0001047469-18-001614.txt : 20180314 0001047469-18-001614.hdr.sgml : 20180314 20180314091506 ACCESSION NUMBER: 0001047469-18-001614 CONFORMED SUBMISSION TYPE: F-1/A PUBLIC DOCUMENT COUNT: 13 FILED AS OF DATE: 20180314 DATE AS OF CHANGE: 20180314 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PolyPid Ltd. CENTRAL INDEX KEY: 0001611842 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: F-1/A SEC ACT: 1933 Act SEC FILE NUMBER: 333-222930 FILM NUMBER: 18688432 BUSINESS ADDRESS: STREET 1: 20 HAMAGSHIMIM STREET, MATALON CENTER CITY: PETACH TIKVA STATE: L3 ZIP: 49348 BUSINESS PHONE: 972-74-7195700 MAIL ADDRESS: STREET 1: 20 HAMAGSHIMIM STREET, MATALON CENTER CITY: PETACH TIKVA STATE: L3 ZIP: 49348 F-1/A 1 a2234591zf-1a.htm F-1/A

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TABLE OF CONTENTS 2

Table of Contents

As filed with the Securities and Exchange Commission on March 14, 2018

Registration No. 333-222930


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



AMENDMENT NO. 1 TO
FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933



PolyPid Ltd.
(Exact name of Registrant as specified in its charter)

Not Applicable
(Translation of Registrant's name into English)

State of Israel
(State or other jurisdiction of
incorporation or organization)
  2834
(Primary Standard Industrial
Classification Code Number)
  Not Applicable
(I.R.S. Employer
Identification Number)

18 Hasivim Street
Petach Tikva 4959376, Israel
Tel: +972 (74) 719-5700

(Address, including zip code, and telephone number, including area code, of Registrant's principal executive offices)



PolyPid Inc.
The Atrium at 47 Maple Street
Suite 302A
Summit, NJ 07901
Telephone: (908) 378-9530

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



Copies to:

Divakar Gupta
Daniel I. Goldberg
Joshua A. Kaufman
Cooley LLP
The Grace Building
1114 Avenue of the Americas
New York, NY 10036
Telephone: (212) 479-6000
Facsimile: (212) 479-6275

 

Oded Har-Even
Eran Ben-Dor
David Huberman
Zysman, Aharoni, Gayer & Co.
41-45 Rothschild Blvd.
Tel Aviv, Israel 6578401
Telephone: +972 (3) 795-5555
Facsimile: +972 (3) 795-5550

 

Peter N. Handrinos
Joshua G. Kiernan
Nathan Ajiashvili
Latham & Watkins LLP
885 Third Avenue
New York, NY 10022
Telephone: (212) 906-1200
Facsimile: (212) 751-4864

 

Barry P. Levenfeld
Adrian Daniels
Yigal Arnon & Co.
1 Azrieli Center
Tel-Aviv, Israel 67021
Telephone: +972 (3) 608-7777
Facsimile: +972 (2) 623-9236



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

            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, check the following box.    o

            If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) 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.    o

            If this Form is a post-effective amendment filed pursuant to Rule 462(c) 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.    o

            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.    o

            Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Emerging growth company    ý

            If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not 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. ý



CALCULATION OF REGISTRATION FEE

       
 

Title of Each Class of Securities
To Be Registered

  Proposed Maximum
Aggregate
Offering Price(1)
  Amount of
Registration
Fee(2)
 

Ordinary Shares, par value NIS 0.80 per share

  $92,000,000   $11,454

 

(1)
Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended. Includes the ordinary shares that the underwriters have the option to purchase.

(2)
Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price.

            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 which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

   


The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to Completion. Dated March 14, 2018

3,333,333 Shares

LOGO

PolyPid Ltd.

Ordinary Shares



          This is an initial public offering of the ordinary shares of PolyPid Ltd. All of the 3,333,333 ordinary shares in this offering are being sold by the company.

          Prior to this offering, there has been no public market for our ordinary shares. It is currently estimated that the initial public offering price per share will be between $21.00 and $24.00. Application has been made to list the ordinary shares on The Nasdaq Global Market under the symbol "POLY."

          We are an "emerging growth company" as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

          Investing in our ordinary shares involves a high degree of risk. See "Risk Factors" on page 11 to read about factors you should consider before buying our ordinary shares.



          Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

  Per Share   Total
 

Public offering price

  $   $  

Underwriting discounts and commissions(1)

  $   $  

Proceeds to PolyPid Ltd., before expenses

  $   $  

(1)
See "Underwriting" beginning on page 169 for additional information regarding underwriting compensation.

          Certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of $19.5 million in ordinary shares in this offering at the initial public offering price per share. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters may determine to sell more, less or no shares in this offering to any of these shareholders, or any of these shareholders may determine to purchase more, less or no shares in this offering. The underwriters will receive the same underwriting discount on any shares purchased by these shareholders as they will on any other shares sold to the public in this offering.

          The underwriters have the option to purchase up to an additional 500,000 ordinary shares from us at the initial price to the public less the underwriting discounts and commissions, within 30 days from the date of this prospectus.



          The underwriters expect to deliver the ordinary shares against payment in New York, New York on or about             , 2018.


Goldman Sachs & Co. LLC

 

Cowen

Cantor

Raymond James   Oppenheimer & Co.



   

Prospectus dated                          , 2018


Table of Contents

TABLE OF CONTENTS



PROSPECTUS SUMMARY

    1  

RISK FACTORS

    11  

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

    63  

USE OF PROCEEDS

    65  

DIVIDEND POLICY

    67  

CAPITALIZATION

    68  

DILUTION

    70  

SELECTED FINANCIAL DATA

    73  

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

    74  

BUSINESS

    89  

MANAGEMENT

    126  

PRINCIPAL SHAREHOLDERS

    144  

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

    147  

DESCRIPTION OF SHARE CAPITAL

    150  

SHARES ELIGIBLE FOR FUTURE SALE

    158  

TAXATION

    161  

UNDERWRITING

    169  

EXPENSES OF THIS OFFERING

    176  

LEGAL MATTERS

    177  

EXPERTS

    177  

ENFORCEMENT OF CIVIL LIABILITIES

    178  

WHERE YOU CAN FIND MORE INFORMATION

    179  

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

    F-1  



          Neither we nor the underwriters have authorized anyone to provide you with information that is different from that contained in this prospectus, any amendment or supplement to this prospectus, or in any free writing prospectus we may authorize to be delivered or made available to you. Neither we nor the underwriters take responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the underwriters are offering to sell ordinary shares and seeking offers to purchase ordinary shares only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front of this prospectus, regardless of the time of delivery of this prospectus or any sale of ordinary shares. Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus.

          Neither we nor any of the underwriters have taken any action to 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. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.

          PolyPid and BonyPid are trademarks of ours that we use in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, our trademarks and tradenames referred to in this prospectus appear without the ® or ™ symbols, but those 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 right of the applicable licensor to our trademark and tradenames.


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MARKET, INDUSTRY AND OTHER DATA

          This prospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. Life Science Intelligence, Inc., the primary source for our market opportunity data included in this prospectus, was commissioned by us to compile this information.

          In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in "Risk Factors." These and other factors could cause our future performance to differ materially from our assumptions and estimates. See "Special Note Regarding Forward-Looking Statements."

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PROSPECTUS SUMMARY

          This summary highlights selected information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before deciding to invest in our ordinary shares, you should read this entire prospectus carefully, including the sections of this prospectus entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our consolidated financial statements and the related notes included elsewhere in this prospectus. Unless the context otherwise requires, references in this prospectus to the "company," "PolyPid," "we," "us," "our" and other similar designations refer to PolyPid Ltd. and its subsidiary, PolyPid Inc. The terms "shekel," "Israeli shekel" and "NIS" refer to New Israeli Shekels, the lawful currency of the State of Israel, and the terms "dollar," "U.S. dollar" or "$" refer to United States dollars, the lawful currency of the United States of America. All references to "shares" in this prospectus refer to ordinary shares of PolyPid Ltd., par value NIS 0.80 per share.

Overview

          We are a clinical-stage pharmaceutical company focused on developing and commercializing novel, locally administered therapies using our transformational PLEX (Polymer-Lipid Encapsulation matriX) technology. Our product candidates are designed to address unmet medical needs by pairing PLEX with active pharmaceutical ingredients, or APIs, which are delivered locally at customized, predetermined release rates and durations over periods ranging from days to several months. We believe that our PLEX technology represents a paradigm shift in the treatment of a wide variety of localized medical conditions, including infection, pain, inflammation and cancer. Our initial family of product candidates pairs PLEX with the widely-used, versatile antibiotic doxycycline, which we refer to as the D-PLEX family. Based on results from our clinical trials to date, none of the 101 patients treated in our clinical trials of our D-PLEX product candidates developed an infection at the treatment site after treatment.

          We are initially focused on the development of our lead product candidate, D-PLEX100, for the prevention of surgical site infections, or SSIs, in bone and soft tissue. We recently reported interim results from our fully-enrolled Phase 1b/2 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery. During the three-month period after treatment, we observed no sternal wound infections in any of the patients treated with D-PLEX100 in combination with the standard of care. In contrast, we observed a 4.5% infection rate in the control group of patients who received the standard of care alone. According to recent literature, the expected infection rate for patients receiving the standard of care alone is 5% to 8%. We plan to submit an Investigational New Drug, or IND, application for D-PLEX100 to the U.S. Food and Drug Administration, or FDA, and a clinical trial application, or CTA, to the European national competent authorities early in the fourth quarter of 2018, and to commence a Phase 3 clinical trial in this indication shortly thereafter. Early in the fourth quarter of 2018, we also plan to commence a Phase 2 clinical trial of D-PLEX100 for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery. Assuming a successful outcome in our Phase 2 clinical trial and subject to FDA feedback, we plan to initiate a Phase 3 clinical trial in the same indication. Although we have not yet discussed our plans with FDA to develop D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, we believe that if the results of this Phase 3 trial, together with the results from our planned Phase 3 trial for the prevention of sternal SSIs, are favorable, these two Phase 3 studies could support a New Drug Application, or NDA, for the prevention of SSIs in bone and soft tissue. We intend to seek approval for our product candidates under the Section 505(b)(2) pathway for marketing approval by the FDA, in the United States, and the hybrid application pathway in the European Union. We may ultimately pursue a broad label for D-PLEX100 for the management of SSIs depending on the results of our clinical trials and further discussions with the FDA regarding this

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strategy. We received a designation of Qualified Infectious Disease Product, or QIDP, from the FDA for D-PLEX100 for the prevention of sternal infection after cardiac surgery.

          Systemic administration of drugs is currently used for the treatment of a wide variety of medical conditions. However, we believe there can be significant disadvantages to systemic administration of drugs for localized conditions, such as the need to use a higher amount of drugs in treatment, prolonged exposure to drugs that may cause side effects (including damage to non-targeted organs), limited efficacy due to poor penetration or access from the bloodstream into the target tissue and challenges related to solubility or sensitivity to blood factors. Localized delivery systems that have been developed to address the problems of systemic administration also have disadvantages, including short release periods and poor control of drug release rates. We believe our PLEX technology has the potential to improve patient outcomes and lower the overall cost of treatment by enabling local, customizable, predetermined and controlled delivery of drugs, thereby addressing many of the shortcomings of systemic administration and existing localized delivery systems.

          Our PLEX technology consists of a proprietary matrix of layers of chemically-inert and biodegradable polymers and lipids that physically entrap an API in a protected reservoir, enabling localized, bioavailable drug delivery at customizable, predetermined release rates and durations over periods ranging from days to several months. We believe that these characteristics may enable our PLEX product candidates to be therapeutically effective using only a small fraction of the APIs required in systemic administration of currently marketed therapies. Because PLEX is agnostic to the nature and size of the underlying drug, it has the potential to be paired with a wide variety of currently marketed drugs or product candidates in development, including small molecules, peptides, antibodies, as well as nucleic acid-based APIs, to create novel therapies in a broad range of indications.

          We are initially developing product candidates using our PLEX technology for the prevention of SSIs. Infection resulting from surgery and trauma can be fatal and creates a significant public health burden despite the extensive use of systemically administered antibiotics both pre- and post-surgery. SSIs occur in approximately 2% to 5% of patients undergoing inpatient surgery worldwide. The WHO reports that SSIs account for an estimated $10 billion of incremental hospital costs per year in the United States and €11 billion per year in the European Union. We expect the costs associated with SSIs to continue to grow in the face of the increasing resistance of bacteria to antibiotics, as safety concerns often preclude the increase of systemic dosages and/or treatment duration to address resistance.

          We believe that, by combining doxycycline with our proprietary PLEX technology, D-PLEX100 has the potential to overcome the limitations of other available treatments and deliver significant advantages in the management of SSIs, including:

    localized delivery of an antibiotic at therapeutically effective concentrations for up to four weeks;

    applicability to a wide range of bacteria in a variety of settings, including methicillin-resistant Staphylococcus aureus, or MRSA, and community-associated MRSA;

    increased penetration and access to the infection site;

    reduced risk of overall toxicity and adverse side effects due to minimization of systemic exposure and significant decrease of total drug volume delivered;

    simplicity of administration during surgery;

    biodegradability; and

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    reduction of patient compliance concerns.

          Our lead product candidate from this family, D-PLEX100, which is being developed to prevent bone and soft tissue SSIs, received QIDP designation from the FDA in February 2017 for the prevention of sternal infection after cardiac surgery. We recently announced the results of the primary efficacy endpoint from our fully-enrolled Phase 1b/2 clinical trial of D-PLEX100 in 81 patients in this indication, observed at the three month follow-up study period. During the three-month period after treatment, we observed no sternal wound infections in any of the 58 patients treated with D-PLEX100 in combination with the standard of care. In contrast, we observed a 4.5% infection rate in the control group of patients who received the standard of care alone. According to recent literature, the expected infection rate for patients receiving the standard of care alone is 5% to 8%. We held an end of Phase 2 meeting with the FDA in the first quarter of 2018 to obtain alignment on our Phase 3 clinical trial design for the prevention of sternal infection after cardiac surgery. We plan to submit an IND for D-PLEX100 to the FDA and a CTA to the European national competent authorities early in the fourth quarter of 2018, and to commence our Phase 3 clinical trial in sternal SSIs after cardiac surgery shortly thereafter. We also plan to commence a Phase 2 trial of D-PLEX100 for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery early in the fourth quarter of 2018. Assuming a successful outcome in our Phase 2 clinical trial and subject to FDA feedback, we plan to initiate a Phase 3 clinical trial in the same indication. Although we have not yet discussed our plans with FDA to develop D-PLEX100 for the prevention of abdominal SSIs, we believe the results of this Phase 3 trial, together with the results from our planned Phase 3 trial for the prevention of sternal SSIs, could support an NDA. We plan to seek approval of D-PLEX100 in the United States under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or the FFDCA, which is administered by the FDA, and the comparable hybrid application pathway in the European Union.

          We have developed D-PLEX1000, which was formerly known as BonyPid-1000 and is another product candidate from the D-PLEX family, for use in connection with orthopedic surgeries for the management of SSIs and support of bone recovery. Often, bone will not heal in the presence of infection. Based on results from our clinical trials of D-PLEX1000 to date, none of the 43 patients treated with D-PLEX1000 developed infections in the target fracture. In a retrospective analysis of the medical records of 49 patients treated for similar open long bone fractures with the standard of care at the same clinical trial sites where we conducted our D-PLEX1000 clinical trials, we found a target fracture infection rate of up to 25%. We have completed enrollment of a pre-pivotal trial in 51 patients evaluating the safety and effectiveness of D-PLEX1000 for the treatment of open tibia fractures. Patients were assessed on a monthly basis. In interim results from the six-month follow-up period of our pre-pivotal trial, we observed that 92% of the 12 evaluable patients treated with D-PLEX1000 in addition to the standard of care reached the primary performance endpoint, the presence of solid radiographic markers for bone healing, as assessed by the establishment of a callus in three out of four cortices, as compared to 62% of the 13 evaluable patients treated with the standard of care alone. Sixty percent of the patients treated with D-PLEX1000 in combination with the standard of care had reached the primary performance endpoint by three months post-operation, as compared to 17% of patients treated with the standard of care alone. Only 36% of patients receiving the standard of care alone showed these markers at four months. It was only at the five-month evaluation that patients in the standard of care arm showed a comparable percentage of patients with these markers as that observed in the group treated with D-PLEX1000 in combination with the standard of care at three months post-operation. We do not currently plan to pursue further independent development of D-PLEX1000, as we believe the orthopedic SSI market can be adequately addressed by D-PLEX100.

          Our PLEX platform technology may have broad applications for localized medical conditions other than the prevention of SSIs. We are pursuing research and development programs for our

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PLEX platform in a variety of potential indications, including for the treatment of SSIs, pain, inflammation and cancer. We are in discussions with global biopharmaceutical companies to license our PLEX platform for use with various biologics and small molecules.

Product Candidate Pipeline

          Our PLEX product candidate pipeline is set forth below:

LOGO

Growth Strategy

    Complete clinical development of and seek approval for D-PLEX100 for the prevention of bone and soft tissue SSIs in the United States and the European Union.

    Pursue expedited and fast track regulatory pathways for the approval and commercialization of our product candidates.

    Leverage our PLEX technology to expand our product pipeline for other indications.

    Evaluate and selectively pursue collaborations with leading biopharmaceutical companies.

    Retain commercial rights in the United States and selectively partner outside of the United States.

    Establish our cGMP manufacturing facility.

    Expand our intellectual property position.

Risks Associated With Our Business

          Our business is subject to a number of risks of which you should be aware before making an investment decision. These risks are discussed more fully in the "Risk Factors" section of this prospectus immediately following this prospectus summary. These risks include, among others, the following:

    We have a limited operating history and have incurred significant losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future, and we may never achieve or maintain profitability.

    We have never generated any revenue from product sales and may never be profitable.

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    We are heavily dependent on the success of our product candidates, including obtaining regulatory approval to market our product candidates in the United States and in the European Union.

    Our product candidates are based on a novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval.

    Our product candidates and the administration of our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.

    We rely on third parties to conduct certain elements of our preclinical studies and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.

    Although we intend to establish our own cGMP compliant manufacturing facility, we expect to utilize a third party to conduct our product manufacturing, in whole or in part, at least through 2019. Therefore, we are subject to the risk that this third party may not perform satisfactorily.

    We currently have no marketing and sales organization. If we are unable to establish sales and marketing capabilities, or enter into agreements with third parties to market and sell our product candidates, if approved, we may be unable to generate any product revenue.

    We may be classified as a passive foreign investment company for the current taxable year and in the foreseeable future, which could cause our U.S. shareholders to suffer adverse tax consequences.

Corporate Information

          We are an Israeli corporation based in Israel near Tel Aviv, and were incorporated in 2008. Our principal executive offices are located at 18 Hasivim Street, P.O. Box 7126, Petach Tikva 4959376 Israel. Our telephone number is +972 (74) 719-5700. Our website address is www.polypid.com. The information contained on our website and available through our website is not incorporated by reference into and should not be considered a part of this prospectus, and the reference to our website in this prospectus is an inactive textual reference only.

Implications of Being an "Emerging Growth Company" and a Foreign Private Issuer

          As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an "emerging growth company" as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:

    a requirement to include only two years of audited financial statements and only two years of related Management's Discussion and Analysis of Financial Condition and Results of Operations disclosure in our initial registration statement;

    reduced executive compensation disclosure; and

    an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002.

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          We may take advantage of these provisions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earlier to occur of: (1) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (2) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (3) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or the SEC. We may choose to take advantage of some but not all of these reduced burdens, and therefore the information that we provide holders of our ordinary shares may be different than the information you might receive from other public companies in which you hold equity. In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards applicable to public companies. We have irrevocably elected to opt out of such extended transition period.

          Upon consummation of this offering, we will report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private issuer status. Even after we no longer qualify as an emerging growth company, as long as we continue to qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

    the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations with respect to a security registered under the Exchange Act;

    the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and

    the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial statements and other specified information, and current reports on Form 8-K upon the occurrence of specified significant events.

          Both foreign private issuers and emerging growth companies are also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we no longer qualify as an emerging growth company, but remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither an emerging growth company nor a foreign private issuer.

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THE OFFERING

Ordinary shares offered by us

  3,333,333 ordinary shares

Ordinary shares to be outstanding immediately after this offering

 

13,112,219 ordinary shares (or 13,612,219 ordinary shares if the underwriters exercise their option to purchase an additional ordinary shares in full)

Option to purchase additional ordinary shares

 

We have granted the underwriters an option for a period of 30 days after the date of this prospectus to purchase up to additional 500,000 ordinary shares.

Use of proceeds

 

We estimate that the net proceeds to us from this offering will be approximately $67.8 million, or approximately $78.2 million if the underwriters exercise their option to purchase 500,000 additional ordinary shares in full, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus.

 

We intend to use the net proceeds from this offering, together with our existing cash, cash equivalents and short-term deposits: (i) to fund the clinical development of D-PLEX100, primarily for our planned Phase 3 clinical trial for the prevention of sternal SSIs after cardiac surgery, as well as our planned Phase 2 clinical trial for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery, and, assuming a successful outcome in our Phase 2 clinical trial, our planned Phase 3 clinical trial in the same indication, and clinical supporting activities, (ii) to continue construction of our pilot manufacturing facility and initiate preparations for our larger commercial-scale cGMP compliant manufacturing facility and (iii) for other research and development activities and general corporate purposes and working capital.

 

See "Use of Proceeds" for more information about the intended use of proceeds from this offering.

Passive foreign investment company considerations

 

Based upon the expected value of our assets, including any goodwill, and the expected nature and composition of our income and assets, we may be classified as a passive foreign investment company, or a PFIC, for the taxable year ending December 31, 2018 and in future taxable years. In particular, so long as we do not generate revenue from operations for any taxable year and do not receive any research and development grants, or if such grants that we receive do not constitute gross income for purposes of the PFIC test, we likely will be classified as a PFIC for such taxable year.

   

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Proposed Nasdaq Global Market symbol

 

Application has been made to have our ordinary shares listed on The Nasdaq Global Market under the symbol "POLY."

          Unless otherwise stated, the number of ordinary shares to be outstanding after this offering is based on 9,778,886 ordinary shares outstanding as of December 31, 2017, and excludes the following:

    2,019,001 ordinary shares reserved for issuance upon the exercise of outstanding options as of December 31, 2017, at a weighted average exercise price of $4.84 per share;

    898,473 ordinary shares reserved for issuance under our Amended and Restated 2012 Share Option Plan, as of the date of this prospectus, as well as any automatic increases in the number of ordinary shares reserved for issuance under the Amended and Restated 2012 Share Option Plan; and

    2,882,215 ordinary shares issuable upon the exercise of outstanding warrants to purchase Series D-2 preferred shares, at a weighted average exercise price of $8.83 per share, which warrants will automatically convert into warrants to purchase ordinary shares upon the closing of this offering and are expected to remain outstanding at the consummation of this offering.

          Unless otherwise indicated, all information in this prospectus assumes or gives effect to:

    an initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus;

    no exercise of the underwriters' option to purchase up to an additional                          ordinary shares;

    the automatic conversion of all outstanding preferred shares into 9,138,485 ordinary shares, which will occur upon the closing of this offering;

    the exercise of warrants to purchase 56,250 Series A preferred shares, and the automatic conversion thereof into 56,250 ordinary shares, which will occur upon the closing of this offering;

    a 1-for-8 reverse share split, and par value adjustment from NIS 0.10 per share to NIS 0.80 per share, effected on February 21, 2018; and

    the adoption of our amended and restated articles of association prior to the closing of this offering, which will replace our amended and restated articles of association as currently in effect.

          Certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of $19.5 million in ordinary shares in this offering at the initial public offering price per share. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters may determine to sell more, less or no shares in this offering to any of these shareholders, or any of these shareholders may determine to purchase more, less or no shares in this offering. The underwriters will receive the same underwriting discount on any shares purchased by these shareholders as they will on any other shares sold to the public in this offering.

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SUMMARY FINANCIAL DATA

          The following table summarizes our financial data. We have derived the following statements of operations data for the years ended December 31, 2016 and 2017 and the balance sheet data as of December 31, 2017 from our audited consolidated financial statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results that may be expected in the future, and our results for any interim period are not necessarily indicative of results that may be expected for any full year. The following summary financial data should be read in conjunction with "Selected Financial Data," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our consolidated financial statements and related notes included elsewhere in this prospectus.

    Year Ended December 31,
 

    2016     2017
 

    (in thousands, except share and per share amounts)  

Research and development, net

  $ 7,708   $ 9,736  

General and administrative

    2,551     4,064  

Operating loss

    10,259     13,800  

Financial expenses, net

    1,133     40,688  

Net loss

  $ 11,392   $ 54,488  

Deemed dividend

  $   $ 1,255  

Net loss attributable to ordinary shares

    11,392     55,743  

Basic and diluted net loss per ordinary share

  $ (24.64 ) $ (102.00 )

Weighted average number of ordinary shares, basic and diluted

    568,078     584,176  

Pro forma basic and diluted net loss per ordinary share(1)

        $ (6.32 )

Pro forma weighted average number of ordinary shares, basic and diluted

          8,822,520  

(1)
See Note 13 to our consolidated financial statements included elsewhere in this prospectus for an explanation of the method used to calculate the historical and pro forma basic and diluted net loss per ordinary share.

    As of December 31, 2017
 

    Actual     Pro Forma(1)     Pro Forma As
Adjusted(2)
 

          (unaudited)        

    (in thousands)  

Balance Sheet Data:

                   

Cash, cash equivalents and short-term deposits

  $ 17,938   $ 17,951     86,117  

Working capital(3)

    15,366     15,379     84,217  

Total assets

    22,984     21,909     90,075  

Convertible preferred shares

    59,983          

Convertible preferred shares warrant liability

    47,399          

Total shareholders' equity (deficiency)

    (88,646 )   17,661     86,498  

(1)
Pro forma balance sheet data give effect to: (i) the automatic conversion of all outstanding preferred shares into 9,138,485 ordinary shares upon the closing of this offering and (ii) the exercise of warrants to purchase 56,250 Series A preferred shares, and the automatic conversion thereof into 56,250 ordinary shares, which will occur upon the closing of this offering.

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(2)
Pro forma as adjusted balance sheet data give additional effect to the sale of 3,333,333 ordinary shares in this offering at the assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(3)
Working capital is defined as total current assets minus total current liabilities

          The pro forma information discussed above is illustrative only and will be adjusted based on the actual initial public offering price and other terms of our initial public offering determined at pricing. Each $1.00 increase (decrease) in the assumed initial public offering price of $22.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash, cash equivalents and short-term deposits, total assets and shareholders' equity (deficiency) by $3.1 million, assuming that the number of ordinary 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. Similarly, each increase (decrease) of 1.0 million shares in the number of ordinary shares offered by us at the assumed initial public offering price would increase (decrease) each of cash, cash equivalents and short-term deposits, total assets and shareholders' equity (deficiency) by $20.9 million.

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RISK FACTORS

          Investing in our ordinary shares involves a high degree of risk. You should carefully consider the risks and uncertainties described below, in addition to the other information set forth in this prospectus, including the consolidated financial statements and the related notes included elsewhere in this prospectus, before purchasing our ordinary shares. If any of the following risks actually occurs, our business, financial condition, cash flows and results of operations could be negatively impacted. In that case, the trading price of our ordinary shares would likely decline and you might lose all or part of your investment.

Risks Related to Our Financial Condition and Capital Requirements

We have a limited operating history and have incurred significant losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future, and we may never achieve or maintain profitability.

          We are a clinical stage pharmaceutical company with a limited operating history. We have incurred net losses each year since our inception, including net losses of $11.4 million and $54.5 million for the years ended December 31, 2016 and 2017, respectively, and net losses attributable to ordinary shares of $11.4 million and $55.7 million for the years ended December 31, 2016 and 2017, respectively. As of December 31, 2017, we had an accumulated deficit of $92.3 million.

          We have devoted substantially all of our financial resources to designing and developing our product candidates, including conducting preclinical studies and clinical trials and providing general and administrative support for these operations. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. Our ability to ultimately achieve recurring revenues and profitability is dependent upon our ability to successfully complete the development of our product candidates, obtain necessary regulatory approvals for and successfully manufacture, market and commercialize our products. We anticipate that our expenses will increase substantially based on a number of factors, including to the extent that we:

    continue our clinical development of D-PLEX100 for the prevention of sternal surgical site infections, or SSIs, after cardiac surgery and SSIs in patients undergoing abdominal surgery, and other potential indications;

    seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies;

    identify, assess, acquire, license and/or develop other product candidates;

    establish and validate one or more commercial-scale current good manufacturing practices, or cGMP, manufacturing facilities;

    establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

    hire personnel and invest in additional infrastructure to support our operations as a public company and expand our product development;

    enter into agreements to license intellectual property from third parties;

    develop, maintain, protect and expand our intellectual property portfolio; and

    experience any delays or encounter issues with respect to any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges

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      that require longer follow-up of existing studies, additional major studies or additional supportive studies in order to pursue marketing approval.

          To date, we have financed our operations primarily through the sale of equity securities, convertible loans made by certain of our shareholders, royalty-bearing and non-royalty bearing grants that we received from the Israeli Innovation Authority, or the IIA, formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry, and non-royalty bearing grants under the European Commission's Seventh Framework Programme for Research, or FP7. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations, or grants. Even if we obtain regulatory approval to market one or more product candidates, our future revenue will depend upon the size of any markets in which such product candidates receive approval, and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors for such product candidates. Further, the net losses that we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. Other unanticipated costs may also arise.

We have never generated any revenue from product sales and may never be profitable.

          We have no products approved for marketing in any jurisdiction and we have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize one or more of our product candidates. We do not anticipate generating revenue from product sales for at least the next several years. Our ability to generate future revenue from product sales will depend heavily on our ability to:

    complete research and preclinical and clinical development of our product candidates in a timely and successful manner;

    obtain regulatory and marketing approval for those of our product candidates for which we complete clinical studies;

    develop and obtain regulatory approval for a sustainable and scalable in-house and/or third-party manufacturing process that meets all applicable regulatory standards for our approved product candidates;

    establish and maintain supply and, if applicable, manufacturing relationships with third parties that can provide adequate, in both amount and quality, products to support clinical development and the market demand for our product candidates, if and when approved;

    launch and commercialize our product candidates for which we obtain regulatory and marketing approval, either directly by establishing a sales force, marketing and distribution infrastructure, and/or with collaborators or distributors;

    expose, educate and train physicians and other medical professionals to use our products;

    obtain market acceptance, if and when approved, of our product candidates from the medical community and third-party payors;

    ensure our product candidates are approved for reimbursement from governmental agencies, health care providers and insurers in jurisdictions where they have been approved for marketing;

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    address any competing technological and market developments that impact our product candidates or their prospective usage by medical professionals;

    identify, assess, acquire and/or develop new product candidates;

    negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and perform our obligations under such collaborations;

    maintain, protect and expand our portfolio of intellectual property rights, including patents, patent applications, trade secrets and know-how;

    avoid and defend against third-party interference or infringement claims;

    attract, hire and retain qualified personnel; and

    locate and lease or acquire suitable facilities to support our clinical development, manufacturing facilities and commercial expansion.

          Even if one or more of our product candidates is approved for marketing and sale, we anticipate incurring significant incremental costs associated with commercializing such product candidates. Our expenses could increase beyond expectations if we are required by the United States Food and Drug Administration, or the FDA, the European Medicines Agency, or the EMA, or other regulatory agencies, domestic or foreign, or ethical committees in medical centers, to change our manufacturing processes or assays or to perform clinical, nonclinical, or other types of studies in addition to those that we currently anticipate. Even if we are successful in obtaining regulatory approvals to market one or more of our product candidates, our revenue earned from such product candidates will be dependent in part upon the size of the markets in the territories for which we gain regulatory approval for such products, the accepted price for such products, our ability to obtain reimbursement for such products at any price, whether we own the commercial rights for that territory in which such products have been approved and the expenses associated with manufacturing and marketing such products for such markets. Therefore, we may not generate significant revenue from the sale of such products, even if approved. Further, if we are not able to generate significant revenue from the sale of our approved products, we may be forced to curtail or cease our operations. Due to the numerous risks and uncertainties involved in product development, it is difficult to predict the timing or amount of increased expenses, or when, or if, we will be able to achieve or maintain profitability.

Even if this offering is successful, we will need to raise substantial additional funding, which may not be available on acceptable terms, or at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our product development efforts or other operations.

          We are currently advancing our product candidates through preclinical and clinical development in an effort to obtain regulatory approval. We recently announced interim results from our Phase 1b/2 clinical trial of our lead product candidate, D-PLEX100, for the prevention of sternal SSIs after cardiac surgery. We plan to submit an Investigational New Drug, or IND, application for D-PLEX100 to the FDA, and a clinical trial application, or CTA, to the European national competent authorities, early in the fourth quarter of 2018, and to commence a Phase 3 clinical trial in this indication shortly thereafter. Early in the fourth quarter of 2018, we also plan to commence a Phase 2 clinical trial in patients undergoing abdominal surgery for the prevention of SSIs.

          Developing our product candidates is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance our product candidates through clinical studies and regulatory approval.

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Furthermore, upon the closing of this offering, we expect to incur additional ongoing costs associated with operating as a public company.

          As of December 31, 2017, we had cash, cash equivalents and short-term deposits of $17.9 million. We will require significant additional financing in the future to fund our operations. Our future funding requirements will depend on many factors, including but not limited to:

    the progress, results and costs of our current and planned clinical trials of D-PLEX100 and our other future product candidates;

    the cost, timing and outcomes of regulatory review of D-PLEX100 and our other future product candidates;

    the costs of establishing and maintaining one or more of our own commercial-scale cGMP manufacturing facilities and/or engaging third-party manufacturers therefor;

    the scope, progress, results and costs of product development, laboratory testing, manufacturing, preclinical development and clinical trials for any other product candidates that we may develop or otherwise obtain in the future;

    the cost of our future activities, including establishing sales, marketing and distribution capabilities for any product candidates in any particular geography where we receive marketing approval for such product candidates;

    the terms and timing of any collaborative, licensing and other arrangements that we may establish;

    the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and

    the level of revenue, if any, received from commercial sales of any product candidates for which we receive marketing approval.

          Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if and when approved, may not achieve commercial success. Our product revenues, if any, will be derived from or based on sales of product candidates that may not be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

          We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all, and the terms of any financing may adversely affect the interests or rights of our shareholders. Even if we believe that we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations. The issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline.

          We may seek additional capital through a combination of equity offerings, debt financings and collaborations and strategic and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. If we raise additional funds through collaboration

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and licensing arrangements with third parties, it may be necessary to relinquish certain rights to our technologies or our product candidates, or to grant licenses on terms that are not favorable to us.

          If we are unable to obtain funding on acceptable terms and on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research, development or manufacturing programs or the commercialization of any approved product, or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

Risks Related to the Discovery, Development and Clinical Testing of Our Product Candidates

We are heavily dependent on the success of our product candidates, including obtaining regulatory approval to market our product candidates in the United States and the European Union.

          To date, we have invested all of our efforts and financial resources to: (i) research and develop our PLEX technology, our lead product candidate, D-PLEX100, and our other product candidates, including conducting preclinical and clinical studies and providing general and administrative support for these operations; and (ii) develop and secure our intellectual property portfolio for our product candidates. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our current and future product candidates. Our product candidates' marketability is subject to significant risks associated with successfully completing current and future clinical trials, including:

    the FDA's timely acceptance of our IND, and the European national competent authorities' timely acceptance of our CTA, which we intend to submit early in the fourth quarter of 2018, for our planned Phase 3 clinical trial of D-PLEX100 for prevention of sternal SSIs after cardiac surgery, and pursuant to which we also plan to conduct a Phase 2 clinical trial in patients undergoing abdominal surgery for the prevention of SSIs, and for any other product candidates for which we may file an IND or a CTA, as applicable, without which we would be unable to commence such clinical trials in the United States or the European Union, respectively;

    acceptance by the FDA, EMA or other regulatory agencies of our parameters for regulatory approval relating to D-PLEX100 and our other product candidates, including our proposed indications, primary and secondary endpoint assessments and measurements, safety evaluations and regulatory pathways;

    the acceptance by the FDA, EMA or other regulatory agencies of the number, design, size, conduct and implementation of our clinical trials, our trial protocols and the interpretation of data from preclinical studies or clinical trials;

    our ability to successfully complete the clinical trials of our product candidates, including timely patient enrollment and acceptable safety and efficacy data and our ability to demonstrate the safety and efficacy of the product candidates undergoing such clinical trials;

    our ability to commence a Phase 3 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery in the United States following an IND submission, if accepted, and our ability to complete such trial in a timely fashion, and that such Phase 3 clinical trial, along with our planned Phase 3 clinical trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, even if both such trials are successfully completed, will be sufficient to support approval of a New Drug Application, or NDA, or that the FDA will allow us to use our planned Phase 3 clinical trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery as the second Phase 3 clinical trial required to support such NDA;

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    the FDA's acceptance of the sufficiency of the data we collected from our preclinical studies and our Phase 1b/2 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery, and that we expect to collect from toxicological studies that we may conduct to support the submission of an IND without requiring additional preclinical studies or clinical trials;

    the willingness of the FDA, EMA or other regulatory agencies to schedule an advisory committee meeting in a timely manner to evaluate and decide on the approval of our regulatory filings, if such advisory committee meetings are required;

    the recommendation of the FDA's advisory committee to approve our applications to market D-PLEX100 and our other product candidates in the United States, and the EMA in the European Union, if such advisory committee reviews are scheduled, without limiting the approved labeling, specifications, distribution or use of the products, or imposing other restrictions;

    the satisfaction of the FDA, EMA or other regulatory agencies with the safety and efficacy of our product candidates;

    the prevalence and severity of adverse events associated with our product candidates;

    the timely and satisfactory performance by third-party contractors, trial sites and principal investigators of their obligations in relation to our clinical trials;

    our success in educating medical professionals and patients about the benefits, administration and use of our product candidates, if approved;

    the availability, perceived advantages, relative cost, safety and efficacy of alternative and competing treatments for the indications addressed by our product candidates;

    the effectiveness of our marketing, sales and distribution strategy, and operations, as well as that of any current and future licensees;

    our ability to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices, or cGMP;

    our ability to obtain, protect and enforce our intellectual property rights with respect to our product candidates; and

    changes to regulatory guidelines.

          Many of these clinical, regulatory and commercial risks are beyond our control. Accordingly, we cannot assure you that we will be able to advance any of our product candidates through clinical development, or to obtain regulatory approval of or commercialize any of our product candidates. If we fail to achieve these objectives or overcome the challenges presented above, we could experience significant delays or an inability to successfully commercialize our product candidates. Accordingly, we may not be able to generate sufficient revenues through the sale of our product candidates to enable us to continue our business.

We may be unable to obtain regulatory approval for our product candidates.

          The research, development, testing, manufacturing, labeling, packaging, approval, promotion, advertising, storage, recordkeeping, marketing, distribution, post-approval monitoring and reporting and export and import of drug products are subject to extensive regulation by the FDA, the EMA and by foreign regulatory authorities in other countries. These regulations differ from country to country. To gain approval to market our product candidates, we must provide data from well-controlled clinical trials that adequately demonstrate the safety and efficacy of the product for the intended indication to the satisfaction of the FDA, EMA or other regulatory authority. We have not yet obtained regulatory approval to market any of our product candidates in the United States

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or any other country. The FDA, EMA or other regulatory agencies can delay, limit or deny approval of our product candidates for many reasons, including:

    regulatory requests for additional analyses, reports, data, non-clinical and preclinical studies and clinical trials;

    our inability to demonstrate that the product candidates are safe and effective for the target indication to the satisfaction of the FDA, EMA or other regulatory agencies;

    the FDA's, EMA's, or other regulatory agencies' disagreement with our trial protocol, the interpretation of data from preclinical studies or clinical trials, or adequacy of the conduct and control of clinical trials;

    clinical holds, other regulatory objections to commencing or continuing a clinical trial or the inability to obtain regulatory approval to commence a clinical trial in countries that require such approvals;

    the population studied in the clinical trial may not be sufficiently broad or representative to assess safety in the patient population for which we seek approval;

    unfavorable or inconclusive results of clinical trials and supportive non-clinical studies, including unfavorable results regarding safety or efficacy of our product candidates observed in clinical trials;

    our inability to demonstrate that clinical or other benefits of our product candidates outweigh any safety or other perceived risks;

    any determination that a clinical trial presents unacceptable health risks to subjects;

    our inability to obtain approval from institutional review boards, or IRBs, to conduct clinical trials at their respective sites;

    the FDA's determination that the 505(b)(2) regulatory pathway is not available for our product candidates;

    the non-approval of the formulation, labeling or the specifications of our product candidates;

    the failure to accept the manufacturing processes or facilities at our manufacturing facility or those of third-party manufacturers with which we contract;

    the potential for approval policies or regulations of the FDA, EMA or other regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval; or

    resistance to approval from the advisory committees of the FDA, EMA or other regulatory agencies for any reason including safety or efficacy concerns.

          In the United States, we will be required to submit an NDA to obtain FDA approval before marketing any of our product candidates. An NDA must include extensive preclinical and clinical data and supporting information to establish the product candidate's safety and efficacy for each desired indication. In the case of an NDA covered by Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or the FFDCA, we may rely in part on data not developed by us and for which we have not obtained a right of reference or use, including published scientific literature or the FDA's findings of safety and/or effectiveness for a previously approved drug. The NDA must also include significant information regarding the chemistry, manufacturing and controls for the product. The FDA may further inspect our manufacturing facilities to ensure that the facilities can manufacture our product candidates and our products, if and when approved, in compliance with the applicable regulatory requirements, as well as inspect our clinical trial sites to ensure that our studies are properly conducted. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and approval may not be obtained. Upon submission of an NDA, the FDA must

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make an initial determination that the application is sufficiently complete to accept the submission for filing. We cannot be certain that any submissions will be accepted for filing and review by the FDA, or ultimately be approved. If the application is not accepted for review or approval, the FDA may require that we conduct additional clinical or preclinical trials, or take other actions before it will reconsider our application. If the FDA requires additional studies or data, we would incur increased costs and delays in the marketing approval process, which may require us to expend more resources than we have available. For example, in connection with our end of phase 2 meeting with the FDA related to our proposed indication for the prevention of SSIs after cardiac surgery, the FDA indicated that two Phase 3 studies would be required to support an NDA for D-PLEX100. We have not yet discussed with the FDA our plan to conduct our second Phase 3 study in abdominal surgery patients rather than in subjects having undergone cardiac surgery to prevent sternal infections. The FDA could determine that a Phase 3 study in abdominal surgery patients does not satisfy the FDA's requirement for a second Phase 3 study to support an NDA for D-PLEX100. Moreover, even if the FDA agrees that a Phase 3 study evaluating D-PLEX100 for the prevention of post-cardiac surgery sternal infections and a second Phase 3 study for the prevention of SSIs following abdominal surgery is sufficient to support an NDA, the FDA may determine that the data from these studies support a more narrow indication than we may propose, if the FDA were to approve the NDA at all. In addition, the FDA may not consider any additional information to be complete or sufficient to support approval.

          Regulatory authorities outside of the United States, such as in the European Union, also have requirements for approval of drugs for commercial sale with which we must comply prior to marketing in those areas. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and obtaining regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. However, the failure to obtain regulatory approval in one jurisdiction could have a negative impact on our ability to obtain approval in a different jurisdiction. Approval processes vary among countries and can involve additional product candidate testing and validation and additional administrative review periods. Seeking foreign regulatory approval could require additional non-clinical studies or clinical trials, which could be costly and time consuming. Foreign regulatory approval may include all of the risks associated with obtaining FDA approval. For all of these reasons, if we seek foreign regulatory approval for any of our other product candidates, we may not obtain such approvals on a timely basis, if at all.

          Even if we eventually complete clinical testing and receive approval of any regulatory filing for our product candidates, the FDA may grant approval contingent on the performance of costly and potentially time-consuming additional post-approval clinical trials or subject to contraindications, black box warnings, restrictive surveillance or Risk Evaluation and Mitigation Strategies, or REMS. Further, the FDA, EMA or other foreign regulatory authorities may also approve our product candidates for a more limited indication or a narrower patient population than we originally requested, and these regulatory authorities may not approve the labeling that we believe is necessary or desirable for the successful commercialization of our product candidates. Following any approval for commercial sale of our product candidates, certain changes to the product, such as changes in manufacturing processes and additional labeling claims, as well as new safety information, will be subject to additional FDA notification, or review and approval. Also, regulatory approval for any of our product candidates may be withdrawn. To the extent we seek regulatory approval in foreign countries, we may face challenges similar to those described above with regulatory authorities in applicable jurisdictions. Any delay in obtaining, or inability to obtain, applicable regulatory approval for any of our product candidates would delay or prevent commercialization of our product candidates and would thus negatively impact our business, results of operations and prospects.

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Clinical drug development is difficult to design and implement and involves a lengthy and expensive process with uncertain outcomes.

          Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. A failure of one or more of our clinical trials can occur at any time during the clinical trial process. We do not know whether future clinical trials, if any, will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. Clinical trials can be delayed, suspended or terminated for a variety of reasons, including failure to:

    generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

    obtain regulatory approval, or feedback on trial design, in order to commence a trial;

    identify, recruit and train suitable clinical investigators;

    reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among CROs and clinical trial sites, and have such CROs and sites effect the proper and timely conduct of our clinical trials;

    obtain and maintain IRB approval at each clinical trial site;

    identify, recruit and enroll suitable patients to participate in a trial;

    have a sufficient number of patients complete a trial or return for post-treatment follow-up;

    ensure clinical investigators and clinical trial sites observe trial protocol or continue to participate in a trial;

    address any patient safety concerns that arise during the course of a trial;

    address any conflicts with new or existing laws or regulations;

    add a sufficient number of clinical trial sites;

    manufacture sufficient quantities at the required quality of product candidate for use in clinical trials; or

    raise sufficient capital to fund a trial.

          We may also experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including:

    we may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials;

    clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs;

    the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

    our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

    regulators or IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site or amend a trial protocol;

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    we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and CROs;

    we or our investigators might have to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;

    the cost of clinical trials of our product candidates may be greater than we anticipate;

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

    there may be changes in government regulations or administrative actions;

    our product candidates may have undesirable adverse effects or other unexpected characteristics;

    we may not be able to demonstrate that a produce candidate's clinical and other benefits outweigh its safety risks;

    we may not be able to demonstrate that a product candidate provides an advantage over current standards of care of future competitive therapies in development;

    regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate; and

    any future collaborators that conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us.

          We may also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by the trial's data safety monitoring board, by the FDA, EMA or other regulatory agencies. Such authorities may suspend or terminate one or more of our clinical trials due to a number of factors, including our failure to conduct the clinical trial in accordance with relevant regulatory requirements or clinical protocols, inspection of the clinical trial operations or trial site by the FDA, EMA or other regulatory agencies resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

          Further, conducting clinical trials in foreign countries, as we plan to do for our product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

          If we experience delays in carrying out or completing any clinical trial of our product candidates, the commercial prospects of our product candidates may be harmed, and our ability to generate product revenues from any of these product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may significantly harm our business and financial condition. 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 our product candidates.

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The results of earlier studies and trials may not be predictive of future trial results, and our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates.

          Results from preclinical studies or early stage clinical trials are not necessarily predictive of future clinical trial results, and interim results of a clinical trial are not necessarily indicative of final results. For example, we observed preliminary evidence of efficacy in our preclinical studies of D-PLEX100 for sternal SSIs after cardiac surgery, but we have not yet conducted a clinical trial of D-PLEX100 in this indication that included efficacy as a final endpoint. We intend to assess efficacy in our upcoming Phase 3 clinical trial of D-PLEX100 in this indication. However, later stage clinical trials may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical and early clinical studies. This failure would cause us to abandon further development of D-PLEX100 in this indication, which is currently our most advanced product candidate.

          There is a high failure rate for drug candidates proceeding through clinical trials. Many companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including due to changes in regulatory policy during the period of our product candidate development. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Frequently, product candidates that have shown promising results in early clinical trials have subsequently suffered significant setbacks in later clinical trials.

Interim, "top-line" and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

          From time to time, we may publish interim, "top-line" or preliminary data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or "top-line" data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse changes between preliminary or interim data and final data could significantly harm our business prospects.

If the FDA does not conclude that D-PLEX100 satisfies the requirements under Section 505(b)(2) of the FFDCA, or Section 505(b)(2), or if we are unable to utilize the hybrid application pathway in the European Union, or if the requirements are not as we expect, the approval pathway for D-PLEX100 will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.

          We intend to utilize the FDA's Section 505(b)(2) regulatory pathway, and the hybrid application pathway in the European Union, which is analogous to the Section 505(b)(2) pathway, to seek NDA approval for D-PLEX100. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, added Section 505(b)(2) to the FFDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies that were not conducted by or for the applicant, and for which the applicant has not received a right of reference or use from the person by or for whom the investigations were

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conducted, which we believe could expedite the development program for D-PLEX100 by potentially decreasing the amount of preclinical and clinical data that we would need to generate in order to obtain FDA approval. However, while we believe that D-PLEX100 is a reformulation of an already-approved drug and, therefore, will be eligible for submission of an NDA under Section 505(b)(2), the FDA may disagree and determine that D-PLEX100 is not eligible for review under such regulatory pathway.

          If we are unable to pursue these regulatory pathways as anticipated, we may need to conduct additional preclinical experiments and clinical trials, provide additional data and information and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to obtain FDA approval for D-PLEX100, and complications and risks associated with D-PLEX100, would likely increase significantly. Moreover, inability to pursue the Section 505(b)(2) or similar regulatory pathway could result in new competitive products reaching the market more quickly than our product candidates, which would likely harm our competitive position and prospects. Even if we are allowed to pursue the Section 505(b)(2) or similar regulatory pathway, D-PLEX100 may not receive the requisite approvals for commercialization, and there is no guarantee the 505(b)(2) or similar pathway would ultimately lead to faster product development or earlier approval.

          In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2) over the last few years, certain competitors and others have objected to the FDA's interpretation of Section 505(b)(2). If the FDA's interpretation of Section 505(b)(2) is successfully challenged, the FDA may be required to change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced in a Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of our potential future NDAs for up to 30 months depending on the outcome of any litigation. It is also not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of the new product. However, even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition.

          Moreover, even if these product candidates are approved under the Section 505(b)(2) pathway, as the case may be, the approval may be subject to limitations on the indicated uses for which the products may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the products.

PLEX is a novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval of our product candidates.

          We have concentrated our efforts and product research on our PLEX drug delivery technology, and our future success depends on the successful development of this technology and products based on it. To our knowledge, no regulatory authority has granted approval to any person or entity, including us, to market and commercialize therapeutics using our novel delivery system. We may never receive approval to market and commercialize any product candidate that utilizes PLEX.

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As an organization, we have never conducted pivotal clinical trials, and we may be unable to do so for any product candidates we may develop, including D-PLEX100.

          We will need to successfully complete pivotal clinical trials in order to obtain the approval of the FDA, EMA or other regulatory agencies to market D-PLEX100 or any of our other product candidates. Carrying out later-stage clinical trials and the submission of a successful NDA is a complicated process. As an organization, we have not previously conducted any later stage or pivotal clinical trials and have limited experience in preparing, submitting and prosecuting regulatory filings. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to NDA submission and approval of D-PLEX100. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing D-PLEX100. See "— Risks Related to our Reliance on Third Parties — We rely on third parties to conduct certain elements of our preclinical and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates."

We may find it difficult to enroll patients in our clinical studies, which could delay or prevent us from proceeding with clinical trials.

          Identifying and qualifying patients to participate in clinical studies of our product candidates is critical to our success. The timing of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we may experience delays in our clinical trials if we encounter difficulties in enrollment. Patient enrollment and retention in clinical trials depends on many factors, including the size of the patient population, the nature of the trial protocol, our ability to recruit clinical trial investigators with the appropriate competencies and experience, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing treatments and ongoing clinical trials of competing drugs for the same indication, the proximity of patients to clinical sites, clinicians' and patients' perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any drugs that may be approved for the indications we are investigating, the eligibility criteria for the study, our ability to obtain and maintain patient consents and the risk that patients enrolled in clinical trials will drop out of the trials before completion.

          We may not be able to identify, recruit and enroll a sufficient number of patients to complete our clinical studies because of the perceived risks and benefits of the product candidate under study, the availability and efficacy of competing therapies and clinical studies, the proximity and availability of clinical study sites for prospective patients and the patient referral practices of physicians. If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of potential products will be delayed.

Our product candidates and the administration of our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.

          Undesirable side effects, including toxicology, caused by our product candidates, or the drugs encapsulated by our product candidates, could cause us or regulatory authorities to interrupt, delay or halt clinical studies and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, EMA or other regulatory agencies. Results of our studies could reveal a high

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and unacceptable severity and prevalence of these or other side effects. In such an event, our clinical studies could be suspended or terminated, and the FDA, EMA or other regulatory agencies could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications. Moreover, during the conduct of clinical trials, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions.

          Drug-related, drug-product related, formulation-related and administration-related side effects could affect patient recruitment, the ability of enrolled patients to complete the clinical study or result in potential product liability claims, which could exceed our clinical trial insurance coverage. We do not currently have product liability insurance and do not anticipate obtaining product liability insurance until such time as we have received FDA, EMA or other comparable foreign authority marketing approval for one of our product candidates and such product is being provided to patients outside of clinical trials.

          Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including but not limited to:

    regulatory authorities may suspend or withdraw approvals of such product;

    regulatory authorities may require additional warnings on the label, such as a "black box" warning or contraindication;
    additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

    we may be required to create a REMS, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use;

    we may be required to recall a product, change the way a product candidate is administered or conduct additional clinical trials;

    we could be sued and held liable for harm caused to patients;

    the product may become less competitive; and

    our reputation may suffer.

          Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.

Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize any of our product candidates, and the approval may be for a more narrow indication than we seek or be subject to other limitations or restrictions that limit its commercial profile.

          We cannot commercialize a product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate. Even if our current or future product candidates meet safety and efficacy endpoints in clinical trials, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.

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          Regulatory authorities also may approve a product candidate for more limited indications than requested or they may impose significant limitations in the form of warnings or a REMS. These regulatory authorities may require precautions or contra-indications with respect to conditions of use or they may grant approval subject to the performance of costly post-marketing clinical trials. In addition, regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of any of our product candidates. For example, the FDA may disagree that a Phase 3 study evaluating D-PLEX100 for the prevention of post-cardiac surgery sternal infections and a second Phase 3 study for the prevention of SSIs following abdominal surgery are sufficient to support an NDA for the prevention of SSIs in bone and soft tissue. Even if the FDA were to agree that these studies were sufficient to support an NDA, the FDA may determine that the data from these studies support a more narrow indication than we may propose, if the FDA were to approve the NDA at all. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates and materially and adversely affect our business, financial condition, results of operations and prospects.

Although D-PLEX100 has been granted Qualified Infectious Disease Product designation by the FDA for the prevention of sternal infection after cardiac surgery, this designation does not guarantee a shorter FDA review process, or that D-PLEX100 will ultimately be approved by the FDA.

          Under the Generating Antibiotic Incentives Now Act, or GAIN Act, the FDA may designate a product as a "qualified infectious disease product," or QIDP. In order to receive this designation, a drug must qualify as an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by either (1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens, or (2) a so-called "qualifying pathogen" found on a list of potentially dangerous, drug-resistant organisms established and maintained by the FDA under the GAIN Act. A sponsor must request such designation before submitting a marketing application. We requested and received QIDP designation for D-PLEX100 for the prevention of sternal infection after cardiac surgery. We anticipate that the QIDP designation will provide, among other benefits, an overall increased level of communication with the FDA during the development process. The benefits of QIDP designation also include eligibility for priority review and an extension by an additional five years of any non-patent market exclusivity period awarded, such as a five-year exclusivity period awarded for a new molecular entity or a three-year market exclusivity period awarded to an applicant whose application relies on new clinical investigations essential to the approval. This extension is in addition to any pediatric exclusivity extension that may be awarded. However, there is limited precedent for understanding the way in which the GAIN Act will be implemented. Receipt of QIDP designation in practice may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures, and does not assure ultimate approval by the FDA or related exclusivity benefits.

Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.

          If our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and comparable requirements outside of the United States. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

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          Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS as a condition of approval of our product candidates, which could include 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. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, EMA or other regulatory agencies and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product's approved label. As such, we may not promote our products for indications or uses for which they do not have FDA, EMA or other regulatory agency approval. The holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process. We could also be asked to conduct post-marketing clinical studies to verify the safety and efficacy of our product candidates in general or in specific patient subsets. An unsuccessful post-marketing study or failure to complete such a clinical study could result in the withdrawal of marketing approval. Furthermore, any new legislation addressing drug safety issues could result in delays in product development or commercialization or increased costs to assure compliance. Foreign regulatory authorities impose similar requirements. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

    issue warning letters asserting that we are in violation of the law;

    seek an injunction or impose civil or criminal penalties or monetary fines;

    suspend or withdraw regulatory approval;

    suspend any of our ongoing clinical trials;

    refuse to approve pending applications or supplements to approved applications submitted by us or our strategic partners;

    restrict the marketing or manufacturing of our products;

    seize or detain products, or require a product recall;

    refuse to permit the import or export of our product candidates; or

    refuse to allow us to enter into government contracts.

          Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our product candidates. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected.

          The FDA's and other regulatory authorities' policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. For example, in December 2016, the 21st Century Cures Act, or Cures Act, was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and

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spur innovation, but its ultimate implementation is unclear. 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, which would adversely affect our business, prospects, financial condition and results of operations.

          We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. For example, certain policies of the Trump administration may impact our business and industry. Namely, the Trump administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA's ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. It is difficult to predict how these Executive Orders will be implemented, and the extent to which they will impact the FDA's ability to exercise its regulatory authority. If these executive actions impose constraints on FDA's ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

If one or more of our product candidates is approved for marketing in the United States, we may be subject, directly or indirectly, to U.S. federal and state healthcare fraud and abuse laws, false claims laws, physician payment transparency laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

          If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our operations may be directly or indirectly through our relationships with physicians, patients, third-party payors and customers, subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business or financial arrangements and relationships through which we research, market, sell and distribute our products. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

    The U.S. Anti-Kickback Statute prohibits, among other things, any person or entity from knowingly and willfully offering, paying, soliciting, receiving or providing any remuneration, directly or indirectly, overtly or covertly, to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable, in whole or in part, under Medicare, Medicaid or other U.S. federal healthcare programs. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution.

    The U.S. federal false claims and civil monetary penalties laws, including the False Claims Act, or FCA, which prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false, fictitious or fraudulent claim for payment to, or approval by, the U.S. federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the U.S. federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes "any request or demand" for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed

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      to "cause" the submission of false or fraudulent claims. The FCA also permits a private individual acting as a "whistleblower" to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties. Government enforcement agencies and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the FCA for a variety of alleged promotional and marketing activities, such as providing free product to customers with the expectation that the customers would bill federal programs for the product; providing consulting fees and other benefits to physicians to induce them to prescribe products; engaging in promotion for "off-label" uses; and submitting inflated best price information to the Medicaid Rebate Program.

    The U.S. Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering 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.

    The Physician Payments Sunshine Act, enacted as part of the PPACA, imposes, among other things, annual reporting requirements for covered manufacturers for certain payments and "transfers of value" provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members.

    HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, impose, among other things, specified requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities and their business associates. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

    European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers.

          Many states have analogous state laws and regulations, such as state anti-kickback and false claims laws, that may apply to our business practices, including but not limited to, research, distribution, sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. In addition, certain states require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, file reports relating to pricing information or marketing expenditures and have laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

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          Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, PPACA has strengthened these laws. For example, recent health care reform legislation, has among other things, amended the intent requirement of the federal anti-kickback and criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. Moreover, PPACA 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 False Claims Act.

          Ensuring that our internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will likely be costly. It is possible that governmental authorities will conclude that our business practices, including arrangements we may have with physicians and other healthcare providers, some of whom may receive stock options as compensation for services provided, do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations were found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, possible exclusion from government funded healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and curtailment of our operations, any of which could substantially disrupt our operations. If the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for us to obtain regulatory clearance or approval of our product candidates and to produce, market and distribute our products after clearance or approval is obtained.

          From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory clearance or approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our product candidates. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require:

    changes to manufacturing methods;

    change in protocol design;

    additional treatment arm (control);

    recall, replacement, or discontinuance of one or more of our products; and

    additional recordkeeping.

          In addition, in the United States, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products profitably. The pharmaceutical industry in the United States, as an example, has been affected by the passage of the Patient Protection and Affordable Care Act and the Health Care and Education

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Reconciliation Act of 2010, collectively PPACA, which, among other things, imposed new fees on entities that manufacture or import certain branded prescription drugs and expanded pharmaceutical manufacturer obligations to provide discounts and rebates to certain government programs. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the PPACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the PPACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the PPACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the PPACA have been enacted. The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the "individual mandate". Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain PPACA-mandated fees, including the so-called "Cadillac" tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. We continue to evaluate the effect that the PPACA and its possible repeal and replacement has on our business. It is uncertain the extent to which any such changes may impact our business or financial condition.

          Further, there has been particular and increasing legislative and enforcement interest in the United States with respect to drug pricing practices in recent years, particularly with respect to drugs that have been subject to relatively large price increases over relatively short time periods. There have been several recent U.S. Congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and in some cases, designed to encourage importation from other countries and bulk purchasing. In the future, there will likely continue to be proposals relating to the reform of the U.S. healthcare system, some of which could further limit coverage and reimbursement of drug products, including our product candidates. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Our results of operations could be adversely affected by the PPACA and by other health care reforms that may be enacted or adopted in the future.

We face intense competition in an environment of rapid technological change and the possibility that our competitors may develop products and drug delivery systems that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully market or commercialize our product candidates.

          The pharmaceutical industry in which we operate is intensely competitive and subject to rapid and significant technological change. We are currently aware of various existing therapies in the market and in development that may in the future compete with our product candidates, including other therapies that address the management of SSIs, as well as other drugs delivery mechanisms that utilize polymer and/or lipid technology to deliver APIs at the local level. Other approaches may also emerge for the prevention or treatment of any of the indications on which we focus, and new technologies may emerge in localized drug delivery.

          We have competitors both in the United States and internationally, including major multinational pharmaceutical companies and specialty pharmaceutical companies. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis products that are more

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effective or less costly than any product candidate that we may develop, or achieve earlier patent protection, regulatory approval, product commercialization and market penetration than we do. Additionally, technologies developed by our competitors may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing our product candidates against competitors. See "Business — Competition."

Even if we obtain and maintain approval for D-PLEX100 or our other product candidates from the FDA, we may never obtain approval outside of the United States, which would limit our market opportunities and adversely affect our business.

          Approval of a product candidate in the United States by the FDA does not ensure approval of such product candidate by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. However, the failure to obtain approval from the FDA or other regulatory authorities may negatively impact our ability to obtain approval in other foreign countries. Sales of D-PLEX100 or our other product candidates outside of the United States will be subject to foreign regulatory requirements governing clinical trials and marketing approval. Even if the FDA grants marketing approval for a product candidate, comparable regulatory authorities of foreign countries also must approve the manufacturing and marketing of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and more onerous than, those in the United States, including additional preclinical studies or clinical trials. In many countries outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that country. In some cases, the price that we intend to charge for our product candidates, if approved, is also subject to approval.

          We intend to submit a marketing authorization application to the EMA for approval of D-PLEX100 in the European Union, but obtaining such approval from the European Commission following the opinion of the EMA is a lengthy and expensive process. Even if a product candidate is approved, the applicable regulatory agency may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States and the European Union also have requirements for approval of product candidates with which we must comply prior to marketing in those countries. 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 product candidates in certain countries.

          Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Also, regulatory approval for a product candidate may be withdrawn. If we fail to comply with the regulatory requirements, our target market will be reduced and our ability to realize the full market potential of D-PLEX100 or our other product candidates will be harmed and our business, financial condition, results of operations and prospects will be adversely affected.

The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.

          If the FDA does not agree that our data support the prevention of SSIs in bone and soft tissue, we intend to seek marketing approval for D-PLEX100 for the prevention of sternal SSIs after cardiac surgery and the prevention of SSIs in patients undergoing abdominal surgery. We will train our marketing and sales personnel to not promote our products, if approved, for any other uses

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outside of any FDA-approved indications for use, known as "off-label uses." We cannot, however, prevent a physician from using our products off-label, when in the physician's independent professional medical judgment he or she deems it appropriate. For example, if we obtain approval of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery and the prevention of SSIs in patients undergoing abdominal surgery, physicians may nevertheless decide to use D-PLEX100 in an attempt to prevent infections in connection with other types of surgeries, and there may be increased risk of injury to patients if physicians attempt to use our products for these uses for which they are not approved. Furthermore, the use of our products for indications other than those approved by the FDA or any foreign regulatory body may not effectively treat such conditions, which could harm our reputation in the marketplace among physicians and patients.

          If the FDA, EMA or any foreign regulatory body determines that our promotional materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, which is used for violators that do not necessitate a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as false claims laws, if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of our operations.

Risks Related to our Reliance on Third Parties

We rely on third parties to conduct certain elements of our preclinical and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.

          We have relied upon, and plan to continue to rely upon, third-party vendors, including CROs, to monitor and manage data for our ongoing preclinical and clinical studies. We rely on these parties for execution of our preclinical and clinical studies, and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the vendors and CROs does not relieve us of our regulatory responsibilities. We and our CROs and other vendors are required to comply with good clinical practice, or GCP, cGMP, the Helsinki Declaration, the International Conference on Harmonization Guideline for Good Clinical Practice, applicable European Commission Directives on Clinical Trials, laws and regulations applicable to clinical trials conducted in other territories, and good laboratory practices, or GLP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area, or EEA, and comparable foreign regulatory authorities for all of our product candidates in clinical development. Regulatory authorities enforce these regulations through periodic inspections of study sponsors, principal investigators, study sites and other contractors. If we or any of our CROs or vendors fail to comply with applicable regulations, including GCP and cGMP regulations, the clinical data generated in our clinical studies may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require us to perform additional clinical studies before approving our marketing applications. Our failure to comply with these regulations may require us to repeat clinical studies, which would delay the regulatory approval process.

          If any of our relationships with these third-party CROs or vendors terminate, we may not be able to enter into arrangements with alternative CROs or vendors or do so on commercially reasonable terms. In addition, our CROs are not our employees, and, except for remedies available

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to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical, nonclinical and preclinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical studies may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. CROs may also generate higher costs than anticipated, which could adversely affect our results of operations and the commercial prospects for our product candidates, increase our costs and delay our ability to generate revenue.

          Replacing or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, we may encounter similar challenges or delays in the future, which could have a material adverse impact on our business, financial condition and prospects.

Independent clinical investigators and CROs that we engage to conduct our clinical trials may not devote sufficient time or attention to our clinical trials or be able to repeat their past success.

          We expect to continue to depend on third parties, including independent clinical investigators and CROs, to conduct our clinical trials. CROs may also assist us in the collection and analysis of data. There is a limited number of third-party service providers and vendors that specialize or have the expertise required to achieve our business objectives. Identifying, qualifying and managing performance of third-party service providers can be difficult, time consuming and cause delays in our development programs.

          These investigators and CROs will not be our employees and we will not be able to control, other than through contract, the amount of resources, including time, which they devote to our product candidates and clinical trials. If independent investigators or CROs fail to devote sufficient resources to the development of our product candidates, or if their performance is substandard, it may delay or compromise the prospects for approval and commercialization of any product candidates that we develop.

          Investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or other regulatory authorities. The FDA or other regulatory authorities may conclude that a financial relationship between us and an investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or other regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval or rejection of our marketing applications by the FDA or other regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.

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          In addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could increase the risk that this information will be misappropriated. Further, the FDA and other regulatory authorities require that we comply with standards, commonly referred to as GCP, for conducting, recording and reporting clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected. Failure of clinical investigators or CROs to meet their obligations to us or comply with GCP procedures could adversely affect the clinical development of our product candidates and harm our business.

We rely on third parties to manufacture the raw materials, including the active pharmaceutical ingredients, that we use to create our product candidates. Our business could be harmed if existing and prospective third parties fail to provide us with sufficient quantities of these materials and products or fail to do so at acceptable quality levels or prices.

          We currently rely on third party suppliers for certain raw materials necessary to manufacture our product candidates for our preclinical studies and clinical trials. Some of these raw materials are difficult to source. Because there are a limited number of suppliers for these raw materials, we may need to engage alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our product candidates for our clinical trials, and if approved, ultimately for commercial sale. In several cases, we rely on a sole provider, and there may be a need to identify additional providers in the future. We do not have any control over the availability of raw materials. If we or our manufacturers are unable to purchase these raw materials on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the development and commercialization of our product candidates or any future product candidates, would be delayed or there would be a shortage in supply, which would impair our ability to meet our development objectives for our product candidates or generate revenues from the sale of any approved products.

          Even following our establishment of our own cGMP-compliant manufacturing capabilities, we intend to continue to rely on third party suppliers for these ingredients, which will expose us to risks including:

    reduced control for certain aspects of manufacturing activities;

    termination or nonrenewal of manufacturing and service agreements with third parties in a manner or at a time that is costly or damaging to us; and

    disruptions to the operations of our third-party manufacturers and service providers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or service provider.

          Certain of our raw material suppliers will be required to become cGMP-compliant and establish a drug master file for the applicable ingredient before we can submit our NDA for D-PLEX100. If these suppliers do not successfully carry out their contractual duties or manufacture our raw materials in accordance with regulatory requirements, we will not be able to submit our NDA as planned or complete, or may be delayed in completing, the clinical trials required for approval of D-PLEX100. In such instances, we may need to locate an appropriate replacement third-party relationship, which may not be readily available or on acceptable terms, which would cause additional delay or increased expense prior to the approval of D-PLEX100 and would thereby have a material adverse effect on our business, financial condition, results of operations and prospects.

          Additionally, we have not yet entered into binding agreements with certain third-party manufacturers to produce the raw materials and products that we use to manufacture our product candidates. Although we intend to rely on third-party manufacturers for the raw materials and

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products to support the manufacturing of our product candidates for commercialization, we have not yet entered into agreements with certain manufacturers. We may be unable to negotiate binding agreements with the manufacturers to support our commercialization activities at commercially reasonable terms.

Although we intend to establish our own cGMP compliant manufacturing facility, we expect to utilize a third party to conduct our product manufacturing, in whole or in part, at least through 2019. Therefore, we are subject to the risk that this third party may not perform satisfactorily.

          Until such time as we establish our manufacturing facility that has been properly validated to comply with FDA cGMP requirements, we will not be able to independently manufacture material for our planned preclinical and clinical programs. We currently rely on a third party manufacturer for the production of D-PLEX100 for our ongoing clinical trial materials. In the event that the establishment of our own manufacturing facility is delayed and if this third-party manufacturer does not successfully carry out its contractual duties, meet expected deadlines or manufacture D-PLEX100 in accordance with regulatory requirements or if there are disagreements between us and this third-party manufacturer, we will not be able to complete, or may be delayed in completing, the clinical trials required for approval of D-PLEX100. In such instances, we may need to locate an appropriate replacement third-party relationship, which may not be readily available or on acceptable terms, which would cause additional delay or increased expense prior to the approval of D-PLEX100 and would thereby have a material adverse effect on our business, financial condition, results of operations and prospects.

          The manufacture of pharmaceutical products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. We and our contract manufacturers must comply with cGMP requirements. Manufacturers of pharmaceutical products often encounter difficulties in production, particularly in scaling up and validating initial production and contamination controls. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if microbial, viral or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.

          We also rely on our third party manufacturer to conduct quality control reviews of and sterilization services for our product candidates. We cannot assure you that any stability, sterility or other issues relating to the manufacture of any of our product candidates will not occur in the future.

          Additionally, our third-party manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If our third-party manufacturers were to encounter any of these difficulties, our ability to provide any product candidates to patients in clinical trials and products to patients, once approved, would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the initiation or completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely. Any adverse developments affecting clinical or commercial manufacturing of our product candidates may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the supply of our product candidates. We may also have to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Accordingly, failures or difficulties faced at any level of our

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supply chain could materially adversely affect our business and delay or impede the development and commercialization of any of our product candidates and could have a material adverse effect on our business, prospects, financial condition and results of operations.

          Any of these events could lead to clinical trial delays or failure to obtain regulatory approval, or impact our ability to successfully commercialize D-PLEX100. Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of product manufacture.

Our reliance on third parties requires us to share our trade secrets and intellectual property, which increases the possibility that a competitor will discover them or that our trade secrets and intellectual property will be misappropriated or disclosed.

          Because we rely on third parties to provide us with the materials that we use to develop and manufacture our product candidates, we may, at times, share trade secrets and intellectual property with such third parties. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements, or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, such as trade secrets and intellectual property. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor's discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business.

          Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets by third parties. A competitor's discovery of our trade secrets would impair our competitive position and have an adverse impact on our business, financial condition, results of operations and prospects.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets. If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.

          We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies and product candidates. Our success depends in large part on our ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our proprietary technology and product candidates.

          We have sought to protect our proprietary position by filing patent applications in the United States and in other countries, with respect to our novel technologies and product candidates, which are important to our business. Patent prosecution is expensive and time consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.

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          As of December 31, 2017, our portfolio of owned patents and patent applications consists of seven families that protect our technology, including 55 issued patents and 49 pending patent applications in jurisdictions including the United States, the European Patent Organization, Canada, Australia, China, Japan and Israel. We cannot offer any assurances about which, if any, patents will issue, the breadth of any such patent or whether any issued patents will be found invalid and unenforceable or will be threatened by third parties. Any successful opposition to these patents or any other patents owned by or licensed to us after patent issuance could deprive us of rights necessary for the successful commercialization of any product candidates that we may develop. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced.

          Further, the patent position of pharmaceutical companies generally is highly uncertain and involves complex legal and factual questions for which legal principles remain unsolved. This renders the patent prosecution process particularly expensive and time-consuming. There is no assurance that all potentially relevant prior art relating to our patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue, and even if such patents cover our product candidates, third parties may challenge their validity, enforceability, or scope, which may result in such patents being narrowed, found unenforceable or invalidated. Furthermore, even if they are unchallenged, our patent applications and any future patents may not adequately protect our intellectual property, provide exclusivity for our product candidates, or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

          If we cannot obtain and maintain effective patent rights for our product candidates, we may not be able to compete effectively, and our business and results of operations would be harmed.

We may not have sufficient patent terms to effectively protect our products and business.

          Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its priority date. Although various extensions may be available, including pursuant to the QIDP status we received for D-PLEX100 for the prevention of sternal SSIs after cardiac surgery, the life of a patent, and the protection it affords, is limited. Even if any of our patent applications mature into issued patents, if we do not have sufficient patent terms or regulatory exclusivity to protect our products, our business and results of operations will be adversely affected.

Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any issued patents.

          Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of any patents that may issue from our patent applications, or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. We therefore cannot be certain that we or our licensors were the first to make the invention claimed in our owned and licensed patent or pending applications, or that we or our licensor were the first to file for patent protection of such inventions. Assuming the other requirements for patentability are met, for United States patent applications filed prior to March 15, 2013, the first to conceive a claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent. After March 15, 2013, under the Leahy-Smith America Invents Act, or the AIA, enacted on September 16, 2011, the United States has moved to a first to file system. The AIA also includes a number of significant changes that

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affect the way patent applications are prosecuted and may also affect patent litigation. The effects of these changes are currently unclear as the United States Patent and Trademark Office, or the USPTO, must still implement various regulations, the courts have yet to address many of these provisions and the applicability of the AIA and new regulations on specific patents discussed herein have not been determined and would need to be reviewed. In general, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any issued patents, all of which could have a material adverse effect on our business and financial condition.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

          Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in our markets of interest. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. If other entities use trademarks similar to ours in different jurisdictions, or have senior rights to ours, it could interfere with our use of our current trademarks throughout the world.

If we are unable to maintain effective proprietary rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets.

          In addition to the protection afforded by any patents that have been or may be granted, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data, trade secrets and intellectual property by maintaining the physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets and intellectual property may otherwise become known or be independently discovered by competitors.

          Although we expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed or that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Misappropriation or unauthorized disclosure of our trade secrets and intellectual property could impair our competitive position and may have a material adverse effect on our business. Additionally, if the steps taken to maintain our trade secrets and intellectual property are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret.

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Intellectual property rights of third parties could adversely affect our ability to commercialize our product candidates, and we might be required to litigate or obtain licenses from third parties in order to develop or market our product candidate. Such litigation or licenses could be costly or not available on commercially reasonable terms.

          It is inherently difficult to conclusively assess our freedom to operate without infringing on third party rights. Our competitive position may suffer if patents issued to third parties or other third party intellectual property rights cover our product candidates or elements thereof, or our manufacturing or uses relevant to our development plans. In such cases, we may not be in a position to develop or commercialize products or our product candidates unless we successfully pursue litigation to nullify or invalidate the third party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms. There may also be pending patent applications that if they result in issued patents, could be alleged to be infringed by our product candidates. If such an infringement claim should be brought and be successful, we may be required to pay substantial damages, be forced to abandon our product candidates or seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable terms, if at all.

          It is also possible that we have failed to identify relevant third party patents or applications. For example, U.S. applications filed before November 29, 2000 and certain U.S. applications filed after that date that will not be filed outside the U.S. remain confidential until patents issue. Patent applications in the U.S. and elsewhere are published approximately 18 months after the earliest filing to which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our product candidates or platform technology could have been filed by others without our knowledge. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our platform technologies, our product candidates or the use of our product candidates. Third party intellectual property right holders may also actively bring infringement claims against us. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in pursuing the development of and/or marketing of our product candidates. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing our product candidates that are held to be infringing. We might, if possible, also be forced to redesign our product candidates so that we no longer infringe the third party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

          Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There have been many lawsuits and other proceedings involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions and reexamination proceedings before the USPTO and corresponding foreign patent offices. 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 pharmaceutical industry expands and more patents are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third parties.

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          Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture, or methods for treatment related to the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any materials formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidates unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable.

          Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture, or methods of use, the holders of any such patents may be able to block our ability to develop and commercialize the applicable product candidate unless we obtain a license or until such patent expires or is finally determined to be invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all.

          Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our 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, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.

          Because our programs may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our ability to acquire, in-license, or use these proprietary rights. In addition, our product candidates may require specific formulations to work effectively and efficiently and the rights to these formulations may be held by others. We may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities.

          For example, we sometimes collaborate with academic institutions to accelerate our preclinical research or development under written agreements with these institutions. Typically, these institutions provide us with an option to negotiate a license to any of the institution's rights in technology resulting from the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our program.

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          In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment. If we are unable to successfully obtain rights to required third-party intellectual property rights, we may have to abandon development of that program and our business and financial condition could suffer.

We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.

          Competitors may infringe our intellectual property or that of our licensors that we may acquire in the future. If we or a future licensing partner were to initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Under the AIA, the validity of U.S. patents may also be challenged in post-grant proceedings before the USPTO. The outcome following legal assertions of invalidity and unenforceability is unpredictable.

          Interference proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patent or patent applications or those of our licensors. An unfavorable outcome 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. Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development partnerships that would help us bring our product candidates to market.

          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. There could also 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 material adverse effect on the price of our ordinary shares.

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

          We employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants, or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees' former employers or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we

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may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be subject to claims challenging the inventorship of our intellectual property.

          We may be subject to claims that former employees, collaborators or other third parties have an interest in or right to compensation with respect to our current patent and patent applications, future patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or claiming the right to compensation. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. To the extent that our employees have not effectively waived the right to compensation with respect to inventions that they helped create, they may be able to assert claims for compensation with respect to our future revenue. As a result, we may receive less revenue from future products if such claims are successful which in turn could impact our future profitability.

Changes in U.S. and international patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

          Our success is heavily dependent on intellectual property. Obtaining and enforcing patents in the pharmaceutical industry involves both technological and legal complexity. Therefore, obtaining and enforcing these patents is costly, time consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain patents or to enforce patents that we might obtain in the future.

We may not be able to protect our intellectual property rights throughout the world.

          Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.

          Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own product candidates and may also export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our product candidates. Future patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

          Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly

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certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products or methods of treatment, which could make it difficult for us to stop the marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our future patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Risks Related to Our Business Operations

Our future success depends in part on our ability to retain our senior management team and to attract, retain and motivate other qualified personnel.

          We are highly dependent on the members of our senior management team. The loss of their services without a proper replacement may adversely impact the achievement of our objectives. Our employees may leave our employment at any time. Recruiting and retaining other qualified employees, consultants and advisors for our business, including scientific and technical personnel, will also be critical to our success. There is currently a shortage of skilled personnel in our industry, which is likely to continue for the foreseeable future. As a result, competition for skilled personnel is intense, and the turnover rate can be high. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical companies for individuals with similar skill sets. In addition, failure to succeed in preclinical or clinical studies may make it more challenging to recruit and retain qualified personnel. The inability to recruit and retain qualified personnel, or the loss of the services of any members of our senior management team without proper replacement, may impede the progress of our research, development and commercialization objectives.

We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

          Our future financial performance and our ability to commercialize product candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth. As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, sales, marketing, financial and legal personnel. Our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenue could be reduced, and we may not be able to implement our business strategy.

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Due to our limited resources and access to capital, we must, and have in the past decided to, prioritize development of certain product candidates over other potential candidates. These decisions may prove to have been wrong and may adversely affect our revenues.

          Because we have limited resources and access to capital to fund our operations, we must decide which product candidates to pursue and the amount of resources to allocate to each. Our decisions concerning the allocation of research, collaboration, management and financial resources toward particular product candidates may not lead to the development of viable commercial products and may divert resources away from better opportunities. Similarly, our decisions to delay, terminate or collaborate with third parties in respect of certain product development programs may also prove not to be optimal and could cause us to miss valuable opportunities. If we make incorrect determinations regarding the market potential of our product candidates or misread trends in the pharmaceutical industry, in particular for our lead product candidate, our business, financial condition and results of operations could be materially adversely affected.

We may not be successful in our efforts to identify, discover or license additional product candidates.

          Although a substantial amount of our effort will focus on the continued clinical testing, potential approval and commercialization of D-PLEX100, the success of our business also depends upon our ability to identify, discover or license additional product candidates. Our research programs or licensing efforts may fail to yield additional product candidates for clinical development for a number of reasons, including but not limited to the following:

    our research or business development methodology or search criteria and process may be unsuccessful in identifying potential product candidates;

    we may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates;

    our product candidates may not succeed in preclinical or clinical testing;

    our product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval;

    competitors may develop alternatives that render our product candidates obsolete or less attractive;

    product candidates we develop may be covered by third parties' patents or other exclusive rights;

    the market for a product candidate may change during our development program so that such product may become unprofitable to continue to develop;

    a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and

    a product candidate may not be accepted as safe and effective by patients, the medical community, or third-party payors.

          If any of these events occur, we may be forced to abandon our development efforts for a program or programs, or we may not be able to identify, license, or discover additional product candidates, which would have a material adverse effect on our business and could potentially cause us to cease operations. Research programs to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.

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Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cybersecurity.

          Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, damage to our reputation, and the further development of our drug candidates could be delayed.

We will incur significant increased costs as a result of operating as a public company in the United States, and our management will be required to devote substantial time to new compliance initiatives.

          As a public company whose ordinary shares are listed in the United States, we will be subject to an extensive regulatory regime, requiring us, among other things, to maintain various internal controls and facilities and to prepare and file periodic and current reports and statements, including reports on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002. Complying with these requirements will be costly and time consuming. We will need to retain additional employees to supplement our current finance staff, and we may not be able to do so in a timely manner, or at all. In the event that we are unable to demonstrate compliance with our obligations as a public company in a timely manner, or are unable to produce timely or accurate financial statements, we may be subject to sanctions or investigations by regulatory authorities, such as the SEC or The Nasdaq Global Market, and investors may lose confidence in our operating results and the price of our ordinary shares could decline.

          Our independent registered public accounting firm was not engaged to perform an audit of our internal control over financial reporting, and as long as we remain an emerging growth company, as such term is defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, we will be exempt from the requirement to have an independent registered public accounting firm perform such audit. Accordingly, no such opinion was expressed or will be expressed any during any such period. Once we cease to qualify as an emerging growth company our independent registered public accounting firm will be required to attest to our management's annual assessment of the effectiveness of our internal controls over financial reporting, which will entail additional costs and expenses.

          Furthermore, we are only in the early stages of determining formally whether our existing internal controls over financial reporting systems are compliant with Section 404 and whether there are any material weaknesses or significant deficiencies in our existing internal controls. These controls and other procedures are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is disclosed accurately and is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.

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International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States or Israel.

          Other than our headquarters and other operations which are located in Israel (as further described below), we currently have limited international operations, but our business strategy incorporates potentially significant international expansion, particularly in anticipation of approval of our product candidates. We plan to retain sales representatives and third party distributors and conduct physician, infectious disease specialist, hospital pharmacist and patient association outreach activities, as well as clinical trials, outside of the United States, EU and Israel. Doing business internationally involves a number of risks, including but not limited to:

    multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits, and licenses;

    failure by us to obtain regulatory approvals for the use of our product candidates in various countries;

    additional potentially relevant third-party patent rights;

    complexities and difficulties in obtaining protection and enforcing our intellectual property;

    difficulties in staffing and managing foreign operations;

    complexities associated with managing multiple payor reimbursement regimes, government payors, prince controls or patient self-pay systems;

    limits in our ability to penetrate international markets;

    financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;

    natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions;

    certain expenses including, among others, expenses for travel, translation and insurance; and

    regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act its books and records provisions, or its anti-bribery provisions.

          Any of these factors could significantly harm our future international expansion and operations and, consequently, our results of operations.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

          Our research, development and manufacturing activities and our third party manufacturers' and suppliers' activities involve the controlled storage, use and disposal of hazardous materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers' facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could

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cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages, such liability could exceed our resources, and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. We do not currently carry biological or hazardous waste insurance coverage.

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

          We are exposed to the risk of fraud or other misconduct by our employees and independent contractors. Misconduct by these parties could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we may establish, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee and independent contractor misconduct could also involve the improper use of information obtained in the course of clinical trials, including individually identifiable information, creating fraudulent data in our preclinical studies or clinical trials or illegal misappropriation of product candidates, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity 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. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. 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 significant fines or other sanctions.

Under applicable employment laws, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.

          We generally enter into non-competition agreements with our employees and certain key consultants. These agreements prohibit our employees and certain key consultants, if they cease working for us, from competing directly with us or working for our competitors or clients for a limited period of time. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees work and it may be difficult for us to restrict our competitors from benefitting from the expertise our former employees or consultants developed while working for us.

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          For example, Israeli courts have required employers seeking to enforce non-compete undertakings of a former employee to demonstrate that the competitive activities of the former employee will harm one of a limited number of material interests of the employer which have been recognized by the courts, such as the secrecy of a company's confidential commercial information or the protection of its intellectual property. If we cannot demonstrate that such interests will be harmed, we may be unable to prevent our competitors from benefiting from the expertise of our former employees or consultants and our ability to remain competitive may be diminished.

Risks Related to Commercialization of Our Product Candidates

We do not have experience producing our product candidates at commercial levels or establishing a cGMP manufacturing facility and may not obtain the necessary regulatory approvals or produce our product candidates at the quality, quantities, locations and timing needed to support commercialization.

          We do not currently have the experience or ability to manufacture our product candidates at commercial levels. We may encounter technical or scientific issues related to manufacturing or development that we may be unable to resolve in a timely manner or with available funds. We also have not completed all of the characterization and validation activities necessary for commercialization and regulatory approvals. If we do not conduct all such necessary activities, our commercialization efforts will be delayed or halted.

          We also may encounter problems hiring and retaining the experienced specialist scientific, quality control and manufacturing personnel needed to operate our manufacturing process, which could result in delays in our production or difficulties in maintaining compliance with applicable regulatory requirements. Any problems in our manufacturing process or facilities could make us a less attractive collaborator for potential partners, including larger pharmaceutical companies, which could limit our access to additional attractive development programs. Problems in our manufacturing process or facilities also could restrict our ability to meet market demand for our product candidates.

If the market opportunities for our product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.

          Our projections of the number of people who have the potential to benefit from treatment with our product candidates are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including the scientific literature, surveys of clinics or market research, and may prove to be incorrect. Our target patient population may be lower than expected, may not be otherwise amenable to treatment with our product candidate or patients may become increasingly difficult to identify and access, all of which would adversely affect our business, financial condition, results of operations and prospects. In addition, medical advances may reduce our target markets. For example, new processes and advances in oral antibiotic medications or new operative procedures may limit the need for localized delivery systems like our product candidates. Further, advances in treatments in the fields in which we are conducting research programs that reduce side effects and have better deliverability to target organs may limit the market for our future product candidates.

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We currently have no marketing and sales organization. If we are unable to establish sales and marketing capabilities, or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any product revenue.

          We have no experience selling and marketing our product candidates, and we currently have no marketing or sales organization. To successfully commercialize any product candidates that may result from our development programs, we will need to develop these capabilities, either on our own or with others. If our product candidates receive regulatory approval, we intend to establish a sales and marketing organization independently or by utilizing experienced third parties with technical expertise and supporting distribution capabilities to commercialize our product candidates in major markets, all of which will be expensive, difficult and time consuming. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact our ability to commercialize our product candidates.

          Further, given our lack of prior experience in marketing and selling pharmaceutical products, our initial estimate of the size of the required sales force may be materially more or less than the size of the sales force actually required to effectively commercialize our product candidates. As such, we may be required to hire sales representatives and third party distributors to adequately support the commercialization of our product candidates, or we may incur excess costs if we hire more sales representatives than necessary. With respect to certain geographical markets, we may enter into collaborations with other entities to utilize their local marketing and distribution capabilities, but we may be unable to enter into such agreements on favorable terms, if at all. We also may enter into collaborations with large pharmaceutical companies to develop and commercialize product candidates. If our future collaborators do not commit sufficient resources to develop and commercialize our future products, if any, and we are unable to develop the necessary marketing capabilities on our own, we will be unable to generate sufficient product revenue to sustain our business. We may compete with companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

          Our efforts to educate the medical community, including physicians, hospital pharmacists and infectious disease specialists, and third-party payors on the benefits of our product candidates may require significant resources and may never be successful. If any of our product candidates are approved but fail to achieve market acceptance among physicians, patients or third-party payors, we will not be able to generate significant revenues from such product, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Delays in establishing and obtaining regulatory approval of our manufacturing process and facility or disruptions in our manufacturing process may delay or disrupt our product development and commercialization efforts.

          We intend to establish our own cGMP compliant manufacturing facility. Building our own manufacturing facility will require additional investment, will be time-consuming and may be subject to delays, including because of shortage of labor or compliance with regulatory requirements. In addition, building a manufacturing facility may cost more than we currently anticipate. Delays or problems in the build out of our manufacturing facility may adversely impact our ability to provide supply for the development and commercialization of D-PLEX100 as well as our financial condition.

          Before we can begin to commercially manufacture D-PLEX100 or any product candidate, whether in a third-party facility or in our own facility, once established, we must obtain regulatory approval from FDA for our manufacturing process and facility. A manufacturing authorization must also be obtained from the appropriate regulatory authorities in the European Union, Israel and

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worldwide. In addition, we must pass a pre-approval inspection of our manufacturing facility by the FDA before D-PLEX100 or any product candidate can obtain marketing approval. In order to obtain approval, we will need to ensure that all of our processes, methods and equipment are compliant with cGMP, and perform extensive audits of vendors, contract laboratories and suppliers. If any of our vendors, contract laboratories or suppliers is found to be out of compliance with cGMP, we may experience delays or disruptions in manufacturing while we work with these third parties to remedy the violation or while we work to identify suitable replacement vendors. For example, a recent cGMP audit by the Israeli Ministry of Health, or MOH, of the manufacturing process in the facility of our contract manufacturer for D-PLEX100 resulted in certain critical observations, which we have been working with our contract manufacturer to address. There can be no guarantee, however, that future inspections by regulatory authorities of our manufacturing facilities or those of our contract manufacturers will result in MOH's agreement that these critical observations have been resolved or that similar inspectional observations will not be identified. If we do not demonstrate to the satisfaction of the applicable regulator that our manufacturing facilities, or those of our contract manufacturers, are in compliance with applicable requirements, we may be materially delayed in the development of our product candidates, which would materially harm our business. The cGMP requirements govern quality control of the manufacturing process and documentation policies and procedures. In complying with cGMP, we will be obligated to expend time, money and effort in production, record keeping and quality control to assure that the product meets applicable specifications and other requirements. If we fail to comply with these requirements, we would be subject to possible regulatory action and may not be permitted to sell any product candidate that we may develop.

If we receive marketing approval for our product candidates, sales will be limited unless the product achieves broad market acceptance by physicians, patients, third-party payors, hospital pharmacists, infectious disease specialists and others in the medical community.

          The commercial success of our product candidates will depend upon the acceptance of the product by the medical community, including physicians, patients, healthcare payors, hospital pharmacists and infectious disease specialists. The degree of market acceptance of any approved product will depend on a number of factors, including:

    the demonstration of clinical safety and efficacy of our product candidates in clinical trials;

    the efficacy, potential and perceived advantages of our product candidates over alternative treatments;

    the cost of treatment relative to alternative treatments;

    the prevalence and severity of any adverse side effects;

    product labeling or product insert requirements of the FDA or other regulatory authorities, including any limitations or warnings contained in a product's approved labeling;

    distribution and use restrictions imposed by the FDA or agreed to by us as part of a mandatory or voluntary risk management plan;

    our ability to obtain third-party coverage and adequate reimbursement;

    the willingness of patients to pay for drugs out of pocket in the absence of third-party coverage;

    the demonstration of the effectiveness of our product candidates in reducing the cost of treatment;

    the strength of marketing and distribution support;

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    the timing of market introduction of competitive products;

    the availability of products and their ability to meet market demand; and

    publicity concerning our product candidates or competing products and treatments.

          If our product candidates are approved but do not achieve an adequate level of acceptance by physicians, patients, healthcare payors, hospital pharmacists and infectious disease specialists, we may not generate sufficient revenue from the product, and we may not become or remain profitable. In addition, our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.

It may be difficult for us to profitably sell our product candidates if coverage and reimbursement for these products is limited by government authorities and/or third-party payor policies.

          In addition to any healthcare reform measures which may affect reimbursement, market acceptance and sales of our product candidates, if approved, will depend on, in part, the extent to which the procedures utilizing our product candidates, performed by health care providers, will be covered by third party payors, such as government health care programs, commercial insurance and managed care organizations. Our product candidates will be purchased or provided by health care providers for utilization in certain surgical procedures. In the event health care providers and patients accept our product candidates as medically useful, cost effective and safe, there is uncertainty regarding whether our product candidates will be directly reimbursed, reimbursed through a bundled payment or if the product candidates will be included in another type of value-based reimbursement program. Third party payors determine the extent to which new products will be covered as a benefit under their plans and the level of reimbursement for any covered product or procedure which may utilize a covered product. It is difficult to predict at this time what third party payors will decide with respect to the coverage and reimbursement for our product candidates.

          A primary trend in the U.S. healthcare industry and elsewhere has been cost containment, including price controls, restrictions on coverage and reimbursement and requirements for substitution of less expensive products and procedures. Third party payors decide which products and procedures they will pay for and establish reimbursement and co-payment levels. Government and other third-party payors are increasingly challenging the prices charged for health care products and procedures, examining the cost effectiveness of procedures, and the products used in such procedures, in addition to their safety and efficacy, and limiting or attempting to limit both coverage and the level of reimbursement. We cannot be sure that coverage will be available for our product candidates, if approved, or, if coverage is available, the level of direct or indirect reimbursement.

          We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the successful commercialization of new products. Further, the adoption and implementation of any future governmental cost containment or other health reform initiative may result in additional downward pressure on the price that we may receive for any approved product.

          Reimbursement by a third-party payor may depend upon a number of factors including the third-party payor's determination that use of a product is:

    a covered benefit or part of a covered benefit under its health plan;

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    safe, effective and medically necessary;

    appropriate for the specific patient;

    cost-effective; and

    neither experimental nor investigational.

          There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about reimbursement are typically made by The Centers for Medicare and Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, as CMS decides whether and to what extent products, and the procedures that utilize such products, will be covered and reimbursed under Medicare. Private payors may follow CMS, but have their own methods and approval processes for determining reimbursement for new products, and the procedures that utilize such products. It is difficult to predict what CMS as well as other payors will decide with respect to reimbursement for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products.

          Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of our products to the payor. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. Further, no uniform policy requirement for coverage and reimbursement exists among third-party payors in the United States. Similarly, health care providers enter into participation agreements with third-party payors wherein reimbursement rates are negotiated. Therefore, coverage and reimbursement can differ significantly from payor to payor and health care provider to health care provider. As a result, we cannot be sure that coverage or adequate reimbursement will be available for our product candidates, if approved. Also, we cannot be sure that reimbursement amounts will not reduce the demand for, or the price of, our future products. If reimbursement is not available, or is available only to limited levels, we may not be able to commercialize our product candidates, or achieve profitably at all, even if approved.

Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material effect on our business, financial condition, results of operations or prospects.

          Our business exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in an FDA investigation of the safety and effectiveness of our products, our manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management's time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price. We do not currently have product liability insurance and do not anticipate obtaining product liability insurance until such time as we have received FDA or other comparable foreign authority approval for a product and there is a product that is being provided to patients outside of clinical trials. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, product liability insurance is becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have a material adverse effect on our business.

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Risks Related to this Offering and Ownership of Our Ordinary Shares

Our executive officers, directors and principal shareholders will maintain the ability to exert significant control over matters submitted to our shareholders for approval.

          Assuming the sale by us of 3,333,333 ordinary shares in this offering, our executive officers, directors and principal shareholders who owned more than 5% of our outstanding ordinary shares before this offering will, in the aggregate, beneficially own shares representing approximately 51.3% of our capital stock. Assuming an initial public offering price of $22.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, if certain of our existing shareholders purchase all the shares they have indicated an interest in purchasing in this offering, the number of our executive officers, directors and principal shareholders who owned more than 5% of our outstanding ordinary shares before this offering will, in the aggregate, beneficially own shares representing approximately 42.6% of our capital stock. As a result, if these shareholders were to act together, they would be able to control all matters submitted to our shareholders for approval, as well as our management and affairs. For example, these persons, if they act together, would control the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of voting power could delay or prevent an acquisition of our company on terms that other stockholders may desire or result in management of our company that our public shareholders disagree with.

If you purchase our ordinary shares in this offering, you will incur immediate and substantial dilution in the book value of your shares.

          The initial public offering price of our ordinary shares will be substantially higher than the net tangible book value per share of our ordinary shares. Therefore, if you purchase ordinary shares in this offering, you will pay a price per share that substantially exceeds our net tangible book value per share after this offering. To the extent outstanding options and warrants are exercised, you will incur further dilution. Based on an assumed initial public offering price of $22.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $16.70 per share, representing the difference between our pro forma net tangible book value per share after giving effect to this offering at the assumed initial public offering price. In addition, purchasers of ordinary shares in this offering will have contributed approximately 54% of the aggregate price paid by all purchasers of our stock but will own only approximately 25% of our ordinary shares outstanding after this offering. See "Dilution."

An active trading market for our ordinary shares may not develop.

          Prior to this offering, there has been no public market for our ordinary shares. The initial public offering price for our ordinary shares will be determined through negotiations with the underwriters. Although we have applied to have our ordinary shares listed on The Nasdaq Global Market, an active trading market for our shares may never develop or be sustained following this offering. If an active market for our ordinary shares does not develop, it may be difficult for you to sell shares you purchase in this offering without depressing the market price for the shares, or at all. In addition, because certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of approximately $19.5 million in ordinary shares in this offering at the initial public offering price per share, the overall trading market for our shares may not be as active as it otherwise would have been had these shares been purchased by other investors.

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The market price of our ordinary shares may be highly volatile, which could result in substantial losses for purchasers of our ordinary shares in this offering.

          The trading price of our ordinary shares is likely to be volatile. The stock market in general, and the market for pharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your ordinary shares at or above the initial public offering price. The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our ordinary shares:

    inability to obtain the approvals necessary to commence further clinical trials;

    unsatisfactory results of clinical trials;

    announcements of regulatory approvals or the failure to obtain them, or specific label indications or patient populations for their use, or changes or delays in the regulatory review process;

    announcements of therapeutic innovations or new products by us or our competitors;

    adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities;

    changes or developments in laws or regulations applicable to any candidate product in any of our platforms;

    any adverse changes to our relationship with manufacturers or suppliers, especially manufacturers of candidate products;

    any intellectual property infringement actions in which we may become involved;

    announcements concerning our competitors or the pharmaceutical industry in general;

    achievement of expected product sales and profitability or our failure to meet expectations;

    our commencement of, or involvement in, litigation;

    any major changes in our Board of Directors or management; and

    legislation in the United States or any other territory relating to the sale or pricing of pharmaceuticals.

          If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our ordinary shares could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.

          In the past, following periods of volatility in the market price of a company's securities, securities class-action litigation often has been instituted against that company. Such litigation, if instituted against us, could cause us to incur substantial costs to defend such claims and divert management's attention and resources, which could seriously harm our business, financial condition, results of operations and prospects.

Sales of a substantial number of shares of our ordinary shares in the public market by our existing shareholders could cause our share price to fall.

          Sales of a substantial number of shares of our ordinary shares in the public market, or the perception that these sales might occur, could depress the market price of our ordinary shares and

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could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our ordinary shares. Substantially all of the shares owned by our existing shareholders and option and warrant holders are subject to lock-up agreements with the underwriters of this offering that restrict the shareholders' ability to transfer our ordinary shares for at least six months from the date of this prospectus. Substantially all of our outstanding shares will become eligible for unrestricted sale upon expiration of the lockup period, as described in the sections of this prospectus entitled "Shares Eligible for Future Sale" and "Underwriting." In addition, shares issued or issuable upon exercise of options and warrants vested as of the expiration of the lock-up period will be eligible for sale at that time. Sales of shares by these shareholders could have a material adverse effect on the trading price of our ordinary shares. Moreover, after this offering, holders of an aggregate of approximately 12,076,950 ordinary shares will have rights, subject to some conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other shareholders. We intend to register all ordinary shares that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements described in the "Underwriting" section of this prospectus. Certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of $19.5 million in ordinary shares in this offering at the initial public offering price per share. Any such shares purchased by these shareholders who are considered to be our affiliates could not be resold in the public market immediately following this offering as a result of restrictions under securities laws, but would be able to be sold following the expiration of these restrictions as described in the "Shares Eligible for Future Sale" section of this prospectus. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters may determine to sell more, less or no shares in this offering to any of these shareholders, or any of these shareholders may determine to purchase more, less or no shares in this offering.

Our management will have broad discretion in the use of the net proceeds from this offering and may allocate the net proceeds from this offering in ways that you and other shareholders may not approve.

          Our management will have broad discretion in the use of the net proceeds, including for any of the purposes described in the section entitled "Use of Proceeds," and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. The failure of our management to use these funds effectively could harm our business. Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities and depositary institutions. These investments may not yield a favorable return to our shareholders.

There is a substantial risk that we are or will become classified as a passive foreign investment company. If we are or become classified as a passive foreign investment company, our U.S. shareholders may suffer adverse tax consequences as a result.

          Generally, for any taxable year, if at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends, interest gains from commodities and securities transactions, the excess of gains over losses from the disposition of assets which produce passive income (including amounts derived by reason of the temporary investment of funds raised in

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offerings of our shares) and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade or business. If we are characterized as a PFIC, our U.S. shareholders may suffer adverse tax consequences, including having gains realized on the sale of our ordinary shares treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable to dividends received on our ordinary shares by individuals who are U.S. holders, and having interest charges apply to distributions by us and gains from the sales of our shares.

          Our status as a PFIC will depend on the nature and composition of our income and the nature, composition and value of our assets (which, assuming we are not a "controlled foreign corporation," or a CFC, under Section 957(a) of the Internal Revenue Code of 1986, as amended, or the Code, for the year being tested, may be determined based on the fair market value of each asset, with the value of goodwill and going concern value determined in large part by reference to the market value of our common shares, which may be volatile). Our status may also depend, in part, on how quickly we utilize the cash proceeds from this offering in our business. Based upon the expected value of our assets, including any goodwill, and the expected nature and composition of our income and assets, we may be classified as a PFIC for the taxable year ending December 31, 2018 and in future taxable years. In particular, so long as we do not generate revenue from operations for any taxable year and do not receive any research and development grants, or even if we receive a research and development grant, if such grant does not constitute gross income for U.S. federal income tax purposes, we likely will be classified as a PFIC for such taxable year. Because the determination of whether we are a PFIC for any taxable year is a factual determination made annually after the end of each taxable year, there can be no assurance that we will not be considered a PFIC in any taxable year.

          The tax consequences that would apply if we are classified as a PFIC would also be different from those described above if a U.S. shareholder were able to make a valid qualified electing fund, or QEF, election. At this time, we do not expect to provide U.S. shareholders with the information necessary for a U.S. shareholder to make a QEF election. Prospective investors should assume that a QEF election will not be available.

If a United States person is treated as owning at least 10% of our shares, such holder may be subject to adverse U.S. federal income tax consequences.

          If a United States person is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our shares, such person may be treated as a "United States shareholder" with respect to each "controlled foreign corporation" in our group (if any). If our group includes one or more U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as controlled foreign corporations (regardless of whether we are or are not treated as a controlled foreign corporation). A United States shareholder of a controlled foreign corporation may be required to annually report and include in its U.S. taxable income its pro rata share of "Subpart F income", "global intangible low-taxed income" and investments in U.S. property by controlled foreign corporations, whether or not we make any distributions. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. A failure to comply with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of limitations with respect to your U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide any assurances that we will assist investors in determining whether any of our non-U.S. subsidiaries are treated as a controlled foreign corporation or whether such investor is treated as a United States shareholder with respect to any of such controlled foreign corporations or furnish to any United States shareholders information that may be necessary to comply with the aforementioned reporting

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and tax paying obligations. A United States investor should consult their own advisors regarding the potential application of these rules to its investment in the shares.

We have never paid cash dividends on our share capital, and we do not anticipate paying any cash dividends in the foreseeable future.

          We have never declared or paid cash dividends on our ordinary shares. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends in the foreseeable future. As a result, capital appreciation, if any, of our ordinary shares will be investors' sole source of gain for the foreseeable future. In addition, Israeli law limits our ability to declare and pay dividends, and may subject our dividends to Israeli withholding taxes.

If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our shares, our share price and trading volume could decline.

          The trading market for our ordinary shares will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, our share price would likely decline. If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our share price or trading volume to decline.

As a foreign private issuer, we are permitted, and intend, to follow certain home country corporate governance practices instead of otherwise applicable Nasdaq requirements, and we will not be subject to certain U.S. securities laws including, but not limited to, U.S. proxy rules and the filing of certain Exchange Act reports.

          As a foreign private issuer, we will be permitted, and intend, to follow certain home country corporate governance practices instead of those otherwise required by the Nasdaq Stock Market for domestic U.S. issuers. Following our home country governance practices as opposed to the requirements that would otherwise apply to a U.S. company listed on The Nasdaq Global Market may provide less protection to you than what is accorded to investors under the listing rules of Nasdaq applicable to domestic U.S. issuers. See the section titled "Management — Corporate Governance Practices."

          As a foreign private issuer, we will be exempt from the rules and regulations under the Securities Exchange Act of 1934, or the Exchange Act, related to the furnishing and content of proxy statements, including the applicable compensation disclosure requirements. Nevertheless, pursuant to regulations promulgated under the Israeli Companies Law, 5759-1999, or the Israeli Companies Law, we are required to disclose the annual compensation of our five most highly compensated office holders on an individual basis. Such disclosure will not be as extensive as that required of a U.S. domestic issuer. Our officers, directors and principal shareholders will also be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we will not be required under the Exchange Act to file reports and financial statements with the SEC as frequently or as promptly as U.S. domestic companies whose securities are registered under the Exchange Act and we will be exempt from filing quarterly reports with the SEC under the Exchange Act. Moreover, we will not be required to comply with

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Regulation FD, which restricts the selective disclosure of material information, although we intend to voluntarily adopt a corporate disclosure policy substantially similar to Regulation FD. These exemptions and leniencies will reduce the frequency and scope of information and protections to which you may otherwise have been eligible in relation to a U.S. domestic issuer.

          We would lose our foreign private issuer status if a majority of our shares are owned by U.S. residents and a majority of our directors or executive officers are U.S. citizens or residents or we fail to meet additional requirements necessary to avoid loss of foreign private issuer status. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly higher. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive than the forms available to a foreign private issuer. We may also be required to modify certain of our policies to comply with accepted governance practices associated with U.S. domestic issuers. Such conversion and modifications will involve additional costs. In addition, we would lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers.

We are an emerging growth company and the reduced disclosure requirements applicable to emerging growth companies may make our ordinary shares less attractive to investors.

          We are an emerging growth company, as defined in the JOBS Act, and we may take advantage of certain exemptions from various requirements that are applicable to other public companies that are not emerging growth companies.

          For as long as we remain an emerging growth company we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not "emerging growth companies." These exemptions include:

    being permitted to provide only two years of audited financial statements, in addition to any required unaudited condensed consolidated interim financial statements, with correspondingly reduced "Management's discussion and analysis of financial condition and results of operations" disclosure;

    not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;

    not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements;

    reduced disclosure obligations regarding executive compensation; and

    exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.

          We will remain an emerging growth company until the earliest of: (i) the last day of our fiscal year during which we have total annual gross revenues of at least $1.07 billion; (ii) the last day of our fiscal year following the fifth anniversary of the closing of this offering; (iii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (iv) the date on which we are deemed to be a "large accelerated filer" under the Exchange Act. We have opted out of the extended transition period made available to emerging growth companies to comply with newly adopted public company accounting requirements.

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          When we are no longer deemed to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act discussed above. We cannot predict if investors will find our ordinary shares less attractive as a result of our reliance on exemptions under the JOBS Act. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for our ordinary shares and our share price may be more volatile.

Risks Related to Israeli Law and Our Operations in Israel

Our headquarters and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability in Israel.

          Our executive offices are located in Petach Tikva, Israel. In addition, the majority of our key employees, officers and directors are residents of Israel. If these or any future facilities in Israel were to be damaged, destroyed or otherwise unable to operate, whether due to war, acts of hostility, earthquakes, fire, floods, hurricanes, storms, tornadoes, other natural disasters, employee malfeasance, terrorist acts, power outages or otherwise, or if performance of our research and development is disrupted for any other reason, such an event could delay our clinical trials or, if our product candidates are approved and we choose to manufacture all or any part of them internally, jeopardize our ability to manufacture our products as promptly as our prospective customers will likely expect, or possibly at all. If we experience delays in achieving our development objectives, or if we are unable to manufacture an approved product within a timeframe that meets our prospective customers' expectations, our business, prospects, financial results and reputation could be harmed.

          Political, economic and military conditions in Israel may directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its neighboring countries, Hamas (an Islamist militia and political group that has historically controlled the Gaza Strip) and Hezbollah (an Islamist militia and political group based in Lebanon). In addition, several countries, principally in the Middle East, restrict doing business with Israel, and additional countries may impose restrictions on doing business with Israel and Israeli companies whether as a result of hostilities in the region or otherwise. Any hostilities involving Israel, terrorist activities, political instability or violence in the region or the interruption or curtailment of trade or transport between Israel and its trading partners could adversely affect our operations and results of operations and the market price of our ordinary shares.

          Our commercial insurance does not cover losses that may occur as a result of an event associated with the security situation in the Middle East. Although the Israeli government is currently committed to covering the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages incurred. Any losses or damages incurred by us could have a material adverse effect on our business, financial condition and results of operations.

          Further, our operations could be disrupted by the obligations of our employees to perform military service. As of December 31, 2017, we had 55 employees based in Israel. Of these employees, some may be military reservists, and may be called upon to perform military reserve duty of up to 36 days per year (and in some cases more) until they reach the age of 40 (and in some cases, up to the age of 45 or older). Additionally, they may be called to active duty at any time under emergency circumstances. In response to increased tension and hostilities in the region, there have been, at times, call-ups of military reservists, and it is possible that there will be additional call-ups in the future. Our operations could be disrupted by the absence of these employees due to military service. Such disruption could harm our business and operating results.

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Our operations are subject to currency and interest rate fluctuations.

          Although our functional currency is the U.S. dollar, and our financial records are maintained in U.S. dollars, we also incur expenses in Euros and New Israeli Shekels. In the future, we expect that a substantial portion of our revenues will be generated in U.S. dollars, Euros and other foreign currencies, although we currently incur a significant portion of our expenses in currencies other than U.S. dollars, mainly New Israeli Shekels. As a result, we are affected by foreign currency exchange fluctuations through both translation risk and transaction risk, and our financial results may be affected by fluctuations in the exchange rates of currencies in the countries in which our prospective product candidates may be sold. We do not currently hedge our foreign currency exchange rate risk.

We received Israeli government grants for certain of our research and development activities, the terms of which may require us to pay royalties and to satisfy specified conditions in order to manufacture products and transfer technologies outside of Israel. If we fail to satisfy these conditions, we may be required to pay penalties and refund grants previously received.

          Our research and development efforts have been financed in part through royalty-bearing and non-royalty-bearing grants in an aggregate amount of approximately $5.0 million that we received from the IIA as of December 31, 2017. The current IIA-approved research and development grants end on December 31, 2017. With respect to the royalty-bearing grants we are committed to pay royalties at a rate of 3.0% on sales proceeds from our products that were developed under IIA programs up to the total amount of grants received, linked to the U.S. dollar and bearing interest at an annual rate of LIBOR applicable to U.S. dollar deposits. We are further required to comply with the requirements of the Israeli Encouragement of Industrial Research, Development and Technological Innovation Law, 5744-1984, as amended, and related regulations, or the Research Law, with respect to those past grants. When a company develops know-how, technology or products using IIA grants, the terms of these grants and the Research Law restrict the transfer or license of such know-how, and the transfer of manufacturing or manufacturing rights of such products, technologies or know-how outside of Israel, without the prior approval of the IIA. Therefore, the discretionary approval of an IIA committee would be required for any transfer or license to third parties inside or outside of Israel of know how or for the transfer outside of Israel of manufacturing or manufacturing rights related to those aspects of such technologies. We may not receive those approvals. Furthermore, the IIA may impose certain conditions on any arrangement under which it permits us to transfer technology or development.

          The transfer or license of IIA-supported technology or know-how outside of Israel may involve the payment of significant amounts, depending upon the value of the transferred or licensed technology or know-how, our research and development expenses, the amount of IIA support, the time of completion of the IIA-supported research project and other factors. These restrictions and requirements for payment may impair our ability to sell, license or otherwise transfer our technology assets outside of Israel or to outsource or transfer development or manufacturing activities with respect to any product or technology outside of Israel. Furthermore, the consideration available to our shareholders in a transaction involving the transfer outside of Israel of technology or know-how developed with IIA funding (such as a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA.

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Provisions of Israeli law and our amended and restated articles of association may delay, prevent or otherwise impede a merger with, or an acquisition of, us, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.

          Israeli corporate law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to such types of transactions. For example, a merger may not be consummated unless at least 50 days have passed from the date on which a merger proposal is filed by each merging company with the Israel Registrar of Companies and at least 30 days have passed from the date on which the shareholders of both merging companies have approved the merger. In addition, a majority of each class of securities of the target company must approve a merger. Moreover, a tender offer for all of a company's issued and outstanding shares can only be completed if the acquirer receives positive responses from the holders of at least 95% of the issued share capital. Completion of the tender offer also requires approval of a majority of the offerees that do not have a personal interest in the tender offer, unless, following consummation of the tender offer, the acquirer would hold at least 98% of the Company's outstanding shares. Furthermore, the shareholders, including those who indicated their acceptance of the tender offer, may, at any time within six months following the completion of the tender offer, claim that the consideration for the acquisition of the shares does not reflect their fair market value, and petition an Israeli court to alter the consideration for the acquisition accordingly, unless the acquirer stipulated in its tender offer that a shareholder that accepts the offer may not seek such appraisal rights, and the acquirer or the company published all required information with respect to the tender offer prior to the tender offer's response date.

          Furthermore, Israeli tax considerations may make potential transactions unappealing to us or to our shareholders whose country of residence does not have a tax treaty with Israel exempting such shareholders from Israeli tax. For example, Israeli tax law does not recognize tax-free share exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral contingent on the fulfillment of a number of conditions, including, in some cases, a holding period of two years from the date of the transaction during which sales and dispositions of shares of the participating companies are subject to certain restrictions. Moreover, with respect to certain share swap transactions, the tax deferral is limited in time, and when such time expires, the tax becomes payable even if no disposition of the shares has occurred. These provisions could delay, prevent or impede an acquisition of us or our merger with another company, even if such an acquisition or merger would be beneficial to us or to our shareholders.

It may be difficult to enforce a judgment of a U.S. court against us and our executive officers and directors and the Israeli experts named in this prospectus in Israel or the United States, to assert U.S. securities laws claims in Israel or to serve process on our executive officers and directors and these experts.

          We were incorporated in Israel. Substantially all of our executive officers and directors reside outside of the United States, and all of our assets and most of the assets of these persons are located outside of the United States. Therefore, a judgment obtained against us, or any of these persons, including a judgment based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States and may not be enforced by an Israeli court. It also may be difficult for you to effect service of process on these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel. Additionally, it may be difficult for an investor, or any other person or entity, to initiate an action with respect to U.S. securities laws in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of U.S. securities

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laws reasoning that Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proven as a fact by expert witnesses, which can be a time consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel that addresses the matters described above. As a result of the difficulty associated with enforcing a judgment against us in Israel, you may not be able to collect any damages awarded by either a U.S. or foreign court. See "Enforceability of Civil Liabilities" for additional information on your ability to enforce a civil claim against us and our executive officers or directors named in this prospectus.

Your rights and responsibilities as a shareholder will be governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.

          The rights and responsibilities of the holders of our ordinary shares are governed by our amended and restated articles of association and by Israeli law. These rights and responsibilities differ in some material respects from the rights and responsibilities of shareholders in U.S. companies. In particular, a shareholder of an Israeli company has a duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the Company and other shareholders, and to refrain from abusing its power in the Company, including, among other things, in voting at a general meeting of shareholders on matters such as amendments to a company's articles of association, increases in a company's authorized share capital, mergers and acquisitions and related party transactions requiring shareholder approval, as well as a general duty to refrain from discriminating against other shareholders. In addition, a shareholder who is aware that it possesses the power to determine the outcome of a vote at a meeting of the shareholders or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company. See "Management — Shareholder Duties" for additional information. There is limited case law available to assist us in understanding the nature of these duties or the implications of these provisions. These provisions may be interpreted to impose additional obligations and liabilities on holders of our ordinary shares that are not typically imposed on shareholders of U.S. companies.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

          This prospectus contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "potential," "positioned," "seek," "should," "target," "will," "would," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

    the timing and conduct of our clinical trials of D-PLEX100 and our other product candidates, including statements regarding the timing, progress and results of current and future preclinical studies and clinical trials, and our research and development programs;

    the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of D-PLEX100 and our other product candidates;

    our plans regarding utilization of regulatory pathways that would allow for accelerated marketing approval in the United States, the European Union and other jurisdictions;

    our expectations regarding timing for application for and receipt of regulatory approval for any of our product candidates;

    our ongoing and planned discovery and development of product candidates;

    our expectations regarding future growth, including our ability to develop, and obtain regulatory approval for, new product candidates;

    our expectations regarding when certain patents may be issued and the protection and enforcement of our intellectual property rights;

    our plans to develop and commercialize our product candidates;

    our estimates regarding the market opportunity for our product candidates;

    our ability to maintain relationships with certain third parties;

    our estimates regarding anticipated capital requirements and our needs for additional financing;

    our planned level of capital expenditures;

    our expectations regarding licensing, acquisitions and strategic partnering;

    our expectations regarding the maintenance of our foreign private issuer status;

    the impact of government laws and regulations; and

    our expectations regarding the use of proceeds from this offering.

          Forward-looking statements are based on our management's current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions, and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this prospectus may turn out to be inaccurate. Important factors that may cause actual results to differ materially from current expectations include, among other things, those listed under "Risk Factors"

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and elsewhere in this prospectus. Potential investors are urged to consider these factors carefully in evaluating the forward-looking statements.

          The forward-looking statements included in this prospectus speak only as of the date of this prospectus. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC after the date of this prospectus. See "Where You Can Find More Information."

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USE OF PROCEEDS

          We estimate that the net proceeds from the sale of ordinary shares in this offering will be approximately $67.8 million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus. If the underwriters exercise their option to purchase up to an 500,000 additional ordinary shares in full, we estimate that the net proceeds to us from this offering will be approximately $78.2 million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each $1.00 increase (decrease) in the assumed initial public offering price of $22.50 per ordinary share would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by $3.1 million, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of ordinary shares we are offering. An increase (decrease) of 1.0 million in the number of ordinary shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by $20.9 million, assuming the assumed initial public offering price stays the same.

          We intend to use the net proceeds from this offering, together with our existing cash, cash equivalents and short-term deposits, as follows:

    approximately $55.0 million to $60.0 million to fund the clinical development of D-PLEX100, primarily for our planned Phase 3 clinical trial for the prevention of sternal SSIs after cardiac surgery, as well as our planned Phase 2 clinical trial for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery, and, assuming a successful outcome in our Phase 2 clinical trial, our planned Phase 3 clinical trial in the same indication, and clinical supporting activities;

    approximately $5.0 million to $10.0 million to fund our manufacturing facility construction, including the construction of our pilot manufacturing facility and the initiation of preparations for our larger commercial-scale cGMP-compliant manufacturing facility; and

    the balance to fund other research and development activities and for other general corporate purposes, including general and administrative expenses and working capital.

          We may also use a portion of the net proceeds from this offering to acquire or invest in complementary products, technologies or businesses, although we have no present agreements or commitments to do so.

          Although we currently anticipate that we will use the net proceeds from this offering as described above, there may be circumstances where a reallocation of funds is necessary. Due to the uncertainties inherent in the clinical development and regulatory approval process, it is difficult to estimate with certainty the exact amounts of the net proceeds from this offering that may be used for any of the above purposes on a stand-alone basis. Amounts and timing of our actual expenditures will depend upon a number of factors, including our sales, marketing and commercialization efforts, regulatory approval and demand for our product candidates, operating costs and other factors described under "Risk Factors" in this prospectus. Accordingly, our management will have flexibility in applying the net proceeds from this offering. An investor will not have the opportunity to evaluate the economic, financial or other information on which we base our decisions on how to use the proceeds.

          Based on our current plans, we believe that our existing cash resources will be sufficient to enable us to fund our operating expenses and capital expenditure requirements for at least the next

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12 months. We anticipate that these funds, together with the net proceeds of this offering, will be sufficient for the initiation and near-completion of our planned Phase 3 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery, the completion of our planned Phase 2 clinical trial of D-PLEX100 for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery, and, assuming a successful outcome in our Phase 2 clinical trial, the initiation of our planned Phase 3 clinical trial of D-PLEX100 in the same indication. We anticipate that we will need to raise additional capital in order to complete our Phase 3 clinical trials and any potential future trials that may be required by regulatory authorities. We have based this estimate on assumptions that may prove to be incorrect, and we could use our available capital resources sooner than we currently expect.

          Pending our application of the net proceeds from this offering, we plan to invest such proceeds in in short-term, investment-grade, interest-bearing securities and depositary institutions.

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DIVIDEND POLICY

          We have never declared or paid any cash dividends to our shareholders of our ordinary shares, and we do not anticipate or intend to pay cash dividends in the foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors in compliance with applicable legal requirements and will depend on a number of factors, including future earnings, our financial condition, operating results, contractual restrictions, capital requirements, business prospects, our strategic goals and plans to expand our business, applicable law and other factors that our board of directors may deem relevant.

          The Israeli Companies Law imposes further restrictions on our ability to declare and pay dividends. See "Description of Share Capital — Dividend and Liquidation Rights" for additional information.

          Payment of dividends may be subject to Israeli withholding taxes. See "Taxation — Material Israeli Tax Considerations" for additional information.

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CAPITALIZATION

          The following table sets forth our cash, cash equivalents and short-term deposits and capitalization as of December 31, 2017, on:

    an actual basis;

    a pro forma basis to give effect to (i) the automatic conversion of all outstanding preferred shares into 9,138,485 ordinary shares upon the closing of this offering and (ii) the exercise of warrants to purchase 56,250 Series A preferred shares, and the automatic conversion thereof into 56,250 ordinary shares, which will occur upon the closing of this offering; and

    a pro forma as adjusted basis to give further effect to the sale of 3,333,333 ordinary shares in this offering at the assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

          The pro forma and pro forma as adjusted data included in the table below are also unaudited. You should read this information together with our condensed consolidated financial statements appearing elsewhere in this prospectus and the information set forth under the headings "Selected Financial Data," "Use of Proceeds" and "Management's Discussion and Analysis of Financial Condition and Results of Operations."

    As of December 31, 2017
 

    Actual     Pro Forma     Pro Forma
As Adjusted
 

    (unaudited)
(in thousands)
 

Cash, cash equivalents and short-term deposits(1)

  $ 17,938   $ 17,951   $ 86,117  

Convertible preferred shares warrant liability

    47,399          

Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-2, D-3 and E shares of NIS 0.80 par value: 12,741,017 shares authorized, actual; no shares authorized, pro forma and pro forma as adjusted; 9,138,485 shares issued and outstanding, actual; no shares issued and outstanding, pro forma and pro forma as adjusted

    59,983          

Shareholders' (deficiency) equity:

                   

Ordinary shares of NIS 0.80 par value: 15,687,500 shares authorized, actual; 28,428,517 shares authorized pro forma; 43,750,000 shares authorized pro forma as adjusted; 584,151 issued and outstanding, actual; 9,778,886 shares issued and outstanding, pro forma; 13,112,219 shares issued and outstanding, pro forma as adjusted

    129     2,251     1,050  

Additional paid-in capital

    3,540     107,725     177,763  

Accumulated deficit

    (92,315 )   (92,315 )   (92,315 )

Total shareholders' (deficiency) equity(1)

    (88,646 )   17,661     86,498  

Total capitalization(1)

  $ 18,736   $ 17,661   $ 86,498  

(1)
Each $1.00 increase or decrease in the assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, respectively, the amount of cash, cash equivalents and short-term deposits, total shareholders' (deficiency) equity and total capitalization by $3.1 million, assuming the number of ordinary 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

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    estimated offering expenses payable by us. We may also increase or decrease the number of ordinary shares we are offering. An increase or decrease of 1.0 million in the number of ordinary shares we are offering would increase or decrease, respectively, the amount of cash, cash equivalents and short-term deposits, total shareholders' (deficiency) equity and total capitalization by $20.9 million, assuming the assumed initial public offering price per ordinary share, as set forth on the cover page of this prospectus, remains the same. The pro forma as adjusted information is illustrative only, and we will adjust this information based on the actual initial public offering price and other terms of this offering determined at pricing.

          The number of ordinary shares issued and outstanding, actual, pro forma and pro forma as adjusted shown in the foregoing table and calculations excludes:

    2,219,443 ordinary shares reserved for issuance under our Amended and Restated 2012 Share Option Plan, including 2,019,001 ordinary shares reserved for issuance upon the exercise of outstanding options at a weighted average exercise price of $4.84 per share; and

    2,882,215 ordinary shares issuable upon the exercise of outstanding warrants to purchase Series D-2 preferred shares, at a weighted average exercise price of $8.83 per share, which warrants will automatically convert into warrants to purchase ordinary shares upon the closing of this offering and are expected to remain outstanding at the consummation of this offering.

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DILUTION

          If you invest in our ordinary shares in this offering, your interest will be immediately diluted to the extent of the difference between the initial public offering price per ordinary share in this offering and the pro forma as adjusted net tangible book value per ordinary share after this offering. Dilution results from the fact that the initial public offering price per ordinary share is substantially in excess of the net tangible book value per ordinary share. As of December 31, 2017, we had a historical net tangible book value of $18.7 million, or $32.08 per ordinary share. Our net tangible book value per share represents total tangible assets less total liabilities, divided by the number of ordinary shares outstanding on December 31, 2017.

          Our pro forma net tangible book value as of December 31, 2017 was $17.7 million, or $1.81 per ordinary share. Pro forma net tangible book value per share represents total tangible assets less total liabilities, divided by the number of ordinary shares outstanding as of December 31, 2017, after giving effect to the automatic conversion of all outstanding preferred shares into ordinary shares and the exercise of warrants to purchase 56,250 Series A preferred shares, and the automatic conversion thereof into 56,250 ordinary shares, which will occur upon the closing of this offering.

          After giving effect to the sale of ordinary shares in this offering at an assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses, and after taking into account the automatic conversion of all of our outstanding preferred shares into ordinary shares and the exercise of warrants to purchase 56,250 Series A preferred shares, and the automatic conversion thereof into 56,250 ordinary shares, which will occur upon the closing of this offering, our pro forma as adjusted net tangible book value at December 31, 2017 would have been $5.80 per share. This represents an immediate increase in pro forma as adjusted net tangible book value of $3.99 per share to existing shareholders and immediate dilution of $16.70 per ordinary share to new investors. The following table illustrates this dilution per ordinary share:

Assumed initial public offering price per ordinary share

        $ 22.50  

Historical net tangible book value per ordinary share as of December 31, 2017

  $ 32.08        

Decrease in net tangible book value per ordinary share due to conversion of preferred shares and exercise of warrants to purchase shares of Series A preferred shares

  $ (30.27 )      

Pro forma net tangible book value per ordinary share as of December 31, 2017

  $ 1.81        

Increase in pro forma net tangible book value per ordinary share attributable to new investors

  $ 3.99        

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

        $ 5.80  

Dilution per ordinary share to new investors participating in this offering

        $ 16.70  

          A $1.00 increase (decrease) in the assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma as adjusted net tangible book value as of December 31, 2017 after this offering by approximately $0.24 per ordinary share, and would increase (decrease) dilution to investors in this offering by $0.24 per ordinary share, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of ordinary shares we are

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offering. An increase (decrease) of 1.0 million in the number of ordinary shares we are offering would increase (decrease) our pro forma as adjusted net tangible book value as of December 31, 2017 after this offering by approximately $1.07 per ordinary share, and would decrease (increase) dilution to investors in this offering by approximately $1.07 per ordinary share, assuming the assumed initial public offering price per ordinary share remains the same, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

          The pro forma and pro forma as adjusted information is illustrative only, and we will adjust this information based on the actual initial public offering price and other terms of this offering determined at pricing.

          If the underwriters exercise in full their option to purchase additional ordinary shares, the pro forma as adjusted net tangible book value will increase to $6.35 per ordinary share, representing an immediate increase in pro forma as adjusted net tangible book value to existing shareholders of $0.56 per ordinary share and an immediate dilution of $0.56 per ordinary share to new investors participating in this offering.

          We may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our equity holders.

          The following table shows, as of December 31, 2017, on a pro forma as adjusted basis, the number of ordinary shares purchased from us, the total consideration paid to us and the average price paid per share during the last five years by existing shareholders and by new investors purchasing ordinary shares in this offering at an assumed initial public offering price of $22.50 per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us:

(in thousands, except share and per

    Shares
Subscribed for/
Purchased
    Total
Consideration
    Average
Price per
 

share amounts and percentages)

    Number     Percent     Amount     Percent     Share
 

Existing shareholders

    7,818,165     70 % $ 61,526,000     45 % $ 7.87  

Investors participating in this offering

    3,333,333     30     75,000,000     55     22.50  

Total

    11,151,498     100 % $ 136,526,000     100 %      

          A $1.00 increase (decrease) in the assumed initial public offering price of $22.50 per ordinary share (the midpoint of the price range set forth on the cover page of this prospectus) would increase (decrease) the total consideration paid by investors participating in this offering, total consideration paid by all shareholders and the average price per share paid by all shareholders by approximately $3.3 million, $3.3 million and $12.54, respectively, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same and before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

          Similarly, a 1.0 million share increase (decrease) in the number of ordinary shares offered by us, as set forth on the cover of this prospectus, would increase (decrease) the total consideration paid by investors participating in this offering, total consideration paid by all shareholders and the average price per share paid by all shareholders by approximately $22.5 million, $22.5 million and $13.09, respectively, assuming the assumed initial public offering price of $22.50 per ordinary share (the midpoint of the price range set forth on the cover page of this prospectus) remains the same,

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and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

          The tables and discussion above shown are based on 9,778,886 ordinary shares outstanding as of December 31, 2017, after giving effect to the automatic conversion of all outstanding preferred shares into ordinary shares and the exercise of warrants to purchase 56,250 Series A preferred shares, and the automatic conversion thereof into 56,250 ordinary shares, each of which will occur upon the closing of this offering, and excludes:

    2,019,001 ordinary shares reserved for issuance upon the exercise of outstanding options as of December 31, 2017, at a weighted average exercise price of $4.84 per share;

    898,473 ordinary shares reserved for issuance under our Amended and Restated 2012 Share Option Plan, as of the date of this prospectus, as well as any automatic increases in the number of ordinary shares reserved for issuance under the Amended and Restated 2012 Share Option Plan; and

    2,882,215 ordinary shares issuable upon the exercise of outstanding warrants to purchase Series D-2 preferred shares as of December 31, 2017, at a weighted average exercise price of $8.83 per share, which warrants will automatically convert into warrants to purchase ordinary shares upon the closing of this offering and are expected to remain outstanding at the consummation of this offering.

          Certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of $19.5 million in ordinary shares in this offering at the initial public offering price per share. Based on an assumed initial public offering price of $22.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, these shareholders would purchase up to an aggregate of 866,667 of the 3,333,333 ordinary shares in this offering based on these indications of interest. However, because indications of interest are not binding agreements or commitments to purchase, these shareholders may determine to purchase more, less or no ordinary shares in this offering. It is also possible that these shareholders could indicate an interest in purchasing more ordinary shares. In addition, the underwriters could determine to sell fewer ordinary shares to any of these shareholders than the shareholders indicate an interest in purchasing or not to sell any ordinary shares to these shareholders. The foregoing discussion and tables do not reflect any potential purchases by these shareholders.

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SELECTED FINANCIAL DATA

          The following table summarizes our financial data. We have derived the following statements of operations data for the years ended December 31, 2016 and 2017 and the balance sheet data as of December 31, 2016 and 2017 from our audited consolidated financial statements included elsewhere in this prospectus, which have been prepared in accordance with U.S. GAAP. Our historical results are not necessarily indicative of the results that may be expected in the future, and our results for any interim period are not necessarily indicative of results that may be expected for any full year. The following selected financial data should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our consolidated financial statements and related notes included elsewhere in this prospectus.

    Year Ended December 31,
 

    2016     2017
 

    (in thousands,
except share and per
share amounts)
 

Research and development, net

  $ 7,708   $ 9,736  

General and administrative

    2,551     4,064  

Operating loss

    10,259     13,800  

Financial expenses, net

    1,133     40,688  

Net loss

  $ 11,392   $ 54,488  

Deemed dividend

  $   $ 1,255  

Net loss attributable to ordinary shares

    11,392     55,743  

Basic and diluted net loss per ordinary share

  $ (24.64 ) $ (102.00 )

Weighted average number of ordinary shares, basic and diluted

    568,078     584,176  

    As of
December 31,
 

    2016     2017
 

    (in thousands)  

Balance Sheet Data:

             

Cash, cash equivalents and short-term deposits

  $ 17,751   $ 17,938  

Working capital(1)

    16,556     15,366  

Total assets

    19,237     22,984  

Convertible preferred shares

    44,026     59,983  

Convertible preferred shares warrant liability

    6,616     47,399  

Total shareholders' deficiency

    (33,959 )   (88,646 )

(1)
Working capital is defined as total current assets minus total current liabilities

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

          You should read the following discussion in conjunction with our audited consolidated financial statements, including the related notes thereto, beginning on page F-1. In addition to historical information, this discussion contains forward-looking statements that involve risks and uncertainties. You should read the sections of this prospectus titled "Risk Factors" and "Special Note Regarding Forward-Looking Statements" for a discussion of the factors that could cause our actual results to differ materially from our expectations.

Overview

          We are a clinical-stage pharmaceutical company focused on developing and commercializing novel, locally administered therapies using our transformational PLEX (Polymer-Lipid Encapsulation matriX) technology. Our product candidates are designed to address unmet medical needs by delivering active pharmaceutical ingredients, or APIs, locally at customizable, predetermined release rates and durations over extended periods ranging from days to several months. We believe that our PLEX technology represents a paradigm shift in the treatment of a wide variety of localized medical conditions, including infection, pain, inflammation and cancer. We are initially focused on the development of our lead product candidate, D-PLEX100, which incorporates an antibiotic, for the prevention of SSIs in bone and soft tissue.

          Since our inception in 2008, we have incurred significant operating losses. Our net losses of $11.4 million and $54.5 million for the years ended December 31, 2016 and 2017, respectively, and net losses attributable to ordinary shares were $11.4 million and $55.7 million for the years ended December 31, 2016 and 2017, respectively. As of December 31, 2017, we had an accumulated deficit of $92.3 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future, and our losses may fluctuate significantly from year to year. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:

    file an IND and a CTA and shortly thereafter initiate our Phase 3 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery and our Phase 2 clinical trial of D-PLEX100 in patients undergoing abdominal surgery for the prevention of SSIs and, assuming a successful outcome in our Phase 2 clinical trial, a Phase 3 clinical trial in the same indication;

    file an NDA seeking regulatory approval for D-PLEX100 pursuant to the FDA's Section 505(b)(2) regulatory pathway in the United States and the hybrid application pathway in the European Union;

    continue to invest in the preclinical research and development of our future product candidates;

    build our pilot manufacturing facility and our larger-scale cGMP manufacturing facility;

    establish a commercial infrastructure to support the marketing, sale and distribution of D-PLEX100 if it receives regulatory approval;

    hire additional research and development and general and administrative personnel to support our operations;

    maintain, expand and protect our intellectual property portfolio; and

    incur additional costs associated with operating as a public company following the completion of this offering.

          We do not have any product candidates approved for sale and have not generated any revenue from product sales. To date, we have financed our operations primarily through private placements of equity securities and convertible debt, as well as grants from the IIA, and the

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European Commission's Seventh Framework Programme for Research, or the FP7. From our inception through December 31, 2017, we have raised an aggregate of $63.7 million from private placements of equity securities and convertible debt. In February 2016, we received an aggregate of $21.9 million in gross proceeds from the sale of shares of our Series D-1 preferred shares and warrants to purchase Series D-2 shares. In August 2016, we received an aggregate of $5.3 million in gross proceeds from the sale of our Series D-3 preferred shares. In the third and fourth quarters of 2017, we received an aggregate of $15.0 million in gross proceeds from the sale of our Series E preferred shares, or the Series E Private Placement, $1.6 million of which we received in a deferred closing in November and December 2017. See "—Results of Operations—Comparison of the Years ended December 31, 2016 and 2017—Net Loss Attributable to Ordinary Shares."

Components of Results of Operations

Revenue

          To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for the next several years.

Research and Development Expenses, Net

          Research and development expenses, net consist primarily of costs incurred in connection with our research and development activities. This includes conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for product candidates. Our research and development expenses primarily consist of:

    salaries and personnel-related costs, including benefits and share-based compensation expense, for our scientific personnel performing research and development activities;

    costs related to executing preclinical studies and clinical trials;

    costs related to acquiring, developing and manufacturing materials for our preclinical studies and clinical trials;

    costs of third party suppliers;

    fees paid to consultants and other third parties who support our product candidate development;

    expenses related to regulatory activities, including filing fees paid to regulatory agencies;

    other costs incurred in seeking regulatory approval of our product candidates; and

    allocated facility-related costs and overhead.

          Research and development expenses are expensed as incurred. We record accrued expenses for research and development activities conducted, on our behalf, by third-party service providers, which include the conduct of pre-clinical studies and clinical trials and contract manufacturing activities. We record these accrued expenses based upon research and development activities performed by such third-party service providers and reported to us, and we include these costs in accrued liabilities in the balance sheets and within research and development expense in the statement of operations.

          We typically use our employee, consultant and infrastructure resources across our development programs. We track outsourced development costs by product candidate or preclinical program, but we do not allocate personnel costs, other internal costs or external consultant costs to specific product candidates or preclinical programs.

          From inception though December 31, 2017, we have incurred approximately $33.3 million in research and development expenses to advance the development of our product candidates and preclinical research and development programs. As of December 31, 2017, we have received

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grants of $5.0 million in the aggregate from the IIA. Pursuant to the terms of the grants, we are required to pay royalties of 3.0% to the IIA on revenues from sales of products for which the research and development was funded, in whole or in part, by the IIA, up to a limit of 100% of the amount of the grant received, plus annual interest calculated at a rate based on 12-month LIBOR. In addition, we must abide by other restrictions associated with the receipt of such grants under the R&D Law that continue to apply following repayment to IIA. These restrictions may impair our ability to outsource manufacturing, engage in change of control transactions or otherwise transfer our knowledge outside of Israel and may require us to obtain IIA approval for certain actions and transactions and pay additional amounts to IIA. In addition, any change of control and any change of ownership of our ordinary shares that would make a non-Israel citizen or resident an "interested party" as defined in the R&D Law requires prior written notice from IIA. As of December 31, 2017, we have also received non-royalty bearing grants of $0.3 million in the aggregate from the IIA and $0.7 million in the aggregate from the FP7.

          Substantially all of our research and development expenses for the years ended December 31, 2016 and 2017 were related to the development of the D-PLEX family.

          We expect our research and development expenses will increase for the foreseeable future as we seek to advance our clinical-stage product candidates and preclinical research and development programs. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our product candidates. This is due to the numerous risks and uncertainties associated with developing such product candidates, including the uncertainty of:

    successful enrollment in and completion of clinical trials;

    establishing an appropriate safety profile;

    receipt of marketing approvals from applicable regulatory authorities;

    establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

    commercializing the product candidates, if and when approved, whether alone or in collaboration with others;

    obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;

    continued acceptable safety profiles of products following approval; and

    retention of key research and development personnel.

          A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product candidate.

General and Administrative Expenses

          General and administrative expenses consist primarily of salaries and personnel-related expenses, including benefits and share-based compensation expense, for employees performing functions other than research and development. This includes personnel in executive, finance and administrative support functions. Other general and administrative expenses include facility-related costs not otherwise allocated to research and development expense, professional fees for auditing, tax and legal services and other consulting fees.

          We expect our general and administrative expenses will increase in the future to support continued research and development activities. We also anticipate that we will incur increased

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accounting, audit, legal, regulatory, compliance and director and officer insurance costs, as well as investor, public relations and compliance expenses, associated with operating as a public company. We also anticipate increased expenses if any of our product candidates receives regulatory approval and we determine to build a commercial infrastructure to support sales and marketing of our products.

Financial Income (Expense), Net

          Financial income (expense), net consists of reevaluation of our preferred share warrant liability, as well as interest income on our cash, cash equivalents and short-term deposits and our foreign exchange gains and losses.

Results of Operations

Comparison of the Years Ended December 31, 2016 and 2017

          The following table summarizes our results of operations for the years ended December 31, 2016 and 2017:

    Year Ended
December 31,
 

    2016     2017
 

    (in thousands)  

Research and development expenses, net

  $ 7,708   $ 9,736  

General and administrative expenses

    2,551     4,064  

Operating loss

    10,259     13,800  

Financial expenses, net

    1,133     40,688  

Net loss

  $ 11,392   $ 54,488  

Deemed dividend

        1,255  

Net loss attributable to ordinary shares

  $ 11,392   $ 55,743  

Research and Development Expenses, Net

          Research and development expenses, net increased by $2.0 million during the year ended December 31, 2017 compared to the year ended December 31, 2016. The increase in research and development expenses resulted primarily from increases in expenses related to the research and clinical development of D-PLEX100. More specifically, this amount included increases in third-party clinical and manufacturing research and development expenses and preclinical and clinical trial costs for our D-PLEX family product candidates, costs associated with the maintenance and prosecution of our intellectual property portfolio and salaries and personnel-related expenses, including benefits, and share-based compensation to research and development employees, driven by increased headcount across all research and development functions from 31 employees as of December 31, 2016 to 41 employees as of December 31, 2017. These increases were partially offset by decreases in third-party consultant costs and regulatory expenses. These increases were further offset by an increase in IIA grants.

General and Administrative Expenses

          General and administrative expenses increased by $1.5 million during the year ended December 31, 2017 compared to the year ended December 31, 2016. The increase in general and administrative expenses resulted primarily from increases in salaries, personnel-related expenses, including benefits, and share-based compensation driven by increased headcount across all general and administrative functions from 12 employees as of December 31, 2016 to 14 employees

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as of December 31, 2017, increases in legal and professional costs and facility and maintenance costs and compensation expenses of $387,000 with respect to an investment by an affiliate of a director in the deferred closing of the Series E Private Placement.

Financial Expenses, Net

          Financial expenses, net increased by $39.6 million during the year ended December 31, 2017 compared to the year ended December 31, 2016. The increase in financial expenses, net relate primarily to the reevaluation of our preferred share warrant liability relating to the receipt of the results from our primary efficacy endpoint from our Phase 1b/2 clinical trial of D-PLEX100, partially offset by increases related to financial income and exchange rate differences.

Net Loss Attributable to Ordinary Shares

          Net loss attributable to ordinary shares increased by $44.3 million during the year ended December 31, 2017 compared to the year ended December 31, 2016. The increase in net loss attributable to ordinary shares includes a deemed dividend of $1.2 million related to shares issued in the deferred closing of the sale of our Series E preferred shares in November and December 2017. As the deferred closing occurred after we received the results of the primary efficacy endpoint from our Phase 1b/2 clinical trial of D-PLEX100, we determined that the fair market value of the Series E preferred shares sold in the deferred closing was higher than at the initial closing.

Liquidity and Capital Resources

Sources of Liquidity

          Since our inception, we have not generated any revenue and have incurred net losses and negative cash flows from our operations. We have funded our operations primarily through the sale of equity securities and convertible debt. From our inception through December 31, 2017, we raised an aggregate of $63.7 million from private placements of equity securities and convertible debt. In the third and fourth quarters of 2017, we received an aggregate of $15.0 million in gross proceeds from the sale of our Series E preferred shares. As of December 31, 2017, we had $17.9 million in cash, cash equivalents and short-term deposits.

          We currently have no ongoing material financing commitments, such as lines of credit or guarantees that are expected to affect our liquidity over the next five years, other than our lease obligations.

Cash Flows

          The following table provides information regarding our cash flows for the periods indicated:

    Year Ended
December 31,
 

    2016     2017
 

    (in thousands)  

Net cash used in operating activities

  $ (9,733 ) $ (12,312 )

Net cash used in investing activities

    (8,069 )   (8,385 )

Net cash provided by financing activities

    26,344     14,383  

Net increase (decrease) in cash and cash equivalents

  $ 8,542   $ (6,314 )

Operating Activities

          Net cash used in operating activities related primarily to our net losses adjusted for non-cash charges and measurements and changes in components of working capital. Adjustments to net

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loss for non-cash items mainly include depreciation, reevaluation of preferred share warrants and share-based compensation.

          Net cash used in operating activities was $12.3 million for the year ended December 31, 2017, as compared to $9.7 million for the year ended December 31, 2016. The increase in net cash used in operating activities was attributable primarily to increased research and development costs, and associated general and administrative expenses, as we conducted research and development and regulatory work related to the D-PLEX family.

Investing Activities

          Net cash used in investing activities related primarily to the acquisition of short-term deposits and the purchase of laboratory equipment, office equipment and furniture and leasehold improvements.

          Net cash used in investing activities was $8.4 million for the year ended December 31, 2017, as compared to $8.1 million for the year ended December 31, 2016. The increase in net cash used in investing activities in 2017 primarily related to the acquisition of short-term deposits, the construction of our pilot manufacturing facility and for the purchase of equipment.

Financing Activities

          Net cash provided by financing activities related primarily to funds raised by the issuance of convertible debt and preferred shares.

          Net cash provided by financing activities was $14.4 million for the year ended December 31, 2017, related to the issuance of shares of our Series E preferred shares, as compared to $26.3 million for the year ended December 31, 2015, related to the issuance of shares of our Series D-1 and D-3 preferred shares.

Funding Requirements

          To date, we have not generated any revenues from the commercial sale of our product candidates, and we do not expect to generate revenue for at least the next few years. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or initiate large, late-stage clinical trials of, and seek marketing approval for, D-PLEX100 and our future product candidates. In addition, if we obtain marketing approval for D-PLEX100 or any of our future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of potential collaborators. Furthermore, following the completion of this offering, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

          We expect that our existing cash, cash equivalents and short-term deposits will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We anticipate that these funds, together with the net proceeds of this offering, will be sufficient for the initiation and near-completion of our planned Phase 3 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery, the completion of our planned Phase 2 clinical trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, and, assuming a successful outcome in our Phase 2 clinical trial, the initiation of our Phase 3 clinical trial of D-PLEX100 in the same indication. We anticipate that we will need to raise additional capital in order

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to complete our Phase 3 clinical trials and any potential future trials that may be required by regulatory authorities. Our future capital requirements will depend on many factors, including:

    the scope, progress, results and costs of our ongoing and planned nonclinical studies and clinical trials of D-PLEX100;

    the number and development requirements of other future product candidates that we may pursue;

    the costs, timing and outcome of regulatory review of D-PLEX100 and our future product candidates;

    the costs and timing of establishing and validating manufacturing processes and facilities for development and commercialization of D-PLEX100 and our future product candidates, if approved, including our pilot and larger-scale manufacturing facilities;

    the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;

    the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval, which may be affected by market conditions, including obtaining coverage and adequate reimbursement of our product candidates from third-party payors, including government programs and managed care organizations, and competition;

    our ability to establish and maintain collaborations on favorable terms, if at all;

    the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and

    the extent to which we acquire or in-license other product candidates and technologies.

          Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of product candidates that we do not expect to be commercially available for many years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.

          Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, grants, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, 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 funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

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Contractual Obligations and Commitments

          The following table summarizes our commitments to settle contractual obligations at December 31, 2017:

    Less than
1 Year
    1 to 3
Years
    4 to 5
Years
    More than
5 Years
    Total
 

    (in thousands)        

Operating lease obligations(1)

  $ 1,068   $ 3,103   $ 1,957   $ 1,965   $ 8,093  

(1)
Operating lease obligation consist of payments pursuant to lease agreements for our Israeli and U.S. facilities and motor vehicle leases.

          The commitment amounts in the table above are associated with contracts that are enforceable and legally binding. The table does not include obligations under agreements that we can cancel without a significant penalty.

          We enter into contracts in the normal course of business for preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.

Off-Balance Sheet Arrangements

          We do not have any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. We do not engage in off-balance sheet financing arrangements. In addition, we do not engage in trading activities involving non-exchange traded contracts.

Critical Accounting Policies

          Our consolidated financial statements are prepared in accordance with accepted accounting principles generally accepted in the United States. The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates. Our most critical accounting policies are summarized below. See note 2 to our consolidated financial statements beginning on page F-1 of this prospectus for a description of our other significant accounting policies.

Share-Based Compensation

          We account for share-based compensation granted to employees, non-employee directors and service providers in accordance with FASB ASC Topic 718, Compensation  — Stock Compensation, or ASC 718, and FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using the option-pricing model, or OPM. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in our statements of operations.

          We recognize compensation costs net of a forfeiture rate only for those shares expected to vest using the straight line method over the requisite service period of the award, which is generally the option vesting term of three years. Upon adoption of ASU 2016-09, we elected to change our accounting policy to account for forfeitures as they occur.

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Option Valuations

          We selected the Black-Scholes-Merton model as the most appropriate fair value method for our option awards. The Black-Scholes-Merton model requires a number of assumptions, of which the most significant are the expected share price, volatility and the expected option term.

          The fair value of ordinary shares underlying the options has historically been determined by management and the board of directors with the assistance of an independent financial and economic consultant. As there has been no public market for our ordinary shares, our board of directors has determined fair value of an ordinary share at the time of grant of the option by calculating the present value of expected future investment returns and considering a number of objective and subjective factors including our business model projections, historical operating and financial performance, data from other comparable companies, sales of convertible preferred shares to unrelated third parties, the lack of liquidity of share capital and general and industry specific economic outlook, among other factors. The fair value of the underlying ordinary shares will be determined by the board of directors until such time as our ordinary shares are listed on an established share exchange or national market system. Our board of directors determined the fair value of ordinary shares based on the valuation performed using the hybrid method, which takes into account the initial public offering and the non-initial public offering scenario method as of December 31, 2017.

Key Assumptions

          The Black-Scholes-Merton option-pricing model requires the input of highly subjective assumptions, including the fair value of the underlying ordinary shares, the expected volatility of the price of our ordinary shares, the expected term of the option, risk-free interest rates and the expected dividend yield of our ordinary shares. These estimates involve inherent uncertainties and the application of the management's judgment. If such inputs change and different assumptions are used, our share-based compensation expenses could be materially different in the future. These assumptions are estimated as follows:

    Fair value of our ordinary shares.  Since our shares were not publicly traded prior to our initial public offering, we estimated the fair value of our ordinary shares. Upon the completion of our initial public offering, our ordinary shares will be valued by reference to the publicly-traded price of our ordinary shares.

    Volatility.  The expected share price volatility was based on the historical volatility of the ordinary shares of comparable companies that are publicly traded.

    Expected term.  The expected term represents the period that our share-based awards are expected to be outstanding. As to the share-option awards granted to employees, the expected term is calculated using the average between the vesting period and the contractual term to the expected term of the options in effect at the time of grant. For option awards granted to non-employees, the expected term is equal to the remaining contractual life of the option, which is generally 10 years from the grant date.

    Risk-free rate.  The risk-free interest rate is based on the yields of U.S. Treasury securities with maturities similar to the expected term of the options in each option group.

    Expected dividend yield.  We have never declared or paid cash dividends and we do not have plans to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.

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          If any of the assumptions used in the Black-Scholes-Merton model change significantly, the share-based compensation expenses in future awards may differ materially as compared with the current awards granted.

          The following table presents the assumptions used to estimate the fair value of options granted to employees, non-employee directors and service providers during the periods presented:

  Year Ended December 31,

  2016   2017

Expected term (in years)

  7 - 10   7 - 10

Expected volatility

  75.0% - 89.0%   75.0% - 94.0%

Risk-free rate

  2.2% - 2.7%   2.2% - 3.03%

Dividend yield

  0.0%   0.0%

          We incurred non-cash share-based compensation expense of $0.6 million and $1.4 million during the years ended December 31, 2016 and 2017, respectively. We expect to continue to grant share option awards in the future, and to the extent that we do, our actual share-based compensation expenses recognized are likely to increase.

Determination of the Fair Value of Stock-Based Compensation Grants

          The following table summarizes by grant date the number of ordinary shares subject to share option awards granted between January 1, 2016 and the date of this prospectus, as well as the associated per-ordinary share exercise price of the award, the estimated fair value per ordinary share on the grant date and the aggregate grant date fair value:

Option Grant Date

    Number of
Ordinary Shares
Underlying
Options Granted
    Estimated Fair
Value Per
Ordinary Share
at Grant Date
    Exercise
Price Per
Ordinary Share
    Aggregate
Grant Date
Fair Value(1)
 

April 5, 2016

    33,000   $ 2.96   $ 2.96   $ 81,890  

August 24, 2016

    15,106   $ 2.96   $ 2.96   $ 43,927  

December 21, 2016

    80,000   $ 3.76   $ 3.76   $ 232,202  

March 8, 2017

    23,875   $ 3.92   $ 3.92   $ 65,629  

May 25, 2017

    58,750   $ 4.00   $ 4.00   $ 168,990  

June 1, 2017

    206,823   $ 3.92   $ 3.92   $ 215,030  

August 5, 2017

    5,875   $ 4.16   $ 8.88   $ 20,900  

November 2, 2017

    565,937   $ 9.52   $ 7.36   $ 5,365,816  

January 30, 2018

    16,563     (2)   $ 18.32     (2)  

February 8, 2018

    37,500     (2)   $ 27.12     (2)
 

(1)
Aggregate grant date fair value was determined using the Black-Scholes-Merton option pricing model.

(2)
We have not obtained a valuation of our ordinary shares as of such dates but intend to obtain valuation for purposes of properly accounting for the grant of these options.

          Based upon the assumed initial public offering price of $22.50 per share, the midpoint of the range set forth on the cover page of this prospectus, the intrinsic value of the awards outstanding as of December 31, 2017 was $35.5 million, of which $20.3 million related to vested options and $15.2 million related to unvested options.

Valuation of Our Ordinary Shares

          The fair value of the ordinary shares underlying our option awards was determined by our board of directors, with input from management. We believe that our board of directors has the

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relevant experience and expertise to determine the fair value of our ordinary share as of each respective grant date. The valuations of our ordinary shares were determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, or the AICPA Practice Aid. The assumptions used in the valuation model are based on future expectations combined with management judgment. Our board of directors, with input from management, exercised significant judgment and considered numerous objective and subjective factors to determine the fair value of our ordinary shares as of the date of each option grant, including the following factors:

    independent valuations performed at periodic intervals by independent third-party valuation specialist;

    our current business projections;

    our stage of development;

    the prices, rights, preferences and privileges of our convertible preferred shares;

    current business conditions;

    the likelihood of a liquidity event for the ordinary shares underlying these options, such as an initial public offering or sale of our company, given prevailing market conditions;

    any adjustments necessary due to the lack of marketability of our ordinary shares;

    the purchase of our preferred shares by third party investors in arms-length transactions; and

    the market performance of comparable publicly traded companies.

          In the event of a qualified initial public offering, our preferred shares would convert into ordinary shares on a one-to-one basis, and accordingly would receive the same amount of proceeds per share as ordinary shares. In the case of a sale or liquidation of the Company, the preferred shares would receive their liquidation preferences and thereafter a fraction in the remaining proceeds with the ordinary shares on a pro-rata basis. Accordingly, we determined the fair value of our ordinary shares under two scenarios and then applied a weighted average of these values based on their relative probabilities in order to calculate the final per share value.

    First, we determined value in an exit scenario due to a liquidity event, such as an initial public offering using the market approach and based on discussions with investment banks. In this scenario, all preferred shares, warrants to purchase Series A preferred shares and options to purchase our ordinary shares convert into, or are deemed to be exercised for, ordinary shares. The firm value is divided by the resulting number of shares to determine a per share value.

    Second, we determined value using the Probability Weighted Excepted Return Method, or PWERM. The PWERM is a scenario-based methodology that estimates the fair value of our ordinary shares based upon an analysis of future values for our company, assuming various outcomes. The ordinary share value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available, as well as the rights of each class of our outstanding capital stock. The weighted average enterprise value is then calculated by applying the unleveraged discounted cash flow approach. We believe that this is the most appropriate valuation method as it theoretically captures various future possible outcomes, including an initial public offering.

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          We then allocated the value between all elements of our securities (preferred shares, ordinary shares, warrants for preferred shares and options for ordinary shares) using the OPM, on the assumption that our preferred shares will benefit from their liquidation preference, as follows:

    Under the OPM, preferred and ordinary shares are treated as a series of call options, with the preferred shares having an exercise price based on the liquidation preference of the respective preferred share. The OPM operates through a series of Black — Scholes — Merton option pricing models, with the strike prices of the options representing the upper and lower bounds of the proceed ranges that a security holder would receive upon a liquidity event. The strike prices occur at break points where the allocation of firm value changes among the various security holders. The ordinary shares are presumed to have value only if funds available for distribution to shareholders exceed the value of the respective liquidation preferences at the time of a liquidity event. The OPM requires an enterprise level input of firm value or a transaction level input of specific security value (typically, a recently issued convertible preferred security) to anchor the allocation of firm value among the various classes of securities.

          In making the final determination, we also applied a discount for lack of marketability right, as applicable, to our ordinary shares.

          In order to estimate the fair value of our ordinary shares for the option grants made on November 2, 2017, we relied primarily on the $12.72 price per share paid in the third and fourth quarters of 2017 for our Series E preferred shares, given the arm's length nature and due diligence associated with this transaction. In addition, we considered the outlook for an initial public offering in the near-term and our current business projections, as well as the results from the primary efficacy endpoint from our Phase 1b/2 clinical trial of D-PLEX100, which we received on November 21, 2017 and considered a significant value-generating event. We then calculated the increase in fair value of our ordinary shares on a linear basis over the fourth quarter of 2017 and applied a discount for lack of marketability of our ordinary shares. Based on this analysis, we derived the fair value of our ordinary shares to be $9.52 per share for these option grants.

          In order to determine the exercise price for the option grants made on January 30, 2018, we relied primarily on the December 31, 2017 valuation, which was the most recent valuation on the date of the grants. The December 31, 2017 valuation was influenced, in part, by the following considerations, in addition to the results from the primary efficacy endpoint from our Phase 1b/2 clinical trial of D-PLEX100: (i) the completion of our sale of shares of Series E preferred shares at a price of $12.72 per share and (ii) the increased probability of an initial public offering.

          In order to determine the exercise price for the option grants made on February 2, 2018, we relied primarily on the December 31, 2017 valuation, which was the most recent valuation on the date of the grants. However, we issued this grant with a higher exercise price to reflect the increased probability of an initial public offering and the end of Phase 2 meeting for D-PLEX100 with the FDA held on February 6, 2018.

Future option awards

          Following the completion of our initial public offering and the listing of our shares on The Nasdaq Global Market, the determination of the fair market value of our ordinary shares for purposes of setting the exercise price of future option awards or other share-based compensation to employees and other grantees will be based on the market price of our shares and will no longer require good faith estimates by our board of directors based on various comparisons or benchmarks.

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Accounting Treatment of the Convertible Preferred Shares

          We classify convertible preferred shares that are redeemable at the option of the holder as mezzanine equity on the balance sheet. They are not included as a component of shareholders' equity (deficiency). The carrying value of the preferred shares is equal to cost. We did not adjust the carrying value to redemption value since it is not probable that the preferred shares will be redeemed.

Warrants to Purchase Convertible Preferred Shares

          Warrants to purchase our convertible preferred shares are classified as a liability on the balance sheet, and measured at fair value, as the underlying shares are contingently redeemable (upon a deemed liquidation event) and, therefore, may obligate us to transfer assets at some point in the future. The warrants are subject to re-measurement to fair value at each balance sheet date and any change in fair value is recognized as a component of financial expenses, net, in the statement of operations.

          The fair value of the warrants on the issuance date and on subsequent reporting dates was determined using the OPM. The fair value of the underlying preferred share price was determined by the board of directors considering, among other things, a third party valuation. The Company's enterprise value was determined based on financing transactions with third parties, price indications from bankers and the discounted cash flow model. The OPM method was then employed to allocate the enterprise value among the various equity classes, deriving a fully marketable value per share for the preferred shares.

Grants and Participation

          Royalty-bearing grants from the IIA for funding approved research and development projects are recognized at the time we are entitled to such grants, on the basis of the costs incurred, and are presented as a deduction from research and development expenses. Since the payment of royalties is not probable when the grants are received, we do not record a liability for amounts received from the IIA until the related revenues are recognized. Non-royalty-bearing grants from the IIA MAGNET program and from FP7 for funding approved research and development projects are recognized at the time we are entitled to such grants, on the basis of the costs incurred, and are presented as a deduction from research and development expenses. In the event of failure of a project that was partly financed by the IIA, we would not be obligated to pay any royalties or repay the amounts received.

          As of December 31, 2017, we have received royalty-bearing grants totaling $4.7 million. Pursuant to the terms of the grants, we are required to pay royalties to IIA of 3.0% on revenues from sales of products developed financed in whole or in part by IIA, up to a limit of 100% of the grants received, plus annual interest calculated on the 12-month LIBOR rate as published on the first business day of each calendar year.

          In addition, we must abide by other restrictions associated with the receipt of such grants under the R&D Law that continue to apply following repayment to IIA. These restrictions may impair our ability to outsource manufacturing or otherwise transfer our knowledge outside of Israel, or engage in change of control transactions, and may require us to obtain IIA approval for certain actions and transactions and pay additional amounts to IIA. In addition, any change of control and any change of ownership of our ordinary shares that would make a non-Israel citizen or resident an "interested party" as defined in the R&D Law requires prior written notice from IIA.

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Recent Accounting Pronouncements

          See note 2 to our consolidated financial statements beginning on page F-1 of this prospectus for a description of recent accounting pronouncements applicable to our consolidated financial statements.

Qualitative and Quantitative Disclosures about Market Risk

Foreign Currency Exchange Risk

          We operate primarily in Israel, and approximately 75% of our expenses are denominated in New Israeli Shekels, or NIS. We are therefore exposed to market risk, which represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. We are subject to fluctuations in foreign currency rates in connection with these arrangements. Changes of 5% and 10% in the U.S. dollar/NIS exchange rate would have increased/decreased operating expenses by approximately 4% and 8%, respectively, during the fiscal year ended on December 31, 2017.

          We do not currently hedge our foreign currency exchange rate risk. In the future, we may enter into formal currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations.

Interest Rate Risk

          We do not anticipate undertaking any significant long-term borrowings. At present, our investments consist primarily of cash and cash equivalents. We may invest in investment-grade marketable securities with maturities of up to three years, including commercial paper, money market funds, and government/non-government debt securities. The primary objective of our investment activities is to preserve principal while maximizing the income that we receive from our investments without significantly increasing risk and loss. Our investments may be exposed to market risk due to fluctuation in interest rates, which may affect our interest income and the fair market value of our investments, if any.

Inflation-Related Risks

          Inflation generally affects us by increasing our NIS-denominated expenses, including labor and rental costs and payment to local suppliers. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the years ended December 31, 2016 and 2017.

JOBS Act Transition Period

          Section 107 of the JOBS Act 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 for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

          We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation, (i) providing an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be

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adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier to occur 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 revenues of at least $1.07 billion or (c) in which we are deemed to be a "large accelerated filer" under the rules of the U.S. Securities and Exchange Commission, which means the market value of our ordinary shares that is held by non-affiliates exceeds $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.

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BUSINESS

          We are a clinical-stage pharmaceutical company focused on developing and commercializing novel, locally administered therapies using our transformational PLEX (Polymer-Lipid Encapsulation matriX) technology. Our product candidates are designed to address unmet medical needs by pairing PLEX with active pharmaceutical ingredients, or APIs, which are delivered locally at predetermined release rates and durations over periods ranging from days to several months. We believe that our PLEX technology represents a paradigm shift in the treatment of a wide variety of localized medical conditions, including infection, pain, inflammation and cancer. Our initial family of product candidates pairs PLEX with the widely-used, versatile antibiotic doxycycline, which we refer to as the D-PLEX family. Based on results from our clinical trials to date, none of the 101 patients treated in our clinical trials of our D-PLEX product candidates developed an infection at the treatment site after treatment.

          We are initially focused on the development of our lead product candidate, D-PLEX100, for the prevention of surgical site infections, or SSIs, in bone and soft tissue. We recently reported interim results from our fully-enrolled Phase 1b/2 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery. During the three-month period after treatment, we observed no sternal wound infections in any of the patients treated with D-PLEX100 in combination with the standard of care. In contrast, we observed a 4.5% infection rate in the control group of patients who received the standard of care alone. According to recent literature, the expected infection rate for patients receiving the standard of care alone is 5% to 8%. We plan to submit an Investigational New Drug, or IND, application for D-PLEX100 to the U.S. Food and Drug Administration, or FDA, and a clinical trial application, or CTA, to the European national competent authorities early in the fourth quarter of 2018, and to commence a Phase 3 clinical trial in this indication shortly thereafter. Early in the fourth quarter of 2018, we also plan to commence a Phase 2 clinical trial of D-PLEX100 for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery. Assuming a successful outcome in our Phase 2 clinical trial and subject to FDA feedback, we plan to initiate a Phase 3 clinical trial in the same indication. Although we have not yet discussed our plans with FDA to develop D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, we believe that if the results of this Phase 3 trial, together with the results from our planned Phase 3 trial for the prevention of sternal SSIs, are favorable, these two Phase 3 studies could support a New Drug Application, or NDA. We intend to seek approval for our product candidates under the Section 505(b)(2) pathway for marketing approval by the FDA in the United States, and the hybrid application pathway in the European Union. We may ultimately pursue a broad label for D-PLEX100 for the management of SSIs depending on the results of our clinical trials and further discussions with the FDA regarding this strategy. We received a designation of Qualified Infectious Disease Product, or QIDP, from the FDA for D-PLEX100 for the prevention of sternal infection after cardiac surgery.

          Systemic administration of drugs is currently used for the treatment of a wide variety of medical conditions. However, we believe there can be significant disadvantages to systemic administration of drugs for localized conditions, such as the need to use a higher amount of drugs in treatment, prolonged exposure to drugs that may cause side effects (including damage to non-targeted organs), limited efficacy due to poor penetration or access from the bloodstream into the target tissue and challenges related to solubility or sensitivity to blood factors. Localized delivery systems that have been developed to address the problems of systemic administration also have disadvantages, including short release periods and poor control of drug release rates. We believe our PLEX technology has the potential to improve patient outcomes and lower the overall cost of treatment by enabling local, customizable, predetermined and controlled delivery of drugs, thereby addressing many of the shortcomings of systemic administration and existing localized delivery systems.

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          Our PLEX technology consists of a proprietary matrix of layers of chemically-inert and biodegradable polymers and lipids that physically entrap an API in a protected reservoir, enabling localized, bioavailable drug delivery at customizable, predetermined release rates and durations over periods ranging from days to several months. We believe that these characteristics may enable our PLEX product candidates to be therapeutically effective using only a small fraction of the APIs required in systemic administration of currently marketed therapies. Because PLEX is agnostic to the nature and size of the underlying drug, it has the potential to be paired with a wide variety of currently marketed drugs or product candidates in development, including small molecules, peptides, antibodies and other proteins, as well as nucleic acid-based APIs, to create novel therapies in a broad range of indications.

          We are initially developing product candidates using our PLEX technology for the prevention of SSIs. Infection resulting from surgery and trauma can be fatal and creates a significant public health burden despite the extensive use of systemically administered antibiotics both pre- and post-surgery. SSIs occur in approximately 2% to 5% of patients undergoing inpatient surgery worldwide. The World Health Organization, or the WHO, reports that SSIs account for an estimated $10 billion of incremental hospital costs per year in the United States and €11 billion per year in the European Union. We expect the costs associated with SSIs to continue to grow in the face of the increasing resistance of bacteria to antibiotics, as safety concerns often preclude the increase of systemic dosages and/or treatment duration to address resistance.

          Our lead product candidate from this family, D-PLEX100, which is being developed to prevent bone and soft tissue SSIs, received QIDP designation from the FDA in February 2017 for the prevention of sternal infection after cardiac surgery. We recently announced the results of the primary efficacy endpoint from our fully-enrolled Phase 1b/2 clinical trial of D-PLEX100 in 81 patients in this indication, observed at the three month follow-up study period. During the three-month period after treatment, we observed no sternal wound infections in any of the 58 patients treated with D-PLEX100 in combination with the standard of care. In contrast, we observed a 4.5% infection rate in the control group of patients who received the standard of care alone. According to recent literature, the expected infection rate for patients receiving the standard of care alone is 5% to 8%. We held an end of Phase 2 meeting with the FDA in the first quarter of 2018, in which we discussed the development of D-PLEX100 for the prevention of post cardiac surgery sternal infection, to obtain alignment on our Phase 3 clinical trial design for the prevention of post-cardiac surgery sternal infections. We plan to submit an IND for D-PLEX100 to the FDA and a CTA to the European national competent authorities early in the fourth quarter of 2018, and to commence our Phase 3 clinical trial in sternal SSIs after cardiac surgery shortly thereafter. We also plan to commence a Phase 2 trial of D-PLEX100 for the prevention of SSIs, to be conducted in patients undergoing abdominal surgery for the prevention of SSIs early in the fourth quarter of 2018. Assuming a successful outcome in our Phase 2 clinical trial and subject to FDA feedback, we plan to initiate a Phase 3 clinical trial in the same indication. Although we have not yet discussed our plans with FDA to develop D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, we believe that if the results of this Phase 3 trial, together with the results from our planned Phase 3 trial for the prevention of sternal SSIs, are favorable, these two Phase 3 studies could support an NDA for the prevention of SSIs in bone and soft tissue. We plan to seek approval of D-PLEX100 under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or the FFDCA, which is administered by the FDA, in the United States, and the comparable hybrid application pathway in the European Union.

          We have developed D-PLEX1000, which was formerly known as BonyPid-1000 and is another product candidate from the D-PLEX family, for use in connection with orthopedic surgeries for the management of SSIs and support of bone recovery. Often, bone will not heal in the presence of infection. Based on results from our pre-pivotal and pilot clinical trials of D-PLEX1000 to date, none of

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the 43 patients treated with D-PLEX1000 developed infections in the target fracture. In a retrospective analysis of the medical records of 49 patients treated for similar open long bone fractures with the standard of care at the same clinical trial sites where we conducted our D-PLEX1000 clinical trials, we found a target fracture infection rate of up to 25%. We have completed enrollment of a pre-pivotal trial in 51 patients evaluating the safety and effectiveness of D-PLEX1000 for the treatment of open tibia fractures. Patients were assessed on a monthly basis. In interim results from the six-month follow-up period of our pre-pivotal trial, we observed that 92% of the patients treated with D-PLEX1000 in addition to the standard of care reached the primary performance endpoint, the presence of solid radiographic markers for bone healing, as assessed by the establishment of a callus in three out of four cortices, as compared to 62% of the 13 evaluable patients treated with the standard of care alone. Sixty percent of the patients treated with D-PLEX1000 in combination with the standard of care had reached the primary performance endpoint by three months post-operation, as compared to 17% of patients treated with the standard of care alone. Only 36% of patients receiving the standard of care alone showed these markers at four months. It was only at the five-month evaluation that patients in the standard of care arm showed a comparable percentage of patients with these markers as that observed in the group treated with D-PLEX1000 in combination with the standard of care at three months post-operation. We do not currently plan to pursue further independent development of D-PLEX1000, as we believe the orthopedic SSI market can be adequately addressed by D-PLEX100.

          Our PLEX platform technology may have broad applications for localized medical conditions other than the prevention of SSIs. We are pursuing research and development programs for our PLEX platform in a variety of potential indications, including for the treatment of SSIs, pain, inflammation and cancer. We are in discussions with global biopharmaceutical companies to license our PLEX platform for use with various biologics and small molecules.

          We are constructing our pilot manufacturing facility, which is intended to comply with the FDA's current good manufacturing practice, or cGMP, regulations, and European Medicines Agency, or EMA, regulations, in Israel to enhance supply chain control, increase supply capacity and meet clinical demand for our planned clinical trials and initial commercial demand in the event that D-PLEX100 receives marketing approval. We also intend to build a larger-scale cGMP manufacturing facility in Israel in the future.

          We have an experienced management team with an average of 14 years of experience in life sciences companies. Members of our board of directors also have extensive experience in the life sciences industry. We believe that our leadership team is well positioned to lead us through clinical development, regulatory approval and commercialization of our product candidates.

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Product Candidate Pipeline

          Our PLEX product candidate pipeline is set forth below:

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Growth Strategy

          Our goal is to leverage our PLEX technology to develop and commercialize a pipeline of transformative therapies for the local delivery of drugs to address unmet medical needs. The key elements of our strategy are as follows:

    Complete clinical development of and seek approval for D-PLEX100 for the prevention of bone and soft tissue SSIs in the United States and the European Union.  We recently announced the results of the primary efficacy endpoint from our Phase 1b/2 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery. We plan to submit an IND for D-PLEX100 to the FDA and a CTA to the European national competent authorities early in the fourth quarter of 2018, and to commence a Phase 3 clinical trial in this indication shortly thereafter. We also plan to commence early in the fourth quarter of 2018 a Phase 2 clinical trial in patients undergoing abdominal surgery for the prevention of SSIs. Assuming a successful outcome in our Phase 2 clinical trial and subject to FDA feedback, we plan to initiate a Phase 3 clinical trial in the same indication. Although we have not yet discussed our plans with FDA to develop D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, we believe that if the results of this Phase 3 trial, together with the results from our planned Phase 3 trial for the prevention of sternal SSIs, are favorable, these two Phase 3 studies could support an NDA. We may ultimately pursue a broad label for D-PLEX100 for the management of SSIs depending on the results of these trials and further discussions with the FDA regarding this strategy. We may also seek regulatory approval of our product candidates outside of the United States and the European Union.

    Pursue expedited and fast track regulatory pathways for the approval and commercialization of our product candidates in the United States and the European Union.  We intend to pursue expedited pathways to approval for our portfolio of product candidates. PLEX is paired with an unmodified drug with established clinical safety, efficacy and tolerability, and the polymers and lipids that we use in PLEX have been used in other medical products that have been approved by the FDA and/or the EMA. Accordingly, we believe that we can pursue expedited clinical development and make regulatory submissions that allow us to rely in part on previous findings of safety and efficacy for the active ingredient, including the Section 505(b)(2) approval pathway in the United States and the comparable regulatory pathway in the European Union, as compared to the

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      development of traditional new molecular entities. Further, D-PLEX100 has received QIDP designation from the FDA for the prevention of sternal infections after cardiac surgery, which we anticipate will provide an overall increased level of communication with the FDA during the development process as it may be eligible for fast track designation upon request and priority review once we submit an NDA.

    Leverage our PLEX technology to expand our product pipeline for the treatment of SSIs and the management of pain and for additional indications.  In addition to the development of D-PLEX100 for the prevention of SSIs, we intend to evaluate PLEX for the treatment of SSIs. We are also currently developing PLEX for the management of chronic or post-surgical pain. PLEX may have broad applications for other localized problems, including the treatment of inflammation and cancer. We intend to maximize the commercial potential of PLEX by exploring these additional indications, either independently or through collaborations with other biopharmaceutical companies.

    Evaluate and selectively pursue collaborations around our PLEX technology with leading biopharmaceutical companies.  Many leading biopharmaceutical companies have currently marketed drugs or product candidates in development that are not viable for systemic administration due to instability, toxicity and cost. We believe that our PLEX technology can be paired with a wide variety of drugs or drug candidates, including small molecules, peptides, antibodies and nucleic acids, to address these limitations and potentially extend the drug's life cycle before and after patent expiration for the underlying drug.

    Independently commercialize in the United States and seek partners to commercialize outside of the United States.  We intend to commercialize our product candidates independently in the United States using a targeted and capital efficient sales force. Outside of the United States, we intend to utilize partners for the commercialization of our product candidates.

    Establish our fully-integrated, cGMP-compliant manufacturing facility.  We are in the process of establishing our pilot cGMP-compliant manufacturing facility in Israel to maintain supply chain control, increase supply capacity and meet clinical demand for our planned clinical trials. In the event that D-PLEX100 receives marketing approval, we believe that the pilot facility will meet initial commercial demand. We also intend to build a larger commercial-scale cGMP-compliant manufacturing facility in Israel in the future.

    Expand our intellectual property position.  We own numerous issued composition of matter and utility patents and pending patent applications that relate to our technology. As of December 31, 2017, we owned 55 issued patents, and we had 49 pending patent applications in the United States, the European Patent Office, Canada, Australia, China, Japan, Israel, Brazil, the Eurasian Patent Organization, India, Mexico, New Zealand, the Philippines, Singapore, South Africa, South Korea and Thailand. Our issued patents expire between 2029 and 2033. We intend to continue to expand our intellectual property portfolio as we develop PLEX for other indications.

Limitations of Systemically Administered Drugs and Current Localized Delivery Systems

          The systemic administration of drugs may have significant disadvantages for the treatment of localized problems, including limited efficacy due to poor penetration from the blood stream into the needed organ or other target tissues, challenges related to solubility or sensitivity to blood factors and prolonged exposure to drugs that may cause damage to non-targeted organs. Further, the increasing resistance of bacteria to antibiotics poses a major public health threat, and safety

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concerns often limit or preclude the increase of dosages and/or treatment duration to address resistance.

          Localized delivery of medications for localized problems can have advantages over systemic administration because it can reduce the risk of overall toxicity and adverse side effects, enable a lower amount of drug to be used in the treatment and potentially increase patient compliance. In order to address the limitations of systemic administration to treat localized medical conditions, an effective localized drug delivery system must be able to deliver the selected drug to the target site, ensure the appropriate drug concentration at the needed site and release the active drug over the entire desired treatment period.

Comparative duration of PLEX vs. available common local delivery platforms

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          Existing localized treatments, including extended release formulations based on polymer-, lipid- and liposomal-based technologies, generally suffer from one or more of the following limitations:

    Short release periods.  An effective regimen to manage infections typically needs to span several weeks due to the persistence of bacteria; most local delivery systems, however, are able to generate local concentrations that are effective for only several days.

    Controllability of drug release rates.  For a localized delivery system to be effective, it must deliver a non-toxic but adequate and constant dosage to the target site throughout the release period. Current systems based only on polymers or only on lipids have limited ability to control drug release rates. In addition, these systems release the drug with an initial high burst, followed by fast decline, which is both less effective than a steadier delivery and may cause safety issues.

    Susceptibility to drug reservoir degradation.  Some drugs need to be isolated from body fluids to prevent rapid degradation. In order to effectively administer such drugs locally over prolonged periods, the implanted drug reservoir needs to be protected until released, ideally in an unhydrated form. We are not aware of any localized drug delivery systems in the market that can protect drugs from hydration inside the body over prolonged periods, and subsequently release them in their active forms.

    Susceptibility to drug reservoir migration.  Drug reservoirs are more effective when anchored at the treatment site and unable to migrate after application. Many localized delivery systems are susceptible to migration away from the treatment site after application.

    Potential chemical modifications to underlying drug.  Some of the currently developed localized delivery systems modify or form chemical bonds with the underlying drug, which

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      may modify its mechanism of action, impede the regulatory process for approval and make development longer and more expensive.

    Limited in applicability to different drug types.  Many localized delivery systems are suited only to a particular drug or class of drugs, and are therefore limited in clinical scope.

    Difficult to use.  Some localized delivery systems require extensive training in their application and are difficult to use. Improper use can adversely affect therapeutic benefit and physician acceptance of the product.

    Manufacturing complexity and cost.  Some localized delivery systems utilize inputs and technologies that are costly or have suboptimal yields, which makes the end product more expensive and limits the system to niche or very high value applications.

          These disadvantages are particularly problematic for the management of infections, where the controlled and prolonged delivery of a drug may be more effective in managing infection than an initial high burst of drug over a shorter duration. While we believe that localized drug delivery systems are well suited to the management of SSIs, particularly in bone and soft tissue, it is important for these systems to overcome these limitations in order to change the treatment paradigm for infection management.

          These limitations are particularly acute in the case of resistant bacteria. The inability to generate a high localized concentration of drug for an extended period of time limits the drug delivery systems' effectiveness in treating antibiotic-resistant infections.

Our Solution: PLEX Technology

          Our PLEX technology consists of a proprietary matrix of several thousand alternating layers of chemically-inert and biodegradable polymers and lipids, which self assemble to physically entrap an API in a protected reservoir, designed to enable localized, bioavailable drug delivery at customizable, predetermined release rates and durations directly at the target site over periods ranging from days to several months. For example, our D-PLEX family of product candidates consists of thousands of layers of polymers and lipids. Drugs captured between the PLEX matrix are intended to be released over time in customizable, predetermined amounts by the gradual disintegration of the layers, from the outer layer to the inner layers, while protecting the inner drug from hydration and enzymes that would otherwise degrade the API. Natural hydration in the body triggers release of the drug in an unmodified active form similar to direct administration.

Predetermined release of API by gradual disintegration of the outer lipid and polymer layers

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          Our PLEX technology is designed to overcome the limitations of both systemic administration and current localized delivery systems. We believe PLEX has a number of key design benefits:

    Constant drug release rate over prolonged periods.  PLEX enables the pre-designed constant drug release over a customizable, predetermined period to accomplish the drug's therapeutic purpose. The release rate and period can be customized to range from a few

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      days to several months based on the number of layers and the disintegration rate of the layers.

    Access to tissues that are difficult to treat through systemic administration.  An application of our PLEX product candidates may provide long lasting treatment even in tissues that are not easily accessible to systemic or topical treatment, such as surgical sites or tissues with limited or interrupted blood supply, or where systemic administration may be limited due to toxicity.

    Anchored to the treatment site.  PLEX physically encapsulates an API in a manner that anchors it to a location and allows for administration where the drug is needed during the desired period. Our PLEX product candidates have not been observed to migrate once applied to the treatment site.

    Potential for improved drug safety profile.  Our PLEX product candidates use a fraction of the APIs required in systemic administration of currently marketed therapies, and these APIs are physically encapsulated in an effort to minimize systemic exposure to body fluids and prevent early degradation. Through controlled release, PLEX is designed to generate concentrations of the API that are therapeutically effective but not toxic.

    No chemical modification required to the encapsulated API.  PLEX encapsulation does not require any chemical changes to the API, which we believe will streamline our development process by allowing us to rely in part on preexisting studies of safety and efficacy and maintain the already proven mechanism of action of the underlying drug.

    Biodegradable.  The PLEX matrix gradually disintegrates in the body, eliminating the need for additional medical procedures to remove the drug reservoir once depleted.

    Broad potential applicability.  Because PLEX is agnostic to the nature and size of the underlying drug, and no chemical bonds develop between the encapsulated drug and the PLEX components, we believe PLEX can be used for the improvement of a wide variety of drug types, including small molecules, peptides, antibodies and other proteins and nucleic acids.

    Efficient manufacturing process.  Our product candidates are manufactured using a scalable process with well-defined, robust unit operations. This highly specialized and precisely controlled manufacturing process enables us to manufacture product candidates reproducibly and efficiently for clinical and commercial applications.

    Easy to use.  Our D-PLEX family of product candidates are supplied as a sterile powder that can be administered locally as a powder or paste during surgery directly to a variety of tissues and solid organs, as illustrated below.

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Preparation and use of D-PLEX100 in open heart surgery

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Our Initial Family of Product Candidates: D-PLEX

          We are developing a family of product candidates for the management of SSIs consisting of PLEX paired with doxycycline, a widely-used, FDA-approved antibiotic, which we refer to as our D-PLEX family. Our D-PLEX family of product candidates are secure antibiotic drug reservoirs that use our PLEX technology to physically encapsulate doxycycline and release it at the local target site at predetermined rates and durations, and are designed to provide localized and prolonged infection management after surgery. The PLEX matrix in this family consists of thousands of layers of polymers and lipids that are designed to mediate the release of doxycycline for up to four weeks. The product candidates in this family are each based on the same specific PLEX formulation and are designed to be used with doxycycline. Our product candidates are supplied as sterile powders and may be administered locally as a powder or paste during surgery to a variety of tissues and solid organs. Based on results from our clinical trials to date, none of the 101 patients treated in our clinical trials of our D-PLEX product candidates developed an infection at the treatment site after treatment.

Surgical Site Infections

          Hospital acquired infections, or HAIs, are infections that patients acquire when receiving medical treatment in a healthcare facility. According to the WHO, HAIs are the most frequent adverse event affecting patient safety worldwide. SSIs are the second most common HAI in both the United States and the European Union and occur in approximately 2% to 5% of patients undergoing inpatient surgery worldwide. However, these figures are likely underestimated because approximately 50% of SSIs become evident only after a patient has been discharged. The incidence and morbidity of SSIs differ based on the surgical procedure performed and patient risk factors, and the extent of the infection depends on the nature of the surgery.

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          According to the WHO, SSIs account for an estimated $10 billion of incremental hospital costs per year in the United States and €11 billion per year in the European Union. Directly attributable costs of SSIs range from approximately $11,000 to $26,000 per infection. In more complex infections involving a prosthetic joint or an antimicrobial-resistant organism, the costs per case can exceed $90,000. SSIs are associated with approximately seven to 11 additional post-operative hospital days, and patients with an SSI have a two to 11 times increased risk of death compared to infection-free patients. The Centers for Disease Control, or the CDC, estimates that the financial costs of treating SSIs will continue to increase, both because more surgeries are being performed and surgical patients present with increasingly complex comorbidities. Moreover, the United States, the Centers for Medicare and Medicaid Services, or CMS, track SSI rates and are increasingly using these statistics to deny reimbursement claims for certain SSIs or reduce total annual CMS payments for hospitals that CMS deems to not meet certain quality metrics for the prevention of infection. CMS also publishes the SSI incidence rate for hospitals, and therefore hospitals have economic and reputational, in addition to human, incentives to prevent SSIs.

          SSIs can affect any post-operative patient, but obese patients, diabetics, smokers, patients older than 60 and patients undergoing longer duration surgeries are considered at high risk to develop SSIs. Despite the high incidence of SSIs, a large proportion of SSIs are estimated to be preventable with the use of evidence-based measures. However, the prevention of SSIs is complex and requires the implementation of a range of safety measures before, during and after surgery. Most significantly, the WHO, CDC and other health organizations recommend the almost universal systemic and/or topical administration of antibiotics and antiseptic measures prior to surgery to help prevent SSIs. When delivered systemically, these antibiotics are used in large quantities over a short period, often with adverse side effects and limited efficacy.

Market Opportunity

          We are initially focused on the use of D-PLEX100 to prevent SSIs in bone and soft tissues, where we believe there is a high unmet need, which is particularly acute in high-risk patients.

    SSIs in Bone Surgeries

          In our bone surgery addressable market opportunity, we include cardiac surgeries and orthopedic surgeries, which includes joint replacements and surgeries, spine surgeries and bone-related trauma surgeries.

          SSIs occur in 5% to 8% of cardiac surgeries but carry a mortality rate of up to 40% for deep sternal wound infections, which are more difficult to treat than superficial infections. Deep sternal wound SSIs are associated with an average of 35 post-operative hospital days, compared with a mean of 11 days for infection-free patients. The cost of care for a patient that develops a deep sternal wound SSI can be as much as three times greater than the cost of care for an infection-free patient.

          SSIs occur in 0.5% to 4.0% of orthopedic surgeries. Orthopedic SSIs are difficult to treat and associated with lifelong infection recurrence risks of 10% to 20%, particularly in the case of methicillin-resistant Staphylococcus aureus, or MRSA, infections. Further, often bone will not heal in the presence of infection, which can result in disabling complications, including amputation. Orthopedic SSIs have been estimated to prolong total hospital stays by a median of two weeks per patient, approximately double readmission rates and increase healthcare costs by more than 300% compared to infection-free patients.

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    SSIs in Soft Tissue Surgeries

          In our soft tissue surgery addressable market opportunity, we include general surgeries, including intestine and bowel surgeries and selected ear, nose and throat surgeries, gynecological and urologic surgeries. SSIs are one of the most frequent complications in open abdominal surgeries, and they represent a significant cause of mortality and morbidity. SSIs occur in approximately 5% to 30% of soft tissue surgeries, including approximately 10% to 15% of abdominal surgeries, which represent the majority of the "General Surgeries" below, approximately 15% to 30% of colorectal surgeries, up to nearly 4% of Cesarean sections and up to 4% of hysterectomies. Patients undergoing colorectal surgeries are at particularly high risk of developing SSIs because the colon and rectal tracts contain more bacteria that are exposed during surgery. Abdominal SSIs are associated with an average of 18 additional post-operative hospital days.

          The tables below provide the estimated sizes of our addressable market opportunity in these categories in the United States and the EU-5, which, for purposes of the following data, includes France, Germany, Italy, Spain and the United Kingdom, based on the number of procedures performed in 2015, according to a study we commissioned from Life Science Intelligence, Inc.:

    Bone Surgeries

    Number of Surgeries
 

Cardiac Surgeries

       

United States

    889,000  

EU-5

    320,000  

Orthopedic Surgeries

       

United States

    4,148,000  

EU-5

    2,590,000  

Total

    7,947,000  

    Soft Tissue Surgeries

    Number of Surgeries
 

General Surgeries

       

United States

    7,182,000  

EU-5

    3,290,000  

Gynecological and Urologic Surgeries

       

United States

    2,942,000  

EU-5

    1,817,000  

Aesthetic Surgeries

       

United States

    608,000  

EU-5

    319,000  

Total

    16,158,000  

          We believe that D-PLEX100 will be used at a significantly higher rate in high-risk patients, whom we estimate to comprise approximately one-third of the total surgical patient population.

Benefits of Doxycycline

          Doxycycline can be used against a variety of organisms and in a variety of settings, including for both identified and unknown bacteria.

          Doxycycline has the following advantages over other antibiotics:

    broad spectrum of activity against both gram-positive and gram-negative bacteria;

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    highly effective against Staphylococcus aureus, the most common bacteria associated with SSIs;

    potent against MRSA and community-associated MRSA strains, often with a relatively low minimal inhibitory concentration;

    low rate of resistant pathogens as compared to other antibiotics;

    good tissue and cell penetration; and

    established clinical history of safe prolonged administration.

          Our D-PLEX product candidates are designed to release doxycycline locally to the surgical site at predetermined release rates and durations for up to four weeks, longer than any existing antibiotic delivery system, which we believe has the potential to be effective and safer than systemic treatment for infection management.

          We believe that, by combining doxycycline with our proprietary PLEX technology, D-PLEX100 has the potential to overcome the limitations of other available treatments and deliver significant advantages in the management of SSIs, including:

    localized delivery of an antibiotic at therapeutically effective concentrations for up to four weeks;

    applicability to a wide range of bacteria in a variety of settings, including MRSA and community-associated MRSA;

    increased penetration and access to the infection site;

    reduced risk of overall toxicity and adverse side effects due to minimization of systemic exposure and significant decrease of total drug volume delivered;

    simplicity of administration during surgery; and

    biodegradability; and

    reduction of patient compliance concerns.

          D-PLEX100 may have multiple positive impacts on the treatment paradigm for infection management. For example, we have observed in our clinical studies that surgeons applying D-PLEX1000 directly to the contaminated or infected open long bone fracture at the first surgery can avoid repeated surgical intervention for treating a potential infection. Further, in the case of resistant bacteria, D-PLEX100 has the potential to overcome resistant bacteria through the creation of the required local concentration at the target site, which would not be feasible using systemic antibiotic treatment regimens.

D-PLEX100: Our Lead Product Candidate for the Prevention of SSIs

          We are developing D-PLEX100 for the prevention of SSIs in bone and soft tissue. D-PLEX100 received QIDP designation from the FDA under the Generating Antibiotic Incentives Now, or GAIN, Act in February 2017 for the prevention of sternal infections after cardiac surgery. We plan to seek approval of D-PLEX100 under Section 505(b)(2) of the FFDCA in the United States and the comparable regulatory pathway in the European Union. We plan to submit an IND for D-PLEX100 to the FDA and a CTA to the European national competent authorities early in the fourth quarter of 2018, and to initiate a Phase 3 clinical trial in sternal SSIs after cardiac surgery shortly thereafter. We also plan to commence early in the fourth quarter of 2018 a Phase 2 clinical trial in Israel in patients undergoing abdominal surgery for the prevention of SSIs. Assuming a successful outcome in our Phase 2 clinical trial and subject to FDA feedback, we plan to initiate a Phase 3 clinical trial

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in the same indication. Although we have not yet discussed our plans with FDA to develop D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, we believe that if the results of this Phase 3 trial, together with the results from our planned Phase 3 trial for the prevention of sternal SSIs, are favorable, these two Phase 3 studies could support an NDA. We may ultimately pursue a broad label for D-PLEX100 for the management of SSIs depending on the results of our clinical trials and further discussions with the FDA regarding this strategy.

          In our pre-IND meeting in August 2017, the FDA indicated alignment on key aspects of our chemistry, manufacturing and control, or CMC, development plan of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery, including their recommendation that we can use the proposed cGMP production process at our third-party manufacturing facility for our planned Phase 3 clinical trial. The FDA also generally accepted our proposed product specification for D-PLEX100 and the raw materials we use to produce D-PLEX100 for our planned IND, as well as our stability plan and the stability data we intend to submit for our planned IND. In the first quarter of 2018, we held an end of phase 2 meeting with the FDA to obtain alignment on the Phase 3 clinical trial design for the prevention of post-cardiac surgery sternal infection.

          In March 2017, the EMA issued a final scientific advice letter indicating alignment with our clinical and CMC development plan for D-PLEX100 for the prevention of sternal SSIs after cardiac surgery for purposes of seeking Marketing Authorization Approval in the European Union.

Clinical Development of D-PLEX100

    Phase 1b/2 Clinical Trial for the Prevention of Sternal SSIs After Cardiac Surgery

          In October 2016, we initiated a two-part Phase 1b/2 clinical trial of D-PLEX100 for the prevention of sternal SSIs after cardiac surgery in 80 patients undergoing cardiac surgery through mid-sternotomy, with no high-risk enrichment. On August 16, 2017, we completed enrollment of this trial. We are conducting this trial at four sites in Israel.

          The first part of the trial was an open label, single arm study of 20 patients who received D-PLEX100 concomitantly with the standard of care, which generally consists of a prophylactic systemic antibiotic. Based on feedback from the FDA, the second part of the trial was designed as a randomized and single blinded study of 60 patients divided in a two-to-one ratio between treatment and control arms. One arm received D-PLEX100 concomitantly with the standard of care, and the second arm received the standard of care only. Dosing occurred during surgery, and patient follow-up continues for six months after treatment. The primary endpoint of this trial is the decrease of SSI rate as measured by the proportion of patients with at least one SSI within 90 days after cardiac surgery. An independent, blinded adjudication committee reviews all patients with infection as identified by the principal investigator. The study also follows the patients' safety for six months after surgery.

          We recently announced the results of the primary efficacy endpoint from this trial observed at the three-month follow-up study period. During the three-month period after treatment, we observed no sternal wound infections in any of the patients treated with D-PLEX100 in combination with the standard of care. In contrast, we observed a 4.5% infection rate in the control group of patients who received the standard of care alone. According to recent literature, the expected infection rate for patients receiving the standard of care alone is 5% to 8%. Patients in the D-PLEX100 and standard of care arm had similar superficial SSI and/or significant wound secretion rates in non-treated harvesting sites as the patients in the standard of care only arm.

          During the three month follow-up period, we also observed a 62% reduction in the number of patients with sternal wound discharge, as well as a 56% reduction in the duration of such discharge events, each as compared to the control group of patients who received the standard of care alone.

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Moreover, in patients treated with D-PLEX100 in combination with the standard of care, we observed reductions in re-hospitalization rates of 25%, re-hospitalization durations of 27% and overall re-hospitalization days of 44%, each as compared to the rates for the control group of patients who received the standard of care alone.

    Planned Phase 3 Clinical Trial for the Prevention of Sternal SSIs After Cardiac Surgery

          We held an end of Phase 2 meeting with the FDA in the first quarter of 2018 to obtain alignment on our Phase 3 clinical trial plan and regulatory approval pathway for D-PLEX100 for the prevention of sternal SSIs after cardiac surgery. Based on feedback from the FDA, we will need to conduct two Phase 3 clinical trials of D-PLEX100. Our first Phase 3 clinical trial will be a prospective, multinational, multicenter, randomized, two-arm, single-blinded clinical trial to evaluate the efficacy and safety of D-PLEX100 in combination with the standard of care for the prevention of sternal SSIs after cardiac surgery. We plan to run an adaptive design clinical trial and enroll between 1,200 and 2,100 patients undergoing median sternotomy in cardiac surgery, ages 18 to 90 years old, with additional SSI-related comorbidities, such as diabetes and abnormal body mass index. Patients will be divided into two arms, one of which will be treated with D-PLEX100 in combination with the standard of care and the other will be treated with the standard of care alone. We intend to enroll patients at clinical trial sites in the United States, Europe and Israel. The primary efficacy endpoint for this clinical trial will be sternal infection rate as measured by the proportion of subjects with a sternal wound infection event, including deep and superficial sternal wound infections, within 90 days after sternotomy for cardiac surgery. We will also evaluate secondary endpoints, including supporting health economic endpoints, as well as safety and tolerability of D-PLEX100 over six months after surgery. The standard amount of time from initiation of a clinical trial to read-out of data is approximately two years. We are also in discussions with the FDA regarding the possibility of a waiver of pediatric studies of D-PLEX100 for the treatment of sternal SSIs after cardiac surgery. We plan to submit an IND for D-PLEX100 to the FDA and a CTA to the European national competent authorities early in the fourth quarter of 2018, and commence the Phase 3 clinical trial in this indication shortly thereafter.

    Planned Phase 2 Clinical Trial in Patients Undergoing Abdominal Surgery for the Prevention of SSIs

          We plan to commence a Phase 2 clinical trial in patients undergoing abdominal surgery for the prevention of SSIs early in the fourth quarter of 2018 in Israel. We recently submitted the clinical trial protocol for review by the Israeli Ministry of Health and the clinical sites' local ethics committees. Subject to feedback from the FDA, we intend for this clinical trial to be a double-arm, single-blinded trial to evaluate the safety and efficacy of D-PLEX100 in combination with the standard of care for the prevention of SSIs. We expect to enroll patients undergoing abdominal surgery at four clinical trial sites in Israel. The primary efficacy endpoint for this clinical trial will be infection rate as measured by the proportion of patients with an SSI, including deep and superficial incisional SSIs, at the treatment site within 30 days after abdominal surgery. We will also evaluate safety and tolerability of D-PLEX100. Assuming a successful outcome in our Phase 2 clinical trial and subject to FDA feedback, we plan to initiate a Phase 3 clinical trial in the same indication. Although we have not yet discussed our plans with FDA to develop D-PLEX100 for the prevention of SSIs in patients undergoing abdominal surgery, we believe that if the results of this Phase 3 trial, together with the results from our planned Phase 3 trial for the prevention of sternal SSIs, are favorable, these two Phase 3 studies could support an NDA.

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Non-Clinical Studies

          We believe that the results of our non-clinical studies will be sufficient to support an IND and CTA for D-PLEX100 for the prevention of sternal infections after cardiac surgery. In a rabbit sternal wound MRSA model, we observed that a single application of D-PLEX100 substantially reduced bacterial content and histopathological evidence of MRSA infection in the sternal wound. In a rat intramuscular SSI model, we observed that a single application of D-PLEX100 reduced bacterial proliferation and infection as detected in macroscopic observations, microbiological assay and histopathological evidence of infection in the wound. We have also conducted in vitro and in vivo pharmacokinetics, safety and toxicology studies, in which we observed D-PLEX100's ability to release doxycycline over a prolonged period and that D-PLEX100 was generally well-tolerated.

D-PLEX100: Potential Ability to Treat and Prevent Antibiotic-Resistant Bacteria-Related Infections

          Antibiotic resistance generally takes the form of relative resistance, wherein the indicated concentrations of API from systemic delivery are no longer effective, and the required concentration of API cannot be delivered safely via systemic administration. Because PLEX is designed to enable the prolonged exposure of a high localized concentration of doxycycline directly to the target site, we believe that D-PLEX100 may be effective in treating and preventing bacterial infections that are otherwise resistant to antibiotics. In rabbit sternal wound models, we observed that a single application of D-PLEX100 substantially reduced bacterial content and histopathological evidence of MRSA and Klebsiella pneumoniae infections, each of which are doxycycline-resistant, in the sternal wound. Further, we have observed evidence suggesting the effectiveness of D-PLEX1000 in two investigator-initiated compassionate use cases of osteomyelitis patients identified with bacterial infections, including MRSA, who were not responding to intensive conventional antibiotic treatments and other conventional treatments. After a single application of D-PLEX1000, the infection was eradicated and bone healing resulted in both patients. D-PLEX100 received QIDP designation from the FDA for the prevention of sternal infection after cardiac surgery. The QIDP program is designed to expedite the development of novel drugs against important pathogens, including antibiotic-resistant bacteria.

D-PLEX1000 for the Management of SSIs and Support of Bone Recovery in Orthopedic Surgeries

          We have developed D-PLEX1000, formerly known as BonyPid-1000, for use in orthopedic surgeries for the management of SSIs and support of bone recovery. D-PLEX1000 incorporates doxycycline and a synthetic bone void filler, comprised of resorbable beta tricalcium phosphate, or b-TCP, granules. Upon implantation in the body, PLEX is designed to release the encapsulated doxycycline in controlled, predetermined amounts for up to four weeks, while the bone filler acts as a scaffold to support osteoconductive bone recovery.

          We have completed enrollment of a clinical trial of the safety and effectiveness of D-PLEX1000 for the treatment of open tibia fractures. The trial is a randomized and single blinded standard of care-controlled study in four patients with Gustilo I and II open long bone fractures, as well as 47 patients with Gustilo IIIA and IIIB open long bone fractures, a severe clinical condition resulting from a traumatic high energy event where the bone is severely damaged and exposed and, therefore, assumed to be contaminated by environmental bacteria. The Gustilo scale is a common classification for the severity of open fractures often used to guide the treatment regimen. The standard of care generally consists of administration of a systemic antibiotic before and after surgery, as well as irrigation and debridement. This multi-center study is being conducted at six sites in Israel and three in Asia. The objective of the study is to determine the safety and efficacy in bone healing of D-PLEX1000 in addition to the standard of care in traumatic open fracture patients over a period of six and 12 months, as compared to the standard of care alone. The

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primary performance endpoint is radiographic-assessed bone healing, as assessed by the presence of a callus in three out of four cortices, to be measured at the end of a 24-week follow-up period, based on independent blinded central radiographic evaluations of X-rays of the target fracture.

          We recently announced interim results from this trial of patients to reach the six-month follow-up period, which was the evaluation point for the primary efficacy endpoint for the clinical trial. Patients were assessed on a monthly basis. No patients treated with D-PLEX1000 in combination with the standard of care developed a deep bone infection at the six-month follow-up period. We observed that 92% of the 12 evaluable patients treated with D-PLEX1000 in addition to the standard of care reached the primary performance endpoint, the presence of solid radiographic markers for bone healing, as assessed by the establishment of a callus in three out of four cortices, at the six-month follow-up period, as compared to 62% of the 13 evaluable of patients treated with the standard of care alone. Sixty percent of the patients treated with D-PLEX1000 in combination with the standard of care had reached the primary performance endpoint by three months post-operation, as compared to 17% of patients treated with the standard of care alone. Only 36% of patients receiving the standard of care alone showed these markers at four months. It was only at the five-month evaluation that patients in the standard of care arm showed a comparable percentage of patients with these markers as that observed in the group treated with D-PLEX1000 in combination with the standard of care at three months post-operation. Pain-free weight bearing was demonstrated in 65% of patients treated with D-PLEX1000 in combination with the standard of care, as compared to 32% of the patients treated with the standard of care alone. We expect to report the full results of this trial in the second half of 2018. No product-related adverse events were reported.

Pilot Clinical Trials

          We conducted two pilot clinical trials that assessed the safety and effectiveness of D-PLEX1000 in patients with infected Gustilo IIIA and IIIB open long bone fractures. These trials were both open-label single arm clinical trials of D-PLEX1000 in addition to the standard of care. We enrolled 19 patients with open long bone fractures. At the six-month follow up date, no deaths, amputations or other serious adverse product-related events were observed. We did not observe any bone infections at the treatment site in the six months following treatment.

          While we do not plan to pursue further independent development of D-PLEX1000, as we believe the prevention of SSIs in the orthopedic market can be adequately addressed by D-PLEX100, we will evaluate potential collaborations to further the development of D-PLEX1000.

D-PLEX500 for the Treatment of Peri-Implantitis (In Collaboration with MIS)

          We are developing D-PLEX500, formerly known as BonyPid-500, with our collaborator, MIS Implants Technologies Ltd., a subsidiary of Dentsply Sirona Inc., for use in periodontal and oral/maxillofacial surgeries to treat peri-implantitis, a destructive inflammatory process affecting the soft and bone tissues surrounding dental implants. D-PLEX500 incorporates doxycycline and a synthetic bone graft substitute comprised of resorbable b-TCP granules and is designed to fill and reconstruct bone defects caused by peri-implantitis. We have observed that D-PLEX500 gradually reabsorbs and is replaced with bone during the healing process.

          In collaboration with MIS, we have completed enrollment of a pilot clinical trial to assess the safety and effectiveness of D-PLEX500 for intrabony peri-implantitis defects in 27 patients. The trial is a prospective, randomized, dual arm, open label study. This multi-center study is being conducted at two sites in Israel. The objective of the study is to determine the safety and effectiveness of D-PLEX500 in addition to the standard of care in healing intrabony peri-implantitis defects in subjects undergoing surgical treatment of peri-implantitis disease over a period of twelve months. The

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primary efficacy endpoint of the trial is the change in depth of the periodontal pocket from baseline to six months. We expect to report results from this trial in the second half of 2018.

          We will pursue further development of D-PLEX500 in dental indications only with a collaborator.

Future Clinical Development

          Our PLEX platform technology may have broad applications for localized medical conditions other than the prevention of SSIs. We are pursuing research and development programs for our PLEX platform in a variety of potential indications, including for the treatment of SSIs, pain, inflammation and cancer.

PLEX for Pain

          Our next application of PLEX is the development of novel therapies for the management of chronic or post-surgical pain. We are currently in preclinical development of a product candidate that pairs PLEX with a widely-used pain API. In our preclinical studies, we have observed periods of reduced pain that are longer than those provided by the standard of care as well as approved local long-acting delivery systems that apply the same widely-used pain API.

PLEX for Other Applications

          We are conducting a research and development program that pairs PLEX with a widely-used corticosteroid for the treatment of inflammation. In our preclinical studies, we have observed prolonged reduction of inflammation using a fraction of the API that would otherwise be systemically administered.

          We have also conducted a number of research and development programs that paired PLEX with anti-cancer agents, proteins, peptides, nucleic acids and growth factors. We continue to evaluate these research and development programs for potential development by us or in collaboration with leading biopharmaceutical companies.

Competition

          The biopharmaceutical industry is intensely competitive and subject to rapid and significant technological change. Our potential competitors include large and experienced companies that enjoy significant competitive advantages over us, such as greater financial, research and development, manufacturing, personnel and marketing resources, greater brand recognition, and more experience and expertise in obtaining marketing approvals from the FDA and foreign regulatory authorities. These companies may develop new drugs to treat the indications that we target, or seek to have existing drugs approved for use for the treatment of the indications that we target.

          These potential competitors may therefore introduce competing products without our prior knowledge and without our ability to take preemptive measures in anticipation of their commercial launch. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in this industry. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis products that are more effective, easier to administer or less costly than our product candidates.

          The current standard of care for preventing SSIs involves the implementation of a range of safety measures before, during and after surgery, including prophylactic and topical antibiotic administration, antiseptic measures and wound care. We anticipate that D-PLEX100, if approved, could be used as a complementary, rather than competitive, addition to the current standard of care for the prevention of SSIs. In addition, we are aware of other approved treatments that can be

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applied locally during surgery for the prevention of SSIs, including triclosan-coated antiseptic sutures and a resorbable gentamicin-collagen sponge. In orthopedic surgeries, we are aware of approved treatments for localized SSI management that pair bone cement premixed with an antibiotic.

          We may also face competition from companies that are developing localized extended release delivery systems, including Pacira Pharmaceuticals, Inc., Flexion Therapeutics, Inc. and Kala Pharmaceuticals, Inc.

MIS Memorandum of Understanding

          In February 2013, we entered into a memorandum of understanding with MIS pursuant to which we are entitled to receive certain milestone-based and sales-based compensation payments from MIS related to the development of D-PLEX500. We agreed to grant MIS an exclusive right to market a specific dental application of D-PLEX500 for a certain period commencing after our receipt of either EMA or FDA marketing approval and the beginning of commercialized sales of D-PLEX500 in the applicable market. In the event that the FDA imposes certain additional requirements with respect to our clinical trials on D-PLEX500, MIS is not obligated to undertake the expenses related to these additional requirements. We will retain all rights to our existing intellectual property and any intellectual property that we develop relating to D-PLEX500 if the agreement is terminated. We are eligible to receive payments of $2.5 million in the aggregate from MIS upon the completion of certain clinical and regulatory milestones, including the receipt of marketing approval for D-PLEX500 in the United States and/or the European Union. MIS may terminate the MOU at any time prior to the commercialization of D-PLEX500, in which case we would be obligated to return all milestone payments we received under the MOU. As of December 31, 2017, we had received $600,000 in the aggregate in milestone payments from MIS pursuant to the MOU.

Manufacturing

          Our product candidates are manufactured using a scalable self-assembly process with well-defined, robust unit operations. This highly specialized and precisely controlled manufacturing process enables us to manufacture product candidates reproducibly and efficiently for clinical and commercial applications. We are constructing a pilot manufacturing facility for the production of our product candidates adjacent to our administrative headquarters in Petach Tikva, Israel. We currently rely on a third party to conduct our product manufacturing and intend to do so, in whole or in part, through at least 2019 when our pilot manufacturing facility is expected to be completed. Our third-party contract manufacturer has advised us that it is in compliance with cGLP and cGMP for the manufacture of drug substance and product. We use additional third-party contract manufacturers for certain raw materials necessary to manufacture our product candidates. We intend to use a portion of the net proceeds of this offering to complete the build-out of this pilot manufacturing facility. We also intend to build a larger-scale cGMP manufacturing facility in Israel in the future, for which we intend to use a portion of the net proceeds of this offering.

Marketing, Sales and Distribution

          Given our stage of development, we do not currently have any internal sales, marketing or distribution infrastructure or capabilities. We have recently formed a U.S. subsidiary, PolyPid Inc., to support our U.S. development and potential commercialization efforts.

          In the event that we receive regulatory approvals for our products in markets outside of the United States, we intend, where appropriate, to pursue commercialization relationships, including strategic alliances and licensing, with pharmaceutical companies and other strategic partners, which are equipped to market or sell our products through their well-developed sales, marketing and distribution organizations in such countries.

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          In addition, we may out-license some or all of our worldwide patent rights to more than one party to achieve the fullest development, marketing and distribution of any products we develop.

Intellectual Property

          Our patent estate includes patents and patent applications with claims directed to our PLEX, D-PLEX100, D-PLEX500 and D-PLEX1000 product candidates, as well as broader claims for potential future product candidates. On a worldwide basis, our patent estate includes 104 issued patents and pending patent applications for our product candidates as well as for manufacturing processes and methods of treatment, as of December 31, 2017.

          Our patents and patent applications mainly relate to a polymer-lipid-based platform for sustained release of an active pharmaceutical agent at a target site such as the site of a surgery. We currently have over thirty issued patents and several pending patent applications worldwide related to compositions for sustained release of an API, including a lipid-saturated matrix formed from a biodegradable polymer, as well as methods for producing such compositions and methods of treatment through the use of such compositions. We also have five issued patents and several pending patent applications worldwide related to compositions for sustained release of an API including a lipid-saturated matrix formed from a non-biodegradable polymer, as well as methods for producing such compositions and methods of treatment through the use of such compositions. We also have seven issued patents and several pending patent applications worldwide related to compositions for sustained release of a nucleic agent including a lipid-saturated matrix formed from a biodegradable polymer, as well as methods for producing such compositions and methods of treatment through the use of such compositions. We also have an issued Australian patent and a pending Indian patent application related to compositions for sustained release of peptidic molecules, as well as methods for producing such compositions and methods of treatment through the use of such compositions. We also have nine issued patents and several pending patent applications worldwide related to methods for treating bone fractures through the use of biocompatible fillers coated with sustained release antibiotic compositions, along with several pending patent applications worldwide related to methods for treating peri-implantitis and surgical site infections through similar processes. Our patent estate includes six granted United States patents as well as granted patents and/or pending patent applications in Australia, Brazil, Canada, China, the Eurasian Patent Organization, the European Patent Office, India, Israel, Japan, Mexico, New Zealand, the Philippines, Singapore, South Africa, South Korea, and Thailand. Our issued patents are expected to remain in effect until at least 2029.

          In addition to patents, we have filed for and obtained trademark registration with the United States Patent and Trademark Office, or the USPTO, for "PolyPid" and "BonyPid". Furthermore, we rely upon trade secrets, know-how and continuing technological innovation to develop and maintain our competitive position.

          Preparing and filing patent applications is a joint endeavor of our research and development team and our in-house and external patent attorneys. Our patent attorneys conduct patent prior-art searches and then analyze the data in order to provide our research and development team with recommendations on a routine basis. This results in:

    protecting our product candidates that are under development;

    encouraging pharmaceutical companies to negotiate development agreements with us; and

    preventing competitors from attempting to design-around our inventions.

          We initially submit applications to the USPTO as provisional patent applications. Then typically we continue by filing non-provisional patent applications under the Patent Cooperation Treaty, or PCT, which is an international patent law treaty that provides a unified procedure for filing a single

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initial patent application to later seek patent protection for an invention in any number of the member states of the PCT. Although a PCT application does not itself issue as a patent, it acts as a placeholder allowing the applicant to seek protection in any of the member states through national-phase applications.

Government Regulation

          The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture and marketing of pharmaceutical products. These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, packaging, recordkeeping, tracking, approval, import, export, distribution, advertising and promotion of our products.

U.S. Government Regulation of Drug Products

          In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FFDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA's refusal to approve pending NDAs, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

          The process required by the FDA before product candidates may be marketed in the United States generally involves the following:

    nonclinical laboratory and animal tests that must be conducted in accordance with good laboratory practices, or GLPs;

    submission of an IND, which must become effective before clinical trials may begin;

    approval by an independent institutional review board, or IRB, for each clinical site or centrally before each trial may be initiated;

    adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed product candidate for its intended use, performed in accordance with good clinical practices, or GCPs;

    submission to the FDA of an NDA and payment of user fees;

    satisfactory completion of an FDA advisory committee review, if applicable;

    pre-approval inspection of manufacturing facilities and selected clinical investigators for their compliance with current good manufacturing practices, or cGMP, and good clinical practices, or GCPs;

    satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;

    FDA approval of an NDA to permit commercial marketing for particular indications for use; and

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    compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post-approval studies.

          The testing and approval process requires substantial time, effort and financial resources. Preclinical studies include laboratory evaluation of drug substance chemistry, pharmacology, toxicity and drug product formulation, as well as animal studies to assess potential safety and efficacy. Prior to commencing the first clinical trial with a product candidate, we must submit the results of the preclinical tests and preclinical literature, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some preclinical studies may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the conduct of the clinical trial by imposing a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Submission of an IND may not result in FDA authorization to commence a clinical trial.

          Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators in accordance with GCP requirements. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development, as well as amendments to previously submitted clinical trials. Further, an independent IRB for each study site proposing to conduct the clinical trial must review and approve the plan for any clinical trial, its informed consent form and other communications to study subjects before the clinical trial commences at that site. The IRB must continue to oversee the clinical trial while it is being conducted, including any changes to the study plans.

          Regulatory authorities, an IRB or the sponsor may suspend or discontinue a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk, the clinical trial is not being conducted in accordance with the FDA's or the IRB's requirements, if the drug has been associated with unexpected serious harm to subjects, or based on evolving business objectives or competitive climate. Some studies also include a data safety monitoring board, which receives special access to unblinded data during the clinical trial and may advise us to halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy.

          In general, for purposes of NDA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

    Phase 1 — Studies are initially conducted to test the product candidate for safety, dosage tolerance, structure-activity relationships, mechanism of action, absorption, metabolism, distribution and excretion in healthy volunteers or subjects with the target disease or condition. If possible, phase 1 trials may also be used to gain an initial indication of product effectiveness.

    Phase 2 — Controlled studies are conducted with groups of subjects with a specified disease or condition to provide enough data to evaluate the preliminary efficacy, optimal dosages and dosing schedule and expanded evidence of safety. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

    Phase 3 — These clinical trials are undertaken in larger subject populations to provide statistically significant evidence of clinical efficacy and to further test for safety in an expanded subject population at multiple clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for

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      product labeling. These trials may be done globally to support global registrations so long as the global sites are also representative of the U.S. population and the conduct of the study at global sites comports with FDA regulations and guidance, such as compliance with GCPs.

          The FDA may require, or companies may pursue, additional clinical trials after a product is approved. These so-called Phase 4 studies may be made a condition to be satisfied after approval. The results of Phase 4 studies can confirm the effectiveness of a product candidate and can provide important safety information.

          Clinical trials must be conducted under the supervision of qualified investigators in accordance with GCP requirements, which includes the requirements that all research subjects provide their informed consent in writing for their participation in any clinical trial, and the review and approval of the study by an IRB. Investigators must also provide information to the clinical trial sponsors to allow the sponsors to make specified financial disclosures to the FDA. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the trial procedures, the parameters to be used in monitoring safety and the efficacy criteria to be evaluated and a statistical analysis plan. Information about some clinical trials, including a description of the trial and trial results, must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov website.

          The manufacture of investigational drugs for the conduct of human clinical trials is subject to cGMP requirements. Investigational drugs and active pharmaceutical ingredients imported into the United States are also subject to regulation by the FDA relating to their labeling and distribution. Further, the export of investigational drug products outside of the United States is subject to regulatory requirements of the receiving country as well as U.S. export requirements under the FFDCA. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and the IRB and more frequently if SAEs occur.

          Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

Orange Book Listing

          In seeking approval for a drug through an NDA, including a 505(b)(2) NDA, applicants are required to list with the FDA patents whose claims cover the applicant's product. Upon approval of an NDA, each of the patents listed in the application for the drug is then published in Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book.

          Any applicant who files a 505(b)(2) NDA referencing a drug listed in the Orange Book must certify to the FDA (1) that no patent information on the drug product that is the subject of the application has been submitted to the FDA; (2) that such patent has expired; (3) the date on which such patent expires; or (4) that such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. This last certification is known as a Paragraph IV certification. Generally, the 505(b)(2) NDA cannot be approved until all listed patents have expired, except where the 505(b)(2) NDA applicant challenges a listed patent through a Paragraph IV certification.

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          If the applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the holder of the NDA for the reference listed drug and the patent owner once the application has been accepted for filing by the FDA. The applicant may also elect to submit a "section viii" statement certifying that its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. The NDA holder or patent owner may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification prevents the FDA from approving the application until the earlier of 30 months from the date of the lawsuit, expiration of the patent, settlement of the lawsuit, a decision in the infringement case that is favorable to the applicant or such shorter or longer period as may be ordered by a court. This prohibition is generally referred to as the 30-month stay. In instances where a 505(b)(2) NDA applicant files a Paragraph IV certification, the NDA holder or patent owner regularly take action to trigger the 30-month stay, recognizing that the related patent litigation may take many months or years to resolve. Thus, approval of a 505(b)(2) NDA could be delayed for a significant period of time depending on the patent certification the applicant makes and the reference drug sponsor's decision to initiate patent litigation.

Exclusivity

          The FDA provides periods of non-patent regulatory exclusivity, which provides the holder of an approved NDA limited protection from new competition in the marketplace for the innovation represented by its approved drug for a period of three or five years following the FDA's approval of the NDA. Five years of exclusivity are available to new chemical entities, or NCEs. An NCE is a drug that contains no active moiety that has been approved by the FDA in any other NDA. An active moiety is the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt, including a salt with hydrogen or coordination bonds, or other noncovalent, or not involving the sharing of electron pairs between atoms, derivatives, such as a complex (i.e., formed by the chemical interaction of two compounds), chelate (i.e., a chemical compound), or clathrate (i.e., a polymer framework that traps molecules), of the molecule, responsible for the therapeutic activity of the drug substance. During the exclusivity period, the FDA may not accept for review or approve an ANDA or a 505(b)(2) NDA submitted by another company that contains the previously approved active moiety. An ANDA or 505(b)(2) application, however, may be submitted one year before NCE exclusivity expires if a Paragraph IV certification is filed.

          If a product is not eligible for the NCE exclusivity, it may be eligible for three years of exclusivity. Three-year exclusivity is available to the holder of an NDA, including a 505(b)(2) NDA, if one or more new clinical trials, other than bioavailability or bioequivalence trials, was essential to the approval of the application and was conducted or sponsored by the applicant. This three-year exclusivity period protects against FDA approval of ANDAs and 505(b)(2) NDAs for the particular condition of the new drug's approval or the change to a marketed product, such as a new formulation for a previously approved drug. Five-year and three-year exclusivity will not delay the submission or approval of a 505(b)(1) NDA; however, an applicant submitting a 505(b)(1) NDA would be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and efficacy.

          In addition, under the Generating Antibiotic Incentives Now, or GAIN, Act, which was enacted as part of the Food and Drug Administration Safety and Innovation Act, or FDASIA, which was signed into law in July 2012, the FDA may designate a product as a qualified infectious disease product, or QIDP. In order to receive this designation, a drug must qualify as an antibiotic or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by either (1) an antibiotic or antifungal resistant pathogen, including novel or emerging

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infectious pathogens, or (2) a so-called "qualifying pathogen" found on a list of potentially dangerous, drug-resistant organisms to established and maintained by the FDA. A sponsor must request such designation before submitting a marketing application. We obtained a QIDP designation in February 2017 for D-PLEX100 for the prevention of post-cardiac surgery sternal infection and may request additional QIDP designations for D-PLEX100 or our other product candidates prior to submitting a marketing application for such product candidates, as appropriate. Upon approving a marketing application for a QIDP-designated product, the FDA will extend by an additional five years any non-patent marketing exclusivity period awarded, such as a three-year exclusivity period awarded for new clinical investigations of previously approved products. This extension is in addition to any pediatric exclusivity extension awarded, and the extension will be awarded only to a drug first approved on or after the date of enactment of the GAIN Act. The GAIN Act prohibits the grant of an exclusivity extension where the application is a supplement to an application for which an extension is in effect or has expired, is a subsequent application for a specified change to an approved product, or is an application for a product that does not meet the definition of QIDP based on the uses for which it is ultimately approved.

Hatch Waxman Amendments and the 505(b)(2) Regulatory Approval Process

          Section 505 of the FFDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for a new drug. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A Section 505(b)(2) NDA is an application that contains full reports of investigations of safety and efficacy, but where at least some of the information required for approval comes from investigations that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. This regulatory pathway enables the applicant to rely, in part, on the FDA's prior findings of safety and efficacy for an existing product, or published literature, in support of its application. Specifically, the applicant may rely upon the FDA's prior findings of safety and efficacy for an approved product that acts as the reference listed drug for purposes of a 505(b)(2) NDA. The FDA may also require 505(b)(2) applicants to perform additional studies or measurements to support any changes from the reference listed drug. The FDA may then approve the new product candidate for all or some of the labeled indications for which the referenced product has been approved, as well as for any new indication sought by the 505(b)(2) applicant. Lastly, the FDA permits marketing applications through Section 505(j), which establishes an abbreviated approval process for a generic version of approved drug products through the submission of an Abbreviated New Drug Application, or ANDA. An ANDA provides for marketing of a generic drug product that has the same active ingredients, dosage form, strength, route of administration, labeling, performance characteristics and intended use, among other things, to a previously approved product. ANDAs are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and efficacy. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent to, or performs in the same manner as, the innovator drug through in vitro, in vivo, or other testing. The generic version must deliver the same amount of active ingredients into a subject's bloodstream in the same amount of time as the innovator drug and can often be substituted by pharmacists under prescriptions written for the reference listed drug.

Special FDA Expedited Review and Approval Programs

          The FDA has various programs, including fast track designation, breakthrough therapy designation, accelerated approval, and priority review, which are intended to expedite or simplify the process for the development and FDA review of drugs that are intended for the treatment of serious or life threatening diseases or conditions and demonstrate the potential to address unmet medical

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needs. The purpose of these programs is to provide important new drugs to patients earlier than under standard FDA review procedures.

          Under the fast track program, the sponsor of a new drug candidate may request that FDA designate the drug candidate for a specific indication as a fast track drug concurrent with, or after, the filing of the IND for the drug candidate. To be eligible for a fast track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life threatening disease or condition and demonstrates the potential to address an unmet medical need, or that the drug qualifies as a QIDP under the GAIN Act. The FDA will determine that a product will fill an unmet medical need if it will provide a therapy where none exists or provide a therapy that may be potentially superior to existing therapy based on efficacy or safety factors. Fast track designation provides additional opportunities for interaction with the FDA's review team and may allow for rolling review of NDA components before the completed application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA. However, FDA's time period goal for reviewing an application does not begin until the last section of the NDA is submitted. The FDA may decide to rescind the fast track designation if it determines that the qualifying criteria no longer apply.

          In addition, a sponsor can request breakthrough therapy designation for a drug if it is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies are eligible for intensive guidance from FDA on an efficient drug development program, organizational commitment to the development and review of the product including involvement of senior managers, and, like fast track products, are also eligible for rolling review of the NDA. Both fast track and breakthrough therapy products are also eligible for accelerated approval and/or priority review, if relevant criteria are met.

          Under the FDA's accelerated approval regulations, the FDA may approve a drug for a serious or life threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. A drug candidate approved on this basis is subject to rigorous post marketing compliance requirements, including the completion of Phase 4 or post approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post approval studies, or confirm a clinical benefit during post marketing studies, will allow FDA to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated approval regulations are subject to prior review by FDA.

          Once an NDA is submitted for a product intended to treat a serious condition, the FDA may assign a priority review designation if FDA determines that the product, if approved, would provide a significant improvement in safety or effectiveness. A priority review means that the goal for the FDA to review an application is six months, rather than the standard review of ten months under current PDUFA guidelines. Under the current PDUFA agreement, these six and ten month review periods are measured from the 60-day filing date rather than the receipt date for NDAs for new molecular entities, which typically adds approximately two months to the timeline for review from the date of submission. Most products that are eligible for fast track breakthrough therapy designation are also likely to be considered appropriate to receive a priority review.

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          Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. In addition, the manufacturer of an investigational drug for a serious or life threatening disease is required to make available, such as by posting on its website, its policy on responding to requests for expanded access. Furthermore, fast track designation, breakthrough therapy designation, accelerated approval and priority review do not change the standards for approval and may not ultimately expedite the development or approval process.

NDA Submission and Review by the FDA

          Assuming successful completion of the required clinical and preclinical testing, among other items, the results of product development, including chemistry, manufacture and controls, nonclinical studies and clinical trials are submitted to the FDA, along with proposed labeling, as part of an NDA. The submission of an NDA requires payment of a substantial user fee to the FDA. These user fees must be filed at the time of the first submission of the application, even if the application is being submitted on a rolling basis. Fee waivers or reductions are available in some circumstances. One basis for a waiver of the application user fee is if the applicant employs fewer than 500 employees, including employees of affiliates, the applicant does not have an approved marketing application for a product that has been introduced or delivered for introduction into interstate commerce, and the applicant, including its affiliates, is submitting its first marketing application.

          In addition, under the Pediatric Research Equity Act, or PREA, an NDA or supplement to an NDA for a new active ingredient, indication, dosage form, dosage regimen or route of administration must contain data that are adequate to assess the safety and efficacy 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 product is safe and effective.

          The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults or full or partial waivers from the pediatric data requirements.

          The FDA must refer applications for drugs that contain active ingredients, including any ester or salt of the active ingredients, that have not previously been approved by the FDA to an advisory committee or provide in an action letter a summary of the reasons for not referring it to an advisory committee. The FDA may also refer drugs which present difficult questions of safety, purity or potency to an advisory committee. An advisory committee is typically a panel that includes clinicians and other experts who review, evaluate and make a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

          The FDA reviews applications to determine, among other things, whether a product is safe and effective for its intended use and whether the manufacturing controls are adequate to assure and preserve the product's identity, strength, quality and purity. Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities, including contract manufacturers and subcontracts, are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical trial sites to assure compliance with GCPs.

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          Once the FDA receives an application, it has 60 days to review the NDA to determine if it is substantially complete to permit a substantive review, before it accepts the application for filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. The FDA's NDA review times may differ based on whether the application is a standard review or priority review application. The FDA may give a priority review designation to drugs that are intended to treat serious conditions and provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA has set the review goal of 10 months from the 60-day filing date to complete its initial review of a standard NDA for a new molecular entity, or NME, and make a decision on the application. For non-NME standard applications, the FDA has set the review goal of 10 months from the submission date to complete its initial review and to make a decision on the application. For priority review applications, the FDA has set the review goal of reviewing NME NDAs within six months of the 60-day filing date and non-NME applications within six months of the submission date. Such deadlines are referred to as the PDUFA date. The PDUFA date is only a goal and the FDA does not always meet its PDUFA dates. The review process and the PDUFA date may also be extended if the FDA requests or the NDA sponsor otherwise provides additional information or clarification regarding the submission.

          Once the FDA's review of the application is complete, the FDA will issue either a Complete Response Letter, or CRL, or approval letter. A CRL indicates that the review cycle of the application is complete and the application is not ready for approval. A CRL generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or preclinical testing, or other information or analyses in order for the FDA to reconsider the application. The FDA has the goal of reviewing 90% of application resubmissions in either two or six months of the resubmission date, depending on the kind of resubmission. Even with the submission of additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA's satisfaction, the FDA may issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

          The FDA may delay or refuse approval of an NDA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product, or impose other conditions, including distribution restrictions or other risk management mechanisms. For example, the FDA may require a risk evaluation and mitigation strategy, or REMS, as a condition of approval or following approval to mitigate any identified or suspected serious risks and ensure safe use of the drug. The FDA may prevent or limit further marketing of a product, or impose additional post-marketing requirements, based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements, FDA notification and FDA review and approval. Further, should new safety information arise, additional testing, product labeling or FDA notification may be required.

          If regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which such product may be marketed or may include contraindications, warnings or precautions in the product labeling, which has resulted in a Black Box warning. The FDA also may not approve the inclusion of labeling claims necessary for successful marketing. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing regulatory standards is not maintained or if problems occur after the product reaches the marketplace. In addition, the FDA may require Phase 4 post-marketing studies to monitor the effect of approved products, and may limit further marketing of the product based on the results of these post-marketing studies.

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Post-approval Requirements

          Any products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including manufacturing, periodic reporting, product sampling and distribution, advertising, promotion, drug shortage reporting, compliance with any post-approval requirements imposed as a conditional of approval such as Phase 4 clinical trials, REMS and surveillance, recordkeeping and reporting requirements, including adverse experiences.

          After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing, annual user fee requirements for any approved products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and to list their drug products, and are subject to periodic announced and unannounced inspections by the FDA and these state agencies for compliance with cGMPs and other requirements, which impose procedural and documentation requirements upon us and our third-party manufacturers.

          Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented, or FDA notification. FDA regulations also require investigation and correction of any deviations from cGMPs and specifications, and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

          Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in withdrawal of marketing approval, mandatory revisions to the approved labeling to add new safety information or other limitations, imposition of post-market studies or clinical trials to assess new safety risks, or imposition of distribution or other restrictions under a REMS program, among other consequences.

          The FDA closely regulates the marketing and promotion of drugs. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA. Physicians, in their independent professional medical judgement, may prescribe legally available products for uses that are not described in the product's labeling and that differ from those tested by us and approved by the FDA. We, however, are prohibited from marketing or promoting drugs for uses outside of the approved labeling.

          In addition, the distribution of prescription pharmaceutical products, including samples, is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution. The Drug Supply Chain Security Act also imposes obligations on manufacturers of pharmaceutical products related to product and tracking and tracing.

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          Failure to comply with any of the FDA's requirements could result in significant adverse enforcement actions. These include a variety of administrative or judicial sanctions, such as refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, cyber letters, modification of promotional materials or labeling, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, debarment, injunctions, fines, consent decrees, corporate integrity agreements, refusals of government contracts and new orders under existing contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement or civil or criminal penalties, including fines and imprisonment. It is also possible that failure to comply with the FDA's requirements relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws. Any of these sanctions could result in adverse publicity, among other adverse consequences.

Other Healthcare Regulations

          Our business activities, including but not limited to, research, sales, promotion, distribution, medical education and other activities are subject to regulation by numerous regulatory and law enforcement authorities in the United States in addition to the FDA, including potentially the Department of Justice, the Department of Health and Human Services and its various divisions, including CMS and the Health Resources and Services Administration, the Department of Veterans Affairs, the Department of Defense and state and local governments. Our business activities must comply with numerous healthcare laws and regulations, including those described below.

          The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for, or purchasing, leasing, ordering, or arranging for the purchase, lease or order of, any good, facility, item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. The term remuneration has been interpreted broadly to include anything of value. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Additionally, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the PPACA, amended the intent requirement of the federal Anti-Kickback Statute, and other healthcare criminal fraud statutes, so that a person or entity no longer needs to have actual knowledge of the federal Anti-Kickback Statute, or the specific intent to violate it, to have violated the statute. The PPACA also provided that a violation of the federal Anti-Kickback Statute is grounds for the government or a whistleblower to assert that a claim for payment of items or services resulting from such violation constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

          The federal civil and criminal false claims laws, including the federal False Claims Act, or FCA, prohibit, among other things, any person or entity from knowingly presenting, or causing to be

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presented, a false claim for payment to, or approval by, the U.S. federal government, including the Medicare and Medicaid programs, or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim or to avoid, decrease or conceal an obligation to pay money to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes "any request or demand" for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to "cause" the submission of false or fraudulent claims. The FCA also permits a private individual acting as a "whistleblower" to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties. Government enforcement agencies and private whistleblowers have investigated pharmaceutical companies for or asserted liability under the FCA for a variety of alleged promotional and marketing activities, such as providing free product to customers with the expectation that the customers would bill federal programs for the product; providing consulting fees and other benefits to physicians to induce them to prescribe products; engaging in promotion for "off-label" uses; and submitting inflated best price information to the Medicaid Rebate Program.

          As a condition of receiving Medicaid coverage for prescription drugs, the Medicaid Drug Rebate Program requires manufacturers to calculate and report to CMS their Average Manufacturer Price, or AMP, which is used to determine rebate payments shared between the states and the federal government and, for some multiple source drugs, Medicaid payment rates for the drug, and for drugs paid under Medicare Part B, to also calculate and report their average sales price, which is used to determine the Medicare Part B payment rate for the drug. In January 2016, CMS issued a final rule regarding the Medicaid Drug Rebate Program, effective April 1, 2016, that, among other things, revises the manner in which the AMP is to be calculated by manufacturers participating in the program and implements certain amendments to the Medicaid rebate statute created under the PPACA. Drugs that are approved under a biologics license application, or BLA, or an NDA, including a 505(b)(2) NDA, are subject to an additional requirement to calculate and report the manufacturer's best price for the drug and inflation penalties which can substantially increase rebate payments. For BLA and NDA drugs, the Veterans Health Care Act requires manufacturers to calculate and report to the Department of Veterans Affairs a different price called the Non-Federal AMP, offer the drugs for sale on the Federal Supply Schedule, and charge the government no more than a statutory price referred to as the Federal Ceiling Price, which includes an inflation penalty. A separate law requires manufacturers to pay rebates on these drugs when paid by the Department of Defense under its TRICARE Retail Pharmacy Program. Knowingly submitting false pricing information to the government creates potential federal False Claims Act liability.

          The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibits, among other things, 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 whether the payor is public or private, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick, scheme or device a material fact or making any materially false, fictitious or fraudulent statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Additionally, the PPACA amended the intent requirement of some of these criminal statutes under HIPAA so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to violate it, to have committed a violation.

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          Additionally, the federal Open Payments program pursuant to the Physician Payments Sunshine Act, created under Section 6002 of the PPACA and its implementing regulations, require some manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with specified exceptions) to report annually information related to specified payments or other transfers of value provided to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually specified ownership and investment interests held by physicians 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.

          In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations, impose requirements relating to the privacy, security and transmission of individually identifiable health information held by covered entities and their business associates. Among other things, HITECH makes HIPAA's security standards directly applicable to business associates, defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, 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.

          Many states have also adopted laws similar to each of the above federal laws, which may be broader in scope and apply to items or services reimbursed by any third-party payor, including commercial insurers. We may also be subject to state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, and/or state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

          Ensuring that our internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will likely be costly. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations were found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, possible exclusion from government funded healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and curtailment of our operations, any of which could substantially disrupt our operations. If the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

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Coverage and Reimbursement

          Our ability to commercialize any products successfully will also depend in part on the extent to which coverage and adequate reimbursement for the procedures utilizing our product candidates, performed by health care providers, once approved, will be available from government health administration authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, determine which procedures, and the products utilized in such procedures, they will cover and establish reimbursement levels. Assuming coverage is obtained for procedures utilizing a given product, by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Patients who undergo procedures for the treatment of their conditions, and their treating physicians, generally rely on third-party payors to reimburse all or part of the costs associated with the procedures which utilize our products. Treating physicians are unlikely to use and order our products unless coverage is provided and the reimbursement is adequate to cover all or a significant portion of the cost of the procedures which utilize our products. Therefore, coverage and adequate reimbursement for procedures, which utilize new products, is critical to the acceptance of such new products. Coverage decisions may depend upon clinical and economic standards that disfavor new products when more established or lower cost therapeutic alternatives are already available or subsequently become available.

          Government authorities and other third-party payors are developing increasingly sophisticated methods of cost containment, such as including price controls, restrictions on coverage and reimbursement and requirements for substitution of less expensive products and procedures. Increasingly, government and other third-party payors are increasingly challenging the prices charged for health care products and procedures, examining the cost effectiveness of procedures, and the products used in such procedures, in addition to their safety and efficacy, and limiting or attempting to limit both coverage and the level of reimbursement. Further, no uniform policy requirement for coverage and reimbursement exists among third-party payors in the United States, which causes significant uncertainty related to the insurance coverage and reimbursement of newly approved products, and the procedures which may utilize such newly approved products. Therefore, coverage and reimbursement can differ significantly from payor to payor and health care provider to health care provider. As a result, the coverage determination process is often a time-consuming and costly process that requires the provision of scientific and clinical support for the use of new products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

          There may be significant delays in obtaining coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved by the FDA. Moreover, eligibility for coverage and reimbursement does not imply that a product, or the procedures which utilize such product, will be paid for in all cases or at a rate which the health care providers who purchase those products will find cost effective. Additionally, we expect pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative changes.

          We cannot be sure that coverage and reimbursement will be available for any product that we commercialize, or the procedures which utilize such product, and, if reimbursement is available, what the level of reimbursement will be. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval.

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Healthcare Reform Measures

          The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals designed to change the healthcare system. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

          For example, the pharmaceutical industry in the United States has been affected by the passage of PPACA, which, among other things, imposed new fees on entities that manufacture or import certain branded prescription drugs and expanded pharmaceutical manufacturer obligations to provide discounts and rebates to certain government programs, expanded health care fraud and abuse laws, revised the methodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs under the Medicaid Drug Rebate Program are calculated, imposed an additional rebate similar to an inflation penalty on new formulations of drugs, extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, expanded the 340B program which caps the price at which manufacturers can sell covered outpatient pharmaceuticals to specified hospitals, clinics and community health centers, and provided incentives to programs that increase the federal government's comparative effectiveness research.

          Since its enactment, there have been judicial and Congressional challenges to certain aspects of the PPACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the PPACA. Since January 2017, President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the PPACA or otherwise circumvent some of the requirements for health insurance mandated by the PPACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the PPACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the PPACA have been signed into law. The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the "individual mandate". Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain PPACA-mandated fees, including the so-called "Cadillac" tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Congress will likely consider other legislation to replace elements of the PPACA.

          Other legislative changes have been proposed and adopted in the United States since the PPACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2.0% per fiscal year, which went into effect in April 2013, and due to subsequent legislative amendments, will remain in effect through 2027 unless additional U.S. Congressional action is taken. In addition, in January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several categories of healthcare providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. Additional changes that may affect our business include new quality and payment programs such as Medicare payment for performance initiatives for physicians under the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA, which will be fully implemented in 2019.

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          In addition, there has been particular and increasing legislative and enforcement interest in the United States with respect to drug pricing practices in recent years, particularly with respect to drugs that have been subject to relatively large price increases over relatively short time periods. Specifically, there have been several recent U.S. Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of prescription drugs under Medicare and reform government program reimbursement methodologies for pharmaceutical products. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In the future, there will likely continue to be proposals relating to the reform of the U.S. healthcare system, some of which could further limit coverage and reimbursement of products, including our product candidates. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.

The Foreign Corrupt Practices Act

          The Foreign Corrupt Practices Act, or 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 the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the companies to maintain books and records that accurately and fairly reflect all transactions of the companies, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

Non-U.S. Government Regulation

          To the extent that any of our product candidates, once approved, are sold in a country outside of the United States, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance programs and reporting of payments or other transfers of value to healthcare professionals.

          In order to market our future products in the EEA (which is comprised of the 28 Member States of the European Union plus Norway, Iceland and Liechtenstein) and many other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EEA, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA. There are two types of marketing authorizations:

    the Community MA, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency, or EMA, and which is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products and medicinal products indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the European Union; and

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    National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member State through the Mutual Recognition Procedure. If the product has not received a National MA in any Member State at the time of application, it can be approved simultaneously in various Member States through the Decentralized Procedure.

          Under the above described procedures, before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

Data and Marketing Exclusivity

          In the EEA, new products authorized for marketing, or reference products, qualify for eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization. The data exclusivity period prevents generic or biosimilar applicants from relying on the pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar marketing authorization in the European Union during a period of eight years from the date on which the reference product was first authorized in the European Union. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the European Union until 10 years have elapsed from the initial authorization of the reference product in the European Union. The 10-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those 10 years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.

Pediatric Investigation Plan

          In the EEA, marketing authorization applications for new medicinal products not authorized have to include the results of studies conducted in the pediatric population, in compliance with a pediatric investigation plan, or PIP, agreed with the EMA's Pediatric Committee, or PDCO. The PIP sets out the timing and measures proposed to generate data to support a pediatric indication of the drug for which marketing authorization is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical trial data can be waived by the PDCO when these data is not needed or appropriate because the product is likely to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations, or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the marketing authorization is obtained in all Member States of the European Union and study results are included in the product information, even when negative, the product is eligible for six months' supplementary protection certificate extension.

Orphan Drug Designation

          In the EEA, a medicinal product can be designated as an orphan drug if its sponsor can establish that the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in ten thousand persons in the European Union when the application is made, or that the product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the European Community and that without incentives it is unlikely that the marketing of the drug

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in the EU would generate sufficient return to justify the necessary investment. For either of these conditions, the applicant must demonstrate that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the EU or, if such method exists, the drug will be of significant benefit to those affected by that condition.

          In the EEA, an application for designation as an orphan product can be made any time prior to the filing of an application for approval to market the product. Marketing authorization for an orphan drug leads to a ten-year period of market exclusivity. During this market exclusivity period, the EMA or the member state competent authorities, cannot accept another application for a marketing authorization, or grant a marketing authorization, for a similar medicinal product for the same indication. The period of market exclusivity is extended by two years for medicines that have also complied with an agreed PIP.

          This period may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan drug designation, for example because the product is sufficiently profitable not to justify market exclusivity. Market exclusivity can be revoked only in very selected cases, such as consent from the marketing authorization holder, inability to supply sufficient quantities of the product, demonstration of "clinical superiority" by a similar medicinal product, or, after a review by the Committee for Orphan Medicinal Products, requested by a member state in the fifth year of the marketing exclusivity period (if the designation criteria are believed to no longer apply). Medicinal products designated as orphan drugs pursuant are eligible for incentives made available by the European Union and its Member States to support research into, and the development and availability of, orphan drugs.

Employees

          As of December 31, 2017, we had 55 full-time employees and five part-time employees, all of whom were based in Israel. Of these employees, 41 are primarily engaged in research and development activities and 14 are primarily engaged in general and administrative matters. A total of 13 employees have an M.D. or Ph.D. degree. None of our employees is represented by a labor union. We have never experienced any employment-related work stoppages and believe our relationships with our employees are good.

          Israeli labor laws govern the length of the workday and workweek, minimum wages for employees, procedures for hiring and dismissing employees, determination of severance pay, annual leave, sick days, advance notice of termination, payments to the National Insurance Institute, and other conditions of employment and include equal opportunity and anti-discrimination laws. While none of our employees is party to any collective bargaining agreements, certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists' Associations) are applicable to our employees in Israel by order of the Israeli Ministry of Economy and Industry. These provisions primarily concern pension fund benefits for all employees, insurance for work-related accidents, recuperation pay and travel expenses. We generally provide our employees with benefits and working conditions beyond the required minimums.

Facilities

          Our principal executive offices are located at 18 Hasivim Street, Petach Tikva 4959376, Israel, where we lease an approximately 31,000 square foot facility. This Israeli facility houses our administrative headquarters, research and development laboratories and pilot manufacturing facility. We also maintain an office at 47 Maple Street, Suite 302A, Summit, New Jersey, which serves as the headquarters for our U.S. subsidiary. We believe that our existing facilities are adequate to meet our current needs, and that suitable additional or alternative spaces will be available in the future on

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commercially reasonable terms. We also intend to build a larger-scale cGMP manufacturing facility in Israel in the future.

Environmental, Health and Safety Matters

          We are subject to extensive environmental, health and safety laws and regulations in a number of jurisdictions, primarily Israel, governing, among other things: the use, storage, registration, handling, emission and disposal of chemicals, waste materials and sewage; chemicals, air, water and ground contamination; air emissions and the cleanup of contaminated sites, including any contamination that results from spills due to our failure to properly dispose of chemicals, waste materials and sewage. Our operations use chemicals and produce waste materials and sewage and require permits from various governmental authorities including, local municipal authorities, the Ministry of Environmental Protection and the Ministry of Health. The Ministry of Environmental Protection and the Ministry of Health, local authorities and the municipal water and sewage company conduct periodic inspections in order to review and ensure our compliance with the various regulations. These laws, regulations and permits could potentially require the expenditure by us of significant amounts for compliance or remediation. If we fail to comply with such laws, regulations or permits, we may be subject to fines and other civil, administrative or criminal sanctions, including the revocation of permits and licenses necessary to continue our business activities. In addition, we may be required to pay damages or civil judgments in respect of third-party claims, including those relating to personal injury (including exposure to hazardous substances we use, store, handle, transport, manufacture or dispose of), property damage or contribution claims. Some environmental, health and safety laws allow for strict, joint and several liability for remediation costs, regardless of comparative fault. We may be identified as a responsible party under such laws. Such developments could have a material adverse effect on our business, financial condition and results of operations. In addition, laws and regulations relating to environmental, health and safety matters are often subject to change. In the event of any changes or new laws or regulations, we could be subject to new compliance measures or to penalties for activities that were previously permitted.

Legal Proceedings

          We are not currently party to any material legal proceedings.

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MANAGEMENT

Executive Officers and Directors

          The following table sets forth information regarding our executive officers and directors, including their ages as of December 31, 2017:

Name

    Age   Position

Executive Officers

         

Amir Weisberg

    62   Chief Executive Officer and Director

Dikla Czaczkes Akselbrad

    44   Chief Financial Officer

Noam Emanuel, Ph.D. 

    58   Chief Technology Officer and Director

Jack Eitan Kyiet

    48   Chief Operating Officer and Director

Dan Jacob Gelvan, Ph.D. 

    53   Executive Vice President

Non-Employee Directors

   
 
 

 

Jacob Harel

    62   Chairman

Yechezkel Barenholz, Ph.D. 

    76   Director

Eli Frydman, Ph.D. 

    51   Director

Chaim Hurvitz

    57   Director
           

Anat Tsour Segal

    51   Director

Our Executive Officers

          Amir Weisberg has served as our Chief Executive Officer and a director since October 2010. From 2007 to 2010, Mr. Weisberg served as the chief executive officer of Implant Protection Ltd. He has over 20 years of entrepreneurial experience, including as chief executive officer of several startup companies in the life science sphere.

          Dikla Czaczkes Akselbrad has served as our Chief Financial Officer since December 2016. Prior to that time, Ms. Czaczkes Akselbrad served as our Chief Strategy Officer from July 2014 to December 2016, and as chief financial officer of Compugen Ltd., a publicly-traded immuno-oncology company, from February 2008 to May 2014. She holds a BA in accounting and economics and an MBA in finance, both from Tel Aviv University, and is a certified public accountant in Israel.

          Noam Emanuel, Ph.D. has served as our Chief Technology Officer and a director since October 2010. Dr. Emanuel has over 15 years of experience in drug development, drug delivery and immunology, including with respect to local, systemic and trans-dermal drug delivery systems, as well as in imaging and diagnostics. He holds a Ph.D. in immunology and drug delivery from the Hebrew University of Jerusalem.

          Jack Eitan Kyiet has served as our Chief Operating Officer since June 2013 and a director since October 2013. He has held several business development and operations positions in publicly traded multi-national medical device companies. From January 2011 to July 2013, he served as director of worldwide supply chain at Biosense Webster, a Johnson & Johnson medical device company. He holds an LL.B. and an MBA from the Haifa University.

          Dan Jacob Gelvan, Ph.D. has served as our Executive Vice President since April 2017. Prior to that time, Dr. Gelvan served as managing director of life science at Aurum Ventures M.K.I. Ltd. from June 2005 to December 2016. He served as a member of our board of directors from January 2014 to February 2017, as well as a member of the board of directors of Vascular Biogenics Ltd, a publicly-traded biopharmaceutical company, from May 2005 to December 2016. He holds a BA and MA in economics from The Hebrew University of Jerusalem and a Ph.D. in business economics from Roskilde University in Denmark.

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Our Non-Employee Directors

          Jacob Harel has served as a director since November 2017 and the chairman of our board of directors since December 2017. Mr. Harel currently serves as the chief executive officer of The Harel Group, a consulting firm that provides business development support to pharmaceutical companies, which he founded in 2014. He previously served for over 27 years in various roles at Merck & Co., Inc., most recently as the executive director of corporate business development from 2008 to April 2014. Mr. Harel currently serves as a member of the board of directors of Insuline Medical. He holds a B.S. in economics from Haifa University and an MBA from Tel Aviv University.

          Prof. Yechezkel Barenholz, Ph.D. has served as a director since April 2008. Prof. Barenholz currently serves as head of the Laboratory of Membrane and Liposome Research at the Department of Biochemistry of the Hadassah Medical School at the Hebrew University of Jerusalem, a position he has held since 1978. He is a recognized world expert in the field of drug delivery, and is the co-inventor of Doxil, the first nano-delivery system approved by the FDA and marketed by major pharmaceutical companies. He holds a B.Sc., M.Sc. and Ph.D. in biochemistry from the Hebrew University of Jerusalem.

          Eli Frydman, Ph.D. has served as a director since November 2016. Dr. Frydman currently serves as managing director of healthcare of Aurum Ventures M.K.I. Ltd., a position he has held since November 2016. Prior to that time, he served as chief business officer of FutuRx Ltd from September 2013 to March 2016 and vice president, chief operating officer of Aposense Ltd from March 2005 to August 2013. He currently serves as a director of Precise Bio, Inc., Beta-o2 Technologies Ltc., LifeBond Ltd. and Nucleix Ltd. He holds a B.Sc. in chemistry and physics from Tel Aviv University, a M.Sc. and Ph.D. in chemistry, materials and nanotechnology from the Weizmann Institute of Science and an MBA from the ENPC School of International Management.

          Chaim Hurvitz has served as a director since February 2016. Mr. Hurvitz currently serves as chief executive officer of CH Health, a private venture capital firm, a position he has held since May 2011. He also currently serves as chairman of Galmed Pharmaceuticals Ltd. and chairman of the pharmaceuticals branch of the Manufacturer's Association of Israel. Mr. Hurvitz previously served as a member of the board of directors of UroGen Pharma Ltd. Mr. Hurvitz served as a director of Teva Pharmaceutical Industries Ltd. from 2010 to 2014 and Aposense Ltd. from 2010 to 2014. He holds a B.A. in political science and economics from Tel Aviv University.

          Anat Tsour Segal has served as a director since April 2008. Ms. Segal founded Anat Segal Consulting & Technology Investments, an independent consulting and investment banking practice advising Israeli technology and healthcare companies, in January 2000. From April 2003 to February 2016, she also served as the founder, chief executive officer and a director of Xenia Venture Capital. She holds a B.A. in economics and management, an MBA in finance and an LL.B. from Tel Aviv University.

Arrangements Concerning Election of Directors; Family Relationships

          Our board of directors consists of seven directors, each of whom will continue to serve pursuant to their appointment until the first annual general meeting of shareholders held after this offering. We are not a party to, and are not aware of, any voting agreements among our shareholders. In addition, there are no family relationships among our executive officers and directors.

Corporate Governance Practices

          Companies incorporated under the laws of the State of Israel, whose shares are publicly traded, including companies with shares listed on The Nasdaq Global Market, are considered

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public companies under Israeli law and are required to comply with various corporate governance requirements under Israeli law relating to such matters as the composition and responsibilities of the audit committee and the compensation committee (subject to certain exceptions that we intend to utilize), and a requirement to have an internal auditor. This is the case even if our shares are not listed on the Tel Aviv Stock Exchange, or TASE, which our shares are not expected to be. These requirements are in addition to the corporate governance requirements imposed by the Nasdaq Rules and other applicable provisions of U.S. securities laws to which we will become subject (as a foreign private issuer) upon the closing of this offering and the listing of our ordinary shares on The Nasdaq Global Market. Under the Nasdaq Rules, a foreign private issuer may generally follow its home country rules of corporate governance in lieu of the comparable requirements of the Nasdaq Rules, except for certain matters including the composition and responsibilities of the audit committee.

          We intend to rely on this "home country practice exemption" with respect to the following Nasdaq requirements:

    Quorum.  As permitted under the Israeli Companies Law and pursuant to our amended and restated articles of association to be effective upon the closing of this offering, the quorum required for an ordinary meeting of shareholders will consist of at least two shareholders present in person, by proxy or by other voting instrument in accordance with the Israeli Companies Law, who hold at least 331/3% of the voting power of our shares. A meeting adjourned for lack of a quorum is generally adjourned to the same day in the following week at the same time and place or to a later time or date if so specified in the summons or notice of the meeting. At the reconvened meeting, any shareholder present in person or by proxy shall constitute a lawful quorum, instead of 331/3% of the issued share capital required under the Nasdaq Rules.

    Proxy Statements.  We will not be required to and, in reliance on home country practice, we do not intend to comply with certain Nasdaq Rules regarding the provision of proxy statements for general meetings of shareholders. Israeli corporate law does not have a regulatory regime for the solicitation of proxies. We intend to provide notice convening an annual general meeting, including an agenda and other relevant documents.

    Shareholder Approval.  We will not be required to and, in reliance on home country practice, we do not intend to comply with certain Nasdaq Rules regarding shareholder approval for certain issuances of securities under Nasdaq Rule 5635. In particular, under the Nasdaq Rules, shareholder approval is generally required for: (i) an acquisition of shares or assets of another company that involves the issuance of 20% or more of the acquirer's shares or voting rights or if a director, officer or 5% shareholder has greater than a 5% interest (or such persons collectively have a 10% or greater interest) in the target company or the assets to be acquired or the consideration to be received and the present or potential issuance of ordinary shares, or securities convertible into or exercisable for ordinary shares, could result in an increase in outstanding common shares or voting power of 5% or more; (ii) the issuance of shares leading to a change of control; (iii) adoption or amendment of a stock option or purchase plan or other equity compensation arrangements, pursuant to which stock may be acquired by officers, directors, employees or consultants (with certain limited exception); and (iv) issuances of 20% or more of the shares or voting rights (including securities convertible into, or exercisable for, equity) of a listed company via a private placement (and/or via sales by directors or officers or 5% shareholders) if such equity is issued (or sold) at below the greater of the book or market value of shares. By contrast, under the Israeli Companies Law, the adoption of, and material changes to, equity-based compensation plans generally require the approval of the board of directors and the compensation committee of the board of directors (for details regarding the

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      approvals required under the Israeli Companies Law for the approval of compensation of the chief executive officer, all other executive officers and directors, see below under "Approval of Related Party Transactions under Israeli Law — Disclosure of Personal Interests of an Office Holder and Approval of Certain Transactions," and "Approval of Related Party Transactions under Israeli Law — Disclosure of Personal Interests of a Shareholder and Approval of Certain Transactions" respectively).

          Other than as stated above, we currently intend to take all actions necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements of the Sarbanes-Oxley Act, the rules adopted by the SEC and The Nasdaq Global Market's listing standards. Nevertheless, we may in the future decide to use the foreign private issuer exemption with respect to some or all of the other Nasdaq corporate governance rules. Following our home country governance practices, as opposed to the requirements that would otherwise apply to a company listed on Nasdaq, may provide less protection than is accorded to investors under the Nasdaq listing requirements applicable to domestic issuers. For more information, see "Risk Factors — As a foreign private issuer, we are permitted, and intend, to follow certain home country corporate governance practices instead of otherwise applicable Nasdaq requirements, and we will not be subject to certain U.S. securities laws including, but not limited to, U.S. proxy rules and the filing of certain Exchange Act reports."

Board Practices

Board of Directors

          Under the Israeli Companies Law, our board of directors is responsible for setting our general policies and supervising the performance of management. Our board of directors may exercise all powers and may take all actions that are not specifically granted to our shareholders or to management. Our executive officers are responsible for our day-to-day management and have individual responsibilities established by our board of directors. Our Chief Executive Officer is appointed by, and serves at the discretion of, our board of directors, subject to the terms of the employment agreement that we have entered into with him. All other executive officers are also appointed by our board of directors, and are subject to the terms of any applicable employment agreements that we may enter into with them.

          Under our amended and restated articles of association, to be effective upon the closing of this offering, our board of directors must consist of at least five directors and not more than eleven directors. Our board of directors will consist of eight directors upon the closing of this offering. Other than vacancies to be filled through selection by the remaining members of our board, the Israeli Companies Law and our amended and restated articles of association provide that directors are elected at the annual general meeting of our shareholders by a vote of the majority of the total voting power of our company voting in person, by proxy or by other voting instrument at that meeting. We have only one class of directors.

          Under the Israeli Companies Law, our board of directors is required to employ independent judgment and discretion when voting, and is prohibited from entering into any voting arrangements with respect to actions taken at meetings of the board. Further, the Israeli Companies Law provides that in the event a director learns about an alleged breach of law or improper conduct of business relating to a company matter, said director must promptly take action to summon a meeting of the board of directors to address any such breach.

          Notwithstanding the exemptions available to foreign private issuers under Nasdaq Rules, we intend to follow the requirements of the Nasdaq Rules with regard to the process of nominating directors by means of our compensation, nominating and corporate governance committee, which is comprised of directors who our board has deemed to be independent under Nasdaq Rules.

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          In addition, our amended and restated articles of association allow our board of directors to appoint directors to fill vacancies on our board of directors, including filling empty board seats up to the maximum number of directors permitted under our articles of association, for a term of office equal to the remaining period of the term of office of each director whose office has been vacated. Vacancies on our board of directors may be filled by a vote of a simple majority of the directors then in office. A director so appointed will hold office until the next annual general meeting of our shareholders in which the other directors then in office are proposed to be replaced or reappointed.

          Directors may be removed from office by a resolution at a general meeting of shareholders adopted by a vote of 65% of the total voting power of our company in accordance with the Israeli Companies Law and our amended and restated articles of association.

          Under the Israeli Companies Law, and except as described below, we would be required to include on our board of directors at least two members, each of whom qualifies as an external director, and as to whom special qualifications and other provisions would be applicable. We would also be required to include one such external director on each of our board committees.

          Under regulations promulgated under the Israeli Companies Law, Israeli companies whose shares are traded on stock exchanges such as the Nasdaq Stock Market that do not have a controlling shareholder (as defined therein) and which comply with the requirements of the jurisdiction where the company's shares are traded with respect to the appointment of independent directors and the composition of an audit committee and compensation committee, may elect not to follow the Israeli Companies Law requirements with respect to the composition of its audit committee and compensation committee and the appointment of external directors. As we do not have a controlling shareholder, we intend to comply with the requirements of the Nasdaq Stock Market with respect to the composition of our board and such committees, and therefore we will be exempt from the Israeli Companies Law requirements with respect thereto, including the appointment of external directors.

Director Independence

          Although not required of foreign private issuers under Nasdaq Rules, we intend to comply with the requirements thereunder applicable to domestic listed companies that a majority of the board of directors be deemed to be independent under such rules, as well as the independence requirements that would be applicable to our audit committee and compensation, nominating and corporate governance committee if we were a domestic listed company, as described below. In light of this obligation, our board of directors has undertaken a review of the independence of our directors under current rules and regulations of the SEC and Nasdaq Rules and considered whether any of our directors has a material relationship with us that could compromise his or her ability to exercise independent judgment in carrying out his or her responsibilities. Based upon information requested from and provided by each director concerning such director's background, employment and affiliations, including family relationships, our board of directors determined that Yechezkel Barenholz, Eli Frydman, Jacob Harel, Chaim Hurvitz and Anat Tsour Segal, representing five of our eight directors, are "independent directors" as defined under current rules and regulations of the SEC and Nasdaq Rules. In making these determinations, our board of directors considered the current and prior relationships that each non-employee director has with our company and all other facts and circumstances that our board of directors deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director and the transactions involving them described in "Certain Relationships and Related Party Transactions."

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Leadership Structure of the Board

          In accordance with the Israeli Companies Law and our amended and restated articles of association, our board of directors is required to appoint one of its members to serve as chairman of the board of directors. Our board of directors has appointed Jacob Harel to serve as chairman of the board of directors.

Board Committees

          Under the Israeli Companies Law and our amended and restated articles of association, our board of directors is permitted to form committees, and to delegate to any such committee powers allotted to the board of directors, subject to certain exceptions. In general, the board of directors may overturn a resolution adopted by a committee it has formed; provided, however, that the board's decision shall not affect the ability of third parties, who were not aware of such decision, to rely on the committee's resolution prior to the time it is overturned. Only members of the board of directors can be members of a board committee, unless the committee is solely advisory.

Audit Committee

          Following the listing of our ordinary shares on The Nasdaq Global Market, our audit committee will consist of Jacob Harel and Anat Tsour Segal.

Israeli Companies Law Requirements

          Under the Israeli Companies Law, we will be required to appoint an audit committee following the closing of this offering.

Nasdaq Listing Requirements

          Under the Nasdaq Rules, we are required to maintain an audit committee consisting of at least three independent directors, each of whom is financially literate and one of whom has accounting or related financial management expertise. We are permitted to phase-in our compliance with the independent audit committee requirements set forth in the Nasdaq Rules and the SEC rules, as follows: (1) we must have one independent member at the time of listing, (2) we must have a majority of independent members within 90 days of listing and (3) we must have all independent members within one year of listing. We expect that, within 90 days of our listing on the Nasdaq Stock Market, a third independent director for audit committee purposes (as determined under the Nasdaq Rules and the SEC rules) will have been added to our audit committee.

          All members of our audit committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and the Nasdaq Stock Market. Our board of directors has determined that is an audit committee financial expert as such term is defined by the SEC rules and has the requisite financial experience as defined by the Nasdaq Rules. Each of the members of our audit committee is "independent" as such term is defined in Rule 10A-3(b)(1) under the Exchange Act and satisfies the independent director requirements under the Nasdaq Rules.

Audit Committee Role

          Our audit committee charter, to be effective upon the listing of our shares on The Nasdaq Global Market, sets forth the responsibilities of the audit committee consistent with the rules and

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regulations of the SEC and the Nasdaq Rules, as well as the requirements for such committee under the Israeli Companies Law, including the following:

    oversight of our independent registered public accounting firm and recommending the engagement, compensation or termination of engagement of our independent registered public accounting firm to the board of directors in accordance with Israeli law;

    recommending the engagement or termination of the person filling the office of our internal auditor; and

    recommending the terms of audit and non-audit services provided by the independent registered public accounting firm for pre-approval by our board of directors.

          Our audit committee provides assistance to our board of directors in fulfilling its legal and fiduciary obligations in matters involving our accounting, auditing, financial reporting, internal control and legal compliance functions by pre-approving the services performed by our independent accountants and reviewing their reports regarding our accounting practices and systems of internal control over financial reporting. Our audit committee also oversees the audit efforts of our independent accountants and takes those actions that it deems necessary to satisfy itself that the auditors are independent of management.

          Under the Israeli Companies Law, our audit committee is responsible, among others, for:

    determining whether there are deficiencies in the business management practices of our company, including in consultation with our internal auditor or the independent auditor, and making recommendations to the board of directors to improve such practices;

    determining whether to approve certain related party transactions (including transactions in which an office holder has a personal interest and whether such transaction is extraordinary or material under the Israeli Companies Law) (see "Approval of Related Party Transactions under Israeli Law — Fiduciary Duties of Directors and Executive Officers");

    establishing the approval process for certain transactions with a controlling shareholder or in which a controlling shareholder has a personal interest;

    where the board of directors approves the working plan of the internal auditor, examining such working plan before its submission to the board of directors and proposing amendments thereto;

    examining our internal audit controls and internal auditor's performance, including whether the internal auditor has sufficient resources and tools to fulfill his responsibilities;

    examining the scope of our auditor's work and compensation and submitting a recommendation with respect thereto to our board of directors, depending on which of them is considering the appointment of our auditor; and

    establishing procedures for the handling of employees' complaints as to the management of our business and the protection to be provided to such employees.

Compensation, Nominating and Corporate Governance Committee and Compensation Policy

          Upon the listing of our ordinary shares on The Nasdaq Global Market, we intend to establish a compensation, nominating and corporate governance committee. The composition of our compensation, nominating and corporate governance committee meets the requirements for and guidance under the Nasdaq Rules and current SEC rules and regulations applicable to domestic issuers. The members of this committee will be Eli Frydman, Jacob Harel, Chaim Hurvitz and Anat Tsour Segal, each of whom is independent in accordance with the Nasdaq rules.

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Israeli Companies Law Requirements

          Under the Israeli Companies Law, the board of directors of a public company must appoint a compensation committee.

          The duties of the compensation committee under the Israeli Companies Law, include the recommendation to the company's board of directors of a policy regarding the terms of engagement of office holders, to which we refer as a compensation policy. That policy must be adopted by the company's board of directors, after considering the recommendations of the compensation, nominating and corporate governance committee, and will need to be approved by the company's shareholders, which approval requires what we refer to as a Special Majority Approval for Compensation. A Special Majority Approval for Compensation requires shareholder approval by a majority vote of the shares present and voting at a meeting of shareholders called for such purpose, provided that either: (i) such majority includes at least a majority of the shares held by all shareholders who are not controlling shareholders and do not have a personal interest in such compensation arrangement, excluding abstentions; or (ii) the total number of shares of non-controlling shareholders and shareholders who do not have a personal interest in the compensation arrangement and who vote against the arrangement does not exceed 2% of the company's aggregate voting rights. Our board of directors has adopted, and our shareholders have approved, a compensation policy to be effective in connection upon the consummation of this offering, which policy will be in effect until the fifth anniversary of this offering.

          The compensation policy must (subject to certain exemptions) set the framework and limitation for decisions concerning the financial terms of employment or engagement of office holders, including exculpation, insurance, indemnification or any monetary payment or obligation of payment in respect of employment or engagement. The compensation policy must relate to certain factors, including advancement of the company's long-term objectives, business plan and policies, and creation of appropriate incentives for office holders. It must also consider, among other things, the company's risk management, size and the nature of its operations. The compensation policy must furthermore consider the following additional factors:

    the education, skills, expertise and accomplishments of the relevant office holder;

    the office holder's roles and responsibilities and prior compensation agreements with him or her;

    the relationship between the terms offered and the average compensation of the company's personnel;

    the impact of disparities in salary upon work relationships in the company;

    the possibility of reducing variable compensation at the discretion of the board of directors;

    the possibility of setting a limit on the exercise value of non-cash variable equity-based compensation; and

    as to severance compensation, the period of service of the office holder, the terms of his or her compensation during such service period, the company's performance during that period of service, the person's contribution towards the company's achievement of its goals and the maximization of its profits, and the circumstances under which the person is leaving the company.

          The compensation policy must also include the following principles:

    the link between variable compensation and long-term performance and measurable criteria;

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    the relationship between variable and fixed compensation, and the ceiling for the value of variable compensation;

    the conditions under which an office holder would be required to repay compensation paid to him or her if it was later shown that the data upon which such compensation was based was inaccurate and was restated in the company's financial statements;

    the minimum holding or vesting period for variable, equity-based compensation; and

    maximum limits for severance compensation.

Compensation, Nominating and Corporate Governance Committee Roles

          The compensation, nominating and corporate governance committee is responsible for (i) recommending the compensation policy to our board of directors for its approval (and subsequent approval by our shareholders) and (ii) duties related to the compensation policy and to the compensation of our office holders, including:

    recommending whether a compensation policy should continue in effect, if the then-current policy has a term of greater than five years from a company's initial public offering, or otherwise three years (approval of either a new compensation policy or the continuation of an existing compensation policy must in any case occur five years from a company's initial public offering, or otherwise every three years);

    recommending to the board of directors periodic updates to the compensation policy;

    assessing implementation of the compensation policy;

    determining whether to approve the terms of compensation of certain office holders which, according to the Israeli Companies Law, require the committee's approval; and

    determining whether the compensation terms of a candidate for the position of the chief executive officer of the company needs to be brought to approval of the shareholders.

          Our compensation, nominating and corporate governance charter, to be effective upon the closing of this offering, sets forth the responsibilities of the compensation, nominating and corporate committee, which include:

    the responsibilities set forth in the compensation policy;

    reviewing and approving the granting of options and other incentive awards to the extent such authority is delegated by our board of directors; and

    reviewing, evaluating and making recommendations regarding the compensation and benefits for our non-employee directors.

          In addition, our compensation, nominating and corporate governance committee is responsible for:

    overseeing our corporate governance functions on behalf of the board;

    making recommendations to the board regarding corporate governance issues;

    identifying and evaluating candidates to serve as our directors consistent with the criteria approved by the board;

    reviewing and evaluating the performance of the board

    serving as a focal point for communication between director candidates, non-committee directors and our management;

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    selecting or recommending to the board for selection candidates to the board; and

    making other recommendations to the board regarding affairs relating to our directors.

Disclosure of Compensation of Executive Officers

          For so long as we qualify as a foreign private issuer, we are not required to comply with the proxy rules applicable to U.S. domestic companies, including the requirement applicable to emerging growth companies to disclose the compensation of our Chief Executive Officer, Chief Financial Officer and other three most highly compensated executive officers on an individual, rather than on an aggregate, basis. Nevertheless, under regulations promulgated under the Israeli Companies Law, we will be required, after we become a public company, to disclose the annual compensation of our five most highly compensated office holders (as defined under the Israeli Companies Law) on an individual basis. This disclosure will not be as extensive as that required of a U.S. domestic issuer. We intend to commence providing such disclosure, at the latest, in the notice (which is generally part of the proxy statement) for our first annual general meeting of shareholders following this offering, which will be furnished under cover of a Report of Foreign Private Issuer on Form 6-K, or we may elect to provide such information at an earlier date.

Internal Auditor

          Under the Israeli Companies Law, the board of directors of an Israeli public company must appoint an internal auditor recommended by the audit committee. An internal auditor may not, among other things, be:

    a person (or a relative of a person) who holds 5% or more of the company's outstanding shares or voting rights;

    a person (or a relative of a person) who has the power to appoint a director or the general manager of the company;

    an office holder (including a director) of the company (or a relative thereof); or

    a member of the company's independent accounting firm, or anyone on its behalf.

          The role of the internal auditor is to examine, among other things, our compliance with applicable law and orderly business procedures, and to report to the chief executive officer, the chairman of the board and the chairman of the audit committee. The internal auditor is entitled to receive notice of audit committee meetings and to participate in them. In addition, the internal auditor may request that the chairman of the audit committee convene a meeting within a reasonable time to discuss an issue raised by the internal auditor. The internal auditor is responsible for preparing a proposal for an annual or periodical audit plan and submit such plan to the board of directors or the audit committee for their approval. We intend to appoint an internal auditor following the closing of this offering.

Approval of Related Party Transactions under Israeli Law

Fiduciary Duties of Directors and Executive Officers

          The Israeli Companies Law codifies the fiduciary duties that office holders owe to a company. Each person listed in the table under "Executive Officers and Directors" is an office holder under the Israeli Companies Law.

          An office holder's fiduciary duties consist of a duty of care and a duty of loyalty. The duty of care requires an office holder to act with the level of care with which a reasonable office holder in

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the same position would have acted under the same circumstances. The duty of loyalty includes an obligation that an office holder act in good faith and in the best interests of the company.

          The duty of care includes a duty to use reasonable means to obtain:

    information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and

    all other important information pertaining to any such action.

          The duty of loyalty includes a duty to:

    refrain from any conflict of interest between the performance of his or her duties to the company and his or her other duties or personal affairs;

    refrain from any activity that is competitive with the company;

    refrain from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and

    disclose to the company any information or documents relating to the company's affairs which the office holder received as a result of his or her position as an office holder.

Disclosure of Personal Interests of an Office Holder and Approval of Certain Transactions

          The Israeli Companies Law requires that an office holder promptly disclose to the board of directors any personal interest that he or she may be aware of and all related material information or documents concerning any existing or proposed transaction with the company. An interested office holder's disclosure must be made promptly and in any event no later than the first meeting of the board of directors at which the transaction is considered. A personal interest includes an interest of any person in an action or transaction of a company, including a personal interest of such person's relative or of a corporate body in which such person or a relative of such person is a 5% or greater shareholder, director or general manager or in which he or she has the right to appoint at least one director or the general manager, but excluding a personal interest stemming from one's ownership of shares in the company.

          A personal interest also includes the personal interest of a person for whom the office holder holds a voting proxy or the personal interest of the office holder with respect to his or her vote on behalf of a person for whom he or she holds a proxy even if such person has no personal interest in the matter. An office holder is not, however, required to disclose a personal interest if it derives solely from the personal interest of his or her relative in a transaction that is not considered an extraordinary transaction. Under the Israeli Companies Law, an "extraordinary transaction" is defined as a transaction (including a unilateral decision by the company) that:

    is not in the ordinary course of business;

    is not on market terms; or

    may have a material impact on a company's profitability, assets or liabilities.

          If it is determined that an office holder has a personal interest in a transaction, which is not an extraordinary transaction, approval by the board of directors is required for the transaction, unless the company's articles of association provide for a different method of approval. Further, so long as an office holder has disclosed his or her personal interest in a transaction, the board of directors may approve an action by the office holder that would otherwise be deemed a breach of his or her duty of loyalty. However, a company may not approve a transaction or action that is not in the company's interest or that is not performed by the office holder in good faith.

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          An extraordinary transaction in which an office holder has a personal interest requires approval first by the company's audit committee and subsequently by the board of directors.

          The compensation of, or an undertaking to indemnify or insure, an office holder who is not a director generally requires approval first by the company's compensation committee, then by the company's board of directors. If such compensation arrangement or an undertaking to indemnify or insure is inconsistent with the company's stated compensation policy, or if the office holder is the chief executive officer (apart from a number of specific exceptions), then such arrangement is further subject to a Special Majority Approval for Compensation. If the shareholders of a company do not approve the compensation terms of office holders at a meeting of the shareholders, other than directors, the compensation committee and board of directors may override the shareholders' decision, subject to certain conditions. Arrangements regarding the compensation, indemnification or insurance of a director require the approval of the compensation committee, board of directors and shareholders by simple majority, in that order, and under certain circumstances, a Special Majority Approval for Compensation.

          Generally, a person who has a personal interest in a matter which is considered at a meeting of the board of directors or the audit committee may not be present at such a meeting or vote on that matter unless the chairman of the audit committee or board of directors (as applicable) determines that he or she should be present in order to present the transaction that is subject to approval. If a majority of the members of the audit committee or the board of directors (as applicable) has a personal interest in the approval of a transaction, then all directors may participate in discussions of the audit committee or the board of directors (as applicable) on such transaction and the voting on approval thereof, but shareholder approval is also required for such transaction.

Disclosure of Personal Interests of Controlling Shareholders and Approval of Certain Transactions

          Pursuant to Israeli law, the disclosure requirements regarding personal interests that apply to directors and executive officers also apply to a controlling shareholder of a public company. In the context of a transaction involving a shareholder of the company, a controlling shareholder also includes a shareholder who holds 25% or more of the voting rights in the company if no other shareholder holds more than 50% of the voting rights in the company. For this purpose, the holdings of all shareholders who have a personal interest in the same transaction will be aggregated.

          The approval of the audit committee, the board of directors and the shareholders of the company, in that order, is required for (i) extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, (ii) the engagement with a controlling shareholder or his or her relative, directly or indirectly, for the provision of services to the company, (iii) the terms of engagement and compensation of a controlling shareholder or his or her relative who is not an office holder or (iv) the employment of a controlling shareholder or his or her relative by the company, other than as an office holder. In addition, the shareholder approval requires one of the following, which we refer to as a Special Majority:

    at least a majority of the shares held by all shareholders who do not have a personal interest in the transaction and who are present and voting at the meeting approves the transaction, excluding abstentions; or

    the shares voted against the transaction by shareholders who have no personal interest in the transaction and who are present and voting at the meeting do not exceed 2% of the aggregate voting rights in the company.

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          To the extent that any such transaction with a controlling shareholder is for a period extending beyond three years and under certain conditions, five years from a company's initial public offering, approval is required at the end of such period unless, with respect to certain transactions, the audit committee determines that the duration of the transaction is reasonable given the circumstances related thereto.

          Arrangements regarding the compensation, indemnification or insurance of a controlling shareholder in his or her capacity as an office holder require the approval of the compensation committee, board of directors and shareholders by a Special Majority.

          Pursuant to regulations promulgated under the Israeli Companies Law, certain transactions with a controlling shareholder or his or her relative, or with directors or other office holders, that would otherwise require approval of a company's shareholders may be exempt from shareholder approval under certain conditions.

Shareholder Duties

          Pursuant to the Israeli Companies Law, a shareholder has a duty to act in good faith and in a customary manner toward the company and other shareholders and to refrain from abusing his or her power in the company, including, among other things, in voting at a general meeting and at shareholder class meetings with respect to the following matters:

    an amendment to the company's articles of association;

    an increase of the company's authorized share capital;

    a merger; or

    the approval of related party transactions and acts of office holders that require shareholder approval.

          A shareholder also has a general duty to refrain from discriminating against other shareholders.

          In addition, certain shareholders have a duty of fairness toward the company. These shareholders include a controlling shareholder, a shareholder who knows that he or she has the power to determine the outcome of a shareholder vote and a shareholder who has the power to appoint or to prevent the appointment of an office holder of the company or other power towards the company. The Israeli Companies Law does not define the substance of the duty of fairness, except to state that the remedies generally available upon a breach of contract will also apply in the event of a breach of the duty to act with fairness.

Exculpation, Insurance and Indemnification of Directors and Officers

          Under the Israeli Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty. An Israeli company may exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care but only if a provision authorizing such exculpation is included in its articles of association. Our amended and restated articles of association which will be effective upon the closing of this offering include such a provision. A company may not exculpate in advance a director from liability arising out of a breach of the duty of care with respect to a distribution.

          Under the Israeli Companies Law, a company may indemnify an office holder in respect of the following liabilities and expenses incurred for acts performed by him or her as an office holder,

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either pursuant to an undertaking made in advance of an event or following an event, provided its articles of association include a provision authorizing such indemnification:

    financial liability imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator's award approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company's activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria;

    reasonable litigation expenses, including attorneys' fees, incurred by the office holder (1) as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding, and (ii) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent; and (2) in connection with a monetary sanction; and

    reasonable litigation expenses, including attorneys' fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf, or by a third party, or in connection with criminal proceedings in which the office holder was acquitted, or as a result of a conviction for an offense that does not require proof of criminal intent.

          Under the Israeli Companies Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder, if and to the extent provided in the company's articles of association:

    a breach of the duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;

    a breach of the duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; and

    a financial liability imposed on the office holder in favor of a third party.

          Under the Israeli Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:

    a breach of the duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;

    a breach of the duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;

    an act or omission committed with intent to derive illegal personal benefit; or

    a fine, civil fine, monetary sanction or forfeit levied against the office holder.

          Under the Israeli Companies Law, exculpation, indemnification and insurance of office holders in a public company must be approved by the compensation committee and the board of directors and, with respect to certain office holders or under certain circumstances, also by the shareholders.

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See "Approval of Related Party Transactions under Israeli Law — Fiduciary Duties of Directors and Executive Officers."

          Our amended and restated articles of association to be effective upon the closing of this offering will permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted or to be permitted by the Israeli Companies Law.

          We intend to obtain directors and officers liability insurance for the benefit of our office holders and intend to increase such coverage in an amount standard for a company of our size prior to the closing of this offering. We intend to maintain such increased coverage and pay all premiums thereunder to the fullest extent permitted by the Israeli Companies Law. In addition, prior to the closing of this offering, we intend to enter into agreements with each of our directors and executive officers exculpating them from liability to us for damages caused to us as a result of a breach of duty of care and undertaking to indemnify them, in each case, to the fullest extent permitted by our amended and restated articles of association to be effective upon the closing of this offering and Israeli law, including with respect to liabilities resulting from this offering to the extent that these liabilities are not covered by insurance. In the opinion of the SEC, however, indemnification of directors and office holders for liabilities arising under the Securities Act is against public policy and therefore unenforceable.

Code of Business Conduct and Ethics

          We will adopt, effective upon the consummation of this offering, a Code of Business Conduct and Ethics applicable to all of our directors and employees, including our Chief Executive Officer, Chief Financial Officer, controller or principal accounting officer, or other persons performing similar functions, which is a "code of ethics" as defined in Item 16B of Form 20-F promulgated by the SEC. Upon the effectiveness of the registration statement of which this prospectus forms a part, the full text of the Code of Business Conduct and Ethics will be posted on our website at www.polypid.com. Information contained on, or that can be accessed through, our website does not constitute a part of this prospectus and is not incorporated by reference herein. If we make any amendment to the Code of Business Conduct and Ethics or grant any waivers, including any implicit waiver, from a provision of the code of ethics, we will disclose the nature of such amendment or waiver on our website to the extent required by the rules and regulations of the SEC. Under Item 16B of Form 20-F, if a waiver or amendment of the Code of Business Conduct and Ethics applies to our principal executive officer, principal financial officer, principal accounting officer or controller and relates to standards promoting any of the values described in Item 16B(b) of Form 20-F, we are required to disclose such waiver or amendment on our website in accordance with the requirements of Instruction 4 to such Item 16B.

Compensation of Executive Officers and Directors

          The aggregate compensation paid and equity-based compensation and other payments expensed by us to our directors and executive officers with respect to the year ended December 31, 2017 was $2.7 million. This amount does not include business travel, relocation, professional and business association dues and expenses reimbursed to office holders, and other benefits commonly reimbursed or paid by companies in our industry.

          As of December 31, 2017, options to purchase 1,053,844 ordinary shares granted to our directors and executive officers were outstanding under our 2012 Share Option Plan at a weighted average exercise price of $4.40 per share. Such number, and the following table, excludes options to purchase up to 546,632 ordinary shares, which are contingent upon the closing of this offering.

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The following table sets forth information regarding options granted to our executive officers and directors during the year ended December 31, 2017:

Name

  Grant Date     Stock
Options
    Exercise
Price
  Expiration
Date

Dan Jacob Gelvan

  May 25, 2017     50,000   $ 4.00   May 25, 2027

Dan Jacob Gelvan

  November 2, 2017     8,750   $ 7.36   November 2, 2027

Chaim Hurvitz

  June 1, 2017     191,823   $ 3.92   June 1, 2027

Chaim Hurvitz

  November 2, 2017     18,750   $ 7.36   November 2, 2027

Anat Tsour Segal

  June 1, 2017     15,000   $ 3.92   June 1, 2027

Anat Tsour Segal

  November 2, 2017     18,750   $ 7.36   November 2, 2027

Eli Frydman

  November 2, 2017     18,750   $ 7.36   November 2, 2027

          Our Chief Executive Officer, Amir Weisberg, and our Chief Technology Officer, Noam Emanuel, each will receive a bonus payment in the amount of 1.0% of the net proceeds to be received by us in connection with this offering, and to our Chief Financial Officer, Dikla Czaczkes Akselbrad, will receive a bonus payment in the amount of 0.5% of the net proceeds to be received by us in connection with this offering, in each case excluding any funds received from our existing shareholders. Upon the closing of this offering, our Chief Operating Officer, Jack Eitan Kyiet, will receive a bonus payment equal to approximately $30,000. The following table sets forth information regarding options granted to certain executive officers and directors, which options shall terminate in the event that this offering has not occurred within 11 months of the grant date:

Name

  Grant Date     Stock
Options
    Exercise
Price
  Expiration
Date

Amir Weisberg

  November 2, 2017     162,500   $ 7.36   November 2, 2027

Dikla Czaczkes Akselbrad

  November 2, 2017     75,000   $ 7.36   November 2, 2027

Noam Emanuel

  November 2, 2017     162,500   $ 7.36   November 2, 2027

Jack Eitan Kyiet

  November 2, 2017     18,750   $ 7.36   November 2, 2027

Chaim Hurvitz

  June 1, 2017     127,882   $ 3.92   June 1, 2027

          Our board of directors has adopted, and our shareholders have approved, a compensation policy to be effective upon the consummation of this offering, which will provide for cash and equity compensation to be paid to our non-employee directors for their service on the board and its committees. Pursuant to the compensation policy, the maximum annual cash compensation to be paid for service on our board of directors is $40,000, or $60,000 for service as the chairperson of our board. In addition, pursuant to the compensation policy, we may also provide additional compensation for service on our board committees as follows: $7,500 for service on our audit committee, or $15,000 for service as the chairperson of our audit committee, and $5,000 for service on our compensation, nominating and corporate governance committee, or $10,000 for service as the chairperson of our compensation, nominating and corporate governance committee. In addition, we intend to award equity compensation in the form of options to each of our non-employee directors who are serving as of the consummation of this offering to purchase ordinary shares with an exercise price equal to the public offering price in this offering, and for newly appointed directors thereafter, to award equity compensation in the form of options to purchase ordinary shares with an exercise price equal to the fair market value of the shares on the date of grant. We further intend to award on an annual basis equity compensation in the form of options to purchase ordinary shares with an exercise price equal to the fair market value of the shares on the date of grant to each of our non-employee directors. The ordinary shares to be issued to our non-employee directors would be awarded under our 2012 Share Option Plan and the awards to be granted thereunder will be subject to the provisions thereof, including with respect to vesting and termination.

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          Other than with our Chief Executive Officer, Mr. Amir Weisberg, our Chief Technology Officer, Dr. Noam Emanuel, and our Chief Operating Officer, Mr. Jack Eitan Kyiet, we do not have written agreements with any director providing for benefits upon the termination of their employment with our company. See "— Agreements with Executive Officers."

Agreements with Executive Officers

          We currently have employment agreements with all of our executive officers. We contribute (usually following a trial period of three months) monthly amounts for the benefit and on behalf of all our employees located in Israel to a pension fund pursuant to Section 14 of Israel's Severance Pay Law. Employees covered by Section 14 are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by us. Payments in accordance with Section 14 release us from any future severance liabilities in respect of those employees. We do not set aside or accrue any additional amounts to provide pension, severance, retirement or other similar benefits or expenses. Our executive officers do not receive benefits upon the termination of their respective employment with us, other than benefits under Section 14.

Equity Incentive Plans

Amended and Restated 2012 Share Option Plan

          Our Amended and Restated 2012 Share Option Plan, or the 2012 Plan, was adopted by our board of directors on August 29, 2012 and amended on January 30, 2018. The 2012 Plan provides for the grant of options to our directors, employees, office holders, service providers and consultants. As of the date of this prospectus, a total of 898,473 shares are reserved but unissued under our 2012 Plan.

          The 2012 Plan is administered by our board of directors, which, on its own or upon the recommendation of a remuneration committee or any other similar committee of the board of directors, shall determine, subject to applicable law, the identity of grantees of awards and various terms of the grant. With respect to those grantees subject to Israeli taxation, the 2012 Plan provides for granting options in compliance with Section 102 of the Israeli Income Tax Ordinance, 1961, or the Ordinance, under the capital gains track, and for grants to non-employee Israeli service providers, consultants and shareholders who hold 10% or more of our total share capital or are otherwise controlling shareholders pursuant to section 3(i) of the Ordinance, as further detailed below.

          Section 102 of the Ordinance allows employees, directors and officers who are not controlling shareholders and are considered Israeli residents to receive favorable tax treatment for compensation in the form of shares or options. Our non-employee service providers and controlling shareholders may only be granted options under section 3(i) of the Ordinance, which does not provide for similar tax benefits. Section 102 includes two alternatives for tax treatment involving the issuance of options or shares to a trustee for the benefit of the grantees and also includes an additional alternative for the issuance of options or shares directly to the grantee. Section 102(b)(2) of the Ordinance, the most favorable tax treatment for the grantee, permits the issuance to a trustee under the "capital gain track." However, under this track we are not allowed to deduct an expense with respect to the issuance of the options or shares.

          Generally, options will not be exercisable before the first anniversary of the date of grant of options, with respect to the 33.0% of the option shares, and with respect to each additional 8.375% of the option shares, become exercisable at the end of each three-month period during the second and third years from the date of grant. Generally, options that are not exercised within ten years from the grant date shall expire.

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          Other than by will or laws of descent, neither the options nor any right in connection with such options are assignable or transferable. If we terminate a grantee's employment or service for cause, all of the grantee's vested and unvested options will expire on the date of termination. Also, and subject to applicable law, if the grantee's employment or services is terminated for cause, then the Company shall have a right of repurchase against any shares issued pursuant to the exercise of options. In the event that the Company shall exercise such right of repurchase, the Company shall pay such grantee for each such share being repurchased an amount equal to the price originally paid by the grantee for such share. Alternatively, the Company may assign such rights of repurchase to its shareholders pro rata to their respective holdings of the Company's issued and outstanding shares.

          If we are party to a merger or consolidation, outstanding options and shares acquired under the 2012 Plan will be subject to the agreement of merger or consolidation, which will provide for one or more of the following: (i) the assumption of such options by the surviving corporation or its parent, (ii) the substitution by the surviving corporation or its parent of new options, or (iii) in the event that the successor entity neither assumes nor substitutes all outstanding options, then each respective grantee shall have a period of 15 days to exercise his or her vested options, after which all remaining options, whether vested or not shall expire. For certain individuals, if their position is terminated within a certain period after the transaction, their options shall accelerate.

          In the event of any variation in our share capital, including a share dividend, share split, combination or exchange of shares, recapitalization, or any other like event, the number, class and kind of shares subject to the 2012 Plan and outstanding options, and the exercise prices of the options, will be appropriately and equitably adjusted so as to maintain the proportionate number of shares without changing the aggregate exercise price of the options.

          On January 30, 2018, our board of directors adopted an appendix to the 2012 Plan for U.S. residents, which was approved by the shareholders on February 8, 2018. Under this appendix, the 2012 Plan provides for the granting of options to U.S. residents in compliance with the U.S. Internal Revenue Code of 1986, as amended.

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PRINCIPAL SHAREHOLDERS

          The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of December 31, 2017 by:

    each person or entity known by us to own beneficially 5% or more of our outstanding ordinary shares;

    each of our directors and executive officers individually; and

    all of our directors and executive officers as a group.

          The beneficial ownership of our ordinary shares is determined in accordance with the rules of the SEC and generally includes any shares over which a person exercises sole or shared voting or investment power, or the right to receive the economic benefit of ownership. For purposes of the table below, we deem ordinary shares issuable pursuant to options that are currently exercisable or exercisable within 60 days of December 31, 2017 to be outstanding and to be beneficially owned by the person holding the options for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.

          The percentage of shares beneficially owned has been computed on the basis of 12,661,101 ordinary shares outstanding as of December 31, 2017, which reflects the assumed exercise for cash of all of our warrants to purchase Series A preferred shares and Series D-2 preferred shares and the subsequent conversion of all of our preferred shares into ordinary shares.

          As of December 31, 2017 and based on their reported registered office, 15 of our shareholders were U.S. persons, holding in aggregate approximately 13.6% of our outstanding ordinary shares immediately prior to this offering. We have also set forth below information known to us regarding any significant change in the percentage ownership of our ordinary shares by any major shareholders during the past three years. Except where otherwise indicated, we believe, based on information furnished to us by such owners, that the beneficial owners of the ordinary shares listed below have sole investment and voting power with respect to such shares.

          Certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of $19.5 million in ordinary shares in this offering at the initial public offering price per share. Based on an assumed initial public offering price of $22.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, these shareholders would purchase up to an aggregate of 866,667 of the 3,333,333 ordinary shares in this offering based on these indications of interest. However, because indications of interest are not binding agreements or commitments to purchase, these shareholders may determine to purchase more, less or no ordinary shares in this offering. It is also possible that these shareholders could indicate an interest in purchasing more ordinary shares. In addition, the underwriters could determine to sell fewer ordinary shares to any of these shareholders than the shareholders indicate an interest in purchasing or not to sell any ordinary shares to these shareholders. The following table does not reflect any potential purchases by these shareholders.

          Following the closing of this offering, all of our shareholders, including the shareholders listed below, will have the same voting rights attached to their ordinary shares, and neither our principal shareholders nor our directors and executive officers will have different or special voting rights with respect to their ordinary shares. See "Description of Share Capital — Voting Rights." A description of any material relationship that our principal shareholders have had with us or any of our predecessors or affiliates within the past three years is included under "Certain Relationships and Related Party Transactions."

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          Unless otherwise noted below, the address of each shareholder, director and executive officer is c/o PolyPid Ltd., 18 Hasivim Street, P.O. Box 7126 Petach Tikva, 4959376 Israel.

          Percentage of
ordinary
shares beneficially
owned
 

Name of beneficial owner

    Ordinary shares
beneficially owned
    Before
offering
    After
offering
 

5% or Greater Shareholders

                   

Aurum Ventures M.K.I. Ltd.(1)

    2,319,415     18.3 %   14.5 %

Shavit Capital Fund III (US), L.P.(2)

    1,154,500     9.1 %   7.2 %

Xenia Venture Capital Ltd.(3)

    773,460     6.1 %   4.8 %

Friendly Angels Club L.L.P.(4)

    722,442     5.7 %   4.5 %

Shirat Hachaim Ltd.(5)

    733,942     5.8 %   4.6 %

Directors and Executive Officers

   
 
   
 
   
 
 

Amir Weisberg(6)

    455,234     3.5 %   2.8 %

Dikla Czaczkes Akselbrad(7)

    45,669     *     *  

Chaim Hurvitz(8)

    778,131     5.9 %   4.9 %

Anat Tsour Segal(9)

    16,563     *     *  

Yechezkel Barenholz, Ph.D.(10)

    56,250     *     *  

Noam Emanuel, Ph.D.(11)

    563,227     4.3 %   3.5 %

Jack Eitan Kyiet.(12)

    757,702     5.7 %   4.7 %

Eli Frydman Ph.D.(13)

    1,563     *     *  

Dan Jacob Gelvan, Ph.D.(14)

    23,677     *     *  

Jacob Harel

             

All directors and executive officers as a group (10 persons)

    2,698,016     21.3 %   16.9 %

*
Indicates beneficial ownership of less than 1% of the total ordinary shares outstanding.

(1)
Consists of (i) 1,342,457 ordinary shares issuable upon conversion of preferred shares and (ii) 976,958 ordinary shares issuable upon exercise of outstanding warrants to purchase preferred shares and the automatic conversion thereof into ordinary shares. Cropwell Limited is the beneficial owner of the shares owned by Aurum Ventures M.K.I. Ltd. Cropwell Limited is owned in equal parts by Brock Nominees Limited and Tenby Nominees Limited, as nominees for Credit Suisse Trust as trustee of the MK Special Assets Trust, the sole beneficiary of which is The MK Trust, of which Morris Kahn is the sole beneficiary. The address of Aurum Ventures M.K.I. Ltd. is 16 Abba Hillel Silver Street, Aurec House, Ramat Gan, 52506 Israel. The percentage ownership of Aurum Ventures M.K.I. Ltd. increased from 4.7% in September 2014 to 18.3% in December 2017.

(2)
Consists of (i) 536,977 ordinary shares issuable upon conversion of preferred shares and (ii) 617,523 ordinary shares issuable upon exercise of outstanding warrants to purchase preferred shares and the automatic conversion thereof into ordinary shares. The general partner of Shavit Capital Fund III (US), L.P. is Shavit Capital Fund GP, L.P., which is managed by Shavit Capital Management 3 (GP) Ltd. in its capacity as the general partner. The controlling shareholder of Shavit Capital Management 3 (GP) Ltd. is Rosigal Consultancy and Investments Ltd., or Rosigal. The controlling shareholder of Rosigal is Gary Leibler. The address of Shavit Capital Fund III (US), L.P. is Jerusalem Technology Park, Building 1B, Box 70, Malha, Jerusalem, 96951 Israel. Shavit Capital Fund III (US), L.P. did not own any shares in September 2014.

(3)
Consists of (i) 717,210 ordinary shares issuable upon conversion of preferred shares and (ii) 56,250 ordinary shares issuable upon exercise of outstanding warrants to purchase preferred shares and the automatic conversion thereof into ordinary shares. Eli Sorzon is the chief executive officer of Xenia Venture Capital Ltd. The address of Xenia Venture Capital Ltd. is Igal Alon 76, Tel Aviv, Israel. The percentage ownership of Xenia Venture Capital Ltd decreased from 17.6% in September 2014 to 6.1% in December 2017.

(4)
Consists of (i) 692,482 ordinary shares issuable upon conversion of preferred shares and (ii) 29,960 ordinary shares issuable upon exercise of outstanding warrants to purchase preferred shares and the automatic conversion thereof

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    into ordinary shares. Eitan Kyiet is the beneficial owner of the shares owned by Friendly Angels Club L.L.P. The address of Friendly Angels Club L.L.P. is Haifa, 34987, Rehov Frank Peleg 6, Israel. The percentage ownership of Friendly Angels Club L.L.P. decreased from 13.5% in September 2014 to 5.7% in December 2017.

(5)
Consists of (i) 636,246 ordinary shares issuable upon conversion of preferred shares and (ii) 97,696 ordinary shares issuable upon exercise of outstanding warrants to purchase preferred shares and the automatic conversion thereof into ordinary shares. Chaim Hurvitz is the beneficial owner of Shirat Hachaim Ltd. The address of Shirat Hachaim Ltd. is 31 Yavne Street, Tel Aviv, Israel 65792. The percentage ownership of Shirat Hachaim Ltd. increased from 2.6% in September 2014 to 5.8% in December 2017.

(6)
Consists of (i) 153,205 ordinary shares issuable upon conversion of preferred shares and (ii) 302,029 ordinary shares issuable upon exercise of outstanding options.

(7)
Consists of 45,669 ordinary shares issuable upon exercise of outstanding options.

(8)
Consists of (i) 44,190 ordinary shares issuable upon exercise of outstanding options and (ii) beneficial ownership of the shares set forth in note 5 above held by Shirat Hachaim Ltd.

(9)
Consists of 16,563 ordinary shares issuable upon exercise of outstanding options.

(10)
Consists of 56,250 ordinary shares issuable upon exercise of outstanding options.

(11)
Consists of (i) 212,500 ordinary shares and (ii) 350,727 ordinary shares issuable upon exercise of outstanding options.

(12)
Consists of (i) 35,260 ordinary shares issuable upon exercise of outstanding options and (ii) beneficial ownership of the shares set forth in note 4 above held by Friendly Angels Club L.L.P.

(13)
Consists of 1,563 ordinary shares issuable upon exercise of outstanding options.

(14)
Consists of (i) 13,570 ordinary shares issuable upon conversion of preferred shares, (ii) 5,211 ordinary shares issuable upon exercise of outstanding warrants to purchase preferred shares and conversion thereof into ordinary shares and (iii) 4,896 ordinary shares issuable upon exercise of outstanding options.

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

          The following is a description of the material terms of those transactions with related parties to which we, or our subsidiaries, are party.

Participation in this Offering

          Certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of $19.5 million in ordinary shares in this offering at the initial public offering price per share. Based on an assumed initial public offering price of $22.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, these shareholders would purchase up to an aggregate of 866,667 of the 3,333,333 ordinary shares in this offering based on these indications of interest. However, because indications of interest are not binding agreements or commitments to purchase, these shareholders may determine to purchase more, less or no ordinary shares in this offering. It is also possible that these shareholders could indicate an interest in purchasing more ordinary shares. In addition, the underwriters could determine to sell fewer ordinary shares to any of these shareholders than the shareholders indicate an interest in purchasing or not to sell any ordinary shares to these shareholders.

Private Placements of our Securities

Sale of Series B Shares

          In December 2012, October 2013 and June 2014, we entered into share purchase agreements for the sale of Series B-1 preferred shares. In June 2014, we entered into a share purchase agreement with certain investors, including some of our directors, executive officers and holders of greater than 5% of our ordinary shares, pursuant to which we issued a total of 825,627 Series B-1 preferred shares for an aggregate price of $4.0 million, or the June 2014 Series B Private Placement. The following table sets forth the aggregate number of shares of Series B-1 preferred shares issued to our related parties in the June 2014 Series B Private Placement:

Participant
  Series B-1
Preferred Shares
 
 

Dan Jacob Gelvan

    8,256  

Friendly Angels Club L.L.P. 

    178,792  

Shirat Hachaim Ltd. 

    41,281  

Xenia Venture Capital Ltd. 

    88,560  

Yechezkel Berenholtz

    10,694  

Aurum Ventures M.K.I. Ltd. 

    206,407  

Sale of Series C Shares

          In June 2015, we entered into a share purchase agreement with certain investors, including holders of greater than 5% of our ordinary shares, pursuant to which we issued a total of 429,073 Series C-2 preferred shares for an aggregate price of $3.8 million, or the Series C Private Placement. The following table sets forth the aggregate number of shares of Series C-2 preferred shares issued to our related parties in the Series C Private Placement:

Participant
  Series C-2
Preferred Shares
 
 

Aurum Ventures M.K.I. Ltd. 

    56,639  

Dan Jacob Gelvan

    783  

Shirat Hachaim Ltd. 

    56,639  

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Sales of Series D Shares

          In February 2016, we entered into a share purchase agreement with certain investors, including holders of greater than 5% of our ordinary shares, pursuant to which we issued a total of 2,485,889 Series D-1 preferred shares for an aggregate price of $21.9 million, or the Series D-1 Private Placement. As part of the Series D-1 Private Placement, we also issued warrants to purchase up to 20,389 Series D-1 preferred shares, at an exercise price of $10.15 per share, and warrants to purchase up to 2,506,273 Series D-2 preferred shares, at an exercise price of $10.15 per share, or the Series D-2 Warrants. The Series D-2 Warrants provided for the issuance of additional warrants to purchase Series D-2 preferred shares, and an adjustment to the exercise price, if we did not complete an initial public offering in the United States by December 31, 2016. In January 2017, we issued additional warrants to purchase up to 375,942 Series D-2 preferred shares, at an exercise price of $8.83 per share, and the exercise price of the Series D-2 Warrants was reduced to $8.83 per share. The following table sets forth the aggregate number of shares of Series D-1 preferred shares and warrants to purchase Series D-2 preferred shares issued to our related parties in the Series D-1 Private Placement:

Participant
  Series D-1
Preferred Shares
 
  Series D-2
Warrants
 
 

Aurum Ventures M.K.I. Ltd. 

    849,529     976,958  

Dan Jacob Gelvan

    4,531     5,211  

Friendly Angels Club L.L.P. 

    26,052     29,960  

Shavit Capital Fund III (US), L.P. 

    536,977     617,523  

Shirat Hachaim Ltd. 

    84,953     97,696  

          In August 2016, we entered into a share purchase agreement with certain investors, including one of our holders of greater than 5% of our ordinary shares, pursuant to which we issued a total of 603,497 Series D-3 preferred shares for an aggregate price of $5.3 million, or the Series D-3 Private Placement. The following table sets forth the aggregate number of shares of Series D-3 preferred shares issued to our related parties in the Series D-3 Private Placement:

Participant
  Series D-3
Preferred Shares
 
 

Shirat Hachaim Ltd. 

    37,169  

Sale of Series E Shares

          In the third and fourth quarters of 2017, we entered into share purchase agreements with certain investors, including one of our holders of greater than 5% of our ordinary shares, pursuant to which we issued a total of 1,178,038 Series E preferred shares for an aggregate purchase price of $15.0 million, or the Series E Private Placement. The following table sets forth the aggregate number of shares of Series E preferred shares issued to our related parties in the Series E Private Placement:

Participant
  Series E
Preferred Shares
 
 

Shirat Hachaim Ltd. 

    110,986  

Convertible Loan Agreements

          In December 2014 and January 2015, we entered into convertible loan agreements with certain of our holders of greater than 5% of our ordinary shares, for an aggregate principal amount

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of $4.4 million, bearing an annual interest rate of 4.0%. The principal amount of the loan agreements and accrued interest converted automatically into 675,651 Series C-1 preferred shares upon the closing of the Series C Private Placement, or the Series C conversion. The following table sets forth the aggregate number of shares of Series C-2 preferred shares issued to our related parties pursuant to the Series C conversion:

Participant
  Original Loan
Amount
 
  Series C-1
Preferred Shares
Converted into
in June 2015
 
 

Aurum Ventures MKI Ltd. 

  $ 1,500,000     229,882  

Friendly Angels Club L.L.P. 

  $ 500,000     76,064  

Shirat Hachaim Ltd. 

  $ 1,500,000     230,602  

Investor Rights Agreement

          We are party to an amended and restated investor rights agreement, or the IRA, with certain of our shareholders. The IRA provides that certain holders of our ordinary shares have the right to demand that we file a registration statement or request that their ordinary shares be covered by a registration statement that we are otherwise filing. The registration rights are described in more detail under "Description of Share Capital — Registration Rights." All rights under the Registration Rights Agreement, other than the registration rights, will terminate upon the closing of this offering.

Agreements and Arrangements With, and Compensation of, Directors and Executive Officers

          Certain of our executive officers have employment agreements with the Company. These agreements will terminate at the closing of this offering and will be replaced by new employment agreements, which will contain customary provisions and representations, including confidentiality, non-competition, non-solicitation and inventions assignment undertakings by the executive officers. Under current applicable Israeli employment laws, we may not be able to enforce (either in whole or in part) covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees. See "Management — Compensation of Executive Officers and Directors."

Indemnification Agreements

          Our amended and restated articles of association permit us to exculpate, indemnify and insure each of our directors and office holders to the fullest extent permitted by the Israeli Companies Law. Upon the closing of this offering, we intend to enter into indemnification agreements with each of our directors and executive officers, undertaking to indemnify them to the fullest extent permitted by Israeli law, including with respect to liabilities resulting from a public offering of our shares, to the extent that these liabilities are not covered by insurance. We have also obtained directors and officers insurance for each of our executive officers and directors. For further information, see "Management — Exculpation, Insurance and Indemnification of Directors and Officers."

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DESCRIPTION OF SHARE CAPITAL

          The following descriptions of our share capital and provisions of our amended and restated articles of association which will be effective upon the closing of this offering are summaries and do not purport to be complete. A form of our amended and restated articles of association will be filed with the SEC as an exhibit to our registration statement, of which this prospectus forms a part. The description of the ordinary shares reflects changes to our capital structure that will occur upon the closing of this offering.

General

          Upon the closing of this offering, our authorized share capital will consist of NIS 35,000,000 divided into 43,750,000 ordinary shares, with a nominal value NIS 0.80 per share, of which             shares will be issued and outstanding (assuming that the underwriters do not exercise their option to purchase additional ordinary shares prior thereto).

          All of our outstanding ordinary shares are validly issued, fully paid and non-assessable. Our ordinary shares are not redeemable and do not have any preemptive rights.

          All ordinary shares have identical voting and other rights in all respects.

Registration Number and Purpose of the Company

          Our registration number with the Israeli Registrar of Companies is 514105923. Our purpose as set forth in our amended and restated articles of association is to engage in any lawful activity. Following the completion of this offering and the resulting registration of our shares for trading, our registration number is expected to change to reflect our becoming a public company.

Conversion of Preferred Shares

          Upon the closing of this offering, all of our preferred shares outstanding will automatically convert into ordinary shares, and will have no further preferences, privileges or priority rights of any kind.

Transfer of Shares

          Our fully paid ordinary shares are issued in registered form and may be freely transferred under our amended and restated articles of association, unless the transfer is restricted or prohibited by another instrument, applicable law or the rules of a stock exchange on which the shares are listed for trading. The ownership or voting of our ordinary shares by non-residents of Israel is not restricted in any way by our amended and restated articles of association or the laws of the State of Israel, except for ownership by nationals of some countries that are, or have been, in a state of war with Israel.

Election of Directors

          Our ordinary shares do not have cumulative voting rights for the election of directors. As a result, the holders of a majority of the voting power represented at a meeting of shareholders have the power to elect all of our directors.

          Under our amended and restated articles of association to be effective upon the closing of this offering, our board of directors must consist of at least five and not more than eleven directors. Our board of directors will consist of seven directors upon the closing of this offering.

          Pursuant to our amended and restated articles of association, each of our directors, will be appointed by a vote of the majority of the total voting power of our company, participating and

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voting at an annual general meeting of our shareholders. Each director will serve until the next annual general meeting following his or her election and his or her successor is duly elected and qualified or until his or her earlier death, resignation or removal by a vote of 65% of the total voting power of our company at a general meeting of our shareholders or until his or her office expires by operation of law. In addition, our amended and restated articles of association allow our board of directors to appoint directors to fill vacancies on the board of directors, including filling empty board seats up to the maximum number of directors permitted under our articles of association, to serve until the next annual general meeting of shareholders. Our amended and restated articles of association do not have a retirement age requirement for our directors.

Dividend and Liquidation Rights

          We may declare a dividend to be paid to the holders of our ordinary shares in proportion to their respective shareholdings. Under the Israeli Companies Law, dividend distributions are determined by the board of directors and do not require the approval of the shareholders of a company unless the company's articles of association provide otherwise. Our amended and restated articles of association do not require shareholder approval of a dividend distribution and provide that dividend distributions may be determined by our board of directors.

          Pursuant to the Israeli Companies Law, the distribution amount is limited to the greater of retained earnings or earnings generated over the previous two years, according to our then last reviewed or audited financial statements, provided that the end of the period to which the financial statements relate is not more than six months prior to the date of the distribution. If we do not meet such criteria, then we may distribute dividends only with court approval. In each case, we are only permitted to distribute a dividend if our board of directors and the court, if applicable, determines that there is no reasonable concern that payment of the dividend will prevent us from satisfying our existing and foreseeable obligations as they become due.

          In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of our ordinary shares in proportion to their shareholdings. This right, as well as the right to receive dividends, may be affected by the grant of preferential dividend or distribution rights to the holders of a class of shares with preferential rights that may be authorized in the future.

Exchange Controls

          There are currently no Israeli currency control restrictions on remittances of dividends on our ordinary shares, proceeds from the sale of the shares or interest or other payments to non-residents of Israel, except for shareholders who are subjects of countries that are, or have been, in a state of war with Israel.

Shareholder Meetings

          Under Israeli law, we are required to hold an annual general meeting of our shareholders once every calendar year that must be held no later than 15 months after the date of the previous annual general meeting. All meetings other than the annual general meeting of shareholders are referred to in our amended and restated articles of association as extraordinary meetings. Our board of directors may call extraordinary meetings whenever it sees fit, at such time and place, within or outside of Israel, as it may determine. In addition, the Israeli Companies Law provides that our board of directors is required to convene an extraordinary meeting upon the written request of (i) any two or more of our directors or one-quarter or more of the members of our board of directors, or (ii) one or more shareholders holding, in the aggregate, either (a) 5% or more of our

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outstanding issued shares and 1% of our outstanding voting power, or (b) 5% or more of our outstanding voting power.

          Subject to the provisions of the Israeli Companies Law and the regulations promulgated thereunder, shareholders entitled to participate and vote at general meetings are the shareholders of record on a date to be decided by the board of directors, which may be between four and 40 days prior to the date of the meeting. Furthermore, the Israeli Companies Law requires that resolutions regarding the following matters must be passed at a general meeting of our shareholders:

    amendments to our articles of association;

    appointment or termination of our auditors

    appointment of external directors (if applicable);

    approval of certain related party transactions;

    increases or reductions of our authorized share capital;

    a merger; and

    the exercise of our board of director's powers by a general meeting, if our board of directors is unable to exercise its powers and the exercise of any of its powers is required for our proper management.

          The Israeli Companies Law requires that a notice of any annual general meeting or extraordinary meeting be provided to shareholders at least 21 days prior to the meeting and if the agenda of the meeting includes the appointment or removal of directors, the approval of transactions with office holders or interested or related parties, or an approval of a merger, notice must be provided at least 35 days prior to the meeting.

          Under Israeli Companies Law, whenever we cannot convene or conduct a general meeting in the manner prescribed under the law or our articles of association, the court may, upon our, shareholders' or directors' request, order that we convene and conduct a general meeting in the manner the court deems appropriate.

Voting Rights

Quorum Requirements

          Pursuant to our amended and restated articles of association, holders of our ordinary shares have one vote for each ordinary share held on all matters submitted to a vote before the shareholders at a general meeting. As a foreign private issuer, the quorum required for our general meetings of shareholders consists of at least two shareholders present in person, by proxy or by other voting instrument in accordance with the Israeli Companies Law who hold or represent between them at least 331/3% of the total outstanding voting rights. A meeting adjourned for lack of a quorum is generally adjourned to the same day in the following week at the same time and place or to a later time or date if so specified in the notice of the meeting. At the reconvened meeting, any shareholder present in person or by proxy shall constitute a lawful quorum.

Vote Requirements

          Our amended and restated articles of association provide that all resolutions of our shareholders require a simple majority vote, unless otherwise required by the Israeli Companies Law or by our amended and restated articles of association. Under the Israeli Companies Law, among others, each of (i) the approval of an extraordinary transaction with a controlling

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shareholder, and (ii) the terms of employment or other engagement of the controlling shareholder of the company or such controlling shareholder's relative (even if such terms are not extraordinary) requires the approval described above under "Management — Approval of Related Party Transactions under Israeli Law — Fiduciary Duties of Directors and Executive Officers — Disclosure of Personal Interests of Controlling Shareholders and Approval of Certain Transactions." Additionally, (i) the approval and extension of a compensation policy and certain deviations therefrom require the approvals described above under "Management — Compensation Committee — Israeli Companies Law Requirements," and (ii) the terms of employment or other engagement of the chief executive officer of the company require the approvals described above under "Management — Disclosure of Personal Interests of an Office Holder and Approval of Certain Transactions." Under our amended and restated articles of association, (i) the removal of a director from office requires the adoption of a resolution at a general meeting of shareholders by 65% of the total voting power of our company; and (ii) the alteration of the rights, privileges, preferences or obligations of any class of our shares requires a simple majority of the class so affected (or such other percentage of the relevant class that may be set forth in the governing documents relevant to such class), in addition to the ordinary majority vote of all classes of shares voting together as a single class at a shareholder meeting.

          Further exceptions to the simple majority vote requirement are a resolution for the voluntary winding up, or an approval of a scheme of arrangement or reorganization, of the company pursuant to Section 350 of the Israeli Companies Law, that governs the settlement of debts and reorganization of a company, which requires the approval of holders of 75% of the voting rights represented at the meeting and voting on the resolution.

Access to Corporate Records

          Under the Israeli Companies Law, shareholders are provided access to: minutes of our general meetings; our shareholders register and principal shareholders register, articles of association and annual audited financial statements; and any document that we are required by law to file publicly with the Israeli Companies Registrar or the Israel Securities Authority. In addition, shareholders may request to be provided with any document related to an action or transaction requiring shareholder approval under the related party transaction provisions of the Israeli Companies Law. We may deny this request if we believe it has not been made in good faith or if such denial is necessary to protect our interest or protect a trade secret or patent.

Modification of Class Rights

          Under the Israeli Companies Law and our amended and restated articles of association, the rights attached to any class of shares, such as voting, liquidation and dividend rights, may be amended by adoption of a resolution by the holders of a majority of the shares of that class present at a separate class meeting, or otherwise in accordance with the rights attached to such class of shares, as set forth in our amended and restated articles of association.

Registration Rights

          We are party to the IRA with certain of our shareholders. Under the IRA, holders of a total of 12,076,950 of our ordinary shares will have the right to require us to register their ordinary shares under the Securities Act under specified circumstances and will have incidental registration rights as described below.

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Demand Registration Rights

          At any time beginning six months after the consummation of this offering, the holders of at least 50% of the registrable securities then outstanding may request that we file a registration statement (including, once we are eligible to use Form F-3, which we anticipate will occur twelve months following the consummation of this offering, a registration of the sale of their shares on a delayed or continuous basis under Form F-3, and in such case pursuant to a demand of at least 50% of the registrable securities then outstanding held by at least two classes of holders) with respect to the registrable securities held by them. This demand right is subject to an anticipated aggregate offering price, net of selling expenses, of at least $4.0 million in an ordinary demand registration and $1.0 million for a registration on Form F-3. Upon receipt of such registration request, we are obligated to use our best efforts to effect, as soon as practicable, the registration under the Securities Act of all registrable securities that the Holders request to be registered. Our shareholders have the right to utilize their demand rights up to two times for an ordinary demand and up to two times for registration on Form F-3.

          We will not be obligated to file a registration statement at any such time if in the good faith judgment of our board of directors (as reflected in a certificate delivered by our chief executive officer or the chairman of our board of directors), such registration would be seriously detrimental to our company, provided that we do not use that exemption more than once in any 12 month period. We also have the right not to effect or take any action to effect a registration statement during the period starting with the date 60 days prior to our good faith estimate of the date of the filing of, and ending on a date 180 days following the effective date of, a Company-initiated registration statement.

Piggyback Registration Rights

          In addition, if we register any of our ordinary shares in connection with the public offering of such securities solely for cash, the holders of all registrable securities are entitled to notice of the registration and to include all or a portion of their registrable securities in the registration. If the public offering that we are effecting is underwritten, the right of any shareholder to include shares in the registration related thereto is conditioned upon the shareholder accepting the terms of the underwriting as agreed between us and the underwriters. Each shareholder may furthermore only include such quantity of registrable securities as the underwriters in their sole discretion determine will not jeopardize the success of our offering.

Expenses

          We will pay all registration expenses (other than underwriting discounts and selling commissions) and the reasonable fees and expenses of a single counsel for the selling shareholders, related to any demand or piggyback registration.

Acquisitions under Israeli Law

Full Tender Offer

          A person wishing to acquire shares of an Israeli public company and who would as a result hold over 90% of the target company's issued and outstanding share capital is required by the Israeli Companies Law to make a tender offer to all of the company's shareholders for the purchase of all of the issued and outstanding shares of the company. A person wishing to acquire shares of a public Israeli company and who would as a result hold over 90% of the issued and outstanding share capital of a certain class of shares is required to make a tender offer to all of the shareholders who hold shares of the relevant class for the purchase of all of the issued and outstanding shares of that class. If the shareholders who do not accept the offer hold less than 5%

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of the issued and outstanding share capital of the company or of the applicable class, and more than half of the shareholders who do not have a personal interest in the offer accept the offer, all of the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However, a tender offer will also be accepted if the shareholders who do not accept the offer hold less than 2% of the issued and outstanding share capital of the company or of the applicable class of shares.

          Upon a successful completion of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder accepted the tender offer or not, may, within six months from the date of acceptance of the tender offer, petition an Israeli court to determine whether the tender offer was for less than fair value and that the fair value should be paid as determined by the court. However the offeror may include in the terms of the tender offer that an offeree who accepted the offer will not be entitled to petition the Israeli court as described above.

          If (i) the shareholders who did not respond or accept the tender offer hold at least 5% of the issued and outstanding share capital of the company or of the applicable class or the shareholders who accept the offer constitute less than a majority of the offerees that do not have a personal interest in the acceptance of the tender offer, or (ii) the shareholders who did not accept the tender offer hold 2% or more of the issued and outstanding share capital of the company (or of the applicable class), the acquirer may not acquire shares from shareholders who accepted the tender offer that will increase its holdings to more than 90% of the company's issued and outstanding share capital or of the applicable class.

Special Tender Offer

          The Israeli Companies Law provides that, subject to certain exceptions, an acquisition of shares of an Israeli public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of 25% or more of the voting rights in the company. This requirement does not apply if there is already another holder of at least 25% of the voting rights in the company. Similarly, the Israeli Companies Law provides that, subject to certain exceptions, an acquisition of shares in a public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of more than 45% of the voting rights in the company, if there is no other shareholder of the company who holds more than 45% of the voting rights in the company.

          A special tender offer must be extended to all shareholders of a company. A special tender offer may be consummated only if (i) the offeror acquired shares representing at least 5% of the voting power in the company and (ii) the number of shares tendered by shareholders who accept the offer exceeds the number of shares held by shareholders who object to the offer (excluding the offeror, controlling shareholders, holders of 25% or more of the voting rights in the company or any person having a personal interest in the acceptance of the tender offer or any of their relatives or any entity controlled by them). If a special tender offer is accepted, then the purchaser or any person or entity controlling it or under common control with the purchaser or such controlling person or entity may not make a subsequent tender offer for the purchase of shares of the target company and may not enter into a merger with the target company for a period of one year from the date of the offer, unless the purchaser or such person or entity undertook to effect such an offer or merger in the initial special tender offer. Shares purchased in contradiction to the tender offer rules under the Israeli Companies Law, will have no rights and will become dormant shares.

Merger

          The Israeli Companies Law permits merger transactions if approved by each party's board of directors and, unless certain requirements described under the Israeli Companies Law are met, by

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a majority vote of each party's shareholders. In the case of the target company, approval of the merger further requires a majority vote of each class of its shares.

          For purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the votes of shares represented at the meeting of shareholders that are held by parties other than the other party to the merger, or by any person (or group of persons acting in concert) who holds (or hold, as the case may be) 25% or more of the voting rights or the right to appoint 25% or more of the directors of the other party, vote against the merger. If, however, the merger involves a merger with a company's own controlling shareholder or if the controlling shareholder has a personal interest in the merger, then the merger is instead subject to the same Special Majority approval that governs all extraordinary transactions with controlling shareholders (as described under "Management — Approval of Related Party Transactions under Israeli Law — Disclosure of Personal Interests of Controlling Shareholders and Approval of Certain Transactions").

          If the transaction would have been approved by the shareholders of a merging company but for the separate approval of each class or the exclusion of the votes of certain shareholders as provided above, a court may still approve the merger upon the petition of holders of at least 25% of the voting rights of a company. For such petition to be granted, the court must find that the merger is fair and reasonable, taking into account the respective values assigned to each of the parties to the merger and the consideration offered to the shareholders of the target company.

          Upon the request of a creditor of either party to the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that, as a result of the merger, the surviving company will be unable to satisfy the obligations of the merging entities, and may further give instructions to secure the rights of creditors.

          In addition, a merger may not be consummated unless at least 50 days have passed from the date on which a proposal for approval of the merger is filed with the Israeli Registrar of Companies and at least 30 days have passed from the date on which the merger was approved by the shareholders of each party.

Anti-Takeover Measures under Israeli Law

          The Israeli Companies Law allows us to create and issue shares having rights different from those attached to our ordinary shares, including shares providing certain preferred rights with respect to voting, distributions or other matters and shares having preemptive rights. As of the closing of this offering, no preferred shares will be authorized under our amended and restated articles of association. In the future, if we do authorize, create and issue a specific class of preferred shares, such class of shares, depending on the specific rights that may be attached to it, may have the ability to frustrate or prevent a takeover or otherwise prevent our shareholders from realizing a potential premium over the market value of their ordinary shares. The authorization and designation of a class of preferred shares will require an amendment to our amended and restated articles of association, which requires the prior approval of the holders of a majority of the voting power attaching to our issued and outstanding shares and voting at a general meeting. The convening of the meeting, the shareholders entitled to participate and the majority vote required to be obtained at such a meeting will be subject to the requirements set forth in the Israeli Companies Law as described above in "— Voting Rights."

Borrowing Powers

          Pursuant to the Israeli Companies Law and our amended and restated articles of association, our board of directors may exercise all powers and take all actions that are not required under law

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or under our amended and restated articles of association to be exercised or taken by our shareholders, including the power to borrow money for company purposes.

Changes in Capital

          Our amended and restated articles of association enable us to increase or reduce our share capital. Any such changes are subject to the provisions of the Israeli Companies Law and must be approved by a resolution duly passed by our shareholders at a general meeting by voting on such change in the capital. In addition, transactions that have the effect of reducing capital, such as the declaration and payment of dividends in the absence of sufficient retained earnings or profits, require the approval of both our board of directors and an Israeli court.

Transfer Agent and Registrar

          The transfer agent and registrar for our ordinary shares is American Stock Transfer & Trust Company, LLC. Its address is 6201 15th Avenue, Brooklyn, NY 11219.

Listing

          Application has been made to have our ordinary shares listed on The Nasdaq Global Market under the symbol "POLY."

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SHARES ELIGIBLE FOR FUTURE SALE

          Prior to this offering, no public market existed for our ordinary shares. Sales of substantial amounts of our ordinary shares following this offering, or the perception that these sales could occur, could adversely affect prevailing market prices of our ordinary shares and could impair our future ability to obtain capital, especially through an offering of equity securities. Assuming that the underwriters do not exercise in full their option to purchase additional ordinary shares with respect to this offering and assuming no exercise of options outstanding following this offering, we will have an aggregate of 13,112,219 ordinary shares outstanding upon the closing of this offering. Of these shares, the ordinary shares sold in this offering will be freely tradable without restriction or further registration under the Securities Act, unless purchased by "affiliates" (as that term is defined under Rule 144 of the Securities Act, or Rule 144), who may sell only the volume of shares described below and whose sales would be subject to additional restrictions described below.

          The remaining ordinary shares will be held by our existing shareholders and will be deemed to be "restricted securities" under Rule 144. Subject to certain contractual restrictions, including the lock-up agreements described below, restricted securities may only be sold in the public market pursuant to an effective registration statement under the Securities Act or pursuant to an exemption from registration under Rule 144, Rule 701 or Rule 904 under the Securities Act. These rules are summarized below. Sales of these shares in the public market after the restrictions under the lock-up agreements lapse, or the perception that those sales may occur, could cause the prevailing market price of our ordinary shares to decrease or to be lower than it might be in the absence of those sales or perceptions.

Eligibility of Restricted Shares for Sale in the Public Market

          Approximately 9,722,636 of our ordinary shares will be eligible for resale pursuant to Rule 144 after 90 days following the pricing of this offering as follows:

    with respect to non-affiliates of our company who will hold an aggregate of 8,014,633 ordinary shares upon the consummation of this offering, following the expiration of a non-affiliate's six-month holding period and subject to our compliance with the current public information requirements under Rule 144; and

    with respect to affiliates of our company who will hold an aggregate of 1,708,003 ordinary shares upon the consummation of this offering, following the expiration of an affiliate's six-month holding period and subject to our compliance with the current public information requirements under Rule 144, and subject to the volume, manner of sale and other limitations under Rule 144 applicable to securities held by affiliates.

          In each case, the shares will also be subject to the contractual restrictions arising under the lock-up agreements described below.

          All of the ordinary shares sold in this offering will be eligible for immediate sale upon the closing of this offering. Certain of our existing shareholders have indicated an interest in purchasing up to an aggregate of $19.5 million in ordinary shares in this offering at the initial public offering price per share. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters may determine to sell more, less or no shares in this offering to any of these shareholders, or any of these shareholders may determine to purchase more, less or no shares in this offering.

Lock-Up Agreements

          We, all of our directors and executive officers and holders of substantially all of our outstanding shares and our shares issuable upon the exercise of options and warrants have signed

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lock-up agreements. Pursuant to such lock-up agreements, such persons have agreed, subject to certain exceptions, not to sell or otherwise dispose of ordinary shares or any securities convertible into or exchangeable for ordinary shares for a period of 180 days after the date of this prospectus without the prior written consent of Goldman Sachs & Co. LLC and Cowen and Company, LLC. Goldman Sachs & Co. LLC and Cowen and Company, LLC may, in their sole discretion, at any time without prior notice, release all or any portion of the ordinary shares from the restrictions in any such agreement.

Rule 144

Shares Held for Six Months

          In general, under Rule 144 as currently in effect, and subject to the terms of any lock-up agreement, commencing 90 days after the closing of this offering, a person (or persons whose shares are aggregated), including an affiliate, who has beneficially owned our ordinary shares for six months or more, including the holding period of any prior owner other than one of our affiliates (i.e., commencing when the shares were acquired from our company or from an affiliate of our company as restricted securities), is entitled to sell our shares, subject to the availability of current public information about us. In the case of an affiliate shareholder, the right to sell is also subject to the fulfillment of certain additional conditions, including manner of sale provisions and notice requirements, and to a volume limitation that limits the number of shares to be sold thereby, within any three-month period, to the greater of:

    1% of the number of ordinary shares then outstanding; or

    the average weekly trading volume of our ordinary shares on the Nasdaq Global Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

          The six month holding period of Rule 144 does not apply to sales of unrestricted securities. Accordingly, persons who hold unrestricted securities may sell them under the requirements of Rule 144 described above without regard to the six-month holding period, even if they were considered our affiliates at the time of the sale or at any time during the ninety days preceding such date.

Shares Held by Non-Affiliates for One Year

          Under Rule 144 as currently in effect, a person (or persons whose shares are aggregated) who is not considered to have been one of our affiliates at any time during the 90 days preceding a sale and who has beneficially owned the shares proposed to be sold for at least one year, including the holding period of any prior owner other than one of our affiliates, is entitled to sell his, her or its shares under Rule 144 without complying with the provisions relating to the availability of current public information or with any other conditions under Rule 144. Therefore, unless subject to a lock-up agreement or otherwise restricted, such shares may be sold immediately upon the closing of this offering.

Rule 701

          In general, under Rule 701, any of our employees, directors, officers, consultants or advisors who received or purchased ordinary shares from us under our 2012 Plan or other written agreement before the closing of this offering is entitled to resell these shares.

          The SEC has indicated that Rule 701 will apply to typical share options granted by an issuer before it becomes subject to the reporting requirements of the Exchange Act, along with the shares acquired upon exercise of these options, including exercises after the closing of this offering.

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Securities issued in reliance on Rule 701 are restricted securities and, subject to the contractual restrictions described above (see "Lock-Up Agreements"), may be sold beginning 90 days after the closing of this offering in reliance on Rule 144 by:

    persons other than affiliates, without restriction; and

    affiliates, subject to the manner-of-sale, current public information and filing requirements of Rule 144, in each case, without compliance with the six-month holding period requirement of Rule 144.

Options

          As of December 31, 2017, options to purchase a total of 2,019,001 ordinary shares were issued and outstanding under our 2012 Plan. Of the total number of issued and outstanding options, 1,203,114 will be vested upon the closing of this offering. See "Management — Equity Incentive Plans — 2012 Share Option Plan." All of our ordinary shares issuable under these options are subject to contractual lock-up agreements with us or the underwriters.

Form S-8 Registration Statement

          Following the completion of this offering, we intend to file a registration statement on Form S-8 under the Securities Act to register up to 2,219,443 ordinary shares, in the aggregate, issued or reserved for issuance under the 2018 Plan. The registration statement on Form S-8 will become effective automatically upon filing.

          Ordinary shares issued upon exercise of a share option and registered pursuant to the Form S-8 registration statement will, subject to vesting provisions and Rule 144 volume limitations applicable to our affiliates, be available for sale in the open market immediately unless they are subject to the 180 day lock-up period or, if subject to the lock-up, immediately after the 180 day lock-up period expires. See "Management — Equity Incentive Plan — 2012 Share Option Plan."

Registration Rights

          Following the closing of this offering, holders of a total of 12,076,950 ordinary shares will have the right to require us to register these shares under the Securities Act under specified circumstances and will have incidental registration rights. After registration pursuant to these rights, these shares will become freely tradable without restriction under the Securities Act. For more information on these registration rights, see "Description of Share Capital — Registration Rights."

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TAXATION

          The following description is not intended to constitute a complete analysis of all tax consequences relating to the acquisition, ownership and disposition of our ordinary shares. You should consult your own tax advisor concerning the tax consequences in your particular situation, as well as any tax consequences that may arise under the laws of any state, local, foreign or other taxing jurisdiction.

Material Israeli Tax Considerations

          The following is a summary of the material Israeli income tax laws applicable to us. This section also contains a discussion of material Israeli income tax considerations concerning the ownership and disposition of our ordinary shares by holders that purchase ordinary shares pursuant to the offering and hold such ordinary shares as capital assets. This summary does not discuss all the aspects of Israeli income tax law that may be relevant to a particular investor in light of his or her personal investment circumstances or to some types of investors subject to special treatment under Israeli law. Examples of this kind of investor include residents of Israel or traders in securities who are subject to special tax regimes not covered in this discussion. To the extent that the discussion is based on new tax legislation that has not yet been subject to judicial or administrative interpretation, we cannot assure you that the appropriate tax authorities or the courts will accept the views expressed in this discussion. This summary is based on laws and regulations in effect as of the date of this prospectus and does not take into account possible future amendments which may be under consideration.

General Corporate Tax Structure in Israel

          As of January 1, 2017, Israeli resident companies like us are generally subject to corporate tax at the rate of 24.0%. As of January 1, 2018, the corporate tax rate will be reduced to 23.0%.

          Capital gains derived by an Israeli resident company are generally subject to tax at the same rate as the corporate tax rate. Under Israeli tax legislation, a corporation will be considered as an "Israeli resident" if it meets one of the following: (a) it was incorporated in Israel; or (b) the control and management of its business are exercised in Israel.

Taxation of our Israeli Individual Shareholders on Receipt of Dividends

          Israeli residents who are individuals are generally subject to Israeli income tax for dividends paid on our ordinary shares (other than bonus shares or share dividends) at a rate of 25.0%, or 30.0% if the recipient of such dividend is a "substantial shareholder" (as defined below) at the time of distribution or at any time during the preceding 12-month period.

          As of January 1, 2017, an additional income tax at a rate of 3.0% is imposed on high earners whose annual taxable income or gain exceeds NIS 640,000.

          A "substantial Shareholder" is generally a person who alone, or together with his or her relative or another person who collaborates with him on a regular basis, holds, directly or indirectly, at least 10.0% of any of the "means of control" of the corporation. "Means of control" generally include the right to vote in a general meeting of shareholders, receive profits, nominate a director or an officer, receive assets upon liquidation, or instruct someone who holds any of the aforesaid rights regarding the manner in which he or she is to exercise such right(s), and whether by virtue of shares, rights to shares or other rights, or in any other manner, including by means of voting or trusteeship agreements.

          The term "Israeli resident" for individuals is generally defined under the Israeli Income Tax Ordinance [New Version], 1961, or the Israeli Tax Ordinance, as an individual whose center of life is

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in Israel. According to the Israeli Tax Ordinance, in order to determine the center of life of an individual, account will be taken of the individual's family, economic and social connections, including: (a) the place of the individual's permanent home; (b) the place of residence of the individual and the individual's family; (c) the place of the individual's regular or permanent place of business or the place of the individual's permanent employment; (d) place of the individual's active and substantial economic interests; (e) place of the individual's activities in organizations, associations and other institutions. The center of life of an individual will be presumed to be in Israel if: (a) the individual was present in Israel for 183 days or more in the tax year; or (b) the individual was present in Israel for 30 days or more in the tax year, and the total period of the individual's presence in Israel in that tax year and the two previous tax years is 425 days or more. The presumption in this paragraph may be rebutted either by the individual or by the assessing officer.

Taxation of Israeli Resident Corporations on Receipt of Dividends

          Israeli resident corporations are generally exempt from Israeli corporate income tax with respect to dividends paid on our ordinary shares unless the distribution is from a Preferred Enterprise, as defined below.

Capital Gains Taxes Applicable to Israeli Resident Shareholders

          The income tax rate applicable to Real Capital Gain derived by an Israeli individual from the sale of shares which had been purchased after January 1, 2012, whether listed on a stock exchange or not, is 25.0%. However, if such shareholder is considered a "Substantial Shareholder" (as defined above) at the time of sale or at any time during the preceding 12-month period, such gain will be taxed at the rate of 30.0%. As of January 1, 2017, an additional income tax at a rate of 3% will be imposed on high earners whose annual taxable income or gain exceeds NIS 640,000.

          Moreover, capital gains derived by a shareholder who is a dealer or trader in securities, or to whom such income is otherwise taxable as ordinary business income, are taxed in Israel at ordinary income rates (currently, up to 50.0% for individuals and as of January 1, 2017, the corporate tax rate is 24.0% and as of January 1, 2018, the corporate tax rate should be reduced to 23.0%).

Taxation of Non-Israeli Shareholders on Receipt of Dividends

          Non-Israeli residents are generally subject to Israeli income tax on the receipt of dividends paid on our ordinary shares at the rate of 25.0% (or 30.0% for individuals, if such individual is a "substantial shareholder" at the time receiving the dividend or on any date in the 12 months preceding such date), which tax will be withheld at source, unless a tax certificate is obtained from the Israeli Tax Authority authorizing withholding-exempt remittances or a reduced rate of tax pursuant to an applicable tax treaty.

          A non-Israeli resident who receives dividends from which tax was withheld is generally exempt from the duty to file tax returns in Israel in respect of such income, provided such income was not derived from a business conducted in Israel by such taxpayer, and such taxpayer has no other taxable sources of income in Israel.

          For example, under the Convention Between the Government of the United States of America and the Government of Israel with Respect to Taxes on Income, as amended, Israeli withholding tax on dividends paid to a U.S. resident for treaty purposes may not, in general, exceed 25.0%, or 15.0% in the case of dividends paid out of the profits of an Approved Enterprise, subject to certain conditions. Where the recipient is a U.S. corporation owning 10.0% or more of the issued and outstanding voting shares of the paying corporation during the part of the paying corporation's taxable year which precedes the date of payment of the dividend and during the whole of its prior

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taxable year (if any) and not more than 25.0% of the gross income of the paying corporation for such prior taxable year (if any) consists of certain interest or dividends and the dividend is not paid from the profits of an Approved Enterprise, the Israeli tax withheld may not exceed 12.5%, subject to certain conditions.

Capital Gains Income Taxes Applicable to Non-Israeli Shareholders

          Provided certain conditions are met, non-Israeli resident shareholders are generally exempt from Israeli capital gains tax on any gains derived from the sale, exchange or disposition of our ordinary shares, provided that such gains were not derived from a permanent establishment or business activity of such shareholders in Israel. However, non-Israeli corporations' shareholders will not be entitled to the foregoing exemptions if Israeli residents (i) have a controlling interest of more than 25.0% in such non-Israeli corporation or (ii) are the beneficiaries of or are entitled to 25.0% or more of the revenues or profits of such non-Israeli corporation, whether directly or indirectly.

          Regardless of whether shareholders may be liable for Israeli income tax on the sale of our ordinary shares, the payment of the consideration may be subject to withholding of Israeli tax at the source. Accordingly, shareholders may be required to demonstrate that they are exempt from tax on their capital gains in order to avoid withholding at source at the time of sale.

Tax Benefits Under the 2011 Amendment

          On January 1, 2011, new legislation amending the Investment Law came into effect, or the 2011 Amendment. The 2011 Amendment introduced a new status of Preferred Enterprise replacing the existing status of "Benefited Enterprise." A Preferred Enterprise entitles the company to corporate tax rates without limitations on dividends and other distributions instead of full exemption from corporate tax. These preferred corporate tax rates vary from 7.5% for Preferred Enterprises residing in a "development zone," or 16.0% for Preferred Enterprises residing in other zones in Israel.

          In order to gain the status of Preferred Enterprise, a company must be an industrial company and at least 25.0% out of its revenues must derive from export to countries with population exceeding 14 million people.

Estate Tax

          Currently, Israeli law does not impose estate taxes.

Material U.S. Federal Income Tax Consequences to U.S. Holders

          The following discussion describes the material U.S. federal income tax considerations relating to the ownership and disposition of our ordinary shares by U.S. Holders (as defined below). This discussion applies to U.S. Holders that purchase ordinary shares pursuant to the offering and hold such ordinary shares as capital assets within the meaning of Section 1221 of the Code. This discussion is based on the U.S. Internal Revenue Code of 1986, as amended, or the Code, U.S. Treasury regulations promulgated thereunder and administrative and judicial interpretations thereof, all as in effect on the date hereof and all of which are subject to change, possibly with retroactive effect. This discussion does not address all of the U.S. federal income tax consequences that may be relevant to specific U.S. Holders in light of their particular circumstances or to U.S. Holders subject to special treatment under U.S. federal income tax law (such as certain financial institutions, insurance companies, broker-dealers and traders in securities or other persons that generally mark their securities to market for U.S. federal income tax purposes, tax-exempt entities, retirement plans, regulated investment companies, real estate investment trusts, certain former citizens or residents of the United States, persons who hold ordinary shares as part of a "straddle," "hedge," "conversion

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transaction," "synthetic security" or integrated investment, persons who received their ordinary shares as compensatory payments, persons that have a "functional currency" other than the U.S. dollar, persons that own directly, indirectly or through attribution 10% or more of our shares by vote or value, persons subject to special tax accounting rules as a result of any item of gross income with respect to the shares being taken into account in an applicable financial statement, corporations that accumulate earnings to avoid U.S. federal income tax, partnerships and other pass-through entities, and investors in such pass-through entities). This discussion does not address any U.S. state or local or non-U.S. tax consequences or any U.S. federal estate, gift or alternative minimum tax consequences.

          As used in this discussion, the term "U.S. Holder" means a beneficial owner of ordinary shares that is, for U.S. federal income tax purposes, (1) an individual who is a citizen or resident of the United States, (2) a corporation (or entity treated as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the United States, any state thereof, or the District of Columbia, (3) an estate the income of which is subject to U.S. federal income tax regardless of its source or (4) a trust (x) with respect to which a court within the United States is able to exercise primary supervision over its administration and one or more United States persons have the authority to control all of its substantial decisions or (y) that has elected under applicable U.S. Treasury regulations to be treated as a domestic trust for U.S. federal income tax purposes.

          If an entity or arrangement treated as a partnership for U.S. federal income tax purposes holds ordinary shares, the U.S. federal income tax consequences relating to an investment in the ordinary shares will depend in part upon the status and activities of such entity or arrangement and the particular partner. Any such entity or arrangement should consult its own tax advisor regarding the U.S. federal income tax consequences applicable to it and its partners of the purchase, ownership and disposition of ordinary shares.

          Persons considering an investment in ordinary shares should consult their own tax advisors as to the particular tax consequences applicable to them relating to the purchase, ownership and disposition of ordinary shares, including the applicability of U.S. federal, state and local tax laws and non-U.S. tax laws.

Passive Foreign Investment Company Consequences

          In general, a corporation organized outside the United States will be treated as a passive foreign investment company, or PFIC, for any taxable year in which either (1) at least 75% of its gross income is "passive income", the PFIC income test, or (2) on average at least 50% of its assets, determined on a quarterly basis, are assets that produce passive income or are held for the production of passive income, the PFIC asset test. Passive income for this purpose generally includes, among other things, dividends, interest, royalties, rents, and gains from the sale or exchange of property that gives rise to passive income. Assets that produce or are held for the production of passive income generally include cash, even if held as working capital or raised in a public offering, marketable securities, and other assets that may produce passive income. Generally, in determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account.

          Our status as a PFIC will depend on the nature and composition of our income and the nature, composition and value of our assets (which, assuming we are not a "controlled foreign corporation," or a CFC, under Section 957(a) of the Internal Revenue Code of 1986, as amended, or the Code, for the year being tested, may be determined based on the fair market value of each asset, with the value of goodwill and going concern value being determined in large part by reference to the market value of our common shares, which may be volatile). Based upon the

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expected value of our assets, including any goodwill and the expected nature and composition of our income and assets, we may be classified as a PFIC for the taxable year ended December 31, 2018 and future taxable years. In particular, so long as we do not generate revenue from operations for any taxable year and do not receive any research and development grants, or even if we receive a research and development grant, if such grant does not constitute gross income for U.S. federal income tax purposes, we likely will be classified as a PFIC for such taxable year. Even if we determine that we are not a PFIC for a taxable year, there can be no assurance that the IRS will agree with our conclusion and that the IRS would not successfully challenge our position. Our status as a PFIC is a fact-intensive determination made on an annual basis after the end of each taxable year. Accordingly, our U.S. counsel expresses no opinion with respect to our PFIC status for our taxable year ending December 31, 2018, and also expresses no opinion with regard to our expectations regarding our PFIC status in the future.

          If we are a PFIC in any taxable year during which a U.S. Holder owns ordinary shares, the U.S. Holder could be liable for additional taxes and interest charges under the "PFIC excess distribution regime" upon (1) a distribution paid during a taxable year that is greater than 125% of the average annual distributions paid in the three preceding taxable years, or, if shorter, the U.S. Holder's holding period for the ordinary shares, and (2) any gain recognized on a sale, exchange or other disposition, including a pledge, of the ordinary shares, whether or not we continue to be a PFIC. Under the PFIC excess distribution regime, the tax on such distribution or gain would be determined by allocating the distribution or gain ratably over the U.S. Holder's holding period for ordinary shares. The amount allocated to the current taxable year (i.e., the year in which the distribution occurs or the gain is recognized) and any year prior to the first taxable year in which we are a PFIC will be taxed as ordinary income earned in the current taxable year. The amount allocated to other taxable years will be taxed at the highest marginal rates in effect for individuals or corporations, as applicable, to ordinary income for each such taxable year, and an interest charge, generally applicable to underpayments of tax, will be added to the tax.

          If we are a PFIC for any year during which a U.S. Holder holds ordinary shares, we must generally continue to be treated as a PFIC by that holder for all succeeding years during which the U.S. Holder holds the ordinary shares, unless we cease to meet the requirements for PFIC status and the U.S. Holder makes a "deemed sale" election with respect to the ordinary shares. If the election is made, the U.S. Holder will be deemed to sell the ordinary shares it holds at their fair market value on the last day of the last taxable year in which we qualified as a PFIC, and any gain recognized from such deemed sale would be taxed under the PFIC excess distribution regime. After the deemed sale election, the U.S. Holder's ordinary shares would not be treated as shares of a PFIC unless we subsequently become a PFIC.

          If we are a PFIC for any taxable year during which a U.S. Holder holds ordinary shares and one of our non-U.S. corporate subsidiaries is also a PFIC (i.e., a lower-tier PFIC), such U.S. Holder would be treated as owning a proportionate amount (by value) of the shares of the lower-tier PFIC and would be taxed under the PFIC excess distribution regime on distributions by the lower-tier PFIC and on gain from the disposition of shares of the lower-tier PFIC even though such U.S. Holder would not receive the proceeds of those distributions or dispositions. Each U.S. Holder is advised to consult its tax advisors regarding the application of the PFIC rules to our non-U.S. subsidiaries.

          If we are a PFIC, a U.S. Holder will not be subject to tax under the PFIC excess distribution regime on distributions or gain recognized on ordinary shares if such U.S. Holder makes a valid "mark-to-market" election for our ordinary shares. A mark-to-market election is available to a U.S. Holder only for "marketable stock." Our ordinary shares will be marketable stock as long as they remain listed on the Nasdaq Global Market and are regularly traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. If a mark-to-market election is in effect,

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a U.S. Holder generally would take into account, as ordinary income for each taxable year of the U.S. holder, the excess of the fair market value of ordinary shares held at the end of such taxable year over the adjusted tax basis of such ordinary shares. The U.S. Holder would also take into account, as an ordinary loss each year, the excess of the adjusted tax basis of such ordinary shares over their fair market value at the end of the taxable year, but only to the extent of the excess of amounts previously included in income over ordinary losses deducted as a result of the mark-to-market election. The U.S. Holder's tax basis in ordinary shares would be adjusted to reflect any income or loss recognized as a result of the mark-to-market election. Any gain from a sale, exchange or other disposition of ordinary shares in any taxable year in which we are a PFIC would be treated as ordinary income and any loss from such sale, exchange or other disposition would be treated first as ordinary loss (to the extent of any net mark-to-market gains previously included in income) and thereafter as capital loss.

          A mark-to-market election will not apply to ordinary shares for any taxable year during which we are not a PFIC, but will remain in effect with respect to any subsequent taxable year in which we become a PFIC. Such election will not apply to any non-U.S. subsidiaries that we may organize or acquire in the future. Accordingly, a U.S. Holder may continue to be subject to tax under the PFIC excess distribution regime with respect to any lower-tier PFICs that we may organize or acquire in the future notwithstanding the U.S. Holder's mark-to-market election for the ordinary shares.

          The tax consequences that would apply if we are a PFIC would also be different from those described above if a U.S. Holder were able to make a valid qualified electing fund, or QEF, election. At this time, we do not expect to provide U.S. Holders with the information necessary for a U.S. Holder to make a QEF election. Prospective investors should assume that a QEF election will not be available.

          Each U.S. person that is an investor of a PFIC is generally required to file an annual information return on IRS Form 8621 containing such information as the U.S. Treasury Department may require. The failure to file IRS Form 8621 could result in the imposition of penalties and the extension of the statute of limitations with respect to U.S. federal income tax.

          The U.S. federal income tax rules relating to PFICs are very complex. Prospective U.S. investors are strongly urged to consult their own tax advisors with respect to the impact of PFIC status on the purchase, ownership and disposition of ordinary shares, the consequences to them of an investment in a PFIC, any elections available with respect to the ordinary shares and the IRS information reporting obligations with respect to the purchase, ownership and disposition of ordinary shares of a PFIC.

Distributions

          As described in the section entitled "— Dividend Policy," we do not anticipate declaring or paying dividends to holders of our common stock in the foreseeable future. However, if we make a distribution contrary to the expectation, subject to the discussion above under "— Passive Foreign Investment Company Consequences," a U.S. Holder that receives a distribution with respect to ordinary shares generally will be required to include the gross amount of such distribution in gross income as a dividend when actually or constructively received to the extent of the U.S. Holder's pro rata share of our current and/or accumulated earnings and profits (as determined under U.S. federal income tax principles). To the extent a distribution received by a U.S. Holder is not a dividend because it exceeds the U.S. Holder's pro rata share of our current and accumulated earnings and profits, it will be treated first as a tax-free return of capital and reduce (but not below zero) the adjusted tax basis of the U.S. Holder's ordinary shares. To the extent the distribution exceeds the adjusted tax basis of the U.S. Holder's ordinary shares, the remainder will be taxed as capital gain. Because we may not account for our earnings and profits in accordance with U.S.

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federal income tax principles, U.S. Holders should expect all distributions to be reported to them as dividends.

          Distributions on ordinary shares that are treated as dividends generally will constitute income from sources outside the United States for foreign tax credit purposes and generally will constitute passive category income. Subject to certain complex conditions and limitations, Israeli taxes withheld on any distributions on ordinary shares may be eligible for credit against a U.S. Holder's federal income tax liability. The rules relating to the determination of the U.S. foreign tax credit are complex, and U.S. Holders should consult their tax advisors regarding the availability of a foreign tax credit in their particular circumstances and the possibility of claiming an itemized deduction (in lieu of the foreign tax credit) for any foreign taxes paid or withheld.

          Dividends paid by a "qualified foreign corporation" are eligible for taxation to non-corporate U.S. holders at a reduced capital gains rate rather than the marginal tax rates generally applicable to ordinary income provided that certain requirements are met. Each U.S. Holder is advised to consult its tax advisors regarding the availability of the reduced tax rate on dividends with regard to its particular circumstances. Each U.S. Holder is advised to consult its tax advisors regarding the availability of the reduced tax rate on dividends with regard to its particular circumstances. Distributions on ordinary shares that are treated as dividends generally will not be eligible for the "dividends received" deduction generally allowed to corporate shareholders with respect to dividends received from U.S. corporations.

          A non-United States corporation (other than a corporation that is classified as a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be considered to be a qualified foreign corporation (a) if it is eligible for the benefits of a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision and which includes an exchange of information provision, or (b) with respect to any dividend it pays on ordinary shares that are readily tradable on an established securities market in the United States. We believe that we qualify as a resident of Israel for purposes of, and are eligible for the benefits of, the U.S.-Israel Treaty, although there can be no assurance in this regard. Further, the IRS has determined that the U.S.-Israel Treaty is satisfactory for purposes of the qualified dividend rules and that it includes an exchange of information provision. Therefore, subject to the discussion above under "— Passive Foreign Investment Company Consequences," if the U.S.-Israel Treaty is applicable, such dividends will generally be "qualified dividend income" in the hands of individual U.S. Holders, provided that certain conditions are met, including holding period and the absence of certain risk reduction transaction requirements. Each U.S. Holder is advised to consult its tax advisors regarding the availability of the reduced tax rate on dividends with regard to its particular circumstances.

Sale, Exchange or Other Disposition of Ordinary Shares

          Subject to the discussion above under "— Passive Foreign Investment Company Consequences," a U.S. Holder generally will recognize capital gain or loss for U.S. federal income tax purposes upon the sale, exchange or other disposition of ordinary shares in an amount equal to the difference, if any, between the amount realized (i.e., the amount of cash plus the fair market value of any property received) on the sale, exchange or other disposition and such U.S. Holder's adjusted tax basis in the ordinary shares. Such capital gain or loss generally will be long-term capital gain taxable at a reduced rate for non-corporate U.S. Holders or long-term capital loss if, on the date of sale, exchange or other disposition, the ordinary shares were held by the U.S. Holder for more than one year. Any capital gain of a non-corporate U.S. Holder that is not long-term capital gain is taxed at ordinary income rates. The deductibility of capital losses is subject to limitations. Any gain or loss recognized from the sale or other disposition of ordinary shares will generally be gain or loss from sources within the United States for U.S. foreign tax credit purposes.

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Medicare Tax

          Certain U.S. Holders that are individuals, estates or trusts and whose income exceeds certain thresholds generally are subject to a 3.8% tax on all or a portion of their net investment income, which may include their gross dividend income and net gains from the disposition of ordinary shares. If you are a United States person that is an individual, estate or trust, you are encouraged to consult your tax advisors regarding the applicability of this Medicare tax to your income and gains in respect of your investment in ordinary shares.

Information Reporting and Backup Withholding

          U.S. Holders may be required to file certain U.S. information reporting returns with the IRS with respect to an investment in ordinary shares, including, among others, IRS Form 8938 (Statement of Specified Foreign Financial Assets). As described above under "Passive Foreign Investment Company Consequences", each U.S. Holder who is a shareholder of a PFIC must file an annual report containing certain information. U.S. Holders paying more than US$100,000 for ordinary shares may be required to file IRS Form 926 (Return by a U.S. Transferor of Property to a Foreign Corporation) reporting this payment. Substantial penalties may be imposed upon a U.S. Holder that fails to comply with the required information reporting.

          Dividends on and proceeds from the sale or other disposition of ordinary shares may be reported to the IRS unless the U.S. Holder establishes a basis for exemption. Backup withholding may apply to amounts subject to reporting if the holder (1) fails to provide an accurate United States taxpayer identification number or otherwise establish a basis for exemption (usually on IRS Form W-9), or (2) is described in certain other categories of persons. However, U.S. Holders that are corporations generally are excluded from these information reporting and backup withholding tax rules. Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules generally will be allowed as a refund or a credit against a U.S. Holder's U.S. federal income tax liability if the required information is furnished by the U.S. Holder on a timely basis to the IRS.

          U.S. Holders should consult their own tax advisors regarding the backup withholding tax and information reporting rules.

          EACH PROSPECTIVE INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN ORDINARY SHARES IN LIGHT OF THE INVESTOR'S OWN CIRCUMSTANCES.

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UNDERWRITING

          We have entered into an underwriting agreement with the underwriters named below with respect to the ordinary shares being offered. Subject to certain conditions, each underwriter has severally agreed to purchase the number of ordinary shares indicated in the following table. Goldman Sachs & Co. LLC, 200 West Street, 29th Floor, New York, New York 10282 and Cowen and Company, LLC, 599 Lexington Avenue, 27th Floor, New York, New York 10022, are the representatives of the underwriters.

Underwriters
  Number of
Ordinary
Shares
 
 

Goldman Sachs & Co. LLC

                   

Cowen and Company, LLC

                   

Cantor Fitzgerald & Co. 

                   

Raymond James & Associates, Inc. 

       

Oppenheimer & Co. Inc. 

                   

Total

    3,333,333  

          The underwriters are committed to take and pay for all of the ordinary shares being offered, if any are taken, other than the ordinary shares covered by the option described below unless and until this option is exercised.

          The underwriters have an option to buy up to an additional 500,000 ordinary shares from the company to cover sales by the underwriters of a greater number of ordinary shares than the total number set forth in the table above. They may exercise that option for 30 days. If any ordinary shares are purchased pursuant to this option, the underwriters will severally purchase ordinary shares in approximately the same proportion as set forth in the table above.

          The following table shows the per ordinary share and total underwriting discounts and commissions to be paid to the underwriters by the company. Such amounts are shown assuming both no exercise and full exercise of the underwriters' option to purchase 500,000 additional ordinary shares.

    Paid by the Company
 

    No Exercise     Full Exercise
 

Per ordinary share

  $                 $                

Total

  $                 $                

          Ordinary shares sold by the underwriters to the public will initially be offered at the initial public offering price set forth on the cover page of this prospectus. Any ordinary shares sold by the underwriters to securities dealers may be sold at a discount of up to $         per ordinary share from the initial public offering price. After the ordinary shares are released for sale to the public, if all the ordinary shares are not sold at the initial public offering price following a bona fide effort to do so, the underwriters may change the initial public offering price and other selling terms. The offering of the ordinary shares by the underwriters is subject to receipt and acceptance and subject to the underwriters' right to reject any order in whole or in part.

          The company, its directors, executive officers and holders of substantially all of its outstanding shares and shares issuable upon the exercise of options and warrants have agreed with the underwriters, subject to certain exceptions, not to dispose of or hedge any of their ordinary shares or securities convertible into or exchangeable for ordinary shares during the period from the date of this prospectus continuing through the date 180 days after the date of this prospectus, except with

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the prior written consent of the representatives. This agreement does not apply to any existing employee benefit plans. See "Shares Available for Future Sale" for a discussion of certain transfer restrictions.

          Prior to the offering, there has been no public market for the ordinary shares. The initial public offering price has been negotiated among the company and the representatives. Among the factors to be considered in determining the initial public offering price of the ordinary shares, in addition to prevailing market conditions, will be the company's historical performance, estimates of the business potential and earnings prospects of the company, an assessment of the company's management and the consideration of the above factors in relation to market valuation of companies in related businesses.

          Application has been made to list the ordinary shares on The Nasdaq Global Market under the symbol "POLY."

          In connection with the offering, the underwriters may purchase and sell the ordinary shares in the open market. These transactions may include short sales, stabilizing transactions and purchases to cover positions created by short sales. Short sales involve the sale by the underwriters of a greater number of ordinary shares than they are required to purchase in the offering, and a short position represents the amount of such sales that has not been covered by subsequent purchases. A "covered short position" is a short position that is not greater than the amount of additional ordinary shares for which the underwriters' option described above may be exercised. The underwriters may cover any covered short position by either exercising their option to purchase additional ordinary shares or purchasing ordinary shares in the open market. In determining the source of ordinary shares to cover the covered short position, the underwriters will consider, among other things, the price of ordinary shares available for purchase in the open market as compared to the price at which they may purchase additional ordinary shares pursuant to the option described above. "Naked" short sales are any short sales that create a short position greater than the amount of additional ordinary shares for which the option described above may be exercised. The underwriters must cover any such naked short position by purchasing ordinary shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the ordinary shares in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for or purchases of ordinary shares made by the underwriters in the open market prior to the completion of the offering.

          The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of the underwriting discount received by it because the representatives have repurchased ordinary shares sold by or for the account of such underwriter in stabilizing or short covering transactions.

          Purchases to cover a short position and stabilizing transactions, as well as other purchases by the underwriters for their own accounts, may have the effect of preventing or retarding a decline in the market price of the company's ordinary shares, and together with the imposition of the penalty bid, may stabilize, maintain or otherwise affect the market price of the ordinary shares. As a result, the price of the ordinary shares may be higher than the price that otherwise might exist in the open market. The underwriters are not required to engage in these activities and may end any of these activities at any time. These transactions may be effected on The Nasdaq Global Market, in the over-the-counter market or otherwise.

          The underwriters do not expect sales to discretionary accounts to exceed five percent of the total number of ordinary shares offered.

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          The company estimates that its share of the total expenses of the offering, excluding estimated underwriting discounts and commissions, will be approximately $2.0 million. The company has also agreed to reimburse the underwriters for certain of their expenses in an amount up to $45,000.

          The company has agreed to indemnify the several underwriters against certain liabilities, including liabilities under the Securities Act of 1933.

          The underwriters and their respective affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. The underwriters and their respective affiliates may in the future provide a variety of these services to the issuer and to persons and entities with relationships with the issuer, for which they received or will receive customary fees and expenses.

          In the ordinary course of their various business activities, the underwriters and their respective affiliates, officers, directors and employees may purchase, sell or hold a broad array of investments and actively trade securities, derivatives, loans, commodities, currencies, credit default swaps and other financial instruments for their own account and for the accounts of their customers, and such investment and trading activities may involve or relate to assets, securities and/or instruments of the issuer (directly, as collateral securing other obligations or otherwise) and/or persons and entities with relationships with the issuer. The underwriters and their respective affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express independent research views in respect of such assets, securities or instruments and may at any time hold, or recommend to clients that they should acquire, long and/or short positions in such assets, securities and instruments.

European Economic Area

          In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive, each, a Relevant Member State, an offer to the public of the ordinary shares may not be made in that Relevant Member State, except that an offer to the public in that Relevant Member State of the ordinary shares may be made at any time under the following exemptions under the Prospectus Directive:

    to any legal entity which is a qualified investor as defined in the Prospectus Directive;

    to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), subject to obtaining the prior consent of the representatives for any such offer; or

    in any other circumstances falling within Article 3(2) of the Prospectus Directive;

provided that no such offer of ordinary shares shall require the company or any underwriter to publish a prospectus pursuant to Article 3 of the Prospectus Directive.

          For the purposes of this provision, the expression an "offer of ordinary shares to the public" in relation to the company's ordinary shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the ordinary shares to be offered so as to enable an investor to decide to purchase the ordinary shares, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State, the expression "Prospectus Directive" means Directive 2003/71/EC (as amended), including by Directive 2010/73/EU and includes any relevant implementing measure in the Relevant Member State.

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          This European Economic Area selling restriction is in addition to any other selling restrictions set out below.

United Kingdom

          In the United Kingdom, this prospectus is only addressed to and directed at qualified investors who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order); or (ii) high net worth entities and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). Any investment or investment activity to which this prospectus relates is available only to relevant persons and will only be engaged with relevant persons. Any person who is not a relevant person should not act or relay on this prospectus or any of its contents.

Canada

          The ordinary shares may be sold in Canada only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the ordinary shares must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

          Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser's province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser's province or territory for particulars of these rights or consult with a legal advisor.

          Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.

Hong Kong

          The ordinary shares may not be offered or sold in Hong Kong by means of any document other than (i) in circumstances which do not constitute an offer to the public within the meaning of the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32 of the Laws of Hong Kong), or the Companies (Winding Up and Miscellaneous Provisions) Ordinance, or which do not constitute an invitation to the public within the meaning of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong), or the Securities and Futures Ordinance, or (ii) to "professional investors" as defined in the Securities and Futures Ordinance and any rules made thereunder, or (iii) in other circumstances which do not result in the document being a "prospectus" as defined in the Companies (Winding Up and Miscellaneous Provisions) Ordinance, and no advertisement, invitation or document relating to the shares may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), which is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to shares which are or are intended to be disposed of only to persons outside Hong Kong or only to "professional investors" in Hong Kong as defined in the Securities and Futures Ordinance and any rules made thereunder.

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Singapore

          This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of the ordinary shares may not be circulated or distributed, nor may the ordinary shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor (as defined under Section 4A of the Securities and Futures Act, Chapter 289 of Singapore, or the SFA, under Section 274 of the SFA, (ii) to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the conditions specified in Section 275 of the SFA or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA, in each case subject to conditions set forth in the SFA.

          Where the ordinary shares are subscribed or purchased under Section 275 by a relevant person which is a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor, the securities (as defined in Section 239(1) of the SFA) of that corporation shall not be transferable for 6 months after that corporation has acquired the ordinary shares under Section 275 of the SFA except: (1) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA), (2) where such transfer arises from an offer in that corporation's securities pursuant to Section 275(1A) of the SFA, (3) where no consideration is or will be given for the transfer, (4) where the transfer is by operation of law, (5) as specified in Section 276(7) of the SFA, or (6) as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore, or Regulation 32.

          Where the ordinary shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is a trust (where the trustee is not an accredited investor (as defined in Section 4A of the SFA)) whose sole purpose is to hold investments and each beneficiary of the trust is an accredited investor, the beneficiaries' rights and interest (howsoever described) in that trust shall not be transferable for 6 months after that trust has acquired the shares under Section 275 of the SFA except: (1) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA), (2) where such transfer arises from an offer that is made on terms that such rights or interest are acquired at a consideration of not less than S$200,000 (or its equivalent in a foreign currency) for each transaction (whether such amount is to be paid for in cash or by exchange of securities or other assets), (3) where no consideration is or will be given for the transfer, (4) where the transfer is by operation of law, (5) as specified in Section 276(7) of the SFA, or (6) as specified in Regulation 32.

Japan

          The securities have not been and will not be registered under the Financial Instruments and Exchange Law of Japan (the Financial Instruments and Exchange Law) and each underwriter has agreed that it will not offer or sell any securities, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan (which term as used herein means any person resident in Japan, including any corporation or other entity organized under the laws of Japan), or to others for re-offering or resale, directly or indirectly, in Japan or to a resident of Japan, except pursuant to an exemption from the registration requirements of, and otherwise in compliance with, the Financial Instruments and Exchange Law and any other applicable laws, regulations and ministerial guidelines of Japan.

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Australia

          No prospectus or other disclosure document (as defined in the Corporations Act 2001 (Cth) of Australia, or the 'Corporations Act, in relation to the ordinary shares has been or will be lodged with the Australian Securities & Investments Commission, or ASIC. This document has not been lodged with ASIC and is only directed to certain categories of exempt persons. Accordingly, if you receive this document in Australia:

    you confirm and warrant that you are either:

    a "sophisticated investor" under section 708(8)(a) or (b) of the Corporations Act;

    a "sophisticated investor" under section 708(8)(c) or (d) of the Corporations Act and that you have provided an accountant's certificate to us which complies with the requirements of section 708(8)(c)(i) or (ii) of the Corporations Act and related regulations before the offer has been made;

    a person associated with the company under section 708(12) of the Corporations Act; or

    a "professional investor" within the meaning of section 708(11)(a) or (b) of the Corporations Act, and to the extent that you are unable to confirm or warrant that you are an exempt sophisticated investor, associated person or professional investor under the Corporations Act any offer made to you under this document is void and incapable of acceptance; and

    you warrant and agree that you will not offer any of the ordinary shares for resale in Australia within 12 months of those ordinary shares being issued unless any such resale offer is exempt from the requirement to issue a disclosure document under section 708 of the Corporations Act.

Switzerland

          The securities may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or SIX, or on any other stock exchange or regulated trading facility in Switzerland. This document does not constitute a prospectus within the meaning of, and 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 or marketing material relating to the securities or the offering may be publicly distributed or otherwise made publicly available in Switzerland.

          Neither this document nor any other offering or marketing material relating to the offering, the company or the securities have 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 securities will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA ("FINMA"), and the offer of the securities has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes ("CISA"). The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of securities.

Israel

          This document does not constitute a prospectus under the Israeli Securities Law, 5728-1968, or the Securities Law, and has not been filed with or approved by the Israel Securities Authority. In the State of Israel, this document is being distributed only to, and is directed only at, and any offer

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of the ordinary shares is directed only at, (i) a limited number of 35 persons or entities in accordance with the Securities Law and the regulations thereunder and (ii) investors listed in the first addendum, or the Addendum, to the Israeli Securities Law, consisting primarily of joint investment in trust funds, provident funds, insurance companies, banks, portfolio managers, investment advisors, members of the Tel Aviv Stock Exchange, underwriters, venture capital funds (all as defined under the Israeli Law), entities with equity in excess of NIS 50 million (other than entities formed for the acquisition of securities from a certain offer) and "qualified individuals," each as defined in the Addendum (as it may be amended from time to time), collectively referred to as Qualified Investors (in each case purchasing for their own account or, where permitted under the Addendum, for the accounts of their clients who are investors listed in the Addendum). Qualified Investors will be required to submit written confirmation that they fall within the scope of the Addendum, are aware of the meaning of same and agree to it. Certain Qualified Investors may be required to submit additional confirmations.

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EXPENSES OF THIS OFFERING

          The following table sets forth the costs and expenses, other than the underwriting discounts and commissions, payable by us in connection with the sale of our ordinary shares being registered. All amounts are estimates except for the SEC registration fee, the FINRA filing fee and The Nasdaq Global Market listing fee.

Item
  Amount
to
be Paid
 
 

SEC registration fee

  $ 10,738  

FINRA filing fee

    13,438  

The Nasdaq Global Market listing fee

    125,000  

Printing and engraving expenses

    150,000  

Legal fees and expenses

    1,339,317  

Accounting fees and expenses

    240,000  

Miscellaneous expenses

    61,507  

Total

  $ 2,000,000  

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LEGAL MATTERS

          The validity of the issuance of our ordinary shares offered in this prospectus and certain other matters of Israeli law will be passed upon for us by Zysman, Aharoni, Gayer & Co., Tel Aviv, Israel. Certain matters of U.S. federal law will be passed upon for us by Cooley LLP, New York, New York. Certain legal matters in connection with this offering will be passed upon for the underwriters by Yigal Arnon & Co., Tel-Aviv, Israel, with respect to Israeli law, and Latham & Watkins LLP with respect to U.S. federal law.


EXPERTS

          The consolidated financial statements as of December 31, 2017 and 2016 and for each of the two years in the period ended December 31, 2017 appearing in this Prospectus and Registration Statement have been audited by Kost, Forer, Gabbay & Kasierer, Certified Public Accountants (Israel), an independent registered public accounting firm and a member firm of Ernst & Young Global, as set forth in their report thereon appearing elsewhere herein, and are included in reliance upon such report given on the authority of such firm as experts in accounting and auditing. The address of Kost, Forer, Gabbay & Kasierer is Menachem Begin 144, Tel Aviv, Israel.

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ENFORCEMENT OF CIVIL LIABILITIES

          We are incorporated under the laws of the State of Israel. Service of process upon us and upon our directors and officers and the Israeli experts named in this registration statement, most of whom reside outside of the United States, may be difficult to obtain within the United States. Furthermore, because substantially all of our assets and substantially all of our directors and officers are located outside of the United States, any judgment obtained in the United States against us or any of our directors and officers may not be collectible within the United States.

          We have been informed by our legal counsel in Israel, Zysman, Aharoni, Gayer & Co., that it may be difficult to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of U.S. securities laws reasoning that Israel is not the most appropriate forum to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law.

          We have irrevocably appointed PolyPid Inc. as our agent to receive service of process in any action against us in any U.S. federal or state court arising out of this offering or any purchase or sale of securities in connection with this offering. Subject to specified time limitations and legal procedures, Israeli courts may enforce a U.S. judgment in a civil matter which, subject to certain exceptions, is non-appealable, including a judgment based upon the civil liability provisions of the Securities Act and the Exchange Act and including a monetary or compensatory judgment in a non-civil matter, provided that among other things:

    the judgment was obtained after due process before a court of competent jurisdiction, according to the laws of the state in which the judgment was given and the rules of private international law currently prevailing in Israel;

    the prevailing law of the foreign state in which the judgment was rendered allows for the enforcement of judgments of Israeli courts;

    adequate service of process has been effected and the defendant has had a reasonable opportunity to be heard and to present his or her evidence;

    the judgment is not contrary to public policy of Israel, and the enforcement of the civil liabilities set forth in the judgment is not likely to impair the security or sovereignty of Israel;

    the judgment was not obtained by fraud and do not conflict with any other valid judgments in the same matter between the same parties;

    an action between the same parties in the same matter is not pending in any Israeli court at the time the lawsuit is instituted in the foreign court; and

    the judgment is enforceable according to the laws of Israel and according to the law of the foreign state in which the relief was granted.

          If a foreign judgment is enforced by an Israeli court, it generally will be payable in Israeli currency, which can then be converted into non-Israeli currency and transferred out of Israel. The usual practice in an action before an Israeli court to recover an amount in a non-Israeli currency is for the Israeli court to issue a judgment for the equivalent amount in Israeli currency at the rate of exchange in force on the date of the judgment, but the judgment debtor may make payment in foreign currency. Pending collection, the amount of the judgment of an Israeli court stated in Israeli currency ordinarily will be linked to the Israeli consumer price index plus interest at the annual statutory rate set by Israeli regulations prevailing at the time. Judgment creditors must bear the risk of unfavorable exchange rates.

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WHERE YOU CAN FIND MORE INFORMATION

          We have filed with the SEC a registration statement on Form F-1 under the Securities Act relating to this offering of our ordinary shares. This prospectus does not contain all of the information contained in the registration statement. The rules and regulations of the SEC allow us to omit certain information from this prospectus that is included in the registration statement. Statements made in this prospectus concerning the contents of any contract, agreement or other document are summaries of all material information about the documents summarized, but are not complete descriptions of all terms of these documents. If we filed any of these documents as an exhibit to the registration statement, you may read the document itself for a complete description of its terms.

          You may read and copy the registration statement, including the related exhibits and schedules, and any document we file with the SEC without charge at the SEC's public reference room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. The SEC also maintains a website that contains reports and other information regarding issuers that file electronically with the SEC. Our filings with the SEC are also available to the public through the SEC's website at http://www.sec.gov.

          Upon completion of this offering, we will be subject to the information reporting requirements of the Exchange Act that are applicable to foreign private issuers, and under those requirements will file reports with the SEC. These other reports or other information may be inspected without charge at the locations described above. As a foreign private issuer, we will be exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we will not be required under the Exchange Act to file reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act.

          We maintain a corporate website at http://www.polypid.com. Information contained on, or that can be accessed through, our website does not constitute a part of this prospectus.

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POLYPID LTD.

CONSOLIDATED FINANCIAL STATEMENTS

AS OF DECEMBER 31, 2017

INDEX

-- - - - - - - - - - - - - - - - - -

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LOGO

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders' and Board of Directors of
POLYPID LTD.

Opinion on the Consolidated Financial Statements

          We have audited the accompanying consolidated balance sheets of Polypid Ltd. (the "Company") as of December 31, 2017 and 2016 and the related consolidated statements of operations, changes in convertible preferred shares and shareholders' deficiency and cash flows for each of the two years in the period ended December 31, 2017 and the related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2017 and 2016, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2017, in conformity with U.S. generally accepted accounting principles.

Basis for Opinion

          These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

          We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting 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.

          Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global

 

 

We have served as the Company's auditor since 2010.
Tel-Aviv, Israel
February 8, 2018 except for Notes 1(d), 2(j), 7, 9, 10, 12, 13, 14 and 15, to which the date is March 14, 2018

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POLYPID LTD AND SUBSIDIARY

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

    December 31,     Pro forma as of
December 31,
 

    2016     2017     2017
 

                (Unaudited)  

Assets

                   

Current assets:

   
 
   
 
   
 
 

Cash and cash equivalents

  $ 10,221   $ 3,907   $ 3,920  

Short-term deposits

    7,530     14,031     14,031  

Prepaid expenses and other receivables

    503     792     792  

Total current assets

    18,254     18,730     18,743  

Long-term assets:

                   

Property and equipment, net

    847     2,926     2,926  

Deferred equity offering costs

        1,088      

Other long-term assets

    136     240     240  

Total long-term assets

    983     4,254     3,166  

Total assets

  $ 19,237   $ 22,984   $ 21,909  

   

The accompanying notes are an integral part of the consolidated financial statements.

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POLYPID LTD AND SUBSIDIARY

CONSOLIDATED BALANCE SHEETS (Continued)

U.S. dollars in thousands (except share and per share data)

    December 31,     Pro forma as of
December 31,
 

    2016     2017     2017
 

                (Unaudited)  

Liabilities, Convertible Preferred Shares and Shareholders' Deficiency

                   

Current liabilities:

   
 
   
 
   
 
 

Trade payables

  $ 778   $ 2,019   $ 2,019  

Other payables and accrued expenses

    920     1,345     1,345  

Total current liabilities

    1,698     3,364     3,364  

Long-term liabilities:

                   

Advances on account of collaboration agreement

    600     600     600  

Other liabilities

    256     284     284  

Convertible preferred shares warrant liability

    6,616     47,399      

Total long-term liabilities

    7,472     48,283     884  

Commitments and Contingencies

                   

Convertible preferred shares:

   
 
   
 
   
 
 

Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-2, D-3 and E shares of NIS 0.8 par value — Authorized: 12,741,017 and 11,553,517 shares at December 31, 2017 and 2016, respectively; Issued and outstanding: 9,138,485 and 7,960,447 shares at December 31, 2017 and 2016, respectively; Aggregate liquidation preference of $84,895 at December 31, 2017

    44,026     59,983      

Shareholders' deficiency:

                   

Share capital —

                   

Ordinary shares of NIS 0.8 par value — Authorized: 15,687,500 and 14,500,000 shares at December 31, 2017 and 2016, respectively; Issued and outstanding: 584,151 and 568,078 shares at December 31, 2017 and 2016

    126     129     2,251  

Additional paid-in capital

    2,487     3,540     107,725  

Accumulated deficit

    (36,572 )   (92,315 )   (92,315 )

Total shareholders' deficiency

    (33,959 )   (88,646 )   17,661  

Total liabilities, convertible preferred shares and shareholders' deficiency

  $ 19,237   $ 22,984   $ 21,909  

   

The accompanying notes are an integral part of the consolidated financial statements.

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POLYPID LTD AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)

    Year ended
December 31,
 

    2016     2017
 

Operating expenses:

             

Research and development, net

  $ 7,708   $ 9,736  

General and administrative

    2,551     4,064  

Operating loss

    10,259     13,800  

Financial expenses, net

    1,133     40,688  

Net loss

  $ 11,392   $ 54,488  

Deemed dividend

        1,255  

Net loss attributable to Ordinary shares

  $ 11,392   $ 55,743  

Basic and diluted net loss per Ordinary share

  $ (24.64 ) $ (102.00 )

Weighted average number of Ordinary shares used in computing basic and diluted net loss per share

    568,078     584,176  

Pro forma basic and diluted net loss per Ordinary share (unaudited)

        $ (6.32 )

Weighted average number of Ordinary shares used in computing basic and diluted net loss per share — pro forma (unaudited)

          8,822,250  

   

The accompanying notes are an integral part of the consolidated financial statements.

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POLYPID LTD AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED SHARES AND CHANGES IN SHAREHOLDERS' DEFICIENCY

U.S. dollars in thousands (except share data)

    Convertible Preferred
shares
        Shareholders' deficiency
 

    Number of
Preferred shares
    Amount     Total         Number of
Ordinary
shares
    Amount     Additional
paid-in
capital
    Accumulated
deficit
    Total
shareholders'
deficiency
 

Balances as of January 1, 2016

    4,871,061   $ 22,934   $ 22,934         568,078   $ 126   $ 1,889   $ (25,180 ) $ (23,165 )

Issuance of series D-1 Preferred shares, net(*)

   
2,485,889
   
16,039
   
16,039
       
   
   
   
   
 

Issuance of series D-3 Preferred shares, net(**)

    603,497     5,053     5,053                          

Share-based compensation

                            598         598  

Net loss

                                (11,392 )   (11,392 )

Balances as of December 31, 2016

    7,960,447     44,026     44,026         568,078     126     2,487     (36,572 )   (33,959 )

Exercise of options

   
   
   
       
16,073
   
3
   
65
   
   
68
 

Issuance of series E Preferred shares, net(***)

    1,178,038     14,315     14,315                          

Deemed dividend related to Series E Preferred Shares (Note 9c)

        1,255     1,255                     (1,255 )   (1,255 )

Share-based compensation (Note 9c)

        387     387                          

Share-based compensation

                            988         988  

Net loss

                                (54,488 )   (54,488 )

Balances as of December 31, 2017

    9,138,485   $ 59,983   $ 59,983         584,151   $ 129   $ 3,540   $ (92,315 ) $ (88,646 )

(*)
Net of $5,215 fair value of warrants liability issued to investors and issuance costs of $787 (cash and share-based).

(**)
Net of issuance costs of $275 in cash.

(***)
Net of issuance costs of $665 in cash and share-based.

   

The accompanying notes are an integral part of the consolidated financial statements.

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POLYPID LTD AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

    Year ended
December 31,
 

    2016     2017
 

Cash flows from operating activities:

             

Net loss

  $ (11,392 ) $ (54,488 )

Adjustments to reconcile net loss to net cash used in operating activities:

             

Depreciation

    127     205  

Re-evaluation of warrants

    1,171     40,783  

Share-based compensation

    598     1,375  

Changes in assets and liabilities:

             

Increase in receivables and prepaid expenses

    (276 )   (705 )

Decrease (increase) in other long-term assets

    3     (104 )

Increase in trade payables

    199     385  

Increase (decrease) in other payables and accrued expenses and other liabilities

    (163 )   237  

Net cash used in operating activities

    (9,733 )   (12,312 )

Cash flows from investing activities:

             

Short-term deposits, net

    (7,530 )   (6,501 )

Purchase of property and equipment

    (539 )   (1,884 )

Net cash used in investing activities

    (8,069 )   (8,385 )

Cash flows from financing activities:

             

Proceeds from issuance of convertible preferred shares and warrants, net

    26,344     14,315  

Proceeds from exercise of options

        68  

Net cash provided by financing activities

    26,344     14,383  

Increase (decrease) in cash and cash equivalents

    8,542     (6,314 )

Cash and cash equivalents at the beginning of the year

    1,679     10,221  

Cash and cash equivalents at the end of the year

  $ 10,221   $ 3,907  

Non cash activity:

             

Purchase of property and equipment

        400  

Deferred equity offering costs

        672  

   

The accompanying notes are an integral part of the consolidated financial statements.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share and per share data)

NOTE 1:- GENERAL

a.
Polypid Ltd. (the "Company") was incorporated under the laws of Israel and commenced its operations on February 28, 2008. The Company is a clinical-stage pharmaceutical company focused on developing and commercializing novel, locally administered therapies using its PLEX (Polymer-Lipid Encapsulation matriX) technology. The Company's product candidates are designed to address unmet medical needs by delivering active pharmaceutical ingredients, or APIs, locally at predetermined release rates and durations over extended periods ranging from days to several months. The Company is initially focused on the development of its lead product candidate, D-PLEX100, which incorporates an antibiotic, for the prevention of surgical site infection in bone and soft tissue.

    In October 2017, the Company established a wholly-owned subsidiary in the Unites States of America.

    Through December 31, 2017, the Company has been primarily engaged in research and development.

b.
The Company's activities since inception have consisted of performing research and development activities. Successful completion of the Company's development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to obtain marketing approval from regulatory authorities; access potential markets; secure financing; conclude a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances. The Company's operations are funded by its shareholders and research and development grants and the Company intends to seek further private or public financing as well as make applications for further research and development grants for continuing its operations. Although management believes that the Company will be able to successfully fund its operations, there can be no assurance that the Company will be able to do so or that the Company will ever operate profitably.

    The Company expects to continue to incur substantial losses over the next several years during its development phase. To fully execute its business plan, the Company will need to complete certain research and development activities, clinical studies and validate the pilot manufacturing plant. Further, the Company's product candidates will require regulatory approval prior to commercialization as well as establish sales, marketing and logistic infrastructures. These activities may span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company.

    As of December 31, 2017, the Company had cash and cash equivalents and short-term deposits of $3,907 and $14,031, respectively. During the year ended December 31, 2017, the Company incurred a net loss of $54,488 and had negative cash flows from operating activities of $12,312. In addition, the Company had an accumulated deficit of $92,315 at December 31, 2017. Management plans to seek additional equity financing through private and public offerings or strategic partnerships and, in the longer term, by generating revenues from product sales.

    The Company's future operations are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed above; (ii) the

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 1:- GENERAL (Continued)

    success of its research and development; activities; (iii) completion of all required clinical studies; (iv) completion of construction of the pilot manufacturing facility and validate such plant; (v) marketing approval by the relevant regulatory authorities; and (vi) market acceptance of the Company's products candidates.

    There can be no assurance that the Company will be successful in obtaining additional financing on favorable terms, or at all.

c.
In February, 2013, the Company signed a memorandum of understanding (the "MOU"), with MIS Implants Technologies Ltd. ("MIS"). The MOU grants MIS an exclusive right to market a specific dental application of the Company's technology for a period of at least 5 years, starting after receipt of either European Medicines Agency ("EMA") marketing approval or U.S. Food and Drug Administration ("FDA") regulatory approval and beginning of commercialized sales in the applicable market, accordingly.

    Under the terms of the MOU, the Company is entitled to receive up to $2,500, subject to meeting certain milestones, as specified in the MOU. Under the terms of the MOU, 45 days following the publication of the results of the clinical study report by the principal investigator, MIS is obligated to inform the Company of its intention to either continue the commercialization of the product or terminate the MOU. In event of termination by MIS, the Company is obligated to return all milestone payments received until such notification. In addition, under the terms of the MOU, within 30 days of notification of FDA requirements for the performance of a clinical trial, MIS may choose to decline to undertake such clinical trial, in which case the license to MIS granted by the Company shall exclude the U.S. territory, MIS shall not be obligated to make additional milestone payments and the Company will be obligated to return any such milestone payment, to the extent received. See Note 2l.

    In the event of termination of the MOU, the Company shall retain all rights to the existing intellectual property and all intellectual property developed during the term of the MOU and shall be obligated to return all milestones received until such termination.

d.
On February 21, 2018 the Board of Directors resolved to consolidate the Company's share capital by applying a reverse share split at a ratio of 8:1 (the "Reverse Split Ratio") such that every 8 Ordinary shares of NIS 0.10 par value, will be substituted by 1 ordinary share, NIS 0.8 par value (the "Split"). The Split will be applied in the same proportion and manner to all of the Company's authorized, issued and outstanding securities, including preferred shares, options and warrants. See Note 10a.

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES

          The consolidated financial statements are prepared according to United States generally accepted accounting principles ("U.S. GAAP").

a.
Use of estimates:

    The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. On an ongoing basis, the

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

    Company's management evaluates estimates, including those related to fair values of convertible preferred shares warrants, fair values of share-based awards, deferred taxes, and contingent liabilities. Such estimates are based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

b.
Consolidated Financial statements in U.S. dollars:

    The accompanying consolidated financial statements have been prepared in U.S. dollars.

    A substantial portion of the Company's expenses are incurred in New Israeli Shekels. However, the Company finances its operations mainly in U.S. dollars, a substantial portion of its expenses are incurred in U.S. dollars and potential revenues from its primary markets are anticipated to be generated in U.S. dollars. As such, the Company's management believes that the U.S. dollar is the currency of the primary economic environment in which the Company operates. Thus, the functional and reporting currency of the Company is the U.S. dollar.

    Transactions and balances denominated in U.S. dollars are presented at their original amounts. Monetary accounts maintained in currencies other than the dollar are re-measured into dollars in accordance with Accounting Standards Codification No. 830, "Foreign Currency Matters" ("ASC 830"). All transaction gains and losses of the re-measurement of monetary balance sheet items are reflected in the statements of operations as financial income or expenses, as appropriate.

c.
Principles of consolidation:

    The consolidated financial statements include the accounts of the Company and its subsidiary. Intercompany balances have been eliminated upon consolidation.

d.
Cash equivalents:

    Cash equivalents are short-term, highly liquid investments that are readily convertible into cash with an original maturity of three months or less, at the date acquired.

e.
Restricted cash:

    Restricted cash is primarily invested in certificates of deposit and is used as security for the Company's lease commitments.

f.
Short-term deposits

    A short-term bank deposit is a deposit with a maturity of more than three months but less than one year. Deposits in U.S. dollars bear interest at rates ranging from 1.39% - 1.65% and 0.35% - 1.39%, per annum, as of December 31, 2017 and 2016, respectively. The Company had no short-term deposits in NIS as of December 31, 2017. Short-term deposits are presented at cost, which approximates market value due to their short maturities.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

g.
Property and equipment, net:

    Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets at the following rates:

  %

Computers, software and laboratory equipment

  15 - 33

Furniture and office equipment

  7 - 15

Leasehold improvements

  Over the shorter of the term of
the lease or its useful life
h.
Impairment of long-lived assets:

    The Company's long-lived assets are reviewed for impairment in accordance with ASC 360, "Property, Plant and Equipment" ("ASC 360"), whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of an asset to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the asset. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds its fair value. During the years ended December 31, 2017 and 2016, no impairment losses have been identified.

i.
Research and development expenses:

    Research and development expenses consist of personnel costs (including salaries, benefits and share-based compensation), materials, consulting fees and payments to subcontractors, chemical, manufacturing and control activities, costs associated with obtaining regulatory approvals, executing pre-clinical and clinical studies and maintenance and prosecution of the Company's intellectual property rights. In addition, research and development expenses include overhead allocations consisting of various administrative and facilities related costs. The Company charges research and development expenses as expenses when incurred. Grants from the Israeli Innovation Authority (IIA) and the European Commission's Seventh Framework Programme for Research (FP7) are offset against research and development costs at the later of when grant receipt is assured or the expenses are incurred.

j.
Accounting for share-based payments:

    The Company accounts for share based compensation in accordance with ASC No. 718, "Compensation — Stock Compensation" that requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The Company recognizes compensation expenses for the value of its awards granted based on the straight-line attribution method over the requisite service period of each of the awards. The Company recognizes forfeitures of awards as they occur.

    The Company selected the Black-Scholes-Merton Option-Pricing Model (OPM) as the most appropriate fair value method for its option awards. The OPM requires a number of

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

    assumptions, of which the most significant are the expected share price, volatility and the expected option term.

    The fair value of Ordinary shares underlying the options has historically been determined by management and the board of directors. As there has been no public market for the Company's Ordinary shares, the board of directors has determined fair value of an Ordinary share at the time of grant of the option by considering a number of objective and subjective factors including data from other comparable companies, sales of convertible preferred shares to unrelated third parties, operating and financial performance, the lack of liquidity of share capital and general and industry specific economic outlook, amongst other factors. The fair value of the underlying Ordinary shares will be determined by the board of directors until such time as the Company's Ordinary shares are listed on an established share exchange or national market system. The Company's board of directors determined the fair value of Ordinary shares based on valuations performed using the OPM method for the years ended December 31, 2017 and 2016.

    The computation of expected volatility is based on actual historical share price volatility of comparable companies. Expected term of options granted is calculated using the average between the vesting period and the contractual term to the expected term of the options in effect at the time of grant. The Company has historically not paid dividends and has no foreseeable plans to pay dividends and, therefore, uses an expected dividend yield of zero in the option pricing model. The risk-free interest rate is based on the yield of U.S. treasury bonds with equivalent terms as the expected term of the options.

    The fair value for options granted to employees during 2017 is estimated at the date of grant using the Black-Scholes-Merton Option Pricing Model with the following assumptions: expected volatility of 75% - 94%, risk free interest rates of 2.25% - 3.03%, dividend yield of 0%, and an expected term of 7 - 10 years. During 2017, the Company's board of directors deemed the fair value of the Company's Ordinary shares to be $3.92 - $9.52 per share as of the grant date of the options.

    The fair value for options granted to employees during 2016 was estimated at the date of grant using the Black-Scholes-Merton Option Pricing Model with the following assumptions: expected volatility of 75% - 89%, risk free interest rates of 2.16% - 2.69%, dividend yield of 0%, and an expected term of 7 - 10 years. The Company's board of directors deemed the fair value of the Company's Ordinary shares to be $2.96 - $3.92 per share as of the grant date of the options.

    The Company accounts for options granted to consultants and other service providers under ASC 718 and ASC 505, "Equity-based payments to non-employees." The fair value of these options was estimated using the Black-Scholes Option Pricing Model. The fair value is re-measured at each reporting date for all unvested options in accordance with ASC 505.

    Total share-based compensation expenses related to employees, consultants and other service providers for the years ended December 31, 2017 and 2016, amounted to $ 1,375 (out of which $667 were related to non-employees) and $598 (out of which $18 were related to non-employees), respectively.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

k.
Grants and participations:

    Royalty-bearing grants from the Israeli Innovation Authority ("IIA") (previously known as Office of the Chief Scientist) of the Ministry of Economy and Industry in Israel for funding of approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred, and are presented as a deduction from research and development expenses. Non-royalty-bearing grants from the IIA MAGNET program and from European Commission's Seventh Framework Programme for Research (FP7) for funding approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred, and are presented as a deduction from research and development expenses.

    Since the payment of royalties is not probable when the grants are received, the Company does not record a liability for amounts received from IIA until the related revenues are recognized. In the event of failure of a project that was partly financed by IIA, the Company will not be obligated to pay any royalties or repay the amounts received.

    The Company recognizes participations in R&D development, as a reduction from R&D expenses. The excess of the recognized amount received over the amount of research and development expenses incurred during the period is recognized as other income within operating income.

l.
Advance on account of collaboration agreement

    Through December 31, 2017, milestone payments totaling $600 were received by the Company from MIS (see Note 1c). These amounts were recorded as an advance on account of the collaboration agreement. To date, no amounts were recognized in the statements of operations with respect to the collaboration agreement, as all the amounts are refundable.

m.
Convertible preferred shares and convertible preferred shares warrant liability:

    The terms of the convertible preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3 and E shares allow the holders to redeem shares, under certain circumstances, outside of the Company's control. Therefore, these shares are classified as mezzanine equity on the balance sheet and are not included as a component of shareholders' deficiency. The carrying value of the convertible preferred shares is equal to cost. The Company has not adjusted the carrying value to redemption value since it is not probable that the convertible preferred shares will be redeemed.

    Warrants to purchase the Company's convertible preferred shares are classified as a liability on the balance sheet, and measured at fair value, as the underlying shares are contingently redeemable (upon a deemed liquidation event) and, therefore, may obligate the Company to transfer assets at some point in the future. The warrants are subject to re-measurement to fair value at each balance sheet date and any change in fair value is recognized as a component of financial expenses, net, in the statement of operation. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants, or the completion of a deemed liquidation event (see Note 10).

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

n.
Fair value of financial instruments:

    The Company applies ASC 820, "Fair Value Measurements and Disclosures" ("ASC 820"), pursuant to which fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the "exit price") in an orderly transaction between market participants at the measurement date.

    In determining fair value, the Company uses various valuation approaches. ASC 820 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company.

    Unobservable inputs are inputs that reflect the Company's assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances.

    Fair value is an exit price, representing the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.

    A three tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value:

    Level 1 — Observable inputs that reflect quoted prices (unadjusted) in active markets for identical assets and liabilities.

    Level 2 — Include other inputs that are directly or indirectly observable in the marketplace.

    Level 3 — Unobservable inputs which are supported by little or no market activity.

    The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

    The financial instruments carried at fair value on the Company's balance sheet as of December 31, 2017 and 2016 are convertible preferred shares warrants classified as a liability. See Note 7.

    The following methods and assumptions were used by the Company in estimating their fair value disclosures for financial instruments:

    The carrying amounts of cash and cash equivalents, short-term deposits, prepaid expenses and other receivables, trade payables, advances on account of collaboration agreement and other accounts payable and accrued expenses approximate their fair value due to the short-term maturity of such instruments.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

o.
Basic and diluted net loss per share:

    Basic loss per share is computed based on the weighted average number of Ordinary shares outstanding during each year. Diluted loss per share is computed based on the weighted average number of Ordinary shares outstanding during each year, plus the dilutive effect of options considered to be outstanding during each year, in accordance with ASC 260, "Earnings Per Share" ("ASC 260").

    For the years ended December 31, 2017 and 2016, all outstanding options have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive for the periods presented.

p.
Income taxes:

    The Company accounts for income taxes in accordance with ASC 740, "Income Taxes" ("ASC 740"). ASC 740 prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed.

    ASC 740 contains a two-step approach to recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2017, and 2016 no liability for unrecognized tax benefits was recorded as a result of ASC 740.

    The Company's policy is to accrue interest and penalties related to unrecognized tax benefits in its taxes on income.

q.
Concentration of credit risks:

    Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents.

    Cash, cash equivalents and short-term deposits are deposited in major banks in Israel. Such investments in Israel may be in excess of insured limits and are not insured in other jurisdictions. Generally, cash and cash equivalents may be redeemed upon demand and, therefore, bear minimal risk (see note 2f).

    The Company has no off-balance sheet concentration of credit risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

r.
Severance pay:

    All the Company's employees have subscribed to Section 14 of Israel's Severance Pay Law, 5723-1963 ("Section 14"). Pursuant to Section 14, employees covered by this section are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by the Company. Payments in accordance with Section 14 release the Company from any future severance liabilities in respect of those employees.

    Neither severance pay liability nor severance pay fund under Section 14 for such employees is recorded on the Company's balance sheet.

    Through February 2016, several employees also provided services to the Company as service providers. The Company has recorded a provision for severance pay liability for such service providers.

    Severance pay expense for the years ended December 31, 2017 and 2016 amounted to $307 and $249, respectively.

s.
Contingent liabilities

    The Company accounts for its contingent liabilities in accordance with ASC 450, "Contingencies" ("ASC 450"). A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter.

    The Company is occasionally a party to routine claims or litigation incidental to its business. The Company does not believe that it is a party to any pending legal proceeding that is likely to have a material adverse effect on its business, financial condition or results of operations. The Company recorded an accrual in the consolidated statement of operations, which it deems appropriate.

t.
Recently adopted accounting pronouncements

    In March 2016, the FASB issued Accounting Standards Update No. 2016-09, Compensation — Stock Compensation (Topic 718): Improvement to Employee Share-based Payment Accounting (ASU 2016-09), to simplify the accounting for share-based payment transactions, including the income tax consequences, an option to recognize gross share-based compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. Upon adoption of ASU 2016-09, the Company elected to change its accounting policy to account for forfeitures as they occur. The guidance was applied on a modified, retrospective basis in the first quarter of fiscal 2017 and did not have a material impact on the Company's financial results.

u.
New pronouncements not yet effective

    In February 2016, the FASB issued ASU 2016-02, "Leases (Topic 842)" ("ASU 2016-02"), whereby, lessees will be required to recognize for all leases at the commencement date a

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

    lease liability, which is a lessee's obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee's right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. A modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the consolidated financial statements must be applied. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Companies may not apply a full retrospective transition approach. ASU 2016-02 is effective for annual and interim periods beginning after December 15, 2018. Early application is permitted.

    In November 2016, the FASB issued Accounting Standards Update No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (ASU 2016-18), which requires companies to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statement of cash flows. This guidance will be effective for us in the first quarter of 2018 and early adoption is permitted. The Company does not expect the guidance to have a material impact on its financial results.

    In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260); (Part I) Accounting for Certain Financial Instruments with Down Round Features. The ASU allows companies to exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity's own stock. As a result, financial instruments (or embedded conversion features) with down round features may no longer be required to be classified as liabilities.

    A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. For equity-classified freestanding financial instruments, such as warrants, an entity will treat the value of the effect of the down round, when triggered, as a dividend and a reduction of income available to common shareholders in computing basic earnings per share. For convertible instruments with embedded conversion features containing down round provisions, entities will recognize the value of the down round as a beneficial conversion discount to be amortized to earnings. The guidance in ASU 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, and the guidance is to be applied using a full or modified retrospective approach. The Company is evaluating the impact of the revised guidance and does not expect it to have a material impact on its financial results.

v.
Pro forma balance sheet and pro forma net loss per ordinary share:

    The Company is contemplating the filing of a Registration Statement with the U.S. Securities and Exchange Commission to register the offer and sale of the Company's Ordinary shares in connection with the Company's planned qualified initial public offering ("Qualified IPO") in accordance with the Company's Amended and Restated Articles of Association.

    A Qualified IPO is defined as a closing of an offering by the Company of its securities to the public in a bona fide underwriting arrangement under the U.S. Securities Act of 1933, the Israeli Securities Law or similar securities law of another jurisdiction, with gross offering proceeds of not less than $22,000.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Continued)

    Immediately prior to the closing of the Qualified IPO, all of the issued and outstanding preferred shares will be automatically converted into ordinary shares. The unaudited pro forma balance sheet as of December 31, 2017 has been prepared assuming the automatic conversion of all outstanding preferred shares and A warrants into 9,194,735 ordinary shares and the classification of D-2 warrants into shareholders' equity. Pro forma net loss per ordinary share is disclosed in the consolidated statements of operations, which also gives effect to the assumed conversion of the preferred shares as described above.

NOTE 3:- PREPAID EXPENSES AND OTHER RECEIVABLES

    December 31,
 

    2016     2017
 

Government authorities

  $ 170   $ 355  

Prepaid expenses

    258     305  

Grants receivable from IIA

    47     100  

Lease deposits

    28     28  

Others

        4  

  $ 503   $ 792  

NOTE 4:- PROPERTY AND EQUIPMENT, NET

    December 31,
 

    2016     2017
 

Cost:

             

Computers and software

  $ 148   $ 191  

Laboratory equipment

    809     1,613  

Furniture and office equipment

    110     133  

Leasehold improvements

    341     1,755  

    1,408     3,692  

Accumulated depreciation

    (561 )   (766 )

Depreciated cost

  $ 847   $ 2,926  

          Depreciation expenses amounted to $205 and $127 for the years ended December 31, 2017 and 2016, respectively.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 5:- OTHER PAYABLES AND ACCRUED EXPENSES

    December 31,
 

    2016     2017
 

Employees and payroll accruals

  $ 439   $ 507  

Accrued expenses

    377     730  

Other expenses

    104     108  

  $ 920   $ 1,345  

NOTE 6:- COMMITMENTS AND CONTINGENT LIABILITIES

a.
The facilities of the Company are leased under operating lease agreements for periods ending no later than 2028. The Company also leases motor vehicles under various operating leases, the latest of which expires in 2020.

    Future minimum lease payments under operating leases as of December 31, 2017 are as follows:

As of December 31, 2017

       

2018

    1,068  

2019

    1,061  

2020

    1,021  

2021

    1,021  

2022

    1,017  

Thereafter

    2,905  

  $ 8,093  

    As of December 31, 2017, the Company made advance payments on account of car leases in the amount of $103.

    Rental and lease expenses for the years ended December 31, 2017 and 2016 were $785 and $626, respectively.

b.
In connection with its research and development programs, through December 31, 2017, the Company received and accrued participation payments from the IIA in the aggregate amount of $4,652. In return for IIA's participation, the Company is committed to pay royalties at a rate of 3% of sales of the developed product, up to 100% of the amount of grants received plus interest at LIBOR rate. Through December 31, 2017, no royalties have been paid or accrued.

c.
On December 22, 2016, the Company received a written demand for a finder's fee in amount of $250, in connection with 2nd 2016 SPA. In September 2017, a suit was filed against the Company in the Tel-Aviv Magistrates Court in amount of $250.

    The Company believes it has strong defense claims and intends to vigorously defend its position. The Company cannot assess the outcome of this claim due its early stage. The Company included a provision in its consolidated financial statements, which management believe it sufficient.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 7:- FAIR VALUE MEASUREMENTS

          Financial instruments measured at fair value on a recurring basis include convertible preferred shares warrants. The warrants are classified as a liability in accordance with ASC 480-10-25 (see Note 9). These warrants were classified as level 3 in the fair value hierarchy since some of the inputs used in the valuation (the share price) were determined based on management's assumptions. The fair value of the warrants on the issuance date and on subsequent reporting dates was determined using the OPM model. The fair value of the underlying convertible preferred share price was determined by the board of directors considering, among others, a third party valuation. The valuation of the Company was performed using a DCF model. The Company's enterprise value was determined based on financing transactions with third parties and price indications from bankers. The OPM method was then employed to allocate the enterprise value among the Company's various equity classes, deriving a fully marketable value per share for the convertible preferred shares.

          The underlying share price was $22.16 for the convertible preferred D-2 shares. The following assumptions were used to estimate the value of the Series D-2 Preferred share warrants as of December 31, 2017: expected volatility of 95.4%, risk free interest rates of 2.69%, dividend yield of 0% and expected term of 4.25 years.

          The underlying share price was $21.92 for the convertible preferred A shares. The following assumptions were used to estimate the value of the Series A Preferred share warrants as of December 31 2017: expected volatility of 95.4%, risk free interest rates of 2.69%, dividend yield of 0% and expected term of 4.25 years.

          In respect with the issuance warrants during 2016, see also Note 9d.

          The change in the fair value of the preferred share warrants liability is summarized below:

    2016     2017
 

Beginning of year

  $ 193   $ 6,616  

Issuance of warrants

    5,252      

Expiration of warrants C-1, C-2 and D-1

        (70 )

Change in fair value

    1,171     40,853  

End of year

  $ 6,616   $ 47,399  

NOTE 8:- INCOME TAXES

a.
Corporate tax rates:

    The corporate tax rate in Israel in 2016 and 2017 was 26.5% and 24%, respectively.

    On January 4, 2016, the Israeli Parliament's approved the Bill for Amending the Income Tax Ordinance (No. 217) (Reduction of Corporate Tax Rate), 2015, which consists of the reduction of the corporate tax rate from 26.5% to 25%.

    In December 2016, the Israeli Parliament approved the Economic Efficiency Law (Legislative Amendments for Applying the Economic Policy for the 2017 and 2018 Budget Years), 2016,

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 8:- INCOME TAXES (Continued)

    which reduces the corporate income tax rate to 24% (instead of 25%) effective from January 1, 2017 and to 23% effective from January 1, 2018.

b.
Net operating losses carry forward:

    The Company has accumulated losses for tax purposes as of December 31, 2017 in the amount of approximately $40,206 which may be carried forward and offset against taxable income in the future for an indefinite period.

c.
Deferred taxes:

    Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company's deferred tax assets are comprised of operating loss carryforwards and other temporary differences.

    Significant components of the Company's deferred tax assets are as follows:

    December 31,
 

    2016     2017
 

Reserves and allowances

  $ 108   $ 148  

Temporary differences

    735     941  

Loss carryforward

    5,749     9,248  

Deferred tax assets before valuation allowance

    6,592     10,337  

Less — valuation allowance

    (6,592 )   (10,337 )

Net deferred tax assets

  $   $  

    Management currently believes that since the Company has a history of losses, and uncertainty with respect to future taxable income, it is more likely than not that the deferred tax assets will not be utilized in the foreseeable future. Thus, a full valuation allowance was provided to reduce deferred tax assets to their realizable value.

    In 2017 and 2016, the main reconciling item of the statutory tax rate of the Company, 24% and 26.5%, respectively, to the effective tax rate of 0%, is tax loss carryforwards for which a full valuation allowance was provided.

d.
Tax assessment:

    The Company received final tax assessments through 2013.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 9:- CONVERTIBLE PREFERRED SHARES AND WARRANTS

a.
The Composition of the Company's Convertible Preferred shares is as follows:

    December 31, 2016     December 31, 2017
 

    Authorized     Issued and
outstanding
    Authorized     Issued and
outstanding
 

    Number of shares  

Series A Convertible Preferred shares of NIS 0.8 par value

    562,500     506,250     562,500     506,250  

Series A-1 Convertible Preferred shares of NIS 0.8 Par value

    937,500     835,721     937,500     835,721  

Series B Convertible Preferred shares of NIS 0.8 par value

    625,000     592,454     625,000     592,454  

Series B-1 Convertible Preferred shares of NIS 0.8 par value

    1,953,517     1,831,912     1,953,517     1,831,912  

Series C-1 Convertible Preferred shares of NIS 0.8 par value

    750,000     675,651     750,000     675,651  

Series C-2 Convertible Preferred shares of NIS 0.8 par value

    475,000     429,073     475,000     429,073  

Series D-1 Convertible Preferred shares of NIS 0.8 par value

    2,625,000     2,485,889     2,625,000     2,485,889  

Series D-2 Convertible Preferred shares of NIS 0.8 par value

    3,000,000         3,000,000      

Series D-3 Convertible Preferred shares of NIS 0.8 par value

    625,000     603,497     625,000     603,497  

Series E Convertible Preferred shares of NIS 0.8 par value

            1,187,500     1,178,038  

Total

    11,553,517     7,960,447     12,741,017     9,138,485  

    The Company issued Series A, A-1, B, B-1, C-1, C-2, D-1, D-3 and E convertible preferred shares between the years 2008 and 2017. The Company classifies the convertible preferred shares outside of shareholders' equity (deficiency) as required by ASC 480-10-S99-3A and ASR 268, since these convertible preferred shares are entitled to liquidation preferences which may trigger a distribution of cash or assets that is not solely within the Company's control.

    Pursuant to the Company's Amended and Restated Articles of Incorporation (the "AoA"), a deemed liquidation event would occur, inter alia, upon the closing of the transfer of the Company's securities to a person or a group of affiliated persons, in one or a series of related transactions, if immediately after such transaction, such person or group of affiliated persons would hold 50% or more of the outstanding voting shares of the Company and upon the occurrence of the events listed in the AoA. For the years ended December 31, 2017 and 2016, the Company did not adjust the carrying values of the convertible preferred shares to the deemed liquidation values of such shares since a deemed liquidation event was not probable at each balance sheet date. Subsequent adjustments to increase the carrying values to the ultimate liquidation values will be made only when it becomes probable that such a deemed liquidation event will occur.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 9:- CONVERTIBLE PREFERRED SHARES AND WARRANTS (Continued)

b.
Preferred shares rights:

    Series A, A-1, B, B-1, C-1,C-2, D-1,D-3 and E convertible preferred shares confer upon their holders all the rights conferred by Ordinary shares, in addition to certain rights stipulated in the Company's AOA, inter alia, the following:

    Dividend rights — the holders of Series A, A-1, B, B-1, C-1, C-2 , D-1, D-3 and E convertible preferred shares shall be entitled to receive on a pari passu basis, prior and in preference to the declaration or payment of any dividend or distribution to the holders of any other class of shares on an as-converted basis if any dividend or distribution is declared by the Company's board of directors, an amount equal to 6% of the applicable original issue price for such preferred shares per annum (the "Preference Dividend").

    The preference order is such that Series E, Series D, Series C-2, Series C-1, Series B-1, Series B, Series A-1 and Series A shareholders shall be entitled, in their respective order, to receive, prior and in preference to the above order, any distribution of any asset, capital, earnings or surplus funds of the Company. After the Preference Dividend has been paid in full, the preferred shareholders' shall participate pro-rata and pari-passu, on an as converted basis with the Ordinary shareholders' in the receipt of any additional dividend distributed.

    Liquidation rights — In the event of any event of liquidation or deemed liquidation event, the Company shall distribute to the holders of convertible preferred shares, prior to and in preference to any payments to any of the holders of any other classes of shares, a per share amount equal to the original issuance price plus 6% annual interest compounded annually from the date of issuance and up to the date of liquidation for each of their shares. Holders of Series E preferred shares and D preferred shares shall receive an amount equal to the original issuance price thereof, times 1.3, plus 6% annual interest, on the original issue price, compounded annually from the date of issuance and up to the date of liquidation for each of their shares plus an amount equal to the declared but unpaid dividends, less the amount any dividend preference previously declared and actually paid.

    The liquidation order is such that Series E, Series D, Series C-2 and Series C-1, Series B-1, Series B Series A-1, and Series A shareholders' shall be entitled, in their respective order, to receive, prior and in preference to the above order any distribution of any asset, capital, earnings or surplus funds of the Company.

    All remaining assets shall be distributed among all the shareholders pro rata in proportion to the number of Ordinary shares held by them on an as converted basis. The original issue price of the Series A, A-1, B, B-1 and C-1 Preferred shares is $1.44, $1.68, $3.44, $4.84, and $6.64 per share, respectively, Series C-2, D-1 and D-3 is $8.83 per share and Series E is $12.72 per share.

    Voting rights — each holder of Series A, A-1, B, B-1, C-1, C-2, D-1, D-3 and E Convertible Preferred share is entitled to one vote per each share held by it (on an as converted basis).

    Conversion — each preferred share is convertible into ordinary shares, at the holder's option, or automatically upon a Qualified Initial Public Offering ("Qualified IPO") of the Company or upon written demand of the Investor Majority (as defined in the AoA).

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 9:- CONVERTIBLE PREFERRED SHARES AND WARRANTS (Continued)

    At the current conversion prices, each share of Series A, A-1, B, B-1, C-1, C-2, D-1, D-3 and E will convert to ordinary shares on a 1-for-1 ratio. The current conversion price per preferred share will be adjusted in the event of recapitalizations, splits, Ordinary share dividends and standard anti-dilution events.

c.
Financing rounds:

    On February 4, 2016, the Company entered into a Share Purchase Agreement (the "2016 SPA") with new and existing investors, the closing of which was consummated on February 24, 2016. According to the 2016 SPA, the Company shall issue to the investors up to 2,548,586 series D-1 Preferred shares for an aggregate amount of up to $22,500, at a price per share of $8.83 and shall grant to the investors and/or any other individuals or entities as instructed by the investors, warrants to purchase up to 2,548,586 D-2 Preferred shares at a price per share of $10.15 against payment of a total exercise amount of up to $25,875.

    The Company issued to the investors 2,485,889 series D-1 convertible preferred shares and warrants for an aggregate consideration of $15,944 (net of $5,215 fair value of warrants liability issued to investors and issuance costs as described below). Issuance costs consisting of: (1) $570 in cash, (2) $180 settled as issuance of Preferred D-1 shares to MarketBridges, and (3) $37 value of warrants issued to MarketBridges (as described below).

    On August 24, 2016, the Company entered into a Securities Purchase Agreement (the "2nd 2016 SPA ") with new and existing investors, the closing of which was consummated on November 8, 2016. According to the 2nd 2016 SPA and the joinder thereto, the Company shall issue to the investors 603,497 Series D-3 Preferred Shares for an aggregate amount of $5,328 at a price per share of $8.83 ($5,053, net of $275 issuance costs in cash).

    During August to October 2017, the Company entered into a Securities Purchase Agreement (the "2017 SPA") with new and existing investors for an aggregate amount of up to $15,000. The Company received $13,410 as part of the initial closing and issued to the investors 1,054,581 Series E Preferred Shares (net of $620 issuance costs) at a price per share of $12.72. Issuance costs consisting of: (1) $102 in cash and (2) $518 settled as issuance of Preferred E shares as a finder fee.

    During November to December, as part of the deferred closing, the Company entered into Joinder Agreements to the 2017 SPA with new and existing investors, and received an additional amount of $1,570 (net of $45 issuance costs) and issued to the investors 123,457 Series E Preferred Shares, at a price per share of $12.72. The fair value of the Series E Preferred Shares issued in the deferred closing to the 2017 SPA was higher than value of the Series Preferred Shares issued in the initial closing to the 2017 SPA, and accordingly, the Company measured a beneficial feature of $1,255 for the deferred closing investors which was accounted for as a deemed dividend and was recorded as mezzanine equity for the year ended December 31, 2017.

    The Company recorded compensation expenses of $387 against mezzanine equity for the year ended December 31, 2017 in respect of a shareholder and director who participated in the deferred closing to the 2017 SPA (see Note 14).

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 9:- CONVERTIBLE PREFERRED SHARES AND WARRANTS (Continued)

    The terms of the convertible preferred E shares allow the holders to redeem shares, under certain circumstances, outside of the Company's control. Therefore, these shares are classified as mezzanine equity on the balance sheet and are not included as a component of shareholders' deficiency. The carrying value of the convertible preferred shares is equal to cost. The Company has not adjusted the carrying value to redemption value since it is not probable that the convertible preferred shares will be redeemed.

d.
Warrants to purchase preferred shares:

    In March 2008, in connection with the March 2008 Founders and Share Purchase Agreement, the Company granted to the investor warrants to purchase preferred A shares, with an exercise price of NIS 0.80.

    The A warrants may be converted at any time until the earlier of (1) consummation of an initial public offering on certain stock exchanges as set forth in the warrant terms, with net proceeds to the Company of at least $15,000 (and pre-money valuation of at least $75,000), (2) merger or consolidation of the Company with another company, and (3) the sale of substantially all of the Company's assets or substantially all of the shares to another party. The Company anticipates that the A warrants will be exercised prior to the closing of this offering.

    In January 2015, in connection with the receipt of convertible loans in the amount of $1,500 to a certain investor (the "Investor"), the Company issued warrants to purchase preferred shares to Market Bridges Ltd. ("MarketBridges"). The C-1 warrants expired on June 11, 2017 prior to any exercise.

    In September 2015, in connection with the issuance of C-2 shares in the amount of $500 to a certain investor (the "New Investor"), the Company issued warrants to purchase preferred shares to MarketBridges. The C-2 warrants expired on September 2, 2017 prior to any exercise.

    On February 23, 2016, in connection with 2016 SPA the Company granted to the investors and/or any other individuals or entities as instructed by the investors, warrants to purchase up to 20,389 D-1 Preferred shares and up to 2,506,273 D-2 Preferred shares at a price per share of $10.15 against payment of a total exercise amount of up to $25,875 (see b above).

    The 2016 SPA, as amended, provided that the Company shall issue additional D-2 warrants to purchase preferred D-2 shares if the Company did not complete an initial public offering ("IPO") by December 31, 2016 of its shares in the United States, which yields gross proceeds to the Company of at least $22 million. In such event, the exercise price of all the D-2 warrants shall concurrently be reduced to $8.83 per preferred D-2 share. Accordingly, during January 2017, the Company issued an additional 375,942 warrants to purchase preferred D-2 shares with an exercise price of $8.83, 6,117 of which were issued as part of the issuance expenses to MarketBridges (see below).

    In February 2016, in connection with 2016 SPA and in accordance with the terms of the Service Finance Agreement with MarketBridges, the Company included the following as part of its issuance costs: (1) $360, representing 5% of the investment made by the New Investor (out of which, $180 was settled in cash and $180 as payment for issuance of 20,389 Preferred D-1

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 9:- CONVERTIBLE PREFERRED SHARES AND WARRANTS (Continued)

    shares and issuance of 20,389 warrants to purchase D-1 Preferred shares) and (2) 40,777 issuance of D-2 warrants with an exercise price of $10.15 representing 5% of the shares to be received by the New Investor (see also b above).

    All outstanding A and D-2 warrants are classified as a long-term liability and are re-measured at each reporting date, as the underlying shares may be redeemed upon an event which is not solely in the control of the Company.

    The D-1 warrants expired on February 4, 2017 prior to any exercise.

    The survival of D-2 warrants shall be limited to a period ending upon the earlier of: (i) the lapse of 5 years from closing; or (ii) deemed liquidation event.

    The D-2 warrants will be exercised automatically if they are still outstanding on the final day of the warrant period as defined in the warrants grant letter, and if the fair market value of a warrant share is more than the exercise price for such share.

    As of December 31, 2017, 2,882,215 D-2 warrants and 56,250 A warrants are outstanding.

NOTE 10:- SHAREHOLDERS' DEFICIENCY

          

a.
General:

    All Ordinary shares, Convertible Preferred shares, options, convertible loans, warrants, exercise prices, per share data and loss per share amounts have been adjusted retroactively for all periods presented in these financial statements, to reflect the eight-to-one reverse share split approved by the Company's board of directors on February 21, 2018 and par value adjustment from NIS 0.1 to NIS 0.8.

b.
Ordinary share capital is composed as follows:

    December 31, 2016     December 31, 2017
 

    Authorized     Issued and
outstanding
    Authorized     Issued and
outstanding
 

    Number of shares
 

Ordinary shares of NIS 0.08 par value

    14,500,000     568,078     15,687,500     584,151  
c.
Ordinary shares rights:

    The Ordinary shares confers upon its holders the right to participate in the general meetings of the Company, to vote at such meetings (each share represents one vote), and to participate in any distribution of dividends or any other distribution of the Company's property, including the distribution of surplus assets upon liquidation.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 10:- SHAREHOLDERS' DEFICIENCY (Continued)

          

d.
Share option plans:

    The Company has authorized through its 2012 Share Option Plan, the grant of options to officers, directors, advisors, management and other key employees of up to 2,219,443 Ordinary shares. The options granted generally have a three-year vesting period and expire ten years after the date of grant. Options granted under the Company's option plan that are cancelled or forfeited before expiration become available for future grant. As of December 31, 2017, 200,442 of the Company's options were available for future grants.

    On July 19, 2015, the board of directors approved that if any transaction (merger, acquisition, reorganization of the company with one or more other entities pursuant to which the company is not the surviving entity or sale of all or substantially all of the assets or shares of the company) is consummated by the Company, then the vesting schedule of the options granted to its senior management shall be accelerated so that 50% of the unvested options shall be fully vested immediately prior to the transaction, and the remaining 50% of the then unvested options shall continue to vest in accordance with the same vesting schedule.

    A summary of the status of options to employees under the Company's option plan as of December 31, 2017 and changes during the relevant period ended on that date is presented below:

    Year ended December 31, 2017  

    Number
of options
    Weighted
average
exercise
price
    Aggregate
intrinsic
value
    Weighted
average
remaining
contractual
life (years)
 

Outstanding at beginning of year

    1,120,280     4.00     1,306     7.43  

Granted

    592,312     6.88              

Exercised

    (16,073 )   4.24              

Forfeited and cancelled

    (1,337 )   2.96              

Outstanding at end of year

    1,695,182     4.96     22,596     7.60  

Exercisable options

    973,288     3.68     14,272     6.14  

Vested and expected to vest

    1,695,182     4.96     22,596     7.60  

    On November 2, 2017, the Company's compensation committee and board of directors resolved to recommend before the shareholders to grant to the Company's CEO, CFO and CTO options to purchase 162,500, 75,000 and 162,500 shares, respectively, at an exercise price of $7.36 per share, which was the fair market value known at such date.

    The options shall vest quarterly and become exercisable during a three-year period as of the vesting commencement date (1/12 at the end of each quarter). It is hereby clarified that if the IPO does not accrue until the eleven month anniversary of the vesting commencement date, any and all options hereby granted shall expire immediately.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 10:- SHAREHOLDERS' DEFICIENCY (Continued)

    A summary of options to employees under the Company's option plan as of December 31, 2016 and changes during the relevant period ended on that date is presented below:

    Year ended December 31, 2016  

    Number
of options
    Weighted
average
exercise
price
    Aggregate
intrinsic
value
    Weighted
average
remaining
contractual
life (years)
 

Outstanding at beginning of year

    1,034,932     2.72     877     8.16  

Granted

    114,356     3.44              

Exercised

                     

Forfeited and cancelled

    (29,008 )   4.96              

Outstanding at end of year

    1,120,280     4.00     1,306     7.43  

Exercisable options

    820,092     3.12     1,259     6.79  

Vested and expected to vest

    1,120,280     4.00     1,306     7.43  

    The total equity-based compensation expense related to all of the Company's equity-based awards recognized for the year ended December 31, 2016 and 2017, was comprised as follows:

    Year ended
December 31,
 

    2016     2017
 

Research and development

    289     393  

General and administrative

    309     982  

Total share-based compensation expense

    598     1,375  

    General and administrative costs include compensation expenses of $387 related to the deferred closing of 2017 SPA (see Note 9c).

    As of December 31, 2017, there were unrecognized compensation costs of $5,630, which are expected to be recognized over a weighted average period of approximately 2.7 years.

    The weighted average grant date fair value of the Company's options granted during the year ended December 31, 2017, and 2016 was $6.88 and $3.44, respectively.

    16,073 options were exercised during the year ended December 31, 2017, no options were exercised during the year ended December 31, 2016. The Company's board of directors deemed the fair value of the Company's Ordinary shares to be $18.32 per share as of December 31, 2017.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 10:- SHAREHOLDERS' DEFICIENCY (Continued)

    The options outstanding as of December 31, 2017 are comprised, as follows:

Exercise
price(*)
    Options
outstanding
as of
December 31,
2017
    Weighted
average
exercise
price
    Weighted
average
remaining
contractual
term
    Options
exercisable
as of
December 31,
2017
    Weighted
average
exercise
price
    Weighted
average
remaining
contractual
term
 
                  (years)                 (years)  
0.24     261,047     0.24     5.22     261,047     0.24     5.04  
1.68     112,870     1.68     5.22     112,870     1.68     5.22  
3.44     87,346     3.44     5.33     87,346     3.44     5.33  
4.84     308,213     4.84     6.33     308,213     4.84     6.33  
8.83     221,319     8.83     7.87     151,905     8.83     7.86  
2.96     39,575     2.96     8.41     19,275     2.96     8.40  
3.76     72,500     3.76     8.98     24,167     3.76     8.98  
3.92     23,875     3.92     9.19     5,969     3.92     9.19  
4.00     58,750     4.00     9.40     2,496     4.00     9.40  
7.36     509,687     7.36     9.84         7.36      
      1,695,182     4.96     7.60     973,288     3.68     6.14  


(*)
The exercise price of the options is denominated in NIS and was translated to USD in the table above using the exchange rate as of the issuance date of the options. The options were granted at the Ordinary share par value.
e.
Options issued to non-employees:

    Outstanding options granted to consultants as of December 31, 2017 were as follows:

Grant date

    Options
outstanding
as of
December 31,
2017
    Exercise
price per
share
    Options
exercisable
as of
December 31,
2017
  Exercisable
through

March 2013

    23,282   $ 1.68     23,282   March 2023

October 2013

    5,982   $ 4.84     5,982   October 2023

June 2014

    5,875   $ 4.84     5,875   June 2024

September 2014

    5,982   $ 4.84     5,982   September 2024

April 2016

    6,250   $ 2.96     3,633   April 2026

December 2016

    7,500   $ 3.76     3,103   March 2023

June 2017

    206,823   $ 3.92     52,299   June 2027

August 2017

    5,875   $ 8.88     3,415   August 2027

November 2017

    56,250   $ 7.36       March 2027

    323,819           103,571    

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 11:- FINANCIAL EXPENSES, NET

    Year ended
December 31,
 

    2016     2017
 

Financial expenses:

             

Revaluation of warrants

   
1,171
   
40,783
 

Others

    108     16  

Total financial expenses, net

    1,279     40,799  

Financial income:

             

Interest from deposits

   
(71

)
 
(90

)

Foreign currency transaction gains, net

    (75 )   (21 )

Total financial income:

    (146 )   (111 )

Financial expenses, net

  $ 1,133   $ 40,688  

NOTE 12:- BASIC AND DILUTED NET LOSS PER SHARE

    The following table sets forth the computation of the Company's basic and diluted net loss per Ordinary share:

    Year ended
December 31,
 

    2016     2017
 

Numerator:

             

Net loss attributable to Ordinary shares as reported

 
$

(11,392

)

$

(54,488

)

Preferred share preference

    (2,608 )   (3,399 )

Deemed dividend

        (1,255 )

Net loss applicable to Ordinary shareholders

  $ (14,000 ) $ (59,142 )

Denominator:

             

Weighted average shares used in computing net loss per Ordinary share, basic and diluted:

   
 
   
 
 

Ordinary share — basic

    568,078     579,676  

Ordinary share equivalents

         

Ordinary share — dilutive

    568,078     579,676  

Net loss per ordinary share, basic and diluted

  $ (24.64 ) $ (102.00 )

    The impact of share-based options, warrants, and the convertible preferred shares on earnings per share is anti-dilutive as the Company had a net loss in 2017 and 2016.

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 13:- PRO FORMA BASIC AND DILUTED NET LOSS PER SHARE

    The following table sets forth the computation of the Company's pro forma basic and diluted net loss per ordinary share (unaudited):

    Year ended
December 31,
2017
 

    Unaudited  

Net loss attributable to ordinary shares as reported

  $ (55,743 )

Shares used in computing net loss per ordinary share, basic and diluted

    579,676  

Pro forma adjustments to reflect assumed conversion of convertible preferred shares and exercise of warrants A

    8,242,844  

Shares used in computing pro forma net loss per ordinary share, basic and diluted

    8,822,520  

Pro forma net loss per ordinary share, basic and diluted

  $ (6.32 )

    The A warrants will expire upon the consummation of the Company's initial public offering. Accordingly, the Company assumes, considering the exercise price of the A warrants and the fair value of the Company's Ordinary Shares at present, and the increase in fair value following the Company's initial public offering, that the investors will exercise the A warrants prior to the warrants' expiration.

    The D-2 warrants, on the other hand, do not expire upon the consummation of the Company's initial public offering. Accordingly, no assumptions are made regarding exercise by investors. Furthermore, pursuant to their terms, if at any time the entire class of Series D-2 preferred shares is converted into Ordinary Shares, then the warrant shall automatically be deemed exercisable into Ordinary Shares. Pursuant to the Company's articles of association currently in effect, upon the consummation of the Company's initial public offering, the entire class of Series D-2 preferred shares shall be converted into Ordinary Shares.

NOTE 14:- RELATED PARTY TRANSACTIONS

a.
The Company executed a transaction with a related party as detailed below.

    As described in Note 9c, on December 20, 2017, as part of the deferred closing of the 2017 SPA a shareholder and director of the Company invested $370 for the issuance of 29,087 Series E Preferred Shares. In this respect, the Company recorded general and administrative compensation expenses of $387 against mezzanine equity for the year ended December 31, 2017.

NOTE 15:- SUBSEQUENT EVENTS

a.
The Company evaluates events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements to identify matters that require

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POLYPID LTD AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

U.S. dollars in thousands (except share and per share data)

NOTE 15:- SUBSEQUENT EVENTS (Continued)

    additional disclosure. For its annual consolidated financial statements as of December 31, 2017 and for the year then ended, the Company evaluated subsequent events through March 14, 2018, the date that the consolidated financial statements were issued. Except as described below, the Company has concluded that no subsequent event has occurred that require disclosure.

b.
On January 30, 2018, the Board of Directors approved to increase the option pool by 750,000 options.

c.
On January 30, 2018, the Board of Directors approved a grant of 16,563 options to certain employees. 33% of the options shall vest on the first anniversary of the vesting commencement date, and additional 8.375% of the options shall vest upon the lapse of each full additional three months of the vesting commencement date, for an additional period of two years.

d.
On January 30, 2018, the Board of Directors of the Company recommended to the Company's shareholders to approve the grant of 37,500 options to Jacob Harel, the Chairman of the Board of Directors. On February 8, 2018, the shareholders of the Company approved this grant.

-- - - - - - - - - - - -

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3,333,333 Shares

PolyPid Ltd.

Ordinary Shares



LOGO



Goldman Sachs & Co. LLC   Cowen

Cantor

Raymond James   Oppenheimer & Co.



          Through and including                           , 2018 (the 25th day after the date of this prospectus), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer's obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.

   


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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS

Item 6.    Indemnification of Directors, Officers and Employees.

          Under the Israeli Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty. An Israeli company may exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care, but only if a provision authorizing such exculpation is included in its articles of association. Our amended and restated articles of association to be effective upon the closing of this offering include such a provision. A company may not exculpate in advance a director from liability arising out of a breach of the duty of care with respect to a distribution.

          Under the Israeli Companies Law, a company may indemnify an office holder with respect to the following liabilities and expenses incurred for acts performed by him or her as an office holder, either pursuant to an undertaking made in advance of an event or following an event, provided its articles of association include a provision authorizing such indemnification:

    financial liability imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator's award approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company's activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria;

    reasonable litigation expenses, including attorneys' fees, incurred by the office holder (1) as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding; and (ii) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent; and (2) in connection with a monetary sanction; and

    reasonable litigation expenses, including attorneys' fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf, or by a third party, or in connection with criminal proceedings in which the office holder was acquitted, or as a result of a conviction for an offense that does not require proof of criminal intent.

          Under the Israeli Companies Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder, if and to the extent provided in the company's articles of association:

    a breach of the duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;

    a breach of the duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; and

    a financial liability imposed on the office holder in favor of a third party.

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          Under the Israeli Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:

    a breach of the duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;

    a breach of the duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;

    an act or omission committed with intent to derive illegal personal benefit; or

    a fine, civil fine, monetary sanction or forfeit levied against the office holder.

          Under the Israeli Companies Law, exculpation, indemnification and insurance of office holders in a public company must be approved by the compensation committee and the board of directors and, with respect to certain office holders or under certain circumstances, also by the shareholders. See "Management — Approval of Related Party Transactions under Israeli Law — Fiduciary Duties of Directors and Executive Officers."

          Our amended and restated articles of association to be effective upon the closing of this offering will permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted or to be permitted by the Israeli Companies Law.

          We intend to obtain directors and officers liability insurance for the benefit of our office holders and intend to continue to maintain such coverage and pay all premiums thereunder to the fullest extent permitted by the Israeli Companies Law. In addition, prior to the closing of this offering, we intend to enter into agreements with each of our directors and executive officers exculpating them from liability to us for damages caused to us as a result of a breach of duty of care and undertaking to indemnify them, in each case, to the fullest extent permitted by our amended and restated articles of association to be effective upon the closing of this offering and Israeli law, including with respect to liabilities resulting from this offering to the extent that these liabilities are not covered by insurance.

          Insofar as the indemnification for liabilities arising under the Securities Act of 1933, as amended, or the Securities Act, may be permitted to directors, officers or persons controlling the registrant, 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.

Item 7.    Recent Sales of Unregistered Securities.

          The following list sets forth information as to all securities we have sold since January 1, 2014, which were not registered under the Securities Act.

    In June 2014, we issued an aggregate of 825,627 Series B-1 preferred shares pursuant to a private placement, at a price per share of $4.84.

    In June 2015, we issued 429,073 Series C-2 preferred shares pursuant to a private placement, at a price per share of $8.83.

    In June 2015, we issued an aggregate of 675,651 Series C-1 preferred shares pursuant to convertible loan agreements, at a price per share of $6.64.

    In September 2015, we issued warrants to purchase up to 2,832 Series C-2 preferred shares, at an exercise price per share of $8.83.

    In February 2016, we issued in connection with a private placement: (i) an aggregate of 2,485,889 Series D-1 preferred shares at a price per share of $8.83, (ii) warrants to

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      purchase up to 20,389 Series D-1 preferred shares, at an exercise price per share of $8.83, and (iii) warrants to purchase up to 2,506,273 Series D-2 preferred shares, which was subsequently adjusted to up to 2,882,215 Series D-2 preferred shares, at an exercise price per share of $10.15.

    In November 2016, we issued an aggregate of 603,497 Series D-3 preferred shares pursuant to a private placement, at a price per share of $8.83.

    In August through December 2017, we issued an aggregate of 1,178,038 Series E preferred shares pursuant to a private placement, at a price per share of $12.72.

          The sales of the above securities were deemed to be exempt from registration under the Securities Act because they were made outside of the United States of America to certain non-U.S. individuals or entities pursuant to Regulation S or, in reliance upon the exemption from registration provided under Section 4(a)(2) of the Securities Act and the regulations promulgated thereunder.

          Additionally, we granted share options to employees, directors, consultants and service providers under our 2012 Plan covering an aggregate of 1,521,427 ordinary shares, with exercise prices ranging from $0.24 to $8.88 per share. Such number excludes options to purchase up to 546,632 ordinary shares, which are contingent upon the closing of this offering.

          We claimed exemption from registration under the Securities Act for these option grants described above under Section 4(a)(2), Regulation S, or under Rule 701 of the Securities Act as transactions pursuant to written compensatory plans or pursuant to a written contract relating to compensation.

          No underwriters were employed in connection with the securities issuances set forth in this Item.

Item 8.    Exhibits and Financial Statement Schedules.

(a)
Exhibits.    See the Exhibit Index attached to this registration statement, which is incorporated by reference herein.

(b)
Financial Statement Schedules.    Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.

Item 9.    Undertakings.

          The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

          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.

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          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; and

    (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.

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EXHIBIT INDEX

  EXHIBIT
NUMBER
  EXHIBIT DESCRIPTION
  1.1 * Form of Underwriting Agreement

 

3.1

 

Amended and Restated Articles of Association of the Registrant, as currently in effect

 

3.2

 

Form of Articles of Association of the Registrant to be effective upon the closing of this offering

 

4.1

*

Warrant to purchase Series A Preferred Shares

 

4.2

*

Form of Warrant to purchase Series D-2 Preferred Shares

 

5.1

 

Opinion of Zysman, Aharoni, Gayer & Co., Israeli counsel to the Registrant, as to the validity of the ordinary shares

 

10.1

*

Form of Officer Indemnity and Exculpation Agreement

 

10.2

 

Amended and Restated PolyPid Ltd. 2012 Share Option Plan

 

10.3

*

Amended and Restated Investors' Rights Agreement, dated October 31, 2017, among the Registrant and the shareholders named therein

 

10.4

*

Lease Agreement, dated March 27, 2014, by and between the Registrant and Ogen Yielding Real Estate Ltd. (unofficial English translation from Hebrew original)

 

10.4.1

*

Addendum to Lease Agreement, dated July 1, 2014, by and between the Registrant and Ogen Yielding Real Estate Ltd. (unofficial English translation from Hebrew original)

 

10.4.2

*

Second Addendum to Lease Agreement, dated July 23, 2017, by and between the Registrant and Ogen Yielding Real Estate Ltd. (unofficial English translation from Hebrew original)

 

10.4.3

*

Third Addendum to Lease Agreement, dated November 28, 2017, by and between the Registrant and Ogen Yielding Real Estate Ltd. (unofficial English translation from Hebrew original)

 

21.1

*

Subsidiaries of the Registrant

 

23.1

 

Consent of Kost, Forer, Gabbay & Kasierer, Certified Public Accountants (Israel), an independent registered public accounting firm and a member firm of Ernst & Young LLP

 

23.2

 

Consent of Zysman, Aharoni, Gayer & Co. (included in Exhibit 5.1)

 

23.3

*

Consent of Life Science Intelligence, Inc.

 

24.1

*

Power of Attorney (included in signature pages of Registration Statement)

*
Previously filed.

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SIGNATURES

          Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-1 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Petach Tikva, Israel on this 14th day of March, 2018.

  POLYPID LTD.

 

By:

 

/s/ AMIR WEISBERG


Amir Weisberg
Chief Executive Officer

          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/ AMIR WEISBERG

Amir Weisberg
  Chief Executive Officer and Director (Principal Executive Officer)   March 14, 2018

*

Dikla Czaczkes Akselbrad

 

Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 

March 14, 2018

*

Jacob Harel

 

Chairman

 

March 14, 2018

*

Yechezkel Barenholz, Ph.D.

 

Director

 

March 14, 2018

*

Noam Emanuel, Ph.D.

 

Director

 

March 14, 2018

*

Eli Frydman Ph.D.

 

Director

 

March 14, 2018

*

Chaim Hurvitz

 

Director

 

March 14, 2018

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SIGNATURE
 
TITLE
 
DATE

 

 

 

 

 

 

 

 

 
*

Jack Eitan Kyiet
  Director   March 14, 2018

*

Anat Tsour Segal

 

Director

 

March 14, 2018

*By:

 

/s/ AMIR WEISBERG

Amir Weisberg
Attorney-in-fact

 

 

 

 

PolyPid Inc.

 

 

 

 

By:

 

/s/ AMIR WEISBERG


 

AUTHORIZED U.S. REPRESENTATIVE

 

March 14, 2018
    Name:   Amir Weisberg        
    Title:   President        

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EX-3.1 2 a2234591zex-3_1.htm EX-3.1

Exhibit 3.1

 

THE COMPANIES LAW - 1999

 

A COMPANY LIMITED BY SHARES

 

AMENDED AND RESTATED

 

ARTICLES OF ASSOCIATION OF

 

POLYPID LTD.

 

PRELIMINARY

 

1.                                      In these Articles of Association, unless the context otherwise requires:

 

The “Articles” shall mean the Articles of Association of the Company as shall be in force from time to time.

 

The “Aurum Group” shall mean (i) Aurum Ventures M.K.I. Ltd. (“Aurum”) and any entity which Controls Aurum, any entity which Aurum Controls, any entity Controlled by the same entity Controlling Aurum or with respect to any of the aforementioned Aurum entities which is an individual, such Person’s spouse, siblings and children or any trust for the benefit of any of the foregoing and any of their respective Controlled entities, and any successor and assignor thereof; and (ii) Dan Gelvan.

 

The “Board of Directors” or “Board” shall mean the Company’s Board of Directors.

 

The “Closing” shall mean the Closing pursuant to the Purchase Agreement.

 

The “Company” shall mean PolyPid Ltd.

 

The “Companies Law” shall mean the Companies Law 5759-1999, as amended from time to time and the provisions of the Companies Ordinance [New Version] 5743-1983 that remain in effect or are given effect from time to time.

 

Control” shall mean holding of more than 50% of the issued and outstanding share capital of a company on an as converted basis and/or the voting rights of a company, and/or the right to appoint the majority of the directors of a company.

 

The “Directors” shall mean the members of Company’s Board of Directors.

 

An “Eligible E Holder” shall mean any holder of Series E Preferred Shares, holding at least 1% of the Company’s issued and outstanding share capital (on an as-converted basis).

 

An “Institutional Entity” shall mean any of the entities listed in the First Supplement of the Securities Law, 5728-1968.

 

The “Issuing Date” shall mean, in the case of a particular Share, the date on which such share was originally issued by the Company to a Shareholder.

 

The “Lead Investor” shall mean Shavit Capital Fund III (US), L.P., a Delaware limited partnership and Gabriel Capital Fund (US), L.P., a Delaware limited partnership.

 

1



 

The “Limited Partners” shall mean the following (i) limited partners of Friendly Angels I., L.P. (“FAC Partnership”): Gerry Rubens, David Delevi, Shabtay Vogel, Eitan Adres, Leo Malamud, Adi Lahat, Eftan Investment Consulting Ltd., Egon Mining and Exploration Ltd., RB Holding Company S.A., Tiferet Hamechonit Leasing Ltd., WG-Fifth Ave LLC, Six Continents Group LLC Defined Benefit Jeffrey Sacks Trustee, Yaki De Levi, Ory Vogel, Saul Goldberg, Jose Birnabaum, Yuval Harari, Joseph Englhard, Eitan Kyiet, Yosef Paciuk, Arnon Wilinski, Ran Gants, Yossi Zaykovsky and Gil Naor, Neveh-Oded Building & Investment company Ltd., Trans Opera SARL, Guibor S.A., Financiere Saint James S.A.S, H. Stark Investments Ltd., Stark Investments (D.H.) Limited, Friendly Angels, L.P. (“Partnership”), Friendly Angels Club Advisors Ltd. and AW Equity S.A and any subsequent limited partner of the Partnership as shall be notified by the general partner of the Partnership and as shall be approved by the Board of Directors of the Company.

 

The “Majority E Holders” shall mean the holders of Series E Preferred Shares holding the majority of the issued and outstanding Series E Preferred Shares.

 

The “Majority Investors” shall mean the holders of Series D-1 Preferred Shares, Series D-2 Preferred Shares and Series D-3 Preferred Shares holding the majority of the issued and outstanding Series D-1 Preferred Shares, Series D-2 Preferred Shares and Series D-3 Preferred Shares, pari passu, on an as converted basis which majority shall in all events (except in relation to the provisions of Article 11(d)(i)(B)) include the Lead Investor, as long as the Lead Investor (and its Permitted Transferees) continues to hold at least 50% of the Series D-1 Preferred Shares issued to it at the Closing (not including, for the avoidance of doubt, any Warrant Shares).

 

The “Office” shall mean the registered office of the Company, as it shall be from time to time.

 

The “Ordinary Shares” are as defined in Article 5.

 

The “Original Issue Price shall generally mean, with respect to each Preferred Share, the original price actually paid or deemed to have been paid to the Company for such Preferred Share, and shall be subject to adjustment as provided herein. The Original Issue Price of each Series A Preferred Share is US$0.18. The Original Issue Price of each Series A-1 Preferred Share is US$0.2094. The Original Issue Price of each Series B Preferred Share is US$0.4295. The Original Issue Price of each Series B-1 Preferred Share is US$0.6056. The Original Issue Price of each Series C-1 Preferred Share is US$0.8276. The Original Issue Price of each Series C-2 Preferred Share is US$1.1035. The Original Issue Price of each Series D-1 Preferred Share is US$ 1.1036. The Original Issue Price of each Series D-2 Preferred Share shall initially be $1.1036, but such figure shall be as may be adjusted under the Purchase Agreement, the Warrant and/or hereunder from time to time in accordance therewith and herewith. The Original Issue Price of each Series D-3 Preferred Share is US$ 1.1036, and the Original Issue Price of each Series E Preferred Share is US$ 1.5895.

 

The “Preferred Shareholders” shall mean the holders of Preferred Shares.

 

The “Preferred Shares” are as defined in Article 5.

 

The “Purchase Agreement shall mean the Securities Purchase Agreement dated effective February 2nd, 2016 by and between the Company and the Investors (as such term is defined therein) (the “Investors”), including for the avoidance of doubt any joinder thereto.

 

2



 

A “Provident Fund” shall mean any of the following (as the case may be): (i) a provident fund, (ii) a study fund, or (iii) a provident fund for severance pay, or (iv) an entity holding shares in the Company on behalf of Provident Fund(s) under its management, as disclosed to the Company.

 

The “Register” shall mean the register of Shareholders that is to be kept pursuant to Section 127 of the Companies Law.

 

The “Series A-1 Group” shall mean the following: Amir Weisberg, Prof. David Segal, Yehuda Nir, Yossi Dotan and Aharon Lukach.

 

A “Shareholder” shall mean any person or entity that is the owner of at least one share of the Company, as registered in the Register.

 

The “Shares” shall mean the Preferred Shares and the Ordinary Shares.

 

The “Warrant Shares” shall mean the Series D-2 Preferred Shares which may be issued upon the exercise of warrants to purchase such shares granted by the Company to any holder thereof (“Warrants”).

 

In these Articles, subject to this Article and unless the context otherwise requires, expressions defined in the Companies Law, or any modification thereof in force on the date upon which these Articles become binding on the Company, shall have the meanings so defined therein; and words importing the singular shall include the plural, and vice versa, and words importing the masculine gender shall include the feminine gender, and words importing persons shall include bodies corporate, unless the context requires otherwise.  The titles of the Articles are not part of the Articles.

 

PRIVATE COMPANY

 

2.                                      The Company is a private company, and accordingly:

 

(a)                                 the right to transfer the Shares of the Company shall be restricted in the manner hereinafter appearing; and

 

(b)                              no invitation shall be issued to the public to subscribe for any shares or debentures or debenture stock of the Company.

 

3.                                      The Company’s objectives are to conduct any legal business. The Company may also make contributions of reasonable amounts for worthy purposes even if such contributions are not made on the basis of business considerations.

 

OFFICE

 

4.                                      The Office shall be at such place as the Board of Directors shall from time to time decide.

 

3



 

LIABILITY OF THE SHAREHOLDERS

 

4A.                             The liability of a Shareholder for the obligations of the Company will be limited to the payment of the consideration (including the premium) for which his shares were issued to him, but not less than the par value of such shares; except in the event that said shares have been issued to such Shareholder lawfully for a consideration which is below the par value, in which event such Shareholders’ liability will be limited to the payment of the consideration for which said shares were issued to him/her/it. The Company may not alter the liability of a Shareholder or obligate any Shareholder to acquire additional shares, without such Shareholder’s written consent.

 

THE CAPITAL

 

5.                                      The authorized share capital of the Company shall be NIS 22,742,814, comprised of 28,428,517 shares, divided into 15,687,500 Ordinary Shares, nominal value NIS 0.80 per share (the “Ordinary Shares”), 562,500 Series A Preferred Shares, nominal value NIS 0.80 per share (the “Series A Preferred Shares”), 937,500 Series A-1 Preferred Shares, nominal value NIS 0.80 per share (the “Series A-1 Preferred Shares”), 625,000 Series B Preferred Shares, nominal value NIS 0.80 per share (the “Series B Preferred Shares”), 1,953,517 Series B-1 Preferred Shares, nominal value NIS 0.80 per share (the “Series B-1 Preferred Shares”), 750,000 Series C-1 Preferred Shares, nominal value NIS 0.80 per share (the “Series C-1 Preferred Shares”), 475,000 Series C-2 Preferred Shares, nominal value NIS 0.80 per share (the “Series C-2 Preferred Shares”, and together with the Series C-1 Preferred Shares, the “Series C Preferred Shares”), 2,625,000 Series D-1 Preferred Shares, nominal value NIS 0.80 per share (the “Series D-1 Preferred Shares”), 3,000,000 Series D-2 Preferred Shares, nominal value NIS 0.80 per share (the “Series D-2 Preferred Shares”), and 625,000 Series D-3 Preferred Shares, nominal value NIS 0.80 per share (the “Series D-3 Preferred Shares” and together with the Series D-1 Preferred Shares and the Series D-2 Preferred Shares, the “Series D Preferred Shares”) and 1,187,500 Series E Preferred Shares, nominal value NIS 0.80 per share (the “Series E Preferred Shares” and together with the Series A Preferred Shares, Series A-1 Preferred Shares, Series B Preferred Shares, Series C Preferred Shares and Series D Preferred Shares, the “Preferred Shares”).

 

RIGHTS, PREFERENCES AND RESTRICTIONS OF PREFERRED SHARES

 

6.                                      The rights, preferences, privileges, and restrictions granted to and imposed on the Preferred Shares, are as set forth below:

 

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DIVIDEND PREFERENCE

 

7.                                      In the event that the Company will distribute any dividends then:

 

(a)                                 Prior to and in preference to the distribution of any dividends to the holders of any class or series of shares of the Company (including Ordinary Shares), each of the holders of the Series E Preferred Shares shall be entitled to receive, pari passu among themselves, for each Series E Preferred Share held by it, cumulative dividends (whether paid in cash or otherwise), if and when declared by the Board, out of any funds legally available for distribution therefor, an amount equal to (A) (i) the Original Issue Price for such Series E Preferred Share (ii) times 1.3 (the “Multiplier”), plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually, (the “Series E Dividend Preference”).

 

(b)                                 Following payment in full of the Series E Dividend Preference, and prior to and in preference to the distribution of any dividends to the holders of any class or series of shares of the Company (except the holders of Series E Preferred Shares), each of the holders of the Series D Preferred Shares shall be entitled to receive, pari passu among themselves, for each Series D Preferred Share held by it, cumulative dividends (whether paid in cash or otherwise), if and when declared by the Board, out of any funds legally available for distribution therefor, an amount equal to: (1) with respect to the holders of the Series D-1 Preferred Shares and/or the Series D-2 Preferred Shares - (A) (i) the applicable Original Issue Price for such Series D Preferred Share (ii) times the Multiplier, plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually, and (2) with respect to the holders of the Series D-3 Preferred Shares — (A) (i) the applicable Original Issue Price for such Series D-3 Preferred Share (ii) times the Multiplier, plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually, (the “Series D Dividend Preference”).

 

(c)                                  Following payment in full of the Series E Dividend Preference and the Series D Dividend Preference, and prior to and in preference to the distribution of any dividends to the holders of any class or series of shares of the Company (except the holders of Series E Preferred Shares and the Series D Preferred Shares), each of the holders of the Series C Preferred Shares shall be entitled to receive, for each Series C Preferred Share held by it, cumulative dividends (whether paid in cash or otherwise), if and when declared by the Board, out of any funds legally available for distribution therefor, an amount equal to (A) (i) the applicable Original Issue Price for such Series C Preferred Share, plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually(the “Series C Dividend Preference”).

 

(d)                                 Following payment in full of the Series E Dividend Preference, Series D Dividend Preference and the Series C Dividend Preference, and prior to and in preference to the distribution of any dividends to the holders of any class or series of shares of the Company (except the holders of Series E Preferred Shares, Series D Preferred Shares and Series C Preferred Shares), each of the holders of the Series B-1 Preferred Shares shall be entitled to receive, for each Series B-1 Preferred Share held by it, cumulative dividends (whether paid in cash or otherwise), if and when declared by the Board, out of any funds legally available for distribution therefor, an amount equal to (A) (i) the applicable Original Issue Price for such Series B-1 Preferred Share, plus (B) interest on the applicable Original

 

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Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually (the “Series B-1 Dividend Preference”).

 

(e)                                  Following payment in full of the Series E Dividend Preference, Series D Dividend Preference, the Series C Dividend Preference, and the Series B-1 Dividend Preference, and prior to and in preference to the distribution of any dividends to the holders of any class or series of shares of the Company (except the holders of Series E Preferred Shares, Series D Preferred Shares, Series C Preferred Shares, and Series B-1 Preferred Shares), each of the holders of the Series B Preferred Shares shall be entitled to receive, for each Series B Preferred Share held by it, cumulative dividends (whether paid in cash or otherwise), if and when declared by the Board, out of any funds legally available for distribution therefor, an amount equal to (A) (i) the applicable Original Issue Price for such Series B Preferred Share, plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually (the “Series B Dividend Preference”).

 

(f)                                   Following payment in full of the Series E Dividend Preference, Series D Dividend Preference, the Series C Dividend Preference, Series B-1 Dividend Preference, and the Series B Dividend Preference, and prior to and in preference to the distribution of any dividends to the holders of any class or series of shares of the Company (except the holders of Series E Preferred Shares, Series D Preferred Shares, Series C Preferred Shares, Series B-1 Preferred Shares, and Series B Preferred Shares), each of the holders of the Series A-1 Preferred Shares shall be entitled to receive, for each Series A-1 Preferred Share held by it, cumulative dividends (whether paid in cash or otherwise), if and when declared by the Board, out of any funds legally available for distribution therefor, an amount equal to (A) (i) the applicable Original Issue Price for such Series A-1 Preferred Share, plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually (the “Series A-1 Dividend Preference”).

 

(g)                                  Following payment in full of the Series E Dividend Preference, Series D Dividend Preference, the Series C Dividend Preference, Series B-1 Dividend Preference, Series B Dividend Preference, and the Series A-1 Dividend Preference, and prior to and in preference to the distribution of any dividends to the holders of any class or series of shares of the Company (except the holders of Series E Preferred Shares, Series D Preferred Shares, Series C Preferred Shares, Series B-1 Preferred Shares, Series B Preferred Shares, and Series A-1 Preferred Shares), each of the holders of the Series A Preferred Shares shall be entitled to receive, for each Series A Preferred Share held by it, cumulative dividends (whether paid in cash or otherwise), if and when declared by the Board, out of any funds legally available for distribution therefor, an amount equal to (A) (i) the applicable Original Issue Price for such Series A Preferred Share, plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%), per annum, calculated from the Issuing Date thereof, compounding annually (the “Series A Dividend Preference”, and together with the Series E Dividend Preference Series D Dividend Preference, the Series C Dividend Preference, Series B-1 Dividend Preference, Series B Dividend Preference, and the Series A-1 Dividend Preference, the “Dividend Preferences”).

 

(h)                                 Following the payment in full of all of the Dividend Preferences set forth in Article 7(a)-(g) above, the holders of the Preferred Shares and the Ordinary Shares shall be entitled to receive, pro rata, on an as-converted basis, any and all other dividends distributed by the Company.

 

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(i)                                     For the avoidance of doubt, no dividends shall be paid on any other class of shares, unless the Dividend Preferences have been paid in full.

 

(j)                                    Notwithstanding the provisions of Article 7(a), if the aggregate dividend that would be due to the holders of: (1) the Series D Preferred Shares, with respect to each Series D Preferred Share held by them, and/or (2) the Series E Preferred Shares, with respect to each Series E Preferred Share held by them, on the relevant date for such distribution, pursuant to a theoretical distribution to all shareholders under Article 8(a) and 8(b) which does not (solely for the purpose of calculating such theoretical distribution) give effect to the Multiplier, equals at least three hundred percent (300%) of the Original Issue Price for such share (the “3X Cap Amount”), then (i) the Multiplier shall not apply for such class of Preferred Shares achieving the 3X Cap Amount (including for the avoidance of doubt, in case where the class of the Series D Preferred Shares achieves the 3X Cap Amount, the Series D-3 Preferred Shares), and (ii) the applicable Dividend Preference (i.e., Series D Dividend Preference and/or Series E Dividend Preference, as applicable) for each such Preferred Share will equal (I) (A) the applicable Original Issue Price of such Preferred Share plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually from the Issuing Date; less (II) the amount of any Dividend Preference previously and actually paid on such class of Preferred Share, and (iii) the holders of such class of Preferred Shares shall receive, upon such distribution, with respect to each Preferred Share held by them on the relevant date for such distribution, their applicable Dividend Preference for such share as modified under clause (ii) above plus the amount payable per such Preferred Share, on an as-converted basis, under Article 7(h).

 

LIQUIDATION PREFERENCE

 

8.                                      In the event of any liquidation or winding up of the Company (whether voluntary or involuntary), the commencement of any bankruptcy or insolvency proceeding under any bankruptcy or insolvency or similar law (whether voluntary or involuntary), by or against the Company, which proceedings shall remain un-dismissed for a period of sixty (60) days, or if the Company by any act indicates its consent to, approval of or acquiescence in, any such proceeding, or the appointment of a receiver or liquidator to all or substantially all of the Company’s assets which appointment shall remain un-dismissed for a period of sixty (60) days or the making of an assignment for the benefit of creditors (a “Liquidation”):

 

(a)                                 Preferred Preferences.

 

(1)                                 Series E Preference. The holders of the Series E Preferred Shares shall be entitled to receive, on a pro-rata and pari passu basis among themselves, prior and in preference to any distribution of any of the assets or surplus funds of the Company or otherwise available for distribution to the holders of any of the other securities of the Company by reason of their ownership thereof, for each Series E Preferred Share held by them, an amount equal to: (I) (A) (i) the applicable Original Issue Price of such Preferred Share (ii) times the Multiplier, plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date; plus (II) an amount equal to the declared but unpaid dividends on each such Series E Preferred Share; less (III) the amount of any Dividend Preference previously and actually paid on such Series E Preferred Share (the “Series E Preference”). If the amount available for distribution in such Liquidation (the “Distributable Proceeds”) is less than the amount needed to pay the holders of Series E Preferred Shares the full Series E Preference amount as provided herein,

 

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then all such Distributable Proceeds shall be distributed among the holders of the Series E Preferred Shares, on a pro rata basis among them in proportion to the amounts such holders would have received had the Distributable Proceeds been sufficient for the distribution of the entire Series E Preference amount.

 

(2)                                 Series D Preference. Following payment in full of the Series E Preference, the holders of the Series D Preferred Shares shall be entitled to receive, on a pro-rata and pari passu basis among themselves, prior and in preference to any distribution of any of the assets or surplus funds of the Company or otherwise available for distribution to the holders of any of the other securities of the Company by reason of their ownership thereof (except the holders of Series E Preferred Shares), for each Series D Preferred Share held by them, an amount equal to: (1) with respect to the holders of the Series D-1 Preferred Shares and/or the Series D-2 Preferred Shares - (I) (A) (i) the applicable Original Issue Price of such Preferred Share (ii) times the Multiplier plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date; plus (II) an amount equal to the declared but unpaid dividends on each such Series D-1 Preferred Share and/or Series D-2 Preferred Share (as applicable); less (III) the amount of any Dividend Preference previously and actually paid on such Series D-1 Preferred Share and/or Series D-2 Preferred Share (as applicable), and (2) with respect to the holders of Series D-3 Preferred Shares — (I) (A) (i) the applicable Original Issue Price of such Preferred Share (ii) times 1.3 plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date; plus (II) an amount equal to the declared but unpaid dividends on such Series D-3 Preferred Share; less (III) the amount of any Dividend Preference previously and actually paid on such Series D-3 Preferred Share, (the “Series D Preference”). If Distributable Proceeds remaining available for distribution in such Liquidation following payment in full of the Series E Preference, is less than the amount needed to pay the holders of Series D Preferred Shares the full Series D Preference amount as provided herein, then all such Distributable Proceeds shall be distributed among the holders of the Series D Preferred Shares, on a pro rata basis among them in proportion to the amounts such holders would have received had the Distributable Proceeds been sufficient for the distribution of the entire Series D Preference amount.

 

(3)                                 Series C Preference. Following payment in full of the Series E Preference and the Series D Preference, the holders of the Series C Preferred Shares shall be entitled to receive, on a pro-rata basis among themselves, prior and in preference to any distribution of any of the assets or surplus funds of the Company or otherwise available for distribution to the holders of any of the other securities of the Company by reason of their ownership thereof (except the holders of Series E Preferred Shares and Series D Preferred Shares), for each Series C Preferred Share held by them, an amount equal to (I) the applicable Original Issue Price of such Preferred Share, plus (II) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date, plus (III) an amount equal to the declared but unpaid dividends on such Series C Preferred Share; less (IV) the amount of any Dividend Preference previously and actually paid on such Series C Preferred Share (the “Series C Preference”). If the Distributable Proceeds remaining available for distribution in such Liquidation following payment in full of the Series E Preference and the Series D Preference, are less than the amount needed to pay the holders of Series C Preferred Shares the full Series C Preference amount as provided herein, then all such remaining Distributable Proceeds shall be distributed among the holders of the Series C Preferred Shares, on a pro rata basis among them in proportion to the amounts such

 

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holders would have received had such remaining Distributable Proceeds been sufficient for the distribution of the entire Series C Preference amount.

 

(4)                                 Series B-1 Preference. Following payment in full of the Series E Preference and the Series D Preference and the Series C Preference, the holders of the Series B-1 Preferred Shares shall be entitled to receive, on a pro-rata basis among themselves, prior and in preference to any distribution of any of the assets or surplus funds of the Company or otherwise available for distribution to the holders of any of the other securities of the Company by reason of their ownership thereof (except the holders of Series E Preferred Shares, Series D Preferred Shares and Series C Preferred Shares), for each Series B-1 Preferred Share held by them, an amount equal to (I) the applicable Original Issue Price of such Preferred Share, plus (II) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date, plus (III) an amount equal to the declared but unpaid dividends on such Series B-1 Preferred Share; less (IV) the amount of any Dividend Preference previously and actually paid on such Series B-1 Preferred Share (the “Series B-1 Preference”). If the Distributable Proceeds remaining available for distribution in such Liquidation following payment in full of the Series E Preference, the Series D Preference and the Series C Preference, are less than the amount needed to pay the holders of Series B-1 Preferred Shares the full Series B-1 Preference amount as provided herein, then all such remaining Distributable Proceeds shall be distributed among the holders of the Series B-1 Preferred Shares, on a pro rata basis among them in proportion to the amounts such holders would have received had such remaining Distributable Proceeds been sufficient for the distribution of the entire Series B-1 Preference amount.

 

(5)                                 Series B Preference. Following payment in full of the Series E Preference, the Series D Preference, the Series C Preference, and the Series B-1 Preference, the holders of the Series B Preferred Shares shall be entitled to receive, on a pro-rata basis among themselves, prior and in preference to any distribution of any of the assets or surplus funds of the Company or otherwise available for distribution to the holders of any of the other securities of the Company by reason of their ownership thereof (except the holders of Series E Preferred Shares, Series D Preferred Shares, Series C Preferred Shares, and Series B-1 Preferred Shares), for each Series B Preferred Share held by them, an amount equal to (I) the applicable Original Issue Price of such Preferred Share, plus (II) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date, plus (III) an amount equal to the declared but unpaid dividends on such Series B Preferred Share; less (IV) the amount of any Dividend Preference previously and actually paid on such Series B Preferred Share (the “Series B Preference”). If the Distributable Proceeds remaining available for distribution in such Liquidation following payment in full of the Series E Preference, the Series D Preference, the Series C Preference, and the Series B-1 Preference, are less than the amount needed to pay the holders of Series B Preferred Shares the full Series B Preference amount as provided herein, then all such remaining Distributable Proceeds shall be distributed among the holders of the Series B Preferred Shares, on a pro rata basis among them in proportion to the amounts such holders would have received had such remaining Distributable Proceeds been sufficient for the distribution of the entire Series B Preference amount.

 

(6)                                 Series A-1 Preference. Following payment in full of the Series E Preference, the Series D Preference, the Series C Preference, the Series B-1 Preference, and the Series B Preference, the holders of the Series A-1 Preferred Shares shall be entitled to receive, on a pro-rata basis among themselves, prior and in preference to any distribution of

 

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any of the assets or surplus funds of the Company or otherwise available for distribution to the holders of any of the other securities of the Company by reason of their ownership thereof (except the holders of Series E Preferred Shares, Series D Preferred Shares, Series C Preferred Shares, Series B-1 Preferred Shares, and Series B Preferred Shares), for each Series A-1 Preferred Share held by them, an amount equal to (I) the applicable Original Issue Price of such Preferred Share, plus (II) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date, plus (III) an amount equal to the declared but unpaid dividends on such Series A-1 Preferred Share; less (IV) the amount of any Dividend Preference previously and actually paid on such Series A-1 Preferred Share (the “Series A-1 Preference”). If the Distributable Proceeds remaining available for distribution in such Liquidation following payment in full of the Series E Preference, the Series D Preference, the Series C Preference, the Series B-1 Preference, and the Series B Preference, are less than the amount needed to pay the holders of Series A-1 Preferred Shares the full Series A-1 Preference amount as provided herein, then all such remaining Distributable Proceeds shall be distributed among the holders of the Series A-1 Preferred Shares, on a pro rata basis among them in proportion to the amounts such holders would have received had such remaining Distributable Proceeds been sufficient for the distribution of the entire Series A-1 Preference amount.

 

(7)                                 Series A Preference. Following payment in full of the Series E Preference, Series D Preference, the Series C Preference, the Series B-1 Preference, the Series B Preference, and the Series A-1 Preference, the holders of the Series A Preferred Shares shall be entitled to receive, on a pro-rata basis among themselves, prior and in preference to any distribution of any of the assets or surplus funds of the Company or otherwise available for distribution to the holders of any of the other securities of the Company by reason of their ownership thereof (except the holders of Series E Preferred Shares, Series D Preferred Shares, Series C Preferred Shares, Series B-1 Preferred Shares, Series B Preferred Shares, and Series A-1 Preferred Shares), for each Series A Preferred Share held by them, an amount equal to (I) the applicable Original Issue Price of such Preferred Share, plus (II) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date, plus (III) an amount equal to the declared but unpaid dividends on such Series A Preferred Share; less (IV) the amount of any Dividend Preference previously and actually paid on such Series A Preferred Share (the “Series A Preference”, and together with the Series E Preference, the Series D Preference, the Series C Preference, the Series B-1 Preference, the Series B Preference, and the Series A-1 Preference, the “Preferred Preferences”). If the Distributable Proceeds remaining available for distribution in such Liquidation following payment in full of the Series E Preference, Series D Preference, the Series C Preference, the Series B-1 Preference, the Series B Preference, and the Series A-1 Preference, are less than the amount needed to pay the holders of Series A Preferred Shares the full Series A Preference amount as provided herein, then all such remaining Distributable Proceeds shall be distributed among the holders of the Series A Preferred Shares, on a pro rata basis among them in proportion to the amounts such holders would have received had such remaining Distributable Proceeds been sufficient for the distribution of the entire Series A Preference amount.

 

(b)                                 Remainder. Following the payment in full of all of the Preferred Preferences set forth in Article 8(a) above, the holders of the Preferred Shares and the Ordinary Shares shall be entitled to receive, pro rata, on an as-converted basis, any and all remaining Distributable Proceeds.

 

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(c)                                  Notwithstanding the provisions of Article 8(a), if the aggregate proceeds that would be due to the holders of: (1) the Series D Preferred Shares, with respect to each Series D-1 Preferred Share and/or Series D-2 Preferred Share held by them, and/or (2) the Series E Preferred Shares, with respect to each Series E Preferred Share held by them, at the closing of the Liquidation, pursuant to a theoretical distribution to all shareholders under Article 8(a) and 8(b) which does not (solely for the purpose of calculating such theoretical distribution) give effect to the Multiplier, equals at least the 3X Cap Amount, then (i) the Multiplier shall not apply for such class of Preferred Shares achieving the 3X Cap Amount (including for the avoidance of doubt, in case where the class of the Series D Preferred Shares achieves the 3X Cap Amount, the Series D-3 Preferred Shares), and (ii) the applicable Preferred Preference (i.e., the Series E Preference and/or Series D Preference, as applicable) for each such Preferred Share will equal (I) (A) the applicable Original Issue Price of such Preferred Share plus (B) interest on the applicable Original Issue Price at the rate of six percent (6%) per year, compounding annually, from the Issuing Date; plus (II) an amount equal to the declared but unpaid dividends on such class of Preferred Share; less (III) the amount of any Dividend Preference previously and actually paid on such class of Preferred Share, and (iii) the holders of such class of Preferred Shares shall receive, at such closing, with respect to each such Preferred Share held by them at the closing of the Liquidation, the applicable Preferred Preference for such share as modified under clause (ii) above plus the amount payable per such Preferred Share, on an as-converted basis, under Article 8(b).

 

(d)                                 Deemed Liquidation.

 

(1)                                 General. For purposes of this Article 8, in addition to any Liquidation, or dissolution or winding up of the Company under applicable law, the Company shall, unless otherwise determined by the Majority Investors and the Majority E Holders, be deemed to be wound up in the event of (each a “Deemed Liquidation”): (i) the sale of all or substantially all of the intellectual property or assets or shares of the Company or (ii) the acquisition of the Company by another entity by means of any transaction or series of related transactions or any reorganization, merger or consolidation with or into any other corporate entity as a result of which the shares of the Company outstanding immediately prior to such transaction will not represent, or are not converted into or exchanged for shares that represent, immediately following such transaction, fifty percent (50%) or more of the outstanding voting power of the Company or the surviving entity, in each case (i) or (ii) (an “M&A Event”) whether by a transaction or a series of related transactions; or (iii) any distribution of a dividend or a series of dividends as a result of the sale or worldwide exclusive license of all or substantially all of the intellectual property or assets of the Company.

 

(2)                                 Allocation of Escrow and Contingent Consideration. In the event of a Deemed Liquidation pursuant to Article 8(d)(1), if any portion of the consideration payable to the Shareholders is payable only upon satisfaction of contingencies (the “Additional Consideration”), then (a) the portion of such consideration that is not Additional Consideration (such portion, the “Initial Consideration”) shall be allocated among the Shareholders in accordance with Article 8(a) and (if relevant) Article 8(b) as if the Initial Consideration were the only consideration payable in connection with such Deemed Liquidation; and (b) any Additional Consideration which becomes payable to the Shareholders upon satisfaction of such contingencies shall be allocated among the Shareholders in accordance with Article 8(a) and (if relevant) Article 8(b) after taking into account the previous payment of the Initial Consideration as part of the same transaction.

 

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For the purposes of this Article 8(d)(2), consideration placed into escrow or retained as holdback to be available for satisfaction of indemnification or similar obligations in connection with such Deemed Liquidation shall be deemed to be Additional Consideration.

 

(3)                                 Non-Cash Proceeds. In the event of a Deemed Liquidation, if the consideration received by the Company is in whole or in part other than cash, the amount deemed paid or distributed to the Shareholders shall be the value of the property, rights or securities paid or distributed to such Shareholders. The value of such property, rights or securities shall be determined in good faith by the Board.

 

(e)                                  Definitive Agreements. The definitive agreements by which the Company is bound in connection with a Deemed Liquidation shall be effected shall provide that the proceeds from such transaction shall be distributed in accordance with Article 8(d); it being understood that such proceeds will not include any payments which may be paid to the employees and/or service providers of the Company following the closing in connection with their employment/engagement, in the nature of salaries, bonuses, options, and retention payments (the “Retention Consideration”).

 

(f)                                   Non-Compliance. In the event the requirements of this Article 8 are not complied with, the Company shall forthwith either:

 

(i)                                     cause such closing to be postponed until such time as the requirements of this Article 8 have been complied with; or

 

(ii)                                  cancel such transaction, in which event the rights, preferences and privileges of the holders of the Preferred Shares shall revert to and be the same as such rights, preferences and privileges existing immediately prior to the date of the first notice referred to above.

 

(g)                                  Notice. The Company shall give each holder of record of Preferred Shares written notice of such impending transaction not later than fourteen (14) days prior to the Shareholders’ meeting called to approve such transaction, or fourteen (14) days prior to the closing of such transaction, whichever is earlier, and shall also notify such holders in writing of the final approval of such transaction. The first of such notices shall describe the material terms and conditions of the impending transaction and the provisions of this Article 8, and the Company shall thereafter give such holders prompt notice of any material changes. The transaction shall in no event take place sooner than fourteen (14) days after the Company has given the first notice provided for herein or sooner than ten (10) days after the Company has given notice of any material changes provided for herein; provided, however, that such periods may be shortened upon the written consent of the Majority Investors.

 

CONVERSION OF PREFERRED SHARES INTO ORDINARY SHARES

 

9.                                      The holders of the Preferred Shares shall have conversion rights as follows (the “Conversion Rights”):

 

(a)                                 Optional Conversion.  Each Preferred Share shall be convertible at the option of the holder thereof, at any time after the date of issuance of such share, at the Office of the Company, into such number of fully paid and non-assessable Ordinary Shares as is determined by dividing the applicable Original Issue Price by the applicable Conversion Price

 

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(as defined in and subject to adjustment under Article 9(d)) at the time in effect for such share.

 

(b)                                 Automatic Conversion. Each Preferred Share shall automatically be converted into such number of fully paid and non-assessable Ordinary Shares as is determined by dividing the applicable Original Issue Price by the applicable Conversion Price (subject to adjustment under Article 9(d)) at the time in effect for such share, upon the earlier to occur of the following (each an “Automatic Conversion”): (i) with respect to (A) the Series D Preferred Shares, the date specified by vote or written consent or agreement of the Majority Investors (B) the Series E Preferred Shares, the date specified by vote or written consent or agreement of the Majority E Holders and (C) with respect to all of the remaining (non-Series D) classes of Preferred Shares and excluding the Series E Preferred Shares, (the “Remaining Preferred”) the holders of the majority of such Remaining Preferred voting as a single class on an as-converted basis (and excluding, in any case, the Series E Preferred Shares); (the “Remaining Preferred Majority”) and (ii) without derogating from the provisions of Article 9(d)(iii), which shall apply to such event subject to and in accordance with the terms of such Article, upon the closing of the Company’s offer, in the United States, of its Ordinary Shares to the public in a firm underwriting pursuant to a registration statement under the U.S. Securities Act of 1933, as amended (the “Securities Act”) or any other securities laws (the “IPO”), resulting in gross proceeds to the Company of at least US$22,000,000 (the “QPO”).

 

(c)                               Mechanics of Conversion. A holder of Preferred Shares seeking (in the case of a conversion at such holder’s option) to convert the same into Ordinary Shares, shall surrender the certificate or certificates therefor, duly endorsed, at the Office of the Company, and shall give written notice by mail, postage prepaid, to the Company at the Office, of the election to convert the same and shall state therein the name or names of any nominee for such holder in which the certificate or certificates for Ordinary Shares are to be issued. Such conversion (in the case of a conversion at such holder’s option) shall be deemed to have been made immediately prior to the close of business on the date of such surrender of the certificate representing the Preferred Shares to be converted, and the person or persons entitled to receive the Ordinary Shares issuable upon such conversion shall be treated for all purposes as the record holder or holders of such Ordinary Shares as of such date.  If the conversion is in connection with an Automatic Conversion, then the conversion shall be deemed to have taken place automatically regardless of whether the certificates representing such shares have been tendered to the Company, but from and after such conversion any such certificates not tendered to the Company shall be deemed to evidence solely the Ordinary Shares received upon such conversion and the right to receive a certificate for such Ordinary Shares. If the conversion is in connection with a QPO, the conversion may, at the option of any holder tendering Preferred Shares for conversion, be conditioned upon the closing with the underwriter of the sale of securities pursuant to such offering, in which event the person(s) entitled to receive the Ordinary Shares issuable upon such conversion of the Preferred Shares shall not be deemed to have converted such Preferred Shares until immediately prior to the closing of such QPO. The Company shall, as soon as practicable after the conversion and tender of the certificate for the Preferred Shares converted, issue and deliver at such Office to such holder of Preferred Shares or to the nominee or nominees of such holder of Preferred Shares, a certificate or certificates for the number of Ordinary Shares to which such holder shall be entitled as aforesaid.

 

(d)                                 Conversion Price and Adjustments. The “Conversion Price” with respect to each Preferred Share shall initially be equal to the applicable Original Issue Price of such

 

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Preferred Share, but shall be subject to adjustment under this Article 9(d). The Conversion Price shall be adjusted from time to time as follows:

 

(i)                                     Subdivision or Combination. If the Company subdivides or combines its Ordinary Shares, the Conversion Price shall be proportionately reduced, in case of a subdivision of shares, as at the effective date of such subdivision, or if the Company fixes a record date for the purpose of so subdividing, as at such record date, whichever is earlier, or shall be proportionately increased, in the case of a combination of shares, as the effective date of such combination, or, if the Company fixes a record date for the purpose of so combining, as at such record date, whichever is earlier.

 

(ii)                                  Dividend Issuances. Without derogating from Article 7, if the Company at any time pays a dividend, with respect to its Ordinary Shares only, payable in additional Ordinary Shares or other securities or rights convertible into, or entitling the holder thereof to receive directly or indirectly, additional Ordinary Shares, without any comparable payment or distribution to the holders of Preferred Shares, then the Conversion Price shall be adjusted as at the date the Company fixes as a record date for the purpose of receiving such dividend (or if no such record date is fixed, as at the date of such payment) to that price determined by multiplying the applicable Conversion Price in effect immediately prior to such record date (or if no record date is fixed then immediately prior to such payment) by a fraction (a) the numerator of which shall be the total number of Ordinary Shares issued and outstanding immediately prior to the payment of such dividend and (b) the denominator of which shall be the total number of Ordinary Shares issued and outstanding immediately prior to the payment of such dividend plus the number of Ordinary Shares issuable in payment of such dividend or distribution.

 

Notwithstanding the foregoing, (a) if such record date shall have been fixed and such dividend is not fully paid or if such distribution is not fully made on the date fixed therefor, the applicable Conversion Price shall be recomputed accordingly as of the close of business on such record date and thereafter the Conversion Price shall be adjusted pursuant to this subsection (ii) as of the time of actual payment of such dividends or distributions; and (b) no such adjustment shall be made if the holders of Preferred Shares simultaneously receive a dividend or other distribution of Ordinary Shares in a number equal to the number of Ordinary Shares as they would have received if all outstanding Preferred Shares had been converted into Ordinary Shares on the date of such event.

 

(iii)                               Price Protection for Investors.

 

(A)                               Until immediately following the earlier of a QPO and a Deemed Liquidation, in the event (and in each such event) of (1) a Deemed Liquidation or (2) the issuance or grant of New Shares by the Company (including, for the avoidance of doubt, (A) any issuance of New Shares in or as part of a public offering or in connection therewith, and (B) the transactions constituting the Deemed Liquidation) (each of (1) and (2), an “Issuance”), except for an Issuance of Exempt Securities, and unless otherwise approved by the Majority Investors, the Conversion Price applicable to:

 

(i) the Series D-1 Preferred Shares (the “Investors’ Conversion Price”) shall be reduced (and, for the avoidance of doubt, in no event increased) to a price equal to a 30% discount on the lowest price per share for which the Company issued New Shares in such transaction (such Issuance price, the “New Price”, and such

 

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adjusted Investors’ Conversion Price, as adjusted from time to time hereunder, the “Adjusted Investors’ Conversion Price”); provided however that for the purposes of this clause, the New Price shall be calculated, at the time of such transaction, as if the fully-diluted share capital of the Company included only 50% of the Warrant Shares actually issued and/or issuable;

 

(ii) the Warrant Shares (the “Warrant Shares Conversion Price”) shall be reduced (and, for the avoidance of doubt, in no event increased) so that it equals the product of (x) the Adjusted Investors’ Conversion Price as determined under clause (A)(i) above times (y) 1.15 (the “Adjusted Warrant Shares Conversion Price”).

 

Notwithstanding the foregoing to the contrary, in the event that (a) a QPO will be consummated within 18 months of the Closing, and (b) the price per share of the Company in the QPO is a price which would not have triggered the Price Protection pursuant to this Article 9(d)(iii) if the QPO had been consummated at the same time as the Closing, then any adjustments previously made to the Investors’ Conversion Price solely pursuant to this Article 9(d)(iii) shall be retroactively cancelled.

 

For example: if the Original Issue Price of the Investors Shares and the Investors’ Conversion Price immediately before the Issuance is US$ 0.40 and the New Price is US$ 0.50, the Adjusted Investors’ Conversion Price shall be US$ 0.35. The Warrant Shares Conversion Price (assuming there has not been a Trigger Event) shall be reduced to US$ 0.4025. If, however, within 18 months of the Closing, a QPO is consummated, the price per share of the Company at the closing of which shall be US $0.58, then immediately prior to the closing of the QPO, the adjustment to the Adjusted Investors’ Conversion Price occasioned by the Issuance at US$ 0.50 shall be retroactively cancelled.

 

If the New Price is or exceeds US $0.58, then no adjustment will be made to the Conversion Price.

 

(B)                            For the purpose of this Article 9(d), the consideration of any New Shares shall be calculated at the U.S. dollar equivalent thereof, on the day such New Shares are issued or deemed to be issued pursuant to Article 9(l).

 

(C)                               New Shares” shall mean shares of whatever class issued or deemed to have been issued pursuant to Article 9(l) by the Company other than the following exempt securities (the “Exempt Securities”): (i) shares or options to be issued to employees, consultants, Directors or observers of the Company (but not including (except for the purpose of this Article 9(d)(iii)(C)(iv) below), a grant, reservation and/or issuance to Amir Weisberg or Noam Emanuel (unless otherwise will be approved by the Lead Investor, in which case such grant of securities will be deemed as Exempt Securities (“Key Shareholder’s Securities”))), under the Company’s share option plan approved by the Company’s board (“ESOP”); notwithstanding the foregoing to the contrary, however, solely for purposes of Article 9(d)(v) below, the Key Shareholders’ Securities will be deemed as Exempt Securities, (ii) shares issued pursuant to the conversion of the Preferred Shares, (iii) Ordinary Shares, issued or issuable, as a share dividend or upon any subdivision of Ordinary Shares, or pursuant to any event for which adjustment is made pursuant to Sub-Articles 9(d)(i), 9(d)(ii), d(iii), d(iv) or 9(f), in which in each case all of the security holders are treated proportionately with the amount of securities they hold, (iv) the issuance of securities pursuant to the

 

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conversion or exercise of convertible or exercisable securities, options or warrants, outstanding as of the Closing, in accordance with their respective terms in effect as of the Closing, and (v) any securities issued or granted to an investor which is deemed by the Board, in good faith, as a strategic investor and is approved by the Lead Investor. For the avoidance of doubt, the holders of the Series D-1 Preferred Shares and Series D-2 Preferred Shares have waived their rights to adjust their Investors’ Conversion Price pursuant to this Article 9(d) as a result of the issuance of Series D-3 Preferred Shares at the Series D-3 Original Issue Price set forth herein (US$ 1.1036) pursuant to the Securities Purchase Agreement signed between the Company and certain investors on August 24, 2016 (the “Series D-3 SPA”), and accordingly, solely for the purpose of Article 9(d)(iii)(A) (price protection for investors), and solely for the purpose of the capital raise pursuant to the Series D-3 SPA, the holders of Series D-3 Preferred Shares acquired under the Series D-3 SPA shall be deemed by the Board as strategic investors approved by the Lead Investor.

 

(D)                               In the event of a Deemed Liquidation, there shall be deemed to have been an Issuance by the Company at the price per share of Company shares reflected by the valuation attributed to the Company in such transaction, on an as-converted and fully-diluted basis (but not including for such purpose the additional securities to be issued by the Company in conjunction with such transaction pursuant to this Article 9(d)(iii)), provided however that for the purposes of this Article 9(d)(iii), the New Price shall be calculated, at the time of such transaction, as if the fully-diluted share capital of the Company included only 50% of the Warrant Shares actually issued and/or then issuable, as provided in Article 9(d)(iii)(A)(i).

 

(iv)                              Trigger Event Adjustment. In the event that, prior to December 31, 2016, the consummation of the QPO has not occurred (the “Trigger Event”), then at such time, unless otherwise will be approved by the Majority Investors, the Warrant Shares Conversion Price shall be reduced (and, for the avoidance of doubt, in no event increased) to an Adjusted Warrant Shares Conversion Price equal to the Adjusted Investors’ Conversion Price. In the event of any Issuances after the Trigger Event, the Adjusted Warrant Shares Conversion Price under clause (iii)(A)(ii) above shall, notwithstanding the provisions of such clause, be reduced (and, for the avoidance of doubt, in no event increased) so that it equals the Adjusted Investors’ Conversion Price as determined in such event under clause (iii)(A)(i) above.

 

(v)                                 Adjustment of Conversion Price for Certain Dilutive Issuances with respect to the Series E Preferred Shares, Series D-3 Preferred Shares, Series C-1 Preferred Shares, Series C-2 Preferred Shares, Series B-1 Preferred Shares, Series B Preferred Shares and the Series A-1 Preferred Shares. If, at any time, the Company shall issue any New Shares for no consideration or at a price per share less than the applicable Conversion Price of the Series E Preferred Shares, Series D-3 Preferred Shares, the, Series C-2 Preferred Shares, the Series C-1 Preferred Shares, Series B-1 Preferred Shares, Series B Preferred Shares and the Series A-1 Preferred Shares (the “Reduced Price”) then in each such event, the Conversion Price of the Series E Preferred Shares, Series D-3 Preferred Shares, the Series C-1 Preferred Shares, Series C-2 Preferred Shares, Series B-1 Preferred Shares, Series B Preferred Shares and the Series A-1 Preferred Shares, as the case may be, unless otherwise determined by the majority holders of such class (as applicable), will be reduced, for no additional consideration, in accordance with the following broad-based weighted average formula:

 

16



 

 

where CP is the reduced Conversion Price; A is the number of Ordinary Shares, on a fully-diluted, as-converted basis (as if all granted Options and Convertible Shares had been fully exercised and/or fully converted into Ordinary Shares, as of such date), outstanding immediately prior to the relevant issuance of the New Shares; P’ is the Conversion Price applicable to the Series E Preferred Shares, the Series D-3 Preferred Shares, the Series C-2 Preferred Shares, Series C-1 Preferred Shares, Series B-1 Preferred Shares, Series B Preferred Shares, and the Series A-1 Preferred Shares, as the case may be, in effect immediately prior to such issuance; C is the number of New Shares; and P’’ is the Reduced Price.

 

(e)                                  Other Distributions. In the event the Company declares a distribution payable in securities of other persons, evidences of indebtedness issued by the Company or other persons, assets (excluding cash dividends) or options or rights not referred to in Sub-Article (d)(ii), then, in each such case, the holders of the Preferred Shares shall be entitled to receive such distribution, in respect of their holdings on an as-converted basis as of the record date for such distribution.

 

(f)                                   Recapitalization. If at any time or from time to time there shall be a recapitalization of the Ordinary Shares (other than a subdivision, combination, or merger transaction provided for elsewhere in this Article or Article 10), provision shall be made so that the holders of the Preferred Shares shall thereafter be entitled to receive upon conversion of the Preferred Shares the number of Ordinary Shares or other securities or property of the Company or otherwise, to which a holder of Ordinary Shares deliverable upon conversion of the Preferred Shares immediately prior to such recapitalization would have been entitled. In any such case, appropriate adjustments shall be made in the application of the provisions of this Article 9 with respect to the rights of the holders of the Preferred Shares after the recapitalization to the end that the provisions of this Article 9 (including adjustments of the Conversion Price then in effect and the number of shares issuable upon conversion of the Preferred Shares) shall be applicable after that event as nearly equivalent as may be practicable.

 

(g)                                  No Impairment. The Company will not, by amendment of these Articles or through any reorganization, recapitalization, transfer of assets, consolidation, merger, 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 to be observed or performed hereunder in this Article 9 by the Company, (i) in respect of, touching or concerning, the Series D Preferred Shares and/or the holders thereof, without the consent of the Majority Investors, provided that if any of such action is in respect of, touching or concerning, only the Series D-3 Preferred Shares (but not or not substantially equally touching or concerning other Series D Preferred Shares and/or the holders thereof, mutatis mutandis), without also obtaining the consent of the holders of Series D-3 Preferred Shares holding the majority of the issued and outstanding Series D-3 Preferred Shares (provided that such majority consent of the holders of Series D-3 Preferred Shares shall not be unreasonably withheld and provided further that any exercise of any existing right of any Shareholder, under these Articles and under that certain Securities Purchase Agreement dated February 4, 2016 by and among the Company, the Lead Investor and other parties (including, without limitation, any existing right of any Shareholder under

 

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Article 9 herein) (collectively, “Additional Agreements”) shall not be deemed as an action that is touching and/or concerning and/or having an adverse effect on the Series D-3 Preferred Shares and/or the holders thereof, and in the event that the holders of Series D-3 Preferred Shares will not be equally affected by an event solely due to the fact that the holders of D-1 Preferred Shares and D-2 Preferred Shares have existing rights under these Articles and the Additional Agreements, then such event which caused the adverse effect will not require the specific additional consent of the D-3 Preferred holders pursuant to this clause (g)(i), (ii) in respect of adversely changing the rights attached to the Series E Preferred Shares, unless such change applies proportionally to all of the classes of shares of the Company, without the consent of the Majority E Holders, and (iii) in respect of, touching or concerning, any class of the Remaining Preferred and/or the rights granted to the holders thereof herein, without the consent of the Remaining Preferred Majority, but will at all times in good faith assist in the carrying out of all the provisions of this Article 9 and in taking of all such action as may be necessary or appropriate in order to protect the conversion rights of the holders of the Preferred Shares against impairment.

 

(h)                                 No Fractional Shares. No fractional shares shall be issued upon conversion of the Preferred Shares, and the number of Ordinary Shares to be issued shall be rounded to the nearest whole share.

 

(i)                                     Certificate of Adjustments. Upon the occurrence of each adjustment or readjustment of a Conversion Price pursuant to this Article 9, the Company, at its expense, shall promptly compute such adjustment or readjustment in accordance with the terms hereof and prepare and furnish to each holder of Preferred Shares a certificate setting forth each adjustment or readjustment and showing in detail the facts upon which such adjustment or readjustment is based, which shall be provided together with an updated capitalization table of the Company prepared on an as-converted and fully-diluted basis. The Company shall furnish or cause to be furnished to such holder a like certificate setting forth (A) such adjustment or readjustment, (B) the Conversion Price, as the case may be, at the time in effect, and (C) the number of Ordinary Shares and the amount, if any, of other property which at the time would be received upon the conversion of each type of Preferred Share.

 

(j)                                    Notice of Record Date. In the event of any taking by the Company of a record of the holders of any class of securities for the purpose of determining the holders thereof who are entitled to receive any dividend (including a cash dividend) or other distribution, any right to subscribe for, purchase or otherwise acquire any shares of any class or any other securities or property, or to receive any other right, the Company shall mail to each holder of Preferred Shares, at least fourteen (14) days prior to the date specified therein, a notice specifying the date on which any such record is to be taken for the purpose of such dividend, distribution or right, and the amount and character of such dividend, distribution or right.

 

(k)                                 Reservation of Shares. The Company shall at all times reserve and keep available out of its authorized but unissued Ordinary Shares, solely for the purpose of effecting the conversion of the Preferred Shares, such number of its Ordinary Shares as shall from time to time be sufficient to effect the conversion of all issued and outstanding Preferred Shares, including for such purpose, all Warrant Shares which may be acquired pursuant to the exercise of Warrants; and if at any time the number of authorized but unissued Ordinary Shares shall not be sufficient to effect the conversion of all such Preferred Shares, in addition to such other remedies as shall be available to the holders of such Preferred Shares, the Company will take such corporate action as may, in the opinion of its counsel, be necessary

 

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to increase its authorized but unissued Ordinary Share capital to such number of shares as shall be sufficient for such purposes.

 

(l)                                     Options or Convertible Shares. ”Convertible Shares” shall mean any evidences of indebtedness, shares or other securities convertible into or exchangeable for Ordinary Shares. “Options” shall mean rights, options or warrants to subscribe for, purchase or otherwise acquire Ordinary Shares or Convertible Shares. In the event the Company at any time or from time to time after the date of the filing of these Articles shall issue any Options or Convertible Shares (other than Exempt Securities) or shall fix a record date for the determination of holders of any class of shares entitled to receive any such Options or Convertible Shares, then the maximum number of Ordinary Shares (as set forth in the instrument relating thereto without regard to any provisions contained therein for a subsequent adjustment of such number) issuable upon the exercise of such Options or, in the case of Convertible Shares, the conversion or exchange of such Convertible Shares or, in the case of Options for Convertible Shares, the exercise of such Options and the conversion or exchange of the underlying securities, shall be deemed to have been issued as of the time of such issue or, in case such a record date shall have been fixed, as of the close of business on such record date, and (if applicable under these Articles) the Conversion Price shall be decreased accordingly, provided that in any such case in which shares are deemed to be issued:

 

(i)                                     so long as the Conversion Price decrease was implemented as contemplated above in this Article 9, and subject to clause (ii) below, no further decrease of the Conversion Price of any Preferred Share shall be made upon the subsequent issue of Convertible Shares or Ordinary Shares in connection with the exercise of such Options or conversion or exchange of such Convertible Shares;

 

(ii)                                  if such Options or Convertible Shares by their terms provide, with the passage of time or otherwise, for any change in the consideration payable to the Company or in the number of Ordinary Shares issuable upon the exercise, conversion or exchange thereof, the Conversion Price and any subsequent adjustments based thereon shall be recomputed to reflect such change as if such change had been in effect as of the original issue thereof (or upon the occurrence of the record date with respect thereto);

 

(iii)                               no readjustment pursuant to clause (ii) above shall have the effect of increasing the Conversion Price of a Preferred Share to an amount above the Conversion Price that would have resulted from any other issuances of New Shares and any other adjustments provided for herein between the original adjustment date and such readjustment date;

 

(iv)                              upon the expiration of any such Options or any rights of conversion or exchange under such Convertible Shares which shall not have been exercised, the Conversion Price of each Preferred Share computed upon the original issue thereof (or upon the occurrence of a record date with respect thereto) and any subsequent adjustments based thereon shall, upon such expiration, be recomputed as if:

 

(A)                               in the case of Convertible Shares or Options for Ordinary Shares, the only New Shares issued were the Ordinary Shares, if any, actually issued upon the exercise of such Options or the conversion or exchange of such Convertible Shares and the consideration received therefor was the consideration actually received by the

 

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Company for the issue of such exercised Options plus the consideration actually received by the Company upon such exercise or for the issue of all such Convertible Shares which were actually converted or exchanged, plus the additional consideration, if any, actually received by the Company upon such conversion or exchange, and

 

(B)                               in the case of Options for Convertible Shares, only the Convertible Shares, if any, actually issued upon the exercise thereof were issued at the time of issue of such Options, and the consideration received by the Company for the New Shares deemed to have been then issued was the consideration actually received by the Company for the issue of such exercised Options, plus the consideration deemed to have been received by the Company (determined pursuant to this Article 9(l) upon the issue of the Convertible Shares with respect to which such Options were actually exercised); and

 

(v)                                 if such record date shall have been fixed and such Options or Convertible Shares are not issued on the date fixed therefor, the adjustment previously made in the Conversion Price which became effective on such record date shall be canceled as of the close of business on such record date, and thereafter the Conversion Price shall be adjusted pursuant to this paragraph as of the actual date of their issuance.

 

10.                               MERGER/CONSOLIDATION

 

Without derogating from Article 11(d), and unless otherwise agreed by the Majority Investors and the Remaining Preferred Majority:

 

(a)                                 Subject to Article 10(d), in case of any merger of the Company with or into another corporation (even if such merger is an M&A Event), as a result of which holders of Preferred Shares receive equity in a private corporation in consideration for the merger (in this Article, “merger”), the Company or such successor corporation, as the case may be, shall, without payment by the holders of Preferred Shares of any additional consideration therefor, issue to the holders of Preferred Shares new preferred shares of a class, in the case of each class of Preferred Shares, with the same rights, preferences, privileges and restrictions granted to and imposed on the Preferred Shares in these Articles (all such classes collectively, the “New Preferred Shares”), including any rights of the Lead Investor hereunder, but providing that the holder of the New Preferred Shares shall have the right to exercise the conversion rights granted by such New Preferred Shares and procure upon such exercise of such conversion rights, in lieu of each Ordinary Share therefor issuable upon exercise of the Conversion Rights of the Preferred Shares, the kind and amount of shares of stock, other securities, money and assets receivable upon such merger by a holder of one Ordinary Share issuable upon exercise of the Conversion Rights had they been exercised immediately prior to such reclassification, change, consolidation, merger, sale or transfer. The provisions of this Article 10(a) shall similarly apply to successive mergers.

 

(b)                                 The Company shall give each holder of record of Preferred Shares written notice of such impending transaction under Article 10(a) not later than ten (10) days prior to the Shareholders’ meeting called to approve such transaction, or ten (10) days prior to the closing of such transaction, whichever is earlier, and shall also notify such holders in writing of the final approval of such transaction. The first of such notices shall describe the material terms and conditions of the impending transaction and the provisions of this Article 10, and the Company shall thereafter give such holders prompt notice of any material changes. The

 

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transaction shall in no event take place sooner than fourteen (14) days after the Company has given the first notice provided for herein or sooner than ten (10) days after the Company has given notice of any material changes provided for herein; provided, however, that such periods may be shortened upon the written consent of the Majority Investors.

 

(c)                                  For the avoidance of doubt, this Article 10 shall not apply to a merger in which the Series D Preferred Shareholders receive their entire Series D Preference in such transaction in liquid proceeds (cash and/or publicly-traded securities).

 

(d)                                 The provisions of this Article 10 are in addition to the other provisions hereof, including but not limited to Articles 8 and 9.

 

Nothing in this Article 10 shall prevent Preferred Shareholders from exercising the rights to convert the Preferred Shares into Ordinary Shares prior to the conclusion of a transaction contemplated herein, in which case the provisions of Article 10 shall not apply to such converted Preferred Shares.

 

VOTING RIGHTS

 

11.                               (a)                                 The holder of each share of the Company shall be entitled to notice of any Shareholders’ meeting in accordance with these Articles.

 

(b)                                 The holder of any outstanding Ordinary Share shall have the right to one vote for each Ordinary Share held, with respect to any question upon which holders of Shares have the right to vote, except to the extent that these Articles or applicable law provide that only holders of Preferred Shares (or one or more classes thereof) shall be entitled to vote on such question.

 

(c)                                  The holder of any Preferred Share shall have the right to one vote for each Ordinary Share into which such Preferred Share could then be converted (with any fractional share determined on an aggregate conversion basis being rounded to the nearest whole share), and with respect to such vote, such holder shall have full voting rights and powers equal to the voting rights and powers of the holders of Ordinary Shares, and shall be entitled to notice of any Shareholders’ meeting in accordance with these Articles (including but not limited to a meeting of the holders of the Preferred Shares as a whole, or such class of Preferred Shares), and shall be entitled to vote, together with holders of Ordinary Shares, with respect to any question upon which holders of Ordinary Shares have the right to vote, and any question upon which holders of Preferred Shares as a whole, or such class of Preferred Shares, have the right to vote.

 

(d)                                 The foregoing or anything else herein notwithstanding, including but in no way limited to Article 67A, (i) the holders of the Series D Preferred Shares shall be entitled to vote, together, as a separate class on, and the approval of the Majority Investors shall be required for, any alteration of, waiver regarding, or change to (in each case, in whole or in part) any right, preference or privilege of the Series D Preferred Shares (including, for the avoidance of doubt, (A) any amendment, repeal or modification of any rights attached to the Series D Preferred Shares or any provision of these Articles resulting in or amounting to such, (B) the creation of any securities which are more senior to, or are otherwise in priority to, the Series D Preferred Shares, it being clarified that, notwithstanding anything else to the contrary set forth herein, taking the action under this clause (B) shall require the consent of the holders of the Series D Preferred Shares holding at least 60% of the issued and

 

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outstanding Series D Preferred Shares, on an as converted basis; provided however that the Series D Preferred Shares held by any shareholder (or its Permitted Transferee) investing in the financing that calls for the creation of such senior/priority securities beyond its or their pre-emptive rights pursuant to Article 14, shall not be counted towards achieving such majority, (C) the conversion of the entire class of Series D Preferred Shares to Ordinary Shares (except for an Automatic Conversion under Article 9(b)(ii) (i.e. a QPO)), and/or (D) any other decisions hereunder or pursuant to applicable law requiring the approval of, or class vote by, the Series D Preferred Shares) (each, a “Preferred D Vote”), and (ii) with respect to each Preferred D Vote, such vote shall be subject to the approval of the Majority Investors, and in the event that such approval shall not be obtained, the foregoing action shall not be taken), which decision shall be binding on all holders of Series D Preferred Shares; provided however that solely for the purposes of item (B) above, the term “Majority Investors” shall not require the approval of the Lead Investor. The foregoing or anything else herein notwithstanding, including but in no way limited to Article 67A, the holders of the Series E Preferred Shares shall be entitled to vote, together, as a separate class on, and the approval of the Majority E Holders shall be required for adversely changing the rights attached to the Series E Preferred Shares, unless such change applies proportionally to all of the classes of shares of the Company (in which case, the consent of the Majority E Holders will not be required). For the avoidance of doubt, it is hereby agreed that any class of Preferred Shares (including, without limitation, Series E Preferred Shares and Series D Preferred Shares) shall vote together with the Ordinary Shares of the Company, as a single class and not as a separate class over all matters and in all shareholders meetings, except as required by law and these Articles. For the purposes of voting rights hereunder, the Series D-1 Preferred Shares, the Series D-2 Preferred Shares and Series D-3 Preferred Shares shall be considered a single class, and shall vote together as a single class on all Preferred D Votes and/or any Class Meetings of the Series D Preferred Shares. Notwithstanding the above and other provisions, if a Preferred D Vote is only in respect of, touching or concerning, only the Series D-3 Preferred Shares (but not or not substantially equally touching or concerning other Series D Preferred Shares and/or the holders thereof, mutatis mutandis), the consent of the holders of Series D-3 Preferred Shares holding the majority of the issued and outstanding Series D-3 Preferred Shares shall also be required, provided that such majority consent shall not be unreasonably withheld, and provided further that any exercise of any existing right, of any Shareholder, under this Articles and/or the Additional Agreements (including, without limitation, any right of any Shareholder under Article 9 herein) shall not be deemed as an action that is touching and/or concerning and/or having an adverse effect on the Series D-3 Preferred Shares and/or the holders thereof, and in the event that the holders of Series D-3 Preferred Shares will not be equally affected by an event solely due to the fact that the holders of D-1 Preferred Shares and D-2 Preferred Shares have existing rights under these Articles and/or the Additional Agreements, then such event which caused the adverse effect will not require the additional specific consent of the D-3 Preferred holders pursuant to this sentence.

 

(e)                                  Notwithstanding the provisions of Section 20(c) of the Companies Law to the contrary, (i) other than as specifically set forth in Article 11(d) and elsewhere herein, and without derogating from any rights of the holders of Series D Preferred Shares hereunder or of the holders of Series E Preferred Shares hereunder (to the extent required pursuant to Article 11(d) above)), a separate class vote of each class of the Preferred Shares shall not be required in order to amend or waive the rights, preferences, privileges or restrictions granted to and imposed upon any class of Preferred Shares or Ordinary Shares, respectively, it being

 

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clarified that (subject to the terms of Article 11(d)(i)(B)) under no circumstances shall any class be granted more senior rights than those of the Series E Preferred Shares, without the approval of the Majority Investors and the Majority E Holders, and (ii) without derogating from the rights of the Lead Investor as specifically specified in these Articles and other than as specifically set forth in Article 11(d) and elsewhere herein, in no event shall any or some of the holders of any class of Preferred Shares and/or Ordinary Shares confer upon their holders the right to any separate Class Meeting (as defined below) or interest meeting or the right to any class or interest vote.

 

12. AGGREGATION OF SHARES

 

Subject to Articles 14(e) and 30(h), and subject to, and unless otherwise required by, applicable securities law:

 

(a)                                 Shares held by two or more shareholders who are Permitted Transferees may be aggregated together, unless otherwise stated herein, for the purpose of determining the availability of any rights under these Articles for such shareholders, including rights which are conditioned on the relevant shareholder holding shares representing a minimum percentage.

 

(b)                                 Shares held by Aurum Group and its Permitted Transferees shall be aggregated together, for the purpose of determining the availability of any rights under these Articles for such shareholders, including rights which are conditioned on the relevant shareholder holding shares representing a minimum percentage.

 

(c)                                  Shares held by the Limited Partners and their Permitted Transferees shall be aggregated together, for the purpose of determining the availability of any rights under these Articles for such shareholders, including rights which are conditioned on the relevant shareholder holding shares representing a minimum percentage.

 

(d)                                 Shares held by the Series A-1 Group and its Permitted Transferees shall be aggregated together, for the purpose of determining the availability of any rights under these Articles for such shareholders, including rights which are conditioned on the relevant shareholder holding shares representing a minimum percentage.

 

(e)                                  Shares held by any Provident Fund and its Permitted Transferees shall be aggregated together, for the purpose of determining the availability of any rights under these Articles for such shareholders, including rights which are conditioned on the relevant shareholder holding shares representing a minimum percentage.

 

(f)                                   Shares held by the Lead Investor and its Permitted Transferees shall be aggregated together, for the purpose of determining the availability of any rights under these Articles for such shareholders, including rights which are conditioned on the relevant shareholder holding shares representing a minimum percentage.

 

(g)                                  Shares held by CY Company and Master Toy and their assignees or Permitted Transferees shall be aggregated together, for the purpose of determining the availability of any rights under these Articles for such shareholders, including rights which are conditioned on the relevant shareholder holding shares representing a minimum percentage.

 

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ALLOTMENT OF SHARES

 

13.                               Subject to the provisions of Article 14, and without derogating from any right of the Preferred Shareholders, including without limitation pursuant to Articles 9 and 11(d), the unissued shares shall be under the control of the Board of Directors, which shall have the power to allot shares or otherwise dispose of them to such persons, on such terms and conditions (including inter-alia terms relating to calls as set forth in Article 33 hereof), and either at nominal value or at a premium, or, subject to the provisions of the Companies Law, at a discount, and at such times, as the Board of Directors may think fit, and the power to give any person the option to acquire from the Company any shares, either at nominal value or at premium, or, subject as aforesaid, at a discount, during such time and for such consideration as the Board of Directors may think fit.

 

PRE-EMPTIVE RIGHTS

 

14.                               (a)                                 Prior to an IPO, each (x) holder of Preferred Shares holding, at such time, at least 3% of the issued and outstanding Company Shares, on an as-converted basis, (y) holder of Shares being a Provident Fund or its Permitted Transferee, or (z) any Eligible E Holder (in this Article 14, each an “Offeree”) shall have a right of pre-emption to purchase its Pro Rata Share (as defined below) of all Equity Securities (as defined below) that the Company may, from time to time, propose to sell and issue after the adoption of these Articles. A “Pro Rata Share” shall be equal to the ratio of (A) the number of the Company’s issued and outstanding Ordinary Shares (including all Ordinary Shares issued or issuable upon conversion of the Preferred Shares) held by an Offeree immediately prior to the issuance of such Equity Securities to (B) the total number of the Company’s issued outstanding Ordinary Shares (including all Ordinary Shares issued or issuable upon conversion of the Preferred Shares) immediately prior to the issuance of such Equity Securities (including but not limited to any Warrant Shares actually issued by the Company upon exercise of the Warrants); it being understood that in no event will options or warrants held by any Offeree will be taken into consideration for purposes of calculating the Pro Rata Shares, only to the extent that such options or warrants are outstanding and have not been fully exercised. For the purposes hereof, the term “Equity Securities” shall mean (i) any Ordinary Shares, Preferred Shares or other security of the Company, (ii) any security convertible, with or without consideration, into any Ordinary Shares, Preferred Shares or other security (including any option to purchase such a convertible security), (iii) any security carrying any warrant or right to subscribe to or purchase any Ordinary Shares, Preferred Shares or other security or (iv) any such warrant or right; provided however that Equity Securities shall not include Exempt Securities.

 

(b)                                 If the Company proposes to issue any Equity Securities, it shall give each Offeree written notice of its intention, describing the Equity Securities, the price and the terms and conditions upon which the Company proposes to issue the same.  Each Offeree shall have fourteen (14) days from the giving of such notice to agree to purchase up to its pro rata share of the Equity Securities.

 

(c)                                  If the Offerees fail to exercise in full their preemptive rights within the periods specified herein, then the Company shall have ninety (90) days thereafter to sell the Equity Securities in respect of which the Offerees’ rights were not exercised, at a price and upon general terms and conditions no more favorable to the purchasers thereof than specified in the Company’s notice to the Offerees pursuant to Article 14(b) hereof.  If the Company has not

 

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sold such Equity Securities within ninety (90) days of the notice provided pursuant to Article 14(b), the Company shall not thereafter issue or sell any Equity Securities, without first offering such securities to the Offerees in the manner provided in this Article.

 

(d)                                 For purposes hereof, a “Permitted Transferee” of a Shareholder shall mean: (i) in the case of a limited partnership, its limited partners, general partners, and the limited and general partners of such limited and general partners, (ii) in the case of a corporation, its shareholders in accordance with their interest in the corporation, (iii) in the case of a limited liability company, its members and former members in accordance with their interest in the limited liability company, (iv) in the case of an individual, a first-degree family member or trust for the benefit of such individual and/or any other of his/her Permitted Transferee(s), and (v) with respect to entities that manage or co-manage, or are managed or whose account is managed by, directly or indirectly, such Shareholder and any of its limited partners, general partners and the limited and general partners of such limited and general partners and management company, (vi) with respect to a trustee of the Company’s employee share option plan, or any other trustee: a beneficiary and vice versa; provided that the Company will obtain a statement signed by the trustee pursuant to which the shares were held in trust solely for the beneficiary, (vii) with respect to Xenia Venture Capital Ltd. - the State of Israel, (viii) with respect to the FAC Partnership - each Limited Partner and also a transfer from each Limited Partner to FAC Partnership, (ix) with respect to any member of the Aurum Group, any other member of the Aurum Group, (x) with respect to any member of the Series A-1 Group and their Permitted Transferees, any other member of such Series A-1 Group and its Permitted Transferees, (vi) with respect to Aurius Trade Limited, Rami Lerner and Zvi Pugach — any of them will be deemed as a Permitted Transferee of each other; and (xi) with respect to a Provident Fund, any other affiliated Provident Fund and/or any other Institutional Entity and/or any other transferee to whom such provident fund is permitted by applicable law or regulation to make such transfer.

 

(e) If the offer to Offerees under this Article 14 may, if carried out, constitute, under applicable laws, an offer to the public which is subject to prospectus requirements, then such offer shall be limited, so that it is made only in a manner according to which it will not, and only to a number of Offerees which ensures that it will not, be subject to such prospectus requirements; and in furtherance of such goal, offerings shall only be made to members of the following groups in the following order of priority: (i) the type of Offerees the offering to which, at such time, is exempted from such prospectus requirement; (ii) holders of Series D Preferred Shares pro rata among themselves; and (iii) other Offerees; with a higher priority being given, within each of the groups in clauses (ii) and (iii), to an Offeree holding a greater percentage of Company Shares than other Offerees in such group (aggregating, for such purpose, the holdings of Permitted Transferees; provided that such Permitted Transferees shall be considered as separate entities to the extent viewed as such by applicable law).

 

BRING-ALONG

 

15.                               (a)                                 Prior to an IPO, subject to the Liquidation Preference rights of the Series E Preferred Shareholders and the Series D Preferred Shareholders and all other holders of Preferred Shares pursuant to Article 8(d) above, in the event of a proposed M&A Event or if any person or entity makes an offer to purchase all of the issued and outstanding share capital of the Company (the “Offer”), and the holders of more than 60% of the issued and outstanding shares of the Company, on an as-converted basis (the “Accepting Holders”), indicate their acceptance of such proposed M&A Event or offer, and such M&A Event or

 

25



 

offer, as applicable, has been approved by the Board of Directors and otherwise in accordance with the provisions of these Articles (collectively, the “Required Consent”), then, at the closing of such transaction, all of the holders of all shares in the Company shall transfer such shares to such person or entity; provided, however, that the consideration paid by the acquirer to the Company or its shareholders (in their capacity as such, without including any Retention Consideration) shall in any event be allocated among the shareholders in accordance with Article 8 above. Each shareholder shall execute and deliver such documents and take such actions (including in shareholder votes) as may be reasonably required by the Board of Directors or the Accepting Holders. Notwithstanding the foregoing, no Shareholder shall be required to (i) make representations and warranties as to any matters other than matters that relate solely to their ownership of shares and their ability to sell such shares, (ii) become subject to any indemnification obligation which is not based on his or its representations and warranties (except to the extent that funds may be paid out of an escrow established to cover breach of representations, warranties and covenants of the Company) or (iii) become subject to any indemnification obligation which could result in liability in excess of the gross proceeds actually paid to such Shareholder in the transaction, other than in case of fraud, willful misconduct or willful misrepresentation by such Shareholder.

 

(b)                                 In the event of an Offer under Article 15(a), then as soon as possible after receipt of the Offer but in any event not less than fifteen (15) days prior to the date set by the acquirer as the final date for accepting such Offer, the Company shall notify in writing each holder of Company securities of such Offer. Such notice shall set forth: (i) the name of the acquirer; and (ii) the proposed amount and form of consideration and terms and conditions of payment offered by the acquirer.

 

(c)                                  In the event that a Shareholder fails to surrender its certificate in connection with the consummation of a transaction as set forth above, such certificate shall be deemed cancelled and the Company shall be authorized to issue a new certificate in the name of the Shareholder and the Board of Directors shall be authorized to establish an escrow account, for the benefit of such Shareholder into which the consideration for such securities represented by such cancelled certificate shall be deposited and to appoint a trustee to administer such account.

 

(d)                                 In the event of an Offer under Article 15(a), Section 341 of the Companies Law shall apply, except as otherwise set forth above.

 

REGISTERED HOLDER

 

16.                               (a)                                 If two or more persons are registered as joint holders of a share they shall be jointly and severally liable for any calls or any other liability with respect to such share.  However with respect to voting, powers of attorney and furnishing notices, the one registered first in the Register, insofar as all the registered joint holders shall not notify the Company in writing to relate to another one of them as the sole owner of the share, as aforesaid, shall be deemed to be the sole owner of the share.

 

(b)                                 If two or more persons are registered together as holders of a share, each one of them shall be permitted to give receipts binding all the joint holders for dividends or other monies in connection with the share and the Company shall be permitted to pay all the dividends or other monies due with respect to the share to one or more of the joint holders, as it shall choose.

 

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SHARE CERTIFICATE

 

17.                               (a)                                 A Shareholder shall be entitled to receive from the Company without payment, one certificate that shall contain that number of shares registered in the name of such Shareholder, their class and serial numbering.  However, in the event of joint holders holding a share, the Company shall not be obligated to issue more than one certificate to all of the joint holders, and the delivery of such a certificate to one of the joint holders shall be deemed to be a delivery to all of the joint holders.

 

(b)                                 Each certificate shall carry the signature or signatures of two Directors or of those persons appointed by the Board of Directors for this purpose and the rubber stamp or the seal or the printed name of the Company.

 

(c)                                  If a share certificate is defaced, lost or destroyed, it may be replaced upon payment of such fee, if any, and on such terms, if any, as to evidence and indemnity as the Board of Directors may think fit.

 

PLEDGE

 

18.                               The Company shall have a lien and first pledge on all the shares, not fully paid, registered in the name of any Shareholder (whether registered in his name only or together with another or others) for any amount still outstanding with respect to that share, whether presently payable or not.  Such a pledge shall exist whether the dates of payment or fulfillment or execution of the obligations, debts or commitments have become due or not, and shall apply to all dividends that shall be decided upon from time to time in connection with these shares.  No benefit shall be created with respect to this share based upon the rules of equity which shall frustrate this pledge, however the Board of Directors may declare at any time with respect to any share, that it is released, wholly or in part, temporarily or permanently, from the provisions of this Article.

 

19.                               The Company may sell, in such manner and at such time as the Board of Directors thinks fit, any of the pledged shares, but no sale shall be made unless the date of payment of the monies or a part thereof has arrived, or the date of fulfillment and performance of the obligations and commitments in consideration of which the pledge exists has arrived, and after a written request has been furnished to the Shareholder or person who has acquired a right in the shares, which sets out the amount or obligation or commitment due from him and which demands their payment, fulfillment or execution, and which informs the person of the Board of Director’s desire to sell the shares in the event of non-fulfillment of the notice, and the person has not fulfilled his obligation pursuant to the notice within seven days after the notice had been sent to him.

 

20.                               The net proceeds of such sale shall be applied in payment of such sum due to the Company or to the fulfillment of the obligation or commitment, and the remainder (if there shall be any) shall be paid to the Shareholder or to the person who has acquired a right in the share sold pursuant to the above.

 

21.                               After execution of a sale as aforesaid, the Board of Directors shall be permitted to sign or to appoint someone to sign a deed of transfer of the sold shares and to register the buyer’s name in the Register as the owner of the sold shares and it shall not be the obligation of the buyer to supervise the application of monies nor will his right in the shares be affected

 

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by a defect or illegality in the sale proceedings after his name has been registered in the Register with respect to those shares.

 

The sole remedy of any person aggrieved by the sale shall be in damages only and against the Company exclusively.

 

TRANSFER OF SHARES AND THE MANAGEMENT THEREOF

 

22.                               Any transfer of shares shall be subject to the approval of the Board of Directors, which approval shall not be unreasonably withheld, provided that the transferor and transferee have complied with all relevant provisions of these Articles. If the Board of Directors shall make use of its powers in accordance with this Article and refuses to register a transfer of shares, it must inform the transferee of its refusal and the reason for such refusal, within 15 days of the day the deed of transfer had been furnished to the Company.

 

23.                               Each transfer of shares shall be made in writing in the form appearing herein below, or in a similar form, or in any form as determined by the Board of Directors from time to time, such form to be delivered to the Office together with the transferred share certificates and any other proof the Board of Directors shall require, if they shall so require, in order to prove the title of the transferor.

 

Deed of Transfer of Shares

 

I,                         of                        in consideration of the sum of NIS        (New Israeli Shekels) paid to me by                         , of                              (hereinafter called the “Transferee”) do hereby transfer to the Transferee              (       )                       share (or shares) having nominal value of NIS             , in PolyPid Ltd., to hold unto the Transferee, its executors, administrators, and assigns, subject to the several conditions on which I held the same at the time of the execution hereof; and I, the Transferee, do hereby agree to take the said share (or shares) subject to the conditions aforesaid.  As witness we have hereunto set our hands the             day of             .

 

 

 

 

 

 

 

Transferee

 

Transferor

 

 

24.                               The deed of share transfer shall be executed both by the transferor and transferee, and the transferor shall be deemed to remain a holder of the share until the name of the transferee is entered into the Register in respect thereof.

 

25.                               The Company shall be permitted to demand a fee for registration of a transfer, at a reasonable rate as to be determined by the Board of Directors from time to time.

 

26.                               The Register may be closed at such dates and for such other periods as determined by the Board of Directors from time to time, upon the condition that the Register shall not be closed for more than 15 days every year.

 

27.                               Upon the death of a Shareholder the remaining holders (in the event that the deceased was a joint holder in a share) or the administrators or executors or heirs of the deceased (in the event the deceased was the sole holder of the share or was the only one of the joint

 

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holders of the share to remain alive) shall be recognized by the Company as the sole holder of any title to the shares of the deceased.  However, nothing aforesaid shall release the estate of a joint holder of a share from any obligation with respect to the share that he held jointly with any other holder.

 

28.                               Any person becoming entitled to a share in consequence of the death or bankruptcy or liquidation of a Shareholder shall, upon such evidence being produced as may from time to time be required by the Board of Directors, have the right, either to be registered as a Shareholder in respect of the share upon the consent of the Board of Directors or, instead of being registered himself, to transfer such share to another person, subject to the provisions contained in these Articles with respect to transfers.

 

29.                               A person becoming entitled to a share because of the death of a Shareholder shall not be entitled to receive notices with respect to Company meetings or to participate or vote therein with respect to that share, or aside from the aforesaid, to use any right of a Shareholder, until he has been accepted as a Shareholder with respect to that share.

 

RIGHT OF FIRST REFUSAL

 

30.                               (a)                                 Any holder of Ordinary Shares (other than such holder all of whose Ordinary Shares were issued upon the conversion of Preferred Shares) and/or any Key Shareholder (as defined below) proposing, prior to the IPO, to sell, assign, transfer, pledge, hypothecate, mortgage or dispose of, by gift or otherwise, or in any way encumber (“Transfer”) all or any of the Ordinary Shares held by them, from time to time (other than a Transfer to a Permitted Transferee) (the “Offeror”), shall, by written notice, offer (the “Offer”) such Ordinary Shares (the “Offered Shares”), on the terms of the proposed transfer, to each (x) holder of Preferred Shares holding, at such time, at least 3% of the issued and outstanding Company Shares, on an as-converted basis, (y) holder of Shares being a Provident Fund or its Permitted Transferee, or (z) any Eligible E Holder (in this Article 30 and Article 31 below, the “Offerees”).

 

(b)                                 The Offeror shall send the notice (the “Notice”) to the Company, which shall in turn send it to the Offerees in the name of the Offeror. The Notice shall state the identity of the Offeror and of the proposed transferee(s), the number of Offered Shares, the price per share and other economic terms of sale of the Offered Shares. Any Offeree may accept such Offer in respect of all or any of the Offered Shares by giving the Company notice to that effect (the “Accepting Shareholder” and the “Acceptance”, respectively) within fifteen (15) days after being served with Notice of the Offer.

 

(c)                                  If the Acceptances provided during such fifteen (15) day period are, in the aggregate, in respect of at least all of the Offered Shares, then the Accepting Shareholders shall acquire the Offered Shares, on the terms set forth in the Notice, in proportion to their respective holdings in the Company (on a fully-diluted, as-converted basis) among themselves; provided that no Accepting Shareholder shall be entitled to acquire, under the provisions of this Sub-Article (c), more than the number of Offered Shares accepted by such Accepting Shareholder under its respective Acceptance, and upon the allocation to such Accepting Shareholder of the full number of shares so accepted by it in its Acceptance, such Accepting Shareholder shall be disregarded in any subsequent computations and allocations hereunder. Any shares remaining after the computation of such respective entitlements shall be re-allocated among the Accepting Shareholders (other than those to be disregarded as

 

29



 

aforesaid), in the same manner, until one hundred percent (100%) of the Offered Shares have been allocated as aforesaid.

 

(d)                                 If no Acceptances are provided during such fifteen (15) day period, then the Offerees shall not be entitled to acquire any of the Offered Shares, and the Transfer shall become subject to the Co-Sale rights under Article 31, before the Offeror may complete the Transfer.

 

(e)                                  If the Acceptances provided during such fifteen (15) day period are, in the aggregate, in respect of some but not all of the total number of Offered Shares, then the Company shall, immediately after the expiration of such period, send written notice (the “Second Notice”) to the Accepting Shareholders. Each Accepting Shareholder shall have an additional option to purchase all or any part of the balance of any such remaining Offered Shares on the terms and conditions set forth in the Notice, by giving the Company notice to that effect (the “Follow-on Acceptance”) within ten (10) days after being served with Second Notice.

 

(i)                                     If all remaining Offered Shares are accepted in Follow-on Acceptances, such shares shall be allocated among those providing the Follow-on Acceptances, in proportion to their respective holdings in the Company (on a fully-diluted, as-converted basis) among themselves, and generally in accordance with the allocations mechanism provided under Article 30(c).

 

(ii)                                  If fewer than the remaining Offered Shares are accepted in Follow-on Acceptances, then the Accepting Shareholders shall not acquire any of the Offered Shares, including those for which Acceptances were provided, and the Transfer of all of the Offered Shares shall become subject to the Co-Sale rights under Article 31 (to the extent such Article is applicable thereto), before the Offeror may complete the Transfer thereof.

 

(f)                                   For the purposes of any Transfer under this Article 30, the respective holdings of any Accepting Shareholder shall mean the respective proportion of the aggregate number of Equity Securities held by such Accepting Shareholder, on a fully-diluted and as-converted basis, to the aggregate number of Ordinary Shares held by all the Accepting Shareholders, on a fully-diluted and as-converted basis.

 

(g)                                  The Company shall not register any Transfer of its shares on its books, unless such Transfer fully complies with the provisions of this Article 30.

 

(h)                                 If the offer to Offerees under this Article 30 may, if carried out, constitute, under applicable laws, an offer to the public which is subject to prospectus requirements, then such offer shall be limited, so that it is made only in a manner according to which it will not, and only to a number of Offerees which ensures that it will not, be subject to such prospectus requirements; and in furtherance of such goal, offerings shall only be made to members of the following groups in the following order of priority: (i) the type of Offerees the offering to which, at such time, is exempted from such prospectus requirement; (ii) holders of Series D Preferred Shares pro rata among themselves; and (iii) other Offerees; with a higher priority being given, within each of the groups in clauses (ii) and (iii), to an Offeree holding a greater percentage of Company Shares than other Offerees in such group (aggregating, for such purpose, the holdings of Permitted Transferees; provided that such Permitted Transferees shall be considered as separate entities to the extent viewed as such by applicable law).

 

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(i)                                     This Article 30 (right of first refusal) shall not apply in the case of a bring along transaction under Article 15.

 

CO-SALE RIGHT

 

31.                               Prior to the consummation of an IPO, if (a) the Offered Shares are not acquired in their entirety by the Offerees pursuant to the right of first refusal set forth in Article 30 above, and (b) solely with respect to any Key Shareholder, if such Key Shareholder wishes to transfer or sell any Equity Securities, then each Offeree under Article 30 shall have the right to participate in the Offeror’s Transfer of the Offered Shares (which were not acquired by the Offerees, as aforesaid) to the proposed transferee(s), as follows.

 

(a)                       Exercise of Right.  If the Offered Shares intended to be Transferred by the Offeror under Article 30 (the “Transferring Shareholder”) are not acquired in their entirety pursuant to the right of first refusal set forth in Article 30, the Company shall notify the Offerees (as defined in Article 30) in writing (the “Co-Sale Notice”), at the end of the relevant notice period(s) thereunder, that they shall have the right, exercisable by written notice to the Company within seven (7) days of receipt of the Co-Sale Notice, to require the Transferring Shareholder to provide, as part of its proposed Transfer of the Offered Shares which were not acquired pursuant to the right of first refusal set forth in Article 30 (the “Residual Shares”), that such Offerees be given the right to participate in the Transfer of the Residual Shares by selling Ordinary Shares (or shares convertible into Ordinary Shares), on the same terms and conditions as the Transferring Shareholder, on a pro-rata basis (the “Offeree’s Pro-Rata Share”), as follows: each Offeree’s Pro-Rata Share shall equal the product obtained by multiplying (1) the aggregate number of the Residual Shares, by (2) a fraction, (x) the numerator of which is the number of shares owned by such Offeree at the time of the Transfer and (y) the denominator of which is the total number of shares owned by the Transferring Shareholder and the Offerees at the time of the Transfer, in each case measured on a fully-diluted and as-converted basis. If any Offeree exercises its rights hereunder, the Transferring Shareholder shall cause the acquirer to purchase, as part of the Transfer, the Offeree’s Pro-Rata Share of each participating Offeree (or any part thereof chosen by such Offeree to be sold, if it gave notice with respect to less than its Offeree’s Pro-Rata Share), and the Transferring Shareholder shall not proceed with such Transfer unless such Offerees are given the right to participate in the Transfer in accordance herewith.

 

(b)                                 Transfer to Transferee(s). Subject to compliance with Article 30 and this Article 31, the Transferring Shareholder shall be entitled, at the expiration of the aforementioned periods, to Transfer all, or the appropriate portion (together with the Offeree’s Pro-Rata Share of each participating Offeree), as applicable, of the Offered Shares, to such proposed transferee(s); provided, however, that in no event shall the Offeror Transfer any of the Offered Shares on terms more favorable to the transferee(s) than those stated in the Notice; and provided further that any of the Offered Shares not Transferred within ninety (90) days after provision of the Notice, shall again be subject to the provisions of Article 30 and this Article 31.

 

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(c)                        Permitted Transferees. For the removal of doubt, a Transfer by a Transferring Shareholder to its Permitted Transferee in accordance with the provisions of these Articles shall not trigger the application of Article 30 or this Article 31.

 

(d)                       This Article 31 (co-sale right) shall not apply in the case of a bring along transaction under Article 15.

 

NO SALE

 

32.                               Notwithstanding anything else to the contrary in these Articles, until the earliest of (i) January 1, 2020, (ii) the consummation of an IPO, (iii) the consummation of a Deemed Liquidation Event, and (iv) the termination of the engagement of the Key Shareholder with the Company (so long as it is not “for cause”), Dr. Noam Emanuel and Amir Weisberg (each, a “Key Shareholder”) shall not Transfer all or any of the Ordinary Shares of the Company and any shares issued upon exercise of any options, or issuable upon exercise of any option, held by the Key Shareholder (a “Restricted Transfer”), unless the Majority Investors have given their prior written consent for any such Restricted Transfer. Any Restricted Transfer by the Key Shareholder shall be subject to this Article 32 as well as the other provisions regarding Transfers set forth in these Articles, including but not limited to Articles 30 and 31. The provisions of this Article 32 shall not apply to any transfer by any of the Key Shareholders to its Permitted Transferee, provided that, upon and as a condition to such transfer, the Permitted Transferee will be deemed to be a Key Shareholder, and further provided that such Permitted Transferee shall not be permitted to transfer any Shares to any party which is not a Permitted Transferee of the Key Shareholder, even if such party would otherwise be a Permitted Transferee of the first Permitted Transferee.

 

CALLS

 

33.                               A Shareholder shall not be entitled to receive dividends nor to use any right a Shareholder has, unless he has paid all the calls that shall be made from time to time, with respect to money unpaid on all of his shares, whether he is the sole holder or holds the shares together with another person, in addition to interest and expenses if there shall be any.

 

34.                               The Board of Directors may, subject to the provisions of these Articles, make calls upon the Shareholders from time to time in respect of any moneys unpaid on their shares, as they shall determine proper, upon the condition that there shall be given reasonable prior notice on every call and each Shareholder shall be obligated to pay the total amount requested from him, or the installment on account of the call (if there shall so be) at the times and places to be determined by the Board of Directors.

 

35.                               The calls for payment shall be deemed to have been requested from the date the Board of Directors shall have decided upon the calls for payment.

 

36.                               The joint holders of a share shall be jointly and severally liable to pay the calls for payment in full and the installment on account, in connection with such calls.

 

37.                               If a sum called in respect of a share is not paid the holders of the share or the person to whom it has been issued shall be liable to pay interest and linkage differentials (“interest”) upon the amount of the call or the payments on account, as determined by the Board of Directors commencing from the day appointed for the payment thereof to the time of actual

 

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payment, but the Board of Directors shall be at liberty to waive payment of that interest, wholly or in part.

 

38.                               Any amount that according to the condition of issuance of a share must be paid at the time of issuance or at a fixed date, whether on account of the sum of the share or premium, shall be deemed for the purposes of these Articles to be a call of payment that was made duly and the date of payment shall be the date appointed for payment.  In the event of non-payment of this amount all of the Articles herein dealing with payment of interest, expenses, forfeiture, pledge and the like and all the other Articles connected therewith, shall apply, as if this sum had been duly requested and notice had been given, as aforesaid.

 

39.                               The Board may make different arrangements at the times of issuance of shares to different shareholders, with respect to the amount of calls to be paid, the times of payment, and the applicable rate of interest.

 

40.                               The Board of Directors may, if it thinks fit, receive from any Shareholder willing to pay in advance all of the monies or a part thereof that shall be due on account of his shares, in addition to any amounts for which the payment in fact has been requested and they shall be permitted to pay him interest at the rate the Board of Directors and the Shareholder shall agree upon, for the amounts paid in advance as aforesaid, or upon the part thereof which is in excess of the amounts whose payment was at the time requested on account of his shares in connection with which the payments have been made in advance, in addition to paying dividends that will be paid for that part of the share which has been paid in advance.

 

FORFEITURE OF SHARES

 

41.                               If a Shareholder fails to pay any call or installment of a call on the day appointed for payment thereof, the Board of Directors may, subject to the provisions of Section 181 of the Companies Law, at any time thereafter during such time as any part of such call or installment remains unpaid, serve a notice on him requiring payment of so much of the call or installment as is unpaid, together with any interest which may have accrued and any expenses that were incurred as a result of such non-payment.

 

42.                               The notice shall name a further day, not earlier than the expiration of seven days from the date of the notice, on or before which the amount of the call or installment or a part thereof is to be made together with interest and any expenses incurred as a result of such non-payment.  The notice shall also state the place the payment is to be made and that in the event of non-payment, at or before the time appointed, the shares in respect of which the call was made will be liable to be forfeited.

 

43.                               If the requirements of any such notice as aforesaid are not complied with, any share in respect of which the notice has been given may at any time thereafter, before the payment required by the notice has been made, be forfeited by a resolution of the Board of Directors to that effect. The forfeiture shall include those dividends that were declared but not yet distributed, with respect to the forfeited shares.

 

44.                               A share so forfeited shall be deemed to be the property of the Company and can be sold or otherwise disposed of, on such terms and in such manner as the Board of Directors thinks fit. At any time before a sale or disposition the forfeiture may be canceled on such terms as the Board of Directors thinks fit.

 

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45.                               A person whose shares have been forfeited shall cease to be a Shareholder in respect of the forfeited shares, but shall notwithstanding remain liable to pay to the Company all monies which, at the date of forfeiture, were presently payable by him to the Company in respect of the shares, but his liability shall cease if and when the Company receives payment in full of the nominal amount of the shares.

 

46.                               The forfeiture of a share shall cause, at the time of forfeiture, the cancellation of all rights in the Company or any claim or demand against it with respect to that share and the other rights and obligations between the share owner and the Company accompanying the share, except for those rights and obligations not included in such a cancellation according to these Articles or that the Law imposes upon former Shareholders.

 

47.                               The provisions of these Articles as to forfeiture shall apply in the case of non-payment of any sum which, by the terms of issue of a share, becomes payable at a fixed time, whether on account of the nominal value of the share, or by way of premium, as if the same had been payable by virtue of a call duly made and notified.

 

MODIFICATION OF CAPITAL

 

48.                               Subject to the rights of the Preferred Shareholders pursuant to these Articles, including but not limited to pursuant to Article 11(d), the Company may, from time to time, by a Shareholders resolution:

 

(a)                                 consolidate and divide all or any of its issued or unissued share capital into shares of larger nominal value than its existing shares;

 

(b)                                 cancel any shares which have not been taken or agreed to be taken by any person;

 

(c)                                  by subdivision of its existing shares, or any of them, divide the whole, or any part, of its share capital into shares of smaller amounts subject, nevertheless, to the provisions of the Companies Law and in a manner that with respect to the shares created as a result of the division it will be possible within the resolution of division to grant to one or more shares a preferable right or advantage with respect to dividend, capital, voting or otherwise over the remaining share or other similar shares; and

 

(d)                                 reduce its share capital and any fund reserved for capital redemption in the manner that it shall deem to be correct, with and subject to, any incident authorized, and consent required, by law.

 

INCREASE OF SHARE CAPITAL

 

49.                               The Company shall be permitted, subject to the rights of the Preferred Shareholders in these Articles (including but not limited to pursuant to the provisions of Article 11(d)), from time to time, by a resolution, to increase its share capital - whether or not all its shares have been issued, or whether the shares issued have been paid in full - by creation of new shares.  This new capital shall be in such an amount, divided into shares in such amounts and have such preferable or deferred or other special rights (subject always to the special rights conferred upon an existing class of share), subject to any condition and restrictions with respect to dividends, return of capital, voting or otherwise, all as shall be directed by the general meeting in its resolution sanctioning the increase of the share capital.

 

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50.                               Subject to any decision to the contrary in the resolution sanctioning the increase in share capital, pursuant to these Articles, the new share capital shall be deemed to be part of the original share capital of the Company and shall be subject to the same provisions with reference to payment of calls, liens, title, forfeiture, transfer and otherwise as apply to the original share capital.

 

GENERAL MEETINGS

 

51.                               A general meeting shall be held once in every year at such time, being not more than fifteen (15) months after the holding of the last preceding general meeting, and place as may be prescribed by the Board of Directors. The above mentioned general meetings shall be called “Ordinary Meetings”. All other general meetings shall be called “Extraordinary General Meetings”. Ordinary Meetings and Extraordinary General Meetings shall be referred to as “General Meetings”.

 

52.                               Subject to the provisions of these Articles the general function of the Ordinary Meeting shall be to receive and to deliberate with respect to the profit and loss statements, the balance sheets, the ordinary reports and accounts of the Board of Directors and auditors; to declare dividends, and to appoint auditors and to fix their compensation; provided that any other matter which may be considered and voted upon by the General Meeting may be discussed and voted upon at any General Meeting. For avoidance of doubt, General Meetings may be held telephonically or by video conference, provided that all Shareholders have an opportunity to hear and be heard by all other Shareholders wishing to participate in such meeting.

 

53.                               The Board of Directors may, whenever it thinks fit - and upon a requisition in writing as provided for in Sections 63 and 64 of the Companies Law, will be required to - convene an Extraordinary General Meeting. Every such requisition shall include the objects for which a meeting should be convened, shall be signed by the requisitioners and shall be sent to the Office of the Company.  If the Board of Directors does not convene a General Meeting within twenty-one (21) days from the date of the submission of the requisition as aforesaid, the requisitioners may, by themselves, convene a General Meeting.  However, the meeting which was so convened shall not be held after three months have passed since the date of the submission of the requisition.

 

NOTICE OF GENERAL MEETINGS

 

54.                               Subject to provisions of these Articles with respect to resolutions, a prior notice of seven (7) days at least shall be given with respect to the place, date and hour of the meeting, and - in the event that a matter requiring a resolution shall be discussed - a general description of the nature of that matter. The notice shall be given, as herein below provided for, to the Shareholders entitled pursuant to these Articles to receive notices from the Company.  With the consent of all the Shareholders who are entitled, at that time, to receive notices, it shall be permitted to convene all meetings and to resolve all types of resolutions, upon a shorter advance notice or without any notice and in such manner, generally, as such be approved by the Shareholders.

 

QUORUM

 

55.                               No deliberation shall be commenced with respect to any matter at the general meeting unless there shall be present a quorum at the time when the General Meeting

 

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proceeds to deliberate. Without derogating from the rights of the Preferred Shareholders in these Articles (including but not limited to pursuant to Article 11(d)), in any meeting a quorum shall be formed when there are present personally or by proxy not less than two Shareholders who hold or represent together fifty-one percent (51%) of the voting rights of the issued share capital of the Company (treating all Preferred Shares on an as-converted basis).

 

56.                               If within half an hour from the time appointed for the meeting a quorum is not present, the meeting shall stand adjourned to the same day during the next week at the same place and time, or any other day and/or any other hour and/or any other place as the Board of Directors shall notify the Shareholders, and, if at the second meeting a quorum is not present within half an hour from the time appointed for the meeting any two Shareholders present personally or by proxy shall be a quorum, and shall, without derogating from the rights of the Preferred Shareholders in these Articles (including but not limited to pursuant to Article 11(d)), be entitled to deliberate and to resolve in respect of the matters for which the meeting was convened.

 

CHAIRMAN

 

57.                               The chairman of the Board of Directors shall preside as chairman at all General Meetings.  If there is no chairman or he is not present within fifteen (15) minutes from the time appointed for the meeting or if he shall refuse to preside at the meeting, the Shareholders present shall elect one of the Directors to act as chairman, and if only one Director is present, he shall act as chairman. If no Directors are present or if they all refuse to preside at the meeting the Shareholders present shall elect one of such Shareholders to preside at the meeting. The Chairman shall have no casting vote and/or additional special rights or privileges at any General Meeting.

 

POWER TO ADJOURN

 

58.                               The chairman may, with the consent of any meeting at which a quorum is present, and shall if so directed by the meeting, adjourn the meeting from time to time and from place to place, as the meeting shall decide.  If the meeting shall be adjourned, a notice shall be given of the adjourned meeting as in the case of an original meeting.  At an adjourned meeting no matters shall be discussed except for those permissible to be discussed at that meeting which decided upon the adjournment.

 

ADOPTION OF RESOLUTIONS

 

59.                               At every General Meeting, a resolution put to the vote of the meeting shall be decided upon by a show of hands, or by any Shareholder present, in person or by proxy, and entitled to vote at the meeting.  The declaration of the chairman that the resolution has been carried or carried unanimously or by a particular majority, or lost, or not carried by a particular majority, shall be final, and an entry to that effect in the minute book of the Company, shall be prima facie evidence of the fact without the necessity of proving the number or proportion of the votes recorded in favor or against such a resolution.  Subject to any provision in these Articles to the contrary, and without derogating from the rights of the Preferred Shareholders in these Articles (including but not limited to pursuant to Article 11(d)), a resolution shall be deemed to be passed at a General Meeting if it received an ordinary majority of the votes participating in the meeting (i.e., the holders of the majority of the shares held by the shareholders which participated in the meeting, in person or by proxy).

 

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60.                               Deleted.

 

VOTES OF SHAREHOLDERS

 

61.                               Subject to and without derogating from the right or preference rights or restrictions existing at that time with respect to a certain class of shares forming part of the capital of the Company, and for the avoidance of doubt without derogating from Article 11(c), each Shareholder present at a meeting, personally or by proxy, shall be entitled, whether at a vote by show of hands or by secret ballot, to one vote for each share held by him, provided that no Shareholder shall be permitted to vote at a General Meeting or appoint a proxy to vote therein except if he has paid all calls for payment and all monies due to the Company from him with respect to his shares.

 

62.                               In the case of joint holders the vote of the senior who tenders a vote, whether in person or by proxy, shall be accepted to the exclusion of the votes of the other joint holders; and for the purpose of this Article seniority shall be determined by the order in which the names stand in the Register. Joint holders of a share of which one of them is present at a meeting shall not vote by proxy. The appointment of a proxy to vote on behalf of a share held by joint holders shall be executed by the signature of the senior of the joint holders.

 

PROXIES

 

63.                                                                               (a)                                 In every vote a Shareholder shall be entitled to vote either personally or by proxy.  A proxy present at a meeting shall also be entitled to request a secret ballot.  A proxy need not be a Shareholder of the Company.

 

(b)                                 A Shareholder of the Company that is a corporation or partnership shall be entitled by decision of its board of directors or by a decision of a person or other body, according to its articles, to appoint a person who it shall deem fit to be its representative at every meeting of the Company.  The representative, appointed as aforesaid, shall be entitled to perform all actions and exercise all powers, on behalf of the corporation he represents all the powers that the corporation itself perform or exercise, as if it was a person.

 

64.                                                                               A vote pursuant to an instruction appointing a proxy shall be valid notwithstanding the death of the appointor or the appointor becoming of unsound mind or the cancellation of the proxy or its expiration in accordance with any law, or the transfer of the shares with respect to which the proxy was given, unless a notice in writing was given of the death, becoming of unsound mind, cancellation or transfer and was received at the Office before the meeting took place.

 

INSTRUMENT OF APPOINTMENT

 

65.                               A letter of appointment of a proxy or power of attorney or other certificate (if there shall be such) pursuant to which the appointee is acting, shall be in writing, and such instrument or a copy thereof confirmed as aforesaid, shall be deposited in the Office, or in another place in Israel or abroad - as the Board of Directors shall direct from time to time generally or with respect to a particular case, no later than upon the commencement of the meeting or adjourned meeting wherein the person referred to in the instrument is appointed to vote; otherwise, that person shall not be entitled to vote that share.  If the appointment shall be for a limited period, the instrument shall be valid for the period contained therein.

 

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66.                               An instrument appointing a proxy (whether for a specific meeting or otherwise) may be in the following form or in any other similar form which the circumstances shall permit:

 

“I,            , of              , a Shareholder holding shares in PolyPid Ltd. and entitled to       votes hereby appoint             , of           , or in his place             , of           , to vote in my name and in my place at the general meeting (regular, extraordinary, adjourned - as the case may be) of the company to be held on the       day of          , 20   and at any adjournment thereof.

 

In witness whereof, I have hereby affixed my signature on this      day of           , 20  .

 

 

 

Appointor’s Signature

 

 

I hereby confirm that the foregoing instrument was signed by the appointor.

 

 

 

(name, profession and address)

 

 

RESOLUTION IN WRITING

 

67.                               A resolution in writing signed by all of the Shareholders then entitled to attend and vote at General Meetings or to which all such Shareholders have given their written consent (by letter, facsimile, email or otherwise) or their oral consent by telephone or otherwise (provided that a written summary thereof has been approved and signed by the chairman), shall be deemed to have been unanimously adopted by a General Meeting duly convened and held.

 

CLASS MEETINGS

 

67A.                      (a)                                 The provisions of these Articles relating to General Meetings shall generally apply, mutatis mutandis, to every class meeting of (A) all of the Preferred Shares (voting together as one separate class) and, (B) the individual classes of Preferred Shares, solely to the extent that the consent of any individual class is required, and (C) the Remaining Preferred (voting together as one single, separate class) (each a “Class Meeting”); provided however that: (i) a quorum at any Class Meeting under clause (A) shall include the Majority Investors; (ii) a quorum at any Class Meeting of the Series D Preferred Shares, shall mean the Majority Investors; (iii) a quorum at any Class Meeting of the Remaining Preferred, shall mean the Remaining Preferred Majority; and (iv) at any adjourned Class Meeting under clauses (i) and (ii), the quorum shall be the Majority Investors and at any adjourned Class Meeting under clause (iii), the quorum shall be the Remaining Preferred Majority; and (v) the provisions of Article 11(d) shall apply to each Preferred D Vote.

 

For all matters touching or concerning any or all classes of the Remaining Preferred, the Remaining Preferred classes shall all be considered a single and separate class, and shall, to the maximum extent permitted under applicable law, vote together as a single class.

 

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For all matters touching or concerning any or all classes of the Series D Preferred Shares, the Series D Preferred Share classes shall all be considered a single and separate class, and shall vote together as a single class.

 

(b)                                           Subject to the rights of the holders of Series D Preferred Shares (the “Series D Preferred Shareholders”) pursuant to these Articles, including but not limited to pursuant to Article 11(d) and rights of the Remaining Preferred Majority pursuant hereto, if at any time the share capital is divided into different classes and/or series of shares, the Company may change, convert, broaden, add or vary in any other manner the rights, advantages, restrictions or provisions related to one or more of the classes or series, if such action was approved by the General Meeting.

 

(c)                                            The foregoing notwithstanding, but for the avoidance of doubt subject to the rights of the Series D Preferred Shareholders pursuant to these Articles, including but not limited to pursuant to Article 11(d), the authorization or issuance of additional securities, including, without limitation, securities which are comprised of a new class of shares having certain rights, preferences or privileges over or relative to any outstanding class of shares, shall not per se be deemed as affecting, changing or varying the rights of any outstanding class of shares and therefore shall not require any consent of the class pursuant to this Article 67A.

 

(d)                                           Subject to the rights of the Series D Preferred Shareholders pursuant to these Articles, including but not limited to Article 11(d), the Company may, from time to time, by a resolution of the General Meeting, authorize and/or issue shares having the same rights as existing shares or with such preferred or deferred rights or rights of redemption or different prices or other special rights and/or restrictions, whether with respect to liquidation, dividends, voting, conversion, repayment of share capital or otherwise, as may be stipulated in such resolution.

 

(e)                                            Subject to Article 67A(a) and to the rights of the Series D Preferred Shareholders pursuant to these Articles, including but not limited to Article 11(d), subject to the rights of the Lead Investor hereunder and subject to the rights of the Remaining Preferred Majority pursuant hereto, any resolution required to be adopted pursuant to these Articles by a separate General Meeting of a certain class of shares, shall be voted upon and adopted by simple majority of the holders of such class entitled to vote thereon, and no holder of a certain class shall be banned, unless the law otherwise expressly prescribes, from participating and voting in a separate General Meeting of such class by virtue of being a holder of more than one class of shares of the Company, irrespective of any conflicting interests that may exist between such different classes of shares. For illustration purposes, in the event that a certain Shareholder is the holder of a Preferred A Share and Ordinary Shares whilst another shareholder is the holder of Ordinary Shares only, the Shareholder holding two classes of shares shall not be banned from voting on a resolution which adversely affects the rights of the Ordinary Shares, irrespective of the affect such change shall have on the Series A Preferred Shares. Anything contained herein to the contrary notwithstanding, subject to any applicable law, a Shareholder shall not be required to refrain from participating in the discussion or voting on any resolution at a shareholders meeting concerning the modification or abrogation of the rights attached to any class of shares held by such Shareholder, due to the fact that such Shareholder may benefit in one way or another from the outcome of such resolution; e.g. a Shareholder shall be entitled to vote on the modification of rights attached to shares held by such Shareholder in a way that may benefit such holder either directly or

 

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indirectly (such as in the case of an increased financial value gained by virtue of such change).

 

(f)                                             To the maximum extent permitted under applicable law, and unless otherwise explicitly provided by these Articles (including but not limited to Article 11(d)) and/or under applicable law, all shareholders of the Company shall vote together as a single class, on an as-converted basis, on any matter presented to the shareholders and all matters shall require an approval by the holders of a majority of the voting power of the Company represented at the meeting of all shareholders of all classes voting together as a single class, on an as-converted basis, including, without limitation, any amendment to these Articles, any issuance of securities of the Company, or any transaction under Sections 341, 342 or 350 of the Israeli Companies Law.

 

(g)                                            Without derogating from the foregoing and without derogating from, and subject to, Article 11(d) and Article 9 and any other rights of the Preferred D Shareholders or the Remaining Preferred Majority, unless otherwise provided by these Articles, it is hereby clarified that:

 

(i)                                     The increase of the authorized and registered number of shares of an existing class of shares, and/or the issuance of additional shares thereof, and/or the creation of a new class of shares identical to an existing class of shares in all respects, except for the price per share paid for such shares, shall not be deemed, for purposes of these Articles, to directly adversely alter the rights attached to the previously issued shares of such class or of any other class;

 

(ii)                                  The creation, authorization and/or the issuance of additional shares or other equity securities of the Company having certain rights, preferences or privileges over or relative to all other shares or equity securities of the Company, including, without limitation, shares that have rights at Liquidation, Deemed Liquidation or distribution of Dividends that are senior to the rights with respect to such events of all existing Preferred Shares, shall not be deemed to be modifying or abrogating the rights, powers and privileges attached to the previously issued shares of any existing class, provided that the rights, preferences or privileges attached to such additional shares or other equity securities apply in the same manner vis-a-vis all other existing series or classes of shares, without a different application to different classes, even though the result of such equal application may be different with respect to different shareholders due to the number of shares held by them and/or even though such an issuance will change the economic value of the existing shares (but not the legal rights of such shares, as illustrated by the example set forth in Article 67A(g)(iii) below), and shall not be subject to the approval of a separate class vote of the holders of the shares of any particular class; and

 

(iii)                               The authorization of a new series of shares or class of shares, or the issuance of such shares, shall not be deemed, for any purpose hereunder (subject, for the avoidance of any doubt, to Article 11(d)), to modify or abrogate the rights attached to an existing class of shares if the rights attached to the new class of shares apply in the same manner vis-a-vis all other existing series or classes of shares, without a different application to different classes, even though the result of such equal application may be different with respect to different Shareholders due to the number of shares held by them and/or even though such an issuance will change the economic value of the existing shares (but not the legal rights of such shares — for example, if (a) the holders of the Ordinary Shares are entitled to appoint one Director and the holders of Preferred A Shares are entitled to appoint one Director; (b) the Board consists of 2 members; and (c) the Company issues a new

 

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class of shares (Preferred E Shares) which are entitled to appoint a Director, and to enable such an appointment, the Articles are amended to provide that the Board may consist of 3 members, then, in such an event, such an act will not be deemed to change, modify or abrogate the rights and powers attached to the Ordinary Shares or the Preferred Shares (as the holders thereof will continue to hold the power to appoint one Director), even if one may argue that the economic value of the Ordinary Shares or the Preferred Shares was decreased by such an act (the holders can then appoint one out of three members to the Board).

 

(h)                                  Subject to and without derogating from the rights of the Preferred D Shareholders including but not limited to Article 11(d) and Article 9: if at any time, a restructure of the Company’s issued or unissued share capital is effectuated (a “Restructure”), and as a result of such Restructure the rights attached to one or more classes of shares are modified or abrogated, then, such Restructure shall require the consent of the holders of the majority of the issued and outstanding shares of such affected class (or classes as the case may be), which shall be obtained at a separate General Meeting of such class (in addition to such other approvals requires under these Articles or applicable law). In the event that such Restructure can be consummated in more than one manner (such as by means of arrangement proceedings approved by a court of law, or alternatively by means of amendment of the Company’s corporate documents), the sole and absolute discretion in determining the manner by which such Restructure shall be consummated shall vest in the Company’s Board.

 

DIRECTORS

 

68.                               The Board of Directors of the Company shall consist of up to nine (9) Directors, which shall be appointed by shareholders holding 60% of the issued and outstanding share capital of the Company; it being understood that the initial directors of the Company shall be: Amir Weisberg, Noam Emanuel, Eitan Kyiet, Anat Segal, Prof. Yechezkel Bernholtz, Eli Frydman and Haim Hurvitz (as the chairman of the board).

 

69.                               The right to appoint a person to the Board of Directors shall include the right to remove and replace such Director. Appointments, removals and replacements shall be effected by furnishing written notification to the Company. Any notice regarding the appointment, removal or replacement of a Director shall be delivered to the Company in writing, and shall become effective on the date fixed in such notice, or upon the delivery thereof to the Company, whichever is later.

 

OBSERVERS

 

70.                               (A) Until QPO and as long as the Lead Investor (and its Permitted Transferees) holds at least 50% of the Series D-1 Preferred Shares issued to it at the Closing (not including, for the avoidance of doubt, any Warrant Shares), the Lead Investor shall have the right, but not the obligation, to appoint a non-voting observer to the Board, and (B) until QPO and as long as Rice Inc. (and its Permitted Transferees) holds at least 3.0% of the issued and outstanding share capital of the Company, it shall have the right, but not the obligation, to appoint a non-voting observer to the Board. Any such observer, and (unless otherwise determined by the Board) any other observer to the Board, shall be entitled to receive all notices, written documents and materials provided to the Directors and to be invited to and to attend all meetings of the Board and its committees in a non-voting capacity. If requested, any such observer shall execute a confidentiality agreement in a reasonable form approved by the Board for such purpose. For the avoidance of doubt, no observer shall be liable toward the

 

41



 

Company or any Shareholder with respect to any action or inaction of the Board. This Article 70, and each other Article hereunder in which a right is granted to or held by the Lead Investor, may not be amended or cancelled without the Lead Investor’s approval.

 

ALTERNATE DIRECTOR

 

71.                                                                               (a)                                 A Director may, by written notice to the Company, appoint an alternate for himself (in these Articles referred to as an “Alternate Director”), remove such Alternate Director and appoint another Alternate Director in place of any Alternate Director appointed by him whose office has been vacated for any reason whatsoever. Unless the appointing Director, by the instrument appointing an Alternate Director or by written notice to the Company, limits such appointment to a specific period of time or restricts it to a specified meeting or action of the Board of Directors, or otherwise restricts its scope, the appointment shall be for an indefinite period, and for all purposes. A Director and/or Alternate Director may act as an Alternate Director of another Director.

 

(b)                                 Any notice given to the Company pursuant to Article 71(a) shall become effective on the date fixed therein, or upon the delivery thereof to the Company, whichever is later.

 

(c)                                  An Alternate Director shall have, subject to the provisions of the instrument by which he was appointed, all the powers and authorities possessed by the Director for which he is serving as an Alternate Director, has.

 

(d)                                 The office of an Alternate Director shall be automatically vacated if his appointment is terminated by the one who appointed him in accordance with these Articles, or upon the occurrence of one of the events described in Article 72 or, if the office of the member of the Board of Directors with respect to whom he serves as an Alternate Director shall be vacated for any reason whatsoever.

 

(e)                                  The Alternate Director has the right to receive notice of the convening of a Board of Directors meeting and may participate in and vote at such meeting only if the Director appointing said Alternate Director is absent from said meeting.

 

72.                                                                               Subject to the provisions of these Articles or to the provisions of an existing contract, the office of a Director shall be vacated, ipso facto, upon the occurrence of any of the following: (i) such Director’s death, (ii) such Director is convicted of a crime as described in Section 232 of the Companies Law, (iii) such Director is removed by a court of law in accordance with Section 233 or the Companies Law, (iv) such Director becomes legally incompetent, (v) if such Director is an individual, such Director is declared bankrupt, (vi) if such Director is a corporate entity, upon its winding-up or liquidation, whether voluntary or involuntary, or (vii) if he was appointed by a Shareholder, upon receipt by the Company of a written notice from the Shareholder who appointed him, of the termination of his appointment.  In addition, the office of a Director shall be vacated by his written resignation.  Such resignation shall become effective on the date fixed therein or upon the delivery to the Company, whichever is later.

 

REMUNERATION OF DIRECTOR

 

73.                               Members of the Board of Directors, not being employees of the Company or professionals providing special professional services for consideration to its members - shall

 

42



 

not receive a salary from funds of the Company unless otherwise prescribed by the Board of Directors, and then only in the amount that the Board shall decide upon, all subject to the provisions of the Companies Law. The Directors and their substitutes, and any observers, shall be entitled to reimbursement for reasonable “out-of-pocket” expenses incurred by them in connection with their attendance at meetings of the Board of Directors and in accordance with a policy established or to be established by the Board of Directors.

 

POWERS AND DUTIES OF DIRECTORS

 

74.                               The business of the Company shall be managed by the Directors. The Directors shall be entitled to exercise all the powers and authorities that the Company has and to perform in its name all the acts that it is entitled to perform according to its Articles and/or the Companies Law except for those which are, pursuant to the Companies Law or the Articles, vested in the General Meeting of the Company, subject to any provisions in the Companies Law or in these Articles or the resolutions that the Company shall adopt in its General Meeting (insofar as they do not contradict the Companies Law or these Articles). However any resolution adopted by the Company in its General Meeting shall not affect the legality of any prior act of the Board of Directors that would be legal and valid, if not for such a resolution.

 

75.                               A Director shall not be required to hold qualifying shares.

 

76.                               [reserved]

 

77.  Subject to the Companies Law, a Director may hold another paid position or function in the Company or in any other company that the Company is a shareholder of or in which it has some other interest, together with his position as a Director (except an auditor) upon those conditions with respect to salary and other matters as decided by the Board of Directors and approved by the General Meeting, to the extent such approval is required under the Companies Law.

 

FUNCTIONS OF THE DIRECTORS

 

78.                                                                               (a)                                 The Directors may meet in order to transact business, to adjourn their meetings or to organize them otherwise as they shall deem fit and to determine the legal quorum necessary to conduct business.

 

(b)                                 A quorum for meetings of the Board shall be the majority of the Directors then in office present personally or represented by their alternate.

 

CHAIRMAN

 

79.                               Until IPO, the Directors may from time to time elect a chairman from the acting Directors (who shall initially by Haim Hurvitz), and decide the period of time he shall hold such an office, and he shall preside at the meetings of the Board of Directors. However, if such a chairman is not elected or if he is not present at any particular meeting, the Directors present may choose one of their number to serve as chairman of that meeting. The Chairman shall have no rights or privileges other than those granted to Directors generally. The above notwithstanding, the Chairman of the Board shall be appointed and removed only with the approval of the Lead Investor.

 

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MEETINGS OF THE BOARD

 

80.                               Subject to any contrary resolution accepted by the Board of Directors, a member of the Board of Directors may at any time call a Board of Directors’ meeting, and the Company shall be required on the request of such member to convene a Board of Directors’ meeting.  The Board of Directors will convene at such location as designated by the Board of Directors.

 

81.                               (a)                                 Any notice of a Board of Directors’ meeting can be given orally, by telephone, in writing, or by email or fax provided that the notice is given not less than two (2) business days before the time appointed for the meeting, unless all the members of the Board of Directors shall agree to a shorter notice.

 

(b)                                 Prior and timely notice of the convening of a Board of Directors’ meeting shall be given to all Directors and observers.

 

(c)                                  Without derogating from the rights of the Preferred Shareholders in these Articles (including but not limited to pursuant to Article 11(d)), if applicable, all acts and determinations of the Board of Directors shall be determined by a simple majority of those attending.

 

(d)                                 Members of the Board of Directors, or any committee designated by the Board of Directors, may participate in a meeting of the Board of Directors, or any committee, by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute attendance in person at the meeting.

 

DELEGATION OF POWER

 

82.                                                                               (a)                                 Notwithstanding anything in these Articles to the contrary, the Board of Directors may, subject to Section 112 of the Companies Law, delegate any of their executive powers to committee(s). The Board of Directors may appoint committees to discuss and generate recommendations regarding issues set forth by the Board of Directors, but such committee(s) shall not have executive powers whatsoever, except in the event such appointment is effected as aforesaid in this Sub-Article 82(a).

 

(b)                                 In the exercise of any power delegated to it by the Board of Directors, all committees shall conform to any regulations that may be imposed upon them by the Board of Directors, if there shall be any such regulation. Subject to Sub-Article (a) above, if no such regulations are adopted by the Board of Directors or if there are no complete and encompassing regulations, the committees shall act pursuant to these Articles dealing with organization of meetings, meetings and functions of the Board of Directors, mutatis mutandis, and insofar as no provision of the Board of Directors shall replace it pursuant to this Article.

 

83.                               All actions performed in a bona fide fashion by the Board of Directors or by a committee of the Board of Directors, or by any person acting as a Director or as a substitute shall be as valid, even if at a later date a flaw shall be discovered in the appointment of such a Director or such a person acting as aforesaid, or that all or some of them were unfit, as if each and every one of those persons shall have been duly appointed and fit to serve as a Director or substitute as the case may be.

 

44



 

PRESIDENT AND/OR CHIEF EXECUTIVE OFFICER (“CEO”)

 

84.                                                                               (a)                                 The Board of Directors may from time to time appoint one or more persons, whether or not he is a member of the Board of Directors, as the President and/or CEO of the Company, either for a fixed period of time or without limiting the time that he or they will stay in office, and they may from time to time (subject to any provision in any contract between him or them and the Company) release him or them from such office and appoint another or others in his or their place.

 

(b)                                 Without derogating from the rights of the Preferred Shareholders hereunder, including but not limited to under Article 11(d), the  Board of Directors may from time to time grant and bestow upon the President and/or CEO, at that time, those powers and authorities that it exercises pursuant to these Articles, as it shall deem fit, and may grant those powers and authorities for such period, and to be exercised for such objectives and purposes and in such time and conditions, and on such restrictions, as it shall decide; and it may grant such authorities whether concurrently with the Board of Directors’ authorities in that area, or in excess of them, or in place thereof or any one of them, and it can from time to time revoke, repeal, or change any one or all of those authorities.

 

(c)                                  Notwithstanding the aforesaid in Article 73, the wages of the President and/or CEO shall be determined from time to time by the Board of Directors (subject to the Companies Law and any provision in any contract between him and the Company).

 

MINUTES

 

85.                                                                               (a)                                 The Directors shall cause minutes to be taken of all General Meetings of the Company, of the appointments of officials of the Company, of Board of Directors’ meetings and of committee meetings that shall include the following items, if applicable:

 

(i)    the names of the members present;

 

(ii)    the matters discussed at the meeting;

 

(iii)    the results of the vote;

 

(iv)    resolutions adopted at the meeting; and

 

(v)    directives given by the meeting to the committees.

 

(b)                                 The minutes of any meeting, signed or appearing to be signed by the chairman of the meeting or by the chairman of the meeting held immediately after that meeting, shall serve as a prima facie proof as to the facts in the minutes.

 

RESOLUTION IN WRITING

 

86.                               A resolution in writing signed by all the members of the Board of Directors, or of a committee, or such a resolution that all the members of the Board of Directors or a committee have agreed to in writing and/or fax and/or email shall be valid for every purpose as a resolution adopted at a Board of Directors’ or committee meeting, as the case may be, that was duly convened and held.  In place of a Director the aforesaid resolution may be signed and delivered by his alternate or his attorney or his alternate’s attorney.

 

45



 

SEAL, STAMP AND SIGNATURES

 

87.                                                                               (a)                                 The Board of Directors shall cause the seal (if the Company shall have a seal) to be kept in safekeeping and it shall be forbidden to use the seal unless prior permission of the Board of Directors is given.  If such permission was given, the seal shall be affixed in the presence of whoever has been so appointed by the Board of Directors, and he shall sign any document upon which the seal has been affixed.

 

(b)                                 The Company shall have at least one rubber stamp. The Directors shall ensure that such a stamp is kept in a safe place.

 

(c)                                  The Board of Directors may designate and authorize any person or persons (even if they are not members of the Board of Directors) to act and to sign in the name of the Company, and the acts and signatures of such a person or persons shall bind the Company, insofar as such person or persons have acted and signed within the limits of their aforesaid authority.

 

(d)                                 The printing of the name of the Company by a typewriter or computer-printer or by hand next to the signatures of the authorized signatories of the Company, pursuant to sub-article (c) above, shall be valid as if the rubber stamp of the Company was affixed.

 

BRANCH REGISTERS

 

88.                               The Company may, subject to the provisions of Sections 138 and 139 inclusive of the Companies Law keep in every other country where those provisions shall apply, a register or registers of Shareholders living in that other country as aforesaid, and to exercise any other powers referred to in the laws with respect to such branch registers.

 

THE SECRETARY, OFFICERS AND ATTORNEYS

 

89.                                                                               (a)                                 The Board of Directors may appoint a secretary of the Company upon the conditions that it finds fit.  The Board of Directors may as well, from time to time, appoint an associate secretary who shall be deemed to be the secretary for the period of his appointment.

 

(b)                                 The Board of Directors may, from time to time appoint to the Company, officers, workers, agents and functionaries to permanent, temporary or special positions, as they shall, from time to time, see fit and set compensation for them.

 

(c)                                  The Board of Directors may, at any time and from time to time, authorize any company, firm, person or group of people, whether this authorization is done by the Board of Directors directly or indirectly, to be the attorneys in fact of the Company for those purposes and with those powers and discretions which shall not exceed those conferred upon the Board of Directors or that the Board of Directors can exercise pursuant to these Articles - and for such a period of time and upon such conditions as the Board of Directors deems proper, and every such authorization may contain such directives as the Board of Directors deems proper for the protection and benefit of the persons dealing with such attorneys.

 

46



 

DIVIDEND

 

90.                               (a)                                 The following Articles 90-101 are subject to the provisions of these Articles, including but not limited to Articles 7 and 8, and subject to any rights or conditions of Preferred Shares and other rights and conditions attached at that time to any share in the capital of the Company granting preferential, special or deferred rights or not granting any rights with respect to dividends.

 

(b)                                 The profits of the Company shall be distributable to the Shareholders of the Company according to the proportion of the nominal value paid up on account of the shares held by them at the date so appointed by the Company, calculated on an as-converted basis. Actual distribution, setting aside or declaration of dividend requires a decision of the Board of Directors.

 

(c) The Board of Directors may issue any share upon the condition that a dividend shall be paid at a certain date or that a portion of the declared dividend for a certain period shall be paid, or that the period for which a dividend shall be paid shall commence at a certain date, or a similar condition, all as decided by the Board of Directors.  In every such case - subject to the provision mentioned in the beginning of this Article - the dividend shall be paid in respect of such a share in accordance with such condition.

 

91.                               At the time of declaration of a dividend the Company may decide that such dividend shall be paid in part or in whole, by way of distribution of certain properties, by way of distribution of fully paid up shares or debentures or debenture stock of the Company, or by way of distribution of fully paid up shares or debentures or debenture stock of any other company or in one or more of the aforesaid ways.  Without derogating from Articles 7 and 8, for purposes of any such distribution, the outstanding Preferred Shares shall be deemed to have been converted into Ordinary Shares as of the time appointed by the Company in order to determine entitlement to participate in such distribution.

 

92.                               The Board of Directors may, from time to time, pay to the Shareholders on account of the forthcoming dividend such interim dividend as shall be deemed just with regard to the situation of the Company.

 

93.                               The Board of Directors may put a lien on any dividend on which the Company has a charge, and it may use it to pay any debts, obligations or commitments with respect to which the charge exists.

 

94.                               The person registered in the Register as a Shareholder on the date appointed by the Company for that purpose shall be the one entitled to receive a dividend. A transfer of shares shall not transfer the right to a dividend which has been declared after the transfer but before the registration of the transfer.

 

95.                               The Company may declare a dividend to be paid to the Shareholders, at a General Meeting, according to their rights and benefits in the profits and to decide the time of payment.  A dividend in excess of that proposed by the Board of Directors shall not be declared. However, the Company may declare at a General Meeting a smaller dividend.

 

96.                               A notice of the declaration of a dividend, whether an interim dividend or otherwise, shall be given to the Shareholders registered in the Register, in the manner provided for in these Articles.

 

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97.                               If payment cannot be made by wire transfer, the dividend may be paid by check or payment order to be mailed to the registered address of a Shareholder or person entitled thereto in the Register or, in the case of registered joint owners, to the addresses of one of the joint owners as registered in the Register.  Every such check shall be made out to the person it is sent to.  The receipt of the person who, on the date of declaration of dividend, is registered as the holder of any share or, in the case of joint holders, of one of the joint holders, shall serve as a release with respect to payments made in connection with that share.

 

98.                               [reserved]

 

99.                               [reserved]

 

100.                        All premiums received from the issue of shares shall be capital funds and they shall be treated for every purpose as capital and not as profits distributable as dividends. The Board of Directors may organize a reserve capital liability account and transfer, from time to time, all such premiums to the reserve capital liability account or use such premiums and monies to cover depreciation or doubtful loss. The Board of Directors may use any monies credited to the capital reserve liability account in any manner that these Articles or the law permits.

 

101.                        [reserved]

 

ACCOUNTS AND AUDIT

 

102.                        The Board of Directors shall cause the Company to maintain proper and complete books and records of account of the Company in accordance with Israeli law. The account books shall be kept in the Office or at such other place as the Board of Directors deem fit and they shall also be open for inspection by the Directors and observers.

 

103.                        The Board of Directors shall determine from time to time, in any specific case or type of case, or generally, whether and to what extent and at what times and places and under what conditions or regulations the accounts and books of the Company, or any of them, shall be open for inspection by the Shareholders, and no Shareholder, not being a Director or observer, shall have any right of inspecting any account book or document of the Company, except as conferred by law or authorized by the Board of Directors or by the Company in a General Meeting, or in a contract with the Shareholder.

 

104.                        Not less than once a year, the Board of Directors shall submit before the Company at a General Meeting financial statements for the period beginning from the previous account, in accordance with the relevant provisions of the Companies Law. To such financial statements shall be attached a report of the auditor and it shall be accompanied by a report from the Board of Directors with respect to the situation of the Company’s business and the amount (if any) which it proposes as a dividend and the amount (if any) that it proposes be set aside for the fund accounts.

 

105.                        Auditors shall be appointed and their function shall be set out in accordance with the Companies Law. The Board shall fix the compensation of the auditor of the Company for its auditing activities, and shall also fix the compensation of the auditor for additional services, if any, which are not auditing activities, and, in each case, shall report thereon to the General Meeting.

 

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NOTICES

 

106.                        A notice or any other document may be served by the Company upon any Shareholder either personally or by sending it by fax or email with confirmed receipt addressed to such Shareholder at his address, wherever situated, as appearing in the Register.

 

107.                        All notices directed to be given to the Shareholders shall, with respect to any shares to which persons are jointly entitled, be given to one of the joint holders, and any notice so given shall be sufficient notice to the holders of such share.

 

108.                        Prior and timely notice of the convening of a Shareholders meeting shall be given to each Shareholder, wherever situated, at the last address provided by the Shareholder.  Any Shareholder registered in the Register who shall, from time to time, furnish the Company with an address at which notices may be served, shall be entitled to receive all notices he is entitled to receive according to these Articles at that address.

 

109.                        A notice may be given by the Company to the persons entitled to a share in consequence of the death or bankruptcy of a Shareholder by sending it through the post in a prepaid letter or postcard or telegram, telex or telefax addressed to them by name, at the address, if any, in Israel furnished for the purpose by the persons claiming to be so entitled or, until such an address has been so furnished, by giving the notice in any manner in which the same might have been given if the death or bankruptcy had not occurred.

 

110.                        Notwithstanding any inference to the contrary in any other provision of these Articles, all notices required or permitted hereunder shall be in writing and shall be deemed effectively given (i) upon personal delivery to the party to be notified; (ii) when sent by confirmed facsimile or email, on the next business day; (iii) seven (7) days after having been sent by registered or certified airmail, return receipt requested, postage prepaid; or (iv) three (3) days after deposit with an internationally recognized overnight courier, specifying next day delivery, with written verification of receipt. Any list of Shareholder or Director contact details which is kept in the ordinary manner in the Company’s possession shall be prima facie proof of the delivery.

 

111.                        In any case where it is necessary to give prior notice of a certain number of days or a notice valid for a certain period, the date of delivery shall be taken into account in the number of days or period.

 

INDEMNITY

 

112.                        Subject to the provisions of the Companies Law, including the receipt of all approvals as required therein or under any applicable law, the Board of Directors may resolve in advance to exempt an “Officer” (as such term is defined in the Companies Law) from all or part of such Officer’s responsibility or liability for damages caused to the Company due to any breach of such Officer’s duty of care towards the Company.

 

113.                        (a)                                 Subject to the provisions of the Companies Law including the receipt of all approvals as required therein or under any applicable law, the Company may indemnify or to enter into an agreement to indemnify in the future any Officer to the fullest extent permitted by the Companies Law.

 

49



 

(b)                                 Subject to the provisions of the Companies Law including the receipt of all approvals as required therein or under any applicable law, the Board of Directors may resolve retroactively to indemnify an Officer with respect to the following liabilities and expenses, provided that such liabilities or expenses were incurred by such Officer in such Officer’s capacity as an Officer of the Company:

 

(1)                                 a monetary liability imposed on him/her in favor of a third party in any judgment, including any settlement confirmed as judgment and an arbitrator’s award which has been confirmed by the court, in respect of an act performed by the Officer by virtue of the Officer being an Officer of the Company;

 

(2)                                 reasonable litigation expenses, including legal fees, paid for by the Officer, in an investigation or proceeding conducted against such Officer by an agency authorized to conduct such investigation or proceeding, and which investigation or proceeding: (i) concluded without the filing of an indictment against such Officer and without there having been a financial obligation imposed against such Officer in lieu of a criminal proceeding, or (ii) concluded without the filing of an indictment against such Officer but with there having been a financial obligation imposed against such Officer in lieu of a criminal proceeding for an offense that does not require proof of criminal intent; all in respect of an act performed by the Officer by virtue of the Officer being an Officer of the Company; or

 

(3)                                 reasonable litigation expenses, including legal fees, paid for by the Officer, or which the Officer is obligated to pay under a court order, in a proceeding brought against the Officer by the Company, or on its behalf, or by a third party, or in a criminal proceeding in which the Officer is found innocent, or in a criminal proceeding in which the Officer was convicted of an offense that does not require proof of criminal intent, all in respect of an act performed by the Officer by virtue of the Officer being an Officer of the Company.

 

(c)                                  Subject to the provisions of the Companies Law including the receipt of all approvals as required therein or under any applicable law, the Board of Directors may resolve in advance to indemnify the Company’s Officer for those liabilities and expenses described in (i) Sub-Article 113(b)(1), provided that such indemnification obligation shall be limited to those events which in the Board’s opinion can be foreseen at the time the undertaking to indemnify is provided and to such expenses and measurements which the Board has determined are reasonable under the circumstances, and provided further that in the undertaking to indemnify such events, expenses and measurements shall be indicated; and (ii) Sub-Articles 113(b)(2) and 113(b)(3).

 

114.                        (a)                                 Subject to the provisions of the Companies Law including the receipt of all approvals as required therein or under any applicable law, the Company may enter into an agreement to insure an Officer for any liability that may be imposed on such Officer in connection with an act performed by such Officer in such Officer’s capacity as an Officer of the Company, with respect to each of the following:

 

(i)                                     violation of the duty of care of the Officer towards the Company or towards another person;

 

50



 

(ii)                                  breach of the fiduciary duty towards the Company, provided that the Officer acted in good faith and with reasonable grounds to assume that the action in question was in the best interests of the Company; and

 

(iii)                               a financial obligation imposed on the Officer for the benefit of another person.

 

(b)                                 Articles 112, 113 and 114(a) shall not apply under any of the following circumstances:

 

(i)                                     a breach of an Officer’s fiduciary duty, in which the Officer did not act in good faith and with reasonable grounds to assume that the action in question was in the best interest of the Company;

 

(ii)                                  a grossly negligent or intentional violation of an Officer’s duty of care;

 

(iii)                               an intentional action by an Officer in which such Officer intended to reap a personal gain illegally; and

 

(iv)                              a fine or ransom levied on an Officer.

 

(c)                                  The Company may procure insurance for or indemnify any person who is not an Officer, including without limitation, any employee, agent, consultant, contractor, or observer, provided, however, that any such insurance or indemnification is in accordance with the provisions of these Articles and the Companies Law.

 

***************************************

 

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EX-3.2 3 a2234591zex-3_2.htm EX-3.2

Exhibit 3.2

 

THE COMPANIES LAW, 1999

A LIMITED LIABILITY COMPANY

 

ARTICLES OF ASSOCIATION

OF

POLYPID LTD.

 

PRELIMINARY

 

1.             DEFINITIONS; INTERPRETATION.

 

(a)          In these Articles, the following terms (whether or not capitalized) shall bear the meanings set forth opposite to them respectively, unless inconsistent with the subject or context.

 

“Articles”

 

shall mean these Articles of Association, as amended from time to time.

 

 

 

“Board of Directors”

 

shall mean the Board of Directors of the Company.

 

 

 

“Chairperson”

 

shall mean the Chairperson of the Board of Directors, or the Chairperson of the General Meeting, as the context provides.

 

 

 

“Company”

 

shall mean POLYPID LTD.

 

 

 

“Companies Law”

 

shall mean the Israeli Companies Law, 5759-1999 and the regulations promulgated thereunder. The Companies Law shall include reference to the Companies Ordinance (New Version), 5743-1983, of the State of Israel, to the extent in effect according to the provisions thereof.

 

 

 

“Director(s)”

 

shall mean the member(s) of the Board of Directors holding office at any given time, including alternate directors.

 

 

 

“External Director(s)”

 

shall mean as defined in the Companies Law.

 

 

 

“General Meeting”

 

shall mean an Annual General Meeting or Special General Meeting of the Shareholders, as the case may be.

 

 

 

“NIS”

 

shall mean New Israeli Shekels.

 

 

 

“Office”

 

shall mean the registered office of the Company at any given time.

 

 

 

“Office Holder” or “Officer”

 

shall mean as defined in the Companies Law.

 

 

 

“RTP Law”

 

shall mean the Israeli Restrictive Trade Practices Law, 5758-1988.

 

 

 

“Securities Law”

 

shall mean the Israeli Securities Law, 5728-1968.

 

 

 

“Shareholder(s)”

 

shall mean the shareholder(s) of the Company, at any given time.

 

 

 

“in writing” or “writing”

 

shall mean written, printed, photocopied, photographic,

 

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typed, sent via email, facsimile or produced by any visible substitute for writing, or partly one and partly another, and signed shall be construed accordingly.

 

(b)           Unless otherwise defined in these Articles or required by the context, terms used herein shall have the meaning provided therefor under the Companies Law.

 

(c)           Unless the context shall otherwise require: words in the singular shall also include the plural, and vice versa; any pronoun shall include the corresponding masculine, feminine and neuter forms; the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”; the words “herein”, “hereof” and “hereunder” and words of similar import refer to these Articles in its entirety and not to any part hereof; all references herein to Articles, Sections or clauses shall be deemed references to Articles, Sections or clauses of these Articles; any references to any agreement or other instrument or law, statute or regulation are to it as amended, supplemented or restated, from time to time (and, in the case of any law, to any successor provisions or re-enactment or modification thereof being in force at the time); any reference to “law” shall include any supranational, national, federal, state, local, or foreign statute or law and all rules and regulations promulgated thereunder (including, any rules, regulations or forms prescribed by any governmental authority or securities exchange commission or authority, if and to the extent applicable); any reference to a “day” or a number of “days” (without any explicit reference otherwise, such as to business days) shall be interpreted as a reference to a calendar day or number of calendar days; reference to month or year means according to the Gregorian calendar; any reference to a “company”, “corporate body” or “entity” shall include a, partnership, corporation, limited liability company, association, trust, unincorporated organization, or a government or agency or political subdivision thereof, and reference to a “person” shall mean any of the foregoing or an individual.

 

(d)           The captions in these Articles are for convenience only and shall not be deemed a part hereof or affect the construction or interpretation of any provision hereof.

 

LIMITED LIABILITY

 

2.             The Company is a limited liability company and therefore each Shareholder’s obligations to the Company shall be limited to the payment of the nominal value of the shares held by such Shareholder, subject to the provisions of the Companies Law.

 

PUBLIC COMPANY; COMPANY’S OBJECTIVES

 

3.             PUBLIC COMPANY; OBJECTIVES.

 

(a)           The Company is a Public Company as such term is defined in and as long as it so qualifies under the Companies Law.

 

(b)           The Company’s objectives are to carry on any business, and do any act, which is not prohibited by law.

 

4.             DONATIONS.

 

The Company may donate a reasonable amount of money (in cash or in kind, including the Company’s securities) for any purpose that the Board of Directors finds appropriate.

 

SHARE CAPITAL

 

5.             AUTHORIZED SHARE CAPITAL.

 

(a)           The share capital of the Company shall consist of NIS 35,000,000 divided into 43,750,000 Ordinary Shares, of a nominal value of NIS 0.80 each (the “Ordinary Shares”).

 

(b)           The Ordinary Shares shall rank pari passu in all respects.

 

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6.             INCREASE OF AUTHORIZED SHARE CAPITAL.

 

(a)           The Company may, from time to time, by a Shareholders’ resolution, whether or not all the shares then authorized have been issued, increase its authorized share capital by the creation of new shares. Any such increase shall be in such amount and shall be divided into shares of such nominal amounts, and such shares shall confer such rights and preferences, and shall be subject to such restrictions, as such resolution shall provide.

 

(b)           Except to the extent otherwise provided in such resolution, any new shares included in the authorized share capital increased as aforesaid shall be subject to all the provisions of these Articles which are applicable to shares of such class included in the existing share capital without regard to class (and, if such new shares are of the same class as a class of shares included in the existing share capital, to all of the provisions which are applicable to shares of such class included in the existing share capital).

 

7.             SPECIAL OR CLASS RIGHTS; MODIFICATION OF RIGHTS.

 

(a)           If at any time the share capital of the Company is divided into different classes of shares, the rights attached to any class, unless otherwise provided by the Companies Law or these Articles, may be modified or cancelled by the Company by a resolution of the General Meeting of the holders of all shares as one class, without any required separate resolution of any class of shares.

 

(b)           The provisions of these Articles relating to General Meetings shall, mutatis mutandis, apply to any separate General Meeting of the holders of the shares of a particular class, it being clarified that the requisite quorum at any such separate General Meeting shall be two or more Shareholders present in person or by proxy and holding not less than one-third (1/3) of the issued shares of such class.

 

(c)           Unless otherwise provided by these Articles, an increase in the authorized share capital, the creation of a new class of shares, an increase in the authorized share capital of a class of shares, or the issuance of additional shares thereof out of the authorized and unissued share capital, shall not be deemed, for purposes of this Article 7, to modify or derogate or cancel the rights attached to previously issued shares of such class or of any other class.

 

8.             CONSOLIDATION, DIVISION, CANCELLATION AND REDUCTION OF SHARE CAPITAL.

 

(a)           The Company may, from time to time, by or pursuant to an authorization of a Shareholders’ resolution, and subject to applicable law:

 

(i)            consolidate all or any part of its issued or unissued authorized share capital into shares of a per share nominal value which is larger, equal to or smaller than the per share nominal value of its existing shares;

 

(ii)           divide or sub-divide its shares (issued or unissued) or any of them, into shares of smaller or the same nominal value (subject, however, to the provisions of the Companies Law), and the resolution whereby any share is divided may determine that, as among the holders of the shares resulting from such subdivision, one or more of the shares may, in contrast to others, have any such preferred or deferred rights or rights of redemption or other special rights, or be subject to any such restrictions, as the Company may attach to unissued or new shares;

 

(iii)          cancel any shares which, at the date of the adoption of such resolution, have not been taken or agreed to be taken by any person, and reduce the amount of its share capital by the amount of the shares so canceled; or

 

(iv)          reduce its share capital in any manner.

 

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(b)           With respect to any consolidation of issued shares and with respect to any other action which may result in fractional shares, the Board of Directors may settle any difficulty which may arise with regard thereto, as it deems fit, and, in connection with any such consolidation or other action which could result in fractional shares, may, without limiting its aforesaid power:

 

(i)            determine, as to the holder of shares so consolidated, which issued shares shall be consolidated into shares of a larger, equal or smaller nominal value per share;

 

(ii)           issue, in contemplation of or subsequent to such consolidation or other action, shares sufficient to preclude or remove fractional share holdings;

 

(iii)          redeem such shares or fractional shares sufficient to preclude or remove fractional share holdings;

 

(iv)          round up, round down or round to the nearest whole number, any fractional shares resulting from the consolidation or from any other action which may result in fractional shares; or

 

(v)           cause the transfer of fractional shares by certain Shareholders of the Company to other Shareholders thereof so as to most expediently preclude or remove any fractional shareholdings, and cause the transferees of such fractional shares to pay the transferors thereof the fair value thereof, and the Board of Directors is hereby authorized to act in connection with such transfer, as agent for the transferors and transferees of any such fractional shares, with full power of substitution, for the purposes of implementing the provisions of this sub-Article 8(b)(v).

 

9.             ISSUANCE OF SHARE CERTIFICATES, REPLACEMENT OF LOST CERTIFICATES.

 

(a)           To the extent that the Board of Directors determines that all shares shall be certificated or, if the Board of Directors does not so determine, to the extent that any Shareholder requests a share certificate, share certificates shall be issued under the corporate seal of the Company or its written, typed or stamped name and may bear the signature of one Director, the Company’s CEO or of any other person or persons authorized therefor by the Board of Directors. Signatures may be affixed in any mechanical or electronic form, as the Board of Directors may prescribe. For the avoidance of doubt, any transfer agent designated by the Company may issue share certificates on behalf of the Company even if the signatories on the share certificate no longer serve in the relevant capacities at the time of such issuance.

 

(b)           Subject to the Article 9(a), each Shareholder shall be entitled to one numbered certificate for all the shares of any class registered in his name. Each certificate may also specify the amount paid up thereon. The Company (as determined by an officer of the Company to be designated by the Chief Executive Officer) shall not refuse a request by a Shareholder to obtain several certificates in place of one certificate, unless such request is, in the opinion of such officer, unreasonable. Where a Shareholder has sold or transferred some of such Shareholder’s shares, such Shareholder shall be entitled to receive a certificate in respect of such Shareholder’s remaining shares, provided that the previous certificate is delivered to the Company before the issuance of a new certificate.

 

(c)           A share certificate registered in the names of two or more persons shall be delivered to the person first named in the Register of Shareholders in respect of such co-ownership.

 

(d)           A share certificate which has been defaced, lost or destroyed, may be replaced, and the Company shall issue a new certificate to replace such defaced, lost or destroyed certificate upon payment of such fee, and upon the furnishing of such evidence of ownership and such indemnity, as the Board of Directors in its discretion deems fit.

 

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10.          REGISTERED HOLDER.

 

Except as otherwise provided in these Articles or the Companies Law, the Company shall be entitled to treat the registered holder of each share as the absolute owner thereof, and accordingly, shall not, except as ordered by a court of competent jurisdiction, or as required by the Companies Law, be obligated to recognize any equitable or other claim to, or interest in, such share on the part of any other person.

 

11.          ISSUANCE AND REPURCHASE OF SHARES.

 

(a)           The unissued shares from time to time shall be under the control of the Board of Directors (and to the full extent permitted by law any Committee (as defined herein) thereof), which shall have the power to issue or otherwise dispose of shares and of securities convertible or exercisable into or other rights to acquire from the Company to such persons, on such terms and conditions, and whether for consideration or otherwise, or subject to the provisions of the Companies Law, at a discount and/or with payment of commission, and at such times, as the Board of Directors (or the Committee, as the case may be) deems fit, and the power to give to any person the option to acquire from the Company any shares or securities convertible or exercisable into or other rights to acquire from the Company, either at par or at a premium, or, subject as aforesaid, at a discount and/or with payment of commission, during such time and for such consideration as the Board of Directors (or the Committee, as the case may be) deems fit.

 

(b)           The Company may at any time and from time to time, subject to the Companies Law, repurchase or finance the purchase of any shares or other securities issued by the Company, in such manner and under such terms as the Board of Directors shall determine, whether from any one or more Shareholders. Such purchase shall not be deemed as payment of dividends and no Shareholder will have the right to require the Company to purchase his shares or offer to purchase shares from any other Shareholders.

 

12.          PAYMENT IN INSTALLMENT.

 

If pursuant to the terms of issuance of any share, all or any portion of the price thereof shall be payable in installments, every such installment shall be paid to the Company on the due date thereof by the then registered holder(s) of the share or the person(s) then entitled thereto.

 

13.          REDEEMABLE SHARES.

 

The Company may, subject to applicable law, issue redeemable shares or other securities and redeem the same upon terms and conditions to be set forth in a written agreement between the Company and the holder of such shares or in their terms of issuance.

 

TRANSFER OF SHARES

 

14.          REGISTRATION OF TRANSFER.

 

No transfer of shares shall be registered unless a proper writing or instrument of transfer (in any customary form or any other form satisfactory to the Board of Directors) has been submitted to the Company (or its transfer agent), together with any share certificate(s) and such other evidence of title as the Board of Directors may reasonably require. Notwithstanding anything to the contrary herein, shares registered in the name of The Depository Trust Company or its nominee shall be transferrable in accordance with the policies and procedures of The Depository Trust Company. Until the transferee has been registered in the Register of Shareholders in respect of the shares so transferred, the Company may continue to regard the transferor as the owner thereof. The Board of Directors, may, from time to time, prescribe a fee for the registration of a transfer, and may approve other methods of recognizing the transfer of shares in order to facilitate the trading of the Company’s shares on the NASDAQ or on any other stock exchange on which the Company’s shares are then listed for trading.

 

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15.          SUSPENSION OF REGISTRATION.

 

The Board of Directors may, in its discretion to the extent it deems necessary, close the Register of Shareholders of registration of transfers of shares for a period determined by the Board of Directors, and no registrations of transfers of shares shall be made by the Company during any such period during which the Register of Shareholders is so closed.

 

TRANSMISSION OF SHARES

 

16.          DECEDENTS’ SHARES.

 

(a)           In case of a share registered in the names of two or more holders, the Company may recognize the survivor(s) as the sole owner(s) thereof unless and until the provisions of Article 16(b) have been effectively invoked.

 

(b)           Any person becoming entitled to a share in consequence of the death of any person, upon producing evidence of the grant of probate or letters of administration or declaration of succession (or such other evidence as the Board of Directors may reasonably deem sufficient (or to an officer of the Company to be designated by the Chief Executive Officer)), shall be registered as a Shareholder in respect of such share, or may, subject to the provisions as to transfer contained herein, transfer such share.

 

17.          RECEIVERS AND LIQUIDATORS.

 

(a)           The Company may recognize any receiver, liquidator or similar official appointed to wind-up, dissolve or otherwise liquidate a corporate Shareholder, and a trustee, manager, receiver, liquidator or similar official appointed in bankruptcy or in connection with the reorganization of, or similar proceeding with respect to a shareholder or its properties, as being entitled to the shares registered in the name of such Shareholder.

 

(b)           Such receiver, liquidator or similar official appointed to wind-up, dissolve or otherwise liquidate a corporate Shareholder and such trustee, manager, receiver, liquidator or similar official appointed in bankruptcy or in connection with the reorganization of, or similar proceedings with respect to a shareholder or its properties, upon producing such evidence as the Board of Directors (or an officer of the Company to be designated by the Chief Executive Officer) may deem sufficient as to his authority to act in such capacity or under this Article, shall with the consent of the Board of Directors (which the Board of Directors may grant or refuse in its absolute discretion), be registered as a shareholder in respect of such shares, or may, subject to the regulations as to transfer herein contained, transfer such shares.

 

GENERAL MEETINGS

 

18.          GENERAL MEETINGS.

 

(a)         An annual General Meeting (“Annual General Meeting”) shall be held at such time and at such place, either within or out of the State of Israel, as may be determined by the Board of Directors, no later than fifteen (15) months after the last Annual General Meeting.

 

(b)         All General Meetings other than Annual General Meetings shall be called “Special General Meetings”.

 

19.          RECORD DATE FOR GENERAL MEETING.

 

Notwithstanding any provision of these Articles to the contrary, and to allow the Company to determine the Shareholders entitled to notice of or to vote at any General Meeting or any adjournment thereof, or entitled to receive payment of any dividend or other distribution or grant of any rights, or entitled to exercise any rights in respect of or to take or be the subject of any other action, the Board of Directors may fix a record date, which shall not be more than the maximum period and not less than the minimum period permitted by law. A determination of Shareholders of record entitled to notice of or to vote at a meeting 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.

 

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20.          SHAREHOLDER PROPOSAL REQUEST.

 

(a)           Any Shareholder or Shareholders of the Company holding at least one percent (1%) or a higher percent, as may be required by the Companies Law from time to time, of the voting rights of the Company (the “Proposing Shareholder(s)”) may request, subject to the Companies Law, that the Board of Directors include a matter on the agenda of a General Meeting to be held in the future, provided that the Board determines that the matter is appropriate to be considered in a General Meeting (a “Proposal Request”). In order for the Board of Directors to consider a Proposal Request and whether to include the matter stated therein in the agenda of a General Meeting, notice of the Proposal Request must be timely delivered in accordance with applicable laws, and the Proposal Request must comply with the requirement of these Articles (including this Article 20) and any applicable law and stock exchange rules and regulations. The Proposal Request must be in writing, signed by all of the Proposing Shareholder(s) making such request, delivered, either in person or by certified mail, postage prepaid, and received by the Secretary (or, in the absence thereof by the Chief Executive Officer of the Company). To be considered timely, a Proposal Request must be received within the time periods prescribed by applicable law. The announcement of an adjournment or postponement of a General Meeting shall not commence a new time period (or extend any time period) for the delivery of a Proposal Request as described above. In addition to any information required to be included in accordance with applicable law, the Proposal Request must include the following: (i) the name, address, telephone number, fax number and email address of the Proposing Shareholder (or each Proposing Shareholder, as the case may be) and, if an entity, the name(s) of the person(s) that controls or manages such entity; (ii) the number of Shares held by the Proposing Shareholder(s), directly or indirectly (and, if any of such Shares are held indirectly, an explanation of how they are held and by whom), which shall be in such number no less than as is required to qualify as a Proposing Shareholder, accompanied by evidence satisfactory to the Company of the record holding of such Shares by the Proposing Shareholder(s) as of the date of the Proposal Request, and a representation that the Proposing Shareholder(s) intends to appear in person or by proxy at the meeting; (iii) the matter requested to be included on the agenda of a General Meeting, all information related to such matter, the reason that such matter is proposed to be brought before the General Meeting, the complete text of the resolution that the Proposing Shareholder proposes to be voted upon at the General Meeting and, if the Proposing Shareholder wishes to have a position statement in support of the Proposal Request, a copy of such position statement that complies with the requirement of any applicable law (if any), (iv) a description of all arrangements or understandings between the Proposing Shareholders and any other Person(s) (naming such Person or Persons) in connection with the matter that is requested to be included on the agenda and a declaration signed by all Proposing Shareholder(s) of whether any of them has a personal interest in the matter and, if so, a description in reasonable detail of such personal interest; (v) a description of all Derivative Transactions (as defined below) by each Proposing Shareholder(s) 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; and (vi) a declaration that all of the information that is required under the Companies Law and any other applicable law and stock exchange rules and regulations to be provided to the Company in connection with such matter, if any, has been provided to the Company. The Board of Directors, may, in its discretion, to the extent it deems necessary, request that the Proposing Shareholder(s) provide additional information necessary so as to include a matter in the agenda of a General Meeting, as the Board of Directors may reasonably require.

 

A “Derivative Transaction” means any agreement, arrangement, interest or understanding entered into by, or on behalf or for the benefit of, any Proposing Shareholder or any of its affiliates or associates, whether of record or beneficial: (1) 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 Company, (2) 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 Company, (3) the effect or intent of which is to mitigate loss, manage risk or benefit of security value or price changes, or (4) which provides the right to vote or increase or decrease the voting power of, such Proposing Shareholder, or any of its affiliates or associates, with respect to any shares or other

 

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securities of the Company, 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 Proposing Shareholder in the securities of the Company held by any general or limited partnership, or any limited liability company, of which such Proposing Shareholder is, directly or indirectly, a general partner or managing member.

 

(b)           The information required pursuant to this Article shall be updated as of (i) the record date of the General Meeting, (ii) five business days before the General Meeting, and (iii) as of the General Meeting, and any adjournment or postponement thereof.

 

(c)           The provisions of Articles 20(a) and 20(b) shall apply, mutatis mutandis, on any matter to be included on the agenda of a Special General Meeting which is convened pursuant to a request of a Shareholder duly delivered to the Company in accordance with the Companies Law.

 

21.          NOTICE OF GENERAL MEETINGS; OMISSION TO GIVE NOTICE.

 

(a)           The Company is not required to give notice of a General Meeting, subject to any mandatory provision of the Companies Law, and any other requirements applicable to the Company. Notwithstanding anything herein to the contrary, to the extent permitted under the Companies Law, with the consent of all Shareholders entitled to vote thereon, a resolution may be proposed and passed at such meeting although a lesser notice period than hereinabove prescribed has been given.

 

(b)           The accidental omission to give notice of a General Meeting to any Shareholder, or the non-receipt of notice sent to such Shareholder, shall not invalidate the proceedings at such meeting or any resolution adopted thereat.

 

(c)           The Company may add additional places for Shareholders to review the full text of the proposed resolutions to be adopted at a General Meeting, including an internet site.

 

PROCEEDINGS AT GENERAL MEETINGS

 

22.          QUORUM.

 

(a)           No business shall be transacted at a General Meeting, or at any adjournment thereof, unless the quorum required under these Articles for such General Meeting or such adjourned meeting, as the case may be, is present when the meeting proceeds to business.

 

(b)           In the absence of contrary provisions in these Articles, two or more Shareholders, present in person or by proxy and holding shares conferring in the aggregate at least one-third (1/3) of the voting power of the Company, shall constitute a quorum of General Meetings. A proxy may be deemed to be two (2) or more Shareholders pursuant to the number of Shareholders represented by the proxy holder.

 

(c)           If within half an hour from the time appointed for the meeting a quorum is not present, then without any further notice the meeting shall be adjourned either (i) to the same day in the next week, at the same time and place, (ii) to such day and at such time and place as indicated in the notice to such meeting, or (iii) to such day and at such time and place as the Chairperson of the General Meeting shall determine (which may be earlier or later than the date pursuant to clause (i) above). No business shall be transacted at any adjourned meeting except business which might lawfully have been transacted at the meeting as originally called. At such adjourned meeting, if the original meeting was convened upon requisition under Section 63 of the Companies Law, one or more Shareholders, present in person or by proxy, and holding the number of shares required for making such requisition, shall constitute a

 

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quorum, but in any other case any Shareholder (not in default as aforesaid) present in person or by proxy, shall constitute a quorum.

 

23.          CHAIRPERSON OF GENERAL MEETING.

 

The Chairperson of the Board of Directors, shall preside as Chairperson of every General Meeting of the Company. If at any meeting the Chairperson is not present within fifteen (15) minutes after the time fixed for holding the meeting or is unwilling to act as Chairperson, any of the following may preside as Chairperson of the meeting (and in the following order): Director, Chief Executive Officer, Chief Financial Officer, Secretary or any person designated by any of the foregoing. If at any such meeting none of the foregoing persons is present or all are unwilling to act as Chairperson, the Shareholders present (in person or by proxy) shall choose a Shareholder or its proxy present at the meeting to be Chairperson. The office of Chairperson shall not, by itself, entitle the holder thereof to vote at any General Meeting nor shall it entitle such holder to a second or casting vote (without derogating, however, from the rights of such Chairperson to vote as a Shareholder or proxy of a Shareholder if, in fact, he is also a Shareholder or such proxy).

 

24.          ADOPTION OF RESOLUTIONS AT GENERAL MEETINGS.

 

(a)           Except as required by the Companies Law or these Articles, including, without limitation, Article 34 below, a resolution of the Shareholders shall be adopted if approved by the holders of a simple majority of the voting power represented at the General Meeting in person or by proxy and voting thereon, as one class, and disregarding abstentions from the count of the voting power present and voting. Without limiting the generality of the foregoing, a resolution with respect to a matter or action for which the Companies Law prescribes a higher majority or pursuant to which a provision requiring a higher majority would have been deemed to have been incorporated into these Articles, but resolutions with respect to which the Companies Law allows the Company’s Articles to provide otherwise, shall be adopted by a simple majority of the voting power represented at the General Meeting in person or by proxy and voting thereon, as one class, and disregarding abstentions from the count of the voting power present and voting.

 

(b)           Every question submitted to a General Meeting shall be decided by a show of hands, but the Chairperson of the General Meeting may determine that a resolution shall be decided by a written ballot. A written ballot may be implemented before the proposed resolution is voted upon or immediately after the declaration by the Chairperson of the results of the vote by a show of hands. If a vote by written ballot is taken after such declaration, the results of the vote by a show of hands shall be of no effect, and the proposed resolution shall be decided by such written ballot.

 

(c)           A declaration by the Chairperson of the General Meeting that a resolution has been carried unanimously, or carried by a particular majority, or rejected, and an entry to that effect in the minute book of the Company, shall be prima facie evidence of the fact without proof of the number or proportion of the votes recorded in favor of or against such resolution.

 

25.          POWER TO ADJOURN.

 

A General Meeting, the consideration of any matter on its agenda or the resolution on any matter on its agenda, may be postponed or adjourned, from time to time and from place to place: (i) by the Chairperson of a General Meeting at which a quorum is present (and he shall if so directed by the meeting, with the consent of the holders of a majority of the voting power represented in person or by proxy and voting on the question of adjournment), but no business shall be transacted at any such adjourned meeting except business which might lawfully have been transacted at the meeting as originally called, or a matter on its agenda with respect to which no resolution was adopted at the meeting originally called; or (ii) by the Board (whether prior to or at the General Meeting).

 

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26.          VOTING POWER.

 

Subject to the provisions of Article 27(a) and to any provision hereof conferring special rights as to voting, or restricting the right to vote, every Shareholder shall have one vote for each share held by him of record, on every resolution, without regard to whether the vote thereon is conducted by a show of hands, by written ballot or by any other means.

 

27.          VOTING RIGHTS.

 

(a)           A company or other corporate body being a Shareholder of the Company may duly authorize any person to be its representative at any meeting of the Company or to execute or deliver a proxy on its behalf. Any person so authorized shall be entitled to exercise on behalf of such Shareholder all the power which the Shareholder could have exercised if it were an individual. Upon the request of the Chairperson of the General Meeting, written evidence of such authorization (in form acceptable to the Chairperson) shall be delivered to him.

 

(b)           Any Shareholder entitled to vote may vote either in person or by proxy (who need not be Shareholder of the Company), or, if the Shareholder is a company or other corporate body, by representative authorized pursuant to Article (a) above.

 

(c)           If two or more persons are registered as joint holders of any share, the vote of the senior who tenders a vote, in person or by proxy, shall be accepted to the exclusion of the vote(s) of the other joint holder(s). For the purpose of this Article 27(c), seniority shall be determined by the order of registration of the joint holders in the Register of Shareholder.

 

PROXIES

 

28.          INSTRUMENT OF APPOINTMENT.

 

(a)           An instrument appointing a proxy shall be in writing and shall be substantially in the following form:

 

“I

 

of

 

 

(Name of Shareholder)

 

(Address of Shareholder)

 

 

 

 

Being a shareholder of POLYPID LTD. hereby appoints

 

 

of

 

 

(Name of Proxy)

 

(Address of Proxy)

 

as my proxy to vote for me and on my behalf at the General Meeting of the Company to be held on the     day of        ,         and at any adjournment(s) thereof.

 

Signed this      day of            ,       .

 

(Signature of Appointor)”

 

 

or in any such form as may be approved by the Board of Directors.

 

(b)           Subject to the Companies Law, the original instrument appointing a proxy or a copy thereof (and the power of attorney or other authority, if any, under which such instrument has been signed) shall be delivered to the Company (at its Office, at its principal place of business, or at the offices of its registrar or transfer agent, or at such place as notice of the meeting may specify) not less than forty eight (48) hours (or such shorter period as the notice shall specify)  before the time fixed for such meeting. Notwithstanding the above, the Chairperson shall have the right to waive the time requirement provided above with respect to all instruments of proxies and to accept any and all instruments of proxy until the beginning of a General Meeting. A document appointing a proxy shall be valid for every adjourned meeting of the General Meeting to which the document relates.

 

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29.          EFFECT OF DEATH OF APPOINTOR OF TRANSFER OF SHARE AND OR REVOCATION OF APPOINTMENT.

 

(a)           A vote cast in accordance with an instrument appointing a proxy shall be valid notwithstanding the prior death or bankruptcy of the appointing Shareholder (or of his attorney-in-fact, if any, who signed such instrument), or the transfer of the share in respect of which the vote is cast, unless written notice of such matters shall have been received by the Company or by the Chairperson of such meeting prior to such vote being cast.

 

(b)           Subject to the Companies Law, an instrument appointing a proxy shall be deemed revoked (i) upon receipt by the Company or the Chairperson, subsequent to receipt by the Company of such instrument, of written notice signed by the person signing such instrument or by the Shareholder appointing such proxy canceling the appointment thereunder (or the authority pursuant to which such instrument was signed) or of an instrument appointing a different proxy (and such other documents, if any, required under Article 28(b) for such new appointment), provided such notice of cancellation or instrument appointing a different proxy were so received at the place and within the time for delivery of the instrument revoked thereby as referred to in Article 28(b) hereof, or (ii) if the appointing Shareholder is present in person at the meeting for which such instrument of proxy was delivered, upon receipt by the Chairperson of such meeting of written notice from such Shareholder of the revocation of such appointment, or if and when such Shareholder votes at such meeting. A vote cast in accordance with an instrument appointing a proxy shall be valid notwithstanding the revocation or purported cancellation of the appointment, or the presence in person or vote of the appointing Shareholder at a meeting for which it was rendered, unless such instrument of appointment was deemed revoked in accordance with the foregoing provisions of this Article 29(b) at or prior to the time such vote was cast.

 

BOARD OF DIRECTORS

 

30.          POWERS OF BOARD OF DIRECTORS.

 

(a)           The Board of Directors may exercise all such powers and do all such acts and things as the Board of Directors is authorized by law or as the Company is authorized to exercise and do and are not hereby or by law required to be exercised or done by the General Meeting. The authority conferred on the Board of Directors by this Article 30 shall be subject to the provisions of the Companies Law, these Articles and any regulation or resolution consistent with these Articles adopted from time to time at a General Meeting, provided, however, that no such regulation or resolution shall invalidate any prior act done by or pursuant to a decision of the Board of Directors which would have been valid if such regulation or resolution had not been adopted.

 

(b)           Without limiting the generality of the foregoing, the Board of Directors may, from time to time, set aside any amount(s) out of the profits of the Company as a reserve or reserves for any purpose(s) which the Board of Directors, in its absolute discretion, shall deem fit, including without limitation, capitalization and distribution of bonus shares, and may invest any sum so set aside in any manner and from time to time deal with and vary such investments and dispose of all or any part thereof, and employ any such reserve or any part thereof in the business of the Company without being bound to keep the same separate from other assets of the Company, and may subdivide or re-designate any reserve or cancel the same or apply the funds therein for another purpose, all as the Board of Directors may from time to time think fit.

 

31.          EXERCISE OF POWERS OF BOARD OF DIRECTORS.

 

(a)           A meeting of the Board of Directors at which a quorum is present shall be competent to exercise all the authorities, powers and discretion vested in or exercisable by the Board of Directors.

 

(b)           A resolution proposed at any meeting of the Board of Directors shall be deemed adopted if approved by a majority of the Directors present, entitled to vote and voting thereon when such resolution is put to a vote. In case of an equality of votes of the Board, the Chairman of the Board shall not have a second casting vote, and the proposed resolution shall be deemed to be defeated.

 

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(c)           The Board of Directors may adopt resolutions, without convening a meeting of the Board of Directors, in writing or in any other manner permitted by the Companies Law, provided that all directors entitled to participate in the meeting and to vote on the subject brought for decision agree thereto. If any resolutions are made pursuant to this Article 31(c), the Chairman of the Board shall record minutes of the decisions stating the manner of voting of each director on the subjects brought for decision as well as the fact that all such directors agreed to take the decision without convening.

 

(d)           The Board may hold meetings by use of any means of communication on the condition that all participating directors can hear each other at the same time.

 

(e)           The Board may, from time to time, in its discretion, borrow or secure any amounts of money required by the Company to conduct its business.

 

(f)            The Board shall be entitled to issue documents of undertaking, such as options, debentures, whether linked or redeemable, convertible debentures or debentures convertible into other securities, or debentures which carry a right to purchase shares or other securities, or any mortgage, pledge, collateral or other charge over the property of the Company and its undertaking, whether present or future, including the uncalled share capital or the share capital which has been called but not yet paid. The deeds of undertaking, debentures of various kinds or other forms of collateral may be issued at a discount, at a premium or otherwise and with such rights as the Board shall determine.

 

32.          DELEGATION OF POWERS.

 

(a)           The Board of Directors may, subject to the provisions of the Companies Law, delegate any or all of its powers to committees (in these Articles referred to as a “Committee of the Board of Directors”, or “Committee”), each consisting of one or more persons (who may or may not be Directors), and it may from time to time revoke such delegation or alter the composition of any such Committee. No regulation imposed by the Board of Directors on any Committee and no resolution of the Board of Directors shall invalidate any prior act done pursuant to a resolution by the Committee which would have been valid if such regulation or resolution of the Board had not been adopted. The meeting and proceedings of any such Committee of the Board of Directors shall, mutatis mutandis, be governed by the provisions herein contained for regulating the meetings of the Board of Directors, so far as not superseded by any regulations adopted by the Board of Directors or by the Companies Law. Unless otherwise expressly prohibited by the Board of Directors in delegating powers to a Committee of the Board of Directors, such Committee shall be empowered to further delegate such powers.

 

(b)           Without derogating from the provisions of Article 44, the Board of Directors may from time to time appoint a Secretary to the Company, as well as officers, agents, employees and independent contractors, as the Board of Directors deems fit, and may terminate the service of any such person. The Board of Directors may, subject to the provisions of the Companies Law, determine the powers and duties, as well as the salaries and compensation, of all such persons.

 

(c)           The Board of Directors may from time to time, by power of attorney or otherwise, appoint any person, company, firm or body of persons to be the attorney or attorneys of the Company at law or in fact for such purposes(s) and with such powers, authorities and discretions, and for such period and subject to such conditions, as it deems fit, and any such power of attorney or other appointment may contain such provisions for the protection and convenience of persons dealing with any such attorney as the Board of Directors deems fit, and may also authorize any such attorney to delegate all or any of the powers, authorities and discretions vested in him.

 

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33.          NUMBER OF DIRECTORS.

 

(a)           The Board of Directors shall consist of such number of Directors, not less than five (5) nor more than eleven (11), including the External Directors (if any), which will be elected if and as required under the Companies Law, as may be fixed from time to time by the Board of Directors.

 

(b)           Notwithstanding anything to the contrary herein, this Article 33 may only be amended or replaced by a resolution adopted at a General Meeting by a majority of 65% of the voting power represented at the General Meeting in person or by proxy and voting thereon, disregarding abstentions from the count of the voting power present and voting.

 

34.          ELECTION AND REMOVAL OF DIRECTORS.

 

(a)           Other than External Directors, if any (who shall be elected and serve in office in strict accordance with the provisions of Israeli law), Directors of the Company shall be elected solely at an Annual General Meeting and shall serve in their office until the next Annual General Meeting, or until they cease to serve in their office in accordance with the provisions of the Articles or any law, whichever is earlier.

 

(b)           Prior to every Annual General Meeting of the Company, and subject to clauses (a) and (f) of this Article, the Board of Directors (or a Committee thereof) shall select, by a resolution adopted by a majority of the Board of Directors (or such Committee), a number of Persons to be proposed to the Shareholders for election as Directors at such Annual General Meeting (the “Nominees”).

 

(c)           Any Proposing Shareholder requesting to include on the agenda of an Annual General Meeting a nomination of a Person to be proposed to the Shareholders for election as Director (such person, an “Alternate Nominee”), may so request provided that it complies with this Article 34(c) and Article 20 and applicable law. Unless otherwise determined by the Board, a Proposal Request relating to Alternate Nominee is deemed to be a matter that is appropriate to be considered only in an Annual General Meeting. In addition to any information required to be included in accordance with applicable law, such a Proposal Request shall include information required pursuant to Article 20, and shall also set forth: (i) the name, address, telephone number, fax number and email address of the Alternate Nominee and all citizenships and residencies of the Alternate Nominee; (ii) a description of all arrangements, relations or understandings between the Proposing Shareholder(s) or any of its affiliates and each Alternate Nominee; (iii) a declaration signed by the Alternate Nominee that he consents to be named in the Company’s notices and proxy materials relating to the Annual General Meeting, if provided or published, and, if elected, to serve on the Board of Directors and to be named in the Company’s disclosures and filings, (iv) a declaration signed by each Alternate Nominee as required under the Companies Law and any other applicable law and stock exchange rules and regulations for the appointment of such an Alternate Nominee and an undertaking that all of the information that is required under law and stock exchange rules and regulations to be provided to the Company in connection with such an appointment has been provided (including, information in respect of the Alternate Nominee as would be provided in response to the applicable disclosure requirements under Form 20-F or any other applicable form prescribed by the U.S. Securities and Exchange Commission); (v) a declaration made by the Alternate Nominee of whether he or she meets the criteria for an independent director and/or External Director of the Company under the Companies Law and/or under any applicable law, regulation or stock exchange rules, and if not, then an explanation of why not; and (vi) any other information required at the time of submission of the Proposal Request by applicable law, regulations or stock exchange rules. In addition, the Proposing Shareholder shall promptly provide any other information reasonably requested by the Company. The Board of Directors may refuse to acknowledge the nomination of any person not made in compliance with the foregoing. The Company shall be entitled to publish any information provided by a Proposing Shareholder pursuant to this Article 34(c) and Article 20, and the Proposing Shareholder shall be responsible for the accuracy and completeness thereof.

 

(d)           The Nominees or Alternate Nominees shall be elected by a resolution adopted at the Annual General Meeting at which they are subject to election.

 

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(e)           Notwithstanding anything to the contrary herein, this Article 34 and Article 37(e) may only be amended, replaced or suspended by a resolution adopted at a General Meeting by a majority of 65% of the voting power represented at the General Meeting in person or by proxy and voting thereon, disregarding abstentions from the count of the voting power present and voting.

 

(f)            Notwithstanding anything to the contrary in these Articles, the election, qualification, removal or dismissal of External Directors shall be only in accordance with the applicable provisions set forth in the Companies Law.

 

35.          COMMENCEMENT OF DIRECTORSHIP.

 

Without derogating from Article 34, the term of office of a Director shall commence as of the date of his appointment or election, or on a later date if so specified in his appointment or election.

 

36.          CONTINUING DIRECTORS IN THE EVENT OF VACANCIES.

 

The Board may at any time and from time to time appoint any person as a Director to fill a vacancy (whether such vacancy is due to a Director no longer serving or due to the number of Directors serving being less than the maximum number stated in Article 33 hereof). In the event of one or more such vacancies in the Board of Directors, the continuing Directors may continue to act in every matter, provided, however, that if they number less than the minimum number provided for pursuant to Article 33 hereof, they may only act in an emergency or to fill the office of director which has become vacant up to a number equal to the minimum number provided for pursuant to Article 33 hereof. The office of a Director that was appointed by the Board of Directors to fill any vacancy shall only be for the remaining period of time during which the Director whose service has ended was filled would have held office, or in case of a vacancy due to the number of Directors serving being less than the maximum number stated in Article 33 hereof, the Board shall determine at the time of appointment the class pursuant to Article 34 to which the additional Director shall be assigned.

 

37.          VACATION OF OFFICE.

 

The office of a Director shall be vacated and he or she shall be dismissed or removed:

 

(a)           ipso facto, upon his or her death;

 

(b)           if he or she is prevented by applicable law from serving as a Director;

 

(c)           if he or she is declared bankrupt;

 

(d)           if the Board determines that due to his or her mental or physical state he or she is unable to serve as a director;

 

(e)           if his or her directorship expires pursuant to these Articles and/or applicable law, including but not limited to instances in which the Board terminated the office of such director in accordance with Section 231 of the Companies Law or due to a court given order in accordance with Section 233 of the Companies Law;

 

(f)            by a resolution adopted at a General Meeting by a majority of 65% of the voting power represented at the General Meeting in person or by proxy and voting thereon, disregarding abstentions from the count of the voting power present and voting. Such removal shall become effective on the date fixed in such resolution;

 

(g)           by his or her written resignation, such resignation becoming effective on the date fixed therein, or upon the delivery thereof to the Company, whichever is later; or

 

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(h)           with respect to an External Director, and notwithstanding anything to the contrary herein, only pursuant to applicable law.

 

38.          CONFLICT OF INTERESTS; APPROVAL OF RELATED PARTY TRANSACTIONS.

 

Subject to the provisions of the Companies Law and these Articles, no Director shall be disqualified by virtue of his office from holding any office or place of profit in the Company or in any company in which the Company shall be a Shareholder or otherwise interested, or from contracting with the Company as vendor, purchaser or otherwise, nor shall any such contract, or any contract or arrangement entered into by or on behalf of the Company in which any Director shall be in any way interested, be avoided, nor, other than as required under the Companies Law, shall any Director be liable to account to the Company for any profit arising from any such office or place of profit or realized by any such contract or arrangement by reason only of such Director’s holding that office or of the fiduciary relations thereby established, but the nature of his interest, as well as any material fact or document, must be disclosed by him at the meeting of the Board of Directors at which the contract or arrangement is first considered, if his interest then exists, or, in any other case, at no later than the first meeting of the Board of Directors after the acquisition of his interest.

 

39.          ALTERNATE DIRECTORS.

 

(a)           Subject to the provisions of the Companies Law, a Director may, by written notice to the Company, appoint, remove or replace any person as an alternate for himself; provided that the appointment of such person shall have effect only upon and subject to its being approved by the Board (in these Articles, an “Alternate Director”). Unless the appointing Director, by the instrument appointing an Alternate Director or by written notice to the Company, limits such appointment to a specified period of time or restricts it to a specified meeting or action of the Board of Directors, or otherwise restricts its scope, the appointment shall be for all purposes, and for a period of time concurrent with the term of the appointing Director.

 

(b)           Any notice to the Company pursuant to Article 39(a) shall be given in writing to the Chairperson of the Board of Directors, or by sending the same in writing to the attention of the Chairperson of the Board of Directors at the principal office of the Company or to such other person or place as the Board of Directors shall have determined for such purpose, and shall become effective on the date fixed therein, upon the receipt thereof by the Company (at the place as aforesaid) or upon the approval of the appointment by the Board, whichever is later.

 

(c)           An Alternate Director shall have all the rights and obligations of the Director who appointed him, provided however, that (i) he may not in turn appoint an alternate for himself (unless the instrument appointing him otherwise expressly provides), and (ii) an Alternate Director shall have no standing at any meeting of the Board of Directors or any Committee thereof while the Director who appointed him is present.

 

(d)           Any individual, who qualifies to be a member of the Board of Directors, may act as an Alternate Director. One person may not act as Alternate Director for several directors.

 

(e)           The office of an Alternate Director shall be vacated under the circumstances, mutatis mutandis, set forth in Article 37, and such office shall ipso facto be vacated if the office of the Director who appointed such Alternate Director is vacated, for any reason.

 

PROCEEDINGS OF THE BOARD OF DIRECTORS

 

40.          MEETINGS.

 

(a)           The Board of Directors may meet and adjourn its meetings and otherwise regulate such meetings and proceedings as the Directors think fit.

 

(b)           Any Director may at any time, and the Secretary, upon the request of such Director, shall, convene a meeting of the Board of Directors, but not less than forty-eight (48) hours’ notice shall be given of any meeting so convened, unless such notice is waived by all of the

 

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Directors as to a particular meeting or unless the matters to be discussed at such meeting are of such urgency and importance, as determined by the Chairperson, that notice ought reasonably to be waived under the circumstances.

 

(c)           Notice of any such meeting shall be given at least 24 hours in advance, unless the urgency of the matter to be discussed at the meeting reasonably necessitates a shorter notice, and in writing and in accordance with Article 62.

 

41.          QUORUM.

 

Until otherwise unanimously decided by the Board of Directors, a quorum at a meeting of the Board of Directors shall be constituted by the presence in person or by any means of communication of a majority of the Directors then in office who are lawfully entitled to participate and vote in the meeting. No business shall be transacted at a meeting of the Board of Directors unless the requisite quorum is present (in person or by any means of communication) when the meeting proceeds to business.

 

42.          CHAIRPERSON OF THE BOARD OF DIRECTORS.

 

The Board of Directors shall, from time to time, elect one of its members to be the Chairperson of the Board of Directors, remove such Chairperson from office and appoint in his place. The Chairperson of the Board of Directors shall preside at every meeting of the Board of Directors, but if there is no such Chairperson, or if at any meeting he is not present within fifteen (15) minutes of the time fixed for the meeting or if he is unwilling to take the chair, the Directors present shall choose one of the Directors present at the meeting to be the Chairperson of such meeting. The office of Chairperson of the Board of Directors shall not, by itself, entitle the holder to a second or casting vote.

 

43.          VALIDITY OF ACTS DESPITE DEFECTS.

 

(a)           All acts done or transacted at any meeting of the Board of Directors, or of a Committee of the Board of Directors, or by any person(s) acting as Director(s), shall, notwithstanding that it may afterwards be discovered that there was some defect in the appointment of the participants in such meeting or any of them or any person(s) acting as aforesaid, or that they or any of them were disqualified, be as valid as if there were no such defect or disqualification.

 

(b)           The General Meeting shall be entitled to ratify any act taken by the Board or any committee without authority or which was tainted by some other defect. From the time of such ratification, every act ratified shall be treated as though lawfully preformed from the outset.

 

CHIEF EXECUTIVE OFFICER

 

44.          CHIEF EXECUTIVE OFFICER.

 

(a)           The Board of Directors shall from time to time appoint one or more persons, whether or not Directors, as Chief Executive Officer of the Company and may confer upon such person(s), and from time to time modify or revoke, such titles and such duties and authorities of the Board of Directors as the Board of Directors may deem fit, subject to such limitations and restrictions as the Board of Directors may from time to time prescribe. Such appointment(s) may be either for a fixed term or without any limitation of time, and the Board of Directors may from time to time (subject to any additional approvals required under, and the provisions of, the Companies Law and of any contract between any such person and the Company) fix their salaries and compensation, remove or dismiss them from office and appoint another or others in his or their place or places.

 

(b)           Unless otherwise determined by the Board of Directors, the Chief Executive Officer shall have authority with respect to the management and operations of the Company in the ordinary course of business.

 

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MINUTES

 

45.          MINUTES.

 

Any minutes of the General Meeting or the Board of Directors or any committee thereof, if purporting to be signed by the Chairperson of the General Meeting, the Board or a committee thereof, as the case may be, or by the Chairperson of the next succeeding General Meeting, meeting of the Board or meeting of a committee thereof, as the case may be, shall constitute prima facie evidence of the matters recorded therein.

 

DIVIDENDS

 

46.          DECLARATION OF DIVIDENDS.

 

The Board of Directors may from time declare, and cause the Company to pay, such dividend as may appear to the Board of Directors to be justified by the profits of the Company and as permitted by the Companies Law. The Board of Directors shall determine the time for payment of such dividends and the record date for determining the Shareholders entitled thereto.

 

47.          AMOUNT PAYABLE BY WAY OF DIVIDENDS.

 

(a)           Subject to the provisions of these Articles and subject to the rights or conditions attached at that time to any share in the capital of the Company granting preferential, special or deferred rights or not granting any rights with respect to dividends, any dividend paid by the Company shall be allocated among the shareholders entitled thereto in proportion to their respective holdings of the shares in respect of which such dividends are being paid.

 

48.          INTEREST.

 

No dividend shall carry interest as against the Company.

 

49.          CAPITALIZATION OF PROFITS, RESERVES, ETC.

 

The Board of Directors may determine that the Company (i) may cause any moneys, investments, or other assets forming part of the undivided profits of the Company, standing to the credit of a reserve fund, or to the credit of a reserve fund for the redemption of capital, or in the hands of the Company and available for dividends, or representing premiums received on the issuance of shares and standing to the credit of the share premium account, to be capitalized and distributed among such of the Shareholders as would be entitled to receive the same if distributed by way of dividend and in the same proportion, on the footing that they become entitled thereto as capital; and (ii) may cause such distribution or payment to be accepted by such Shareholders in full satisfaction of their interest in the said capitalized sum.

 

50.          IMPLEMENTATION OF POWERS.

 

For the purpose of giving full effect to any resolution under Article 49, and without derogating from the provisions of Article 51 hereof, the Board of Directors may settle any difficulty which may arise in regard to the distribution as it thinks expedient, and, in particular, may fix the value for distribution of any specific assets and may determine that cash payments shall be made to any Shareholders upon the footing of the value so fixed, or that fractions of less value than a certain determined value may be disregarded in order to adjust the rights of all parties, and may vest any such cash, shares, debentures, debenture stock or specific assets in trustees upon such trusts for the persons entitled to the dividend or capitalized fund as may seem expedient to the Board of Directors. Where requisite, a proper contract shall be filed in accordance with Section 291 of the Companies Law, and the Board of Directors may appoint any person to sign such contract on behalf of the persons entitled to the dividend or capitalized fund.

 

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51.          UNCLAIMED DIVIDENDS.

 

All unclaimed dividends or other moneys payable in respect of a share may be invested or otherwise made use of by the Board of Directors for the benefit of the Company until claimed. The payment by the Directors of any unclaimed dividend or such other moneys into a separate account shall not constitute the Company a trustee in respect thereof, and any dividend unclaimed after a period of seven years from the date of declaration of such dividend, and any such other moneys unclaimed after a like period from the date the same were payable, shall be forfeited and shall revert to the Company, provided, however, that the Board of Directors may, at its discretion, cause the Company to pay any such dividend or such other moneys, or any part thereof, to a person who would have been entitled thereto had the same not reverted to the Company. The principal (and only the principal) of any unclaimed dividend of such other moneys shall be, if claimed, paid to a person entitled thereto.

 

52.          MECHANICS OF PAYMENT.

 

Any dividend or other moneys payable in cash in respect of a share may be paid by check or payment order sent through the post to, or left at, the registered address of the person entitled thereto or by transfer to a bank account specified by such person (or, if two or more persons are registered as joint holders of such share or are entitled jointly thereto in consequence of the death or bankruptcy of the holder or otherwise, to the joint holder whose name is registered first in the Register of Shareholders or his bank account or the person who the Company may then recognize as the owner thereof or entitled thereto under Article 16 or 17 hereof, as applicable, or such person’s bank account), or to such person and at such other address as the person entitled thereto may by writing direct, or in any other manner the Board deems appropriate. Every such check or warrant or other method of payment shall be made payable to the order of the person to whom it is sent, or to such person as the person entitled thereto as aforesaid may direct, and payment of the check or warrant by the banker upon whom it is drawn shall be a good discharge to the Company.

 

53.          RECEIPT FROM A JOINT HOLDER.

 

If two or more persons are registered as joint holders of any share, or are entitled jointly thereto in consequence of the death or bankruptcy of the holder or otherwise, any one of them may give effectual receipts for any dividend or other moneys payable or property distributable in respect of such share.

 

ACCOUNTS

 

54.          BOOKS OF ACCOUNT.

 

The Company’s books of account shall be kept at the Office of the Company, or at such other place or places as the Board of Directors may think fit, and they shall always be open to inspection by all Directors. No Shareholder, not being a Director, shall have any right to inspect any account or book or other similar document of the Company, except as conferred by law or authorized by the Board of Directors. The Company shall make copies of its annual financial statements available for inspection by the Shareholders at the principal offices of the Company. The Company shall not be required to send copies of its annual financial statements to the Shareholders.

 

55.          AUDITORS.

 

The appointment, authorities, rights and duties of the auditor(s) of the Company, shall be regulated by applicable law, provided, however, that in exercising its authority to fix the remuneration of the auditor(s), the Shareholders in General Meeting may act (and in the absence of any action in connection therewith shall be deemed to have so acted) to authorize the Board of Directors (with right of delegation to management) to fix such remuneration subject to such criteria or standards, and if no such criteria or standards are so provided, such remuneration shall be fixed in an amount commensurate with the volume and nature of the services rendered by such auditor(s).

 

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SUPPLEMENTARY REGISTERS

 

56.          SUPPLEMENTARY REGISTERS.

 

Subject to and in accordance with the provisions of Sections 138 and 139 of the Companies Law, the Company may cause supplementary registers to be kept in any place outside Israel as the Board of Directors may think fit, and, subject to all applicable requirements of law, the Board of Directors may from time to time adopt such rules and procedures as it may think fit in connection with the keeping of such branch registers.

 

EXEMPTION, INDEMNITY AND INSURANCE

 

57.          INSURANCE.

 

Subject to the provisions of the Companies Law with regard to such matters, the Company may enter into a contract for the insurance of the liability, in whole or in part, of any of its Office Holders imposed on such Office Holder due to an act performed by or an omission of the Office Holder in the Office Holder’s capacity as an Office Holder of the Company arising from any matter permitted by law, including the following:

 

(a)           a breach of duty of care to the Company or to any other person;

 

(b)           a breach of duty of loyalty to the Company, provided that the Office Holder acted in good faith and had reasonable grounds to assume that the act that resulted in such breach would not prejudice the interests of the Company;

 

(c)           a financial liability imposed on such Office Holder in favor of any other person in his or her capacity as an Office Holder; and

 

(d)           any other event, occurrence, matter or circumstance under any law with respect to which the Company may, or will be able to, insure an Office Holder, and to the extent such law requires the inclusion of a provision permitting such insurance in these Articles, then such provision is deemed to be included and incorporated herein by reference (including, without limitation, in accordance with Section 56h(b)(1) of the Securities Law, if and to the extent applicable, and Section 50P of the RTP Law).

 

58.          INDEMNITY.

 

(a)           Subject to the provisions of the Companies Law, the Company may retroactively indemnify an Office Holder of the Company with respect to the following liabilities and expenses, provided that such liabilities or expenses were imposed on such Office Holder or incurred by such Office Holder due to an act performed by or an omission of the Office Holder in such Office Holder’s capacity as an Office Holder of the Company:

 

(i)            a financial liability imposed on an Office Holder in favor of another person by any court judgment, including a judgment given as a result of a settlement or an arbitrator’s award which has been confirmed by a court in respect of an act performed by the Office Holder; provided, however, that any such indemnification shall be limited to: (a) events which, to the opinion of the Board, are foreseeable in light of the Company’s actual operations at the time of granting such indemnification, and (b) such events deemed by the Board to be foreseeable are listed in the indemnification undertaking together with a set amount or criteria determined by the Board to be reasonable;

 

(ii)           reasonable litigation expenses, including attorneys’ fees, expended by the Office Holder as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, or in connection with a financial sanction, provided that (1) no indictment (as defined in the Companies Law) was filed against such office holder as a result of such investigation or proceeding; and (2) no financial liability in lieu of a criminal

 

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proceeding (as defined in the Companies Law) was imposed upon him or her as a result of such investigation or proceeding or if such financial liability was imposed, it was imposed with respect to an offence that does not require proof of criminal intent;

 

(iii)          reasonable litigation costs, including attorney’s fees, expended by an Office Holder or which were imposed on an Office Holder by a court in proceedings filed against the Office Holder by the Company or in its name or by any other person or in a criminal charge in respect of which the Office Holder was acquitted or in a criminal charge in respect of which the Office Holder was convicted for an offence which did not require proof of criminal intent; and

 

(iv)          any other event, occurrence, matter or circumstance under any law with respect to which the Company may, or will be able to, indemnify an Office Holder, and to the extent such law requires the inclusion of a provision permitting such indemnity in these Articles, then such provision is deemed to be included and incorporated herein by reference (including, without limitation, in accordance with Section 56h(b)(1) of the Securities Law, if and to the extent applicable, and Section 50P(b)(1) of the RTP Law).

 

(b)           Subject to the provisions of the Companies Law, the Company may undertake to indemnify an Office Holder, in advance, with respect to those liabilities and expenses described in the following Articles:

 

(i)            Sub-Article 60(a)(ii) to 60(a)(iv); and

 

(ii)           Sub-Article 60(a)(i), provided that:

 

(1)           the undertaking to indemnify is limited to such events which the Board of Directors shall deem to be likely to occur in light of the operations of the Company at the time that the undertaking to indemnify is made and for such amounts or criterion which the Directors may, at the time of the giving of such undertaking to indemnify, deem to be reasonable under the circumstances; and

 

(2)           the undertaking to indemnify shall set forth such events which the Directors shall deem to be likely to occur in light of the operations of the Company at the time that the undertaking to indemnify is made, and the amounts and/or criterion which the Directors may, at the time of the giving of such undertaking to indemnify, deem to be reasonable under the circumstances.

 

59.          EXEMPTION.

 

Subject to the provisions of the Companies Law and the Securities Law, the Company hereby exempts and releases, in advance, any Office Holder from any liability to the Company for damages arising out of a breach of the Office Holder’s duty of care towards the Company.

 

60.          GENERAL.

 

(a)           Any amendment to the Companies Law adversely affecting the right of any Office Holder to be indemnified or insured pursuant to Articles 57 to 59 and any amendments to Articles 57 to 59 shall be prospective in effect, and shall not affect the Company’s obligation or ability to indemnify or insure an Office Holder for any act or omission occurring prior to such amendment, unless otherwise provided by applicable law.

 

(b)           The provisions of Articles 57 to 59 (i) shall apply to the maximum extent permitted by law (including, the Companies Law, the Securities Law and the RTP Law); and (ii) are not intended, and shall not be interpreted so as to restrict the Company, in any manner, in respect of the procurement of insurance and/or in respect of indemnification (whether in advance or retroactively) and/or exemption, in favor of any person who is not an Office Holder,

 

20



 

including, without limitation, any employee, agent, consultant or contractor of the Company who is not an Office Holder; and/or any Office Holder to the extent that such insurance and/or indemnification is not specifically prohibited under law.

 

WINDING UP

 

61.          WINDING UP.

 

If the Company is wound up, then, subject to applicable law and to the rights of the holders of shares with special rights upon winding up, the assets of the Company available for distribution among the Shareholders shall be distributed to them in proportion to the nominal value of their respective holdings of the shares in respect of which such distribution is being made.

 

NOTICES

 

62.          NOTICES.

 

(a)           Any written notice or other document may be served by the Company upon any Shareholder either personally, by facsimile, email or other electronic transmission, or by sending it by prepaid mail (airmail if sent internationally) addressed to such Shareholder at his address as described in the Register of Shareholders or such other address as he may have designated in writing for the receipt of notices and other documents.

 

(b)           Any written notice or other document may be served by any Shareholder upon the Company by tendering the same in person to the Secretary or the Chief Executive Officer of the Company at the principal office of the Company, by facsimile transmission, or by sending it by prepaid registered mail (airmail if posted outside Israel) to the Company at its Office.

 

(c)           Any such notice or other document shall be deemed to have been served:

 

(i)            in the case of mailing, forty-eight (48) hours after it has been posted, or when actually received by the addressee if sooner than forty-eight hours after it has been posted;

 

(ii)           in the case of overnight air courier, on the next business day following the day sent, with receipt confirmed by the courier, or when actually received by the addressee if sooner than three business days after it has been sent;

 

(iii)          in the case of personal delivery, when actually tendered in person, to such addressee; or

 

(iv)          in the case of facsimile, email or other electronic transmission, on the first business day (during normal business hours in place of addressee) on which the sender receives automatic electronic confirmation by the addressee’s facsimile machine that such notice was received by the addressee or delivery confirmation from the addressee’s email or other communication server.

 

(d)           If a notice is, in fact, received by the addressee, it shall be deemed to have been duly served, when received, notwithstanding that it was defectively addressed or failed, in some other respect, to comply with the provisions of this Article 64.

 

(e)           All notices to be given to the Shareholders shall, with respect to any share to which persons are jointly entitled, be given to whichever of such persons is named first in the Register of Shareholders, and any notice so given shall be sufficient notice to the holders of such share.

 

(f)            Any Shareholder whose address is not described in the Register of Shareholders, and who shall not have designated in writing an address for the receipt of notices, shall not be entitled to receive any notice from the Company.

 

21



 

(g)           Notwithstanding anything to the contrary contained herein, notice by the Company of a General Meeting, containing the information required by applicable law and these Articles to be set forth therein, which is published, within the time otherwise required for giving notice of such meeting, in:

 

(i)            at least two daily newspapers in the State of Israel shall be deemed to be notice of such meeting duly given, for the purposes of these Articles, to any Shareholder whose address as registered in the Register of Shareholders (or as designated in writing for the receipt of notices and other documents) is located in the State of Israel; and

 

(ii)           one daily newspaper in the City of New York and in one international wire service shall be deemed to be notice of such meeting duly given, for the purposes of these Articles, to any Shareholder whose address as registered in the Register of Shareholders (or as designated in writing for the receipt of notices and other documents) is located outside the State of Israel.

 

(h)           The mailing or publication date and the date of the meeting shall be counted as part of the days comprising any notice period.

 

*        *        *

 

22



EX-5.1 4 a2234591zex-5_1.htm EX-5.1

Exhibit 5.1

 

March 14, 2018

 

To:

PolyPid Ltd.

18 Hasivim St.

Petach Tikva 4959376, Israel

 

Re: Registration Statement on Form F-1

 

Ladies and Gentlemen:

 

We have acted as Israeli counsel to PolyPid Ltd. (the “Company”), an Israeli company, in connection with the registration by the Company of ordinary shares, par value NIS 0.80 per share of the Company (the “Ordinary Shares”), including Ordinary Shares issuable upon exercise of the underwriters’ over-allotment option, in connection with an underwritten public offering of the Company (the “Offering”).

 

In connection with this opinion, we have examined the originals, or photocopies or copies, certified or otherwise identified to our satisfaction, of registration statement on Form F-1 (Registration Statement No. 333-222930) (the “Registration Statement”) filed by the Company with the SEC and as to which this opinion is filed as an exhibit, the exhibits to the Registration Statement including the form of Underwriting Agreement between the Company and Goldman Sachs & Co. LLC and Cowen and Company, LLC, as representatives of the underwriters listed therein, copies of the Company’s articles of association, resolutions of the Company’s Board of Directors (the “Board”) which have heretofore been approved and relate to the Offering, and such statutes, regulations, corporate records, documents, certificates and such other instruments that we have deemed relevant and necessary for the basis of our opinions hereinafter expressed. In such examination, we have assumed: (i) the authenticity of original documents and the genuineness of all signatures; (ii) the conformity to the originals of all documents submitted to us as copies; (iii) the truth, accuracy and completeness of the information, representations and warranties contained in the corporate records, documents, certificates and instruments we have reviewed; (iv) the due execution and delivery of all documents where due execution and delivery are a prerequisite to the effectiveness thereof; and (v) the legal capacity of all natural persons.

 

We are members of the Israel Bar and we express no opinion as to any matter relating to the laws of any jurisdiction other than the laws of the State of Israel and have not, for the purpose of giving this opinion, made any investigation of the laws of any other jurisdiction than the State of Israel.

 

Based upon and subject to the foregoing, we are of the opinion that (i) the Ordinary Shares have been duly authorized for issuance by all necessary corporate action by the Company; and (ii) upon payment to the Company of the consideration in such amount and form as shall be determined by the Board or an authorized committee thereof, the Ordinary Shares, when issued and sold in the Offering as described in the Registration Statement (including any additional Ordinary Shares pursuant to Rule 462(b) under the Securities Act), will be duly and validly issued, fully paid and non-assessable.

 

We hereby consent to the filing of this opinion as an exhibit to the Company’s Registration Statement and to the use of our name wherever it appears in the Registration Statement. In giving such consent, we do not believe that we are “experts” within the meaning of such term as used in the Securities Act of 1933, as amended, or the rules and regulations of the Securities and Exchange Commission issued thereunder with respect to any part of the Registration Statement, including this opinion as an exhibit or otherwise.

 

We further consent to the incorporation by reference of this letter and consent into any registration statement filed pursuant to Rule 462(b) under the Securities Act with respect to the Ordinary Shares.

 



 

 

Very truly yours,

 

 

 

/s/ Zysman, Aharoni, Gayer & Co.

 

Zysman, Aharoni, Gayer & Co.

 



EX-10.2 5 a2234591zex-10_2.htm EX-10.2

Exhibit 10.2

 

POLYPID LTD.

AMENDED AND RESTATED 2012 SHARE OPTION PLAN

 

1.         Definitions

 

As used herein capitalized terms shall have the meanings set forth in Annex A hereto, unless the context clearly indicates to the contrary.

 

2.         The Plan

 

2.1       Purpose

 

The purpose and intent of the Plan is to advance the interests of the Company by affording to selected employees, officers, directors, consultants and other services providers of the Company or Affiliated Companies an opportunity to acquire a proprietary interest in the Company or to increase their proprietary interest therein, as applicable, by the grant in their favor, of Options, thus providing such Grantee an additional incentive to become, and to remain, employed or engaged by the Company or Affiliated Company, as the case may be, and encouraging such Grantee’s sense of proprietorship and stimulating his or her active interest in the success of the Company and the Affiliated Company by which such Grantee is employed or engaged.

 

2.2       Effective Date and Term

 

The Plan shall become effective as of the day it was adopted by the Board, and shall continue in effect until the earlier of (a) its termination by the Board; or (b) the date on which all of the Options available for issuance under the Plan have been granted and exercised; or (c) the lapse of ten (10) years from the date the Plan is adopted by the Board.

 

3.         Administration

 

3.1                     This Plan and any Sub-Plans shall be administered by the Board. The Board may appoint a committee which, subject to any applicable limitations imposed by the Companies Law, and/or by any other applicable Law, shall have all of the powers of the Board granted herein (in which event of such limitations, such committee may make recommendations to the Board). Subject to the above, the term “Board” whenever used herein, shall mean the Board or such appointed committee, as applicable.

 

3.2                     Unless specifically required otherwise under applicable Mandatory Law, the Board shall have sole and full discretion and authority, without the need to submit its determinations or actions to the shareholders of the Company for their approval or authorization, to administer the Plan and any Sub-Plans and all actions related thereto, including without limitation the performance, at any time and from time to time, of any and all of the following:

 

3.2.1          the designation of Grantees;

 

3.2.2          the determination of the terms of each grant of Options (which need not be identical), including without limitation the number of Options to be granted in favor of each Grantee and the vesting schedule and the Exercise Price thereof and the documents to be executed by the Grantee;

 

3.2.3          the determination of the applicable tax regimes to which the Options will be subject;

 

3.2.4          the determination of the terms and form of the Option Agreements (which need not be identical), whether a general form or a specific form with respect to a certain Grantee;

 

3.2.5          the modification or amendment of the Exercise Period, vesting schedules (including by way of acceleration) and/or of the Exercise Price of Options, including without limitation the reduction thereof, either prior to or following their grant; the repricing of Options or any other action which is or may be treated as repricing under generally accepted accounting principles; the grant to the holder of an outstanding Option, in exchange for such Option, of a new Option having a purchase price equal to, lower than or higher than the Exercise

 



 

Price provided in the Option so surrendered and canceled, and containing such other terms and conditions as the Board may prescribe;

 

3.2.6          any other action and/or determination deemed by the Board to be required or advisable for the administration of the Plan and/or any Sub-Plan or Option Agreement;

 

3.2.7          the determination of the Fair Market Value of the Shares, and the mechanism of such determination;

 

3.2.8          the interpretation of the Plan, any Sub-Plans, and the Option Agreements;

 

3.2.9          the adoption of Sub-Plans, including without limitation the determination, if the Board sees fit to so determine, that to the extent any terms of such Sub-Plan are inconsistent with the terms of this Plan, the terms of such Sub-Plan shall prevail; and

 

3.2.10   the extension of the period of the Plan or any Sub-Plans.

 

3.3                     The Board may, without shareholder approval, amend, modify (including by adding new terms and rules), and/or cancel or terminate this Plan, any Sub-Plans, and any Options granted under this Plan or any Sub-Plans, any of their terms, and/or any rules, guidelines or policies relating thereto. Notwithstanding the foregoing (a) material amendments to the Plan or any Sub-Plans (but not the exercise of discretion under the Plan or any Sub-Plans) shall be subject to shareholder approval to the extent so required by applicable Mandatory Law; and (b) no termination or amendment of the Plan or any Sub-Plan shall affect any then outstanding Options nor the Board’s ability to exercise its powers with respect to such outstanding Options granted prior to the date of such termination, unless expressly provided by the Board.

 

3.4                     Unless otherwise determined by the Board, any amendment or modification of this Plan and/or any applicable Sub-Plan and/or Option Agreement shall apply to the relationship between the Grantee and the Company; and such amendment or modification shall be deemed to have been included, ab initio, in the Plan and any such applicable Sub-Plan and/or Option Agreement, and shall have full force and effect with respect to the relationship between the Company and the Grantee.

 

4.         Eligibility

 

The persons eligible for participation in the Plan as Grantees include employees, officers, directors, consultants, and other service providers of the Company or any Affiliated Company (including persons who are responsible for or contribute to the management, growth or profitability of, or who provide substantial services to, the Company or any Affiliated Company). The Board, in its sole discretion shall select from time to time the individuals, from among the persons eligible to participate in the Plan, who shall receive Options. In determining the persons in favor of whom Options are to be granted, the number of Options to be granted thereto and the terms of such grants, the Board may take into account the nature of the services rendered by such person, his/her present and future potential contribution to the Company or to the Affiliated Company by which he/she is employed or engaged, and such other factors as the Board in its discretion shall deem relevant.

 

5.         Option Pool

 

The total number of Options to be granted pursuant to this Plan shall be 23,905,701 (twenty three million nine hundred and five thousand seven hundred and one) and the Company has reserved sufficient Shares for the purpose of the Plan, subject to adjustment as set forth in Section 12 below (the “Share Reserve”), and as shall be amended by the Board from time to time. The Share Reserve will automatically increase on January 1 of each year, for a period of not more than ten years, commencing on January 1 of the year following the year in which the IPO Date occurs and ending on (and including) January 1, 2028, by an amount equal to 4% of the total number of Shares outstanding on December 31st of the preceding calendar year.  Notwithstanding the foregoing, the Board may act prior to January 1 of a given year to provide that there will be no January increase in the Share Reserve

 



 

for such year or that the increase in the Share Reserve for such year will be a lesser number of Shares than would otherwise occur pursuant to the preceding sentence.

 

The Company shall at all times until the expiration or termination of this Plan keep reserved a sufficient number of Shares to meet the requirements of this Plan. Any of such Shares, which, as of the expiration or termination of this Plan, remain unissued and not subject to outstanding Options, shall at such time cease to be reserved for the purposes of this Plan. Should any Option for any reason expire or be canceled prior to its exercise or relinquishment in full, such Option may be returned to said pool of Options and may again be granted under this Plan.

 

6.         Grant of Options

 

6.1                     The Options shall be granted for no consideration.

 

6.2                     Each Option granted pursuant to the Plan shall be evidenced by an Option Agreement.

 

6.3                     Each Grantee shall be required to execute, in addition to the Option Agreement, any and all other documents required by the Company or any Affiliated Company, whether before or after the grant of the Options (including without limitation any customary documents and undertakings towards a trustee, if any, and/or the tax authorities). Notwithstanding anything to the contrary in this Plan or in any Sub-Plan, no Option shall be deemed granted unless all documents required by the Company or any Affiliated Company to be signed by the Grantee prior to or upon the grant of such Option, shall have been duly signed and delivered to the Company or such Affiliated Company.

 

7.         Terms of Options

 

Option agreements between the Company and a Grantee will be in such form approved by the Board, which may be a general form or a specific form with respect to a certain Grantee.

 

Unless otherwise determined by the Board (which determination shall not require shareholder approval, unless so required in order to comply with the provisions of applicable Mandatory Law) and provided accordingly in the applicable Option Agreement, such Option Agreement shall set forth, by appropriate language, the number of Options granted thereunder and the substance of all of the following provisions:

 

7.1                     Exercise Price: The Exercise Price for each Grantee shall be as determined by the Board and specified in the applicable Option Agreement. Without derogating from and in addition to the provisions of Section 18 of the Plan, the Exercise Price shall be denominated in the currency of the primary economic environment of, at the Company’s discretion, either the Company or the Grantee (that is the functional currency of the Company or the currency in which the Grantee is paid).

 

7.2       Vesting: Unless otherwise determined by the Board with respect to any specific Grantee and/or to any specific grant (which determination shall not require shareholder approval unless so required in order to comply with the provisions of applicable Mandatory Law) and provided accordingly in the applicable Option Agreement, the Options shall vest (become exercisable) according to the following 3 year vesting schedule:

 

Period of Grantee’s Continuous Service from
the Start Date:

 

Portion of Total Number of Options
that becomes Vested and Exercisable

 

Upon the completion of a full twelve (12) months of continuous Service

 

33

%

Upon the lapse of each full additional three month(s) of the Grantee’s continuous Service thereafter, until all the Options are vested (i.e. 100% of the grant will be vested after 4 years)

 

8.375

%

 

For the purposes hereof, the “Start Date” shall mean the Date of Grant, unless otherwise determined by the Board (which determination shall not require shareholder approval unless so required in order

 



 

to comply with the provisions of the Companies Law), and provided accordingly in the applicable Option Agreement.

 

For the purposes hereof, the term “Service” means a Grantee’s employment or engagement by the Company or an Affiliated Company. Service shall be deemed terminated upon the effective date of the termination of the employment/engagement relationship. A Grantee’s Service shall not be deemed terminated or interrupted solely as a result of a change in the capacity in which the Grantee renders Service to the Company or an Affiliated Company (i.e., as an employee, officer, director, consultant, etc.); nor shall it be deemed terminated or interrupted due solely to a change in the identity of the specific entity (out of the Company and its Affiliated Companies) to which the Grantee renders such Service, provided that there is no actual interruption or termination of the continuous provision by the Grantee of such Service to any of the Company and its Affiliated Companies. Furthermore, a Grantee’s Service with the Company or Affiliated Company shall not be deemed terminated or interrupted as a result of any military leave, sick leave, or other bona fide leave of absence taken by the Grantee and approved by the Company or such Affiliated Company by which the Grantee is employed or engaged, as applicable; provided, however, that if any such leave exceeds ninety (90) days, then on the ninety-first (91st) day of such leave the Grantee’s Service shall be deemed to have terminated unless the Grantee’s right to return to Service with the Company or such Affiliated Company is secured by statute or contract. Notwithstanding the foregoing, unless otherwise designated by the Company or Affiliated Company, as the case may be, or required by law, time spent in a leave of absence shall not be treated as time spent providing Service for the purposes of calculating accrued vesting rights under the vesting schedule of the Options. Without derogating from the aforesaid, the Service of a Grantee to an Affiliated Company shall also be deemed terminated in the event that such Affiliated Company for which the Grantee performs Service ceases to fall within the definition of an “Affiliated Company” under this Plan, effective as of the date said Affiliated Company ceases to be such. In all other cases in which any doubt may arise regarding the termination of a Grantee’s Service or the effective date of such termination, or the implications of absence from Service on vesting, the Corporation, in its discretion, shall determine whether the Grantee’s Service has terminated and the effective date of such termination and the implications, if any, on vesting.

 

The Board shall be entitled, but not obliged, at its sole discretion, to accelerate, in whole or in part, the vesting schedule of any Option, including, without limitation, in connection with a Merger Transaction and/or an IPO.

 

7.3                     Expiration DateUnless expired earlier pursuant to either Section 7.4 or Section 9 below, unexercised Options shall expire and terminate and become null and void upon the lapse of ten (10) years from the Date of Grant (the “Expiration Date”).

 

7.4                     Exercise Period:

 

7.4.1           Each Option shall be exercisable from the date upon which it becomes vested until the Expiration Date of such Option (the “Exercise Period”).

 

7.4.2           Notwithstanding anything to the contrary contained in this Plan, in the event of a merger of the Company with or into another corporation, or the sale of all or substantially all the assets or the shares of the Company (such merger or sale: a “Merger Transaction”), the surviving or the acquiring entity, as the case may be, or its respective parent company or subsidiary (the “Successor Entity”) may either assume the Company’s rights and obligations under outstanding Options or substitute the outstanding Options, as follows:

 

(a)                      For purposes of this Section 7.4.2, the outstanding Options shall be deemed assumed or substituted by the Successor Entity if, following the consummation of the Merger Transaction, the outstanding Options confer the right to receive, for each share underlying any outstanding Option immediately prior to the consummation of the Merger Transaction, the same consideration (whether shares, cash or other securities or property) to which an existing holder of a Share on the effective date of consummation of the Merger Transaction was entitled; provided, however, that if the consideration to which such existing holder is entitled comprises

 



 

consideration other than or in addition to securities of the Successor Entity, then the Board may determine, with the consent of the Successor Entity, that the consideration to be received by the Grantees for their outstanding Options will comprise solely securities of the Successor Entity equal in their market value to the per share consideration received by the holders of Shares in the Merger Transaction.

 

(b)                      In the event that the Successor Entity neither assumes nor substitutes all of the outstanding Options of a Grantee, then such Grantee shall have a period of 15 days (or if so decided by the Board, such longer period as the Board may determine in its sole discretion) from the date designated by the Company in a written notice given to the Grantee (such date to be no earlier than the date upon which said notice is delivered to the Grantee) to exercise his or her Vested Options.

 

(c)                       All Options, whether vested or not, which are neither assumed or substituted by the Successor Entity, nor exercised by the end of the said 15-day period, shall expire effective as of the date of the consummation of the Merger Transaction, whereupon they shall become null and void and shall no longer entitle the Grantee to any right in or towards the Company or the Successor Entity.

 

7.5       Exercise Notice and Payment:

 

Vested Options may be exercised at one time or from time to time during the Exercise Period, by giving a written notice of exercise (the “Exercise Notice”) to the Company, at their principal offices, in accordance with the following terms, or such other procedures as shall be determined from time to time by the Board and notified in writing to the Grantees:

 

(a)                      The Exercise Notice must be signed by the Grantee and must be delivered to the Company, prior to the termination of the Options, by certified or registered mail - return receipt requested, with a copy delivered to the Chief Financial Officer (or such other authorized representative) of the Affiliated Company with which the Grantee is employed or engaged, if applicable.

 

(b)                      The Exercise Notice will specify the number of Vested Options being exercised.

 

(c)                       The Exercise Notice will be accompanied by payment in full of the Exercise Price for the exercised Options and by such other representations and agreements as required by the Company with respect to the Grantee’s investment intent regarding the Exercised Shares. Payment will be made by personal check or cashier’s check payable to the order of the Company, or at the discretion of the Board, payment of such other lawful consideration as the Board may determine (such as, by way of example, cashless exercise), provided however, that in case of payment by check, the Options shall not be deemed exercised, and the Company shall not issue the Exercised Shares in respect thereof, until the check shall have been fully and irrevocably honored by the bank on which it was drawn.

 

7.6       Conditions of Issuance

 

No Options shall be deemed exercised nor shall any Share be issued thereunder, until the Company has been provided with confirmation by the applicable tax authorities or is otherwise under a tax arrangement, which either: (a)waives or defers the tax withholding obligation with respect to such exercise and issuance; or (b) confirms receipt of the payment of all the tax due with respect to such exercise; or (c) confirms the conclusion of another arrangement with the Grantee regarding the tax amounts, if any, that are to be withheld by the Company or any Affiliated Company under Law with respect to such exercise, and which arrangement is satisfactory to the Company. If such confirmations/exemptions/arrangements are not available under the tax subjections of the Grantee, the Company shall be entitled to require as a condition of issuance that the Grantee remit an amount sufficient to satisfy all federal, state and other governmental withholding tax requirements related thereto. A determination of the Company’s counsel that a withholding tax is required in connection with the exercise of Options shall be conclusive for the purposes of this requirement condition.

 



 

Furthermore, notwithstanding any other provision of this Plan, the Company shall have no obligation to issue or deliver Shares under the Plan unless the exercise of the Option and the issuance and delivery of the underlying Shares comply with, and do not result in a breach of, all applicable Laws, to the satisfaction of the Company in its sole discretion, and have received, if deemed desirable by the Company, the approval of legal counsel for the Company with respect to such compliance. The Company may further require the Grantee to satisfy any qualifications that may be necessary or appropriate, to evidence compliance with applicable Laws.

 

As a condition to the exercise of an Option, the Company may require, among other things, that: (a) the Grantee represent and warrant at the time of any exercise that the underlying Shares are being purchased only for investment and without any present intention to sell or distribute such Shares, and make such other representations, warranties and covenants as may be reasonably required to comply with applicable laws; (b) a legend be stamped on the certificates representing such underlying Shares (or otherwise applied to any Shares issued in book entry form) indicating that they may not be pledged, sold or otherwise transferred unless an opinion of legal counsel (acceptable by the Company’s counsel) stating that such transfer is not in violation of any applicable Law, is provided; and (c) the Grantee execute and deliver to the Company such an agreement as may be in use by the Company setting forth certain terms and conditions applicable to the Shares.

 

8.         Transferability

 

8.1       The Options are not publicly traded.

 

8.2                     Other than by will or laws of descent, neither the Options nor any of the rights in connection therewith shall be assignable, transferable, made subject to attachment, lien or encumbrance of any kind, and the Grantee shall not grant with respect thereto any power of attorney or transfer deed, whether valid immediately or in the future.

 

8.3                     Following the exercise of Vested Options, the Exercised Shares shall be transferable; provided, however, that Exercised Shares may be subject to applicable securities regulations, a right of first refusal, one or more repurchase options, market stand-off provisions, lock up periods and such other conditions and restrictions as may be included in the Company’s Articles, the Plan, any applicable Sub-Plan, the applicable Option Agreement, and/or any conditions and restrictions included in the Company’s Securities Law Compliance Manual/Insider Trade Policy, or similar document, if any, all as determined by the Board in its discretion, provided however, that if the Options are subject to a right of first refusal or a repurchase option, then for as long as the Company is not publicly traded, a Grantee shall not transfer any Exercised Shares, prior to the lapse of six (6) months and one day from the date on which s/he exercised the Options. The Company shall have the right to assign at any time any repurchase or right of first refusal right it may have, whether or not such right is then exercisable, to one or more persons as may be selected by the Company. Upon request by the Company, the Grantee shall execute any agreement or document evidencing such transfer restrictions prior to the receipt of Exercised Shares hereunder, and shall promptly present to the Company any and all certificates representing Exercised Shares for the placement on such certificates of appropriate legends evidencing any such transfer restrictions.

 

The Grantee may transfer or sell only Exercised Shares, or any part thereof, to any third party, provided that all of the following conditions have been met prior to such transfer: (a) the transfer is made in accordance with and subject to the provisions of the Company’s Articles (including, without limitation, any rights of first refusal provided therein, if any); and (b) the transferee confirmed in writing its acceptance of the terms and conditions of the Plan, any applicable Sub-Plan and the applicable Option Agreement with respect to the Exercised Shares being transferred, instead of the Grantee, to the satisfaction of the Board (including the execution of the proxy referred to in Section 10.2 below); and (c) actual payment of all taxes required to be paid upon such sale and transfer of the Exercised Shares has been made to the tax assessor, and the trustee (if applicable) received confirmation from the tax assessor that all taxes required to be paid upon such sale and transfer have been paid.

 



 

Any transfer that is not made in accordance with the Plan, any applicable Sub-Plan or the applicable Option Agreement shall be null and void.

 

8.4                     No transfer of an Exercised Share or Option by the Grantee by will or by the laws of descent shall be effective against the Company, unless and until: (a) the Company shall have been furnished with written notice thereof, accompanied by an authenticated copy of probate of a will together with the will or inheritance order and/or such other evidence as the Board may deem necessary to establish the validity of the transfer; and (b) the contemplated transferee(s) shall have confirmed to the Company in writing its acceptance of the terms and conditions of the Plan, any applicable Sub-Plan and Option Agreement, with respect to the Exercised Share or Options being transferred, to the satisfaction of the Board.

 

8.5                     In the event that prior to an IPO, holders holding in the aggregate no less than a controlling interest in the Company (“Selling Shareholders”) elect to sell all or substantially all of their shares in the Company either to a third party or to one shareholder of the Company, then, if so requested by the purchaser, the Grantee shall be obligated to join the sale and sell all of his/her Shares in the Company (and if requested, also his/her unexpired Vested Options), all under the same terms under which the Selling Shareholders have agreed to sell their shares (provided that with respect to Vested Options, the Exercise Price shall be deducted from the purchase price paid for the shares in such transaction) and in accordance with the provisions of the Articles of the Company.

 

9.         Termination of Options and Repurchase of Exercised Shares

 

9.1                     Notwithstanding anything to the contrary, any Option granted in favor of any Grantee but not exercised by such Grantee within the Exercise Period and in strict accordance with the terms of the Plan, any applicable Sub-Plan and the applicable Option Agreement, shall, upon the lapse of the Exercise Period, immediately expire and terminate and become null and void.

 

9.2                     Upon the termination of a Grantee’s Service, for any reason whatsoever, any Options granted in favor of such Grantee, which are not Vested Options, shall immediately expire and terminate and become null and void.

 

9.3                     Additionally, in the event of the termination of a Grantee’s Service for Cause (a) all of such Grantee’s Vested Options shall also, upon such termination for Cause, immediately expire and terminate and become null and void; and (b) any and all of such Grantee’s Exercise Shares shall be subject to the Company’s “Repurchase Right”, as described below.

 

For the purposes hereof the term “Cause” shall mean (a) the conviction of the Grantee for any felony involving moral turpitude or affecting the Company or any Affiliated Company; (b) the embezzlement of funds of the Company or any Affiliated Company; (c) any breach of the Grantee’s fiduciary duties or duties of care towards the Company or any Affiliated Company (including without limitation any disclosure of confidential information of the Company or any Affiliated Company or any breach of a non-competition undertaking); (d) any conduct in bad faith reasonably determined by the Board to be materially detrimental to the Company or, with respect to any Affiliated Company, reasonably determined by the Board of Directors of such Affiliated Company to be materially detrimental to either the Company or such Affiliated Company; or (e) any other event classified under any applicable agreement between the Grantee and the Company or the Affiliated Company, as applicable, as a “cause” for termination or by other language of similar substance.

 

The Company’s “Repurchase Right” shall be as follows: If any Grantee’s Service is terminated by the Company for Cause, then, within 180 days after such termination, the Company shall have the right, but not the obligation, to repurchase from the Grantee, or his or her legal representative, as the case may be, all or part of the Shares s/he exercised pursuant to the Options, if any. The Repurchase Right shall be exercised by the Company by giving the Grantee, or his/her legal representative written notice, within said 180 days, of its intention to exercise the Repurchase Right, indicating the number of such Exercised Shares to be repurchased and the date on which the repurchase is to be effected, and

 



 

shall pay the Grantee for each such Exercised Share being repurchased, an amount equal to the price originally paid by the Grantee for such Exercised Shares, subject to adjustments as provided in Section 12 below. Any certificate(s) representing such Exercised Shares to be repurchased shall, prior to the close of business on the date specified for the repurchase, be delivered to the Company together with a duly endorsed stock assignment certificate. Payment shall be made in cash, cash equivalents, or in any other way of payment allowed under any applicable Law, and authorized by the Board. Concurrently with the exercise of the Repurchase Right, if exercised, the Grantee (or the holder of the Exercised Shares so repurchased) shall no longer have any rights as a holder of such repurchased Exercised Shares. Such repurchased Exercised Shares shall be deemed to have been repurchased, whether or not the certificate(s) therefor, if any, have been delivered. If the Grantee fails to deliver any such stock certificate(s) or if such repurchased Exercised Shares were issued in book entry form, the Company shall be entitled to take such action as may be necessary to remove the requisite number of Shares registered in the name of the Grantee from the books and records of the Company. The Repurchase Right shall be in addition to any and all other rights and remedies available to the Company.

 

In the event that the Company shall be prohibited, on account of any applicable Mandatory Law, from repurchasing Exercised Shares, the Company may assign the Repurchase Right to its wholly owned subsidiary, or if the same is not possible on account of any applicable Law, to all of the stockholders of the Company at the time of the exercise of said right (excluding other shareholders pursuant to the exercise of Options), on a pro-rata, as converted basis, all under the same terms and conditions set forth in this Plan, in which event the Company portion shall inform the Grantee of the identity of the particular assignee in the Company’s Notice, and the provisions of this Section regarding the Company shall apply to such assignee(s), mutatis mutandis.

 

In the event that at the time the Company wishes to exercise its Repurchase Right, the Grantee does not own a sufficient number of Exercised Shares to satisfy the Company’s Repurchase Right, in addition to performing any obligations necessary to satisfy the Company’s Repurchase Right, the Company may require the Grantee to deliver to the Company, for each Exercised Share that is the subject of the Repurchase Right and is not available for repurchase as it has been sold or transferred, an aggregate cash amount, equal to the difference between the fair market value of each such missing Share and the price originally paid by the Grantee to the Company for each such Exercised Share, as adjusted.

 

9.4                     Unless otherwise determined by the Board (which determination shall not require shareholder approval, unless so required in order to comply with the provisions of applicable Mandatory Law), following termination of Grantee’s Service other than for Cause, the Expiration Date of such Grantee’s Vested Options shall be deemed the earlier of: (a) the Expiration Date of such Vested Options as was in effect immediately prior to such termination; or (b) 3 (three) calendar months following the date of such termination or, if such termination is the result of death or disability of the Grantee, 12 (twelve) calendar months from the date of such termination.

 

9.5                     Notwithstanding anything to the contrary herein, upon the issuance of a court order declaring the bankruptcy of a Grantee, or the appointment of a receiver or a provisional receiver for a Grantee over all of his assets, or any material part thereof, or upon making a general assignment for the benefit of his creditors, any outstanding Options issued in favor of such Grantee (whether vested or not) shall immediately expire and terminate and become null and void and shall entitle neither the Grantee nor the Grantee’s receiver, successors, creditors or assignees to any right in or towards the Company or any Affiliated Company in connection with the same, and all interests and rights of the Grantee or the Grantee’s receiver, successors, creditors or assignees in and to the same, shall expire.

 

10.                     Rights as Shareholder, Voting Rights, Dividends and Bonus Shares

 

10.1              It is hereby clarified that a Grantee shall not, by virtue of this Plan, any applicable Sub-Plan or the applicable Option Agreement or any Option granted to the Grantee, have any of the rights of a shareholder with respect to the Shares underlying the Options, until the Options have been exercised and the Exercised Shares issued in the Grantee’s name.

 



 

10.2              Prior to the closing of an IPO, the Board shall be entitled to require, as a condition to the exercise of any Option, that the Grantee (and the trustee, if there is a trustee who is the holder of the Exercised Shares) sign and deliver to such person as may be designated by the Board (the “Nominee”) an irrevocable proxy, in a form to be provided by the Company, appointing the Nominee as the sole person entitled to exercise the voting rights conferred by such shares. The Nominee shall not exercise the voting rights conferred by the Exercised Shares held by him or with respect to which the Nominee has been given an irrevocable proxy as aforesaid, in any way whatsoever, and shall not issue a proxy to any person or entity to vote such shares, unless otherwise instructed by the Board, and in accordance with such instructions. Unless instructed otherwise by the Board, the Nominee shall vote such Exercised Shares in a manner pro-rata to the votes of the other voting shares, such that the votes of the Exercised Shares shall not affect the end result of the vote. The Nominee shall be indemnified and held harmless by the Company, to the extent permitted by applicable law, against any cost or expense (including counsel fees) reasonably incurred by him/it, or any liability (including any sum paid in settlement of a claim with the approval of the Company) arising out of any act or omission to act in connection with the voting of the aforesaid proxy unless arising out of such Nominee’s own fraud or bad faith. Such indemnification shall be in addition to any rights of indemnification the Nominee(s) may have as a director or otherwise under the Company’s Articles, any agreement, any vote of shareholders or disinterested directors, insurance policy or otherwise.

 

10.3              Notwithstanding anything to the contrary herein or in the Company’s Articles, none of the Grantees shall have (and they hereby waive the right to have), any pre-emptive rights to purchase, along with the other shareholders in the Company, a pro rata portion of any securities proposed to be offered by the Company prior to the offering thereof to any third party or any rights of first refusal to purchase any securities of the Company offered by the other shareholders of the Company.

 

10.4              Cash dividends paid or distributed, if any, with respect to the Exercised Shares shall be remitted directly to the Grantee who is entitled to the Exercised Shares for which the dividends are being paid or distributed, subject to any applicable taxation on such distribution of dividend, and the withholding thereof.

 

10.5              All bonus shares to be issued by the Company, if any, with regard to the Exercised Shares held by a trustee, if any, shall be registered in the name of such trustee and all provisions applying to such Exercised Shares, shall apply to the bonus shares issued by virtue thereof, mutatis mutandis.

 

11.       Liquidation

 

In the event that the Company is liquidated or dissolved while unexercised Options remain outstanding under the Plan, then all or part of such outstanding Options may be exercised in full by the Grantees as of immediately prior to the effective date of such liquidation or dissolution of the Company, without regard to the vesting terms thereof.

 

12.       Adjustments

 

The number of Shares to which each outstanding Option is exercisable, together with those Shares otherwise reserved for the purposes of the Plan for Options not yet exercised as provided under Section 5 above, shall be proportionately adjusted for any increase or decrease in the number of Shares resulting from a stock split, reverse stock split, combination or reclassification of the Shares, as well as for any distribution of bonus shares. Such adjustment shall be made by the Board, whose determination in that respect shall be final, binding and conclusive.

 

All provisions applying to the Exercised Shares shall apply to all Shares received as a result of an adjustment as described above.

 

No adjustment shall be made by virtue of the distribution, if any, of any cash or similar dividend.

 



 

13.       No Interference

 

Neither the Plan nor any applicable Sub-Plan or Option Agreement shall affect, in any way, the rights or powers of the Company or its shareholders to make or to authorize any sale, transfer or change whatsoever in all or any part of the Company’s assets, obligations or business, or any other business, commercial or corporate act or proceeding, whether of a similar character or otherwise; any adjustments, recapitalizations, reorganizations or other changes in the Company’s capital structure or business; any merger or consolidation of the Company; any issue of bonds, debentures, shares (including preferred or prior preference shares ahead of or affecting the existing shares of the Company including the shares into which the Options granted hereunder are exercisable or the Exercised Shares or the rights thereof, etc.); or the dissolution or liquidation of the Company; and none of the above acts or authorizations shall entitle the Grantee to any right or remedy, including without limitation, any right of compensation for any dilution resulting from any issuance of any shares or of any other securities in the Company to any person or entity whatsoever.

 

14.       No Employment/Engagement/Continuance of Service Obligations

 

Nothing in the Plan, in any applicable Sub-Plan or Option Agreements, or in any Option granted hereunder shall be construed as guaranteeing the Grantee’s continuous employment, engagement or service with the Company or any Affiliated Company, and no obligation of the Company or any Affiliated Company as to the length of the Grantee’s employment, engagement or service shall be implied by the same. The Company and its Affiliated Companies reserve the right to terminate the employment, engagement or service of any Grantee pursuant to such Grantee’s terms of employment, engagement or service and any law.

 

15.       No Representation

 

The Company does not and shall not, through this Plan, any applicable Sub-Plan or the applicable Option Agreement, make any representation towards any Grantee with respect to the Company, its business, its value or either its shares in general or the Exercised Shares in particular.

 

Each Grantee, upon entering into the applicable Option Agreement, shall represent and warrant toward the Company that his/her consent to the grant of the Options issued in his/her favor and the exercise (if so exercised) thereof, neither is nor shall be made, in any respect, upon the basis of any representation or warranty made by the Company or by any of its directors, officers, shareholders or employees, and is and shall be made based only upon his/her examination and expectations of the Company, on an “as is” basis. Each Grantee shall waive any claim whatsoever of “non-conformity” of any kind, and any other cause of action or claim of any kind with respect to the Options and/or their underlying Shares.

 

16.       Tax Consequences

 

16.1              Any and all tax and/or other mandatory payment consequences arising from the grant or exercise of any Option, the payment for or the transfer of the Exercised Shares to the Grantee, or the sale of the Exercised Shares by the Grantee, or from any other event or act in connection therewith (including without limitation, in the event that the Options do not qualify under the tax classification/tax track in which they were intended) (whether of the Company, any Affiliated Company, a trustee, if applicable, or the Grantee), shall be borne solely by the Grantee.

 

16.2              The Company, any Affiliated Company and a trustee, if applicable, may each withhold (including at source), deduct and/or set-off, from any payment made to the Grantee, the amount of the tax and/or other mandatory payment the withholding of which is required with respect to the Options and/or the Exercised Shares under any applicable Law. The Company or an Affiliated Company may require the Grantee, through payroll withholding, cash payment or otherwise, to make adequate provision for any such tax withholding obligations of the Company, Affiliated Company or a trustee, if applicable, arising in connection with the Options or the Exercised Shares. Without derogating from the aforesaid, each Grantee shall provide the Company and/or any applicable Affiliated Company with any executed documents, certificates and/or forms that may be required from time to time by the Company or such Affiliated Company in order to determine and/or establish the tax liability of such Grantee.

 



 

16.3              Furthermore, each Grantee shall indemnify the Company, any applicable Affiliated Company and a trustee, if applicable, or any one thereof, and hold them harmless from and against any and all liability in relation with any such tax and/or other mandatory payments or interest or penalty thereon, including without limitation, liabilities relating to the necessity to withhold, or to have withheld, any such tax and/or other mandatory payments from any payment made to the Grantee.

 

17.       Non-Exclusivity of the Plan

 

The adoption by the Board of this Plan and any Sub-Plans shall not be construed as amending, modifying or rescinding any previously approved incentive arrangements, or as creating any limitations on the power of the Board to adopt such other incentive arrangements as it may deem desirable, including without limitation the grant of options for shares in the Company otherwise than under the Plan, and such arrangements may be either applicable generally or only in specific cases.

 

18.       Currency Exchange Rates

 

Except as otherwise determined by the Board, all monetary values with respect to Options granted pursuant to this Plan, including without limitation the fair market value and the Exercise Price of each Option, shall be stated in United States Dollars. In the event that the Exercise Price is in fact to be paid in New Israeli Shekels, the conversion rate shall be the last known representative rate of the US Dollar to the New Israeli Shekels on the date of payment.

 


 

ANNEX A

 

Capitalized Terms used in the 2012 Share Option Plan, shall have the meanings set forth below:

 

1.1                               Affiliated Company” — means any present or future entity (a) which holds a controlling interest in the Company; (b) in which the Company holds a controlling interest; (c) in which a controlling interest is held by another entity, who also holds a controlling interest in the Company; or (d) which has been designated an “Affiliated Company” by resolution of the Board.

 

1.2                               Board” — means the Board of Directors of the Company.

 

1.3                               Cause” — as defined in Section 9.3 of the Plan.

 

1.4                               Company” — PolyPid Ltd.

 

1.5                               Companies Law” — the State of Israel’s Companies Law, 5759 — 1999, as amended from time to time, and the rules and regulations promulgated thereunder.

 

1.6                               Date of Grant” — the date determined by the Board to be the effective date of the grant of Options to a Grantee, or, if the Board has not determined such effective date, the date of the resolution of the Board approving the grant of such Options.

 

1.7                               Exercise Notice” - as defined in Section 7.5 of the Plan.

 

1.8                               Exercise Period” - as defined in Section 7.4 of the Plan.

 

1.9                               Exercise Price” - the price to be paid for the exercise of each Option.

 

1.10                        Exercised Shares” - the Shares that are issued upon the exercise of the Options.

 

1.11                        Expiration Date” - as defined in Section 7.3 of the Plan.

 

1.12                        Fair Market Value” means as of any date, the value of a Share determined as follows:

 

(i)                                     If the Shares are listed on any established stock exchange in Israel or the United States, including without limitation the Tel -Aviv Stock Exchange and the Nasdaq Stock Market, the Fair Market Value shall be the last reported sale price for such Shares (or the highest closing bid, if no sales were reported), as quoted on such exchange for the last market trading day prior to time of determination, as reported in The Wall Street Journal, or such other source as the Board deems reliable;;

 

(ii)                                 If the Shares are regularly quoted by one or more recognized securities dealers, but selling prices are not reported, the Fair Market Value shall be the mean between the highest bid and lowest asked prices for the Shares on the last market trading day prior to the day of determination; or

 

(iii)                              In the absence of an established market for the Shares, the Fair Market Value thereof shall be determined in good faith by the Board.

 

1.13                        Grantee” — a person or entity to whom Options are granted.

 

1.14                        IPO” — an initial public offering of securities of the Company in the United States in conjunction with the listing of such securities on any established stock exchange in Israel or the United States, including without limitation the Tel -Aviv Stock Exchange and the Nasdaq Stock Market.  The “IPO

 



 

Date” means the date of the underwriting agreement between the Company and the underwriter(s) managing the IPO, pursuant to which the securities are priced for the IPO.

 

1.15                        Law” — federal, state and/or foreign, laws, rules and/or regulations and/or rules, regulations, guidelines and/or requirements of any relevant securities and exchange and/or tax commission and/or authority and/or any relevant stock exchange or quotations systems.

 

1.16                        Mandatory Law” — provisions of Law, which may not be contrarily addressed or regulated by the determination and/or consent of the Company and/or other parties.

 

1.17                        Merger Transaction” - as defined in Section 7.4 of the Plan.

 

1.18                        Option(s)” - an option(s) granted within the framework of this Plan, each of which imparts the right to purchase one Share.

 

1.19                        Option Agreement” — with respect to any Grantee — a written option agreement or a written instrument, executed by and between the Company and the Grantee, which shall set forth the terms and conditions with respect to the Options.

 

1.20                        Plan” - this Company’s 2012 Israeli Share Option Plan, as may be amended from time to time as set forth herein.

 

1.21                        “Service” — as defined in Section 7.2 of the Plan.

 

1.22                        Share(s)” — Ordinary Share(s) of the Company, par value of NIS 0.10 each, to which, subject to the provisions herein, are attached the rights specified in the Company’s Articles, as may be amended from time to time.

 

1.23                        “Start Date” — as defined in Section 7.2 of the Plan.

 

1.24                        Sub-Plan” - any supplements or sub-plans to the Plan adopted by the Board, applicable to Grantees employed in a certain country or region or subject to the laws of a certain country or region, as deemed by the Board to be necessary or desirable to comply with the laws of such region or country, or to accommodate the tax policy or custom thereof, which, if and to the extent applicable to any particular Grantee, shall constitute an integral part of the Plan.

 

1.25                        Vested Option(s)” — that portion of the Options which the Grantee is entitled to exercise in accordance with the provisions of Section 7.2 of the Plan or, if inconsistent with the provisions of Section 7.2 of the Plan - the provisions of the Option Agreement of such Grantee.

 



 

POLYPID LTD. - 2012 SHARE OPTION PLAN

Sub-Plan for Grantees Subject to Israeli Taxation

 

This Sub-Plan (“Sub-Plan”) to the 2012 PolyPid Ltd. Share Option Plan (the “Plan”) is hereby established effective          , 2012.

 

1.                                      Definitions

 

As used herein, the following terms shall have the meanings hereinafter set forth, unless the context clearly indicates to the contrary. Any capitalized term used herein which is not specifically defined in this Sub-Plan shall have the meaning set forth in the Plan.

 

1.1                               Affiliated Company,” for purposes of eligibility under the Sub-Plan shall have the meaning of the term in the Plan, provided however that any affiliated entity shall be an “employing company” within the meaning of such term in Section 102 of the Ordinance.

 

1.2                               Controlling Shareholder” - shall have the meaning ascribed to it in Section 32(9) of the Ordinance.

 

1.3                               Election” — the election by the Company, with respect to grant of 102 Trustee Options, of either one of the following tax tracks — “Capital Gains Tax Track” or “Ordinary Income Tax Track”, as provided in and in accordance with the Section 102.

 

1.4                               Employee” - a person who is employed by the Company or its Affiliated Company, including an individual who is serving as a director or an office holder, but excluding any Controlling Shareholder, all as determined in Section 102 of the Ordinance.

 

1.5                               Fair Market Value” - solely for the purposes of 102 Trustee Options, if and to the extent Section 102 prescribes a specific mechanism for determining the Fair Market Value of the Exercised Shares, then notwithstanding the definition in the Plan, the Fair Market Value of 102 Trustee Options shall be as prescribed in Section 102, if applicable.

 

Without derogating from the definition of “Fair Market Value” enclosed in the Plan and solely for the purpose of determining the tax liability pursuant to Section 102(b)(3) of the Ordinance, if at the date of grant the Company’s shares are listed on any established stock exchange or a national market system or if the Company’s shares will be registered for trading within ninety (90) days following the date of grant of the Capital Gains Tax Track options, the fair market value of the Shares at the date of grant shall be determined in accordance with the average value of the Company’s shares on the thirty (30) trading days preceding the date of grant or on the thirty (30) trading days following the date of registration for trading, as the case may be.

 

1.6                               ITA” - the Israeli Tax Authorities.

 

1.7                               102 Non-Trustee Option” — an Option granted not through a Trustee in accordance with and pursuant to Section 102.

 

1.8                               3(i) Option” — an Option granted pursuant to Section 3(i) of the Ordinance.

 

1.9                               Ordinance” - the Israeli Income Tax Ordinance [New Version], 1961, and the rules and regulations promulgated thereunder, as are in effect from time to time, and any similar successor rules and regulations.

 

1.10                        Restricted Period” — as defined in Section 4.3 herein below.

 

1.11                        Section 102” — Section 102 of the Ordinance and the rules and regulations promulgated thereunder, as are in effect from time to time, and any similar successor rules and regulations.

 



 

1.12                        Trustee” - the trustee designated or replaced by the Company and/or applicable Affiliated Company for the purposes of the Plan and approved by the Israeli Tax Authorities all in accordance with the provisions of Section 102.

 

1.13                        102 Trustee Option” — an Option granted through a Trustee in accordance with and pursuant to Section 102.

 

2.                                      General

 

2.1                               The purpose of this Sub-Plan is to establish certain rules and limitations applicable to Options granted to Grantees, the grant of Options to whom (or the exercise thereof by whom) are subject to taxation by the Israeli Income Tax (“Israeli Grantees”), in order that such Options may comply with the requirements of Israeli law, including, if applicable, Section 102.

 

2.2                               The Plan and this Sub-Plan are complementary to each other and shall be read and deemed as one. In the event of any contradiction, whether explicit or implied, between the provisions of this Sub-Plan and the Plan, the provisions of this Sub-Plan shall prevail with respect to Options granted to Israeli Grantees.

 

2.3                               Options may be granted under this Sub-Plan in one of the following tax tracks, at the Company’s discretion and subject to applicable restrictions or limitations as provided in applicable law including without limitation any applicable restrictions and limitations in Section 102 regarding the eligibility of Israeli Grantees to each of the following tax tracks, based on their capacity and relationship towards the Company:

 

(i)                                     102 Trustee Options - in such tax track as determined in accordance with the Election; or

(ii)                                  102 Non-Trustee Options; or

(iii)                               3(i) Options.

 

For avoidance of doubt, the designation Options to any of the above tax tracks shall be subject to the terms and conditions set forth in Section 102.

 

2.3(a)                The Company’s Election of the type of 102 Trustee Options as Capital Gain Tax Track or Ordinary Income Tax Track granted to Employees, shall be appropriately filed with the ITA before the Date of Grant of an 102 Trustee Option. Such Election shall become effective beginning the first Date of Grant of a 102 Trustee Option under this Plan and shall remain in effect until the end of the year following the year during which the Company first granted 102 Trustee Options. The Election shall obligate the Company to grant only the type of 102 Trustee Option it has elected, and shall apply to all Israeli Grantees who were granted 102 Trustee Options during the period indicated herein, all in accordance with the provisions of Section 102(g) of the Ordinance. For the avoidance of doubt, such Election shall not prevent the Company from granting 102 Non-Trustee Options simultaneously.

 

3.                                      Administration

 

Without derogating from the powers and authorities of the Board detailed in the Plan, the Board shall have the sole and full discretion and authority, without the need to submit its determinations or actions to the shareholders of the Company for their approval or authorization, unless such approval is required to comply with applicable Mandatory Law, to administer this Sub-Plan and to take all actions related hereto and to such administration, including without limitation the performance, from time to time and at any time, of any and all of the following:

 

(a)                                 the determination of the specific tax track (as described in Section 2.3 and 2.3(a) above) in which the Options are to be issued.

 

(b)                                 the Election;

 

(c)                                  the appointment of the Trustee;

 

(d)                                 the adoption of forms of Option Agreements to be applied with respect to Israeli Grantees (the “Israeli Option Agreement”), incorporating and reflecting, inter alia, relevant provisions

 



 

regarding the grant of Options in accordance with this Sub-Plan, and the amendment or modification from time to time of the terms of such Israeli Option Agreements.

 

4.                                      102 Trustee Options

 

4.1                               Grant in the Name of Trustee:

 

Notwithstanding anything to the contrary in the Plan, 102 Trustee Options granted hereunder shall be granted to, and the Exercised Shares issued pursuant thereto and all rights attached thereto (including bonus shares), issued to, the Trustee, and all shall be registered in the name of the Trustee, who shall hold them in trust until such time as they are released by the transfer or sale thereof by the Trustee. In the case the requirements of Section 102 for 102 Trustee Options are not met, than the 102 Trustee Options may be regarded as 102 Non-Trustee Option, all in accordance with the provisions of Section 102. Notwithstanding anything to the contrary in the Plan, the Date of Grant of a 102 Trustee Option shall be the date determined by the Board to be the effective date of the grant of the 102 Trustee Options to an Israeli Grantee, or, if the Board has not determined such effective date, the date of the resolution of the Board approving the grant of such Options, which in the case of 102 Trustee Options shall not be before the lapse of 30 days (or such other period which may be determined by the Ordinance from time to time) from the date upon which the Plan is first submitted to the relevant Israeli Tax Authorities.

 

4.2                               The persons eligible for participation in the Israeli Sub Plan as Israeli Grantees shall include any Employees and/or Non-Employees of the Company or of any Affiliated Company; provided, however, that (i) Employees may only be granted 102 Trustee Options; and (ii) Non-Employees and/or Controlling Shareholders may only be granted 3(i) Options.

 

4.3                               The Company may designate Options granted to Employees pursuant to Section 102 as 102 Non-Trustee Options or 102 Trustee Options.

 

4.4                               The grant of 102 Trustee Options shall be made under this Sub Plan adopted by the Board, and shall be conditioned upon the approval of this Sub Plan by the ITA.

 

4.5                               102 Trustee Options may either be classified as Capital Gain Tax Track Options or Ordinary Income Tax Track Options.

 

4.6                               No 102 Trustee Options may be granted under this Sub Plan to any eligible Employee, unless and until, the Company’s Election, is appropriately filed with the ITA. Such Election shall become effective beginning the first date of grant of a 102 Trustee Options under this Sub Plan and shall remain in effect at least until the end of the year following the year during which the Company first granted 102 Trustee Options. The Election shall obligate the Company to grant only the type of 102 Trustee Options it has elected, and shall apply to all Israeli Grantees who were granted 102 Trustee Options during the period indicated herein, all in accordance with the provisions of Section 102(g) of the Ordinance. For the avoidance of doubt, such Election shall not prevent the Company from granting 102 Non-Trustee Options simultaneously.

 

4.7                               All 102 Trustee Options must be held in trust by a Trustee.

 

4.8                               For the avoidance of doubt, the designation of 102 Non-Trustee Options and 102 Trustee Options shall be subject to the terms and conditions set forth in Section 102.

 

4.9                               Exercise of Vested 102 Trustee Options:

 

Unless other procedures shall be determined from time to time by the Board and notified to the Israeli Grantees, the mechanism of exercising vested 102 Trustee Options shall be in accordance with the provisions of the Plan and of the Israeli Sub Plan, except that any notice of exercise of 102 Trustee Options shall be made in such form and method in compliance with the provisions of Section 102 and shall also be delivered in copy to the authorized representative of the Affiliated Company with which the Israeli Grantee is employed and/or engaged, if applicable, and to the Trustee.

 



 

4.10                        Restrictions on Transfer:

 

(a)                                 102 Trustee Options and the Exercised Shares issued pursuant to the exercise thereof, and all rights attached thereto (including bonus shares), shall be held by the Trustee for such period of time as required by the provisions of Section 102 applicable to Options granted through a Trustee in the applicable tax track, as per the Election (the “Restricted Period”).

 

(b)                                 Subject to the provisions of Section 102 and any rules or regulation or orders or procedures promulgated thereunder, the Israeli Grantee shall provide the Company and the Trustee with a written undertaking and confirmation under which the Israeli Grantee confirms that he/she is aware of the provisions of Section 102 and the Elected tax track and agrees to the provisions of the Trust Note between the Company and the Trustee, and undertakes not to release, by sale or transfer, the 102 Trustee Options, and the Exercised Shares issued pursuant to the exercise thereof, and all rights attached thereto (including bonus shares) prior to the lapse of the Restricted Period. The Israeli Grantee shall not be entitled to sell or release from trust the 102 Trustee Options, nor the Exercised Shares issued pursuant to the exercise thereof, nor any right attached thereto (including bonus shares), nor to request the transfer or sale of any of the same to any third party, before the lapse of the Restricted Period. Notwithstanding the above, if any such sale or transfer occurs during the Restricted Period, the sanctions under Section 102 of the Ordinance and under any rules or regulation or orders or procedures promulgated thereunder shall apply to and shall be borne by such Israeli Grantee.

 

(c)                                  Without derogating and subject to the above, and to all other applicable restrictions in the Plan, this Sub-Plan, the Option Agreement and applicable Law, the Trustee shall not release, by sale or transfer, the Exercised Shares issued pursuant to the exercise of the 102 Trustee Options, and all rights attached thereto (including bonus shares) to the Israeli Grantee, or to any third party to whom the Israeli Grantee wishes to sell the Exercised Shares (unless the contemplated transfer is by will or laws of descent) unless and until the Trustee has either (a) withheld payment of all taxes required to be paid upon the sale or transfer thereof, if any, or (b) received confirmation either that such payment, if any, was remitted to the tax authorities or of another arrangement regarding such payment, which is satisfactory to the Company and the Trustee. For the removal of doubt, it is clarified that the Trustee may release by sale or transfer to a third party only Exercised Shares (and not Options).

 

4.11                        Rights as Stockholder:

 

Without derogating from the provisions of the Plan, it is hereby further clarified that with respect to Exercised Shares issued pursuant to the exercise of 102 Trustee Options, as long as they are registered in the name of the Trustee, the Trustee shall be the registered owner of such shares. Notwithstanding, the Trustee shall not exercise the voting rights conferred by such Exercised Shares in any way whatsoever, and shall not issue a proxy to any person or entity to vote such shares (other than to the applicable Israeli Grantee, subject to and in accordance with the provisions of Section 102). Notwithstanding, the Company shall be entitled at its sole discretion, and not required, to distribute dividends directly to the Trustee and the Trustee shall make reasonable efforts to remit the amount of cash dividends to the Israeli Grantees who is entitled to the Exercised Shares for which the dividends are being paid or distributed, subject to any applicable taxation on such distribution of dividend, applicable laws and the withholding thereof.

 

4.12                        Bonus Shares:

 

All bonus shares to be issued by the Company, if any, with regard to Exercised Shares issued pursuant to the exercise of 102 Trustee Options, while held by the Trustee, shall be registered in the name of the Trustee; and all provisions applying to such Exercised Shares shall apply to bonus shares issued by virtue thereof, if any, mutatis mutandis. Said bonus shares shall be subject to the Restricted Period of the Exercised Shares by virtue of which they were issued.

 



 

4.13                        Voting:

 

Without derogating from the provisions of Section 10.2 of the Plan, with respect to Exercised Shares of 102 Trustee Options, such Exercised Shares shall be voted in accordance with the provisions of Section 102.

 

4.14.                     Conditions of Issuance:

 

Without derogating from the provisions of Section 7.6 of the Plan, and in addition thereto, the arrangements with the ITA referred to therein shall, in the event of 102 Trustee Options also need to be satisfactory to the Trustee.

 

5.                                      102 Non-Trustee Options

 

5.1                               102 Non-Trustee Options granted hereunder shall be granted to, and the Exercised Shares issued pursuant to the exercise thereof, issued to, the Israeli Grantee.

 

5.2                               Without derogating and subject to the above, and to all other applicable restrictions in the Plan, this Sub-Plan, the Option Agreement and applicable Law, the Exercised Shares issued pursuant to the exercise of the 102 Non-Trustee Options, and all rights attached thereto (including bonus shares) shall not be transferred unless and until the Company has either (a) withheld payment of all taxes required to be paid upon the sale or transfer thereof, if any, or (b) received confirmation either that such payment, if any, was remitted to the ITA or of another arrangement regarding such payment, which is satisfactory to the Company.

 

5.3                               An Israeli Grantee to whom 102 Non-Trustee Options are granted must provide, upon termination of his/her employment, a surety or guarantee to the satisfaction of the Company, to secure payment of all taxes which may become due upon the future transfer of his/her Exercised Shares to be issued upon the exercise of his/her outstanding 102 Non-Trustee Options, all in accordance with the provisions of Section 102.

 

6.                                      3(i) Options

 

6.1                               3(i) Options granted hereunder shall be granted to, and the Exercised Shares issued pursuant thereto issued to, the Israeli Grantee.

 

6.2                               Without derogating and subject to the above, and to all other applicable restrictions in the Plan, this Sub-Plan, the Option Agreement and applicable law, the Exercised Shares issued pursuant to the exercise of the 3(i) Options, and all rights attached thereto (including bonus shares) shall not be transferred unless and until the Company has either (a) withheld payment of all taxes required to be paid upon the sale or transfer thereof, if any, or (b) received confirmation either that such payment, if any, was remitted to the tax authorities or of another arrangement regarding such payment, which is satisfactory to the Company.

 

6.3                               The Company may require, as a condition to the grant of the 3(i) Options, that an Israeli Grantee to whom 3(i) Options are to be granted, provide a surety or guarantee to the satisfaction of the Company, to secure payment of all taxes which may become due upon the future transfer of his/her Exercised Shares to be issued upon the exercise of his/her outstanding 3(i) Options.

 

7.                                      Tax Consequences

 

Without derogating from and in addition to any provisions of the Plan, any and all tax and/or other mandatory payment consequences arising from the grant or exercise of Options, the payment for or the transfer or sale of Exercised Shares, or from any other event or act in connection therewith (including without limitation, in the event that the Options do not qualify under the tax classification/tax track in which they were intended) whether of the Company, an Affiliated Company, the Trustee or the Israeli Grantee, including without limitation any non-compliance of the Israeli Grantee with the provisions hereof, shall be borne solely by the Israeli Grantee. The Company, any applicable Affiliated Company, and the Trustee, may each withhold (including at source), deduct and/or set-off, from any payment made to the Israeli Grantee, the amount of the taxes and/or other mandatory payments the of which is required with respect to the Options and/or Exercised Shares. Furthermore, each Israeli Grantee shall indemnify the Company, the applicable

 



 

Affiliated Company and the Trustee, or any one thereof, and to hold them harmless from any and all liability for any such tax and/or other mandatory payments or interest or penalty thereupon, including without limitation liabilities relating to the necessity to withhold, or to have withheld, any such tax and/or other mandatory payments from any payment made to the Israeli Grantee.

 

Without derogating from the aforesaid, each Israeli Grantee shall provide the Company and/or any applicable Affiliated Company with any executed documents, certificates and/or forms that may be required from time to time by the Company or such Affiliated Company in order to determine and/or establish the tax liability of such Israeli Grantee.

 

Without derogating from the foregoing, it is hereby clarified that the Israeli Grantee shall bear and be liable for all tax and other consequences in the event that his/her 102 Trustee Options and/or the Exercised Shares issued pursuant to the exercise thereof are not held for the entire Restricted Period, all as provided in Section 102.

 

The Company and or when applicable the Trustee shall not be required to release any Share Certificate (or any Shares issued in book entry form) to an Israeli Grantee until all required payments have been fully made.

 

8.                                      Currency Exchange Rates

 

Except as otherwise determined by the Board, all monetary values with respect to Options granted pursuant to this Sub-Plan, including without limitation the Fair Market Value and the Exercise Price of each Option, shall be stated in United States Dollars. In the event that the Exercise Price is in fact to be paid in New Israeli Shekels, at the sole discretion of the Board, the conversion rate shall be the last known representative rate of the US Dollar to the New Israeli Shekels on the date of payment.

 

9.                                      Subordination to the Ordinance

 

9.1                               It is clarified that the grant of the 102 Trustee Options hereunder is subject to the approval by the ITA of the Plan, this Sub-Plan and the Trustee, in accordance with Section 102.

 

9.2                               Any provisions of the Section 102 or Section 3(i) of the Ordinance and/or any of the rules or regulations promulgated thereunder, which is not expressly specified in the Plan or in the applicable Option Agreement, including without limitation any such provision which is necessary in order to receive and/or to keep any tax benefit, shall be deemed incorporated into this Sub-Plan and binding upon the Company, and applicable Affiliated Company and the Israeli Grantee.

 

9.3                               With regards to 102 Trustee Option, the provisions of the Plan and/or this Sub-Plan and/or the Option Agreement shall be subject to the provisions of Section 102 and the Tax Assessing Officer’s permit, and the said provisions and permit shall be deemed an integral part of the Plan and of this Sub-Plan and of the Option Agreement.

 

9.4                               The Options, the Plan, this Sub-Plan and any applicable Option Agreements are subject to the applicable provisions of the Ordinance, which shall be deemed an integral part of each, and which shall prevail over any term that is inconsistent therewith.

 

9.5                               Any provision of Section 102 and/or the said permit which is necessary in order to receive and/or to keep any tax benefit pursuant to Section 102, which is not expressly specified in the Plan or the Sub Plan or the Option Agreement, shall be considered binding upon the Company and the Israeli Grantees.

 



 

POLYPID LTD. 2012 SHARE OPTION PLAN

Sub-Plan for U.S. Persons

 

1.                                      Purpose of the Sub-Plan

 

This Sub-Plan (the “Sub-Plan”) is part of the 2012 Share Option Plan of PolyPid Ltd. (the “Plan”) and is adopted by the Board pursuant to Section 1.24 of Annex A of the Plan.  All terms not otherwise defined herein shall have the meaning ascribed to them in the Plan.  This Sub-Plan governs grants of Options to United States employees, officers, consultants, and other service providers.

 

2.                                      Provisions of the Sub-Plan

 

The provisions of this Sub-Plan shall supersede and govern in the case of inconsistency between the provisions of this Sub-Plan and the provisions of the Plan; provided, however, that this Sub-Plan shall not be construed to grant to any Grantee rights not consistent with the terms of the Plan, unless specifically provided herein.

 

3.                                      Shares Available for Allocation; Other Board Limitations

 

10,000,000 (ten million) shares may be granted pursuant to this Sub-Plan as ISOs (as defined below).  Shares underlying ISOs that fail to vest or be fully exercised prior to expiration or other termination shall again become available for grant as ISOs pursuant to this Sub-Plan as permitted by applicable law.

 

Notwithstanding Section 3.2 or 3.3 of the Plan, no changes by the Board shall, without approval of the Company’s shareholders:  (a) increase the total number of Shares available for grant pursuant to this Sub-Plan as ISOs, except by operation of the provisions of Section 12 of the Plan; (b) change the class of persons eligible to receive grants pursuant to this Sub-Plan; or (c) extend the date on which ISOs can be granted pursuant to this Sub-Plan beyond the tenth (10th) anniversary of the earlier of the date the Board adopts this Sub-Plan or the date of shareholder approval described in the preceding paragraph.

 

4.                                      Eligibility

 

The individuals who shall be eligible to receive Options under the Plan that are subject to the provisions of this Sub-Plan shall be employees, directors, and other individuals and entities who are United States citizens or who are resident aliens of the United States for United States federal tax purposes (collectively, “U.S. Persons”) and who render services to the management, operation or development of the Company or an Affiliated Company and who have contributed or may be expected to contribute materially to the success of the Company or an Affiliated Company.

 

5.                                      Terms and Conditions of Options

 

(a)                                 In General.  Every Option granted to a U.S. Person shall be evidenced by an Option Agreement in such form as the Board shall approve from time to time, specifying the number of Shares, the time or times at which the Option shall become exercisable in whole or in part, whether the Option is intended to be an incentive stock option (“ISO”) or a nonqualified stock option (“NSO”), and such other terms and conditions as the Board shall approve, and containing or incorporating by reference the terms and conditions set forth in this Sub-Plan.  The Plan and this Sub-Plan shall be administered in such a manner as to permit those Options granted hereunder and specially designated as an ISO to qualify as incentive stock options as described in Section 422 of United States Internal Revenue Code of 1986, as amended (the “Code”).

 



 

(b)                                 Limitations Relating to ISOs.

 

(i)                                     ISOs shall not be granted to any person who is not an employee of the Company or an affiliate satisfying the requirements of Code Sections 424(e) or 424(f) (generally, a corporation in the group with respect to which there is at least fifty percent (50%) voting power) (for purposes of this Sub-Plan, an “ISO Corporation”).

 

(ii)                                  The special United States federal tax rules applicable to ISOs are not available to an ISO that is exercised at any time later than three (3) months following termination of employment with an ISO Corporation.  Accordingly, such an Option (if otherwise exercisable) shall be treated as an NSO upon exercise, rather than an ISO, for United States tax purposes.

 

(iii)                               Notwithstanding Section 7.3 of the Plan, no ISO granted to a Grantee who owns (directly or under the attribution rules of Code Section 424(d)) stock possessing more than ten percent (10%) of the total combined voting power of all classes of stock of the Company or any ISO Corporation shall expire later than five (5) years from its date of grant.

 

(iv)                              Method of Exercise.  Unless otherwise provided in the applicable Option Agreement, an ISO may be exercised only using any of the following methods:

 

(A)                               In cash or by check, payable to the order of the Company;

 

(B)                               By payment in cash or by check, payable to the order of the Company, of the par value of the Shares to be acquired and by payment of the balance of the exercise price in whole or in part by delivery of the Grantee’s recourse promissory note, in a form specified by the Board and to the extent consistent with applicable law, secured by the Shares acquired upon exercise of the Option and such other security as the Board may require;

 

(C)                               By (1) delivery of an irrevocable and unconditional undertaking by a creditworthy broker to deliver promptly to the Company sufficient funds to pay the exercise price and any required tax withholding or (2) delivery by the Grantee to the Company of a copy of irrevocable and unconditional instructions to a creditworthy broker to deliver promptly to the Company cash or a check sufficient to pay the exercise price and any required tax withholding;

 

(D)                               By delivery (either by actual delivery or attestation) of Shares owned by the Grantee valued at their Fair Market Value, provided (1) the method of payment is then permitted under applicable law, (2) the Shares, if acquired directly from the Company, was owned by the Grantee for a minimum period of time, if any, as may be established by the Board in its sole discretion, and (3) the Shares is not subject to any repurchase, forfeiture, unfulfilled vesting or other similar requirements; or

 

(E)                                By any combination of the above permitted forms of payment.

 

In no event shall the “net exercise” method be used to exercise an ISO.

 

(v)                                 Notice of ISO Stock Disposition.  The Grantee must notify the Company promptly in the event that the Grantee sells, transfers, exchanges or otherwise disposes of any Shares issued upon exercise of an ISO before the later of (i) the second (2nd)

 



 

anniversary of the date of grant of the ISO or (ii) the first (1st) anniversary of the date the shares were issued upon his exercise of the ISO.

 

(d)                                 Exercise Price.  The exercise price of each Option shall be as specified by the Board in its discretion; provided, however, that the price shall be at least 100 percent (100%) of the Fair Market Value of the Shares on the date on which the Board grants the Option (or such later date as the Board shall specify), which shall be considered the date of grant of the Option for purposes of fixing the price; and provided, further, that the price with respect to an ISO granted to a Grantee who at the time of grant owns (directly or under the attribution rules of Code Section 424(d)) stock representing more than ten percent (10%) of the voting power of all classes of stock of the Company or of any ISO Corporation shall be at least 110 percent (110%) of the Fair Market Value of the Shares on the date of grant of the ISO.

 

(e)                                  Effect of Cessation of Employment or Service Relationship.  The Board shall determine in its discretion and specify in each applicable Option Agreement the effect, if any, of the termination of the Grantee’s employment with or performance of services for the Company or any Affiliated Company on the exercisability of the Option.

 

(f)                                   No Rights as Stockholder.  .  A Grantee shall have no rights as a stockholder with respect to any Shares covered by an Option until the date of issuance of a stock certificate (or book entry is made) to him or her for the Shares.  No adjustment shall be made for dividends or other rights for which the record date is earlier than the date the stock certificate is issued (or book entry is made), other than as required or permitted by the Plan.

 

For the avoidance of doubt, the provisions of Section 10.2 of the Plan shall apply to any Shares issued pursuant to the exercise of an Option.

 

(g)                                  Certain Adjustments Prohibited.  Notwithstanding any provision in Sections 3.2.5, 7.4.2 or 12 of the Plan, no adjustment shall be made to the terms or conditions of an Option under the terms of the Plan unless the adjustment would not otherwise cause adverse tax consequences to the Grantee under Code Section 409A or result in the loss of ISO status under Code Section 424 (without the Grantee’s consent).

 

6.                                      Requirements of Law

 

(a)                                 The Company shall not be required to transfer Shares or to sell or issue any Shares upon the exercise of any Option if the issuance of such Shares will result in a violation by the Grantee or the Company of any provisions of any law, statute or regulation of any governmental authority.  Specifically, in connection with the Securities Act of 1933, as amended from time to time (the “Securities Act”), upon the exercise of any Option, the Company will not be required to issue Shares unless the Board has received evidence satisfactory to it to the effect that the holder of the Option will not transfer such shares except pursuant to a registration statement in effect under the Securities Act or unless an opinion of counsel satisfactory to the Company has been received by the Company to the effect that registration is not required.  Any determination in this connection by the Board shall be conclusive.  The Company shall not be obligated to take any other affirmative action in order to cause the exercise of an Option to comply with any law or regulations of any governmental authority, including, without limitation, the Securities Act or applicable state securities laws in the United States.

 

(b)                                 All other provisions of this Sub-Plan and the Plan notwithstanding, this Sub-Plan and the Plan shall be administered and construed so as to avoid any person who receives an Option Grant incurring any adverse tax consequences under Code Section 409A.  The Board shall suspend the application of any provisions of the Plan which could, in its sole determination, result in an adverse tax consequence to any person under Code Section 409A.

 



 

7.                                      Tax Withholding

 

To the extent required by law, the Company may withhold or cause to be withheld income and other taxes with respect to any income recognized by a Grantee by reason of the exercise of an Option, and as a condition to the receipt of any Option the Grantee shall agree that if the amount payable to him or her by the Company or any Affiliated Company employing the Grantee in the ordinary course is insufficient to pay such taxes, then the Grantee shall upon the request of the Company pay to the Company an amount sufficient to satisfy its tax.

 



EX-23.1 6 a2234591zex-23_1.htm EX-23.1

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We consent to the reference to our firm under the caption “Experts” and to the use of our report dated February 8, 2018 (except for Notes 1(d), 2(j), 7, 9, 10, 12, 13, 14 and 15, as to which the date is March 14) in the Registration Statement on Form F-1 and related Prospectus of Polypid Ltd. dated March 14, 2018.

 

 

/s/ KOST FORER GABBAY & KASIERER

A Member of Ernst & Young Global

Tel-Aviv, Israel

March 14, 2018

 



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