with the Company; or (ii) age 60 with five years of service with the Company. “Retirement” shall mean, in the case of directors, the termination of service with the Company (other than for Cause) during or after the calendar year in which a Participant has or will reach age 75 with five years of service with the Company.

 

  (gg) Rule 16b-3” shall mean Rule 16b-3 promulgated under the Exchange Act, as amended from time to time.

 

  (hh) Securities Act” shall mean the Securities Act of 1933, as amended from time to time.

 

  (ii) Stock Appreciation Right” shall mean the right, granted to a Participant under Section 6(d), to be paid an amount measured by the appreciation in the Fair Market Value of a share of Company Stock from the date of grant to the date of exercise of the right, with payment to be made in cash and/or a share of Company Stock, as specified in the Award or determined by the Administrator.

 

  (jj) Stock Bonus” shall mean a bonus payable in shares of Company Stock granted pursuant to Section 6(e) hereof.

 

  (kk) Subsidiary” shall mean an entity (whether or not a corporation) that is wholly or majority owned or controlled, directly or indirectly, by the Company; provided, however, that with respect to Incentive Stock Options, the term “Subsidiary” shall include only an entity that qualifies under Section 424(f) of the Code as a “subsidiary corporation” with respect to the Company.

 

 4 

 

 

3.  Administration of the Plan.

 

The Plan shall be administered by the Administrator, which shall be the Company’s Board of Directors or a Committee appointed by the Board of Directors. The Administrator shall have the authority, in its sole discretion, subject to and not inconsistent with the express terms and provisions of the Plan, to administer the Plan and to exercise all the powers and authorities either specifically granted to it under the Plan or necessary or advisable in the administration of the Plan, including, without limitation, the authority to grant Awards; to determine the persons to whom and the time or times at which Awards shall be granted; to determine the type and number of Awards to be granted (including whether an Option granted is an Incentive Stock Option or a Nonstatutory Stock Option); to determine the number of shares of Company Stock to which an Award may relate and the terms, conditions, restrictions and performance criteria, if any, relating to any Award; to determine whether, to what extent, and under what circumstances an Award may be settled, cancelled, forfeited, exchanged or surrendered; to make adjustments in the performance goals that may be required for any award in recognition of unusual or nonrecurring events affecting the Company or the financial statements of the Company (to the extent not inconsistent with Section 162(m) of the Code, if applicable), or in response to changes in applicable laws, regulations, or accounting principles; to construe and interpret the Plan and any Award; to prescribe, amend and rescind rules and regulations relating to the Plan; to determine the terms and provisions of Agreements; and to make all other determinations deemed necessary or advisable for the administration of the Plan.

 

The Administrator may, in its absolute discretion, without amendment to the Plan, (a) accelerate the date on which any Option granted under the Plan becomes exercisable, waive or amend the operation of Plan provisions respecting exercise after termination of employment or otherwise adjust any of the terms of such Option; and (b) accelerate the vesting date, or waive any condition imposed hereunder, with respect to any Award or otherwise adjust any of the terms applicable to any such Award. Notwithstanding the foregoing, and subject to Sections 4(c) and 4(d), neither the Administrator nor its delegates shall have the authority to re-price (or cancel and/or re-grant) any Option, Stock Appreciation Right or, if applicable, other Award at a lower exercise, base or purchase price without first obtaining the approval of the Company’s stockholders.

 

Subject to Section 162(m) of the Code and except as required by Rule 16b-3 of the Exchange Act with respect to grants of Awards to individuals who are subject to Section 16 of the Exchange Act, or as otherwise required for compliance with Rule 16b-3 of the Exchange Act or other applicable law, the Administrator may delegate all or any part of its authority under the Plan to officers or managers of the Company.

 

Subject to Section 162(m) of the Code and Section 16 of the Exchange Act, to the extent the Administrator deems it necessary, appropriate or desirable to comply with foreign law or practices and to further the purpose of the Plan, the Administrator may, without amending this Plan, establish special rules applicable to Awards granted to Participants who are foreign nationals, are employed outside the United States, or both, including rules that differ from those set forth in the Plan, and grant Awards to such Participants in accordance with those rules.

 

All decisions, determinations and interpretations of the Administrator shall be final and binding on all persons with any interest in an Award, including the Company and the Participant (or any person claiming any rights under the Plan from or through any Participant). No member of the Administrator acting in their capacity as Administrator shall be liable for any action taken or determination made in good faith with respect to the Plan or any Award.

  

4. Stock Subject to the Plan.

  

  (a) Shares Available for Awards. The maximum aggregate number of shares of Company Stock reserved for issuance under the Plan (all of which may be granted as Incentive Stock Options) shall be One Million Seven Hundred and Fifty Thousand (1,750,000) shares. Notwithstanding the foregoing, of the One Million Seven Hundred and Fifty Thousand (1,750,000) shares reserved for issuance under this Plan, no more than One Million (1,000,000) of such shares shall be issued as Full Value Awards. Shares of Company Stock reserved under the Plan may be authorized but unissued Company Stock or authorized and issued Company Stock held in the Company’s treasury. The Administrator may direct that any stock certificate evidencing shares issued pursuant to the Plan shall bear a legend setting forth such restrictions on transferability as may apply to such shares pursuant to the Plan.

 

 5 

 

 

  (b) Individual Limitation. To the extent required by Section 162(m) of the Code, the total number of shares of Company Stock subject to Awards awarded to any one Participant during any tax year of the Company, shall not exceed Five Hundred Thousand (500,000) shares (subject to adjustment as provided herein).

 

  (c) Adjustment for Change in Capitalization. In the event that the Administrator shall determine that any dividend or other distribution (whether in the form of cash, Company Stock, or other property), recapitalization, Company Stock split, reverse Company Stock split, reorganization, reclassification, merger, consolidation, spin-off, combination, repurchase, share exchange, liquidation, dissolution or other similar corporate transaction or event, affects the Company Stock such that an adjustment is appropriate in order to prevent dilution or enlargement of the rights of Participants under the Plan, then the Administrator shall make such equitable changes or adjustments as it deems necessary or appropriate to any or all of (i) the number and kind of shares of Company Stock that may thereafter be issued in connection with Awards; (ii) the number and kind of shares of Company Stock, securities or other property (including cash) issued or issuable in respect of outstanding Awards; (iii) the exercise price, grant price or purchase price relating to any Award; and (iv) the maximum number of shares subject to Awards which may be awarded to any employee during any tax year of the Company; provided that, with respect to Incentive Stock Options, any such adjustment shall be made in accordance with Section 424 of the Code; and provided further that, no such adjustment shall cause any Award hereunder which is or could be subject to Section 409A of the Code to fail to comply with the requirements of such section.

 

  (d) Specific Adjustments. Notwithstanding the foregoing, in connection with a spin-off or similar corporate transaction, the Administrator shall be required with respect to the Plan and to Awards granted thereunder to make adjustments described in this Section 4(d) that may include, but are not limited to, (i) the imposition of restrictions on any distribution with respect to Restricted Stock or similar Awards; and (ii) the substitution of comparable Options to purchase the common stock of another entity or Stock Appreciation Rights or Other Stock-Based Awards denominated in the securities of another entity, which may be settled in the form of cash, Company Stock, stock of such other entity, or other securities or property, as determined by the Administrator to the extent that any existing gain would otherwise be diminished without payment of adequate compensation to the holder of the award; and, in the event of such a substitution, references in this Plan and in the applicable Award Agreements thereunder to “Company Stock” or “Stock” shall be deemed to also refer to the securities of the other entity where appropriate.

 

  (e) Reuse of Shares. Except as set forth below, if any shares subject to an Award are forfeited, cancelled, exchanged or surrendered, or if an Award terminates or expires without a distribution of shares to the Participant, the shares of stock with respect to such Award shall, to the extent of any such forfeiture, cancellation, exchange, surrender, withholding, termination or expiration, again be available for Awards under the Plan. Notwithstanding the foregoing, upon the exercise of any Award granted in tandem with any other Awards, such related Awards shall be cancelled to the extent of the number of shares of Company Stock as to which the Award is exercised and such number of shares shall no longer be available for Awards under the Plan. In addition, notwithstanding the forgoing, the shares of stock surrendered or withheld as payment of either the exercise price of an Option (including shares of stock otherwise underlying an Award of a Stock Appreciation Right that are retained by the Company to account for the appreciation base of such Stock Appreciation Right) and/or withholding taxes in respect of an Award shall no longer be available for Awards under the Plan.

 

5. Eligibility.

 

The persons who shall be eligible to receive Awards pursuant to the Plan shall be the individuals the Administrator shall select from time to time, who are employees (including officers of the Company and its Subsidiaries, whether or not they are directors of the Company or its Subsidiaries), Nonemployee Directors, and consultants of the Company and its Subsidiaries; provided, that Incentive Stock Options shall be granted only to employees (including officers and directors who are also employees) of the Company or its Subsidiaries.

 

 6 

 

 

6. Awards Under the Plan.

 

  (a) Agreement.  The Administrator may grant Awards in such amounts and with such terms and conditions as it shall determine in its sole discretion, subject to the terms and provisions of the Plan. Each Award granted under the Plan shall be evidenced by an Agreement as the Administrator may in its sole discretion deem necessary or desirable and unless Administrator determines otherwise, such Agreement must be signed, acknowledged and returned by the Participant to the Company. Unless the Administrator determines otherwise, any failure by the Participant to sign and return the Award Agreement within such reasonable period of time following the granting of the Award as the Administrator shall prescribe shall cause such Award to the Participant to be null and void. By accepting an Award or other benefits under the Plan (including participation in the Plan), each Participant shall be conclusively deemed to have indicated acceptance and ratification of, and consent to, all provisions of the Plan and the Award Agreement.

 

  (b) Stock Options.

 

  (i) Grant of Stock Options. The Administrator may grant Options under the Plan to purchase shares of Company Stock in such amounts and subject to such terms and conditions as it shall from time to time determine in its sole discretion, subject to the terms and provisions of the Plan. The exercise price of the share purchasable under an Option shall be determined by the Administrator but in no event shall the exercise price be less than the Fair Market Value per share on the grant date of such Option. The date as of which the Administrator adopts a resolution granting an Option shall be considered the day on which such Option is granted unless such resolution specifies a later date.

 

  (ii) Identification. Each Option shall be clearly identified in the applicable Award Agreement as either an Incentive Stock Option or a Nonstatutory Stock Option and shall state the number of shares of Company Stock to which the Option (and/or each type of Option) relates.

 

  (c) Special Requirements for Incentive Stock Options.

 

  (i) To the extent that the aggregate Fair Market Value of shares of Company Stock with respect to which Incentive Stock Options are exercisable for the first time by a Participant during any calendar year under the Plan and any other stock option plan of the Company shall exceed $100,000, such Options shall be treated as Nonstatutory Stock Options. Such Fair Market Value shall be determined as of the date on which each such Incentive Stock Option is granted.

 

  (ii) No Incentive Stock Option may be granted to an individual if, at the time of the proposed grant, such individual owns (or is deemed to own under the Code) stock possessing more than 10% of the total combined voting power of all classes of stock of the Company unless (A) the exercise price of such Incentive Stock Option is at least 110% of the Fair Market Value of a share of Company Stock at the time such Incentive Stock Option is granted and (B) such Incentive Stock Option is not exercisable after the expiration of five years from the date such Incentive Stock Option is granted.

 

  (d) Stock Appreciation Rights.

 

  (i) The Administrator may grant a related Stock Appreciation Right in connection with all or any part of an Option granted under the Plan, either at the time such Option is granted or at any time thereafter prior to the exercise, termination or cancellation of such Option, and subject to such terms and conditions as the Administrator shall from time to time determine in its sole discretion, consistent with the terms and provisions of the Plan, provided, however, that in no event shall the appreciation base of the shares of Company Stock subject to the Stock Appreciation Right be less than the Fair Market Value per share on the grant date of such Stock Appreciation Right. The holder of a related Stock Appreciation Right shall, subject to the terms and conditions of the Plan and the applicable Award Agreement, have the right by exercise thereof to surrender to the Company for cancellation all or a portion of such related Stock Appreciation Right, but only to the extent that the related Option is then exercisable, and to be paid therefor an amount equal to the excess (if any) of (i) the aggregate Fair Market Value of the shares of Company Stock subject to the related Stock Appreciation Right or portion thereof surrendered (determined as of the exercise date) over (ii) the aggregate appreciation base of the shares of Company Stock subject to the Stock Appreciation Right or portion thereof surrendered. Upon any exercise of a related Stock Appreciation Right or any portion thereof, the number of shares of Company Stock subject to the related Option shall be reduced by the number of shares of Company Stock in respect of which such Stock Appreciation Right shall have been exercised.

 

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  (ii) The Administrator may grant unrelated Stock Appreciation Rights in such amount and subject to such terms and conditions, as the Administrator, shall from time to time determine in its sole discretion, subject to the terms and provisions of the Plan, provided, however, that in no event shall the appreciation base of the shares of Company Stock subject to the Stock Appreciation Right be less than the Fair Market Value per share on the grant date of such Stock Appreciation Right. The holder of an unrelated Stock Appreciation Right shall, subject to the terms and conditions of the Plan and the applicable Award Agreement, have the right to surrender to the Company for cancellation all or a portion of such Stock Appreciation Right, but only to the extent that such Stock Appreciation Right is then exercisable, and to be paid therefor an amount equal to the excess (if any) of (x) the aggregate Fair Market Value of the shares of Company Stock subject to the Stock Appreciation Right or portion thereof surrendered (determined as of the exercise date), over (y) the aggregate appreciation base of the shares of Company Stock subject to the Stock Appreciation Right or portion thereof surrendered.

 

  (iii) The grant or exercisability of any Stock Appreciation Right shall be subject to such conditions as the Administrator in its sole discretion, shall determine.

 

  (e) Restricted Stock and Stock Bonus.

 

  (i) The Administrator may grant Restricted Stock awards, alone or in tandem with other Awards under the Plan, subject to such restrictions, terms and conditions, as the Administrator shall determine in its sole discretion and as shall be evidenced by the applicable Award Agreements. The vesting of a Restricted Stock award granted under the Plan may be conditioned upon the completion of a specified period of employment or service with the Company or any Subsidiary, upon the attainment of specified performance goals, and/or upon such other criteria as the Administrator may determine in its sole discretion.

 

  (ii) Each Agreement with respect to a Restricted Stock award shall set forth the amount (if any) to be paid by the Participant with respect to such Award and when and under what circumstances such payment is required to be made.

 

  (iii) The Administrator may, upon such terms and conditions as the Administrator determines in its sole discretion, provide that a certificate or certificates representing the shares underlying a Restricted Stock award shall be registered in the Participant’s name and bear an appropriate legend specifying that such shares are not transferable and are subject to the provisions of the Plan and the restrictions, terms and conditions set forth in the applicable Award Agreement, or that such certificate or certificates shall be held in escrow by the Company on behalf of the Participant until such shares become vested or are forfeited. Except as provided in the applicable Award Agreement, no shares underlying a Restricted Stock award may be assigned, transferred, or otherwise encumbered or disposed of by the Participant until such shares have vested in accordance with the terms of such Award.

 

  (iv) If and to the extent that the applicable Award Agreement may so provide, a Participant shall have the right to vote and receive dividends on the shares underlying a Restricted Stock award granted under the Plan. Unless otherwise provided in the applicable Award Agreement, any stock received as a dividend on or in connection with a stock split of the shares underlying a Restricted Stock award shall be subject to the same restrictions as the shares underlying such Restricted Stock award.

 

 8 

 

 

  (v) The Administrator may grant Stock Bonus awards, alone or in tandem with other Awards under the Plan, subject to such terms and conditions as it shall determine in its sole discretion and as may be evidenced by the applicable Award Agreement.

 

  (f) Performance Awards.

 

  (i) The Administrator may grant Performance Awards, alone or in tandem with other Awards under the Plan, to acquire shares of Company Stock in such amounts and subject to such terms and conditions as the Administrator shall from time to time in its sole discretion determine, subject to the terms of the Plan. To the extent necessary to satisfy the short-term deferral exception to Section 409A of the Code, unless the Administrator shall determine otherwise, the Performance Awards shall provide that payment shall be made within 2 1/2 months after the end of the year in which the Participant has a legally binding vested right to such award.

 

  (ii) In the event that the Administrator grants a Performance Award or other Award (other than Nonstatutory Stock Option or Incentive Stock Option or a Stock Appreciation Right) that is intended to constitute qualified performance-based compensation within the meaning Section 162(m) of the Code, the following rules shall apply (as such rules may be modified by the Administrator to conform with Section 162(m) of the Code and the Treasury Regulations thereunder as may be in effect from time to time, and any amendments, revisions or successor provisions thereto): (a) payments under the Performance Award shall be made solely on account of the attainment of one or more objective performance goals established in writing by the Administrator not later than 90 days after the commencement of the period of service to which the Performance Award relates (but in no event after 25% of the period of service has elapsed); (b) the performance goal(s) to which the Performance Award relates shall be based on one or more of the following business criteria applied to the Participant and/or a business unit or the Company and/or a Subsidiary: (1) scientific progress; (2) product development progress; (3) business development progress; (4) sales; (5) sales growth; (6) earnings growth; (7) cash flow or cash position; (8) gross margins; (9) stock price; (10) financings (issuance of debt or equity); (11) market share; (12) total shareholder return; (13) net revenues; (14) earnings per share of Company Stock; (15) net income (before or after taxes); (16) return on assets; (17) return on sales; (18) return on assets; (19) equity or investment; (20) improvement of financial ratings; (21) achievement of balance sheet or income statement objectives; (22) total stockholder return; (23) earnings from continuing operations; levels of expense; cost or liability; (24) earnings before all or any interest; taxes; depreciation and/or amortization (“EBIT”; “EBITA” or “EBITDA”); (25) cost reduction goals; (26) business development goals (including without limitation product launches and other business development-related opportunities); (27) identification or consummation of investment opportunities or completion of specified projects in accordance with corporate business plans; including strategic mergers; acquisitions or divestitures; (28) meeting specified market penetration or value added goals; (29) development of new technologies (including patent application or issuance goals); and (30) any combination of; or a specified increase or decrease of one or more of the foregoing over a specified period; and (c) once granted, the Administrator may not have discretion to increase the amount payable under such Award, provided, however, that whether or not an Award is intended to constitute qualified performance-based compensation within the meaning of Section 162(m) of the Code, the Administrator, to the extent provided by the Administrator at the time the Award is granted or as otherwise permitted under Section 162(m) of the Code, shall have the authority to make appropriate adjustments in performance goals under an Award to reflect the impact of extraordinary items not reflected in such goals. For purposes of the Plan, extraordinary items shall be defined as (1) any profit or loss attributable to acquisitions or dispositions of stock or assets including, without limitation, licenses; (2) any changes in accounting standards that may be required or permitted by the Financial Accounting Standards Board or adopted by the Company after the goal is established; (3) all items of gain, loss or expense for the year related to restructuring charges for the Company; (4) all items of gain, loss or expense for the year determined to be extraordinary or unusual in nature or infrequent in occurrence or related to the disposal of a segment of a business; (5) all items of gain, loss or expense for the year related to discontinued operations that do not qualify as a segment of a business as defined in APB Opinion No. 30; and (6) such other items as may be prescribed by Section 162(m) of the Code and the Treasury Regulations thereunder as may be in effect from time to time, and any amendments, revisions or successor provisions and any changes thereto. The Board of Directors or the Committee shall, prior to making payment under any award under this Section 6(f), certify in writing that all applicable performance goals have been attained. Notwithstanding anything to the contrary contained in the Plan or in any applicable Award Agreement, no dividends or dividend equivalents will be paid with respect to unvested Performance Awards.

 

 9 

 

 

  (g) Other Stock-Based Award; Cash-Based Award.

 

  (i) The Administrator is authorized to grant Awards to Participants in the form of Other Stock-Based Awards or Other Cash-Based Awards, as deemed by the Administrator to be consistent with the purposes of the Plan. To the extent necessary to satisfy the short-term deferral exception to Section 409A of the Code, unless the Administrator shall determine otherwise, the awards shall provide that payment shall be made within 2½ months after the end of the year in which the Participant has a legally binding vested right to such award. With respect to Other Cash-Based Awards intended to qualify as performance based compensation under Section 162(m) of the Code, (i) the maximum value of the aggregate payment that any Participant may receive with respect to any such Other Cash-Based Award shall be in such amounts and subject to such terms and conditions as the Board of Directors or the Committee shall determine; (ii) the maximum value of the aggregate payment that any Participant may receive with respect to any such Other Cash-Based Award that is a Long-Term Incentive Award is the highest amount paid pursuant to clause (i) above multiplied by a fraction, the numerator of which is the number of months in the performance period and the denominator of which is twelve, and (iii) such additional rules set forth in Section 6(f) applicable to Awards intended to qualify as performance-based compensation under Section 162(m) shall apply. The Administrator may establish such other rules applicable to the Other Stock-Based Awards or Cash-Based Awards to the extent not inconsistent with Section 162(m) of the Code.

  

  (h) Exercisability of Awards; Cancellation of Awards in Certain Cases.

 

  (i) Except as hereinafter provided, each Agreement with respect to an Option or Stock Appreciation Right shall set forth the period during which and the conditions subject to which the Option or Stock Appreciation Right evidenced thereby shall be exercisable, and each Agreement with respect to a Restricted Stock award, Stock Bonus award, Performance Award or other Award shall set forth the period after which and the conditions subject to which amounts underlying such Award shall vest or be deliverable, all such periods and conditions to be determined by the Administrator in its sole discretion.
  (ii) Except as provided in Section 7(d) hereof, no Option or Stock Appreciation Right may be exercised and no shares of Company Stock underlying any other Award under the Plan may vest or become deliverable more than ten years after the date of grant (the “Stated Expiration Date”).

  

  (iii) Except as provided in Section 7 hereof, no Option or Stock Appreciation Right may be exercised and no shares of Common Stock underlying any other Award under the Plan may vest or become deliverable unless the Participant is at such time in the employ (for Participants who are employees) or service (for Participants who are Nonemployee Directors or consultants) of the Company or a Subsidiary (or a company, or a parent or subsidiary company of such company, issuing or assuming the relevant right or award in a Change in Control) and has remained continuously so employed or in service since the relevant date of grant of the Award.

 

  (iv) An Option or Stock Appreciation Right shall be exercisable by the filing of a written notice of exercise or a notice of exercise in such other manner with the Company, on such form and in such manner as the Administrator in its sole discretion prescribe, and by payment in accordance with Section 6(i) hereof.

 

 10 

 

 

  (v) Unless the applicable Award Agreement provides otherwise, the “Option exercise date” and the “Stock Appreciation Right exercise date” shall be the date that the written notice of exercise, together with payment, are received by the Company.

  

  (i) Payment of Award Price.

 

  (i) Unless the applicable Award Agreement provides otherwise or the Administrator in its sole discretion otherwise determines, any written notice of exercise of an Option or Stock Appreciation Right must be accompanied by payment of the full Option or Stock Appreciation Right exercise price.

 

  (ii) Payment of the Option exercise price and of any other payment required by the Award Agreement to be made pursuant to any other Award shall be made in any combination of the following: (a) by certified or official bank check payable to the Company (or the equivalent thereof acceptable to the Administrator); (b) with the consent of the Administrator its sole discretion, by personal check (subject to collection) which may in the discretion of the Administrator be deemed conditional; (c) unless otherwise provided in the applicable Award Agreement, and as permitted by the Administrator by delivery of previously-acquired shares of Common Stock owned by the Participant having a Fair Market Value (determined as of the Option exercise date, in the case of Options, or other relevant payment date as determined by the Administrator, in the case of other Awards) equal to the portion of the exercise price being paid thereby; and/or (d) unless otherwise provided in applicable Award Agreement, and as permitted by the Administrator, on a net-settlement basis with the Company withholding the amount of Common Stock sufficient to cover the exercise price and tax withholding obligation. Payment in accordance with clause (a) of this Section 6(i)(ii) may be deemed to be satisfied, if and to the extent that the applicable Award Agreement so provides or the Administrator permits, by delivery to the Company of an assignment of a sufficient amount of the proceeds from the sale of Company Stock to be acquired pursuant to the Award to pay for all of the Company Stock to be acquired pursuant to the Award and an authorization to the broker or selling agent to pay that amount to the Company and to effect such sale at the time of exercise or other delivery of shares of Company Stock.

 

7. Termination of Employment.

 

  (a) Except as otherwise provided in the applicable Award Agreement or other agreement between the Participant and the Company, upon termination of a Participant’s employment or service with the Company and its Subsidiaries by the Company or its Subsidiary for Cause (or in the case of a Nonemployee Director upon such Nonemployee Director’s failure to be renominated as Nonemployee Director of the Company), the portions of outstanding Awards granted to such Participant that are exercisable as of the date of such termination of employment or service shall remain exercisable, and any payment or notice provided for under the terms of any other outstanding Award as respects the portion thereof that is vested as of the date of such termination of employment or service, may be given, for a period of ninety (90) days from and including the date of termination of employment or service (and shall thereafter terminate). All portions of outstanding Awards granted to such Participant that are not exercisable as of the date of such termination of employment or service, and any other outstanding Award which is not vested as of the date of such termination of employment or service shall terminate upon the date of such termination of employment or service.

 

  (b) Except as otherwise provided in the applicable Award Agreement or other agreement between the Participant and the Company, upon termination of the Participant’s employment or service with the Company and its Subsidiaries for any reason other than as described in subsection (a), (c), (d) or (e) hereof, the portions of outstanding Awards granted to such Participant that are exercisable as of the date of such termination of employment or service shall remain exercisable for a period of ninety (90) days (and shall terminate thereafter), and any payment or notice provided for under the terms of any other outstanding Award as respects the portion thereof vested as of the date of termination of employment or service may be given, for a period of ninety (90) days from and including the date of termination of employment or service (and shall terminate thereafter). All additional portions of outstanding Awards granted to such Participant that are not exercisable as of the date of such termination of employment or service, and any other outstanding Award that is not vested as of the date of such termination of employment or service shall terminate upon the date of such termination of employment or service.

 

 11 

 

 

  (c) Except as otherwise provided in the applicable Award Agreement or other agreement between the Participant and the Company, if the Participant voluntarily Retires with the consent of the Company or the Participant’s employment or service terminates due to Disability, all outstanding Awards (except, in the event a Participant voluntarily Retires, with respect to Awards (other than Options and Stock Appreciation Rights) intended to qualify as performance-based compensation within the meaning of Section 162(m) of the Code) granted to such Participant shall continue to vest in accordance with the terms of the applicable Award Agreements. The Participant shall be entitled to exercise each such Award and to make any payment, give any notice or to satisfy other condition under each such other Award, in each case, for a period of one year from and including the later of (i) the date such entire Award becomes vested or exercisable in accordance with the terms of such Award and (ii) the date of Retirement, and thereafter such Awards or parts thereof shall be canceled. Notwithstanding the foregoing, the Administrator in its sole discretion may provide for a longer or shorter period for exercise of an Award or may permit a Participant to continue vesting under an Award or to make any payment, give any notice or to satisfy other condition under any other Award.

 

  (d) Except as otherwise provided in the applicable Award Agreement or other agreement between the Participant and the Company, if the Participant’s employment or service terminates by reason of death, or if the Participant’s employment or service terminates under circumstances providing for continued rights under subsection (b), (c) or (e) of this Section 7 and during the period of continued rights described in subsection (b), (c) or (e) the Participant dies, all outstanding Awards granted to such Participant shall vest and become fully exercisable (if applicable), and any payment or notice provided for under the terms of any other outstanding Award may be immediately paid or given and any condition may be satisfied, by the person to whom such rights have passed under the Participant’s will (or if applicable, pursuant to the laws of descent and distribution) for a period of one year from and including the date of the Participant’s death and thereafter all such Awards or parts thereof shall be canceled.

 

  (e) Except as otherwise provided in the applicable Award Agreement or other agreement between the Participant and the Company, upon termination of a Participant’s employment or service with the Company and its Subsidiaries (i) by the Company or its Subsidiaries without Cause (including, in case of a Nonemployee Director, the failure to be elected as a Nonemployee Director); or (ii) by the Participant for “good reason” or any like term as defined under any employment agreement with the Company or a Subsidiary to which a Participant may be a party to, the portions of outstanding Awards granted to such Participant which are exercisable as of the date of termination of employment or service of such Participant shall remain exercisable, and any payment or notice provided for under the terms of any other outstanding Award as respects the portion thereof vested as of the date of termination of employment or service may be given, for a period of one year from and including the date of termination of employment or service and shall terminate thereafter.

  

  (f) Notwithstanding anything in this Section 7 to the contrary, no Option or Stock Appreciation Right may be exercised and no shares of Company Stock underlying any other Award under the Plan may vest or become deliverable past the Stated Expiration Date. In addition, the Administrator in its sole discretion, and in accordance with Section 409A of the Code, shall determine (i) for purposes of the Plan, whether any termination of employment or service is a voluntary Retirement with the Company’s consent or is due to Disability for purposes of the Plan; (ii) whether any leave of absence (including any short-term or long-term Disability or medical leave) constitutes a termination of employment or service, or a failure to have remained continuously employed or in service, for purposes of the Plan (regardless of whether such leave or status would constitute such a termination or failure for purposes of employment law); (iii) the applicable date of any such termination of employment or service; and (iv) the impact, if any, of any of the foregoing on Awards under the Plan.

 

 12 

 

 

8. Effect of Change in Control.

 

Unless otherwise determined in an Award Agreement, in the event of a Change in Control:

 

  (a) With respect to each outstanding Award that is assumed or substituted in connection with a Change in Control, in the event of a termination of a Participant’s employment or service by the Company without Cause during the 12-month period following such Change in Control, on the date of such termination (i) such Award shall become fully vested and, if applicable, exercisable; (ii) the restrictions, payment conditions, and forfeiture conditions applicable to any such Award granted shall lapse; and (iii) any performance conditions imposed with respect to Awards shall be deemed to be fully achieved at target levels.

 

  (b) For purposes of this Section 8, an Award shall be considered assumed or substituted if, following the Change in Control, the Award remains subject to the same terms and conditions that were applicable to the Award immediately prior to the Change in Control except that, if the Award related to shares of Company Stock, the Award instead confers the right to receive common stock of the acquiring entity.

 

  (c) With respect to each outstanding Award that is not assumed or substituted in connection with a Change in Control, immediately upon the occurrence of the Change in Control, (i) such Award shall become fully vested and, if applicable, exercisable; (ii) the restrictions, payment conditions, and forfeiture conditions applicable to any such Award granted shall lapse; and (iii) any performance conditions imposed with respect to Awards shall be deemed to be fully achieved at target levels.

  

  (d) Notwithstanding any other provision of the Plan: (i) in the event of a Change in Control, except as would otherwise result in adverse tax consequences under Section 409A of the Code, the Board may, in its sole discretion, provide that each Award shall, immediately upon the occurrence of a Change in Control, be cancelled in exchange for a payment in cash or securities in an amount equal to (x) the excess of the consideration paid per Share in the Change in Control over the exercise or purchase price (if any) per Share subject to the Award multiplied by (y) the number of Shares granted under the Award; and (ii) with respect to any Award that constitutes a deferral of compensation subject to Section 409A of the Code, in the event of a Change in Control that does not constitute a change in the ownership or effective control of the Company or in the ownership of a substantial portion of the assets of the Company under Section 409A(a)(2)(A)(v) of the Code and regulations thereunder, such Award shall be settled in accordance with its original terms or at such earlier time as permitted by Section 409A of the Code.

  

9. Miscellaneous.

 

  (a) The Administrator may specify in an Award Agreement at the time of the Award that the Participant’s rights, payments and benefits with respect to an Award shall be subject to reduction, cancellation, forfeiture or recoupment upon the occurrence of certain specified events, in addition to any otherwise applicable vesting or performance conditions of an Award. Such events shall include, but shall not be limited to, termination of service for Cause, violation of material Company policies, breach of non-competition, confidentiality or other restrictive covenants that may apply to the Participant, or other conduct by the Participant that is detrimental to the business or reputation of the Company. Notwithstanding any other provision hereof, the Administrator shall have the right at any time to deny or delay a Participant’s exercise of Options if such Participant is reasonably believed by the Administrator to have engaged in material conduct adverse to the interests of the Company.

 

  (b) Participants are and at all times shall remain subject to the trading window policies adopted by the Company from time to time throughout the period of time during which they may exercise Options, Stock Appreciation Rights or sell shares of Company Stock acquired pursuant to the Plan.

 

10. No Special Employment Rights, No Right to Award.

 

  (a) Nothing contained in the Plan or any Agreement shall confer upon any Participant any right with respect to the continuation of employment or service by the Company or interfere in any way with the right of the Company, subject to the terms of any separate employment agreement to the contrary, at any time to terminate such employment or service or to increase or decrease the compensation of the Participant.

 

 13 

 

 

  (b) No person shall have any claim or right to receive an Award hereunder. The granting of an Award to a Participant at any time shall neither require the Company to grant any other Award to such Participant or other person at any time or preclude the Company from making subsequent grants to such Participant or any other person.

 

11. Securities Matters; No Assignment or Transfer.

 

  (a) The Company shall be under no obligation to effect the registration pursuant to the Securities Act of any interests in the Plan or any shares of Company Stock to be issued hereunder or to effect similar compliance under any state laws. Notwithstanding anything herein to the contrary, the Company shall not be obligated to cause to be issued or delivered any certificates evidencing shares of Company Stock pursuant to the Plan unless and until the Company is advised by its counsel that the issuance and delivery of such certificates is in compliance with all applicable laws, regulations of governmental authority and the requirements of any securities exchange or securities market on which shares of Company Stock are traded. The Administrator may require, as a condition of the issuance and delivery of certificates evidencing shares of Company Stock pursuant to the terms hereof, that the recipient of such shares make such agreements and representations, and that such certificates bear such legends, as the Administrator in its sole discretion, deems necessary or desirable.

 

  (b) The transfer of any shares of Company Stock hereunder shall be effective only at such time as counsel to the Company shall have determined that the issuance and delivery of such shares is in compliance with all applicable laws, regulations of governmental authority and the requirements of any securities exchange or securities market on which shares of Company Stock are traded. The Administrator may, in its sole discretion, defer the effectiveness of any transfer of shares of Company Stock hereunder in order to allow the issuance of such shares to be made pursuant to registration or an exemption from registration or other methods for compliance available under federal or state securities laws. The Administrator shall inform the Participant in writing of its decision to defer the effectiveness of a transfer. During the period of such deferral in connection with the exercise of an Award, the Participant may, by written notice, withdraw such exercise and obtain the refund of any amount paid with respect thereto.

 

12. Withholding Taxes.

 

  (a) Whenever cash is to be paid pursuant to an Award, the Company shall have the right to deduct therefrom an amount sufficient to satisfy any federal, state and local withholding tax requirements related thereto.

 

  (b) Whenever shares of Company Stock are to be delivered pursuant to an Award, the Company shall have the right to require the Participant to remit to the Company in cash an amount sufficient to satisfy any federal, state and local (including jurisdictions outside the United States) withholding tax requirements related thereto. With the approval of the Administrator a Participant may satisfy the foregoing requirement by electing to have the Company withhold from delivery shares of Company Stock having a value equal to the minimum amount of tax required to be withheld. Such shares shall be valued at their Fair Market Value on the date of which the amount of tax to be withheld is determined. Fractional share amounts shall be settled in cash. Such a withholding election may be made with respect to all or any portion of the shares to be delivered pursuant to an Award.

 

13. Non-Competition and Confidentiality.

 

The Administrator may specify in an Award Agreement that the Participant’s rights, payments and benefits with respect to an Award shall be conditioned upon the Participant making a representation regarding compliance with non-competition, confidentiality or other restrictive covenants that may apply to the Participant and providing that the Participant’s rights, payments and benefits with respect to an Award shall be subject to reduction, cancellation, forfeiture or recoupment on account of a breach of such representations.

  

 14 

 

 

14. Notification of Election Under Section 83(b) of the Code.

 

If any Participant shall, in connection with the acquisition of shares of Company Stock under the Plan, make the election permitted under Section 83(b) of the Code, such Participant shall notify the Company of such election within 10 days of filing notice of the election with the Internal Revenue Service.

 

15. Amendment or Termination of the Plan

 

The Administrator may, at any time, suspend or terminate the Plan or revise or amend it in any respect whatsoever; provided, however, that the requisite stockholder approval shall be required if and to the extent the Administrator determines that such approval is appropriate or necessary for purposes of satisfying Section 162(m) or Section 422 of the Code, Rule 16b-3 or other applicable laws, rules or regulations. Awards may be granted under the Plan prior to the receipt of such stockholder approval of the Plan but each such grant shall be subject in its entirety to such approval and no Award may be exercised, vested or otherwise satisfied prior to the receipt of such approval. No amendment or termination of the Plan may, without the consent of a Participant, adversely affect the Participant’s rights under any outstanding Award.

 

16. Transferability; Nonassignability.

 

  (a) Awards under the Plan shall not be assignable or transferable by the Participant, except by will or by the laws of descent and distribution, and shall not be subject in any manner to assignment, alienation, pledge, encumbrance or charge. Notwithstanding the foregoing, the Administrator may provide in an Award Agreement that the Participant shall have the right to designate a Beneficiary or Beneficiaries who shall be entitled to any rights, payments or other benefits specified under an Award following the Participant’s death. During the lifetime of a Participant, an Award shall be exercised only by such Participant or such Participant’s guardian or legal representative. In the event of a Participant’s death, an Award may, to the extent permitted by the Award Agreement, be exercised by the Participant’s Beneficiary as designated by the Participant in the manner prescribed by the Administrator or, in the absence of an authorized Beneficiary designation, by the legatee of such Award under the Participant’s will or by the Participant’s estate in accordance with the Participant’s will or the laws of descent and distribution, in each case in the same manner and to the same extent that such Award was exercisable by the Participant on the date of the Participant’s death.

 

  (b) Notwithstanding anything else in this Section 16 to the contrary, the Administrator may in its discretion provide in an Award Agreement that an Award in the form of a Nonstatutory Stock Option, share-settled Stock Appreciation Right, Restricted Stock, or share-settled Other Stock-Based Award may be transferred, on such terms and conditions as the Administrator deems appropriate, either (i) by will or by the laws of descent and distribution; (ii) by instrument to a Beneficiary; (ii) by instrument to an inter vivos or testamentary trust (or other entity) in which the Award is to be passed to the Participant’s designated beneficiaries; or (iii) with the prior written approval of the Company, by gift, in a form acceptable to the Company. Any transferee of the Participant’s rights shall succeed and be subject to all of the terms of the applicable Award Agreement and the Plan.

 

17. Effective Date and Term of Plan.

 

The Plan came into existence on the date that the Plan was adopted by the Board of Directors. However, no Award may be granted under the Plan prior to the IPO Date. In addition, the Plan shall be subject to the requisite approval of the stockholders of the Company. Unless earlier terminated by the Board of Directors, the right to grant Awards under the Plan shall terminate on the close of business on August 30, 2027. Awards outstanding at Plan termination shall remain in effect according to their terms and the provisions of the Plan.

  

18. Applicable Law.

 

Except to the extent preempted by any applicable federal law, the Plan shall be construed and administered in accordance with the laws of the State of Delaware, without reference to its principles of conflicts of law.

 

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19. Participant Rights.

 

  (a) No Participant shall have any claim to be granted any award under the Plan, and there is no obligation for uniformity of treatment for Participants. Except as provided specifically herein, a Participant or a transferee of an Award shall have no rights as a stockholder with respect to any shares covered by any award until the date of the issuance of the Award  to him or her for such shares (which may be certificated or uncertificated as stated herein).

 

  (b) Determinations by the Administrator under the Plan relating to the form, amount and terms and conditions of grants and Awards need not be uniform, and may be made selectively among persons who receive or are eligible to receive grants and awards under the Plan, whether or not such persons are similarly situated.

 

20. Unfunded Status of Awards.

 

The Plan is intended to constitute an “unfunded” plan for incentive and deferred compensation. With respect to any payments not yet made to a Participant pursuant to an Award, nothing contained in the Plan or any Agreement shall give any such Participant any rights that are greater than those of a general creditor of the Company.

 

21. No Fractional Shares.

 

No fractional shares of Company Stock shall be issued or delivered pursuant to the Plan. The Administrator shall determine whether cash, other Awards, or other property shall be issued or paid in lieu of such fractional shares or whether such fractional shares or any rights thereto shall be forfeited or otherwise eliminated.

 

22. Interpretation.

 

The Plan is designed and intended, to the extent applicable, to comply with Section 162(m) of the Code, and to provide for grants and other transactions which are exempt under Rule 16b-3, and all provisions hereof shall be construed in a manner to so comply. Awards under the Plan are intended to comply with Code Section 409A to the extent subject thereto and the Plan and all Awards shall be interpreted in accordance with Code Section 409A and Department of Treasury regulations and other interpretive guidance issued thereunder, including without limitation any such regulations or other guidance that may be issued after the Effective Date of the Plan. Notwithstanding any provision in the Plan to the contrary, no payment or distribution under this Plan that constitutes an item of deferred compensation under Code Section 409A and becomes payable by reason of a Participant’s termination of employment or service with the Company will be made to such Participant until such Participant’s termination of employment or service constitutes a “separation from service” (as defined in Code Section 409A). For purposes of this Plan, each amount to be paid or benefit to be provided shall be construed as a separate identified payment for purposes of Code Section 409A. If a Participant is a “specified employee” (as defined in Code Section 409A), then to the extent necessary to avoid the imposition of taxes under Code Section 409A, such Participant shall not be entitled to any payments upon a termination of his or her employment or service until the earlier of: (i) the expiration of the six (6)-month period measured from the date of such Participant’s “separation from service” or (ii) the date of such Participant’s death. Upon the expiration of the applicable waiting period set forth in the preceding sentence, all payments and benefits deferred pursuant to this Section 22 (whether they would have otherwise been payable in a single lump sum or in installments in the absence of such deferral) shall be paid to such Participant in a lump sum as soon as practicable, but in no event later than sixty (60) calendar days following such expired period, and any remaining payments due under this Plan will be paid in accordance with the normal payment dates specified for them herein.

 

 

16

 

 

EX-4.12 24 fs12017ex4-12_adialpharma.htm FORM OF STOCK OPTION GRANT NOTICE, OPTION AGREEMENT

Exhibit 4.12

 

FORM OF

ADIAL PHARMACEUTICALS, INC.

STOCK OPTION GRANT NOTICE

 

Adial Pharmaceuticals, Inc. (the “Company”), pursuant to its 2017 Equity Incentive Plan (the “Plan”), hereby grants to Optionholder an option to purchase the number of shares of the Company’s Common Stock set forth below. This option is subject to all terms and conditions as set forth herein and in the related Option Agreement, the Plan and the Notice of Exercise, each of which are attached hereto and incorporated herein in their entirety.

 

  Optionholder:    
  Date of Grant:    
  Vesting Commencement Date:    
  Number of Shares Subject to Option:    
  Exercise Price (Per Share):    
  Total Exercise Price:    
  Expiration Date:    

 

Type of Grant:   Incentive Stock Option1 Nonstatutory Stock Option

 

Vesting Schedule:  
   
Payment: By one or a combination of the following items (described in the Option Agreement):
   
     By cash or check
      By delivery of already owned shares

 

Additional Terms/Acknowledgements: Optionholder acknowledges receipt of, and understands and agrees to, this Stock Option Grant Notice, the Option Agreement and the Plan. Optionholder acknowledges and agrees that this Stock Option Grant Notice and the Option Agreement may not be modified, amended or revised except as provided in the Plan. Optionholder further acknowledges that as of the Date of Grant, this Stock Option Grant Notice, the Option Agreement, and the Plan set forth the entire understanding between Optionholder and the Company regarding this option award and supersede all prior oral and written agreements, promises and/or representations on that subject with the exception of (i) options previously granted and delivered to Optionholder, (ii) any compensation recovery policy that is adopted by the Company or is otherwise required by applicable law, and (iii) any written employment or severance arrangement that would provide for vesting acceleration of this option upon the terms and conditions set forth therein. By accepting this option, Optionholder consents to receive such documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

  

1 If this is an Incentive Stock Option, it (plus other outstanding Incentive Stock Options) cannot be first exercisable for more than $100,000 in value (measured by exercise price) in any calendar year. Any excess over $100,000 is a Nonstatutory Stock Option.

  

 

 

  

Adial Pharmaceuticals, Inc.     Optionholder
         
By:        
  Signature     Signature
         
Title:     Date:   
         
Date:        

 

Attachments: Option Agreement, Notice of Exercise and 2017 Equity Incentive Plan.

  

 2 

 

 

FORM OF

ADIAL PHARMACEUTICALS, INC.

OPTION AGREEMENT

(INCENTIVE STOCK OPTION OR NONSTATUTORY STOCK OPTION)

 

Pursuant to your Stock Option Grant Notice (Grant Notice) and this Option Agreement, Adial Pharmaceuticals, Inc. (the “Company) has granted you an option under its 2017 Equity Incentive Plan (the “Plan) to purchase the number of shares of the Company’s Common Stock (the Company Stock”) indicated in your Grant Notice at the exercise price indicated in your Grant Notice. Defined terms not explicitly defined in this Option Agreement but defined in the Plan shall have the same definitions as in the Plan.

 

The details of your option are as follows:

 

1.          VESTING SCHEDULE. Your option shall vest and become exercisable at the time or times set forth in the accompanying Grant Notice.  In the event of a Change in Control, vesting of your option (if any) shall be as set forth in the Plan unless vesting upon a Change in Control is set forth in the Grant Notice, in which case the Grant Notice will govern the option vesting schedule notwithstanding the provisions of Section 15 herein.

 

2.          NUMBER OF SHARES AND EXERCISE PRICE. The number of shares of Company Stock subject to your option and your exercise price per share referenced in your Grant Notice may be adjusted from time to time for certain events, including such as stock dividends, split ups, mergers, spin-offs and the other events specified in the Plan.

 

3.          METHOD OF PAYMENT. Payment of the exercise price is due in full upon exercise of all or any part of your option. You may elect to make payment of the exercise price in cash or by check or by delivery to the Company of certificates representing shares of outstanding Company Stock already owned by you that are owned free and clear of any liens, claims, encumbrances or security interests together with stock powers duly executed and with signature guaranteed. In the event payment is made by delivery of such shares, said shares shall be deemed to have a per share value equal to the per share market value of the shares on the date of exercise. Notwithstanding the foregoing, you may not exercise your option by tender to the Company of Company Stock to the extent such tender would violate the provisions of any law, regulation or agreement restricting the redemption of the Company’s stock.

 

4.          WHOLE SHARES. You may exercise your option only for whole shares of Company Stock.

 

5.          SECURITIES LAW COMPLIANCE. Notwithstanding anything to the contrary contained herein, you may not exercise your option unless the shares of Company Stock issuable upon such exercise are then registered under the Securities Act or, if such shares of Company Stock are not then so registered, the Company has determined that such exercise and issuance would be exempt from the registration requirements of the Securities Act. The exercise of your option also must comply with other applicable laws and regulations governing your option, and you may not exercise your option if the Company determines that such exercise would not be in material compliance with such laws and regulations.

 

6.          TERM. You may not exercise your option before the commencement or after the expiration of its term. The term of your option commences on the Date of Grant and unless otherwise specified in the Grant Notice expires upon the earliest of:

 

(a)          Pursuant to the terms of your employment or consulting arrangement;

 

(b)          The Expiration Date indicated in your Grant Notice; or

 

(c)           The day before the tenth (10th) anniversary of the Date of Grant.         

 

If your option is an Incentive Stock Option, note that to obtain the federal income tax advantages associated with an Incentive Stock Option, the Code requires that at all times beginning on the Date of Grant of your option and ending on the day three (3) months before the date of your option’s exercise, you must be an employee of the Company or an Affiliate (defined as any “parent” or “subsidiary” of the Company as such terms are defined in Rule 405 of the Securities Act), except in the event of your death or Disability.

 

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7.          EXERCISE.

 

(a)          You may exercise the vested portion of your option during its term or as set forth in Section 1, if applicable, by delivering the attached Notice of Exercise together with the exercise price to the Chief Financial Officer of the Company, or to such other person as the Company may designate, during regular business hours, together with such additional documents as the Company may then require. Each election to exercise this option shall be in writing, signed by you, and delivered or mailed to the Chief Financial Officer of the Company at its principal office, 1180 Seminole Trail, Suite 495, Charlottesville, Virginia 22901. The address for and the recipient of such Notice of Exercise may be changed in the Company’s sole discretion and any such changes will be communicated to you. In the event an option is exercised by the executor or administrator of your estate, by a Beneficiary, or by the person or person to whom the option has been transferred by your will or the applicable laws of descent and distribution, the Company shall be under no obligation to deliver Company Stock thereunder unless and until the Company is satisfied that the person or person exercising the option is or are your duly appointed executor or administrator or the person to whom the option has been transferred by your will or by the applicable laws of descent and distribution.

 

(b)          By exercising your option you agree that, as a condition to any exercise of your option, the Company may require you to enter into an arrangement providing for the payment by you to the Company of any tax withholding obligation of the Company arising by reason of (1) the exercise of your option, (2) the lapse of any substantial risk of forfeiture to which the shares of Company Stock are subject at the time of exercise, or (3) the disposition of shares of Company Stock acquired upon such exercise.

 

(c)          If your option is an Incentive Stock Option, by exercising your option you agree that you will notify the Company in writing within fifteen (15) days after the date of any disposition of any of the shares of the Company Stock issued upon exercise of your option that occurs within two (2) years after the date of your option grant or within one (1) year after such shares of Company Stock are transferred upon exercise of your option.

 

8.           PAYMENT.

 

(a)          Payment in full by a certified or bank check should be made for all the shares of which your option is exercised at the time of such exercise, and no shares shall be delivered until such payment is made.

 

(b)          Alternatively, payment may be made by delivering to the Company shares of outstanding Company Stock of the Company together with stock powers duly executed and with signature guaranteed. In the event payment is made in whole or in part by such shares, said shares shall be deemed to have a per share value equal to the closing price of the shares on the last trading day immediately preceding the date the shares are then being issued.

 

(c)          The Company shall not be obligated to deliver any Company Stock unless and until: (1) all applicable Federal and state laws and regulations have been complied with; and (2) the shares to be delivered have been listed, or authorized to be added to the list by the applicable exchange where they are listed.

and (3) all legal matters in connection with the issuance and delivery of the shares of Company Stock have been approved by counsel for the Company. You shall have no rights as a shareholder until the Company Stock is actually delivered to you.

 

9.         TRANSFERABILITY.

 

(a)          If your option is an Incentive Stock Option, your option is not transferable, except by will or by the laws of descent and distribution, and is exercisable during your life only by you. Notwithstanding the foregoing, you shall have the right to designate a Beneficiary or Beneficiaries who shall be entitled to any rights, payments or other benefits specified under the option following your death, or in the absence of an authorized Beneficiary designation, by the legatee of the option under your will or by your estate in accordance with your will or the laws of descent and distribution, in each case in the same manner and to the same extent that the option was exercisable by you on the date of your death.

 

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(b)          If your option is a Nonstatutory Stock Option, your option is not transferable, except (i) by will or by the laws of descent and distribution, (ii) by instrument to a Beneficiary, (iii) by instrument to an inter vivos or testamentary trust (or other entity) in which the option is to be passed to your designated beneficiaries; and (iv) with the prior written approval of the Company, by gift, in a form acceptable by the Company.

 

10.         OPTION NOT A SERVICE CONTRACT. Your option is not an employment or service contract, and nothing in your option shall be deemed to create in any way whatsoever any obligation on your part to continue in the employ of the Company or an affiliate, or of the Company or an affiliate to continue your employment. In addition, nothing in your option shall obligate the Company or an affiliate, their respective stockholders, Boards of Directors, officers or employees to continue any relationship that you might have as a Director or consultant for the Company or an affiliate.

 

11.         WITHHOLDING OBLIGATIONS.

 

(a)          At the time you exercise your option, in whole or in part, or at any time thereafter as requested by the Company, you hereby authorize withholding from payroll and any other amounts payable to you, and otherwise agree to make adequate provision for any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or an affiliate, if any, which arise in connection with the exercise of your option.

 

(b)          Upon your request and subject to approval by the Company, in its sole discretion, and compliance with any applicable legal conditions or restrictions, the Company may withhold from fully vested shares of Company Stock otherwise issuable to you upon the exercise of your option a number of whole shares of Company Stock having a fair market value, determined by the Company as of the date of exercise based on the closing price of the shares on the last trading day immediately preceding the date the shares are then being issued, not in excess of the minimum amount of tax required to be withheld by law (or such lower amount as may be necessary to avoid classification of your option as a liability for financial accounting purposes). If the date of determination of any tax withholding obligation is deferred to a date later than the date of exercise of your option, share withholding pursuant to the preceding sentence shall not be permitted unless you make a proper and timely election under Section 83(b) of the Code, covering the aggregate number of shares of Company Stock acquired upon such exercise with respect to which such determination is otherwise deferred, to accelerate the determination of such tax withholding obligation to the date of exercise of your option. Notwithstanding the filing of such election, shares of Company Stock shall be withheld solely from fully vested shares of Company Stock determined as of the date of exercise of your option that are otherwise issuable to you upon such exercise. Any adverse consequences to you arising in connection with such share withholding procedure shall be your sole responsibility.

 

(c)          You may not exercise your option unless the tax withholding obligations of the Company and/or any affiliate are satisfied. Accordingly, you may not be able to exercise your option when desired even though

your option is vested, and the Company shall have no obligation to issue a certificate for such shares of Company Stock or release such shares of Company Stock from any escrow provided for herein unless such obligations are satisfied.

 

13.         TAX CONSEQUENCES. You hereby agree that the Company does not have a duty to design or administer the Plan or its other compensation programs in a manner that minimizes your tax liabilities. You shall not make any claim against the Company, or any of its officers, directors, employees or affiliates related to tax liabilities arising from your option or your other compensation. In particular, you acknowledge that this option is exempt from Section 409A of the Code only if the exercise price per share specified in the Grant Notice is at least equal to the Fair Market Value per share of the Company Stock on the Date of Grant and there is no other impermissible deferral of compensation associated with the option.

 

14.         NOTICES. Any notices provided for in your option or the Plan shall be given in writing and shall be deemed effectively given upon receipt or, in the case of notices delivered by mail by the Company to you, five (5) days after deposit in the United States mail, postage prepaid, addressed to you at the last address you provided to the Company.

 

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15.         GOVERNING PLAN DOCUMENT. Your option is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your option, and is further subject to all interpretations, amendments, rules and regulations, which may from time to time be promulgated and adopted pursuant to the Plan. In the event of any conflict between the provisions of your option and those of the Plan, the provisions of the Plan shall control.

 

16.         RIGHTS OF OPTIONEE. This Agreement does not entitle you to any voting rights or, except for the foregoing notice provisions, any other rights as a stockholder of the Company. No dividends are payable or will accrue on your option or the shares of Company Stock purchasable under this Agreement until, and except to the extent that, your option are exercised. Upon the surrender of your option and payment of the Exercise Price as provided above, the person or entity entitled to receive the shares of the Company Stock issuable upon such exercise shall be treated for all purposes as the record holder of such shares as of the close of business on the date of the surrender of your option for exercise as provided above. Upon the exercise of your option, you shall have all of the rights of a stockholder in the Company.

 

17.         GOVERNING LAW. This Agreement shall be governed by, construed and enforced in accordance with the laws of the State of Delaware without giving effect to its principles governing conflicts of law.

  

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NOTICE OF EXERCISE

 

ADIAL PHARMACEUTICALS, INC.

 

  Date of Exercise:  

 

Ladies and Gentlemen:

 

This constitutes notice under my stock option that I elect to purchase the number of shares for the price set forth below.

 

  Type of option (check one): Incentive Stock Option Nonstatutory Stock Option

 

  Stock option dated:    
       
 

Number of shares as to which option

is exercised:

   
       
  Certificates to be issued in name of:    
       
  Total exercise price: $    
       
  Cash payment delivered herewith: $    

 

  Value of _______ shares of    
  Adial Pharmaceuticals, Inc.2: $                             

 

By this exercise, I agree: (i) to provide such additional documents as you may require pursuant to the terms of the 2017 Equity Incentive Plan; (ii) to provide for the payment by me to you (in the manner designated by you) of your withholding obligation, if any, relating to the exercise of this option; and (iii) if this exercise relates to an incentive stock option, to notify you in writing within fifteen (15) days after the date of any disposition of any of the shares of Company Stock issued upon exercise of this option that occurs within two (2) years after the date of grant of this option or within one (1) year after such shares of Company Stock are issued upon exercise of this option.

 

Very truly yours,

 

 

 

 

 

 

 

2 Shares must be valued in accordance with the terms of the option being exercised, and must be owned free and clear of any liens, claims, encumbrances or security interests. Certificates must be endorsed or accompanied by an executed assignment separate from certificate.

 

 

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EX-4.13 25 fs12017ex4-13_adialpharma.htm FORM OF OPTION AGREEMENT

Exhibit 4.13

 

ADial Pharmaceuticals, LLC

Option Agreement

 

Recipient: ___________________ (“Recipient”)
Option for: ______________ Class A Units (the “Units”)
Exercise Price: $___________________ per Unit (the “Exercise Price”)
Effective Date: ___________________ (the “Effective Date”)
Expiration Date: ___________________ (the “Expiration Date”)

 

THIS OPTION AGREEMENT (this “Agreement”) is made and entered into effective as the Effective Date by and between ADial Pharmaceuticals, LLC, a limited liability company organized under the laws of the Commonwealth of Virginia (the “Company”), and Recipient.

 

All capitalized terms used herein shall have the same meaning that they have in the Company’s Second Amended and Restated Operating Agreement dated February 3, 2014 (the “Operating Agreement”), unless otherwise indicated or unless the context otherwise requires. As used herein, the terms “employ”, “employed”, “employment” refer to and mean the obligation to provide services to the Company or the holding of office in the Company as a director, officer, employee or consultant, as applicable. For clarity, if Recipient is a non-employee director, a non-employee officer or a consultant, use of these terms herein does not confer or imply an employee relationship between the Company and Recipient as that term is used in the context of labor applications.

 

WITNESSETH:

 

WHEREAS the Company desires to give its directors, officers, employees and consultants an added incentive to promote the growth of the Company through the participation in the equity of the Company;

 

WHEREAS, the Company desires to grant to Recipient an option to purchase the Units, on the terms and conditions hereinafter set forth;

 

NOW, THEREFORE, for and in consideration of the premises and the mutual agreements and covenants hereinafter set forth and of other good and valuable consideration, the receipt, adequacy and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

1.       GRANT OF OPTION. Subject to the terms and conditions of this Agreement, including the vesting provisions of Section 3 below, the Company hereby grants to Recipient the right and option (the “Option”) to purchase the Units, subject to the terms herein, including, without limitation, the vesting provisions set forth in Section 3 herein.

 

The Units which are subject to the Option are sometimes referred to herein as the “Option Units.”

 

 

2.       OPTION.

 

(a)       Option Price. The price to purchase each Option Unit shall be the Exercise Price.

 

(b)       Exercise of Option. Subject to subparagraph (f) hereof, Recipient may exercise this Option with respect to all or any portion of his vested Option Units at any time prior to the Expiration Date.

 

(c)       Manner of Exercise. This Option may be exercised by delivering written notice of exercise in the form of the Exercise Letter, a form of which is at Exhibit A, paying the purchase price set forth herein, and by delivering a completed Member Signature Page, a form of which is attached as Exhibit B, binding Recipient into the Operating Agreement to the Chief Executive Officer of the Company, in person, or by mail, postage prepaid, addressed to the attention of the Chief Executive Officer at the location at which the Company then maintains its principal office, and if so mailed, the date of mailing will be considered the date of exercise.

 

(d)       Person Who May Exercise Option. During the lifetime of Recipient, this Option shall be exercisable only by Recipient, or if Recipient is disabled, by his duly appointed guardian or legal representative.

 

(e)       Operating Agreement. In accordance with the Company’s Operating Agreement, all Units of the Company are subject to certain restrictions. Upon the exercise of an Option, Recipient (or his or her guardian, legal representative or personal representative, as applicable) agrees to execute and be bound by the terms and conditions of such Operating Agreement, as a precondition of being issued any Units.

 

(f)       Termination of Option. Notwithstanding any other provisions to the contrary, this Option, to the extent that it has not previously been exercised or that Recipient’s employment has been terminated for any reason, including termination by resignation or by reason of death or disability, prior to vesting (which will terminate this Option), will terminate upon the Expiration Date hereof.

 

3.       VESTING. The Option granted hereunder will vest as follows: while Recipient is employed by that Company, 1/6th will vest on the first day of the month that begins on or after the date 6 months after the Effective Date (the “Initial Vesting Date”), and, thereafter 1/36th will vest monthly on the first day of each month following the Initial Vesting Date for 30 months in equal 1/36th increments so that the Option will be fully vested on the first day of the month that begins on or after the date 36 months after the Effective Date. In the event of a Liquidity Event (defined below), the Option shall fully vest simultaneously with such Liquidity Event unless such Liquidity Event is as part of an Adjusting Event (defined in Section 5 below) with the intent of facilitating a public offering of securities of the Company. For purposes of this Agreement a “Liquidity Event” means (i) any transaction or series of related transactions by the Company or its equity holders in which a majority of the voting power of the members is transferred to one or more persons who were not previously equity holders of the Company, (ii) any merger or consolidation of the Company with or into any other entity, after which the members of the Company do not hold, either directly or indirectly, a majority of the voting equity of the surviving entity, or (iii) a sale of all or substantially all of the operating assets of the Company.

 

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4.       TRANSFERABILITY. This Agreement and any rights hereunder shall be nontransferable and nonassignable by Recipient, except that it may be transferred in the event of Recipient’s death to Recipient’s heirs.

 

5.       ADJUSTMENT OF UNITS. In the event of any recapitalization, reclassification, split-up or consolidation of, or other change in, the Units, or an exchange of the outstanding Units of the Company, in connection with a merger, consolidation, reincorporation or other reorganization of the Company for a different number of Units or for shares of stock or other securities of the Company or for Units or other securities of the other company (an “Adjusting Event”), then the Board of Directors shall, in such manner as they shall determine in their sole discretion, appropriately adjust the number of the Option Units or the number of Units or other securities that shall then be subject to this Option and/or the Exercise Price per Unit or share that must be paid thereafter upon exercise of this Option and may, in such manner as they shall determine in their sole discretion, modify this agreement to take into account the new structure and entity, including, without limitation, potentially binding the Option under an option plan as then approved or placing restrictions on the sale and/or registration of securities acquired under this Agreement.

 

6.       INVESTMENT REPRESENTATION. Recipient hereby represents, warrants and agrees that:

 

(a)       He understands the offer of Units under this Agreement is made pursuant to a claim of exemption from the registration provisions of the Securities Act of 1933, as amended (the “Act”) and applicable state securities law;

 

(b)       The Company is not obligated to issue Units upon exercise of this Option until there has been compliance with any Federal or state laws or regulations that the Company may deem applicable;

 

(c)       The Option Units will be purchased for his own account for investment purposes only and not with a view to resale or distribution thereof;

 

(d)       The Option Units may be unregistered and, if so, will be required to be held indefinitely, unless such Units are subsequently registered or an exemption from registration is then available; and

 

(e)       The Company is under no obligation to register the Option Units, to comply with any such exemption or to supply Recipient with any information necessary to enable him to make routine sales of such Units under Rule 144 or any other rule or regulation of the Securities and Exchange Commission.

 

7.       NO RIGHTS AS MEMBER OR TO EMPLOYMENT. The Recipient shall not have any interest in or membership rights with respect to any Units that are subject to this Option until such Units have been issued and delivered to Recipient pursuant to the exercise of this Option. Furthermore, this Option does not confer upon Recipient any rights of employment with the Company, including without limitation any right to continue in the employ of the Company, nor does it affect the right of the Company to terminate the services provided by Recipient as a Director of the Company at any time, with or without cause, or to continue or alter the terms of such services.

 

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8.       DRAG-ALONG PROVISIONS. The Company shall have the right, but not the obligation, to “call”, effective immediately prior to a Liquidity Event (defined below), any and all unexercised portions of the Option, as fully vested in accordance with Section 3 above, and to issue, subject to all terms and conditions of the Operating Agreement, to Recipient such Units to which Recipient would be entitled upon Recipient’s exercise of the fully vested Option. Upon the Company’s exercise of such call right, the Exercise Price under this Agreement for such Units shall be immediately due and payable to the Company, and the Company shall be entitled (i) to deduct such price from any amounts due to Recipient or (ii) to effect a redemption of such number of Units at fair market value (reasonably determined in the discretion of the Board of Directors) as shall be necessary to pay such purchase price. Notwithstanding any other provision of this Agreement, the purchase price of Units issued upon exercise of the Company’s call right shall be no greater than the fair market value of such Units. The Recipient agrees to execute such documentation as is reasonably requested to document the issuance of Units to Recipient, including, but not limited to, the Operating Agreement then in effect.

 

9.       WITHHOLDING TAXES. As a condition of exercise of this Option, the Company may, in its sole discretion, withhold or require Recipient to pay or reimburse the Company for any taxes which the Company determines are required to be withheld in connection with the grant or any exercise of this Option. The Recipient understands that the Option granted hereunder does not qualify for favorable tax treatment under Section 422 of the Internal Revenue Code as an “incentive stock option.”

 

10.       HEIRS AND SUCCESSORS. This Agreement and all terms and conditions hereof shall be binding upon the Company and its successors and assigns, and upon Recipient and his or her heirs, legatees and legal representatives.

 

11.       GOVERNING LAW. This Agreement shall be interpreted, governed, and enforced in accordance with the laws of the Commonwealth of Virginia, notwithstanding its choice of law principles. The invalidity or unenforceability of any portion hereof shall in no way affect the validity or enforceability of any other portion of this Agreement, and any portion held to be invalid or unenforceable shall be deemed modified, restricted, or omitted to the extent necessary to make this Agreement enforceable.

 

IN WITNESS WHEREOF, the Company has caused this Agreement to be executed by its duly authorized representative and Recipient has executed this Agreement, all as of the date and year first above written.

 

ADial Pharmaceuticals, LLC   Recipient
         
By:     By:  
  William B. Stilley, CEO     [NAME]

 

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Exhibit A

 

Option Exercise Letter

 

_____________, 20__

 

ADial Pharmaceuticals, L.L.C.

204 E. High St.

Charlottesville, VA 22902

Attention: CEO

 

Gentlemen:

 

In connection with my purchase of ______________ membership units (the “Units”) of ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “Company”) pursuant and subject to the terms and conditions of the option agreement between me and the Company dated __________________, (the “Option Agreement”) and the Company’s Operating Agreement of __________________, as amended (the “Operating Agreement”), I am delivering this investment letter. Unless otherwise defined herein, capitalized terms used in this investment letter shall have the same meanings ascribed to them in the Operating Agreement.

 

In connection with my acquisition of Units in the Company, I represent and warrant the following:

 

(1)       I understand that by virtue of this investment, I will have acquired a Membership Interest in the Company. Furthermore, I acknowledge that I have received a copy of the Operating Agreement and agree to be bound by the terms and conditions therein.

 

(2)       I have sufficient knowledge and experience in financial and business matters to be capable of evaluating the merits and risks of this investment and understand and acknowledge that my rights and privileges with respect to the Units, including, without limitation, any rights to transfer the Units, are all subject to the provisions of the Articles of Organization and the Operating Agreement of the Company, as the same may be amended from time to time.

 

(3)       I understand that this investment involves a high degree of risk because the Company has a limited operating history and that there is no guarantee of profitability or continued operation of the Company.

 

(4)       I am acquiring the Units pursuant to the terms of the Option Agreement entered into in connection with my serving as a Director of the Company. I acknowledge that I am able to bear the economic risk of this investment, and that I might have to hold the Units for an indefinite period of time, since the Units have not been registered. Furthermore, I acknowledge that I might have to bear a complete economic loss, in the event that the business does not succeed.

 

(5)       In making my decision to acquire Units of the Company, I have relied upon independent investigations made by me. I have taken the opportunity to examine any and all documents and, to the extent I have deemed necessary, to ask pertinent questions and receive answers, concerning the terms and conditions of my acquisition of such Units or any other matter pertaining to such investment, and to obtain any additional information necessary to verify the accuracy of the information given to me.

 

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Exhibit A

 

(6)       I understand that the Units will not be registered under the Securities Act of 1933, as amended (the “Act”), and that the Units that I acquire cannot be sold to any person except pursuant to the terms of the Operating Agreement and in full compliance with all applicable federal and state securities laws.

 

(7)       I understand that no federal or state agency has passed upon the Units or made any finding or determination concerning the fairness of this investment.

 

(8)       I am acquiring the Units for my own investment account and have no intention, agreement or arrangement to redistribute, divide, assign or transfer the Units or to sell them to any other person.

 

(9)       I have reviewed with my own tax advisors the immediate and prospective federal, state, local and foreign tax consequences of this investment, and I am relying solely on the statements of such advisors and not on the statements or representations of the Company or any of its agents with respect to such tax consequences or any other matter. I have not relied on any advice given by the Company’s legal counsel.

 

(10)       I have adequate net worth and means of providing for my current and future needs and possible contingencies and have no need for liquidity in this investment. My commitment to investments that are not readily marketable is not disproportionate to my net worth and my investment in the Units covered by this letter and will not cause my overall commitment to become excessive.

 

(11)       The foregoing representations and warranties shall survive my acquisition of the Units in the Company, and I agree to indemnify and hold harmless the Company and its directors, officers, agents and representatives, for and from any and all losses, liabilities, claims, damages and expenses, including, without limitation, attorneys fees and dispute costs, caused by my breach of any agreement, representation or warranty contained herein or as a result of the reliance of the Company or any other indemnities on such agreement, representation or warranty.

 

  Sincerely,  
     
  Signature:  
     
  Printed Name:  

 

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Exhibit B

 

ADIAL PHARMACEUTICALS, L.L.C.

MEMBER SIGNATURE PAGE

 

In consideration for the sale of LLC Units in ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “LLC”), by the LLC to the undersigned, the undersigned hereby approves and consents to, and agrees to be bound by, the terms of that certain operating agreement of the ADial Pharmaceuticals, L.L.C. effective _________________, as may be amended and/or restated from time to time (the “Operating Agreement”) and concurrently herewith enters into the Operating Agreement with all existing members of the LLC by executing and delivering to the LLC this Member Signature Page.

 

Upon the undersigned’s execution and delivery of this Member Signature Page, the undersigned’s delivery of all monies and/or other items required by management of the LLC, and acceptance of this Member Signature Page by the LLC, the undersigned shall become a Member of the LLC.

 

If the undersigned is purchasing LLC Units jointly with another, all such joint owners must execute this Member Signature Page.

 

Effective Date: ________________, 2017.

 

Member Name:     Co-Member Name (if applicable):
         
     
         
Signed:     Signed:  
Print:     Print:  

Title (if required):

   

Title (if required):

 
         
     

Fed. Tax ID/Social Security Number

 

Fed. Tax ID/Social Security Number

     

Address:

   

Address:

 
     
     
     
     
     
         
Email Address:     Email Address:  
         
     

 

  Accepted on behalf of ADial Pharmaceuticals, L.L.C.
     
  By:  
    William B. Stilley
    CEO

 

 

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EX-10.1 26 fs12017ex10-1_adialpharma.htm LICENSE AGREEMENT

Exhibit 10.1

 

 

 

 

LICENSE AGREEMENT

 

Between The

 

University of Virginia Patent Foundation

 

And

 

ADial Pharmaceuticals, L.L.C.

 

Effective

 

January 21, 2011

 

 

 

 

 

 

 

TABLE OF CONTENTS

 

Article 1 DEFINITION OF TERMS 4
1.1 “AC Agreement” 4
1.2 “Additional Inventions” 5
1.3 “Affiliate” 5
1.4 “Confidential Information” 5
1.5 “Equity” 5
1.6 “Field” 5
1.7 “Licensed Know-how” 5
1.8 “Licensed Patents” 6
1.9 “Licensed Product” 6
1.1 “Licensed Rights” 6
1.11 “Net Sales” 6
1.12 “Non-patent Countries” 7
1.13 “Patent Countries” 7
1.14 “Patenting Costs” 7
1.15 The terms “sale”, “sold” and “sell” 7
1.16 “Sublicensee” 7
1.17 “Sublicensing Revenue” 8
1.18 “UVA” 8
     
Article 2 GRANT 8
2.1 Grant to Licensee 8
2.2 Option to Additional Inventions. 8
2.3 Affiliate Rights 8
2.4 Right to Sublicense 9
2.5 Government Rights 9
2.6 Reservation by Licensor 9
     
Article 3 FINANCIAL CONSIDERATION 10
3.1 Issue Fee 10
3.2 Running Royalties 10
3.3 Third Party Royalties 10
3.4 Minimum Annual Royalties 11
3.5 Performance Milestone Payments 11
3.6 Sublicensing Payments 11
3.7 Equity Ownership 12
     
Article 4 DILIGENCE 12
4.1 Commercialization Program 12
4.2 Diligence Milestones 12
4.3 Diligence Reporting 13
     
Article 5 REPORTS AND RECORDS 13
5.1 Record Accounting 13
5.2 Product Reports 14
5.3 Payments 15
5.4 Financial Projections 15

 

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Article 6 PATENT PROSECUTION 15
6.1 Patent Prosecution 15
6.2 Patent Reimbursements 16
6.3 Infringement of Licensed Patents 17
6.4 Patent Extensions 18
     
Article 7 DURATION AND TERMINATION 18
7.1 Contract Term 18
7.2 Bankruptcy 19
7.3 Licensor Termination 19
7.4 Licensee Termination 20
7.5 Continued Obligations 20
7.6 Effect on Sublicenses 20
7.7 Survivability 20
     
Article 8 CONFIDENTIALITY 21
8.1 Confidential Information 21
8.2 Security 21
8.3 Publication 21
     
Article 9 GOVERNING LAW AND ARBITRATION 21
9.1 Law To Govern 21
9.2 Arbitration Proceedings 22
     
Article 10 INDEMNIFICATION AND INSURANCE 22
10.1 Licensee Indemnification 22
10.2 Extent of Insurance 23
10.3 Term of Insurance 24
10.4 Lapse of Coverage 24
10.5 Sublicensee Insurance 24
     
Article 11 REPRESENTATIONS AND WARRANTIES 25
11.1 No Encumbrances 25
11.2 Licensee Warranty 25
11.3 Licensor Warranty 25
11.4 Infringement Actions by 3rd Parties 25
11.5 Disclaimers 26
11.6 Limitation of Liability. 26
     
Article 12 PAYMENTS AND NOTICES 26
Article 13 ASSIGNMENT 27
Article 14 NON-USE OF NAMES 27
Article 15 EXPORT CONTROLS 28
Article 16 MARKING 28
Article 17 FORCE MAJEURE 28
Article 18 SEVERABILITY 29
Article 19 HEADERS 29
Article 20 BENEFIT AND WAIVER 29
Article 21 ENTIRE AGREEMENT 29
Appendix A Licensed Patents  

 

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ADIAL/UVAPF LICENSE AGREEMENT

 

This Agreement is entered into and made effective as of January 21, 2011 (the “Effective Date”) by and between the University of Virginia Patent Foundation (“Foundation”), a not-for-profit corporation of the Commonwealth of Virginia having its principal offices at 250 West Main Street, Charlottesville, VA, 29902; and ADial Pharmaceuticals, L.L.C. (“Adial”), a Virginia limited liability company having its principal offices at 1001 Research Park Drive, Suite 100, Charlottesville, VA 22911.

 

W I T N E S S E T H

 

WHEREAS, Foundation owns certain proprietary know-how, patent applications and/or patents (collectively, the “Licensed Rights”, as further defined below) pertaining to the treatment of addiction disorders filed on behalf of Bankole Johnson and co-inventors (the “Inventors”) at the University of Virginia (“UVA”, as further defined below);

 

WHEREAS, Adial wishes to hold an exclusive, worldwide license under the Licensed Patents and Licensed Know-how which will provide Adial with the exclusive right to make, use, import, offer to sell and sell Licensed Products in the Field, and Adial is committed to developing Licensed Products and to bringing such products to market; and

 

WHEREAS, Foundation is willing to grant such a license to Adial, in consideration of Adial’s satisfaction of its obligations hereunder, and for other good and valuable consideration as set forth hereinbelow.

 

WHEREAS, Adial Corporation, a Virginia corporation, (“AC”) and Foundation entered into an Adial/Foundation License Agreement of July 22, 2008, as amended on July 10, 2009 and March 15, 2010, (the “AC Agreement”), which was subsequently assigned by AC to Adial on December 6, 2010, which assignment was accepted by Foundation;

 

WHEREAS, Adial and Foundation wish to supersede the AC Agreement with this Agreement;

 

NOW, THEREFORE, in consideration of the premises set forth above and the mutual covenants set forth below, the parties hereto agree as follows:

 

Article 1
DEFINITION OF TERMS

 

1.1        “AC Agreement” shall have the meaning set forth in the preamble to this Agreement.

 

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1.2        “Additional Inventions” shall mean domestic and foreign patent applications and patents (including, without limitation, reissues or temporal extensions of same) on inventions conceived and discoveries made:

 

(a)which are assigned by UVA to Foundation;
(b)which are invented or discovered by Dr. Bankole A. Johnson and/or Dr. Ming Li;
(c)which are relevant to the Field;
(d)for which Adial has timely exercised its option to include such patent applications and patents hereunder, which option is provided for in Section 2.2; and
(e)which are invented within three (3) years after the Effective Date.

 

1.3        “Affiliate” shall mean any affiliate that Adial authorizes to practice under the Licensed Rights; “affiliate” shall mean any legal entity that controls, is controlled by, or is under common control with Adial. The term “control” shall mean possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting securities, by contract, or otherwise. The term “entity” includes without limitation any individual, corporation, or other organization.

 

1.4        “Confidential Information” shall mean any information exchanged between Foundation and Adial, its Affiliates and Sublicensees, either orally or in writing or other tangible medium other than that which (i) is or becomes known to the public without fault of the party receiving the information; (ii) the receiving party can establish from documentary evidence that it knew prior to the receipt of the same from the disclosing party; (iii) is obtained without obligation of confidentiality from a third party having the right to disclose same without breach of any obligation of confidentiality to the disclosing party; (iv) is independently developed by the receiving party without regard to the information disclosed to it.

 

1.5        “Equity” shall mean stock, membership interests, partnership interests, options, warrants, and other forms of equity securities convertible into any of the foregoing in Adial or its assets, as may be in existence or issued from time to time by Adial and/or its successors and/or assigns.

 

1.6        “Field” shall mean the field of human or animal therapeutic, prophylactic, diagnostic and/or other medical use.

 

1.7        “Licensed Know-how” shall mean all proprietary information, trade secrets (as defined by the Uniform Trade Secrets Act) and tangible research property (including biological materials, chemical compounds, prototypes and other research tools) necessary or useful for practicing the Licensed Patents or developing, making, using, or selling Licensed Products that is discovered or developed by the Inventors or personnel under their supervision in their laboratories and which is (i) within the Field, (ii) not subject to the rights of any third parties due to obligations originating prior to the Effective Date (other than those of the United States Government as set forth in 35 U.S.C. §§200-206, 37 C.F.R. Part 401) or research sponsor restrictions, and (iii) owned or controlled by Foundation. For clarity, Licensed Know-how includes, without limitation, clinical and non-clinical data and regulatory filings developed by the Inventor or their clinics or laboratories.

 

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1.8         “Licensed Patents” shall mean the patents and/or patent applications listed in Appendix A, all patent applications (domestic and foreign) directly or indirectly claiming priority to the same (except that for continuation-in-part applications, only those claims that are entitled to the priority filing date of any of the above-referenced patents or applications), and all patents issuing therefrom, including, without limitation, reissues, extensions and re-examinations.

 

1.9         “Licensed Product” shall mean any product in the Field that (i) is covered by (in whole or in part), or is made, uses a process covered by (in whole or in part), one or more pending or issued claim in one or more of the Licensed Patents (including reissues and re-examinations), and/or (ii) embodies, contains, uses, is used or made through the use of, or was in whole or in part derived from the Licensed Know-how.

 

1.10        “Licensed Rights” shall mean collectively the Licensed Patents and Licensed Know-how.

 

1.11        “Net Sales” shall mean the amounts received by Adial and its Affiliates and Sublicensees from the manufacture or use of Licensed Products, or the sale, offer to sell or importation of Licensed Products, less (i) discounts or rebates actually allowed from the billed amount, (ii) credits or allowances actually allowed upon claims or returns, (iii) rebates, credits, and chargeback payments (or the equivalent thereof) granted to managed health care organizations, wholesalers, or to federal, state/provincial, local and other governments, including their agencies, purchasers, and/or reimbursers, or to trade customers, (iv) taxes or other government charges imposed with respect to the sale of such Licensed Products, and (v) shipping and insurance charges as separately itemized in invoice. For non-cash and partial-cash sales, Net Sales shall include the fair market value of non-cash consideration received for such sale of the same quantity of Licensed Products. For sales not at arms-length, Net Sales shall be equal to the fair market price of such Licensed Products as when transferred in comparable arms-length transactions. Notwithstanding the foregoing, Net Sales shall not include, and shall be deemed zero with respect to, (1) the distribution of reasonable quantities of Licensed Products for use as free promotional samples, and if distributed by an Affiliate or Sublicensee, for which Adial receives no royalty payment, (2) Licensed Products provided for research, development, or compassionate use purposes at or below documented actual cost, or (3) Licensed Products provided by Adial to a Sublicensee or Affiliate provided that Net Sales by such Sublicensee or Affiliate are subject to royalties under Section 3.2.

 

Notwithstanding the foregoing, in the event that a Licensed Product is sold by Adial, an Affiliate thereof, or a Sublicensee in combination or a bundle with other products or services (such combination or bundle, a “Bundled Product”), Net Sales shall be calculated by multiplying the Net Sales for such Bundled Product by the fraction, A/(A+B), where A is the average sale price, during the royalty-paying period in question, of the subject Licensed Product sold or used separately, and B is the average sale price during the royalty-paying period in question, of the other products, processes or services in the Bundled Product sold separately. If no separate sales are made of the subject Licensed Product or of the other products, processes or services in such Bundled Product during the royalty-paying period in question, Net Sales for the purposes of determining royalty payments with respect to such Bundled Product shall be commercially reasonable and determined by good faith negotiation between the parties based on the relative value(s) of the various constituents of such Bundled Product and the portion thereof represented by the Licensed Product(s) included therein. If the parties cannot agree, then the matter shall be submitted to an arbitrator per Section 9.2 herein for final determination.

 

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1.12        “Non-patent Countries” shall mean all countries of the world other than Patent Countries. A country in which a patent application is filed, but such application is withdrawn or abandoned by Foundation in good faith prior to the issuance of a corresponding patent, shall become a Non-patent Country upon such withdrawal or abandonment. A country in which a patent issues but such patent is abandoned in good faith by Foundation shall become a Non-patent Country upon such abandonment.

 

1.13        “Patent Countries” shall mean countries for which the Licensed Patents cover or previously covered the Licensed Product at issue or its method of manufacture or use and include at least one (i) pending patent application, (ii) issued and unexpired patent, or (iii) issued patent that has expired at the end of its full term or has been invalidated, revoked, or otherwise been rendered unenforceable during its term (other than via abandonment or withdrawal by Foundation in good faith).

 

1.14        “Patenting Costs” shall mean any reasonable, documented past or ongoing costs incurred or to be incurred, including government fees and attorneys’ fees, in the course of preparing, filing, prosecuting and maintaining any of the Licensed Patents, including continuations, re-examinations, reissues and appeals.

 

1.15        The terms “sale”, “sold” and “sell” as used in this Agreement include without limitation, sales, leases, licenses, rentals and other modes of distribution or transfer of a product or its beneficial use.

 

1.16        “Sublicensee” shall mean any non-affiliated third party to whom Adial has granted a Sublicense. “Sublicense” shall mean an agreement in which Adial (i) grants a license to any of the rights to Licensed Patents, (ii) agrees not to assert such rights or to sue, prevent or seek a legal remedy for the practice of same, (iii) assigns or otherwise transfers this Agreement and/or the rights acquired by it (except for transfers or assignments resulting from acquisitions, mergers, consolidations, reorganizations, or other transfers or similar transactions as specified in Article 13 Assignment hereinbelow), or (iv) is under an obligation to grant, assign or transfer any such rights (except for transfers or assignments resulting from acquisitions, mergers, consolidations, reorganizations, or other transfers or similar transactions as specified in Article 13 Assignment hereinbelow) or non-assertion, or to forebear from granting or transferring such rights to any other entity, including licenses, option agreements, right of first refusal agreements, or other agreements. For clarity, selling products to third parties, including without limitation, end users, distributors, and the like, will not be considered a sublicense.

 

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1.17        “Sublicensing Revenue” shall mean the fair market cash value of any and all non-running royalty consideration received by Adial from Sublicensees in connection with the grant of rights to the Licensed Patents under its Sublicenses, including without limitation license issue fees, option fees and other licensing fees, milestone payments, minimum annual royalties, equity or other payments of any kind whatsoever (but excluding running royalties paid for, and other payments calculated on the basis of, Net Sales of Licensed Products by Sublicensees), irrespective of whether such revenues are received in the form of cash, barter, credit, stock, warrants, release from debt, goods or services, licenses back, a premium on the sale of Equity (i.e., payments for Equity that exceed the then-current fair market value of the Equity), equity exchanges (where the value attributed to Equity is greater than the then-current fair market value), or any other form whatever. Sublicensing Revenue shall exclude purchases of equity or debt of Adial at or below fair market value, payments made for actual manpower, overhead, material costs, and out-of-pocket or third party costs and expenses in carrying out research and development projects as reasonably detailed in collaboration or research agreements.

 

1.18        “UVA” shall mean the University of Virginia, its governors, trustees, officers, agents, employees, faculty, staff and students.

 

Article 2
GRANT

 

2.1Grant to Licensee

In consideration of Adial’s satisfaction of its obligations hereunder, Foundation hereby grants to Adial the exclusive, worldwide license in the Field under its interest in and to the Licensed Patents, and a non-exclusive worldwide license in the Field under the Licensed Know-how in each case to make, have made, use, offer to sell, sell and import Licensed Products throughout the term hereof.

 

2.2Option to Additional Inventions.

With respect to inventions conceived and discoveries made which are Additional Inventions that may be the subject of a patent application or patent, Foundation shall give written notice to Adial of same. Adial shall have an irrevocable option, exercisable by written notice within ninety (90) days of receiving such notice from Foundation, to elect to include such new patent application and/or patent within the Licensed Patents hereunder (i.e. add by amendment to Appendix A). If Adial does not exercise such option within ninety (90) days, Foundation shall be free to license same to third parties, exclusively or otherwise, without any obligation to Adial therefor.

 

2.3Affiliate Rights

The rights licensed to Adial hereunder, except for the right to sublicense granted in the following paragraph, shall be extended to Affiliates designated in writing by Adial, provided that each such Affiliate first agrees in writing to be bound by the terms and conditions of this Agreement. Adial shall deliver to Foundation a copy of said writing within thirty (30) days of its execution. Adial agrees to be fully responsible for the performance of such Affiliates hereunder.

 

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2.4Right to Sublicense

Adial shall have the right to sublicense any or all of the rights licensed hereunder to non-affiliated third parties, provided that (i) each Sublicense contains terms and conditions functionally equivalent to those set forth in the Government Rights, Reservation by Licensor, and Patent Extensions paragraphs and in the Marking, Export Control, Non-Use of Names, and Severability articles of this Agreement; (ii) that each Sublicense is otherwise consistent with, and contains provisions reasonably sufficient to enable Adial to comply with, the terms and conditions of this Agreement; (iii) a copy of each Sublicense is provided to Foundation promptly following its execution, together with a written statement disclosing any and all material prior and contemporaneous contractual relationships between Adial and the Sublicensee; and (iv) Adial represents and warrants that no such other contractual relationships contain consideration to Adial reasonably attributable to the sublicensing of the Licensed Rights. Adial acknowledges that failure of a Sublicensee to satisfy the obligations of this Agreement named above or otherwise applicable to such Sublicensee will, absent corrective action by Adial, construe breach hereof.

 

2.5Government Rights

Notwithstanding anything herein to the contrary, any and all licenses and other rights granted hereunder are limited by and subject to the rights and requirements of the United States Government (“Government”) which may attach as a result of Government sponsorship of research at UVA in which one or more inventions covered by the Licensed Patents was conceived or reduced to practice, as set forth in 35 U.S.C. §§200-206, 37 C.F.R. Part 401 and in the relevant Government research contracts with UVA, and as such rights and requirements may be amended or modified by law. To the extent applicable, such rights and requirements include without limitation (i) the grant of a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the Government any of the Licensed Patents throughout the world (as set forth in 35 U.S.C. §202(c)(4)), and (ii) the requirement that Licensed Products used or sold in the United States will be manufactured substantially in the United States (as set forth in 35 U.S.C. §204).

 

2.6Reservation by Licensor

Notwithstanding anything herein to the contrary, the above grant is subject to a reservation of rights by Foundation for itself and UVA to practice under the Licensed Rights solely for educational, not-for-profit research, patient care and treatment, and other internal, noncommercial purposes, provided that the exercise of such reserved rights by Foundation shall not (i) be on behalf of, sponsored with funding received from, or subject to any intellectual property rights granted to any commercial third party nor (ii) include any human use or clinical administration without prior written approval from Adial. Foundation further excludes from the license granted herein the right to bring an infringement action against, seek monetary damages from, or seek an injunction against, any Inventor or their present or future not-for-profit employers even after such employment has ended, for infringement of any of the Licensed Rights in carrying out not-for-profit research. Nothing herein shall be construed to require Foundation to bring any such action against any such party. Such reservation shall further include the right to provide Licensed Know-how, and to grant licenses under the Licensed Patents, to not-for-profit and governmental institutions solely for their internal research and scholarly use only, in accordance with the NIH Guidelines for Obtaining and Disseminating Biomedical Research Resources (as published in the U.S. Federal Register / vol 64, No. 246 – 12/23/99).

 

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Article 3
FINANCIAL CONSIDERATION

 

In consideration of the rights, privileges, and licenses granted hereunder, Adial shall pay royalties and other consideration to Foundation in the manner hereafter provided:

 

3.1Issue Fee

A license issue fee of one hundred thousand dollars (U.S. $100,000) shall be paid to Foundation in the form of Equity in ADial in accordance with Section 3.7 below.

 

3.2Running Royalties

Throughout the term of this Agreement, Adial shall pay quarterly to Foundation, on a Licensed Product-by-Licensed Product and country-by-country basis, a running royalty in an amount equal to:

 

A.Two percent (2%) of Net Sales of Licensed Products sold in Patent Countries in such quarter; and
B.One percent (1%) of Net Sales of Licensed Products sold in Non-patent Countries in such quarter.

 

No multiple running royalties shall be payable because the Licensed Product, or the manufacture or use thereof, are or shall be covered by more than one Licensed Patent, or by both Licensed Patents and Licensed Know-how. Adial’s obligation to pay running royalties shall end on a Licensed-Product-by-Licensed Product and country-by-country basis according to the Term as defined in Section 7.1.

 

3.3Third Party Royalties

In the event that (a) a Licensed Product is deemed by a final, unappealable decision of a court of competent jurisdiction to infringe a claim of a patent(s) owned or controlled by a third party in any given country, and Adial, an Affiliate thereof, or any Sublicensee licenses such patent(s) in settlement of such claims, or to avoid future such claims, or (b) Adial, an Affiliate thereof, or any Sublicensee reasonably determines that it is necessary for freedom to operate to pay royalties to a third party to obtain a license to practice any third party’s rights in order to manufacture, use, commercialize or develop a Licensed Product in any given country, then Adial may deduct an amount equal to fifty percent (50%) of any fees, milestones or royalties due to such third parties for such rights (or such amounts paid by Adial, its Affiliate, or any Sublicensee in settlement of any infringement action) from any amounts due Foundation under Sections 3.2 and 3.6, provided that the amounts due under Sections 3.2 and 3.6 shall never be reduced by more than fifty percent (50%) by the effects of this paragraph in any event.

 

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3.4Minimum Annual Royalties

For the 2017 calendar year and each subsequent calendar year during the term of this Agreement, ADial shall pay to Foundation a Minimum Annual Royalty payment in the amount of forty-thousand dollars (U.S. $40,000) annually. Adial shall make such payment to Foundation within sixty (60) days of the end of the calendar year in which it is due. For each calendar year, the payments paid to Foundation under Section 3.2 Running Royalties for such calendar year’s Net Sales, Sublicensing Revenue, and performance milestones achieved shall be creditable against the Minimum Annual Royalty due under this Section 3.4 (i.e. amounts shall be due under this Section 3.4 only to the extent the amount specified below exceeds the amounts paid or payable pursuant to Sections 3.2, 3.5, and 3.6 for a particular calendar year’s Net Sales, Sublicensing Revenue, and performance milestones).

 

3.5Performance Milestone Payments

Adial shall pay to Foundation the following performance milestone amounts:

 

A.A milestone payment of one hundred seventy-five thousand dollars (U.S. $175,000) upon initiation of Phase III clinical trials (defined as the dosing of the first patient) for the first Licensed Product by or on behalf of Adial, an Affiliate, or Sublicensee; and

 

B.A milestone payment of two hundred seventy-five thousand dollars (U.S. $275,000) upon filing and acceptance for review of a New Drug Application with the FDA by or on behalf of Adial, an Affiliate, or Sublicensee for the first Licensed Product.

 

C.A milestone payment of one million dollars (U.S. $1,000,000) upon approval for sale (including marketing and/or reimbursement approval, where applicable) of the first Licensed Product by the regulatory authority in the U.S., the European Union or Japan.

 

Fifty percent (50%) of the above milestone payments shall be due for the second Licensed Product to achieve each milestone. Licensed Products are considered different Licensed Products if they have a different active ingredient(s).

 

Adial shall promptly provide Foundation with commercially reasonable evidence of Adial having achieved each of the above-defined Performance Milestones.

 

3.6 Sublicensing Payments

Adial shall pay to Foundation fifteen percent (15%) of Sublicensing Revenues. However, Adial shall pay a running royalty on Net Sales of Licensed Products by Sublicensee under the Running Royalties paragraph hereinabove, and not under this paragraph.

 

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3.7Equity Ownership

Adial shall transfer to Foundation four percent (4%) of the Equity in Adial in existence as of the Effective Date. Such Equity shall be issued to Foundation in the form of common stock (or the equivalent limited liability company membership interest). The parties agree that such Equity is valued at one hundred thousand dollars ($100,000) as of the Effective Date, which shall be the date of the transfer of such Equity, and that transfer of such Equity fully satisfies the Issue Fee payment due under Section 3.1 above. The transfer of such Equity to Foundation shall be made in accordance with the terms and conditions of an Equity subscription agreement having commercially reasonable terms and conditions, the drafting of which shall be the responsibility of Adial, to be executed on the Effective Date. Said Equity subscription agreement shall contain provisions for, among others, the right for Foundation to have its shares registered by “piggyback” on any public offering which may be made, subject only to “lock-up” and other restrictive provisions that are no more restrictive than those binding any other comparable pre-offering Equity holder.

 

Article 4
DILIGENCE

 

4.1Commercialization Program

Adial shall use commercially reasonable efforts to bring at least one Licensed Product to market through a diligent commercialization program, which program shall include but not be limited to the development, marketing, promotion, distribution and sale of such Licensed Products. A report of Adial’s efforts, and progress made, in bringing Licensed Products to market shall be provided to Foundation in accordance with the Diligence Reporting paragraph below. For purposes of this Article 4, the acts of Adial’s Affiliates and Sublicensees and any other collaborators of Adial shall be deemed the acts of Adial for purposes of satisfying Adial’s obligations hereunder.

 

4.2Diligence Milestones

In partial satisfaction of its obligations under the previous paragraph, Adial shall use commercially reasonable efforts to achieve the following commercial goals (the “Milestones”) by the dates set forth below (the “Milestone Dates”):

 

A.Initiate FDA Phase III clinical trials for a Licensed Product by July 1, 2014; and

 

B.Submit a New Drug Application with the FDA for a Licensed Product by July 1, 2016.
   
C.Achieve first commercial sale of a Licensed Product by July 1, 2017.

 

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4.3Diligence Reporting

Throughout the course of commercial development of Licensed Products by Adial, its Affiliates and Sublicensees, Adial shall provide Foundation with reasonably detailed confidential periodic summary reports evidencing its efforts in, progress made, and future plans for, its development of Licensed Products and bringing same to market (such reports to be provided no less frequently than once per year, the first report to be due within 12 months after the Effective Date). In addition, Adial shall provide to Foundation commercially reasonable evidence of Adial having achieved each of the above-defined commercial Milestones within thirty (30) days after the corresponding Milestone Date set forth above. Should Adial fail to achieve a Milestone by the relevant Milestone Date, Adial shall, within thirty (30) days after the Milestone Date, provide Foundation with commercially reasonable evidence of the existence of a reasonable, good-faith business or technical justification for such failure. Provided that Adial has made such a showing, Foundation and Adial shall then negotiate in good faith to reasonably adjust the Milestone Date to take into consideration the reason for such failure. Should Adial and Foundation be unable, within a reasonable period of time, to reach agreement on such an adjustment, or agreement regarding whether such an adjustment is warranted, Adial and Foundation hereby agree to submit the matter to binding arbitration in accordance with the arbitration provisions set forth hereinbelow, and the arbitrators shall determine (i) whether an adjustment of the Milestone Date is warranted (which shall be determined in the affirmative if the reasons asserted by Adial are found to have been made in good faith, the evidence provided by Adial is found to be reasonable, and the reasons asserted are found, using reasonable business judgment, to justify the delay) and, if adjustment is warranted, (ii) what the adjusted Milestone Date should be. However, Adial’s failure to achieve any Milestone by the Milestone Date for same, followed by Adial’s failure to timely provide commercially reasonable evidence of the existence of a reasonable, good-faith business or technical justification for such failure, or followed by the arbitrators’ finding that an adjustment of the Milestone Dates is not warranted, shall constitute a breach of this Agreement; and upon such occurrences Foundation shall have the right, but not the obligation, to terminate this Agreement in accordance with the termination provisions set forth below.

 

Article 5
REPORTS AND RECORDS

 

5.1Record Accounting

Adial shall keep complete and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to Foundation by Adial hereunder, and for otherwise verifying Adial’s performance hereunder. Such books of account shall be kept at Adial’s principal place of business, and shall be maintained for at least five (5) years following the end of the reporting period to which they pertain. Such books and the supporting data shall be open at all reasonable times to the inspection by Foundation’s internal auditing personnel, and/or an independent certified public accountant retained by Foundation and/or employed by Foundation, for the purpose of verifying Adial’s royalty statement or compliance in other respects with this Agreement. Such examinations shall be made during reasonable business hours, and not more than once during each calendar year. Adial shall also provide itself with a comparable right of audit of each Affiliate and Sublicensee, and Adial shall audit each Affiliate and Sublicensee upon Foundation’s request, provided that, with respect to each Sublicensee, Adial shall not in any event be required by any such request to audit any particular Sublicensee more than once during each calendar year. The results of any audit of any Affiliate or Sublicensee will be subject to inspection by Foundation’s auditors. Should any of the foregoing examinations reveal an underpayment by Adial, Adial shall immediately pay to Foundation the underpaid amount and interest due thereon (as provided for herein). Should the underpayment be more than five percent (5%) of the total amount due with respect to the audited period, then Adial shall bear the reasonable, documented cost of such examination, including accountant’s fees and expenses, and Adial shall promptly reimburse Foundation for all such audit costs.

 

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5.2Product Reports

Within sixty (60) days of the end of each calendar quarter following the date of the first commercial sale of a Licensed Product, Adial shall deliver to Foundation complete and accurate reports, giving such particulars of the business conducted by Adial and its Affiliates and Sublicensees during the preceding three-month period under this Agreement as shall be pertinent to a royalty accounting hereunder. These reports shall include at least the following:

 

A.The numbers of each Licensed Product sold by Adial and each Affiliate and Sublicensee;

 

B.Total receipts for Licensed Products sold by Adial and each Affiliate and Sublicensee;

 

C.Deductions applicable as provided in the definition of Net Sales;

 

D.Total royalties due to Foundation;

 

E.Names and addresses of all Sublicensees of Adial;

 

F.Payments and other consideration received from each Sublicensee, as further described in the definition of Sublicensing Revenues; and

 

G.Payments due to Foundation under the Sublicensing Payments paragraph hereinabove.

 

In addition to the foregoing reports, Adial shall deliver annually a report containing Adial’s financial statements for the preceding twelve (12) months including, at a minimum, a balance sheet and an operating statement. Such reports shall be considered Confidential Information, and shall be subject to the confidentiality provisions contained herein. Furthermore, at any time during the term of this Agreement, in the event that Adial or an Affiliate no longer qualifies as a “small entity” (as defined in 37 C.F.R. 1.27), or if Adial sublicenses any Licensed Rights to a Sublicensee that is not, or at some point does not, qualify as a “small entity”, Adial shall promptly notify Foundation of same.

 

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5.3Payments

With each quarterly report submitted, Adial shall pay to Foundation the royalties and other payments due and payable under this Agreement. If no royalties shall be due, Adial shall so report. Payments shall be paid in United States Dollars in Charlottesville, Virginia, or at such other place as Foundation may reasonably designate consistent with the laws and regulations controlling in any foreign country. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate stated in the Wall Street Journal on the last business day of the calendar quarterly reporting period to which such royalty payments relate, and all transfer fees in connection with payment shall be borne by Adial. All payments shall be made within sixty (60) days after the end of the calendar quarter in which they became due and payable to Foundation. Any amounts due hereunder (except for the Past Patenting Costs) which are unpaid sixty (60) days after the end of the calendar quarter shall bear simple interest accrued at the annual rate of twelve percent (12%). Any taxes required to be withheld by Adial from payments otherwise due hereunder in order to comply with the tax laws of the United States or any other country shall be promptly paid by Adial to the appropriate tax authorities, the amount payable to Foundation under this Agreement shall be reduced by the amount withheld or paid for taxes on such payment amounts, and Adial shall furnish Foundation with original official tax receipts or other appropriate evidence issued by the appropriate tax authorities sufficient to enable Foundation to support a claim for income tax credit or refund in respect of any sum so withheld. In each country where the local currency is blocked and cannot be removed from the country under such country’s applicable law, royalties accrued in that country shall be paid to the Foundation in the country in local currency by deposit in a local bank designated by the Foundation, unless the parties otherwise agree.

 

5.4Financial Projections

To assist Foundation in projecting its future incomes, beginning when royalties are first paid, Adial shall provide Foundation with copies of any projections of Net Sales prepared for its annual financial statements or provided to actual or potential investors during the preceding calendar year within three (3) months of the end of each calendar year. Foundation acknowledges that such projections are speculative, and that Adial shall have no liability for Foundation’s reliance on same. Foundation agrees that such projections will be considered Confidential Information, and shall be subject to the confidentiality provisions contained herein.

 

Article 6
PATENT PROSECUTION

 

6.1Patent Prosecution

 

6.1.1.      Foundation is the owner of the Licensed Patents, and shall have exclusive responsibility for the preparation, filing, prosecution and maintenance of the Licensed Patents, including choice of patent counsel. However, Foundation shall keep Adial fully informed of patent prosecution, will seek Adial’s comments and suggestions prior to taking material actions for the same, and will take all prosecution actions reasonably recommended by Adial which would expand the scope or term of rights sought. Foundation will also authorize Adial to communicate directly with Foundation’s patent counsel. The parties shall cooperate with each other to insure that each Licensed Patent reflects and will reflect, to the extent practicable and to the best of Adial’s and Foundation’s knowledge, all items of commercial interest to Adial. Adial will cover all of Foundation’s Patenting Costs, in accordance with the Patent Reimbursements paragraph below. Amounts paid to Foundation to cover Patenting Costs shall first be applied to outstanding Patenting Costs in the order in which they were accrued.

 

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6.1.2.      All information exchanged between Foundation’s counsel, the parties and/or the Inventors regarding preparation, filing, prosecution or maintenance of the Licensed Patents shall be deemed Confidential Information.  In addition, the parties acknowledge and agree that, with regard to such preparation, filing prosecution and maintenance of the Licensed Patents, the interests of the parties as licensor and licensee are to obtain the strongest and broadest patent protection possible, and as such, are aligned and are legal in nature.  The parties agree and acknowledge that they have not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning the Licensed Patents, including without limitation, privilege under the common interest doctrine and similar or related doctrines.

 

6.2Patent Reimbursements

 

6.2.1.      Ongoing Patenting Costs: For any Patenting Costs to be incurred by counsel retained by or employed by Foundation, Foundation or its counsel shall inform Adial (either orally or in writing, including via email) of all material actions necessary for the filing, prosecution, issuance and maintenance of such Licensed Patents, together with an estimate of Patenting Costs for same. Adial shall promptly instruct Foundation in writing whether to take such action at Adial’s expense.

 

A.For prosecution and maintenance of foreign applications and patents, if instruction to take such action is given, Adial’s written response shall be accompanied by payment of all of the estimated Patenting Costs to Foundation’s counsel, unless Adial has previously made arrangements with counsel to pay such Patenting Costs in a manner acceptable to Foundation. Adial shall remit payment of the balance of the actual Patenting Costs incurred within thirty (30) days after its receipt of invoices for such actual Patenting Costs; if the portion of such Patenting Costs paid in advance by Adial exceeds actual Patenting Costs incurred, the overpayment shall be credited toward future Patenting Costs or promptly refunded to Adial, as elected by Adial in its sole discretion.

 

B.For prosecution or maintenance of U.S. applications or patents, Adial shall reimburse Foundation or its counsel within thirty (30) days after its receipt of the invoices for Patent Costs incurred.

 

Payments directly to Foundation’s counsel are made with the understanding that such payments do not create an attorney-client relationship between Adial and such counsel. Time is of the essence with respect to such payments.

 

If Foundation does not receive from Adial written instruction to take a material action to protect a Licensed Patent within thirty (30) days of the statutory bar date for such material action, and if the Licensed Patent is a foreign application or patent, verification from Adial that estimated Patenting Costs have been received by Foundation’s counsel, Foundation shall have no obligation to take or have taken such material action to protect the Licensed Patent at issue, even if the result is the irrevocable loss of rights. If Adial does not provide written instructions to take a material action to protect a Licensed Patent within thirty (30) days of any statutory bar date or, with respect to any foreign application or patent, verify that any above-referenced estimated Patenting Costs have been received by Foundation’s counsel, Foundation shall have the right to (i) abandon some or all of such patents or patent applications at Foundation’s sole discretion or (ii) incur those costs at its own expense, and Foundation will notify Adial of its intent when Foundation makes its decision. In either case, Foundation shall have the right, upon ten (10) days written notice to Adial, to exclude such patents or patent applications from the definition of Licensed Patents and licenses granted hereunder, and Foundation shall be free to license rights to such patents or patent applications to third parties without any further obligation to Adial.

 

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6.2.2.      Unpaid Patenting Costs: Any amounts due hereunder that remain unpaid thirty (30) days after Adial receives an invoice from Foundation or its counsel for same shall bear simple interest accrued at the annual rate of twelve percent (12%) from the date such payment first became due. In addition, after said thirty (30) days, Foundation shall thereafter have the right to take action to terminate this Agreement in accordance with the Licensor Termination paragraph below. However, nothing herein shall be construed to release Adial from any obligations to reimburse or pay Patenting Costs that matured prior to the effective date of termination of this Agreement in accordance with the Licensor Termination paragraph.

 

6.2.3.      Past Patenting Costs: Within thirty (30) days after the Effective Date, Adial shall reimburse Foundation for any Patenting Costs incurred by Foundation prior to the Effective Date that have not been previously reimbursed by AC or Adial.

 

6.3Infringement of Licensed Patents

If either party believes that any of the rights granted hereunder are being or have been infringed by a third party, such party shall notify the other of such belief, and as part of such notice shall provide copies of all documentary evidence of the alleged infringement. Except in the limited cases for which Foundation has excluded from the license the right to bring an infringement action against Inventors and their not-for-profit institutions in the Reservation by Licensor paragraph above, Adial shall have the first option to bring an infringement action against the alleged infringer at Adial’s sole expense. If Adial exercises its option, which shall be made in writing within one hundred and eighty (180) days after the parties’ receipt of said notice of infringement, Foundation will cooperate as requested by Adial (including but not limited to Foundation being joined as a party to any such action), and will be compensated by Adial for its reasonable, documented out-of-pocket expenses, which Foundation will only be required to expend if Adial has approved same for reimbursement.

 

Adial shall be free to enter into any settlement, consent judgment, or other voluntary disposition of any such matter, provided that no settlement, consent judgment, or other voluntary final disposition of such suits that materially adversely affects the Licensed Patents or admits fault or wrongdoing on the part of Foundation may be entered into without the consent of Foundation, which consent shall not be unreasonably withheld. Foundation shall provide Adial notice of such consent or denial of such consent within ten (10) days of any request for consent by Adial, provided that in the event Foundation wishes to deny such consent, such notice shall include a written description of Foundation’s reasonable objections to the proposed settlement, consent judgment, or other voluntary disposition. If Foundation has not consented within ten (10) days or has denied such consent, Adial will meet with Foundation in Charlottesville, VA, to discuss the proposed settlement, consent judgment, or other voluntary disposition. If, after such meeting, Foundation has not provided notice of its consent, the parties will submit any disputes over the reasonableness of Foundation’s objections to expedited, single-arbitrator arbitration in Washington, D.C. No discovery will be allowed, and each party will have one (1) hour to present its case to the arbitrator

 

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Any damages paid (including without limitation statutory damages, compensatory damages, lost profits damages, exemplary damages, increased damages, and awards of costs and attorney’s fees) or amounts received in settlement with respect to, in either case, the infringement of the Licensed Patents shall first be applied to the reimbursement of Adial’s reasonable costs, expenses and legal fees, including amounts Adial has reimbursed to Foundation. The remaining balance of such damages or amounts received shall be retained by Adial and treated as Sublicensing Revenue subject to payments under Section 3.6 (with the date of such settlement or disposition being deemed the “point at which the Sublicense is executed” for purposes of determining payments due under Section 3.6). In the event that Adial does not timely exercise its option to bring or pursue an infringement action against an alleged infringer, Foundation shall have the right (but not the obligation) to do so at its sole expense, and to retain all recovered damages. In such instances Adial will cooperate as requested by Foundation, and will be reimbursed by Foundation for its reasonable out-of-pocket expenses, which Adial will only be required to expend if Foundation has approved same for reimbursement.

 

In the event of any challenge to the validity of any Licensed Patent (or similar proceeding), Adial will have the right to participate (at its own expense) in the proceedings.

 

6.4Patent Extensions

Adial and Foundation agree that the Licensed Patents shall be extended by all means provided by law or regulation, including without limitation extensions provided under U.S. law at 35 U.S.C. §§154(b) and 156. Adial hereby agrees to provide Foundation with all necessary assistance in securing such extensions, including without limitation, providing all information regarding applications for regulatory approval, approvals granted, and the timing of same. Adial acknowledges that extensions under 35 U.S.C. §156 must be applied for within sixty (60) days of the date that a Licensed Product receives permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use, and that Adial’s failure to promptly provide the necessary information or assistance to Foundation during such sixty day period will cause serious injury to Foundation, for which Adial will be liable at law.

 

Article 7
DURATION AND TERMINATION

 

7.1Contract Term

The term of this Agreement (the “Term”) shall commence on the Effective Date and shall continue, on a country-by-country and Licensed Product-by-Licensed Product basis:

 

(i) in each Patent Country until the expiration, abandonment, withdrawal, invalidation, revocation, or otherwise rendering unenforceable of the last to expire or be revoked, abandoned, withdrawn, invalidated, or otherwise rendered unenforceable of the Licensed Patents covering the Licensed Product in such country (except when a Patent Country becomes a Non-patent Country in accordance with Section 1.12 above, in which case clause (ii) below shall then apply);

 

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(ii) in Non-patent Countries until the expiration, abandonment, withdrawal, invalidation, revocation, or otherwise rendering unenforceable of the last to expire or be revoked, abandoned, withdrawn, invalidated, or otherwise rendered unenforceable of the Licensed Patents covering the Licensed Product in the U.S., European Union, or Japan;

 

unless sooner terminated in accordance with the provisions hereinbelow. Upon expiration of this Agreement pursuant to the foregoing, Adial shall have the perpetual, unrestricted, fully-paid, royalty-free right, with rights of sublicense, to make, use, and sell, lease, import or otherwise dispose of the applicable Licensed Product(s) in the applicable country(ies).

 

7.2Bankruptcy

If Adial becomes bankrupt or insolvent, files a petition in bankruptcy, or is placed in the hands of a receiver, assignee, or trustee for the benefit of creditors, whether by the voluntary act of Adial or otherwise, Adial shall notify Foundation in writing and Foundation shall have the right to terminate this Agreement upon written notice given within thirty (30) days of such notice from Adial, inasmuch as permitted under applicable and prevailing law, except that if Adial shall have such proceeding discharged within one hundred and twenty (120) days then this Agreement shall be reinstated as if it had never been terminated.

 

7.3Licensor Termination

If Adial fails to make a payment to Foundation of running royalties, Patenting Costs or any other payment in accordance with the terms of this Agreement, or upon Adial’s other material breach or default of any material term of this Agreement (except for any breach of provision of Article 10 Indemnification and Insurance hereinbelow), or non-payment or other material breach of any other agreement between Adial or its Affiliates and Foundation, UVA or their Affiliates (including, for example, sponsored research agreements, procurement agreements, or other license or option agreements), Foundation shall have the right to serve notice upon Adial of Foundation’s intention to terminate the entirety of the rights, privileges and licenses granted hereunder within sixty (60) days from the mailing of such notice. If Adial does not timely pay all such overdue amounts to Foundation, its Affiliate, or UVA, or, as applicable, if Adial fails to reasonably cure such material breach or default and to timely provide Foundation with reasonably acceptable written evidence of such cure, then the rights, privileges, and licenses granted hereunder may be immediately terminated by Foundation at any time after said sixty (60) day period by written notice to Adial. Notwithstanding the above, if the matter of breach is disputed in Adial’s reasonable determination and the parties authorized officials are unable to reach agreement, then the matter shall be submitted to arbitration per Section 9.2 Arbitration Proceedings during which the termination of this Agreement will not become effective. After the arbitration decision, Adial shall have thirty (30) days to cure such breach and if not cured, termination will automatically become effective.

 

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7.4Licensee Termination

Adial shall have the right to terminate this Agreement, in whole or with respect to any Licensed Patents, at any time by providing Foundation with sixty (60) days advance notice by certified mail. Upon such termination, Foundation shall be free to license such rights to third parties, without any further obligation to Adial whatsoever.

 

7.5Continued Obligations

Upon termination of this Agreement in whole or in part for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination. Except as set forth in the Lapse of Coverage paragraph hereinbelow, after the effective date of such termination, Adial and its Affiliates and Sublicensees may, for a period of one (1) year, sell all Licensed Products, and complete Licensed Products in the process of manufacture at the time of such termination and sell the same, provided that (i) Adial shall pay to Foundation the running royalties and other payments as required hereinabove (subject to any expiration under Section 7.1), (ii) insurance required hereunder shall be in effect, and (iii) Adial shall submit the reports required by the Product Reports paragraph hereof.

 

7.6Effect on Sublicenses

Upon termination of this Agreement in whole or in part, for any reason, Adial shall promptly notify its Sublicensees of such termination. Upon termination of this Agreement, (i) Adial shall no longer have the authority to grant further sublicenses and (ii) each Sublicense shall, to the extent provided for in such Sublicense and not imposing any obligations on Foundation in excess of those imposed on Foundation herein, survive termination of this Agreement and automatically be assigned to Foundation upon such termination, provided that the financial terms for Foundation are no less favorable than those in this Agreement.

 

7.7Survivability

The provisions of the Financial Considerations, Reports and Records, Confidentiality, Indemnification and Insurance, Representations and Warranties, Export Control and Non-Use of Names articles of this Agreement shall survive termination of this Agreement. In the event of a partial termination hereof (e.g., with respect to a Licensed Patent in a particular country), those same articles shall survive with respect to the terminated rights, and all of the provisions hereof shall continue in full force and effect with respect to the non-terminated rights.

 

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Article 8
CONFIDENTIALITY

 

8.1Confidential Information

During the term of this Agreement and for a period of five (5) years thereafter, the parties agree that all Confidential Information shall be maintained in confidence by the receiving party and shall not be disclosed by the receiving party to any third parties unless agreed to in writing by the party providing the information; nor shall any such Confidential Information be used by the receiving party for any purpose other than those contemplated by this Agreement; except, however, the parties agree that nothing herein will be construed to prevent (i) the parties from providing information about this Agreement and amounts paid as part of other routinely prepared summary documents or financial statements, and (ii) Foundation from reporting consideration received hereunder to UVA and the Inventors. Additionally, Confidential Information may be disclosed if required by law or regulation; if required for submissions to the FDA or similar foreign agencies; or, by Adial, if disclosed to current or potential investors, sublicensees, or development partners that are bound by confidentiality agreements.

 

8.2Security

Adial and Foundation agree that the confidentiality obligations hereunder shall require that each party use those security and confidentiality procedures and practices as each would use for its own confidential records, which shall in any event be no less than commercially reasonable. Adial acknowledges that UVA and Foundation are separate entities, that these confidentiality provisions do not bind UVA, and that the protection of Adial’s Confidential Information may require Adial to enter into a separate confidentiality agreement with UVA.

 

8.3Publication

In recognition of the academic mission of the University of Virginia, Adial agrees that nothing herein shall prevent UVA or Foundation from disclosing or publishing UVA or Foundation information, or create any legal liability for doing so, irrespective of whether such information comprises Licensed Know-how or other UVA or Foundation Confidential Information, provided that (i) if the Inventors provide the Foundation with a manuscript of any proposed paper or an abstract of any proposed presentation describing any inventions included within the Licensed Rights or other technology claimed or described in the patents and patent applications included in the Licensed Patents, Foundation shall provide the same to Adial and (ii) as reasonably requested by Adial, Foundation shall instruct its patent counsel to make such patent filings or conduct the prosecution of the patents and patent applications included in the Licensed Patents as appropriate prior to publication or presentation of such material to prevent the loss of any rights granted under this Agreement.

 

Article 9
GOVERNING LAW AND ARBITRATION

 

9.1Law To Govern

This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Virginia, without regard to its or any other jurisdiction’s conflicts of laws provisions.

 

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9.2Arbitration Proceedings

Claims, disputes, or controversies between the parties concerning the validity, construction, or scope of any of the Licensed Patents shall be resolved in the Federal District Court seated in Washington, DC. All other claims, disputes or controversies arising under, out of, or in connection with this Agreement, which have not been resolved by good faith negotiations between the parties within sixty (60) days of identification of such controversy, shall, upon notice from one party to the other following such sixty (60) day period, be resolved by final and binding arbitration by a panel of three (3) arbitrators in Washington, DC, under the Commercial Arbitration Rules of the American Arbitration Association (the “AAA”), except where those rules conflict with this provision, in which case this provision controls. The arbitration shall be conducted by a panel of three (3) independent, neutral arbitrators that are industry experts experienced in the issues comprising the dispute. Adial and Foundation shall each be entitled to select one such arbitrator, with the two such arbitrators so selected selecting the third such arbitrator. In the event either party fails to select its arbitrator within ten (10) days of the initiation of arbitration under this Section 9.2, the arbitrator selected by the other party within such ten (10) day period shall be entitled to select the third such arbitrator. The arbitrators shall have no power to add to, subtract from, or modify any of the terms or conditions of this Agreement. Each party shall bear its own costs, fees and expenses in the arbitration and shall share equally the arbitrators’ fees, unless the arbitrators determine that their fees are to be paid by the non-prevailing party. Any award rendered in such arbitration may be enforced by either party in the courts of the Commonwealth of Virginia seated in Charlottesville. The parties hereby irrevocably consent and submit to the exclusive jurisdiction and venue of each court and arbitration site cited above for the purposes each is mentioned. Notwithstanding the foregoing, either party may seek injunctive, equitable, or similar relief from any court of competent jurisdiction as necessary to enforce its rights without the requirement of arbitration (including but not limited to a party’s rights with respect to patent infringement, breaches of confidentiality, misappropriation of trade secrets, and the like).

 

Article 10
INDEMNIFICATION AND INSURANCE

 

10.1Licensee Indemnification

Adial agrees to indemnify, hold harmless and defend Foundation and UVA against any and all claims arising from Adial’s, its Affiliates’ or Sublicensees’ exercise of any rights under this Agreement, including without limitation, against any damages, losses or liabilities whatsoever for death, injury to person or damage to property, or for the infringement of third party intellectual property rights, as a result of the making, use, importation, sale, development, design, promotion, possession, operation or other disposition of any Licensed Products, or the practice of the Licensed Patents or the Licensed Know-how by Adial, its Affiliates, Sublicensees, customers, assignees, or other transferees, to the extent that such claims, damages, losses or liabilities do not result from Foundation’s or UVA’s negligence, intentional misconduct, breach of this Agreement, or failure to comply with any applicable laws, rules, or regulations. As used in this paragraph, “UVA” and “Foundation” include their officers, directors, trustees, personnel, agents, employees, faculty, students, successors and assigns; “Adial” includes any and all of its parents, assigns, successors, officers, directors, trustees, personnel, agents, and employees. Adial acknowledges that the technology embodied in the rights licensed hereunder is experimental and agrees to take reasonable precautions to prevent death, personal injury, illness and property damage. Adial shall obtain and maintain product liability and general liability insurance in accordance with the requirements of Section 10.2 herein, and shall require each of its authorized Affiliates and Sublicensees to have such insurance. Evidence of the existence and sufficiency of such insurance shall be provided to Foundation upon request.

 

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10.2Extent of Insurance

Neither Adial nor any Affiliate shall make, use, import, offer to sell or sell any Licensed Product, or engage in any other act involving any Licensed Product or the Licensed Rights, if such act could possibly create material risk of a claim against Foundation or UVA for personal injury of property damage, unless Adial shall have first provided Foundation with a certificate of insurance, to be updated yearly, proving that Adial or such Affiliates or Sublicensees have in force, during the term of this Agreement, a policy of liability insurance with sufficient occurrence and annual aggregate limits to indemnify Foundation and UVA against liability claims for accidental death, injury, illness or other damages arising from such act, as required by the previous paragraph. Such insurance policy must, during the applicable term specified in Section 10.3 below, consist of broad form contractual liability coverage and shall further include liability insurance covering Licensed Products with total limits of not less than:

 

(1)ten million U.S. dollars (U.S. $10,000,000) annual aggregate and five million U.S. dollars (U.S. $5,000,000) for each occurrence as a combined single limit for bodily injury or death and for property damage for the use of Licensed Products in, on or with humans as part of clinical trials, prophylactic, diagnostic or therapeutic use undertaken on behalf of Adial, its Affiliates, or its Sublicensees, or with Licensed Products supplied by Adial, its Affiliates, or its Sublicensees. Such insurance policy shall name Foundation and UVA as additional insured parties but shall not include UVA- or investigator-sponsored trials independent of Adial, its Affiliates, or its Sublicensees being conducted at UVA with respect to any Licensed Product; and

 

(2)two million U.S. dollars (U.S. $2,000,000) annual aggregate and one million U.S. dollars (U.S. $1,000,000) for each occurrence as a combined single limit for bodily injury or death and for property damage for the use of Licensed Products not covered by (1) above; or

 

(3)if Adial has provided UVAPF with evidence that is reasonably acceptable to demonstrate that Adial or its Sublicensee has sufficient financial resources to support meaningfully the indemnification obligations undertaken herein and agrees to do so, then Adial and/or its Sublicensee shall have the option of self insuring.

 

Adial agrees that, unless coverage satisfying the requirements of this Agreement is first provided under another policy in compliance with the foregoing provisions and without any gap in coverage, the required coverage will not be reduced below the minimums established above or canceled by Adial without the prior written approval of the Executive Director of Foundation. Any such reduction of such coverage below the minimums described above without written approval or first obtaining alternative coverage satisfying the requirements of this Agreement under another policy in compliance with the foregoing provisions and without any gap in coverage, or any other violation of the provisions of this paragraph, shall be deemed a material breach of this Agreement. Adial may request elimination of the above insurance requirements provided it has provided reasonable evidence that Adial or its Sublicensee has sufficient financial resources to support meaningfully the indemnification obligations undertaken, such request not to be unreasonably withheld.

 

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10.3Term of Insurance

Unless expressly waived in writing by Foundation, Adial agrees that the above-described liability insurance policy shall be continuously maintained in force for so long as this Agreement remains in effect, and such policy will provide coverage as described above whether such liability may occur or be claimed for a period of up to six (6) years after termination hereof, provided that the insurance coverage described in paragraph (1) of Section 10.2 shall not be required of Adial until such time as Adial, an Affiliate thereof, or a Sublicensee has on its own behalf undertaken the use of Licensed Products in, on or with humans as part of clinical trials, diagnostic or therapeutic use. Neither Adial nor any third party shall terminate or reduce the face value of such insurance coverage below the minimums established above while such policy is in effect, unless coverage satisfying the requirements of this Agreement is first provided under another policy in compliance with the foregoing provisions and without any gap in coverage.

 

10.4Lapse of Coverage

This Agreement and the licenses granted herein to Adial shall immediately and automatically terminate without notice in the event Adial, or its Affiliates, Sublicensees or other party acting under authority of Adial, fails to obtain the insurance required hereunder, or if the insurance lapses or is cancelled and coverage satisfying the requirements of this Agreement is not first provided under another policy in compliance with the foregoing provisions. A termination occurring under this paragraph shall occur and become effective at the time such insurance coverage ends or becomes required and is not obtained, and Adial and its Affiliates shall have no right to complete production and sale of Licensed Products under the Continued Obligations paragraph hereinabove. Nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination. Notwithstanding the foregoing, to the extent that automatic termination resulted from a lapse of the above-required insurance, and to the extent that such rights are still available for licensing, Adial shall have the right to reinstate the effectiveness of this Agreement by obtaining the required insurance, whereupon this Agreement shall automatically become effective as of the date of reinstatement of said insurance, and shall remain in full force and effect without any further action of the parties.

 

10.5Sublicensee Insurance

Adial shall insert indemnification and insurance requirements reasonably sufficient to enable Sublicensee to comply with Adial’s obligations under this Article 10 in any Sublicense in which Adial grants to a third party the right to make, use, import, offer to sell or sell any Licensed Product, including naming UVA and Foundation as additional insured parties for the sale or other dispensation of Licensed Product.

 

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Article 11
REPRESENTATIONS AND WARRANTIES

 

11.1No Encumbrances

Each party hereto acknowledges and agrees that no representation or promise not expressly contained in this Agreement has been made by the other party hereto or by any of its agents, employees, representatives or attorneys concerning the subject matter of this Agreement. Each party further warrants and represents that, to the best of its knowledge, it has the full right and power to make the promises and grant the licenses set forth in this Agreement and that there are no outstanding agreements, assignments or encumbrances in existence which are inconsistent with the provisions of this Agreement.

 

11.2Licensee Warranty

Adial warrants and represents that it shall use commercially reasonable efforts to diligently pursue the development, manufacture, and sale of at least one Licensed Product throughout the term of this Agreement. For purposes of this Section 11.2, the acts of Adial’s Affiliates and Sublicensees shall be deemed the acts of Adial for purposes of satisfying Adial’s obligations hereunder.

 

11.3Licensor Warranty

Foundation hereby represents and warrants to Adial that to the best of its knowledge Foundation is the owner of all right, title, and interest in the Licensed Rights, free and clear of any claims or encumbrances, except as indicated in the Government Rights and the Reservation by Licensor paragraphs hereinabove. However, in the event that a third party makes a claim of inventorship or ownership of a Licensed Patent based solely upon information not known to Foundation prior to the Effective Date, and after a good faith evaluation of such claim it is necessary to add such party to the Licensed Patent as an inventor and/or to assign an undivided interest in and to said Licensed Patent to such third party, then such action shall not be considered a breach of this Agreement. In such instance, Foundation and Adial shall negotiate in good faith to reasonably amend the Agreement to take into consideration any change in the scope of the license granted herein resulting from such co-ownership of the Licensed Patent at issue.

 

11.4Infringement Actions by 3rd Parties

Adial acknowledges and agrees that all rights licensed by Foundation hereunder are licensed without any representation, indemnification or warranty with respect to possible infringement of third party rights. In the event of a third party infringement action against either party with respect to Adial’s or its Affiliates’ or Sublicensees’ use, manufacture, or sale of any Licensed Product, Adial will defend Foundation at Adial’s expense, with the understanding that breaching such obligation may result in a default judgment against Adial, its Affiliates, Sublicensees, and/or Foundation (however, Adial’s failure to defend shall not prevent Foundation from defending itself). Adial shall indemnify, defend and hold Foundation harmless from any such judgment, and without limitation shall pay any damages awarded in any judgment against Foundation. Foundation will cooperate as requested by Adial, and will be compensated by Adial for its reasonable out-of-pocket expenses incurred in such cooperation, which Foundation will only be required to expend if Adial has approved same for reimbursement. No settlement, consent judgment, or other voluntary final disposition of any suit that would affect the validity, scope or enforceability of the Licensed Rights, by estoppel, admission or otherwise, or Foundation’s rights in or to same, may be entered into without the consent of Foundation. Notwithstanding anything to the contrary, Adial shall not in any event be responsible for any third party infringement action resulting from the activities of Foundation, UVA, or, to the extent acting in their role as UVA faculty and researchers, the Inventors, if such activities are conducted entirely independently of Adial, its Affiliates, or Sublicensees.

 

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11.5Disclaimers

Nothing in this Agreement shall be construed as (i) a warranty or representation by Foundation as to the validity or scope of any Licensed Rights, (ii) a warranty or representation that anything made, used, imported, developed, promoted, offered for sale, sold, or otherwise disposed of under any license granted in this Agreement does not or will not infringe patents, trade secrets or other proprietary rights of third parties; (iii) a representation or warranty of operability or that development of a commercial products is possible; (iv) an obligation to bring or prosecute actions or suits against third parties for infringement; (v) conferring the right to use in advertising, publicity or otherwise any trademark, trade name, or names, or any contraction, abbreviation, simulation or adaptation thereof of Adial, UVA or Foundation (except at required by law or other regulation); (vi) conferring by implication, estoppel or otherwise any license or rights under any patents of Foundation other than the Licensed Patents; (vii) any other representations or warranties, either express or implied, unless specified in this Agreement; (viii) directly or indirectly operating or applying as a waiver of sovereign immunity by the Commonwealth of Virginia; or (ix) imposing any obligation or any liability on any party contrary to the laws of the Commonwealth of Virginia. EXCEPT WITH RESPECT TO THE WARRANTIES MADE EXPLICITLY BY FOUNDATION IN THIS AGREEMENT, (I)ALL RIGHTS ARE LICENSED HEREUNDER “AS IS” AND (II) FOUNDATION DISCLAIMS AND MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE LICENSED RIGHTS, OR ANY LICENSED PRODUCTS.

 

11.6Limitation of Liability.

NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT.

 

Article 12
PAYMENTS AND NOTICES

 

Any payment, notice, or other communication given under this Agreement (except for correspondence necessary in Article 6 Patent Prosecution hereinabove) shall be in writing and sent by certified first class mail (return receipt requested) or overnight courier, or by facsimile or other electronic means, provided that a copy of such facsimile is promptly sent by certified first class mail (return receipt requested) or overnight courier, addressed to the parties as follows (or at such other addresses as the parties may notify each other in writing):

 

Adial:

ADial Pharmaceuticals, LLC

1001 Research Park Drive

Suite 100

Charlottesville, VA 22911

Attention: CEO

Foundation:

University of Virginia Patent Foundation

250 West Main Street, Suite 300

Charlottesville, Virginia 22902

Attention: Executive Director

 

 26 

 

 

Article 13
ASSIGNMENT

 

So long as Adial is not in material breach of this Agreement in any respect, Adial may transfer this Agreement, by assignment or otherwise, and/or the rights acquired by it hereunder upon obtaining consent from Foundation for the same (such consent will not be unreasonably withheld), provided that any transfer or assignment to an Affiliate of Adial or that is made in conjunction with the sale or other transfer of all of that portion of Adial’s business concerning addiction in humans, regardless of whether such transfer is in the form of a sale of the Adial’s assets, a sale of at least the majority shares of Adial’s Equity or other form of acquisition, an equity exchange or other form of merger, acquisition, consolidation, reorganization, or other transfer or similar transaction shall not require the prior consent of Foundation (the parties acknowledge that this Agreement is inherently transferred by Adial in a merger or acquisition, and the parties hereby consider this Agreement transferred as a result of such transfer of Adial’s business). Adial shall give Foundation written notice of Adial’s intent to so transfer this Agreement twenty (20) days prior to completion of such transfer, along with a draft of the proposed transfer agreement as it exists at that time and a copy of the proposed transfer agreement in substantially the form in which it is to be executed at least three (3) days before said execution, pursuant to which such transferee shall agree in writing to be bound by the terms and conditions of this Agreement. Upon completion of such transfer, the term “Adial” as used herein shall include such transferee. If the transferee in any transfer or assignment contemplated above shall not have agreed in writing to be bound by the terms and conditions of this Agreement, Foundation shall have the right to terminate this Agreement upon written notice.

 

Article 14
NON-USE OF NAMES

 

Except as provided by law or other regulations, neither party shall use the names of the other, or any adaptation thereof, or of their employees, officers, or agents, or any adaptation thereof, in any advertisement, promotional or sales literature without prior written consent obtained from such party in each case. However, Adial may state that it licensed from Foundation one or more of the patents and/or patent applications comprising the Licensed Patents, and Foundation may state that it licensed to Adial one or more of the patents and/or patent applications comprising the Licensed Patents, and may further include (i) UVA Inventors’ names, (ii) invention titles and summaries, (iii) technology field of use, and (iv) the type and extent of the license, but may not include terms and conditions of this Agreement, or other Confidential Information, unless such disclosure is required by law, rule or regulation. The parties agree to take all reasonable precautions to prevent any such public information regarding the Licensed Patents or this Agreement from containing inaccuracies or from otherwise being misconstrued or misleading, and such information shall clearly indicate the party responsible for the conception of the Licensed Patents, and the ongoing research and development efforts at Adial and at UVA. Foundation understands that Adial will provide copies of this Agreement and other Foundation Confidential Information to third parties under confidentiality agreements in the ordinary course of its business.

 

 27 

 

 

Article 15
EXPORT CONTROLS

 

It is understood that Foundation and Adial are subject to United States laws and regulations (including the Arms Export Control Act, as amended, and the Export Administration Act of 1979) controlling the export of technical data, computer software, laboratory prototypes, and other commodities, and that such obligations hereunder are contingent on compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by Adial that Adial shall not export data or commodities to certain foreign countries without prior approval of such agency. Foundation does not represent that a license is not required, or that, if required, such a license shall be issued.

 

Article 16
MARKING

 

Adial shall mark all Licensed Products made or sold in the United States in accordance with 35 U.S.C. §287(a), and will mark all Licensed Products made or sold in other countries in accordance with the laws and regulations then applicable in each such country; and Adial acknowledges that it will be liable to Foundation for actual infringement damages lost due to improper or defective patent marking, but not any punitive, treble, or court-increased damages that might otherwise have been awarded for willful infringement.

 

Article 17
FORCE MAJEURE

 

No party shall be liable for any failure to perform as required by this Agreement, to the extent such failure to perform is caused by acts of God or natural disaster, interference by civil or military authorities, non-administrative government actions, and war or terrorism.

 

 28 

 

 

Article 18
SEVERABILITY

 

Should any provision of this Agreement be determined to be unenforceable or otherwise unlawful, then such provision shall be without effect, as if such provision had not been included herein, and the remaining terms of this Agreement shall survive. In such instance, the parties shall promptly meet to agree upon further terms which shall, within the confines of the law, most substantially satisfy the intention of the parties as reflected by the ineffective provision. If such agreement between the parties is not reached within thirty (30) days of the date such provision is determined to be unenforceable or otherwise unlawful, the parties agree to submit such matter to binding arbitration in accordance with the arbitration provisions in Section 9.2 hereinabove.

 

Article 19
HEADERS

 

The article and paragraph headings contained in this Agreement are for reference purposes only, and shall not in any way affect the meaning or interpretation of this Agreement.

 

Article 20
BENEFIT AND WAIVER

 

This Agreement is binding upon and shall inure to the benefit of the parties hereto, their representatives, successors and permitted assigns. No failure or successive failures on the part of the parties, to enforce any provisions of this Agreement, and no waiver or successive waivers on either party’s part of any condition of this Agreement, shall operate as a discharge of such provision or condition, or render the same invalid, or impair the right of such party to enforce same in the event of any subsequent breach or breaches by the other party.

 

Article 21
ENTIRE AGREEMENT

 

This Agreement supersedes the AC Agreement as of the Effective Date. The parties hereto acknowledge that as of the Effective Date this Agreement sets forth the entire agreement and understanding of the parties hereto as to the subject matter hereof, and supersedes any and all prior written and oral agreements, understandings, promises or offers, including without limitation any term sheet which preceded its drafting, and shall not be subject to any change or modification except by the execution of a written instrument subscribed to by the parties hereto and explicitly referencing this Agreement and specifying that it is the parties’ intent to modify the terms and/or conditions set forth herein. The parties acknowledge that invoices, purchase orders or other mechanisms for administering any payment or other obligation set forth herein shall not contain terms and conditions separate from, in addition to, and/or in conflict with this Agreement, and that any such terms, if present, shall be void and without effect, and shall not be enforceable by any party hereto. The initial drafting of this Agreement by Foundation was for the convenience of both parties, and both parties agree that such fact shall not result in any of the above clauses being construed against Foundation should such clauses become in dispute.

 

 29 

 

 

IN WITNESS WHEREOF, the parties hereto have agreed and accepted the terms and conditions of, and have duly executed this Agreement to be made effective as of the Effective Date.

 

For The University of Virginia Patent Foundation:   ForADial Pharmaceuticals, LLC
     
By: /s/ Miette H. Michie   By: /s/ William B. Stilley, III
  Miette H. Michie     William B. Stilley, III
  Interim Executive Director and CEO     Chief Executive Officer
         
Date:  January 19, 2011   Date:  January 21, 2011
         
By: /s/ Erik L. Hewlett      
  Erik L. Hewlett      
  Chairman      
         
Date: January 21, 2011      

 

 30 

 

 

Appendix A

LICENSED PATENTS

 

1.PCT/US2007/088100, filed 12/19/07

“Combined Effects of Topiramate and Ondansetron on Alcohol Consumption”

Foundation Docket#: 01347 TechID: JOHNSON-COMBO

 

2.PCT/US2008/052628, filed 1/31/08

“Topiramate plus Naltrexone for the Treatment of Addictive Disorders”

Foundation Docket#: 01354 TechID: JOHNSON-NALTREXON

 

3.PCT/US2008/064232, filed 5/20/08

“Medication Combinations for the Treatment of Alcoholism and Drug Addiction”

Foundation Docket#: 01454 TechID: JOHNSON-TRIPLE

 

4.PCT/US2008/073738, filed 8/20/2008

“Method, Computer Program Product And System For Individual Assessment Of Alcohol Sensitivity”

Foundation Docket#: 01442 TechID: JOHNSON-ASI

 

5.PCT/US2009/035420, file 2/27/2009

“Serotonin Transporter Gene and Treatment of Alcoholism”

Foundation Docket#: 01493 TechID: JOHNSON-GENE

 

6.PCT/US2010/001273, filed 4/30/2010

“Serotonin Transporter Gene and Treatment of Alcoholism”

Foundation Docket#: 01652 TechID: JOHNSON-GENE2

 

7.U.S. Provisional Patent Application 61/263,599, filed 11/23/2009, now abandoned

“Serotonin Transporter Gene and Treatment of Alcoholism”

Foundation Docket#: 01706 TechID: JOHNSON-TT

 

8.U.S. Provisional Patent Application 61/300,591, filed 2/2/2010 and U.S. Provisional Patent Application 61/429,416, filed 1/3/2011

Molecular Genetic Approach to Treatment and Diagnosis of Alcohol and Drug Dependence

Foundation Docket#: 01716 TechID: JOHNSON-COMBOGENE

 

9.U.S. Provisional Patent Application 61/323,931, filed 4/14/2010

“Dual Medications Synergize to Decrease the Endophenotype of Severe Drinking in Rats”

Foundation Docket#: 01745 TechID: JOHNSON-SYNERGY

 

10.U.S. Provisional Patent Application 61/361,203 filed 7/2/2010

“Serotonin Transporter Gene and Treatment of Alcoholism”

Foundation Docket#: 01771 TechID: JOHNSON-TTCOMP

 

 

 

 

 

EX-10.2 27 fs12017ex10-2_adialpharma.htm AMENDMENT #1 TO LICENSE AGREEMENT

Exhibit 10.2

 

AMENDMENT #1 TO

LICENSE AGREEMENT

 

This Amendment #1, dated as of October 21, 2013 (this “Agreement”), to the Original License Agreement (as defined below) is by and between the University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group, a Virginia not-for-profit corporation of the Commonwealth of Virginia, having its principal offices at 250 West Main Street, Charlottesville, VA 29902 (“UVA LVG”), and ADial Pharmaceuticals, LLC, a Virginia limited liability company (“Adial” and together with “UVA LVG”, the “Parties”).

 

WHEREAS, the Parties have entered into that certain licensing agreement dated as of January 21, 2011 (“Original License Agreement”); and

 

WHEREAS, the Parties wish to amend the Original License Agreement as provided herein.

 

NOW, THEREFORE in consideration of the premises set forth above and the mutual covenants set forth below, the parties hereto agree as follows:

 

AGREEMENT

 

1.       Section 3.5(A) of the Original License Agreement is hereby deleted in its entirety and replaced with the following text:

 

“A milestone payment of one hundred seventy five thousand dollars (U.S. $175,000) in the following installments:

 

(i)twenty thousand dollars ($20,000) shall be paid upon the initiation of Phase III clinical trials (defined as the dosing of the first patient) by or on behalf of Adial, an Affiliate, or Sublicensee for the first Licensed Product., and
(ii)one hundred fifty five thousand dollars ($155,000) shall be paid upon the earliest to occur of:

 

a.the completion of the Phase III clinical trial (defined as the dosing of the last patient) by or on behalf of Adial, an Affiliate, or Sublicensee for the first Licensed Product;
b.the execution of a Sublicense as defined in Section 1.16 of the Original License Agreement;
c.an Assignment as defined in Article 13 of the Original License Agreement; or
d.a Sale of Adial. For the purpose of this Section 3.5(A), “Sale” shall mean any transaction or series or combination of transactions, other than in the ordinary course of trade or business, whereby, directly or indirectly, control of Adial or all of substantially all of its securities or assets is transferred for consideration (in cash or marketable securities), including, without limitation, a sale or exchange of capital stock or assets, a merger or consolidation, a recapitalization by third parties, a tender or exchange offer, a leveraged buy-out, and/or the formation of a joint venture. For purposes of the foregoing, “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and business of Adial, through the ownership of more than 50% of the voting securities of Adial.”

 

 

 

 

2.       Section 10.2(1) and Section 10.2(2) are hereby deleted in their entirety and replaced with the following text:

 

a)“Commercial general liability: One million Dollars ($1,000,000) each occurrence, two million Dollars ($2,000,000) general aggregate. Adial shall have thirty (30) days following the Effective Date to obtain such coverage;
b)Products liability: From the date immediately prior to any Phase I clinical trial: two million Dollars ($2,000,000) each occurrence, five million Dollars ($5,000,000) aggregate;
c)Products liability: From the date immediately prior to any sale, lease, or other transfer of Licensed Product: ten million Dollars ($ 10,000,000) each occurrence, ten million Dollars ($10,000,000) aggregate; and
d)At any given time, if consistent with the risk profile of Adial and reasonably required in writing by UVA LVG’s insurance carrier, the Parties shall negotiate, in good faith, reasonable changes to the amounts of insurance coverages and/or financial ratings of Adial’s insurance carrier. UVA LVG shall provide Adial with (i) a 30-day prior written notice of any request to negotiate a change to its insurance coverage under this section and (ii) an additional reasonable period for Adial to make any agreed upon changes to its insurance coverage. Further, in the event Adial anticipates sales of Licensed Products in a field of heightened risk, Adial will notify UVA LVG of such plans.

 

3.       Except as provided herein, the terms and obligations of the Parties under the Original License Agreement shall remain as specified therein.

 

 2 

 

 

IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the date first written above.

 

University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group
         
By: /s/ Michael P. Straightiff   By: /s/ Erik L. Hewlett
Name:  Michael P. Straightiff, Director   Name:  Erik L. Hewlett
Date:   October 23, 2013   Date:   October 25, 2013

 

ADial Pharmaceuticals, LLC  
     
By: /s/ James Dada  
Name:  James Dada, VP, Finance  
Date:   October 21, 2013  

 

 

3 

 

 

EX-10.3 28 fs12017ex10-3_adialpharma.htm AMENDMENT #2 TO LICENSE AGREEMENT

Exhibit 10.3

 

AMENDMENT #2 TO

LICENSE AGREEMENT

 

This Amendment #1, dated as of May 18, 2016 (this “Agreement”), to the Original License Agreement (as defined below) is by and between the University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group, a Virginia not-for-profit corporation of the Commonwealth of Virginia, having its principal offices at 250 West Main Street, Charlottesville, VA 29902 (“UVA LVG”), and ADial Pharmaceuticals, LLC, a Virginia limited liability company (“Adial” and together with “UVA LVG”, the “Parties”).

 

WHEREAS, the Parties have entered into that certain licensing agreement dated as of January 21, 2011 and as amended on October 21, 2013 (together, “Original License Agreement”); and

 

WHEREAS, the Parties wish to amend the Original License Agreement as provided herein.

 

NOW, THEREFORE in consideration of the premises set forth above and the mutual covenants set forth below, the parties hereto agree as follows:

 

AGREEMENT

 

1.       The date in Section 4.2 A. is changed to December 31, 2017.

 

2.       The date in Section 4.2 B. is changed to December 31, 2021.

 

3.       The date in Section 4.2 C. is changed to December 31, 2022.

 

4.       Except as provided herein, the terms and obligations of the Parties under the Original License Agreement shall remain as specified therein.

 

IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the date first written above.

 

University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group     ADial Pharmaceuticals, LLC
     
By: /s/ Michael P. Straightiff   By: /s/ William B. Stilley
Name:  Michael P. Straightiff   Name:  William B. Stilley, CEO
Date: May 17, 2016   Date: April 18, 2016

 

 

EX-10.4 29 fs12017ex10-4_adialpharma.htm AMENDMENT #3 TO LICENSE AGREEMENT

Exhibit 10.4

 

AMENDMENT #3 TO

LICENSE AGREEMENT

 

This Amendment #3, dated as of March 27, 2017 (this “Agreement”), to the Original License Agreement (as defined below) is by and between the University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group, a Virginia not-for-profit corporation of the Commonwealth of Virginia, having its principal offices at 722 Preston Avenue, Suite 107, Charlottesville, VA 29903 (“UVA LVG”), and ADial Pharmaceuticals, LLC, a Virginia limited liability company (“Adial” and together with “UVA LVG”, the “Parties”).

 

WHEREAS, the Parties have entered into that certain licensing agreement dated as of January 21, 2011 and as amended on October 21, 2013, and as further amended on May 18, 2016 (together, “Original License Agreement”); and

 

WHEREAS, the Parties wish to amend the Original License Agreement as provided herein.

 

NOW, THEREFORE in consideration of the premises set forth above and the mutual covenants set forth below, the parties hereto agree as follows:

 

AGREEMENT

 

1.        The date in Section 4.2 A. is changed to December 31, 2018.

 

2.        Except as provided herein, the terms and obligations of the Parties under the Original License Agreement shall remain as specified therein.

 

IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the date first written above.

 

University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group   ADial Pharmaceuticals, LLC
         
By:

/s/ Patrick J. Klepcyk

  By: /s/ William Stilley
Name: Patrick J. Klepcyk, Director Licensing   Name: William Stilley, CEO
Date: April 6, 2017   Date: April 6, 2017
         
By: /s/ Erik L. Hewlett      
Name: Erik L. Hewlett      
Date: April 19, 2017      

  

EX-10.5 30 fs12017ex10-5_adialpharma.htm EXECUTIVE EMPLOYMENT AGREEMENT

Exhibit 10.5

 

EXECUTIVE EMPLOYMENT AGREEMENT

William B. Stilley, III

 

This Executive Employment Agreement (this “Agreement”) is effective as of December 6, 2010 (the “Effective Date”), between ADial Pharmaceuticals, LLC, a Virginia limited liability company (the “Company”), and William B. Stilley, III (“Executive”).

 

RECITALS:

 

A.      The Board of Directors of the Company (the “Board”), as defined in the Company’s Operating Agreement dated November 23, 2010 (the “Operating Agreement”), believes that it is in the best interests of the Company and its Members to employ and compensate Executive in return for his diligent service to the Company.

 

B.       The Company and Executive wish to enter into this Agreement for the benefit of the Company, its Members and Executive.

 

AGREEMENT:

 

In consideration of the promises and undertakings set forth herein and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the Company and Executive agree as follows:

 

1.Certain Definitions. For purposes of this Agreement, the following terms denoted by capitalization of initial letters shall have the definitions ascribed below:

 

(a)Annual Salary” means the greater of (i) two hundred ten thousand dollars ($210,000); or (ii) the highest gross annual salary rate payable to Executive by the Company, any wholly owned subsidiary of the Company or any Successor (as defined herein) prior to the effective date of termination of this Agreement.

 

(b)Cause” shall be determined by majority vote of the Board, in good faith, and shall mean: (A) Executive’s - continued failure to substantially perform Executive’s duties with the Company (other than any such failure resulting from Executive’s incapacity due to physical or mental illness, or any actual or anticipated failure of Executive’s performance after the Company’s issuance of a notice of termination or Executive’s issuance of a notice of termination for Good Reason), after a written demand for substantial performance is delivered to Executive by the Board, which demand specifically identifies the manner in which the Board believes that Executive has not substantially performed Executive’s duties, and after receipt of which demand Executive shall have had a thirty (30) day period within which to cure such failure; (B) Executive’s - misconduct which is demonstrably and materially injurious to the Company, monetarily or otherwise; or (C) Executive’s felony conviction for a violation of a criminal law. Without limitation to the foregoing, “Cause” does not include acts or omissions attributable to bad judgment or negligence, unless due to, habitual and continued bad judgment or negligence.

 

 Page 1 of 11

 

(c)Employment Date” means the date Executive reports for work with the Company as shown below the signature block of this Agreement.

 

(d)Good Reason” means, without Executive’s express written consent, the occurrence of any of the following events:

 

(i)the assignment to Executive of duties neither appropriate for a senior level executive of an entity like the Company, or the assignment to Executive of any duties that Executive believes in good faith to entail a substantial increase in Executive’s exposure to potential personal liability (whether or not indemnifiable by the Company) or a substantial increase in occupational risk to Executive’s personal health or safety; or

 

(ii)a reduction by the Company in Executive’s salary without Executive's consent: or

 

(iii)the failure by the Company, without Executive’s consent, to pay to Executive any portion of Executive’s salary, bonus, or any compensation due to Executive under any deferred compensation program, or to pay any benefit under any employee compensation, benefit or welfare plan then in effect, within ten (10) business days of the date such compensation or benefit is due; or

 

(iv)the failure by the Company to provide Executive with vacation and related benefits (or compensation in lieu thereof) to which Executive is entitled under this Agreement; or

 

(v)the assignment of Executive without Executive's consent, to an office or location more than one hundred twenty (120) miles from the City of Charlottesville , Virginia (other than on a temporary basis not exceeding on average five (5) days per month in any three (3) month period); or

 

(vi)the breach by the Company of this Agreement;

 

provided, however, that none of the events set forth in foregoing clauses (i) - (vi) will constitute “Good Reason” unless and until Executive provides the Company with written notice of the event and thirty (30) days to cure or remedy such event, except that if after any such event is cured once and it reoccurs, or if any of the foregoing events occur after more than three distinct non-recurring events are cured, no notice and opportunity to cure or remedy will be required before such event constitutes Good Reason.

 

(e)Material Transaction” means the consummation of any of the following: (A) any transaction or series of related transactions by the Company or its equity holders in which a majority of the Company’s voting power is transferred to one or more persons or entities who were not previously equity holders of the Company, (B) any merger or consolidation of the Company with or into any other entity, after which the Members of the Company do not hold, either directly or indirectly, a majority of the voting equity of the surviving entity, (C) the sale, conveyance, exclusive license or other disposition of a material portion of the business and/or assets of the Company to a non-affiliated entity (it being agreed, by way of illustration and not limitation, that the sale, conveyance, exclusive license or other disposition of either, or both, of the Company’s drug candidates currently designated as AD/04 and AD/01 to a non-affiliated entity shall constitute a Material Transaction).

 

 Page 2 of 11

 

(f)Membership Units” shall as such term is defined in the Operating Agreement.

 

(g)Nondisclosure Agreement” shall have the meaning stated in Section 13 below.

 

(h)Personal Items” shall have the meaning stated in Section 5(c) below.

 

(i)Right of Repurchase” shall have the meaning stated in Section 10 below.

 

(j)Successor” shall mean any person, firm, corporation or other business entity which at any time, whether by purchase, merger, consolidation or otherwise, directly or indirectly, acquires all or substantially all of the business and/or assets of the Company.

 

(k)Term” shall have the meaning stated in Section 2 below.

 

2.Term. Unless earlier terminated as provided herein, the initial term of this Agreement will commence on the Effective Date and continue for a period of one year from the Effective Date; provided, however, that commencing on such one-year anniversary date and on each annual anniversary of such date thereafter, the term of this Agreement will automatically be renewed for additional one (1) year terms unless, not later than thirty (30) days prior to the end of the initial term or any renewal term, either party has given written notice to the other party that it does not wish to renew this Agreement. Notwithstanding the foregoing, it is understood and agreed that in the event this Agreement is terminated as a result of the Company or any Successor giving such notice of non-renewal, the Company’s or such Successor’s obligations under Sections 7 and 8 shall survive and be enforceable under the terms hereof to the same extent as if this Agreement remained in effect. The initial term of this Agreement and all renewals thereof are referred to herein as the “Term.”

 

3.Positions. The Company hereby employs Executive and Executive hereby accepts employment effective as of the Effective Date. During the Term, Executive shall serve as a member of the Board, as described in the Operating Agreement; and, commencing on the Employment Date and during the Term, Executive shall serve as Chief Executive Officer of the Company, as described in the Operating Agreement.

 

4.Salary and Bonus.

 

(a)Salary. Effective as of the Employment Date, Executive’s Annual Salary will be Two Hundred Ten Thousand Dollars ($210,000), which Annual Salary may be increased from time to time by the Board; provided, however, that from the Employment Date until the occurrence of the Milestone Bonus Trigger, all amounts payable as Annual Salary which exceed $60,000 (on an annual basis) (the “Milestone Bonus Amounts”) shall not be paid to Executive, but will accrue, interest free. All such accrued amounts shall be paid to Executive on the Company’s next regular payroll date following the occurrence of the Milestone Bonus Trigger, and thereafter Executive shall be paid based on Executive’s full annual base salary rate. The “Milestone Bonus Trigger” shall mean the earliest to occur of the following events:

 

(i)The Company or its members, in a single transaction or a series of transactions, receives at least One Million Dollars ($1,000,000.00) in aggregate gross proceeds, including, without limitation, through the issuance of equity interests, debt, cancellation of indebtedness, or sale of assets;

 

 Page 3 of 11

 

(ii)The consummation of a Material Transaction;

 

(iii)A liquidation or dissolution of the Company.

 

In the event Executive’s employment is terminated for any reason by the Company or by Executive prior to the occurrence of the Milestone Bonus Trigger, Executive shall forfeit all rights to receive the Milestone Bonus Amounts.

 

(b)Bonuses; Six-Month Review. Six (6) months after the Effective Date, the Board (or its designated subcommittee) will review Executive’s performance and will establish a bonus and equity plan (including without limitation, an annual bonus plan) for Executive commensurate with such plans customarily established for executives with similar responsibilities and performance. Additionally, Executive shall be eligible to participate in all bonus or similar incentive plans adopted from time to time by the Board. Any bonuses awarded to Executive, unless otherwise specifically provided by the Board or committee administering such plan or program, shall be paid no later than March 15 of the year following the year in which such bonus was earned.

 

5.Benefits and Personal Items.

 

(a)Health Insurance and other Benefits. Commencing on the Employment Date and during the Term, the Company will provide comprehensive health insurance for Executive and his immediate family and dependents. Additionally, Executive will be entitled to receive any other benefits, and participate in any other retirement, profit sharing, life insurance, disability insurance and other benefit plans as may be offered by the Company to its senior executives or other employees as of the Effective Date or thereafter.

 

(b)Vacation, Personal Days, Sick Days, and Holidays. During the Term, Executive will be entitled to twenty (20) days of paid vacation per year, two (2) paid personal days per year and ten (10) paid sick days per year. Additionally, the Company will establish a holiday schedule of not less than ten (10) holidays per fiscal year. Upon termination of Executive’s employment, the Company shall pay Executive an amount equal to any accrued but unused vacation within thirty (30) days of such termination.

 

 Page 4 of 11

 

(c)Personal Items. During the Term, the Company will provide Executive with a (i) personal laptop computer, (ii) a personal digital assistant and (iii) a cell phone (items (ii) and (iii) may be one item) (collectively the “Personal Items”). The Company agrees that it is in the Company’s best interests to allow Executive to use the Personal Items for Executive’s personal use and Executive is authorized to do so. Notwithstanding any provision to the contrary herein, in the Nondisclosure Agreement or in any other agreement between the Company and Executive, the Company acknowledges and agrees that any such personal information, data, software or other material contained in or stored on any of the Personal Items (“Personal Materials”) shall be and remain the sole property of Executive. The Company agrees that the Personal Materials shall be deemed the confidential information of Executive and the Company shall not review, access or disclose any of such Personal Materials without the prior written consent of Executive. Further, the Company agrees that upon termination of Executive’s employment for any reason, Executive shall be entitled to retain all Personal Materials (and if returning the Personal Items to the Company upon termination, remove all Personal Materials from the Personal Items prior to return) and a copy of Executive’s calendar and contacts, whether residing or stored on the Personal Items or otherwise.

 

6.Business Expenses. The Company shall pay, or reimburse Executive for all reasonable expenses incurred by Executive related to conduct of the business of the Company; provided that the Executive complies with the Company’s reasonable policies for the reimbursement or advancement of business expenses that are now or hereafter in effect.

 

7.Termination. This Agreement and Executive’s employment by the Company shall or may be terminated, as the case may be, as follows:

 

(a)Termination upon Expiration of the Term. This Agreement and Executive’s employment by the Company shall terminate upon the expiration of the Term if either party provides written notice of non-renewal pursuant to Section 2 hereof.

 

(b)Termination by Executive. Executive may terminate this Agreement and his employment by the Company (i) for Good Reason, or (ii) otherwise at any time and for any reason upon sixty (60) days’ notice to the Company.

 

(c)Termination by the Company. The Company may terminate this Agreement and Executive’s employment by the Company upon notice to Executive (or his personal representative (as applicable): (i) at any time and for any reason upon written notice to Executive; (ii) for Cause; (iii) upon Executive’s death in which case this Agreement shall terminate immediately; provided that such termination shall not prejudice any benefits payable to Executive’s heirs or beneficiaries which are fully vested as of the date of death and provided further that all “Membership Units” in the Company previously issued to Executive that would have been released from the Right of Repurchase over the next six (6) months of Executive’s employment will immediately become fully released from such Right of Repurchase as of the date of termination; or (iv) if Executive is “permanently disabled” in which case this Agreement shall terminate immediately; provided that such termination shall not prejudice any benefits payable to Executive, Executive’s spouse or beneficiaries which are fully vested as of the date of the termination of this Agreement and provided further that all restricted Membership Units in the Company previously issued to Executive that would have been released from the Right of Repurchase over the next six (6) months of Executive’s employment will immediately become fully released from such Right of Repurchase as of the date of termination. For purposes of this Agreement, Executive shall be considered “permanently disabled” when a qualified medical doctor mutually acceptable to the Company and Executive or Executive’s personal representative shall have certified in writing that: (A) Executive is unable, because of a medically determinable physical or mental disability, to perform the essential functions of Executive’s job, with or without a reasonable accommodation, for more than one hundred and eighty (180) calendar days measured from the last full day of work; or (B) by reason of mental or physical disability, it is unlikely that Executive will be able, within one hundred and eighty (180) calendar days, to resume the essential functions of Executive’s job, with or without a reasonable accommodation, and to otherwise discharge Executive’s duties under this Agreement. Executive shall continue to be compensated as otherwise provided herein during such 180-day period, except that any compensation due to Executive may be reduced by the amount of disability income, if any, provided by a Company sponsored disability plan.

 

 Page 5 of 11

 

8.Company Obligations upon Termination.

 

(a)If Executive’s employment with the Company (A) is terminated: (i) by the Company for Cause, (ii) by the Company pursuant to Section 7(c)(iii) or (iv), or (iii) by Executive pursuant to Section 7(b)(ii); or (B) if Executive elects not to renew the Term, the Company shall have no further obligations hereunder other than the payment of all compensation and other benefits accrued or payable to Executive through the date of such termination which shall be paid on or before the Company’s next regularly scheduled payday unless such amount is not then-calculable, in which case payment shall be made on the first regularly scheduled payday after the amount is calculable.

 

(b)If Executive’s employment with the Company (A) is terminated: (i) by the Company without Cause or (ii) by Executive for Good Reason; or (B) if the Company elects not to renew the Term, Executive shall receive from the Company:

 

(i)An amount equal to the sum of (A) Executive’s then-current Annual Salary (as defined in Section 1(a)) and (B), payable in twelve (12) equal monthly installments on the first business day of each calendar month following the month in which termination of employment occurs;

 

(ii)Payment of health, dental insurance premiums for Executive and his family under the Company’s then existing group health plan(s), for a period of eighteen (18) months following termination. In the event Executive and his family shall, for any reason, no longer be eligible participants, Executive shall be entitled, for each remaining month of such 18-month benefit, to payment of the amount of the gross aggregate monthly premium(s) last paid for Executive and his family under such plan(s). Such amount may be paid monthly or in one lump sum, at the Company’s discretion. Executive shall be responsible for any taxes due on such payments;

 

 Page 6 of 11

 

(iii)Without any further payment from Executive, Executive’s Company-owned Personal Items. Executive may, at Executive’s option within 14 days after termination, return the cellular phone to the Company, in which event the Company shall pay any termination or other fees related to the cellular phone or the cellular phone plan; and

 

(iv)The immediate lapsing of six (6) months of the Company’s Right of Repurchase.

 

9.Excise Tax. If Executive on the date of Executive’s termination of employment is a “specified employee” (as defined in Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), and the regulations promulgated thereunder (“Section 409A”)), notwithstanding the provisions of Section 8, if and solely to the extent required in order to avoid the imposition on Executive of any excise tax under Section 409A, the payment of any severance or other payments under Section 8 shall not commence until, and shall be made on, the first business day after the date that is six (6) months following the date of Executive’s termination of employment, and in such event the initial payment shall include a catch-up amount covering amounts that would otherwise have been paid during the six-month period following Executive’s termination date.

 

10.Membership Interests; Right of Repurchase. As of the Effective Date, Executive has purchased and owns 700,000 Membership Units. The Company shall have a right of repurchase (the “Right of Repurchase”) with respect to 560,000 of such Membership Units (the “Remaining Units”). The Right of Repurchase shall lapse according to the following schedule: the Remaining Units shall become fully released from the Right of Repurchase at the rate of 1/48th of such Remaining Units per month commencing on the Effective Date, such that all of the Remaining Units shall be released from the Right of Repurchase on the fourth annual anniversary of the Effective Date. In addition, the Right of Repurchase shall lapse on an accelerated basis as to 100% of the Remaining Units upon the consummation of a Material Transaction or upon a liquidation or dissolution of the Company. If Executive’s employment is terminated for any reason prior to the expiration of the Right of Repurchase, the Company shall have the right to repurchase such of the Remaining Units as are subject to the Right of Repurchase as of the date of termination for the original amount of $0.00001 per Membership Unit paid by Executive for such Remaining Units to be repurchased. The Company shall deliver written notice (the “Notice”) to Executive within sixty (60) days of termination of employment of its election to exercise such Right of Repurchase as to the Remaining Units still subject to the Right of Repurchase; otherwise the Right of Repurchase shall expire at the end of such 60-day period. If Company delivers the Notice, then the units will be purchased by the Company on the date -twelve (12) months after such Notice (the “Purchase Date”). If a Material Transaction occurs before the Purchase Date, then the Right of Repurchase shall lapse for any and all Remaining Units and Executive shall retain ownership of all Membership Units owned by Executive at the time of Executive’s termination.

 

11.No Obligation to Mitigate. Executive will not be required to mitigate the amount of any payment or benefit provided for in this Agreement by seeking other employment or otherwise, nor will the amount of any payment or benefit provided for in this Agreement be reduced by any compensation or benefit earned by Executive as the result of employment by another employer, by retirement benefits, by offset or otherwise; provided, that payments by a Successor designated as payments under this Agreement will be credited against the obligations under this Agreement whether or not the paying entity is the Company.

 

 Page 7 of 11

 

12.Section 409A. To the extent that any provision of this Agreement is subject to Section 409A, such provision is intended to comply with Section 409A. Deferral or acceleration of any payment contemplated by this Agreement which is subject to Section 409A is strictly prohibited unless specifically permitted by Section 409A; Executive’s rights to any payments subject to Section 409A are not subject to anticipation, alienation, sale, transfer, pledge, encumbrance, attachment or garnishment and, where applicable, may only be transferred by will or the laws of descent and distribution; and to the fullest extent permitted by law, each payment and payment rights hereunder shall be treated as a separate payment for purposes of Section 409A.

 

13.Nondisclosure and Inventions Assignment. Prior to this Agreement becoming effective, Executive will execute the Company’s standard Employee Nondisclosure and Assignment of Inventions Agreement (“Nondisclosure Agreement”), a copy of which is attached to this agreement as Exhibit A.

 

14.Withholding. Notwithstanding any withholding policy or procedure which the Company may have adopted or may adopt with respect to withholding from distributions paid to Executive as a Member of the Company, the Company or its Successor shall be entitled to reduce any payments due hereunder by normal withholdings required by law.

 

15.Indemnification. The Company shall indemnify Executive, to the maximum extent permitted by applicable law, against all costs, damages, liabilities, losses, charges and expenses of any kind incurred or sustained by Executive in connection with any action, suit or proceeding to which Executive may be a party or in which Executive may be a witness by reason of Executive’s being an officer, manager or executive of the Company or any subsidiary or affiliate of or Successor to the Company. If, after the resolution of an action in which Executive is found in a final, non-appealable judgment by a U.S. court of competent jurisdiction to be at fault due to willful misconduct of Executive, then Executive shall reimburse the Company for a reasonable apportionment of reasonable legal fees actually incurred by the Company directly related to defending Executive against such claim. In addition, Executive shall be entitled to full coverage under any directors’ and officers’ liability insurance policy maintained by the Company for one or more officers of the Company or members of the Board, and, to the extent that any indemnification is offered to any employee, officer, director or other agent of the Company, that has any terms that are more broad and/or beneficial to the indemnitee than the above, then the indemnification provided to Executive hereunder will be automatically amended to include such increased terms.

 

16.Notices. For the purpose of this Agreement, notices and all other communications provided for in the Agreement will be in writing and will be deemed to have been duly given when: (a) personally delivered; (b) deposited for next day delivery by Federal Express, or other similar overnight courier services; or (c) three days after being mailed by certified or registered mail, return receipt requested, postage prepaid, addressed to the party at its last known address, after reasonable inquiry, provided that all notices to the Company will be directed to the attention of its Secretary, or to such other address as either party may have furnished to the other in writing in accordance herewith.

 

 Page 8 of 11

 

17.Survival. Notwithstanding the termination of Executive’s employment, the parties’ rights and obligations shall survive to the extent that any performance is required under this Agreement after the expiration or termination of such employment.

 

18.No Consequential or Special Damages. In no event shall either of the parties be liable to the other for consequential or special damages of any kind or nature.

 

19.Dispute Resolution

 

(a)Any dispute or disagreement arising out of or in connection with this Agreement, including without limitation its validity and interpretation, shall be negotiated in good faith by the parties upon either party submitting a written request to the other to negotiate. The request to negotiate may include a request for mediation in which event the parties will act in good faith to agree upon a single mediator and to mediate the dispute. If the dispute is not settled by negotiation or if no mediator is agreed upon within thirty (30) days of the request, or if a mediator is agreed upon and the dispute is not settled through mediation within ninety (60) days of the request, the dispute shall be submitted to arbitration, and shall be finally settled, in accordance with the Commercial Rules of the American Arbitration Association by a single arbitrator in Charlottesville, Virginia.

 

(b)In arriving at his or her award the arbitrator shall make every effort to find a solution to the dispute in the provisions of this Agreement and shall give full effect to all parts hereof. However, if a solution cannot be found in the provisions of this Agreement, the arbitrator shall apply the local domestic law of the Commonwealth of Virginia; provided, however, that the arbitrator shall have no authority to modify any provisions of this Agreement or to award a remedy for a dispute involving this Agreement other than a benefit specifically provided under or by virture of this Agreement. Both parties shall make disclosure of all materials relevant to the dispute at the request of the other, and any disputes over such disclosure shall be resolved by the arbitrator.

 

(c)The award of the arbitrator shall be final and binding upon the parties. Judgment upon the award may be entered in any court having jurisdiction. An application may be made to any such court for a judicial acceptance of the award and an order for enforcement.

 

(d)Each party shall be responsible for its own expenses relating to the conduct of any mediation or arbitration provided for hereunder (including reasonable attorney’s fees and expenses), and the parties shall share evenly the fees of any mediator, and of the American Arbitration Association and any arbitrator.

 

20.Binding Effect. The obligations of the parties will be binding on and inure to the benefit of their respective heirs, successors, assigns, personal representatives and affiliates, including, without limitation, any Successors. Any Successor shall be deemed substituted for the Company under the terms of this Agreement.

 

 Page 9 of 11

 

21.Integration. This Agreement and the Nondisclosure Agreement constitute the parties’ entire agreement with respect to the subject matter hereof and supersede all prior agreements and understandings between the parties with respect to the same. Subject to the provisions of Section 2 for automatic Term renewal, a waiver, discharge, amendment, modification or termination of this Agreement or any provision hereof will be valid and effective only if in writing and executed by both parties hereto. A written waiver of a right, remedy or obligation under a provision of this Agreement will not constitute a waiver of the provision itself, a waiver of any succeeding right, remedy or obligation under the provision, or a waiver of any other right, remedy, or obligation under this Agreement. Any delay or failure by a party in enforcing any obligation or in exercising any right or remedy will not operate as a waiver of it or affect that party’s right later to enforce the obligation or exercise the right or remedy, and a single or partial exercise of a right or remedy by a party does not preclude any further exercise of it or the exercise of any other right or remedy of that party.

 

22.Severability. If any provision of this Agreement is held by a court or other tribunal of competent jurisdiction to be invalid, void or unenforceable in any respect or with respect to any matter, such provision in all other respects and with respect to all other matters, and the remaining provisions with respect to all matters, will nevertheless continue in full force and effect without being impaired or invalidated and will be enforceable to the full extent permitted by law.

 

23.Governing Law. This Agreement will be governed by and construed in accordance with the laws of the Commonwealth of Virginia as such laws are applied to agreements entered into and to be performed entirely within the Commonwealth of Virginia between Virginia residents.

 

24.Construction. Unless the context of this Agreement otherwise requires, (a) words of any gender will be deemed to include each other gender; (b) the words “herein,” “hereof’ and “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular article, section, paragraph, or other subdivision, (c) words using the singular or plural in number will also include the plural or singular in number, respectively; (d) the terms “Section” or “subsection” will refer to the specified Section or subsection of this Agreement; (e) the terms of any provision of the Code, or any other statute, regulation or form, or part thereof, will be deemed also to refer to successor provisions to such provisions; and (f) the headings of the sections of this Agreement are inserted for convenience only and will not be deemed to constitute part of this Agreement or to affect its construction.

 

25.Counterparts. This Agreement may be executed in more than one counterpart, each of which shall be deemed an original, and all of which shall be deemed a single agreement.

 

 Page 10 of 11

 

WITNESS the following duly authorized signatures:

 

ADial Pharmaceuticals, LLC  

EXECUTIVE:

         
By: /s/ Bankole A. Johnson   By: /s/ William B. Stilley, III
  Bankole A. Johnson     William B. Stilley, III
  Chairman      

  

Employment Date Certification

 

I hereby certify that I reported for work with the Company on December 6, 2010 (the “Employment Date”) and that a copy of this certification has been provided to the Company.

 

By: /s/ William B. Stilley, III  
  William B. Stilley, III  

 

 Page 11 of 11

 

Exhibit A

 

Company’s Employee Nondisclosure and Assignment of Inventions Agreement

 

(Attached)

 

 

 

ADIAL PHARMACEUTIALS, L.L.C

CONFIDENTIALITY, NON-DISCLOSURE AND

OWNERSHIP OF EMPLOYEE DEVELOPMENTS AGREEMENT

 

As an employee of ADial Pharmaceutials, L.L.C. (“Employer”), I hereby agree to observe all the provisions of this Agreement, as well as all other rules and policies that the Employer may announce from time to time.

 

Section 1

AVOIDANCE OF CONFLICT OF INTEREST

 

1.1 While employed by Employer, I will not engage in any other business activity that conflicts with my duties to Employer. Under no circumstances will I work for any competitor or have any financial interest in any competitor of Employer; provided, however, that this Agreement does not prohibit investment of a reasonable part of my assets in the stock or securities of any competitor whose stock or securities are traded on a national exchange.

 

Section 2

OWNERSHIP OF EMPLOYEE DEVELOPMENTS

 

2.1 While employed by Employer, I will devote my inventive skills only to Employer, Employer shall be entitled to own and control all proprietary technology and all technological and business ideas and inventions, whether patentable or unpatentable, including, without limitation, discoveries, formulas, processes, machines, manufactures, compositions, compounds, accounting methods, business and financial plans and other financial, operating, and training ideas, methods, processes, and materials, including, without limitation, works of expression and all copyrights in such works (collectively “Ideas, Inventions and Works”), that are developed, created, or conceived by me during employment, to the extent that they relate to Employer's current or potential business. Accordingly, I will disclose, deliver, and assign, and hereby do assign, to Employer all such Ideas, Inventions and Works, and I agree to execute all documents, patent applications, and arrangements necessary to further document such ownership and/or assignment and to take whatever other steps may be needed to give Employer the full benefit of them. Without limitation to the foregoing, I specifically agree that all copyrightable Ideas, Inventions and Works (“Copyrightable Works”) generated or developed during my employment by me during employment, to the extent that they relate to Employer's current or potential business, including but not limited to computer programs and documentation, shall be considered works made for hire under the copyright laws of the United States and shall, upon creation, be owned exclusively by Employer. To the extent that any such Copyrightable Works, under applicable law, may not be considered works made for hire, I hereby assign to Employer the ownership of all copyrights in such Copyrightable Works, without the necessity of any further consideration, and Employer shall be entitled to register and hold in its own name all copyrights in respect of such Copyrightable Works.

 

Section 3

CONFIDENTIALITY; RETURN OF MATERIALS

 

3.1 I recognize that my position with Employer requires considerable responsibility and trust, and, in reliance on my loyalty, Employer may entrust me with highly sensitive confidential, restricted, and proprietary information involving trade secrets and confidential information.

 

3.2 For purposes of this Agreement, a “Trade Secret” is any scientific or technical information, design, process, procedure, formula, or improvement that is valuable and not generally known to competitors of Employer. “Confidential Inforzmation” is any data or information, other than Trade Secrets, that is material, competitively sensitive, and not generally known by the public, such as, by way of example only, Employer’s business plans, prospective and actual collaborators and product development plans.

 

3.3 I will not use or disclose any Trade Secrets of Employer during my employment and for so long afterwards as the pertinent information or data remain Trade Secrets, whether or not the Trade Secrets are in written or tangible form, except as required to perform my duties for Employer.

 

 

 

3.4 I will not use or disclose any Confidential Information of Employer during my employment and for so long afterwards as the pertinent information or data remain Confidential Information, but in no event for longer than three (3) years after termination of my employment, whether or not the Confidential Information is in written or tangible form, except as required to perform my duties for Employer.

 

3.5 Upon the request of Employer and, in any event, upon the termination of my employment, I will leave with Employer all materials of any nature whatsoever involving any Trade Secrets or Confidential Information of Employer, including, without limitation, all computer programs, documentation, memoranda, notes, records, drawings, manuals, or other documents pertaining to Employer's business or my employment (including all copies thereof).

 

Section 4

NO INTERFERENCE WITH PERSONNEL RELATIONS

 

4.1 During my employment with Employer and for a period of twelve (12) months afterwards, I will not knowingly solicit, entice, or persuade any other employees of Employer to leave the services of Employer for any reason.

 

Section 5

MISCELLANEOUS

 

5.1 This Agreement shall inure to the benefit of, and be binding upon, Employer and its subsidiaries and affiliates, together with their successors and assigns, and me, together with my executor, administrator, personal representative, heirs, and legatees.

 

5.2 This Agreement merges and supersedes all prior agreements, undertakings, covenants, or conditions, whether oral or written, express or implied, to the extent they contradict or conflict with the provisions hereof.

 

5.3 Although it is understood that my employment was and now is, and that my continued employment is and will be, contingent on the acceptance and observance of this Agreement, this Agreement shall not be construed to modify the terms of my employment or the status of my employment.

 

IN WITNESS WHEREOF, I have accepted and executed this Agreement as of the 3rd day of December 2010.

 

EMPLOYEE:     EMPLOYER:
         
/s/ William B. Stilley   ADIAL PHARMACEUTICALS, L.L.C.
Name: William B. Stilley                                            
Social Security No. #####                                      By: /s/ Bankole A. Johnson
Address: #####                                                         Bankole A. Johnson
Charlottesville, VA 29911                        Chairman

 

 

 

 

EX-10.6 31 fs12017ex10-6_adialpharma.htm SALARY FORBEARANCE AGREEMENT

Exhibit 10.6

 

SALARY FORBEARANCE AGREEMENT

 

This Salary Forbearance Agreement (this “Agreement”) is effective as of August 17, 2016 (the “Effective Date”), between ADial Pharmaceuticals, LLC, a Virginia limited liability company (the “Company”), and William B. Stilley, III (“Executive”). The Company and Executive are each “Party” and together, the “Parties”.

 

RECITALS

 

A.      The Executive Committee of the Board of Directors of the Company (the “Board”), as the terms are defined in the Company’s Second Amended & Restated Operating Agreement dated February 3, 2016 (the “Operating Agreement”), believes that it is in the best interests of the Company and its Members (defined in the Operating Agreement) to continue the employ of Executive.

 

B.       Executive has provided notice of Good Reason as that term is defined in the Executive Employment Agreement between the Company and Executive dated December 6, 2010 (the “EA”) and Good Reason exists.

 

C.       Executive is due all unpaid salary at the rate specified in Section 1(a) of the EA (i.e. $210,000 per year) for the full time of his employment (“Salary Due”) and, that if his employment is terminated for any reason, he would be immediately due twelve (12) months of salary (i.e. $210,000) under Section 8(b)(i) (the “Severance”). Salary Due and Severance are together the “Total Liability”, which is a liability to the Company potentially greater than $500,000.

 

AGREEMENT

 

In consideration of the promises and undertakings set forth herein and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the Company and Executive agree as follows:

 

1.Salary Forgiveness. Executive hereby irrevocably and forever releases and discharges the Company from its obligation to pay the Total Liability subject to the following terms and conditions:

 

(a)The Parties agree that the Executive’s current salary (as previously referenced in Section 4(a) of the EA) shall be set at $5,000 per month as of the Effective Date. As the Company’s prospects develop and change during the term of his employment with the Company and prior to the occurrence of the event described in Section 1(d) hereof, the Company will pay Executive a salary in an amount negotiated in good faith between the Parties based on the ability of the Company to pay a cash salary to Executive with the recognition that Executive’s salary as stated in the EA is below market salary for Executive.

 

 Page 1 of 4

 

(b)The Company will periodically evaluate the performance of Executive for additional performance bonuses and equity awards.

 

(c)No other portion of Executive’s compensation or the terms of his employment are affected by the aforementioned release, including, without limitation, his participation in the Company’s ADial’s Performance Bonus Plan (the “PBP”) approved on February 17, 2015 and amended on January 25, 2016.

 

(d)If the Company raises financing of more than $1,000,000 while Executive is still employed by Company, then the full $210,000 annual salary as stated in the EA will begin to be paid in cash from that date forward, and any waiver of any continuing terms of the EA and the Severance will no longer exist (i.e., going forward Executive will be paid at the rate of $210,000 per year and Severance if terminated in a manner that qualifies for Severance in the EA at the rate of $210,000).

 

(e)The Company will not take legal or punitive action against Executive, with the sole exception being for criminal misconduct.

 

(f)Bankole Johnson may not Control the Company (as that term is defined below).

 

In the event of violation of any of the above conditions, then the Total Liability shall immediately become due and payable to Executive. In such event, Executive’s claim against the Company shall be subordinate to those certain convertible promissory notes issued by the Company in or about August 2016, except that Executive may elect to apply the Total Liability as an offset against any claims against Executive which may be brought by Company or its Members.

 

“Control the Company” means (i) to have the ability to appoint or to actually appoint (A) a majority of the Board members or (B) a majority of the Board members that vote on any matter; or (ii) the ability to direct or to actually direct any Member or combination of Members holding (A) a majority of the Membership Units entitled to vote or (B) voting a majority of the Membership Units voted on any matter. “Appoint” and “direct” as used in this paragraph, include, without limitation, to do so directly or indirectly with such terms interpreted in the broadest sense.

 

2.Third Party Employment. Recognizing that Executive is working at a reduced current cash salary, Executive is approved to work and consult for third parties as long as he continues to reasonably perform his duties to the Company and subject to providing proper disclosures as required of all members of the Board (all per Section 5.7 of the Operating Agreement).

 

3.No Other Amendment to the EA. Other than as specifically stated herein, all other terms of the EA remain unchanged.

 

4.General Release. In consideration for the promises set forth herein and in addition to the other terms herein, the Company agrees to and hereby does, for itself and for its affiliates, forever and irrevocably fully release and discharge Executive from any and all grievances, liens, suits, judgments, claims, demands, debts, defenses, actions or causes of action, obligations, damages, and liabilities whatsoever, which it now has, has had, or may have against them, whether the same be known or unknown, accrued or un-accrued, at law, in equity, or mixed, arising from acts occurring through the date hereof; provided however, that the Company may take action to enforce this Agreement.

 

 Page 2 of 4

 

5.Binding Effect. The obligations of the parties will be binding on and inure to the benefit of their respective heirs, successors, assigns, personal representatives and affiliates, including, without limitation, any Successors. Any Successor shall be deemed substituted for the Company under the terms of this Agreement.

 

6.Amendments; Waivers. Waiver, discharge, amendment, modification or termination of this Agreement or any provision hereof will be valid and effective only if in writing and executed by both parties hereto. A written waiver of a right, remedy or obligation under a provision of this Agreement will not constitute a waiver of the provision itself, a waiver of any succeeding right, remedy or obligation under the provision, or a waiver of any other right, remedy, or obligation under this Agreement. Any delay or failure by a party in enforcing any obligation or in exercising any right or remedy will not operate as a waiver of it or affect that party’s right later to enforce the obligation or exercise the right or remedy, and a single or partial exercise of a right or remedy by a party does not preclude any further exercise of it or the exercise of any other right or remedy of that party.

 

7.Severability. If any provision of this Agreement is held by a court or other tribunal of competent jurisdiction to be invalid, void or unenforceable in any respect or with respect to any matter, such provision in all other respects and with respect to all other matters, and the remaining provisions with respect to all matters, will nevertheless continue in full force and effect without being impaired or invalidated and will be enforceable to the full extent permitted by law; and, to the extent possible, any terms determined to invalid, void or unenforceable will be modified to comport with the intent herein.

 

8.Governing Law. This Agreement will be governed by and construed in accordance with the laws of the Commonwealth of Virginia as such laws are applied to agreements entered into and to be performed entirely within the Commonwealth of Virginia between Virginia residents.

 

9.Construction. Unless the context of this Agreement otherwise requires, (a) words of any gender will be deemed to include each other gender; (b) the words “herein,” “hereof’ and “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular article, section, paragraph, or other subdivision, (c) words using the singular or plural in number will also include the plural or singular in number, respectively; (d) the terms “Section” or “subsection” will refer to the specified Section or subsection of this Agreement; and (e) the headings of the sections of this Agreement are inserted for convenience only and will not be deemed to constitute part of this Agreement or to affect its construction.

 

10.Counterparts. This Agreement may be executed in more than one counterpart, each of which shall be deemed an original, and all of which shall be deemed a single agreement.

 

[Signature page follows.]

 

 Page 3 of 4

 

WITNESS the following duly authorized signatures:

 

ADIAL PHARMACEUTICALS, LLC   EXECUTIVE:
         
By: /s/ William B. Stilley, III   By: /s/ William B. Stilley, III
Print: William B. Stilley, III     William B. Stilley, III
Title: CEO      
 

(as authorized by Board resolutions dated 2016-08-03 and 2016-08-06)

     

 

 

Page 4 of 4

 

 

EX-10.7 32 fs12017ex10-7_adialpharma.htm CONSULTING AGREEMENT - JOSEPH TRULUCK

Exhibit 10.7 

 

   

414 Water St.

Charlottesville, VA 22911-5848

434-422-9800

www.adialpharma.com

 

April 25, 2016

Joseph Truluck

1534A Wilhelmina Rise

Honolulu, HI 96816

 

Dear Joe:

 

I am pleased to offer you a position a with ADial Pharmaceuticals, LLC ("ADial") as Vice President, Operations & Finance. Your employment commences today, April 25, 2016 and will be as an independent contractor but will be reported on a K-1 if you are a member of ADial while it is an LLC.

 

In line with your independent contractor status, you will work part time and will perform your work on behalf of the company during the times largely determined by you and with many tasks determined by you.

 

As part of the terms of your employment, you are also being granted 207,319 Class A Profits Interest Membership Units in ADial. These units will be subject to forfeiture and capital accounting as more fully delineated in the Unit Award Agreement granting such units.

 

You will also be awarded 0.5% of a Transaction under ADial’s Performance Bonus Plan dated January 25, 2016 (the “PBP”) with a “tail” proportionally identical to that of the CEO. For clarity, this means that 0.5% of a Transaction is equal to 9.5% of the Pool and it will be awarded for the portion subject to the discretion of the CEO. Capitalized terms not otherwise defined herein and “tail” in this paragraph have the meaning as defined in the PBP.

 

You will report to William Stilley, ADial’s CEO. Your duties will include activities related to operations, finance and company administration, interfacing and managing with company vendors and potential partners, supporting the CEO, and other activities as requested by the CEO.

 

As a condition of employment, you will enter into ADial’s Confidentiality, Non-Disclosure, Avoidance Of Conflicts Of Interest And Ownership Of Employee Developments Agreement, which assigns to ADial all intellectual property related to ADial’s business developed by you while you are employed by ADial.

 

Should you accept our offer, please indicate your acceptance by signing in the space below.

 

Sincerely yours,   Agreed and accepted:
     
/s/ William B. Stilley   /s/ Joseph Truluck

William B. Stilley

  Joseph Truluck
CEO    

 

EX-10.8 33 fs12017ex10-8_adialpharma.htm TERMINATION AGREEMENT

Exhibit 10.8 

 

TERMINATION AGREEMENT

 

This Termination Agreement (this “Agreement”) is made effective as of the last date of signature, below (the “Effective Date”), between

 

(i) Cato Holding Company d/b/a Cato BioVentures, a North Carolina corporation (“Cato”), and

 

(ii) ADial Pharmaceuticals, LLC, a Virginia limited liability company (“ADial”).

 

Recitals:

 

i.      On October 25, 2013, the parties entered into a Strategic Master Services Agreement (the “MSA”) under which Cato would provide compensated services to ADial, with a portion of such services being issued in the form of a warrant to purchase membership interests in ADial (the “Warrant”);

 

ii.     On October 28, 2013, the parties entered into a Work Order identified as “ADI01” under the MSA describing services to be provided by Cato to ADial (the “Work Order”);

 

iii.    ADial made an up-front payment to Cato of $143,251 under the Work Order;

 

iv.    ADial has terminated the Work Order and MSA effective July 15, 2015; and

 

v.     The parties wish to enter into this Agreement to resolve the outstanding issues as a result of such termination, including the disposition of the Warrant, compensation for services performed, and repayment of amounts previous paid by ADial to Cato.

 

Therefore, the parties agree as follows:

 

1.     Payments. Out of the $143,251 previously paid by ADial to Cato, Cato shall keep $55,000 as revenue for services performed, provide ADial with a $15,000 credit as described in Section 2, and refund the rest to ADial. As of the date of this Agreement, Cato has refunded $70,000 to ADial.

 

2.     Services Credit. ADial shall have a $15,000 credit for future services performed by Cato for ADial or its successors under a Work Order valued at $150,000 or greater which is entered into within five (5) years of the date of this Agreement.

 

 

 

3.     Option. ADial hereby grants Cato an option to participate in its next offering and issuance of securities (other than securities in the form of non-convertible debt and securities which have been registered under the Securities Act of 1933, as amended) occurring after the date of this Agreement where the total expected proceeds to ADial are at least $3,000,000 (the “Offering”), on the following terms:

 

3.1.  ADial shall provide at least thirty (30) days notice of the expected closing date of the Offering. Such notice shall contain a copy of any terms sheet and other documents, disclosure statements, offering circulars or similar related to the Offering (collectively, “Deal Documents”) which are then available. ADial shall provide updated Deal Documents to Cato as they are provided to other prospective investors in the Offering.

 

3.2.  Cato shall be entitled to buy the same securities offered to other investors in the Offering on the same terms offered to them, except that (i) Cato shall be entitled to a 15% discount below the lowest price offered to a majority of the other investors in the Offering (as measured by the amount invested and not by the number of investors), (ii) Cato shall be entitled to invest up to $100,000 on such terms, and (iii) such terms shall not require Cato to invest additional amounts in future offerings nor impose any penalty or detriment on Cato for not investing in any future offerings. Cato may exercise the option on a “cashless” basis.

 

3.3.  The option specified in this Section 2 shall terminate on the five-year anniversary of the effectiveness of this Agreement if it remains unexercised before then. In addition, if Cato elects not to participate in the Offering, the option will not apply to any future offering. Further, if retirement of this Option is required by an acquirer of ADial, Cato shall have the right, but not the obligation, to purchase any amount up to 70,423 Class B Units in ADial at a price of $1.42 per unit (adjusted for splits, reclassifications, reorganizations, etc.) upon thirty (30) days written notice (including provision of related Deal Documents) of such transaction by ADial; and, if Cato does not exercise this option, then the option specified in Section 2 shall immediately terminate.

 

3.4.  Cato represents and warrants that it is acquiring this option for investment purposes and not with a view to, of for resale in connection with, any distribution or public offering. Cato represents that it has knowledge and experience in financial and business matters, that it is capable of evaluating the merits and risks and of bearing the economic risks of the acquisition of this option and the securities purchaseable upon its exercise.

 

3.5.  If ADial converts to a different form of entity (whether by merger or otherwise) or engages in a corporate transaction such as a merger or share exchange before this option terminates, then this option shall apply to the successor entity after such conversion or transaction.

 

4.     Termination of Work Order and MSA. The Work Order and MSA are hereby terminated effective July 15, 2015, and, except as provided in this Agreement, neither party shall have any further obligation to the other under the Work Order or the MSA. Notwithstanding the preceding sentence, the rights and obligations of the Parties set forth in Sections 7, 9, 11, 12, 14, 20, and 24 of the MSA shall survive; and Sections 24.3 and 24.4 of the MSA shall apply to and govern for this Agreement.

 

 

 

In witness whereof, the parties have executed this Agreement as of the Effective Date.

 

Cato Holding Company   ADial Pharmaceuticals, LLC
d/b/a Cato BioVentures      
         
By: /s/ Mike Cato   By: /s/ William B. Stilley
         
Printed Name: Mike Cato   Printed Name: William B. Stilley
         
Title: CEO   Title: Vice President
         
Date: March 14, 2016   Date: March 14, 2016

 

 

 

 

 

EX-10.9 34 fs12017ex10-9_adialpharma.htm SECURITIES PURCHASE AGREEMENT

Exhibit 10.9

 

SECURITIES PURCHASE AGREEMENT

 

This SECURITIES PURCHASE AGREEMENT (the “Agreement”), dated as of May 1, 2017, by and between ADIAL PHARMACEUTICALS, LLC, a Virginia limited liability company, with headquarters located at 204 E. High Street, Charlottesville, VA 22902 (the “Company”), and FIRSTFIRE GLOBAL OPPORTUNITIES FUND, LLC, a Delaware limited liability company, with its address at 1040 First Avenue, Suite 190, New York, NY 10022 (the “Buyer”).

 

WHEREAS:

 

A. The Company and the Buyer are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”) and Rule 506(b) promulgated by the United States Securities and Exchange Commission (the “SEC”) under the 1933 Act;

 

B. Buyer desires to purchase from the Company, and the Company desires to issue and sell to the Buyer, upon the terms and conditions set forth in this Agreement, a Senior Secured Promissory Note of the Company, in the aggregate principal amount of $287,500.00 (as the principal amount thereof may be increased pursuant to the terms thereof, and together with any note(s) issued in replacement thereof or as a dividend thereon or otherwise with respect thereto in accordance with the terms thereof, in the form attached hereto as Exhibit A, the “Note”), upon the terms and subject to the limitations and conditions set forth in such Note;

 

C. The Buyer wishes to purchase, upon the terms and conditions stated in this Agreement, such principal amount of the Note as is set forth immediately below its name on the signature pages hereto;

 

D. The Company wishes to issue those certain Commitment Shares (as defined herein) (the “Commitment Shares”), to the Buyer as additional consideration for the purchase of the Note, as further provided herein; and

 

E. The Company wishes to issue that certain warrant to purchase shares of Common Stock in the form attached hereto as Exhibit B (the “Warrant”), to the Buyer as additional consideration for the purchase of the Note, as further provided herein.

 

F. For purposes of this Agreement, until such time as the Company is a corporation and is no longer a limited liability company, the term Common Stock shall mean the Class A membership units of the Company.

 

NOW THEREFORE, in consideration of the foregoing and of the agreements and covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Company and the Buyer hereby agree as follows:

 

1. Purchase and Sale of Note.

 

a. Purchase of Note. On the Closing Date (as defined below), the Company shall issue and sell to the Buyer, and the Buyer agrees to purchase from the Company, the Note as further provided herein.

 

b. Form of Payment. On the Closing Date: (i) the Buyer shall pay the purchase price of $250,000.00 (the “Purchase Price”) for the Note, to be issued and sold to it at the Closing (as defined below), by wire transfer of immediately available funds to the Company, in accordance with the Company’s written wiring instructions, against delivery of the Note, and (ii) the Company shall deliver such duly executed Note on behalf of the Company, to the Buyer, against delivery of such Purchase Price.

 

c. Closing Date. Subject to the satisfaction (or written waiver) of the conditions thereto set forth in Section 6 and Section 7 below, the date and time of the issuance and sale of the Note pursuant to this Agreement (the “Closing Date”) shall be 4:00 PM, Eastern Time on the date first written above, or such other mutually agreed upon time.

 

d. Closing. The closing of the transactions contemplated by this Agreement (the “Closing”) shall occur on the Closing Date at such location as may be agreed to by the parties (including via exchange of electronic signatures).

 

 

 

1A. Warrant and Commitment Shares.

 

a. Upon an Initial Public Offering (“IPO”). Within three (3) business days of the consummation of the Company’s initial public offering (the “IPO”), the Company shall issue to Buyer the following:

 

(i) The Warrant pursuant to the terms contained in the form attached as Exhibit B. At issuance of the Warrant, the number of Warrant Shares (as defined in the Warrant) purchasable under the Warrant shall be equal to $287,500 divided by the price per share of Common Stock obtainable under the IPO (the “IPO Price”) and the Exercise Price (as defined in the Warrant) shall be equal to IPO Price; and

 

(ii) The number of shares of Common Stock equal to the quotient of $29,000.00 divided by the IPO Price (the “Commitment Shares”).

 

b.  Upon a Next Financing. In the event a Next Financing (defined below) is consummated prior to the IPO, then the Company shall provide Buyer ten (10) business days written notice of the terms of the Next Financing, but not sooner than twenty (20) business days prior to consummation of the Next Financing, and, upon the election of Buyer (the “Election”), at Buyer’s sole discretion, and written notice of such election, the Company shall, instead of issuing the securities stated in 1A.a. above, issue Buyer the following:

 

(i) A Warrant to purchase the amount and kind of securities sold in the Next Financing that could be purchased for $287,500 at Next Financing Price (defined below). The aggregate price to exercise the Warrant will be $287,500. To the extent reasonably possible, a Warrant will be issued using the form attached hereto as Exhibit B (e.g. the Warrant Shares will be modified to be the securities offered in the Next Financing). If any of the securities to be issued upon exercise of the Warrant provide that they convert into securities of the Company upon consummation of an IPO then the Warrant shall provide that the Warrant shall terminate upon the consummation of the IPO unless exercised at least thirty (30) days prior to consummation of the IPO; and

 

(ii) The Commitment Shares, which will be the amount and kind of securities purchasable for an investment amount of $29,000 in the Next Financing at the Next Financing Price.

 

For clarity, if Buyer does not make the Election for any Next Financing, then Buyer shall retain the right to make the Election upon a subsequent Next Financing; and if Byer makes the Election for any Next Financing, Buyer will not have the right to make the Election for subsequent Next Financings.

 

The “Next Financing” means a financing of the Company (i) that is not an IPO, (ii) that is prior to the IPO, and (iii) in which the Company receives net proceeds in excess of $250,000.00 (to be aggregated with respect to any financings with common terms from the sale, grant, or disposition of any of its or its Subsidiaries' convertible debt, equity or equity equivalent securities, including without limitation any debt, common stock, preferred stock or other instrument or security).

 

The “Next Financing Price” means the lowest price paid by an investor in the Next Financing.

 

As used in this Agreement, the term “business day” shall mean any day other than a Saturday, Sunday or a day on which commercial banks in the city of New York, New York are authorized or required by law or executive order to remain closed.

 

2. Buyer ’ s Representations and Warranties. The Buyer represents and warrants to the Company as of the Closing Date that:

 

a. Investment Purpose. As of the Closing Date, the Buyer is purchasing the Note, the Commitment Shares, the Warrant, and the shares of Common Stock issuable upon exercise of the Warrant, such shares of Common Stock being collectively referred to herein as the “Conversion Shares” and, collectively with the Note, Warrant, Warrant Shares, and Commitment Shares, the “Securities”) for its own account and not with a present view towards the public sale or distribution thereof, except pursuant to sales registered or exempted from registration under the 1933 Act; provided, however, that by making the representations herein, the Buyer does not agree to hold any of the Securities for any minimum or other specific term and reserves the right to dispose of the Securities at any time in accordance with or pursuant to a registration statement or an exemption under the 1933 Act.

 

 2 

 

b. Accredited Investor Status. The Buyer is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D (an “Accredited Investor”).

 

c. Reliance on Exemptions. The Buyer understands that the Securities are being offered and sold to it in reliance upon specific exemptions from the registration requirements of United States federal and state securities laws and that the Company is relying upon the truth and accuracy of, and the Buyer’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of the Buyer set forth herein in order to determine the availability of such exemptions and the eligibility of the Buyer to acquire the Securities.

 

d. Information. The Buyer and its advisors, if any, have been, and for so long as the Note remains outstanding will continue to be, furnished with all materials relating to the business, finances and operations of the Company and materials relating to the offer and sale of the Securities which have been requested by the Buyer or its advisors. The Buyer and its advisors, if any, have been, and for so long as the Note remains outstanding will continue to be, afforded the opportunity to ask questions of the Company regarding its business and affairs. Notwithstanding the foregoing, the Company has not disclosed to the Buyer any material nonpublic information regarding the Company or otherwise and will not disclose such information unless such information is disclosed to the public prior to or promptly following such disclosure to the Buyer. Neither such inquiries nor any other due diligence investigation conducted by Buyer or any of its advisors or representatives shall modify, amend or affect Buyer’s right to rely on the Company’s representations and warranties contained in Section 3 below.

 

e. Governmental Review. The Buyer understands that no United States federal or state agency or any other government or governmental agency has passed upon or made any recommendation or endorsement of the Securities.

 

f. Transfer or Re-sale. The Buyer understands that (i) the sale or resale of the Securities has not been and is not being registered under the 1933 Act or any applicable state securities laws, and the Securities may not be transferred unless (a) the Securities are sold pursuant to an effective registration statement under the 1933 Act, (b) the Buyer shall have delivered to the Company, at the cost of the Company, an opinion of counsel (which may be the Legal Counsel Opinion (as defined below)) that shall be in form, substance and scope customary for opinions of counsel in comparable transactions to the effect that the Securities to be sold or transferred may be sold or transferred pursuant to an exemption from such registration, which opinion shall be accepted by the Company, (c) the Securities are sold or transferred to an “affiliate” (as defined in Rule 144 promulgated under the 1933 Act (or a successor rule) (“Rule 144”)) of the Buyer who agrees to sell or otherwise transfer the Securities only in accordance with this Section 2(f) and who is an Accredited Investor. Notwithstanding the foregoing or anything else contained herein to the contrary, the Securities may be pledged in connection with a bona fide margin account or other lending arrangement secured by the Securities, and such pledge of Securities shall not be deemed to be a transfer, sale or assignment of the Securities hereunder, and the Buyer in effecting such pledge of Securities shall be not required to provide the Company with any notice thereof or otherwise make any delivery to the Company pursuant to this Agreement or otherwise.

 

g. Legends. The Buyer understands that until such time as the Note, Warrant, and, upon exercise of the Warrant in accordance with its respective terms, the Conversion Shares, have been registered under the 1933 Act or may be sold pursuant to Rule 144, Rule 144A under the 1933 Act or Regulation S without any restriction as to the number of securities as of a particular date that can then be immediately sold, the Securities may bear a restrictive legend in substantially the following form (and a stop-transfer order may be placed against transfer of the certificates for such Securities):

 

“NEITHER THE ISSUANCE AND SALE OF THE SECURITIES REPRESENTED BY THIS CERTIFICATE NOR THE SECURITIES INTO WHICH THESE SECURITIES ARE [CONVERTIBLE/EXERCISABLE] HAVE BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR APPLICABLE STATE SECURITIES LAWS. THE SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD, TRANSFERRED OR ASSIGNED (I) IN THE ABSENCE OF (A) AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR (B) AN OPINION OF COUNSEL (WHICH COUNSEL SHALL BE SELECTED BY THE HOLDER), IN A GENERALLY ACCEPTABLE FORM, THAT REGISTRATION IS NOT REQUIRED UNDER SAID ACT. NOTWITHSTANDING THE FOREGOING, THE SECURITIES MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN OR FINANCING ARRANGEMENT SECURED BY THE SECURITIES.”

 

 3 

 

The legend set forth above shall be removed and the Company shall issue a certificate for the applicable shares of Common Stock without such legend to the holder of any Security upon which it is stamped or (as requested by such holder) issue the applicable shares of Common Stock to such holder by electronic delivery by crediting the account of such holder’s broker with The Depository Trust Company (“DTC”), if, unless otherwise required by applicable state securities laws, (a) such Security is registered for sale under an effective registration statement filed under the 1933 Act, or (b) the Company or the Buyer provides the Legal Counsel Opinion to the effect that a public sale or transfer of such Security may be made without registration under the 1933 Act, which opinion shall be accepted by the Company so that the sale or transfer is effected. The Company shall be responsible for the fees of its transfer agent and all DTC fees associated with any such issuance. The Buyer agrees to sell all Securities, including those represented by a certificate(s) from which the legend has been removed, in compliance with applicable prospectus delivery requirements, if any.

 

h. Authorization; Enforcement. This Agreement has been duly and validly authorized by the Buyer and has been duly executed and delivered on behalf of the Buyer, and this Agreement constitutes a valid and binding agreement of the Buyer enforceable in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting creditors’ rights generally and except as may be limited by the exercise of judicial discretion in applying principles of equity.

 

i. Residency. The Buyer is a resident of the jurisdiction set forth immediately below the Buyer’s name on the signature pages hereto.

 

3. Representations and Warranties of the Company. The Company represents and warrants to the Buyer as of the Closing Date that:

 

a. Organization and Qualification. The Company and each of its Subsidiaries (as defined below), if any, is a limited liability company duly organized, validly existing and in good standing under the laws of the jurisdiction of formation, with full power and authority (corporate and other) to own, lease, use and operate its properties and to carry on its business as and where now owned, leased, used, operated and conducted. Schedule 3(a), if attached hereto, sets forth a list of all of the Subsidiaries of the Company and the jurisdiction in which each is incorporated or organized. The Company and each of its Subsidiaries is duly qualified as a foreign entity to do business and is in good standing in every jurisdiction in which its ownership or use of property or the nature of the business conducted by it makes such qualification necessary except where the failure to be so qualified or in good standing would not have a Material Adverse Effect. “Material Adverse Effect” means any material adverse effect on the business, operations, assets, financial condition or prospects of the Company or its Subsidiaries, if any, taken as a whole, or on the transactions contemplated hereby or by the agreements or instruments to be entered into in connection herewith. “Subsidiaries” means any corporation or other organization, whether incorporated or unincorporated, in which the Company owns, directly or indirectly, any equity or other ownership interest.

 

b. Authorization; Enforcement. (i) The Company has all requisite power and authority to enter into and perform this Agreement, the Note, and to consummate the transactions contemplated hereby and thereby and to issue the Securities, in accordance with the terms hereof and thereof, (ii) the execution and delivery of this Agreement, the Warrant, the Note, and the issuance of the Conversion Shares by the Company and the consummation by it of the transactions contemplated hereby and thereby (including without limitation, the issuance of the Note, Warrant, as well as the issuance and reservation for issuance of the Conversion Shares issuable upon exercise of the Warrant) have been duly authorized by the Company’s Board of Directors and no further consent or authorization of the Company, its Board of Directors, its shareholders, or its debt holders is required, (iii) this Agreement and the Note (together with any other instruments executed in connection herewith or therewith) have been duly executed and delivered by the Company by its authorized representative, and such authorized representative is the true and official representative with authority to sign this Agreement, the Note and the other instruments documents executed in connection herewith or therewith and bind the Company accordingly, and (iv) this Agreement constitutes, and upon execution and delivery by the Company of the Note, each of such instruments will constitute, a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with their terms.

 

 4 

 

c. Capitalization; Governing Documents. As of May 1, 2017, the issued and outstanding capital stock and warrants of the Company consists of: 14,100,394 Class A membership units, 1,870,469 Class B membership units, 2,218,894 Class A Profits Interest membership units, warrants to purchase 723,916 Class A membership units for $0.001 per unit and warrants to purchase 1,870,469 Class B membership units for $1.42 per unit were outstanding. Additionally, the Company is party to a convertible note series in the principal amount of $235,000 that will potentially convert into a number of membership units approximately equal to 10% of the fully-diluted membership interests in the Company post-conversion. All of such outstanding membership units of the Company and the Conversion Shares, are, or upon issuance will be, duly authorized, validly issued, fully paid and non - assessable. No membership units of the Company are subject to preemptive rights or any other similar rights of the shareholders of the Company or any liens or encumbrances imposed through the actions or failure to act of the Company. As of the effective date of this Agreement, other than noted above (i) there are no outstanding options, warrants, scrip, rights to subscribe for, puts, calls, rights of first refusal, agreements, understandings, claims or other commitments or rights of any character whatsoever relating to, or securities or rights convertible into or exchangeable for any membership units of the Company or any of its Subsidiaries, or arrangements by which the Company or any of its Subsidiaries is or may become bound to issue additional equity of the Company or any of its Subsidiaries prior to an IPO, (ii) there are no agreements or arrangements under which the Company or any of its Subsidiaries is obligated to register the sale of any of its or their securities under the 1933 Act and (iii) there are no anti -dilution or price adjustment provisions contained in any security issued by the Company (or in any agreement providing rights to security holders) that will be triggered by the issuance of any of the Securities. The Company has furnished to the Buyer true and correct copies of the Company’s Certificate of Organization as in effect on the date hereof (“Certificate of Organization”), the Company’s Operating Agreement, as in effect on the date hereof (the “Operating Agreement”), and the terms of all securities convertible into or exercisable for Common Stock of the Company and the material rights of the holders thereof in respect thereto.

 

d. Issuance of Conversion Shares. The Conversion Shares are duly authorized and reserved for issuance and, upon exercise of the Warrant in accordance with its terms, will be validly issued, fully paid and non-assessable, and free from all taxes, liens, claims and encumbrances with respect to the issue thereof and shall not be subject to preemptive rights or other similar rights of shareholders of the Company and will not impose personal liability upon the holder thereof.

 

e. Issuance of Warrant. The issuance of the Warrant is duly authorized and will be validly issued and free from all taxes, liens, claims and encumbrances with respect to the issue thereof and shall not be subject to preemptive rights or other similar rights of shareholders of the Company and will not impose personal liability upon the holder thereof.

 

f. Acknowledgment of Dilution. The Company understands and acknowledges the potentially dilutive effect of the Conversion Shares to the Common Stock. The Company further acknowledges that its obligation to issue, upon exercise of the Warrant, the Conversion Shares, in accordance with this Agreement, and the Note are absolute and unconditional regardless of the dilutive effect that such issuance may have on the ownership interests of other shareholders of the Company.

 

g. Ranking; No Conflicts. The Note shall be a senior secured debt obligation of the Company, with priority in payment and performance over all existing and future indebtedness of the Company. The execution, delivery and performance of this Agreement and the Note by the Company and the consummation by the Company of the transactions contemplated hereby and thereby (including, without limitation, the issuance and reservation for issuance of the Conversion Shares) will not (i) conflict with or result in a violation of any provision of the Certificate of Organization or Operating Agreement, or (ii) violate or conflict with, or result in a breach of any provision of, or constitute a default (or an event which with notice or lapse of time or both could become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, note, evidence of indebtedness, indenture, patent, patent license or instrument to which the Company or any of its Subsidiaries is a party, or (iii) result in a violation of any law, rule, regulation, order, judgment or decree (including federal and state securities laws and regulations and regulations of any self-regulatory organizations to which the Company or its securities is subject) applicable to the Company or any of its Subsidiaries or by which any property or asset of the Company or any of its Subsidiaries is bound or affected (except for such conflicts, defaults, terminations, amendments, accelerations, cancellations and violations as would not, individually or in the aggregate, have a Material Adverse Effect). Neither the Company nor any of its Subsidiaries is in violation of its Certificate of Organization, Operating Agreement or other organizational documents and neither the Company nor any of its Subsidiaries is in default (and no event has occurred which with notice or lapse of time or both could put the Company or any of its Subsidiaries in default) under, and neither the Company nor any of its Subsidiaries has taken any action or failed to take any action that would give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which the Company or any of its Subsidiaries is a party or by which any property or assets of the Company or any of its Subsidiaries is bound or affected, except for possible defaults as would not, individually or in the aggregate, have a Material Adverse Effect. The businesses of the Company and its Subsidiaries, if any, are not being conducted, and shall not be conducted so long as the Buyer owns any of the Securities, in violation of any law, ordinance or regulation of any governmental entity. Except as specifically contemplated by this Agreement and as required under the 1933 Act and any applicable state securities laws, the Company is not required to obtain any consent, authorization or order of, or make any filing or registration with, any court, governmental agency, regulatory agency, self-regulatory organization or stock market or any third party in order for it to execute, deliver or perform any of its obligations under this Agreement and the Note in accordance with the terms hereof or thereof or to issue and sell the Note in accordance with the terms hereof and, upon exercise of the Warrant, issue Conversion Shares. All consents, authorizations, orders, filings and registrations which the Company is required to obtain pursuant to the preceding sentence have been obtained or effected on or prior to the date hereof.

 

 5 

 

h. Non-Shell. The Company has never been a “shell company” as described in Rule 144(i)(1)(i).

 

i. Absence of Certain Changes. Since January 1, 2017, there has been no material adverse change and no material adverse development in the assets, liabilities, business, properties, operations, financial condition, results of operations, or prospects of the Company or any of its Subsidiaries.

 

j. Absence of Litigation. There is no action, suit, claim, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the Company or any of its Subsidiaries, threatened against or affecting the Company or any of its Subsidiaries, or their officers or directors in their capacity as such, that could have a Material Adverse Effect. The Company and its Subsidiaries are unaware of any facts or circumstances which might give rise to any of the foregoing.

 

k. Intellectual Property. The Company and each of its Subsidiaries owns or possesses the requisite licenses or rights to use all patents, patent applications, patent rights, inventions, know-how, trade secrets, trademarks, trademark applications, service marks, service names, trade names and copyrights (“Intellectual Property”) necessary to enable it to conduct its business as now operated (and, as presently contemplated to be operated in the future); there is no claim or action by any person pertaining to, or proceeding pending, or to the Company’s knowledge threatened, which challenges the right of the Company or of a Subsidiary with respect to any Intellectual Property necessary to enable it to conduct its business as now operated (and, as presently contemplated to be operated in the future); to the best of the Company’s knowledge, the Company’s or its Subsidiaries’ current and intended products, services and processes do not infringe on any Intellectual Property or other rights held by any person; and the Company is unaware of any facts or circumstances which might give rise to any of the foregoing. The Company and each of its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of their Intellectual Property.

 

l. No Materially Adverse Contracts, Etc. Neither the Company nor any of its Subsidiaries is subject to any charter, corporate or other legal restriction, or any judgment, decree, order, rule or regulation which in the judgment of the Company’s officers has or is expected in the future to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is a party to any contract or agreement which in the judgment of the Company’s officers has or is expected to have a Material Adverse Effect.

 

m. Tax Status. The Company and each of its Subsidiaries has made or filed all federal, state and foreign income and all other tax returns, reports and declarations required by any jurisdiction to which it is subject (unless and only to the extent that the Company and each of its Subsidiaries has set aside on its books provisions reasonably adequate for the payment of all unpaid and unreported taxes) and has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations, except those being contested in good faith and has set aside on its books provisions reasonably adequate for the payment of all taxes for periods subsequent to the periods to which such returns, reports or declarations apply. There are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company know of no basis for any such claim. The Company has not executed a waiver with respect to the statute of limitations relating to the assessment or collection of any foreign, federal, state or local tax. None of the Company’s tax returns is presently being audited by any taxing authority.

 

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n. Transactions with Affiliates. Except for arm’s length transactions pursuant to which the Company or any of its Subsidiaries makes payments in the ordinary course of business upon terms no less favorable than the Company or any of its Subsidiaries could obtain from third parties and that certain promissory note accepted by the Company from Bankole A. Johnson, the Company’s Chairman, (i.e. Johnson owes the Company the funds) in the principal amount of $35,000 (of which $20,326 in principal is outstanding as of the date of this note and for which the final payment is due June 6, 2017), none of the officers, directors, or employees of the Company is presently a party to any transaction with the Company or any of its Subsidiaries (other than for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any corporation, partnership, trust or other entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner.

 

o. Disclosure. All information relating to or concerning the Company or any of its Subsidiaries set forth in this Agreement and provided to the Buyer pursuant to Section 2(d) hereof and otherwise in connection with the transactions contemplated hereby is true and correct in all material respects and the Company has not omitted to state any material fact necessary in order to make the statements made herein or therein, in light of the circumstances under which they were made, not misleading. No event or circumstance has occurred or exists with respect to the Company or any of its Subsidiaries or its or their business, properties, prospects, operations or financial conditions, which, under applicable law, rule or regulation, requires public disclosure or announcement by the Company but which has not been so publicly announced or disclosed (assuming for this purpose that the Company’s reports filed under the 1934 Act are being incorporated into an effective registration statement filed by the Company under the 1933 Act).

 

p. Acknowledgment Regarding Buyer’s Purchase of Securities. The Company acknowledges and agrees that the Buyer is acting solely in the capacity of arm’s length purchaser with respect to this Agreement and the transactions contemplated hereby. The Company further acknowledges that the Buyer is not acting as a financial advisor or fiduciary of the Company (or in any similar capacity) with respect to this Agreement and the transactions contemplated hereby and any statement made by the Buyer or any of its respective representatives or agents in connection with this Agreement and the transactions contemplated hereby is not advice or a recommendation and is merely incidental to the Buyer’s purchase of the Securities. The Company further represents to the Buyer that the Company’s decision to enter into this Agreement has been based solely on the independent evaluation of the Company and its representatives.

 

q. No Integrated Offering. Neither the Company, nor any of its affiliates, nor any person acting on its or their behalf, has directly or indirectly made any offers or sales in any security or solicited any offers to buy any security under circumstances that would require registration under the 1933 Act of the issuance of the Securities to the Buyer. The issuance of the Securities to the Buyer will not be integrated with any other issuance of the Company’s securities (past, current or future) for purposes of any shareholder approval provisions applicable to the Company or its securities.

 

r. No Brokers. The Company has taken no action which would give rise to any claim by any person for brokerage commissions, transaction fees or similar payments relating to this Agreement or the transactions contemplated hereby.

 

s. Permits; Compliance. The Company and each of its Subsidiaries is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exemptions, consents, certificates, approvals and orders necessary to own, lease and operate its properties and to carry on its business as it is now being conducted (collectively, the “Company Permits”), and there is no action pending or, to the knowledge of the Company, threatened regarding suspension or cancellation of any of the Company Permits. Neither the Compa ny nor any of its Subsidiaries is in conflict with, or in default or violation of, any of the Company Permits, except for any such conflicts, defaults or violations which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. Since January 1, 2017, neither the Company nor any of its Subsidiaries has received any notification with respect to possible conflicts, defaults or violations of applicable laws, except for notices relating to possible conflicts, defaults or violations, which conflicts, defaults or violations would not have a Material Adverse Effect.

 

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t. Environmental Matters.

 

(i) There are, to the Company’s knowledge, with respect to the Company or any of its Subsidiaries or any predecessor of the Company, no past or present violations of Environmental Laws (as defined below), releases of any material into the environment, actions, activities, circumstances, conditions, events, incidents, or contractual obligations which may give rise to any common law environmental liability or any liability under the Comprehensive Environmental Response, Compensation and Liability Act of 1980 or similar federal, state, local or foreign laws and neither the Company nor any of its Subsidiaries has received any notice with respect to any of the foregoing, nor is any action pending or, to the Company’s knowledge, threatened in connection with any of the foregoing. The term ”Environmental Laws” means all federal, state, local or foreign laws relating to pollution or protection of human health or the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata), including, without limitation, laws relating to emissions, discharges, releases or threatened releases of chemicals, pollutants contaminants, or toxic or hazardous substances or wastes (collectively, “Hazardous Materials”) into the environment, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or han dling of Hazardous Materials, as well as all authorizations, codes, decrees, demands or demand letters, injunctions, judgments, licenses, notices or notice letters, orders, permits, plans or regulations issued, entered, promulgated or approved thereunder.

 

(ii) Other than those that are or were stored, used or disposed of in compliance with applicable law, no Hazardous Materials are contained on or about any real property currently owned, leased or used by the Company or any of its Subsidiaries, and no Hazardous Materials were released on or about any real property previously owned, leased or used by the Company or any of its Subsidiaries during the period the property was owned, leased or used by the Company or any of its Subsidiaries, except in the normal course of the Company’s or any of its Subsidiaries’ business.

 

(iii) There are no underground storage tanks on or under any real property owned, leased or used by the Company or any of its Subsidiaries that are not in compliance with applicable law.

 

u. Title to Property. The Company and its Subsidiaries have good and marketable title in fee simple to all real property and good and marketable title to all personal property owned by them which is material to the business of the Company and its Subsidiaries, in each case free and clear of all liens, encumbrances and defects except such as are described in Schedule 3(u), if attached hereto, or such as would not have a Material Adverse Effect. Any real property and facilities held under lease by the Company and its Subsidiaries are held by them under valid, subsisting and enforceable leases with such exceptions as would not have a Material Adverse Effect.

 

v. Insurance. The Company and each of its Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as management of the Company believes to be prudent and customary in the businesses in which the Company and its Subsidiaries are engaged. Neither the Company nor any such Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a Material Adverse Effect. Upon written request the Company will provide to the Buyer true and correct copies of all policies relating to directors ’ and officers’ liability coverage, errors and omissions coverage, and commercial general liability coverage.

 

w. Internal Accounting Controls. The Company and each of its Subsidiaries maintain a system of internal accounting controls sufficient, in the judgment of the Company’s board of directors, to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

 

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x. Foreign Corrupt Practices. Neither the Company, nor any of its Subsidiaries, nor any director, officer, agent, employee or other person acting on behalf of the Company or any Subsidiary has, in the course of his actions for, or on behalf of, the Company, used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity; made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any foreign or domestic government official or employee. Agreement) is solvent (i.e., its assets have a fair market value in excess of the amount required to pay its probable liabilities on its existing debts as they become absolute and matured) and currently the Company has no information that would lead it to reasonably conclude that the Company would not, after giving effect to the transaction contemplated by this Agreement, have the ability to, nor does it intend to take any action that would impair its ability to, pay its debts from time to time incurred in connection therewith as such debts mature. The Company’s financial statements for its most recent fiscal year end and interim financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

 

z. No Investment Company. The Company is not, and upon the issuance and sale of the Securities as contemplated by this Agreement will not be an “investment company” required to be registered under the Investment Company Act of 1940 (an “Investment Company”). The Company is not controlled by an Investment Company.

 

aa. No Off Balance Sheet Arrangements. There is no transaction, arrangement, or other relationship between the Company or any of its Subsidiaries and an unconsolidated or other off balance sheet entity that has not been disclosed to Buyer.

 

bb. No Disqualification Events. None of the Company, any of its predecessors, any affiliated issuer, any director, executive officer, other officer of the Company participating in the offering hereunder, any beneficial owner of 20% or more of the Company’s outstanding voting equity securities, calculated on the basis of voting power, nor any promoter (as that term is defined in Rule 405 under the 1933 Act) connected with the Company in any capacity at the time of sale (each, an “Issuer Covered Person”) is subject to any of the “Bad Actor” disqualifications described in Rule 506(d)(1)(i) to (viii) under the 1933 Act (a “Disqualification Event”), except for a Disqualification Event covered by Rule 506(d)(2) or (d)(3). The Company has exercised reasonable care to determine whether any Issuer Covered Person is subject to a Disqualification Event.

 

cc. Manipulation of Price. The Company has not, and to its knowledge no one acting on its behalf has: (i) taken, directly or indirectly, any action designed to cause or to result, or that could reasonably be expected to cause or result, in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or paid any compensation for soliciting purchases of, any of the Securities, or (iii) paid or agreed to pay to any person any compensation for soliciting another to purchase any other securities of the Company.

 

dd. Breach of Representations and Warranties by the Company. The Company agrees that if the Company breaches any of the material representations or warranties set forth in this Section 3 and in addition t o any other remedies available to the Buyer pursuant to this Agreement, it will be considered an Event of Default under Section 3.4 of the Note.

 

4. ADDITIONAL COVENANTS, AGREEMENTS AND ACKNOWLEDGEMENTS.

 

a. Best Efforts. The parties shall use their best efforts to satisfy timely each of the conditions described in Section 6 and 7 of this Agreement.

 

b. Form D; Blue Sky Laws. The Company agrees to file a Form D with respect to the Securities as required under Regulation D and to provide a copy thereof to the Buyer promptly after such filing. The Company shall, on or before the Closing Date, take such action as the Company shall reasonably determine is necessary to qualify the Securities for sale to the Buyer at the applicable closing pursuant to this Agreement under applicable securities or “blue sky” laws of the states of the United States (or to obtain an exemption from such qualification), and shall provide evidence of any such action so taken to the Buyer on or prior to the Closing Date.

 

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c. Use of Proceeds. The Company shall use the proceeds for the payment of all outstanding amounts owed to the Company’s auditor, accountant, and legal counsel, and for working capital and other general corporate purposes, provided, however, that the proceeds shall not be used for the repayment of any indebtedness owed to officers (except payment of expense reports submitted in the ordinary course of business), directors or employees of the Company or their affiliates or in violation or contravention of any applicable law, rule or regulation.

 

d. Restrictions on Sale. The Buyer hereby agrees not to sell or otherwise transfer, make any short sale of, grant any option for the purchase of, or enter into any hedging or similar transaction with the same economic effect as a sale, of any Common Stock (or other securities) of the Company held by the Buyer (other than those included in the registration) during the 180-day period following the effective date of the registration statement for the Company’s IPO (including, without limitation, to accommodate regulatory restrictions on (i) the publication or other distribution of research reports and (ii) analyst recommendations and opinions, including, but not limited to, the restrictions contained in NASD Rule 2711(f)(4) or NYSE Rule 472(f)(4), or any successor provisions or amendments thereto) (the “Lock-Up Period”); provided, that substantially all current holders, including all officers, directors and 5% holders, of the Company’s voting securities are bound by the same requirement during the Lock-Up Period. The obligations described in this Section 4(d) shall not apply to a registration relating solely to employee benefit plans on Form S-l or Form S-8 or similar forms that may be promulgated in the future, or a registration relating solely to a transaction on Form S-4 or similar forms that may be promulgated in the future. The Company may impose stop-transfer instructions and may stamp each certificate with a legend as substantially set forth below with respect to the shares of Common Stock subject to the foregoing restriction until the end of such 180-day period. To effect the above, the Buyer agrees to execute a market stand-off agreement with the underwriters in the offering in customary form consistent with the provisions of this Section 4(d).

 

THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO RESTRICTIONS ON TRANSFERABILITY AND RESALE, INCLUDING A LOCK-UP PERIOD IN THE EVENT OF A PUBLIC OFFERING, AS SET FORTH IN THE NOTE PURSUANT TO WHICH THESE SHARES WERE ISSUED, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE COMPANY.  

 

e. Usury. To the extent it may lawfully do so, the Company hereby agrees not to insist upon or plead or in any manner whatsoever claim, and will resist any and all efforts to be compelled to take the benefit or advantage of, usury laws wherever enacted, now or at any time hereafter in force, in connection with any action or proceeding that may be brought by the Buyer in order to enforce any right or remedy under this Agreement, the Note and any document, agreement or instrument contemplated thereby. Notwithstanding any provision to the contrary contained in this Agreement, the Note and any document, agreement or instrument contemplated thereby, it is expressly agreed and provided that the total liability of the Company under this Agreement, the Note or any document, agreement or instrument contemplated thereby for payments which under New York law are in the nature of interest shall not exceed the maximum lawful rate authorized under applicable law (the “Maximum Rate”), and, without limiting the foregoing, in no event shall any rate of interest or default interest, or both of them, when aggregated with any other sums which under New York law in the nature of interest that the Company may be obligated to pay under this Agreement, the Note and any document, agreement or instrument contemplated thereby exceed such Maximum Rate. It is agreed that if the maximum contract rate of interest allowed by New York law and applicable to this Agreement, the Note and any document, agreement or instrument contemplated thereby is increased or decreased by statute or any official governmental action subsequent to the date hereof, the new maximum contract rate of interest allowed by law will be the Maximum Rate applicable to this Agreement, the Note and any document, agreement or instrument contemplated thereby from the effective date thereof forward, unless such application is precluded by applicable law. If under any circumstances whatsoever, interest in excess of the Maximum Rate is paid by the Company to the Buyer with respect to indebtedness evidenced by this Agreement, the Note and any document, agreement or instrument contemplated thereby, such excess shall be applied by the Buyer to the unpaid principal balance of any such indebtedness or be refunded to the Company, the manner of handling such excess to be at the Buyer’s election.

 

f. Restriction on Activities. Commencing as of the date first above written, and until the payment of the Note in full, the Company shall not, directly or indirectly, without the Buyer’s prior written consent, which consent shall not be unreasonably withheld: (a) change the nature of its business; (b) sell, divest, acquire, change the structure of any material assets other than in the ordinary course of business; or (c) solicit any offers for, respond to any unsolicited offers for, or conduct any negotiations with any other person or entity in respect of any Variable Rate Transaction (as defined herein), whether a transaction similar to the one contemplated hereby or any other investment.

 

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g. This section intentionally left blank.

 

h. Corporate Existence. The Company will, so long as the Buyer beneficially owns any of the Securities, maintain its corporate existence and shall not sell all or substantially all of the Company’s assets, except in connection with its intended conversion from a limited liability company to a corporation or in the event of a merger or consolidation or sale of all or substantially all of the Company’s assets, where the surviving or successor entity in such transaction assumes the Company’s obligations hereunder and under the agreements and instruments entered into in connection herewith.

 

i. No Integration. The Company shall not make any offers or sales of any security (other than the Securities) under circumstances that would require registration of the Securities being offered or sold hereunder under the 1933 Act or cause the offering of the Securities to be integrated with any other offering of securities by the Company for the purpose of any stockholder approval provision applicable to the Company or its securities.

 

j. Breach of Covenants. The Company acknowledges and agrees that if the Company breaches any of the material covenants set forth in this Section 4, in addition to any other remedies available to the Buyer pursuant to this Agreement, it will be considered an Event of Default under Section 3.4 of the Note.

 

k. Compliance with 1934 Act; Public Information Failures. At the time that the Company becomes subject to the reporting requirements of the 1934 Act, and for so long as the Buyer beneficially owns the Note, , the Company shall comply with the reporting requirements of the 1934 Act; and the Company shall continue to be subject to the reporting requirements of the 1934 Act.

 

l. Acknowledgement Regarding Buyer’s Trading Activity. The Company acknowledges and agrees that (i) the Buyer has not been asked to agree, nor has the Buyer agreed, to desist from purchasing or selling, long and/or short, securities of the Company, or “derivative” securities based on securities issued by the Company or to hold the Securities for any specified term; (ii) the Buyer, and counter-parties in “derivative” transactions to which any the Buyer is a party, directly or indirectly, presently may have a “short” position in the Common Stock, and (iii) the Buyer shall not be deemed to have any affiliation with or control over any arm’s length counter-party in any “derivative” transaction. The Company further understands and acknowledges that the Buyer may engage in hedging and/or trading activities at various times during the period that the Securities are outstanding, including, without limitation, during the periods that the value of the Conversion Shares are being determined and (b) such hedging and/or trading activities, if any, can reduce the value of the existing stockholders’ equity interest in the Company both at and after the time the hedging and/or trading activities are being conducted. The Company acknowledges that such aforementioned hedging and/or trading activities do not constitute a breach of this Agreement or any of the documents executed in connection herewith.

 

m. This section intentionally left blank.

 

n. Legal Counsel Opinions. Upon the request of the Buyer from to time to time, the Company shall be responsible (at its cost) for promptly supplying to the Company’s transfer agent and the Buyer a customary legal opinion letter of its counsel (the “Legal Counsel Opinion”) to the effect that the resale of the Conversion Shares by the Buyer or its affiliates, successors and assigns is exempt from the registration requirements of the 1933 Act pursuant to Rule 144 (provided the requirements of Rule 144 are satisfied an d provided the Conversion Shares are not then registered under the 1933 Act for resale pursuant to an effective registration statement). Should the Company’s legal counsel fail for any reason to issue the Legal Counsel Opinion, the Buyer may (at the Company’s cost) secure another legal counsel to issue the Legal Counsel Opinion, and the Company will instruct its transfer agent to accept such opinion. The Company hereby agrees that it may never take the position that it is a “shell company” in connection with its obligations under this Agreement or otherwise.

 

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o. This section intentionally left blank.

 

p. Most Favored Nation. While the Note or any principal amount, interest or fees or expenses due thereunder remain outstanding and unpaid, the Company shall not enter into any public or private offering of its securities (including securities convertible into shares of Common Stock) with any individual or entity (an “Other Investor”) that has the effect of establishing rights or otherwise benefiting such Other Investor in a manner more favorable in any material respect to such Other Investor than the rights and benefits established in favor of the Buyer by this Agreement or the Note unless, in any such case, the Buyer has been provided with written notice (the “Company Notice”) and no less than 10 days to exercise the right, but not the obligation, to exchange its rights and obligations hereunder (i.e. to the Securities) for the rights and obligations established with the Other Investor, except that Buyer shall retain a senior position to the Other Investor. In order to exercise such right, Buyer shall send the Company a written notice of its exercise (the “Buyer Notice”). If the Buyer Notice is not received by the Company within ten (10) days of Buyer’s receipt of the Company Notice, the rights under this Section 4.14 shall terminate with respect to such offering of the Company’s securities.

 

q. Subsequent Variable Rate Transactions. From the date hereof until such time as the Buyer no longer holds the Note the Company shall be prohibited from effecting or entering into an agreement involving a Variable Rate Transaction. “Variable Rate Transaction” means a transaction in which the Company (i) issues or sells any debt or equity securities that are convertible into, exchangeable or exercisable for, or include the right to receive, additional shares of Common Stock either (A) at a conversion price, exercise price or exchange rate or other price that is based upon, and/or varies with, the trading prices of or quotations for the shares of Common Stock at any time after the initial issuance of such debt or equity securities or (B) with a conversion, exercise or exchange price that is subject to being reset at some future date after the initial issuance of such debt or equity security or upon the occurrence of specified or contingent events directly or indirectly related to the business of the Company or the market for the Common Stock or (ii) enters into any agreement, including, but not limited to, an equity line of credit, whereby the Company may issue securities at a future determined price. Any Purchaser shall be entitled to obtain injunctive relief against the Company to preclude any such issuance, which remedy shall be in addition to any right to collect damages.

 

5. Transfer gent Instruction s. The Company shall issue irrevocable instructions to the Company’s transfer agent once its common stock is publicly traded to issue certificates, registered in the name of the Buyer or its nominee, upon exercise of the Warrant, the Conversion Shares, in such amounts as specified from time to time by the Buyer to the Company in accordance with the terms thereof (the “Irrevocable Transfer Agent Instructions”). In the event that the Company proposes to replace its transfer agent, the Company shall provide, prior to the effective date of such replacement, a fully executed Irrevocable Transfer Agent Instructions in a form as initially delivered pursuant to this Agreement (including but not limited to the provision to irrevocably reserved shares of Common Stock in the Reserved Amount (as defined in the Note)) signed by the successor transfer agent to the Company and the Company. Prior to registration of the Conversion Shares under the 1933 Act or the date on which the Conversion Shares may be sold pursuant to Rule 144 without any restriction as to the number of Securities as of a particular date that can then be immediately sold, all such certificates shall bear the restrictive legend specified in Section 2(g) of this Agreement. The Company warrants that: (i) no instruction other than the Irrevocable Transfer Agent Instructions referred to in this Section 5 will be given by the Company to its transfer agent and that the Securities shall otherwise be freely transferable on the books and records of the Company as and to the extent provided in this Agreement and the Note; (ii) it will not direct its transfer agent not to transfer or delay, impair, and/or hinder its transfer agent in transferring (or issuing)(electronically or in certificated form) any certificate for Securities to be issued to the Buyer as and when required by this Agreement; (iii) it will not fail to remove (or directs its transfer agent not to remove or impairs, delays, and/or hinders its transfer agent from removing) any restrictive legend (or to withdraw any stop transfer instructions in respect thereof) on any certificate for any Securities issued to the Buyer as and when required by the and this Agreement and (iv) it will provide any required corporate resolutions and issuance approvals to its transfer agent within 6 hours of each exercise of the Warrant. Nothing in this Section shall affect in any way the Buyer’s obligations and agreement set forth in Section 2(g) hereof to comply with all applicable prospectus delivery requirements, if any, upon re-sale of the Securities. If the Buyer provides the Company, at the cost of the Company, with (i) an opinion of counsel in form, substance and scope customary for opinions in comparable transactions, to the effect that a public sale or transfer of such Securities may be made without registration under the 1933 Act and such sale or transfer is effected or (ii) the Buyer provides reasonable assurances that the Securities can be sold pursuant to Rule 144, the Company shall permit the transfer, and, in the case of the Securities, promptly instruct its transfer agent to issue one or more certificates, free from restrictive legend, in such name and in such denominations as specified by the Buyer. The Company acknowledges that a breach by it of its obligations hereunder will cause irreparable harm to the Buyer, by vitiating the intent and purpose of the transactions contemplated hereby. Accordingly, the Company acknowledges that the remedy at law for a breach of its obligations under this Section 5 may be inadequate and agrees, in the event of a breach or threatened breach by the Company of the provisions of this Section, that the Buyer shall be entitled, in addition to all other available remedies, to an injunction restraining any breach and requiring immediate transfer, without the necessity of showing economic loss and without any bond or other security being required.

 

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6. Conditions to the Company’ s Obligation to Sell. The obligation of the Company hereunder to issue and sell the Note to the Buyer at the Closing is subject to the satisfaction, at or before the Closing Date, of each of the following conditions thereto, provided that these conditions are for the Company’s sole benefit and may be waived by the Company at any time in its sole discretion:

 

a. The Buyer shall have executed this Agreement and delivered the same to the Company.

 

b. The Buyer shall have delivered the Purchase Price in accordance with Section 1(b) above.

 

c. The representations and warranties of the Buyer shall be true and correct in all material respects as of the date when made and as of the Closing Date, as though made at that time (except for representations and warranties that speak as of a specific date), and the Buyer shall have performed, satisfied and complied in all material respects with the covenants, agreements and conditions required by this Agreement to be performed, satisfied or complied with by the Buyer at or prior to the Closing Date.

 

d. No litigation, statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by or in any court or governmental authority of competent jurisdiction or any self-regulatory organization having authority over the matters contemplated hereby which prohibits the consummation of any of the transactions contemplated by this Agreement.

 

7. Conditions to The Buyer’ s Obligation to Purchase. The obligation of the Buyer hereunder to purchase the Note, on the Closing Date, is subject to the satisfaction, at or before the Closing Date, of each of the following conditions, provided that these conditions are for the Buyer’s sole benefit and may be waived by the Buyer at any time in its sole discretion:

 

a. The Company shall have executed this Agreement and delivered the same to the Buyer.

 

b. The Company shall have delivered to the Buyer the duly executed Note in such denominations as the Buyer shall request and in accordance with Section 1(b) above.

 

c. This section intentionally left blank.

 

d. This section intentionally left blank.

 

e. The representations and warranties of the Company shall be true and correct in all material respects as of the date when made and as of Closing Date, as though made at such time (except for representations and warranties that speak as of a specific date) and the Company shall have performed, satisfied and complied in all material respects with the covenants, agreements and conditions required by this Agreement to be performed, satisfied or complied with by the Company at or prior to the Closing Date.

 

f. No litigation, statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by or in any court or governmental authority of competent jurisdiction or any self-regulatory organization having authority over the matters contemplated hereby which prohibits the consummation of any of the transactions contemplated by this Agreement.

 

g. No event shall have occurred which could reasonably be expected to have a Material Adverse Effect on the Company.

 

h. This section intentionally left blank.

 

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i. The Company shall have delivered to the Buyer (i) a certificate evidencing the formation and good standing of the Company and each of its Subsidiaries in such entity’s jurisdiction of formation issued by the Secretary of State (or comparable office) of such jurisdiction, as of a date within ten (10) days of the Closing Date and (ii) resolutions adopted by the Company’s Board of Directors at a duly called meeting or by written consent duly authorizing this Agreement and all other documents, instruments and transactions contemplated hereby.

 

8. Governing Law; Miscellaneous.

 

a. Governing Law; Venue. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without regard to principles of conflicts of laws. Any action brought by either party against the other concerning the transactions contemplated by this Agreement, the Note, or any other agreement, certificate, instrument or document contemplated hereby shall be brought only in the state courts of New York or in the federal courts located in the state and county of New York. The parties to this Agreement hereby irrevocably waive any objection to jurisdiction and venue of any action instituted hereunder and shall not assert any defense based on lack of jurisdiction or venue or based upon forum non conveniens. EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT IT MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT OR ANY TRANSACTIONS CONTEMPLATED HEREBY. The prevailing party shall be entitled to recover from the other party its reasonable attorney’s fees and costs. Each party hereby irrevocably waives personal service of process and consents to process being served in any suit, action or proceeding in connection with this Agreement, the Note, or any other agreement, certificate, instrument or document contemplated hereby or thereby by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law.

 

b. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which shall constitute one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party. A facsimile or .pdf signature shall be considered due execution and shall be binding upon the signatory thereto with the same force and effect as if the signature were an original, not a facsimile or .pdf signature. Delivery of a counterpart signature hereto by facsimile or email/.pdf transmission shall be deemed validly delivery thereof.

 

c. Construction; Headings. This Agreement shall be deemed to be jointly drafted by the Company and the Buyer and shall not be construed against any person as the drafter hereof. The headings of this Agreement are for convenience of reference only and shall not form part of, or affect the interpretation of, this Agreement.

 

d. Severability. In the event that any provision of this Agreement, the Note, or any other agreement or instrument delivered in connection herewith is invalid or unenforceable under any applicable statute or rule of law, then such provision shall be deemed inoperative to the extent that it may conflict therewith and shall be deemed modified to conform with such statute or rule of law. Any such provision which may prove invalid or unenforceable under any law shall not affect the validity or enforceability of any other provision of this Agreement, the Note, or any other agreement, certificate, instrument or document contemplated hereby or thereby.

 

e. Entire Agreement; Amendments. This Agreement, the Note, and the instruments referenced herein contain the entire understanding of the parties with respect to the matters covered herein and therein and, except as specifically set forth herein or therein, neither the Company nor the Buyer makes any representation, warranty, covenant or undertaking with respect to such matters. No provision of this Agreement or any agreement or instrument contemplated hereby may be waived or amended other than by an instrument in writing signed by the Buyer.

 

 14 

 

f. Notices. All notices, demands, requests, consents, approvals, and other communications required or permitted hereunder shall be in writing and, unless otherwise specified herein, shall be (i) personally served, (ii) deposited in the mail, registered or certified, return receipt requested, postage prepaid, (iii) delivered by reputable air courier service with charges prepaid, or (iv) transmitted by hand delivery, telegram, e -mail or facsimile, addressed as set forth below or to such other address as such party shall have specified most recently by written notice. Any notice or other communication required or permitted to be given hereunder shall be deemed effective (a) upon hand delivery or delivery by e-mail or facsimile, with accurate confirmation generated by the transmitting facsimile machine, at the address or number designated below (if delivered on a business day during normal business hours where such notice is to be received), or the first business day following such delivery (if delivered other than on a business day during normal business hours where such notice is to be received) or (b) on the second business day following the date of mailing by express courier service, fully prepaid , addressed to such address, or upon actual receipt of such mailing, whichever shall first occur. The addresses for such communications shall be:

 

If to the Company, to:

 

ADIAL PHARMACEUTICALS, LLC

204 E. High Street

Charlottesville, VA 22902

Attention: William Stilley

e-mail: wstilley@adialpharma.com

 

With a copy by e-mail only to (which copy shall not constitute notice):

 

GRACIN & MARLOW, LLP

405 Lexington Avenue

26th Floor

New York, New York 10174

Attn: Leslie Marlow, Esq.

e-mail: lmarlow@gracinmarlow.com

 

If to the Buyer:

 

FIRSTFIRE GLOBAL OPPORTUNITIES FUND, LLC

1040 First Avenue, Suite 190

New York, NY 10022

Attn: Eli Fireman

e-mail: eli@firstfirecapital.com

 

With a copy by e-mail only to (which copy shall not constitute notice):

 

LEGAL & COMPLIANCE, LLC

330 Clematis Street, Suite 217

West Palm Beach, FL 33401

Attn: Chad Friend, Esq., LL.M.

e-mail: CFriend@LegalandCompliance.com

 

g. Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors and assigns. Neither the Company nor the Buyer shall assign this Agreement or any rights or obligations hereunder without the prior written consent of the other. Notwithstanding the foregoing, subject to Section 2(f), the Buyer may assign its rights hereunder to any person that purchases Securities in a private transaction from the Buyer or to any of its “affiliates,” as that term is defined under the 1934 Act, without the consent of the Company and the Company may assign it as part of a reincorporation merger or a reorganization to convert to a corporation.

 

h. Third Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other person.

 

 15 

 

i. Survival. The representations and warranties of the Company and the agreements and covenants set forth in this Agreement shall survive the closing hereunder notwithstanding any due diligence investigation conducted by or on behalf of the Buyer. The Company agrees to indemnify and hold harmless the Buyer and all their officers, directors, employees and agents for loss or damage arising as a result of or related to any breach or alleged breach by the Company of any of its representations, warranties and covenants set forth in this Agreement or any of its covenants and obligations under this Agreement, including advancement of expenses as they are incurred.

 

j. Publicity. The Company and the Buyer shall have the right to review a reasonable period of time before issuance of any press releases with respect to the transactions contemplated hereby; provided, however, that the Company shall be entitled, without the prior approval of the Buyer, to make any press release or SEC, OTCBB (or other applicable trading market) or FINRA filings with respect to such transactions as is required by applicable law and regulations (although the Buyer shall be consulted by the Company in connection with any such press release prior to its release and shall be provided with a copy thereof and be given an opportunity to comment thereon).

 

k. Expense Reimbursement; Further Assurances. At the Closing to occur as of the Closing Date, the Company shall pay on behalf of the Buyer or reimburse the Buyer for its legal fees and expenses incurred in connection with this Agreement in the amount of $6,000. Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents, as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.

 

l. No Strict Construction. The language used in this Agreement will be deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against any party.

 

m. Indemnification. In consideration of the Buyer’s execution and delivery of this Agreement and acquiring the Securities hereunder, and in addition to all of the Company’s other obligations under this Agreement or the Note, the Company shall defend, protect, indemnify and hold harmless the Buyer and its stockholders, partners, members, officers, directors, employees and direct or indirect investors and any of the foregoing persons’ agents or other representatives (including, without limitation, those retained in connection with the transactions contemplated by this Agreement) (collectively, the “Indemnitees”) from and against any and all actions, causes of action, suits, claims, losses, costs, penalties, fees, liabilities and damages, and expenses in connection therewith (irrespective of whether any such Indemnitee is a party to the action for which indemnification hereunder is sought), and including reasonable attorneys’ fees and disbursements (the “Indemnified Liabilities”), incurred by any Indemnitee as a result of, or arising out of, or relating to (a) any misrepresentation or breach of any material representation or warranty made by the Company in this Agreement, the Note or any other agreement, certificate, instrument or document contemplated hereby or thereby, (b) any breach of any material covenant, agreement or obligation of the Company contained in this Agreement, the Note or any other agreement, certificate, instrument or document contemplated hereby or thereby or (c) any cause of action, suit or claim brought or made against such Indemnitee by a third party (including for these purposes a derivative action brought on behalf of the Company) and arising out of or resulting from (i) the execution, delivery, performance or enforcement of this Agreement, the Note or any other agreement, certificate, instrument or document contemplated hereby or thereby, (ii) any transaction financed or to be financed in whole or in part, directly or indirectly, with the proceeds of the issuance of the Securities, or (iii) the status of the Buyer or holder of the Securities as an investor in the Company pursuant to the transactions contemplated by this Agreement. To the extent that the foregoing undertaking by the Company may be unenforceable for any reason, the Company shall make the maximum contribution to the payment and satisfaction of each of the Indemnified Liabilities that is permissible under applicable law.

 

n. Remedies. The Company acknowledges that a breach by it of its obligations hereunder will cause irreparable harm to the Buyer by vitiating the intent and purpose of the transaction contemplated hereby. Accordingly, the Company acknowledges that the remedy at law for a breach of its obligations under this Agreement or the Note will be inadequate and agrees, in the event of a breach or threatened breach by the Company of the provisions of this Agreement or the Note, that the Buyer shall be entitled, in addition to all other available remedies at law or in equity, and in addition to the penalties assessable herein, to an injunction or injunctions restraining, preventing or curing any breach of this Agreement or the Note and to enforce specifically the terms and provisions hereof, without the necessity of showing economic loss and without any bond or other security being required.

 

 16 

 

o. Payment Set Aside. To the extent that the Company makes a payment or payments to the Buyer hereunder or pursuant to the Note, or the Buyer enforces or exercises its rights hereunder or thereunder, and such payment or payments or the proceeds of such enforcement or exercise or any part thereof are subsequently invalidated, declared to be fraudulent or preferential, set aside, recovered from, disgorged by or are required to be refunded, repaid or otherwise restored to the Company, a trustee, receiver or any other person or entity under any law (including, without limitation, any bankruptcy law, foreign, state or federal law, common law or equitable cause of action), then to the extent of any such restoration the obligation or part thereof originally intended to be satisfied shall be revived and continued in full force and effect as if such payment had not been made or such enforcement or setoff had not occurred.

 

p. Failure or Indulgence Not Waiver. No failure or delay on the part of the Buyer in the exercise of any power, right or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such power, right or privilege preclude other or further exercise thereof or of any other right, power or privileges. All rights and remedies of the Buyer existing hereunder are cumulative to, and not exclusive of, any rights or remedies otherwise available.

 

[Signature Page Follows]

 

 17 

 

IN WITNESS WHEREOF, the undersigned Buyer and the Company have caused this Agreement to be duly executed as of the date first above written.

 

ADIAL PHARMACEUTICALS, LLC  
     
By: /s/ William Stilley  
  Name: WILLIAM STILLEY  
  Title: CHIEF EXECUTIVE OFFICER  

 

FIRSTFIRE GLOBAL OPPORTUNITIES FUND, LLC  
     
By: FirstFire Capital Management LLC, its manager  
     
By: /s/ Eli Fireman  
  ELI FIREMAN  

 

SUBSCRIPTION AMOUNT:

 

Principal Amount of Note: $287,500.00

Actual Amount of Purchase Price of Note: $250,000.00*

  

*  The purchase price of $250,000.00 shall be paid within one (1) business day after the full execution of the Note and all related transaction documents.

 

 18 

 

EXHIBIT A FORM OF

 

NOTE

 

[See Exhibit 4.7 to the Form S-1]

 

 

 19 

 

EXHIBIT B

 

FORM OF WARRANT

 

[See Exhibit 4.5 to the Form S-1]

 

 

20

 

 

EX-10.10 35 fs12017ex10-10_adialpharma.htm SECURITY AGREEMENT

Exhibit 10.10

 

SECURITY AGREEMENT

 

THIS SECURITY AGREEMENT (this "Agreement"), is entered into as of May 1, 2017, by and between ADial Pharmaceuticals, LLC, a Virginia limited liability company (the "Borrower"), FirstFire Global Opportunities Fund LLC, a Delaware limited liability company (individually, a "Secured Party" and, collectively, the "Secured Parties"). All capitalized terms not otherwise defined herein shall the meanings ascribed to them in that certain Securities Purchase Agreement and Note (as defined below) by and between Borrower and the Secured Party of even date (the "Note Purchase Agreement").

 

RECITALS

 

WHEREAS, the Secured Parties have loaned monies to Borrower, as more particularly described in the Note Purchase Agreement and as evidenced by the 2% Senior Secured Promissory Note in the principal amount of $287,500.00 issued by Borrower to the Secured Party (the "Note");

 

WHEREAS, the term "Secured Party" as used in this Agreement shall mean, collectively, all holders of the Note, including those persons who become holders of Note subsequent to the date hereof; and

 

WHEREAS, this Agreement is being executed and delivered by Borrower to secure the Note.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, each of the parties hereto hereby agrees as follows:

 

1. Obligations Secured. This Agreement secures, in part, the prompt payment and performance of all obligations of Borrower under the Note, and all renewals, extensions, modifications, amendments, and/or supplements thereto (collectively, the "Secured Obligations").

 

2.  Grant of Security.

 

a. Collateral. Borrower hereby grants, pledges, and assigns for the benefit of the Secured Parties, and there is hereby created in favor of each of the Secured Parties, a security interest in and to all of Borrower's right, title, and interest in, to, and under all of the collateral set forth on Exhibit A hereto (collectively, "Collateral").

 

b. Effective Date. This grant of security shall be effective as of the date hereof.

 

c. Subordination. The Note and the Secured Obligations shall not be subordinated, or junior in interest, to any other obligations of Borrower.

 

d. Filings to Perfect Security. The Company will (and is hereby authorized to) file with any filing office such financing statements, amendments, addenda, continuations, terminations, assignments and other records (whether or not executed by Borrower) to perfect and to maintain perfected security interests in the Collateral by the Secured Parties, whereby (a) promptly upon the execution of this Agreement, a Financing Statement on Form UCC-1 (the "Financing Statement'') shall be filed with the Virginia Secretary of State on behalf of the Secured Parties with respect to the Collateral; The Financing Statement shall designate each of the Secured Parties as a Secured Party and Borrower as the debtor, shall identify the security interest in the Collateral, and contain any other items required by law.

 

 

 

  

The Financing Statement shall contain a description of collateral consistent with the description set forth herein and shall not describe the collateral as "all assets" or "all personal property."

 

3. Transfers and Other Liens. Except as set forth herein or in the Note, Borrower shall not, without the prior written consent of all of the Secured Parties, at their sole and absolute discretion:

 

a. Sell, transfer, assign, or dispose of (by operation of law or otherwise), any of the Collateral other than a Permitted Disposition;

 

b. Create or suffer to exist any lien, security interest, or other charge or encumbrance upon or with respect to any of the Collateral, except Permitted Liens or the security interests created hereby; or

 

c. Permit any of the Collateral to be levied upon under any legal process.

 

For the purposes hereof, “Permitted Disposition” means (i) dispositions of inventory or used, obsolete, warn out or surplus equipment, in the ordinary course of business, (ii) licensing, sublicensing, on a non-exclusive basis of intellectual property in the ordinary course of business, (iii) leasing or subleasing of assets in the ordinary course of business, (iv) the disposition of cash and cash equivalents in the ordinary course of business, (v) (v) the lapse or abandonment of intellectual property to the extent not economically desirable in the conduct of the Borrower’s business so long such lapse is not materially adverse to the interests of the Secured Party; (vi) the sale of equipment to the extent that such equipment is exchanged for credit against the purchase price of similar replacement equipment, or the proceeds of such sale are applied with reasonable promptness to the purchase price of such replacement equipment or other capital expenditures; (vii) the disposition, forgiveness or discount of delinquent notes or accounts receivable in the ordinary course of business for purposes of collection only; (viii) dispositions permitted by Secured Party in writing; (ix) other dispositions of property in any fiscal year during the term of this Agreement whose net book value in the aggregate does not exceed 10% of Borrower’s total consolidated assets as shown on the balance sheet for the immediately preceding fiscal year; and (x) (A) the surrender of contractual rights in the ordinary course of business and (B) the settlement, release or surrender of any contract, tort or other litigation claims in the ordinary course of business other than any commercial tort claim pledged to the Secured Party; and (xi) disposition or transfer of any leasehold interest at the natural expiration of such lease or upon the earlier termination of the lease as provided therein.

 

-2-

 

 

For the purposes hereof, “Permitted Liens” means: (i) statutory Liens of landlords, carriers, warehousemen, processors, mechanics, materialmen or suppliers incurred in the ordinary course of business and securing amounts not yet due or declared to be due by the claimant thereunder or amounts which are being contested in good faith and by appropriate proceedings and for which Borrower has maintained adequate reserves; (ii) Liens or security interests in favor of Secured Party; (iii) zoning restrictions and easements, licenses, covenants and other restrictions affecting the use of real property and not interfering in any material respect with ordinary conduct of business of Borrower; (iv) Liens in connection with purchase money indebtedness and capitalized leases otherwise having a principal amount not exceeding $200,000 in the aggregate outstanding at any time, provided, that such Liens attach only to the assets the purchase of which was financed by such purchase money indebtedness or which is the subject of such capitalized leases and proceeds and replacement thereof; (v) Liens specifically permitted by Secured Party in writing; (vi) Liens for taxes, assessments and other government charges or levies not yet due and payable or which are being contested in good faith and by appropriate proceedings and for which Borrower has maintained adequate reserves; (vii) Liens consisting of deposits or pledges made in the ordinary course of business in connection with workers’ compensation, unemployment, social security and similar laws, or to secure the performance of statutory obligations, bids, leases, government contracts, trade contracts, and other similar obligations (exclusive of obligations for the payment of borrowed money); (viii) licenses (with respect to intellectual property and other property), leases, subleases and usage arrangements granted to third parties in the ordinary course of business; (ix) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods; (x) Liens of collecting banks under the UCC on items in the course of collection, statutory Liens and rights of set-off of banks; (xi) non-exclusive licenses of intellectual property rights in the ordinary course of business; and (xii) Liens arising from filing UCC financing statements relating solely to leases not prohibited by this Agreement.

 

4. Representations and Warranties. Borrower hereby represents and warrants to the Secured Parties as follows: (a) to Borrower' s knowledge, Borrower is the owner of the Collateral (or, in the case of after-acquired Collateral, at the time Borrower acquires rights in the Collateral, will be the owner thereat) and that, except as expressly provided herein, no other person has (or, in the case of after-acquired Collateral, at the time Borrower acquires rights therein, will have) any right, title, claim or interest (by way of Lien or otherwise) in, against or to the Collateral; (b) to Borrower's knowledge, except as expressly provided herein, upon the filing of a Financing Statement with the Virginia Secretary of State, the Secured Parties (or in the case of after-acquired Collateral, at the time Borrower acquires rights therein, will have) will have a perfected security interest in the Collateral to the extent that a security interest in the Collateral can be perfected by such filing; (c) all Accounts Receivable (as defined in Exhibit A) are genuine and enforceable against the party obligated to pay the same; (d) Borrower has full power and authority to enter into the transactions provided for in this Agreement and the Note; (e) this Agreement and the Note, when executed and delivered by Borrower, will constitute the legal, valid and binding obligations of Borrower enforceable in accordance with their terms; (t) the execution and delivery by Borrower of this Agreement and the Note and the performance and consummation of the transactions contemplated hereby and thereby do not and will not violate Borrower's Certificate of Incorporation or Bylaws or any material judgment, order, writ, decree, statute, rule or regulation applicable to Borrower (g) there does not exist any default or violation by Borrower of or under any of the terms, conditions or obligations of (i) any indenture, mortgage, deed of trust, franchise, permit, contract, agreement, or other instrument to which Borrower is a party or by which Borrower is bound, or (ii) any law, ordinance, regulation, ruling, order, injunction, decree, condition or other requirement applicable to or imposed upon Borrower by any law, the action of any court or any governmental authority or agency; and the execution, delivery and performance of this Agreement will not result in any such default or violation; (h) there is no action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand pending or, to the knowledge of Borrower, threatened which adversely affects Borrower's business or financial condition and there is no basis known to Borrower for any action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand which could result in the same; and (i) this Agreement and the Note do not contain any untrue statement of material fact or omit to state a material fact necessary in order to make the statements contained in this Agreement and the Note not misleading.

 

-3-

 

 

 

5. Events of Default. For purposes of this Agreement, the term "Event of Default" shall mean and refer to any of the following:

 

a. Failure of Borrower to perform or observe any covenant set forth in this Agreement, or to perform or observe any other term, condition, covenant, warranty, agreement or other provision contained in this Agreement, where such failure continues for fifteen (15) days after receipt of written notice from Lender specifying such failure;

 

b. Any material representation or warranty made or furnished by Borrower in writing in connection with this Agreement and the Note or any statement or representation made in any certificate, report or opinion delivered pursuant to this Agreement or in connection with this Agreement is false, incorrect or incomplete in any material respect at the time it is furnished; or

 

c. Occurrence of any other Event of Default as defined in the Note.

 

6. Remedies. Upon the occurrence and during the continuance of an Event of Default (subject to the notice and cure provisions provided for herein, if any), each Secured Party shall have the rights of a secured creditor under the Virginia Uniform Commercial Code, all rights granted by the Note, this Security Agreement and by law, including the right to require Borrower to assemble the Collateral and make it available to the Secured Parties at a place to be designated by Borrower. The rights and remedies provided in this Agreement and the Note are cumulative and may be exercised independently or concurrently, and are not exclusive of any other right or remedy provided at law or in equity. No failure to exercise or delay by the Secured Parties in exercising any right or remedy under this Agreement or the Note shall impair or prohibit the exercise of any such rights or remedies in the future or be deemed to constitute a waiver or limitation of any such right or remedy or acquiescence therein. Every right and remedy granted to the Secured Parties under this Agreement and the Note or by law or in equity may be exercised by any Secured Party at any time and from time to time.

 

7. Further Assurances. Borrower agrees that, from time to time, at its own expense, it will:

 

a. Protect and defend the Collateral against all claims and demands of all persons at any time claiming the same or any interest therein, and preserve and protect Secured Party's security interest in the Collateral.

 

b. Promptly execute and deliver to Secured Parties all instruments and documents, and take all further action necessary or desirable, as any Secured Party may reasonably request to (i) continue, perfect, or protect any security interest granted or purported to be granted hereby, and (ii) enable a Secured Party to exercise and enforce any of Secured Party's rights and remedies hereunder with respect to any Collateral.

 

c. Permit a Secured Party's representatives to inspect and make copies of all books and records relating to the Collateral, wherever such books and records are located, and to conduct an audit relating to the Collateral at any reasonable time or times.

 

-4-

 

 

8. Notices. All notices required or permitted hereunder shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed telex, e-mail or facsimile if sent during normal business hours of the recipient, if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent as follows:

 

If to the Borrower, to:

 

ADIAL PHARMACEUTICALS, LLC

204 E. High Street

Charlottesville, VA 22902

Attention: William Stilley

e-mail: wstilley@adialpharma.com

 

If to the Secured Party:

 

FIRSTFIRE GLOBAL OPPORTUNITIES FUND, LLC

1040 First Avenue, Suite 190

New York, NY 10022

Attn: Eli Fireman

e-mail: eli@firstfirecapital.com

 

With a copy by e-mail only to (which copy shall not constitute notice):

 

LEGAL & COMPLIANCE, LLC

330 Clematis Street, Suite 217

West Palm Beach, FL 33401

Attn: Chad Friend, Esq., LL.M.

e-mail: CFriend@LegalandCompliance.com

 

or to such other address or telecopy number as the party to whom notice is to be given may have furnished to the other party in writing in accordance herewith.

 

10. Amendments and Waivers. No modification, amendment or waiver of any provision of, or consent required by, this Agreement, nor any consent to any departure herefrom, shall be effective unless it is in writing and signed by each of the parties hereto. Such modification, amendment, waiver or consent shall be effective only in the specific instance and for the purpose for which given.

 

11. Exclusivity and Waiver of Rights. No failure to exercise and no delay in exercising on the part of any party, any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power or privilege preclude any other right, power or privilege. The rights and remedies herein provided are cumulative and are not exclusive of any other rights or remedies provided by law.

 

-5-

 

 

12. Invalidity. Any term or provision of this Agreement shall be ineffective to the extent it is declared invalid or unenforceable, without rendering invalid or enforceable the remaining terms and provisions of this Agreement.

 

13. Headings. Headings used in this Agreement are inserted for convenience only and shall not affect the meaning of any term or provision of this Agreement.

 

14. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original instrument, but all of which collectively shall constitute one and the same agreement.

 

15. Assignment. Except in connection with the Borrower’s conversion or reincorporation by merger to Delaware corporation, this Agreement and the rights and obligations hereunder shall not be assignable or transferable by the any of the parties without the prior written consent of all Secured Parties, at their sole and absolute discretion.

 

16. Survival. Unless otherwise expressly provided herein, all representations warranties, agreements and covenants contained in this Agreement shall survive the execution hereof and shall remain in full force and effect until the earliest to occur of (a) the payment in full of the Note, and (b) the conversion of the principal and accrued and unpaid interest and all other amounts owing under the Note into common stock of Borrower.

 

17. Miscellaneous. This Agreement shall inure to the benefit of each of the parties hereto and all their respective successors and permitted assigns. Nothing in this Agreement is intended or shall be construed to give to any other person, firm or corporation any legal or equitable right, remedy or claim under or in respect of this Agreement or any provision herein contained.

 

18. GOVERNING LAW. THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK (WITHOUT GIVING EFFECT TO ANY CHOICE OR CONFLICT OF LAWS PROVISIONS).

 

19. CONSENT TO JURISDICTION. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY AND UNCONDITIONALLY SUBMITS TO THE NON- EXCLUSIVE JURISDICTION OF THE COURTS OF THE STATE AND COUNTY OF NEW YORK. EACH OF THE PARTIES HERETO AGREES THAT ALL ACTIONS OR PROCEEDINGS ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY MUST BE LITIGATED EXCLUSIVELY IN ANY SUCH STATE OR FEDERAL COURT, AND ACCORDINGLY, EACH OF THE PARTIES HERETO IRREVOCABLY WAIVES ANY OBJECTION WHICH IT MAY NOW OR HEREAFTER HAVE TO THE LAYING OF THE VENUE OF ANY SUCH LITIGATION IN ANY SUCH COURT.

 

20. WAIVER OF JURY TRIAL. EACH OF THE PARTIES HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT. EACH OF THE PARTIES HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND EACH OF THE OTHER PARTIES HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 20.

 

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21. Attorneys' Fees. In the event that any suit or action is instituted to enforce any provision in this Agreement, the prevailing party in such dispute shall be entitled to recover from the losing party all fees, costs and expenses of enforcing any right of such prevailing party under or with respect to this Agreement, including without limitation, such reasonable fees and expenses of attorneys and accountants, which shall include, without limitation, all fees, costs and expenses of appeals.

 

22. Entire Agreement. This Agreement contains the entire agreement among the parties with respect to the transactions contemplated by this Agreement and supersedes all prior agreements or understandings among the parties with respect to the subject matter hereof.

 

[SIGNATURE PAGE(S) FOLLOW]

 

-7-

 

 

IN WITNESS WHEREOF, this Security Agreement has been executed as of the date first set written above.

  

“SECURED PARTY” 

 

FIRSTFIRE GLOBAL OPPORTUNITIES FUND, LLC

 

By: FirstFire Capital Management LLC, its manager

 

By: /s/ Eli Fireman  
  ELI FIREMAN  

 

"BORROWER"

 

ADIAL PHARMACEUTICALS, LLC

 

By: /s/ William Stilley  
 

Name: WILLIAM STILLEY

 
 

Title: CHIEF EXECUTIVE OFFICER

 

 

-8-

 

 

EXHIBIT A

 

COLLATERAL

 

Borrower hereby grants, pledges, and assigns for the benefit of each Secured Party, and there is hereby created in favor of the Secured Parties, a security interest in and to all of Borrower's right, title, and interest in, to, and under all assets and all personal property of Borrower, whether now or hereafter existing, or now owned or hereafter acquired, including but not limited to the following (collectively, "Collateral"):

 

1. All accounts, chattel paper, contracts, contract rights, accounts receivable, tax refunds, Note receivable, documents, other choses in action and general intangibles, including, but not limited to, proceeds of inventory and returned goods and proceeds from the sale of goods and services, and all rights, liens, securities, guaranties, remedies and privileges related thereto, including the right of stoppage in transit and rights and property of any kind forming the subject matter of any of the foregoing ("Accounts Receivable");

 

2. All time, savings, demand, certificate of deposit or other accounts in the name of Borrower or in which Borrower has any right, title or interest, including but not limited to all sums now or at any time hereafter on deposit, and any renewals, extensions or replacements of and all other property which may from time to time be acquired directly or indirectly using the proceeds of any of the foregoing;

 

3. All inventory and equipment of every type or description wherever located, including, but not limited to all raw materials, parts, containers, work in process, finished goods, goods in transit, wares, merchandise furniture, fixtures, hardware, machinery, tools, parts, supplies, automobiles, trucks, other intangible property of whatever kind and wherever located associated with the Borrower's business, tools and goods returned for credit, repossessed, reclaimed or otherwise reacquired by Borrower;

 

4. All documents of title and other property from time to time received, receivable or otherwise distributed in respect of, exchange or substitution for or addition to any of the foregoing including, but not limited to, any documents of title;

 

5. All know-how, information, permits, patents, copyrights, goodwill, trademarks, trade names, licenses and approvals held by Borrower, including all other intangible property of Borrower;

 

6. All assets of any type or description that may at any time be assigned or delivered to or come into possession of Borrower for any purpose for the account of Borrower or as to which Borrower may have any right, title, interest or power, and property in the possession or custody of or in transit to anyone for the account of Borrower, as well as all proceeds and products thereof and accessions and annexations thereto; and

 

7. All proceeds (including but not limited to insurance proceeds) and products of and accessions and annexations to any of the foregoing.

 

-9-

 

 

8. All of the following assets of the Borrower:

 

AD04 Clinical Trial Material – Active

 

Approximately 26,000 blister packs of 18 tablets each stored in palletized cartons at controlled room temperature.

Location:        Catalent Pharma Solutions

         3031 Red Lion Rd

         Philadelphia, PA 19114

 

AD04 Clinical Trial Material – Placebo

 

Approximately 26,000 blister packs of 18 tablets each stored in palletized cartons at controlled room temperature.

 

Location:         Catalent Pharma Solutions

          3031 Red Lion Rd

          Philadelphia, PA 19114

 

Computers, printers, polycom telephones, regulatory files, and corporate files.

 

Location:          204 E. High Street

          Charlottesville, VA 22902

          and

          308 Pleasant Place

          Charlottesville, VA 22902

 

Electronic files in ADial’s Sharevault account and ADial’s Dropbox account.

 

 

-10-

 

 

EX-10.11 36 fs12017ex10-11_adialpharma.htm SETTLEMENT AGREEMENT AND RELEASE OF CLAIMS

Exhibit 10.11 

 

SETTLEMENT AGREEMENT AND RELEASE OF CLAIMS

 

This Settlement Agreement and Release Of Claims (this "Settlement Agreement") is made and entered into as of January 25, 2016 by and between Bankole Johnson ("Johnson") and ADial Pharmaceuticals, LLC ("ADial")(collectively, the "Parties").

 

WHEREAS, Johnson commenced a lawsuit against ADial in the Circuit Court for Albemarle County, Virginia, Case No: CL14000695-00, seeking relief for breach of the contract for Johnson's consulting services and ADial filed counterclaims thereto (the lawsuit and counterclaim being sometimes referred to herein as the “Litigation”); and

 

WHEREAS, the Parties now desire to settle fully and finally all claims and possible claims that Johnson may have against ADial, and any claims and possible claims ADial may have against Johnson relating to the aforementioned Litigation, without further resort to litigation or other proceedings, based on the settlement agreement set forth below.

 

“Affiliates” shall mean any entity controlled by a Party or that controls a Party through an equitable ownership of 50% or more.

 

NOW THEREFORE, in consideration of the promises and agreements herein contained, the value and sufficiency of which is agreed by the Parties, the Parties agree as follows:

 

1.Cash Payment. The amount of fifteen thousand five hundred ninety-six dollars ($15,596.00) will be paid to Johnson by ADial upon execution of this Agreement.
2.Johnson Services.
2.1.In addition to Johnson’s activities as Chairman of the ADial Board, Johnson agrees to provide occasional consultation by e-mail or phone outside of Board meetings upon request of the Company and subject to Johnson’s reasonable availability.
2.2.In consideration of the services in 2.1 above, Johnson will be allocated 1.25% of the ADial’s Performance Bonus Plan (the “PBP”) approved on February 17, 2015 and the current PBP shall be replaced with the PBP attached as Exhibit A attached hereto.
2.3.Johnson may pursue other consulting work as long as it is not for the pharmacogenetic treatment of alcohol addiction.
3.Johnson Release. In consideration for the promises set forth herein Johnson agrees to and hereby does, for himself and for his Affiliates, officers, directors and agents in their representative capacities, as well as his and their successors and assigns (the “Johnson Parties”), forever and irrevocably fully release and discharge ADial and all present and former officers, directors, employees, agents, attorneys, predecessors, successors, assigns, benefit plans, Affiliates, and representatives thereof (the “ADial Parties”), from the subject matter of the Litigation and any and all other grievances, liens, suits, judgments, claims, demands, debts, defenses, actions or causes of action, obligations, damages, and liabilities whatsoever (specifically including, without limitation, payment of any additional escrow account funds), with the sole exception of acts of scientific fraud, which he now has, has had, or may have against them, whether the same be known or unknown, accrued or unaccrued, at law, in equity, or mixed, arising from acts occurring through the date hereof; provided however, that Johnson may take action to enforce this Settlement Agreement. It is expressly understood and agreed that Johnson’s Consulting Agreement and the PEPCO agreement are terminated and all claims or obligations arising thereunder are hereby released.

  
 

 

 

4.ADial Release. In consideration for the promises set forth herein, ADial agrees to and hereby does, for itself and for the ADial Parties, forever and irrevocably fully release and discharge the Johnson Parties from the subject matter of the Litigation and any and all other grievances, liens, suits, judgments, claims, demands, debts, defenses, actions or causes of action, obligations, damages, and liabilities whatsoever, with the sole exception of acts of scientific fraud, which it now has, has had, or may have against them, whether the same be known or unknown, accrued or unaccrued, at law, in equity, or mixed, arising from acts occurring through the date hereof; provided however, that ADial may take action to enforce this Settlement Agreement. It is expressly understood and agreed that Johnson’s Consulting Agreement and the PEPCO agreement are terminated and all claims or obligations arising thereunder are hereby released.
5.Suit Dismissal. In exchange for the promises set forth in this Settlement Agreement, the Parties acknowledge and agree that an order of dismissal with prejudice will be filed with the Court upon the execution of this Agreement. Each Party shall bear their own fees and costs in the litigation. Any Party who takes action to enforce this Settlement Agreement shall be entitled to collect its reasonable costs and attorney’s fees in any action to enforce this Settlement Agreement in which such Party substantially prevails. The parties agree to keep the terms of this Settlement Agreement confidential, except as may be deemed necessary by either party for business purposes, or as required by law.

 

6.Entire Agreement. This Settlement Agreement sets forth the entire understanding between the Parties, and fully supersedes any and all prior agreements or understandings between the Parties or any of them, whether written or oral, pertaining to the Litigation and may not be modified or amended except in writing signed by each of the parties hereto.

 

7.Law & Venue. This Settlement Agreement shall in all respects be interpreted, enforced and governed under the laws of the Commonwealth of Virginia, and shall be interpreted in accordance with the plain meaning of its terms and not strictly for or against any of the Parties hereto. Any actions under this agreement shall be pursued in the Circuit Court for Albemarle County, Virginia and the parties hereto waive any arguments against choice of such venue.

 

8.Attorneys. The Parties each represent that they have read and fully understand all of the provisions of this Settlement Agreement; that prior to signing this Settlement Agreement, each has had a full opportunity to discuss thoroughly all of its terms with their attorney. This Settlement Agreement may be signed in counterparts.

 

 2 
 

 

IN WITNESS WHEREOF, the undersigned, pursuant to due and proper authority, have signed this Settlement Agreement as of the dates hereinafter set forth.

 

      For ADial Pharmaceuticals, LLC
         
By: /s/ Bankole Johnson   By: /s/ William B. Stilley
  Bankole Johnson     William B. Stilley
  Date: January 26, 2015     CEO
        January 25, 2016

 

 3 
 

 

Exhibit A

 

Performance Bonus Plan

 

The Company hereby modifies the bonus plan (the “Plan”) as described herein.

 

Purpose:

To provide incentive for Company personnel and motivate Company personnel to achieve the goals of the Company, which are to bring in funds to the Company through one or more transactions that provide funds to the Company and/or its members with such funds received at the time of the transaction and/or in the future (each and any a “Transaction”). The purpose includes, without limitation, to create motivation to position the Company to achieve future Transactions and Transactions that have the possibility of contingent future payments.

 

Bonus Pool:

A bonus pool (the “Pool”) will be created as follows:

·5.25% of funds received related to any Transaction will be set aside as the Pool for payment as bonuses.
·Once a total of $735,000 has been paid in bonuses under the Plan (i.e. $14,700 million has been received from Transactions), no more bonuses will be paid and the Plan will terminate.

 

Bonuses under the Plan will be awarded from the Pool at the discretion of the CEO subject to the following:

1.23.8% of the Pool will be awarded to Bankole Johnson (i.e. 1.25% of funds received related to any Transaction).
2.No more than 60% of the Pool may be awarded to the CEO.
3.Subject to the above, the award percentages will be determined by the CEO at the time of any Transaction and will carry forward if any funds related to Transaction (including follow-on Transactions deriving from an original Transaction) are received in the future, even if the personnel have left the Company at the time of actual receipt of the funds (i.e. they will be “residuals” due the personnel).
4.There will be a 12 month “tail” for transactions for the current CEO if he is terminated without cause (defined as gross negligence or material willful misconduct) by the Company equal to 60% of the Pool for transactions in first 6 months following termination and equal to 30% of the Pool for transactions that occur 7-12 months out from termination.
5.There will be a 12 month “tail” for transactions for Bankole Johnson if he is terminated as chairman without cause (defined as a pattern of severe gross negligence or material willful misconduct) by the Company equal to 23.8% of the Pool for transactions in first 6 months following termination and equal to 11.9% of the Pool for transactions that occur 7-12 months out from termination.

 

It is understood that the Plan is being approved as part of the contract with current Company personnel in order to retain them and may not be adversely modified without the permission of any affected persons.

 

 4 

EX-10.12 37 fs12017ex10-12_adialpharma.htm PROMISSORY NOTE

Exhibit 10.12 

 

THIS INSTRUMENT CONTAINS A CONFESSION OF JUDGMENT PROVISION WHICH CONSTITUTES A WAIVER OF IMPORTANT RIGHTS YOU MAY HAVE AS A DEBTOR AND ALLOWS THE CREDITOR TO OBTAIN A JUDGMENT AGAINST YOU WITHOUT ANY FURTHER NOTICE. THIS INSTRUMENT FURTHER CONTAINS A WAIVER OF JURY TRIAL PROVISION WHICH CONSTITUTES A WAIVER OF IMPORTANT RIGHTS YOU MAY HAVE AS A DEBTOR.

 

 

PROMISSORY NOTE (this “Note”)

 

US$35,000.00   November 24, 2016
    Charlottesville, VA

  

For value received, Bankole A. Johnson, with address for purposes hereunder of 11020 Hunters View Road, Ellicott City, MD 21042-6109 (“Johnson") promises to pay to the order of ADial Pharmaceuticals, L.L.C., a Virginia limited liability company ("ADial"), at 204 East High Street, Charlottesville, VA 22902, (or at such other place as ADial may designate in writing) the sum of $35,000.00 (thirty-five thousand and no/100 dollars) with interest on or before June 6, 2017 (the "Due Date") under the payment schedule attached hereto as Schedule 1.

 

1.Interest. Interest will be calculated at an annual percentage rate of five percent (5%), compounded monthly, beginning January 6, 2017, until paid in full. Any amounts outstanding under this Note on the 6th day of each month shall be added to the principal balance of this Note on such date and accrue interest thereafter.

 

2.Prepayment. Johnson may prepay this Note (in whole or in part) at any time prior to the Due Date without penalty.

 

3.Events of Default. The following are events of default by Johnson (“Default”) under this Note:

 

a.the failure of Johnson to pay the amounts due hereunder on or before the date stated on Schedule 1;
b.the death of Johnson;
c.the filing of bankruptcy proceedings involving Johnson as a Debtor;
d.the application for appointment of a receiver for Johnson;
e.the making of a general assignment for the benefit of Johnson's creditors;
f.the insolvency of Johnson; or
g.if Johnson breaches any other term herein.

 

4.Effect of Default. Upon a Default, this Note and any other obligations of Johnson to ADial, shall become due immediately, without demand or notice and this Note shall, notwithstanding the rate stated in Section 1 above, then bear an interest rate of 18% (eighteen percent) per annum (or the maximum amount allowed by law, whichever is less) on any outstanding amounts with interest compounding monthly. In the event of Default, Johnson will reimburse all reasonable attorney or other collection fees and expenses incurred by ADial in collecting any amounts due.

 

  
 

 

Additionally, Johnson recognizes and agrees that failure to pay the amounts due under Schedule 1 will cause severe hardship to ADial, including, without limitation, the use of precious management time and effort, extreme mental and emotional stress on management and its members, and loss of prestige; therefore, after Default, for each day any amount due hereunder is outstanding, Johnson shall pay to ADial liquidated damages in the amount of $200.00 (two hundred dollars) per day or the maximum amount per day allowed by law, whichever is less, beginning 15 (fifteen) days after the failure to make timely payment of any amount due and continuing until all amounts due hereunder are paid in full.

 

Furthermore, Johnson has executed the Irrevocable Proxy attached as Exhibit A, which proxy shall only become effective in the event that Johnson fails to timely pay the amounts due hereunder on or before the dates stated on Schedule 1 and which Irrevocable Proxy shall only remain effective until all amounts then due and owing hereunder are paid in full, thereby curing said default.

 

5.Johnson Waivers. Johnson waives demand, protest, notice of nonpayment and any and all lack of diligence or delays in collection or enforcement of this Note. No renewal or extension of this Note, delay in enforcing any right of ADial under this Note, or assignment by ADial of this Note shall affect the liability of Johnson. All rights of ADial under this Note are cumulative and may be exercised concurrently or consecutively at ADial's option. Johnson may not assign this Note.

 

Further, in the event of Default for failure to make timely payment of any amount due hereunder,

 

(a)Johnson agrees to garnishment of his wages as allowed by Maryland law and hereby agrees to such garnishment and waives any defense against such garnishment; and

 

(b)In addition to any other waivers herein, Johnson specifically waives any defense of the amount and value of the daily liquidated damages stated in Section 4 above as being $200.00 per day.

 

6.Right of Offset. Any amounts that may come due from ADial to Johnson, or any entity controlled by him, including, without limitation, the trusts described in ADial’s records as En Fideicomiso De Mi Vida 11/23/2010, En Fideicomiso De Mis Suenos 11/23/2010, and En Fideicomiso De Mi Amor 11/23/2010, due to the ownership of equity interests in ADial or otherwise, may first be used to pay amounts that are due or will be due under this Note (i.e., ADial shall have a right to forgive a portion of this Note in lieu of paying any amounts that otherwise would be payable to Johnson in his capacity as a member of ADial).

 

7.Prohibition of Transfer. Until this Note is retired as paid in full, Johnson shall not assign or transfer any membership units of ADial owned or controlled by him, including, without limitation, the membership units owned by the trusts described in ADial’s records as En Fideicomiso De Mi Vida 11/23/2010, En Fideicomiso De Mis Suenos 11/23/2010, and En Fideicomiso De Mi Amor 11/23/2010, and any such assignment or transfer will be null and void and not recognized by ADial.

 

8.Choice of Law & Venue. This Note will be deemed to have been made and delivered in Charlottesville, VA and will be governed in all respects by the internal laws of the Commonwealth of Virginia without regard to the principles of conflict of laws. Johnson and ADial each hereby (i) agrees that any legal action arising out of or relating to this Note shall be instituted exclusively in Charlottesville General District Court (the “Court”), (ii) waives any objection to the venue for any reason whatsoever, (iii) irrevocably consents to the jurisdiction of the Court in any such action, and (iv) agrees to accept and acknowledge service or any and all process that may be served in any such action in the Court.

 

 2 
 

 

 

9.WAIVER OF RIGHT TO JURY TRIAL. JOHNSON HEREBY WAIVES TRIAL BY JURY IN REGARD TO ANY CAUSES OF ACTION, CLAIMS, OBLIGATIONS, DAMAGES OR ANY COMPLAINTS, WHICH JOHNSON MAY HAVE ARISING OUT OF THIS NOTE AND IN REGARD TO ANY ACTION, OR PROCEEDING, WHICH ADIAL MAY BRING TO ENFORCE ANY PROVISION OF THIS NOTE. BY THE EXECUTION OF THIS NOTE, JOHNSON HEREBY REPRESENTS THAT JOHNSON IS REPRESENTED BY COMPETENT COUNSEL WHO HAS FULLY AND COMPLETELY ADVISED JOHNSON OF THE MEANING AND RAMIFICATION OF THE WAIVER OF THE RIGHT TO A TRIAL BY JURY OR THAT HE HAD AMPLE OPPORTUNITY TO SEEK SUCH ADVICE OF COUNSEL BUT ELECTED NOT TO DO SO.

 

10.CONFESSION OF JUDGMENT. THE UNDERSIGNED HEREBY MAKES, CONSTITUTES AND APPOINTS BRIAN S. JOHNSON, ESQUIRE, OF CHARLOTTESVILLE, VA AS THE UNDERSIGNED’S TRUE AND LAWFUL ATTORNEY-IN-FACT, WITH FULL POWER AND AUTHORITY FOR THE UNDERSIGNED, IN THE UNDERSIGNED’S NAME, PLACE AND STEAD, TO CONFESS JUDGMENT ON THE UNDERSIGNED’S BEHALF IN THE CIRCUIT COURT OF THE CITY OF CHARLOTTESVILLE, VIRGINIA, IN THE EVENT OF A DEFAULT HEREUNDER FOR ALL AMOUNTS OWING UNDER THIS NOTE AS SHOWN ON THE RECORDS OF ADIAL. THIS POWER OF ATTORNEY IS A POWER OF ATTORNEY COUPLED WITH AN INTEREST AND MAY NOT BE TERMINATED BY THE UNDERSIGNED, ITS SUCCESSORS AND ASSIGNS.

 

11.Headings. Heading are for organizational purposes only and have no effect on this Note.

 

12.Invalid Provisions. If any provisions of this Agreement shall be held to be invalid or unenforceable, the remaining provisions shall continue to be valid and enforceable, and if by limiting any such provision it would become valid or enforceable, then such provision shall be deemed to be written, construed, and enforced as so limited.
   

By: /s/ Bankole A. Johnson              (seal)    
  Bankole A. Johnson    

 

 3 
 

 

 

 

COMMONWEALTH OF VIRGINIA

CITY/COUNTY OF _______________________, to-wit:

 

The foregoing instrument was acknowledged before me ________________________________, Notary Public, this ____ day of November, 2016, by _________________.

 

 

       
    Notary Public  

Registration Number __________________

My commission expires: ___/____/20____

 

 4 
 

 

 

Schedule 1

Payment Schedule

 

 

 

 

 5 
 

IRREVOCABLE PROXY

 

The undersigned, a member of ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “Company”), hereby irrevocably (to the fullest extent permitted by law) appoints and constitutes the Board of Directors of the Company as the attorney and proxy of the undersigned with full power of substitution and re-substitution, to the full extent of the undersigned’s rights with respect to (a) the outstanding membership units of the Company owned of record by the undersigned or controlled by the undersigned as of the date of this proxy, including, without limitation, the membership units originally owned by John F. Riccardi’s that were subjected to a proxy in favor of the undersigned and the membership units owned by the trusts with names En Fideicomiso De Mi Vida 11/23/2010, En Fideicomiso De Mis Suenos 11/23/2010, and En Fideicomiso De Mi Amor 11/23/2010 in the Company’s records and (b) any and all other membership units of the Company that the undersigned may acquire on or after the date hereof (membership units in (a) and (b) are, collectively, the “Units”). The undersigned warrants that there are no other irrevocable proxies in place covering the Units as of the signing of this Proxy, and upon the execution hereof, any other prior proxies that may have been given by the undersigned with respect to any of the Units are hereby revoked. The undersigned further agrees that no subsequent proxies will be given with respect to any of the Units, and if given in violation of this explicit agreement, they shall be of no force or effect.

 

The attorney and proxy named above will be empowered, and may exercise this proxy, to vote the Units at any time at any meeting of the members of the Company, however called, or in connection with any solicitation of written consents from the members of the Company, on all matters to come before the members, including but not limited to the approval of the sale and issuance of additional membership units by the Company. Notwithstanding anything else herein, the undersigned retains the sole right to, and does not grant a right to sell, vote to sell, or otherwise commit to sell or hypothecate the Units.

 

This proxy shall be binding upon the heirs, estate, executors, personal representatives, successors and assigns of the undersigned (including any transferee of any of the Units).

 

This proxy shall be construed in accordance with, and governed in all respects by, the internal laws of the Commonwealth of Virginia (without giving effect to principles of conflicts of laws).

 

This proxy is related to that certain Promissory Note between the undersigned and the Company dated November 24, 2016 (the “Note”) and subject to the terms of Section 4 of the Note.

 

This proxy shall be automatically canceled and of no further effect upon the retirement of the Note as fully paid and is not cancellable for any other reason.

 

Dated: November 24, 2016

 

Signed: /s/ Bankole A. Johnson                 (seal)    
  Bankole A. Johnson    

 6 
 

 

 

 

COMMONWEALTH OF VIRGINIA

CITY/COUNTY OF _______________________, to-wit:

 

The foregoing instrument was acknowledged before me ________________________________, Notary Public, this ____ day of November, 2016, by _________________,

 

 

       
    Notary Public  

 

Registration Number __________________

My commission expires: ___/____/20____

 

 7 

EX-10.13 38 fs12017ex10-13_adialpharma.htm FORM OF SUBSCRIPTION AGREEMENT

Exhibit 10.13

 

Investor Name: ___________________

 

State of Domicile: ___________________

 

Investment Amount: ___________________

 

 

 

 

ADIAL PHARMACEUTICALS, LLC

 

SUBSCRIPTION AGREEMENT

 

TO THE OFFERING OF

 

CLASS B UNITS

 

 

 

 

INSTRUCTIONS: IN ORDER TO PURCHASE NOTES OF ADIAL, LLC, YOU MUST COMPLETE THIS SUBSCRIPTION AGREEMENT BY FILLING IN THE REQUESTED INFORMATION, CHECKING THE APPROPRIATE BOXES, AND SIGNING AND RETURNING THE APPROPRIATE DOCUMENTS TO THE COMPANY.

 

 

 

 

ADIAL PHARMACEUTICALS, L.L.C.

SUBSCRIPTION AGREEMENT

 

 

 

THE SECURITIES OF ADIAL PHARMACEUTICALS, L.L.C. TO BE OFFERED IN THIS OFFERING HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), BUT ARE BEING OFFERED IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION PROVIDED BY REGULATION D PROMULGATED BY THE SECURITIES AND EXCHANGE COMMISSION UNDER THE SECURITIES ACT. THE SECURITIES MAY NOT BE OFFERED, SOLD, PLEDGED TRANSFERRED, ASSIGNED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF SUCH REGISTRATION OR AN EXEMPTION THEREFROM.

 

 

 

Instructions

 

Upon tender of this Subscription Agreement to ADial Pharmaceuticals, L.L.C. (the “Company”), this Subscription Agreement shall constitute an irrevocable subscription by the undersigned (the “Investor”) for a membership interest in the form of Units (defined in Section 2.a below).

 

Please read this Subscription Agreement carefully and deliver this fully completed and executed Subscription Agreement

 

by sending a scan of the document to wstilley@adialpharma.com.

 

or

 

by sending the original by mail to ADial Pharmaceuticals, LLC

204 East High Street

Charlottesville, VA 22902

 

If you have any questions, please contact Mr. Stilley at (434) 422-9803. Your payment for the Aggregate Subscription Amount, as reflected in Section 13 shall be due to the Company within 10 business days of the receipt of a notice of acceptance from the Company.

 

Each Investor, if more than one is required because of type of ownership, must execute this Subscription Agreement.

 

Subscription

 

1.Receipt and Review of the Offering Summary Documents. The undersigned acknowledges that he has been furnished with and has carefully read the Second Amended & Restated Operating Agreement Of Adial Pharmaceuticals, L.L.C. dated February 3, 2014, (the “Operating Agreement”), the Company’s presentation, and the Company’s Q4-2016 and Q1-2017 quarterly update letters, which include audited financial statements for the years ended December 31, 2015 and 2016, (the “Information”). The undersigned is aware that:

 

a.The Company has a modest operating history, and there is no assurance that the Company’s operations will be profitable;

 

 

 

 

b.There are substantial risks incident to the ownership of the Units, and such an investment is speculative and involves a high degree of risk of loss by the undersigned of his entire investment in the Company; and

 

c.No federal or state agency has passed upon the Units or made any finding or determination concerning the fairness of this investment, and the Information may not have been filed with or reviewed by state securities administrators because of the limited nature of the offering.

 

2.Subscription.

 

a.Subject to the terms and conditions hereof, the undersigned hereby irrevocably subscribes for and agrees to purchase Class B membership units (as defined in the Operating Agreement) in the Company (“Units”), at a Per Unit Purchase Price set forth in Section 13 below in the Aggregate Subscription Amount set forth in Section 13 below.

 

b.An irrevocable offer to subscribe for the Units shall be deemed to be made only upon tender to the Company of the following:

 

(i)this Subscription Agreement completed and executed by each Investor intending to own the Units subscribed for hereby;

 

(ii)a completed and signed Member Signature Page to the Operating Agreement;

 

(iii)a completed and signed IRS Form W-9; and

 

(iv)any other information or documents that may be required by the Company to verify the accuracy of any statement or representation made herein.

 

3.Acceptance by Company. The undersigned further agrees that this subscription is and shall be irrevocable. The undersigned understands that the Company will notify the undersigned whether his investment has been accepted and upon receipt of the notice of acceptance from the Company, the undersigned agrees that he/she will pay in full the Aggregate Subscription Amount within 10 business days.

 

The Company reserves the right in its sole discretion to reject any subscription in its entirety or, in the alternative, to allocate to any prospective Investor a smaller amount of Units than he or she has subscribed to purchase. For clarity, the Company shall have the right to reduce, on a pro rata basis, or by lot, or by rejecting those subscriptions that were received last, or by any other means determined at the sole discretion of the Company, the amount of the Units to which the undersigned subscriber has subscribed. Furthermore, the Company shall not be required to accept subscriptions in the order received.

 

 2 

 

 

4.Acknowledgments of the Investor. The undersigned acknowledges that the Company cannot guarantee that a new partnering transaction (including, without limitation, an option agreement for such a partnering transaction) with a drug development collaborator, with terms and conditions acceptable to the Company, will be consummated; that the Company or all or some of its assets will be acquired; that any of its products will be commercially viable or successful, or that the additional financing needed to develop and commercialize the Companies assets will materialize.

 

5.Limitation on Transfer of the Units. The undersigned understands that an investment in the Company is an illiquid investment. In particular, the undersigned recognizes and agrees that:

 

a.Due to restrictions more fully described below, and the lack of any market existing or to exist for the Units, investment in the Company will be illiquid.

 

b.The undersigned must bear the economic risk of investment in the Company for an indefinite period of time since the Units have not been registered under the Securities Act or under the securities laws of any other jurisdictions. Therefore, the Units cannot be offered, sold, transferred, pledged or hypothecated to any person unless such transfer is in full compliance with all applicable federal laws or the securities laws of any other applicable jurisdictions. The Company is not obligated to register the Units under the Securities Act or the securities laws of any other jurisdictions.

 

c.The Units will bear a restrictive legend prohibiting transfers thereof except in compliance with applicable federal and state securities laws and will not be transferred of record except in compliance therewith. The Company may require that the proposed transferor provide the Company with an opinion of counsel satisfactory to the Company that such transfer complies with applicable federal and state securities laws. Stop transfer instructions will be issued to the Company’s transfer agent, if any, with respect to the Units or, if the Company acts as its own transfer agent, the Company will make a notation on its records concerning these restrictions on transfer.

 

6.Representations of the Investor. The undersigned hereby represents and warrants to the Company that:

 

a.The address set forth herein is his true and correct address, and he has no present intention of becoming a resident of any other state or jurisdiction.

 

b.The undersigned is aware that any projections and estimates that may be included in the Information are subject to numerous factors beyond the Company’s control and are based on assumptions that may not prove correct. The undersigned understands that any projections and estimates in the Information are for purposes of illustration only and that there can be no assurance that actual results will correspond with the results contemplated in such projections and estimates.

 

 3 

 

 

c.The undersigned has been furnished with the Information and has been given ample opportunity to ask questions of and receive answers from representatives of the Company concerning the terms and conditions of this investment and to obtain additional information necessary to verify the accuracy of the information set forth in the Information. The undersigned has not received or been furnished with any information, statement or representation, oral or written, which varies in any material way from the information presented and statements made in the Information.

 

d.The undersigned is acquiring the Units for which he hereby subscribes as an investment for his own account, as principal, and without any intention of reselling or distributing all or any part of them, and he has no present intention, agreement or arrangement to divide his participation with others or to resell, assign, transfer or otherwise dispose of the Units unless and until the Units are registered or an exemption from such registration is available under federal securities laws or the securities laws of any other jurisdictions.

 

e.The undersigned has adequate net worth and means of providing for his current and potential future needs and personal contingencies to sustain a complete loss of his investment in the Company and has no need for liquidity in his investment. The undersigned’s overall commitments to investments that are not readily marketable are not disproportionate to his net worth, and his investment in the Units will not cause such overall commitments to become excessive. The undersigned has carefully evaluated the financial risk associated with this investment and acknowledges that he is able to bear the loss of his entire investment.

 

f.The undersigned has such knowledge and experience in business and financial matters that he is capable of evaluating the Company and the activities thereof and the risks and merits of investment in the Units and of making an informed investment decision thereon.

 

g.The undersigned acknowledges that neither the Company nor any person acting on behalf of the Company offered to sell him the Units by means of any form of general/public solicitation or advertising, such as media advertising, or at any seminar or meeting where the attendees were invited by any form of general/public solicitation or advertising.

 

h.The undersigned has not distributed the Information to anyone, and he has not made any copies thereof.

 

i.Accredited Investor Status. The undersigned is an “Accredited Investor,” as that term is defined in Regulation D (“Regulation D”) promulgated under the Securities Act because the undersigned satisfies one or more of the criterion set forth on Exhibit A attached hereto.

 

7.Agreement to be Bound by Terms and Conditions. The undersigned hereby adopts, accepts and agrees to be bound by all of the terms and conditions of the offering set forth in the Information.

 

 4 

 

 

8.Agreement to Indemnify Company. The undersigned hereby agrees to indemnify and hold harmless the Company and its affiliates from any and all damages, losses, costs and expenses (including reasonable attorneys’ fees) that they may incur (i) by reason of any breach by the undersigned of any of the representations, warranties or agreements contained herein, (ii) with respect to any and all claims made by or involving any person, other than the undersigned personally, claiming any interest, right, title, power or authority in respect of the Units purchased hereunder. The undersigned further agrees and acknowledges that the foregoing provisions shall survive any sale or transfer, or attempted sale or transfer, of any of the undersigned’s Units not in accordance with this Agreement or the Company’s Operating Agreement and survive the undersigned’s death or dissolution.

 

9.Transferability. The undersigned agrees not to transfer or assign this Agreement, or any of his interest herein, and any attempt to do so shall be null and void.

 

10.Revocation. The undersigned acknowledges and agrees that his subscription for the Units, made by the execution and delivery of this Agreement, is irrevocable and that such subscription shall survive the death or disability of the undersigned, except as provided herein.

 

11.Notices. All notices or other communications given or made hereunder shall be in writing and shall be delivered, mailed, postage prepaid, or electronically sent as follows: if to the undersigned, at the address set forth next to the undersigned’s signature, and if to the Company, to ADial Pharmaceuticals, LLC, c/o William Stilley, 204 East High Street, Charlottesville, VA 22902. Each party may change its address by written notice to the other party.

 

12.Conversion of the Company to a Corporation/ Merger of the Company with a Corporation. The Company may choose to be converted to or merged into a corporation through one transaction or a series of transactions (a “Conversion”) and the Units may or may not be converted into shares of stock or other securities at such ratio as approved in the Conversion Approval (as hereinafter defined). A Conversion may be effected if approved by (i) Members holding two thirds (2/3) of Units, in aggregate, (ii) Members holding a majority of each class of Units, and (iii) Members holding a majority of Profits Interest Units (together, a “Conversion Approval”). By executing this Agreement, the undersigned hereby consents to the Conversion, approves of an amendment to the Operating Agreement to effectuate a Conversion and agrees to execute documents to effectuate any such Conversion. In addition, the undersigned hereby irrevocably grants the Board of Directors of the Company a proxy to vote all Units as required by statute or otherwise to effect the Conversion.

 

13.Market Stand Off. The undersigned shall not sell or otherwise transfer, make any short sale of, grant any option for the purchase of, or enter into any hedging or similar transaction with the same economic effect as a sale of any securities held by the undersigned (other than those included in the registration) of any Entity (as defined below) during the one hundred eighty (180) day period following the effective date of the registration statement for the Entity’s initial public offering filed under the Securities Act (or such other period as may be requested by the Entity or an underwriter to accommodate regulatory restrictions on (i) the publication or other distribution of research reports and (ii) analyst recommendations and opinions, including, but not limited to, the restrictions contained in NASD Rule 2711(f)(4) or NYSE Rule 472(f)(4), or any successor provisions or amendments thereto). The obligations described in this Section shall not apply to a registration relating solely to employee benefit plans on Form S-8 or similar forms that may be promulgated in the future, or a registration relating solely to a transaction on Form S-4 or similar forms that may be promulgated in the future. The Entity may impose stop-transfer instructions and may stamp each certificate with a legend with respect to the shares of common stock (or other securities) subject to the foregoing restriction until the end of such one hundred eighty (180) day (or other) period. The undersigned further agrees to execute a market stand-off agreement with the relevant underwriters in customary form consistent with the provisions of this Section. For the purposes of this Section, the terms “Entity” shall mean the Company, any successor thereto, any entity into which the Company may convert or otherwise reorganize into, any entity engaged in a merger with the Company (whether in a series of mergers or one merger and whether the Company is the survivor in a merger or becomes a subsidiary of an entity engaged in the merger) or any entity which acquires substantially all of the Company’s assets.

 

 5 

 

 

14.Miscellaneous.

 

a.Notwithstanding the place where this Agreement may be executed by any of the parties hereto, the parties expressly agree that the terms and provisions hereof shall be construed in accordance with and governed by the laws of the Commonwealth of Virginia.

 

b.This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and may be amended only by a writing executed by all parties.

 

c.This Agreement shall be binding upon the heirs, estate, legal representatives, successors and assigns of the parties hereto.

 

d.The representations, warranties and agreements contained herein shall survive the delivery and payment for the Units.

 

The remainder of this page is intentionally left blank.

 

 6 

 

 

15.Price and Aggregate Subscription Amount. The undersigned hereby subscribes to the amount and at the price indicated below:

 

  “Per Unit Purchase Price” $1.06
  “Aggregate Subscription Amount”: $__________________

 

IN WITNESS WHEREOF, the undersigned has executed this Subscription Agreement effective this ______ day of ______________, 2017.

 

Subscriber Name (as it is to appear in the company records):

  Co-Member Name (if applicable):
         
         
Signed:     Signed:  
Print:     Print:  
Title (if required):      Title (if required):   
         
     
Fed. Tax ID/Social Security Number     Fed. Tax ID/Social Security Number  
         
Address:     Address:  
         
         
         
         
Email Address:   Email Address:
     
         

 

 

ACCEPTANCE BY COMPANY

(To be completed by the Company)

 

Approved and accepted in accordance with the terms and conditions of the Subscription Agreement set forth above.

 

Aggregate Subscription Amount Accepted: $ _____________________________

 

Number of Class B Units Subscribed: __________________________________

 

ADIAL PHARMACEUTICALS, L.L.C.

 

By:     Date: __________, 2017
  William B. Stilley      
  CEO      

 

 

 7 

 

 

EXHIBIT A

 

Accredited Investor Status. The undersigned is an “Accredited Investor,” as that term is defined in Regulation D (“Regulation D”) promulgated under the Securities Act because (one or more must apply):

 

1.The undersigned is a bank, or any savings and loan association or other institution whether acting in its individual or fiduciary capacity; any broker or dealer registered pursuant to section 15 of the Securities Exchange Act of 1934; any insurance company; any investment company registered under the Investment Company Act of 1940 or a business development company; any Small Business Investment Company licensed by the U.S. Small Business Administration under the Small Business Investment Act of 1958; any plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, if such plan has total assets in excess of $5,000,000; any employee benefit plan within the meaning of the Employee Retirement Income Security Act of 1974 if the investment decision is made by a plan fiduciary, which is either a bank, savings and loan association, insurance company, or registered investment adviser, or if the employee benefit plan has total assets in excess of $5,000,000 or, if a self-directed plan, with investment decisions made solely by persons that are Accredited Investors;

 

2.The undersigned is a private business development company as defined in section 202(a)(22) of the Investment Advisers Act of 1940;

 

3.The undersigned is an organization described in section 501(c)(3) of the Internal Revenue Code, corporation, Massachusetts or similar business trust, or partnership, not formed for the specific purpose of acquiring the Units subscribed for hereby, with total assets in excess of $5,000,000;

 

4.The undersigned is a director, executive officer, or general partner of the Company, or a director, executive officer, or general partner of a general partner of the Company;

 

5.The undersigned is a natural person whose individual net worth, or joint net worth with the undersigned’s spouse, at the time of his or her purchase exceeds $1,000,000, excluding the value of the primary residence of such natural person;

 

6.The undersigned is a natural person who had an individual income in excess of $200,000 in each of the two most recent years or joint income with the undersigned’s spouse in excess of $300,000 in each of those years and has a reasonable expectation of reaching the same income level in the current year;

 

7.The undersigned is a trust, with total assets in excess of $5,000,000, not formed for the specific purpose of acquiring the Units subscribed for hereby, whose purchase is directed by a sophisticated person as described in Regulation D; or

 

8.The undersigned is an entity in which all of the equity owners are accredited investors.

 

 8 

 

 

ADIAL PHARMACEUTICALS, L.L.C.

MEMBER SIGNATURE PAGE

 

In consideration for the sale of LLC Units in ADial Pharmaceuticals, L.L.C., a Virginia limited liability company (the “LLC”), by the LLC to the undersigned, the undersigned hereby approves and consents to, and agrees to be bound by, the terms of that certain Second Amended and Restated Operating Agreement of the ADial Pharmaceuticals, L.L.C. effective February 3, 2014, as may be amended and/or restated from time to time (the “Operating Agreement”) and concurrently herewith enters into the Operating Agreement with all existing members of the LLC by executing and delivering to the LLC this Member Signature Page.

 

Upon the undersigned’s execution and delivery of this Member Signature Page, the undersigned’s delivery of all monies and/or other items required by management of the LLC, and acceptance of this Member Signature Page by the LLC, the undersigned shall become a Member of the LLC.

 

If the undersigned is purchasing LLC Units jointly with another, all such joint owners must execute this Member Signature Page.

 

Effective Date: ________________, 2017.

 

Member Name:     Co-Member Name (if applicable):
         
         
         
Signed:     Signed:  
Print:     Print:  
Title (if required):      Title (if required):   
         
     
Fed. Tax ID/Social Security Number   Fed. Tax ID/Social Security Number
         
Address:     Address:  
         
         
         
         
Email Address:   Email Address:
     
         

 

  Accepted on behalf of ADial Pharmaceuticals, L.L.C.
     
  By:  
    William B. Stilley
    CEO

 

 

9

 

EX-10.14 39 fs12017ex10-14_adialpharma.htm CONSULTING AGREEMENT

Exhibit 10.14

 

 

 

 

 C R E S C E N D O    C O M M U N I C A T I O N S,    L L C 

 

 

Mr. William B. Stilley

Adial Pharmaceuticals, LLC

204 East High Street

Charlottesville, VA 22902

 

This letter confirms the following agreement between our respective companies. It replaces, ab initio, any other agreements related to the subject matter herein entered prior to the date last written below.

 

1.Adial Pharmaceuticals, LLC (“Company”) hereby retains Crescendo Communications, LLC (“Crescendo”) effective October 1, 2016 through September 30, 2018, to provide the Services defined below.

 

2.The services to be performed by Crescendo on behalf of the Company will consist of the following (“Services”):

 

2.1Corporate Planning

 

a.Develop an in-depth familiarization with the Company’s business objectives and bring to its attention potential or actual opportunities which meet those objectives or logical extensions thereof.

 

b.Alert the Company to potential strategic partnerships.

 

c.Comment on the Company’s corporate development including such factors as position in competitive environment, financial performances vs. competition, strategies, operational viability, etc.

 

2.2Financial Public Relations

 

a.Review and comment upon the Company’s reports to shareholders, corporate presentation, website materials and other financial publications.

 

b.Bring to the Company’s attention outstanding examples of financial presentations in other industries, including both overall reporting and portions of reports.

 

c.Review and comment upon the Company’s financial public relations plan.

 

d.Keep the Company informed on any externally originated information disseminated about it.

  

Crescendo Communications, LLC

 

 

Adial Pharmaceuticals, LLC
Page 2/4

 

2.3Business Strategies

 

a.Evaluate business strategies and recommend changes where appropriate.

 

b.Critically evaluate the Company’s performance in view of its corporate planning and business objectives.

 

2.4Shareholder Relations

 

a.Review, comment on and advise the Company as to responses to communications from shareholders.

 

b.Assist the Company in improving its shareholder relations by developing long range programs for shareholder communication.

 

c.Advise the Company as to selection of suitable outside counsel and advisors.

 

d.Review and prepare marketing materials as required, including presentations, website and data room materials.

 

e.Assist in drafting press releases as necessary.

 

The parties agree and acknowledge that Crescendo will not be engaging in any broker-dealer activities on behalf of the Company and its compensation is not dependent on it performing any broker-dealer activities and specifically Crescendo will not be (i) engaged in soliciting investors for the Company, negotiating any transaction on behalf of the Company with any investors or investment banks or fund managers; (ii) providing investment advice or acting as a financial consultant; or (iii) participating in any securities transaction on behalf of the Company.

 

3.In consideration of the Services, immediately after the IPO, the Company shall issue to Crescendo the number of restricted shares of the Company as shall be necessary to bring Crescendo’s equity ownership in the Company to 4.8% based on the total fully diluted outstanding shares immediately prior to the IPO but not including options issued to employees, officers, directors, and consultants after June 1, 2017. Shares shall vest 50% upon issuance and, if there is an IPO, 50% on December 31, 2017. In addition, the Company immediately following an IPO shall issue Crescendo 5-year warrants to purchase such number of shares of common stock of the Company as shall equal 4.9% of the then total fully diluted outstanding shares (for this calculation fully diluted does not include options issued to employees, officers, directors, and consultants after June 1, 2017) with an exercise price equal to the price of the shares issued in the IPO. The warrants shall have a cashless exercise feature and be immediately exercisable, provided, however, that no warrants may be exercised if the issuance of such warrants would create the situation where Crescendo owned more that 4.99% of the shares of the Company. In the event the Company does not complete an IPO on or before December 31, 2017, the Company shall have the right to terminate the agreement without issuing the securities stated above.

 

Crescendo Communications, LLC

 

 

Adial Pharmaceuticals, LLC
Page 3/4

 

4.Crescendo acknowledges its responsibility to use reasonable efforts to preserve the confidentiality of any information disclosed by Company on a confidential basis to Crescendo, except for disclosures required by court order, subpoena or other judicial process.

 

5.Company understands and acknowledges that Crescendo will rely upon the accuracy of all information (“Information”) provided to it by Company. Company shall have full responsibility and liability to Crescendo for such Information and Company shall indemnify, defend and hold Crescendo harmless from and against any demands, claims, judgments and liabilities arising from or related thereto or from the nature and/or use of the Company’s products or services (collectively “Claims Against Crescendo”). Company shall reimburse Crescendo for amounts payable by Crescendo in settlement of or in payment of any Claims Against Crescendo resulting from Crescendo’s reasonable use of the Information and indemnify Crescendo for all costs and expenses incurred by Crescendo in connection therewith, including without limitation, attorney’s fees and costs of defending Claims Against Crescendo, except in cases where damages are due to Crescendo’s gross negligence or willful misconduct.

 

6.As used herein, “shares” means membership units while ADial remains a limited liability company.

 

7.This Agreement constitutes the entire understanding and agreement between the parties with respect to the subject matter here of and all prior contemporaneous understandings; negotiations and agreements are merged herein.

 

8.The Agreement may not be altered, extended, or modified nor any of its provisions waived, except by a document in writing signed by the party against whom such alteration, modification, extension or waiver is sought to be enforced.

 

9.A waiver by either party of any breach, act or omission of the other party is not to be deemed a waiver of any subsequent similar breach, act or omission.

 

Crescendo Communications, LLC

 

  

Adial Pharmaceuticals, LLC
Page 4/4

 

10.The terms and provisions of this Agreement shall be binding upon and shall inure to the benefit of the parties, and their respective successors and assigns.

 

11.This agreement shall be governed by, construed and enforced under the laws of the State of New York without reference to any choice of law doctrine. With respect to any and all controversies or claims arising out of or relating to this Agreement or any alleged breach hereof, the parties agree hereto to submit to the exclusive jurisdiction of the state courts of the State of New York.

 

12.Crescendo shall have the right to terminate this Agreement at any time for convenience upon thirty (30) days’ prior written notice.

 

13.This Agreement supersedes all prior agreements and understandings between the parties hereto with respect to the subject matter hereof.

 

  Very truly yours,
   
  CRESCENDO COMMUNICATIONS, LLC
     
  By: /s/ David K. Waldman
    David K. Waldman, President & CEO

 

Agreed to and Approved

this 30th day of June 2017.

 

Adial Pharmaceuticals, LLC

 

By: /s/ William B. Stilley  
  William B. Stilley, CEO  

 

 

 

Crescendo Communications, LLC

EX-10.15 40 fs12017ex10-15_adialpharma.htm EMPLOYMENT AGREEMENT - WILLIAM B. STILLEY

Exhibit 10.15

 

EMPLOYMENT AGREEMENT

 

This Employment Agreement (this “Agreement”) is entered into as of [_______], 2017 (the “Effective Date”) by and between Adial Pharmaceuticals, Inc., a Delaware corporation, (the “Company”), and William B. Stilley, III (the “Executive”).

 

Recitals

 

WHEREAS, the Company desires to employ the Executive as a full-time employee of the Company and the Executive desires to accept employment with the Company upon the terms and conditions hereinafter set forth.

 

NOW THEREFORE, in consideration of the premises and the mutual covenants hereinafter set forth, and intending to be legally bound hereby, it is hereby agreed as follows:

 

Agreement

 

1.       Definitions.

 

1.1.       “Affiliate” means as to any Person, any other Person that directly or indirectly controls, or is under common control with, or is controlled by, such first Person. As used in this definition, “control” (including, with its correlative meanings, “controlled by” and “under common control with”) shall mean possession, directly or indirectly, of power to direct or cause the direction of management or policies (whether through ownership of voting equity interests, by contract or otherwise). For the avoidance of doubt, each member of the Company Group (other than the Company) is an Affiliate of the Company.

 

1.2.       “Board” means the Board of Directors of the Company.

 

1.3.       “Cause” means the Executive’s: (i) conviction for, or entering of a plea of guilty or nolo contendere (or its equivalent under any applicable legal system) with respect to: (A) a felony or (B) any crime involving moral turpitude; (ii) commission of fraud, misrepresentation, embezzlement or theft against any Person; (iii) engaging in any intentional activity that injures or would reasonably be expected to injure (monetarily or otherwise), in any material respect, the reputation, the business or a business relationship of the Company or any of its Affiliates; (iv) gross negligence or willful misconduct in the performance of the Executive’s duties to the Company or its Affiliates under this Agreement, or willful refusal or failure to carry out the lawful instructions of the Board that are consistent with the Executive’s title and position; (v) violation of any fiduciary duty owed to the Company or any of its Affiliates; or (vi) breach of any Restrictive Covenant (as defined below) or material breach or violation of any other provision of this Agreement, of a written policy or code of conduct of the Company or any of its Affiliates (as in effect from time to time) or any other agreement between the Executive and the Company or any of its Affiliates. Except when such acts constituting Cause which, by their nature, cannot reasonably be expected to be cured, the Executive shall have twenty (20) days following the delivery of written notice by the Company of its intention to terminate the Executive’s employment for Cause within which to cure any acts constituting Cause. Following such twenty (20) day cure period, and if the reason stated in the notice is not cured, the Executive shall be given five (5) business days prior written notice to appear (with or without counsel) before the full Board for the opportunity to present information regarding his views on the alleged Cause event. After the Company provides the original notice of its intent to terminate Executive’s employment for Cause, the Company may suspend the Executive, with pay, from all his duties and responsibilities and prevent him from accessing the Company’s or its Affiliates’ premises or contacting any personnel of the Company or any of its Affiliates until a final determination on the hearing is made. The Executive will not be terminated for Cause until a majority of the independent directors approve such termination following the hearing.

 

 

 

 

1.4.       “Change of Control” means: (i) the accumulation (if over time, in any consecutive twelve (12) month period), whether directly, indirectly, beneficially or of record, by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended) of 50.1% or more of the shares of the outstanding voting securities of the Company, whether by merger, consolidation, sale or other transfer of shares (other than a merger or consolidation where the stockholders of the Company immediately prior to the merger or consolidation are immediately after such merger or consolidation the direct or indirect beneficial owners of a majority of the voting securities of the entity that survives such merger or consolidation), (ii) a sale of all or substantially all of the assets of the Company and its Subsidiaries, determined on a consolidated basis; (iii) a merger or consolidation of the Company in which its voting securities immediately prior to the merger or consolidation do not represent, or are not converted into securities that represent, a majority of the voting power of all voting securities of the surviving entity immediately after the merger or consolidation; or (iv) during any period of twelve (12) consecutive months, the Continuing Directors cease for any reason to constitute at least a majority of the Board even if one of such Continuing Directors were to resign and not be replaced by a Continuing Director; provided, however, that the following acquisitions shall not constitute a Change of Control for the purposes of this Agreement: (A) any acquisitions of voting securities or securities convertible, exercisable or exchangeable into voting securities directly from the Company or (B) any acquisition of voting securities or securities convertible, exercisable or exchangeable into voting securities by any employee benefit plan (or related trust) sponsored by or maintained by the Company or any of its Subsidiaries; provided further, that a transaction will not be a Change of Control unless it satisfies the requirements of Treasury Regulation 1.409A-3(i)(5)(v), (vi) or (vii).

 

1.5.       “Code” means the Internal Revenue Code of 1986, as amended.

 

1.6.       “Company Group” means the Company and the direct and indirect Subsidiaries of the Company.

 

1.7.       “Company Invention” means any Invention that is Invented by the Executive (alone or jointly with others) (i) in the course of, in connection with, or as a result of the Executive’s employment or other service with any member of the Company Group (whether before, on or after the Effective Date), (ii) at the direction or request of any member of the Company Group, or (iii) through the use of, or that is related to, facilities, equipment, Confidential Information, other Company Inventions, intellectual property or other resources of any member of the Company Group, whether or not during the Executive’s work hours.

 

Page 2 of 31

 

1.8.       “Confidential Information” shall mean all information of a sensitive, confidential or proprietary nature respecting the business and activities of any member of the Company Group or any of their respective Affiliates, or the predecessors and successors of any member of the Company Group or any of their respective Affiliates, including, without limitation, the terms and provisions of this Agreement (except for the terms and provisions of Sections 4.4 through 4.17), and the clients, customers, suppliers, computer or other files, projects, products, computer disks or other media, computer hardware or computer software programs, marketing plans, financial information, methodologies, Inventions, know-how, research, developments, processes, practices, approaches, projections, forecasts, formats, systems, data gathering methods and/or strategies of any member of the Company Group or any of their respective Affiliates. “Confidential Information” also includes all information received by the Company or any other member of the Company Group under an obligation of confidentially to a third party. Notwithstanding the foregoing, Confidential Information shall not include any information that is generally available, or is made generally available, to the public other than as a result of a direct or indirect unauthorized disclosure by the Executive or any other Person subject to a confidentiality obligation.

 

1.9.       “Continuing Director” means an individual who: (i) at the beginning of the preceding twelve (12) month period, was a director of the Board, and (ii) any new director whose election by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the directors then still in office who either were directors at the beginning of the 12-month period or whose election or nomination for election was previously so approved.

 

1.10.       “Disability” means that the Executive has been unable, as reasonably determined by the Board (excluding the Executive) in good faith, to perform the Executive’s duties under this Agreement for a period of ninety (90) consecutive days or for a total of one hundred and twenty (120) days (whether or not consecutive) during any period of twelve (12) consecutive months, as a result of injury, illness or any other physical or mental impairment.

 

1.11.       “Good Reason” means any of the following actions taken by the Company without the Executive’s prior written consent: (i) a material reduction in the Executive’s duties, responsibilities or authority; (ii) a reduction of the Executive’s Base Salary (defined below); (iii) failure or refusal of a successor to the Company to either materially assume the Company’s obligations under this Agreement or enter into a new employment agreement with the Executive on terms that are materially similar to those provided under this Agreement, in any case, in the event of a Change of Control; (iv) relocation of the Executive’s primary work location that results in an increase in the Executive’s one-way driving distance by more than twenty-five (25) miles from the Executive’s then-current principal residence; or (v) a material breach of this Agreement by the Company. Notwithstanding the foregoing, Good Reason shall not be deemed to exist unless: (A) the Executive gives the Company written notice within sixty (60) days after the occurrence of the event which the Executive believes constitutes the basis for Good Reason, specifying the particular act or failure to act which the Executive believes constitutes the basis for Good Reason, (B) the Company fails to cure such act or failure to act within thirty (30) days after receipt of such notice and (C) the Executive terminates his employment within thirty (30) days after the end of such thirty (30) day cure period specified in clause (B).

 

Page 3 of 31

 

1.12.       “Invented” means made, conceived, invented, authored, or first actually reduced to practice (in any case, whether partially or fully).

 

1.13.       “Invention” means any invention, formula, therapy, diagnostic technique, discovery, improvement, idea, technique, design, method, art, process, methodology, algorithm, machine, development, product, service, technology, strategy, software, work of authorship or other Works (as defined in Section 4.13), trade secret, innovation, trademark, data, database, or the like, whether or not patentable, together with all intellectual property rights therein.

 

1.14.       “Person” means an individual, partnership, limited liability company, corporation, association, joint stock company, trust, joint venture, unincorporated organization, investment fund, any other business entity and a governmental entity or any department, agency or political subdivision thereof.

 

1.15.       “Subsidiary” means, with respect to any Person, any other Person in which such first Person has a direct or indirect equity ownership interest of at least 50%.

 

1.16.       “Term of Employment” means the period commencing on the date hereof and ending on the fifth (5th) anniversary of Executive’s employment under this Agreement.

 

1.17.       “Termination Date” means the date the Executive’s employment with the Company terminates for any reason.

 

2.       Employment.

 

2.1.       Executive’s Representations. The Executive represents that: (i) the Executive is entering into this Agreement voluntarily and that the Executive’s employment hereunder and compliance with the terms and conditions hereof will not conflict with or result in the breach by the Executive of any agreement to which the Executive is a party or by which the Executive may be bound and (ii) in connection with the Executive’s employment with the Company or any other member of the Company Group, the Executive will not: (A) violate any non-competition, non-solicitation or other similar covenant or agreement by which the Executive is or may be bound or (B) use any confidential or proprietary information that the Executive may have obtained in connection with the Executive’s employment or engagement with any other Person.

 

2.2.       Position; Duties and Responsibilities. During the Term of Employment, the Executive shall be employed as the Company’s Chief Executive Officer, with such duties and responsibilities that are consistent with such position as may be assigned by the Board (excluding the Executive) from time to time. In addition, during the Term of Employment, the Executive shall serve in such other officer and/or director positions with any member of the Company Group (for no additional compensation) as may be determined by the Board (excluding the Executive) from time to time. The Executive further agrees that, during the Term of Employment, he shall not knowingly take any action that is contrary to, or in conflict with, the best interests of the Company Group.

 

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2.3.       Reporting; Outside Activities. During the Term of Employment, the Executive shall report to the Board, and the Executive shall diligently and conscientiously devote the Executive’s full business time, attention, energy, skill and best efforts to the business and affairs of the Company Group. The Executive may also: (i) continue to serve as a member of the board of or as an advisor to any organization listed in Exhibit A hereto, (ii) serve on other boards or as an advisor as may be approved by the Board (excluding the Executive) in its sole discretion, (iii) engage in educational, charitable and civic activities and (iv) manage the Executive’s personal and business investments and affairs, so long as such activities: (A) do not, individually or in the aggregate, interfere with the performance of the Executive’s duties under this Agreement and (B) are not contrary to the interests of the Company Group or competitive in any way with the Company Group. Subject to the foregoing, during the Term of Employment, the Executive shall not, directly or indirectly, render any services of a business, commercial, or professional nature to any other Person, whether for compensation or otherwise, without the prior written consent of the Board (excluding the Executive), which consent shall not be unreasonably withheld.

 

3.       Compensation and Other Benefits.

 

3.1.       Base Salary. During the Term of Employment, the Executive shall initially receive an initial base salary per annum of Three Hundred Fifty Thousand ($350,000) Dollars, payable in cash in accordance with the Company’s normal payroll practices as in effect from time to time. During the Term of Employment, the Board may periodically review the Executive’s base salary and the Board (excluding the Executive) may, in its sole discretion, set such base salary to an amount it determines to be appropriate, provided, however, that any reduction will qualify as Good Reason under Section 1.11. The Executive’s base salary, as may be in effect from time to time, is referred to herein as “Base Salary.”

 

3.2.       Annual Bonus. During the Term of Employment, the Executive shall be eligible to earn an annual performance bonus based on the achievement of the performance goals established by the Board or a committee thereof in its sole discretion, with an annual target bonus opportunity of thirty (30%) percent of the Base Salary and the potential to earn a higher bonus for above target performance, with the amount of any such bonus to be determined in the sole discretion of the Board or a committee thereof, in any case, excluding the Executive (the “Annual Bonus”). Any Annual Bonus earned for any performance period may be paid in cash or any equity or equity-based awards (or any combination thereof), as determined in the sole discretion of the Board or a committee thereof, in any case, excluding the Executive, with such determination to be made before January 1 of the performance period to which such Annual Bonus relates (or such later date permitted under Section 409A (as defined below)). Any earned Annual Bonus that is payable in cash shall be paid in a lump sum, and any earned Annual Bonus that is payable in equity or equity-based awards shall be granted, in any case, by no later than the first March 15th to occur after the end of the applicable performance period. The Board (excluding the Executive) shall act in good faith in determining the value of the portion of any earned Annual Bonus that will be paid in the form of equity or equity-based awards. Except as set forth in Section 4.2, the Executive must be employed by the Company on the bonus payment date in order to receive an earned Annual Bonus with respect to any performance period. With respect to any performance period commencing in any year following the year in which a Change of Control occurs, no portion of the Annual Bonus shall be paid in a form other than cash.

 

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3.3.       Equity Grants. During the Term of Employment, the Executive shall be eligible for equity or equity-based awards that may be granted to the Executive at such times, in such amounts and in such manner as the Board (excluding the Executive) may determine in its sole discretion, but, in good faith, taking into account the roles of and responsibilities of Executive relative to industry norms for similar positions. Any such equity or equity-based awards shall be subject to the terms and conditions set forth in the applicable plan and award agreement.

 

3.4.       Expense Reimbursement. During the Term of Employment, the Company shall reimburse the Executive’s reasonable and necessary business expenses incurred in connection with performing the Executive’s duties hereunder in accordance with its then-prevailing policies and procedures for expense reimbursement (which shall include appropriate itemization and substantiation of expenses incurred).

 

3.5.       Benefit Plans; Vacation. During the Term of Employment, the Executive shall be entitled to participate in all broad-based employee benefit plans and programs maintained from time to time for the benefit of the Company’s employees (e.g., medical, dental and disability benefits) to the extent that the Executive satisfies the eligibility requirements of such plans or programs (including, without limitation, minimum hours worked) and subject to applicable law and the terms and conditions of such plans or programs; provided, however, that the Company may amend, modify or terminate any such plans or programs at any time in its discretion. Notwithstanding the foregoing, the Company will provide medical (including dental and vision) benefits to Executive during the Term of Employment at least as comprehensive as those provided as of July 1, 2017. During the Term of Employment, the Executive shall be entitled to twenty five (25) days of paid time off per calendar year (pro-rated for partial years), subject to the Company’s paid time off policy, as in effect from time to time.

 

3.6.       Personal Items. During the Term, the Company will provide the Executive with a cellular phone/digital assistant, including service, and a personal laptop computer (together, the “Personal Items”). The Company authorizes the Executive to use the Personal Items for his personal use to the extent such use does not interfere with the performance of his duties hereunder. Notwithstanding any provision to the contrary herein or in any other agreement between the Company and the Executive, the Company acknowledges and agrees that any personal information, related data, personal software or other materials not related to the Company’s business operations or otherwise constituting confidential or proprietary information of the Company contained in or stored on any of the Personal Items (“Personal Materials”) shall be and remain the confidential property of the Executive. The Company agrees that upon termination of the Executive’s employment for any reason, the Executive shall be entitled to retain all Personal Materials (and if returning the Personal Items to the Company upon termination, promptly remove all Personal Materials from the Personal Items prior to their timely return) and a copy of the Executive’s calendar and contacts, whether residing or stored on the Personal Items or otherwise. In the event of termination under Sections 4.2.2, 4.2.3, or 4.2.4 below, then, without any further payment from the Executive, the Executive may retain the Personal Items, provided that any Company-owned information, data, software or other material contained in or stored on any of the Personal Items is promptly returned to the Company, including, without limitation, a copy of the Executive’s business contacts. If within 14 days after termination, the Executive returns the cellular phone to the Company, then the Company shall be responsible for any termination or other fees related to the cellular phone or related service plan.

 

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4.       Termination; Restrictive Covenants. Upon the Termination Date, the Executive shall be deemed to have immediately resigned from any and all officer, director and other positions the Executive then holds with the Company and its Affiliates (and this Agreement shall constitute notice of resignation by the Executive without any further action by the Executive), and the Executive agrees to execute and deliver such further instruments as are requested by the Company in furtherance of the foregoing. Except as expressly provided in Section 4.2, all rights the Executive may have to compensation and employee benefits from the Company or its Affiliates shall terminate immediately upon the Termination Date. Notwithstanding the above, if Executive’s deemed resignation as a director of the Board shall not be effective unless such resignation is accepted by the Board (excluding Executive) within thirty (30) days of the Termination Date.

 

4.1.       General. The Company may terminate the Term of Employment and the Executive’s employment at any time, with or without Cause or due to Disability, upon written notice to the Executive. The Executive may terminate the Term of Employment and the Executive’s employment for Good Reason or for any other reason at any time upon not less than sixty (60) days’ prior written notice to the Company; provided, that following its receipt of the Executive’s notice of termination, the Company may elect to reduce the notice period and cause the Termination Date to occur earlier, and action by the Company shall entitle the Executive to notice pay, severance pay or benefits or pay in lieu of notice or lost wages or benefits. In addition, the Term of Employment and the Executive’s employment with the Company shall terminate immediately upon the Executive’s death.

 

4.2.       Separation Payments.

 

4.2.1.       General. Except as otherwise provided in this Section 4.2, in the event that the Executive’s employment with the Company terminates for any reason, the Executive (or the Executive’s estate or legal representative, as applicable) shall be entitled to receive only: (i) the cash portion of the Base Salary earned but unpaid through the Termination Date, paid in accordance with the Company’s normal payroll policies (or at such earlier time as required by applicable law), (ii) any accrued but unused vacation in accordance with the Company’s policies and applicable law, (iii) any unreimbursed business expenses incurred prior to the Termination Date that are otherwise reimbursable, with such expenses to be reimbursed in accordance with the Company’s expense reimbursement policies (as may be in effect from time to time), and (iv) any vested benefits earned by the Executive under any employee benefit plan of the Company or its Affiliates under which the Executive was participating immediately prior to the Termination Date, with such benefits to be provided in accordance with the terms of the applicable employee benefit plan (the items described in the foregoing clauses (i) through (iv), collectively, the “Accrued Benefits”). All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in Sections 4.2.2, 4.2.3, or 4.2.4 shall immediately terminate upon the Termination Date.

 

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4.2.2.       Death and Disability. In the event that the Executive’s employment is terminated due to the Executive’s death or by the Company due to Disability, in either case, during the Term of Employment, then in addition to the Accrued Benefits, and subject to Section 4.2.4, the Executive (or the Executive’s estate or legal representative, as applicable) shall be entitled to receive: (i) the Annual Bonus earned in the fiscal year immediately preceding the fiscal year in which such termination occurred, to the extent that such Annual Bonus is unpaid as of the Termination Date, with such amount to be payable in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred (the “Unpaid Prior Year Bonus”); (ii) the Annual Bonus for the year in which the Termination Date occurs, but multiplied by a fraction (A) the numerator of which is the number of days in the fiscal year that have transpired through the Termination Date and (B) the denominator of which is the number of days in such fiscal year (to be paid in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred); (iii) if the Executive and his eligible dependents are eligible for, and timely elect COBRA continuation coverage, the Company shall reimburse the Executive (or the Executive’s estate or legal representative, as applicable) for the COBRA premiums for the Executive and his eligible dependents under the Company’s medical, dental and vision benefit plans for a period of 12 months following the Termination Date (the “COBRA Benefit”); provided, however, that notwithstanding the foregoing, the COBRA Benefit shall not be provided to the extent that it would result in any fine, penalty or tax on the Company or any of its Affiliates (under Section 105(h) of the Code or the Patient Protection and Affordable Care Act of 2010, or otherwise); provided further, that the COBRA Benefit shall cease earlier if the Executive or his dependents become eligible for health coverage under the health plan of another employer; and (iv) to the extent the following will not result in a violation of Section 409A, with respect to each equity award received by Executive from the Company or any of its direct or indirect parent companies that is outstanding as of the Termination Date, accelerated vesting immediately upon the Termination Date of, (I) with respect to any such equity award received in payment of Base Salary or an Annual Bonus, 100% of such equity award and, (II) with respect to any equity award not described in clause (I), the greater of (x) the portion of the unvested equity award that would have become vested within 12 months after the Termination Date had the Executive remained employed by the Company during such 12-month period (without regard for the vesting schedule set forth in any applicable plan or agreement governing such equity award) or (y) the portion of the unvested equity award that is subject to accelerated vesting (if any) upon such termination under the applicable equity plan or award agreement; provided, however, that any equity awards that are subject to the satisfaction of performance goals shall be deemed earned at not less than target performance; and provided, further, that, with respect to any equity award that is in the form of a stock option or stock appreciation right, the option or stock appreciation right shall remain outstanding and exercisable for 12 months following the Termination Date or, if longer, such period following the Termination Date as provided under the applicable equity plan or award agreement (but in no event beyond the expiration date of the applicable option or stock appreciation right). All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in this Section 4.2.2, shall immediately terminate upon the Termination Date.

 

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4.2.3.       Termination Without Cause or for Good Reason– Not In Connection with a Change of Control. If, during the Term of Employment, the Executive’s employment is terminated by the Company without Cause (and not due to death or Disability) or by Executive for Good Reason, in either case, and such termination is not covered by Section 4.2.4, then the Executive shall be entitled to receive the Accrued Benefits and, subject to Section 4.2.4: (i) the Unpaid Prior Year Bonus, with such amount to be payable in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred; (ii) the Annual Bonus for the year in which the Termination Date occurs, but multiplied by a fraction (A) the numerator of which is the number of days in the fiscal year that have transpired through the Termination Date and (B) the denominator of which is the number of days in such fiscal year (to be paid in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred); (iii) continuation of the Base Salary as of the Termination Date for twelve (12) months following the Termination Date, with all portions of such Base Salary to be paid in cash in equal installments in accordance with the Company’s normal payroll policies, with the first such payment to be made on the sixtieth (60th) day following the Termination Date and to include a catch-up covering any payroll dates between the Termination Date and the date of the first payment, and (iv) the COBRA Benefit for a period of twelve (12) months following the Termination Date; provided, however, that notwithstanding the foregoing, the COBRA Benefit shall not be provided to the extent that it would result in any fine, penalty or tax on the Company or any of its Affiliates (under Section 105(h) of the Code or the Patient Protection and Affordable Care Act of 2010, or otherwise); provided further, that the COBRA Benefit shall cease earlier if the Executive (or his dependents) become eligible for health coverage under the health plan of another employer. All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in this Section 4.2.3, shall immediately terminate upon the Termination Date.

 

4.2.4.       Termination Without Cause or for Good Reason – In Connection with a Change of Control. If, during the Term of Employment, the Executive’s employment is terminated by the Company without Cause (and not due to death or Disability) or by Executive for Good Reason, in either case, (A) upon or within 24 months following a Change of Control or (B) within 60 days prior to such Change of Control, then the Executive shall be entitled to receive the Accrued Benefits and, subject to Section 4.2.5: (i) the Unpaid Prior Year Bonus, with such amount to be payable in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred; (ii) a lump sum payment equal to two times the sum of Executive’s Base Salary (at the highest rate in effect during the 24 month period commencing on the date of such Change of Control) and the higher of Executive’s target Annual Bonus opportunity and the Annual Bonus paid to Executive with respect to the fiscal year immediately preceding the fiscal year in which such termination occurred, with such payment to be paid in cash on the first payroll date after the effective date of the release (as described in Section 4.2.5) and in all events no later than 70 days after such termination and (iii) a payment equal to 24 times the monthly COBRA premium for Executive and his eligible dependents (at the rate in effect for Executive’s coverage at the time of his termination, regardless of whether Executive elects COBRA coverage), with two-thirds of such payment to be paid in cash on the first payroll date after the effective date of the release (as described in Section 4.2.5) and in all events no later than 70 days after such termination, and with the remaining one-third to be paid according to the same schedule as the COBRA Benefit is provided in clause (iii) of Section 4.2.3 (i.e., in installments over 12 months following the Termination Date). Notwithstanding the foregoing, in the event that a termination described in clause (B) of this Section 4.2.4 occurs, then the payments described in clauses (ii) and (iii) of this Section 4.2.4 shall be paid over the same 12-month period and in the same manner as set forth in clauses (iii) and (iv) of Section 4.2.3, respectively, rather than being paid in a lump sum. In addition, if (and only if), during the Term of Employment, the Executive’s employment is terminated by the Company without Cause (and not due to death or Disability) or by Executive for Good Reason, in either case, upon or within 24 months following a Change of Control, then, to the extent the following will not result in a violation of Section 409A, the Executive shall be entitled to, in addition to the Accrued Benefits and the payments set forth in the foregoing clauses (i) through (iii), and subject to Section 4.2.5, immediate and full accelerated vesting of all equity awards received by Executive from the Company or any of its direct or indirect parent companies that are outstanding as of the Termination Date without regard for the vesting schedule set forth in any applicable plan or agreement governing such equity awards; provided that, any equity awards that are subject to the satisfaction of performance goals shall be deemed earned at not less than target performance; and provided, further, that, with respect to any equity award that is in the form of a stock option or stock appreciation right, the option or stock appreciation right shall remain outstanding and exercisable for 24 months following the Termination Date (but in no event beyond the expiration date of the applicable option or stock appreciation right). All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in this Section 4.2.4, shall immediately terminate upon the Termination Date.

 

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4.2.5.       Release Requirement. Payment and provision of the benefits set forth in Sections 4.2.2, 4.2.3, or 4.2.4 (other than the Accrued Benefits) is subject to the Executive’s (or, as applicable, the Executive’s estate’s or legal representative’s) execution of a general release of claims and covenant not to sue in form and substance satisfactory to the Company, such that such release becomes effective, with all revocation periods having expired unexercised, within sixty (60) days after the Termination Date. Notwithstanding the foregoing, if such sixty (60) day period ends in a calendar year after the calendar year in which the Executive’s employment terminates, then to the extent required by Section 409A, any severance payment set forth in Sections 4.2.2, 4.2.3, or 4.2.4 (other than the Accrued Benefits) that would have been made during the calendar year in which the Executive’s employment terminates instead shall be withheld and paid on the first payroll date in the calendar year after the calendar year in which the Executive’s employment terminates, with all remaining payments to be made as if no such delay had occurred.

 

4.3.       Violation of Restrictive Covenants. Without limiting the remedies provided to the Company and its Affiliates as set forth in this Article 4, upon the Executive’s breach of any of the Restrictive Covenants (as defined below), other than any immaterial and unintentional breach by the Executive of the confidentiality obligations set forth in Section 4.11, the Company will have no obligation to continue to pay or provide any of the compensation or benefits under Section 4.2 (other than the Accrued Benefits) and the Executive shall repay to the Company any amounts paid under Section 4.2 (other than the Accrued Benefits) after such breach occurred.

 

4.4.       Restrictive Covenants. As an inducement and as essential consideration for the Company to enter into this Agreement, and in exchange for other good and valuable consideration, the Executive hereby agrees to the restrictive covenants contained in Sections 4.5 through 4.17 (the “Restrictive Covenants”). The Company and the Executive agree that the Restrictive Covenants are essential and narrowly tailored to preserve the goodwill of the business of the Company and its Affiliates, to maintain the confidential and trade secret information of the Company and its Affiliates, and to protect other legitimate business interests of the Company and its Affiliates, and that the Company would not have entered into this Agreement without the Executive’s agreement to the Restrictive Covenants. For purposes of the Restrictive Covenants, each reference to “Company,” “Company Group” and “Affiliate,” shall also refer to the predecessors and successors of the Company, the members of the Company Group and any of their Affiliates (as the case may be).

 

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4.5.       Non-Competition. During the period commencing on the Effective Date and ending twenty four (24) months after the Termination Date (the “Restrictive Period”), regardless of the reason for Executive’s termination of employment, the Executive shall not, in any state of the United States or European Union where the Company conducts business as of the Termination Date, engage in, or own, manage, operate or control, or participate in the ownership, management, operation or control of any business or entity that develops, sells or provides products or services competitive with the products or services developed, sold or provided by any member of the Company Group at the time of cessation of the employment of Executive. Notwithstanding the foregoing, nothing in this Section 4.5 shall prevent the Executive from owning, as a passive investor, up to five percent (5%) of the securities of any entity that are publicly traded on a national securities exchange. For the avoidance of doubt, nothing in this Section 4.5 prevents the Executive from working in the pharmaceutical industry as long as such positions and activities are not competitive with the business of the Company Group. As used in this Section 4.5, “competitive” shall mean products or services using the same mechanism of action or for the treatment of the same (or substantially similar) indication. Executive agrees that this covenant is reasonable with respect to its duration, geographical area, and scope.

 

4.6.       Customer Non-Solicitation. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Executive’s employment with the Company), for purposes of providing products or services that are competitive with those provided by any member of the Company Group, on the Executive’s own behalf or on behalf of any other Person, solicit any customer or client of any member of the Company Group with whom the Executive had contact, solicited, or served within the twelve (12) months prior to the Termination Date.

 

4.7.       Customer Non-Acceptance. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Executive’s employment with the Company), for purposes of providing products or services that are competitive with those provided by any member of the Company Group, on the Executive’s own behalf or on behalf of any other Person, accept business from any customer or client of any member of the Company Group with whom the Executive had contact, solicited, or served within the twelve (12) months prior to the Termination Date.

 

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4.8.       Employee and Independent Contractor Non-Solicitation. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Term of Employment), on the Executive’s own behalf or on behalf of any other Person, solicit for employment or engagement any individual who: (A) is employed by, or an independent contractor of, any member of the Company Group at the time of such solicitation or (B) was employed by, or an independent contractor of, any member of the Company Group within twelve (12) months prior to such solicitation.

 

4.9.       Employee and Independent Contractor Non-Acceptance. During the period commencing on the Effective Date and ending twenty four (24) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Term of Employment), on the Executive’s own behalf or on behalf of any other Person, employ or engage any individual who (A) is employed by, or an independent contractor of, any member of the Company Group at the time of such employment or engagement or (B) was employed by, or an independent contractor of, any member of the Company Group within twelve (12) months prior to such employment or engagement.

 

4.10.       Non-Disparagement. During the Term of Employment and at all times thereafter, neither the Company nor the Executive shall not, directly or through any other Person make any public or private statements (whether orally, in writing, via electronic transmission, or otherwise) that disparage, denigrate or malign the other party or any of the Company’s respective businesses, products, services, activities, operations, affairs, reputations or prospects; or any of the Company’s respective officers, employees, directors, partners (general and limited), agents, members or shareholders. For purposes of clarification, and not limitation, a statement shall be deemed to disparage, denigrate or malign the other party if such statement could be reasonably construed to adversely affect the opinion any other Person may have or form of such first Person. The foregoing limitations shall not be violated by truthful statements made by the Executive or the Company: (i) to any governmental authority or (ii) which are in response to legal process, required governmental testimony or filings, or administrative or arbitral proceedings (including, without limitation, depositions in connection with such proceedings).

 

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4.11.       Confidentiality; Return of Property. During the Term of Employment and for a period of seven (7) years thereafter, the Executive shall not, without the prior express written consent of the Company, directly or indirectly, use on the Executive’s behalf or on behalf of any other Person, or divulge, disclose or make available or accessible to any Person, any Confidential Information, other than when required to do so in good faith to perform the Executive’s duties and responsibilities hereunder while employed by any member of the Company Group, when required to do so by a lawful order of a court of competent jurisdiction, any governmental authority or agency, or any recognized subpoena power, or in connection with reporting possible violations of federal law or regulation to any governmental agency or entity, or making other disclosures that are protected under the whistleblower provisions of federal law or regulation. In the event that the Executive becomes legally compelled (by oral questions, interrogatories, request for information or documents, subpoena, criminal or civil investigative demand or similar process) to disclose any Confidential Information, then prior to such disclosure, the Executive will provide the Board with prompt written notice so that the Company may seek (with the Executive’s cooperation) a protective order or other appropriate remedy and/or waive compliance with the provisions of this Agreement. In the event that such protective order or other remedy is not obtained, then the Executive will furnish only that portion of the Confidential Information which is legally required, and will cooperate with the Company in the Company’s efforts to obtain reliable assurance that confidential treatment will be accorded to the Confidential Information. In addition, the Executive shall not create any derivative work or other product based on or resulting from any Confidential Information (except in the good faith performance of the Executive’s duties under this Agreement while employed by any member of the Company Group). The Executive shall also proffer to the Board’s designee, no later than the Termination Date (or upon the earlier request of the Company), and without retaining any copies, notes or excerpts thereof, all property of the Company and its Affiliates, including, without limitation, memoranda, computer disks or other media, computer programs, diaries, notes, records, data, customer or client lists, marketing plans and strategies, and any other documents consisting of or containing Confidential Information, that are in the Executive’s actual or constructive possession or which are subject to the Executive’s control at such time. To the extent the Executive has retained any such property or Confidential Information on any electronic or computer equipment belonging to the Executive or under the Executive’s control, the Executive agrees to so advise Company and to follow Company’s instructions in permanently deleting all such property or Confidential Information and all copies. Notwithstanding the foregoing, in accordance with the Defend Trade Secrets Act of 2016, the Executive shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that: (a) is made (I) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and (II) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.

 

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4.12.       Ownership of Inventions. The Executive acknowledges and agrees that all Company Inventions (including all intellectual property rights arising therein or thereto, all rights of priority relating to patents, and all claims for past, present and future infringement, misappropriation relating thereto), and all Confidential Information, hereby are and shall be the sole and exclusive property of the Company (collectively, the “Company IP”). The Executive further acknowledges and agrees that any rights arising in the Executive in any Invention Invented by the Executive, whether alone or jointly with others, during the twelve (12) months following the Termination Date and relating in any way to work performed by the Executive for any member of the Company Group during the Executive’s employment with or service for any member of the Company Group (“Post-employment Inventions”), shall hereby be deemed to be Company Inventions and the sole and exclusive property of the Company; provided, however, that the Board (excluding the Executive) in its sole discretion may elect to compensate the Executive for any Post-employment Inventions. For consideration acknowledged and received, the Executive hereby irrevocably assigns, conveys and sets over to the Company all of the Executive’s right, title and interest in and to all Company IP. The Executive acknowledges and agrees that the compensation received by the Executive for employment or services provided to the Company is adequate consideration for the foregoing assignment. The Executive further agrees to disclose in writing to the Board any Company Inventions (including, without limitation, all Post-employment Inventions), promptly following their conception or reduction to practice. Such disclosure shall be sufficiently complete in technical detail and appropriately illustrated by sketch or diagram to convey to one skilled in the art of which the Company Invention pertains, a clear understanding of the nature, purpose, operations, and other characteristics of the Company Invention. The Executive agrees to execute and deliver such deeds of assignment or other documents of conveyance and transfer as the Company may request to confirm in the Company or its designee the ownership of the Company Inventions, without compensation beyond that provided in this Agreement. The Executive further agrees, upon the request of the Company and at its expense, that the Executive will execute any other instrument and document necessary or desirable in applying for and obtaining patents in the United States and in any foreign country with respect to any Company Invention. The Executive further agrees, whether or not the Executive is then an employee or other service provider of any member of the Company Group, upon request of the Company, to provide reasonable assistance, at the Company’s sole expense, with respect to the perfection, recordation or other documentation of the assignment of Company IP hereunder, and the enforcement of the Company’s rights in any Company IP, and to cooperate to the extent and in the manner reasonably requested by the Company, subject to the Executive’s then schedule, in any litigation or other claim or proceeding (including, without limitation, the prosecution or defense of any claim involving a patent) involving any Company IP covered by this Agreement, with compensation at the Executive’s customary hourly rate, together with all reasonable out-of-pocket expenses incurred by the Executive in satisfying the requirements of this Section 4.12 shall be paid by the Company or its designee. The Executive shall not, on or after the date of this Agreement, directly or indirectly challenge the validity or enforceability of the Company’s ownership of, or rights with respect to, any Company IP, including, without limitation, any patent issued on, or patent application filed in respect of, any Company Invention.

 

4.13.       Works for Hire. The Executive also acknowledges and agrees that all works of authorship, in any format or medium, and whether published or unpublished, created wholly or in part by the Executive, whether alone or jointly with others: (i) in the course of, in connection with, or as a result of the Executive’s employment or other service with any member of the Company Group (whether before or after the Effective Date), (ii) at the direction or request of any member of the Company Group, or (iii) through the use of, or that is related to, facilities, equipment, Confidential Information, other Company Inventions, intellectual property or other resources of any member of the Company Group, whether or not during the Executive’s work hours (“Works”), are works made for hire as defined under United States copyright law, and that the Works (and all copyrights arising in the Works) are owned exclusively by the Company and all rights therein will automatically vest in the Company without the need for any further action by any party. To the extent any such Works are not deemed to be works made for hire, for consideration acknowledged and received, the Executive hereby waives any “moral rights” in such Works and the Executive hereby irrevocably assigns, transfers, conveys and sets over to the Company or its designee, without compensation beyond that provided in this Agreement, all right, title and interest in and to such Works, including without limitation all rights of copyright arising therein or thereto, and further agrees to execute such assignments or other deeds of conveyance and transfer as the Company may request to vest in the Company or its designee all right, title and interest in and to such Works, including all rights of copyright arising in or related to the Works.

 

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4.14.       Cooperation. During and after the Term of Employment, the Executive agrees to cooperate with the Company Group in any internal investigation, any administrative, regulatory, or judicial proceeding or any dispute with a third party concerning issues about which the Executive has knowledge or that may relate to the Executive or the Executive’s employment with the Company. The Executive’s obligation to cooperate hereunder includes, without limitation, being available to the Company Group upon reasonable notice for interviews and factual investigations, appearing in any forum at the Company Group’s request to give testimony (without requiring service of a subpoena or other legal process), volunteering to the Company Group pertinent information, and turning over to the Company Group all relevant documents which are or may come into the Executive’s possession. The Company shall promptly compensate the Executive at his usual and customary hourly rate, plus reimburse the Executive for the reasonable out of pocket expenses incurred by the Executive in connection with such cooperation.

 

4.15.       Injunctive Relief. The Executive acknowledges and agrees that the Company and its Affiliates will have no adequate remedy at law and would be irreparably harmed if the Executive breaches or threatens to breach any of the Restrictive Covenants. The Executive agrees that the Company and its Affiliates shall be entitled to equitable and/or injunctive relief to prevent any breach or threatened breach of any of the Restrictive Covenants, and to specific performance of each of the terms thereof, in each case, in addition to any other legal or equitable remedies that the Company and its Affiliates may have, as well as the costs and reasonable attorneys’ fees it/they incur in enforcing any of the Restrictive Covenants. The Executive further agrees that: (i) any breach or claimed breach of the provisions set forth in this Agreement by, or any other claim the Executive may have against, the Company or any of its Affiliates will not be a defense to enforcement of any Restrictive Covenant and (ii) the circumstances of the Executive’s termination of employment with the Company will have no impact on the Executive’s obligations to comply with any Restrictive Covenant. The Restrictive Covenants are intended for the benefit of the Company and each of its Affiliates. Each Affiliate of the Company is an intended third party beneficiary of the Restrictive Covenants, and each Affiliate of the Company, as well as any successor or assign of the Company or such Affiliate, may enforce the Restrictive Covenants. The Executive further agrees that the Restrictive Covenants are in addition to, and not in lieu of, any non-competition, non-solicitation, protection of confidential information or intellectual property, or other similar covenants in favor of the Company or any of its Affiliates by which the Executive may be bound.

 

4.16.       Tolling During Periods of Breach. The parties hereto agree and intend that the Restrictive Covenants (to the extent not perpetual) be tolled during any period that the Executive is in breach of any such Restrictive Covenant, with such tolling to cease with respect to a Restrictive Covenant once the Executive is in compliance with such Restrictive Covenant, so that the Company and its Affiliates are provided with the full benefit of the restrictive periods set forth herein.

 

4.17.       Notification of New Employer. In the event that the Executive is employed or otherwise engaged by any other Person following the Termination Date and during the Restrictive Period, the Executive agrees to notify, and consents to the notification by Company and its Affiliates of, such Person of the Restrictive Covenants.

 

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5.       Miscellaneous.

 

5.1.       Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Virginia, applied without reference to principles of conflicts of law.

 

5.2.       Mediation. Any controversy, dispute or claim arising out of or relating to this Agreement, Executive’s employment or service with any member of the Company Group or the termination thereof shall, if not settled by direct negotiation between the parties, be subject to non-binding mediation under the Employment Arbitration Rules and Mediation Procedures of the American Arbitration Association (“AAA”) as in effect on the date of the notice of demand for mediation. Any demand for mediation by either party shall be made in writing and served upon the other party and shall set forth with reasonable specificity the basis of the dispute and the relief sought. Any mediation hereunder shall be conducted before an independent mediator mutually selected by the parties. If the parties are unable to agree to a mediator within ten (10) days after the receipt of a demand for mediation by either party, the mediator will be chosen by alternatively striking from a list of five mediators obtained by the Company from AAA, and the Executive shall have the first strike. The mediation hearing will occur at a time and place convenient to the parties in the Commonwealth of Virginia. Notwithstanding the foregoing, any claims under Section 4.15 are exempt from this Section 5.2 and may be brought in any court of competent jurisdiction without mediation.

 

5.3.       Venue; WAIVER OF JURY TRIAL. In the event that any controversy, dispute or claim arising out of or relating to this Agreement, Executive’s employment or service with any member of the Company Group or the termination thereof is not settled through mediation pursuant to Section 5.2, both the Executive and the Company agree to appear before and submit exclusively to the jurisdiction of the federal courts located in Charlottesville, Virginia with respect to such controversy, dispute or claim (or if such controversy, dispute or claim may not be brought in federal court, the state courts located in Charlottesville, Virginia). Both the Executive and the Company also agree to waive, to the fullest possible extent, the defense of an inconvenient forum or lack of jurisdiction. THE COMPANY AND THE EXECUTIVE HEREBY WAIVE, TO THE EXTENT PERMITTED BY APPLICABLE LAW, TRIAL BY JURY IN ANY LITIGATION IN ANY COURT WITH RESPECT TO, IN CONNECTION WITH, OR ARISING OUT OF THE EXECUTIVE’S EMPLOYMENT BY, OR SERVICE WITH, ANY MEMBER OF THE COMPANY GROUP OR THE TERMINATION THEREOF, OR THIS AGREEMENT OR THE VALIDITY, PROTECTION, INTERPRETATION, COLLECTION OR ENFORCEMENT THEREOF (WHETHER ARISING IN CONTRACT, EQUITY, TORT OR OTHERWISE).

 

5.4.       Amendments. This Agreement may not be amended or modified otherwise than by a written agreement executed by the parties hereto or their respective successors and legal representatives.

 

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5.5.       Notices. All notices and other communications hereunder shall be in writing, and shall be given by hand-delivery to the other party, by reputable overnight courier, or by registered or certified mail, return receipt requested, postage prepaid, addressed as follows:

 

  To the Company:

Adial Pharmaceuticals, Inc.

2246 Ivy Road

Charlottesville, VA 22903

Attention: Kermit Anderson, James Newman

     
  With a copy (which copy shall not constitute notice) to:

Gracin Marlow, LLP

Chrysler Building

405 Lexington Avenue

26th Floor

New York, New York 10174

Attention: Leslie Marlow

     
  To the Executive: at the residence address most recently filed with the Company;

 

or to such other address as any party shall have furnished to the other in writing in accordance herewith. All such notices shall be deemed to have been duly given: (i) when delivered personally to the recipient, (ii) one (1) business day after being sent to the recipient by reputable overnight courier service (charges prepaid); or (iii) four (4) business days after being mailed to the recipient by certified or registered mail, return receipt requested and postage prepaid.

 

5.6.       Indemnification. The Parties agree to enter the Indemnification Agreement attached at Exhibit B hereto.

 

5.7.       Withholding. The Company may withhold from any amounts payable under this Agreement such federal, state or local income taxes as are required to be withheld pursuant to any applicable law or regulation.

 

5.8.       Code Section 409A Compliance.

 

5.8.1.       The provisions of this Agreement are intended to comply with Section 409A of the Code and any final regulations and guidance promulgated thereunder (“Section 409A”) or an exemption thereunder and shall be construed in a manner consistent with the requirements for avoiding taxes or penalties under Section 409A. The Company and Executive agree to work together in good faith to consider amendments to this Agreement and to take such reasonable actions which are necessary, appropriate or desirable to avoid imposition of any additional tax or income recognition prior to actual payment or provision of benefit to Executive under Section 409A.

 

5.8.2.       To the extent that Executive will be reimbursed for costs and expenses or in-kind benefits, except as otherwise permitted by Section 409A, (a) the right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit, (b) the amount of expenses eligible for reimbursement, or in-kind benefits, provided during any taxable year shall not affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year; provided that the foregoing clause (b) shall not be violated with regard to expenses reimbursed under any arrangement covered by Section 105(b) of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect and (c) such payments shall be made on or before the last day of the taxable year following the taxable year in which Executive incurred the expense.

 

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5.8.3.       A termination of employment shall not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits upon or following a termination of employment unless such termination constitutes a “Separation from Service” within the meaning of Section 409A and, for purposes of any such provision of this Agreement references to a “termination,” “termination of employment” or like terms shall mean Separation from Service.

 

5.8.4.       Any payments under this Agreement that may be excluded from Section 409A either as separation pay due to an involuntary separation from service or as a short-term deferral shall be excluded from Section 409A to the maximum extent possible. Each installment payable hereunder shall constitute a separate payment for purposes of Treasury Regulation Section 1.409A-2(b), including Treasury Regulation Section 1.409A-2(b)(2)(iii). Each payment that is made within the terms of the “short-term deferral” rule set forth in Treasury Regulation Section 1.409A-1(b)(4) is intended to meet the “short-term deferral” rule. Each other payment is intended to be a payment upon an involuntary termination from service and payable pursuant to Treasury Regulation Section 1.409A-1(b)(9)(iii), et. seq., to the maximum extent permitted by that regulation, with any amount that is not exempt from Section 409A being subject to Section 409A.

 

5.8.5.       Notwithstanding anything to the contrary in this Agreement, if Executive is a “specified employee” within the meaning of Section 409A at the time of Executive’s termination, then only that portion of the severance and benefits payable to Executive pursuant to this Agreement, if any, and any other severance payments or separation benefits which may be considered deferred compensation under Section 409A that is payable on account of the Executive’s termination (other than by reason of death) (together, the “Deferred Compensation Separation Benefits”) that are due to Executive on or within the six (6) month period following Executive’s termination will accrue during such six (6) month period and will become payable in one lump sum cash payment on the date that is six (6) months and one (1) day following the date of Executive’s termination of employment. All subsequent Deferred Compensation Separation Benefits, if any, will be payable in accordance with the payment schedule applicable to each payment or benefit. Notwithstanding anything herein to the contrary, if Executive dies following termination but prior to the six (6) month anniversary of Executive’s termination date, then any payments delayed in accordance with this paragraph will be payable in a lump sum as soon as administratively practicable after the date of Executive’s death (but not earlier than such payment would have been made absent such death) and all other Deferred Compensation Separation Benefits will be payable in accordance with the payment schedule applicable to each payment or benefit.

 

5.8.6.       Notwithstanding anything herein to the contrary, neither the Company nor any of its Affiliates shall have any liability to the Executive or to any other Person if the payments and benefits provided in this Agreement that are intended to be exempt from or compliant with Section 409A are not so exempt or compliant.

 

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5.9.       Excess Parachute Payments under Code Section 280G. Notwithstanding any other provisions of this Agreement, if any “payments” (including, without limitation, any benefits or transfers of property or the acceleration of the vesting of any benefits) in the nature of compensation under any arrangement that is considered contingent on a Change of Control for purposes of Section 280G of the Code, together with any other payments that the Executive has the right to receive from the Company or any corporation that is a member of an “affiliated group” (as defined in Section 1504(a) of the Code without regard to Section 1504(b) of the Code) of which the Company is a member or from any other Person, would constitute a “parachute payment” (as defined in Section 280G(b)(2) of the Code), such “payments” may, at the Executive’s sole election, be reduced to the largest amount that will result in no portion of such “payments” being subject to the excise tax imposed by Section 4999 of the Code. Any such reduction in “payments” shall be applied first against the latest scheduled cash payments; then current cash payments; then any equity or equity derivatives that are included under Section 280G of the Code at full value rather than accelerated value (with the highest value reduced first); then any equity or equity derivatives included under Section 280G of the Code at an accelerated value (and not at full value), with the highest value reduced first (as such values are determined under Treasury Regulation Section 1.280G-1, Q&A 24); and finally any other non-cash benefits will be reduced (in the order of latest scheduled payments to earliest scheduled payments). All calculations hereunder shall be performed by a nationally recognized independent accounting firm selected by the Company, with the full cost of such firm being borne by the Company. Any determinations made by such firm shall be final and binding on the Executive and the Company.

 

5.10.       Severability. The terms and provisions of this Agreement are intended to be separate and divisible provisions and if, for any reason, any one or more of them is held to be invalid or unenforceable, neither the validity nor the enforceability of any other provision of this Agreement shall thereby be affected. It is the intention of the parties to this Agreement that the Restrictive Covenants be reasonable in duration, geographic scope and in all other respects. The Executive agrees that the Restrictive Covenants, including, without limitation, the duration, geographic scope and activity restrictions of each restriction, are reasonable in light of the Executive’s senior position. However, if for any reason any court of competent jurisdiction shall find any provisions of the Restrictive Covenants unreasonable in duration or geographic scope or otherwise, it is the intention of the parties that the restrictions and prohibitions contained therein shall be modified by the court to be effective to the fullest extent allowed under applicable law in such jurisdiction.

 

5.11.       Captions. The captions of this Agreement are not part of the provisions hereof and shall have no force or effect.

 

5.12.       Counterparts. This Agreement may be executed in counterparts and delivered by facsimile transmission or electronic transmission in “portable document format,” each of which shall be an original and which taken together shall constitute one and the same document.

 

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5.13.       Entire Agreement. This Agreement contains the entire agreement concerning the subject matter hereof and supersedes all prior agreements, understandings, discussions, negotiations and undertakings, whether written or oral, between the parties and their Affiliates relating to such subject matter, including, but not limited to, that certain Employment Agreement, between the parties, dated December 6, 2010 and that certain Salary Forbearance Agreement between the parties, dated August 17, 2016, which are superseded in their entirety by this Agreement, including, but not limited to, that certain Employment Agreement, between the parties, dated December 6, 2010 and any future payment obligations under that certain Salary Forbearance Agreement between the parties, dated August 17, 2016, which are superseded in their entirety by this Agreement. For clarity and, in any case, notwithstanding the foregoing, Executive’s participation in the Company’s Performance Bonus Plan approved on February 17, 2015, as amended on January 25, 2016, shall be unchanged by this Agreement and any provisions of the Salary Forbearance Agreement not relating any future payment obligations to Executive, including, but not limited to, the releases and salary forgiveness set forth therein, shall remain in full force and effect.

 

5.14.       Survivorship. The provisions of Article 1, Article 5, Section 2.1 and Sections 4.4 through 4.17 shall survive the termination of the Executive’s employment with the Company and this Agreement in accordance with their terms.

 

5.15.       Successors and Assigns. The Company may assign, without the Executive’s consent, its rights and/or delegate its obligations under this Agreement to any successor of the Company, whether by operation of law, agreement or otherwise (including, without limitation, any Person who acquires all or a substantial portion of the business of the Company Group (whether direct or indirect and whether structured as a stock sale, asset sale, merger, recapitalization, consolidation or other transaction)) and, in connection with any such delegation of its obligations hereunder (but only so long as such assignee or delegee has consented in writing to be bound by the obligations hereunder) shall be released from such obligations hereunder. This Agreement may not be assigned by the Executive. Except as otherwise provided herein, this Agreement shall bind and inure to the benefit of and be enforceable by the Executive, the Company and their respective successors and permitted assigns.

 

[signatures to follow on next page]

 

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IN WITNESS WHEREOF, the Executive has hereunto set the Executive’s hand and the Company has caused this Agreement to be executed in its name on its behalf, all as of the day and year first above written.

 

ADIAL PHARMACEUTICALS, INC.   EXECUTIVE:
       
By:      
  Joseph Truluck, COO and CFO   William B. Stilley

 

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Exhibit A

Board and Advisory Positions

 

1.Board Member, Soccer Association of the Charlottesville Area
2.Board Member, Wooglin Company [the Beta Theta Pi fraternity housing/alumni organization]
3.Advisor, Adenosine Therapeutics, LLC
4.Advisor, Diffusion Pharmaceuticals, Inc.
5.Advisor, Contraline, Inc.
6.Advisor, Lewis & Clark Pharmaceuticals, Inc.

 

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Exhibit B

Indemnification Agreement

 

[See attached]

 

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INDEMNIFICATION AGREEMENT

 

This Indemnification Agreement (the “Agreement”) is made and entered into this ___ day of ________, 2017, by and between Adial Pharmaceuticals Inc., a Delaware corporation (the “Company”, which term shall include, where appropriate, any Entity (as hereinafter defined) controlled directly or indirectly by the Company), and __________ (the “Indemnitee”).

 

WHEREAS, it is essential to the Company that it be able to retain and attract as directors and officers the most capable persons available;

 

WHEREAS, increased corporate litigation has subjected directors and officers to litigation risks and expenses, and the limitations on the availability of directors and officers liability insurance have made it increasingly difficult for the Company to attract and retain such persons;

 

WHEREAS, the Company’s Certificate of Incorporation, as amended, and Bylaws (the “Certificate” and the “Bylaws”, respectively), provide that the Company is authorized to indemnify its directors and officers to the fullest extent permissible by applicable law and permit it to make other indemnification arrangements and agreements;

 

WHEREAS, the Company desires to provide Indemnitee with specific contractual assurance of Indemnitee’s rights to full indemnification against litigation risks and expenses (regardless, among other things, of any amendment to or revocation of the Certificate or Bylaws or any change in the ownership of the Company or the composition of its board of directors (the “Board of Directors”));

 

WHEREAS, the Company intends that this Agreement provide Indemnitee with greater protection than that which is provided by the Certificate and Bylaws; and

 

WHEREAS, Indemnitee is relying upon the rights afforded under this Agreement in becoming or continuing as a director and/or officer of the Company.

 

NOW, THEREFORE, in consideration of the promises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree as follows:

 

1.Definitions.

 

(a)       “Corporate Status” describes the status of a person who is serving or has served (i) as a director and/or officer of the Company, (ii) in any capacity with respect to any employee benefit plan of the Company or (at the request of the Company) any employee benefit plan of any other Entity, or (iii) as a director and/or officer of any other Entity at the request of the Company. For purposes of subsections (ii) and (iii) of this Section 1(a), if Indemnitee is serving or has served as a director and/or officer of a Subsidiary (as defined below), or in any capacity with respect to any employee benefit plan of a Subsidiary, Indemnitee shall be deemed to be serving at the request of the Company. If Indemnitee is an employee of the Company, Corporate Status shall not include actions taken by Indemnitee in any capacity other than as a director and/or officer or as a representative of any employee benefit plan.

 

(b)       “Entity” shall mean any corporation, partnership, limited liability company, joint venture, trust, foundation, association, organization or other legal entity.

 

(c)       “Expenses” shall mean all fees, costs and expenses incurred by Indemnitee in connection with any Proceeding (as defined below), including, without limitation, reasonable attorneys’ fees, disbursements and retainers (including, without limitation, any such fees, disbursements and retainers incurred by Indemnitee pursuant to Sections 11 and 12(c) of this Agreement), fees and disbursements of expert witnesses, private investigators and professional advisors (including, without limitation, accountants and investment bankers), court costs, transcript costs, fees of experts, travel expenses, duplicating, printing and binding costs, telephone and fax transmission charges, postage, delivery services, secretarial services and other disbursements and expenses.

 

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(d)       “Indemnifiable Expenses”, “Indemnifiable Liabilities” and “Indemnifiable Amounts” shall have the meanings ascribed to those terms in Section 3(a) below.

 

(e)       “Liabilities” shall mean judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement.

 

(f)       “Proceeding” shall mean any threatened, pending or completed claim, action, suit, arbitration, alternate dispute resolution process, investigation, administrative hearing, appeal or any other proceeding, whether civil, criminal, administrative, arbitrative or investigative, whether formal or informal, including a proceeding initiated by Indemnitee pursuant to Section 11 of this Agreement to enforce Indemnitee’s rights hereunder.

 

(g)       “Subsidiary” shall mean any corporation, partnership, limited liability company, joint venture, trust or other Entity of which the Company owns (either directly or through or together with another Subsidiary of the Company) either (i) a general partner, managing member or other similar interest or (ii) (A) 50% or more of the voting power of the voting capital equity interests of such corporation, partnership, limited liability company, joint venture or other Entity or (B) 50% or more of the outstanding voting capital stock or other voting equity interests of such corporation, partnership, limited liability company, joint venture or other Entity.

 

(h)       “to the fullest extent permissible by applicable law” shall include, but not be limited to: (i) the fullest extent permitted by the provisions of the General Corporation Law of the State of Delaware (the “DGCL”) that authorize or contemplate additional or supplementary indemnification by agreement, or the corresponding provisions of any amendment to or replacement of the DGCL or such provisions thereof; and (ii) the fullest extent authorized or permitted by any amendments to or replacements of the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its directors and/or officers.

 

2.       Services of Indemnitee. In consideration of the Company’s covenants and commitments hereunder, Indemnitee agrees to serve or continue to serve as a director and/or officer of the Company. However, this Agreement shall not impose any obligation on Indemnitee or the Company to continue Indemnitee’s service to the Company beyond any period otherwise required by law or by other agreements or commitments of the parties, if any.

 

3.       Agreement to Indemnify. The Company agrees to hold harmless and indemnify Indemnitee to the fullest extent permissible by applicable law as follows:

 

(a)       Proceedings. Subject to the exceptions contained in Section 4(a) below, if Indemnitee was or is a party or is threatened to be made a party to any Proceeding by reason of Indemnitee’s Corporate Status, Indemnitee shall be indemnified by the Company against all Expenses and Liabilities actually and reasonably incurred or paid by Indemnitee in connection with such Proceeding (referred to herein as “Indemnifiable Expenses “and “Indemnifiable Liabilities”, respectively, and collectively as “Indemnifiable Amounts”).

 

(b)       Conclusive Presumption Regarding Standard of Care. In making any determination required to be made under Delaware law with respect to entitlement to indemnification hereunder, the person, persons or entity making such determination shall presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee submitted a request therefor in accordance with Section 5 of this Agreement, and the Company shall have the burden of proof to overcome that presumption in connection with the making by any person, persons or Entity of any determination contrary to that presumption.

 

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4.       Exceptions to Indemnification. Subject to Section 20 below, Indemnitee shall be entitled to indemnification under Section 3(a) above in all circumstances and with respect to each and every specific claim, issue or matter involved in the Proceeding out of which Indemnitee’s claim for indemnification has arisen to the fullest extent permissible by applicable law, except as follows:

 

(a)       Proceedings. If indemnification is requested under Section 3(a) and it has been finally adjudicated by a court of competent jurisdiction that, in connection with such specific claim, issue or matter, Indemnitee failed to act (i) in good faith and (ii) in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, or, with respect to any criminal Proceeding, Indemnitee had reasonable cause to believe that Indemnitee’s conduct was unlawful, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder to the extent that they arise out of such claim, issue or matter.

 

(b)       Insurance Proceeds. To the extent payment is actually made to the Indemnitee under a valid and collectible insurance policy maintained at the expense of the Company in respect of Indemnifiable Amounts in connection with such specific claim, issue or matter, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder except in respect of any excess of such Indemnifiable Amounts beyond the amount of payment under such insurance.

 

5.       Procedure for Payment of Indemnifiable Amounts. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Amounts for which Indemnitee seeks payment under Section 3 of this Agreement and the basis for the claim. The Company shall pay such Indemnifiable Amounts to Indemnitee promptly, but in no event later than thirty (30) calendar days after receipt of such request. At the request of the Company, Indemnitee shall furnish such documentation and information as are reasonably available to Indemnitee and necessary to establish that Indemnitee is entitled to indemnification hereunder.

 

6.       Indemnification for Expenses of a Party Who is Wholly or Partly Successful. Notwithstanding any other provision of this Agreement, and without limiting any such provision, to the extent that Indemnitee is, by reason of Indemnitee’s Corporate Status, a party to and is successful, on the merits or otherwise, in any Proceeding, Indemnitee shall be indemnified to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify to the fullest extent permissible by applicable law Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with each successfully resolved claim, issue or matter. For purposes of this Agreement, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, by reason of settlement, judgment, order or otherwise, shall be deemed to be a successful result as to such claim, issue or matter.

 

7.       Effect of Certain Resolutions. Neither the settlement nor termination of any Proceeding nor the failure of the Company to award indemnification or to determine that indemnification is payable shall create a presumption that Indemnitee is not entitled to indemnification hereunder. In addition, the termination of any Proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent shall not create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, had reasonable cause to believe that Indemnitee’s action was unlawful.

 

8.       Agreement to Advance Expenses; Undertaking. The Company shall advance to the fullest extent permissible by applicable law all Expenses actually and reasonably incurred by or on behalf of Indemnitee in connection with any Proceeding in which Indemnitee is involved by reason of such Indemnitee’s Corporate Status within thirty (30) calendar days after the receipt by the Company of a written statement from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Advances shall be unsecured and interest free. Advances shall be made without regard to Indemnitee’s ability to repay the expenses and without regard to Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement. To the extent required by Delaware law, Indemnitee hereby undertakes to repay any and all of the amount of Indemnifiable Expenses paid to Indemnitee if it is finally determined by a court of competent jurisdiction that Indemnitee is not entitled under this Agreement to indemnification with respect to such Expenses. This undertaking is an unlimited general obligation of Indemnitee.

 

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9.       Procedure for Advance Payment of Expenses. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Expenses for which Indemnitee seeks an advancement under Section 8 of this Agreement, together with documentation evidencing that Indemnitee has incurred such Indemnifiable Expenses.

 

10.       Indemnification for Expenses of a Witness. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his or her Corporate Status, a witness in any Proceeding to which Indemnitee is not a party, he or she shall be indemnified by the Company to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection therewith.

 

11.Remedies of Indemnitee.

 

(a)       Right to Petition Court. In the event that Indemnitee makes a request for payment of Indemnifiable Amounts under Sections 3 and 5 above or a request for an advancement of Indemnifiable Expenses under Sections 8 and 9 above and the Company fails to make such payment or advancement in a timely manner pursuant to the terms of this Agreement, Indemnitee may petition the Court of Chancery of the State of Delaware to enforce the Company’s obligations under this Agreement.

 

(b)       Burden of Proof. In any judicial proceeding brought under Section 11(a) above, the Company shall have the burden of proving that Indemnitee is not entitled to payment of Indemnifiable Amounts hereunder.

 

(c)       Expenses. The Company agrees to reimburse Indemnitee in full for any Expenses in connection with any Proceeding incurred by Indemnitee in connection with investigating, preparing for, litigating, defending or settling any action brought by Indemnitee under Section 11(a) above, or in connection with any claim or counterclaim brought by the Company in connection therewith, whether or not Indemnitee is successful in whole or in part in connection with any such action, except to the extent that it has been finally adjudicated by a court of competent jurisdiction that such reimbursement would be unlawful.

 

(d)       Failure to Act Not a Defense. The failure of the Company (including its Board of Directors or any committee thereof, independent legal counsel or stockholders) to make a determination concerning the permissibility of the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses under this Agreement shall not be a defense in any action brought under Section 11(a) above, and shall not create a presumption that such payment or advancement is not permissible.

 

12.Defense of the Underlying Proceeding.

 

(a)       Notice by Indemnitee. Indemnitee agrees to notify the Company promptly upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding which may result in the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses hereunder; provided, however, that the failure to give any such notice shall not disqualify Indemnitee from the right, or otherwise affect in any manner any right of Indemnitee, to receive payments of Indemnifiable Amounts or advancements of Indemnifiable Expenses unless the Company’s ability to defend in such Proceeding is materially and adversely prejudiced thereby.

 

(b)       Defense by Company. Subject to the provisions of the last sentence of this Section 12(b) and of Section 12(c) below, the Company shall have the right to defend Indemnitee in any Proceeding which may give rise to the payment of Indemnifiable Amounts hereunder; provided, however, that the Company shall notify Indemnitee of any such decision to defend within ten (10) calendar days of the Company’s receipt of notice of any such Proceeding under Section 12(a) above. The Company shall not, without the prior written consent of Indemnitee, consent to the entry of any judgment against Indemnitee or enter into any settlement or compromise which (i) includes an admission of fault of Indemnitee or (ii) does not include, as an unconditional term thereof, the full release of Indemnitee from all liability in respect of such Proceeding, which release shall be in form and substance reasonably satisfactory to Indemnitee. This Section 12(b) shall not apply to a Proceeding brought by Indemnitee under Section 11(a) above or pursuant to Section 20 below.

 

(c)       Indemnitee’s Right to Counsel. Notwithstanding the provisions of Section 12(b) above, in any Proceeding to which Indemnitee is a party by reason of Indemnitee’s Corporate Status, at the Indemnittee’s option Indemnitee shall have the right to retain counsel of Indemnitee’s choice, at the expense of the Company, to represent Indemnitee in connection with any such matter and the Expenses incurred by Indemnitee in any such matter shall constitute Indemnifiable Expenses.

 

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13.       Representations and Warranties of the Company. The Company hereby represents and warrants to Indemnitee as follows:

 

(a)       Authority. The Company has all necessary power and authority to enter into, and be bound by the terms of, this Agreement, and the execution, delivery and performance of the undertakings contemplated by this Agreement have been duly authorized by the Company.

 

(b)       Enforceability. This Agreement, when executed and delivered by the Company in accordance with the provisions hereof, shall be a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization or similar laws affecting the enforcement of creditors’ rights generally.

 

14.       Insurance. The Company shall, from time to time, make the good faith determination whether or not it is practicable for the Company to obtain and maintain a policy or policies of insurance with a reputable insurance company providing the Indemnitee with coverage for losses from wrongful acts. For so long as Indemnitee shall have Corporate Status, Indemnitee shall be named as an insured in all policies of director and officer liability insurance in such a manner as to provide Indemnitee the same rights and benefits as are accorded to the most favorably insured of the Company’s officers and directors. If, at the time of the receipt of a notice of a claim pursuant to the terms of this Agreement, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies. Notwithstanding the foregoing, the Company shall have no obligation to obtain or maintain such insurance if the Company determines in good faith that such insurance is not reasonably available, if the premium costs for such insurance are disproportionate to the amount of coverage provided, or if the coverage provided by such insurance is limited by exclusions so as to provide an insufficient benefit.

 

15.       No Duplication of Payments. The Company shall not be liable under this Agreement to make any payment in connection with any claim made against Indemnitee to the extent Indemnitee has otherwise actually received payment under any insurance policy, provision of the Certificate or the Bylaws or otherwise of the amounts otherwise indemnifiable hereunder. The Company’s obligation to indemnify or advance Expenses hereunder to Indemnitee as a result of the Indemnitee’s Corporate Status with an Entity other than the Company shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of Expenses from such other Entity.

 

16.       Contract Rights Not Exclusive. The rights to payment of Indemnifiable Amounts and advancement of Indemnifiable Expenses provided by this Agreement shall be in addition to, but not exclusive of, any other rights which Indemnitee may have at any time under applicable law, the Certificate or Bylaws, or any other agreement, vote of stockholders or directors (or a committee of directors) or otherwise, both as to action in Indemnitee’s official capacity and as to action in any other capacity as a result of Indemnitee’s serving as a director of the Company.

 

17.       Successors. This Agreement shall be (a) binding upon all successors and assigns of the Company (including any transferee of all or a substantial portion of the business, stock and/or assets of the Company and any direct or indirect successor by merger or consolidation or otherwise by operation of law) and (b) binding on and shall inure to the benefit of the heirs, personal representatives, executors and administrators of Indemnitee. This Agreement shall continue for the benefit of Indemnitee and such heirs, personal representatives, executors and administrators after Indemnitee has ceased to have Corporate Status.

 

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18.       Change in Law. To the extent that a change in Delaware law (whether by statute or judicial decision) or the Certificate shall permit broader indemnification or advancement of expenses than is provided under the terms of the Bylaws and this Agreement, Indemnitee shall be entitled to such broader indemnification and advancements, and this Agreement shall be deemed to be amended to such extent.

 

19.       Severability. Whenever possible, each provision of this Agreement shall be interpreted in such a manner as to be effective and valid under applicable law, but if any provision of this Agreement, or any clause thereof, shall be determined by a court of competent jurisdiction to be illegal, invalid or unenforceable, in whole or in part, such provision or clause shall be limited or modified in its application to the minimum extent necessary to make such provision or clause valid, legal and enforceable, and the remaining provisions and clauses of this Agreement shall remain fully enforceable and binding on the parties.

 

20.       Indemnitee as Plaintiff. Except as provided in Section 11(c) of this Agreement and in the next sentence, Indemnitee shall not be entitled to payment of Indemnifiable Amounts or advancement of Indemnifiable Expenses with respect to any Proceeding brought by Indemnitee against the Company, any Subsidiary, any Entity which it controls, any director or officer thereof or any third party, unless the Board of Directors has consented to the initiation of such Proceeding or the Company provides indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law. This Section shall not apply to counterclaims or affirmative defenses asserted by Indemnitee in an action brought against Indemnitee.

 

21.       Modifications and Waivers; Counterparts. Except as provided in Section 18 above with respect to changes in Delaware law which broaden the right of Indemnitee to be indemnified by the Company or to receive advancements, no supplement, modification or amendment of this Agreement shall be binding unless executed in writing by each of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions of this Agreement (whether or not similar), nor shall such waiver constitute a continuing waiver. This Agreement may also be executed and delivered by facsimile signature and in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement.

 

22.       General Notices. All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when delivered by hand, (b) when transmitted by facsimile and receipt is acknowledged during normal business hours, and if not, the next business day after transmission or (c) if mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed:

 

(i)If to Indemnitee, to:

 

[●]

 

(ii)If to the Company, to:

 

Adial Pharmaceuticals Inc.

1180 Seminole Trail, Suite 495

Charlottesville, VA 22901

Attn: CEO

 

With copy to

_____________________

 

or to such other address as may have been furnished in the same manner by any party to the others.

 

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23.       Governing Law; Consent to Jurisdiction; Service of Process. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without regard to its rules of conflict of laws. Each of the Company and Indemnitee hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the Court of Chancery of the State of Delaware and the courts of the United States of America located in the State of Delaware (the “Delaware Courts”) for any litigation arising out of or relating to this Agreement and the transactions contemplated hereby (and agrees not to commence any litigation relating thereto except in such courts), waives any objection to the laying of venue of any such litigation in the Delaware Courts and agrees not to plead or claim in any Delaware Court that such litigation brought therein has been brought in an inconvenient forum. Each of the parties hereto agrees, (a) to the extent such party is not otherwise subject to service of process in the State of Delaware, to appoint and maintain an agent in the State of Delaware as such party's agent for acceptance of legal process, and (b) that service of process may also be made on such party by prepaid certified mail with a proof of mailing receipt validated by the United States Postal Service constituting evidence of valid service. Service made pursuant to (a) or (b) above shall have the same legal force and effect as if served upon such party personally within the State of Delaware. For purposes of implementing the parties’ agreement to appoint and maintain an agent for service of process in the State of Delaware, each such party does hereby appoint The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, New Castle County, Delaware 19801, as such agent and each such party hereby agrees to complete all actions necessary for such appointment. Upon written application by Indemnitee to the Company, the Company shall, on an annual basis, reimburse Indemnitee the annual fee charged by The Corporation Trust Company to serve as Indemnitee’s agent for service of process within 30 days following the written application for reimbursement.

 

24.       Joinders. Subsidiaries of the Company may from time to time join this Agreement by signing a joinder in substantially the form attached hereto as Exhibit A. The Company and all Subsidiaries that have joined this Agreement shall be jointly and severally liable for all obligations of the Company under this Agreement.

 

25.       Assignment. Except as otherwise set forth herein, neither this Agreement nor any of the rights, interests or obligations hereunder may be assigned by any party hereto, without the prior written consent of all of the other parties hereto.

 

26.       Entire Agreement. Without limitation to the Certificate and the Bylaws, this Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.

 

[The remainder of this page is intentionally blank]

 

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IN WITNESS WHEREOF, the parties hereto have executed this Indemnification Agreement as of the day and year first above written.

 

  ADIAL PHARMACEUTICALS INC.
     
  By: /s/                               
    Name:
    Title:

 

  INDEMNITEE
               
  /s/     
  Name:

 

 

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EX-10.16 41 fs12017ex10-16_adialpharma.htm EMPLOYMENT AGREEMENT - JOSEPH TRULUCK

Exhibit 10.16

 

EMPLOYMENT AGREEMENT

 

This Employment Agreement (this “Agreement”) is entered into as of [_______], 2017 (the “Effective Date”) by and between Adial Pharmaceuticals, Inc., a Delaware corporation, (the “Company”), and Joseph A. M. Truluck (the “Executive”).

 

Recitals

 

WHEREAS, the Company desires to employ the Executive as a full-time employee of the Company and the Executive desires to accept employment with the Company upon the terms and conditions hereinafter set forth.

 

NOW THEREFORE, in consideration of the premises and the mutual covenants hereinafter set forth, and intending to be legally bound hereby, it is hereby agreed as follows:

 

Agreement

 

1.            Definitions.

 

1.1.         “Affiliate” means as to any Person, any other Person that directly or indirectly controls, or is under common control with, or is controlled by, such first Person. As used in this definition, “control” (including, with its correlative meanings, “controlled by” and “under common control with”) shall mean possession, directly or indirectly, of power to direct or cause the direction of management or policies (whether through ownership of voting equity interests, by contract or otherwise). For the avoidance of doubt, each member of the Company Group (other than the Company) is an Affiliate of the Company.

 

1.2.         “Board” means the Board of Directors of the Company.

 

1.3.         “Cause” means the Executive’s: (i) conviction for, or entering of a plea of guilty or nolo contendere (or its equivalent under any applicable legal system) with respect to: (A) a felony or (B) any crime involving moral turpitude; (ii) commission of fraud, misrepresentation, embezzlement or theft against any Person; (iii) engaging in any intentional activity that injures or would reasonably be expected to injure (monetarily or otherwise), in any material respect, the reputation, the business or a business relationship of the Company or any of its Affiliates; (iv) gross negligence or willful misconduct in the performance of the Executive’s duties to the Company or its Affiliates under this Agreement, or willful refusal or failure to carry out the lawful instructions of the Board that are consistent with the Executive’s title and position; (v) violation of any fiduciary duty owed to the Company or any of its Affiliates; or (vi) breach of any Restrictive Covenant (as defined below) or material breach or violation of any other provision of this Agreement, of a written policy or code of conduct of the Company or any of its Affiliates (as in effect from time to time) or any other agreement between the Executive and the Company or any of its Affiliates. Except when such acts constituting Cause which, by their nature, cannot reasonably be expected to be cured, the Executive shall have twenty (20) days following the delivery of written notice by the Company of its intention to terminate the Executive’s employment for Cause within which to cure any acts constituting Cause. Following such twenty (20) day cure period, and if the reason stated in the notice is not cured, the Executive shall be given five (5) business days prior written notice to appear (with or without counsel) before the full Board for the opportunity to present information regarding his views on the alleged Cause event. After the Company provides the original notice of its intent to terminate Executive’s employment for Cause, the Company may suspend the Executive, with pay, from all his duties and responsibilities and prevent him from accessing the Company’s or its Affiliates’ premises or contacting any personnel of the Company or any of its Affiliates until a final determination on the hearing is made. The Executive will not be terminated for Cause until a majority of the independent directors approve such termination following the hearing.

 

 

 

 

1.4.         “Change of Control” means: (i) the accumulation (if over time, in any consecutive twelve (12) month period), whether directly, indirectly, beneficially or of record, by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended) of 50.1% or more of the shares of the outstanding voting securities of the Company, whether by merger, consolidation, sale or other transfer of shares (other than a merger or consolidation where the stockholders of the Company immediately prior to the merger or consolidation are immediately after such merger or consolidation the direct or indirect beneficial owners of a majority of the voting securities of the entity that survives such merger or consolidation), (ii) a sale of all or substantially all of the assets of the Company and its Subsidiaries, determined on a consolidated basis; (iii) a merger or consolidation of the Company in which its voting securities immediately prior to the merger or consolidation do not represent, or are not converted into securities that represent, a majority of the voting power of all voting securities of the surviving entity immediately after the merger or consolidation; or (iv) during any period of twelve (12) consecutive months, the Continuing Directors cease for any reason to constitute at least a majority of the Board even if one of such Continuing Directors were to resign and not be replaced by a Continuing Director; provided, however, that the following acquisitions shall not constitute a Change of Control for the purposes of this Agreement: (A) any acquisitions of voting securities or securities convertible, exercisable or exchangeable into voting securities directly from the Company or (B) any acquisition of voting securities or securities convertible, exercisable or exchangeable into voting securities by any employee benefit plan (or related trust) sponsored by or maintained by the Company or any of its Subsidiaries; provided further, that a transaction will not be a Change of Control unless it satisfies the requirements of Treasury Regulation 1.409A-3(i)(5)(v), (vi) or (vii).

 

1.5.         “Code” means the Internal Revenue Code of 1986, as amended.

 

1.6.        “Company Group” means the Company and the direct and indirect Subsidiaries of the Company.

 

1.7.         “Company Invention” means any Invention that is Invented by the Executive (alone or jointly with others) (i) in the course of, in connection with, or as a result of the Executive’s employment or other service with any member of the Company Group (whether before, on or after the Effective Date), (ii) at the direction or request of any member of the Company Group, or (iii) through the use of, or that is related to, facilities, equipment, Confidential Information, other Company Inventions, intellectual property or other resources of any member of the Company Group, whether or not during the Executive’s work hours.

 

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1.8.        “Confidential Information” shall mean all information of a sensitive, confidential or proprietary nature respecting the business and activities of any member of the Company Group or any of their respective Affiliates, or the predecessors and successors of any member of the Company Group or any of their respective Affiliates, including, without limitation, the terms and provisions of this Agreement (except for the terms and provisions of Sections 4.4 through 4.17), and the clients, customers, suppliers, computer or other files, projects, products, computer disks or other media, computer hardware or computer software programs, marketing plans, financial information, methodologies, Inventions, know-how, research, developments, processes, practices, approaches, projections, forecasts, formats, systems, data gathering methods and/or strategies of any member of the Company Group or any of their respective Affiliates. “Confidential Information” also includes all information received by the Company or any other member of the Company Group under an obligation of confidentially to a third party. Notwithstanding the foregoing, Confidential Information shall not include any information that is generally available, or is made generally available, to the public other than as a result of a direct or indirect unauthorized disclosure by the Executive or any other Person subject to a confidentiality obligation.

 

1.9.         “Continuing Director” means an individual who: (i) at the beginning of the preceding twelve (12) month period, was a director of the Board, and (ii) any new director whose election by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the directors then still in office who either were directors at the beginning of the 12-month period or whose election or nomination for election was previously so approved.

 

1.10.       “Disability” means that the Executive has been unable, as reasonably determined by the Board (excluding the Executive) in good faith, to perform the Executive’s duties under this Agreement for a period of ninety (90) consecutive days or for a total of one hundred and twenty (120) days (whether or not consecutive) during any period of twelve (12) consecutive months, as a result of injury, illness or any other physical or mental impairment.

 

1.11.       “Good Reason” means any of the following actions taken by the Company without the Executive’s prior written consent: (i) a material reduction in the Executive’s duties, responsibilities or authority; (ii) a reduction of the Executive’s Base Salary (defined below); (iii) failure or refusal of a successor to the Company to either materially assume the Company’s obligations under this Agreement or enter into a new employment agreement with the Executive on terms that are materially similar to those provided under this Agreement, in any case, in the event of a Change of Control; (iv) relocation of the Executive’s primary work location that results in an increase in the Executive’s one-way driving distance by more than twenty-five (25) miles from the Executive’s then-current principal residence; or (v) a material breach of this Agreement by the Company. Notwithstanding the foregoing, Good Reason shall not be deemed to exist unless: (A) the Executive gives the Company written notice within sixty (60) days after the occurrence of the event which the Executive believes constitutes the basis for Good Reason, specifying the particular act or failure to act which the Executive believes constitutes the basis for Good Reason, (B) the Company fails to cure such act or failure to act within thirty (30) days after receipt of such notice and (C) the Executive terminates his employment within thirty (30) days after the end of such thirty (30) day cure period specified in clause (B). For the avoidance of doubt, as long as Executive is maintained as a “C-level” officer, change of title and responsibilities will not be Good Reason under (i) above (e.g. changing to being Chief Operating Officer only will not constitute Good Reason).

 

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1.12.       “Invented” means made, conceived, invented, authored, or first actually reduced to practice (in any case, whether partially or fully).

 

1.13.       “Invention” means any invention, formula, therapy, diagnostic technique, discovery, improvement, idea, technique, design, method, art, process, methodology, algorithm, machine, development, product, service, technology, strategy, software, work of authorship or other Works (as defined in Section 4.13), trade secret, innovation, trademark, data, database, or the like, whether or not patentable, together with all intellectual property rights therein.

 

1.14.       “Person” means an individual, partnership, limited liability company, corporation, association, joint stock company, trust, joint venture, unincorporated organization, investment fund, any other business entity and a governmental entity or any department, agency or political subdivision thereof.

 

1.15.       “Subsidiary” means, with respect to any Person, any other Person in which such first Person has a direct or indirect equity ownership interest of at least 50%.

 

1.16.      “Term of Employment” means the period commencing on the date hereof and ending on the third (3rd) anniversary of Executive’s employment under this Agreement.

 

1.17.       “Termination Date” means the date the Executive’s employment with the Company terminates for any reason.

 

2.            Employment.

 

2.1.         Executive’s Representations. The Executive represents that: (i) the Executive is entering into this Agreement voluntarily and that the Executive’s employment hereunder and compliance with the terms and conditions hereof will not conflict with or result in the breach by the Executive of any agreement to which the Executive is a party or by which the Executive may be bound and (ii) in connection with the Executive’s employment with the Company or any other member of the Company Group, the Executive will not: (A) violate any non-competition, non-solicitation or other similar covenant or agreement by which the Executive is or may be bound or (B) use any confidential or proprietary information that the Executive may have obtained in connection with the Executive’s employment or engagement with any other Person.

 

2.2.         Position; Duties and Responsibilities. During the Term of Employment, the Executive shall be employed as the Company’s Chief Operating Officer and Chief Financial Officer, with such duties and responsibilities that are consistent with such position as may be assigned by the Board (excluding the Executive) from time to time. In addition, during the Term of Employment, the Executive shall serve in such other officer and/or director positions with any member of the Company Group (for no additional compensation) as may be determined by the Board (excluding the Executive) from time to time. The Executive further agrees that, during the Term of Employment, he shall not knowingly take any action that is contrary to, or in conflict with, the best interests of the Company Group.

 

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2.3.         Reporting; Outside Activities. During the Term of Employment, the Executive shall report to the Chief Executive Officer, and the Executive shall diligently and conscientiously devote the Executive’s business time, attention, energy, skill and best efforts as necessary, but in no event less than seventy percent (50%) of his business time, to the business and affairs of the Company Group. The Executive may also: (i) continue to serve as a member of the board of or as an advisor, consultant or employee to any organization listed in Exhibit A hereto, (ii) serve on other boards or as an advisor as may be approved by the Board (excluding the Executive) in its sole discretion, (iii) engage in educational, charitable and civic activities and (iv) manage the Executive’s personal and business investments and affairs, so long as such activities: (A) do not, individually or in the aggregate, interfere with the performance of the Executive’s duties under this Agreement and (B) are not contrary to the interests of the Company Group or competitive in any way with the Company Group. Subject to the foregoing, during the Term of Employment, the Executive shall not, directly or indirectly, render any services of a business, commercial, or professional nature to any other Person, whether for compensation or otherwise, without the prior written consent of the Board (excluding the Executive), which consent shall not be unreasonably withheld.

 

3.            Compensation and Other Benefits.

 

3.1.         Base Salary. During the Term of Employment, the Executive shall initially receive an initial base salary per annum of One Hundred Forty-three Thousand ($143,000) Dollars, payable in cash in accordance with the Company’s normal payroll practices as in effect from time to time. During the Term of Employment, the Board may periodically review the Executive’s base salary and the Board (excluding the Executive) may, in its sole discretion, set such base salary to an amount it determines to be appropriate, provided, however, that any reduction will qualify as Good Reason under Section 1.11. The Executive’s base salary, as may be in effect from time to time, is referred to herein as “Base Salary.”

 

3.2.         Annual Bonus. During the Term of Employment, the Executive shall be eligible to earn an annual performance bonus based on the achievement of the performance goals established by the Board or a committee thereof in its sole discretion, with an annual target bonus opportunity of twenty (20%) percent of the Base Salary and the potential to earn a higher bonus for above target performance, with the amount of any such bonus to be determined in the sole discretion of the Board or a committee thereof, in any case, excluding the Executive (the “Annual Bonus”). Any Annual Bonus earned for any performance period may be paid in cash or any equity or equity-based awards (or any combination thereof), as determined in the sole discretion of the Board or a committee thereof, in any case, excluding the Executive, with such determination to be made before January 1 of the performance period to which such Annual Bonus relates (or such later date permitted under Section 409A (as defined below)). Any earned Annual Bonus that is payable in cash shall be paid in a lump sum, and any earned Annual Bonus that is payable in equity or equity-based awards shall be granted, in any case, by no later than the first March 15th to occur after the end of the applicable performance period. The Board (excluding the Executive) shall act in good faith in determining the value of the portion of any earned Annual Bonus that will be paid in the form of equity or equity-based awards. Except as set forth in Section 4.2, the Executive must be employed by the Company on the bonus payment date in order to receive an earned Annual Bonus with respect to any performance period.

 

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3.3.         Equity Grants. During the Term of Employment, the Executive shall be eligible for equity or equity-based awards that may be granted to the Executive at such times, in such amounts and in such manner as the Board (excluding the Executive) may determine in its sole discretion, but, in good faith, taking into account the roles of and responsibilities of Executive relative to industry norms for similar positions. Any such equity or equity-based awards shall be subject to the terms and conditions set forth in the applicable plan and award agreement.

 

3.4.         Expense Reimbursement. During the Term of Employment, the Company shall reimburse the Executive’s reasonable and necessary business expenses incurred in connection with performing the Executive’s duties hereunder in accordance with its then-prevailing policies and procedures for expense reimbursement (which shall include appropriate itemization and substantiation of expenses incurred).

 

3.5.         Benefit Plans; Vacation. During the Term of Employment, the Executive shall be entitled to participate in all broad-based employee benefit plans and programs maintained from time to time for the benefit of the Company’s employees (e.g., medical, dental and disability benefits) to the extent that the Executive satisfies the eligibility requirements of such plans or programs (including, without limitation, minimum hours worked) and subject to applicable law and the terms and conditions of such plans or programs; provided, however, that the Company may amend, modify or terminate any such plans or programs at any time in its discretion. During the Term of Employment, the Executive shall be entitled to twenty five (25) days of paid time off per calendar year (pro-rated for partial years), subject to the Company’s paid time off policy, as in effect from time to time.

 

4.            Termination; Restrictive Covenants. Upon the Termination Date, the Executive shall be deemed to have immediately resigned from any and all officer, director and other positions the Executive then holds with the Company and its Affiliates (and this Agreement shall constitute notice of resignation by the Executive without any further action by the Executive), and the Executive agrees to execute and deliver such further instruments as are requested by the Company in furtherance of the foregoing. Except as expressly provided in Section 4.2, all rights the Executive may have to compensation and employee benefits from the Company or its Affiliates shall terminate immediately upon the Termination Date. Notwithstanding the above, if Executive’s deemed resignation as a director of the Board shall not be effective unless such resignation is accepted by the Board (excluding Executive) within thirty (30) days of the Termination Date.

 

4.1.         General. The Company may terminate the Term of Employment and the Executive’s employment at any time, with or without Cause or due to Disability, upon written notice to the Executive. The Executive may terminate the Term of Employment and the Executive’s employment for Good Reason or for any other reason at any time upon not less than sixty (60) days’ prior written notice to the Company; provided, that following its receipt of the Executive’s notice of termination, the Company may elect to reduce the notice period and cause the Termination Date to occur earlier, and action by the Company shall entitle the Executive to notice pay, severance pay or benefits or pay in lieu of notice or lost wages or benefits. In addition, the Term of Employment and the Executive’s employment with the Company shall terminate immediately upon the Executive’s death.

 

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4.2.         Separation Payments.

 

4.2.1.      General. Except as otherwise provided in this Section 4.2, in the event that the Executive’s employment with the Company terminates for any reason, the Executive (or the Executive’s estate or legal representative, as applicable) shall be entitled to receive only: (i) the cash portion of the Base Salary earned but unpaid through the Termination Date, paid in accordance with the Company’s normal payroll policies (or at such earlier time as required by applicable law), (ii) any accrued but unused vacation in accordance with the Company’s policies and applicable law, (iii) any unreimbursed business expenses incurred prior to the Termination Date that are otherwise reimbursable, with such expenses to be reimbursed in accordance with the Company’s expense reimbursement policies (as may be in effect from time to time), and (iv) any vested benefits earned by the Executive under any employee benefit plan of the Company or its Affiliates under which the Executive was participating immediately prior to the Termination Date, with such benefits to be provided in accordance with the terms of the applicable employee benefit plan (the items described in the foregoing clauses (i) through (iv), collectively, the “Accrued Benefits”). All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in Sections 4.2.2 or 4.2.3, shall immediately terminate upon the Termination Date.

 

4.2.2.     Death and Disability. In the event that the Executive’s employment is terminated due to the Executive’s death or by the Company due to Disability, in either case, during the Term of Employment, then in addition to the Accrued Benefits, and subject to Section 4.2.4, the Executive (or the Executive’s estate or legal representative, as applicable) shall be entitled to receive: (i) the Annual Bonus earned in the fiscal year immediately preceding the fiscal year in which such termination occurred, to the extent that such Annual Bonus is unpaid as of the Termination Date, with such amount to be payable in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred (the “Unpaid Prior Year Bonus”); (ii) the Annual Bonus for the year in which the Termination Date occurs, but multiplied by a fraction (A) the numerator of which is the number of days in the fiscal year that have transpired through the Termination Date and (B) the denominator of which is the number of days in such fiscal year (to be paid in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred); (iii) if the Executive and his eligible dependents are eligible for, and timely elect COBRA continuation coverage, the Company shall reimburse the Executive (or the Executive’s estate or legal representative, as applicable) for the COBRA premiums for the Executive and his eligible dependents under the Company’s medical, dental and vision benefit plans for a period of 12 months following the Termination Date (the “COBRA Benefit”); provided, however, that notwithstanding the foregoing, the COBRA Benefit shall not be provided to the extent that it would result in any fine, penalty or tax on the Company or any of its Affiliates (under Section 105(h) of the Code or the Patient Protection and Affordable Care Act of 2010, or otherwise); provided further, that the COBRA Benefit shall cease earlier if the Executive or his dependents become eligible for health coverage under the health plan of another employer; and (iv) to the extent the following will not result in a violation of Section 409A, with respect to each equity award received by Executive from the Company or any of its direct or indirect parent companies that is outstanding as of the Termination Date, accelerated vesting immediately upon the Termination Date of, (I) with respect to any such equity award received in payment of Base Salary or an Annual Bonus, 100% of such equity award and, (II) with respect to any equity award not described in clause (I), the greater of (x) the portion of the unvested equity award that would have become vested within 12 months after the Termination Date had the Executive remained employed by the Company during such 12-month period (without regard for the vesting schedule set forth in any applicable plan or agreement governing such equity award) or (y) the portion of the unvested equity award that is subject to accelerated vesting (if any) upon such termination under the applicable equity plan or award agreement; provided, however, that any equity awards that are subject to the satisfaction of performance goals shall be deemed earned at not less than target performance; and provided, further, that, with respect to any equity award that is in the form of a stock option or stock appreciation right, the option or stock appreciation right shall remain outstanding and exercisable for 12 months following the Termination Date or, if longer, such period following the Termination Date as provided under the applicable equity plan or award agreement (but in no event beyond the expiration date of the applicable option or stock appreciation right). All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in this Section 4.2.2, shall immediately terminate upon the Termination Date.

 

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4.2.3.     Termination Without Cause or for Good Reason. If, during the Term of Employment, the Executive’s employment is terminated by the Company without Cause (and not due to death or Disability) or by Executive for Good Reason, in either case, then the Executive shall be entitled to receive the Accrued Benefits and, subject to Section 4.2.4: (i) the Unpaid Prior Year Bonus, with such amount to be payable in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred; (ii) the Annual Bonus for the year in which the Termination Date occurs, but multiplied by a fraction (A) the numerator of which is the number of days in the fiscal year that have transpired through the Termination Date and (B) the denominator of which is the number of days in such fiscal year (to be paid in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred); (iii) continuation of the Base Salary as of the Termination Date for six (6) months following the Termination Date, with all portions of such Base Salary to be paid in cash in equal installments in accordance with the Company’s normal payroll policies, with the first such payment to be made on the sixtieth (60th) day following the Termination Date and to include a catch-up covering any payroll dates between the Termination Date and the date of the first payment, and (iv) the COBRA Benefit for a period of twelve (12) months following the Termination Date; provided, however, that notwithstanding the foregoing, the COBRA Benefit shall not be provided to the extent that it would result in any fine, penalty or tax on the Company or any of its Affiliates (under Section 105(h) of the Code or the Patient Protection and Affordable Care Act of 2010, or otherwise); provided further, that the COBRA Benefit shall cease earlier if the Executive (or his dependents) become eligible for health coverage under the health plan of another employer. All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in this Section 4.2.3, shall immediately terminate upon the Termination Date.

 

4.2.4.      Release Requirement. Payment and provision of the benefits set forth in Sections 4.2.2 or 4.2.3 (other than the Accrued Benefits) is subject to the Executive’s (or, as applicable, the Executive’s estate’s or legal representative’s) execution of a general release of claims and covenant not to sue in form and substance satisfactory to the Company, such that such release becomes effective, with all revocation periods having expired unexercised, within sixty (60) days after the Termination Date. Notwithstanding the foregoing, if such sixty (60) day period ends in a calendar year after the calendar year in which the Executive’s employment terminates, then to the extent required by Section 409A, any severance payment set forth in Sections 4.2.2 or 4.2.3 (other than the Accrued Benefits) that would have been made during the calendar year in which the Executive’s employment terminates instead shall be withheld and paid on the first payroll date in the calendar year after the calendar year in which the Executive’s employment terminates, with all remaining payments to be made as if no such delay had occurred.

 

4.3.        Violation of Restrictive Covenants. Without limiting the remedies provided to the Company and its Affiliates as set forth in this Article 4, upon the Executive’s breach of any of the Restrictive Covenants (as defined below), other than any immaterial and unintentional breach by the Executive of the confidentiality obligations set forth in Section 4.11, the Company will have no obligation to continue to pay or provide any of the compensation or benefits under Section 4.2 (other than the Accrued Benefits) and the Executive shall repay to the Company any amounts paid under Section 4.2 (other than the Accrued Benefits) after such breach occurred.

 

4.4.        Restrictive Covenants. As an inducement and as essential consideration for the Company to enter into this Agreement, and in exchange for other good and valuable consideration, the Executive hereby agrees to the restrictive covenants contained in Sections 4.5 through 4.17 (the “Restrictive Covenants”). The Company and the Executive agree that the Restrictive Covenants are essential and narrowly tailored to preserve the goodwill of the business of the Company and its Affiliates, to maintain the confidential and trade secret information of the Company and its Affiliates, and to protect other legitimate business interests of the Company and its Affiliates, and that the Company would not have entered into this Agreement without the Executive’s agreement to the Restrictive Covenants. For purposes of the Restrictive Covenants, each reference to “Company,” “Company Group” and “Affiliate,” shall also refer to the predecessors and successors of the Company, the members of the Company Group and any of their Affiliates (as the case may be).

 

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4.5.        Non-Competition. During the period commencing on the Effective Date and ending twenty four (24) months after the Termination Date (the “Restrictive Period”), regardless of the reason for Executive’s termination of employment, the Executive shall not, in any state of the United States or European Union where the Company conducts business as of the Termination Date, engage in, or own, manage, operate or control, or participate in the ownership, management, operation or control of any business or entity that develops, sells or provides products or services competitive with the products or services developed, sold or provided by any member of the Company Group at the time of cessation of the employment of Executive. Notwithstanding the foregoing, nothing in this Section 4.5 shall prevent the Executive from owning, as a passive investor, up to five percent (5%) of the securities of any entity that are publicly traded on a national securities exchange. For the avoidance of doubt, nothing in this Section 4.5 prevents the Executive from working in the pharmaceutical industry as long as such positions and activities are not competitive with the business of the Company Group. As used in this Section 4.5, “competitive” shall mean products or services using the same mechanism of action or for the treatment of the same (or substantially similar) indication. Executive agrees that this covenant is reasonable with respect to its duration, geographical area, and scope.

 

4.6.        Customer Non-Solicitation. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Executive’s employment with the Company), for purposes of providing products or services that are competitive with those provided by any member of the Company Group, on the Executive’s own behalf or on behalf of any other Person, solicit any customer or client of any member of the Company Group with whom the Executive had contact, solicited, or served within the twelve (12) months prior to the Termination Date.

 

4.7.        Customer Non-Acceptance. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Executive’s employment with the Company), for purposes of providing products or services that are competitive with those provided by any member of the Company Group, on the Executive’s own behalf or on behalf of any other Person, accept business from any customer or client of any member of the Company Group with whom the Executive had contact, solicited, or served within the twelve (12) months prior to the Termination Date.

 

4.8.        Employee and Independent Contractor Non-Solicitation. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Term of Employment), on the Executive’s own behalf or on behalf of any other Person, solicit for employment or engagement any individual who: (A) is employed by, or an independent contractor of, any member of the Company Group at the time of such solicitation or (B) was employed by, or an independent contractor of, any member of the Company Group within twelve (12) months prior to such solicitation.

 

4.9.        Employee and Independent Contractor Non-Acceptance. During the period commencing on the Effective Date and ending twenty four (24) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Term of Employment), on the Executive’s own behalf or on behalf of any other Person, employ or engage any individual who (A) is employed by, or an independent contractor of, any member of the Company Group at the time of such employment or engagement or (B) was employed by, or an independent contractor of, any member of the Company Group within twelve (12) months prior to such employment or engagement.

 

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4.10.      Non-Disparagement. During the Term of Employment and at all times thereafter, neither the Company nor the Executive shall not, directly or through any other Person make any public or private statements (whether orally, in writing, via electronic transmission, or otherwise) that disparage, denigrate or malign the other party or any of the Company’s respective businesses, products, services, activities, operations, affairs, reputations or prospects; or any of the Company’s respective officers, employees, directors, partners (general and limited), agents, members or shareholders. For purposes of clarification, and not limitation, a statement shall be deemed to disparage, denigrate or malign the other party if such statement could be reasonably construed to adversely affect the opinion any other Person may have or form of such first Person. The foregoing limitations shall not be violated by truthful statements made by the Executive or the Company: (i) to any governmental authority or (ii) which are in response to legal process, required governmental testimony or filings, or administrative or arbitral proceedings (including, without limitation, depositions in connection with such proceedings).

 

4.11.      Confidentiality; Return of Property. During the Term of Employment and for a period of seven (7) years thereafter, the Executive shall not, without the prior express written consent of the Company, directly or indirectly, use on the Executive’s behalf or on behalf of any other Person, or divulge, disclose or make available or accessible to any Person, any Confidential Information, other than when required to do so in good faith to perform the Executive’s duties and responsibilities hereunder while employed by any member of the Company Group, when required to do so by a lawful order of a court of competent jurisdiction, any governmental authority or agency, or any recognized subpoena power, or in connection with reporting possible violations of federal law or regulation to any governmental agency or entity, or making other disclosures that are protected under the whistleblower provisions of federal law or regulation. In the event that the Executive becomes legally compelled (by oral questions, interrogatories, request for information or documents, subpoena, criminal or civil investigative demand or similar process) to disclose any Confidential Information, then prior to such disclosure, the Executive will provide the Board with prompt written notice so that the Company may seek (with the Executive’s cooperation) a protective order or other appropriate remedy and/or waive compliance with the provisions of this Agreement. In the event that such protective order or other remedy is not obtained, then the Executive will furnish only that portion of the Confidential Information which is legally required, and will cooperate with the Company in the Company’s efforts to obtain reliable assurance that confidential treatment will be accorded to the Confidential Information. In addition, the Executive shall not create any derivative work or other product based on or resulting from any Confidential Information (except in the good faith performance of the Executive’s duties under this Agreement while employed by any member of the Company Group). The Executive shall also proffer to the Board’s designee, no later than the Termination Date (or upon the earlier request of the Company), and without retaining any copies, notes or excerpts thereof, all property of the Company and its Affiliates, including, without limitation, memoranda, computer disks or other media, computer programs, diaries, notes, records, data, customer or client lists, marketing plans and strategies, and any other documents consisting of or containing Confidential Information, that are in the Executive’s actual or constructive possession or which are subject to the Executive’s control at such time. To the extent the Executive has retained any such property or Confidential Information on any electronic or computer equipment belonging to the Executive or under the Executive’s control, the Executive agrees to so advise Company and to follow Company’s instructions in permanently deleting all such property or Confidential Information and all copies. Notwithstanding the foregoing, in accordance with the Defend Trade Secrets Act of 2016, the Executive shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that: (a) is made (I) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and (II) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.

 

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4.12.      Ownership of Inventions. The Executive acknowledges and agrees that all Company Inventions (including all intellectual property rights arising therein or thereto, all rights of priority relating to patents, and all claims for past, present and future infringement, misappropriation relating thereto), and all Confidential Information, hereby are and shall be the sole and exclusive property of the Company (collectively, the “Company IP”). The Executive further acknowledges and agrees that any rights arising in the Executive in any Invention Invented by the Executive, whether alone or jointly with others, during the twelve (12) months following the Termination Date and relating in any way to work performed by the Executive for any member of the Company Group during the Executive’s employment with or service for any member of the Company Group (“Post-employment Inventions”), shall hereby be deemed to be Company Inventions and the sole and exclusive property of the Company; provided, however, that the Board (excluding the Executive) in its sole discretion may elect to compensate the Executive for any Post-employment Inventions. For consideration acknowledged and received, the Executive hereby irrevocably assigns, conveys and sets over to the Company all of the Executive’s right, title and interest in and to all Company IP. The Executive acknowledges and agrees that the compensation received by the Executive for employment or services provided to the Company is adequate consideration for the foregoing assignment. The Executive further agrees to disclose in writing to the Board any Company Inventions (including, without limitation, all Post-employment Inventions), promptly following their conception or reduction to practice. Such disclosure shall be sufficiently complete in technical detail and appropriately illustrated by sketch or diagram to convey to one skilled in the art of which the Company Invention pertains, a clear understanding of the nature, purpose, operations, and other characteristics of the Company Invention. The Executive agrees to execute and deliver such deeds of assignment or other documents of conveyance and transfer as the Company may request to confirm in the Company or its designee the ownership of the Company Inventions, without compensation beyond that provided in this Agreement. The Executive further agrees, upon the request of the Company and at its expense, that the Executive will execute any other instrument and document necessary or desirable in applying for and obtaining patents in the United States and in any foreign country with respect to any Company Invention. The Executive further agrees, whether or not the Executive is then an employee or other service provider of any member of the Company Group, upon request of the Company, to provide reasonable assistance, at the Company’s sole expense, with respect to the perfection, recordation or other documentation of the assignment of Company IP hereunder, and the enforcement of the Company’s rights in any Company IP, and to cooperate to the extent and in the manner reasonably requested by the Company, subject to the Executive’s then schedule, in any litigation or other claim or proceeding (including, without limitation, the prosecution or defense of any claim involving a patent) involving any Company IP covered by this Agreement, with compensation at the Executive’s customary hourly rate, together with all reasonable out-of-pocket expenses incurred by the Executive in satisfying the requirements of this Section 4.12 shall be paid by the Company or its designee. The Executive shall not, on or after the date of this Agreement, directly or indirectly challenge the validity or enforceability of the Company’s ownership of, or rights with respect to, any Company IP, including, without limitation, any patent issued on, or patent application filed in respect of, any Company Invention.

 

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4.13.      Works for Hire. The Executive also acknowledges and agrees that all works of authorship, in any format or medium, and whether published or unpublished, created wholly or in part by the Executive, whether alone or jointly with others: (i) in the course of, in connection with, or as a result of the Executive’s employment or other service with any member of the Company Group (whether before or after the Effective Date), (ii) at the direction or request of any member of the Company Group, or (iii) through the use of, or that is related to, facilities, equipment, Confidential Information, other Company Inventions, intellectual property or other resources of any member of the Company Group, whether or not during the Executive’s work hours (“Works”), are works made for hire as defined under United States copyright law, and that the Works (and all copyrights arising in the Works) are owned exclusively by the Company and all rights therein will automatically vest in the Company without the need for any further action by any party. To the extent any such Works are not deemed to be works made for hire, for consideration acknowledged and received, the Executive hereby waives any “moral rights” in such Works and the Executive hereby irrevocably assigns, transfers, conveys and sets over to the Company or its designee, without compensation beyond that provided in this Agreement, all right, title and interest in and to such Works, including without limitation all rights of copyright arising therein or thereto, and further agrees to execute such assignments or other deeds of conveyance and transfer as the Company may request to vest in the Company or its designee all right, title and interest in and to such Works, including all rights of copyright arising in or related to the Works.

 

4.14.      Cooperation. During and after the Term of Employment, the Executive agrees to cooperate with the Company Group in any internal investigation, any administrative, regulatory, or judicial proceeding or any dispute with a third party concerning issues about which the Executive has knowledge or that may relate to the Executive or the Executive’s employment with the Company. The Executive’s obligation to cooperate hereunder includes, without limitation, being available to the Company Group upon reasonable notice for interviews and factual investigations, appearing in any forum at the Company Group’s request to give testimony (without requiring service of a subpoena or other legal process), volunteering to the Company Group pertinent information, and turning over to the Company Group all relevant documents which are or may come into the Executive’s possession. The Company shall promptly compensate the Executive at his usual and customary hourly rate, plus reimburse the Executive for the reasonable out of pocket expenses incurred by the Executive in connection with such cooperation.

 

4.15.      Injunctive Relief. The Executive acknowledges and agrees that the Company and its Affiliates will have no adequate remedy at law and would be irreparably harmed if the Executive breaches or threatens to breach any of the Restrictive Covenants. The Executive agrees that the Company and its Affiliates shall be entitled to equitable and/or injunctive relief to prevent any breach or threatened breach of any of the Restrictive Covenants, and to specific performance of each of the terms thereof, in each case, in addition to any other legal or equitable remedies that the Company and its Affiliates may have, as well as the costs and reasonable attorneys’ fees it/they incur in enforcing any of the Restrictive Covenants. The Executive further agrees that: (i) any breach or claimed breach of the provisions set forth in this Agreement by, or any other claim the Executive may have against, the Company or any of its Affiliates will not be a defense to enforcement of any Restrictive Covenant and (ii) the circumstances of the Executive’s termination of employment with the Company will have no impact on the Executive’s obligations to comply with any Restrictive Covenant. The Restrictive Covenants are intended for the benefit of the Company and each of its Affiliates. Each Affiliate of the Company is an intended third party beneficiary of the Restrictive Covenants, and each Affiliate of the Company, as well as any successor or assign of the Company or such Affiliate, may enforce the Restrictive Covenants. The Executive further agrees that the Restrictive Covenants are in addition to, and not in lieu of, any non-competition, non-solicitation, protection of confidential information or intellectual property, or other similar covenants in favor of the Company or any of its Affiliates by which the Executive may be bound.

 

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4.16.      Tolling During Periods of Breach. The parties hereto agree and intend that the Restrictive Covenants (to the extent not perpetual) be tolled during any period that the Executive is in breach of any such Restrictive Covenant, with such tolling to cease with respect to a Restrictive Covenant once the Executive is in compliance with such Restrictive Covenant, so that the Company and its Affiliates are provided with the full benefit of the restrictive periods set forth herein.

 

4.17.      Notification of New Employer. In the event that the Executive is employed or otherwise engaged by any other Person following the Termination Date and during the Restrictive Period, the Executive agrees to notify, and consents to the notification by Company and its Affiliates of, such Person of the Restrictive Covenants.

 

5.           Miscellaneous.

 

5.1.        Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Virginia, applied without reference to principles of conflicts of law.

 

5.2.        Mediation. Any controversy, dispute or claim arising out of or relating to this Agreement, Executive’s employment or service with any member of the Company Group or the termination thereof shall, if not settled by direct negotiation between the parties, be subject to non-binding mediation under the Employment Arbitration Rules and Mediation Procedures of the American Arbitration Association (“AAA”) as in effect on the date of the notice of demand for mediation. Any demand for mediation by either party shall be made in writing and served upon the other party and shall set forth with reasonable specificity the basis of the dispute and the relief sought. Any mediation hereunder shall be conducted before an independent mediator mutually selected by the parties. If the parties are unable to agree to a mediator within ten (10) days after the receipt of a demand for mediation by either party, the mediator will be chosen by alternatively striking from a list of five mediators obtained by the Company from AAA, and the Executive shall have the first strike. The mediation hearing will occur at a time and place convenient to the parties in the Commonwealth of Virginia. Notwithstanding the foregoing, any claims under Section 4.15 are exempt from this Section 5.2 and may be brought in any court of competent jurisdiction without mediation.

 

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5.3.        Venue; WAIVER OF JURY TRIAL. In the event that any controversy, dispute or claim arising out of or relating to this Agreement, Executive’s employment or service with any member of the Company Group or the termination thereof is not settled through mediation pursuant to Section 5.2, both the Executive and the Company agree to appear before and submit exclusively to the jurisdiction of the federal courts located in Charlottesville, Virginia with respect to such controversy, dispute or claim (or if such controversy, dispute or claim may not be brought in federal court, the state courts located in Charlottesville, Virginia). Both the Executive and the Company also agree to waive, to the fullest possible extent, the defense of an inconvenient forum or lack of jurisdiction. THE COMPANY AND THE EXECUTIVE HEREBY WAIVE, TO THE EXTENT PERMITTED BY APPLICABLE LAW, TRIAL BY JURY IN ANY LITIGATION IN ANY COURT WITH RESPECT TO, IN CONNECTION WITH, OR ARISING OUT OF THE EXECUTIVE’S EMPLOYMENT BY, OR SERVICE WITH, ANY MEMBER OF THE COMPANY GROUP OR THE TERMINATION THEREOF, OR THIS AGREEMENT OR THE VALIDITY, PROTECTION, INTERPRETATION, COLLECTION OR ENFORCEMENT THEREOF (WHETHER ARISING IN CONTRACT, EQUITY, TORT OR OTHERWISE).

 

5.4.        Amendments. This Agreement may not be amended or modified otherwise than by a written agreement executed by the parties hereto or their respective successors and legal representatives.

 

5.5.        Notices. All notices and other communications hereunder shall be in writing, and shall be given by hand-delivery to the other party, by reputable overnight courier, or by registered or certified mail, return receipt requested, postage prepaid, addressed as follows:

 

  To the Company:

Adial Pharmaceuticals, Inc.

2246 Ivy Road

Charlottesville, VA 22903

Attention: Kermit Anderson, James Newman

     
  With a copy (which copy shall not constitute notice) to:

Gracin Marlow, LLP

Chrysler Building

405 Lexington Avenue

26th Floor

New York, New York 10174

Attention: Leslie Marlow

     
  To the Executive: at the residence address most recently filed with the Company;

 

or to such other address as any party shall have furnished to the other in writing in accordance herewith. All such notices shall be deemed to have been duly given: (i) when delivered personally to the recipient, (ii) one (1) business day after being sent to the recipient by reputable overnight courier service (charges prepaid); or (iii) four (4) business days after being mailed to the recipient by certified or registered mail, return receipt requested and postage prepaid.

 

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5.6.        Indemnification. The Parties agree to enter the Indemnification Agreement attached at Exhibit B hereto.

 

5.7.        Withholding. The Company may withhold from any amounts payable under this Agreement such federal, state or local income taxes as are required to be withheld pursuant to any applicable law or regulation.

 

5.8.        Code Section 409A Compliance.

 

5.8.1.     The provisions of this Agreement are intended to comply with Section 409A of the Code and any final regulations and guidance promulgated thereunder (“Section 409A”) or an exemption thereunder and shall be construed in a manner consistent with the requirements for avoiding taxes or penalties under Section 409A. The Company and Executive agree to work together in good faith to consider amendments to this Agreement and to take such reasonable actions which are necessary, appropriate or desirable to avoid imposition of any additional tax or income recognition prior to actual payment or provision of benefit to Executive under Section 409A.

 

5.8.2.     To the extent that Executive will be reimbursed for costs and expenses or in-kind benefits, except as otherwise permitted by Section 409A, (a) the right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit, (b) the amount of expenses eligible for reimbursement, or in-kind benefits, provided during any taxable year shall not affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year; provided that the foregoing clause (b) shall not be violated with regard to expenses reimbursed under any arrangement covered by Section 105(b) of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect and (c) such payments shall be made on or before the last day of the taxable year following the taxable year in which Executive incurred the expense.

 

5.8.3.     A termination of employment shall not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits upon or following a termination of employment unless such termination constitutes a “Separation from Service” within the meaning of Section 409A and, for purposes of any such provision of this Agreement references to a “termination,” “termination of employment” or like terms shall mean Separation from Service.

 

5.8.4.     Any payments under this Agreement that may be excluded from Section 409A either as separation pay due to an involuntary separation from service or as a short-term deferral shall be excluded from Section 409A to the maximum extent possible. Each installment payable hereunder shall constitute a separate payment for purposes of Treasury Regulation Section 1.409A-2(b), including Treasury Regulation Section 1.409A-2(b)(2)(iii). Each payment that is made within the terms of the “short-term deferral” rule set forth in Treasury Regulation Section 1.409A-1(b)(4) is intended to meet the “short-term deferral” rule. Each other payment is intended to be a payment upon an involuntary termination from service and payable pursuant to Treasury Regulation Section 1.409A-1(b)(9)(iii), et. seq., to the maximum extent permitted by that regulation, with any amount that is not exempt from Section 409A being subject to Section 409A.

 

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5.8.5.     Notwithstanding anything to the contrary in this Agreement, if Executive is a “specified employee” within the meaning of Section 409A at the time of Executive’s termination, then only that portion of the severance and benefits payable to Executive pursuant to this Agreement, if any, and any other severance payments or separation benefits which may be considered deferred compensation under Section 409A that is payable on account of the Executive’s termination (other than by reason of death) (together, the “Deferred Compensation Separation Benefits”) that are due to Executive on or within the six (6) month period following Executive’s termination will accrue during such six (6) month period and will become payable in one lump sum cash payment on the date that is six (6) months and one (1) day following the date of Executive’s termination of employment. All subsequent Deferred Compensation Separation Benefits, if any, will be payable in accordance with the payment schedule applicable to each payment or benefit. Notwithstanding anything herein to the contrary, if Executive dies following termination but prior to the six (6) month anniversary of Executive’s termination date, then any payments delayed in accordance with this paragraph will be payable in a lump sum as soon as administratively practicable after the date of Executive’s death (but not earlier than such payment would have been made absent such death) and all other Deferred Compensation Separation Benefits will be payable in accordance with the payment schedule applicable to each payment or benefit.

 

5.8.6.     Notwithstanding anything herein to the contrary, neither the Company nor any of its Affiliates shall have any liability to the Executive or to any other Person if the payments and benefits provided in this Agreement that are intended to be exempt from or compliant with Section 409A are not so exempt or compliant.

 

5.9.        Excess Parachute Payments under Code Section 280G. Notwithstanding any other provisions of this Agreement, if any “payments” (including, without limitation, any benefits or transfers of property or the acceleration of the vesting of any benefits) in the nature of compensation under any arrangement that is considered contingent on a Change of Control for purposes of Section 280G of the Code, together with any other payments that the Executive has the right to receive from the Company or any corporation that is a member of an “affiliated group” (as defined in Section 1504(a) of the Code without regard to Section 1504(b) of the Code) of which the Company is a member or from any other Person, would constitute a “parachute payment” (as defined in Section 280G(b)(2) of the Code), such “payments” may, at the Executive’s sole election, be reduced to the largest amount that will result in no portion of such “payments” being subject to the excise tax imposed by Section 4999 of the Code. Any such reduction in “payments” shall be applied first against the latest scheduled cash payments; then current cash payments; then any equity or equity derivatives that are included under Section 280G of the Code at full value rather than accelerated value (with the highest value reduced first); then any equity or equity derivatives included under Section 280G of the Code at an accelerated value (and not at full value), with the highest value reduced first (as such values are determined under Treasury Regulation Section 1.280G-1, Q&A 24); and finally any other non-cash benefits will be reduced (in the order of latest scheduled payments to earliest scheduled payments). All calculations hereunder shall be performed by a nationally recognized independent accounting firm selected by the Company, with the full cost of such firm being borne by the Company. Any determinations made by such firm shall be final and binding on the Executive and the Company.

 

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5.10.      Severability. The terms and provisions of this Agreement are intended to be separate and divisible provisions and if, for any reason, any one or more of them is held to be invalid or unenforceable, neither the validity nor the enforceability of any other provision of this Agreement shall thereby be affected. It is the intention of the parties to this Agreement that the Restrictive Covenants be reasonable in duration, geographic scope and in all other respects. The Executive agrees that the Restrictive Covenants, including, without limitation, the duration, geographic scope and activity restrictions of each restriction, are reasonable in light of the Executive’s senior position. However, if for any reason any court of competent jurisdiction shall find any provisions of the Restrictive Covenants unreasonable in duration or geographic scope or otherwise, it is the intention of the parties that the restrictions and prohibitions contained therein shall be modified by the court to be effective to the fullest extent allowed under applicable law in such jurisdiction.

 

5.11.      Captions. The captions of this Agreement are not part of the provisions hereof and shall have no force or effect.

 

5.12.      Counterparts. This Agreement may be executed in counterparts and delivered by facsimile transmission or electronic transmission in “portable document format,” each of which shall be an original and which taken together shall constitute one and the same document.

 

5.13.      Entire Agreement. This Agreement contains the entire agreement concerning the subject matter hereof and supersedes all prior agreements, understandings, discussions, negotiations and undertakings, whether written or oral, between the parties and their Affiliates relating to such subject matter.

 

5.14.      Survivorship. The provisions of Article 1, Article 5, Section 2.1 and Sections 4.4 through 4.17 shall survive the termination of the Executive’s employment with the Company and this Agreement in accordance with their terms.

 

5.15.      Successors and Assigns. The Company may assign, without the Executive’s consent, its rights and/or delegate its obligations under this Agreement to any successor of the Company, whether by operation of law, agreement or otherwise (including, without limitation, any Person who acquires all or a substantial portion of the business of the Company Group (whether direct or indirect and whether structured as a stock sale, asset sale, merger, recapitalization, consolidation or other transaction)) and, in connection with any such delegation of its obligations hereunder (but only so long as such assignee or delegee has consented in writing to be bound by the obligations hereunder) shall be released from such obligations hereunder. This Agreement may not be assigned by the Executive. Except as otherwise provided herein, this Agreement shall bind and inure to the benefit of and be enforceable by the Executive, the Company and their respective successors and permitted assigns.

 

[signatures to follow on next page]

 

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IN WITNESS WHEREOF, the Executive has hereunto set the Executive’s hand and the Company has caused this Agreement to be executed in its name on its behalf, all as of the day and year first above written.

 

ADIAL PHARMACEUTICALS, INC.   EXECUTIVE:
       
By:         
  William B. Stilley, CEO   Joseph A. M. Truluck

  

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Exhibit A

Board, Advisory, Consultant, Employee Positions

 

1.Adenosine Therapeutics, LLC, Vice President of Operations and Finance

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

 

 

 

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Exhibit B

Indemnification Agreement

 

[See attached]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

 

 

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INDEMNIFICATION AGREEMENT

 

This Indemnification Agreement (the “Agreement”) is made and entered into this ___ day of ________, 2017, by and between Adial Pharmaceuticals Inc., a Delaware corporation (the “Company”, which term shall include, where appropriate, any Entity (as hereinafter defined) controlled directly or indirectly by the Company), and __________ (the “Indemnitee”).

 

WHEREAS, it is essential to the Company that it be able to retain and attract as directors and officers the most capable persons available;

 

WHEREAS, increased corporate litigation has subjected directors and officers to litigation risks and expenses, and the limitations on the availability of directors and officers liability insurance have made it increasingly difficult for the Company to attract and retain such persons;

 

WHEREAS, the Company’s Certificate of Incorporation, as amended, and Bylaws (the “Certificate” and the “Bylaws”, respectively), provide that the Company is authorized to indemnify its directors and officers to the fullest extent permissible by applicable law and permit it to make other indemnification arrangements and agreements;

 

WHEREAS, the Company desires to provide Indemnitee with specific contractual assurance of Indemnitee’s rights to full indemnification against litigation risks and expenses (regardless, among other things, of any amendment to or revocation of the Certificate or Bylaws or any change in the ownership of the Company or the composition of its board of directors (the “Board of Directors”));

 

WHEREAS, the Company intends that this Agreement provide Indemnitee with greater protection than that which is provided by the Certificate and Bylaws; and

 

WHEREAS, Indemnitee is relying upon the rights afforded under this Agreement in becoming or continuing as a director and/or officer of the Company.

 

NOW, THEREFORE, in consideration of the promises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree as follows:

 

1.Definitions.

 

(a)          “Corporate Status” describes the status of a person who is serving or has served (i) as a director and/or officer of the Company, (ii) in any capacity with respect to any employee benefit plan of the Company or (at the request of the Company) any employee benefit plan of any other Entity, or (iii) as a director and/or officer of any other Entity at the request of the Company. For purposes of subsections (ii) and (iii) of this Section 1(a), if Indemnitee is serving or has served as a director and/or officer of a Subsidiary (as defined below), or in any capacity with respect to any employee benefit plan of a Subsidiary, Indemnitee shall be deemed to be serving at the request of the Company. If Indemnitee is an employee of the Company, Corporate Status shall not include actions taken by Indemnitee in any capacity other than as a director and/or officer or as a representative of any employee benefit plan.

 

(b)          “Entity” shall mean any corporation, partnership, limited liability company, joint venture, trust, foundation, association, organization or other legal entity.

 

(c)          “Expenses” shall mean all fees, costs and expenses incurred by Indemnitee in connection with any Proceeding (as defined below), including, without limitation, reasonable attorneys’ fees, disbursements and retainers (including, without limitation, any such fees, disbursements and retainers incurred by Indemnitee pursuant to Sections 11 and 12(c) of this Agreement), fees and disbursements of expert witnesses, private investigators and professional advisors (including, without limitation, accountants and investment bankers), court costs, transcript costs, fees of experts, travel expenses, duplicating, printing and binding costs, telephone and fax transmission charges, postage, delivery services, secretarial services and other disbursements and expenses.

 

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(d)          “Indemnifiable Expenses”, “Indemnifiable Liabilities” and “Indemnifiable Amounts” shall have the meanings ascribed to those terms in Section 3(a) below.

 

(e)          “Liabilities” shall mean judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement.

 

(f)           “Proceeding” shall mean any threatened, pending or completed claim, action, suit, arbitration, alternate dispute resolution process, investigation, administrative hearing, appeal or any other proceeding, whether civil, criminal, administrative, arbitrative or investigative, whether formal or informal, including a proceeding initiated by Indemnitee pursuant to Section 11 of this Agreement to enforce Indemnitee’s rights hereunder.

 

(g)          “Subsidiary” shall mean any corporation, partnership, limited liability company, joint venture, trust or other Entity of which the Company owns (either directly or through or together with another Subsidiary of the Company) either (i) a general partner, managing member or other similar interest or (ii) (A) 50% or more of the voting power of the voting capital equity interests of such corporation, partnership, limited liability company, joint venture or other Entity or (B) 50% or more of the outstanding voting capital stock or other voting equity interests of such corporation, partnership, limited liability company, joint venture or other Entity.

 

(h)          “to the fullest extent permissible by applicable law” shall include, but not be limited to: (i) the fullest extent permitted by the provisions of the General Corporation Law of the State of Delaware (the “DGCL”) that authorize or contemplate additional or supplementary indemnification by agreement, or the corresponding provisions of any amendment to or replacement of the DGCL or such provisions thereof; and (ii) the fullest extent authorized or permitted by any amendments to or replacements of the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its directors and/or officers.

 

2.            Services of Indemnitee. In consideration of the Company’s covenants and commitments hereunder, Indemnitee agrees to serve or continue to serve as a director and/or officer of the Company. However, this Agreement shall not impose any obligation on Indemnitee or the Company to continue Indemnitee’s service to the Company beyond any period otherwise required by law or by other agreements or commitments of the parties, if any.

 

3.            Agreement to Indemnify. The Company agrees to hold harmless and indemnify Indemnitee to the fullest extent permissible by applicable law as follows:

 

(a)          Proceedings. Subject to the exceptions contained in Section 4(a) below, if Indemnitee was or is a party or is threatened to be made a party to any Proceeding by reason of Indemnitee’s Corporate Status, Indemnitee shall be indemnified by the Company against all Expenses and Liabilities actually and reasonably incurred or paid by Indemnitee in connection with such Proceeding (referred to herein as “Indemnifiable Expenses “and “Indemnifiable Liabilities”, respectively, and collectively as “Indemnifiable Amounts”).

 

(b)          Conclusive Presumption Regarding Standard of Care. In making any determination required to be made under Delaware law with respect to entitlement to indemnification hereunder, the person, persons or entity making such determination shall presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee submitted a request therefor in accordance with Section 5 of this Agreement, and the Company shall have the burden of proof to overcome that presumption in connection with the making by any person, persons or Entity of any determination contrary to that presumption.

 

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4.            Exceptions to Indemnification. Subject to Section 20 below, Indemnitee shall be entitled to indemnification under Section 3(a) above in all circumstances and with respect to each and every specific claim, issue or matter involved in the Proceeding out of which Indemnitee’s claim for indemnification has arisen to the fullest extent permissible by applicable law, except as follows:

 

(a)          Proceedings. If indemnification is requested under Section 3(a) and it has been finally adjudicated by a court of competent jurisdiction that, in connection with such specific claim, issue or matter, Indemnitee failed to act (i) in good faith and (ii) in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, or, with respect to any criminal Proceeding, Indemnitee had reasonable cause to believe that Indemnitee’s conduct was unlawful, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder to the extent that they arise out of such claim, issue or matter.

 

(b)          Insurance Proceeds. To the extent payment is actually made to the Indemnitee under a valid and collectible insurance policy maintained at the expense of the Company in respect of Indemnifiable Amounts in connection with such specific claim, issue or matter, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder except in respect of any excess of such Indemnifiable Amounts beyond the amount of payment under such insurance.

 

5.            Procedure for Payment of Indemnifiable Amounts. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Amounts for which Indemnitee seeks payment under Section 3 of this Agreement and the basis for the claim. The Company shall pay such Indemnifiable Amounts to Indemnitee promptly, but in no event later than thirty (30) calendar days after receipt of such request. At the request of the Company, Indemnitee shall furnish such documentation and information as are reasonably available to Indemnitee and necessary to establish that Indemnitee is entitled to indemnification hereunder.

 

6.            Indemnification for Expenses of a Party Who is Wholly or Partly Successful. Notwithstanding any other provision of this Agreement, and without limiting any such provision, to the extent that Indemnitee is, by reason of Indemnitee’s Corporate Status, a party to and is successful, on the merits or otherwise, in any Proceeding, Indemnitee shall be indemnified to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify to the fullest extent permissible by applicable law Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with each successfully resolved claim, issue or matter. For purposes of this Agreement, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, by reason of settlement, judgment, order or otherwise, shall be deemed to be a successful result as to such claim, issue or matter.

 

7.            Effect of Certain Resolutions. Neither the settlement nor termination of any Proceeding nor the failure of the Company to award indemnification or to determine that indemnification is payable shall create a presumption that Indemnitee is not entitled to indemnification hereunder. In addition, the termination of any Proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent shall not create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, had reasonable cause to believe that Indemnitee’s action was unlawful.

 

8.            Agreement to Advance Expenses; Undertaking. The Company shall advance to the fullest extent permissible by applicable law all Expenses actually and reasonably incurred by or on behalf of Indemnitee in connection with any Proceeding in which Indemnitee is involved by reason of such Indemnitee’s Corporate Status within thirty (30) calendar days after the receipt by the Company of a written statement from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Advances shall be unsecured and interest free. Advances shall be made without regard to Indemnitee’s ability to repay the expenses and without regard to Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement. To the extent required by Delaware law, Indemnitee hereby undertakes to repay any and all of the amount of Indemnifiable Expenses paid to Indemnitee if it is finally determined by a court of competent jurisdiction that Indemnitee is not entitled under this Agreement to indemnification with respect to such Expenses. This undertaking is an unlimited general obligation of Indemnitee.

 

9.            Procedure for Advance Payment of Expenses. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Expenses for which Indemnitee seeks an advancement under Section 8 of this Agreement, together with documentation evidencing that Indemnitee has incurred such Indemnifiable Expenses.

 

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10.          Indemnification for Expenses of a Witness. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his or her Corporate Status, a witness in any Proceeding to which Indemnitee is not a party, he or she shall be indemnified by the Company to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection therewith.

  

11.Remedies of Indemnitee.

 

(a)         Right to Petition Court. In the event that Indemnitee makes a request for payment of Indemnifiable Amounts under Sections 3 and 5 above or a request for an advancement of Indemnifiable Expenses under Sections 8 and 9 above and the Company fails to make such payment or advancement in a timely manner pursuant to the terms of this Agreement, Indemnitee may petition the Court of Chancery of the State of Delaware to enforce the Company’s obligations under this Agreement.

 

(b)          Burden of Proof. In any judicial proceeding brought under Section 11(a) above, the Company shall have the burden of proving that Indemnitee is not entitled to payment of Indemnifiable Amounts hereunder.

 

(c)          Expenses. The Company agrees to reimburse Indemnitee in full for any Expenses in connection with any Proceeding incurred by Indemnitee in connection with investigating, preparing for, litigating, defending or settling any action brought by Indemnitee under Section 11(a) above, or in connection with any claim or counterclaim brought by the Company in connection therewith, whether or not Indemnitee is successful in whole or in part in connection with any such action, except to the extent that it has been finally adjudicated by a court of competent jurisdiction that such reimbursement would be unlawful.

 

(d)          Failure to Act Not a Defense. The failure of the Company (including its Board of Directors or any committee thereof, independent legal counsel or stockholders) to make a determination concerning the permissibility of the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses under this Agreement shall not be a defense in any action brought under Section 11(a) above, and shall not create a presumption that such payment or advancement is not permissible.

 

12.Defense of the Underlying Proceeding.

 

(a)          Notice by Indemnitee. Indemnitee agrees to notify the Company promptly upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding which may result in the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses hereunder; provided, however, that the failure to give any such notice shall not disqualify Indemnitee from the right, or otherwise affect in any manner any right of Indemnitee, to receive payments of Indemnifiable Amounts or advancements of Indemnifiable Expenses unless the Company’s ability to defend in such Proceeding is materially and adversely prejudiced thereby.

 

(b)          Defense by Company. Subject to the provisions of the last sentence of this Section 12(b) and of Section 12(c) below, the Company shall have the right to defend Indemnitee in any Proceeding which may give rise to the payment of Indemnifiable Amounts hereunder; provided, however, that the Company shall notify Indemnitee of any such decision to defend within ten (10) calendar days of the Company’s receipt of notice of any such Proceeding under Section 12(a) above. The Company shall not, without the prior written consent of Indemnitee, consent to the entry of any judgment against Indemnitee or enter into any settlement or compromise which (i) includes an admission of fault of Indemnitee or (ii) does not include, as an unconditional term thereof, the full release of Indemnitee from all liability in respect of such Proceeding, which release shall be in form and substance reasonably satisfactory to Indemnitee. This Section 12(b) shall not apply to a Proceeding brought by Indemnitee under Section 11(a) above or pursuant to Section 20 below.

 

(c)          Indemnitee’s Right to Counsel. Notwithstanding the provisions of Section 12(b) above, in any Proceeding to which Indemnitee is a party by reason of Indemnitee’s Corporate Status, at the Indemnittee’s option Indemnitee shall have the right to retain counsel of Indemnitee’s choice, at the expense of the Company, to represent Indemnitee in connection with any such matter and the Expenses incurred by Indemnitee in any such matter shall constitute Indemnifiable Expenses.

 

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13.          Representations and Warranties of the Company. The Company hereby represents and warrants to Indemnitee as follows:

 

(a)          Authority. The Company has all necessary power and authority to enter into, and be bound by the terms of, this Agreement, and the execution, delivery and performance of the undertakings contemplated by this Agreement have been duly authorized by the Company.

 

(b)          Enforceability. This Agreement, when executed and delivered by the Company in accordance with the provisions hereof, shall be a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization or similar laws affecting the enforcement of creditors’ rights generally.

 

14.          Insurance. The Company shall, from time to time, make the good faith determination whether or not it is practicable for the Company to obtain and maintain a policy or policies of insurance with a reputable insurance company providing the Indemnitee with coverage for losses from wrongful acts. For so long as Indemnitee shall have Corporate Status, Indemnitee shall be named as an insured in all policies of director and officer liability insurance in such a manner as to provide Indemnitee the same rights and benefits as are accorded to the most favorably insured of the Company’s officers and directors. If, at the time of the receipt of a notice of a claim pursuant to the terms of this Agreement, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies. Notwithstanding the foregoing, the Company shall have no obligation to obtain or maintain such insurance if the Company determines in good faith that such insurance is not reasonably available, if the premium costs for such insurance are disproportionate to the amount of coverage provided, or if the coverage provided by such insurance is limited by exclusions so as to provide an insufficient benefit.

 

15.          No Duplication of Payments. The Company shall not be liable under this Agreement to make any payment in connection with any claim made against Indemnitee to the extent Indemnitee has otherwise actually received payment under any insurance policy, provision of the Certificate or the Bylaws or otherwise of the amounts otherwise indemnifiable hereunder. The Company’s obligation to indemnify or advance Expenses hereunder to Indemnitee as a result of the Indemnitee’s Corporate Status with an Entity other than the Company shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of Expenses from such other Entity.

 

16.          Contract Rights Not Exclusive. The rights to payment of Indemnifiable Amounts and advancement of Indemnifiable Expenses provided by this Agreement shall be in addition to, but not exclusive of, any other rights which Indemnitee may have at any time under applicable law, the Certificate or Bylaws, or any other agreement, vote of stockholders or directors (or a committee of directors) or otherwise, both as to action in Indemnitee’s official capacity and as to action in any other capacity as a result of Indemnitee’s serving as a director of the Company.

 

17.          Successors. This Agreement shall be (a) binding upon all successors and assigns of the Company (including any transferee of all or a substantial portion of the business, stock and/or assets of the Company and any direct or indirect successor by merger or consolidation or otherwise by operation of law) and (b) binding on and shall inure to the benefit of the heirs, personal representatives, executors and administrators of Indemnitee. This Agreement shall continue for the benefit of Indemnitee and such heirs, personal representatives, executors and administrators after Indemnitee has ceased to have Corporate Status.

 

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18.          Change in Law. To the extent that a change in Delaware law (whether by statute or judicial decision) or the Certificate shall permit broader indemnification or advancement of expenses than is provided under the terms of the Bylaws and this Agreement, Indemnitee shall be entitled to such broader indemnification and advancements, and this Agreement shall be deemed to be amended to such extent.

 

19.          Severability. Whenever possible, each provision of this Agreement shall be interpreted in such a manner as to be effective and valid under applicable law, but if any provision of this Agreement, or any clause thereof, shall be determined by a court of competent jurisdiction to be illegal, invalid or unenforceable, in whole or in part, such provision or clause shall be limited or modified in its application to the minimum extent necessary to make such provision or clause valid, legal and enforceable, and the remaining provisions and clauses of this Agreement shall remain fully enforceable and binding on the parties.

 

20.          Indemnitee as Plaintiff. Except as provided in Section 11(c) of this Agreement and in the next sentence, Indemnitee shall not be entitled to payment of Indemnifiable Amounts or advancement of Indemnifiable Expenses with respect to any Proceeding brought by Indemnitee against the Company, any Subsidiary, any Entity which it controls, any director or officer thereof or any third party, unless the Board of Directors has consented to the initiation of such Proceeding or the Company provides indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law. This Section shall not apply to counterclaims or affirmative defenses asserted by Indemnitee in an action brought against Indemnitee.

 

21.          Modifications and Waivers; Counterparts. Except as provided in Section 18 above with respect to changes in Delaware law which broaden the right of Indemnitee to be indemnified by the Company or to receive advancements, no supplement, modification or amendment of this Agreement shall be binding unless executed in writing by each of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions of this Agreement (whether or not similar), nor shall such waiver constitute a continuing waiver. This Agreement may also be executed and delivered by facsimile signature and in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement.

 

22.          General Notices. All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when delivered by hand, (b) when transmitted by facsimile and receipt is acknowledged during normal business hours, and if not, the next business day after transmission or (c) if mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed:

 

(i)If to Indemnitee, to:

 

[●]

 

(ii)If to the Company, to:

 

Adial Pharmaceuticals Inc.

1180 Seminole Trail, Suite 495

Charlottesville, VA 22901

Attn: CEO

 

With copy to

_____________________

 

or to such other address as may have been furnished in the same manner by any party to the others.

 

 Page 26 of 28

 

 

23.          Governing Law; Consent to Jurisdiction; Service of Process. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without regard to its rules of conflict of laws. Each of the Company and Indemnitee hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the Court of Chancery of the State of Delaware and the courts of the United States of America located in the State of Delaware (the “Delaware Courts”) for any litigation arising out of or relating to this Agreement and the transactions contemplated hereby (and agrees not to commence any litigation relating thereto except in such courts), waives any objection to the laying of venue of any such litigation in the Delaware Courts and agrees not to plead or claim in any Delaware Court that such litigation brought therein has been brought in an inconvenient forum. Each of the parties hereto agrees, (a) to the extent such party is not otherwise subject to service of process in the State of Delaware, to appoint and maintain an agent in the State of Delaware as such party's agent for acceptance of legal process, and (b) that service of process may also be made on such party by prepaid certified mail with a proof of mailing receipt validated by the United States Postal Service constituting evidence of valid service. Service made pursuant to (a) or (b) above shall have the same legal force and effect as if served upon such party personally within the State of Delaware. For purposes of implementing the parties’ agreement to appoint and maintain an agent for service of process in the State of Delaware, each such party does hereby appoint The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, New Castle County, Delaware 19801, as such agent and each such party hereby agrees to complete all actions necessary for such appointment. Upon written application by Indemnitee to the Company, the Company shall, on an annual basis, reimburse Indemnitee the annual fee charged by The Corporation Trust Company to serve as Indemnitee’s agent for service of process within 30 days following the written application for reimbursement.

 

24.          Joinders. Subsidiaries of the Company may from time to time join this Agreement by signing a joinder in substantially the form attached hereto as Exhibit A. The Company and all Subsidiaries that have joined this Agreement shall be jointly and severally liable for all obligations of the Company under this Agreement.

 

25.          Assignment. Except as otherwise set forth herein, neither this Agreement nor any of the rights, interests or obligations hereunder may be assigned by any party hereto, without the prior written consent of all of the other parties hereto.

 

26.          Entire Agreement. Without limitation to the Certificate and the Bylaws, this Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.

 

[The remainder of this page is intentionally blank]

 

 Page 27 of 28

 

 

IN WITNESS WHEREOF, the parties hereto have executed this Indemnification Agreement as of the day and year first above written.

 

  ADIAL PHARMACEUTICALS INC.
     
  By: /s/        
    Name:
    Title:

  

  INDEMNITEE
     
  /s/     
  Name:

 

 

Page 28 of 28

 

EX-10.17 42 fs12017ex10-17_adialpharma.htm EMPLOYMENT AGREEMENT - TOMASZ H. ZASTAWNY

Exhibit 10.17

 

EMPLOYMENT AGREEMENT

 

This Employment Agreement (this “Agreement”) is entered into as of [_______], 2017 (the “Effective Date”) by and between Adial Pharmaceuticals, Inc., a Delaware corporation, (the “Company”), and Tomasz H. Zastawny, Ph.D. (the “Executive”).

 

Recitals

 

WHEREAS, the Company desires to employ the Executive as a full-time employee of the Company and the Executive desires to accept employment with the Company upon the terms and conditions hereinafter set forth.

 

NOW THEREFORE, in consideration of the premises and the mutual covenants hereinafter set forth, and intending to be legally bound hereby, it is hereby agreed as follows:

 

Agreement

 

1.       Definitions.

 

1.1.       “Affiliate” means as to any Person, any other Person that directly or indirectly controls, or is under common control with, or is controlled by, such first Person. As used in this definition, “control” (including, with its correlative meanings, “controlled by” and “under common control with”) shall mean possession, directly or indirectly, of power to direct or cause the direction of management or policies (whether through ownership of voting equity interests, by contract or otherwise). For the avoidance of doubt, each member of the Company Group (other than the Company) is an Affiliate of the Company.

 

1.2.       “Board” means the Board of Directors of the Company.

 

1.3.       “Cause” means the Executive’s: (i) conviction for, or entering of a plea of guilty or nolo contendere (or its equivalent under any applicable legal system) with respect to: (A) a felony or (B) any crime involving moral turpitude; (ii) commission of fraud, misrepresentation, embezzlement or theft against any Person; (iii) engaging in any intentional activity that injures or would reasonably be expected to injure (monetarily or otherwise), in any material respect, the reputation, the business or a business relationship of the Company or any of its Affiliates; (iv) gross negligence or willful misconduct in the performance of the Executive’s duties to the Company or its Affiliates under this Agreement, or willful refusal or failure to carry out the lawful instructions of the Board that are consistent with the Executive’s title and position; (v) violation of any fiduciary duty owed to the Company or any of its Affiliates; or (vi) breach of any Restrictive Covenant (as defined below) or material breach or violation of any other provision of this Agreement, of a written policy or code of conduct of the Company or any of its Affiliates (as in effect from time to time) or any other agreement between the Executive and the Company or any of its Affiliates. Except when such acts constituting Cause which, by their nature, cannot reasonably be expected to be cured, the Executive shall have twenty (20) days following the delivery of written notice by the Company of its intention to terminate the Executive’s employment for Cause within which to cure any acts constituting Cause. Following such twenty (20) day cure period, and if the reason stated in the notice is not cured, the Executive shall be given five (5) business days prior written notice to appear (with or without counsel) before the full Board for the opportunity to present information regarding his views on the alleged Cause event. After the Company provides the original notice of its intent to terminate Executive’s employment for Cause, the Company may suspend the Executive, with pay, from all his duties and responsibilities and prevent him from accessing the Company’s or its Affiliates’ premises or contacting any personnel of the Company or any of its Affiliates until a final determination on the hearing is made. The Executive will not be terminated for Cause until a majority of the independent directors approve such termination following the hearing.

 

 

 

 

1.4.       “Change of Control” means: (i) the accumulation (if over time, in any consecutive twelve (12) month period), whether directly, indirectly, beneficially or of record, by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended) of 50.1% or more of the shares of the outstanding voting securities of the Company, whether by merger, consolidation, sale or other transfer of shares (other than a merger or consolidation where the stockholders of the Company immediately prior to the merger or consolidation are immediately after such merger or consolidation the direct or indirect beneficial owners of a majority of the voting securities of the entity that survives such merger or consolidation), (ii) a sale of all or substantially all of the assets of the Company and its Subsidiaries, determined on a consolidated basis; (iii) a merger or consolidation of the Company in which its voting securities immediately prior to the merger or consolidation do not represent, or are not converted into securities that represent, a majority of the voting power of all voting securities of the surviving entity immediately after the merger or consolidation; or (iv) during any period of twelve (12) consecutive months, the Continuing Directors cease for any reason to constitute at least a majority of the Board even if one of such Continuing Directors were to resign and not be replaced by a Continuing Director; provided, however, that the following acquisitions shall not constitute a Change of Control for the purposes of this Agreement: (A) any acquisitions of voting securities or securities convertible, exercisable or exchangeable into voting securities directly from the Company or (B) any acquisition of voting securities or securities convertible, exercisable or exchangeable into voting securities by any employee benefit plan (or related trust) sponsored by or maintained by the Company or any of its Subsidiaries; provided further, that a transaction will not be a Change of Control unless it satisfies the requirements of Treasury Regulation 1.409A-3(i)(5)(v), (vi) or (vii).

 

1.5.       “Code” means the Internal Revenue Code of 1986, as amended.

 

1.6.       “Company Group” means the Company and the direct and indirect Subsidiaries of the Company.

 

1.7.       “Company Invention” means any Invention that is Invented by the Executive (alone or jointly with others) (i) in the course of, in connection with, or as a result of the Executive’s employment or other service with any member of the Company Group (whether before, on or after the Effective Date), (ii) at the direction or request of any member of the Company Group, or (iii) through the use of, or that is related to, facilities, equipment, Confidential Information, other Company Inventions, intellectual property or other resources of any member of the Company Group, whether or not during the Executive’s work hours.

  

  Page 2 of 28

 

 

1.8.       “Confidential Information” shall mean all information of a sensitive, confidential or proprietary nature respecting the business and activities of any member of the Company Group or any of their respective Affiliates, or the predecessors and successors of any member of the Company Group or any of their respective Affiliates, including, without limitation, the terms and provisions of this Agreement (except for the terms and provisions of Sections 4.4 through 4.17), and the clients, customers, suppliers, computer or other files, projects, products, computer disks or other media, computer hardware or computer software programs, marketing plans, financial information, methodologies, Inventions, know-how, research, developments, processes, practices, approaches, projections, forecasts, formats, systems, data gathering methods and/or strategies of any member of the Company Group or any of their respective Affiliates. “Confidential Information” also includes all information received by the Company or any other member of the Company Group under an obligation of confidentially to a third party. Notwithstanding the foregoing, Confidential Information shall not include any information that is generally available, or is made generally available, to the public other than as a result of a direct or indirect unauthorized disclosure by the Executive or any other Person subject to a confidentiality obligation.

 

1.9.       “Continuing Director” means an individual who: (i) at the beginning of the preceding twelve (12) month period, was a director of the Board, and (ii) any new director whose election by the Board or nomination for election by the Company’s stockholders was approved by a vote of at least a majority of the directors then still in office who either were directors at the beginning of the 12-month period or whose election or nomination for election was previously so approved.

 

1.10.       “Disability” means that the Executive has been unable, as reasonably determined by the Board (excluding the Executive) in good faith, to perform the Executive’s duties under this Agreement for a period of ninety (90) consecutive days or for a total of one hundred and twenty (120) days (whether or not consecutive) during any period of twelve (12) consecutive months, as a result of injury, illness or any other physical or mental impairment.

 

1.11.       “Good Reason” means any of the following actions taken by the Company without the Executive’s prior written consent: (i) a material reduction in the Executive’s duties, responsibilities or authority; (ii) a reduction of the Executive’s Base Salary (defined below); (iii) failure or refusal of a successor to the Company to either materially assume the Company’s obligations under this Agreement or enter into a new employment agreement with the Executive on terms that are materially similar to those provided under this Agreement, in any case, in the event of a Change of Control; (iv) relocation of the Executive’s primary work location that results in an increase in the Executive’s one-way driving distance by more than twenty-five (25) miles from the Executive’s then-current principal residence; or (v) a material breach of this Agreement by the Company. Notwithstanding the foregoing, Good Reason shall not be deemed to exist unless: (A) the Executive gives the Company written notice within sixty (60) days after the occurrence of the event which the Executive believes constitutes the basis for Good Reason, specifying the particular act or failure to act which the Executive believes constitutes the basis for Good Reason, (B) the Company fails to cure such act or failure to act within thirty (30) days after receipt of such notice and (C) the Executive terminates his employment within thirty (30) days after the end of such thirty (30) day cure period specified in clause (B).

 

  Page 3 of 28

 

 

1.12.       “Invented” means made, conceived, invented, authored, or first actually reduced to practice (in any case, whether partially or fully).

 

1.13.       “Invention” means any invention, formula, therapy, diagnostic technique, discovery, improvement, idea, technique, design, method, art, process, methodology, algorithm, machine, development, product, service, technology, strategy, software, work of authorship or other Works (as defined in Section 4.13), trade secret, innovation, trademark, data, database, or the like, whether or not patentable, together with all intellectual property rights therein.

 

1.14.       “Person” means an individual, partnership, limited liability company, corporation, association, joint stock company, trust, joint venture, unincorporated organization, investment fund, any other business entity and a governmental entity or any department, agency or political subdivision thereof.

 

1.15.       “Subsidiary” means, with respect to any Person, any other Person in which such first Person has a direct or indirect equity ownership interest of at least 50%.

 

1.16.       “Term of Employment” means the period commencing on the date hereof and ending on the third (3rd) anniversary of Executive’s employment under this Agreement.

 

1.17.       “Termination Date” means the date the Executive’s employment with the Company terminates for any reason.

 

2.       Employment.

 

2.1.       Executive’s Representations. The Executive represents that: (i) the Executive is entering into this Agreement voluntarily and that the Executive’s employment hereunder and compliance with the terms and conditions hereof will not conflict with or result in the breach by the Executive of any agreement to which the Executive is a party or by which the Executive may be bound and (ii) in connection with the Executive’s employment with the Company or any other member of the Company Group, the Executive will not: (A) violate any non-competition, non-solicitation or other similar covenant or agreement by which the Executive is or may be bound or (B) use any confidential or proprietary information that the Executive may have obtained in connection with the Executive’s employment or engagement with any other Person.

 

2.2.       Position; Duties and Responsibilities. During the Term of Employment, the Executive shall be employed as the Company’s Chief Development Officer, with such duties and responsibilities that are consistent with such position as may be assigned by the Board (excluding the Executive) from time to time. In addition, during the Term of Employment, the Executive shall serve in such other officer and/or director positions with any member of the Company Group (for no additional compensation) as may be determined by the Board (excluding the Executive) from time to time. The Executive further agrees that, during the Term of Employment, he shall not knowingly take any action that is contrary to, or in conflict with, the best interests of the Company Group.

  

  Page 4 of 28

 

 

2.3.       Reporting; Outside Activities. During the Term of Employment, the Executive shall report to the Chief Executive Officer, and the Executive shall diligently and conscientiously devote the Executive’s business time, attention, energy, skill and best efforts as necessary, but in no event less than seventy percent (70%) of his business time, to the business and affairs of the Company Group. The Executive may also: (i) continue to serve as a member of the board of or as an advisor to any organization listed in Exhibit A hereto, (ii) serve on other boards or as an advisor as may be approved by the Board (excluding the Executive) in its sole discretion, (iii) engage in educational, charitable and civic activities and (iv) manage the Executive’s personal and business investments and affairs, so long as such activities: (A) do not, individually or in the aggregate, interfere with the performance of the Executive’s duties under this Agreement and (B) are not contrary to the interests of the Company Group or competitive in any way with the Company Group. Subject to the foregoing, during the Term of Employment, the Executive shall not, directly or indirectly, render any services of a business, commercial, or professional nature to any other Person, whether for compensation or otherwise, without the prior written consent of the Board (excluding the Executive), which consent shall not be unreasonably withheld.

 

3.       Compensation and Other Benefits.

 

3.1.       Base Salary. During the Term of Employment, the Executive shall initially receive an initial base salary per annum of Two Hundred Sixty Thousand ($260,000) Dollars, payable in cash in accordance with the Company’s normal payroll practices as in effect from time to time. During the Term of Employment, the Board may periodically review the Executive’s base salary and the Board (excluding the Executive) may, in its sole discretion, set such base salary to an amount it determines to be appropriate, provided, however, that any reduction will qualify as Good Reason under Section 1.11. The Executive’s base salary, as may be in effect from time to time, is referred to herein as “Base Salary.”

 

3.2.       Annual Bonus. During the Term of Employment, the Executive shall be eligible to earn an annual performance bonus based on the achievement of the performance goals established by the Board or a committee thereof in its sole discretion, with an annual target bonus opportunity of twenty (20%) percent of the Base Salary and the potential to earn a higher bonus for above target performance, with the amount of any such bonus to be determined in the sole discretion of the Board or a committee thereof, in any case, excluding the Executive (the “Annual Bonus”). Any Annual Bonus earned for any performance period may be paid in cash or any equity or equity-based awards (or any combination thereof), as determined in the sole discretion of the Board or a committee thereof, in any case, excluding the Executive, with such determination to be made before January 1 of the performance period to which such Annual Bonus relates (or such later date permitted under Section 409A (as defined below)). Any earned Annual Bonus that is payable in cash shall be paid in a lump sum, and any earned Annual Bonus that is payable in equity or equity-based awards shall be granted, in any case, by no later than the first March 15th to occur after the end of the applicable performance period. The Board (excluding the Executive) shall act in good faith in determining the value of the portion of any earned Annual Bonus that will be paid in the form of equity or equity-based awards. Except as set forth in Section 4.2, the Executive must be employed by the Company on the bonus payment date in order to receive an earned Annual Bonus with respect to any performance period.

 

  Page 5 of 28

 

 

3.3.       Equity Grants. During the Term of Employment, the Executive shall be eligible for equity or equity-based awards that may be granted to the Executive at such times, in such amounts and in such manner as the Board (excluding the Executive) may determine in its sole discretion, but, in good faith, taking into account the roles of and responsibilities of Executive relative to industry norms for similar positions. Any such equity or equity-based awards shall be subject to the terms and conditions set forth in the applicable plan and award agreement.

 

3.4.       Expense Reimbursement. During the Term of Employment, the Company shall reimburse the Executive’s reasonable and necessary business expenses incurred in connection with performing the Executive’s duties hereunder in accordance with its then-prevailing policies and procedures for expense reimbursement (which shall include appropriate itemization and substantiation of expenses incurred).

 

3.5.       Benefit Plans; Vacation. During the Term of Employment, the Executive shall be entitled to participate in all broad-based employee benefit plans and programs maintained from time to time for the benefit of the Company’s employees (e.g., medical, dental and disability benefits) to the extent that the Executive satisfies the eligibility requirements of such plans or programs (including, without limitation, minimum hours worked) and subject to applicable law and the terms and conditions of such plans or programs; provided, however, that the Company may amend, modify or terminate any such plans or programs at any time in its discretion. During the Term of Employment, the Executive shall be entitled to twenty five (25) days of paid time off per calendar year (pro-rated for partial years), subject to the Company’s paid time off policy, as in effect from time to time.

 

4.       Termination; Restrictive Covenants. Upon the Termination Date, the Executive shall be deemed to have immediately resigned from any and all officer, director and other positions the Executive then holds with the Company and its Affiliates (and this Agreement shall constitute notice of resignation by the Executive without any further action by the Executive), and the Executive agrees to execute and deliver such further instruments as are requested by the Company in furtherance of the foregoing. Except as expressly provided in Section 4.2, all rights the Executive may have to compensation and employee benefits from the Company or its Affiliates shall terminate immediately upon the Termination Date. Notwithstanding the above, if Executive’s deemed resignation as a director of the Board shall not be effective unless such resignation is accepted by the Board (excluding Executive) within thirty (30) days of the Termination Date.

 

4.1.       General. The Company may terminate the Term of Employment and the Executive’s employment at any time, with or without Cause or due to Disability, upon written notice to the Executive. The Executive may terminate the Term of Employment and the Executive’s employment for Good Reason or for any other reason at any time upon not less than sixty (60) days’ prior written notice to the Company; provided, that following its receipt of the Executive’s notice of termination, the Company may elect to reduce the notice period and cause the Termination Date to occur earlier, and action by the Company shall entitle the Executive to notice pay, severance pay or benefits or pay in lieu of notice or lost wages or benefits. In addition, the Term of Employment and the Executive’s employment with the Company shall terminate immediately upon the Executive’s death.

 

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4.2.       Separation Payments.

 

4.2.1.       General. Except as otherwise provided in this Section 4.2, in the event that the Executive’s employment with the Company terminates for any reason, the Executive (or the Executive’s estate or legal representative, as applicable) shall be entitled to receive only: (i) the cash portion of the Base Salary earned but unpaid through the Termination Date, paid in accordance with the Company’s normal payroll policies (or at such earlier time as required by applicable law), (ii) any accrued but unused vacation in accordance with the Company’s policies and applicable law, (iii) any unreimbursed business expenses incurred prior to the Termination Date that are otherwise reimbursable, with such expenses to be reimbursed in accordance with the Company’s expense reimbursement policies (as may be in effect from time to time), and (iv) any vested benefits earned by the Executive under any employee benefit plan of the Company or its Affiliates under which the Executive was participating immediately prior to the Termination Date, with such benefits to be provided in accordance with the terms of the applicable employee benefit plan (the items described in the foregoing clauses (i) through (iv), collectively, the “Accrued Benefits”). All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in Sections 4.2.2 or 4.2.3, shall immediately terminate upon the Termination Date.

 

4.2.2.       Death and Disability. In the event that the Executive’s employment is terminated due to the Executive’s death or by the Company due to Disability, in either case, during the Term of Employment, then in addition to the Accrued Benefits, and subject to Section 4.2.4, the Executive (or the Executive’s estate or legal representative, as applicable) shall be entitled to receive: (i) the Annual Bonus earned in the fiscal year immediately preceding the fiscal year in which such termination occurred, to the extent that such Annual Bonus is unpaid as of the Termination Date, with such amount to be payable in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred (the “Unpaid Prior Year Bonus”); (ii) the Annual Bonus for the year in which the Termination Date occurs, but multiplied by a fraction (A) the numerator of which is the number of days in the fiscal year that have transpired through the Termination Date and (B) the denominator of which is the number of days in such fiscal year (to be paid in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred); (iii) if the Executive and his eligible dependents are eligible for, and timely elect COBRA continuation coverage, the Company shall reimburse the Executive (or the Executive’s estate or legal representative, as applicable) for the COBRA premiums for the Executive and his eligible dependents under the Company’s medical, dental and vision benefit plans for a period of 12 months following the Termination Date (the “COBRA Benefit”); provided, however, that notwithstanding the foregoing, the COBRA Benefit shall not be provided to the extent that it would result in any fine, penalty or tax on the Company or any of its Affiliates (under Section 105(h) of the Code or the Patient Protection and Affordable Care Act of 2010, or otherwise); provided further, that the COBRA Benefit shall cease earlier if the Executive or his dependents become eligible for health coverage under the health plan of another employer; and (iv) to the extent the following will not result in a violation of Section 409A, with respect to each equity award received by Executive from the Company or any of its direct or indirect parent companies that is outstanding as of the Termination Date, accelerated vesting immediately upon the Termination Date of, (I) with respect to any such equity award received in payment of Base Salary or an Annual Bonus, 100% of such equity award and, (II) with respect to any equity award not described in clause (I), the greater of (x) the portion of the unvested equity award that would have become vested within 12 months after the Termination Date had the Executive remained employed by the Company during such 12-month period (without regard for the vesting schedule set forth in any applicable plan or agreement governing such equity award) or (y) the portion of the unvested equity award that is subject to accelerated vesting (if any) upon such termination under the applicable equity plan or award agreement; provided, however, that any equity awards that are subject to the satisfaction of performance goals shall be deemed earned at not less than target performance; and provided, further, that, with respect to any equity award that is in the form of a stock option or stock appreciation right, the option or stock appreciation right shall remain outstanding and exercisable for 12 months following the Termination Date or, if longer, such period following the Termination Date as provided under the applicable equity plan or award agreement (but in no event beyond the expiration date of the applicable option or stock appreciation right). All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in this Section 4.2.2, shall immediately terminate upon the Termination Date.

 

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4.2.3.       Termination Without Cause or for Good Reason. If, during the Term of Employment, the Executive’s employment is terminated by the Company without Cause (and not due to death or Disability) or by Executive for Good Reason, in either case, then the Executive shall be entitled to receive the Accrued Benefits and, subject to Section 4.2.4: (i) the Unpaid Prior Year Bonus, with such amount to be payable in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred; (ii) the Annual Bonus for the year in which the Termination Date occurs, but multiplied by a fraction (A) the numerator of which is the number of days in the fiscal year that have transpired through the Termination Date and (B) the denominator of which is the number of days in such fiscal year (to be paid in cash and/or fully vested shares of the Company’s common stock (as determined by the Company in its sole discretion) at the same time as if no such termination had occurred); (iii) continuation of the Base Salary as of the Termination Date for six (6) months following the Termination Date, with all portions of such Base Salary to be paid in cash in equal installments in accordance with the Company’s normal payroll policies, with the first such payment to be made on the sixtieth (60th) day following the Termination Date and to include a catch-up covering any payroll dates between the Termination Date and the date of the first payment, and (iv) the COBRA Benefit for a period of twelve (12) months following the Termination Date; provided, however, that notwithstanding the foregoing, the COBRA Benefit shall not be provided to the extent that it would result in any fine, penalty or tax on the Company or any of its Affiliates (under Section 105(h) of the Code or the Patient Protection and Affordable Care Act of 2010, or otherwise); provided further, that the COBRA Benefit shall cease earlier if the Executive (or his dependents) become eligible for health coverage under the health plan of another employer. All other rights the Executive may have to compensation and employee benefits from the Company or its Affiliates, other than as set forth in this Section 4.2.3, shall immediately terminate upon the Termination Date.

 

4.2.4.       Release Requirement. Payment and provision of the benefits set forth in Sections 4.2.2 or 4.2.3 (other than the Accrued Benefits) is subject to the Executive’s (or, as applicable, the Executive’s estate’s or legal representative’s) execution of a general release of claims and covenant not to sue in form and substance satisfactory to the Company, such that such release becomes effective, with all revocation periods having expired unexercised, within sixty (60) days after the Termination Date. Notwithstanding the foregoing, if such sixty (60) day period ends in a calendar year after the calendar year in which the Executive’s employment terminates, then to the extent required by Section 409A, any severance payment set forth in Sections 4.2.2 or 4.2.3 (other than the Accrued Benefits) that would have been made during the calendar year in which the Executive’s employment terminates instead shall be withheld and paid on the first payroll date in the calendar year after the calendar year in which the Executive’s employment terminates, with all remaining payments to be made as if no such delay had occurred.

 

4.3.       Violation of Restrictive Covenants. Without limiting the remedies provided to the Company and its Affiliates as set forth in this Article 4, upon the Executive’s breach of any of the Restrictive Covenants (as defined below), other than any immaterial and unintentional breach by the Executive of the confidentiality obligations set forth in Section 4.11, the Company will have no obligation to continue to pay or provide any of the compensation or benefits under Section 4.2 (other than the Accrued Benefits) and the Executive shall repay to the Company any amounts paid under Section 4.2 (other than the Accrued Benefits) after such breach occurred.

 

4.4.       Restrictive Covenants. As an inducement and as essential consideration for the Company to enter into this Agreement, and in exchange for other good and valuable consideration, the Executive hereby agrees to the restrictive covenants contained in Sections 4.5 through 4.17 (the “Restrictive Covenants”). The Company and the Executive agree that the Restrictive Covenants are essential and narrowly tailored to preserve the goodwill of the business of the Company and its Affiliates, to maintain the confidential and trade secret information of the Company and its Affiliates, and to protect other legitimate business interests of the Company and its Affiliates, and that the Company would not have entered into this Agreement without the Executive’s agreement to the Restrictive Covenants. For purposes of the Restrictive Covenants, each reference to “Company,” “Company Group” and “Affiliate,” shall also refer to the predecessors and successors of the Company, the members of the Company Group and any of their Affiliates (as the case may be).

 

4.5.       Non-Competition. During the period commencing on the Effective Date and ending twenty four (24) months after the Termination Date (the “Restrictive Period”), regardless of the reason for Executive’s termination of employment, the Executive shall not, in any state of the United States or European Union where the Company conducts business as of the Termination Date, engage in, or own, manage, operate or control, or participate in the ownership, management, operation or control of any business or entity that develops, sells or provides products or services competitive with the products or services developed, sold or provided by any member of the Company Group at the time of cessation of the employment of Executive. Notwithstanding the foregoing, nothing in this Section 4.5 shall prevent the Executive from owning, as a passive investor, up to five percent (5%) of the securities of any entity that are publicly traded on a national securities exchange. For the avoidance of doubt, nothing in this Section 4.5 prevents the Executive from working in the pharmaceutical industry as long as such positions and activities are not competitive with the business of the Company Group. As used in this Section 4.5, “competitive” shall mean products or services using the same mechanism of action or for the treatment of the same (or substantially similar) indication. Executive agrees that this covenant is reasonable with respect to its duration, geographical area, and scope.

 

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4.6.       Customer Non-Solicitation. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Executive’s employment with the Company), for purposes of providing products or services that are competitive with those provided by any member of the Company Group, on the Executive’s own behalf or on behalf of any other Person, solicit any customer or client of any member of the Company Group with whom the Executive had contact, solicited, or served within the twelve (12) months prior to the Termination Date.

 

4.7.       Customer Non-Acceptance. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Executive’s employment with the Company), for purposes of providing products or services that are competitive with those provided by any member of the Company Group, on the Executive’s own behalf or on behalf of any other Person, accept business from any customer or client of any member of the Company Group with whom the Executive had contact, solicited, or served within the twelve (12) months prior to the Termination Date.

 

4.8.       Employee and Independent Contractor Non-Solicitation. During the period commencing on the Effective Date and ending twelve (12) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Term of Employment), on the Executive’s own behalf or on behalf of any other Person, solicit for employment or engagement any individual who: (A) is employed by, or an independent contractor of, any member of the Company Group at the time of such solicitation or (B) was employed by, or an independent contractor of, any member of the Company Group within twelve (12) months prior to such solicitation.

 

4.9.       Employee and Independent Contractor Non-Acceptance. During the period commencing on the Effective Date and ending twenty four (24) months after the Termination Date, regardless of the reason for Executive’s termination of employment, the Executive shall not (except on the Company’s behalf during the Term of Employment), on the Executive’s own behalf or on behalf of any other Person, employ or engage any individual who (A) is employed by, or an independent contractor of, any member of the Company Group at the time of such employment or engagement or (B) was employed by, or an independent contractor of, any member of the Company Group within twelve (12) months prior to such employment or engagement.

 

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4.10.       Non-Disparagement. During the Term of Employment and at all times thereafter, neither the Company nor the Executive shall not, directly or through any other Person make any public or private statements (whether orally, in writing, via electronic transmission, or otherwise) that disparage, denigrate or malign the other party or any of the Company’s respective businesses, products, services, activities, operations, affairs, reputations or prospects; or any of the Company’s respective officers, employees, directors, partners (general and limited), agents, members or shareholders. For purposes of clarification, and not limitation, a statement shall be deemed to disparage, denigrate or malign the other party if such statement could be reasonably construed to adversely affect the opinion any other Person may have or form of such first Person. The foregoing limitations shall not be violated by truthful statements made by the Executive or the Company: (i) to any governmental authority or (ii) which are in response to legal process, required governmental testimony or filings, or administrative or arbitral proceedings (including, without limitation, depositions in connection with such proceedings).

 

4.11.       Confidentiality; Return of Property. During the Term of Employment and for a period of seven (7) years thereafter, the Executive shall not, without the prior express written consent of the Company, directly or indirectly, use on the Executive’s behalf or on behalf of any other Person, or divulge, disclose or make available or accessible to any Person, any Confidential Information, other than when required to do so in good faith to perform the Executive’s duties and responsibilities hereunder while employed by any member of the Company Group, when required to do so by a lawful order of a court of competent jurisdiction, any governmental authority or agency, or any recognized subpoena power, or in connection with reporting possible violations of federal law or regulation to any governmental agency or entity, or making other disclosures that are protected under the whistleblower provisions of federal law or regulation. In the event that the Executive becomes legally compelled (by oral questions, interrogatories, request for information or documents, subpoena, criminal or civil investigative demand or similar process) to disclose any Confidential Information, then prior to such disclosure, the Executive will provide the Board with prompt written notice so that the Company may seek (with the Executive’s cooperation) a protective order or other appropriate remedy and/or waive compliance with the provisions of this Agreement. In the event that such protective order or other remedy is not obtained, then the Executive will furnish only that portion of the Confidential Information which is legally required, and will cooperate with the Company in the Company’s efforts to obtain reliable assurance that confidential treatment will be accorded to the Confidential Information. In addition, the Executive shall not create any derivative work or other product based on or resulting from any Confidential Information (except in the good faith performance of the Executive’s duties under this Agreement while employed by any member of the Company Group). The Executive shall also proffer to the Board’s designee, no later than the Termination Date (or upon the earlier request of the Company), and without retaining any copies, notes or excerpts thereof, all property of the Company and its Affiliates, including, without limitation, memoranda, computer disks or other media, computer programs, diaries, notes, records, data, customer or client lists, marketing plans and strategies, and any other documents consisting of or containing Confidential Information, that are in the Executive’s actual or constructive possession or which are subject to the Executive’s control at such time. To the extent the Executive has retained any such property or Confidential Information on any electronic or computer equipment belonging to the Executive or under the Executive’s control, the Executive agrees to so advise Company and to follow Company’s instructions in permanently deleting all such property or Confidential Information and all copies. Notwithstanding the foregoing, in accordance with the Defend Trade Secrets Act of 2016, the Executive shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that: (a) is made (I) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and (II) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.

 

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4.12.       Ownership of Inventions. The Executive acknowledges and agrees that all Company Inventions (including all intellectual property rights arising therein or thereto, all rights of priority relating to patents, and all claims for past, present and future infringement, misappropriation relating thereto), and all Confidential Information, hereby are and shall be the sole and exclusive property of the Company (collectively, the “Company IP”). The Executive further acknowledges and agrees that any rights arising in the Executive in any Invention Invented by the Executive, whether alone or jointly with others, during the twelve (12) months following the Termination Date and relating in any way to work performed by the Executive for any member of the Company Group during the Executive’s employment with or service for any member of the Company Group (“Post-employment Inventions”), shall hereby be deemed to be Company Inventions and the sole and exclusive property of the Company; provided, however, that the Board (excluding the Executive) in its sole discretion may elect to compensate the Executive for any Post-employment Inventions. For consideration acknowledged and received, the Executive hereby irrevocably assigns, conveys and sets over to the Company all of the Executive’s right, title and interest in and to all Company IP. The Executive acknowledges and agrees that the compensation received by the Executive for employment or services provided to the Company is adequate consideration for the foregoing assignment. The Executive further agrees to disclose in writing to the Board any Company Inventions (including, without limitation, all Post-employment Inventions), promptly following their conception or reduction to practice. Such disclosure shall be sufficiently complete in technical detail and appropriately illustrated by sketch or diagram to convey to one skilled in the art of which the Company Invention pertains, a clear understanding of the nature, purpose, operations, and other characteristics of the Company Invention. The Executive agrees to execute and deliver such deeds of assignment or other documents of conveyance and transfer as the Company may request to confirm in the Company or its designee the ownership of the Company Inventions, without compensation beyond that provided in this Agreement. The Executive further agrees, upon the request of the Company and at its expense, that the Executive will execute any other instrument and document necessary or desirable in applying for and obtaining patents in the United States and in any foreign country with respect to any Company Invention. The Executive further agrees, whether or not the Executive is then an employee or other service provider of any member of the Company Group, upon request of the Company, to provide reasonable assistance, at the Company’s sole expense, with respect to the perfection, recordation or other documentation of the assignment of Company IP hereunder, and the enforcement of the Company’s rights in any Company IP, and to cooperate to the extent and in the manner reasonably requested by the Company, subject to the Executive’s then schedule, in any litigation or other claim or proceeding (including, without limitation, the prosecution or defense of any claim involving a patent) involving any Company IP covered by this Agreement, with compensation at the Executive’s customary hourly rate, together with all reasonable out-of-pocket expenses incurred by the Executive in satisfying the requirements of this Section 4.12 shall be paid by the Company or its designee. The Executive shall not, on or after the date of this Agreement, directly or indirectly challenge the validity or enforceability of the Company’s ownership of, or rights with respect to, any Company IP, including, without limitation, any patent issued on, or patent application filed in respect of, any Company Invention.

  

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4.13.       Works for Hire. The Executive also acknowledges and agrees that all works of authorship, in any format or medium, and whether published or unpublished, created wholly or in part by the Executive, whether alone or jointly with others: (i) in the course of, in connection with, or as a result of the Executive’s employment or other service with any member of the Company Group (whether before or after the Effective Date), (ii) at the direction or request of any member of the Company Group, or (iii) through the use of, or that is related to, facilities, equipment, Confidential Information, other Company Inventions, intellectual property or other resources of any member of the Company Group, whether or not during the Executive’s work hours (“Works”), are works made for hire as defined under United States copyright law, and that the Works (and all copyrights arising in the Works) are owned exclusively by the Company and all rights therein will automatically vest in the Company without the need for any further action by any party. To the extent any such Works are not deemed to be works made for hire, for consideration acknowledged and received, the Executive hereby waives any “moral rights” in such Works and the Executive hereby irrevocably assigns, transfers, conveys and sets over to the Company or its designee, without compensation beyond that provided in this Agreement, all right, title and interest in and to such Works, including without limitation all rights of copyright arising therein or thereto, and further agrees to execute such assignments or other deeds of conveyance and transfer as the Company may request to vest in the Company or its designee all right, title and interest in and to such Works, including all rights of copyright arising in or related to the Works.

 

4.14.       Cooperation. During and after the Term of Employment, the Executive agrees to cooperate with the Company Group in any internal investigation, any administrative, regulatory, or judicial proceeding or any dispute with a third party concerning issues about which the Executive has knowledge or that may relate to the Executive or the Executive’s employment with the Company. The Executive’s obligation to cooperate hereunder includes, without limitation, being available to the Company Group upon reasonable notice for interviews and factual investigations, appearing in any forum at the Company Group’s request to give testimony (without requiring service of a subpoena or other legal process), volunteering to the Company Group pertinent information, and turning over to the Company Group all relevant documents which are or may come into the Executive’s possession. The Company shall promptly compensate the Executive at his usual and customary hourly rate, plus reimburse the Executive for the reasonable out of pocket expenses incurred by the Executive in connection with such cooperation.

 

4.15.       Injunctive Relief. The Executive acknowledges and agrees that the Company and its Affiliates will have no adequate remedy at law and would be irreparably harmed if the Executive breaches or threatens to breach any of the Restrictive Covenants. The Executive agrees that the Company and its Affiliates shall be entitled to equitable and/or injunctive relief to prevent any breach or threatened breach of any of the Restrictive Covenants, and to specific performance of each of the terms thereof, in each case, in addition to any other legal or equitable remedies that the Company and its Affiliates may have, as well as the costs and reasonable attorneys’ fees it/they incur in enforcing any of the Restrictive Covenants. The Executive further agrees that: (i) any breach or claimed breach of the provisions set forth in this Agreement by, or any other claim the Executive may have against, the Company or any of its Affiliates will not be a defense to enforcement of any Restrictive Covenant and (ii) the circumstances of the Executive’s termination of employment with the Company will have no impact on the Executive’s obligations to comply with any Restrictive Covenant. The Restrictive Covenants are intended for the benefit of the Company and each of its Affiliates. Each Affiliate of the Company is an intended third party beneficiary of the Restrictive Covenants, and each Affiliate of the Company, as well as any successor or assign of the Company or such Affiliate, may enforce the Restrictive Covenants. The Executive further agrees that the Restrictive Covenants are in addition to, and not in lieu of, any non-competition, non-solicitation, protection of confidential information or intellectual property, or other similar covenants in favor of the Company or any of its Affiliates by which the Executive may be bound.

 

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4.16.       Tolling During Periods of Breach. The parties hereto agree and intend that the Restrictive Covenants (to the extent not perpetual) be tolled during any period that the Executive is in breach of any such Restrictive Covenant, with such tolling to cease with respect to a Restrictive Covenant once the Executive is in compliance with such Restrictive Covenant, so that the Company and its Affiliates are provided with the full benefit of the restrictive periods set forth herein.

 

4.17.       Notification of New Employer. In the event that the Executive is employed or otherwise engaged by any other Person following the Termination Date and during the Restrictive Period, the Executive agrees to notify, and consents to the notification by Company and its Affiliates of, such Person of the Restrictive Covenants.

 

5.       Miscellaneous.

 

5.1.       Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Virginia, applied without reference to principles of conflicts of law.

 

5.2.       Mediation. Any controversy, dispute or claim arising out of or relating to this Agreement, Executive’s employment or service with any member of the Company Group or the termination thereof shall, if not settled by direct negotiation between the parties, be subject to non-binding mediation under the Employment Arbitration Rules and Mediation Procedures of the American Arbitration Association (“AAA”) as in effect on the date of the notice of demand for mediation. Any demand for mediation by either party shall be made in writing and served upon the other party and shall set forth with reasonable specificity the basis of the dispute and the relief sought. Any mediation hereunder shall be conducted before an independent mediator mutually selected by the parties. If the parties are unable to agree to a mediator within ten (10) days after the receipt of a demand for mediation by either party, the mediator will be chosen by alternatively striking from a list of five mediators obtained by the Company from AAA, and the Executive shall have the first strike. The mediation hearing will occur at a time and place convenient to the parties in the Commonwealth of Virginia. Notwithstanding the foregoing, any claims under Section 4.15 are exempt from this Section 5.2 and may be brought in any court of competent jurisdiction without mediation.

 

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5.3.       Venue; WAIVER OF JURY TRIAL. In the event that any controversy, dispute or claim arising out of or relating to this Agreement, Executive’s employment or service with any member of the Company Group or the termination thereof is not settled through mediation pursuant to Section 5.2, both the Executive and the Company agree to appear before and submit exclusively to the jurisdiction of the federal courts located in Charlottesville, Virginia with respect to such controversy, dispute or claim (or if such controversy, dispute or claim may not be brought in federal court, the state courts located in Charlottesville, Virginia). Both the Executive and the Company also agree to waive, to the fullest possible extent, the defense of an inconvenient forum or lack of jurisdiction. THE COMPANY AND THE EXECUTIVE HEREBY WAIVE, TO THE EXTENT PERMITTED BY APPLICABLE LAW, TRIAL BY JURY IN ANY LITIGATION IN ANY COURT WITH RESPECT TO, IN CONNECTION WITH, OR ARISING OUT OF THE EXECUTIVE’S EMPLOYMENT BY, OR SERVICE WITH, ANY MEMBER OF THE COMPANY GROUP OR THE TERMINATION THEREOF, OR THIS AGREEMENT OR THE VALIDITY, PROTECTION, INTERPRETATION, COLLECTION OR ENFORCEMENT THEREOF (WHETHER ARISING IN CONTRACT, EQUITY, TORT OR OTHERWISE).

 

5.4.       Amendments. This Agreement may not be amended or modified otherwise than by a written agreement executed by the parties hereto or their respective successors and legal representatives.

 

5.5.       Notices. All notices and other communications hereunder shall be in writing, and shall be given by hand-delivery to the other party, by reputable overnight courier, or by registered or certified mail, return receipt requested, postage prepaid, addressed as follows:

 

  To the Company:

Adial Pharmaceuticals, Inc.

2246 Ivy Road

Charlottesville, VA 22903

Attention: Kermit Anderson, James Newman

     
  With a copy (which copy shall
not constitute notice) to:

Gracin Marlow, LLP

Chrysler Building

405 Lexington Avenue

26th Floor

New York, New York 10174

Attention: Leslie Marlow

     
  To the Executive: at the residence address most recently filed with the Company;
     
  With a copy (which copy shall
not constitute notice) to:

Rubin and Rudman LLP

50 Rowes Wharf

Boston, MA 02110

Attn: Peter B. Finn, Esq.

 

After August 25, 2017:

Rubin and Rudman LLP

53 State Street

Boston, MA 02109

Attn: Peter B. Finn, Esq.

 

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or to such other address as any party shall have furnished to the other in writing in accordance herewith. All such notices shall be deemed to have been duly given: (i) when delivered personally to the recipient, (ii) one (1) business day after being sent to the recipient by reputable overnight courier service (charges prepaid); or (iii) four (4) business days after being mailed to the recipient by certified or registered mail, return receipt requested and postage prepaid.

 

5.6.       Indemnification. The Parties agree to enter the Indemnification Agreement attached at Exhibit B hereto.

 

5.7.       Withholding. The Company may withhold from any amounts payable under this Agreement such federal, state or local income taxes as are required to be withheld pursuant to any applicable law or regulation.

 

5.8.       Code Section 409A Compliance.

 

5.8.1.       The provisions of this Agreement are intended to comply with Section 409A of the Code and any final regulations and guidance promulgated thereunder (“Section 409A”) or an exemption thereunder and shall be construed in a manner consistent with the requirements for avoiding taxes or penalties under Section 409A. The Company and Executive agree to work together in good faith to consider amendments to this Agreement and to take such reasonable actions which are necessary, appropriate or desirable to avoid imposition of any additional tax or income recognition prior to actual payment or provision of benefit to Executive under Section 409A.

 

5.8.2.       To the extent that Executive will be reimbursed for costs and expenses or in-kind benefits, except as otherwise permitted by Section 409A, (a) the right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit, (b) the amount of expenses eligible for reimbursement, or in-kind benefits, provided during any taxable year shall not affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year; provided that the foregoing clause (b) shall not be violated with regard to expenses reimbursed under any arrangement covered by Section 105(b) of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect and (c) such payments shall be made on or before the last day of the taxable year following the taxable year in which Executive incurred the expense.

 

5.8.3.       A termination of employment shall not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits upon or following a termination of employment unless such termination constitutes a “Separation from Service” within the meaning of Section 409A and, for purposes of any such provision of this Agreement references to a “termination,” “termination of employment” or like terms shall mean Separation from Service.

 

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5.8.4.       Any payments under this Agreement that may be excluded from Section 409A either as separation pay due to an involuntary separation from service or as a short-term deferral shall be excluded from Section 409A to the maximum extent possible. Each installment payable hereunder shall constitute a separate payment for purposes of Treasury Regulation Section 1.409A-2(b), including Treasury Regulation Section 1.409A-2(b)(2)(iii). Each payment that is made within the terms of the “short-term deferral” rule set forth in Treasury Regulation Section 1.409A-1(b)(4) is intended to meet the “short-term deferral” rule. Each other payment is intended to be a payment upon an involuntary termination from service and payable pursuant to Treasury Regulation Section 1.409A-1(b)(9)(iii), et. seq., to the maximum extent permitted by that regulation, with any amount that is not exempt from Section 409A being subject to Section 409A.

 

5.8.5.       Notwithstanding anything to the contrary in this Agreement, if Executive is a “specified employee” within the meaning of Section 409A at the time of Executive’s termination, then only that portion of the severance and benefits payable to Executive pursuant to this Agreement, if any, and any other severance payments or separation benefits which may be considered deferred compensation under Section 409A that is payable on account of the Executive’s termination (other than by reason of death) (together, the “Deferred Compensation Separation Benefits”) that are due to Executive on or within the six (6) month period following Executive’s termination will accrue during such six (6) month period and will become payable in one lump sum cash payment on the date that is six (6) months and one (1) day following the date of Executive’s termination of employment. All subsequent Deferred Compensation Separation Benefits, if any, will be payable in accordance with the payment schedule applicable to each payment or benefit. Notwithstanding anything herein to the contrary, if Executive dies following termination but prior to the six (6) month anniversary of Executive’s termination date, then any payments delayed in accordance with this paragraph will be payable in a lump sum as soon as administratively practicable after the date of Executive’s death (but not earlier than such payment would have been made absent such death) and all other Deferred Compensation Separation Benefits will be payable in accordance with the payment schedule applicable to each payment or benefit.

 

5.8.6.       Notwithstanding anything herein to the contrary, neither the Company nor any of its Affiliates shall have any liability to the Executive or to any other Person if the payments and benefits provided in this Agreement that are intended to be exempt from or compliant with Section 409A are not so exempt or compliant.

 

5.9.       Excess Parachute Payments under Code Section 280G. Notwithstanding any other provisions of this Agreement, if any “payments” (including, without limitation, any benefits or transfers of property or the acceleration of the vesting of any benefits) in the nature of compensation under any arrangement that is considered contingent on a Change of Control for purposes of Section 280G of the Code, together with any other payments that the Executive has the right to receive from the Company or any corporation that is a member of an “affiliated group” (as defined in Section 1504(a) of the Code without regard to Section 1504(b) of the Code) of which the Company is a member or from any other Person, would constitute a “parachute payment” (as defined in Section 280G(b)(2) of the Code), such “payments” may, at the Executive’s sole election, be reduced to the largest amount that will result in no portion of such “payments” being subject to the excise tax imposed by Section 4999 of the Code. Any such reduction in “payments” shall be applied first against the latest scheduled cash payments; then current cash payments; then any equity or equity derivatives that are included under Section 280G of the Code at full value rather than accelerated value (with the highest value reduced first); then any equity or equity derivatives included under Section 280G of the Code at an accelerated value (and not at full value), with the highest value reduced first (as such values are determined under Treasury Regulation Section 1.280G-1, Q&A 24); and finally any other non-cash benefits will be reduced (in the order of latest scheduled payments to earliest scheduled payments). All calculations hereunder shall be performed by a nationally recognized independent accounting firm selected by the Company, with the full cost of such firm being borne by the Company. Any determinations made by such firm shall be final and binding on the Executive and the Company.

 

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5.10.       Severability. The terms and provisions of this Agreement are intended to be separate and divisible provisions and if, for any reason, any one or more of them is held to be invalid or unenforceable, neither the validity nor the enforceability of any other provision of this Agreement shall thereby be affected. It is the intention of the parties to this Agreement that the Restrictive Covenants be reasonable in duration, geographic scope and in all other respects. The Executive agrees that the Restrictive Covenants, including, without limitation, the duration, geographic scope and activity restrictions of each restriction, are reasonable in light of the Executive’s senior position. However, if for any reason any court of competent jurisdiction shall find any provisions of the Restrictive Covenants unreasonable in duration or geographic scope or otherwise, it is the intention of the parties that the restrictions and prohibitions contained therein shall be modified by the court to be effective to the fullest extent allowed under applicable law in such jurisdiction.

 

5.11.       Captions. The captions of this Agreement are not part of the provisions hereof and shall have no force or effect.

 

5.12.       Counterparts. This Agreement may be executed in counterparts and delivered by facsimile transmission or electronic transmission in “portable document format,” each of which shall be an original and which taken together shall constitute one and the same document.

 

5.13.       Entire Agreement. This Agreement contains the entire agreement concerning the subject matter hereof and supersedes all prior agreements, understandings, discussions, negotiations and undertakings, whether written or oral, between the parties and their Affiliates relating to such subject matter.

 

5.14.       Survivorship. The provisions of Article 1, Article 5, Section 2.1 and Sections 4.4 through 4.17 shall survive the termination of the Executive’s employment with the Company and this Agreement in accordance with their terms.

 

5.15.       Successors and Assigns. The Company may assign, without the Executive’s consent, its rights and/or delegate its obligations under this Agreement to any successor of the Company, whether by operation of law, agreement or otherwise (including, without limitation, any Person who acquires all or a substantial portion of the business of the Company Group (whether direct or indirect and whether structured as a stock sale, asset sale, merger, recapitalization, consolidation or other transaction)) and, in connection with any such delegation of its obligations hereunder (but only so long as such assignee or delegee has consented in writing to be bound by the obligations hereunder) shall be released from such obligations hereunder. This Agreement may not be assigned by the Executive. Except as otherwise provided herein, this Agreement shall bind and inure to the benefit of and be enforceable by the Executive, the Company and their respective successors and permitted assigns.

 

[signatures to follow on next page]

 

  Page 17 of 28

 

 

IN WITNESS WHEREOF, the Executive has hereunto set the Executive’s hand and the Company has caused this Agreement to be executed in its name on its behalf, all as of the day and year first above written.

  

ADIAL PHARMACEUTICALS, INC.   EXECUTIVE:
     
By:     By:                      
  William B. Stilley, CEO     Tomasz H. Zastawny, Ph.D.

 

  Page 18 of 28

 

 

Exhibit A

Board and Advisory Positions

 

1.Advisor/Mentor for the founders of Clara Healthcare (https://www.clarahealth.com)
2.Advisor/Partner for Quark Ventures. (http://quarkventures.com)
3.Advisor to the CEO for Amrita Therapeutics (http://www.amritatherapeutics.com)

 

  Page 19 of 28

 

 

Exhibit B

Indemnification Agreement

 

[See attached]

 

  Page 20 of 28

 

 

INDEMNIFICATION AGREEMENT

 

This Indemnification Agreement (the “Agreement”) is made and entered into this ___ day of ________, 2017, by and between Adial Pharmaceuticals Inc., a Delaware corporation (the “Company”, which term shall include, where appropriate, any Entity (as hereinafter defined) controlled directly or indirectly by the Company), and __________ (the “Indemnitee”).

 

WHEREAS, it is essential to the Company that it be able to retain and attract as directors and officers the most capable persons available;

 

WHEREAS, increased corporate litigation has subjected directors and officers to litigation risks and expenses, and the limitations on the availability of directors and officers liability insurance have made it increasingly difficult for the Company to attract and retain such persons;

 

WHEREAS, the Company’s Certificate of Incorporation, as amended, and Bylaws (the “Certificate” and the “Bylaws”, respectively), provide that the Company is authorized to indemnify its directors and officers to the fullest extent permissible by applicable law and permit it to make other indemnification arrangements and agreements;

 

WHEREAS, the Company desires to provide Indemnitee with specific contractual assurance of Indemnitee’s rights to full indemnification against litigation risks and expenses (regardless, among other things, of any amendment to or revocation of the Certificate or Bylaws or any change in the ownership of the Company or the composition of its board of directors (the “Board of Directors”));

 

WHEREAS, the Company intends that this Agreement provide Indemnitee with greater protection than that which is provided by the Certificate and Bylaws; and

 

WHEREAS, Indemnitee is relying upon the rights afforded under this Agreement in becoming or continuing as a director and/or officer of the Company.

 

NOW, THEREFORE, in consideration of the promises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree as follows:

 

1.Definitions.

 

(a)       “Corporate Status” describes the status of a person who is serving or has served (i) as a director and/or officer of the Company, (ii) in any capacity with respect to any employee benefit plan of the Company or (at the request of the Company) any employee benefit plan of any other Entity, or (iii) as a director and/or officer of any other Entity at the request of the Company. For purposes of subsections (ii) and (iii) of this Section 1(a), if Indemnitee is serving or has served as a director and/or officer of a Subsidiary (as defined below), or in any capacity with respect to any employee benefit plan of a Subsidiary, Indemnitee shall be deemed to be serving at the request of the Company. If Indemnitee is an employee of the Company, Corporate Status shall not include actions taken by Indemnitee in any capacity other than as a director and/or officer or as a representative of any employee benefit plan.

 

(b)       “Entity” shall mean any corporation, partnership, limited liability company, joint venture, trust, foundation, association, organization or other legal entity.

 

(c)       “Expenses” shall mean all fees, costs and expenses incurred by Indemnitee in connection with any Proceeding (as defined below), including, without limitation, reasonable attorneys’ fees, disbursements and retainers (including, without limitation, any such fees, disbursements and retainers incurred by Indemnitee pursuant to Sections 11 and 12(c) of this Agreement), fees and disbursements of expert witnesses, private investigators and professional advisors (including, without limitation, accountants and investment bankers), court costs, transcript costs, fees of experts, travel expenses, duplicating, printing and binding costs, telephone and fax transmission charges, postage, delivery services, secretarial services and other disbursements and expenses.

  

  Page 21 of 28

 

 

(d)       “Indemnifiable Expenses”, “Indemnifiable Liabilities” and “Indemnifiable Amounts” shall have the meanings ascribed to those terms in Section 3(a) below.

 

(e)       “Liabilities” shall mean judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement.

 

(f)       “Proceeding” shall mean any threatened, pending or completed claim, action, suit, arbitration, alternate dispute resolution process, investigation, administrative hearing, appeal or any other proceeding, whether civil, criminal, administrative, arbitrative or investigative, whether formal or informal, including a proceeding initiated by Indemnitee pursuant to Section 11 of this Agreement to enforce Indemnitee’s rights hereunder.

 

(g)       “Subsidiary” shall mean any corporation, partnership, limited liability company, joint venture, trust or other Entity of which the Company owns (either directly or through or together with another Subsidiary of the Company) either (i) a general partner, managing member or other similar interest or (ii) (A) 50% or more of the voting power of the voting capital equity interests of such corporation, partnership, limited liability company, joint venture or other Entity or (B) 50% or more of the outstanding voting capital stock or other voting equity interests of such corporation, partnership, limited liability company, joint venture or other Entity.

 

(h)       “to the fullest extent permissible by applicable law” shall include, but not be limited to: (i) the fullest extent permitted by the provisions of the General Corporation Law of the State of Delaware (the “DGCL”) that authorize or contemplate additional or supplementary indemnification by agreement, or the corresponding provisions of any amendment to or replacement of the DGCL or such provisions thereof; and (ii) the fullest extent authorized or permitted by any amendments to or replacements of the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its directors and/or officers.

 

2.       Services of Indemnitee. In consideration of the Company’s covenants and commitments hereunder, Indemnitee agrees to serve or continue to serve as a director and/or officer of the Company. However, this Agreement shall not impose any obligation on Indemnitee or the Company to continue Indemnitee’s service to the Company beyond any period otherwise required by law or by other agreements or commitments of the parties, if any.

 

3.       Agreement to Indemnify. The Company agrees to hold harmless and indemnify Indemnitee to the fullest extent permissible by applicable law as follows:

 

(a)       Proceedings. Subject to the exceptions contained in Section 4(a) below, if Indemnitee was or is a party or is threatened to be made a party to any Proceeding by reason of Indemnitee’s Corporate Status, Indemnitee shall be indemnified by the Company against all Expenses and Liabilities actually and reasonably incurred or paid by Indemnitee in connection with such Proceeding (referred to herein as “Indemnifiable Expenses “and “Indemnifiable Liabilities”, respectively, and collectively as “Indemnifiable Amounts”).

 

(b)       Conclusive Presumption Regarding Standard of Care. In making any determination required to be made under Delaware law with respect to entitlement to indemnification hereunder, the person, persons or entity making such determination shall presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee submitted a request therefor in accordance with Section 5 of this Agreement, and the Company shall have the burden of proof to overcome that presumption in connection with the making by any person, persons or Entity of any determination contrary to that presumption.

 

  Page 22 of 28

 

 

4.       Exceptions to Indemnification. Subject to Section 20 below, Indemnitee shall be entitled to indemnification under Section 3(a) above in all circumstances and with respect to each and every specific claim, issue or matter involved in the Proceeding out of which Indemnitee’s claim for indemnification has arisen to the fullest extent permissible by applicable law, except as follows:

 

(a)       Proceedings. If indemnification is requested under Section 3(a) and it has been finally adjudicated by a court of competent jurisdiction that, in connection with such specific claim, issue or matter, Indemnitee failed to act (i) in good faith and (ii) in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, or, with respect to any criminal Proceeding, Indemnitee had reasonable cause to believe that Indemnitee’s conduct was unlawful, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder to the extent that they arise out of such claim, issue or matter.

 

(b)       Insurance Proceeds. To the extent payment is actually made to the Indemnitee under a valid and collectible insurance policy maintained at the expense of the Company in respect of Indemnifiable Amounts in connection with such specific claim, issue or matter, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder except in respect of any excess of such Indemnifiable Amounts beyond the amount of payment under such insurance.

 

5.       Procedure for Payment of Indemnifiable Amounts. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Amounts for which Indemnitee seeks payment under Section 3 of this Agreement and the basis for the claim. The Company shall pay such Indemnifiable Amounts to Indemnitee promptly, but in no event later than thirty (30) calendar days after receipt of such request. At the request of the Company, Indemnitee shall furnish such documentation and information as are reasonably available to Indemnitee and necessary to establish that Indemnitee is entitled to indemnification hereunder.

 

6.       Indemnification for Expenses of a Party Who is Wholly or Partly Successful. Notwithstanding any other provision of this Agreement, and without limiting any such provision, to the extent that Indemnitee is, by reason of Indemnitee’s Corporate Status, a party to and is successful, on the merits or otherwise, in any Proceeding, Indemnitee shall be indemnified to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify to the fullest extent permissible by applicable law Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with each successfully resolved claim, issue or matter. For purposes of this Agreement, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, by reason of settlement, judgment, order or otherwise, shall be deemed to be a successful result as to such claim, issue or matter.

 

7.       Effect of Certain Resolutions. Neither the settlement nor termination of any Proceeding nor the failure of the Company to award indemnification or to determine that indemnification is payable shall create a presumption that Indemnitee is not entitled to indemnification hereunder. In addition, the termination of any Proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent shall not create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, had reasonable cause to believe that Indemnitee’s action was unlawful.

 

8.       Agreement to Advance Expenses; Undertaking. The Company shall advance to the fullest extent permissible by applicable law all Expenses actually and reasonably incurred by or on behalf of Indemnitee in connection with any Proceeding in which Indemnitee is involved by reason of such Indemnitee’s Corporate Status within thirty (30) calendar days after the receipt by the Company of a written statement from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Advances shall be unsecured and interest free. Advances shall be made without regard to Indemnitee’s ability to repay the expenses and without regard to Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement. To the extent required by Delaware law, Indemnitee hereby undertakes to repay any and all of the amount of Indemnifiable Expenses paid to Indemnitee if it is finally determined by a court of competent jurisdiction that Indemnitee is not entitled under this Agreement to indemnification with respect to such Expenses. This undertaking is an unlimited general obligation of Indemnitee.

 

9.       Procedure for Advance Payment of Expenses. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Expenses for which Indemnitee seeks an advancement under Section 8 of this Agreement, together with documentation evidencing that Indemnitee has incurred such Indemnifiable Expenses.

  

  Page 23 of 28

 

 

10.       Indemnification for Expenses of a Witness. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his or her Corporate Status, a witness in any Proceeding to which Indemnitee is not a party, he or she shall be indemnified by the Company to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection therewith.

 

11.Remedies of Indemnitee.

 

(a)       Right to Petition Court. In the event that Indemnitee makes a request for payment of Indemnifiable Amounts under Sections 3 and 5 above or a request for an advancement of Indemnifiable Expenses under Sections 8 and 9 above and the Company fails to make such payment or advancement in a timely manner pursuant to the terms of this Agreement, Indemnitee may petition the Court of Chancery of the State of Delaware to enforce the Company’s obligations under this Agreement.

 

(b)       Burden of Proof. In any judicial proceeding brought under Section 11(a) above, the Company shall have the burden of proving that Indemnitee is not entitled to payment of Indemnifiable Amounts hereunder.

 

(c)       Expenses. The Company agrees to reimburse Indemnitee in full for any Expenses in connection with any Proceeding incurred by Indemnitee in connection with investigating, preparing for, litigating, defending or settling any action brought by Indemnitee under Section 11(a) above, or in connection with any claim or counterclaim brought by the Company in connection therewith, whether or not Indemnitee is successful in whole or in part in connection with any such action, except to the extent that it has been finally adjudicated by a court of competent jurisdiction that such reimbursement would be unlawful.

 

(d)       Failure to Act Not a Defense. The failure of the Company (including its Board of Directors or any committee thereof, independent legal counsel or stockholders) to make a determination concerning the permissibility of the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses under this Agreement shall not be a defense in any action brought under Section 11(a) above, and shall not create a presumption that such payment or advancement is not permissible.

 

12.Defense of the Underlying Proceeding.

 

(a)       Notice by Indemnitee. Indemnitee agrees to notify the Company promptly upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding which may result in the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses hereunder; provided, however, that the failure to give any such notice shall not disqualify Indemnitee from the right, or otherwise affect in any manner any right of Indemnitee, to receive payments of Indemnifiable Amounts or advancements of Indemnifiable Expenses unless the Company’s ability to defend in such Proceeding is materially and adversely prejudiced thereby.

 

(b)       Defense by Company. Subject to the provisions of the last sentence of this Section 12(b) and of Section 12(c) below, the Company shall have the right to defend Indemnitee in any Proceeding which may give rise to the payment of Indemnifiable Amounts hereunder; provided, however, that the Company shall notify Indemnitee of any such decision to defend within ten (10) calendar days of the Company’s receipt of notice of any such Proceeding under Section 12(a) above. The Company shall not, without the prior written consent of Indemnitee, consent to the entry of any judgment against Indemnitee or enter into any settlement or compromise which (i) includes an admission of fault of Indemnitee or (ii) does not include, as an unconditional term thereof, the full release of Indemnitee from all liability in respect of such Proceeding, which release shall be in form and substance reasonably satisfactory to Indemnitee. This Section 12(b) shall not apply to a Proceeding brought by Indemnitee under Section 11(a) above or pursuant to Section 20 below.

 

(c)       Indemnitee’s Right to Counsel. Notwithstanding the provisions of Section 12(b) above, in any Proceeding to which Indemnitee is a party by reason of Indemnitee’s Corporate Status, at the Indemnittee’s option Indemnitee shall have the right to retain counsel of Indemnitee’s choice, at the expense of the Company, to represent Indemnitee in connection with any such matter and the Expenses incurred by Indemnitee in any such matter shall constitute Indemnifiable Expenses.

 

  Page 24 of 28

 

 

13.       Representations and Warranties of the Company. The Company hereby represents and warrants to Indemnitee as follows:

 

(a)       Authority. The Company has all necessary power and authority to enter into, and be bound by the terms of, this Agreement, and the execution, delivery and performance of the undertakings contemplated by this Agreement have been duly authorized by the Company.

 

(b)       Enforceability. This Agreement, when executed and delivered by the Company in accordance with the provisions hereof, shall be a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization or similar laws affecting the enforcement of creditors’ rights generally.

 

14.       Insurance. The Company shall, from time to time, make the good faith determination whether or not it is practicable for the Company to obtain and maintain a policy or policies of insurance with a reputable insurance company providing the Indemnitee with coverage for losses from wrongful acts. For so long as Indemnitee shall have Corporate Status, Indemnitee shall be named as an insured in all policies of director and officer liability insurance in such a manner as to provide Indemnitee the same rights and benefits as are accorded to the most favorably insured of the Company’s officers and directors. If, at the time of the receipt of a notice of a claim pursuant to the terms of this Agreement, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies. Notwithstanding the foregoing, the Company shall have no obligation to obtain or maintain such insurance if the Company determines in good faith that such insurance is not reasonably available, if the premium costs for such insurance are disproportionate to the amount of coverage provided, or if the coverage provided by such insurance is limited by exclusions so as to provide an insufficient benefit.

 

15.       No Duplication of Payments. The Company shall not be liable under this Agreement to make any payment in connection with any claim made against Indemnitee to the extent Indemnitee has otherwise actually received payment under any insurance policy, provision of the Certificate or the Bylaws or otherwise of the amounts otherwise indemnifiable hereunder. The Company’s obligation to indemnify or advance Expenses hereunder to Indemnitee as a result of the Indemnitee’s Corporate Status with an Entity other than the Company shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of Expenses from such other Entity.

 

16.       Contract Rights Not Exclusive. The rights to payment of Indemnifiable Amounts and advancement of Indemnifiable Expenses provided by this Agreement shall be in addition to, but not exclusive of, any other rights which Indemnitee may have at any time under applicable law, the Certificate or Bylaws, or any other agreement, vote of stockholders or directors (or a committee of directors) or otherwise, both as to action in Indemnitee’s official capacity and as to action in any other capacity as a result of Indemnitee’s serving as a director of the Company.

 

17.       Successors. This Agreement shall be (a) binding upon all successors and assigns of the Company (including any transferee of all or a substantial portion of the business, stock and/or assets of the Company and any direct or indirect successor by merger or consolidation or otherwise by operation of law) and (b) binding on and shall inure to the benefit of the heirs, personal representatives, executors and administrators of Indemnitee. This Agreement shall continue for the benefit of Indemnitee and such heirs, personal representatives, executors and administrators after Indemnitee has ceased to have Corporate Status.

 

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18.       Change in Law. To the extent that a change in Delaware law (whether by statute or judicial decision) or the Certificate shall permit broader indemnification or advancement of expenses than is provided under the terms of the Bylaws and this Agreement, Indemnitee shall be entitled to such broader indemnification and advancements, and this Agreement shall be deemed to be amended to such extent.

 

19.       Severability. Whenever possible, each provision of this Agreement shall be interpreted in such a manner as to be effective and valid under applicable law, but if any provision of this Agreement, or any clause thereof, shall be determined by a court of competent jurisdiction to be illegal, invalid or unenforceable, in whole or in part, such provision or clause shall be limited or modified in its application to the minimum extent necessary to make such provision or clause valid, legal and enforceable, and the remaining provisions and clauses of this Agreement shall remain fully enforceable and binding on the parties.

 

20.       Indemnitee as Plaintiff. Except as provided in Section 11(c) of this Agreement and in the next sentence, Indemnitee shall not be entitled to payment of Indemnifiable Amounts or advancement of Indemnifiable Expenses with respect to any Proceeding brought by Indemnitee against the Company, any Subsidiary, any Entity which it controls, any director or officer thereof or any third party, unless the Board of Directors has consented to the initiation of such Proceeding or the Company provides indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law. This Section shall not apply to counterclaims or affirmative defenses asserted by Indemnitee in an action brought against Indemnitee.

 

21.       Modifications and Waivers; Counterparts. Except as provided in Section 18 above with respect to changes in Delaware law which broaden the right of Indemnitee to be indemnified by the Company or to receive advancements, no supplement, modification or amendment of this Agreement shall be binding unless executed in writing by each of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions of this Agreement (whether or not similar), nor shall such waiver constitute a continuing waiver. This Agreement may also be executed and delivered by facsimile signature and in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement.

 

22.       General Notices. All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when delivered by hand, (b) when transmitted by facsimile and receipt is acknowledged during normal business hours, and if not, the next business day after transmission or (c) if mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed:

 

(i)If to Indemnitee, to:

 

[●]

 

(ii)If to the Company, to:

 

Adial Pharmaceuticals Inc.

1180 Seminole Trail, Suite 495

Charlottesville, VA 22901

Attn: CEO

 

With copy to

_____________________

 

or to such other address as may have been furnished in the same manner by any party to the others.

 

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23.       Governing Law; Consent to Jurisdiction; Service of Process. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without regard to its rules of conflict of laws. Each of the Company and Indemnitee hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the Court of Chancery of the State of Delaware and the courts of the United States of America located in the State of Delaware (the “Delaware Courts”) for any litigation arising out of or relating to this Agreement and the transactions contemplated hereby (and agrees not to commence any litigation relating thereto except in such courts), waives any objection to the laying of venue of any such litigation in the Delaware Courts and agrees not to plead or claim in any Delaware Court that such litigation brought therein has been brought in an inconvenient forum. Each of the parties hereto agrees, (a) to the extent such party is not otherwise subject to service of process in the State of Delaware, to appoint and maintain an agent in the State of Delaware as such party's agent for acceptance of legal process, and (b) that service of process may also be made on such party by prepaid certified mail with a proof of mailing receipt validated by the United States Postal Service constituting evidence of valid service. Service made pursuant to (a) or (b) above shall have the same legal force and effect as if served upon such party personally within the State of Delaware. For purposes of implementing the parties’ agreement to appoint and maintain an agent for service of process in the State of Delaware, each such party does hereby appoint The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, New Castle County, Delaware 19801, as such agent and each such party hereby agrees to complete all actions necessary for such appointment. Upon written application by Indemnitee to the Company, the Company shall, on an annual basis, reimburse Indemnitee the annual fee charged by The Corporation Trust Company to serve as Indemnitee’s agent for service of process within 30 days following the written application for reimbursement.

 

24.       Joinders. Subsidiaries of the Company may from time to time join this Agreement by signing a joinder in substantially the form attached hereto as Exhibit A. The Company and all Subsidiaries that have joined this Agreement shall be jointly and severally liable for all obligations of the Company under this Agreement.

 

25.       Assignment. Except as otherwise set forth herein, neither this Agreement nor any of the rights, interests or obligations hereunder may be assigned by any party hereto, without the prior written consent of all of the other parties hereto.

 

26.       Entire Agreement. Without limitation to the Certificate and the Bylaws, this Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.

 

[The remainder of this page is intentionally blank]

  

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IN WITNESS WHEREOF, the parties hereto have executed this Indemnification Agreement as of the day and year first above written.

 

  ADIAL PHARMACEUTICALS INC.
     
  By: /s/                            
    Name:
    Title:

 

  INDEMNITEE
     
  /s/        
  Name:

 

 

Page 28 of 28

 

EX-10.18 43 fs12017ex10-18_adialpharma.htm FORM OF INDEMNIFICATION AGREEMENT

Exhibit 10.18

 

INDEMNIFICATION AGREEMENT

 

This Indemnification Agreement (the “Agreement”) is made and entered into this ___ day of ________, 2017, by and between Adial Pharmaceuticals Inc., a Delaware corporation (the “Company”, which term shall include, where appropriate, any Entity (as hereinafter defined) controlled directly or indirectly by the Company), and __________ (the “Indemnitee”).

 

WHEREAS, it is essential to the Company that it be able to retain and attract as directors and officers the most capable persons available;

 

WHEREAS, increased corporate litigation has subjected directors and officers to litigation risks and expenses, and the limitations on the availability of directors and officers liability insurance have made it increasingly difficult for the Company to attract and retain such persons;

 

WHEREAS, the Company’s Certificate of Incorporation, as amended, and Bylaws (the “Certificate” and the “Bylaws”, respectively), provide that the Company is authorized to indemnify its directors and officers to the fullest extent permissible by applicable law and permit it to make other indemnification arrangements and agreements;

 

WHEREAS, the Company desires to provide Indemnitee with specific contractual assurance of Indemnitee’s rights to full indemnification against litigation risks and expenses (regardless, among other things, of any amendment to or revocation of the Certificate or Bylaws or any change in the ownership of the Company or the composition of its board of directors (the “Board of Directors”));

 

WHEREAS, the Company intends that this Agreement provide Indemnitee with greater protection than that which is provided by the Certificate and Bylaws; and

 

WHEREAS, Indemnitee is relying upon the rights afforded under this Agreement in becoming or continuing as a director and/or officer of the Company.

 

NOW, THEREFORE, in consideration of the promises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree as follows:

 

1.Definitions.

 

(a)       “Corporate Status” describes the status of a person who is serving or has served (i) as a director and/or officer of the Company, (ii) in any capacity with respect to any employee benefit plan of the Company or (at the request of the Company) any employee benefit plan of any other Entity, or (iii) as a director and/or officer of any other Entity at the request of the Company. For purposes of subsections (ii) and (iii) of this Section 1(a), if Indemnitee is serving or has served as a director and/or officer of a Subsidiary (as defined below), or in any capacity with respect to any employee benefit plan of a Subsidiary, Indemnitee shall be deemed to be serving at the request of the Company. If Indemnitee is an employee of the Company, Corporate Status shall not include actions taken by Indemnitee in any capacity other than as a director and/or officer or as a representative of any employee benefit plan.

 

(b)       “Entity” shall mean any corporation, partnership, limited liability company, joint venture, trust, foundation, association, organization or other legal entity.

 

(c)       “Expenses” shall mean all fees, costs and expenses incurred by Indemnitee in connection with any Proceeding (as defined below), including, without limitation, reasonable attorneys’ fees, disbursements and retainers (including, without limitation, any such fees, disbursements and retainers incurred by Indemnitee pursuant to Sections 11 and 12(c) of this Agreement), fees and disbursements of expert witnesses, private investigators and professional advisors (including, without limitation, accountants and investment bankers), court costs, transcript costs, fees of experts, travel expenses, duplicating, printing and binding costs, telephone and fax transmission charges, postage, delivery services, secretarial services and other disbursements and expenses.

 

Page 1 of 8

 

 

(d)       “Indemnifiable Expenses”, “Indemnifiable Liabilities” and “Indemnifiable Amounts” shall have the meanings ascribed to those terms in Section 3(a) below.

 

(e)       “Liabilities” shall mean judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement.

 

(f)       “Proceeding” shall mean any threatened, pending or completed claim, action, suit, arbitration, alternate dispute resolution process, investigation, administrative hearing, appeal or any other proceeding, whether civil, criminal, administrative, arbitrative or investigative, whether formal or informal, including a proceeding initiated by Indemnitee pursuant to Section 11 of this Agreement to enforce Indemnitee’s rights hereunder.

 

(g)       “Subsidiary” shall mean any corporation, partnership, limited liability company, joint venture, trust or other Entity of which the Company owns (either directly or through or together with another Subsidiary of the Company) either (i) a general partner, managing member or other similar interest or (ii) (A) 50% or more of the voting power of the voting capital equity interests of such corporation, partnership, limited liability company, joint venture or other Entity or (B) 50% or more of the outstanding voting capital stock or other voting equity interests of such corporation, partnership, limited liability company, joint venture or other Entity.

 

(h)       “to the fullest extent permissible by applicable law” shall include, but not be limited to: (i) the fullest extent permitted by the provisions of the General Corporation Law of the State of Delaware (the “DGCL”) that authorize or contemplate additional or supplementary indemnification by agreement, or the corresponding provisions of any amendment to or replacement of the DGCL or such provisions thereof; and (ii) the fullest extent authorized or permitted by any amendments to or replacements of the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its directors and/or officers.

 

2.       Services of Indemnitee. In consideration of the Company’s covenants and commitments hereunder, Indemnitee agrees to serve or continue to serve as a director and/or officer of the Company. However, this Agreement shall not impose any obligation on Indemnitee or the Company to continue Indemnitee’s service to the Company beyond any period otherwise required by law or by other agreements or commitments of the parties, if any.

 

3.       Agreement to Indemnify. The Company agrees to hold harmless and indemnify Indemnitee to the fullest extent permissible by applicable law as follows:

 

(a)       Proceedings. Subject to the exceptions contained in Section 4(a) below, if Indemnitee was or is a party or is threatened to be made a party to any Proceeding by reason of Indemnitee’s Corporate Status, Indemnitee shall be indemnified by the Company against all Expenses and Liabilities actually and reasonably incurred or paid by Indemnitee in connection with such Proceeding (referred to herein as “Indemnifiable Expenses “and “Indemnifiable Liabilities”, respectively, and collectively as “Indemnifiable Amounts”).

 

(b)       Conclusive Presumption Regarding Standard of Care. In making any determination required to be made under Delaware law with respect to entitlement to indemnification hereunder, the person, persons or entity making such determination shall presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee submitted a request therefor in accordance with Section 5 of this Agreement, and the Company shall have the burden of proof to overcome that presumption in connection with the making by any person, persons or Entity of any determination contrary to that presumption.

 

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4.       Exceptions to Indemnification. Subject to Section 20 below, Indemnitee shall be entitled to indemnification under Section 3(a) above in all circumstances and with respect to each and every specific claim, issue or matter involved in the Proceeding out of which Indemnitee’s claim for indemnification has arisen to the fullest extent permissible by applicable law, except as follows:

 

(a)       Proceedings. If indemnification is requested under Section 3(a) and it has been finally adjudicated by a court of competent jurisdiction that, in connection with such specific claim, issue or matter, Indemnitee failed to act (i) in good faith and (ii) in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, or, with respect to any criminal Proceeding, Indemnitee had reasonable cause to believe that Indemnitee’s conduct was unlawful, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder to the extent that they arise out of such claim, issue or matter.

 

(b)       Insurance Proceeds. To the extent payment is actually made to the Indemnitee under a valid and collectible insurance policy maintained at the expense of the Company in respect of Indemnifiable Amounts in connection with such specific claim, issue or matter, Indemnitee shall not be entitled to payment of Indemnifiable Amounts hereunder except in respect of any excess of such Indemnifiable Amounts beyond the amount of payment under such insurance.

 

5.       Procedure for Payment of Indemnifiable Amounts. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Amounts for which Indemnitee seeks payment under Section 3 of this Agreement and the basis for the claim. The Company shall pay such Indemnifiable Amounts to Indemnitee promptly, but in no event later than thirty (30) calendar days after receipt of such request. At the request of the Company, Indemnitee shall furnish such documentation and information as are reasonably available to Indemnitee and necessary to establish that Indemnitee is entitled to indemnification hereunder.

 

6.       Indemnification for Expenses of a Party Who is Wholly or Partly Successful. Notwithstanding any other provision of this Agreement, and without limiting any such provision, to the extent that Indemnitee is, by reason of Indemnitee’s Corporate Status, a party to and is successful, on the merits or otherwise, in any Proceeding, Indemnitee shall be indemnified to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify to the fullest extent permissible by applicable law Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with each successfully resolved claim, issue or matter. For purposes of this Agreement, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, by reason of settlement, judgment, order or otherwise, shall be deemed to be a successful result as to such claim, issue or matter.

 

7.       Effect of Certain Resolutions. Neither the settlement nor termination of any Proceeding nor the failure of the Company to award indemnification or to determine that indemnification is payable shall create a presumption that Indemnitee is not entitled to indemnification hereunder. In addition, the termination of any Proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent shall not create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, had reasonable cause to believe that Indemnitee’s action was unlawful.

 

8.       Agreement to Advance Expenses; Undertaking. The Company shall advance to the fullest extent permissible by applicable law all Expenses actually and reasonably incurred by or on behalf of Indemnitee in connection with any Proceeding in which Indemnitee is involved by reason of such Indemnitee’s Corporate Status within thirty (30) calendar days after the receipt by the Company of a written statement from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Advances shall be unsecured and interest free. Advances shall be made without regard to Indemnitee’s ability to repay the expenses and without regard to Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement. To the extent required by Delaware law, Indemnitee hereby undertakes to repay any and all of the amount of Indemnifiable Expenses paid to Indemnitee if it is finally determined by a court of competent jurisdiction that Indemnitee is not entitled under this Agreement to indemnification with respect to such Expenses. This undertaking is an unlimited general obligation of Indemnitee.

 

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9.       Procedure for Advance Payment of Expenses. Indemnitee shall submit to the Company a written request specifying the Indemnifiable Expenses for which Indemnitee seeks an advancement under Section 8 of this Agreement, together with documentation evidencing that Indemnitee has incurred such Indemnifiable Expenses.

 

10.       Indemnification for Expenses of a Witness. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his or her Corporate Status, a witness in any Proceeding to which Indemnitee is not a party, he or she shall be indemnified by the Company to the fullest extent permissible by applicable law against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection therewith.

 

11.Remedies of Indemnitee.

 

(a)       Right to Petition Court. In the event that Indemnitee makes a request for payment of Indemnifiable Amounts under Sections 3 and 5 above or a request for an advancement of Indemnifiable Expenses under Sections 8 and 9 above and the Company fails to make such payment or advancement in a timely manner pursuant to the terms of this Agreement, Indemnitee may petition the Court of Chancery of the State of Delaware to enforce the Company’s obligations under this Agreement.

 

(b)       Burden of Proof. In any judicial proceeding brought under Section 11(a) above, the Company shall have the burden of proving that Indemnitee is not entitled to payment of Indemnifiable Amounts hereunder.

 

(c)       Expenses. The Company agrees to reimburse Indemnitee in full for any Expenses in connection with any Proceeding incurred by Indemnitee in connection with investigating, preparing for, litigating, defending or settling any action brought by Indemnitee under Section 11(a) above, or in connection with any claim or counterclaim brought by the Company in connection therewith, whether or not Indemnitee is successful in whole or in part in connection with any such action, except to the extent that it has been finally adjudicated by a court of competent jurisdiction that such reimbursement would be unlawful.

 

(d)       Failure to Act Not a Defense. The failure of the Company (including its Board of Directors or any committee thereof, independent legal counsel or stockholders) to make a determination concerning the permissibility of the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses under this Agreement shall not be a defense in any action brought under Section 11(a) above, and shall not create a presumption that such payment or advancement is not permissible.

 

12.Defense of the Underlying Proceeding.

 

(a)       Notice by Indemnitee. Indemnitee agrees to notify the Company promptly upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding which may result in the payment of Indemnifiable Amounts or the advancement of Indemnifiable Expenses hereunder; provided, however, that the failure to give any such notice shall not disqualify Indemnitee from the right, or otherwise affect in any manner any right of Indemnitee, to receive payments of Indemnifiable Amounts or advancements of Indemnifiable Expenses unless the Company’s ability to defend in such Proceeding is materially and adversely prejudiced thereby.

 

(b)       Defense by Company. Subject to the provisions of the last sentence of this Section 12(b) and of Section 12(c) below, the Company shall have the right to defend Indemnitee in any Proceeding which may give rise to the payment of Indemnifiable Amounts hereunder; provided, however, that the Company shall notify Indemnitee of any such decision to defend within ten (10) calendar days of the Company’s receipt of notice of any such Proceeding under Section 12(a) above. The Company shall not, without the prior written consent of Indemnitee, consent to the entry of any judgment against Indemnitee or enter into any settlement or compromise which (i) includes an admission of fault of Indemnitee or (ii) does not include, as an unconditional term thereof, the full release of Indemnitee from all liability in respect of such Proceeding, which release shall be in form and substance reasonably satisfactory to Indemnitee. This Section 12(b) shall not apply to a Proceeding brought by Indemnitee under Section 11(a) above or pursuant to Section 20 below.

 

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(c)       Indemnitee’s Right to Counsel. Notwithstanding the provisions of Section 12(b) above, in any Proceeding to which Indemnitee is a party by reason of Indemnitee’s Corporate Status, at the Indemnittee’s option Indemnitee shall have the right to retain counsel of Indemnitee’s choice, at the expense of the Company, to represent Indemnitee in connection with any such matter and the Expenses incurred by Indemnitee in any such matter shall constitute Indemnifiable Expenses.

 

13.       Representations and Warranties of the Company. The Company hereby represents and warrants to Indemnitee as follows:

 

(a)       Authority. The Company has all necessary power and authority to enter into, and be bound by the terms of, this Agreement, and the execution, delivery and performance of the undertakings contemplated by this Agreement have been duly authorized by the Company.

 

(b)       Enforceability. This Agreement, when executed and delivered by the Company in accordance with the provisions hereof, shall be a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization or similar laws affecting the enforcement of creditors’ rights generally.

 

14.       Insurance. The Company shall, from time to time, make the good faith determination whether or not it is practicable for the Company to obtain and maintain a policy or policies of insurance with a reputable insurance company providing the Indemnitee with coverage for losses from wrongful acts. For so long as Indemnitee shall have Corporate Status, Indemnitee shall be named as an insured in all policies of director and officer liability insurance in such a manner as to provide Indemnitee the same rights and benefits as are accorded to the most favorably insured of the Company’s officers and directors. If, at the time of the receipt of a notice of a claim pursuant to the terms of this Agreement, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies. Notwithstanding the foregoing, the Company shall have no obligation to obtain or maintain such insurance if the Company determines in good faith that such insurance is not reasonably available, if the premium costs for such insurance are disproportionate to the amount of coverage provided, or if the coverage provided by such insurance is limited by exclusions so as to provide an insufficient benefit.

 

15.       No Duplication of Payments. The Company shall not be liable under this Agreement to make any payment in connection with any claim made against Indemnitee to the extent Indemnitee has otherwise actually received payment under any insurance policy, provision of the Certificate or the Bylaws or otherwise of the amounts otherwise indemnifiable hereunder. The Company’s obligation to indemnify or advance Expenses hereunder to Indemnitee as a result of the Indemnitee’s Corporate Status with an Entity other than the Company shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of Expenses from such other Entity.

 

16.       Contract Rights Not Exclusive. The rights to payment of Indemnifiable Amounts and advancement of Indemnifiable Expenses provided by this Agreement shall be in addition to, but not exclusive of, any other rights which Indemnitee may have at any time under applicable law, the Certificate or Bylaws, or any other agreement, vote of stockholders or directors (or a committee of directors) or otherwise, both as to action in Indemnitee’s official capacity and as to action in any other capacity as a result of Indemnitee’s serving as a director of the Company.

 

17.       Successors. This Agreement shall be (a) binding upon all successors and assigns of the Company (including any transferee of all or a substantial portion of the business, stock and/or assets of the Company and any direct or indirect successor by merger or consolidation or otherwise by operation of law) and (b) binding on and shall inure to the benefit of the heirs, personal representatives, executors and administrators of Indemnitee. This Agreement shall continue for the benefit of Indemnitee and such heirs, personal representatives, executors and administrators after Indemnitee has ceased to have Corporate Status.

 

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18.       Change in Law. To the extent that a change in Delaware law (whether by statute or judicial decision) or the Certificate shall permit broader indemnification or advancement of expenses than is provided under the terms of the Bylaws and this Agreement, Indemnitee shall be entitled to such broader indemnification and advancements, and this Agreement shall be deemed to be amended to such extent.

 

19.       Severability. Whenever possible, each provision of this Agreement shall be interpreted in such a manner as to be effective and valid under applicable law, but if any provision of this Agreement, or any clause thereof, shall be determined by a court of competent jurisdiction to be illegal, invalid or unenforceable, in whole or in part, such provision or clause shall be limited or modified in its application to the minimum extent necessary to make such provision or clause valid, legal and enforceable, and the remaining provisions and clauses of this Agreement shall remain fully enforceable and binding on the parties.

 

20.       Indemnitee as Plaintiff. Except as provided in Section 11(c) of this Agreement and in the next sentence, Indemnitee shall not be entitled to payment of Indemnifiable Amounts or advancement of Indemnifiable Expenses with respect to any Proceeding brought by Indemnitee against the Company, any Subsidiary, any Entity which it controls, any director or officer thereof or any third party, unless the Board of Directors has consented to the initiation of such Proceeding or the Company provides indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law. This Section shall not apply to counterclaims or affirmative defenses asserted by Indemnitee in an action brought against Indemnitee.

 

21.       Modifications and Waivers; Counterparts. Except as provided in Section 18 above with respect to changes in Delaware law which broaden the right of Indemnitee to be indemnified by the Company or to receive advancements, no supplement, modification or amendment of this Agreement shall be binding unless executed in writing by each of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions of this Agreement (whether or not similar), nor shall such waiver constitute a continuing waiver. This Agreement may also be executed and delivered by facsimile signature and in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement.

 

22.       General Notices. All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when delivered by hand, (b) when transmitted by facsimile and receipt is acknowledged during normal business hours, and if not, the next business day after transmission or (c) if mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed:

 

(i)If to Indemnitee, to:

 

[●]

 

(ii)If to the Company, to:

 

Adial Pharmaceuticals Inc.

1180 Seminole Trail, Suite 495

Charlottesville, VA 22901

Attn: CEO

 

With copy to

_____________________

 

or to such other address as may have been furnished in the same manner by any party to the others.

 

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23.       Governing Law; Consent to Jurisdiction; Service of Process. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware without regard to its rules of conflict of laws. Each of the Company and Indemnitee hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the Court of Chancery of the State of Delaware and the courts of the United States of America located in the State of Delaware (the “Delaware Courts”) for any litigation arising out of or relating to this Agreement and the transactions contemplated hereby (and agrees not to commence any litigation relating thereto except in such courts), waives any objection to the laying of venue of any such litigation in the Delaware Courts and agrees not to plead or claim in any Delaware Court that such litigation brought therein has been brought in an inconvenient forum. Each of the parties hereto agrees, (a) to the extent such party is not otherwise subject to service of process in the State of Delaware, to appoint and maintain an agent in the State of Delaware as such party's agent for acceptance of legal process, and (b) that service of process may also be made on such party by prepaid certified mail with a proof of mailing receipt validated by the United States Postal Service constituting evidence of valid service. Service made pursuant to (a) or (b) above shall have the same legal force and effect as if served upon such party personally within the State of Delaware. For purposes of implementing the parties’ agreement to appoint and maintain an agent for service of process in the State of Delaware, each such party does hereby appoint The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, New Castle County, Delaware 19801, as such agent and each such party hereby agrees to complete all actions necessary for such appointment. Upon written application by Indemnitee to the Company, the Company shall, on an annual basis, reimburse Indemnitee the annual fee charged by The Corporation Trust Company to serve as Indemnitee’s agent for service of process within 30 days following the written application for reimbursement.

 

24.       Joinders. Subsidiaries of the Company may from time to time join this Agreement by signing a joinder in substantially the form attached hereto as Exhibit A. The Company and all Subsidiaries that have joined this Agreement shall be jointly and severally liable for all obligations of the Company under this Agreement.

 

25.       Assignment. Except as otherwise set forth herein, neither this Agreement nor any of the rights, interests or obligations hereunder may be assigned by any party hereto, without the prior written consent of all of the other parties hereto.

 

26.       Entire Agreement. Without limitation to the Certificate and the Bylaws, this Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.

  

[The remainder of this page is intentionally blank]

 

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IN WITNESS WHEREOF, the parties hereto have executed this Indemnification Agreement as of the day and year first above written.

 

 

  ADIAL PHARMACEUTICALS INC.
     
  By: /s/                    
    Name:
    Title:

 

  INDEMNITEE
     
  /s/
  Name:

 

 

Page 8 of 8

 

 

EX-10.19 44 fs12017ex10-19_adialpharma.htm SUBLEASE AGREEMENT

Exhibit 10.19

 

SUBLEASE AGREEMENT

 

THIS SUBLEASE AGREEMENT (this “Sublease”) is made by and between Inspyr Therapeutics, Inc. (“Sublessor”), and ADial Pharmaceuticals, LLC (“Sublessee). Sublessor and Sublessee are the “Parties” and each a “Party”.

 

This Sublease is entered into, and is subordinate to, that certain Deed of Lease dated December 22, 2011 (the “Prime Lease”), by and between Seminole Trail Properties, LLC (the “Landlord”) and Sublessor, as Tenant. Capitalized terms not otherwise defined herein shall have the meaning as defined in the Prime Lease.

 

WHEREAS, Sublessor desires to sub-lease two furnished offices (the “Offices”) in the Leased Premises with the address of 1180 Seminole Trail, Ste 495, Charlottesville, VA 22901 to Sublessee and Sublessee desires to sub-lease the Offices.;

 

WHEREAS, Sublessor was formerly known as Lewis and Clark Pharmaceuticals, Inc., and is the successor in regards to the Prime Lease of Lewis and Clark Pharmaceuticals, LLC.

 

NOW, THEREFOR, for good and valuable consideration, the sufficiency of which is hereby agreed, the Parties agree as set forth below.

 

1.Definitions.

 

1.1.“Commencement Date”: August 18, 2017

 

1.2.“Expiration Date”: September 30, 2019.

 

1.3.“Rent”: $300 per month while Sublessee is a private company; $1,300 per month beginning on the day that is the first day of a month after Sublessee is a public company.

 

2.Grant of Sublease. In consideration of the payment of the Rent and of the covenants and agreements made by the respective parties hereto, Sublessor subleases to Sublessee and Sublessee hereby subleases from Sublessor the Offices, upon the terms and conditions herein provided, from the Commencement Date until the Expiration Date.

 

3.Early Termination: Either Party may terminate this Sublease upon written notice to the other Party specifying the date of termination as long as such date of termination is not earlier than the last day of the month following the month in which such notice is given.

 

4.Rent. Sublessee covenants and agrees to pay to Sublessor the Rent, payable in advance on the first (1st) day of each month during the term of this Sublease

 

5.Provided Services. Utilities, electrical and interne access will be provided by Sublessor. Sublessee may use available parking at the Property and other general use spaces in the Leased Premises and Property.

   

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6.Use and Subletting: Sublessee will use the Offices for general business purposes only and may not sublet the Offices or any part thereof or transfer possession or occupancy thereof to any person, firm, or corporation without the prior written consent of Sublessor.

 

7.Signage. Subject to approval of Landlord, Sublessee shall have the right to place signs on the interior of the Leased Premises, at Sublessee’s expense, in the locations agreed by and subject to approval of the Sublessor, such approval not to be unreasonably withheld.

 

8.Assignment. This Sublease may not be assigned except in the event of the merger, conversion, or acquisition of a Party in which all, or substantially all, of the assigning Party’s business is controlled by the surviving/acquiring entity, in which case it shall be automatically assigned.

 

In witness whereof the parties have executed this Agreement as of August 16, 2017.

  

Inspyr Therapeutics, Inc.   ADial Pharmaceuticals, LLC
     
Signed: /s/ Chris Lowe   Signed: /s/ William Stilley
Chris Lowe   William Stilley
CEO   CEO

 

 

 

Page 2 of 2

 

EX-10.20 45 fs12017ex10-20_adialpharma.htm AMENDMENT #4 TO LICENSE AGREEMENT

Exhibit 10.20

 

AMENDMENT #4 TO
LICENSE AGREEMENT

 

This Amendment #4, dated as of August 15, 2017 (this “Agreement”), to the Original License Agreement (as defined below) is by and between the University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group, a Virginia not-for-profit corporation of the Commonwealth of Virginia, having its principal offices at 722 Preston Avenue, Suite 107, Charlottesville, VA 29903 (“UVA LVG”), and ADial Pharmaceuticals, LLC, a Virginia limited liability company (“Adial” and together with “UVA LVG”, the “Parties”).

 

WHEREAS, the Parties have entered into that certain licensing agreement dated as of January 21, 2011 and as amended on October 21, 2013, and as further amended on May 18, 2016 and March 27, 2017 (together, “Original License Agreement”); and

 

WHEREAS, the Parties wish to amend the Original License Agreement as provided herein.

 

NOW, THEREFORE in consideration of the premises set forth above and the mutual covenants set forth below, the parties hereto agree as follows:

 

AGREEMENT

 

1.      The date in Section 4.2 B. is changed to December 31, 2023.

 

2.      The date in Section 4.2 C. is changed to December 31, 2024.

 

3.      Except as provided herein, the terms and obligations of the Parties under the Original License Agreement shall remain as specified therein.

 

IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the date first written above.

 

University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group  

ADial Pharmaceuticals, LLC

         
By: /s/ Michael P. Straightiff    By: /s/ William Stilley 
Name:   Michael P. Straightiff
Executive Director
  Name: William Stilley, CEO
Date: August 15, 2017
Date: 08/18/2017  

         
By: /s/ Peter M. Grant, II       
Name: Peter M. Grant, II
Chair, Board of Directors
     
Date: 8/18/2017      

 

 

 

EX-23.1 46 fs12017ex23-1_adialpharma.htm CONSENT OF FRIEDMAN LLP

Exhibit 23.1

 

 

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 

We hereby consent to the inclusion in this Registration Statement on Form S-1 of our report dated May 11, 2017, which includes an explanatory paragraph as to the company’s ability to continue as going concern, with respect to the financial statements of ADial Pharmaceuticals, L.L.C. as of December 31, 2016 and 2015 and for the years then ended. We also consent to the reference to our firm under the heading “Experts” in such Registration Statement.

 

/s/ Friedman LLP

 

East Hanover, New Jersey

September 6, 2017

 

EX-23.3 47 fs12017ex23-3_adialpharma.htm CONSENT OF IPSOS-INSIGHT, LLC

Exhibit 23.3

 

Consent of Ipsos-Insight, LLC

We hereby consent to (1) the use of and all references to the name of IPSOS-INSIGHT, LLC (d/b/a Ipsos Health) in the prospectus included in the registration statement on Form S-1 of ADial Pharmaceuticals, LLC (the “Company”) and any amendments thereto (the “Registration Statement”); including, but not limited to, the use of the information supplied by us and set forth under the “Prospectus Summary” and “Business” sections; and (2) the filing of this consent as an exhibit to the Registration Statement by the Company for the use of our data and information cited in the above-mentioned sections of the Registration Statement. If, subsequent to the date of this Consent, the Company proposes to amend the Registration Statement to: (i) include additional information provided by us or (ii) materially modify the interpretation of the existing information, we will promptly review the modifications in accordance with our agreement with the Company and, if approved, enter into a revised Consent.

  

Sincerely,    
     
     
By: /s/ Mark Campbell    
Name: Mark Campbell    
Title: VP & Treasurer    
     
August 31, 2017    
     

 

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