-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, G2DR3ZwSnJUuysB76mjrkaRuookgAgegMNavjl0iSOlJu4jjEnJFBDRDRP/hJkTD 2KJ7HxZcihhr0YjhaWOYjw== 0001144204-06-009961.txt : 20060315 0001144204-06-009961.hdr.sgml : 20060315 20060315125257 ACCESSION NUMBER: 0001144204-06-009961 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20051231 FILED AS OF DATE: 20060315 DATE AS OF CHANGE: 20060315 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DOV PHARMACEUTICAL INC CENTRAL INDEX KEY: 0001066833 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 223374365 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-49730 FILM NUMBER: 06687430 BUSINESS ADDRESS: STREET 1: 433 HACKENSACK AVENUE CITY: HACKENSACK STATE: NJ ZIP: 07601 BUSINESS PHONE: 2019680980 MAIL ADDRESS: STREET 1: 433 HACKENSACK AVENUE CITY: HACKENSACK STATE: NJ ZIP: 07601 10-K 1 v037548_10k.htm
 


 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K

(Mark One)
x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2005

OR

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________ to ____________

Commission file number 000-49730



DOV PHARMACEUTICAL, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
(State or Other Jurisdiction
of Incorporation or Organization)
 
22-3374365
(I.R.S. Employer
Identification No.)
 
Continental Plaza
433 Hackensack Avenue
Hackensack, New Jersey 07601
(Address of principal executive office)

(201) 968-0980
(Registrant’s telephone number, including area code)


 
Securities registered pursuant to Section 12 (b) of the Act: None

Securities registered pursuant to Section 12 (g) of the Act:
Common Stock, $0.0001 par value

Indicate by check mark whether registrant is a “well-known seasoned issuer” (as defined in Rule 12b-2 of the Act). Yes o No x
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x
 
Indicate by check mark whether registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o
 
Indicate by check mark whether registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definitions of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Act.
Large Accelerated Filer o Accelerated Filer x Non-accelerated Filer o
 
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x

The aggregate market value of the voting stock held by non-affiliates of registrant as of June 30, 2005 totaled approximately $427.8 million based on the then-closing stock price as reported by the Nasdaq National Market.

On February 17, 2006, there were outstanding 23,265,005 shares of registrant’s common stock, par value $0.0001 per share.
 





 
DOV PHARMACEUTICAL, INC.

Form 10-K

For the Year Ended December 31, 2005

Table of Contents
 

   
Page Number
   PART 1
   
 
   ITEM 1.
   ITEM 1a.
22 
   ITEM 1b.
34 
   ITEM 2.
34 
   ITEM 3.
34 
   ITEM 4.
34 
   
 
   PART II
 
 
   ITEM 5.
34 
   ITEM 6.
35 
   ITEM 7.
36 
   ITEM 7A.
46 
   ITEM 8.
46 
   ITEM 9.
46 
   ITEM 9A.
46 
   ITEM 9B.
47 
      
 
   PART III
 
 
   ITEM 10.
49 
   ITEM 11.
53 
   ITEM 12.
58 
   ITEM 13.
61 
   ITEM 14.
61 
   
 
   PART IV
 
 
   ITEM 15.
62 
   
 
68 

 
i


 
PART I


This Report on Form 10-K includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, including statements regarding our expectations with respect to the progress of and level of expenses for our clinical trial programs. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:

·
demonstrate the safety and efficacy of product candidates at each stage of development;
   
·
meet our development schedule for our product candidates, including with respect to clinical trial initiation, enrollment and completion;
   
·
meet applicable regulatory standards and receive required regulatory approvals on our anticipated time schedule or at all;
   
·
meet or require our partners to meet obligations and achieve milestones under our license and other agreements;
   
·
develop an acceptable development plan under and otherwise achieve the results contemplated by the 2005 amendment to our license agreement with Merck;
   
·
obtain and maintain collaborations as required with pharmaceutical partners;
   
·
obtain substantial additional funds;
   
·
obtain and maintain all necessary patents, licenses and other intellectual property rights; and
   
·
produce drug candidates in commercial quantities at reasonable costs and compete successfully against other products and companies.

You should refer to the “Item 1A. Risk Factors" for a detailed discussion of some of the factors that may cause our actual results to differ materially from our forward-looking statements. We qualify all our forward-looking statements by these cautionary statements. There may also be other factors that may materially affect our forward-looking statements and our future results. As a result of the foregoing, readers should not place undue reliance on our forward-looking statements. We undertake no obligation and do not intend to update any forward-looking statement.
 

1

 

OVERVIEW

We are a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system, or CNS, disorders. We currently have three product candidates in various stages of clinical development by us, namely, bicifadine, DOV 21,947 and DOV 102,677. We have entered into collaborations for two additional DOV product candidates, indiplon and DOV 216,303, and are seeking a partner for a third product candidate, DOV diltiazem. Bicifadine is our lead product candidate for the treatment of pain. In April 2005 and May 2005, our sublicensee, Neurocrine Biosciences, Inc., or Neurocrine, submitted two New Drug Applications, or NDAs, to the U.S. Food and Drug Administration, or FDA, with respect to indiplon, our product candidate for the treatment of insomnia. We intend to submit our first NDA for bicifadine to the FDA, in the first half of 2007. Our discovery program remains focused on GABAA receptor modulators and reuptake inhibitors for the treatment of CNS disorders. Our preclinical research includes the identification of second generation compounds for pain, anxiety, depression and other important CNS disorders.

Bicifadine is the subject of an extensive clinical development program with three ongoing Phase III trials in patients with chronic low back pain, or CLBP. In addition, two Phase II exploratory trials were recently initiated in February 2006 for bicifadine in the treatment of osteoarthritis and painful diabetic neuropathy. Bicifadine already has demonstrated efficacy in Phase II and Phase III clinical trials involving moderate to severe pain following dental surgery and bunionectomy.

DOV 21,947, our lead product candidate for depression, is a triple reuptake inhibitor, or TRI, and is expected to enter a 300-patient Phase II clinical trial in the third quarter of 2006. DOV 21,947 is related to DOV 216,303, another of our TRIs. We recently announced statistically significant efficacy results from a Phase II clinical trial with DOV 216,303 for the treatment of depression, and currently are evaluating the drug in a number of preclinical models to determine different indications for its further development. DOV 102,677 is another of our TRIs, for which the next study will be a Phase Ib clinical trial in normal volunteers and is scheduled for 2007.

Our current capabilities enable us to take compounds from drug discovery through all stages of clinical development to NDA filing. Our core scientific expertise is in cellular and molecular pharmacology underlying neurotransmission. We have substantial clinical development expertise in our departments of clinical research, data management, biostatistics, medical writing, pharmaceutical development and regulatory affairs. Our senior management team has substantial experience in CNS drug discovery and development. Members of our management have participated in the discovery, development and commercialization of new drugs that have been successfully brought to market. We continue to work to build these capabilities and the next phase of our growth will focus on the expansion of our strategic marketing and commercialization programs and an increase in our internal laboratory capabilities. In February 2006, we entered into a ten-year operating lease for an approximately 133,000 square foot facility in Somerset, New Jersey, that will serve as our new global corporate and development headquarters. The new headquarters will contain laboratory and pilot-scale manufacturing space and we expect to take occupancy in May 2006.
 
To enhance our drug development and commercialization efforts we have out-licensed rights to certain of our product candidates. We have sublicensed indiplon to Neurocrine, which entered into a development and commercialization agreement for indiplon with Pfizer, Inc., or Pfizer, in December 2002. We sublicensed DOV 21,947 and DOV 216,303 to Merck & Co., Inc. in a 2004 development and commercialization agreement which was amended in August 2005. The amendment transfers to us from Merck certain development contemplated by the license agreement. It also permits expansion of the parties’ relationship to include an additional TRI from the DOV preclinical pipeline for inclusion in the original license agreement with no additional upfront payment. If the DOV studies for DOV 21,947 are successful, we may be reimbursed by Merck for pre-agreed expenses and may receive a success premium. Subsequently, we could receive payment for achievement of certain clinical development and regulatory milestones pursuant to the existing agreement. Both parties retain certain termination rights.
 

2


OUR BUSINESS STRATEGY

Our goal is to become a leading biopharmaceutical company focused primarily on products for the treatment of CNS disorders. The key elements of our strategy are to:

Pursue development and commercialization of our lead product candidates. We have five product candidates undergoing DOV-driven or collaborative clinical development. These product candidates address four separate and substantial pharmaceutical markets: insomnia, pain, depression and alcohol abuse. We have designed the clinical programs for the product candidates we are developing in an effort to provide clear and defined paths to attain regulatory approval. We intend to continue to devote substantial resources to completing clinical testing and commercializing these product candidates.

Expand our product candidate portfolio with novel drug candidates that address unmet needs in large, established markets.  We seek to identify and develop, either internally or through collaborative agreements, novel drug candidates that address unmet needs in large, established markets. For example, our product candidates for the treatment of pain and insomnia, bicifadine and indiplon, respectively, have demonstrated positive results equivalent to, or better than, currently marketed products. We intend to continue expanding our existing product candidate portfolio by discovering and developing novel drug compounds both internally and through focused outsourced research and development. We also intend to expand our portfolio by identifying, in-licensing and developing additional compounds that are potentially superior to currently marketed products and by developing additional applications and formulations for our existing discovery and licensed compounds.

Reduce clinical development and commercialization risk by building a diversified product portfolio. We have built and intend to continue to build a portfolio of diverse product candidates to address CNS disorders to reduce the risks associated with the clinical development of any one drug. We have focused our in-licensing and development resources on compounds in all stages of research and clinical development for which there exists a significant amount of informative clinical data. We believe this reduces the risk that these compounds will have safety concerns and enhances our chances of demonstrating efficacy in clinical trials. We focus on developing multiple compounds with diverse mechanisms of action to limit the risk of difficulties associated with a particular mechanism of action. Finally, a single mechanism of action may have multiple therapeutic uses. We intend to investigate the efficacy of our compounds for these diverse uses in order to enhance the commercial potential of our product candidates. We believe that our portfolio approach reduces undue dependence on any single compound or therapeutic application to achieve commercial success and creates multiple potential sources of revenue.

Selectively establish collaborations with global pharmaceutical companies to assist in the development of our products, mitigate financial risk and retain significant commercial upside. We leverage the resources and the development, regulatory and commercialization expertise of our corporate collaborators to advance the development of our potential products. We intend to continue to seek to establish alliances that will enhance our product development and commercialization efforts, including alliances that allow us to retain significant development and commercialization rights for our product candidates.

We currently have collaborations with:

·  
Neurocrine/Pfizer, for indiplon for the treatment of insomnia; and

·  
Merck, for DOV 216,303 for the treatment of depression, anxiety and addiction and DOV 21,947 for all indications.

In August 2005, we amended our 2004 license agreement with Merck for DOV 21,947 and DOV 216,303. As part of the amendment, we instead of Merck will undertake certain clinical development of DOV 21,947 while retaining the ability to achieve the original milestone payments and royalties on product sales, if any, in the event our development activities achieve results to be agreed upon with Merck. In addition, we also retained co-promotion rights for DOV 21,947 in the U.S. 

 
3


OUR PRODUCT PIPELINE

The following table summarizes our product candidates currently in clinical and preclinical development:
 
       
Product
Indication(s)
Status
Marketing Rights
       
Indiplon
Insomnia
PDUFA Dates: May 15, 2006 and June 27, 20061
Pfizer/Neurocrine
Bicifadine
Pain
Phase III
DOV
DOV 21,947
Depression
Phase Ib/Phase II planned
Merck/DOV
DOV 102,677
Alcohol Abuse / Alcoholism
Phase Ib Planned
DOV
DOV 216,303
Indications other than Depression,
Anxiety and Addiction
Preclinical/Phase II2
DOV
DOV Diltiazem
Angina and Hypertension
Phase I/Phase III planned for 20073
DOV
DOV 216,303
Depression, Anxiety and Addiction
4
Merck/DOV
___________
1. The FDA has committed to an action by May 15, 2006 for both NDAs, according to Neurocrine’s public disclosures as of February 7, 2006.
 
2. Although we have completed a Phase II with DOV 216,303 in depressed patients, we are currently evaluating it in preclinical models to determine the next retained indication, if any, other than indications licensed by Merck, that we will pursue in clinical development. Merck has licensed the rights to depression, anxiety and addiction.

3. In July 2004, we reached agreement with the FDA on the scope and design of the clinical trials required for submission of an NDA for DOV diltiazem; we are seeking a partner for final development and commercialization.

4. Our sublicensee for DOV 216,303, Merck, has elected not to authorize disclosure of its development plans.

For an explanation of the terms Preclinical, Phase I, Phase II and Phase III, please refer to the text in subheading “Government Regulation” in this “Business” section.


OUR PRODUCTS UNDER DEVELOPMENT

Clinical Development Programs

Indiplon: Our product candidate for insomnia
 
Insomnia is a neurological disorder with approximately 85 million adults in the U.S. reporting trouble sleeping a few nights or more per week, according to a 2005 report from Mattson Jack (an epidemiological database used to determine the prevalence of a disease or disorder). Mattson Jack also reports that approximately 22 million adults in the U.S. experience chronic insomnia, having trouble sleeping every night or almost every night. In addition, according to the National Sleep Foundation (2003), frequent sleep problems in individuals that are 55 to 84 years old, if ignored, can complicate the treatment of other medical conditions, including arthritis, diabetes, heart and lung disease and depression. According to a 2005 report from IMS Health, the U.S. insomnia pharmaceutical market was $2.2 billion in 2004 and was expected to exceed $2.7 billion in 2005.

The most frequently prescribed drugs currently marketed to treat insomnia target the neurotransmitter gamma aminobutryic acid, or GABA. Neurotransmitters are chemicals in the CNS that either excite or inhibit neuronal function. GABA is the principal inhibitory neurotransmitter in the CNS. Benzodiazepines, or BDZs, target the GABAA receptors.


4


During the 1980s, BDZs were commonly used as sedatives to treat insomnia. This class of drugs produces several undesirable side effects, including negative interactions with other CNS depressants, such as alcohol, the development of tolerance upon repeat dosing and rebound insomnia, or the worsening of insomnia following discontinuation of dosing. Additional side effects, due to the long half-life, or the duration of action, of a compound associated with this class of drugs, include next-day residual sedation effects and impairment of coordination and memory. Memory impairment, which can include amnesia for events occurring prior to and after drug administration, is of particular concern in the elderly, who comprise approximately 18 percent of the total insomnia population, according to Mattson Jack (2005).

During the late 1980s, the class of drugs known as non-BDZs was developed to target a specific site on the GABAA receptor. The non-BDZs have a reduced incidence of side effects that are believed to be attributable to binding more selectively on a GABAA receptor subtype than the BDZs. The most commonly prescribed of the non-BDZs in the U.S. are Ambien®, Sonata® and Lunesta®. Ambien is the current market leader, with approximately $1.8 billion in worldwide sales in 2005, according to Sanofi-Aventis.

Indiplon, our insomnia product candidate, is a non-BDZ shown to be more potent and fast-acting than currently marketed non-BDZs, including Ambien.

In 1998, we licensed indiplon from Wyeth Holdings Corporation, or Wyeth, and sublicensed it to Neurocrine. In December 2002, Neurocrine entered into a development and commercialization agreement with Pfizer for indiplon. We are entitled to a 3.5 percent royalty on worldwide net sales of indiplon, if any.

In April 2005 and May 2005 Neurocrine submitted two indiplon NDAs, for an immediate release, or IR, capsule formulation and a modified release, or MR, tablet formulation for the treatment of insomnia. Neurocrine is developing indiplon in these two formulations, a short acting capsule and a longer acting tablet to address the different needs of the insomnia patient population. These formulations capitalize on key features of indiplon: its ability to induce sleep quickly - approximately 15 minutes after taking the pill - and its rapid elimination from the body, which essentially eliminates the next-day residual sedation effects commonly produced by other drugs of this class.

In January 2006, the FDA requested and received submission of results from Neurocrine’s driving study, completed in late 2005. Based on feedback from the FDA, Neurocrine has stated that it anticipates labeling that includes data from this study, which showed no impairment in next-day driving performance. The FDA has stated its intent to issue a combined package insert in lieu of individual package inserts for the capsule and tablet NDAs. To complete review of the driving study and the combined package insert, the FDA has advised Neurocrine that the Prescription Drug User Fee Act, or PDUFA, dates for the capsule and the tablet NDAs have been moved to May 15, 2006 and June 27, 2006, respectively. However the FDA has committed to an action by May 15, 2006 for both NDAs.

Neurocrine’s indiplon program has now successfully completed clinical trials demonstrating that indiplon capsules and tablets help patients consistently fall asleep faster, increase the amount of time they sleep during the night, decrease number of nighttime awakenings and improve overall sleep quality over the course of short or long-term treatment without evidence of tolerance when administered nightly for up to three months or withdrawal upon discontinuation of nightly dosing - complications often seen with extended use of older-generation sleep medications. Neurocrine also has noted that, in its Phase II and Phase III clinical studies, indiplon demonstrated efficacy with no significant next-day residual sedation at clinically relevant doses and showed, in a driving study, no impairment in next-day driving performance. Neurocrine’s NDAs for indiplon contain data from a total of 74 clinical trials that included approximately 8,000 adult and elderly subjects, more than 350,000 patient exposures and more than 80 preclinical studies. The data reported from these trials consistently have met both primary and secondary endpoints demonstrating the efficacy and safety of indiplon.

The preceding descriptions of Neurocrine’s clinical development and clinical trial results of indiplon are based on Neurocrine’s public disclosures through February 7, 2006.
 

5


Bicifadine: Our Novel Analgesic

Drugs for the treatment of pain, or analgesics, have historically been placed into the following general categories:

·
narcotics or opioids, e.g., morphine, codeine, Demerol® and Percodan®; and

·
non-narcotic prostaglandin inhibitors, e.g., aspirin, acetaminophen, ibuprofen and COX-2 inhibitors.

While drugs in both these categories are regularly used in the treatment of pain, their use has been limited because of various side effect profiles. In addition, administering these drugs for extended time periods has been problematic. Although prostaglandin inhibitors have been used for the treatment of pain, particularly pain associated with inflammation, their efficacy is limited to milder types of pain and they often display undesirable side effects relating to the gastrointestinal tract and liver. Narcotics are also used to treat pain, but tolerance develops rapidly and higher doses often lead to physical dependence and additional side effects, including respiratory depression. Ultram®, marketed by Ortho-McNeil, Inc., was originally thought to be a non-narcotic but its metabolites have been reported to act at certain opiate receptors and have the potential to cause morphine-like psychic and physical dependence. Despite these drawbacks, U.S. sales in 2005 of narcotic and non-narcotic analgesics reached nearly $7.6 billion according to IMS. Furthermore, in September 2004, Merck withdrew Vioxx®, a COX-2 inhibitor, from the market, citing increased risk of stroke and heart attack in extended use. In April 2005, Pfizer withdrew Bextra®, another COX-2 inhibitor, citing increased risk of rare but serious skin reactions. The withdrawal of these drugs has had a significant impact on the treatment of pain and the pain market and, we believe, opened up greater opportunities for bicifadine.

The FDA has granted approval for two other classes of compounds for the management of specific types of chronic pain. In the first class, Neurontin®, marketed by Pfizer, is an anticonvulsant whose actions on ion channels in neuronal tissue are likely responsible for its therapeutic effects in a certain type of neuropathic pain (postherpetic neuralgia). Sharing a similar structure with Neurontin is Lyrica®, also marketed by Pfizer, which was approved in December 2004 for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. In the second class, Cymbalta®, marketed by Eli Lilly and Co., was granted approval in September 2004 for the management of diabetic peripheral neuropathic pain. Cymbalta’s mechanism of action is believed to result from the inhibition of the uptake of serotonin and norepinephrine (SNRI) in nerve cells, properties also possessed by bicifadine.

Bicifadine, in a sustained release, or SR, formulation, is our product candidate for the treatment of pain. Bicifadine is a chemically distinct molecule with a unique profile of pharmacological activity. Its primary pharmacological action is to enhance and prolong the actions of norepinephrine and serotonin by inhibiting the transport proteins that terminate the physiological actions of the two biogenic amines. While we believe that bicifadine also possesses additional neurochemical properties that contribute to its analgesic effects, the exact nature of these other properties is under investigation. Preclinical studies and clinical trials indicate that either or a combination of these individual actions may account for the analgesic properties of bicifadine.

Bicifadine is not a narcotic and, in preclinical studies, has been shown not to act at any opiate receptor. In preclinical studies to date, bicifadine has not demonstrated abuse, addiction or dependence potential, although, in a Phase I clinical trial, the immediate release, or IR, formulation did cause mild and transient euphoric mood in some subjects. Four Phase I clinical trials and 14 Phase II clinical trials involving more than 1,000 patients were conducted by Wyeth or DOV with an IR formulation of bicifadine. In five exploratory double-blind, placebo-controlled Phase II clinical trials of the IR formulation conducted by Wyeth, bicifadine demonstrated a statistically significant reduction in pain versus placebo, in some cases with an outcome suggesting it might be comparable to or better than positive controls such as codeine. In addition to these trials with the IR formulation, we have conducted eight Phase I clinical trials using the SR formulation, a formulation that permits less frequent daily dosing, improves tolerability and for which patents have been filed. We are evaluating the SR formulation in our ongoing clinical development programs and this formulation is intended for commercial use.


6


Chronic Pain Drug Development Program

In March 2004 and February 2006, we reached agreement with the FDA on a plan for the balance of the Phase III bicifadine preclinical and clinical program necessary to submit an NDA for chronic pain. The agreed upon program must include positive results from two placebo-controlled dose-response studies of three months’ treatment duration in patients with CLBP, such as those that are currently ongoing. We also will need to obtain long-term safety observations from at least 100 CLBP patients treated with bicifadine for one year and 300 CLBP patients treated with bicifadine for six months at the maximal recommended dose, which is anticipated to be 400 mg b.i.d. The FDA did not express any particular concerns regarding the safety profile of bicifadine based on the results of preclinical and clinical testing, including observations from previously conducted clinical trials in which more than 1,500 subjects received bicifadine SR. A significant outcome of our February 2006 meeting was the FDA’s stated receptivity to review an NDA for a broad label chronic pain indication for bicifadine using the current CLBP clinical trials package provided we would commit to study bicifadine in two additional models of chronic pain in Phase IV post-approval studies, such as osteoarthritis or neuropathic pain. We intend to make this commitment. In the event that we are not ultimately able to provide positive evidence of efficacy in two Phase IV studies, the bicifadine indication in the product labeling may be revised to that of chronic low back pain.

Another outcome of the February 2006 FDA meeting was a discussion of the Phase I clinical trial package necessary for the submission of the first NDA for bicifadine in chronic pain. The Phase I program will include a QTc study in normal volunteers. A QTc study measures the QT portion of an electrocardiogram and assesses a drug's potential to produce changes in cardiac rhythm. To date, there have been no cardiac - or other - meaningful safety concerns in our preclinical studies or in clinical studies involving more than 2,500 subjects treated with bicifadine. 

We also discussed with the FDA the status of its informal Special Protocol Assessment, or SPA, for study 020 and the potential for dose titration in study 022, our long-term safety and efficacy trial of bicifadine in CLBP patients, as described below. Because we subsequently amended the protocol for study 020 following study initiation and designated a single primary endpoint in that trial, according to FDA guidelines the informal SPA originally discussed with the FDA is no longer in effect. However, we do not feel that this will be an impediment to securing FDA regulatory approval for bicifadine

As part of our bicifadine development program, we also are conducting our animal carcinogenicity study. The “In life” data has been collected and this study has yielded no apparent signals to date. The final analysis is expected to be completed in the second quarter of 2006. We intend to submit our first NDA submission for bicifadine in the first half of 2007. This expectation is based upon, among other things, projected rate of patient enrollment, positive clinical trial outcomes and continued absence of safety concerns.

Phase III Chronic Pain Trials of Bicifadine In Progress

In September 2004, we initiated a pivotal, Phase III, U.S. clinical trial of bicifadine in approximately 600 patients with moderate to severe CLBP (study 020). The clinical trial is a randomized, double-blind, placebo-controlled, outpatient, multi-center study assessing the efficacy and tolerability of three dose levels of bicifadine - 200 mg, 300 mg and 400 mg b.i.d. - over a three-month period. Patients who complete the study are eligible for up to one year of additional treatment in a bicifadine open-label safety and efficacy study (study 022). The primary efficacy endpoint is the change in pain severity rating as measured by the 100 mm Visual Analog Scale, or VAS, score between baseline and the end of dosing. The acceptability of this primary endpoint was affirmed by the FDA in February 2006. In December 2005, we announced a positive futility analysis for study 020, meaning an independent external statistical examination of interim trial data supports continuing the trial through to completion.  This analysis of data on the improvement in pain scores from baseline to end of treatment - the primary endpoint of the clinical trial - indicates that bicifadine has at least a 40 percent chance of being statistically superior to the placebo treatment.  We completed enrollment in this trial in January 2006 and expect to announce results in the second quarter of 2006.


7


We currently are enrolling subjects into a second Phase III clinical trial of bicifadine in patients with moderate to severe CLBP (study 021). The trial is expected to enroll approximately 475 patients and is a randomized, double-blind, placebo-controlled, outpatient, multi-center study assessing the efficacy and tolerability of two dose levels of bicifadine - 200 mg b.i.d. and 400 mg b.i.d. - over a three-month period. The primary efficacy endpoint is the change in pain severity rating as measured by the 100 mm VAS score between baseline and the end of dosing. We expect to report the results of the 021 study in the fourth quarter of 2006.  In both studies 020 and 021, secondary endpoints include changes in measures of functional disability, patients’ global impression of change, patient and physician global evaluation of bicifadine, incidence of discontinuation due to lack of efficacy, use of rescue medication and other analgesia-related rating scales. Safety is being measured by adverse event occurrences, vital signs, ECGs, clinical lab tests and other measures.

We also are enrolling subjects into an open-label Phase III, multi-center clinical trial to evaluate the long-term safety and efficacy of bicifadine in patients with CLBP (study 022). This clinical trial will enroll approximately 1,550 total patients with CLBP, 1,050 of whom will be entered directly into this study and randomized to receive either 400 mg b.i.d. of bicifadine or any appropriate pharmacological analgesic treatment or treatments, or “standard of care” or SOC, selected by the investigator. If the 400 mg b.i.d. dose (800 mg total daily dose) is not adequately tolerated, patients can be given a lower dose (600 mg, 400 mg or 200 mg total daily dose) and remain in the clinical trial. To date, about 30 percent of patients have been down-titrated from 400 mg b.i.d. to one of these alternate dosing regimens. Most of these patients have down-titrated to the 600 mg or 400 mg total daily dose. This clinical trial also will enroll approximately 500 U.S. patients who will have completed twelve weeks of treatment in either study 020 or study 021. Such “rollover” patients receive 400 mg b.i.d.of bicifadine. The primary objective of this clinical trial is to evaluate the safety of bicifadine for up to one year in patients with CLBP with the goal of accumulating an overall safety package of data in 100 patients with one year of dosing and 300 patients with at least six months of dosing at 400 mg b.i.d., the top anticipated dose. The ongoing results from study 022 suggest that bicifadine is at least as effective as SOC in treating CLBP and is safe and well-tolerated.  Initial data suggest that patients receiving bicifadine “de novo” experience a decrease in pain, as measured by VAS score, from a rating of approximately 70 mm to 40 mm over the first four weeks. Further, patients who have “rolled over” from study 020 or 021 are entering the trial with an average VAS score of about 40 mm and continue to decrease their pain scores over the following weeks and months. The positive data trends are continuing, with dosing now spanning twelve months and total patients enrolled in study 022 exceeding 700.  This study is being conducted in approximately 117 centers and we expect to complete in December 2006 the safety package needed to submit our first NDA for bicifadine in the first half of 2007.

In the first quarter of 2006, we plan to initiate a substudy within the long-term safety trial. In this substudy, approximately 100 CLBP patients who are randomized to 400 mg b.i.d. of bicifadine will receive at the outset one of two titration regimens: 200 mg b.i.d. of bicifadine during week one and 300 mg b.i.d. of bicifadine during week two followed by 400 mg b.i.d. of bicifadine for the remainder of the study; or the same titration steps given for two weeks for each dose level followed by 400 mg b.i.d. for the remainder of the trial. This substudy will thus provide information whether the tolerability of a titration regimen to 400 mg b.i.d. of bicifadine is superior to that seen upon starting treatment on day one with the top anticipated dose of 400 mg b.i.d.

Phase II Chronic Pain Trials In Progress

In February 2006, we initiated two exploratory Phase II clinical trials of bicifadine: one in patients with osteoarthritis and one in patients with painful diabetic neuropathy.

The osteoarthritis trial is a multi-center, double-blind, placebo-controlled, four-way crossover trial designed to assess the efficacy, tolerability and pharmacokinetics of bicifadine alone and in combination with ibuprofen. The clinical trial expects to enroll 60 patients with osteoarthritis of the hip or knee. Each patient receives one week of dosing for each of the following four treatment regimens: bicifadine, ibuprofen, bicifadine plus ibuprofen and placebo. There is a one week washout period between each of the dosing arms. Efficacy is determined using change from baseline for pain via VAS scores, the WOMAC arthritis index, patients’ global improvement assessments and other recognized measures. Preclinical studies of bicifadine show the drug has demonstrated efficacy in models of inflammatory pain.


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The painful diabetic neuropathy trial is a randomized, multiple-dose, open-label, two-phase overlap trial designed to assess the efficacy and safety of bicifadine and potential interactions of bicifadine and oxycodone used concurrently. The clinical trial will randomize 50 patients with painful diabetic neuropathy into two parallel four-week treatment groups. In this trial, patients will receive either bicifadine or oxycodone alone for two weeks and then both drugs dosed concurrently for the remaining two weeks. Analgesic efficacy is determined at the end of each two-week period using patient VAS scores for pain, the trial’s primary endpoint. Secondary efficacy endpoints include patient ratings of global improvement and use of rescue medication. Preclinical studies of bicifadine show the drug has substantial analgesic effects in models of neuropathic pain in both diabetic animals and in animals with sensory neuron damage near the spinal cord.

DOV expects to complete dosing for both Phase II trials in the third quarter of 2006.

Acute Pain Drug Development Program
 
In March 2004 and March 2006, we received guidance from the FDA on a plan for the balance of the Phase III bicifadine program necessary to submit an NDA for acute pain. The March 2006 meeting revealed that the FDA is receptive to reviewing an NDA for a broad label acute pain indication for bicifadine based on the successful outcomes from two Phase III clinical trials in repeat-dose acute pain models. This is fewer trials than expected, and there was agreement that one of these trials may be in a non-surgical pain model. This FDA guidance marks a significant improvement for the bicifadine acute pain program in terms of the regulatory path, and we will have further communication with the FDA as we determine the optimal acute pain models to pursue as part of an acute pain NDA package. We announced in March 2006 that we discontinued the conduct of an ongoing vaginal hysterectomy Phase III trial as we believe that this more severe post-surgical pain model is unlikely to support the repeat dosing analysis of bicifadine now required for registration. We also then determined that although the recently completed positive efficacy bunionectomy Phase III trial provides compelling evidence that bicifadine is an effective analgesic in a severe post-surgical pain model, the high rate of “rescue” medication use confounds the repeat dosing analysis required by the FDA.
 
Completed Acute Pain Trials of Bicifadine
 
In August 2002, we completed a Phase II clinical trial in the U.S. involving 750 patients in the treatment of moderate to severe post-surgical dental pain. This Phase II trial was a single-dose, double-blind, placebo-controlled, study that evaluated three controlled release doses of bicifadine and one dose of codeine compared to placebo. Bicifadine produced a highly statistically significant, dose-related reduction in pain compared to placebo at each of the two higher doses. The efficacy of bicifadine was at least equivalent to codeine at all three doses. The trial demonstrated bicifadine to be safe and relatively well-tolerated without producing any serious adverse events. Both codeine and the two higher doses of bicifadine produced significantly more adverse events than placebo, with the bicifadine 400 mg and 600 mg doses producing 22 percent and 37 percent, respectively, versus 11 percent for placebo. The most frequently reported adverse events were nausea and vomiting.

In September 2003, we completed a 540-patient, double-blind, placebo-controlled Phase III clinical trial to compare three doses of bicifadine and one dose of tramadol to placebo in a moderate to severe post-surgical dental pain model. Bicifadine, in a dose-dependent fashion, produced a highly statistically significant reduction in pain compared to placebo, as did the single-dose level of tramadol. Statistically significant increases in analgesia were measured as early as one hour after administration and analgesia was sustained for the balance of the six-hour measurement period. The maximal efficacy of bicifadine was statistically indistinguishable from tramadol. Both bicifadine and tramadol were safe and relatively well-tolerated without producing any serious adverse events.

In September 2005, we completed a Phase III randomized, double-blind, placebo-controlled, outpatient, multi-center clinical trial to assess the efficacy and safety of three dose levels of bicifadine in patients with moderate to severe acute pain following bunionectomy surgery for a five-day period incorporating tramadol as an active control. The bunionectomy Phase III trial ultimately enrolled 325 patients at five sites in the U.S. The design and analysis of the study compared 200 mg and 400 mg t.i.d. of bicifadine to placebo with 100 mg t.i.d. of tramadol as an active control. Statistically significant increases in analgesia were measured as early as 30 minutes after administration and these effects were sustained for the balance of the eight-hour measurement period. The maximal efficacy of bicifadine was statistically indistinguishable from tramadol. While both bicifadine and tramadol were safe and relatively well-tolerated without producing any serious adverse events, the high level of “rescue” analgesic medication used in both the placebo and active drug groups confounded an assessment of the analgesic actions of bicifadine or tramadol under repeat dosing conditions, which are an FDA requirement.
 

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DOV 21,947 and DOV 216,303: Our Triple Reuptake Inhibitors, or TRIs, for Depression

Depression is a disorder in which the affected person experiences a mental state of sadness, despair, discouragement and hopelessness. Other symptoms may include apathy, withdrawal from social contact, an inability to experience pleasure, changes in appetite and sleep patterns, low energy levels, difficulty concentrating and thoughts of suicide. Neurotransmitters regulate numerous functions in the CNS, and imbalances in them have been linked to a number of psychiatric disorders, including depression. The actions of these neurotransmitters are terminated by specific transport proteins that remove them from synapses in the brain. Antidepressants are thought to produce their therapeutic effects by inhibiting the uptake activity of one or more of these transport proteins, effectively increasing the concentration and duration of action of these neurotransmitters at their receptors.

The emergence of selective serotonin reuptake inhibitors, or SSRIs, starting with Prozac® in January 1988, followed by Zoloft® in February 1992 and Paxil® in January 1993, has had a dramatic impact on the antidepressant market. According to IMS figures, sales of antidepressants in the U.S. increased from approximately $424 million in 1987, the year prior to the introduction of Prozac, to approximately $13.7 billion in 2004. Despite this widespread commercial success, SSRIs suffer from the following limitations:

·  
30-40 percent of patients do not experience an adequate therapeutic response to a given drug;
·  
three or more weeks of therapy are often required before meaningful improvement is observed; and
·  
side effects such as nervousness, agitation, insomnia and sexual dysfunction.

Dual uptake inhibitors, referred to as SNRIs, like Effexor®, launched in 1994, and Cymbalta, launched in August 2004, block the uptake of both serotonin and norepinephrine and are appreciably more potent on the serotonin system. While these drugs may be more effective than SSRIs in some patients, SNRIs still take three or more weeks of therapy before a meaningful improvement is observed. In addition, SNRIs have their own unique set of side effects, including nausea, headache, sleepiness, dry mouth, sexual dysfunction and dizziness.

Both preclinical studies and clinical trials indicate that a drug inhibiting uptake of all three, serotonin, norepinephrine and dopamine, may produce a faster onset of action or provide greater efficacy than traditional antidepressants. We believe that such a ‘broad spectrum’ antidepressant would represent a breakthrough in the treatment of depression.

DOV 21,947 and DOV 216,303 are TRIs affecting the neurotransmitters serotonin, norepinephrine and dopamine. In preclinical studies, DOV 21,947 and DOV 216,303 were shown to inhibit the uptake of all three neurotransmitters. In animal models highly predictive of antidepressant action, DOV 21,947 and DOV 216,303 were more potent than Tofranil®, an SNRI, and the SSRIs Prozac and Celexa. Because of their ability to inhibit the uptake of all three neurotransmitters implicated in depression, we believe DOV 21,947 and DOV 216,303 may be more effective and have a more rapid onset than other antidepressants.

We have completed several Phase I studies of DOV 21,947 and intend to initiate a Phase II clinical trial in the third quarter of 2006. DOV 21,947 is related to DOV 216,303. In December 2005 we dosed the initial set of subjects in a second Phase Ib clinical trial of DOV 21,947.  At the highest dose levels explored - well separated from what is believed to be the therapeutic range - rashes were noted in some subjects. In the third quarter of 2006, we expect to initiate a Phase II double-blind clinical trial of DOV 21,947 vs. placebo in depressed outpatients.

Before sublicensing DOV 216,303 to Merck, we completed a Phase II efficacy trial in patients with major depressive disorder. The clinical trial was a randomized, multi-center, double-blind, safety, efficacy and tolerability study with 67 patients and compared 50 mg b.i.d. of DOV 216,303 to 20 mg b.i.d. of citalopram, an SSRI. Patients who completed two weeks of treatment in both the DOV 216,303 and citalopram groups demonstrated reductions from baseline (p<0.0001) in the total HAM-D scores. This study also showed that DOV 216,303 was generally well-tolerated, with no serious adverse events occurring. Merck has licensed the rights to DOV 216,303 for depression, anxiety and addiction. We are currently evaluating DOV 216,303 in preclinical models to determine additional indications, outside of the Merck indications, to pursue in clinical development.


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DOV 102,677: Our TRI for Alcohol Abuse & Alcoholism

Alcoholism, also known as alcohol dependence, is a disease with symptoms including:

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craving: a strong need or compulsion to drink;
·  
loss of control: the inability to limit one’s drinking on any given occasion;
·  
physical dependence: withdrawal symptoms, such as nausea, sweating, shakiness and anxiety, occur when alcohol use is stopped after a period of heavy drinking; and
·  
tolerance: the need to drink greater amounts of alcohol in order to ‘get high.’

The most recent alcohol use and abuse study conducted by the U.S. Department of Health and Human Services (“The 2001 National Household Survey on Drug Abuse”), estimates that approximately 14 million Americans - 7.4 percent of the population - meet the diagnostic criteria for alcohol abuse or alcoholism. Yet, this level of incidence is met by a general lack of effective treatments for alcohol abuse.

DOV 102,677 is a TRI with preferential action on the dopamine transporter protein and is related to DOV 21,947 and DOV 216,303. In a Phase Ia clinical trial, DOV 102,677 was shown to be safe and well-tolerated at doses ≤ 150 mg. At higher doses, abnormal color vision, which was both transient and reversible, was observed in the majority of subjects.  Results of this Phase Ia trial and results from an animal model of alcohol abuse have led us to identify DOV 102,677 as a development candidate to treat alcohol abuse and alcoholism rather than depression. We intend to initiate a Phase Ib repeat-dose clinical trial in normal volunteers for DOV 102,677 in the alcohol abuse indication in 2007.

Preclinical Development Programs

Our discovery program remains focused on GABAA receptor modulators and reuptake inhibitors for the treatment of CNS disorders. Our co-founders, Dr. Bernard Beer and Dr. Arnold Lippa, conducted pioneering work on GABAA receptors. This work classified GABAA receptors into biochemically, pharmacologically and functionally distinct receptor subtypes. They demonstrated that different receptor subtypes influence different behaviors such as anxiety, sedation and amnesia. Furthermore, through their research delineating the actions of BDZs on GABAA receptors, they were the first to discover non-BDZ compounds that act on specific subtypes of GABAA receptors.

BDZs are believed to produce their undesirable effects at therapeutic doses because they affect all GABAA receptor subtypes. We believe that compounds that selectively act on specific GABAA receptor subtypes produce the desired therapeutic effects in the absence of the undesirable effects associated with BDZs. For example, compounds acting at one GABAA receptor subtype may reduce anxiety without sedation, while compounds acting at another GABAA receptor subtype may produce sedation without memory impairment, or other effects associated with acting at other subtypes.

Our internal discovery effort with GABAA receptor modulators has yielded a series of compounds we are currently evaluating. These new chemical entities, currently in the lead optimization phase, are significantly more potent than ocinaplon, our previous anti-anxiety product candidate, and we have prioritized our preclinical pipeline and 2006 activities accordingly. These compounds appear to function as partial positive allosteric modulators at specific GABAA receptor subtypes that may be involved in the treatment of various anxiety disorders, including generalized anxiety disorder, or GAD, and panic.  

In August 2005, we suspended further dosing in the ongoing Phase III clinical trial of ocinaplon following the occurrence of enzyme elevations in liver function tests, or LFTs, for one subject. We have since evaluated the safety findings from all subjects in the Phase III trial. During this study the overall incidence of an elevation in liver enzymes greater than three times normal was eight percent in the ocinaplon-treated subjects and zero percent in the placebo-controlled subjects. Based upon the data, in October 2005 we discontinued the development of ocinaplon for GAD. We are evaluating ocinaplon in preclinical models to determine possible alternative indications for which the risk of liver damage would be reduced. We plan to select a preclinical candidate for clinical development in GAD in the third quarter of 2006.

Our preclinical research and discovery activities and program also includes our work to identify second generation bicifadine compounds.

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Cardiovascular Disorders

Chronic stable angina, or angina pectoris, refers to recurring severe constricting pain in the chest due to inadequate blood supply to the heart caused by heart disease. Angina attacks are more likely to occur during the morning and afternoon hours. Likewise, hypertension is greater in the morning hours. According to the 2002 practice guidelines update for the management of patients with chronic stable angina, published by the American College of Cardiology/American Heart Association/American College of Physicians-American Society of Internal Medicine, the number of patients in the U.S. with stable angina was estimated at 16.5 million. According to Decision Resources, high blood pressure or hypertension was estimated to affect more than 50 million people in the U.S.
 
Diltiazem belongs to a well-known class of drugs called calcium channel blockers. Calcium channel blockers remain a standard of care in the treatment of chronic stable angina and hypertension and continue to be highly endorsed by the medical community. Although comparative studies have demonstrated equivalent anti-angina effects for many marketed calcium channel blockers, a lower incidence of side effects with diltiazem was often reported in these studies. According to IMS figures for 2004, sales of diltiazem products in the U.S. totaled $799 million.

In an effort to provide both therapeutic blood levels of diltiazem for longer periods of time and improved patient compliance, several slow or extended release preparations of diltiazem have been developed for the treatment of hypertension and chronic stable angina. However, these commercially available, once-daily, extended release formulations produce only a partial reduction of chronic stable angina. According to published studies, currently marketed diltiazem products such as Tiazac®, Cardizem® and Dilacor XR® only reduce the number of angina attacks by approximately 50-60 percent when given at FDA-approved therapeutic doses. We believe incomplete reduction in angina demonstrated by current treatments may be the result of inadequate blood levels of the drug in the morning hours, when approximately half of all angina attacks occur. Experts in chronic stable angina have confirmed their dissatisfaction with the ability of current extended release products to adequately treat many of their patients on a once-a-day basis.

DOV Diltiazem, our proprietary formulation of diltiazem, is our product candidate for the treatment of angina and hypertension. DOV diltiazem combines an immediate release component with a controlled release component in order to provide prompt and improved blood levels throughout the day compared to currently marketed diltiazem products.

We believe that DOV diltiazem will reduce morning angina attacks to a significantly greater extent than commercially available products because of its combination of immediate and extended release components. Data from three Phase I trials indicate that our patented formulation produces clinically relevant blood levels within 30 minutes of administration and results in higher blood levels in the morning than Tiazac. In 2004, we reached agreement with the FDA’s Cardio-Renal Division on the scope and design of the clinical trials required for submission of an NDA for DOV diltiazem. The FDA agreed that no additional preclinical or toxicology studies would be required for the NDA submission. We are currently evaluating strategic relationships to advance DOV diltiazem into Phase III clinical development and commercialization while continuing to focus primarily on our CNS programs. We intend that further clinical development of DOV diltiazem be conducted by a licensee of this product, assuming we are able to secure attractive license terms.


Collaborations and Licensing Agreements

One of our business strategies is to establish alliances with industry leaders to access their unique technologies and capabilities. To date, we have established the following collaborations and licensing agreements:


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Neurocrine Biosciences, Inc. and Pfizer, Inc.

In June 1998, we sublicensed indiplon to Neurocrine on an exclusive, worldwide basis for ten years or, if later, the expiration of any patent covering either the compound or the marketed product, currently 2023. At the end of the term, Neurocrine will be deemed to have a fully-paid, royalty-free license to the compound and the marketed product. During the term of the agreement and after payments to our licensor, Wyeth, we are entitled to receive a royalty equal to 3.5 percent of net sales for the later of the expiration of the Wyeth patents in such country and a period of the first ten years post launch in a given market, if any, and additional net milestone payments of $1.5 million upon FDA approval. As noted below, the royalty term has been expanded to include Neurocrine patents covering indiplon. During 2004, we received $2.0 million from Neurocrine for the milestone due upon NDA filing.

In December 2002, Neurocrine and Pfizer announced a global agreement for the exclusive worldwide development and commercialization of indiplon. Neurocrine and Pfizer are responsible for the research, development and commercialization of indiplon. We have the right to terminate our agreement with Neurocrine, with regard to the entire territory, if Neurocrine terminates the research and development program or halts the research and development program for six months or longer within the U.S., other than for reasons relating to regulatory constraints. Likewise, if Neurocrine halts, for six months or longer, or terminates the research and development program in any other country, we have the right to terminate the agreement with respect to that country. If we terminate the agreement due to an uncured breach by Neurocrine, it must transfer to us all information and know-how related to indiplon or the marketed product, and all governmental filings and approvals.

In February 2004, we reorganized our sublicense agreement with Neurocrine in respect to indiplon. As part of the reorganization, Neurocrine acquired Wyeth’s interest under the license covering indiplon entered into between Wyeth and DOV in 1998. The restated sublicense agreement with Neurocrine expands the royalty term to include the life of Neurocrine patents as well as Wyeth patents covering indiplon. The revised agreement allows Neurocrine to pay to us royalty payments, that are 3.5 percent of net sales, and milestone payments net of those amounts that would be owed by DOV to Wyeth. In addition, the first milestone payment to Wyeth of $2.5 million upon an NDA was changed to $1.0 million upon an NDA filing and $1.5 million upon an NDA approval. Thus the net milestones payable to DOV is $2.0 million upon an NDA filing (which was paid in December 2004) and $1.5 million upon an NDA approval.

Merck Agreement

On August 5, 2004, we entered into an agreement with Merck for the worldwide development and commercialization of DOV 21,947 for all therapeutic indications and of DOV 216,303 for the treatment of depression, anxiety and addiction. Additionally, Merck obtained rights of first offer and refusal regarding a licensing agreement for DOV 102,677 under certain circumstances and for additional consideration. Merck assumed financial responsibility for development and commercialization of a product containing at least one of the licensed compounds. The parties agreed to work together to clinically develop licensed product and we have reserved the right to co-promote the sales of product in the U.S. to psychiatrists and other specialists who treat depression.

Under the agreement, we received a $35.0 million up-front licensing payment. In addition, we could receive as much as $300.0 million for achieving certain clinical development and regulatory milestones for multiple territories and approval of two indications, and up to $120.0 million upon achievement of certain sales thresholds. Merck assumed responsibility for the development, manufacturing and commercialization of DOV 21,947 and agreed to pay us royalties on worldwide sales, if any, which increase based upon certain sales thresholds.


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In August 2005, we announced that our license agreement with Merck for DOV 21,947 and DOV 216,303 had been amended. The milestones, royalties and business terms originally established in the August 2004 license agreement were retained in full along with DOV’s co-promote rights. The amendment transfers to us from Merck certain development contemplated by the license agreement. It also permits expansion of the parties’ relationship to include an additional TRI from the DOV preclinical pipeline for inclusion in the original license agreement with no additional upfront payment. If the DOV studies for DOV 21,947 are successful, we may be reimbursed by Merck for pre-agreed expenses and may receive a success premium. Subsequently, we could receive payment for achievement of certain clinical development and regulatory milestones pursuant to the existing agreement. Both parties retain certain termination rights.

Elan Corporation, plc and Elan International Services, Ltd.

In January 1999, Elan and we established a joint venture and formed DOV (Bermuda), Ltd., or DOV Bermuda, a holding company, and Nascime Limited, or Nascime, an operating company, to develop controlled release formulations of bicifadine for the treatment of pain and ocinaplon for the treatment of anxiety disorders and epilepsy. Pursuant to the original agreements, through December 31, 2002, Elan and we funded the joint venture in proportion to our equity interests in the venture, 19.9 percent and 80.1 percent, respectively.

Effective January 1, 2003, Elan no longer funded its pro rata portion of the joint venture's expenses and, after funding ours and Elan’s portion of the joint venture's expenses for the first and second quarters of 2003, our equity ownership in the joint venture increased to 83.0 percent from 80.1 percent.

On October 21, 2003, we entered into an agreement with Elan and certain of Elan’s affiliates to terminate the joint venture and acquire 100 percent ownership of Nascime, the joint venture’s operating company. In connection with this agreement, among other things, Elan and we agreed to eliminate all material consent rights found in the 1999 stock purchase and license agreements. The termination agreement ended Elan’s involvement in the nearly five-year joint venture established to develop controlled release formulations of bicifadine and ocinaplon.
 
Pursuant to the termination agreement, we paid $5.0 million to a subsidiary of Elan in respect of its 17 percent equity stake in the joint venture. We agreed to indemnify Elan and its affiliates, subject to certain limitations, for claims arising from the past, present and any future activities of the joint venture companies, including activities related to the conduct of the joint venture's clinical trials. Each party waived any rights and released the other parties from any claims arising under certain of the principal joint venture agreements. Elan granted to Nascime, now wholly owned by us, a new non-exclusive, royalty-free, perpetual, worldwide license to make and sell the two product candidates in controlled release formulations using the Elan intellectual property licensed to the joint venture, including that developed during the venture. In connection with the license grant, Elan will be entitled to receive up to an aggregate of $3.0 million when the products are licensed or come to market. We recently have taken steps to transfer to us the intellectual property held by Nascime.

Biovail Laboratories Incorporated and Biovail

In January 2001, we entered into a license, research and development agreement with Biovail to develop, manufacture and market DOV diltiazem. Biovail’s license to use DOV diltiazem was exclusive and worldwide in scope. In March 2003, following Biovail’s receipt of marketing authorization for Cardizem LA, we and Biovail agreed to terminate the license agreement. The separation agreement provided for the return to us of the patent license covering DOV diltiazem, a $1.0 million payment by us to Biovail and contingent payments by us to Biovail of $3.0 million upon issuance of marketing authorization for the drug and up to $7.5 million based upon sales, if any. We and Biovail have delivered mutual releases relating to the license agreement.


Market Exclusivity, Patent Protection and Intellectual Property

We believe that establishing and maintaining market exclusivity for our product candidates is critical to our long-term success. We utilize a number of methods to establish and maintain market exclusivity, including taking advantage of statutory market exclusivity provisions, seeking patent protection for our product candidates and otherwise protecting our intellectual property.


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The Hatch-Waxman Act

Under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Act, newly approved drugs and indications benefit from a statutory period of marketing exclusivity. Under the Hatch-Waxman Act, the FDA provides marketing exclusivity to the first applicant to gain approval for a particular new drug by prohibiting the filing of an abbreviated NDA, or ANDA, by a generic competitor for up to five years after the drug is first approved. The Hatch-Waxman Act also provides three years of marketing exclusivity for a new indication for an existing drug. This market exclusivity is provided even in the absence of patent protection for the approved drug. If the drug is also claimed in a patent, a third party may file an ANDA four years after the drug is first approved, provided that the third party certifies that the applicable patent is invalid or not infringed.

Because they appear to be compounds with new active ingredients, we believe ocinaplon, bicifadine and DOV 216,303 will each be eligible for the five-year exclusivity provisions of the Hatch-Waxman Act if they are the first approved drugs containing their active compounds. Since certain patents relating to bicifadine and ocinaplon have expired, in the absence of new patent protection based on patent applications currently being pursued by DOV, these market exclusivity provisions may be of particular importance to the success of these compounds if they are approved by the FDA.

The Hatch-Waxman Act also permits an extension of up to five years of the term of a patent for new approved products to compensate for patent term lost during the drug development and FDA regulatory review process if the applicant can show that research and development has been sufficiently continuous during the FDA review process. Only one patent applicable to any approved drug is eligible for extension under these provisions. In addition, this extension must be applied for after NDA approval of the new drug covered by the patent and before expiration of the patent. We will review at the time patent term extensions for some of our current patents under the Hatch-Waxman Act to add patent life beyond the expiration date. Since patent term extensions for patent term lost require prior NDA approval of the product, our prospective eligibility for extensions is subject to the expected length of clinical trials, patent life and factors involved in the filing and approval of an NDA.

Patents and Intellectual Property Protection

We seek to protect our rights in the compounds, formulations, processes, therapeutic uses, technologies and other valuable intellectual property invented, developed, licensed or used by us through a number of methods, including the use of patents, patent extensions, license agreements and confidentiality agreements. We have or have licensed from others twelve issued U.S. patents, seven of which have expired, including the patent for the use of bicifadine for pain, the use of DOV 216,303 for the treatment of depression and a patent covering ocinaplon.

The patent that currently provides protection for the use of bicifadine and DOV 216,303 for alcohol, cocaine and other addictive disorders is due to expire in December 2018. In 2002, we filed a provisional patent application claiming a novel, three-dimensional composition of matter for bicifadine, as well as therapeutic uses and methods of manufacture for this composition. This application was perfected in 2003 as a regular utility patent application and a separate, international, or PCT, patent application. Also in 2002 and 2003, we filed U.S. provisional and U.S. utility and PCT patent applications claiming novel controlled release formulations of bicifadine. In 2004, we filed a U.S. provisional patent application directed to the use of bicifadine for controlling fever and menopausal symptoms, including hot flashes. This application was perfected in 2005 as regular U.S. utility and PCT patent applications. In 2005 we filed a U.S. provisional application directed to therapeutic uses, compositions and methods employing bicifadine to treat neuropathic disorders, including neuropathic pain, and a second U.S. provisional application directed to therapeutic uses, compositions and methods employing bicifadine to treat urological disorders, including urinary incontinence. Each of these provisional applications is planned to be perfected in 2006 as U.S. regular utility and PCT patent applications. Also in 2005 we filed a U.S. provisional application directed to novel synthetic methods and intermediates for the production of bicifadine and related compounds, and this application was recently perfected as U.S. regular utility and PCT patent applications. In 2006, we intend to file several additional patent applications directed to novel therapeutic uses and compositions of bicifadine.


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The patent covering ocinaplon composition of matter expired in June 2003. Intermediates useful for manufacturing ocinaplon are currently protected by a patent that is due to expire in February 2007. In 2002, we filed a provisional patent claiming controlled release formulations of ocinaplon. Additional patent applications are planned for filing in 2006 directed to new compositions, formulations and methods for production of ocinaplon.

A composition of matter patent for indiplon, patent no. 6,399,621, which falls under our license agreement and our sublicense to Neurocrine, was issued to a former Wyeth subsidiary, American Cyanamid, in June 2002 and is due to expire in August 2020. A further composition of matter patent covering indiplon, patent no. 6,544,999, was issued to Neurocrine in April 2003 and is due to expire in October 2020. A further composition of matter patent covering a novel polymorphic form (different crystal structure) of indiplon, patent no. 6,903,106 was issued in June 2005 and is due to expire in 2023.

In December 2000, a patent issued covering the compound formulation of DOV diltiazem. This patent is due to expire in April 2018. Additionally, in May 2001, we filed a patent application covering an additional release characteristic of DOV diltiazem.

In April 2002, a patent was issued claiming the composition of matter, use and method of treatment and method of manufacture for DOV 21,947, a triple uptake inhibitor under development for the treatment of depression. This patent is due to expire in January 2021.

In January 2003, a patent was issued claiming the composition of matter, use and method of manufacture of DOV 102,677, our candidate for the treatment of indications including depression, obesity, Parkinson’s disease, restless leg syndrome and attention deficit disorder. This patent will expire in 2023. Additional patent applications are planned for filing in 2005 directed to new compositions and uses for DOV 102,677. In 2006, we received a Notice of Allowance on a U.S. patent directed to methods for production of DOV 102,677, which patent is scheduled to issue in the near future.

In addition to protecting our compounds described above, we intend to supplement our current patents with additional patent applications covering new compositions of matter, uses, methods of manufacture and formulations, as appropriate. Once a basic product patent expires, we may be able to derive additional commercial exclusivity and benefits, including from:

·
later-granted patents on processes or intermediates related to the most economical method of manufacture of the active ingredient of the product;

·
patents directed to additional therapeutic uses; and

·
patents directed to related compositions and improved clinical formulations.

In-Licenses

Wyeth. In May 1998, we licensed from Wyeth, on an exclusive, worldwide basis, indiplon, bicifadine, ocinaplon and DOV 216,303 for any indication, including insomnia, pain, anxiety and depression. We have the right to develop and commercialize these compounds, including the right to grant sublicenses to third parties, subject to Wyeth's right of first refusal.

In February, 2004, we reorganized our exclusive license agreement with Wyeth. Under the restated agreement, we are obligated to pay Wyeth royalties of 3.5 percent of net sales for ocinaplon and DOV 216,303 and 5.0 percent of net sales for bicifadine, and milestones of $2.5 million each for ocinaplon and DOV 216,303 and $5.0 million for bicifadine upon NDA filing, and $4.5 million each for bicifadine, ocinaplon and DOV 216,303 upon a NDA approval. The royalty rate for bicifadine, ocinaplon and DOV 216,303 will increase by 0.5 percent should we partner or sublicense that compound. In addition, should we partner or sublicense a compound, the next milestone payable to Wyeth for that compound will be accelerated to become due upon partnering. Since we licensed certain rights to DOV 216,303 to Merck, should Merck achieve sales on this compound, we will owe Wyeth a royalty of 4.0 percent on those sales. The milestone payable to them upon NDA filing of $2.5 million was accelerated and paid in 2004. As part of the reorganization, Neurocrine acquired Wyeth’s interest under the license covering indiplon, with the result that the 2.5 percent royalty payable by us to Wyeth and the $2.5 million in milestones was eliminated. Accordingly, the reorganization with Neurocrine allows Neurocrine to pay to us royalty and milestone payments net of those that would be owed by us to Wyeth, or 3.5 percent on worldwide net sales, if any, and a $1.5 million milestone upon NDA approval.



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If Wyeth terminates the license upon an uncured breach by us, and by Neurocrine under the standby license, we must transfer to Pfizer all information, data and know-how relating to the products and any government authorizations, in addition to our rights derived from our sublicensees with regard to the products. The agreement expires as to each compound for the later of the expiration of the Wyeth patents in such country and a period of ten years following the launch of each compound in each country. Upon such expiration, with respect to each country we will have a fully paid, royalty-free license with the right to make, use or sell the compounds without any further monetary obligation to Wyeth.

Elan. On October 21, 2003, in connection with termination of the joint venture with Elan, Elan granted to Nascime Limited, the former joint venture operating company, now wholly owned by us, a non-exclusive, royalty-free, perpetual, worldwide license to make and sell controlled release formulations of ocinaplon and bicifadine using the Elan intellectual property licensed to the joint venture, including that developed during the venture. We are required to pay Elan milestones, amounting to $1.0 million for ocinaplon and $0.5 million for bicifadine upon license of the products to a third party for development or commercialization, and additional equal amounts upon commercial launch, or an aggregate of $3.0 million upon commercial launch of both products if we do not license the products to a third party. The Elan intellectual property under license includes certain Elan know-how and all Elan patents owned, licensed or controlled by Elan subsequent to the license agreement. We recently have taken steps to transfer to us the intellectual property held by Nascime.


Manufacturing

We have and will continue to rely on third-party contract manufacturers to produce sufficient quantities of our product candidates for use in our preclinical studies and clinical trials. We also intend to rely on third-party contract manufacturers to produce sufficient quantities for large-scale commercialization. In this regard, we have and will continue to engage those contract manufacturers who have the capability to manufacture drug products in amounts required for commercialization.


Marketing and Sales

We have limited marketing and no sales or distribution capabilities. In December 2005, we established an internal division of strategic marketing and commercialization. To augment our limited capabilities in this area, we will need to either acquire or internally develop sales and distribution capabilities, or make arrangements with third parties to perform these services for us, in order to commercialize any of our product candidates.


Government Regulation

Regulation by government authorities in the U.S. and foreign countries is a significant factor in the development, manufacture and marketing of our proposed products and in our ongoing research and product development activities. All our products will require regulatory approval by government agencies prior to commercialization. In particular, human therapeutic products are subject to rigorous preclinical studies and clinical trials and other approval procedures of the FDA and corresponding regulatory authorities in foreign countries. Various federal and state statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record-keeping related to such products and their marketing. The process of obtaining these approvals and the subsequent substantial compliance with appropriate federal and state statutes and regulations require the expenditure of substantial time and financial resources.

Preclinical studies generally are conducted in laboratory animals to evaluate the potential safety and the efficacy of a drug product. In the U.S., drug developers submit the results of preclinical studies to the FDA as a part of an investigational new drug application, or IND, which must become effective before they can begin clinical trials in the U.S. An IND becomes effective 30 days after receipt by the FDA unless the FDA objects to it. Typically, clinical evaluation involves a time-consuming and costly three-phase process.

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Phase I
Refers typically to closely-monitored clinical trials and includes the initial introduction of an investigational new drug into human patients or normal volunteer subjects. Phase I clinical trials are designed to determine the metabolism and pharmacologic actions of a drug in humans, the side effects associated with increasing drug doses and, if possible, to gain early evidence on effectiveness. Phase I trials also include the study of structure-activity relationships and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. During Phase I clinical trials, sufficient information about a drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase II studies. The total number of subjects and patients included in Phase I clinical trials varies, but is generally in the range of 20 to 80.
   
Phase II
Refers to controlled clinical trials conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. These clinical trials are typically well controlled, closely monitored and conducted in a relatively small number of patients, usually involving no more than several hundred patients.
   
Phase III
Refers to expanded controlled and uncontrolled clinical trials, also involving patients with the disease or condition under study. These clinical trials are performed after preliminary evidence suggesting effectiveness of a drug has been obtained. They are intended to gather additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase III trials usually include from several hundred to several thousand patients.
 
The FDA closely monitors the progress of each of the three phases of clinical trials that are conducted in the U.S. and may, at its discretion, re-evaluate, alter, suspend or terminate the testing based upon the data accumulated to that point and the FDA’s assessment of the risk/benefit ratio to the patient. To date we have conducted certain of our clinical trials outside the U.S., where they are monitored by the cognizant national regulatory agencies. Currently, on-going clinical trials are being conducted in the U.S., Canada, Guatemala, India and Israel. All clinical trial test design and results, whether the trial is conducted in the U.S. or abroad, are subject to review by the FDA following IND or NDA filings.

Once Phase III trials are completed, drug developers submit the results of preclinical studies and clinical trials to the FDA, in the form of a NDA, for approval to commence commercial sales. In response, the FDA may grant marketing approval, request additional information or deny the application if the FDA determines that the application does not meet regulatory approval criteria. FDA approval may not be granted on a timely basis, or at all. Furthermore, the FDA may prevent a drug developer from marketing a product under a label for its desired indications, which may impair commercialization of the product. Similar regulatory procedures must also be complied with in countries outside the U.S.

If the FDA approves the NDA, the drug becomes available for physicians to prescribe in the U.S. After approval, the drug developer must submit periodic reports to the FDA, including descriptions of any adverse reactions reported. The FDA may request or require additional trials to evaluate any adverse reactions or long-term effects.

In addition to studies requested by the FDA after approval, a drug developer may conduct other trials and studies to explore use of the approved compound for treatment of new indications. The purpose of these trials and studies and related publications is to broaden the application and use of the drug and its acceptance in the medical community.

We will have to complete an approval process, similar to the U.S. approval process, in virtually every foreign target market for our products in order to commercialize our product candidates in those countries. The approval procedure and the time required for approval vary from country to country and may involve additional testing. Foreign approvals may not be granted on a timely basis, or at all. In addition, regulatory approval of prices is required in most countries other than the U.S. We face the risk that the resulting prices would be insufficient to generate an acceptable return to us or our collaborators.
 

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Competition

The pharmaceutical industry is highly competitive and marked by a number of established, large pharmaceutical companies, as well as smaller emerging companies, whose activities are directly focused on our target markets and areas of expertise. Many of our competitors possess greater financial, managerial and technical resources and have established reputations for successfully developing and marketing drugs, all of which put us at a competitive disadvantage. We face and will continue to face competition in the discovery, in-licensing, development and commercialization of our product candidates, which could severely impact our ability to generate revenue or achieve significant market acceptance of our drug candidates. Furthermore, new developments occur in the pharmaceutical industry at a rapid pace. These developments may render our product candidates or technologies obsolete or noncompetitive.

We have five product candidates undergoing DOV-driven or collaborative clinical development addressing four different and substantial pharmaceutical markets. Competition in these markets includes the following drugs and pharmaceutical companies:

Insomnia Market

Indiplon would compete in the sedative and hypnotic market, which, as defined by IMS, demonstrated one of the highest sales growth rates among any therapeutic area in 2005. Sales for the year ending 2005 were $2.8 billion, with a one year growth rate of more than 30 percent. Prescription growth jumped into double-digit figures with a one year increase of almost 12 percent. Sanofi-Aventis’ Ambien continues to dominate the market with sales of $2.1 billion. Sepracor’s Lunesta was just launched in March, 2005 and captured $322 million in sales by year’s end, demonstrating the market’s sensitivity and acceptance to novel new entries. Sanofi-Aventis launched Ambien CR in September 2005 and captured $73 million of sales in a four-month period.

Pain Market

Bicifadine would target the analgesic market. The two principal classes of pain treatments, as defined by IMS, are the antiarthritic class and the analgesic class. Due to the incidence and prevalence of pain, both classes have a very large volume in sales and in total prescriptions.

Sales of antiarthritics in 2005 were $7.9 billion which represents a one year growth decrease of 19.1 percent in value due to the withdrawal of additional COX-2 inhibitors (for example, Celebrex and Bextra, both marketed by Pfizer). This has led other antiarthritics, such as Mobic®, marketed by Boehringer Ingelheim, to capture a significant share of this class. In 2005, Mobic sales more than doubled with total sales of $1 billion.

Sales of the analgesic class, as defined by IMS, reached $10.5 billion in 2005 which represented a flat annual growth rate and an increase of approximately five percent in total prescriptions. This class is dominated by narcotics. Sales of longer acting non-injectable narcotics that are actively marketed such as Actiq® by Cephalon, Inc., Avinza® by Ligand Pharmaceuticals, Inc., and Kadian® by Alpharma, Inc., continue to show strong growth in sales and prescriptions. Non-narcotics, such as the synthetic non-narcotic subclass as defined by IMS, demonstrated positive growth in total prescriptions, but negative growth in 2005 sales because of generic erosion in price. Branded synthetic non-narcotic products such as Ultram® and Ultracet®, both marketed by Johnson & Johnson, enjoyed very strong sales when heavily promoted, but are now off-patent and are demonstrating significant sales declines. Conversely, generic tramadol has been showing continual growth in prescriptions since entering the market in 2002.

Depression Market

DOV 21,947 and 216,303 would target the antidepressant market, which is dominated by SSRIs and SNRIs that comprise nearly 80 percent of the antidepressant market. Significant SSRI market positions are held by Zoloft, marketed by Pfizer, Celexa and Lexapro®, marketed by Forest Laboratories, Inc., and Paxil, marketed by GlaxoSmithKline. SNRI market leaders include Effexor, marketed by Wyeth, and Cymbalta, marketed by Eli Lilly and Co., which is also co-promoted for neuropathic pain. In 2004 IMS estimated that the SSRI and SNRI markets combined totaled $11 billion.


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Alcohol Abuse

DOV 102,677 would compete in the alcohol abuse market. Campral®, marketed by Forest, is the leading prescription pharmaceutical in this market. Alcohol abuse is an underserved space, met by a general lack of effective treatments. The most recent alcohol use and abuse study conducted by the U.S. Department of Health and Human Services (“The 2001 National Household Survey on Drug Abuse”), estimates that approximately 14 million Americans - 7.4 percent of the population - meet the diagnostic criteria for alcohol abuse or alcoholism.


Employees

As of December 31, 2005, we had 111 employees, consisting of 109 full-time employees and two part-time employees. Of the full-time employees, 31 hold Ph.D., M.D. or equivalent degrees. None of our employees are represented by a collective bargaining arrangement, and we believe the relationship with our employees is good.


Our Scientific Advisory Board

Our scientific advisory board, or SAB, advises us with respect to our product development strategy as well as the scientific and business merits of licensing opportunities and acquisition of compounds and the availability of opportunities for collaborations with other pharmaceutical companies. The SAB consists of a group of highly regarded and experienced scientists and clinicians. A formal, three-day meeting is held off-site annually in the spring. We have, in the past, compensated certain SAB members with stock options pursuant to our 2000 stock option and grant plan, and expenses for attendance at the annual meeting. Certain of the SAB members receive compensation for consulting services. The current SAB members are:

Robert Cancro, M.D. is the chairman of our Scientific Advisory Board and one of our co-founders. From 1976 until his retirement in 2006, Dr. Cancro served as professor and chairman of the Department of Psychiatry at New York University School of Medicine, Director of Psychiatry at New York University Hospital and director of the Nathan S. Kline Institute for Psychiatric Research.  Today, he continues to serve as a professor in the Department of Psychiatry at New York University School of Medicine and as director of the Mental Illness Prevention Center.  Prior to 1976, Dr. Cancro was a professor in the Department of Psychiatry at the University of Connecticut Health Center.  Dr. Cancro is a widely published, internationally recognized psychiatrist and educator, having received numerous honors and awards.  He is on the editorial board of several scientific journals and is an examiner for the American Board of Psychiatry and Neurology Inc. Dr. Cancro is a Fellow of the American Psychiatric Association, the American College of Psychiatrists and the American College of Physicians.  Dr. Cancro is president and a director of the International Committee Against Mental Illness and Chairman of the Section on Psychiatric Rehabilitation of the World Psychiatric Association.

Arvid Carlsson, M.D., Ph.D. is a world-renowned neuropharmacologist and the recipient of numerous prizes and awards, including the Nobel Prize and the Legion of Honour. Dr. Carlsson has been Professor Emeritus at the University of Gothenburg, Sweden since 1989. Prior to that, he was Professor, Pharmacology Department, University of Gothenburg since 1959 and served as chairman from 1959 to 1976. He has conducted groundbreaking research in the areas of depression, schizophrenia and Parkinson’s disease.

John W. Daly, Ph.D. is an internationally known chemist/pharmacologist. Now a scientist emeritus in the National Institute of Diabetes and Digestive and Kidney Diseases, Dr. Daly was chief of NIDDK’s Laboratory of Bioorganic Chemistry, a laboratory he founded and headed from 1981 to 1997. Natural products discovered through the research of Dr. Daly’s lab, primarily alkaloids derived from amphibian skin, have had a major impact on knowledge of how the nervous system functions and how drugs interact with the nervous system. During Dr. Daly’s 40-year tenure at NIH, his numerous accomplishments have included the discovery of the “NIH Shift” — an unexpected molecular process involved in the conversion of the amino acids phenylalanine and tryptophan to the important neurotransmitters dopamine, norepinephrine and serotonin.

 
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Author of more than 500 research papers, a book (Cyclic Nucleotides in the Nervous System) and many book chapters, Dr. Daly was elected to the National Academy of Sciences in 1997. Among his many other honors are the Hillebrand Award from the American Chemical Society in 1978, the Research Achievement Award from the American Society of Pharmacognosy in 1997, the Karl Wilhelm Scheele Award from the Swedish Academy of Pharmaceutical Sciences in 1999 and in 2002, the American Chemical Society’s Ernest Guenther Award in the Chemistry of Natural Products. That same year, he was also named among the most-cited pharmacologists in the world.

David H. Farb, Ph.D. is a Professor and has served since 1990 as Chairman of the Department of Pharmacology and Experimental Therapeutics at the Boston University School of Medicine, where he also serves as Director of the Program in Biomedical Neuroscience.  Additionally, he is Director of the university-wide interdisciplinary NIGMS-funded Biomolecular Pharmacology Training Program, the interdepartmental Program in Biomedical Neuroscience and heads the Laboratory of Molecular Neurobiology.  Dr. Farb chairs the Executive Committee for the Medical Sciences Training Program and is a member of the Bioinformatics Program.  He is currently President of New England Pharmacologists Chapter of ASPET.  Prior to joining BU, Dr. Farb was a full professor with tenure and Head of the Molecular Pharmacology Research Program at the SUNY Downstate Medical Center.  He also was elected Presiding Officer of the Graduate School at SUNY. While in New York, Dr. Farb was elected Chair of the Section of Biological Sciences at the New York Academy of Sciences, where he subsequently founded the Section of Neuroscience.  He received his B.A. in Chemistry from Long Island University and the Ph.D. in Biochemistry at Brandeis University.  Dr. Farb’s current research is directed toward understanding the mechanisms of action of abused substances and steroid hormones and their interactions with excitatory and inhibitory amino acid receptors in the central nervous system. The research also focuses on the mechanism of action and discovery of neuromodulators as therapeutic agents and on the structure, function, and cellular dynamics of ion channels and receptors in the brain and spinal cord.

Roger Guillemin, M.D., Ph.D. is a Nobel Laureate and distinguished professor at The Salk Institute. Dr. Guillemin received the Nobel Prize for his work on brain hormones, which brought to light an entirely new class of hormones important in regulating growth, development, reproduction and stress response. Drugs based upon these molecules are used for the management or treatment of infertility, precocious puberty, dwarfism, diabetes, prostate cancer and pituitary tumors (acromegaly). He has served on several committees of the National Institutes of Health, as President of the Endocrine Society and is a member of the National Academy of Science and of several other foreign academies.

Arnold S. Lippa, Ph.D. is a co-founder of DOV and served as our Chief Executive Officer from April 1995 to July 2005. Since our inception in April 1995, Dr. Lippa has served as our Chairman of our Board of Directors. Prior to 1985, he served as Director of Molecular Neurobiology and held other positions at American Cyanamid. In addition, Dr. Lippa has consulted for various pharmaceutical and biotechnology companies and has been a graduate faculty professor at the New York University School of Medicine and the City University of New York.
 
Website Availability of Reports

Our Internet website address is http://www.dovpharm.com. Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available free of charge through our Internet website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Our Internet website and the information contained therein or connected thereto are not intended to be incorporated into this Annual Report on Form 10-K.

Our Corporate Information

We were incorporated in May 1995 in New Jersey and reincorporated in Delaware in November 2000. Our principal executive offices are located at 433 Hackensack Avenue, Hackensack, NJ 07601. The telephone number of our principal executive offices is (201) 968-0980.
 
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If any of the events covered by the following risks occur, our business, results of operations and financial condition could be harmed. In that case, the trading price of our common stock could decline. Moreover, our actual results may differ materially from our forward-looking statements as a result of the following factors.

Risks Related to our Business

Our stock price is likely to be volatile and the market price of our common stock may decline.

Market prices for securities of biopharmaceutical companies have been particularly volatile. In particular, our stock price has fluctuated between a high of $21.49 and a low of $12.79 since January 1, 2005. Some of the factors that may cause the market price of our common stock to fluctuate include:

  ·
results of clinical trials conducted by us or on our behalf, or by our competitors, such as results in the ongoing Phase III clinical trial with bicifadine in patients with chronic low back pain expected early in the second quarter of 2006;
   
  ·
delays in initiating clinical trials;
   
  ·
business or legal developments concerning our collaborators or licensees, including Merck, Pfizer and Neurocrine;
   
  ·
delays or disagreements with Merck in the development of DOV 21,947 to be conducted by us under the August 2005 amendment to the license agreement with Merck;
   
  ·
regulatory developments or enforcement in the United States and foreign countries, such as the result of the projected May 15, 2006 action by the FDA for the indiplon NDA filings;
   
  ·
developments or disputes concerning patents or other proprietary rights;
   
  ·
changes in estimates or recommendations by securities analysts;
   
  ·
public concern over our drugs that treat CNS disorders, including any drugs that we may develop in the future;
   
  ·
litigation;
   
  ·
future sales of our common stock;
 

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  ·
general market conditions;
   
  ·
changes in the structure of health care payment systems;
   
  ·
failure of any of our product candidates, if approved, to achieve commercial success;
   
  ·
economic and other external factors or other disasters or crises; and
   
  ·
period-to-period fluctuations in our financial results.

If any of the foregoing risks occur, our stock price could fall and in some cases expose us to class action lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management. In this regard, following a decline in the aftermarket trading price of our common stock in connection with our initial public offering, beginning on April 30, 2002, a number of class action lawsuits were filed naming us as defendants, in addition to certain of our officers and directors and certain of our underwriters. On December 20, 2002, we entered into a settlement agreement, which was approved by the court on April 16, 2003, to settle these lawsuits. Pursuant to the settlement agreement, we have paid the class members (inclusive of their attorneys' fees and costs) $250,000 in cash and issued them six-year warrants to purchase 500,000 shares of our common stock with an exercise price of $10.00 per share. Upon issuance, we determined the value of the warrants to be $2.2 million.

If our outstanding convertible debt is converted into shares of our common stock, existing common stockholders will experience immediate equity dilution and, as a result, our stock price may go down.
 
The 2.5% subordinated convertible debentures that we issued in December 2004 and January 2005 are convertible, at the option of the holders, into shares of our common stock at initial conversion rates of 43.9560 shares of common stock per $1,000 principal amount of notes, or $22.75 per share, subject to adjustment in certain circumstances. If all the debentures were converted at their initial conversion rate, we would be required to issue approximately 3,516,484 shares of our common stock. We have reserved shares of our authorized common stock for issuance upon conversion of the debentures. If the debentures are converted into shares of our common stock, our existing stockholders will experience immediate equity dilution and our common stock price may be subject to significant downward pressure.

We have incurred losses since our inception and expect to incur significant losses for the foreseeable future, and we may never reach profitability.

Since our inception in April 1995 through December 31, 2005, we have incurred significant operating losses and, as of December 31, 2005, we had an accumulated deficit of $153.3 million. We have not yet completed the development, including obtaining regulatory approvals, of any product candidate and, consequently, have not generated any revenues from the sale of products. Even if we succeed in developing and commercializing one or more of our product candidates, we may never achieve significant sales revenue and we expect to incur operating losses for the foreseeable future. We also expect to continue to incur significant operating expenses and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we:

  ·
conduct clinical trials;
   
  ·
conduct research and development on existing and new product candidates;
   
  ·
make milestone payments;
   
  ·
seek regulatory approvals for our product candidates;
   
  ·
commercialize our product candidates, if approved;
   
  ·
hire additional clinical, scientific and management personnel;
   
  ·
add operational, financial and management information systems and personnel; and
   
  ·
identify additional compounds and acquire rights from third parties to those compounds through a license to us.


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We must generate significant revenue to achieve and maintain profitability. We may not be able to generate sufficient revenue and we may never be able to achieve or maintain profitability.

We are dependent on the successful outcome of clinical trials for our lead product candidates.

None of our product candidates are currently approved for sale by the FDA or by any other regulatory agency in the world, and our product candidates may never be approved for sale or become commercially viable. Before obtaining regulatory approval for the sale of our product candidates, they must be subjected to extensive preclinical and clinical testing to demonstrate their safety and efficacy for humans and we intend to devote a significant portion of our resources in the upcoming year to the development of bicifadine. Our success will depend on the success of our currently ongoing clinical trials and clinical trials that have not yet begun.

There are a number of difficulties and risks associated with clinical trials including, but not limited to, the possibilities that:

  ·
we may discover that a product candidate causes or may cause harmful side effects; 
   
  ·
we may discover that a product candidate, even if safe when taken alone, may interfere with the actions of other drugs taken at the same time such that its marketability is materially reduced;
   
  ·
we may discover that a product candidate does not exhibit the expected therapeutic results in humans;
   
  ·
a product candidate may lend itself to user abuse, in which case labeling may adversely affect its marketability;
   
  ·
results may not be statistically significant or predictive of results that will be obtained from large-scale, advanced clinical trials;
   
  ·
we or the FDA may suspend or delay initiation of further clinical trials of our product candidates for any of a number of reasons, including safety or delay in obtaining clinical trial material;
   
  ·
we may be delayed in the FDA protocol review process;
   
  ·
patient recruitment may be slower than expected; and
   
  ·
patients may drop out of our clinical trials.

In October 2003, the FDA placed the start of our Phase III clinical trial of ocinaplon, our anti-anxiety product candidate, on hold and requested that we produce additional safety information. We supplied this information to the FDA and with FDA concurrence initiated a Phase III clinical trial in the fourth quarter of 2004. In August 2005, we announced that we had suspended the trial due to a recent occurrence of enzyme elevations in liver function tests, or LFTs, for one subject in the trial and, following our trial report to the FDA, the agency joined in the clinical hold. We have since evaluated the safety findings from all subjects in ocinaplon clinical trials. During this study the overall incidence of an elevation in liver enzymes greater than three times normal was eight percent. Based upon these data, we have discontinued the development of ocinaplon for generalized anxiety disorder. 

Given the uncertainty surrounding the regulatory and clinical trial process, we may not be able to successfully advance the development of effective or safe, commercially viable products.

The August 2005 amendment to our license agreement with Merck conditions Merck’s obligation to reimburse us, including to reimburse us at a premium, for certain clinical tests on DOV 21,947 and to pay us a development milestone upon the successful outcome of a certain test measured by criteria to be agreed upon by the parties. We may not be able to achieve agreement with Merck on such criteria.
 

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If we are unable to successfully develop and commercialize any one or more of our product candidates, this could severely harm our business, impair our ability to generate revenues and adversely impact our stock price.

We may not receive regulatory approvals for our product candidates, approvals may be delayed or the approvals we receive may not be sufficient to fulfill our current goals for our product candidates.

Regulation by government authorities in the United States and foreign countries is a significant factor in the development, manufacture and commercialization of our product candidates and in our ongoing research and development activities. Our partner Neurocrine filed two NDAs for indiplon for the treatment of insomnia in April and May 2005. All our other product candidates are in various stages of research and development and we have not yet requested or received regulatory approval to commercialize any product candidate from the FDA or any other regulatory body.

In particular, human therapeutic products are subject to rigorous preclinical testing, clinical trials and other approval procedures of the FDA and similar regulatory authorities in foreign countries. The FDA regulates, among other things, the development, testing, manufacture, safety, efficacy, record keeping, labeling, storage, approval, advertising, promotion, sale and distribution of biopharmaceutical products. Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information to the FDA for each therapeutic indication to establish the product candidate’s safety and efficacy. The approval process may take many years to complete and the approvals we receive may not allow us to pursue all the desired indications or uses for each of our product candidates. Additionally, even after receipt of FDA approval, the FDA may request additional clinical trials to evaluate any adverse reactions or long-term effects. The scope and expense of such post-approval trials could be extensive and costly to us. Any FDA or other regulatory approval of our product candidates, once obtained, may be withdrawn. If our product candidates are marketed abroad, they will also be subject to extensive regulation by foreign governments.

Any failure to receive regulatory approvals necessary to commercialize our product candidates would have a material adverse effect on our business. The process of obtaining these approvals and the subsequent compliance with appropriate federal and state statutes and regulations require spending substantial time and financial resources. If we, or our collaborators or licensees, fail to obtain or maintain or encounter delays in obtaining or maintaining regulatory approvals, it could adversely affect the marketing of any product candidates we develop, our ability to receive product or royalty revenues and our liquidity and capital resources.

As noted above, in October 2003, the FDA placed the start of our Phase III clinical trial of ocinaplon, on hold and requested that we produce additional safety information. We supplied this information to the FDA and with FDA approval initiated a Phase III clinical trial in the fourth quarter of 2004. In August 2005, we announced that we had suspended the trial following a recent occurrence of enzyme elevations in LFTs for one subject in the trial and, following our trial report to the FDA, the agency joined in the clinical hold. We have since evaluated the safety findings from all subjects in ocinaplon clinical trials. During this study the overall incidence of an elevation in liver enzymes greater than three times normal was eight percent. Based upon these data, we have discontinued the development of ocinaplon for GAD.
 
On September 28, 2004, we announced that we had initiated a pivotal, Phase III, U.S. clinical trial in patients with moderate to severe chronic lower back pain. This clinical trial is being conducted in accordance with a protocol (revised as described below) that we originally submitted to the FDA in accordance with the FDA’s special protocol assessment, or SPA, guidelines in May 2004. Following submission of the protocol to the FDA, we had meetings with the agency to reach agreement on the study design. Following our meeting with the FDA in September 2004, we revised the protocol in response to comments from the FDA, and initiated this clinical trial in accordance with the revised protocol. We received oral confirmation from the FDA that the revised protocol was acceptable, however did not obtain formal documentation of the agreement from the FDA regarding this revised protocol. In a letter dated February 2006, the FDA stated that there was no formal agreement for the protocol because the protocol had been amended subsequent to the original SPA submission. We can give no assurance that as clinical trials proceed or as part of an NDA review process, if any, the FDA will not determine that a previously approved special protocol assessment for a particular protocol is no longer valid. This could have a material adverse effect on the NDA approval process, if any.
 

25



Our operating results are subject to fluctuations that may cause our stock price to decline.

Our revenue is unpredictable and has fluctuated significantly from year-to-year and quarter-to-quarter and will likely continue to be highly volatile. We believe that period-to-period comparisons of our past operating results are not good indicators of our future performance and should not be relied on to predict our future results. In the future, our operating results in a particular period may not meet the expectations of any securities analysts whose attention we may attract, or those of our investors, which may result in a decline in the market price of our common stock.

We rely on the efforts of Neurocrine and Pfizer and ultimately Merck for the development, design and implementation of clinical trials, regulatory approval and commercialization of indiplon and our product candidates DOV 216,303 and DOV 21,947.

In 1998, we sublicensed indiplon to Neurocrine without retaining any material rights other than the right to receive milestone payments and royalties on product sales, if any. In December 2002, Neurocrine entered into a development and commercialization agreement with Pfizer for indiplon. In August 2004, we sublicensed DOV 216,303 for certain indications and DOV 21,947 for all indications to Merck without retaining any material rights other than our participation in the ongoing clinical plan collaboration, the right to receive milestone payments and royalties on product sales, if any, and co-promotion. The clinical development, design and implementation of clinical trials, the preparation of filings for FDA approval and, if approved, the subsequent commercialization of these product candidates are within the control of our partners. We will lack control over the process and, as a result, our ability to receive any revenue from these product candidates is dependent on the success of their efforts. Our partners may fail or otherwise decide not, or otherwise not have the ability, to devote the resources necessary to successfully develop and commercialize the product candidates, which would impair our ability to receive milestone or royalty payments, if any, in respect of the product candidates.

We entered into an amendment of our license agreement with Merck on August 5, 2005 which provides for us to conduct certain development of DOV 21,947 that would otherwise have been the responsibility of Merck under the terms of the agreement. Merck has the right to choose one of our preclinical triple reuptake inhibitors for inclusion under the license agreement with no further up-front fee. In the event we are unable to produce successful results from these clinical trials under criteria to be agreed upon by the parties, Merck will not be obligated to reimburse our costs of such development. Merck is not presently performing any clinical studies with DOV 21,947 under this arrangement and continues to have the right to terminate the license agreement.

Our success in developing our product candidates depends upon the performance of our licensees and collaborative partners.

Our efforts to develop, obtain regulatory approval for and commercialize our existing and any future product candidates depend in part upon the performance of our licensees and collaborative partners. Currently, we have license and collaborative agreements with Merck, Neurocrine, Pfizer and Wyeth. Neurocrine has entered into a development and commercialization agreement with Pfizer involving a further sublicense under our agreement with Neurocrine. In connection with certain of these agreements, we have granted certain rights, including development and marketing rights and rights to defend and enforce our intellectual property. We do not have day-to-day control over the activities of our licensees or collaborative partners and cannot assure you that they will fulfill their obligations to us, including their development and commercialization responsibilities in respect of our product candidates. Our license agreement with Merck was amended on August 5, 2005 to provide that we would assume responsibility for certain development of DOV 21,947 that Merck would have otherwise been responsible for under the agreement. Merck is not presently performing any clinical studies under this arrangement and continues to have the right to terminate the license agreement. We also cannot assure you that our licensees or collaborators will properly maintain or defend our intellectual property rights or that they will not utilize our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability. Further, we cannot assure you that our licensees or collaborators will not encounter conflicts of interest, or changes in business strategy, or that they will not acquire or develop rights to competing products, all of which could adversely affect their willingness or ability to fulfill their obligations to us.
 

26



From January 1999 until October 21, 2003, Elan and we were engaged in developing controlled release formulations of bicifadine and ocinaplon pursuant to our joint venture. In October 2003, we acquired from Elan 100% ownership of Nascime, the joint venture's operating subsidiary, and the product candidates bicifadine and ocinaplon. This acquisition ended our involvement with Elan in the nearly five-year joint venture. In March 2003, we and Biovail terminated our collaboration for DOV diltiazem.
 
Any failure on the part of our licensees or collaborators to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our product candidates and affect our ability to realize product revenues. Disagreements with our licensees or collaborators could require or result in litigation or arbitration, which could be time-consuming and expensive. If we or our licensees or collaborators fail to maintain our existing agreements or establish new agreements as necessary, we could be required to undertake development, manufacturing and commercialization activities solely at our own expense. This would significantly increase our capital requirements and may also delay the commercialization of our product candidates.

Under the August 5, 2005, amendment to our license agreement with Merck, we are now responsible for designing, conducting and bearing the costs of certain clinical trials that Merck would have otherwise been obligated to perform under the terms of the license agreement. If the results of these clinical trials do not meet the criteria of success to be agreed upon with Merck, we may not be reimbursed for the costs of conducting such trials, unless Merck agrees. If Merck does not continue the license agreement, our business and results may be adversely affected.

On August 5, 2005, we amended our license agreement with Merck such that we are now responsible for conducting certain development of DOV 21,947 that had been the responsibility of Merck under the agreement. Merck has the right to choose one of our preclincial triple reuptake inhibitors for inclusion under the agreement with no further up-front fee. In the event we are unable to produce successful results from these clinical trials under criteria of success to be agreed upon by the parties, Merck will not be obligated to reimburse our costs of such development. Merck is not presently performing any clinical studies with DOV 21,947 under this arrangement and continues to have the right to terminate the license agreement. If the trials are not successful, Merck may elect to reimburse us notwithstanding and retain DOV 21,947. If the Merck agreement is terminated, we will need to pursue alternative arrangements for the development and commercialization of DOV 21,947, and we may be unable to reach an agreement with another party on economic terms as favorable as those in the Merck agreement.

The independent clinical investigators and contract research organizations that we rely upon to assist in the conduct of our clinical trials may not be diligent, careful or timely, and may make mistakes, in the conduct of our trials.

We depend on independent clinical investigators and contract research organizations, or CROs, to assist in the conduct of our clinical trials under their agreements with us. The investigators are not our employees, and we cannot control the amount or timing of resources that they devote to our programs. If independent investigators fail to devote sufficient time and resources to our drug development programs, or if their performance is substandard, it will delay the approval of our FDA applications and our introduction of new drugs. The CROs we contract with to assist with the execution of our clinical trials play a significant role in the conduct of the trials and the subsequent collection and analysis of data. Failure of the CROs to meet their obligations could adversely affect clinical development of our products. Moreover, these independent investigators and CROs may also have relationships with other commercial entities, some of which may compete with us. If independent investigators and CROs assist our competitors at our expense, it could harm our competitive position.

Our existing collaborative and licensing agreements contain, and any such agreements that we may enter into in the future may contain, covenants that restrict our product development and commercialization activities.
 

27



Our existing license and collaborative agreements contain covenants that restrict our product development and our ability to compete in collaborative agreements. In addition, certain of our agreements no longer effective have involved, among other things, restrictions on the issuance of debt and equity securities and limitations on our ability to license our product candidates to third parties. Because of existing restrictive covenants, if our licensees or collaborators fail to fulfill their obligations to us or we are otherwise not able to maintain these relationships, we cannot assure you that we will be able to enter into alternative arrangements or assume the development of these product candidates ourselves. This would significantly affect our ability to commercialize our product candidates. Further, we cannot assure you, even if alternative arrangements are available to us, that they will be any less restrictive on our business activities.

If we are unable to create sales, marketing and distribution capabilities, or enter into agreements with third parties to perform these functions, we will not be able to commercialize our product candidates.

We do not have any sales, marketing or distribution capabilities. In order to commercialize our product candidates, if any are approved, we must either acquire or internally develop sales, marketing and distribution capabilities or make arrangements with third parties to perform these services for us. If we obtain FDA approval for our existing product candidates, we intend to rely on relationships with one or more pharmaceutical companies or other third parties with established distribution systems and direct sales forces to market our product candidates. If we decide to market any of our product candidates directly, we must either acquire or internally develop a marketing and sales force with technical expertise and supporting distribution capabilities. The acquisition or development of a sales and distribution infrastructure would require substantial resources, which may divert the attention of our management and key personnel, and negatively impact our product development efforts. Moreover, we may not be able to establish in-house sales and distribution capabilities or relationships with third parties. To the extent we enter into co-promotion or other licensing agreements, our product revenues are likely to be lower than if we directly marketed and sold our product candidates, and any revenue we receive will depend upon the efforts of third parties, which may not be successful.

If we cannot raise additional funding, we may be unable to complete development of our product candidates.

At December 31, 2005, we had cash and cash equivalents and marketable securities of $97.6 million. We currently have no commitments or arrangements for any financing. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our anticipated operating expenses, debt obligations and capital requirements until at least March 31, 2007. We believe that we will require additional funding to continue our research and development programs, including preclinical testing and clinical trials of our product candidates, for operating expenses and to pursue regulatory approvals for our product candidates. We may continue to seek additional capital through public or private financing or collaborative agreements. If adequate funds are not available to us as we need them, we may be required to curtail significantly or eliminate at least temporarily one or more of our product development programs.

Our indebtedness and debt service obligations may adversely affect our cash flow, cash position and stock price.
 
In December 2004 and January 2005, we sold $80.0 million aggregate principal amount of 2.5% subordinated convertible debentures due in January 2025. Our annual debt service obligation on these debentures is $2.0 million. The holders of the debentures may require us to purchase all or a portion of their debentures on January 15, 2012, January 15, 2015 and January 15, 2020. If we issue other debt securities prior to conversion of the debentures, our debt service obligations will increase further.
 
We intend to fulfill our debt service obligations from our existing cash, cash equivalents and marketable securities. In the future, if the holders require us to purchase all or a portion of their debentures and we are unable to generate cash or raise additional cash through financings sufficient to meet these obligations, we may have to delay or curtail research, development and commercialization programs. The holders’ right to require us to purchase the debentures, prior to maturity in January 2025, may be exercised in January 2012, 2015 and 2020.
 

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The success of our business depends upon the members of our senior management team, our scientific staff and our ability to continue to attract and retain qualified scientific, technical and business personnel.

We are dependent on the principal members of our management team and scientific staff for our business success. The loss of any of these people could impede the achievement of our development and business objectives. We do not carry key man life insurance on the lives of any of our key personnel. There is intense competition for human resources, including management, in the scientific fields in which we operate and there can be no assurance that we will be able to attract and retain qualified personnel necessary for the successful development of our product candidates, and any expansion into areas and activities requiring additional expertise. In addition, there can be no assurance that such personnel or resources will be available when needed. In addition, we rely on a significant number of consultants to assist us in formulating our research and development strategy and other business activities. All of our consultants may have commitments to, or advisory or consulting agreements with, other entities that may limit their availability to us.

We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

As is commonplace in the biotechnology industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

Because some of our patents with respect to some of our product candidates have expired or will expire in the near term, we may be required to rely solely on the Hatch-Waxman Act for market exclusivity.

A number of patents that we licensed from Wyeth have expired, including certain patents that provide protection for the use of DOV 216,303 for the treatment of depression, the use of bicifadine for the treatment of pain and the use of ocinaplon for anxiety. Patents protecting intermediates useful in the manufacture of ocinaplon are due to expire in 2007. The numerous patent applications pending and others in preparation covering our compounds, even if filed and approved, may not afford us adequate protection against generic versions of our product candidates or other competitive products. In the event we achieve regulatory approval to market any of our product candidates, including bicifadine, DOV 216,303 or ocinaplon, and we are unable to obtain adequate patent protection for the ultimate marketed product, we will be required to rely to a greater extent on the Hatch-Waxman Act, and applicable foreign legislation, to achieve market exclusivity. The Hatch-Waxman Act generally provides for marketing exclusivity to the first applicant to gain approval for a particular drug by prohibiting filing of an abbreviated NDA, or ANDA, by a generic competitor for up to five years after the drug is first approved. The Hatch-Waxman Act, however, also accelerates the approval process for generic competitors using the same active ingredients once the period of statutory exclusivity has expired. It may also in practice encourage more aggressive legal challenges to the patents protecting approved drugs. In addition, because some of our patents have expired, third parties may develop competing product candidates using our product compounds and if they obtain regulatory approval for those products prior to us, we would be barred from seeking an ANDA for those products under the Hatch-Waxman Act for the applicable statutory exclusivity period.

Our business activities require compliance with environmental laws, which if violated could result in significant fines and work stoppage.

Our research and development programs, and the manufacturing operations and disposal procedures of our contractors and collaborators, are affected by federal, state, local and foreign environmental laws. Although we intend to use reasonable efforts to comply with applicable environmental laws, our contractors and collaborators may not comply with these laws. Failure to comply with environmental laws could result in significant fines and work stoppage, and may harm our business.
 

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We intend to pursue a rapid growth strategy, which could give rise to difficulties in managing and successfully implementing such growth.

We intend to pursue a strategy of growth, both with regard to infrastructure and personnel, and will seek to aggressively develop our current product candidates and to acquire new product candidates. In the event of rapid growth in our operations, we will need to hire additional personnel, some of whom, due to the specialized scientific and technical nature of our business, must possess advanced degrees, be highly skilled and have many years of experience. We may be unable to attract and retain the necessary qualified personnel, or such personnel may not be available when needed, to successfully meet our growth needs. We cannot assure you that we will be able to obtain the personnel needed to achieve such growth or that we will be able to obtain and maintain all regulatory approvals or employ the best personnel to ensure compliance with all applicable laws, regulations and licensing requirements that may be necessary as a result of such growth.

We currently do not have operational laboratory facilities. The absence of such facilities and technical staff requires us to rely on contract parties for all preclinical, formulations and analytical work. We have recently committed to a ten-year operating lease for 133,686 square feet facility in Somerset, New Jersey which is expected to serve as our corporate headquarters and principal place of business effective May 2006. This new facility has office and laboratory space. The use of such facilities, even if they lead to cost savings and improved control and turn-around time, is expected to require substantial management time, personnel transition and relocation costs. The facility will result in a higher level of fixed overhead.

Our bylaws require us to indemnify our officers and directors to the fullest extent permitted by law, which may obligate us to make substantial payments and in some instances payments in advance of judicial resolution of entitlement.

Our bylaws require that we indemnify our directors, officers and scientific advisory board members, and permit us to indemnify our other employees and agents, to the fullest extent permitted by the Delaware corporate law. This could require us, with some legally prescribed exceptions, to indemnify our directors, officers and scientific advisory board members against any and all expenses, judgments, penalties, fines and amounts reasonably paid in defense or settlement in connection with an action, suit or proceeding relating to their association with us. For directors, our bylaws require us to pay in advance of final disposition all expenses including attorneys' fees incurred by them in connection with any action, suit or proceeding relating to their status or actions as directors. Advance payment of legal expenses is discretionary for officers, scientific advisory board members and other employees or agents. We may make these advance payments provided that they are preceded or accompanied by an undertaking on behalf of the indemnified party to repay all advances if it is ultimately determined that he or she is not entitled to be indemnified by us. Accordingly, we may incur expenses to meet these indemnification obligations, including expenses that in hindsight are not qualified for reimbursement and possibly not subject to recovery as a practical matter.

Provisions of Delaware law, our charter and by-laws and our stockholders rights plan may make a takeover more difficult.

Provisions of our certificate of incorporation and by-laws and in the Delaware corporate law may make it difficult and expensive for a third party to pursue a tender offer, change in control or takeover attempt that is opposed by our management and board of directors. Moreover, our stockholders rights plan, adopted in October 2002, commonly called a poison pill, empowers our board of directors to delay or negotiate, and thereby possibly to thwart, any tender or takeover attempt the board of directors opposes. Public stockholders who might desire to participate in such a transaction may not have an opportunity to do so. We also have a staggered board of directors that makes it difficult for stockholders to change the composition of our board of directors in any one year. These anti-takeover provisions could substantially impede the ability of public stockholders to change our management and board of directors.
 

30



Risks Related to our Industry

We face intense competition and if we are unable to compete effectively, the demand for our products, if any, may be reduced.

The pharmaceutical industry is highly competitive and marked by a number of established, large pharmaceutical companies, as well as smaller emerging companies, whose activities are directly focused on our target markets and areas of expertise. We face and will continue to face competition in the discovery, in-licensing, development and commercialization of our product candidates, which could severely impact our ability to generate revenue or achieve significant market acceptance of our product candidates. Furthermore, new developments, including the development of other drug technologies and methods of preventing the incidence of disease, occur in the pharmaceutical industry at a rapid pace. These developments may render our product candidates or technologies obsolete or noncompetitive.

We are focused on developing product candidates for the treatment of central nervous system and other disorders that involve alterations in neuronal processing. We have a number of competitors. If one or more of their products or programs are successful, the market for our product candidates may be reduced or eliminated. Compared to us, many of our competitors and potential competitors have substantially greater:
 
   ·
capital resources and access to capital;
   
   ·
research and development resources, including personnel and technology;
   
   ·
regulatory experience;
   
   ·
preclinical study and clinical testing experience; and
   
   ·
manufacturing, distribution and marketing experience.

As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than we. Our competitors may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates or technologies. Our competitors may also develop drugs that are more effective or useful and less costly than ours and may also be more successful than we and our collaborators or licensees in manufacturing and marketing their products.

If we are unable to protect our intellectual property, our competitors could develop and market products based on our discoveries, which may reduce demand for our product candidates.

To a substantial degree, our success will depend on the following intellectual property achievements:

   ·
our ability to obtain patent protection for our proprietary technologies and product candidates, as well as our ability to preserve our trade secrets;
   
   ·
the ability of our collaborators and licensees to obtain patent protection for their proprietary technologies and product candidates covered by our agreements, as well as their ability to preserve related trade secrets; and
   
   ·
our ability to prevent third parties from infringing upon our proprietary rights, as well as the ability of our collaborators and licensees to accomplish the same.

Because of the substantial length of time and expense associated with bringing new products through the development and regulatory approval processes in order to reach the marketplace, the pharmaceutical industry places considerable importance on obtaining patent and trade secret protection for new technologies, products and processes. Accordingly, we, either alone or together with our collaborators or licensees, intend to seek and enhance patent protection for our proprietary technologies and product candidates. The risk exists, however, that these patents may be unobtainable and that the breadth of the claims in a patent, if obtained, may not provide adequate protection of our, or our collaborators’ or licensees’ proprietary technologies or product candidates.
 

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We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our collaborators, licensees, employees and consultants. We also have invention or patent assignment agreements with our employees and some of, but not all, our collaborators and consultants. If our employees, collaborators or consultants breach these agreements or common law principles, we may not have adequate remedies for any such breach, and our trade secrets may otherwise become known to or independently discovered by our competitors.

In addition, although we own or otherwise have certain rights to a number of patents and patent applications, the issuance of a patent is not conclusive as to its validity or enforceability, and third parties may challenge the validity or enforceability of our patents or the patents of our collaborators or licensees. We cannot assure you how much protection, if any, will be given to our patents if we attempt to enforce them or if they are challenged in court or in other proceedings. It is possible that a competitor may successfully challenge our patents, or the patents of our collaborators or licensees, or that challenges will result in elimination of patent claims and therefore limitations of coverage. Moreover, competitors may infringe our patents, the patents of our collaborators or licensees, or successfully avoid them through design innovation. To prevent infringement or unauthorized use, we may need to file infringement claims, which are expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the ground that our patents do not cover its technology. In addition, interference proceedings brought by the U.S. Patent and Trademark Office may be necessary to determine the priority of inventions with respect to our patent applications or those of our collaborators or licensees. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and be a distraction to management. We cannot assure you that we, or our collaborators or licensees, will be able to prevent misappropriation of our respective proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States.

The intellectual property of our competitors or other third parties may prevent us from developing or commercializing our product candidates.

Our product candidates and the technologies we use in our research may inadvertently infringe the patents or violate the proprietary rights of third parties. In addition, other parties conduct their research and development efforts in segments where we, or our collaborators or licensees, focus research and development activities. We cannot assure you that third parties will not assert patent or other intellectual property infringement claims against us, or our collaborators or licensees, with respect to technologies used in potential product candidates. Any claims that might be brought against us relating to infringement of patents may cause us to incur significant expenses and, if successfully asserted against us, may cause us to pay substantial damages. Even if we were to prevail, any litigation could be costly and time-consuming and could divert the attention of our management and key personnel from our business operations. In addition, any patent claims brought against our collaborators or licensees could affect their ability to carry out their obligations to us. Furthermore, as a result of a patent infringement suit brought against us, or our collaborators or licensees, the development, manufacture or potential sale of product candidates claimed to infringe a third party’s intellectual property may have to stop or be delayed, unless that party is willing to grant certain rights to use its intellectual property. In such cases, we may be required to obtain licenses to patents or proprietary rights of others in order to continue to commercialize our product candidates. We may not, however, be able to obtain any licenses required under any patents or proprietary rights of third parties on acceptable terms, or at all. Even if we, or our collaborators or licensees were able to obtain rights to a third party’s intellectual property, these rights may be non-exclusive, thereby giving our competitors potential access to the same intellectual property. Ultimately, we may be unable to commercialize some of our potential products or may have to cease some of our business operations as a result of patent infringement claims, which could severely harm our business.

Our ability to receive royalties and profits from product sales depends in part upon the availability of approved reimbursement for the use of our products from third-party payors, for which we may or may not qualify.
 

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Our royalties or profits will be heavily dependent upon the availability of reimbursement for the use of our products from third-party health care payors, both in the United States and in foreign markets. The health care industry and these third-party payors are experiencing a trend toward containing or reducing the costs of health care through various means, including lowering reimbursement rates and negotiating reduced payment schedules with service providers for drug products. These cost-containment efforts could adversely affect the market acceptance of our product candidates and may also harm our business. There can be no assurance that we will be able to offset any of the payment reductions that may occur.

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:

  ·
safe, effective and medically necessary;
   
  ·
appropriate for the specific patient;
   
  ·
cost-effective; and
   
  ·
neither experimental nor investigational.

Reimbursement approval is required from each third-party payor individually, and seeking this approval is a time-consuming and costly process. Third-party payors may require cost-benefit analysis data from us in order to demonstrate the cost-effectiveness of any product we might bring to market. We cannot assure you that we will be able to provide data sufficient to gain acceptance with respect to reimbursement. There also exists substantial uncertainty concerning third-party reimbursement for the use of any drug product incorporating new technology. We cannot assure you that third-party reimbursement will be available for our product candidates utilizing new technology, or that any reimbursement authorization, if obtained, will be adequate. If such reimbursement approval is denied or delayed, the marketability of our product candidates could be materially impaired.

We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product and may have to limit its commercialization.

The use of our product candidates in clinical trials and the sale of any approved products may expose us to a substantial risk of product liability claims and the adverse publicity resulting from such claims. These claims might be brought against us by study participants or once a drug has received regulatory approval and is marketed, by consumers, health care providers, pharmaceutical companies or others selling our products. If we cannot successfully defend ourselves against these claims, we may incur substantial losses or expenses, or be required to limit the commercialization of our product candidates. We have obtained limited product liability insurance coverage for our clinical trials in the amount of $10 million per occurrence and $10 million in the aggregate. Our insurance coverage, however, may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. We intend to expand our insurance coverage to include the sale of commercial products if we obtain marketing approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us would decrease our cash and could cause our stock price to fall.

We may not be able to utilize any of or all our net operating losses to offset future taxable income.

As a company experiencing growth through the sale of equity, we may be limited under the tax code in the tax deductions we can take against income for net operating loss carryforwards if during the three years preceding such income shareholder control of our company changed to a significant degree or if our research and development expenditures were incurred by our subsidiary Nascime Limited outside the United States.
 

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None.
 

We currently lease and occupy approximately 41,137 square feet in our executive offices located in Hackensack, New Jersey. However we recently provided notice to our existing landlord that we would vacate the existing premises. As our existing lease contained a provision for early termination, we will only be required to pay for rent at our current facility through August 2006. We recently committed to a ten-year operating lease for a 133,686 square foot facility in Somerset, New Jersey which is expected to serve as our corporate headquarters and principal place of business effective May 2006. This new facility has laboratory and office space. See “Item 9B. Other Information” for a description of the lease for our new facility.


We are not a party to any material legal proceedings.


No matters were submitted to a vote of security holders, through the solicitation of proxies or otherwise, during the fourth quarter of the fiscal year covered by this Form 10-K.
 
 
PART II

 
Our common stock is traded on the Nasdaq National Market under the symbol DOVP.
 
The following table sets forth the high and low sales prices for our common stock, as quoted on the Nasdaq National Market, for each quarter since our initial public offering on April 24, 2002. The purchase price to underwriters on that date was $13.00.
 

 
 
High
 
Low
 
 
Year 2004
             
First Quarter
 
$
17.97
 
$
12.26
 
Second Quarter
   
20.17
   
11.60
 
Third Quarter
   
17.16
   
12.66
 
Fourth Quarter
   
19.82
   
16.05
 
 
Year 2005
             
First Quarter
 
$
18.40
 
$
12.79
 
Second Quarter
   
19.37
 
$
13.57
 
Third Quarter
   
21.49
 
$
14.66
 
Fourth Quarter
   
17.02
 
$
13.63
 
 
Year 2006
             
First Quarter (through March 1, 2006)
 
$
19.76
 
$
14.07
 
 
As of December 31, 2005, there were approximately 14 stockholders of record of our common stock. We cannot estimate with any confidence or accuracy how many beneficial owners are represented by the stockholders of record.

We have not paid any cash dividends on our common stock since inception and do not anticipate paying cash dividends in the foreseeable future.

See Part III, Item 12 of this Form 10-K for information regarding securities authorized for issuance under equity compensation plans.
 

34

 


The following selected financial data should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and with our financial statements and related notes and other financial data included in Part II, Items 7 and 8 in this Form 10-K.

The following tables present selected financial data at and for the years ended December 31, 2001, 2002, 2003, 2004 and 2005. The statement of operations data for the years ended December 31, 2003, 2004 and 2005, and the balance sheet data at December 31, 2004 and 2005, have been derived from our audited financial statements included in Part II, Item 8 in this Form 10-K. The balance sheet data as of December 31, 2001, 2002 and 2003 and the statements of operations data for the year ended December 31, 2001 and 2002, have been derived from our audited financial statements not included in this Form 10-K.
 
 
 
Years Ended December 31,
 
 
 
2001
 
2002
 
2003
 
2004
 
2005
 
Statement of Operations Data:
 
(in thousands, except per share data)
Revenue
 
$
5,711
 
$
2,390
 
$
2,969
 
$
2,542
 
$
8,647
 
Operating expenses:
                               
License expense
   
1,111
   
   
1,000
   
2,500
   
 
Research and development expense
   
5,525
   
10,311
   
22,684
   
24,764
   
53,983
 
General and administrative expense
   
2,343
   
3,903
   
5,173
   
6,360
   
9,110
 
Loss from operations
   
(3,268
)
 
(11,824
)
 
(25,888
)
 
(31,082
)
 
(54,446
)
Loss in investment in DOV Bermuda
   
(1,434
)
 
(1,017
)
 
   
   
 
Interest income
   
366
   
1,067
   
851
   
934
   
3,712
 
Interest expense
   
(1,491
)
 
(2,017
)
 
(2,947
)
 
(2,954
)
 
(2,502
)
Other income (expense), net
   
423
   
(3,029
)
 
1,104
   
(8
)
 
(5
)
Net loss before tax
   
(5,404
)
 
(16,820
)
 
(26,880
)
 
(33,110
)
 
(53,241
)
Income tax benefit
   
   
   
149
   
189
   
273
 
Net loss
   
(5,404
)
 
(16,820
)
 
(26,731
)
 
(32,921
)
 
(52,968
)
Deemed dividend on issuance of series D preferred
   
(97
)
 
   
   
   
 
Net loss attributable to common stockholders
 
$
(5,501
)
$
(16,820
)
$
(26,731
)
$
(32,921
)
$
(52,968
)
Basic and diluted net loss per share
 
$
(1.12
)
$
(1.47
)
$
(1.73
)
$
(1.67
)
$
(2.32
)
Weighted average shares used in computing basic and
diluted net loss per share
   
4,894,138
   
11,440,731
   
15,489,426
   
19,729,765
   
22,837,265
 

   
As of December 31,
 
   
2001
 
2002
 
2003
 
2004
 
2005
 
Balance Sheet Data:
 
(in thousands)
Cash and cash equivalents and marketable securities
 
$
13,652
 
$
60,346
 
$
52,162
 
$
132,222
 
$
97,552
 
Working capital(1)
   
11,831
   
54,114
   
46,516
   
91,334
   
78,516
 
Total assets
   
18,080
   
66,150
   
53,852
   
136,723
   
102,187
 
Long-term debt
   
12,796
   
13,800
   
14,886
   
65,000
   
80,000
 
Redeemable preferred stock
   
14,838
   
   
   
   
 
Accumulated deficit
   
(23,845
)
 
(40,665
)
 
(67,396
)
 
(100,317
)
 
(153,285
)
Total stockholders' (deficit) equity
   
(18,036
)
 
40,759
   
35,905
   
27,936
   
(19,301
)
(1) Represents current assets less current liabilities.
 

35


 

Executive Overview

We are a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system, or CNS, disorders. In 1998, we licensed four of our product candidates for all indications from Wyeth: indiplon, for the treatment of insomnia, bicifadine, for the treatment of pain, ocinaplon, for the treatment among other indications of anxiety, and DOV 216,303, for the treatment of depression and other indications. In October 2005, we discontinued the development of ocinaplon for general anxiety disorder, or GAD.

Since our inception, we have incurred significant operating losses and we expect to do so for the foreseeable future. As of December 31, 2005, we had an accumulated deficit of $153.3 million. We have depended upon equity and debt financings and license fee and milestone payments from our collaborative partners and licensees to fund our research and product development programs and expect to do so for the foreseeable future.

We anticipate that our quarterly results of operations will fluctuate for several reasons, including the timing and extent of research and development efforts, the timing and extent of adding new employees and infrastructure, the timing of milestone, license fee and royalty payments and the timing and outcome of regulatory approvals.

In pursuing our strategy, we enter into collaboration and/or license agreements with strategic partners from time to time. We currently have relationships with Neurocrine and Merck. In 1998, we sublicensed the worldwide development and commercialization of indiplon to Neurocrine in 1998 in exchange for the right to receive payments upon the achievement of certain clinical development milestones and royalties based on product sales, if any. Neurocrine subsequently entered into a worldwide development and commercialization agreement with Pfizer for indiplon. In 2004, we received a $2.0 million milestone payment from Neurocrine for the new drug application, or NDA, filing for indiplon. However, because the original NDA filing was not accepted by the FDA and our agreement with Neurocrine indicates that the $2.0 million milestone is earned once an NDA has been submitted according to certain FDA regulations, we recognized this payment as revenue once the filing was accepted by the FDA on June 14, 2005.

 On August 5, 2004, we entered into an agreement with Merck for the worldwide development and commercialization of all indications for DOV 21,947 and certain indications for DOV 216,303 in exchange for a $35.0 million up-front payment and the right to receive further payments of up to $420.0 million upon the achievement of certain milestones and royalties based on product net sales, if any. As described below this original agreement was amended in 2005. The up-front payment has been deferred and is being amortized to revenue over the estimated research and development period. As of June 1, 2005, we revised this estimate to 72 months from 51 months and, accordingly, the amortization of the remaining balance beginning June 1, 2005 reflects this revised time period. This adjustment to the estimate for the development period was made as a result of the need to collect and assess additional clinical data which has extended the total development timeline. The time period of the development period is a significant estimate used in the preparation of our financial statements and is subject to Merck developing the compound in accordance with the estimated development schedule. This development period estimate may fluctuate from period to period and the fluctuation may be significant. On August 5, 2005, we amended our agreement with Merck such that we have agreed to assume responsibility for certain development work for DOV 21,947, subject to reimbursement for certain of our development costs in certain circumstances. In addition, Merck is permitted to select an additional preclinical triple reuptake inhibitor product candidate for inclusion in the agreement with no further up-front fee.
 

36



Our revenue has consisted primarily of license fees and milestone payments from our collaborative partners and licensees. We record revenue on an accrual basis when amounts are considered collectible. In accordance with EITF 00-21, we evaluate all new agreements to determine if they are a single unit of accounting or separable. Revenue received in advance of performance obligations, or in cases where we have a continuing obligation to perform services, is deferred and amortized over the performance period. Revenue from milestone payments that represent the culmination of a separate earnings process is recorded when the milestone is achieved. Contract revenues are recorded as the services are performed. License and milestone revenue are typically not consistent or recurring in nature. Our revenue has fluctuated from year-to-year and quarter-to-quarter and this will likely continue.

Our operating expenses consist primarily of license expense, costs associated with research and development and general and administrative costs associated with our operations. Research and development expense consists primarily of compensation and other related costs of our personnel dedicated to research and development activities, clinical and preclinical trial expenses, including toxicology studies, costs of manufacturing clinical and preclinical trial materials and preclinical studies, and professional fees related to clinical trials. General and administrative expense consists primarily of the costs of our senior management, finance and administrative staff, business insurance, professional fees and costs associated with being a public reporting entity.

We are currently conducting three Phase III clinical trials for bicifadine, two Phase II clinical trials and four Phase I clinical trials. During 2006, we intend to initiate for bicifadine nine additional Phase I clinical trials and continue with other development activities in preparation for an NDA filing in chronic pain in 2007. With the change in development responsibilities for DOV 21,947 from Merck to DOV, we intend to initiate a Phase II clinical trial in 2006 as well as continue with other development activities for the drug candidate. We intend to continue the development of DOV 216,303 for the indications we have retained. We also expect to continue to fortify our patent portfolio for each of our lead product and discovery candidates. As we expand our development activities, we expect to increase our personnel and related expenses.

It is not unusual for the clinical development of these types of products to each take five to ten years or more, and for total development costs for each to exceed $100 million. We are not responsible financially for the clinical program for indiplon, and we are unable to estimate the amount of expenditures necessary to complete its development. As of December 31, 2005, we have spent approximately $52.5 million on the development of bicifadine in connection with its clinical development program. As of December 31, 2005, we have incurred approximately $2.5 million, $3.7 million and $3.7 million in development expenses for DOV 21,947, DOV 102,677 and DOV 216,303, respectively. Prior to discontinuing development of ocinaplon for GAD in the fourth quarter of 2005, we incurred approximately $26.1 million in its development.

We expect that the development of our product candidates in clinical development will require substantial additional time and expense. The time and cost of completing the clinical development of our product candidates will depend on a number of factors, including the disease or medical condition to be treated, clinical trial design and endpoints, availability of patients to participate in trials, the results of clinical trials, the number of clinical trials required to be conducted, unanticipated trials, the length of time of the regulatory review process, the relative efficacy of the product versus treatments already approved and our ability to enter into new development collaborations. In light of these many uncertainties, we are unable to estimate with absolute certainty the length of time or costs required to complete the development of these product candidates.

In January 1999, Elan loaned us $8.0 million in the form of a 7% convertible promissory note to fund our investment in DOV Bermuda. In May 2004, Elan converted the entire outstanding principal and accrued interest of this note totaling $11.6 million on that date into 2,907,162 shares of our common stock. Elan agreed, in January 1999, to lend us up to $7.0 million to fund our pro rata share of research and development funding in DOV Bermuda, a joint venture we had entered into with Elan. For this purpose, we issued to Elan a convertible line of credit promissory note bearing interest at 10% per annum compounded semi-annually on the amount outstanding. This convertible line of credit promissory note was sold to an institutional holder during 2004 and upon maturity on January 20, 2005, was converted into 1,180,246 shares of our common stock.


37



During 2003, we granted options and warrants to outside consultants at fair value on the date of grant in exchange for future services. These options and warrants are required to be accounted for in accordance with Statement of Financial Accounting Standards, or SFAS 123 "Accounting for Stock Based Compensation" and EITF 96-18 "Accounting for Equity Instruments that are Issued to other than Employees for Acquiring, or in Conjunction with Selling Goods or Services" and at the fair value of the consideration received, or the fair value of the equity instrument issued, whichever may be more readily measured. As the performance of services is completed, we revalue the options and warrants that have been earned during the period. We valued these securities at the fair value using a Black-Scholes methodology. During 2005, 2004 and 2003, in connection with the grant of these stock options and warrants to outside consultants, we recorded a reduction in operating expenses of $195,000 and expenses totaling $315,000 and $694,000, respectively. We may be required to record additional expense on a quarterly basis based upon increases in the fair value of our common stock. Please refer to note 9 of our financial statements, “Stock Option Plans - Non-Employee Options and Warrants,” included under Part II, Item 8 of this Form 10-K.

Results of Operations

Years Ended December 31, 2005 and 2004

Revenue. Revenue increased $6.1 million to $8.6 million in 2005 from $2.5 million in 2004. In 2005 and 2004, our revenue was comprised of $6.6 million and $2.4 million, respectively, of amortization of the $35.0 million fee we received on the signing of the license, research and development agreement for our collaboration with Merck. The up-front payment has been deferred and is being amortized to revenue over the estimated research and development period. As of June 1, 2005, we revised this estimate to 72 months from 51 months and, accordingly, the amortization of the remaining balance beginning June 1, 2005 reflects this revised time period. This adjustment to the estimate for the development period was made as a result of the need to collect and assess additional clinical data, which has extended the total development timeline. In addition, in 2005 we recorded $2.0 million for the achievement of a milestone under the Neurocrine agreement described above. In 2004, we recorded $140,000 of contract services revenue associated with work we performed under the Merck collaboration.
 
License Expense. License expense for 2004 is comprised of the $2.5 million paid to Wyeth for the licensing of certain rights to DOV 216,303 to Merck in August 2004. As this milestone payment was made prior to FDA approval of a drug developed from DOV 216,303, the entire amount was expensed in the third quarter of 2004.  
 
Research and Development Expense. Research and development expense increased $29.2 million to $54.0 million in 2005 from $24.8 million in 2004. The increase in research and development expense was primarily associated with increased external development costs of $23.4 million, compensation and related expenses of $3.7 million and associated overhead of $2.1 million as we increased our personnel to support our expanded programs, offset by a decrease in non-cash stock compensation to outside consultants of $183,000. Included in the increase in external development costs is an increase of $20.1 million for bicifadine, $2.1 million for ocinaplon, $716,000 for DOV dilitazem, $332,000 for DOV 102,677 and $2.3 million for our discovery and preclinical programs offset by a decrease in costs of $996,000 for DOV 21,947, $856,000 for DOV 51,892 and $305,000 for DOV 216,303. We expect research and development costs for DOV 21,947 to increase in future periods as we have assumed responsibility under our relationship with Merck for certain development activities. In certain circumstances, we may be eligible for reimbursement from Merck of certain of these development costs at a premium.
 

38



General and Administrative Expense. General and administrative expense increased $2.7 million to $9.1 million in 2005 from $6.4 million in 2004. The increase was primarily attributable to an increase in compensation expense of $2.4 million and professional fees of $365,000. The increase in compensation expense is due primarily to $790,000 in severance expense related to the termination of employment of our co-founder Dr. Lippa, $809,000 in non-cash compensation expense related to the amortization of the restricted stock granted to Dr. Hudson upon his appointment as Chief Executive Officer in July 2005 and to Dr. Lippa, our former Chief Executive Officer, in May 2005 (please refer to note 8 of our financial statements included under Part II, Item 8 of this Form 10-K) and $497,000 related to salaries and $323,000 related to payroll overhead expenses as we increased our personnel to support our operations. Professional fees increased primarily due to an increase in consulting fees of $237,000 and in legal fees of $295,000.

Interest Income. Interest income increased $2.8 million to $3.7 million from $934,000 in 2004 primarily due to higher average cash balances and the increase in average interest rates over the period.

Interest Expense. Interest expense decreased $452,000 to $2.5 million in 2005 from $3.0 million in 2004. We recorded an increase in interest expense of $2.0 million on the convertible debentures placed in December 2004 and January 2005 and $400,000 in amortization of deferred charges on this debt in 2005. This increase was offset by a decrease of $2.9 million of interest recorded on our convertible promissory note and convertible line of credit promissory note in 2004. This decrease was due to the conversion of the notes in May 2004 and January 2005.

Other Expense, net. Other expense, net was de minimis and was virtually unchanged from prior year.

Income Tax Benefit. In 2005 and 2004 we sold a portion of our previous years’ state net operating losses as part of the New Jersey Economic Development Authority technology business tax certificate program, thus recognized an income tax benefit of $273,000 and $290,000, respectively. In 2004, taking into account the $35.0 million up-front fee we received on the closing of the license, research and development agreement for our collaboration with Merck, we generated taxable income for the 2004 tax year under the New Jersey alternative minimum assessment thus recognized income tax expense to $101,000.

Years Ended December 31, 2004 and 2003

Revenue. Revenue decreased $426,000 to $2.5 million from $3.0 million in 2003. In 2004, our revenue was comprised of $2.4 million of amortization of the $35.0 million fee we received on the signing of the license, research and development agreement for our collaboration with Merck and $140,000 of contract services revenue associated with work we performed under the collaboration. The up-front payment was recorded as deferred revenue and was being amortized to revenue over the estimated research and development period of 51 months. This estimate was revised in 2005 to 72 months. In 2003, revenue was comprised solely of the recognition of $3.0 million of deferred revenue from the Biovail agreement as described below.

On March 28, 2003 we entered into a separation agreement with Biovail that provided for the return of our December 2000 patent for the immediate and controlled release formulation of diltiazem and termination of the 2001 exclusive license agreement with Biovail for development of the DOV compound for the treatment of angina and hypertension. As the separation agreement ends our performance obligations, we recognized the remaining deferred revenue, totaling $3.0 million as of December 31, 2002, as revenue in the first quarter of 2003. Going forward, we will not record any additional revenue from Biovail for this product candidate.

License Expense.  License expense increased $1.5 million to $2.5 million in 2004 from $1.0 million in 2003. License expense for 2004 is comprised of the $2.5 million paid to Wyeth for the licensing of certain rights to DOV 216,303 to Merck in August 2004. As this milestone payment is prior to FDA approval, the entire amount was expensed in the third quarter of 2004. In connection with the termination in 2003 of the 2001 Biovail agreement and the return of the patent as described below, we agreed to a $1.0 million payment to Biovail upon signing. This payment was to obtain the patent and related clinical data from Biovail. As this product will require FDA approval prior to marketing and the patent has no alternative future use, we expensed the entire license fee in 2003.
 

39



In January 2001, Biovail and we entered into a license, research and development agreement to develop, manufacture and market DOV diltiazem for the treatment of angina and hypertension. Through January 2003, DOV diltiazem was being jointly developed through the collaborative arrangement. In March 2003, we entered into a separation agreement with Biovail that provided for the return of our December 2000 patent for the immediate release and controlled release formulations of diltiazem and termination of the 2001 exclusive license agreement with Biovail for the development of DOV diltiazem.
 
Research and Development Expense. Research and development expense increased $2.1 million to $24.8 million in 2004 from $22.7 million in 2003. However, in 2003, research and development expense included $5.3 million for the purchase of the remaining interest in bicifadine and ocinaplon discussed below. Therefore the overall relative increase was approximately $7.4 million of which approximately $5.7 million of the increase was attributable to increased costs associated with the clinical development for bicifadine, including an increase of $3.5 million in manufacturing and packaging related costs associated with clinical and pre-clinical trial materials and $1.1 million in toxicology costs, and $1.2 million in clinical trial expenditures. In addition we increased our expenditures on two of our preclinical compounds in preparation for moving these two compounds into clinical trials in 2005. For DOV 102,677 we increased our expenditures by $1.7 million and for DOV 51,892 by $1.1 million. We increased our expenditures on DOV 21,947 by $636,000. As a result of the prolonged clinical trial hold for ocinaplon, we decreased our expenditures on this compound in 2004 by $3.1 million and also had a decrease in costs for DOV 216,303 of $229,000. These decreases were offset by an increase in expenditures for DOV diltiazem of $335,000 and in our general preclinical and research and development program of $433,000. The remaining increase in research and development expense was attributable to an increase in costs associated with payroll and overhead allocated of $1.1 million offset by a decrease in professional fees including consulting and medical writing of $332,000. Non-cash compensation expense for consultants and employees decreased $386,000.

In the fourth quarter of 2003 we paid $5.0 million for the purchase of Elan’s interest in Nascime Limited and the joint venture product candidates, bicifadine and ocinaplon, and $306,000 for transfer taxes associated with the acquisition. The purchase relates to early stage technology that, in our opinion, has not yet reached technological feasibility, since the products will ultimately require regulatory approval prior to commercialization. Therefore, the $5.3 million purchase price was expensed as in-process research and development in the fourth quarter of 2003.
 
General and Administrative Expense. General and administrative expense increased $1.2 million to $6.4 million in 2004 from $5.2 million in 2003. The increase was primarily attributable to increased office and related expenses of $293,000, increased professional fees of $292,000, and increased payroll related costs associated with our increase in personnel of $602,000. The increase in office and related expenses was primarily related to an increase in directors’ and officers’ insurance of $104,000, fees and permits of $95,000, travel and entertainment expense of $74,000 and rent expense of $29,000. The increase in professional fees was primarily related to an increase in accounting fees of $320,000 and an increase in recruitment fees of $114,000, offset by a reduction in legal expenses of $144,000. The increase in payroll costs was primarily attributable to an increase in salaries of $779,000 and an increase in payroll overhead of $55,000 offset by a decrease in non-cash compensation expense for consultants and employees of $254,000.

Interest Income. Interest income increased $83,000 to $934,000 from $851,000 in 2003 primarily due to the increase in average interest rates over the period.

Interest Expense. Interest expense remained relatively unchanged as we recorded $3.0 million in 2004 and $2.9 million in 2003. In May 2004, the holder of the convertible promissory note converted the outstanding principal and accrued interest totaling $11.6 million into 2,907,162 shares of our common stock, thus reducing the contractual interest expense recorded in 2004 by $432,000 from 2003. We recorded contractual interest expense of $372,000 on our convertible line of credit promissory note in 2004 and $337,000 in the comparable period in 2003. Both the convertible promissory note and convertible line of credit promissory note contained interest payable either in cash or common stock at the holder's option. In accordance with EITF 00-27, we evaluate this conversion feature each time interest is accrued to the notes. This feature resulted in additional interest expense of $2.2 million in 2004 a net increase of $368,000 from 2003, due primarily to the increase in the fair value of our common stock offset by the reduction due to the conversion of the convertible promissory note. On January 20, 2005, the convertible line of credit promissory note was converted into 1,180,246 shares of our common stock.
 

40



Other Income (Expense), net. Other income (expense), net decreased $1.1 million to $8,000 in other expense, net in 2004 from $1.1 million in other income, net in 2003. In 2003, other income, net, consisted primarily of the $1.6 million in other income attributable to the directors’ and officers’ insurance recovery discussed below, offset by a decrease in the value of warrants to acquire Neurocrine common stock of $251,000 and loss on sale of securities of $191,000. Following a decline in the aftermarket trading price of our common stock in connection with our initial public offering, beginning on April 30, 2002, a number of class action lawsuits were filed naming us as defendants, in addition to certain of our officers and directors and certain of our underwriters. On December 20, 2002, we entered into a settlement agreement, which was approved by the court on April 16, 2003, to settle these lawsuits. In connection with the settlement, we reached an agreement with the primary carrier of our directors' and officers' liability insurance policy. In that regard, our insurance carrier paid $1.6 million to us in settlement of the shareholder class action lawsuits. 
 
Income Tax Benefit. In 2004 and 2003 we sold a portion of our previous years’ state net operating losses as part of the New Jersey Economic Development Authority technology business tax certificate program, thus recognized an income tax benefit of $290,000 and $149,000, respectively. In 2004, taking into account the $35.0 million up-front fee we received on the closing of the license, research and development agreement for our collaboration with Merck, we generated taxable income for the 2004 tax year under the New Jersey alternative minimum assessment thus recognized income tax expense to $101,000.
 
Liquidity and Capital Resources

For the three years ended December 31, 2005, 2004 and 2003, we funded our operations principally from sales of our equity and debt securities and license revenues. At December 31, 2005, our cash and cash equivalents and marketable securities totaled $97.6 million compared with $132.2 million at December 31, 2004. At December 31, 2005, we had working capital of $78.5 million.

Net cash used in operations during the year ended December 31, 2005 amounted to $48.3 million, as compared to net cash provided by operations of $7.8 million in 2004. The increase in cash used in operations resulted primarily from an increase in clinical development activities and increases in compensation expense. In addition, in 2004 net cash provided by operations benefited from the up-front licensing payment of $35.0 million received in 2004 discussed above. Net cash used in operations benefited from an increase in accounts payable and accrued liabilities of $10.4 million due to an increase in volume and timing of payments, offset by the realization of $2.0 million in milestone revenue received in 2004 but earned in 2005. Non-cash expenses related to stock-based compensation, interest expense and depreciation and amortization expenses were $1.7 million, $3.5 million and $4.2 million in the years ended December 31, 2005, 2004 and 2003, respectively. Non-cash amortization of premium paid on marketable securities and depreciation in the value of investments was $1.3 million, $909,000 and $1.4 million, net in the years ended December 31, 2005, 2004 and 2003, respectively. .

Net cash provided by investing activities during the year ended December 31, 2005 was $12.1 million compared to net cash used in investing activities of $61.9 million for the comparable period in 2004. This fluctuation resulted primarily from the timing differences in investment purchases, sales and maturities and the fluctuations in our portfolio mix between cash equivalents and short-term investment holdings. We expect similar fluctuations to continue in future periods.

Net cash provided by financing activities during the period ended December 31, 2005 was $15.6 million as compared to $73.7 million in the comparable period in 2004. Net cash provided by financing activities in the year ended December 31, 2005 was primarily related to net proceeds of $14.6 million from the issuance of $15.0 million of 2.5% subordinated convertible debentures in January 2005 as compared to $62.6 million from the issuance of $65.0 million of 2.5% subordinated convertible debentures in December 2004 and $10.0 million from the sale of our common stock to an institutional investor in March 2004.  
 

41



In February 2006, we committed to a ten year operating lease for a 133,686 sq. foot facility in Somerset, New Jersey which will serve as our corporate headquarters and principal place of business effective May 2006. In connection with this lease we have entered into a stand-by letter of credit facility for $4.2 million to serve as collateral for our performance under the lease. The stand-by letter of credit is collateralized by restricted cash and, as such, this cash is not available to us through March 2016. Our new facility, which includes expanded office space and laboratory facilities will result in an increase in our monthly occupancy costs.

Factors That May Affect Future Financial Condition and Liquidity

We believe that our existing cash and cash equivalents will be sufficient to fund our anticipated operating expenses, debt obligations and capital requirements until at least March 31, 2007. Our future capital uses and requirements depend on numerous factors, including:

  ·
our progress with research and development;
  ·
our ability to maintain and establish, and the scope of, collaborations that finance research and development of our clinical candidates;
  ·
the progress and success of clinical trials and preclinical studies of our product candidates;
  ·
the design, and Merck’s approval thereof, and progress of the clinical studies we have agreed to conduct on DOV 21,947 under the amendment of our license agreement with Merck;
  ·
the costs and timing of obtaining, enforcing and defending our patent and intellectual rights; and
  ·
the costs and timing of regulatory approvals.

In addition to the foregoing, our future capital uses and requirements are also dependent in part on the ability of our licensees and collaborative partners to meet their obligations to us, including the fulfillment of their development and commercialization responsibilities in respect of our product candidates. Our sublicensee and collaborative partners, Neurocrine, Pfizer and Merck, may encounter conflicts of interest, changes in business or clinical strategy, or they may acquire or develop rights to competing products, all of which could adversely affect their ability or willingness to fulfill their obligations to us and, consequently, require us to satisfy, through the commitment of additional funds or personnel or both, any shortfalls in their performance. In addition, our future capital uses and requirements have been impacted by our agreement to undertake certain development activities with respect to DOV 21,947 that Merck would have otherwise been responsible for under our original license agreement with Merck. We will be spending substantial funds in an amount to be determined as we conduct this development of DOV 21,947. If certain of these studies are successful when measured against criteria to be agreed upon with Merck, we will be reimbursed for our costs of conducting these development activities, receive a success premium on certain of these activities and be entitled to receive the first of the milestones under the license agreement. If the clinical studies are not successful, we may not be reimbursed for our costs and may never receive milestone payments under the license to Merck unless Merck elects to make such payments and continue the relationship under the license agreement. Moreover, Merck has reserved the right to terminate its license with us upon four months’ notice.

To meet future capital requirements, we may attempt to raise additional funds through equity or debt financings, collaborative agreements with corporate partners or from other sources. If adequate funds are not available, or available on an acceptable basis, we may be required to curtail or delay significantly one or more of our product development programs. In addition, future milestone payments under some of our collaborative or license agreements are contingent upon our meeting particular research or development goals. The amount and timing of future milestone payments are contingent upon the terms of each collaborative or license agreement. Milestone performance criteria are specific to each agreement and based upon future performance. Therefore, we are subject to significant variation in the timing and amount of our revenues, milestone expenses and results of operations from period to period.


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Contractual Obligations

Future minimum payments for all contractual obligations for years subsequent to December 31, 2005, are as follows:

   
Payments Due by Period
 
 
 
 
 
 
 
Less than
1 Year
 
1- 3
Years
 
3- 5
Years
 
More Than
5 Years
 
Total(2)
 
   
(in thousands)
 
Convertible subordinated debentures(1)
 
$
2,000
 
$
4,000
 
$
4,000
 
$
108,000
 
$
118,000
 
Operating leases (3) 
   
3,220
   
5,721
   
5,698
   
16,123
   
30,762
 
Total
 
$
5,220
 
$
9,721
 
$
9,698
 
$
124,123
 
$
148,762
 
 
 
(1)
Included are interest payments of approximately $2.0 million annually through 2025.
 
 
(2)
Excludes our obligations to Merck to fund clinical studies called for by the amendment to the license agreement with Merck inasmuch as we have reserved the right to terminate the amendment at any time.
 
 
(3)
In February 2006, we committed to a ten year operating lease for 133,686 sq. feet facility in Somerset, New Jersey which is expected to serve as our corporate headquarters and principal place of business effective May 2006. This lease commits us to annual fixed rent of $2.8 million for the first five years of the lease and $3.1 million for the next five years of the lease. In addition, in February 2006, we provided notice to our existing landlord that we would vacate the existing premises. As our existing lease contained a provision for early termination, we will only be required to pay for rent at our current facility through August 2006. Although the final agreements with respect to these transactions occurred after December 31, 2005 we have included the net amounts of these changes in operating lease obligations in the table.

The table above excludes future milestones and royalties that may be owed to Wyeth, Elan and Biovail under terms of existing agreements as payments are contingent upon future events. We do not expect to pay any royalties under these agreements in 2006. In May 1998, we licensed from Wyeth, on an exclusive, worldwide basis, indiplon, bicifadine, ocinaplon and DOV 216,303. We have the right to develop and commercialize these compounds, including the right to grant sublicenses to third parties, subject to Wyeth's right of first refusal. In February 2004, we entered into agreements to reorganize our exclusive license agreement with Wyeth in respect of these four compounds and our sublicense agreement with Neurocrine in respect of indiplon. Under the restated license agreements, if we sell the products ourselves, we are obligated to pay Wyeth royalties of 3.5% of net sales for ocinaplon and DOV 216,303 and 5.0% of net sales for bicifadine, and milestones of $2.5 million for ocinaplon and $5.0 million for bicifadine upon NDA filing and $4.5 million each for bicifadine, ocinaplon and DOV 216,303 upon a NDA approval. The royalty rate for bicifadine, ocinaplon and DOV 216,303 will increase by 0.5% should we partner or sublicense that compound. In addition, should we partner or sublicense a compound, the next milestone payable to Wyeth for that compound will be accelerated to become due upon partnering. As we have licensed certain rights to DOV 216,303 to Merck the next milestone payable to Wyeth of $2.5 million was accelerated and paid in 2004. In addition, should Merck achieve sales on this compound, we will be obligated to pay Wyeth a royalty of 4.0% on those sales. As part of the reorganization, Neurocrine acquired Wyeth’s interest under the license covering indiplon. Accordingly, the reorganization with Neurocrine allows Neurocrine to pay to us royalty and milestone payments net of those amounts that would be owed by us to Wyeth under our 1998 agreement with Wyeth. In connection with Elan’s license grant to us in October 2003, Elan is entitled to receive up to an aggregate of $3.0 million when bicifadine and ocinaplon are licensed or come to market. In connection with the Biovail separation agreement, we may be obligated to make payments to Biovail of $3.0 million upon issuance of marketing authorization for DOV diltiazem and up to $7.5 million based upon sales, if any.
 

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The table also excludes any severance or termination payments that would be due to certain of our employees under their employment contracts should they be terminated without cause or terminate following a change of control prior to the expiration of their contract term as the amounts are not determinable at this time. We file our employment agreements with our current and former executive officers with the SEC and these agreements are available at “www.sec.gov.”

Off-Balance Sheet Arrangements

The $80.0 million of outstanding convertible subordinated debentures we have outstanding at December 31, 2005 are convertible into approximately 3.5 million shares of our common stock.  If all these debentures were converted, our stockholders could experience significant dilution. We would not receive any additional cash proceeds upon the conversion of the debentures.


Recent Accounting Pronouncements
 
In December 2004, the FASB issued SFAS No. 123R, “Share-Based Payment.”  SFAS No. 123R is a revision of FASB Statement 123, “Accounting for Stock-Based Compensation” and supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees,” and its related implementation guidance. The Statement focuses primarily on accounting for transactions in which an entity obtains employee services in share-based payment transactions. SFAS No. 123R requires a public entity to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award (with limited exceptions). That cost will be recognized over the period during which an employee is required to provide service in exchange for the award. This statement is effective as of the beginning of the first annual reporting period that begins after June 15, 2005 and thus we will adopt the standard in the first quarter of 2006.

As permitted by SFAS 123, we currently account for share-based payments to employees using APB Opinion 25’s intrinsic value method and, as such, we generally recognize no compensation cost for employee stock options. We will adopt the provisions of SFAS No. 123R on a prospective basis in the first quarter of 2006. As a result of the provisions of SFAS 123R, we expect the compensation charges under SFAS 123R to be in the range of $7.0 million to $8.0 million for the year ended December 31, 2006 which reflects the awards granted through February 2006. We can not estimate compensation charges with respect to future awards as this is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, the volatility of our stock price, forfeiture rates and the timing of future employee stock option grants. We will recognize compensation cost for stock-based awards which vest after December 31, 2005, on a straight-line basis over the requisite service period of the award...

In May 2005, the FASB issued SFAS 154, “Accounting Changes and Error Corrections,” which replaces APB Opinion No. 20, “Accounting Changes,” and supersedes FASB Statement No. 3, “Reporting Accounting Changes in Interim Financial Statements—an amendment of APB Opinion No. 28.” SFAS 154 requires retrospective application to prior period financial statements of changes in accounting principle, unless it is impracticable to determine either the period-specific effects or the cumulative effect of the change. When it is impracticable to determine the period-specific effects of an accounting change on one or more individual prior periods presented, SFAS 154 requires that the new accounting principle be applied to the balances of assets and liabilities as of the beginning of the earliest period for which retrospective application is practicable and that a corresponding adjustment be made to the opening balance of retained earnings for that period rather than being reported in an income statement. When it is impracticable to determine the cumulative effect of applying a change in accounting principle to all prior periods, SFAS 154 requires that the new accounting principle be applied as if it were adopted prospectively from the earliest date practicable. SFAS 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005.  We do not expect the implementation of SFAS 154 to have a significant impact on our results of operations.
 

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Critical Accounting Policies

The preparation of financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. We believe the following critical accounting policies affect the more significant judgments and estimates used in the preparation of our financial statements.

Collaboration and license agreements. Revenue from up-front payments, technology license fees and milestone payments received for the delivery of products and services representing the culmination of a separate earnings process is recognized when due and the amounts are judged to be collectible. Revenue from up-front payments, technology license fees and milestone payments received in connection with other rights and services, which represent continuing obligations to us, is deferred and recognized over the term of the continuing obligation. Historically, recognition of revenue for such an up-front payment included an estimate by management as to the development period associated with such up-front payments. On August 5, 2004, we entered into an agreement with Merck for the worldwide development and commercialization of all indications for DOV 21,947 and certain indications for DOV 216,303 in exchange for a $35.0 million up-front payment and the right to receive further payments of up to $420.0 million upon the achievement of certain milestones and royalties based on product net sales, if any. The up-front payment has been deferred and is being amortized to revenue over the estimated research and development period. As of June 1, 2005, we revised this estimate to 72 months from 51 months and, accordingly, the amortization of the remaining balance beginning June 1, 2005 reflects this revised time period. This adjustment to the estimate for the development period was made as a result of the need to collect and assess additional clinical data, which has extended the total development timeline. This development period estimate may fluctuate from period to period and this fluctuation might be significant. For example, if as of January 1, 2006 we were to increase by 10% the estimated development period, we would record approximately $623,000 less of revenue in 2006.

Research and development. Research and development costs are expensed when incurred and include allocations for payroll and related costs and other corporate overhead.  Costs assigned to assets to be used in a particular research and development project acquired that have no alternative further use are charged to expenses as in-process research and development expense as of the date of consummation.

Stock-based compensation. In general, we grant stock options to employees for a fixed number of shares with an exercise price equal to the fair market value of our common stock on the date of grant. We recognize no compensation expense on these employee stock option grants. Prior to our common stock becoming publicly traded, we granted stock options for a fixed number of shares to employees with an exercise price less than the fair market value of our common stock on the date of grant. We recognize the difference between the exercise price and fair market value as compensation expense, which is recognized on an accelerated basis over the vesting period of the stock options. Our accounting treatment will change effective the first quarter of 2006. See above under “Recent Accounting Pronouncements.” We also have, in the past, granted options and warrants to outside consultants at fair value on the date of grant in exchange for future services. These options and warrants are required to be accounted for in accordance with SFAS 123 "Accounting for Stock Based Compensation" and EITF 96-18 "Accounting for Equity Instruments that are Issued to other than Employees for Acquiring, or in Conjunction with Selling Goods or Services" at the fair value of the consideration received, or the fair value of the equity instrument issued, whichever may be more readily measured. As the performance of services is completed, we revalue the options and warrants that have been earned during the period. We value these securities at the fair value using a Black-Scholes methodology.

Investments. We review our investment portfolio for potential “other-than-temporary” declines in value on an individual investment basis. We assess, on a quarterly basis, significant declines in value that may be considered other-than-temporary and, if necessary, recognize and record the appropriate charge by writing-down the carrying value of such investments. In making this assessment, we take into consideration a wide range of objective and subjective information, including but not limited to the following: the magnitude and duration of historical decline in market prices, credit rating activity, assessments of liquidity, public filings and statements made by the issuer. We have not identified any investments with “other-than-temporary” declines in value as of December 31, 2005.
 

45



Income taxes. We have net deferred tax assets at December 31, 2005 that are totally offset by a valuation allowance due to our determination that the criteria for recognition have not been met. We believe that a full valuation allowance on deferred tax assets will continue to be required if losses are reported in future periods. If, as a result of profitable operations, we determine that we are able to realize our net deferred tax assets in the future, an adjustment to the deferred tax asset would be made, increasing income (or decreasing loss) in the period in which such a determination is made.

On an ongoing basis, we evaluate our estimates that affect our reported assets, liabilities, revenues, earnings, financial position and various disclosures. We base our estimates on circumstances, the results of which form our basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions and conditions. Our significant accounting policies are also described in note 2 to our financial statements included under Part II, Item 8 of this Form 10-K.


To date, we have invested our cash balances with substantial financial institutions. In the future, the primary objective of our investment activities will be to maximize the income we receive from our investments consistent with preservation of principal and minimum risk. Some of the securities that we invest in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk in the future, we intend to maintain our portfolio of cash equivalents and investments in a variety of securities, including commercial paper, money market funds, government and non-government debt securities and corporate obligations. Due to the short holding period of these types of investments, we have concluded that we do not have a material financial market risk exposure.


See the list of our Financial Statements filed with this Form 10-K under Item 15 below.
 
 
None.


Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.
 

46



As required by SEC Rule 13a-15(b), we carried out an evaluation, with the participation of our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the operation of our disclosure controls and procedures and our internal controls over financial reporting as of December 31, 2005. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective.

Management’s Report on Internal Control Over Financial Reporting

Internal control over financial reporting refers to a process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:

(1)    Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
 
(2)    Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorization of our management and directors; and
 
(3)    Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 

Management is responsible for establishing and maintaining adequate internal control over financial reporting for the company. Management has used the framework set forth in Internal Control—Integrated Framework published by the Committee of Sponsoring Organizations of the Treadway Commission, known as COSO, to evaluate the effectiveness of the Company’s internal control over financial reporting. Based on this evaluation, management has concluded that, as of December 31, 2005, our internal control over financial reporting is effective.

Management’s assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2005 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears in Part IV, Item 15 of this Form 10-K.

Changes in Internal Control over Financial Reporting

There have been no changes in our internal control over financial reporting during the quarter ended December 31, 2005 that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.


Somerset Lease

On December 20, 2005, we entered into a Lease Agreement with Paragon 150 Pierce Street, L.L.C. for the lease of a building comprised of approximately 133,000 square feet located at 150 Pierce Street, Franklin Township, New Jersey. The premises are expected to serve as our corporate headquarters and principal place of business effective May 2006. The lease, which was contingent upon the landlord’s purchase of the premises, was amended by the Lease Modification Agreement and the Second Lease Modification Agreement, each dated as of February 28, 2006.
 

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As a result of the landlord’s consummation of its purchase of the premises, the term of the lease commenced on February 28, 2006 and will expire on the tenth anniversary of such date. The rent is payable in monthly installments amounting to approximately $2.85 million per year for the first five years of the initial term and $3.13 million per year for the second half of the initial term. The lease provides us with two options to extend the lease term, each for five-year periods. The rent during each extension term shall be equal to the fair market rental value for similar properties at the time of the extension.

In addition to fixed rent, we must pay as additional rent the amount by which all costs and expenses incurred by the landlord to maintain, repair, insure, operate and manage the property during any lease year of the term exceed the amount of such costs and expenses incurred during the first twelve months of the initial term. Additionally, we are solely responsible for the costs of all utilities provided to the premises. As collateral for our performance under the lease, we have delivered to the landlord an unconditional, irrevocable, stand-by letter of credit in the amount of approximately $4.2 million, which is subject to reduction in certain events.

We have the option to purchase the premises at a price calculated according to the lease by giving notice of our intention to exercise such option to the landlord on or before the last day of the 42nd full month of the initial term. We also have a right of first offer in the event the landlord intends to sell the premises to a third party. The lease and its two amendments are attached as Exhibit 10.46 to this Annual Report on Form 10-K.

In connection with our anticipated move to our new headquarters in Somerset, we have notified MSNW Continental Associates, LLC, our landlord for our executive offices in Hackensack, that we intend to terminate our lease for such executive offices. The termination of such lease will be effective August 31, 2006.

Scott Myers’ Employment and Stock Option Agreements

In connection with his employment by us in December 2005, we entered into an employment agreement with Mr. Myers dated as of December 1, 2005, which provides for his employment as Senior Vice President, Strategic Marketing and Commercialization until December 2008. Under the employment agreement, we have agreed to pay him base compensation of at least $330,000 per year. For 2006, we will pay him $330,000 in base salary. The agreement provides for benefits, the reimbursement of expenses and the payment of incentive compensation, which will be determined by our board of directors in its sole discretion. We are obligated to continue to pay Mr. Myers his base and incentive compensation and to continue his benefits for a period of nine months if he is terminated upon becoming disabled or for a period of 90 days upon his death. If Mr. Myers terminates his employment with us for good reason, or within six months of a change of control, or if we terminate Mr. Myers without cause, he is entitled to receive his base compensation for the balance of his employment agreement, namely December 2008, and all stock options granted to him will vest. The agreement also requires Mr. Myers to refrain from competing with us and from soliciting our customers and clients for the duration of his employment and for a period following employment equal to the length of time we make severance payments to him.

Additionally, upon the commencement of Mr. Myers’ employment, we granted him options to purchase 285,000 shares of our common stock pursuant to the employment agreement and a stock option agreement also dated as of December 1, 2005. Such options, which were issued to Mr. Myers outside of our 2000 Stock Option and Grant Plan, have an exercise price of $14.28 per share, the closing price of our common stock on the commencement date of employment, and will vest 50% on June 1, 2007 and will continue to vest ratably thereafter over the next six quarters. The employment agreement and the stock option agreement are attached as Exhibits 10.42 and 10.43, respectively, to this Annual Report on Form 10-K.
 

48


 
PART III



Executive Officers and Directors
 
The following table provides information about our directors, executive officers and key employees.
 
Name
Age
Position
Leslie Hudson
59
Chief Executive Officer, President and Director
Phil Skolnick, Ph.D., D.Sc. (hon)
59
Senior Vice President, Research and Chief Scientific Officer
Barbara G. Duncan
41
Senior Vice President, Finance, Chief Financial Officer and Treasurer
Robert Horton
66
Senior Vice President, General Counsel and Secretary
Warren Stern, Ph.D.
61
Senior Vice President, Drug Development and Assistant Secretary
Scott Myers.
39
Senior Vice President, Strategic Marketing and Commercialization
Arnold S. Lippa, Ph.D.
59
Chairman of the Board
Zola Horovitz, Ph.D.
71
Director
Patrick Ashe
42
Director
Daniel S. Van Riper
65
Director
Theresa A. Bischoff
52
Director
Jonathan Silverstein
37
Director

Leslie Hudson joined us in July 2005 and serves as our chief executive officer and president. Dr. Hudson is a director of Nabi Biopharmaceuticals, Inc. and Hooper Holmes, Inc. Prior to joining us, Dr. Hudson served in executive positions at Pharmacia Corporation, Glaxo Inc., and Repligen Corporation. At Pharmacia, Dr. Hudson was Senior Vice President of Research and Exploratory Development, led e-business and commercial development, and ultimately was Group Vice President and General Manager for the company’s ophthalmology franchise. At Glaxo, he initially led the division of cell and molecular biology and had responsibility for the therapeutic areas of oncology, inflammation and metabolic diseases and was promoted to Vice President for Discovery. After the acquisition of Pharmacia by Pfizer, Dr. Hudson was at the University of Pennsylvania for two years where he led and restructured the university’s overall commercialization and economic development efforts. Prior to joining the pharmaceutical industry, Les spent nearly nine years at St. George’s Hospital Medical School in London as full professor of immunology and chairman of the department. He received a Ph.D. from the Middlesex Hospital Medical School, University of London in 1975, was elected associate of the Royal College of Science and received his B.S. degree, summa cum laude, from the Imperial College of Science, Technology, and Medicine, University of London, in 1968.
 
Phil Skolnick, Ph.D., D.Sc. (hon.) joined us in January 2001 and serves as our senior vice president, research and chief scientific officer. Prior to joining us, Dr. Skolnick served as a Lilly research fellow (Neuroscience) at Eli Lilly & Company from January 1997 to January 2001 where he spearheaded several innovative programs in drug discovery. From 1986 to August 1997, he served as senior investigator and chief, laboratory of neuroscience, at the National Institutes of Health. Dr. Skolnick served as a research professor of psychiatry at the Uniformed Services University of the Health Sciences from 1989 to 1998. He is currently an adjunct professor of anesthesiology at The Johns Hopkins University, an adjunct professor of pharmacology and toxicology at Indiana University School of Medicine and research professor of psychiatry at New York University School of Medicine. Dr. Skolnick is an editor of Current Protocols in Neuroscience and also serves on the editorial advisory boards of the European Journal of Pharmacology, Cellular and Molecular Neurobiology, the Journal of Molecular Neuroscience, and Pharmacology, Biochemistry & Behavior. He received a B.S. (summa cum laude) from Long Island University in 1968 and his Ph.D. from The George Washington University in 1972. Dr. Skolnick was awarded the D.Sc. honoris causa from Long Island University in 1993 and the University of Wisconsin-Milwaukee in 1995.
 

49


 
Barbara G. Duncan joined us in August 2001 and serves as our senior vice president, finance and chief financial officer and treasurer. Prior to joining us, Ms. Duncan served as a vice president of Lehman Brothers Inc. in its corporate finance division from August 1998 to August 2001, where she provided financial advisory services primarily to companies in the life sciences and general industrial industries. From September 1994 to August 1998, Ms. Duncan was an associate and director at SBC Warburg Dillon Read, Inc. in its corporate finance group, where she focused primarily on structuring mergers, divestitures and financings for companies in the life sciences and general industrial industries. She also worked for PepsiCo, Inc. from 1989 to 1992 in its international audit division, and was a certified public accountant in the audit division of Deloitte & Touche from 1986 to 1989. Ms. Duncan received her B.S. from Louisiana State University in 1985 and her M.B.A. from the Wharton School, University of Pennsylvania, in 1994.
 
Robert Horton joined us in August 2002 and serves as senior vice president and general counsel and as secretary. Mr. Horton is a director of Nascime Ltd. and DOV Pharmaceutical Luxembourg S.a.r.l. Prior to joining us, Mr. Horton served with Goodwin Procter LLP from 2001 - 2003 and with Friedman Siegelbaum LP from 1996 - 2001, in their New York law offices. Prior thereto, Mr. Horton served with Balber Pickard et. al. (formerly, Stults Balber Horton and Slotnick) in New York City. He has served in the JAG Corps and in New Jersey and New York City government. He has practiced corporate and securities law for over 25 years and represented us since shortly after our formation. He was graduated Beta Gamma Sigma from the University of Virginia in 1961 and Order of the Coif from the University of Chicago, where he received his law degree, in 1964. He is a member of the California and New York bars.
 
Warren Stern, Ph.D. joined us as a consultant in September 2003 and started full-time in December 2003 as senior vice president, drug development. Dr. Stern is a director of Suven Life Sciences USA, LLC/Asian Clincial Trials Limited, or Suven. Previously he was senior vice president of scientific and medical Services at PAREXEL International Corporation, a major contract research organization, or CRO, where he had worked for the past five and one-half years. Dr. Stern has also held senior level positions in clinical research at Cato Research Ltd., a CRO, Forest Laboratories, Inc. and earlier, Burroughs Wellcome Co. Previously, Dr. Stern was president and CEO of Pharmatec Inc., a CNS-oriented drug delivery company. He has also founded two drug delivery companies, Research Triangle Pharmaceuticals and Nobex, Inc. Dr. Stern has over 25 years' experience in drug development in CNS and other fields. He directed the successful NDA submissions of bupropion (Wellbutrin) and citalopram (Celexa). He has performed preclinical studies and clinical trials in psychopharmacology and published some 90 papers describing the results of his research in animal pharmacology and CNS-oriented clinical trials. Dr. Stern is the inventor on six patents and on three patent applications, including patents related to CNS products, and two drug delivery systems. He received his Ph.D. in psychopharmacology from Indiana University in 1969 and completed postdoctoral fellowships at Boston State Hospital and at the Worcester Foundation for Experimental Biology.
 
Scott Myers joined us in December of 2005 and serves as our senior vice president, strategic marketing and commercialization. Mr. Myers spent the last five years with Johnson & Johnson in several, senior functional and general management leadership roles. Prior to Johnson & Johnson, Mr. Myers was co-founder of the ISO-HealthCare Group, a global strategy consultancy. He has also held positions at Baxter Healthcare and Andersen Consulting. He earned his B.A in biology from Northwestern University and an M.B.A. in finance and international business from the University of Chicago.
 
Arnold S. Lippa, Ph.D. is a co-founder and serves as chairman of our board of directors. Dr. Lippa served as our chief executive officer since our inception in April 1995 through June 2005. Dr. Lippa also currently serves as an officer of Aurora Capital LLC and Atypical BioCapital Management LLC. Prior to founding DOV in 1995, Dr. Lippa founded Fusion Associates, Ltd., an investment and management company specializing in the creation and management of biomedical companies. Dr. Lippa served as Fusion's managing director from 1989 to 1995. From 1989 through 1990, Dr. Lippa served as Vega Biotechnologies, Inc.'s chairman and chief executive officer. In 1984, Dr. Lippa co-founded Praxis Pharmaceuticals, Inc. and served as president and chief operating officer until 1988. Prior to 1985, he served as director of molecular neurobiology and held other positions at American Cyanamid. In addition, Dr. Lippa has consulted for various pharmaceutical and biotechnology companies and has been a graduate faculty professor at the New York University School of Medicine and the City University of New York. He received his B.A. from Rutgers University in 1969 and his Ph.D. in psychobiology from the University of Pittsburgh in 1973.
 

50


 
Zola Horovitz, Ph.D. has been a member of our board of directors since our inception in April 1995. Dr. Horovitz currently is a consultant to the pharmaceutical and biotechnology industries and serves as a director of Genvec, Inc., BioCryst Pharmaceuticals, Inc., Palatin Technologies, Inc., Avigen, Inc., Genaera Pharmaceuticals, Inc., Immunicon Corp. and Nitromed, Inc. Before joining us, Dr. Horovitz served 35 years in various managerial and research positions at Bristol-Myers Squibb and its affiliates. At Bristol-Myers Squibb, Dr. Horovitz served as vice president, business development and planning from 1991-1994, vice president, licensing in 1990, and vice president, research, planning and scientific liaison from 1985-1989. Dr. Horovitz received a B.S. in pharmacy and his M.S. and Ph.D. in pharmacology from the University of Pittsburgh in 1955, 1958 and 1960 respectively.
 
Patrick Ashe has been a member of our board of directors since January 1999. He currently serves as a director and senior vice president, business development at AGI Therapeutics Research, Ltd. and as a director of AGI Therapeutics PLC. From May 1994 to November 2001, Mr. Ashe served as vice president, commercial development at Elan Pharmaceutical Technologies, a division of Elan Corporation, plc and from November 2001 to May 2005 was senior vice president, business development of Athpharma Ltd. Additionally, from January 1999 to November 2001, Mr. Ashe served as co-manager, and until November 2005 served as a director, of Nascime Limited. Mr. Ashe was graduated from University College Dublin with a B.Sc. in pharmacology in 1985 and completed his M.B.A. at Dublin City University's Business School in 1994.
 
Daniel S. Van Riper became a member of our board of directors in March 2002. Mr. Van Riper is also a director of Hubbell Incorporated, where he serves on the audit, compensation and finance committees, a director of New Brunswick Scientific Co., Inc. where he serves on the compensation and governance committee and a director of 3D Systems Corporation where he chairs the finance committee and serves on the compensation committee. Mr. Van Riper currently is an independent financial consultant and served as special advisor to Sealed Air Corporation from January 2002 to June 2005. From July 1998 to January 2002 he served as senior vice president and chief financial officer of Sealed Air Corporation. He is a former director of Millennium Chemicals Inc., where he served on the audit committee and chaired the compensation committee. Previously, Mr. Van Riper was a partner of KPMG LLP, where he worked from June 1962 to June 1998. Mr. Van Riper was graduated with high honors and a B.S. in accounting and completed his M.B.A. in economics and finance from Rutgers University. He is a certified public accountant and is a member of the American Institute of Certified Public Accountants and Beta Gamma Sigma, national honorary business fraternity.
 
Theresa A. Bischoff became a member of our board of directors in December 2003. Ms. Bischoff is also a trustee of Mutual of America Capital Management and University of Connecticut Foundation. Ms. Bischoff currently serves as the chief executive officer of the American Red Cross in Greater New York. She has also served as chair of the Association of American Medical Colleges, the policy setting and advocacy organization for the 125 medical schools and 400 major teaching hospitals in the United States. From 1984 to 2003, Ms. Bischoff served as president and also held various other positions at the NYU Medical Center. Prior to joining NYU Medical Center, she worked in corporate finance at Squibb Corporation and Great Northern Nekoosa. Ms. Bischoff received a B.S. in accounting from University of Connecticut in 1975 and a M.B.A. from the New York University in 1991. Ms. Bischoff is also a certified public accountant.
 
Jonathan Silverstein became a member of our board of directors in December 2003. Mr. Silverstein is a general partner of OrbiMed Advisors LLC., a health care fund manager based in New York. Mr. Silverstein is also a director of Given Imaging, Ltd., Emphasys Medical, Avanir Pharmaceuticals, Insulet Corporation, Adiana, superDimension and Predix Pharmaceuticals. Mr. Silverstein is a former director of LifeCell Corporation, Orthovita and Auxilium Pharmaceuticals. From 1996 to 1998, he was the director of life sciences at Sumitomo Bank Limited.  From 1994 to 1996, he was an associate at Hambro Resource Development. Mr. Silverstein has a B.A. in economics from Denison University and a J.D. and M.B.A. from the University of San Diego. 
 

51


 
Audit Committee and Audit Committee Financial Expert

We have an established audit committee comprised solely of non-management directors all of whom are independent under both Section 10A of the Securities Act of 1934, or Exchange Act, and under the Nasdaq marketplace rules. The audit committee determines the selection, retention and compensation of our independent registered public accounting firm, reviews the scope and results of audits, submits appropriate recommendations to the board of directors regarding audits, reviews our internal controls, provides pre-approval of principal accountant fees and services and is responsible for reviewing quarterly and annual filings with the SEC and releases containing our financial results. The current members of the audit committee are Theresa Bischoff, Zola Horovitz and Daniel Van Riper (chairman). The audit committee met six times during 2005. Our board of directors has determined that our audit committee members are independent and that Daniel Van Riper and Theresa Bischoff each qualify as an audit committee financial expert in accordance with SEC rules. For Mr. Van Riper’s and Ms. Bischoff’s relevant experience, see their biographies listed in “Executive Officers and Directors” above.
 
 
Section 16(a) Beneficial Ownership Reporting Compliance
 
Section 16(a) of the Exchange Act requires our directors and executive officers, and persons who own more than ten percent of a registered class of our equity securities, to file reports of ownership with the SEC and Nasdaq. Directors, executive officers and greater than ten-percent beneficial owners are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file.
 
Based solely on a review of filings with the SEC, we believe that other than the exceptions detailed below, all of our directors and executive officers have complied with the reporting requirements of Section 16(a) of the Securities Exchange Act of 1934, during fiscal 2005.
 
   
Reporting Requirement
   
Name
 
Form
 
Required Filing Date
 
Actual Filed Date
Scott Myers
 
Form 3
 
December 12, 2005
 
December 16, 2005
Zola Horovitz    Form 4    October 19, 2005    October 21, 2005(1) 
 
(1) Attempted timely filing rejected due to Edgar Access Code issues.

We undertake to prepare Section 16 filings for our officers and directors.

Code of Ethics
 
We have adopted a code of ethics that applies to all our employees, including our chief executive officer and chief financial officer. This code of ethics is designed to comply with SEC requirements and the Nasdaq marketplace rules related to codes of conduct. A copy of our Code of Business Conduct and Ethics Policy may be obtained on our website at http://www.dovpharm.com. We intend to post on our website any amendments to, or waiver from, our code of ethics for the benefit of our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing a similar function, and other named executives.


52


 
 
Summary Compensation Table
 
The following table sets forth certain compensation information for the years indicated as to our CEO and the four additional most highly compensated executive officers (the named executives) based on salary and bonus for the fiscal years ended December 31, 2005, 2004 and 2003. In addition, we have included information for our former chief executive officer and president whose employment terminated effective July 28, 2005.

 
 
 
 
 
 
 
 
 
Long-Term Compensation Awards
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annual Compensation
 
Securities
Underlying
 
Restricted
 
 
All Other
 
Name and Principal Position
 
Year
 
Salary
 
Bonus(1)
 
Options(1)
 
Stock Awards
 
Compensation
 
Leslie Hudson(2)
 
2005
 
$
174,904
 
$
   
225,000
 
$
2,120,000
 
$
84,710
 
Chief Executive Officer and President
                                     
                                       
Phil Skolnick, Ph.D., D.Sc. (hon)(3)
 
2005
   
327,692
   
75,000
   
25,000
   
   
13,042
 
Senior Vice President, Research and
 
2004
   
299,038
   
50,000
   
100,000
   
   
13,290
 
Chief Scientific Officer
 
2003
   
273,558
   
30,000
   
   
   
8,100
 
                                       
Barbara Duncan (4)
 
2005
   
327,692
   
75,000
   
   
   
12,242
 
Senior Vice President, Finance, Chief
 
2004
   
298,077
   
50,000
   
125,000
   
   
12,300
 
Financial Officer and Treasurer
 
2003
   
258,942
   
30,000
   
   
   
8,100
 
                                       
Robert Horton (5)
 
2005
   
327,692
   
75,000
   
125,000
   
   
15,077
 
Senior Vice President, General
 
2004
   
307,211
   
50,000
   
25,000
   
   
15,048
 
Counsel and Secretary
 
2003
   
250,000
   
   
   
   
9,525
 
                                       
Warren Stern (6)
 
2005
   
327,692
   
75,000
   
25,000
   
   
13,599
 
Senior Vice President, Drug
 
2004
   
300,000
   
   
   
   
13,815
 
Development and Assistant Secretary
 
2003
   
24,077
   
   
285,000
   
   
46,000
 
                                       
Arnold S. Lippa, Ph.D.(7)
 
2005
   
248,991
   
100,000
   
45,000
   
903,000
   
9,726
 
Chairman
 
2004
   
363,212
   
125,000
   
25,000
   
   
33,895
 
   
2003
   
325,769
   
50,000
   
   
   
30,408
 
 
 
(1)
Does not reflect bonuses determined and paid in 2006 and options granted in 2006 to the five named executive officers aggregating $205,000 and 105,000 respectively.
   
(2)
Dr. Hudson joined us effective July 28, 2005. Dr. Hudson was paid a contractual bonus of $85,000 in January 2006. Other compensation includes $70,966 in relocation expense reimbursement, $8,000 for reimbursement of certain legal expenses, $5,000 for automobile allowance and $744 for life insurance premiums. In addition, in 2006 we granted Dr. Hudson 50,000 options.
   
(3)
All other compensation represents $12,000, $12,000, and $8,100 in 2005, 2004 and 2003 for automobile allowance and $1,042 and $1,290 in 2005 and 2004 for life insurance premiums. In 2006, we paid Dr. Skolnick a $30,000 bonus and granted him 15,000 options.
   
(4)
All other compensation represents $12,000 $12,000 and $8,100 in 2005, 2004 and 2003 for automobile allowance and $242 and $300 in 2005 and 2004 for life insurance premiums. In 2006, we paid Ms. Duncan a $30,000 bonus and granted her 15,000 options.
   
(5)
All other compensation represents $12,000, $12,000 and $8,100 in 2005, 2004 and 2003 for automobile allowance, $3,077 and $3,048 in 2005 and 2004 for life insurance premiums and $1,425 in 2003 for moving expenses. In 2006, we paid Mr. Horton a $15,000 bonus.
 
53

 

(6)
All other compensation represents $12,000, $12,000 and $1,000 in 2005, 2004 and 2003 for automobile allowance, $45,000 in 2003 for consulting expenses and $1,599 and $1,815 in 2005 and 2004 for life insurance premiums. Dr. Stern joined the Company effective December 2, 2003. In 2006, we paid Dr. Stern a $45,000 bonus and granted him 25,000 options.
   
(7)
Dr. Lippa’s employment as chief executive officer and president of the Company terminated effective July 28, 2005. In connection with this termination, Dr. Lippa will receive cash payments equal to his annual salary of $365,750 for two years of which approximately $201,000 was paid in February 2006 and the remainder will be paid bi-weekly through June 2007. He continues as chairman of the board. All other compensation represents $9,180, $16,723 and $16,668, in 2005, 2004 and 2003 for automobile allowance, $546, $8,018 and $13,740, in 2005, 2004 and 2003 for life insurance premiums and $9,154 in 2004 for advances repaid in 2005.
 
Option Grants in Last Fiscal Year 

The following table sets forth information with respect to the named executives and our former chief executive officer and president concerning the grant of stock options during 2005. All the options were granted at the fair market value on the date of grant as determined by the Board of Directors.
 
 
 
Individual Grants
 
 
 
Name
 
 
Options
Granted
 
% of Total
Options
Granted
 
Exercise or
Base Price
($/Sh)
 
 
Expiration
Date
 
 
Grant Date
PresentValue
 
Leslie Hudson
   
225,000
   
17.6
%
$
21.20
 
07/28/2015
 
$
2,996,090
 
Phil Skolnick, Ph.D. D. Sc. (hon)
   
25,000
   
2.0
   
16.77
 
02/01/2015
   
265,775
 
Barbara Duncan
   
   
   
 
   
 
Robert Horton (1)
   
125,000
   
9.8
   
20.27
 
07/29/2015
   
1,595,597
 
Warren Stern, Ph.D.
   
25,000
   
2.0
   
16.77
 
02/01/2015
   
265,775
 
Arnold S. Lippa, Ph.D.
   
45,000
   
3.5
   
16.77
 
02/01/2015
   
478,395
 

 
(1)
25,000 options were granted on February 1, 2005 at an exercise price of $16.77 and 100,000 options were granted on July 29, 2005 in connection with renewal of employment agreement at an exercise price of $21.15.
 
Option Exercises in Last Fiscal Year and Year-End Option Values

The following table sets forth certain information as of December 31, 2005, regarding options held by the named executives and our former chief executive officer and president.

   
Shares
     
Number of Securities Underlying Unexercised Options at Fiscal Year-End(1)
 
Value ($) of Unexercised in-the-Money Options
at Fiscal Year-End(2)
 
Name
 
Acquired on Exercise
 
Value ($)
Realized
 
Number
Exercisable
 
Number
Unexercisable
 
Value ($)
Exercisable
 
Value ($)
Unexercisable
 
Leslie Hudson, Ph.D.
   
 
$
   
   
225,000
 
$
 
$
 
Phil Skolnick, Ph.D. D. Sc. (hon)
   
15,000
   
200,900
   
368,333
   
66,667
   
3,753,166
   
45,834
 
Barbara Duncan
   
25,000
   
326,000
   
314,083
   
110,417
   
3,210,540
   
199,625
 
Robert Horton
   
50,000
   
481,000
   
164,583
   
135,417
   
1,556,875
   
10,625
 
Warren Stern, Ph.D.
   
   
   
189,998
   
120,002
   
   
 
Arnold S. Lippa, Ph.D.
   
   
   
225,183
   
55,417
   
2,544,181
   
10,625
 
 

(1)
Includes both in-the money and out-of-the-money options.
(2)
Fair value of DOV’s common stock at December 31, 2005 ($14.68 based on the closing sales price reported on Nasdaq) less the exercise price.

54



Compensation of the Chief Executive Officer 

Dr. Hudson’s base salary during fiscal year 2005 was $425,000. His base salary for 2006 is $437,750 and he received a contractual bonus of $85,000 in January 2006. He also received an award of 50,000 stock options in February 2006.
 
Compensation of Directors

Our independent outside directors each receive $4,000 for each quarterly board meeting and receive options to purchase 15,000 shares of our common stock for a full year of service on the annual shareholders meeting date. In May 2005, Dr. Horovitz, Mr. Ashe, Ms. Bischoff and Mr. Van Riper each received options to purchase 15,000 shares of our common stock at an exercise price of $15.05 per share. These options will become exercisable in equal (25%), annual installments, after the completion of each full year of service following such grant. Our compensation committee members receive $1,000 for each meeting in which they participate with a limit of one such payment per quarter and the chairman of the compensation committee receives additional compensation of $500 per quarter. Our audit committee members receive $1,000 for each meeting in which they participate and the chairman of the audit committee receives additional compensation of $3,000 per quarter. We have agreed to reimburse our directors for their reasonable expenses incurred in attending meetings of the board of directors and its committees.
 
Compensation Committee Interlocks and Insider Participation

During 2005, Dr. Horovitz, Mr. Van Riper and Mr. Ashe served on DOV’s compensation committee. During 2005, there were no interlocks with other companies within the meaning of the SEC’s proxy rules. None of the members of the compensation committee is or has been an officer or employee of DOV or any of its subsidiaries.
 
Employment Agreements

Leslie Hudson, Ph.D. In connection with his employment by us in July 2005, we entered into an employment agreement with Dr. Hudson which provides for his employment as Chief Executive Officer and President until July 28, 2008. Under the agreement, we will pay Dr. Hudson base compensation of at least $425,000 per year. For 2006, we will pay him $437,750 in base salary. The agreement provides for benefits, the reimbursement of expenses and the payment of incentive compensation, which will be determined by our board of directors in its sole discretion. Additionally, upon commencement of employment on July 28, 2005, we granted Dr. Hudson 100,000 shares of restricted stock and options to purchase 225,000 shares of our common stock at an exercise price of 21.20, each vesting ratably annually over four years. Dr. Hudson also received a bonus of $85,000 in January 2006, and the parties have agreed that his target bonus for fiscal year 2006 and each subsequent year of his employment agreement will be 40% of base compensation upon achievement of milestones established by the compensation committee of the board of directors. He is also eligible for other benefits, including relocation allowances of which $78,966 was paid in 2005. We are obligated to continue to pay Dr. Hudson his base and incentive compensation and to continue his benefits for a period of nine months if he is terminated upon becoming disabled or for a period of 90 days upon his death. For qualified events of severance, Dr. Hudson will be entitled to base compensation for the balance of his agreement subject to a minimum of one-year base compensation and an additional severance payment equal to his prior incentive bonus in the case of a termination following a change of control. The agreement also requires Dr. Hudson to refrain from competing with us and from soliciting our customers and clients for the duration of his employment and for a period following employment equal to the length of time we make severance payments to him.
 

55



Phil Skolnick, Ph.D., D.Sc.(hon). In connection with his employment by us in January 2001, we entered into an employment agreement (as amended in January 2004) with Dr. Skolnick, which provides for his employment as Senior Vice-President, Research and Chief Scientific Officer until January 19, 2007. Under the agreement, we will pay Dr. Skolnick base compensation of at least $300,000 per year. For 2006, we will pay him $344,000 in base salary. The agreement provides for benefits, the reimbursement of expenses and the payment of incentive compensation, which will be determined by our board of directors in its sole discretion. Additionally, upon the commencement of Dr. Skolnick's employment, we granted him options to purchase 405,000 shares of our common stock (adjusted for subsequent 1.62-for-1 stock split) at an exercise price of $2.78 per share (as so adjusted). The options are completely vested. In addition, in January 2004, in connection with renewal of his employment agreement, we granted him options to purchase 100,000 shares of our common stock at an exercise price of $13.58 per share that vested 50% on July 9, 2005 and will continue to vest ratably thereafter over the next six quarters. We are obligated to continue to pay Dr. Skolnick his base and incentive compensation and to continue his benefits for a period of nine months if he is terminated upon becoming disabled or for a period of 90 days upon his death. If Dr. Skolnick terminates his employment with us for good reason, or within six months of a change of control, or if we terminate Dr. Skolnick without cause, he is entitled to receive his base compensation for the balance of his employment agreement, namely January 19, 2007, and stock options granted to him in January 2004 will vest immediately. The agreement also requires Dr. Skolnick to refrain from competing with us and from soliciting our customers and clients for the duration of his employment and for a period following employment equal to the length of time we make severance payments to him.

Barbara Duncan. In connection with her employment by us in August 2001, we entered into an employment agreement with Ms. Duncan (as amended in August 2004), which provides for her employment as Vice President, Finance and Chief Financial Officer until August 21, 2007. Ms. Duncan’s title was changed to Senior Vice President, Finance and Chief Financial Officer in February 2005. Under the agreement, we will pay Ms. Duncan base compensation of at least $300,000 per year. For 2006, we will pay her $344,000 in base salary. The agreement provides for benefits, the reimbursement of expenses and the payment of incentive compensation, which will be determined by our board of directors in its sole discretion. Additionally, upon the commencement of Ms. Duncan's employment, we granted her options to purchase 364,500 shares of our common stock (adjusted for subsequent 1.62-for-1 stock split) at an exercise price of $4.01 per share (as so adjusted). The options are completely vested. In addition, in August 2004, in connection with renewal of her employment agreement, we granted her options to purchase 100,000 shares of our common stock at an exercise price of $12.79 per share that vested 50% on February 3, 2006 and will continue to vest ratably thereafter over the next six quarters. We are obligated to continue to pay Ms. Duncan her base and incentive compensation and to continue her benefits for a period of nine months if she is terminated upon becoming disabled or for a period of 90 days upon her death. If Ms. Duncan terminates her employment with us for good reason, or within six months of a change of control, or if we terminate Ms. Duncan without cause, she is entitled to receive her base compensation for the balance of the employment agreement, namely August 21, 2007, and all options granted to her will immediately vest except that stock options granted to her in August 2004 will vest on a schedule of 62,500 to the extent not vested if the change of control occurs within the second year and the balance of 100,000 to the extent not vested if the change of control occurs within the third year. The agreement also requires Ms. Duncan to refrain from competing with us and from soliciting our customers and clients for the duration of her employment and for a period following employment equal to the length of time we make severance payments to her.

Robert Horton. In connection with his employment by us in August 2002, we entered into an employment agreement with Mr. Horton (as amended in July 2005), which provides for his employment as Vice President and General Counsel until August 16, 2008. Mr. Horton’s title was changed to Senior Vice President and General Counsel in February 2005. Under the agreement, we will pay Mr. Horton base compensation of at least $330,000 per year. For 2006, we will pay him $340,000 in base salary. The agreement provides for benefits, the reimbursement of expenses and the payment of incentive compensation, which will be determined by our board of directors in its sole discretion. Additionally, upon the commencement of Mr. Horton's employment, we granted him options to purchase 250,000 shares of our common stock at an exercise price of $4.40 per share. The options are completely vested. In addition, in July 2005, in connection with renewal of his employment agreement, we granted him options to purchase 100,000 shares of our common stock at an exercise price of $21.15 per share that vest 50% on January 29, 2007 and will continue to vest ratably thereafter over the next six quarters. We are obligated to continue to pay Mr. Horton his base and incentive compensation and to continue his benefits for a period of nine months if he is terminated upon becoming disabled, if he terminates his employment with us for good reason, or if we terminate Mr. Horton without cause. He will also be entitled to base compensation and benefits for a period of 90 days upon his death. If Mr. Horton terminates his employment within six months of a change of control he is entitled to receive his base compensation for the balance of his employment agreement, namely July 29, 2007, or if a longer period, one year thereafter, and all stock options granted to him in July 2005 will vest on a schedule of 25,000 if the change of control occurs within the first year, 37,500 to the extent not vested if the change of control occurs within the second year and the balance of 100,000 to the extent not vested if the change of control occurs within the third year. The agreement also requires Mr. Horton to refrain from competing with us and from soliciting our customers and clients for the duration of his employment and for a period following employment equal to the length of time we make severance payments to him.
 

56



Warren Stern, Ph.D. In connection with his engagement in September 2003, Dr. Stern and we entered into a consulting agreement and an employment agreement. The employment agreement provides for Dr. Stern to serve as Senior Vice President, Drug Development until September 10, 2006. Under the consulting agreement, pending commencement of full-time employment, we paid Dr. Stern $45,000. Under the employment agreement, once Dr. Stern commenced full-time employment in December 2003, we have agreed to pay him $300,000 per year. For 2006, we will pay him $345,000 in base salary. The employment agreement provides for benefits, the reimbursement of expenses and the payment of incentive compensation, which will be determined by our board of directors in its sole discretion. Additionally, as of September 10, 2003, we granted Dr. Stern options to purchase 285,000 shares of our common stock at an exercise price of $15.36 per share. The options vested 50% on June 2, 2005, with the remainder vesting ratably, on quarterly basis, over the next 18 months. We are obligated to continue to pay Dr. Stern his base and incentive compensation and to continue his benefits for a period of nine months if he is terminated upon becoming disabled or for a period of 90 days upon his death. If Dr. Stern terminates his employment with us for good reason, or within six months of a change of control, or if we terminate Dr. Stern without cause, he is entitled to receive his base compensation for the balance of his employment agreement, namely September 10, 2006, and these initial stock options granted to him will immediately vest. The employment agreement also requires Dr. Stern to refrain from competing with us and from soliciting our customers and clients for the duration of his employment and for a period following employment equal to the time we make severance payments to him.

Scott Myers. In connection with his employment by us in December 2005, we entered into an employment agreement with Mr. Myers which provides for his employment as Senior Vice President, Strategic Marketing and Commercialization until December 2008. Under the employment agreement, we have agreed to pay him base compensation of at least $330,000 per year. For 2006, we will pay him $330,000 in base salary. The agreement provides for benefits, the reimbursement of expenses and the payment of incentive compensation, which will be determined by our board of directors in its sole discretion. Additionally, upon the commencement of Mr. Myers’ employment, we granted him options to purchase 285,000 shares of our common stock at an exercise price of $14.28 per share that vest 50% on June 1, 2007 and will continue to vest ratably thereafter over the next six quarters. We are obligated to continue to pay Mr. Myers his base and incentive compensation and to continue his benefits for a period of nine months if he is terminated upon becoming disabled or for a period of 90 days upon his death. If Mr. Myers terminates his employment with us for good reason, or within six months of a change of control, or if we terminate Mr. Myers without cause, he is entitled to receive his base compensation for balance of his employment agreement, namely through December 2008, and all stock options granted to him will vest. The agreement also requires Mr. Myers to refrain from competing with us and from soliciting our customers and clients for the duration of his employment and for a period following employment equal to the length of time we make severance payments to him.

Arnold Lippa, Ph.D. On May 23, 2005, we entered into a two-year employment agreement with Dr. Lippa, our then Chief Executive Officer, which continued his existing agreement, with certain changes, that was extended in January 2005. Such changes include severance protection in the event of a termination of employment without cause or good reason equal to payment of base compensation for the greater of one year and the balance of the term of the agreement, subject to consulting obligations. In addition, the agreement includes a change in control severance protection equal to two years’ base compensation, elimination of a 2% bonus based upon gross proceeds in the event of a sale of the Company and elimination of incentive compensation for licensing. He was also awarded 60,000 shares of restricted common stock, valued at $903,000, under the our 2000 stock option and grant plan, subject to ratable annual vesting over three years provided he remains as a director of the Company. As of July 28, 2005, Dr. Lippa’s employment terminated thus requiring us to pay the contractual severance. As a result, the Company recorded a severance obligation of $790,000 as of June 30, 2005. Dr. Lippa remains as chairman of the board of directors.

We file our executive officer’s employment agreements with the SEC and these agreements are publicly available at “www.sec.gov.”
 

57


 

 
The following table sets forth, as of February 17, 2006, certain information regarding the beneficial ownership of our common stock by:
 
  ·
each person known by us to beneficially own 5% or more of a class of our common stock;
   
  ·
each of our directors;
   
  ·
each of our executive officers for whom compensation information is given in the Summary Compensation Table in Part III, Item 11 of this Form 10-K; and
   
  ·
all our directors and executive officers of as a group.

 
The number of shares beneficially owned by each stockholder is determined under rules issued by the SEC (Rule 13d-3(d)(1) under the Securities Exchange Act of 1934, as amended) and includes voting or investment power with respect to securities. Under these rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting power or investment power and includes any shares to which an individual or entity has the right to acquire beneficial ownership within 60 days of February 17, 2006, through the exercise of any warrant, stock option or other right. The inclusion in this calculation of such shares, however, does not constitute an admission that the named stockholder is a direct or indirect beneficial owner of such shares. Each of the stockholders listed has sole voting and investment power with respect to the shares beneficially owned by the stockholder unless noted otherwise, subject to community property laws where applicable.
 

58


 
Name of Beneficial Owner
 
Number of Shares
Beneficially Owned
 
Percentage of
Class(1)
 
FMR(3)
82 Devonshire Street
Boston, MA 02109
   
2,631,834
   
11.3
%
OrbiMed Advisors, LLC(2)
767 Third Avenue
30th Floor
New York, NY 10017
   
2,028,028
   
8.6
 
Columbia Wanger Asset Management, L.P.(3)
227 West Monroe Street, Suite 3000
Chicago, IL 60606
   
1,495,000
   
6.4
 
Barclays Bank PLC.(3)
45 Fremont Street
San Francisco, CA 94105
   
1,247,845
   
5.4
 
HBK Investments L.P.(3)
300 Crescent Court, Suite 700
Dallas, TX 75201
   
1,238,828
   
5.3
 
Credit Suisse Asset Management(3)
466 Lexington Avenue
New York, NY 10017
   
1,173,438
   
5.0
 
Arnold S. Lippa(4)
   
687,717
   
2.9
 
Phil Skolnick(5)
   
346,249
   
1.5
 
Barbara G. Duncan(6)
   
326,167
   
1.4
 
Robert Horton(7)
   
222,917
   
1.0
 
Warren Stern(8)
   
219,997
   
*
 
Zola Horovitz(9)
   
118,150
   
*
 
Leslie Hudson(10)
   
100,000
   
*
 
Patrick Ashe(11)
   
87,450
   
*
 
Daniel S. Van Riper(12)
   
23,400
   
*
 
Theresa A. Bischoff(13)
   
12,150
   
*
 
Jonathan Silverstein(14)
   
   
*
 
All directors and executive officers as a group (11 persons)(15)
   
2,144,197
   
8.7
%
_______________
*Less than one percent.

(1)
As of February 17, 2006, the number of outstanding shares of our common stock and common stock equivalents was 23,265,005.
(2)
OrbiMed Advisors, LLC and OrbiMed Capital, LLC, together with Samuel D. Isaly, who owns a controlling interest in each of the foregoing entities, has or shares, either directly or indirectly, voting and investment power with respect to the shares of our common stock held of record by UBS Juniper Crossover Fund, L.L.C., Caduceus Private Investments, LP and OrbiMed Associates LLC. Includes 1,635,171 shares of common stock and warrants to purchase 392,857 shares of common stock that are currently exercisable. The information reported herein is based solely upon public filings made with the SEC by or on behalf of the beneficial holders so listed.  
(3)
The information reported herein is based solely upon public filings made with the SEC by or on behalf of the beneficial holder so listed.
(4)
Includes 449,200 shares of common stock and options to purchase 238,517 shares of common stock that are currently exercisable. Excludes options to purchase 42,083 shares of common stock that are not exercisable, within 60 days of February 17, 2006. Such 449,200 shares of common stock owned by Dr. Lippa were reported as 10,000 fewer in prior reports.
(5)
Includes options to purchase 346,249 shares of common stock that are currently exercisable. Excludes options to purchase 58,751 shares of common stock that are not exercisable within 60 days of February 17, 2006.


59



(6)
Includes 25,000 shares of common stock and options to purchase 301,167 shares of common stock that are currently exercisable. Excludes options to purchase 73,333 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(7)
Includes 50,000 shares of common stock and options to purchase 172,917 shares of common stock that are currently exercisable. Excludes options to purchase 127,083 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(8)
Includes options to purchase 219,997 shares of common stock that are currently exercisable. Excludes options to purchase 115,003 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(9)
Includes 50,200 shares of common stock and options to purchase 67,950 shares of common stock that are currently exercisable. Excludes options to purchase 33,750 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(10)
Includes 100,000 shares of common stock. Excludes options to purchase 275,000 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(11)
Includes options to purchase 87,450 shares of common stock that are currently exercisable. Excludes options to purchase 33,750 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(12)
Includes options to purchase 23,400 shares of common stock that are currently exercisable. Excludes options to purchase 33,750 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(13)
Includes options to purchase 12,150 shares of common stock that are currently exercisable. Excludes options to purchase 27,150 shares of common stock that are not exercisable within 60 days of February 17, 2006.
(14)
Mr. Silverstein is a general partner of OrbiMed Advisors, LLC that, together with certain funds managed by OrbiMed, owns the securities referenced in footnote 2 above.  Mr. Silverstein's beneficial ownership does not include beneficial ownership of the securities that are presented for OrbiMed Advisors, LLC in this principal stockholder table.
(15)
Includes options to purchase 1,469,797 shares of common stock that are exercisable within 60 days of February 17, 2006. Excludes options to purchase 1,104,654 shares of common stock that are not exercisable within 60 days of February 17, 2006.

Stock Option Plans
 
The following table provides information with respect to compensation plans under which equity compensation is authorized at December 31, 2005.
 
   
 
Securities to be Issued Upon Exercise of Outstanding Options
 
Weighted Average Exercise Price of Outstanding Options
 
 
Number of Securities Remaining Available for Future Issue
 
Equity Compensation Plans Approved by Shareholders
   
3,255,966
 
$
10.65
   
507,193
 
Equity Compensation Plan Not Approved by Shareholders
   
285,000
 
$
14.28
   
 
Total
   
3,540,966
 
$
10.94
   
507,193
 

Stock Option Grants to Phil Skolnick and Scott Myers Outside of the 1998 or 2000 Plan
 
In connection with the commencement of Dr. Skolnick's employment with us in January 2001, we granted him stock options to acquire 405,000 shares of our common stock at an exercise price of $2.78 per share (such shares and price as adjusted for our subsequent 1.62-for-1 stock split). As of December 31, 2005, all the 310,000 options outstanding were vested. During 2005, Dr. Skolnick exercised 15,000 options.
 
In connection with the commencement of Mr. Myer's employment with us in December 2005, we granted him stock options to acquire 285,000 shares of our common stock at an exercise price of $14.28 per share. None of these options are currently vested.
 

60


 

In July 2003, we concluded a private placement of 1,428,571 shares of our common stock and three-year warrants to purchase an aggregate of 392,857 shares of our common stock at an exercise price of $16.00 per share to a group of funds managed by OrbiMed Advisors, LLC, for gross proceeds of $15,000,000. The investors also received the right to nominate a director to our board of directors. Jonathan Silverstein, a director of OrbiMed Advisors, LLC joined our board effective December 19, 2003.
 
In July 2005, our chief executive officer and president, Dr. Arnold Lippa, terminated his employment with us. As a result, the Company recorded a severance obligation of $790,000 as of June 30, 2005 of which approximately $201,000 was paid in February 2006. Dr. Lippa remains as chairman of our board of directors. Please refer to Item 11. Executive Compensation - Employment Agreements for details of his employment agreement.
 
In 2005, Dr. Stern received 20,000 options to purchase common stock in Suven, a contract research organization which provides services for the Company outside the United States, for services he provided to it as a consultant. Dr. Stern is a director of Suven Life Sciences USA, LLC/Asian Clinical Trials Limited.
 

The audit committee regularly reviews and determines whether specific projects or expenditures with our independent registered public accounting firm, PricewaterhouseCoopers LLP, potentially affects their independence. The audit committee's policy is to pre-approve all audit and permissible non-audit services provided by PricewaterhouseCoopers LLP. Pre-approval is generally provided by the audit committee for up to one year, is detailed as to the particular service or category of services to be rendered, and is generally subject to a specific budget. The audit committee may also pre-approve additional services or specific engagements on a case-by-case basis. Management is required to provide quarterly updates to the audit committee regarding the extent of any services provided in accordance with this pre-approval, as well as the cumulative fees for all non-audit services incurred to date. During 2005, the audit committee pre-approved all of the services provided by PricewaterhouseCoopers LLP. 

The aggregate fees and expenses billed for professional services rendered by our independent registered public accounting firm, PricewaterhouseCoopers LLP, with respect to fiscal years ended 2005 and 2004 were as follows:

     
Years Ended December 31,
 
     
2005
 
2004
 
(1)
 
Audit Fees
 
$
323,670
 
$
420,100
 
(2)
 
Audit Related Fees
   
35,830
   
15,000
 
(3)
 
Tax Fees
   
140,700
   
118,000
 
(4)
 
All Other Fees
   
4,600
   
 
 
 
Total
 
$
504,800
 
$
553,100
 

Audit fees include fees for the integrated audit of our financial statements, management’s assessment of the effectiveness of internal control over financial reporting at December 31, 2005 and 2004 (Sarbanes-Oxley 404 compliance) and the effectiveness of internal control of financial reporting at December 31, 2005 and 2004. Audit fees also include quarterly reviews, the audit fees for Nascime Ltd., our wholly-owned subsidiary, fees for review of the registration statements on forms S-1, S-3 and S-8 and fees for review of our convertible debt offering. Audit fees related to the Sarbanes-Oxley Act of 2002 Section 404 compliance in 2005 and 2004 totaled $115,000 and $125,000, respectively. In 2005 and 2004, tax related fees include fees for tax advice in relation to Nascime, an analysis of the Section 382 limitations on the utilization of net operating losses’, and tax return preparation services. In 2004, audit related fees are attributable to the review of the Merck agreement.
 

61



Non-Audit Services

  Prior to adoption of the Sarbanes-Oxley Act of 2002, our audit committee’s charter required pre-approval of all non-audit services by our independent registered public accounting firm, PricewaterhouseCoopers LLP, which would include the following: tax research and consultations; international tax consulting; tax assistance and compliance in international locations; assistance with transfer pricing; expatriate tax services; consultations and assistance with other taxes including state and local taxes, sales and use taxes, customs and duties; review of intercompany agreements; and assistance with international manufacturing tax issues. The audit committee’s amended charter adopted in March 2004 continues pre-approval requirements for permitted non-audit services that may be performed by our registered independent public accounting firm.
 
PART IV
 
 

(a)
The following documents are filed as part of this report:
 
(1)
List of Financial Statements.
 
The following financial statements of DOV Pharmaceutical, Inc. and Report of PricewaterhouseCoopers LLP are included in this report:
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of December 31, 2005 and 2004
Consolidated Statements of Operations for the Years Ended December 31, 2005, 2004 and 2003
 
Consolidated Statements of Stockholders’ (Deficit)/ Equity for the Years Ended December 31, 2005, 2004 and 2003
Consolidated Statements of Cash Flows for the Years Ended December 31, 2005, 2004 and 2003
Notes to Consolidated Financial Statements
   
(2)
List of all Financial Statement Schedules..
 
All the schedules called for are omitted because they are not applicable or the required information is included in the financial statements or notes thereto.
   
(3)
List of Exhibits.
 
Exhibits are incorporated herein by reference or are filed with this report as indicated in the “Index to Exhibits” in part (b) below (numbered in accordance with Item 601 of Regulation S-K).


62



(b)
Exhibits.


The following exhibits are filed as part of, or incorporated by reference into, this report:

 

Exhibit
No.
 
Description
3.1
 
Fourth Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Quarterly Report on Form 10-Q on May 29, 2002 and incorporated herein by reference).
3.2
 
Amended and Restated By-Laws of Registrant (filed as Exhibit 3.2 to the Quarterly Report on Form 10-Q on May 29, 2002 and incorporated herein by reference).
3.3
 
Certificate of Designations, Preferences and Rights of a Series of Preferred Stock of Registrant classifying and designating the Series E Junior Participating Cumulative Preferred Stock (filed as Exhibit 3.1 to the Current Report on Form 8-K on October 16, 2002 and incorporated herein by reference).
4.1
 
See Exhibits 3.1, 3.3 and 4.3 for instruments defining the rights of holders of common stock of Registrant.
4.2
 
Specimen certificate for shares of common stock, $0.0001 par value per share, of Registrant (filed as Exhibit 4.2 to Amendment No. 4 to the Registration Statement on Form S-1 (File No. 333-81484) on April 5, 2002 and incorporated herein by reference).
4.3
 
Shareholder Rights Agreement dated as of October 8, 2002, by and between Registrant and Continental Stock Transfer & Trust Co., as Rights Agent (filed as Exhibit 4.1 to the Current Report on Form 8-K on October 16, 2002 and incorporated herein by reference).
4.4
 
Indenture, dated December 22, 2004, between Registrant, as Issuer, and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.1 to Registrant’s Current Report on Form 8-K filed December 23, 2004).
10.1
 
Lease Agreement dated as of May 24, 1999, by and between Continental Investors, L.P. and Registrant for commercial premises located at 433 Hackensack Avenue, Hackensack, New Jersey (filed as Exhibit 10.1 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference).
10.2
 
License Agreement dated as of May 29, 1998, by and between Registrant and American Cyanamid Company (filed as Exhibit 10.2 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-81484) on February 6, 2002 and incorporated herein by reference).1
10.3
 
Sublicense and Development Agreement dated as of June 30, 1998, by and between Registrant and Neurocrine Biosciences, Inc. as amended by that certain Consent and Agreement referred to in item 10.19 (filed as Exhibit 10.4 to Amendment No. 5 to the Registration Statement on Form S-1 (File No. 333-81484) on April 24, 2002 and incorporated herein by reference).1
10.4
 
License, Research and Development Agreement dated as of January 12, 2001, by and between Registrant and Biovail Laboratories Incorporated as amended by that certain Confidential Patent License, Settlement, and Special Mutual Release Agreement (filed as Exhibit 10.4 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-81484) on February 6, 2002 and incorporated herein by reference).1 
10.5
 
Guaranty dated as of January 12, 2001, by Biovail Corporation in favor of Registrant (filed as Exhibit 10.5 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference). 
10.6
 
Joint Development and Operating Agreement dated as of January 21, 1999, by and among Registrant, Elan Corporation, plc, Elan International Services, Ltd., DOV Bermuda, Ltd. (formerly DOV Newco, Ltd.), and Nascime Limited as amended by that certain Termination Agreement referred to in item 10.23 (filed as Exhibit 10.7 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-81484) on February 6, 2002 and incorporated herein by reference).1 
10.7
 
Letter Agreement dated as of January 21, 1999, by and among Registrant, Elan Corporation, plc, Elan International Services, Ltd., DOV Bermuda, Ltd. (formerly known as DOV Newco, Ltd.), and Nascime Limited as amended by that certain Termination Agreement referred to in item 10.23 signed in connection with the Joint Development and Operating Agreement referred to in item 10.6 (filed as Exhibit 10.8 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference). 
 

63

 
 
Exhibit
No.
 
Description
10.8
 
License Agreement dated as of January 20, 1999, by and between Registrant and Nascime Limited as amended by that certain Termination Agreement referred to in item 10.23 (filed as Exhibit 10.9 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-81484) on February 6, 2002 and incorporated herein by reference).1 
10.9
 
License Agreement dated as of January 20, 1999, by and between Nascime Limited and Elan Corporation, plc as amended by that certain Termination Agreement referred to in item 10.23 (filed as Exhibit 10.10 to Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-81484) on February 6, 2002 and incorporated herein by reference).1 
10.10
 
Registration Rights Agreement dated as of January 21, 1999, by and between Registrant and Elan International Services, Ltd. as amended by that certain Letter Agreement and further amended by that certain Termination Agreement (filed as Exhibit 10.13 to the Registration Statement on Form S-1 (File No. 333- 81484) on January 28, 2002 and incorporated herein by reference).
10.11
 
Registration Rights Agreement dated as of January 21, 1999, by and among Registrant, DOV Bermuda, Ltd. (formerly known as DOV Newco, Ltd.), and Elan International Services, Ltd. for shares of common stock received pursuant to the Joint Development and Operating Agreement referred to in item 10.6 as amended by that certain Termination Agreement referred to in item 10.23 (filed as Exhibit 10.14 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference).
10.12
 
Registration Rights Agreement dated as of June 20, 2000, by and among Registrant and Series C Investors (filed as Exhibit 10.16 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference).
10.13
 
Amended and Restated Stockholders Agreement dated as of August 30, 2001 by and among Registrant, Arnold Lippa, Bernard Beer, Series C Investors and Series D Investors (filed as Exhibit 10.18 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference).
10.14
 
Registration Rights Agreement dated as of August 30, 2001 by and among Registrant, Series C Investors and Series D Investors (filed as Exhibit 10.19 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference).
10.15
 
Form of Warrant Agreement (filed as Exhibit 10.20 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference).
10.16
 
1998 Stock Option Plan (filed as Exhibit 10.21 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference).
10.17
 
2000 Stock Option and Grant Plan (filed as Exhibit 10.22 to the Registration Statement on Form S-1 (File No. 333-81484) on January 28, 2002 and incorporated herein by reference) as amended by the Amended and Restated 2000 Stock Option and Grant Plan and the Second Amendment thereto (each filed as Appendix C to the Proxy Statement dated April 26, 2004 and April 25, 2005).
10.18
 
Stock Option Agreement dated as of July 10, 2000, by and between Registrant and Philip Skolnick for the grant of 250,000 stock options (filed as Exhibit 10.25 to Amendment No. 4 to the Registration Statement on Form S-1 (File No. 333-81484) on April 5, 2002 and incorporated herein by reference).
 

64

 

Exhibit
No.
 
Description
10.19
 
Consent and Agreement dated as of March 24, 2003, by and between Registrant, Neurocrine Biosciences, Inc. and ACY (filed as Exhibit 10.35 to the Annual Report on Form 10-K on March 31, 2003 and incorporated herein by reference).
10.20
 
Securities Purchase Agreement dated as of July 1, 2003 by and among Registrant, PW Juniper Crossover Fund, L.L.C., Caduceus Private Investment, LP, and OrbiMed Associates LLC (filed as Exhibit 10.1 to the Current Report on Form 8-K on July 8, 2003 and incorporated herein by reference).
10.21
 
Registration Rights Agreement dated as of July 1, 2003 by and among Registrant, PW Juniper Crossover Fund, L.L.C., Caduceus Private Investments, LP, and OrbiMed Associates LLC (filed as Exhibit 10.2 to the Current Report on Form 8-K on July 8, 2003 and incorporated herein by reference).
10.22
 
Form of Warrant Agreement dated as of July 1, 2003, by and among Registrant, PW Juniper Crossover Fund, L.L.C., Caduceus Private Investments, LP, and OrbiMed Associates LLC (filed as Exhibit 10.3 to the Current Report on Form 8-K on July 8, 2003 and incorporated herein by reference).
10.23
 
Termination Agreement dated as of October 21, 2003 by and among Registrant, Elan Corporation, plc, Elan International Services, Ltd., Elan Pharma International Limited, DOV (Bermuda), Ltd., and Nascime Limited (filed as Exhibit 10.1 to the Current Report on Form 8-K on October 22, 2003 and incorporated herein by reference).
10.24
 
Restated Employment Agreement dated as of January 19, 2004, by and between Registrant and Philip Skolnick (filed as Exhibit 10.40 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).
10.25
 
Employment Agreement dated as of June 23, 2005, by and between Registrant and Robert Horton (filed as Exhibit 10.58 to the Quarterly Report on Form 10-Q on August 9, 2005 and incorporated herein by reference).
10.26
 
Employment Agreement dated as of September 10, 2003, by and between Registrant and Warren Stern (filed as Exhibit 10.42 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).
10.27
 
Severance Agreement dated as of March 12, 2004, by and between Registrant and Bernard Beer (filed as Exhibit 10.43 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).
10.28
 
Third Amendment to Lease Agreement dated as of February 13, 2004, by and between Continental Investors, L.P. and Registrant for commercial premises located at 433 Hackensack Avenue, Hackensack, New Jersey (filed as Exhibit 10.44 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).
10.29
 
Audit committee charter dated March 6, 2006.
10.30
 
Fourth Amendment to Lease Agreement dated as of March 11, 2004, by and between Continental Investors, L.P. and Registrant for commercial premises located at 433 Hackensack Avenue, Hackensack, New Jersey (filed as Exhibit 10.46 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).


 

65




Exhibit
No.
 
Description
10.31
 
Consent Agreement and Amendment dated February 25, 2004 by and among Wyeth Holdings Corporation, Neurocrine Biosciences, Inc. and Registrant (filed as Exhibit 10.49 to the Quarterly Report on Form 10-Q on November 9, 2004 and incorporated herein by reference).
10.32
 
License Agreement dated February 25, 2004 by and among Wyeth Holdings Corporation and Registrant (filed as Exhibit 10.50 to the Quarterly Report on Form 10-Q on November 9, 2004 and incorporated herein by reference).
10.33
 
Amended and Restated License Agreement dated February 25, 2004 by and among Wyeth Holdings Corporation and Registrant (filed as Exhibit 10.51 to the Quarterly Report on Form 10-Q on November 9, 2004 and incorporated herein by reference).
10.34
 
Employment Agreement dated as of August 3, 2004, by and between Registrant and Barbara Duncan (filed as Exhibit 10.52 to the Quarterly Report on Form 10-Q on November 9, 2004 and incorporated herein by reference).
10.35
 
Exclusive License, Development and Commercialization Agreement, dated August 5, 2004, by and between MSD Warwick (Manufacturing) Ltd. and Registrant, portions of which are subject to a request for confidential treatment (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed September 14, 2004).1
10.36
 
Fifth Amendment to Lease Agreement dated November 15, 2004 by and among MSNW Continental Associates, LLC and Registrant (filed as Exhibit 10.56 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).
10.37
 
Form of stock option agreement for options granted under the 2000 Stock Option and Grant Plan, as amended (filed as Exhibit 10.57 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).
10.38
 
Amended and Restated Employment Agreement, dated as of May 23, 2005, by and between DOV Pharmaceutical, Inc. and Arnold S. Lippa. (filed as Exhibit 10.1 to Form 8-K on May 27, 2005 and incorporated herein by reference).
10.39
 
Restricted Stock Award Agreement, dated as of May 23, 2005, by and between DOV Pharmaceutical, Inc. and Arnold S. Lippa. (filed as Exhibit 10.1 to Form 8-K on May 27, 2005 and incorporated herein by reference).
10.40
 
Amendment Agreement dated August 5, 2005, between MSD Warwick (Manufacturing) Ltd. and Registrant, portions of which are subject to a confidential treatment request (filed as Exhibit 10.1 to the Quarterly Report on Form 10-Q on November 9, 2005 and incorporated herein by reference).1
10.41
 
Employment Agreement, dated as of June 29, 2005, by and between DOV Pharmaceutical, Inc. and Leslie Hudson (filed as Exhibit 10.1 to Form 8-K on July 6, 2005 and incorporated herein by reference).
10.42
 
Employment Agreement, dated as of December 1, 2005, by and between DOV Pharmaceutical, Inc. and Scott Myers.
10.43
 
Stock Option Agreement, dated as of December 1, 2005, by and between DOV Pharmaceutical, Inc. and Scott Myers.
10.44
 
Sixth Amendment to Lease Agreement dated July 7, 2005 by and among MSNW Continental Associates, LLC and Registrant.
10.45
 
Seventh Amendment to Lease Agreement dated September 7, 2005 by and among MSNW Continental Associates, LLC and Registrant.
10.46
 
Lease Agreement dated December 20, 2005 by and among Paragon 150 Pierce Street, LLC and Registrant as amended by the Lease Modification Agreement dated as of February 28, 2006 and the Second Lease Modification Agreement dated as of February 28, 2006.
14.1
 
Code of Business Conduct and Ethics (filed as Exhibit 14.1 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference).
14.2
 
Audit Committee Complaint Procedures (filed as Exhibit 14.2 to the Annual Report on Form 10-K on March 15, 2004 and incorporated herein by reference). 
21.1
 
Subsidiaries of Registrant.
23.1
 
Consent of PricewaterhouseCoopers LLP.

66



Exhibit
No.
 
 
Description
31.1
 
Certification of Chief Executive Officer of DOV Pharmaceutical, Inc., pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
 
Certification of Chief Financial Officer of DOV Pharmaceutical, Inc., pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32
 
Certifications of Chief Executive Officer and Chief Financial Officer of DOV Pharmaceutical, Inc. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
     
1
 
Previously filed with confidential treatment of certain provisions

 
67




Pursuant to the requirements of Section 13 or 15(d) of the Securities Act of 1934, Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 
DOV Pharmaceutical, Inc.
   
 
By:
/s/ Leslie Hudson                                               
   
Name: Leslie Hudson
Title:  Chief Executive Officer and President
Date: March 15, 2006

Pursuant to the requirements of the Securities Act of 1933, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature
 
Capacity
 
Date
         
 
/s/ Leslie Hudson
 
Chief Executive Officer, President and Director (Principal Executive Officer)
 
March 15, 2006
Leslie Hudson
     
 
/s/ Barbara G. Duncan
 
Senior Vice President of Finance, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
 
March 15, 2006
Barbara G. Duncan
     
 
/s/ Arnold S. Lippa
 
Director
 
March 15, 2006
Arnold S. Lippa
     
 
/s/ Zola Horovitz
 
Director
 
March 15, 2006
Zola Horovitz
     
 
/s/ Patrick Ashe
 
Director
 
March 15, 2006
Patrick Ashe
     
 
/s/ Daniel S. Van Riper
 
Director
 
March 15, 2006
Daniel S. Van Riper
     
 
/s/ Theresa A. Bischoff
 
Director
 
March 15, 2006
Theresa A. Bischoff
     
 
/s/ Jonathan Silverstein
 
Director
 
March 15, 2006
Jonathan Silverstein
     


68


 
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

INDEX TO FINANCIAL STATEMENTS



F-1

 


To the Board of Directors and Stockholders of
DOV Pharmaceutical, Inc.

We have completed integrated audits of DOV Pharmaceutical, Inc.’s 2005 and 2004 consolidated financial statements and of its internal control over financial reporting as of December 31, 2005 and an audit of its 2003 consolidated financial statements in accordance with the standards of the Public Company Accounting Oversight Board (United States). Our opinions, based on our audits, are presented below.

Consolidated financial statements

In our opinion, the consolidated financial statements listed in the accompanying index present fairly, in all material respects, the financial position of DOV Pharmaceutical, Inc. and its subsidiaries (the Company) at December 31, 2005 and December 31, 2004, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2005 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit of financial statements includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

Internal control over financial reporting

Also, in our opinion, management’s assessment, included in Management’s Report on Internal Control Over Financial Reporting included in Part II, Item 9A, that the Company maintained effective internal control over financial reporting as of December 31, 2005 based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO), is fairly stated, in all material respects, based on those criteria. Furthermore, in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2005, based on criteria established in Internal Control — Integrated Framework issued by the COSO. The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting. Our responsibility is to express opinions on management’s assessment and on the effectiveness of the Company’s internal control over financial reporting based on our audit. We conducted our audit of internal control over financial reporting in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. An audit of internal control over financial reporting includes obtaining an understanding of internal control over financial reporting, evaluating management’s assessment, testing and evaluating the design and operating effectiveness of internal control, and performing such other procedures as we consider necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinions.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
 
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ PricewaterhouseCoopers LLP


Florham Park, New Jersey
March 14, 2006


F-2


 
DOV PHARMACEUTICAL, INC.
 

   
December 31,
 
   
2005
 
2004
 
Assets
             
Current assets:
             
Cash and cash equivalents
 
$
8,425,552
 
$
28,934,473
 
Accounts receivable
   
   
355,969
 
Marketable securitiesshort-term
   
89,126,835
   
80,051,777
 
Prepaid expenses and other current assets
   
2,011,051
   
1,415,712
 
Total current assets
   
99,563,438
   
110,757,931
 
Marketable securitieslong-term
   
   
23,235,823
 
Property and equipment, net
   
623,520
   
476,419
 
Deferred charges, net
   
1,999,548
   
2,252,380
 
               
Total assets
 
$
102,186,506
 
$
136,722,553
 
               
Liabilities and Stockholders’ Equity
             
Current liabilities:
             
Accounts payable
 
$
8,643,356
 
$
3,273,357
 
Accrued expenses
   
6,892,738
   
3,911,550
 
 Convertible line of credit promissory note
   
   
4,003,275
 
Deferred revenuecurrent
   
5,511,810
   
8,235,294
 
Total current liabilities
   
21,047,904
   
19,423,476
 
               
Deferred revenuenon-current
   
20,439,633
   
24,362,745
 
Convertible subordinated debentures
   
80,000,000
   
65,000,000
 
Commitments and contingencies
             
Stockholders' equity:
             
Preferred stock—undesignated preferred stock, $1.00 par value, 6,550,357 shares authorized, 0 shares issued and outstanding at December 31, 2005 and 2004
   
   
 
Common stock, $.0001 par value, 60,000,000 shares authorized, 23,090,970 issued and outstanding at December 31, 2005 and 21,462,628 issued and outstanding at December 31, 2004
   
2,309
   
2,146
 
Additional paid-in capital
   
136,495,644
   
128,500,216
 
Accumulated other comprehensive loss
   
(298,411
)
 
(247,553
)
Accumulated deficit
   
(153,284,922
)
 
(100,317,086
)
Unearned compensation
   
(2,215,651
)
 
(1,391
)
Total stockholders' equity (deficit)
   
(19,301,031
)
 
27,936,332
 
Total liabilities and stockholders' equity
 
$
102,186,506
 
$
136,722,553
 

The accompanying notes are an integral part of these consolidated financial statements.
 

F-3


 
DOV PHARMACEUTICAL, INC.


   
Years Ended December 31,
 
   
2005
 
2004
 
2003
 
Revenue
 
$
8,646,596
 
$
2,542,381
 
$
2,968,750
 
Operating expenses:
                   
License expense
   
   
2,500,000
   
1,000,000
 
Research and development expense
   
53,982,908
   
24,764,118
   
22,683,859
 
General and administrative expense
   
9,110,135
   
6,360,158
   
5,173,581
 
Loss from operations
   
(54,446,447
)
 
(31,081,895
)
 
(25,888,690
)
Interest income
   
3,711,747
   
934,360
   
851,104
 
Interest expense
   
(2,501,676
)
 
(2,953,986
)
 
(2,947,084
)
Other income (expense), net
   
(4,415
)
 
(7,855
)
 
1,104,323
 
Net loss before tax
   
(53,240,791
)
 
(33,109,376
)
 
(26,880,347
)
Income tax benefit
   
272,955
   
188,772
   
149,000
 
  Net loss
 
$
(52,967,836
)
$
(32,920,604
)
$
(26,731,347
)
                     
Basic and diluted net loss per share
 
$
(2.32
)
$
(1.67
)
$
(1.73
)
Weighted average shares used in computing basic and diluted net loss per share
   
22,837,265
   
19,729,765
   
15,489,426
 

The accompanying notes are an integral part of these consolidated financial statements.


F-4


 
DOV PHARMACEUTICAL, INC.


   
Series B
Preferred Stock
 
 
 
Common
Stock
 
 
Additional
Paid-In Capital
 
 
 
Accumulated
Deficit
 
 
 
Unearned
Compensation
 
Accumulated Other Comprehensive Loss
 
Total
Stockholders’
(Deficit)/ Equity
 
Balance, December 31, 2002
   
354,643
 
$
1,441
 
$
81,523,234
 
$
(40,665,135
)
$
(275,733
)
$
(179,091
)
$
40,759,359
 
Issuance of common stock and warrants
   
   
208
   
18,883,828
   
   
   
   
18,884,036
 
Amortization of unearned compensation
   
   
   
54,430
   
   
235,631
   
   
290,061
 
Issuance of options for services
   
   
   
694,360
   
   
   
   
694,360
 
Interest payable in convertible securities
   
   
   
1,857,961
   
   
   
   
1,857,961
 
Comprehensive loss:
                                           
Net loss, year ended December 31, 2003
   
   
   
   
(26,731,347
)
 
   
   
(26,731,347
)
Unrealized gain on marketable securities
   
   
   
   
   
   
150,863
   
150,863
 
Comprehensive loss
   
   
   
   
   
   
   
(26,580,484
)
Balance, December 31, 2003
   
354,643
   
1,649
   
103,013,813
   
(67,396,482
)
 
(40,102
)
 
(28,228
)
 
35,905,293
 
Issuance of stock
   
   
67
   
9,964,938
   
   
   
   
9,965,005
 
Issuance of stock for exercise of options and warrants
   
   
82
   
1,135,644
   
   
   
   
1,135,726
 
Issuance of stock for conversion of preferred
   
(354,643
)
 
57
   
354,586
   
   
   
   
 
Issuance of stock for conversion of debt
   
   
291
   
11,499,694
   
   
   
   
11,499,985
 
Amortization of unearned compensation, net
   
   
   
314,635
   
   
29,938
   
   
344,573
 
Revaluation of options for services
   
   
   
(8,773
)
 
   
8,773
   
   
 
Interest payable in convertible securities
   
   
   
2,225,679
   
   
   
   
2,225,679
 
Comprehensive loss:
                                           
Net loss, year ended December 31, 2004
   
   
   
   
(32,920,604
)
 
   
   
(32,920,604
)
Unrealized loss on marketable securities
   
   
   
   
   
   
(219,325
)
 
(219,325
)
Comprehensive loss
   
   
   
   
   
   
   
(33,139,929
)
Balance, December 31, 2004
   
   
2,146
   
128,500,216
   
(100,317,086
)
 
(1,391
)
 
(247,553
)
 
27,936,332
 
Issuance of stock for exercise of options and warrants
   
   
29
   
1,058,644
   
   
   
   
1,058,673
 
Issuance of stock for compensation
   
   
16
   
3,022,984
   
   
(3,023,000
)
 
   
 
Issuance of stock for conversion of debt
   
   
118
   
4,024,520
   
   
   
   
4,024,638
 
Amortization of unearned compensation, net
   
   
   
   
   
808,740
   
   
808,740
 
Revaluation of options for services
   
   
   
(194,504
)
 
   
   
   
(194,504
)
Interest payable in convertible securities
   
   
   
83,784
   
   
   
   
83,784
 
Comprehensive loss:
                                           
Net loss, year ended December 31, 2005
   
   
   
   
(52,967,836
)
 
   
   
(52,967,836
)
Unrealized loss on marketable securities
   
   
   
   
   
   
(50,858
)
 
(50,858
)
Comprehensive loss
   
   
   
   
   
   
   
(53,018,694
)
Balance, December 31, 2005
   
 
$
2,309
 
$
136,495,644
 
$
(153,284,922
)
$
(2,215,651
)
$
(298,411
)
$
(19,301,031
)
 
The accompanying notes are an integral part of these consolidated financial statements.
 

F-5


 
DOV PHARMACEUTICAL, INC.
 

   
Years Ended December 31,
 
   
2005
 
2004
 
2003
 
Cash flows from operating activities
                   
Net loss
 
$
(52,967,836
)
$
(32,920,604
)
$
(26,731,347
)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
                   
Purchased in-process research and development
   
   
   
5,305,681
 
Non-cash amortization of premium paid on marketable securities
   
1,317,033
   
909,486
   
1,196,880
 
Non-cash litigation settlement income
   
   
   
(42,651
)
Net depreciation in investments
   
   
   
250,782
 
Realized loss in marketable securities
   
   
   
182,354
 
Net loss on sale of investments
   
   
   
8,839
 
Non-cash interest expense
   
105,147
   
2,913,361
   
2,943,737
 
Depreciation of assets
   
531,170
   
221,109
   
155,358
 
Amortization of deferred charges
   
401,068
   
58,302
   
94,868
 
Non-cash compensation charges
   
808,740
   
29,938
   
290,061
 
Options and common stock issued/revalued for services
   
(194,504
)
 
314,635
   
694,360
 
Changes in operating assets and liabilities:
                   
Due from DOV Bermuda (Elan Portion)
   
   
   
193,058
 
Accounts receivable
   
355,969
   
(355,969
)
 
47,289
 
Prepaid expenses and other current assets
   
(315,289
)
 
(97,878
)
 
(487,093
)
Accounts payable
   
5,369,999
   
1,433,702
   
(60,004
)
Accrued expenses
   
2,981,188
   
2,690,736
   
179,762
 
Deferred revenue
   
(6,646,596
)
 
32,598,039
   
(2,968,750
)
Net cash provided by (used in) operating activities
   
(48,253,911
)
 
7,794,857
   
(18,746,816
)
                     
Cash flows from investing activities
                   
Purchase of in-process research and development
   
   
   
(5,305,681
)
Purchases of marketable securities
   
(139,579,923
)
 
(125,039,485
)
 
(76,237,406
)
Sales of marketable securities
   
152,372,796
   
63,494,000
   
73,104,160
 
Sales of investments
   
   
   
786,854
 
Purchases of property and equipment
   
(678,271
)
 
(332,578
)
 
(181,808
)
Net cash provided by (used in) investing activities
   
12,114,602
   
(61,878,063
)
 
(7,833,881
)
                     
Cash flows from financing activities
                   
Borrowings under convertible debenture, net of issuance costs
   
14,571,715
   
62,625,949
   
 
Proceeds from issuance of stock, net of cash costs
   
   
9,965,005
   
14,753,248
 
Proceeds from options and warrants exercised
   
1,058,673
   
1,135,726
   
1,738,875
 
Net cash provided by financing activities
   
15,630,388
   
73,726,680
   
16,492,123
 
Net (decrease) increase in cash and cash equivalents
   
(20,508,921
)
 
19,643,474
   
(10,088,574
)
Cash and cash equivalents, beginning of year
   
28,934,473
   
9,290,999
   
19,379,573
 
Cash and cash equivalents, end of year
 
$
8,425,552
 
$
28,934,473
 
$
9,290,999
 
 
Supplemental disclosures of cash flow information
                   
Interest paid
 
$
1,127,778
 
$
3,818
 
$
3,346
 
Non-cash issuance of warrants
   
   
 
$
2,391,913
 
Issuance of stock upon conversion of debt
 
$
4,024,638
 
$
11,570,504
   
 
 
The accompanying notes are an integral part of these consolidated financial statements.
 

F-6


 
DOV PHARMACEUTICAL, INC.
 

1. The Company

Organization

DOV Pharmaceutical, Inc. (the “Company”) was incorporated in May 1995 under the laws of New Jersey and reincorporated in Delaware in November 2000.

The Company is a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system disorders. The Company has product candidates in clinical trials, and one product candidate for which two new drug applications, or NDAs, were filed in the first half of 2005, targeting insomnia, pain and depression. The Company has established strategic alliances with select partners to access their unique technologies and their commercialization capabilities. The Company operates principally in the United States but it also conducts clinical studies outside the United States.

2. Significant Accounting Policies

Basis of Presentation

The financial statements are presented on the basis of accounting principles that are generally accepted in the United States. The consolidated financial statements include accounts of the Company and its subsidiaries. Intercompany accounts and transactions are eliminated in consolidation.

Certain prior period amounts have been reclassified to conform to current period presentation.
 
Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make certain estimates and assumptions that affect the reported assets, liabilities, revenues, earnings, financial position and various disclosures. Significant estimates have included accrued litigation settlement costs, the value of investments, the valuation allowance recorded for deferred tax assets and the development period for the Company’s products. Actual results could differ from those estimates and the differences could be material.

Segment and Geographic Information

The Company has determined it has one reportable operating segment as defined by Statement of Financial Accounting Standards No. 131, "Disclosures about Segments of an Enterprise and Related Information."
 

F-7



Cash, Cash Equivalents and Marketable Securities

The Company considers all highly liquid investments with a maturity of 90 days or less when purchased to be cash equivalents. The Company has evaluated its investment policies consistently with Statement of Financial Accounting Standards ("SFAS") No. 115, "Accounting for Certain Investments in Debt and Equity Securities," and has determined that all its investment securities are to be classified as available-for-sale. Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in Stockholders´ Equity under the caption "Accumulated Other Comprehensive Income (Loss)." The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in other income and expense. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. At December 31, 2005 and 2004, short-term marketable securities included $21.2 million and $61.6 million of investments, respectively, primarily comprised of investment grade asset-backed, variable-rate debt obligations, commercial paper and money market funds.  Accordingly, the investments in these securities are recorded at cost, which approximates fair value due to their variable interest rates, which typically reset every 28 days.  Despite the long-term nature of their stated contractual maturities, the Company has the ability to quickly liquidate these securities, thus they are classified as short-term marketable securities.

Property and Equipment

Property and equipment are stated at cost. Depreciation is provided on furniture and fixtures and machinery and equipment over their estimated useful lives ranging from 2 to 7 years, using principally the straight-line method. Leasehold improvements are amortized over the lesser of the term of the respective lease or the useful lives of the related assets. Expenditures for maintenance and repairs are expensed to operations as incurred. Gains and losses from sales and retirements are included in income (loss) from operations as they occur. In the fourth quarter of 2005, due to a change in information technology at the Company, the Company determined that certain assets with a residual book value of $167,000 would no longer be utilized and therefore the estimated useful life was adjusted to reflect the zero economic value of these assets.

Impairment of Long-Lived Assets

The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of their carrying amount or fair value, less cost to sell. 

Deferred Charges

Deferred charges are issuance costs for the convertible debentures, the convertible promissory note and the convertible line of credit promissory note and were and are being amortized over the term of the instruments in the case of the convertible promissory note and the convertible line of credit promissory note and over seven years, that is, to the first put date, for the convertible debentures. Please refer to Footnote 5.

Revenue Recognition

Revenue is recognized under collaboration or research and development agreements when services are performed or when contractual obligations and/or milestones are met and amounts are considered collectible. The Company has adopted the milestone payment method to account for milestone payments received pursuant to development agreements. Revenues from milestone payments that represent the culmination of a separate earnings process are recorded when the milestone is achieved. Cash received in advance of revenue recognition for license fees is recorded as deferred revenue and recognized when earned over the research and development period. On August 5, 2004, the Company entered into an agreement with Merck (and amended in August 2005) for the worldwide development and commercialization of all indications for DOV 21,947 and certain indications for DOV 216,303 in exchange for a $35.0 million up-front payment and the right to receive further payments of up to $420.0 million upon the achievement of certain milestones and royalties based on product net sales, if any. The up-front payment has been deferred and is being amortized to revenue over the estimated research and development period of 72 months. The time period of the development period is a significant estimate used in the preparation of the financial statements.
 

F-8



Royalty revenue will be recognized upon the sale of the related products, provided the royalty amounts are fixed or determinable and collection of the related receivable is probable. The Company has not recognized royalty revenue to date.

Research and Development

Research and development costs are expensed when incurred and include allocations for payroll and related costs and other corporate overhead. Costs assigned to acquired assets to be used in a particular research and development project that have no alternative future use are charged to expenses as in-process research and development expense as of the date of acquisition.

The following represents a detail of amounts included in research and development expense:

   
Years Ended December 31,
 
 
 
2005
 
2004
 
2003
 
Payroll related and associated overhead
 
$
10,720,094
 
$
5,773,704
 
$
4,774,687
 
Clinical and preclinical trial costs
   
41,525,596
   
18,103,432
   
11,497,889
 
Purchased in-process research and development
   
   
   
5,305,681
 
Professional fees
   
1,128,136
   
503,789
   
836,158
 
Travel
   
609,082
   
383,193
   
269,444
 
Total research and development expense
 
$
53,982,908
 
$
24,764,118
 
$
22,683,859
 
 
Net Loss Per Share

Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. For certain periods, the Company has excluded the shares issuable on conversion of the convertible subordinated debentures, convertible promissory note, the convertible line of credit promissory note, convertible preferred stock, outstanding options and warrants to purchase common stock from the calculation of diluted net loss per share, as such securities are antidilutive as indicated in the table below.

 
 
Years Ended December 31,
 
 
 
2005
 
2004
 
2003
 
Net loss attributable to common stockholders
 
$
(52,967,836
)
$
(32,920,604
)
$
(26,731,347
)
Basic and diluted:
                   
Weighted-average shares used in computing basic and diluted net loss per share
   
22,837,265
   
19,729,765
   
15,489,426
 
Basic and diluted net loss per share
 
$
(2.32
)
$
(1.67
)
$
(1.73
)
Antidilutive securities not included in basic and diluted net loss per share calculation:
                   
Convertible subordinated debentures
   
3,516,484
   
2,857,143
   
 
Convertible preferred stock
   
   
   
574,521
 
Convertible promissory note
   
   
   
2,827,780
 
Convertible line of credit promissory note
   
   
1,173,981
   
1,064,966
 
Options
   
3,540,966
   
2,646,176
   
2,631,370
 
Warrants
   
819,731
   
895,366
   
1,396,766
 
     
7,877,181
   
7,572,666
   
8,495,403
 


F-9



Comprehensive Loss
 
 
Years Ended December 31,
 
 
 
2005
 
2004
 
2003
 
Net loss
 
$
(52,967,836
)
$
(32,920,604
)
$
(26,731,347
)
Reclassification for losses included in net loss
   
   
   
182,354
 
Net unrealized losses on marketable securities
   
(50,858
)
 
(219,325
)
 
(31,491
)
Comprehensive loss
 
$
(53,018,694
)
$
(33,139,929
)
$
(26,580,484
)

Other Income (Expense), net
 
 
Years Ended December 31,
 
 
 
2005
 
2004
 
2003
 
Directors’ and officers’ insurance recovery (Note 14)
 
$
 
$
 
$
1,556,000
 
Decrease in value of warrants to acquire Neurocrine stock, net (Note 12)
   
   
   
(250,759
)
Decrease in value of warrants related to shareholder class action lawsuit (Note 14)
   
   
   
42,651
 
Other expense, net
   
(4,415
)
 
(7,855
)
 
(243,569
)
Other income (expense), net
 
$
(4,415
)
$
(7,855
)
$
1,104,323
 

Stock-Based Compensation

The Company accounts for stock-based compensation expense for options granted to employees using the intrinsic value method prescribed in Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," and has adopted the disclosure only alternative of SFAS No. 123, "Accounting for Stock-Based Compensation".

If the Company had elected to recognize compensation expense based upon the fair value at the date of grant for awards under these plans, consistent with the methodology prescribed by SFAS 123, the effect on the Company's net loss would be as follows:

 
 
For the Years Ended December 31,
 
 
 
2005
 
2004
 
2003
 
Net loss attributed to common stockholders:
                   
As reported
 
$
(52,967,836
)
$
(32,920,604
)
$
(26,731,347
)
Add: total stock-based employee compensation expense determined under APB No. 25
   
808,740
   
29,938
   
290,061
 
Deduct: total stock-based employee compensation expense determined under fair
value based method for all awards
   
(6,116,809
)
 
(3,871,325
)
 
(1,684,376
)
Pro forma
 
$
(58,275,905
)
$
(36,761,991
)
$
(28,125,662
)
Basic and diluted net loss per share applicable to common stockholders:
                   
As reported
 
$
(2.32
)
$
(1.67
)
$
(1.73
)
Pro forma
 
$
(2.55
)
$
(1.86
)
$
(1.82
)

For purposes of the computation of the pro forma effects on the net loss above, the fair value of each employee option is estimated using the Black-Scholes option pricing model and using the following assumptions:

 
 
December 31,
 
 
 
2005
 
2004
 
2003
 
Risk-free interest rate
 
3.73%-4.49%
 
3.78%-4.90%
 
3.46%-4.41%
 
Expected lives
 
6 years
 
6-10 years
 
10 years
 
Expected dividends
 
None
 
None
 
None
 
Expected volatility
 
64.27%-67.90%
 
69.74%-76.27%
 
76.58%-87.41%
 


F-10



The weighted average per share fair value of Company's common stock options granted to directors, officers and employees for the years ended December 31, 2005, 2004 and 2003 approximated $16.75, $10.97 and $10.59 respectively.

Income Taxes

Deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year end, based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

Risks and Uncertainties

The Company is subject to risks common to companies in the biopharmaceutical industry, including but not limited to successful commercialization of product candidates, protection of proprietary technology and compliance with FDA regulations. 

Liquidity
 
Since the Company’s inception, it has incurred significant operating losses and management expects that it will continue to do so for the foreseeable future. As of December 31, 2005, it had an accumulated deficit of $153.3 million. The Company has depended upon equity and debt financings and license fee and milestone payments from its collaborative partners and licensees to fund its operations and research and product development programs and expects to do so for the foreseeable future. The Company currently has no commitments or arrangements for any financing. Management believes that existing cash and cash equivalents and marketable securities will be sufficient to fund the Company’s anticipated operating expenses, debt obligations and capital requirements until at least March 31, 2007. If at any time sufficient capital is not available, either through existing capital resources or through raising additional funds, the Company may be required to delay, reduce the scope of, eliminate or divest one or more of its product development programs.  

Concentration of Credit Risk

Cash and cash equivalents are invested in deposits with significant financial institutions. The Company has not experienced any losses on its deposits of cash and cash equivalents. Management believes that the financial institutions are financially sound and, accordingly, minimal credit risk exists. Approximately $5.6 million of the Company's cash balance was uninsured at December 31, 2005.

Derivatives

In accordance with SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities, all derivative instruments are recorded on the balance sheet at fair value. Changes in fair value of derivatives are recorded each period in current earnings or other comprehensive income depending on whether a derivative is designated as part of a hedge transaction and if so depending on the type of hedge transaction.

Recent Accounting Pronouncements

The Financial Accounting Standards Board (“FASB”) issued SFAS No. 123 (Revised 2004) (“SFAS No. 123R”), “Share-Based Payment,” in December 2004.  SFAS No. 123R is a revision of FASB Statement 123, “Accounting for Stock-Based Compensation” and supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees,” and its related implementation guidance. The Statement focuses primarily on accounting for transactions in which an entity obtains employee services in share-based payment transactions. SFAS No. 123R requires a public entity to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award (with limited exceptions). That cost will be recognized over the period during which an employee is required to provide service in exchange for the award. This statement is effective as of the beginning of the first annual reporting period that begins after June 15, 2005 and the Company will adopt the standard in the first quarter of 2006.
 

F-11



As permitted by SFAS 123, the Company currently accounts for share-based payments to employees using APB Opinion 25’s intrinsic value method and, as such, it generally recognizes no compensation cost for employee stock options. The Company will adopt the provisions of SFAS No. 123R on a prospective basis in the first quarter of 2006. As a result of the provisions of SFAS 123R, the Company expects the compensation charges under SFAS 123R to be in the range of $7.0 million to $8.0 million for the year ended December 31, 2006 which reflects the awards granted through February 2006. Management has not estimated compensation charges with respect to future awards as this is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, the volatility of our stock price, forfeiture rates and the timing of future employee stock option grants. We will recognize compensation cost for stock-based awards which vest after December 31, 2005, on a straight-line basis over the requisite service period of the award.

In May 2005, the FASB issued SFAS 154, “Accounting Changes and Error Corrections,” which replaces APB Opinion No. 20, “Accounting Changes,” and supersedes FASB Statement No. 3, “Reporting Accounting Changes in Interim Financial Statements—an amendment of APB Opinion No. 28.” SFAS 154 requires retrospective application to prior periods financial statements of changes in accounting principle, unless it is impracticable to determine either the period-specific effects or the cumulative effect of the change. When it is impracticable to determine the period-specific effects of an accounting change on one or more individual prior period presented, SFAS 154 requires that the new accounting principle be applied to the balances of assets and liabilities as of the beginning of the earliest period for which retrospective application is practicable and that a corresponding adjustment be made to the opening balance of retained earnings for that period rather than being reported in an income statement. When it is impracticable to determine the cumulative effect of applying a change in accounting principle to all prior periods, SFAS 154 requires that the new accounting principle be applied as if it were adopted prospectively from the earliest date practicable. SFAS 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005.  Management does not expect the implementation of SFAS 154 to have a significant impact on the Company's results of operations.

3. Marketable Securities         
 
Available-for-sale securities are classified as short-term regardless of their maturity date if the Company has them available to fund operations within one year of the balance sheet date. Auction-rate securities are highly liquid securities that have floating interest or dividend rates that reset periodically through an auctioning process that sets rates based on bids. Issuers include municipalities, closed-end bond funds and corporations. These securities can either be debt or preferred shares. The following is a summary of marketable securities classified as "available-for-sale" securities as required by SFAS 115 as of December 31, 2005.

 
 
 
 
 
 
 
Gross Unrealized Losses
 
 
 
 
 
Amortized Cost
 
Gross Unrealized Gains
 
Less than 12 Months
 
 
Greater than 12 Months
 
Estimated
Fair Value
 
Institutional money market
 
$
2,580,748
 
$
 
$
 
$
 
$
2,580,748
 
Amounts included in cash and cash equivalents
 
$
2,580,748
 
$
 
$
 
$
 
$
2,580,748
 
Corporate debt
 
$
68,250,246
 
$
 
$
(299,915
)
$
 
$
67,950,331
 
Auction rate securities
   
21,175,000
   
1,504
   
   
   
21,176,504
 
Amounts included in marketable securities - short-term
 
$
89,425,246
 
$
1,504
 
$
(299,915
)
$
 
$
89,126,835
 
 
 

F-12


The following is a summary of the amortized cost and estimated value of debt securities by contractual maturity at December 31, 2005, excluding securities classified as cash and cash equivalents.
 
   
 
Amortized Cost
 
Estimated
Fair Value
 
Due in less than one year
 
$
89,425,246
 
$
89,126,836
 
Due between one and two years
   
   
 
               
Total 
 
$
89,425,246
 
$
89,126,836
 

 
The following is a summary of marketable securities classified as "available-for-sale" securities as required by SFAS 115 as of December 31, 2004.
 
   
 
 
 
 
Gross Unrealized Losses
 
 
 
 
 
Amortized Cost
 
Gross Unrealized Gains
 
Less than 12 MonthsGross Unrealized Losses
 
 
Greater than 12 Months
 
Estimated
Fair Value
 
Institutional money market
 
$
23,045,858
 
$
 
$
 
$
 
$
23,045,858
 
Amounts included in cash and cash equivalents
 
$
23,045,858
 
$
 
$
 
$
 
$
23,045,858
 
Corporate debt
 
$
16,994,099
 
$
 
$
(77,222
)
$
 
$
16,916,877
 
Asset-backed securities
   
1,514,605
   
   
(4,705
)
 
   
1,509,900
 
Auction rate securities
   
61,624,790
   
210
   
   
   
61,625,000
 
Amounts included in marketable securities - short-term
 
$
80,133,494
 
$
210
 
$
(81,927
)
$
 
$
80,051,777
 
Corporate debt
 
$
23,401,659
 
$
 
$
(165,836
)
$
 
$
23,235,823
 
Amounts included in marketable securities - long-term
 
$
23,401,659
 
$
 
$
(165,836
)
$
 
$
23,235,823
 


F-13



4. Property and Equipment

Property and equipment consist of the following at:
   
 
 
December 31,
 
 
 
Years
 
2005
 
2004
 
Furniture and fixtures
 
7
 
$
409,454
 
$
324,949
 
Machinery and equipment
 
2-5
   
1,183,067
   
672,056
 
Leasehold improvements
 
2-5
   
300,481
   
217,726
 
           
1,893,002
   
1,214,731
 
Less accumulated depreciation
         
1,269,482
   
738,312
 
Property and equipment, net 
       
$
623,520
 
$
476,419
 

5. Convertible Subordinated Debentures
 
In December 2004 and January 2005, the Company completed a private placement of $80.0 million aggregate principal amount of 2.5% convertible subordinated debentures due January 15, 2025. The holders of the debentures may require us to purchase all or a portion of their debentures on January 15, 2012, January 15, 2015 and January 15, 2020 (the investor repurchase dates), in each case at a price equal to the principal amount of the debentures to be purchased, plus accrued and unpaid interest, if any, to the purchase date. The debentures are unsecured and subordinated in right of payment to all existing and future senior debt, as defined in the indenture governing the debentures. The Company will pay interest semi-annually of $1,000,000 on January 15 and July 15 of each year, commencing July 15, 2005.
 
The Company has reserved 3,516,484 shares of common stock for issuance upon conversion of the debentures. The Company incurred issuance costs related to this private placement of approximately $2.8 million, which have been recorded as other assets and are being amortized to interest expense through the first investor repurchase date of the debentures. The Company has filed a shelf registration statement with the SEC covering resales of the debentures and the common stock issuable upon conversion of the debentures, which was declared effective on May 9, 2005.
 
Holders may convert their debentures at any time at the conversion rate prior to the close of business on the business day prior to the maturity date or, if the debentures are called for redemption, on the business day prior to the redemption date. The initial conversion rate is 43.9560 shares of the Company’s common stock for each $1,000 principal amount of debentures, or $22.75 per share. In addition, if certain corporate transactions that constitute a change of control occur on or prior to January 15, 2012, the conversion rate will increase in certain circumstances, unless such transactions constitute a public acquirer change of control and the Company elects to satisfy its conversion obligation with public acquirer common stock. The Company may redeem for cash the debentures in whole or in part at any time beginning on January 15, 2008 and prior to January 15, 2012, at a redemption price equal to 100% of the principal amount of the debentures to be redeemed, plus accrued and unpaid interest, including liquidated damages, if any, to but excluding the redemption date, provided the last reported sale price of the Company’s common stock has exceeded 140% of the conversion price for at least 20 trading days in any consecutive 30-day trading period ending on the trading day prior to the date of mailing of the notice of redemption. On or after January 20, 2012, the Company may redeem for cash some of or all the debentures at any time at a redemption price equal to 100% of the principal amount of the debentures to be redeemed, plus any accrued and unpaid interest, including liquidated damages, if any, to but excluding the redemption date. 
 
The fair value of our subordinated convertible debentures, based on the price for the debentures at December 31, 2005 and 2004 approximated $70.6 million and $68.6 million respectively.

6. Transaction with Elan

In January 1999, the Company and Elan International Services, Ltd. ("EIS"), a wholly-owned subsidiary of Elan, formed DOV Bermuda, which then owned 100% of the issued and outstanding share capital of Nascime Limited, an Irish private limited company ("Nascime"). DOV Bermuda was formed for the special and limited purpose of holding all the issued and outstanding shares of Nascime. The principal business of Nascime is to carry on the business of development, testing, exploitation, registration, manufacture, commercial realization and licensing of two of the Company's compounds, ocinaplon and bicifadine, utilizing certain Elan technology. In June 2000, EIS transferred its DOV Bermuda shares to a wholly-owned non-consolidated subsidiary, EPIL II.
 

F-14



Historically, both the Company and EIS had certain preemptive rights, which allowed them to maintain their respective ownership interests in future fundings of DOV Bermuda, and both were subject to dilution if they choose not to participate in future equity offerings. Although the Company was the majority shareholder, the joint development agreement gave management participation to both the Company and EIS. Because the minority shareholder, EIS, had substantive participating rights through management participation, the Company accounted for its investment in the joint venture using the equity method of accounting, in accordance with EITF 96-16. Effective January 2003, Elan's participating rights expired.  As a result, as of January 1, 2003, the Company consolidates the results of DOV Bermuda. Elan has not funded its pro rata portion of the joint venture expenses, effective January 1, 2003. During 2003, the Company funded Elan’s portion of the expenses that resulted in Elan’s ownership in the joint venture declining to 17% as of June 30, 2003.

As discussed above, the primary purpose of the joint venture was to develop two of the Company's compounds utilizing the Elan technology. DOV Bermuda has no operations or employees and historically contracted out the research and development of the compounds to either the Company or Elan. EIS and the Company have historically funded the expenses of DOV Bermuda based on their respective ownership interests. DOV Bermuda then reimbursed the Company and Elan for the work performed on behalf of DOV Bermuda.

On March 24, 2003, the Company and Elan agreed to eliminate the exchange feature of the instrument previously referred to as the convertible exchangeable promissory note discussed below. The exchange right had previously given Elan the ability to exchange, at any time during the term of the note, the principal portion of the note into an equal ownership position with the Company in DOV Bermuda. All other significant terms of the note, which included the right to convert the principal and accrued interest at any time into shares of the Company’s common stock at $3.98 per share until the expiration of the note in January 2005, remained the same. In connection with this amendment to the note, the Company issued to Elan International Services, Ltd. ("EIS"), a wholly-owned subsidiary of Elan, warrants to purchase 75,000 shares of DOV common stock with a strike price of $10.00 per share and with an expiration date of January 21, 2006. As of March 24, 2003, the Company determined the fair value of the warrants at $164,000, which was capitalized and was amortized over the remaining term of the note. Elan converted the warrants into common stock in January 2005.

On October 21, 2003, the Company entered into an agreement with Elan to acquire 100% ownership of Nascime from DOV Bermuda. In connection with the acquisition, the Company paid $5.0 million to a subsidiary of Elan in respect of its 17% equity stake in the joint venture. Elan granted to the operating company a non-exclusive, royalty-free, perpetual, worldwide license to make and sell the two product candidates in controlled release formulations using the Elan intellectual property licensed to the joint venture, including that developed during the venture. In connection with the license grant, the Company is required to pay Elan milestones, amounting to $1.0 million for ocinaplon and $0.5 million for bicifadine upon license of the products to a third party for development or commercialization, and additional equal amounts upon commercial launch, or an aggregate of $3.0 million upon commercial launch of both products if it does not license the products to a third party. The Elan intellectual property under license includes certain Elan know-how and all Elan patents owned, licensed or controlled by Elan subsequent to the license agreement. This acquisition ends Elan's involvement in the nearly five-year joint venture established to develop controlled release formulations of bicifadine and ocinaplon. In accordance with FASB 141, “Business Combinations”, the transaction was accounted for as an acquisition of assets.

The acquisition by the Company of Nascime and the product candidates, bicifadine and ocinaplon, relate to early stage technology that, in the opinion of the Company's management, has not yet reached technological feasibility, as the products will ultimately require regulatory approval prior to commercialization. In that regard, the $5.0 million purchase price was expensed as in-process research and development in the fourth quarter of 2003. In connection with the acquisition, costs of $306,000 were incurred related to stamp transfer taxes paid to Ireland. These costs are also included in research and development expense as they relate to costs of acquired assets.
 

F-15



Elan Notes

In January 1999, the Company issued a convertible promissory note in the amount of $8,010,000 and a convertible line of credit promissory note in the maximum initial principal amount of $7,008,750 to EIS. The fair value of the convertible line of credit promissory note outstanding was $21,190,356 as of December 31, 2004. The excess fair value over the carrying amount is due to the increased value of the conversion feature in this note since its issuance. The estimated fair-value amount has been determined using the Black-Scholes methodology.

a. Convertible Promissory Note

On May 25, 2004, EIS converted the outstanding principal and accrued interest totaling $11.6 million into 2,907,162 shares of the Company’s common stock. The convertible promissory note provided for interest to accrue at the rate of 7% per annum compounded on a semi-annual basis.

During 2004 and 2003, the interest feature in the convertible promissory note was determined to include a beneficial conversion feature as the interest is convertible into shares of the Company or payable in cash at the option of EIS. The Company is accounting for this feature in accordance with EITF 98-5 "Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios" and EITF 00-27 "Application of Issue 98-5 to Certain Convertible Instruments." The Company recorded $893,792 and $1,178,871 of additional interest expense associated with this beneficial conversion feature in 2004 and 2003, respectively, with a corresponding increase in additional paid-in capital.

For the years ended December 31, 2004 and 2003, the accrued interest excluding the additional interest noted above on the note amounted to $315,939 and $748,309 respectively was recorded as interest expense and added to the principal balance of the note.

b. Convertible Line of Credit Promissory Note
 
During 2004, EIS sold the convertible line of credit promissory note to an institutional investor and on January 20, 2005, the holder converted the entire balance of the note and the accrued interest into 1,180,246 shares of the Company’s common stock. The convertible line of credit promissory note provided for interest to accrue at the rate of 10% per annum compounded on a semi-annual basis.

At December 31, 2005 and 2004, principal borrowings were $0 and $2,441,600, respectively under the convertible line of credit promissory note. For the years ended December 31, 2005, 2004 and 2003 accrued interest expense on this note amounted to $21,364, $371,743 and $337,468 respectively, which was recorded as interest expense and added to the principal balance of the note.

Also during 2005, 2004 and 2003 the interest feature in the note was determined to include a beneficial conversion feature as the interest is convertible into shares of the Company or payable in cash at the option of EIS. The Company is accounting for this feature in accordance with EITF 98-5 and EITF 00-27. The Company recorded $83,784, $1,331,887 and $679,089 of additional interest expense associated with this beneficial conversion feature in 2005, 2004 and 2003 respectively, with a corresponding increase to additional paid-in capital.
 

F-16



7. Accrued Expenses

Accrued expenses consist of the following:

 
 
December 31,
 
 
 
2005
 
2004
 
Accrued milestone prepaid by Neurocrine (Note 12)
 
$
 
$
2,000,000
 
Accrued investigator fees
   
2,473,676
   
 
Accrued professional fees
   
380,950
   
722,777
 
Accrued bonuses
   
1,131,940
   
633,000
 
Accrued other
   
667,881
   
39,979
 
Accrued taxes
   
40,500
   
173,875
 
Accrued interest
   
922,222
   
40,625
 
Accrued payroll, vacation and other
   
1,275,569
   
301,294
 
   
$
6,892,738
 
$
3,911,550
 

8. Income Taxes

No U.S. Federal taxes are payable at December 31, 2005 and 2004. However, as of December 31, 2005 and 2004, the Company did have a $6,000 and $101,000 state tax liability computed under the New Jersey alternative minimum assessment regime.

During 2005 and 2004, the Company sold $3.5 million and $3.7 million, respectively, of state net operating loss (“NOL”) carryforwards under the New Jersey Tax Benefit Transfer Program. The proceeds from the sale of the NOLs amounted to $273,000 and $290,000, which are reported as a tax benefit in 2005 and 2004, respectively.

At December 31, 2005, the Company had approximately $90.3 million of federal and $72.0 million of state NOL carryforwards available to offset future taxable income. The federal and state NOL carryforwards will begin expiring in 2010 if not utilized. The Company accounts for its income taxes under Statement of Financial Accounting Standards No. 109, Accounting for Income Taxes (SFAS No. 109). Included in the federal and state NOL carryforwards is approximately $10.8 million related to non-qualified stock option expense.
 
For financial reporting purposes, a valuation allowance of $58.9 million has been recorded at December 31, 2005, to fully offset the deferred tax asset related to these carryforwards in accordance with SFAS 109. SFAS 109 requires the Company to record a valuation allowance when it is "more likely than not that some portion or all of the deferred tax assets will not be realized."

Pursuant to Section 382 of the Internal Revenue Code of 1986, as amended, the annual utilization of a company's net operating loss carryforwards may be limited if the Company experiences a change in ownership of more than 50 percentage points within a three-year period. The Company has completed its evaluation of its changes in ownerships pursuant to the definition in Section 382 of the Internal Revenue Code of 1986, as amended, which limits the annual utilization of a company’s NOLs if a company experiences a change of ownership. An ownership change occurs with respect to a corporation if it is a loss corporation on a testing date and, immediately after the close of the testing date, the percentage of stock of the corporation owned by one or more five-percent shareholders has increased by more than 50 percentage points over the lowest percentage of stock of such corporation owned by such shareholders at any time during the testing period. While the Company has determined that such ownership changes have occurred, the overall NOL limitation imposed by Section 382 will not materially impact the Company's ability to utilize its NOLs.
 

F-17



The principal components of the deferred tax asset, assuming a 34% Federal tax rate and a 9% gross state tax rate, are as follows:

 
 
December 31,
 
 
 
2005
 
2004
 
Deferred tax assets:
             
Fixed assets and intangible assets
 
$
592,805
 
$
500,188
 
Capitalized research and development, net
   
9,570,481
   
 
Deferred revenue
   
11,159,120
   
14,017,157
 
Accrued other
   
392,361
   
77,637
 
Net operating loss carryforward
   
37,190,602
   
10,806,536
 
Total gross deferred tax assets
   
58,905,369
   
25,401,518
 
Valuation allowance
   
(58,905,369
)
 
(25,401,518
)
Net deferred tax assets
 
$
 
$
 
 
The net change in valuation allowance for 2005 and 2004 was an increase of approximately $33.5 million and $13.9 million, respectively, which is primarily the result of additional net operating losses incurred by the Company for which a benefit has not been recorded as well as the retroactive capitalization of certain research and development expenditures previously deducted. The Company's subsidiary in Ireland did not incur income taxes in 2005 based on its current business activities.

The difference between the Federal statutory tax rate (34%) and the effective tax rate (0.5%) is primarily due to the increase in valuation allowance in all periods presented and the sale of the state NOL carryforwards.
  
9. Equity Transactions  

On July 2, 2003, the Company concluded a private placement of 1,428,571 shares of its common stock and three-year warrants to purchase an aggregate of 392,857 shares of the Company’s common stock at an exercise price of $16.00 per share to a group of funds managed by OrbiMed Advisors, LLC, for gross proceeds of $15.0 million. The investors also received the right to nominate a director to the Company’s board of directors.
 
On March 29, 2004, the Company concluded a private placement of 666,667 shares of common stock to an institutional investor for gross proceeds of $10.0 million. Pursuant to the securities purchase agreement and registration rights agreement, the Company filed a registration statement for the registrable securities, which was declared effective on April 15, 2004.

On May 25, 2004, the Company’s convertible promissory note totaling $11.6 million of outstanding principal and accrued interest was converted into 2,907,162 shares of the Company’s common stock. In connection with this, the Company charged to additional paid in capital the remaining associated deferred charges of $71,000.

On January 20, 2005, the Company’s convertible promissory line of credit note totaling $4.0 million of outstanding principal and accrued interest was converted into 1,180,246 shares of the Company’s common stock.

Stock Option Plans

1998 Stock Option Plan

The Company's 1998 Stock Option Plan (the "1998 Plan") was adopted by the Company's board of directors on September 10, 1998. Under the 1998 Plan, the Company has granted stock options to selected officers, employees, directors and consultants of the Company. The Company's board of directors administers the 1998 Plan. The 1998 Plan provided for the issuance of 2,025,000 shares of common stock. As of December 31, 2005, options to purchase 414,200 shares of common stock were outstanding under the 1998 Plan. As of October 15, 2000 all new option grants are issued under the 2000 stock option plan. The term of the options granted under the 1998 Plan is ten years. Awards under the 1998 Plan are fully vested.
 

F-18



2000 Stock Option and Grant Plan

The Company's 2000 Stock Option and Grant Plan (the "2000 Plan") was adopted by the Company's board of directors on November 18, 2000 and amended on March 20, 2002, May 30, 2003, December 19, 2003, May 24, 2004 and May 23, 2005. The 2000 Plan provides for the granting of stock, stock options, restricted stock and stock appreciation rights. Under the 2000 Plan, the Company has granted options to certain employees and non-employee advisors. The Company's board of directors administers the 2000 Plan. Options granted under the 2000 Plan have a maximum term of ten years. Options issued generally vest either 25% on the first anniversary of grant and  the balance ratably over the next 36 months or 25% on the first anniversary of grant and the balance ratably over the next three years or 50% 18 months after grant and the balance ratably quarterly over the next 18 months. The 2000 Plan also provides the Company's board of directors with the discretion to accelerate exercisability of any award. As of December 31, 2005, the 2000 Plan allowed for the issuance of up to 3,692,090 shares of common stock plus that number of shares of common stock underlying any future termination, cancellation or reacquisition options granted under the 1998 Plan. Additionally, if any of the 310,000 outstanding options granted under the non-plan option grant (as described below) are terminated, canceled or otherwise reacquired by the Company, that number of reacquired shares will also become available for issuance under the 2000 Plan. As of December 31, 2005, options to purchase 2,531,766 shares of common stock and 160,000 restricted stock awards were outstanding and 507,193 shares of common stock were available for future grants under the 2000 Plan.

During 2005, the Company awarded its then current Chief Executive Officer 60,000 shares of restricted common stock, valued at $903,000, under the Company’s 2000 stock option and grant plan, subject to ratable annual vesting over three years provided he remains as a director of the Company. In addition, the Company awarded its new Chief Executive Officer 100,000 shares of restricted stock, valued at $2.1 million vesting annually ratably over four years. The Company recorded a charge to operations of $808,000 during 2005 in relation to these grants.

Non-Plan Option Grants

In 2000, in connection with the commencement of employment, the Company granted to an officer stock options to acquire 405,000 shares of common stock at an exercise price of $2.78 per share. Of these, 310,000 are vested and remain outstanding as of December 31, 2005.

In 2005, in connection with the commencement of employment, the Company granted to an officer stock options to acquire 285,000 shares of common stock at an exercise price of $14.28 per share. As December 31, 2005, none are vested and all remain outstanding.

Employee and Director Grants

Prior to 2003, the Company granted stock options to employees and directors with an exercise price less than fair market value. These options gave rise to unearned compensation as of the date of the grant, which amount has been amortized to operations over the vesting period. These options resulted in a charge to operations of $1,389, $29,938 and $235,631 in 2005, 2004 and 2003, respectively.

Non-Employee Options and Warrants

In September 2003, the Company issued 285,000 options to a non-employee consultant. 50% of the options vested on June 3, 2005 (18 months after the consultant became a full-time employee), with the remainder vesting ratably quarterly over the next 18 months. The options resulted in a charge to operations of $243,263 in 2003. The non-employee consultant became an employee in December 2003.  

In February 2002, the Company issued 8,100 options to a non-employee consultant. 25% of the options vest at the end of each year for the next four years. The options resulted in a reduction of expenses in operations of $11,504 in 2005 and a charge to operations of $21,020 and $43,371 in, 2004 and 2003, respectively.
 

F-19



The Company granted 64,800 options to non-employees for the year ended December 31, 2001. These options were valued at fair value and resulted in a reduction of expenses in operations of $183,000 and a charge to operations of $293,616 and $407,726 in 2004 and 2003, respectively.

Option activity for the years ended December 31, 2003, 2004 and 2005 was as follows:

   
Options
 
Weighted Average Options Exercise Price
 
Options Outstanding, December 31, 2002
   
2,950,599
 
$
3.56
 
Granted
   
592,300
 
$
12.82
 
Exercised
   
(560,954
)
$
3.13
 
Forfeited
   
(350,575
)
$
5.28
 
Options Outstanding, December 31, 2003
   
2,631,370
 
$
5.51
 
Granted
   
610,750
 
$
13.86
 
Exercised
   
(519,507
)
$
3.27
 
Forfeited
   
(76,437
)
$
10.97
 
Options Outstanding, December 31, 2004
   
2,646,176
 
$
7.72
 
Granted
   
1,282,250
 
$
16.75
 
Exercised
   
(231,520
)
$
4.57
 
Forfeited
   
(155,940
)
$
13.36
 
Options Outstanding, December 31, 2005
   
3,540,966
 
$
10.94
 


 
 
Options Outstanding as of
December 31, 2005
 
Options Exercisable as of
December 31, 2005
 
 
 
Weighted Average Remaining Contractual Life
 
Number Outstanding
 
 
Weighted Average Exercise Price
 
Number Exercisable
 
 
Weighted Average Exercise Price
 
                       
Price range $2.27-$7.00
   
4.98 years
   
1,385,006
 
$
3.52
   
1,335,181
 
$
3.44
 
Price range $7.01-$11.74
   
6.45 years
   
34,160
   
8.18
   
19,440
   
8.20
 
Price range $11.75-$16.48
   
8.74 years
   
1,440,250
   
14.36
   
370,918
   
14.50
 
Price range $16.49-$21.20
   
9.16 years
   
681,550
   
18.93
   
45,750
   
16.89
 
           
3,540,966
   
10.94
   
1,771,289
   
6.16
 

Warrants

At December 31, 2005, warrants to purchase 819,731 shares of the Company's common stock were outstanding with a weighted average exercise price of $12.63. All outstanding warrants are fully vested. The details of the warrants for common stock outstanding at December 31, 2005 were as follows:

Number of Shares
Underlying Warrants
 
Exercise Price
 
Expiration Date
 
392,857
 
$
16.00
 
July 2006
 
48,498
 
$
6.17
 
August 2006
 
2,980
 
$
6.17
 
October 2006
 
375,396
 
$
10.00
 
June 2009
 
819,731
             


F-20



10. Employment Agreements

On May 23, 2005, the Company entered into a two-year employment agreement with Dr. Lippa, the Company’s then Chief Executive Officer, which continued his existing agreement, with certain changes, that was extended in January 2005. Such changes include severance protection in the event of a termination of employment without cause or good reason equal to payment of base compensation for the greater of one year and the balance of the term of the agreement, subject to consulting obligations. In addition, the agreement includes a change in control severance protection equal to two years’ base compensation, elimination of a 2% bonus based upon gross proceeds in the event of a sale of the Company and elimination of incentive compensation for licensing. He was also awarded 60,000 shares of restricted common stock, valued at $903,000, under the Company’s 2000 stock option and grant plan, subject to ratable annual vesting over three years provided he remains as a director of the Company. As of July 28, 2005, Dr. Lippa’s employment terminated thus requiring the Company to pay the contractual severance. As a result, the Company recorded a severance obligation of $790,000 as of June 30, 2005. Dr. Lippa remains as chairman of the board of directors.
 
On June 29, 2005, the Company entered into a three-year employment agreement with Dr. Hudson as Chief Executive Officer and President. Under the agreement, Dr. Hudson will receive a salary of at least $425,000 per annum and will receive, upon commencement of employment on July 28, 2005, 100,000 shares of restricted stock, valued at $2.1 million, and 225,000 stock options at an exercise price of $21.20, each vesting ratably annually over four years. Dr. Hudson will also receive a bonus of $85,000 in January 2006, and the parties have agreed that his target bonus for fiscal year 2006 and each subsequent year of his employment agreement will be 40% of base compensation upon achievement of milestones established by the compensation committee of the board of directors. He will also be eligible for other benefits, including relocation allowances. For qualified events of severance, Dr. Hudson will be entitled to base compensation for the balance of his agreement subject to a minimum of one-year base compensation and an additional severance payment equal to his prior incentive bonus in the case of a termination following a change of control.
 
The Company has also entered into employment agreements with several other key employees that range in term from one to three years. The agreements provide for a base salary subject to annual increases and incentive compensation if the Company achieves certain milestones as defined in the agreements plus a performance bonus as determined by the Company's board of directors. Certain of these agreements provide for compensation and incentive compensation if the employee is terminated without cause or if the employee terminates because of the Company's failure to pay amounts due, demotion of title or responsibilities, or certain changes of control.

11. Savings and Investment Plan

The Company adopted the DOV Pharmaceutical, Inc. 401(k) Savings and Investment Plan (the "401(k) Plan"), effective January 1, 2002, which qualifies under Section 401(k) of the Internal Revenue Code of 1986, as amended. The 401(k) Plan is a defined contribution plan established to provide retirement benefits for all employees who have attained 21 years of age.

The 401(k) Plan is employee funded up to an elective annual deferral and also provides an option for the Company to contribute to the 401(k) Plan at the discretion of the 401(k) Plan's trustees. During fiscal 2005, 2004 and 2003, the Company did not contribute to the 401(k) Plan.

12. Significant Agreements

Wyeth Agreement

In May 1997, the Company entered into an option agreement with American Cyanamid, now Wyeth, to license four compounds from them and paid $10,000 as an option fee. In May 1998, the Company exercised its option and entered into a license agreement with Wyeth pursuant to which the Company paid $300,000 to Wyeth for certain rights to four compounds, indiplon, ocinaplon, bicifadine and DOV 216,303. As each of the four compounds licensed in from Wyeth require the approval of the FDA prior to their commercialization, are prior to technological feasibility and have no alternative future use, the Company wrote off the entire amount paid to Wyeth as research and development expense. If Wyeth terminates the license upon an uncured breach by the Company, the Company must transfer all information, data and know-how relating to the products and any government authorizations, in addition to the Company’s rights derived from its sublicensees with regard to the products. The agreement expires as to each compound the later of the expiration of the Wyeth patents in such country and ten years following the launch of each compound in each country. Upon such expiration, with respect to each country the Company will have a fully-paid, royalty-free license with the right to make, use or sell the compounds without any further monetary obligation to Wyeth.
 

F-21



In 2001, Neurocrine made a milestone payment to the Company of $1,300,000 in cash and warrants to purchase 75,000 shares of Neurocrine common stock of which the Company owed to Wyeth 35%. Before distributing Wyeth’s portion of the warrants to Wyeth and selling its portion of the warrants in 2003, the Company adjusted the value of the warrants to their then depreciated fair value and thus recognized a decrease in the value of warrants to acquire Neurocrine common stock of $251,000. 

On February 25, 2004, the Company entered into agreements to reorganize its exclusive license agreement with Wyeth and its sublicense agreement with Neurocrine in respect of indiplon. The restated agreement with Wyeth amends among other items the financial obligations due to Wyeth in respect of bicifadine, ocinaplon and DOV 216,303 such that the Company is now obligated to pay a fixed royalty percentage and fixed milestone payments. The restated agreement provides that if the Company sells the product itself, the Company will be obligated to pay Wyeth 3.5% of net sales for ocinaplon and DOV 216,303 and 5.0% of net sales for bicifadine, and potential additional aggregate milestones of $7.0 million for ocinaplon, $7.0 million for DOV 216,303 and $9.5 million for bicifadine. The royalty rate for bicifadine, ocinaplon and DOV 216,303 will increase by 0.5% should the Company partner or sublicense that compound, in which case the next milestone payable to Wyeth for that compound will be accelerated to become due upon partnering. As the Company has licensed certain rights to DOV 216,303 to Merck, should Merck achieve sales on this compound, the Company will owe Wyeth a royalty of 4.0% on those sales. In connection with the closing of the Merck Agreement, the Company owed Wyeth $2.5 million related to DOV 216,303. As this milestone payment is prior to FDA approval, the entire amount was expensed in the third quarter of 2004.

Neurocrine Agreement

In June 1998, the Company entered into a sublicense and development agreement for one of the Company's compounds (indiplon) with Neurocrine. The Company is entitled to receive milestone payments on certain development events and royalties on net sales, if any.

In connection with this agreement, the former Chief Executive Officer and former President of the Company, respectively, entered into consulting agreements with Neurocrine in which they agreed to provide certain consulting services for an annual service fee of $50,000 each. Subsequently, these original consulting agreements were terminated and new consulting agreements with entities in which the Chief Executive Officer and President retain beneficial ownership were implemented. To date, services under these agreements have not been requested. This portion of the Neurocrine agreement is not reflected in the financial statements of the Company.

In December 2002, Neurocrine and Pfizer Inc. announced a global agreement for the exclusive worldwide development and commercialization of indiplon.  In connection with this agreement, the Company and Neurocrine, together with its licensor Wyeth, agreed to establish three standby licenses, one to Neurocrine from Wyeth in case the Company’s license agreement is terminated by reason of the Company’s default, another to Neurocrine's partner (subsequently Pfizer, as noted below) from the Company in case the sublicense agreement with Neurocrine is terminated by reason of Neurocrine's default and a third standby license from Wyeth to Neurocrine's partner in case both Neurocrine and the Company default in the respective agreements.
 
As noted above, on February 25, 2004, the Company entered into agreements to reorganize its sublicense agreement with Neurocrine. The restated agreement provides for a royalty term of the last to expire of Wyeth patents or any patent owned or controlled by Neurocrine covering indiplon and ten years. As part of the reorganization, Neurocrine acquired Wyeth’s interest under the license covering indiplon. Accordingly, the reorganization with Neurocrine allows Neurocrine to pay to DOV royalty and milestone payments net of those amounts that would be owed by the Company to Wyeth under the earlier agreement. The Company’s economics will therefore remain unchanged and it will continue to be entitled to receive $1.5 million in aggregate milestones upon Neurocrine’s NDA approval and 3.5% royalty on worldwide sales. In 2004, the Company received a $2.0 million milestone payment from Neurocrine for the NDA filing for indiplon. However, because the original NDA filing was not accepted by the FDA and the agreement with Neurocrine indicates that the $2.0 million milestone is earned once an NDA has been submitted according to certain FDA regulations, the Company recognized this payment as revenue once the filing was accepted by the FDA on June 14, 2005.
 

F-22



Merck Agreement

On August 5, 2004, the Company entered into a license agreement with a subsidiary of Merck & Co. Inc., or Merck, for the worldwide development and commercialization of DOV 21,947 for all therapeutic indications and of DOV 216,303 for the treatment of depression, anxiety and addiction. The agreement became effective in September 2004. Additionally, Merck obtained rights of first offer and refusal regarding a licensing agreement for DOV 102,677 under certain circumstances and for additional consideration. Under the original agreement, Merck assumed financial responsibility for development and commercialization of a product containing at least one of the licensed compounds; however this agreement was amended in August 2005 (as described below). The parties have agreed to work together to clinically develop licensed product and DOV has reserved the right to co-promote the sales of product in the United States to psychiatrists and other specialists who treat depression.

Under the agreement, DOV received a $35.0 million up-front licensing payment. In addition, the Company is entitled to receive milestone payments of up to $420.0 million, as well as royalties on worldwide net sales, if any. In accordance with the Emerging Issues Task Force (EITF) Issue No. 00-21, “Accounting for Revenue Arrangements with Multiple Deliverables” the Company has evaluated the arrangement to determine if the deliverables are separable into units of accounting and then applied applicable revenue recognition criteria.  The Company has determined that the license and the collaboration are a single element for accounting purposes. As a result, the $35 million up-front licensing payment and any future milestones received will be amortized and taken into revenue over the term of the collaboration.  As the Company has a continuing obligation with respect to collaboration on development of product candidates, until an NDA is filed, the up-front payment has been deferred and will be amortized and taken into revenue over the estimated research and development period of 72 months.

On August 5, 2005, Merck and DOV amended their license agreement such that the Company will initially carry out at its expense certain development work involving DOV 21,947. Merck is authorized to choose one of the Company’s preclinical triple reuptake inhibitors for inclusion in the agreement at no additional up-front fee. Merck may reassume the financial development and commercialization under the agreement for DOV 21,947 at any time and is required to do so upon successful completion of a pivotal Phase II clinical trial as defined by Merck. Upon this occurrence, Merck will reimburse DOV for its approved development expenditures for DOV 21,947 incurred and pay a success premium on certain of that work. In addition, the first development milestone in the original agreement will be payable to DOV. Merck and DOV have each retained certain termination rights under the amendment. If the test results are not successful as defined, Merck may elect to make such payments to DOV and retain DOV 21,947 but is not required to do so.

Biovail Agreement

On March 28, 2003, the Company entered into a separation agreement with Biovail that provided for the return of the Company's December 2000 patent for the immediate and controlled release of diltiazem and termination of the 2001 exclusive license agreement with Biovail for development of the DOV compound for the treatment of angina and hypertension. In consideration of the termination of the 2001 agreement and the return of the patent, DOV agreed to a $1.0 million payment to Biovail upon signing, contingent payments to Biovail of $3.0 million upon receipt of marketing authorization for the drug and up to a maximum of $7.5 million based upon sales. The Company recorded a charge for the $1.0 million signing payment in the first quarter of 2003. This payment was to obtain the patent and related clinical data from Biovail. As this product will require FDA approval prior to marketing and the patent has no alternative future use, the Company expensed the entire license fee. As the separation agreement ends DOV's performance obligations, the agreement also resulted in the recognition in the first quarter of 2003 the remaining deferred revenue, totaling approximately $3.0 million as of December 31, 2002, of the original $7.5 million license fee paid to DOV in 2001. In addition, as a result of the separation agreement, Biovail and DOV also agreed to release any and all claims.

Operating Leases

The Company leases office space under a long-term operating lease expiring in the year 2008. The Company also leases various office and transportation equipment under operating leases with terms ranging from one to three years.
 

F-23



As of December 31, 2005, the total non-cancelable future minimum rental payments under the above-mentioned leases are as follows:

Year ending December 31,
     
2006
 
$
1,202,376
 
2007
   
1,217,830
 
2008
   
613,981
 
2009
   
 
   
$
3,034,187
 

Rent expense incurred for office space and equipment leases amounted to $699,588, $406,838 and $348,347 and for the years ended December 31, 2005, 2004 and 2003.

In February 2006, the Company committed to a ten year operating lease for 133,686 sq. feet facility in Somerset, New Jersey which will serve as its corporate headquarters and principal place of business effective May 2006. In connection with this lease the Company has entered into a stand-by letter of credit facility for $4.2 million to serve as collateral for its performance under the lease. As a result of the Landlord’s consummation of its purchase of the premises, the term of the lease commenced on February 28, 2006 and will expire on the tenth anniversary of such commencement date. The lease provides the Company with two options to extend the lease term, each for five year periods. The rent is payable in monthly installments and is approximately $2.9 million per year for the first five years of the initial term and $3.1 million per year for the remainder of the initial term.

13. Contingencies

From April 30, 2002, a number of class action lawsuits were filed naming as defendants the Company, certain of the Company’s officers and directors and certain of the underwriters in the Company’s April 24, 2002 initial public offering of 5,000,000 shares of its common stock. On December 20, 2002, the Company entered into an agreement, which was approved by the court on April 16, 2003, to settle these lawsuits. The settlement includes all defendants and covers as a class all those who purchased common stock of the Company in or traceable to the Company’s initial public offering through December 20, 2002 and suffered damages. The Company paid in the aggregate to the class members (inclusive of their attorneys’ fees and costs) $250,000 and issued 500,000 six-year warrants to purchase common stock exercisable at $10.00 per share. As of June 2, 2003 (the issuance date), the Company determined the value of these warrants at $2,227,846 and recorded the warrants as stockholders’ equity.

In connection with the securities class action lawsuits described above, the Company’s providers of primary and excess liability insurance for directors and officers, D&O, asserted that the policy binders they issued in connection with the Company’s initial public offering were not effective because, among other reasons, they never approved the documentation provided with the policy application, including the final registration statement, and that such approval is a prerequisite to their policies’ effectiveness. The Company strongly disagreed with their positions, advised the carriers that the Company intended to hold them to their original binder terms as the Company vigorously pursued resolution of these matters, and initiated arbitration against the primary D&O carrier. The Company reached agreement with the excess D&O carrier that, for claims other than the securities class action lawsuits described above, the excess D&O policy would remain in place, effective for losses in excess of $10,300,000. In April 2003, prior to commencement of arbitration, the Company and the primary carrier reached a settlement. Under the settlement terms, the carrier paid the Company approximately $1,556,000.

The primary carrier also issued a D&O policy, including entity coverage, for three years at a fixed rate that the Company believes is competitive. While the carrier retains the right to reprice the policy premium upon the second policy anniversary if there is further claim experience, any repricing not acceptable to the Company will relieve it of its obligation to keep the policy in force. The Company has also been issued D&O insurance by the original excess carrier for excess insurance. The insurance recovery was recorded in the second quarter of 2003 as other income.
 

F-24



From time to time and in the ordinary course of business, the Company may be subject to various claims, charges and litigation. In the opinion of management, final judgments from such pending claims, charges, and litigation, if any, against the Company, would not have a material adverse effect on its financial position, result of operations, or cash flows.

14. Quarterly Financial Data (Unaudited)

The following table contains selected unaudited statement of operations information for each quarter of 2005, 2004 and 2003. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results of any future period.

   
Quarters Ended
 
 
 
Mar 31
 
Jun 30
 
Sep 30
 
Dec 31(a)
 
2005
 
(In thousands, except per share data)
 
Revenue 
 
$
2,059
 
$
3,832
 
$
1,378
 
$
1,378
 
Net loss after tax benefit 
   
(9,108
)
 
(11,218
)
 
(15,710
)
 
(16,932
)
Net loss attributable to common stockholders 
   
(9,108
)
 
(11,218
)
 
(15,710
)
 
(16,932
)
Basic and diluted net loss per share 
   
(0.41
)
 
(0.49
)
 
(0.68
)
 
(0.73
)
                           
2004
                         
Revenue 
 
$
 
$
 
$
343
 
$
2,199
 
Net loss after tax benefit 
   
(7,690
)
 
(8,342
)
 
(12,008
)
 
(4,881
)
Net loss attributable to common stockholders 
   
(7,690
)
 
(8,342
)
 
(12,008
)
 
(4,881
)
Basic and diluted net loss per share 
   
(0.46
)
 
(0.43
)
 
(0.56
)
 
(0.23
)

(a) In the fourth quarter of 2003 the Company paid $5.0 million for the purchase of Nascime and the product candidates, bicifadine and ocinaplon, and $306,000 for transfer taxes associated with the acquisition. The $5.3 million is included as research and development expense.


F-25




 
 
 
 
EX-10.29 2 v037548_ex10-29.htm
Exhibit 10.29

DOV PHARMACEUTICAL, INC.
AUDIT COMMITTEE CHARTER

I. General Statement of Purpose

The audit committee is created and its members appointed by the board of directors to assist in the oversight of the integrity of the company’s systems of internal control, financial statements and the qualifications, independence and performance of the company’s independent auditors. To this end, the audit committee’s primary functions are to oversee the company’s accounting and financial reporting processes and the audits of the company’s financial statements and to appoint, retain, terminate and evaluate the performance of the company’s independent auditors. In carrying out its primary function the audit committee shall provide an open avenue of communication among the independent auditors, financial and senior management and the board of directors. The audit committee shall fulfill these responsibilities by carrying out the activities enumerated in section V of this charter. 

II. Composition

The audit committee shall consist of at least three members of the board, each of whom must be independent according to both NASD rules for listed companies and the Sarbanes-Oxley Act of 2002, or SOX, and moreover not own or control 20% or more of the company's voting securities, or such lesser amount as may be established by the SEC.

As an exception to the above independence criteria, a director who is not an employee of the company or family member of an employee and meets all the above qualifications except those of the NASD can be an audit committee member. For this to occur, the board, under exceptional and limited circumstances, must determine that the director's membership is required in the best interests of the company and its stockholders. The company must then disclose, in the next following annual proxy statement, the nature of the relationship and the reasons for that determination. A member appointed and whose appointment continues under this exception may not serve on the audit committee for more than two years and may not chair the committee.

Each member of the audit committee must be able to understand financial statements and at least one member must be financially sophisticated as contemplated by NASD rules. Moreover, it is contemplated but not required that at least one member of the audit committee be an “audit committee financial expert” under SEC rules. Those rules require among other things that, in addition to understanding financial statements, the financial expert have an understanding of generally accepted accounting principles and their application as well as experience with internal controls for financial reporting.

Members of the audit committee shall be appointed annually by the board and may be replaced or removed by the board with or without cause. Resignation or removal of a director, for whatever reason, shall if a member of the audit committee mean automatic resignation or removal from the committee. Any vacancy on the audit committee may be filled only by the board. The board shall designate one member of the audit committee to be the chair.

 
 

 
 
III. Compensation

A member may not, other than in his or her capacity as a member of the audit committee, the board or any other board committee, receive any compensation from the company. A member may receive additional director fees to compensate for the significant time and effort required to serve on the audit committee.

IV. Meetings

The audit committee shall meet not less frequently than quarterly to review each quarterly earnings release and quarterly report, and on further occasions as required to review internal controls, audit progress and the annual report. Apart from these required meetings, the committee may have additional meetings as often as it determines. A majority of the members of the audit committee shall constitute a quorum for purposes of holding a meeting and the committee may act by a vote of a majority of the members present at the meeting. In lieu of a meeting, where warranted in special circumstances the audit committee may act by unanimous written consent.

V. Responsibilities and Authority

Matters Relating to Selection, Performance and Independence of Auditors

 
·
Sole authority to appoint, terminate and determine compensation for its independent auditors; although the committee may seek stockholder ratification of its appointment for informational purposes

 
·
Instruct the company’s independent auditors to report directly to audit committee

 
·
Exercise oversight of the company’s independent auditors’ work including resolution of disagreements between management and the independent auditors

 
·
Pre-approval of all audit, audit-related, tax and other services to be provided by the company’s independent auditors that are not prohibited by SOX, SEC or Public Company Accounting Oversight Board

 
·
Pre-approval of audit-related and non-audit services may be delegated to one or more members of audit committee, who shall promptly report such approved services at the first full committee meeting following such approval

 
·
Review and approve scope and staffing of the company’s independent auditors’ overall audit plan
 
 
2

 
 
 
·
Require independent auditors to provide audit committee with written disclosures and letter required by Independence Standards Board Standard No. 1, and to submit to audit committee on a periodic basis a formal written statement delineating all relationships between independent auditors and company

 
·
Discuss with independent auditors any disclosed relationships or services that may impact objectivity and independence, and take appropriate action to satisfy audit committee of auditors' independence

 
·
Discuss with company and independent auditors whether services of independent auditors required to be reported in annual report or proxy statement are compatible with maintaining auditors' independence

Audited Financial Statements

 
·
Review overall audit plan with independent auditors and management responsible for preparing company's financial statements

 
·
Review and discuss with management and independent auditors as appropriate:
 
·
Company's annual audited financial statements including all critical accounting policies and practices used or to be used by company and any significant financial reporting issues that have arisen in connection with preparation of audited financial statements, prior to filing company's annual report

·
Any analysis prepared by management or independent auditors setting forth significant financial reporting issues and judgments made in connection with preparation of financial statements including analyses of effect of alternative GAAP methods on financial statements

·
Ramifications of use of such alternative disclosures and treatments on financial statements and treatment preferred by independent auditors, and consider other material written communications between independent auditors and management including any management letter or schedule of unadjusted differences

·
Major issues relating to adequacy of company's internal controls and procedures for financial reporting and risk management policies

·
Major changes in and other issues regarding accounting principles and procedures including any significant changes in company's selection or application of accounting principles and
 
 
3

 
 
·
Effect on financial statements of regulatory and accounting initiatives as well as off-balance sheet transactions and structures

 
·
Review and discuss outside presence of management any audit problems or difficulties and management's response thereto including any difficulties encountered by independent auditors in the course of their work, including any restrictions on scope of their activities or access to information, responsibilities, budget and staffing of company's internal audit function if any or financial reporting function and any significant accounting issues raised with management

 
·
Review and discuss matters brought to attention of audit committee by independent auditors pursuant to Statement on Auditing Standards No. 61 and No. 90 (SAS 61 and SAS 90) including any

·
Restriction on scope of independent auditors' activities or access to requested information

·
Accounting adjustments proposed by independent auditors but not made by management

·
Communication between independent auditors and its national office regarding significant auditing or accounting issues presented by management

·
Management or internal control letter issued, or proposed to be issued, by independent auditors and

·
Significant disagreement between company and independent auditors

 
·
Review and discuss with independent auditors their report pursuant to Securities Exchange Act on their non-audit services if any

 
·
If brought to audit committee's attention, discuss with CEO, CFO and general counsel (a) significant deficiencies and material weaknesses in design or operation of internal controls and procedures for financial reporting that could adversely affect company's ability to record, process, summarize and report financial information or (b) any fraud involving management or other employees who have a significant role in company's internal controls and procedures for financial reporting
 
 
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·
Based on its review of (a) reports from independent auditors on company’s system of internal controls and its review of auditing, accounting and financial reporting process and (b) discussions with management including review of matters required to be discussed by SAS 61 and SAS 90, recommend to board whether company's audited financial statements should be included in 10-K

 
·
Prepare audit committee report required by Item 306 of Regulation S-K to be included in company's annual proxy statement

Unaudited Quarterly Financial Statements

 
·
Discuss with management and independent auditors and review any financial information including press releases and Form 10-Q submitted to a governmental body or the public including any certification, report, opinion or review by the independent auditors.

Procedures for Addressing Complaints and Concerns

 
·
Establish and require company to publish or file procedures for receipt, retention and treatment of complaints received by company regarding accounting, internal accounting controls or auditing matters and confidential, anonymous submission to audit committee by employees of concerns regarding questionable accounting or auditing matters or disclosure controls

Regular Reports to Board

 
·
Regularly report to board on and review with board any issues that arise with respect to quality or integrity of company's financial statements, compliance with legal or regulatory requirements, performance and independence of auditors, performance of internal audit function if any and any other matters that audit committee considers appropriate or is requested by board to review

Review of Charter

 
·
Review at least annually and more often as appropriate adequacy of charter and recommend amendments if any to board

Engagement of Advisors

 
·
Engage and determine compensation for independent counsel to audit committee and such other advisors necessary or appropriate to carry out its responsibilities and powers
 
Legal and Regulatory Compliance

 
·
Discuss with management legal and regulatory requirements applicable to company and its subsidiaries and company's compliance, and make recommendations to board regarding compliance
 
 
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·
Discuss with CEO, CFO and general counsel legal matters (including pending or threatened litigation) that may have a material effect on company's financial statements or its legal and regulatory compliance policies and procedures
 
General

 
·
Form and delegate authority to subcommittees consisting of one or more of its members to carry out its responsibilities and exercise its powers

 
·
Require that any officer or employee of company, company's outside legal counsel, independent auditors or any other professional retained by company attend a meeting of audit committee or meet with any member of or advisor to committee

* * *
Notwithstanding the responsibilities and powers of the audit committee set forth in this charter, it is not intended to carry responsibility for planning or conducting audits of the company's financial statements or determining whether the company's financial statements are complete, accurate and prepared in accordance with GAAP. Such responsibilities are the duty of management and, to the extent of their audit responsibilities, the independent auditors. In addition, it is not the duty of the audit committee to conduct investigations or to assure compliance with laws and regulations. The audit committee shall be entitled to rely upon advice and information it receives if it believes to be reliable or has reason to draft in its discussions and communications with management, independent auditors and such experts, advisors and professionals it may consult.

(Adopted by board of directors on March 6, 2006, further amending charter adopted March 21, 2003 and amended March 14, 2005)
 
 
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EX-10.42 3 v037548_ex10-42.htm
Exhibit 10.42

EMPLOYMENT AGREEMENT dated as of December 1, 2005, between Scott Myers (the "Executive") and DOV Pharmaceutical, Inc., a Delaware corporation (the "Company").

WHEREAS, the Company and the Executive desire to enter into this Employment Agreement to assure the Company of the continued services of the Executive and to set forth the duties and compensation of the Executive, all upon the terms and conditions hereinafter set forth;

NOW, THEREFORE, in consideration of the agreements and covenants contained herein, the Executive and the Company hereby agree as follows:

ARTICLE I

Employment

Section 1.01. Term. The initial term of this Employment Agreement shall commence upon commencement of the Executive’s employment and, unless sooner terminated pursuant to Article III hereof, shall terminate on the date that is three years thereafter (the “Initial Employment Period”). Unless sooner terminated pursuant to Article III, the parties may by written agreement renew this Agreement for one year (each such one-year period hereinafter referred to as a “Renewal Period”; the Initial Employment Period and all Renewal Periods hereinafter referred to as the “Employment Period”).

Section 1.02. Position. The Company shall employ the Executive and the Executive shall serve as Senior Vice President of Strategic Marketing and Commercialization during the Employment Period.

Section 1.03. Duties. (a) Subject to the responsibility vested in the Board of Directors of the Company (the “Board”) under the General Corporation Law of the State of Delaware, the Executive shall have such responsibility and authority as are customarily possessed and exercisable by the Senior Vice President of Strategic Marketing and Commercialization of a corporation. The Executive shall also perform such other executive and administrative duties (not inconsistent with the position of Senior Vice President of Strategic Marketing and Commercialization) as the Executive may reasonably be expected to be capable of performing on behalf of the Company and any subsidiaries and affiliates of the Company as may from time to time be authorized or directed by the Board.

(b) During the Employment Period, the Executive shall perform faithfully the duties covered by Section 1.02(a) to the best of his ability and devote his full business time and attention to the Company's business and not engage in any other business activities except with the approval of the Board provided that he may subject to Section 4.01 invest in companies not requiring his services and may subject to Section 1.03(a) devote reasonable time to charitable and civic affairs.

 
 

 
 
(c) The Company shall provide and pay for a standard directors and officers insurance policy insuring the Executive against liability arising out of the performance of his duties, and shall indemnify and hold the Executive harmless from liability arising out of his services hereunder.

ARTICLE II

Compensation

Section 2.01. Basic Compensation. As compensation for the Executive's services hereunder, the Company shall pay to the Executive an annual salary of $330,000 (as adjusted, "Basic Compensation"), payable in bi-weekly or monthly installments. The Basic Compensation may be increased in the discretion of the Board.

Section 2.02. Incentive Compensation. (a) In addition to Basic Compensation, the Executive shall together with other executive staff be considered at least annually for incentive compensation (“Incentive Compensation”) upon recommendation by the Compensation Committee. Its recommendation shall, among other factors considered relevant, take into account performance of the Company, increase in value of the Company and the Executive’s contribution thereto. Incentive Compensation shall be determined in the discretion of the Board upon such recommendation.

(b)  Incentive Compensation shall be paid to the Executive within 30 days after the Board’s determination provided that the Company may determine to pay out Incentive Compensation over a period not to exceed six months.

Section 2.03. Other Benefits. (a) During the Employment Period, the Company shall provide the Executive and maintain on the Executive’s behalf, or reimburse the Executive for carrying comprehensive medical insurance, disability insurance and life insurance of $300,000 on the life of the Executive. In addition, the Executive shall have the right to participate in the Company's other programs for the benefit of employees in accordance with their terms and as the same may be amended from time to time.

(b) The Executive shall be eligible to participate in the Company’s stock option program. The terms of options held by the Executive (including the 285,000 options referred to below) shall be governed by the Company’s standard stock option agreement in use at the time of grant, which for all options held by or issued to the Executive may incorporate the terms established by the Company’s stock option plan if any adopted subsequent to the date of grant provided that notwithstanding such stock option terms if any to be adopted to the contrary the Executive’s options to the extent not vested shall vest upon a termination of employment or pursuant to Section 3.01(d), or Section 3.03 or Section 3.04 but be exercisable during the post-employment period established by such terms to be adopted. The Executive is granted non-qualified options to purchase 285,000 shares of the Company’s common stock at a strike price determined by the closing price on commencement of the executive’s employment, vesting half in 18 months of full time employment and the balance vesting ratably quarterly over the remaining 18 months of full time employment. The other terms of such options shall be governed by the Company’s standard stock option agreement to be entered into, which will incorporate the terms established by the Company’s stock option plan as the same may be amended from time to time provided that, notwithstanding such stock option terms if any to the contrary, the Executive’s options to the extent not vested shall accelerate and vest fully upon a termination of employment pursuant to Section 3.01(d) and accelerate and vest ratably upon a termination pursuant to Section 3.04, but be exercisable during the post-employment period established by such terms to be adopted.

 
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(c)  The Company shall pay to or on behalf of the Executive a monthly automobile allowance of $1,000.

(d)  The Executive shall be entitled to six weeks of paid vacation in each calendar year. The Executive shall also be entitled to the same standard paid holidays given by the Company to senior executives generally, all as determined from time to time by the Board or appropriate committee thereof. Vacation time shall cumulate and carry forward from year to year provided that the Executive shall not be entitled to more than ten weeks of vacation in any one year without the permission of the Compensation Committee and provided that the Executive shall coordinate his vacation schedule with the Chief Executive Officer.

(e) The Company shall reimburse the Executive for travel or other expenses or disbursements reasonably incurred or made by him in connection with the Company's business during the Employment Period upon receipt of reasonable documentation thereof.

(f) The Company shall pay the Executive for expenses incurred by the Executive for corporate housing and travel to and from his primary residence until the earlier of the Company’s relocation and May 31, 2006.

(g) The Company shall reimburse the Executive for reasonable legal fees and expenses up to $8,000 incurred in connection with review of this Employment Agreement.

(h) The benefits set forth in this Section 2.03 shall be collectively referred to as the “Benefits.”
 
ARTICLE III

Termination of Employment

Section 3.01. Termination of Employment by Company

(a) Except as otherwise provided in this Article III and in Article IV, upon the occurrence of any of the following events, this Agreement and the rights and obligations of the parties hereunder shall terminate:

(i)
"Disability" (as defined in Section 3.05(a)) of the Executive; or

 
(ii)
conduct by the Executive constituting "Cause" (as defined in Section 3.05(b)); or
 
 
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(b)  In the case of termination pursuant to Section 3.01(a)(i), the Company shall be obligated to pay the Executive and the Executive shall be entitled to receive, in complete and total satisfaction of the obligations of the Company hereunder, an amount equal to Basic Compensation, Incentive Compensation and Benefits for the period commencing on the date of termination and ending on the date that is nine months after the date of termination. Basic Compensation, Incentive Compensation and Benefits shall be paid in the manner and at the intervals provided in Article II.

(c)  In the case of termination pursuant to Section 3.01(a)(ii), the Company shall be obligated to pay the Executive and the Executive shall be entitled to receive, in complete and total satisfaction of the obligations of the Company hereunder, an amount equal to Basic Compensation, Incentive Compensation and Benefits through the date of such termination.

(d) In the case of termination of the Executive by the Company other than pursuant to Section 3.01(a) or Section 3.02, the Company shall be obligated to pay the Executive and the Executive shall be entitled to receive, in complete and total satisfaction of the obligations of the Company hereunder, an amount equal to Basic Compensation commencing on the date of termination and ending three years after commencement of employment. Basic Compensation shall be paid at the intervals set forth in Article II.

Section 3.02. Death. In the event of the death of the Executive during the Employment Period, the Employment Period shall terminate on the date of death and the Executive's designated beneficiary or, if none, his estate shall be entitled to receive, in complete and total satisfaction of the Company's obligations hereunder, Basic Compensation, Incentive Compensation and Benefits through such date of death and for a period of 90 days thereafter.

Section 3.03. Termination of Employment by the Executive. (a) If during the Employment Period there should occur any of the following events (each of the following being an event giving the Executive the right to resign for "Good Reason”): (i) a change in the title and/or responsibilities of the Executive, such that the Executive is no longer functionally the Senior Vice President of Strategic Marketing and Commercialization and no longer has such responsibilities and authorities as are customarily exercisable by the Senior Vice President of Strategic Marketing and Commercialization of a corporation or (ii) a failure by the Company to provide the Executive with Basic Compensation, Incentive Compensation or Benefits, other than a failure that is not in bad faith and is remedied by the Company within 15 days after receipt of notice thereof given by the Executive, or (iii) a breach by the Company of a material term of this Agreement that is not remedied by the Company within 15 days of notice thereof by the Executive, the Executive may elect to terminate his employment by notice to the Company (subject to Article IV). If the Executive exercises such election, the Employment Period shall terminate effective upon the later to occur of (x) receipt of such notice by the Company and (y) expiration of the 15-day period referred to in Section 3.03(a)(ii) or (iii).

(b)  If the Executive exercises his election to terminate pursuant to Section 3.03(a), the Company shall be obligated to pay the Executive and the Executive shall be entitled to receive, in complete and total satisfaction of the obligations of the Company hereunder, an amount equal to Basic Compensation for the period commencing on the date of such termination and ending three years after commencement of employment.

 
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(c)  If the Executive terminates this Employment Agreement for any reason other than those contained in Section 3.03(a), or this Agreement terminates pursuant to Section 3.02, the rights and obligations of the parties hereunder shall terminate immediately (except as otherwise provided in Article IV) and the Employment Period shall terminate immediately except that the Executive shall be entitled to receive, in complete and total satisfaction of the obligations of the Company hereunder, his Basic Compensation, Incentive Compensation and Benefits through the date of such termination.

Section 3.04. Change of Control. In the event the Executive terminates his employment within six months following a Change of Control (as defined in Section 3.05), the Company shall be obligated to pay the Executive, and the Executive shall be entitled to receive in complete and total satisfaction of the obligations of the Company hereunder, an amount equal to the Executive’s Basic Compensation for the period commencing on the date of termination and ending three years after commencement of employment or, if a larger period, nine months thereafter.

Section 3.05. Definitions of Certain Terms. (a) "Disability" shall mean any physical or mental condition of the Executive that renders the Executive incapable of performing any substantial portion of the services contemplated hereby (as confirmed by competent medical evidence) and that has continued for at least 90 consecutive business days in any 12-month period or a total of six months during any 12-month period.

(b)  The following shall constitute conduct entitling the Company to terminate the Executive's employment for "Cause": (i) the Executive's willful refusal to perform or substantial disregard of the Executive’s duties to the Company that is not cured within ten days of written notice (specifying the failure) thereof from the Board, (ii) the commission by the Executive of a willful and material breach of Article IV, (iii) the conviction of any felony by the Executive (or the equivalent thereof under the laws of any state), (iv) the commission of any act constituting financial dishonesty against the Company (which act would be chargeable as a crime under applicable law), (v) the Executive‘s engaging in any other act of dishonesty, fraud, intentional misrepresentation, moral turpitude, illegality or harassment that, as determined in good faith by the Board, would (A) materially adversely affect the business or reputation of the Company with its current or prospective customers, supplies, lenders and/or other third parties with whom it does or might do business or (B) expose the Company to a risk of civil or criminal legal damage, liabilities or penalties, (vi) the repeated failure by the Executive to follow the directives of the Company’s chief executive officer or Board, or (vii) any material misconduct by the Executive in connection with the business affairs of the Company.

It shall be presumed that any termination of the Executive by the Company is without Cause, and such presumption may only be overcome by clear and convincing evidence that the termination of the Executive’s employment can properly be construed as for Cause. If the issue of “Cause” is litigated in a proceeding in any court or through any means of alternative dispute resolution and such issue is resolved in the Executive’s favor, the Company shall reimburse the Executive for all reasonable attorney’s fees, costs and expenses incurred by the Executive in such proceeding.

 
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(c)  ”Change of Control“ shall mean: (i) a merger or consolidation of the Company with or into another corporation other than a transaction (A) in which the Company is the surviving Corporation (except where such other merger or consolidation party is controlled by or under common control with another corporation) or (B) merging or consolidating the Company with any corporation controlling, controlled by or under common control with the Company (in which case the surviving corporation shall be deemed the ”Company“ for purposes of this Agreement), or (ii) the sale of all or substantially all the assets of the Company to any corporation or entity, other than a sale to any corporation or entity controlling, controlled by or under common control with the Company prior to such transaction (in which case the surviving corporation shall be deemed the ”Company“ for purposes of this Agreement).

ARTICLE IV

Non-Competition; Confidential Information

Section 4.01 Non-Competition. (a) Subject to Sections 4.01(b) and 4.01(c), the Executive shall not engage in any activities, whether as employer, proprietor, partner, stockholder (other than as the holder of less than 5% of the stock of a corporation listed on a national securities exchange or in the National Association of Securities Dealers, Inc. Automated Quotation System (such a corporation being hereinafter referred to as a "Public Corporation")), director, employee, consultant or otherwise, of any company with substantially the same business as or that competes directly with the Company in the United States during the following periods:

(i)
the Employment Period; and

(ii)
during any period after the termination of this Agreement pursuant to Article 3 for which the Executive is being or has been paid Basic Compensation.

(b)  The Executive shall not be deemed to be in breach of this Agreement by reason of services performed for a subsidiary or affiliate of the Company. 
 
(c) Notwithstanding anything to the contrary contained herein, if the Company finds that the Executive has violated any covenants contained in Section 4.01, 4.02 or 4.03, the Company shall be obligated to pay any amounts due to the Executive ("Escrow Amount") to Goodwin Procter LLP, as escrow agent ("Escrow Agent"), at 599 Lexington Avenue, New York, New York 10022. Escrow Agent shall hold the Escrow Amount in escrow until a court or agency legally empowered to enforce the covenants contained in Section 4.01, 4.02 and 4.03 reaches a final determination whether the Executive has violated any such covenants or until mutually instructed by the parties. Escrow Agent shall disburse the Escrow Amount in accordance with such court or agency's final determination or pursuant to such party instructions.

 
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Section 4.02 Non-Interference. During the Employment Period and the period of non-competition as determined pursuant to Section 4.01(a), the Executive:

(a)  shall not publicly disparage any of the products, services or actions of the Company or any of the Company's subsidiaries or affiliates; and

(b)  shall not, whether for his own account or for the account of any other individual, partnership, firm, corporation or other business organization, solicit, endeavor to entice away from the Company, or otherwise interfere with the relationship of the Company with any person or entity who is, or was within the then most recent 12-month period, a customer or client of the Company.
 
Section 4.03. Trade Secrets. The Executive shall not, at any time during the Employment Period or thereafter, use (except for the sole benefit of the Company, the Company's subsidiaries and affiliates) or, without the written consent of the Board, divulge to any person (other than, during the Employment Period, an executive of the Company or any of the Company's subsidiaries or other person to whom disclosure is reasonably necessary or appropriate or legally required in connection with the Executive's duties hereunder) any trade secrets or other confidential information of the Company or any of its subsidiaries or affiliates, except to the extent that (a) such information becomes a matter of public record, or is published in a newspaper, magazine or other periodical available to the general public, in each case, through no violation of this Agreement by the Executive or (b) such disclosure is required by oral questions, interrogatories, requests for information or documents, subpoena, civil investigative demand or similar process provided that the Executive shall immediately notify the Company of the existence, terms and circumstances surrounding such a request so that it may seek an appropriate protective order. When the Executive ceases to be employed by the Company, the Executive shall surrender to the Company all records and documents in any form obtained by him or entrusted to him during the course of his employment hereunder (together with all copies thereof) that pertain to the business of the Company or its subsidiaries or affiliates or that were paid for by the Company or any of the Company's subsidiaries or affiliates provided that the Executive may retain copies of such documents as may be necessary for the Executive's personal records for federal income tax purposes or, with the approval of the Board, for other purposes relating to the Executive's legal affairs, which approval shall not be unreasonably withheld.

Section 4.04. Survival of Terms. The covenants contained in Sections 4.01, 4.02 and 4.03 shall survive the termination of the Executive's employment.
 
ARTICLE V

Miscellaneous

Section 5.01. Services as Officer or Director. During the Employment Period, the Executive shall, if elected or appointed, serve as a director of the Company and as an officer and director of all current and future subsidiaries and affiliates of the Company without any additional compensation for such services provided that the Executive shall be provided with reasonable and customary directors and officers insurance if any such corporation is or becomes publicly held and further provided that the Company shall cause any such subsidiary and affiliate to save the Executive harmless from any and all liability arising out of the performance of the Executive’s duties as director and officer.

 
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Section 5.02. Right to Change Business. This Agreement and any rights or privileges granted to the Executive hereunder shall not prevent the Company or any of the Company's subsidiaries from exercising its corporate powers to modify the business operations or activities of such entity.

Section 5.03. Notices. Any notice or request required or permitted to be given under this Employment Agreement shall be sufficient if in writing and delivered personally or sent by registered mail, return receipt requested, to the addresses set forth below or to any other address designated by either party by notice similarly given. Such notice shall be deemed to have been given upon the personal delivery thereof or three days after the date of such mailing thereof, as the case may be.

If to the Executive, to:
J. Robert Horton
c/o DOV Pharmaceutical, Inc.
433 Hackensack Avenue
Hackensack, New Jersey 07601

If to the Company, to:

DOV Pharmaceutical, Inc.
433 Hackensack Avenue
Hackensack, New Jersey 07601
Attention of the CEO


Section 5.05. Assignment and Succession. The Executive acknowledges that the services to be rendered by him hereunder are unique and personal. Accordingly, the Executive may not assign any of his rights or delegate any of his duties or obligations under this Agreement. The rights and obligations of the Company under this Agreement shall inure to the benefit of and be binding upon its successors and assigns.

Section 5.06. Headings. The headings contained in this Agreement are for convenience of reference only and shall not define or limit the provisions hereof.

Section 5.07. Applicable Law. This Agreement shall be interpreted in accordance with the laws of the State of New Jersey, without regard to conflict of law rules. Each party hereby irrevocably consents and submits to the in personam jurisdiction of any court of general jurisdiction in the State of New Jersey, which shall serve as the sole and exclusive forum in any suit, action or proceeding arising out of or in connection with this Agreement.

 
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Section 5.08. Withholding Taxes. The Company may withhold from any amounts payable under this Agreement such federal, state or local taxes as shall be required to be withheld pursuant to any applicable law or regulations.

Section 5.9. Entire Agreement; Amendments. This Agreement contains the entire understanding of the parties hereto with regard to the subject matter contained herein, and supersedes all prior agreements or understandings between the parties hereto or any related parties. This Agreement may be amended only pursuant to a writing signed by both parties hereto.

Section 5.10. Waivers. Any term or provisions of this Agreement may be waived, or the time for its performance may be extended, by the party or parties entitled to the benefits thereof but only to the extent evidenced by a writing executed by such party. The failure of any party hereto to enforce at any time any provision of this Agreement shall not be construed to be a waiver of such provision, nor in any way to affect the validity of this Agreement or any part hereof or the right of any party thereafter to enforce each and every such provision. No waiver of any breach of this Agreement shall be held to constitute a waiver of any other or subsequent breach.

Section 5.11. Partial Invalidity. Each provision hereof shall be interpreted in such manner as to be effective and valid under applicable law, but in case any one or more of the provisions contained herein is for any reason held to be unenforceable in any respect, such unenforceability shall not affect any other provisions of this Agreement, and this Agreement shall be construed as if such unenforceable provision or provisions had never been contained herein unless the deletion of such provision or provisions would result in such a material change as to cause the remaining terms hereof to be unreasonable.
 
Section 5.12. Execution of Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be considered an original instrument, but all of which shall be considered one and the same agreement, and shall become binding when one or more counterparts have been signed by each of the parties and delivered to the other.

IN WITNESS WHEREOF the Company has caused this Agreement to be signed by its duly authorized officer and the Executive has signed this Agreement as of the day and year first above written.
 
     
  DOV Pharmaceutical, Inc.
 
 
 
 
 
 
  By:   /s/ J. Robert Horton
 
J. Robert Horton
  Senior Vice President and General Counsel

     
  By:   /s/ Scott Myers
 
Scott Myers
   
 
 
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EX-10.43 4 v037548_ex10-43.htm
Stock Option Agreement
Relating to but not under the DOV Pharmaceutical, Inc.
2000 Stock Option and Grant Plan

Name of Optionee:
Scott Myers (the “Optionee”)
   
No. of Option Shares: 285,000 Shares of Common Stock
   
Grant Date: December 1, 2005 (the “Grant Date”)
   
50% Vesting Date   50% on June 1, 2007
   
Further Vesting Schedule  8.33% ratably thereafter per quarter (subject to change of control acceleration pursuant to Section 2.03 (b) of December 1, 2005 employment agreement)
   
Expiration Date: December 1, 2015 (the “Expiration Date”)
   
Option Exercise Price/Share: $14.28 (the “Option Exercise Price”)
 
DOV Pharmaceutical, Inc., a Delaware corporation (together with all successors thereto, the Company), hereby grants to the Optionee, who is an officer, employee, director, consultant or other key person of the Company or any of its Subsidiaries, an option (the Stock Option) to purchase on or prior to the Expiration Date, or such earlier date as is specified herein, all or any part of the number of shares of Common Stock, par value $0.0001 per share (Common Stock), of the Company indicated above (the Option Shares, and such shares once issued shall be referred to as the Issued Shares), at the Option Exercise Price, subject to the terms and conditions set forth in this Qualified Stock Option Agreement (this “Agreement”).

1. Definitions. For the purposes of this Agreement, the following terms shall have the following respective meanings. All capitalized terms used herein and not otherwise defined shall have the respective meanings set forth in the Plan.

An Affiliate of any Person means a Person that directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with the first mentioned Person. A Person shall be deemed to control another Person if such first person possesses directly or indirectly the power to direct, or cause the direction of, the management and policies of the second Person, whether through the ownership of voting securities, by contract or otherwise. 

Bankruptcy shall mean (i) the filing of a voluntary petition under any bankruptcy or insolvency law, or a petition for the appointment of a receiver or the making of an assignment for the benefit of creditors, with respect to the Optionee or any Permitted Transferee, or (ii) the Optionee or any Permitted Transferee being subjected involuntarily to such a petition or assignment or to an attachment or other legal or equitable interest with respect to the Optionee¢s or such Permitted Transferee¢s assets, which involuntary petition or assignment or attachment is not discharged within sixty (60) days after its date, and (iii) the Optionee or any Permitted Transferee being subject to a transfer of the Stock Option or the Issued Shares by operation of law, except by reason of death.

Cause shall mean a vote of the Board resolving that the Optionee should be dismissed as a result of (i) the commission of any act by the Optionee constituting financial dishonesty against the Company (which act would be chargeable as a crime under applicable law); (ii) the Optionee¢s engaging in any other act of dishonesty, fraud, intentional misrepresentation, moral turpitude, illegality or harassment which, as determined in good faith by the Board, would: (A) materially adversely affect the business or the reputation of the Company with its current or prospective customers, suppliers, lenders and/or other third parties with whom it does or might do business; or (B) expose the Company to a risk of civil or criminal legal damages, liabilities or penalties; (iii) the repeated failure by the Optionee to follow the directives of the Company¢s chief executive officer or Board or (iv) any material misconduct, violation of the Company¢s policies, or willful and deliberate non-performance of duty by the Optionee in connection with the business affairs of the Company.

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Permitted Transferees shall mean any of the following to whom the Optionee may transfer Issued Shares hereunder: the Optionee¢s spouse, children (natural or adopted), stepchildren or a trust for their sole benefit of which the Optionee is the settlor; provided, however, that any such trust does not require or permit distribution of any Issued Shares during the term of this Agreement unless subject to its terms. Upon the death of the Optionee (or a Permitted Transferee to whom shares have been transferred hereunder), the term Permitted Transferees shall also include such deceased Optionee¢s (or such deceased Permitted Transferees) estate, executions, administrations, personal representations, heirs, legatees and distributees, as the case may be.

Person shall mean any individual, corporation, partnership (limited or general), limited liability company, limited liability partnership, association, trust, joint venture, unincorporated organization or any similar entity.

Sale Event shall mean, regardless of form thereof, consummation of (i) the dissolution or liquidation of the Company, (ii) the sale of all or substantially all the assets of the Company on a consolidated basis to an unrelated person or entity, (iii) a merger, reorganization or consolidation in which the outstanding shares of Stock are converted into or exchanged for a different kind of securities of the successor entity and the holders of the Company¢s outstanding voting power immediately prior to such transaction do not own a majority of the outstanding voting power of the successor entity immediately upon completion of such transaction, (iv) the sale of all or a majority of the outstanding capital stock of the Company to an unrelated person or entity or (v) any other transaction in which the owners of the Company¢s outstanding voting power immediately prior to such transaction do not own at least a majority of the outstanding voting power of the successor entity immediately upon completion of the transaction.

Service Relationship shall mean any relationship as an employee, part-time employee, director or consultant of the Company or any Subsidiary of the Company such that, for example, a Service Relationship shall be deemed to continue without interruption in the event the Optionee¢s status changes from full-time employee to part-time employee or consultant.

Subsidiary shall mean any corporation (other than the Company) in any unbroken chain of corporations or other entities beginning with the Company if each of the corporations (other than the last corporation in the unbroken chain) owns stock or other interests possessing 50 percent or more of the total combined voting power of all classes of stock or in one of the other corporations in the chain.

2. Vesting, Exercisability, and Termination.

(a) No portion of this Stock Option may be exercised until such portion shall have vested.

(b) Except as set forth in Section 6, and subject to the determination of the Committee to accelerate the above vesting schedule, this Stock Option shall be vested and exercisable with respect to the Option Shares as set forth above.

(c) Termination. Except as may otherwise be provided by the Committee, if the Optionee¢s Service Relationship with the Company or a Subsidiary is terminated, the period within which to exercise this Stock Option may be subject to earlier termination as set forth below:

(i) Termination Due to Death, Disability or Retirement. If the Optionee¢s Service Relationship terminates by reason of such Optionee¢s death, disability (as defined in Section 422(c) of the Code) or retirement (after attainment of age sixty (60)) this Stock Option may be exercised, to the extent exercisable on the date of such termination, by the Optionee, the Optionee¢s legal representative or legatee for a period of twelve (12) months from the date of death, disability or retirement or until the Expiration Date, if earlier. 

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(ii) Other Termination. If the Optionee¢s employment terminates for any reason other than death, disability or retirement (after attainment of age sixty (60)), and unless otherwise determined by the Committee, this Stock Option may be exercised, to the extent exercisable on the date of termination, for a period of ninety (90) days from the date of termination or until the Expiration Date, if earlier, provided however, if the Optionee¢s Service Relationship is terminated for Cause, this Stock Option shall terminate immediately upon the date of such termination.

For purposes hereof, the Committee¢s determination of the reason for termination of the Optionee¢s Service Relationship shall be conclusive and binding on the Optionee and his or her representatives or legatees. Any portion of the Stock Option that is not exercisable on the date of termination of the Service Relationship shall terminate immediately and be null and void.

(d) It is understood and intended that this Stock Option is not intended to qualify as an incentive stock option as defined in Section 422 of the Code.

3. Exercise of Stock Option.

(a) The Optionee may exercise this Stock Option only in the following manner: Prior to the Expiration Date (subject to Section 6), the Optionee may deliver a Stock Option exercise notice (an Exercise Notice) in the form of Appendix A hereto indicating his or her election to purchase some or all of the Option Shares with respect to which this Stock Option is exercisable at the time of such notice. Such notice shall specify the number of Option Shares to be purchased. Payment of the purchase price may be made by one or more of the methods described below. Payment instruments will be received subject to collection.

(i) in cash, by certified or bank check, or other instrument acceptable to the Committee in U.S. funds payable to the order of the Company in an amount equal to the purchase price of such Option Shares;

(ii) by the Optionee delivering to the Company a promissory note if the Board has expressly authorized the loan of funds to the Optionee for the purpose of enabling or assisting the Optionee to effect the exercise of his or her Stock Option; provided that at least so much of the exercise price as represents the par value of the Stock shall be paid other than with a promissory note if otherwise required by state law; or

(iii) if the Initial Public Offering has occurred, then (A) through the delivery (or attestation to ownership) of shares of Common Stock that have been purchased by the Optionee on the open market or that have been held by the Optionee for at least six months and are not subject to restrictions under any plan of the Company, (B) by the Optionee delivering to the Company a properly executed Exercise Notice together with irrevocable instructions to a broker to promptly deliver to the Company cash or a check payable and acceptable to the Company to pay the option purchase price, provided that in the event the Optionee chooses to pay the option purchase price as so provided, the Optionee and the broker shall comply with such procedures and enter into such agreements of indemnity and other agreements as the Committee shall prescribe as a condition of such payment procedure, or (C) a combination of (i), (ii), (iii)(A) and (iii)(B) above.

(b) Certificates for the Option Shares so purchased will be issued and delivered to the Optionee upon compliance to the satisfaction of the Committee with all requirements under applicable laws or regulations in connection with such issuance. Until the Optionee shall have complied with the requirements hereof, the Company shall be under no obligation to issue the Option Shares subject to this Stock Option, and the determination of the Committee as to such compliance shall be final and binding on the Optionee. The Optionee shall not be deemed to be the holder of, or to have any of the rights of a holder with respect to, any shares of Common Stock subject to this Stock Option unless and until this Stock Option shall have been exercised pursuant to the terms hereof, the Company shall have issued and delivered the Issued Shares to the Optionee, and the Optionee¢s name shall have been entered as a stockholder of record on the books of the Company. Thereupon, the Optionee shall have full dividend and other ownership rights with respect to such Issued Shares, subject to the terms of this Agreement.

3

 
(c) Notwithstanding any other provision hereof, no portion of this Stock Option shall be exercisable after the Expiration Date.

4. Incorporation of Plan. Notwithstanding anything herein to the contrary, this Stock Option shall also be subject to and governed by all the terms and conditions of the Plan that are not necessary to achieve or maintain incentive stock option status under section 422 of the Code.

5. Transferability of Stock Option. This Agreement is personal to the Optionee and is not transferable by the Optionee in any manner other than by will or by the laws of descent and distribution. The Stock Option may be exercised during the Optionee¢s lifetime only by the Optionee (or by the Optionee¢s guardian or personal representative in the event of the Optionee¢s incapacity). The Optionee may elect to designate a beneficiary by providing written notice of the name of such beneficiary to the Company, and may revoke or change such designation at any time by filing written notice of revocation or change with the Company; such beneficiary may exercise the Optionee¢s Stock Option in the event of the Optionee¢s death to the extent provided herein. If the Optionee does not designate a beneficiary, or if the designated beneficiary predeceases the Optionee, the legal representative of the Optionee may exercise this Stock Option to the extent provided herein in the event of the Optionee¢s death.

6. Effect of Certain Transactions. In the case of a Sale Event, this Stock Option shall terminate upon the effective time of any such Sale Event unless provision is made in connection with such transaction in the sole discretion of the parties thereto for the continuation or assumption of this Stock Option heretofore granted, or the substitution of this Stock Option with a new Stock Option of the successor entity or a parent thereof, with such adjustment as to the number and kind of shares and the per share exercise prices as such parties shall agree. In the event of such termination, the Optionee shall be permitted, for a specified period of time prior to the consummation of the Sale Event as determined by the Committee, to exercise all or portions of the Stock Option which are then exercisable.

7. Withholding Taxes. The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event for federal income tax purposes, pay to the Company or make arrangements satisfactory to the Committee for payment of any federal, state and local taxes required by law to be withheld on account of such taxable event. Subject to approval by the Committee, the Optionee may elect to have the minimum tax withholding obligation satisfied, in whole or in part, by authorizing the Company to withhold from shares of Common Stock to be issued or transferring to the Company, a number of shares of Common Stock with an aggregate Fair Market Value that would satisfy the minimum withholding amount due. The Optionee acknowledges and agrees that the Company or any Subsidiary of the Company has the right to deduct from payments of any kind otherwise due to the Optionee, or from the Option Shares to be issued in respect of an exercise of this Stock Option, any federal, state or local taxes of any kind required by law to be withheld with respect to the issuance of Option Shares to the Optionee.

8. Restrictions on Transfer of Issued Shares. None of the Issued Shares acquired upon exercise of the Stock Option shall be sold, assigned, transferred, pledged, hypothecated, given away or in any other manner disposed of or encumbered, whether voluntarily or by operation of law, unless such transfer is in compliance with all applicable securities laws (including, without limitation, the Securities Act of 1933, as amended, and the rules and regulations thereunder (the Act)), and such disposition is in accordance with the terms and conditions of Sections 8 and 9. In connection with any transfer of Issued Shares, the Company may require the transferor to provide at the Optionee¢s own expense an opinion of counsel to the transferor, satisfactory to the Company, that such transfer is in compliance with all foreign, federal and state securities laws (including, without limitation, the Act). Any attempted disposition of Issued Shares not in accordance with the terms and conditions of Sections 8 and 9 shall be null and void, and the Company shall not reflect on its records any change in record ownership of any Issued Shares as a result of any such disposition, shall otherwise refuse to recognize any such disposition and shall not in any way give effect to any such disposition of any Issued Shares. Subject to the foregoing general provisions, Issued Shares may be transferred pursuant to the following specific terms and conditions:

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(a) Transfers to Permitted Transferees. The Optionee may sell, assign, transfer or give away any or all of the Issued Shares to Permitted Transferees; provided, however, that such Permitted Transferee(s) shall, as a condition to any such transfer, agree to be subject to the provisions of this Agreement to the same extent as the Optionee (including, without limitation, the provisions of Sections 8, 9, 10 and 12) and shall have delivered a written acknowledgment to that effect to the Company.

(b) Transfers Upon Death. Upon the death of the Optionee, any Issued Shares then held by the Optionee at the time of such death and any Issued Shares acquired thereafter by the Optionee¢s legal representative pursuant to this Agreement shall be subject to the provisions of Sections 8, 9, 10 and 12, if applicable, and the Optionee¢s estate, executors, administrators, personal representatives, heirs, legatees and distributees shall be obligated to convey such Issued Shares to the Company or its assigns under the terms contemplated hereby.

(c) Companys Right of First Refusal. In the event that the Optionee (or any Permitted Transferee holding Issued Shares subject to this Section 8(c)) desires to sell or otherwise transfer all or any part of the Issued Shares, the Optionee (or Permitted Transferee) first shall give written notice to the Company of the Optionee¢s (or Permitted Transferee¢s) intention to make such transfer. Such notice shall state the number of Issued Shares which the Optionee (or Permitted Transferee) proposes to sell (the Offered Shares), the price and the terms at which the proposed sale is to be made and the name and address of the proposed transferee. At any time within thirty (30) days after the receipt of such notice by the Company, the Company or its assigns may elect to purchase all or any portion of the Offered Shares at the price and on the terms offered by the proposed transferee and specified in the notice. The Company or its assigns shall exercise this right by mailing or delivering written notice to the Optionee (or Permitted Transferee) within the foregoing 30-day period. If the Company or its assigns elect to exercise its purchase rights under this Section 8(c), the closing for such purchase shall, in any event, take place within forty-five (45) days after the receipt by the Company of the initial notice from the Optionee (or Permitted Transferee). In the event that the Company or its assigns do not elect to exercise such purchase right, or in the event that the Company or its assigns do not pay the full purchase price within such 45-day period, the Optionee (or Permitted Transferee) may, within sixty (60) days thereafter, sell the Offered Shares to the proposed transferee and at the same price and on the same terms as specified in the Optionee¢s (or Permitted Transferee¢s) notice. Any Shares purchased by such proposed transferee shall no longer be subject to the terms of this Agreement. Any Shares not sold to the proposed transferee shall remain subject to this Agreement.

9. Company¢s Right of Repurchase.

(a) Right of Repurchase. The Company shall have the right (the Repurchase Right) upon the occurrence of any of the events specified in Section 9(b) below (the Repurchase Event) to repurchase from the Optionee (or any Permitted Transferee) some or all (as determined by the Company) of the Issued Shares held or subsequently acquired upon exercise of this Stock Option in accordance with the terms hereof by the Optionee (or any Permitted Transferee) at the price per share specified below. The Repurchase Right may be exercised by the Company within twenty-four (24) months following the date of such event (the Repurchase Period). The Repurchase Right shall be exercised by the Company by giving the holder written notice on or before the last day of the Repurchase Period of its intention to exercise the Repurchase Right, and, together with such notice, tendering to the holder an amount equal to the Fair Market Value of the shares, determined as provided in Section 9(c). The Company may assign the Repurchase Right to one or more Persons. Upon such notification, the Optionee and any Permitted Transferees shall promptly surrender to the Company any certificates representing the Issued Shares being purchased, together with a duly executed stock power for the transfer of such Issued Shares to the Company or the Company¢s assignee or assignees. Upon the Company¢s or its assignee¢s receipt of the certificates from the Optionee or any Permitted Transferees, the Company or its assignee or assignees shall deliver to him, her or them a check for the Repurchase Price of the Issued Shares being purchased; provided, however, that the Company may pay the Repurchase Price for such shares by offsetting and canceling any indebtedness then owed by the Optionee to the Company. At such time, the Optionee and/or any holder of the Issued Shares shall deliver to the Company the certificate or certificates representing the Issued Shares so repurchased, duly endorsed for transfer, free and clear of any liens or encumbrances.

5

 
(b) Company¢s Right to Exercise Repurchase Right. The Company shall have the Repurchase Right in the event that any of the following events shall occur:

(i) The termination of the Optionee¢s Service Relationship with the Company and its Subsidiaries for any reason whatsoever, regardless of the circumstances thereof, and including without limitation upon death, disability, retirement, discharge or resignation for any reason, whether voluntarily or involuntarily; or

(ii) The Optionee¢s or Permitted Transferee¢s Bankruptcy.

(c)  Determination of Fair Market Value. The fair market value of the Issued Shares shall be, for purposes of this Section 9, determined by the Board as of the date the Board elects to exercise its repurchase rights in connection with a Repurchase Event. 

10. Drag Along Right. In the event the holders of a majority of the Company¢s equity securities then outstanding (the Majority Shareholders) determine to sell or otherwise dispose of all or substantially all the assets of the Company or all or fifty percent (50%) or more of the capital stock of the Company in each case in a transaction constituting a change in control of the Company, to any non-Affiliate(s) of the Company or any of the Majority Shareholders, or to cause the Company to merge with or into or consolidate with any non-Affiliate(s) of the Company or any of the Majority Shareholders (in each case, the Buyer) in a bona fide negotiated transaction (a Sale), the Optionee, including any Permitted Transferees, shall be obligated to and shall upon the written request of a Majority Shareholders (subject to Section 6): (a) sell, transfer and deliver, or cause to be sold, transferred and delivered, to the Buyer, his or her Issued Shares (including for this purpose all of such Optionee¢s or his or her Permitted Transferee¢s Issued Shares that presently or as a result of any such transaction may be acquired upon the exercise of options (following the payment of the exercise price therefor)) on substantially the same terms applicable to the Majority Shareholders (with appropriate adjustments to reflect the conversion of convertible securities, the redemption of redeemable securities and the exercise of exercisable securities as well as the relative preferences and priorities of preferred stock); and (b) execute and deliver such instruments of conveyance and transfer and take such other action, including voting such Issued Shares in favor of any Sale proposed by the Majority Shareholders and executing any purchase agreements, merger agreements, indemnity agreements, escrow agreements or related documents, as the Majority Shareholders or the Buyer may reasonably require in order to carry out the terms and provisions of this Section 10.

11. Escrow Arrangement.

(a) Escrow. In order to carry out the provisions of Sections 8, 9 and 10 of this Agreement more effectively, the Company shall hold any Issued Shares in escrow together with separate stock powers executed by the Optionee in blank for transfer, and any Permitted Transferee shall, as an additional condition to any transfer of Issued Shares, execute a like stock power as to such Issued Shares. The Company shall not dispose of the Issued Shares except as otherwise provided in this Agreement. In the event of any repurchase by the Company (or any of its assigns), the Company is hereby authorized by the Optionee and any Permitted Transferee, as the Optionee¢s and each such Permitted Transferee¢s attorney-in-fact, to date and complete the stock powers necessary for the transfer of the Issued Shares being purchased and to transfer such Issued Shares in accordance with the terms hereof. At such time as any Issued Shares are no longer subject to the Company¢s repurchase and first refusal rights, the Company shall, at the written request of the Optionee, deliver to the Optionee (or the relevant Permitted Transferee) a certificate representing such Issued Shares with the balance of the Issued Shares to be held in escrow pursuant to this Section 11.

6

 
(b) Remedy. Without limitation of any other provision of this Agreement or other rights, in the event that the Optionee, any Permitted Transferees or any other person or entity is required to sell the Optionee¢s Issued Shares pursuant to the provisions of Sections 8, 9 and 10 of this Agreement and in the further event that he or she refuses or for any reason fails to deliver to the Company or its designated purchaser of such Issued Shares the certificate or certificates evidencing such Issued Shares together with a related stock power, the Company or such designated purchaser may deposit the applicable purchase price for such Issued Shares with a bank designated by the Company, or with the Company¢s independent public accounting firm, as agent or trustee, or in escrow, for the Optionee, any Permitted Transferees or other person or entity, to be held by such bank or accounting firm for its benefit of and for delivery thereto, or in its discretion, pay such purchase price by offsetting any indebtedness then owed by the Optionee as provided above. Upon any such deposit and/or offset by the Company or its designated purchaser of such amount and upon notice to the person or entity who was required to sell the Issued Shares to be sold pursuant to the provisions of Sections 8, 9 and 10, such Issued Shares shall at such time be deemed to have been sold, assigned, transferred and conveyed to such purchaser, the holder thereof shall have no further rights thereto (other than the right to withdraw the payment thereof held in escrow, if applicable), and the Company shall record such transfer in its stock transfer book or in any appropriate manner.

12. Lockup Provision. The Optionee agrees, if requested by the Company and any underwriter engaged by the Company, not to sell or otherwise transfer or dispose of any Issued Shares (including, without limitation pursuant to Rule 144 under the Act) held by him or her for such period following the effective date of any registration statement of the Company filed under the Act as the Company or such underwriter shall specify reasonably and in good faith, not to exceed one hundred eighty (180) days in the case of the Company¢s Initial Public Offering or ninety (90) days in the case of any other public offering.

13. Miscellaneous Provisions.

(a)  Termination. The Company¢s repurchase rights under Section 9, the restrictions on transfer of Issued Shares under Section 8(c) and the Drag Along obligations under Section 10 shall terminate upon the closing of the Company¢s Initial Public Offering or upon consummation of any Sale Event, as a result of which shares of the Company (or successor entity) of the same class as the Issued Shares are registered under Section 12 of the Exchange Act and publicly traded on NASDAQ/NMS or any national security exchange.

(b) Equitable Relief. The parties hereto agree and declare that legal remedies may be inadequate to enforce the provisions of this Agreement and that equitable relief, including specific performance and injunctive relief, may be used to enforce the provisions of this Agreement.

.  (c) Adjustments for Changes in Capital Structure. If, as a result of any reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in the Common Stock, the outstanding shares of Common Stock are increased or decreased or are exchanged for a different number or kind of shares of the Company¢s stock, the restrictions contained in this Section 8 shall apply with equal force to additional and/or substitute securities, if any, received by the Optionee in exchange for, or by virtue of his or her ownership of, Issued Shares.

(d) Change and Modifications. This Agreement may not be orally changed, modified or terminated, nor shall any oral waiver of any of its terms be effective. This Agreement may be changed, modified or terminated only by an agreement in writing signed by the Company and the Optionee.

(e)  Governing Law. This Agreement shall be governed by and construed in accordance with the laws of Delaware without regard to conflict of law principles.

7

 
(f ) Headings. The headings are intended only for convenience in finding the subject matter and do not constitute part of the text of this Agreement and shall not be considered in the interpretation of this Agreement.

(g)  Saving Clause. If any provision(s) of this Agreement shall be determined to be illegal or unenforceable, such determination shall in no manner affect the legality or enforceability of any other provision hereof.

(h)  Notices. All notices, requests, consents and other communications shall be in writing and be deemed given when delivered personally, by telex or facsimile transmission or when received if mailed by first class registered or certified mail, postage prepaid. Notices to the Company or the Optionee shall be addressed as set forth underneath their signatures below, or to such other address or addresses as may have been furnished by such party in writing to the other.

(i)  Benefit and Binding Effect. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto, their respective successors, permitted assigns, and legal representatives. The Company has the right to assign this Agreement, and such assignee shall become entitled to all the rights of the Company hereunder to the extent of such assignment.

(j) Dispute Resolution. Except as provided below, any dispute arising out of or relating to this Agreement or the breach, termination or validity hereof shall be finally settled by binding arbitration conducted expeditiously in accordance with the J.A.M.S./Endispute Comprehensive Arbitration Rules and Procedures (the J.A.M.S. Rules). The arbitration shall be governed by the United States Arbitration Act, 9 U.S.C. sec. 1-16, and judgment upon the award rendered by the arbitrators may be entered by any court having jurisdiction thereof. The place of arbitration shall be located within the State of New Jersey.

The parties covenant and agree that the arbitration shall commence within sixty (60) days of the date on which a written demand for arbitration is filed by any party hereto. In connection with the arbitration proceeding, the arbitrator shall have the power to order the production of documents by each party and any third-party witnesses. In addition, each party may take up to three (3) depositions as of right, and the arbitrator may in his or her discretion allow additional depositions upon good cause shown by the moving party. However, the arbitrator shall not have the power to order the answering of interrogatories or the response to requests for admission. In connection with any arbitration, each party shall provide to the other, no later than seven (7) business days before the date of the arbitration, the identity of all persons that may testify at the arbitration and a copy of all documents that may be introduced at the arbitration or considered or used by a party¢s witness or expert. The arbitrator¢s decision and award shall be made and delivered within six (6) months of the selection of the arbitrator. The arbitrator¢s decision shall set forth a reasoned basis for any award of damages or finding of liability. The arbitrator shall not have power to award damages in excess of actual compensatory damages and shall not multiply actual damages or award punitive damages or any other damages that are specifically excluded under this Agreement, and each party hereby irrevocably waives any claim to such damages.

The parties covenant and agree that they will participate in the arbitration in good faith. This Section 13(j) applies equally to requests for temporary, preliminary or permanent injunctive relief, except that in the case of temporary or preliminary injunctive relief any party may proceed in court without prior arbitration for the limited purpose of avoiding immediate and irreparable harm.

8

 
Each of the parties hereto (i) hereby irrevocably submits to the jurisdiction of any United States District Court of competent jurisdiction for the purpose of enforcing the award or decision in any such proceeding, (ii) hereby waives, and agrees not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution (except as protected by applicable law), that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court, and hereby waives and agrees not to seek any review by any court of any other jurisdiction which may be called upon to grant an enforcement of the judgment of any such court. Each of the parties hereto hereby consents to service of process by registered mail at the address to which notices are to be given. Each of the parties hereto agrees that its, his or her submission to jurisdiction and its, his or her consent to service of process by mail is made for the express benefit of the other parties hereto. Final judgment against any party hereto in any such action, suit or proceeding may be enforced in other jurisdictions by suit, action or proceeding on the judgment, or in any other manner provided by or pursuant to the laws of such other jurisdiction.

(k)  Counterparts. For the convenience of the parties and to facilitate execution, this Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same document.

[SIGNATURE PAGE FOLLOWS]

9


The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned as of the date first above written.
 
     
  DOV PHARMACEUTICAL, INC.
 
 
 
 
 
 
  By:   /s/ J. Robert Horton
 
J. Robert Horton
  SVP and General Counsel
   
 
Address:
433 Hackensack Avenue
Hackensack, NJ 07601 
 
The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned as of the date first above written.

     
  OPTIONEE
 
 
 
 
 
 
  By:   /s/ Scott Myers
 
Scott Myers
   
  Grant Date: December 1, 2005 
   
 
Address:
________________________
________________________
________________________ 

A-1

 
[SPOUSE¢S CONSENT
I acknowledge that I have read the
foregoing Incentive Stock Option Agreement
and understand the contents thereof.

____________________________________][A spouse’s consent is required only if the Optionee’s state of residence is one of the following community property states: Arizona, California, Idaho, Louisiana, New Mexico, Nevada, Texas, Washington and Wisconsin (check WI statute).]

     
  DESIGNATED BENEFICIARY:
 
 
 
 
 
 
         
 
 
Beneficiary's Address:
________________________
________________________
________________________
 
A-2

 
Appendix A

STOCK OPTION EXERCISE NOTICE


DOV Pharmaceutical, Inc.
Attention: Chief Financial Officer
____________________________
____________________________


Pursuant to the terms of my stock option agreement dated __________ (the Agreement), I, _______________, hereby [Circle One] partially/fully exercise such option by including herein payment in the amount of $______ representing the purchase price for [Fill in number of Option Shares] _______ option shares. I have chosen the following form(s) of payment:

[ ] 1. Cash
[ ] 2. Certified or bank check payable to DOV Pharmaceutical, Inc.
[ ] 3. Other (as described in the Agreement (please describe))
   _____________________________________________________.

Sincerely yours,


____________________________________
Name:

Address:
_________________________________
_________________________________
_________________________________
 

EX-10.44 5 v037548_ex10-44.htm

Exhibit 10.44

SIXTH AMENDMENT TO LEASE

THIS SIXTH AMENDMENT ("the Amendment") made as of July 6, 2005, by and between MSNW CONTINENTAL ASSOCIATES, LLC, a Delaware limited liability company with an office at 67 Park Place East, 8th Floor, Morristown, New Jersey 07960 ("Lessor") and DOV PHARMACEUTICAL, INC., a Delaware corporation, located at 433 Hackensack Avenue, Hackensack, New Jersey 07601 ("Lessee").

WITNESSETH:

WHEREAS, Lessor’s predecessor-in-interest and Lessee entered into a lease dated May 24, 1999, as modified by a First Amendment to Lease dated July 31, 2000 (the “First Amendment”) a Second Amendment to lease dated July 30, 2002 (the “Second Amendment”), a Third Amendment to lease dated February 12, 2003 (the “Third Amendment”), a Fourth Amendment to lease dated March ___, 2004 (the “Fourth Amendment”), and a Fifth Amendment to Lease dated November 15, 2004 (the “Fifth Amendment”) (the lease, as amended by the First Amendment, the Second Amendment, the Third Amendment, the Fourth Amendment and the Fifth Amendment is hereinafter referred to as the “Lease”), whereby Lessee is currently in possession of two separate premises on the lobby level, one containing approximately 7,185 gross rentable square feet of space and the other containing approximately 4,420 gross rentable square feet of space respectively (the “Lobby Premises”), approximately 4,099 gross rentable square feet on the twelfth (12th) floor (the “12th Floor Premises”) and two separate premises on the sixth (6th) floor, one containing approximately 1,951 gross rentable square feet of space and the other containing approximately 1,330 rentable square feet of space respectively (collectively, the “6th Floor Premises”) (the 12th Floor Premises and the 6th Floor Premises are collectively referred to herein as the "Surrender Premises") in the building known as 433 Hackensack Avenue, Hackensack, New Jersey (the "Building"); and

WHEREAS, Lessee desires to surrender to Lessor, as of the Surrender Date (as hereinafter defined), the Surrender Premises and relocate to other premises within the building known as 411 Hackensack Avenue, Hackensack, New Jersey (the “411 Building”); and

WHEREAS, the parties hereto desire to amend the Lease in accordance with this Amendment.

NOW, THEREFORE, Lessor and Lessee agree as follows:

1. For purposes of this Amendment, capitalized terms have the meanings ascribed to them in the Lease unless otherwise defined herein.

2. Lessor and Lessee hereby acknowledge and agree that, subject to paragraph 9 of the Fifth Amendment, the Termination Date of the Lease, as amended by this Amendment, is June 30, 2008.

 
 

 
 
3. For purposes of this Amendment, the "Surrender Date" shall be 11:59 p.m. on the day immediately preceding the Effective Date (as hereinafter defined).

4. Effective as of the Surrender Date, Lessee hereby surrenders to Lessor all of its right, title and interest under the Lease in and to the Surrender Premises, it being understood and agreed that all of Lessee's estate under the Lease in and to the Surrender Premises shall be wholly terminated and extinguished as of the Surrender Date; and Lessor hereby accepts from Lessee as of the Surrender Date, such surrender of all of Lessee's right, title and interest under the Lease in and to the Surrender Premises.

5. Lessee hereby agrees that effective as of the Surrender Date, the Surrender Premises shall be surrendered to Lessor, broom clean, vacant, unleased and free and clear of all rights of occupancy by others, and in the condition required by the Lease. Lessee represents and covenants to Lessor that nothing has been done or suffered and nothing will be done or suffered whereby the estate of Lessee in and to the Surrender Premises or any portion thereof, has been or will be encumbered in any way whatsoever; that Lessee has the legal right to surrender same; and that no one other than Lessee, has acquired or will acquire by, through or under Lessee, any right, title or interest in or to the Surrender Premises or any portion thereof.

Notwithstanding any provisions of this Amendment to the contrary, Lessee agrees that Lessee shall remain liable for the payment of Fixed Basic Rent and Additional Rent relating to the Surrender Premises, including any retroactive adjustments or escalation charges thereto which may be payable pursuant to the terms and provisions of the Lease, on account of the Surrender Premises for the period up to and including the Surrender Date. Effective as of the Surrender Date, provided Lessee complies with the obligations set forth in the first subparagraph of this Section 5 and subject to it’s continuing obligations set forth in the second subparagraph of this Section 5, Lessee shall be released from all other obligations with respect to the Surrender Space.

6. Effective as of June 15, 2005 (the "Effective Date") Lessee shall lease from Lessor 16,264 gross rentable square feet on the ninth (9th) floor (the "Expansion Premises") in the 411 Building which Expansion Premises are shown on Exhibit A annexed hereto and made a part hereof. Reference Page Paragraphs (5) and (7) of the Lease shall be deemed modified accordingly.

7. From and after the Effective Date, the following shall apply with respect to the Expansion Premises:

(a) Paragraph (8) of the Reference page (“Electric Rent Inclusion Factor”) shall be deemed deleted and replaced as follows:

(8) Lessee Electric: Twenty-Four Thousand Three Hundred Ninety-Six and 00/100 Dollars ($24,396.00) per year, which shall be payable in addition to (and not included in) Annual Fixed Basic Rent.

 
2

 
 
(b) Any and all references in the Lease to “Electric Rent Inclusion Factor” shall be replaced by “Lessee Electric”. All references to increasing or decreasing the Term Fixed Basic Rent as a result of changes in the Electric Rent Inclusion Factor shall be changed to refer to increasing or decreasing the Lessee Electric. No change in the method of measuring Lessee’s electrical consumption, as a result of Lessor no longer redistributing electricity to the Premises, as provided in Paragraph 24(E), separately metering electrical consumption, as provided in Paragraph 24(J), or any other provision in the Lease, shall affect Term Fixed Basic Rent or Monthly Fixed Basic Rent, but may affect the amount of Lessee Electric. Lessee Electric shall be paid in monthly installments of Two Thousand Thirty-Three and 00/100 Dollars ($2,033.00), at the same time and in the manner as Monthly Fixed Basic Rent. Lessee Electric is an estimated amount subject to adjustment as provided in Paragraph 24(B) of the Lease. Paragraphs 24(B)(iii) and (iv) of the Lease shall be deleted and replaced as follows:

(iii) Lessee agrees that an independent electrical engineering consultant selected by Lessor shall from time to time make a survey of the electric power demand of the electric lighting fixtures and the electric equipment of Lessee used in the Premises to determine the average monthly electric consumption thereof, said survey to be at Lessee’s expense. Lessor reserves the right to estimate Lessee’s electric consumption until such a survey is made. The estimate will be based on One and 50/100 Dollars ($1.50) per square foot per year of the rentable area of the Expansion Premises and Lessee agrees to pay Lessor Twenty-Four Thousand Three Hundred Ninety-Six and 00/100 Dollars ($24,396.00) per year (“Lessee Electric”), payable in equal monthly installments of Two Thousand Thirty-Three and 00/100 Dollars ($2,033.00) per month as Additional Rent. Lessee Electric is not included in Annual Fixed Basic Rent. The aforesaid survey shall take into account, among other things, any special electrical requirements of the Lessee and use by Lessee of electrical energy at times other than during Building Hours on Business Days. Unless objected to by Lessee in accordance with the terms and conditions of paragraph 24(B) of the Lease, the finding of such engineer or consultant as to the proper Lessee Electric based on such average monthly electric consumption shall be conclusive and the Lessee Electric shall be revised to twelve (12) times the average monthly electric determined by the survey, effective as of the first day of the month following the month in which the survey is completed;

(iv) If the Electric Rates (as hereafter defined) on which the initial determination of the consultant was based shall be increased or decreased, than the Lessee Electric shall be increased or decreased in the amount equal to the change in Lessor’s cost of supplying electrical current to the Premises resulting from such rate change, retroactive if necessary, to the date of such increase or decrease in such Electric Rates.

(c) Paragraph 22 of the Lease shall be amended to provide that Lessee shall pay the sum of One Hundred and 00/100 dollars ($100.00) per hour for use of HVAC beyond Building Hours, plus the additional percentage increase over the Base Utility Rate as set forth in the Lease. In no event shall Lessee pay less than the sum of $100.00 per hour for such overtime use.

(d) Paragraph (12) of the Reference Page is hereby amended in its entirety to read as follows:

 
3

 
 
(12) A total of 64 spaces, of which 24 shall be in the covered parking area described in Section 38 below.

(e) Lessee’s Percentage is 2.76% and Paragraph 10 of the Reference Page shall be amended accordingly.

(f) Term Fixed Basic Rent shall be payable in advance on the first day of each month of the Term as follows:
 
Period
Annual Fixed Basic Rent
Monthly Fixed Basic Rent
     
June 15, 2005 -
June 30, 2006
$439,128.00
$36,594.00
     
July 1, 2006-
June 30-2007
$447,260.00
$37,271.67
     
July 1, 2007-
June 30, 2008
$455,392.00
$37,949.33

Reference Page Section (9) of the Lease shall be deemed amended accordingly.

(g) The Base Year for all Base Period Costs shall be calendar year 2005, and Reference Page Sections 2(A), (B) and (C) of the Lease shall be deemed amended accordingly.

8. From and after the Effective Date, the following shall apply with respect to the Lobby Premises:

(a) Paragraph (8) of the Reference page (“Electric Rent Inclusion Factor”) shall be deemed deleted and replaced as follows:

(8) Lessee Electric: Seventeen Thousand Four Hundred Seven and 50/100 Dollars ($17,407.50) per year, which shall be payable in addition to (and not included in) Annual Fixed Basic Rent.

(b) Any and all references in the Lease to “Electric Rent Inclusion Factor” shall be replaced by “Lessee Electric”. All references to increasing or decreasing the Term Fixed Basic Rent as a result of changes in the Electric Rent Inclusion Factor shall be changed to refer to increasing or decreasing the Lessee Electric. No change in the method of measuring Lessee’s electrical consumption, as a result of Lessor no longer redistributing electricity to the Premises, as provided in Paragraph 24(E), separately metering electrical consumption, as provided in Paragraph 24(J), or any other provision in the Lease, shall affect Term Fixed Basic Rent or Monthly Fixed Basic Rent, but may affect the amount of Lessee Electric. Lessee Electric shall be paid in monthly installments of One Thousand Four Hundred Fifty and 63/100 Dollars ($1,450.63), at the same time and in the manner as Monthly Fixed Basic Rent. Lessee Electric is an estimated amount subject to adjustment as provided in Paragraph 24(B) of the Lease. Paragraphs 24(B)(iii) and (iv) of the Lease shall be deleted and replaced as follows:

 
4

 
 
(iii) Lessee agrees that an independent electrical engineering consultant selected by Lessor shall from time to time make a survey of the electric power demand of the electric lighting fixtures and the electric equipment of Lessee used in the Lobby Premises to determine the average monthly electric consumption thereof, said survey to be at Lessee’s expense. Lessor reserves the right to estimate Lessee’s electric consumption until such a survey is made. The estimate will be based on One and 50/100 Dollars ($1.50) per square foot per year of the rentable area of the Premises and Lessee agrees to pay Lessor Seventeen Thousand Four Hundred Seven and 50/100 Dollars ($17,407.50) per year (“Lessee Electric”), payable in equal monthly installments of One Thousand Four Hundred Fifty and 63/100 Dollars ($1,450.63) per month as Additional Rent. Lessee Electric is not included in Annual Fixed Basic Rent. The aforesaid survey shall take into account, among other things, any special electrical requirements of the Lessee and use by Lessee of electrical energy at times other than during Building Hours on Business Days. The finding of such engineer or consultant as to the proper Lessee Electric based on such average monthly electric consumption shall be conclusive and the Lessee Electric shall be revised to twelve (12) times the average monthly electric determined by the survey, effective as of the first day of the month following the month in which the survey is completed;

(iv) If the Electric Rates (as hereafter defined) on which the initial determination of the consultant was based shall be increased or decreased, than the Lessee Electric shall be increased or decreased in the amount equal to the change in Lessor’s cost of supplying electrical current to the Premises resulting from such rate change, retroactive if necessary, to the date of such increase or decrease in such Electric Rates.

(c) Paragraph 22 of the Lease shall be amended to provide that Lessee shall pay the sum of One Hundred and 00/100 dollars ($100.00) per hour for use of HVAC beyond Building Hours, plus the additional percentage increase over the Base Utility Rate as set forth in the Lease. In no event shall Lessee pay less than the sum of $100.00 per hour for such overtime use.

(d) Paragraph (12) of the Reference Page is hereby amended in its entirety to read as follows:

(12) A total of 46 spaces, of which 33 shall be in the covered parking area described in Section 38 below.

(e) Lessee’s Percentage is 2.0% and Paragraph 10 of the Reference Page shall be amended accordingly.

(f) Term Fixed Basic Rent shall be payable in advance on the first day of each month of the Term as follows:

 
5

 
 
Period
Annual Fixed Basic Rent
Monthly Fixed Basic Rent
     
June 15, 2005 -
June 30, 2006
$313,335.00
$26,111.25
     
July 1, 2006-
June 30-2007
$319,137.50
$26,594.79
     
July 1, 2007-
June 30, 2008
$324,940.00
$27,078.33

Reference Page Section (9) of the Lease shall be deemed amended accordingly.
 
9. Lessee has inspected the Relocated Premises and Relocated Building, and is thoroughly acquainted with their respective conditions and agrees to take same "AS IS". Lessee acknowledges that the taking of the Relocated Premises by Lessee shall be conclusive evidence that the Relocated Premises and the Relocated Building were in good and satisfactory condition at the time possession of the Relocated Premises were so taken.

10. Lessee represents and warrants to the Lessor that Lessee has not dealt with any broker in bringing about this Amendment other than GVA Williams. Lessee agrees to indemnify and hold Lessor harmless from any and all claims of any broker and expenses in connection therewith arising out of or in connection with the negotiation of or the entering into this Amendment by Lessor and Lessee.

11. Lessee represents, warrants and covenants that, to the best of Lessee’s knowledge, Lessor is not in default under any of its obligations under the Lease and that, to the best of Lessee's knowledge, Lessee is not in default of any of its obligations under the Lease, and no event has occurred which, with the passage of time or the giving of notice, or both, would constitute a default by either Lessor or Lessee thereunder.

12. Paragraph 44 of the Lease is amended to provide the following addresses for notices to Lessor:

MSNW Continental Associates, LLC
411 Hackensack Avenue
Hackensack, New Jersey 07601
Attention: Property Manager

 
6

 
 
with copies to:    MSNW Continental Associates, LLC
c/o Normandy Real Estate Management, LLC
1776 On the Green
 
67 Park Place East, 8th Floor
Morristown, New Jersey 07960
Attention: General Counsel


13. Except as modified by this Amendment, the Lease and all the covenants, agreements, terms, provisions and conditions thereof (including, without limitation, paragraph 9 of the Fifth Amendment) shall remain in full force and effect and are hereby ratified and affirmed.

14. The covenants, agreements, terms, provisions and conditions contained in this Amendment shall bind and inure to the benefit of the parties hereto and their respective successors and except as otherwise provided in the Lease as modified by this Amendment, their respective assigns. In the event of any conflict between the terms contained in this Amendment and the Lease, the terms herein shall supersede and control the obligations and liabilities of the parties.

15. The submission of this Amendment for examination does not constitute a reservation of, or option for, the Premises, and this Amendment becomes effective only upon execution and delivery thereof by Lessor and Lessee.
 

[Signature Page to Follow]

 
7

 

IN WITNESS WHEREOF, Lessor and Lessee have executed this Amendment as of the date and year first above written, and acknowledge to each other that they possess the requisite authority to enter into this transaction and to sign this Amendment.


ATTEST:
 
 
 
 
By: ________________
Name: ______________
Title: _______________
 
 
WITNESS:
 
 
 
 
 
 
 
 
 
 
 
By: /s/ Susan M. Gately
Name:Susan M. Gately
Title: VP of Finance
LESSEE:
 
DOV PHARMACEUTICAL, INC.
 
 
By: /s/ Arnold Lippa
Name:  Arnold Lippa
Its: Chief Executive Officer
 
 
LESSOR:
 
MSNW CONTINENTAL ASSOCIATES, LLC, a Delaware limited liability company
 
BY: MSNW CONTINENTAL ACQUISITION, LLC, a Delaware limited liability company, its sole member
 
BY: NORMANDY CONTINENTAL ADMINISTRATOR II, LLC, a Delaware limited liability company, its Administrator
 
 
BY: /s/ Frank Mancini
             Frank Mancini
             Vice President
 
 
8

 


EXHIBIT A

EXPANSION PREMISES


 
9

 







EX-10.45 6 v037548_ex10-45.htm
Exhibit 10.45

SEVENTH AMENDMENT TO LEASE

THIS SEVENTH AMENDMENT ("the Amendment") made as of September 7, 2005, by and between MSNW CONTINENTAL ASSOCIATES, LLC, a Delaware limited liability company with an office at 67 Park Place East, 8th Floor, Morristown, New Jersey 07960 ("Lessor") and DOV PHARMACEUTICAL, INC., a Delaware corporation, located at 433 Hackensack Avenue, Hackensack, New Jersey 07601 ("Lessee").

WITNESSETH:

WHEREAS, Lessor’s predecessor-in-interest and Lessee entered into a lease dated May 24, 1999, as modified by a First Amendment to Lease dated July 31, 2000 (the “First Amendment”) a Second Amendment to Lease dated July 30, 2002 (the “Second Amendment”), a Third Amendment to Lease dated February 12, 2003 (the “Third Amendment”), a Fourth Amendment to Lease dated March ___, 2004 (the “Fourth Amendment”), a Fifth Amendment to Lease dated November 15, 2004 (the “Fifth Amendment”), and a Sixth Amendment to Lease dated July 6, 2005 (the “Sixth Amendment”) (the lease, as amended by the First Amendment, the Second Amendment, the Third Amendment, the Fourth Amendment, the Fifth Amendment and the Sixth Amendment is hereinafter referred to as the “Lease”); and

WHEREAS, Lessee desires to lease additional premises within the building known as 433 Hackensack Avenue, Hackensack, New Jersey (the “433 Building”); and

WHEREAS, the parties hereto desire to amend the Lease in accordance with this Amendment.

NOW, THEREFORE, Lessor and Lessee agree as follows:

1. For purposes of this Amendment, capitalized terms have the meanings ascribed to them in the Lease unless otherwise defined herein.

2. Effective as of September 1, 2005 (the “Temporary Expansion Premises Commencement Date”), Lessee shall lease from Lessor 4,098 gross rentable square feet on the twelfth (12th) floor in the 433 Building, which premises are shown on Exhibit A annexed hereto and made a part hereof (the “Temporary Expansion Premises”). Lessee shall lease the Temporary Expansion Premises from the Temporary Expansion Premises Commencement Date through that date upon which the Expansion Premises (as hereinafter defined) is available and ready for Lessee’s occupancy (which date shall be no later than January 9, 2006, and is referred to herein as the “Expansion Premises Commencement Date”).

3. Effective as of the Expansion Premises Commencement Date, Lessee shall surrender to Lessor all of its right, title and interest under the Lease in and to the Temporary Expansion Premises, it being understood and agreed that all of Lessee's estate under the Lease in and to the Temporary Expansion Premises shall be wholly terminated and extinguished as of the Expansion Premises Commencement Date; and Lessor shall accept from Lessee as of the Expansion Premises Commencement Date, such surrender of all of Lessee's right, title and interest under the Lease in and to the Temporary Expansion Premises.

 
 

 
 
4. Lessee hereby agrees that effective as of the Expansion Premises Commencement Date, the Temporary Expansion Premises shall be surrendered to Lessor, broom clean, vacant, unleased and free and clear of all rights of occupancy by others, and in the condition required by the Lease. Lessee represents and covenants to Lessor that nothing has been done or suffered and nothing will be done or suffered whereby the estate of Lessee in and to the Temporary Expansion Premises or any portion thereof, has been or will be encumbered in any way whatsoever; that Lessee has the legal right to surrender same; and that no one other than Lessee, has acquired or will acquire by, through or under Lessee, any right, title or interest in or to the Temporary Expansion Premises or any portion thereof.

Notwithstanding any provisions of this Amendment to the contrary, Lessee agrees that Lessee shall remain liable for the payment of Fixed Basic Rent and Additional Rent relating to the Temporary Expansion Premises, including any retroactive adjustments or escalation charges thereto which may be payable pursuant to the terms and provisions of the Lease, on account of the Temporary Expansion Premises for the period up to and including the Expansion Premises Commencement Date.

5. Effective as of the Expansion Premises Commencement Date through and including the Termination Date, Lessee shall lease from Lessor 9,169 gross rentable square feet on the second (2nd) floor (the "Expansion Premises") in the 433 Building which Expansion Premises are shown on Exhibit B annexed hereto and made a part hereof. Reference Page Paragraphs (5) and (7) of the Lease shall be deemed modified accordingly.

6. From and after the Temporary Expansion Premises Commencement Date through the Expansion Premises Commencement Date, the following shall apply with respect to the Temporary Expansion Premises:

(a) Paragraph (8) of the Reference page (“Electric Rent Inclusion Factor”) shall be deemed deleted and replaced as follows:

(8) Lessee Electric: Six Thousand One Hundred Forty-Seven and 00/100 Dollars ($6,147.00) per year, which shall be payable in addition to (and not included in) Annual Fixed Basic Rent.

(b) Any and all references in the Lease to “Electric Rent Inclusion Factor” shall be replaced by “Lessee Electric”. All references to increasing or decreasing the Term Fixed Basic Rent as a result of changes in the Electric Rent Inclusion Factor shall be changed to refer to increasing or decreasing the Lessee Electric. No change in the method of measuring Lessee’s electrical consumption, as a result of Lessor no longer redistributing electricity to the Premises, as provided in Paragraph 24(E), separately metering electrical consumption, as provided in Paragraph 24(J), or any other provision in the Lease, shall affect Term Fixed Basic Rent or Monthly Fixed Basic Rent, but may affect the amount of Lessee Electric. Lessee Electric shall be paid in monthly installments of Five Hundred Twelve and 25/100 Dollars ($512.25), at the same time and in the manner as Monthly Fixed Basic Rent. Lessee Electric is an estimated amount subject to adjustment as provided in Paragraph 24(B) of the Lease. Paragraphs 24(B)(iii) and (iv) of the Lease shall be deleted and replaced as follows:

 
2

 
 
(iii) Lessee agrees that an independent electrical engineering consultant selected by Lessor may from time to time make a survey of the electric power demand of the electric lighting fixtures and the electric equipment of Lessee used in the Premises to determine the average monthly electric consumption thereof, said survey to be at Lessee’s expense. Lessor reserves the right to estimate Lessee’s electric consumption until such a survey is made. The estimate will be based on One and 50/100 Dollars ($1.50) per square foot per year of the rentable area of the Expansion Premises and Lessee agrees to pay Lessor Six Thousand One Hundred Forty-Seven and 00/100 Dollars ($6,147.00) per year (“Lessee Electric”), payable in equal monthly installments of Five Hundred Twelve and 25/100 Dollars ($512.25) per month as Additional Rent. Lessee Electric is not included in Annual Fixed Basic Rent. The aforesaid survey shall take into account, among other things, any special electrical requirements of the Lessee and use by Lessee of electrical energy at times other than during Building Hours on Business Days. Unless objected to by Lessee in accordance with the terms and conditions of paragraph 24(B) of the Lease, the finding of such engineer or consultant as to the proper Lessee Electric based on such average monthly electric consumption shall be conclusive and the Lessee Electric shall be revised to twelve (12) times the average monthly electric determined by the survey, effective as of the first day of the month following the month in which the survey is completed;

(iv) If the Electric Rates (as hereafter defined) on which the initial determination of the consultant was based shall be increased or decreased, than the Lessee Electric shall be increased or decreased in the amount equal to the change in Lessor’s cost of supplying electrical current to the Premises resulting from such rate change, retroactive if necessary, to the date of such increase or decrease in such Electric Rates.

(c) Paragraph 22 of the Lease shall be amended to provide that Lessee shall pay the sum of One Hundred and 00/100 dollars ($100.00) per hour for use of HVAC beyond Building Hours, plus the additional percentage increase over the Base Utility Rate as set forth in the Lease. In no event shall Lessee pay less than the sum of $100.00 per hour for such overtime use.

(d) Paragraph (12) of the Reference Page is hereby amended in its entirety to read as follows:

(12) A total of 16 spaces, of which 12 shall be in the covered parking area described in Section 38 below.

(e) Lessee’s Percentage is 0.7% and Paragraph 10 of the Reference Page shall be amended accordingly.

(f) Term Fixed Basic Rent shall be payable in advance on the first day of each month of the Term as follows:

 
3

 
 

Period
Annual Fixed Basic Rent
Monthly Fixed Basic Rent
Temporary Expansion Premises
   
Commencement Date -
   
Expansion Premises
   
Commencement Date
$110,646.00
$9,220.50

Reference Page Section (9) of the Lease shall be deemed amended accordingly.

(g) The Base Year for all Base Period Costs shall be calendar year 2005, and Reference Page Sections 2(A), (B) and (C) of the Lease shall be deemed amended accordingly.

7. From and after the Expansion Premises Commencement Date, the following shall apply with respect to the Expansion Premises:

(a) Paragraph (8) of the Reference page (“Electric Rent Inclusion Factor”) shall be deemed deleted and replaced as follows:

(8) Lessee Electric: Thirteen Thousand Seven Hundred Fifty-Three and 50/100 Dollars ($13,753.50) per year, which shall be payable in addition to (and not included in) Annual Fixed Basic Rent.

(b) Any and all references in the Lease to “Electric Rent Inclusion Factor” shall be replaced by “Lessee Electric”. All references to increasing or decreasing the Term Fixed Basic Rent as a result of changes in the Electric Rent Inclusion Factor shall be changed to refer to increasing or decreasing the Lessee Electric. No change in the method of measuring Lessee’s electrical consumption, as a result of Lessor no longer redistributing electricity to the Premises, as provided in Paragraph 24(E), separately metering electrical consumption, as provided in Paragraph 24(J), or any other provision in the Lease, shall affect Term Fixed Basic Rent or Monthly Fixed Basic Rent, but may affect the amount of Lessee Electric. Lessee Electric shall be paid in monthly installments of One Thousand One Hundred Forty-Six and 13/100 Dollars ($1,146.13), at the same time and manner as Monthly Fixed Basic Rent. Lessee Electric is an estimated amount subject to adjustment as provided in Paragraph 24(B) of the Lease. Paragraphs 24(B)(iii) and (iv) of the Lease shall be deleted and replaced as follows:

(iii) Lessee agrees that an independent electrical engineering consultant selected by Lessor may from time to time make a survey of the electric power demand of the electric lighting fixtures and the electric equipment of Lessee used in the Lobby Premises to determine the average monthly electric consumption thereof, said survey to be at Lessee’s expense. Lessor reserves the right to estimate Lessee’s electric consumption until such a survey is made. The estimate will be based on One and 50/100 Dollars ($1.50) per square foot per year of the rentable area of the Premises and Lessee agrees to pay Lessor Thirteen Thousand Seven Hundred Fifty-Three and 50/100 Dollars ($13,753.50) per year (“Lessee Electric”), payable in equal monthly installments of One Thousand One Hundred Forty-Six and 13/100 Dollars ($1,146.13) per month as Additional Rent. Lessee Electric is not included in Annual Fixed Basic Rent. The aforesaid survey shall take into account, among other things, any special electrical requirements of the Lessee and use by Lessee of electrical energy at times other than during Building Hours on Business Days. Unless objected to by Lessee in accordance with the terms and conditions of paragraph 24(B) of the Lease, the finding of such engineer or consultant as to the proper Lessee Electric based on such average monthly electric consumption shall be conclusive and the Lessee Electric shall be revised to twelve (12) times the average monthly electric determined by the survey, effective as of the first day of the month following the month in which the survey is completed;

 
4

 
 
(iv) If the Electric Rates (as hereafter defined) on which the initial determination of the consultant was based shall be increased or decreased, than the Lessee Electric shall be increased or decreased in the amount equal to the change in Lessor’s cost of supplying electrical current to the Premises resulting from such rate change, retroactive if necessary, to the date of such increase or decrease in such Electric Rates.

(c) Paragraph 22 of the Lease shall be amended to provide that Lessee shall pay the sum of One Hundred and 00/100 dollars ($100.00) per hour for use of HVAC beyond Building Hours, plus the additional percentage increase over the Base Utility Rate as set forth in the Lease. In no event shall Lessee pay less than the sum of $100.00 per hour for such overtime use.

(d) Paragraph (12) of the Reference Page is hereby amended in its entirety to read as follows:

(12) A total of 36 spaces, of which 27 shall be in the covered parking area described in Section 38 below.

(e) Lessee’s Percentage is 1.55% and Paragraph 10 of the Reference Page shall be amended accordingly.

(f) Term Fixed Basic Rent shall be payable in advance on the first day of each month of the Term as follows:

Period
Annual Fixed Basic Rent
Monthly Fixed Basic Rent
     
Expansion Premises
   
Commencement Date -
   
June 30, 2006
$247,563.00
$20,630.25
     
July 1, 2006 - June 30, 2007
$252,147.50
$21,012.29
     
July 1, 2007 - June 30, 2008
$256,732.00
$21,394.33

 
5

 
 
Reference Page Section (9) of the Lease shall be deemed amended accordingly.

(g) The Base Year for all Base Period Costs shall be calendar year 2005, and Reference Page Sections 2(A), (B) and (C) of the Lease shall be deemed amended accordingly.

8. Lessee has inspected the Temporary Expansion Premises and Expansion Premises, and is thoroughly acquainted with their respective conditions and agrees to take same "AS IS"; provided, however, that Lessor shall relocate from the 12th floor to the 2nd floor one (1) existing supplemental air-conditioning unit or provide Tenant with a supplemental air-conditioning unit similar to the unit located on the 12th floor. However, notwithstanding the foregoing, in the event Lessee exercises its termination option by January 1, 2006, such that Lessee does not lease and occupy the Expansion Premises through at least June 30, 2006, then Lessee shall reimburse Lessor upon demand a pro-rata portion of the cost of the supplemental air-conditioning unit in an amount equal to the product of $75.88 multiplied by the number of days from the termination date through June 30, 2006 (so, for example, if the termination date is May 31, 2006, then Lessee’s pro-rata amount shall be $2,276.40 (i.e., $75.88 x 30)). Lessee acknowledges that the taking of the Temporary Expansion Premises and the Expansion Premises by Lessee shall be conclusive evidence that each of the respective premises was in good and satisfactory condition at the time possession of each of the respective premises was so taken.

9. Lessee represents and warrants to the Lessor that Lessee has not dealt with any broker in bringing about this Amendment other than GVA Williams. Lessee agrees to indemnify and hold Lessor harmless from any and all claims of any broker and expenses in connection therewith arising out of or in connection with the negotiation of or the entering into this Amendment by Lessor and Lessee.

10. Lessee represents, warrants and covenants that, to the best of Lessee’s knowledge, Lessor is not in default under any of its obligations under the Lease and that, to the best of Lessee's knowledge, Lessee is not in default of any of its obligations under the Lease, and no event has occurred which, with the passage of time or the giving of notice, or both, would constitute a default by either Lessor or Lessee thereunder.

11. Except as modified by this Amendment, the Lease and all the covenants, agreements, terms, provisions and conditions thereof (including, without limitation, paragraph 9 of the Fifth Amendment) shall remain in full force and effect and are hereby ratified and affirmed.

12. The covenants, agreements, terms, provisions and conditions contained in this Amendment shall bind and inure to the benefit of the parties hereto and their respective successors and except as otherwise provided in the Lease as modified by this Amendment, their respective assigns. In the event of any conflict between the terms contained in this Amendment and the Lease, the terms herein shall supersede and control the obligations and liabilities of the parties.

 
6

 
 
13. The submission of this Amendment for examination does not constitute a reservation of, or option for, the Premises, and this Amendment becomes effective only upon execution and delivery thereof by Lessor and Lessee.

[Signature Page to Follow]

IN WITNESS WHEREOF, Lessor and Lessee have executed this Amendment as of the date and year first above written, and acknowledge to each other that they possess the requisite authority to enter into this transaction and to sign this Amendment.

ATTEST:
 
 
 
 
By: /s/ Matthew Moore
Name:  Matthew Moore
Title: Director of Corporate Development
 
 
WITNESS:
 
 
 
 
 
 
 
 
 
 
 
By: /s/ William O’Keefe
Name: William O’Keefe
Title: VP - Leasing
LESSEE:
 
DOV PHARMACEUTICAL, INC.
 
 
By: /s/ J. Robert Horton
Name:  J. Robert Horton
Its: Sr. Vice President and General Counsel
 
 
LESSOR:
 
MSNW CONTINENTAL ASSOCIATES, LLC, a Delaware limited liability company
 
BY: MSNW CONTINENTAL ACQUISITION, LLC, a Delaware limited liability company, its sole member
 
BY: NORMANDY CONTINENTAL ADMINISTRATOR II, LLC, a Delaware limited liability company, its Administrator
 
 
BY: /s/ Frank Mancini
             Frank Mancini
             Vice President
 
 
7

 

EXHIBIT A

THE TEMPORARY EXPANSION PREMISES

 
8

 

EXHIBIT B

THE EXPANSION PREMISES


 
9

 

 
EX-10.46 7 v037548_ex10-46.htm
Exhibit 10.46



 








PARAGON 150 PIERCE STREET, L.L.C.

Landlord


DOV PHARMACEUTICAL, INC.
 
Tenant
--------------------------------------------------------
150 Pierce Street
Franklin Township, New Jersey
 

 
 

 


Table of Contents

1.
SUMMARY OF DEFINED TERMS
1
2.
PREMISES
3
3.
TERM
3
4.
CONSTRUCTION BY LANDLORD
4
5.
FIXED RENT; LETTER OF CREDIT
6
6.
ADDITIONAL RENT
10
7.
UTILITY CHARGES
16
8.
SIGNS; USE OF PREMISES AND COMMON AREAS
16
9.
ENVIRONMENTAL MATTERS
18
10.
TENANT'S ALTERATIONS
20
11.
CONSTRUCTION LIENS
22
12.
ASSIGNMENT AND SUBLETTING
22
13.
LANDLORD'S RIGHT OF ENTRY
26
14.
REPAIRS AND MAINTENANCE
26
15.
INSURANCE; SUBROGATION RIGHTS
29
16.
INDEMNIFICATION
30
17.
QUIET ENJOYMENT
31
18.
FIRE DAMAGE
31
19.
SUBORDINATION; RIGHTS OF MORTGAGEE
32
20.
CONDEMNATION
33
21.
ESTOPPEL CERTIFICATE
34
22.
DEFAULT
34
23.
INTENTIONALLY OMITTED
39
24.
LANDLORD'S REPRESENTATIONS AND WARRANTIES
39
25.
SURRENDER
39
26.
RULES AND REGULATIONS
39
27.
GOVERNMENTAL REGULATIONS
40
28.
NOTICES
40
29.
BROKERS
41
30.
INTENTIONALLY OMITTED
41
31.
LANDLORD'S LIABILITY
41
32.
AUTHORITY
41
33.
NO OFFER
42
34.
EXTENSION OPTION
42
35.
OPTION TO PURCHASE
43
36.
CONTINGENCY
45
37.
RIGHT OF OFFER FOR PURCHASE
45
38.
TENANT FINANCIAL INFORMATION
47
39.
MISCELLANEOUS PROVISIONS
47
40.
WAIVER OF TRIAL BY JURY
49
41.
CONSENT TO JURISDICTION
50
 
 
 

 
 
EXHIBIT A
 
52
EXHIBIT B
 
53
EXHIBIT C
 
54
EXHIBIT D
 
55
EXHIBIT E
 
58
EXHIBIT F
 
59
EXHIBIT G
 
60
EXHIBIT H
 
61
 
 
 

 

LEASE

THIS LEASE ("Lease") entered into as of the 20th day of December, 2005, between PARAGON 150 PIERCE STREET, L.L.C., a New Jersey limited liability company, with an address at One Paragon Drive, Suite 145, Montvale, New Jersey 07645 ("Landlord"), and DOV PHARMACEUTICAL, INC., a Delaware corporation, with its principal place of business at Continental Plaza, 433 Hackensack Avenue, Hackensack, New Jersey 07601 ("Tenant").
 
WITNESSETH
 
In consideration of the mutual covenants herein set forth, and intending to be legally bound, the parties hereto covenant and agree as follows:

1. SUMMARY OF DEFINED TERMS.

The following defined terms, as used in this Lease, shall have the meanings and shall be construed as set forth below:

 
(a)
"Building": The Building located at 150 Pierce Street, Franklin Township, New Jersey, which the parties stipulate and agree contains 133,686 rentable square feet.

 
(b)
INTENTIONALLY DELETED.

 
(c)
"Premises": The Building, the land and all other improvements located at 150 Pierce Street, Franklin Township, New Jersey as more particularly described on Exhibit "A" and made a part hereof.

 
(d)
"Term": From the Commencement Date for a period of one hundred twenty (120) months, ending on the last day of the tenth (10th) Lease Year (as defined in Article 1(q) below.

(e) "Fixed Rent":

 

LEASE YEAR
MONTHLY INSTALLMENTS
ANNUAL FIXED RENT
     
Years 1-5
$233,950.50
$2,807,406.00
     
Years 6-10
$257,345.55
$3,088,146.60

 
(f)
Rental Payment Address”: If not wired: c/o PARAGON 150 PIERCE STREET, L.L.C., One Paragon Drive, Suite 145, Montvale, New Jersey 07645.
 
 
1

 

     
 
(g)
"Letter of Credit": $4,211,109.00.
     
 
(h)
INTENTIONALLY DELETED.
     
 
(i)
"Tenant's Allocated Share": 100%.
 
(j)
Rentable Area":  Premises: 133,686 ft.
        Building: 133,686 ft.

 
(k)
"Permitted Uses": Tenants may use the Premises for general office, research and development, vivarium, biological and chemical laboratory (including, without limitation, biochemical assays, preclinical research support utilizing chemical synthesis and isotopes and research using rodents and such other related uses as are allowed from time to time by applicable law), pilot plant, light manufacturing, storage and any uses necessary to the foregoing, including, without limitation, cafeteria, computer rooms and fitness center, and for no other purposes. Tenant's rights to use the Premises shall be subject to all applicable laws and governmental rules and regulations and to all reasonable requirements of the insurers of the Building.
 
 
(l)
"Broker”: GVA Williams

 
(m)
"Notice Address/Contact":

Landlord:
PARAGON 150 PIERCE STREET, L.L.C.
One Paragon Drive, Suite 145
Montvale, New Jersey 07645
Attn: Mr. Mark Schaevitz, Managing Member
 
 
 
 
 
Tenant:
DOV PHARMACEUTICAL, INC.
150 Pierce Street
Franklin Township, New Jersey
Attn: Robert Horton, Esq., General Counsel
 
 
 
 
 
(n)
Additional Rent”: All sums of money or charges required to be paid by Tenant under this Lease other than Fixed Rent, whether or not such sums or charges are designated as “Additional Rent”.

 
(o)
Rent”: All Annual Fixed Rent, monthly installments of Annual Fixed Rent, Fixed Rent and Additional Rent payable by Tenant to Landlord under this Lease.
 
(p)
Base Year”: twelve (12) months, commencing from and after the Commencement Date.
 
 
2

 

(q)
Lease Year”: A "Lease Year" shall be comprised of a period of twelve (12) consecutive months. The first Lease Year shall commence on the Commencement Date but, notwithstanding the first sentence of this paragraph, if the Commencement Date is not the first day of a month, then the first Lease Year shall include the additional period from the Commencement Date to the end of the then current month. Each succeeding Lease Year shall end on the anniversary date of the last day of the preceding Lease Year. For example, if the Commencement Date is February 1, 2006, then the first Lease Year would commence on February 1, 2006 and end on January 31, 2007, and each succeeding Lease Year would commence on February 1st and end on January 31st. If, however, the Commencement Date is February 2, 2006, then the first Lease Year would commence on February 2, 2006 and end on February 28, 2007, the second Lease Year would commence on March 1, 2007 and end on February 29, 2008, and each succeeding Lease Year would commence on March 1st and end on either February 28th or 29th of the applicable Lease Year.
 
 
(r)
Utilities”: The “Utilities” shall be the utilities described in Article 7 hereof and the payment obligations with respect thereto also as set forth in said Article 7.

2. PREMISES. 

Landlord does hereby lease, demise and let unto Tenant and Tenant does hereby hire and lease from Landlord the Premises for the Term, upon the provisions, conditions and limitations set forth herein.

3. TERM.  

(a)  The Term of this Lease shall commence (the "Commencement Date") on the “Closing Date” under that certain Agreement of Purchase and Sale by and between Conopco, Inc. and Paragon 150 Pierce Street LLC, dated November 15, 2005. The Term shall expire on the last day of the tenth (10th) Lease Year (the “Expiration Date”). The Commencement Date shall be confirmed by Landlord and Tenant by the execution of a Confirmation of Lease Term in the form attached hereto as Exhibit "B". If Tenant fails to execute or object to the Confirmation of Lease Term within twenty (20) business days of its delivery, Landlord’s determination of such dates shall be deemed accepted.
 
 
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4. CONSTRUCTION BY LANDLORD.

(a) Landlord, at Tenant’s expense (except as otherwise provided below), shall construct and do such other work in the Premises to prepare the Premises for Tenant’s use and occupancy (collectively, the "Landlord's Work") as required by Tenant, subject to and in accordance with the provisions of this Article 4. Tenant shall, at its sole cost and expense and subject to the Tenant Allowance (as hereinafter defined), cause its architect and/or engineer to prepare and deliver to Landlord an initial set of complete and coordinated plans and specifications for each aspect of Landlord’s Work (the “Initial Completed Plans”). The Initial Completed Plans shall contain sufficient detail of the proposed Landlord’s Work so as to enable Tenant’s architect and/or engineer to prepare final construction documents for Landlord’s Work. Landlord shall review the Initial Completed Plans and shall advise Tenant whether it approves or disapproves of the Initial Completed Plans within ten (10) business days of Tenant’s submission of same. In the event Landlord disapproves of the Initial Completed Plans, Landlord shall provide Tenant with the basis of its disapproval and Tenant shall resubmit revised Initial Completed Plans for Landlord’s approval in accordance with the terms of this Lease until such time as Landlord approves same. It is further agreed that, in the event Landlord shall fail to approve or disapprove of the Initial Completed Plans within said ten (10) business day period, Landlord shall be deemed to have approved of same. Upon Landlord’s approval of the Initial Completed Plans, Tenant shall, at its sole cost and expense and subject to the Tenant Allowance, cause its architect and/or engineer to prepare and deliver to Landlord final construction documents for Landlord’s Work based upon the approved Initial Completed Plans (the “Final Construction Documents”). Upon Landlord’s receipt of the Final Construction Documents, Landlord shall solicit bids for Landlord’s Work in accordance with the provisions of subparagraph (b) below. Upon completion of the bidding process as aforesaid, Landlord shall, together with its submittal of the documentation required under subparagraph (b) below, advise Tenant of the following: (i) the scheduled date by which Landlord anticipates it shall substantially complete Landlord’s Work (the “Stated Completion Date”) and (ii) the estimated Costs for Landlord’s Work (as determined under Article 4(b) below).

(b) Following the completion of the bidding process for Landlord’s Work , Landlord shall provide Tenant with the estimate from the general contractor designated by Landlord to perform Landlord’s Work (“Landlord’s General Contractor”) of the costs and expenses to perform Landlord’s Work based on the Final Construction Documents, including a 7% general conditions and 10% overhead and profit charge, and a Construction Management Fee payable to Landlord in the amount of two (2%) percent of the hard costs of Landlord’s Work in connection with Landlord’s services in supervising, performing and/or reviewing all of Landlord’s Work (such costs and expenses are collectively herein referred to as the “Costs of Landlord’s Work”). Such submission shall include the bid packages from the proposed subcontractors in each category and Landlord’s notes and recommendations thereon. Tenant shall have the right to submit to Landlord a list of one (1) subcontractor for each trade to be involved in Landlord’s Work (which subcontractor Tenant would like to be included as one of the subcontractors from which Landlord shall request a bid as set forth above). In the event that Tenant submits to Landlord such list of subcontractors, Landlord and/or Landlord’s General Contractor shall include the one (1) subcontractor in each trade set forth on such Tenant’s list in its request for bids for each such trade. Notwithstanding the foregoing, in the event Tenant elects to include any specialized work as part of Landlord’s Work, Tenant may select a subcontractor to perform such specialized work (the “Specialized Subcontractor”) and Landlord and/or Landlord’s General Contractor shall coordinate and cooperate with the Specialized Subcontractor in order to permit the Specialized Subcontractor to perform its portion of Landlord’s Work simultaneously with the performance of Landlord’s Work. Tenant acknowledges that any subcontractor selected by Tenant pursuant to this Article 4(b) must be reputable, licensed and insured in the State of New Jersey. Within two (2) business days after submission of such information, Landlord and Tenant shall meet to discuss the Final Construction Documents, the pricing and the Stated Completion Date. Tenant shall advise Landlord, no later than five (5) business days after its receipt of the Final Construction Documents, whether it approves or disapproves the Stated Completion Date, the Costs of Landlord’s Work and whether Landlord is authorized to commence the performance of Landlord’s Work. Tenant shall be deemed to have accepted the same and authorized the performance of Landlord’s Work if it fails to respond to Landlord’s submission within said five (5) business day period. In the event Tenant disapproves all or any portion of Landlord’s submission, it is agreed that the parties shall immediately meet thereafter to discuss, in good faith, and agree upon a mutually acceptable Stated Completion Date and Costs of Landlord’s Work.

 
4

 
 
(c) Promptly after Tenant has approved the Costs of Tenant’s Work, the parties have established the Stated Completion Date and Tenant has authorized Landlord to commence construction, Landlord shall obtain all permits and approvals required for Landlord’s Work and commence and diligently prosecute Landlord’s Work to completion. Landlord shall cause Landlord’s Work to be performed in a good and workmanlike manner, in compliance with all applicable laws, codes, ordinances, rules and regulations and in accordance with the Final Construction Documents. Landlord’s Work shall be deemed “substantially complete” on the date as of which the only items of Landlord’s Work to be completed are punch list items and Landlord provides Tenant with a certification from Landlord’s architect that Landlord’s Work has been substantially completed in accordance with the Final Construction Documents. Notwithstanding anything contained herein to the contrary, it is further agreed that in the event Landlord does not substantially complete Landlord’s Work by the agreed to Stated Completion Date, subject to Force Majeure and Tenant Delay, Tenant shall receive a rent credit in an amount equal to one day for each day after the Stated Completion Date until the date that Landlord’s Work is substantially completed. A “Tenant Delay” shall be defined as any delay in the fulfillment of any of the conditions to the occurrence of an obligation under this Article 4 which Landlord is responsible for fulfilling, to the extent that such delay is caused by: (i) Tenant’s failure to respond to a submission by Landlord within the time periods provided herein, (ii) any changes requested by Tenant after the final approval of Final Construction Documents; (iii) the negligence or misconduct of Tenant or any of its agents or employees; (iv) Tenant’s lack of cooperation in connection Landlord’s Work (such as Tenant’s failure to attend construction meetings or respond, in a timely manner, to Landlord’s request for information relating to Landlord’s Work); or (v) the performance of work by anyone employed or engaged by Tenant.

 
5

 
 
(d) Landlord shall only be responsible for payment of a maximum cost of $2,673,720.00 (i.e., $20.00 per rentable square foot) (the “Tenant Allowance”) toward all Costs of Landlord’s Work and all “soft costs” as defined and to the extent permitted below. All such Costs of Landlord’s Work in excess of the Tenant Allowance, after first deducting costs and expenses incurred by Tenant for a third party provider for soft costs permitted to be applied against the Tenant Allowance, shall be borne by Tenant, and shall be paid to Landlord as follows: (i) twenty-five (25%) percent of such costs shall be payable by Tenant to Landlord prior to the commencement of Landlord’s Work, and (ii) the remaining seventy-five (75%) of such costs shall be payable by Tenant to Landlord in periodic installments, within thirty (30) days of Landlord’s presentation of bill and/or invoices with respect to such costs, such payment(s) to be based on a fraction, the numerator of which is the total amount of such excess costs and the denominator of which is the Costs for Landlord’s Work. If, however, the total Costs for Landlord’s Work is less than the maximum amount of the Tenant Allowance set forth above, then Landlord shall bear all such charges, and Tenant shall be paid an amount equal to the difference between the Tenant Allowance and the actual total cost of Landlord’s Work (it being understood and agreed by the parties hereto that such payment shall be made by Landlord’s Mortgagee (as hereinafter defined)in a single lump sum within forty-five (45) days of the satisfaction of the conditions set forth in this Lease). Tenant hereby acknowledges that not more than 35% of the Tenant Allowance shall be used for “soft costs”. The term “soft costs”, as used herein, shall generally include, without limitation, the fees and charges of any architects, engineers and other consultants engaged by Tenant in connection with the subject work; the fees and charges incurred in connection with obtaining governmental and quasi-governmental permits, authorizations and approvals; the costs and charges incurred in connection with the installation of Tenant’s data and telecommunication wiring and cabling in and about the Premises (or any portion thereof); and the costs and expenses incurred by Tenant in connection with the relocation, acquisition and installation of Tenant’s furniture, fixtures and equipment in the Premises (or any portion thereof). In the event portions of the Tenant Allowance are used for services and purposes other than for Landlord’s Work, such amounts shall be payable to Tenant (or the third party provider of such service) within thirty (30) days after delivery of an invoice or reasonable documentation therefor.

 
5.
FIXED RENT; LETTER OF CREDIT.

(a) Tenant shall pay to Landlord without notice or demand, and without set-off, except as otherwise provided in this Lease, the annual Fixed Rent payable in the monthly installments of Fixed Rent as set forth in Article 1(e), in advance on the first day of each calendar month during the Term by wire transfer of immediately available funds pursuant to the wiring instructions annexed hereto as Exhibit “C”.. In the event Tenant is unable to make any such payment by wire transfer, such amounts shall be forwarded to Landlord at the address set forth in Article 1(f) above. Notwithstanding the immediately preceding sentence, the first full month's installment and any initial partial month and the Letter of Credit shall be delivered to Landlord upon the execution of this Lease by Tenant.

 
6

 
 
(b) In the event any Fixed Rent or Additional Rent, charge, fee or other amount due from Tenant under the terms of this Lease are not paid to Landlord within 7 days of when due more than once in any twelve (12) month period, Tenant shall also pay as Additional Rent a service and handling charge equal to five (5%) percent of the total payment then due. The aforesaid late fee shall begin to accrue on the initial date of a payment due date, irrespective of any grace period granted hereunder. This provision shall not prevent Landlord from exercising any other remedy herein provided or otherwise available at law or in equity in the event of any default by Tenant.

(c)  (i) Prior to the transfer of title to the Premises to Landlord, Tenant shall deliver to Landlord, an unconditional, irrevocable, stand-by letter of credit (the “Letter of Credit”) in the amount specified by Article 1(g) hereof, to serve as collateral for the full and faithful performance and observance by Tenant of all of the terms, conditions, covenants and agreements of this Lease. The Letter of Credit must conform to the requirements of Article 5(c)(ii), below, and the rights and obligations of the parties with respect to the Letter of Credit shall be governed by the provisions of Article 5(c)(iii), (iv), (v) and (vi), below. Provided that no default has occurred under this Lease on the part of Tenant beyond the expiration of applicable notice and cure periods provided for herein for the cure thereof, Tenant shall have the right to reduce the amount of the Letter of Credit to $2,807,000.00 upon Tenant providing Landlord with evidence acceptable to Landlord and Landlord’s Mortgagee that Tenant has achieved two (2) consecutive years of profitability of a minimum of $10,000,000.00, excluding non-cash charges for employee stock options.

(ii) The Letter of Credit must conform to each the following requirements:

(A) the Letter of Credit may only be issued by and drawable upon a commercial bank, trust company, national banking association or savings and loan association that maintains an office in  the State of New Jersey or in New York City at which the Letter of Credit may be drawn upon (the "Issuing Bank") and shall be in substantially in the form annexed hereto as Exhibit “D”. Landlord hereby approves Bank of America or Bear Stearns as the Issuing Bank. The Issuing Bank must have outstanding unsecured, uninsured or unguaranteed indebtedness, or must have issued a Letter of Credit or other credit facility that constitutes the primary security for any outstanding indebtedness (which is otherwise uninsured and unguaranteed), that is then rated, without regard to qualification of such rating by symbols such as “+” or “-” or numerical notation, “Aa” or better by Moody’s Investors Service and “AA” or better by Standard & Poor’s Ratings Service (and is not on credit-watch with negative implications), and must then have combined capital, surplus and undivided profits of not less than $500,000,000;

(B) the Letter of Credit shall indicate the address of the Issuing Bank in the State of New Jersey or in New York City where it can be drawn upon;

(C) the Letter of Credit shall name Landlord as beneficiary under the Letter of Credit with its address at One Paragon Drive, Suite 145, Montvale, New Jersey 07645;

 
7

 
 
(D) the Letter of Credit must be payable to Landlord or an authorized representative of Landlord upon presentation of only the Letter of Credit and a sight draft, and shall not contain as a condition to a draw the requirement of Landlord's certification or other statement as to the existence of Tenant's default;

(E) the Letter of Credit must contain affirmative statements providing that (1) partial draws are permitted, and (2) the beneficiary may, from time to time, transfer or assign the Letter of Credit without the consent of Tenant or the Issuing Bank, and (3) upon transfer or assignment of the Letter of Credit by the beneficiary, neither the beneficiary nor its transferee/assignee shall be responsible for payment of any fees or charges imposed by the issuer in connection with such assignment. Moreover, Tenant hereby acknowledges and agrees that, in the event any such fees or charges are imposed by the issuer in relation to a transfer or assignment of the Letter of Credit and/or in relation to any addition, modification or deletion to the existing Letter of Credit, Tenant shall promptly pay such fees and/or charges and, in the event Tenant fails to pay same, the beneficiary or its transferee/assignee may apply a portion of the draw in satisfaction of such fees and/or charges;

(F) the Letter of Credit shall be subject to the International Standby Practices 1998, International Chamber of Commerce Publication No. 590;

(G) the Letter of Credit shall be deemed to be automatically renewed, without amendment, for consecutive one year periods through a date that is not earlier than sixty (60) days after the Expiration Date of this Lease, or any renewal or extension thereof, unless written notice of nonrenewal of the Letter of Credit has been given by the Issuing Bank to Landlord (sent to Landlord via certified mail, return receipt requested). Upon the Issuing Bank's giving of such notice, if any, Tenant must replace the Letter of Credit with a new Letter of Credit, satisfying the requirements of this Article 5(c)(ii), at least thirty (30) days prior to the termination of the existing Letter of Credit. Failure by Tenant to replace the existing Letter of Credit as required herein shall constitute a default under this Lease and there shall be no notice or opportunity to cure said default. Thereupon, Landlord shall be permitted to draw upon the original Letter of Credit up to the full amount thereon;

(H) the Letter of Credit must expressly state that all fees and expenses are for the account of Tenant and that the failure of Tenant to pay any such fees or expenses shall not affect the rights of the beneficiary thereunder; and

(i) the original Letter of Credit to be delivered by Tenant upon execution of this Lease shall be in the amount set forth in Article 1(g) hereof, and shall not reference or set forth the schedule of reduced amounts set forth at the end of Article 5(c)(i). Rather, if and when Tenant becomes entitled to reduce the amount of the Letter of Credit then being held by Landlord pursuant to this Lease, Landlord shall, upon written request by Tenant, cooperate in good faith with Tenant and the Issuing Bank for the exchange of (x) the original Letter of Credit then being held by Landlord pursuant to this Lease, for (y) the appropriate amendment to, or replacement of, such Letter of Credit.

 
8

 
 
Tenant acknowledges and agrees that Landlord shall have no responsibility or liability on account of any error by the Issuing Bank.

(iii) In the event Tenant defaults in payment of Fixed Rent, Additional Rent, or other sums due from Tenant to Landlord under this Lease, or in performance or observance of any other term, covenant, condition or agreement of this Lease, in either case after the expiration of applicable notice periods provided herein for the cure thereof, Landlord may notify the Issuing Bank and thereupon draw upon the Letter of Credit, in whole or in part, at Landlord’s election, and use, apply or retain the whole or any part of such monies to the extent required for the payment of any sums as to which Tenant is in default (including, without limitation, any damages or deficiency accrued before or after summary proceedings or other re-entry by Landlord) or for coverage or reimbursement of any sums which Landlord may expend or may be required to expend by reason of such default by Tenant. In the event Landlord so uses, applies or retains all or any portion of such monies represented by the Letter of Credit, Tenant shall forthwith restore the amount so used, applied or retained, upon delivery of written notice by Landlord detailing such use, application or retention, through delivery of a new or amended Letter of Credit which conforms to the requirements of Article 5(c)(ii), above. In the event Landlord shall not apply all of the proceeds of such Letter of Credit to cover Tenant's default as permitted hereunder, Landlord shall hold the unapplied portion of such proceeds as a security deposit under this Lease until such time as Tenant shall deliver a substitute Letter of Credit, in which case, Landlord shall return such proceeds to Tenant.

(iv) In the event of a sale or lease of all or a portion of the Premises, Landlord shall have the right to transfer its rights under the Letter of Credit to the vendee or lessee and Landlord shall thereupon be released by Tenant from all liability in connection with the Letter of Credit; Tenant agrees to look solely to the new landlord with respect to the return of, or any dispute arising in connection with, such Letter of Credit; and the provisions hereof shall apply to each such transfer or assignment made of such rights to a new landlord. Tenant shall not assign or encumber or attempt to assign or encumber the Letter of Credit. Any such assignment, encumbrance, attempted assignment or attempted encumbrance by Tenant shall be deemed void and of no force or effect, nor shall same be binding upon Landlord or its successors or assigns.

(v) The acceptance of the Letter of Credit or the exercise of any remedies under this Article 5(c) by Landlord shall not be a limitation on Landlord's damages, remedies or other rights under this Lease, or construed as a payment of liquidated damages or an advance payment of Fixed Rent or any Additional Rent.

(vi) Tenant shall cooperate, at Landlord’s sole cost and expense (except when the amount of the Letter of Credit is being reduced under subparagraph (c)(i) above or otherwise, in which case it shall be at Tenant’s sole cost and expense), with Landlord to promptly execute and deliver to Landlord any and all modifications, amendments, and replacements of the Letter of Credit, as Landlord may reasonably request to carry out the intent, terms and conditions of this Article 5(c).

 
9

 
 
(vii) Tenant shall have the right to replace the Letter of Credit with another equivalent form of collateral and/or security for this Lease, provided such replacement collateral and/or security is acceptable to Landlord and Landlord’s Mortgagee, in their sole and absolute discretion.

6. ADDITIONAL RENT.

(a) Commencing as of the first day of the second Lease Year, and in each lease year thereafter during the Term (as same may be extended), Tenant shall pay to Landlord Tenant’s Allocated Share of the following charges (“Recognized Expenses”), without deduction or set off, except as otherwise provided herein, to the extent such Recognized Expenses exceed those Recognized Expenses incurred during the Base Year set forth in Article 1(p) of this Lease:

(i)  Operating Expenses. All costs and expenses related to the maintenance, repair, operation, and management of the Premises incurred by Landlord, including, but not limited to:

(A)  All costs and expenses related to the operation, maintenance, repair or replacement of the Premises, including, but not limited to, lighting, cleaning the Building exterior and janitorial and cleaning services to the Building, trash removal and recycling, repairs, partial replacement and maintenance of the roof, parking areas, storm water management system, fire suppression and alarm systems, removing snow, ice and debris and maintaining all landscape areas (including replacing and replanting flowers, shrubbery and trees), maintaining, repairing and partially replacing all other exterior improvements at the Premises, all repairs and compliance costs necessitated by laws enacted or which become effective after the date hereof (including, without limitation, any additional regulations or requirements enacted after the date hereof regarding the Americans With Disabilities Act required of Landlord under applicable laws and rules and regulations and management fees (it being understood and agreed that, with respect to management fees only, any increases to the dollar amount of the management fee included in the Base Year shall be determined using a cost of living adjustment formula only).

(B) All costs and expenses incurred by Landlord for environmental testing, sampling or monitoring required by statute, regulation or order of governmental authority as a result of the activities at the Premises of Tenant, an Affiliate or a Business Group (as such terms are defined in Paragraph 12(i) below) and/or the successors, assigns, or subtenants of Tenant, an Affiliate or a Business Group, excluding any costs or expenses incurred in conjunction with the spilling or depositing of any hazardous substance for which any other person or other tenant is legally liable. 

(C) INTENTIONALLY DELETED.

(D) All insurance premiums paid or payable by Landlord for insurance with respect to the Premises as follows: (a) fire and extended coverage insurance (including demolition and debris removal); (b) insurance against Tenant defaults, Landlord's rental loss or abatement (but not including business interruption coverage on behalf of Tenant) from damage or destruction from environmental hazards, fire or other casualty; (c) Landlord's commercial general liability insurance (including bodily injury and property damage) and boiler insurance; and (d) such other reasonable insurance as Landlord or any reputable mortgage lending institution holding a mortgage on the Premises may require that is customarily carried by prudent landlord of properties similar to the Premises. If the coverage period of any of such insurance obtained by Landlord commences before or extends beyond the Term, the premium therefore shall be prorated to the Term. Should Tenant's occupancy or use of the Premises at any time change and thereby cause an increase in such insurance premiums on the Building and/or Premises, Tenant shall pay to Landlord the entire amount of such reasonably documented increase, irrespective of the Base Year.

 
10

 
 
In no event shall Operating Expenses include:

(1) payment of principal, interest or other charges on mortgages or payment of any rent by Landlord on account of any ground lease encumbering the Premises; (2) advertising, marketing costs, and leasing commissions of Landlord or any affiliate; (3) costs for which Landlord is has the right to be reimbursed under insurance polices or otherwise by third parties; (4) legal and accounting expenses related to lease negotiations and enforcement of leases; (5) damages, penalties, fines, or interest that Landlord is obligated to pay by reason of any tort liability of Landlord, Landlord’s violation of applicable law or failure by Landlord to comply with its lease obligations or to timely pay any component of Operating Expenses; (6) salaries of executives or principals of Landlord; (7) charitable and political contributions; (8) compensations paid to any Building employee to the extent that the same is not fairly allocable to the work or service provided by such employee to the Premises; (9) taxes and any estate, succession, inheritance, profit, use, occupancy, gross receipts, rental, capital gains, and transfer taxes imposed upon Landlord; (10) any bad debt loss, rent loss or reserves for bad debts or rent loss; (11) any expenses which are not paid or incurred in respect of the Premises but rather in respect of other real property owned by Landlord or affiliates of Landlord, provided that with respect to any expenses attributable in part to the Premises and in part to other real property owned by Landlord (including, without limitation, salaries, fringe benefits and other compensation of Landlord’s personnel who provide services to both the Premises and other properties), Operating Expenses shall include only such portion thereof as are apportioned by Landlord to the Premises on a fair and equitable basis; (12) costs incurred with respect to a sale or transfer of all or any portion of the Premises or any interest therein or in any person of whatever tier owning an interest therein; (13) amounts paid to subsidiaries or other affiliates of Landlord for services to the Premises to the extent only that the costs of such services materially exceed the costs if such services had been rendered by an unaffiliated party; (14) capital expenditures relating to: (a) the expansion of the Building, (b) the replacement of the entire facade of the Building, (c) the replacement of the entire roof of the Building, (d) the replacement of the entire HVAC system in the Building or the replacement, at the same time, of all of the components of such system (except that the cost of replacing particular components of such system shall be included in Operating Expenses); or (e) compliance with applicable laws, codes, ordinances and regulations in effect prior to the Commencement Date; (15) capital expenditures principally designed to market the Premises for lease to a successor tenant or for sale or other transfer to a successor owner and not otherwise required in connection with Landlord’s maintenance, repair and replacement obligations under this Lease or necessary, in Landlord’s reasonable opinion, to prevent the deterioration or degradation of the Premises or the value thereof; (16) depreciation, amortization (except as otherwise expressly provided herein) and other non-cash charges; and (17) all costs of Landlord’s general corporate and general administrative and overhead expenses. It is further agreed that the costs of capital expenditures which are includable in Operating Expenses will not exceed $100,000.00 in any given Escalation Year (but, if in excess of $100,000.00, such excess cost(s) may be carried forward and included in subsequent Escalation Year(s) or will be payable by Tenant to Landlord upon the exercise of Tenant’s rights under Paragraph 35 hereof until such time as such excess is paid in full by Tenant).

 
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(ii)  "Taxes" shall be the real estate taxes, assessments, special or otherwise, sewer rents, rates and charges, and any other governmental charges, general, specific, ordinary or extraordinary, foreseen or unforeseen, levied on a calendar year or fiscal year basis against the Premises. In no event shall Taxes include franchise, transfer, excise, estate, gift, income or profits taxes. If at any time during the Term the method of taxation prevailing at the date hereof shall be altered so that there shall be levied, assessed or imposed in lieu of, or as in addition to, or as a substitute for, the whole or any part of the taxes, levies, impositions or charges now levied, assessed or imposed on all or any part of the Premises (a) a tax, assessment, levy, imposition or charge based upon the rents received by Landlord, whether or not wholly or partially as a capital levy or otherwise, or (b) a tax, assessment, levy, imposition or charge measured by or based in whole or in part upon all or any part of the Premises and imposed on Landlord, or (c) a license fee measured by the rent payable by Tenant to Landlord, or (d) any other tax, levy, imposition, charge or license fee however described or imposed; then all such taxes, levies, impositions, charges or license fees or any part thereof, so measured or based, shall be deemed to be Taxes. Landlord shall pay all Taxes hereunder to the applicable governmental authority on or before the date that such sums would become delinquent under applicable law. Landlord shall provide evidence of payment of Taxes to Tenant promptly upon written request by Tenant.

(b) Tenant shall pay, in monthly installments in advance, on account of Tenant’s Allocated Share of Recognized Expenses, the estimated amount of Recognized Expenses for such year in excess of the Base Year, as determined by Landlord in its reasonable discretion and as set forth in a notice to Tenant, such notice to include the basis for such calculation. Prior to the end of the calendar year in which the Lease commences and thereafter for each successive calendar year (each, an “Escalation Year”), or part thereof, Landlord shall send to Tenant a statement of projected Recognized Expenses in excess of the Base Year and shall indicate what Tenant’s projected share of Recognized Expenses shall be. Said amount shall be paid in equal monthly installments in advance by Tenant as Additional Rent commencing January 1 of the applicable Escalation Year. Upon Tenant’s request, Landlord shall meet with Tenant during December of each year, to review Landlord’s anticipated Operating Expenses for the EscalationYear next following. Landlord agrees, in good faith, to take into account any suggestions of Tenant regarding Recognized Expenses.

 
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(c)  If during the course of any Escalation Year, Landlord shall demonstrate by evidence reasonably acceptable to Tenant that Recognized Expenses shall be different than that upon which the aforesaid projections were originally based, then Landlord shall be entitled to adjust the amount not more than twice in any such year by reallocating the remaining payments for such year, for the months of the Escalation Year which remain for the revised projections, and to advise Tenant of an adjustment in future monthly amounts to the end result that Recognized Expenses shall be collected on a reasonably current basis each Escalation Year.

(d)  By April 30th of each Escalation Year or as soon thereafter as administratively available, Landlord shall send to Tenant a statement of actual Recognized Expenses for the prior Escalation Year showing Tenant’s Allocated Share due from Tenant. Landlord shall use its reasonable efforts to provide Tenant with the aforesaid statements on or before April 30th of each Escalation Year; provided, however, if Landlord is unable to provide such statements by April 30th, Landlord shall not have been deemed to waive its right to collect any such amounts as Additional Rent. Notwithstanding the foregoing, in the event Landlord shall fail to provide a statement for a particular Escalation Year within two (2) years thereafter, Landlord shall be deemed to have waived its right to collect any such amounts for such Escalation Year. In the event the amount prepaid by Tenant exceeds the amount that was actually due, then Landlord shall issue a credit to Tenant in an amount equal to the over charge, which credit Tenant may apply to further payments on account of Recognized Expenses until Tenant has been fully credited with the over charge. If the credit due to Tenant is more than the aggregate total of future rental payments, Landlord shall pay to Tenant the difference between the credit in such aggregate total. In the event Landlord had undercharged Tenant, then Landlord shall send Tenant an invoice with the additional amount due, which amount shall be paid in full by Tenant within thirty (30) days of receipt.

(e)  Each of the Recognized Expenses amounts, whether requiring lump sum payment or constituting projected monthly amounts added to the Fixed Rent, shall for all purposes be treated and considered as Additional Rent and the failure of Tenant to pay the same as and when due in advance and without demand shall have the same effect as failure to pay any installment of the Fixed Rent and shall afford Landlord all the remedies in the Lease therefor as well as at law or in equity.

(f)  If this Lease terminates other than at the end of a calendar year, Landlord’s annual estimate of Recognized Expenses shall be accepted by the parties as the actual Recognized Expenses for the year the Lease ends until Landlord provides Tenant with actual statements in accordance with Section 6(d) above.

(g) (i) If Landlord obtains a reduction in tax assessments and/or Taxes which results in a reduction in Taxes for any Escalation Year as a result of proceedings respecting applications filed or made on or after the date of execution of this Lease, then for purposes of calculating Tenant’s Allocated Share of Taxes due pursuant to this Lease for such Escalation Year, the Taxes imposed shall be reduced accordingly and, if Landlord shall receive any tax refund or remission in respect to the Taxes for any Escalation Year which Tenant has actually paid Tenant’s Allocated Share of the Taxes as herein provided then, provided Tenant is not in default hereunder beyond applicable notice periods provided for herein for the cure thereof, Landlord shall reimburse Tenant for Tenant’s Allocated Share thereof, after first deducting therefrom the share of Landlord’s cost and expense in procuring such refund or remission.

 
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(ii) Tenant shall not, without Landlord’s prior written consent, institute or maintain any action, proceeding or application in any court or body or with any governmental authority for the purpose of changing the Taxes. However, if Landlord has failed to commence such a proceeding by the thirtieth (30th) day prior to the final date to file challenges for the tax year in question and Landlord has not provided to Tenant in writing, upon Tenant’s written request, a reasonable justification (which reasonable justification shall include, without limitation, that there are less than three (3) years remaining in the term hereof) for not doing so prior to such thirtieth (30th) day and provided further that Tenant is leasing at least seventy-five (75%) percent of the square footage of the Building at such time, then Tenant shall be permitted to commence such a proceeding for the Escalation Year in question, at Tenant’s sole cost and expense, and upon prior written notice to Landlord. In the event Tenant commences such a proceeding as permitted herein, Tenant shall furnish Landlord with copies of all documents delivered and received by or on behalf of Tenant in connection with said proceeding and shall permit Landlord to participate in all negotiations and meetings with municipal officials and representatives regarding the same. Landlord agrees to cooperate with Tenant in commencing such a proceeding and to execute any documentation reasonably requested by Tenant in connection therewith. In the event any such action initiated Tenant is successful, then Tenant shall receive, or have credited against its rent thereafter due (at Landlord’s option) an amount equal to Tenant’s Allocated Share of any tax refund or credit obtained thereby to the extent said Taxes were actually paid by Tenant (after reimbursement to the appropriate party for legal fees and other out of pocket expenses). In any event, Tenant agrees that it will not stipulate or settle any proceeding initiated by Tenant unless the terms of such stipulation are agreed to, in writing, by Landlord, which shall not be unreasonably withheld or delayed.

(h) Tenant shall have the right to audit the amount of the Recognized Expenses charged by Landlord for any year, provided such audit is performed in accordance with each of the following requirements: (i) as of time Tenant delivers its written objection under subparagraph (ii) below, Tenant shall have made timely payment of such Recognized Expenses within applicable notice and cure periods provided for herein; (ii) Tenant shall have delivered written objection to Landlord as to the amount of the subject Recognized Expenses (and of Tenant’s intent to exercise its audit right hereunder) within six (6) months of Tenant having received the annual statement for the subject Recognized Expenses; (iii) such audit shall be performed by employees of Tenant or a reputable firm of certified public accountants engaged by Tenant on a fee-paid basis (as opposed to a contingency fee basis); (iv) the accounting firm engaged by Tenant must execute and deliver to Landlord an undertaking, whereby such accounting firm (A) covenants not to disclose to any person or entity (other than Tenant) any information received by or made available to such accounting firm in connection with the audit, and (B) agrees not to solicit or accept engagement by other tenants of the Premises for the purposes of performing an audit on their behalf; (v) such audit is performed during regular business hours, upon prior appointment with Landlord and at Landlord’s record-keeping office; (vi) while Tenant’s auditor shall be permitted to review and copy the applicable books and records at Landlord’s record-keeping office, no such books or records be removed from such record-keeping office; and (vii) such audit is completed within ninety (90) days following the start thereof.

 
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In the event that it is ultimately determined (by agreement of the parties or by a final court determination) that the actual Recognized Expenses for any year, as defined and chargeable to Tenant under this Lease, are less than the amount set forth in the statement of Recognized Expenses submitted by Landlord for such year, then Landlord shall reimburse Tenant for such overcharge within thirty (30) days of receipt of notice thereof. In the event that it is ultimately determined (by agreement of the parties or by a final court determination) that the actual Recognized Expenses for any year, as defined and chargeable to Tenant under this Lease, are more than the amount set forth in the statement of Recognized Expenses submitted by Landlord for such year, then Tenant shall reimburse Landlord for such undercharge within thirty (30) days of receipt of notice thereof. In the event that it is ultimately determined (by agreement of the parties or by a final court determination) that the actual Recognized Expenses for any year, as defined and chargeable to Tenant under this Lease, are less than the amount set forth in the statement of Recognized Expenses submitted by Landlord for such year by more than ten percent (10%), then Landlord shall reimburse Tenant for the actual and reasonable costs of such audit. In the event it is ultimately determined (by agreement of the parties or by a final court determination) that the actual Recognized Expenses are more than the amount set forth in the statement of Recognized Expenses submitted by Landlord for such year by more than ten percent (10%), then Tenant shall reimburse Landlord for its actual and reasonable costs in responding to such audit. Notwithstanding anything contained herein to the contrary, if this Lease is terminated as a result of Tenant’s default under this Lease, Landlord shall have no obligation to reimburse Tenant for any such overcharge nor any obligation to reimburse Tenant for the costs of such audit.

(i)  In calculating the Recognized Expenses as hereinbefore described, if for thirty (30) or more days during the preceding Lease Year (including the Base Year) less than one hundred (100%) percent of the rentable area of the Building shall have been occupied by Tenant, then the Recognized Expenses attributable to the Property shall be deemed for such Lease Year (including the Base Year) to be amounts equal to the Recognized Expenses which would normally be expected to be incurred had such occupancy of the Building been one hundred (100%) percent throughout such lease year, as reasonably determined by Landlord (i.e., taking into account that certain expenses depend on occupancy (e.g., janitorial) and certain expenses do not (e.g., landscaping)). Notwithstanding the foregoing, in the event the Building shall not be fully occupied during any Lease Year following the Base Year and, as a result thereof, the cost of those services that are based solely on occupancy are actually reduced, such occupancy-based costs shall not be “grossed up” for purposes of calculating Recognized Expenses under this Article 6. In no event however, shall Tenant be entitled to a reimbursement of Recognized Expenses should the Recognized Expenses for such Lease Year be less than the Recognized Expenses for the Base Year as a result of Landlord calculating Recognized Expenses in such a manner.

 
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(j) It is further agreed that the parties may, but shall not be obligated to, convert this Lease into a “net” lease at any time following the Base Year, subject to the prior written consent of Landlord’s Mortgagee and the parties entering into a mutually acceptable amendment to this Lease.

7. UTILITY CHARGES.

From and after the Commencement Date, Tenant shall be responsible for payment of all costs and expenses incurred in connection with any utilities (the “Utilities”) provided to the Premises, including, without limitation, electricity, gas, and water necessary for Tenant’s use of the Premises. Tenant shall be responsible for all deposits required for such services. Tenant shall pay the service provider directly for all costs and expenses incurred in connection with the Utilities. Upon Landlord’s request, Tenant shall also promptly provide Landlord with evidence (such as paid receipts) that the Utilities have been so paid

Tenant’s obligations for the payment of the costs incurred for the Utilities used at the Premises prior to the termination of this Lease shall survive termination hereof. Except as otherwise provided in Section 14(h) below, Landlord shall not be liable for any interruption or delay in electric or any other utility service for any reason. Tenant shall have access to the Building and the Premises on a twenty-four (24) hour a day, seven (7) day a week basis.

 
8.
SIGNS; USE OF PREMISES AND COMMON AREAS.

(a) Tenant shall have the exclusive right, at its sole cost and expense, to install signage on the Premises, including without limitation, its name and logo on the Building’s exterior facade and/or on a monument sign to be installed at the entrance to the Premises. All of Tenant’s signage, including any monument sign, shall be subject to applicable laws, regulations, ordinances and municipal approvals, as well as Landlord’s prior written approval (such approval not to be unreasonably withheld) as to size, color, content, illumination, composition, material and location. Tenant, at its sole cost and expense, shall obtain all required permits and approvals for all of Tenant’s signage. All such signs shall be placed, erected, maintained, repaired, replaced and removed by Tenant, at Tenant’s sole cost and expense.

(b) Tenant may use and occupy the Premises only for the express and limited purposes stated in Article 1(k) above; and the Premises shall not be used or occupied, in whole or in part, for any other purpose without the prior written consent of Landlord; provided that Tenant's right to so use and occupy the Premises shall remain expressly subject to the provisions of "Governmental Regulations", Article 27 herein.

 
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(c) Tenant shall not overload any floor or part thereof in the Building, including any public corridors or elevators therein, bringing in, placing, storing, installing or removing any large or heavy articles. Landlord may require, at Tenant's sole cost and expense, supplementary supports of such material and dimensions as Landlord may deem necessary to properly distribute the weight. Landlord may also require, at the time such article is installed, that Tenant : (i) remove such large or heavy articles at the expiration or sooner termination of this Lease, and (ii) restore the Premises to the condition same existed prior to the installation of such large or heavy articles.

(d) Tenant shall not install in or for the Premises or the Building, without Landlord’s prior written approval, any equipment which requires more electric current than Landlord is required to provide under this Lease, and Tenant shall ascertain from Landlord the maximum amount of load or demand for or use of electrical current which can safely be permitted in and for the Premises and/or the Building, taking into account the capacity of electric wiring in the Building and the needs of Building common areas (interior and exterior) and the requirements of other tenants of the Building, and shall not in any event connect a greater load than such safe capacity.

(e) Tenant shall not commit or suffer any waste upon the Building or Premises or any nuisance.

(f) Tenant shall also have the exclusive right for so long as Tenant is the sole occupant of the Building, to use the exterior paved driveways and walkways of the Building for vehicular and pedestrian access to designated parking areas of the Premises for the parking of automobiles of Tenant and its employees and business visitors, incident to Tenant's permitted use of the Premises.

(g) Tenant shall have the exclusive right (provided Tenant remains the only tenant occupying space at the Building), subject to all applicable laws, to erect or place a telecommunications disk antenna or similar telecommunications equipment (the “Telecommunications Equipment”) on the roof of the Building, in accordance with the following provisions, which Telecommunications Equipment shall be designed in accordance with sound engineering standards and shall be subject to Landlord’s reasonable approval as to size, weight, location, screening, mounting and connection. Upon Landlord’s approval of any such Telecommunications Equipment, Tenant shall, at Tenant’s sole cost and expense, install such Telecommunications equipment, subject to the supervision of Landlord. Notwithstanding the foregoing, any penetration of the roof shall, at Landlord’s option but at Tenant’s expense, be performed by Landlord’s roofing contractor. Subsequent to the installation of the Telecommunications Equipment, Tenant shall comply with all applicable laws and keep the Premises free and clear from liens arising from or relating to such Telecommunications Equipment. Tenant shall also be responsible for procuring any licenses, approvals or permits as may be required by any applicable governmental authority for the installation and use of the Telecommunications Equipment and the related support systems. Landlord shall reasonably cooperate with Tenant, at Tenant’s sole cost and expense, in procuring such licenses, approvals and permits. Tenant shall, at its sole cost and expense, maintain, repair and replace the Telecommunications Equipment. Upon the expiration or sooner termination of this Lease, Tenant shall remove all Telecommunications Equipment and restore the roof and the Building to the condition it was in before any such installation.

 
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9.
ENVIRONMENTAL MATTERS.
 
(a) Hazardous Substances.

Tenant may bring to, store, handle, manage, and use at the Premises, hazardous substances incidental to its normal business operations strictly in accordance with the Comprehensive Environmental Response, Compensation and Liability Act of 1980, 42 U.S.C. 9501 et seq. (“CERCLA”); the Clean Air Act, 42 U.S.C. 7401 et seq.; the Water Pollution Control Act, 33 U.S.C. 1251 et seq. (the Clean Water Act “); and the New Jersey Industrial Site Recovery Act, N.J.S.A. 13:1K-6 et seq.,(“ISRA”), and regulations promulgated pursuant to the foregoing, as any may be amended from time to time (collectively, the “Applicable Environmental Laws”). Landlord may conduct from time to time, and upon prior notice to Tenant, environmental inspections of the Property including, without limitation, testing of soils and groundwater. Landlord shall not unreasonably interfere with Tenant’s use of the Premises when conducting such inspections, provided such use is in accordance with the Permitted Uses. Tenant shall promptly send Landlord, upon delivery or receipt, a copy of all documents delivered to or received from any governmental agency concerning environmental matters and/or environmental conditions at the Property.

(b) ISRA Compliance.

(A) Tenant hereby represents that its current NAICS Code is 541700. If Tenant’s operations at the Premises now or hereafter constitute an “Industrial Establishment” as defined under and subject to the requirements of ISRA, then prior to: (1) closing operations or transferring ownership or operations of Tenant at the Premises (as defined under ISRA), (2) the expiration or sooner termination of this Lease, or (3) any assignment of this Lease or any subletting of any portion of the Premises; Tenant shall, at its expense, comply with all requirements of ISRA pertaining thereto. Without limitation of the foregoing, Tenant’s obligations shall include (i) the proper filing of an initial notice under N.J.S.A. 13:1K-9(a) to the New Jersey Department of Environmental Protection (“NJDEP”) and (ii) the performance of all remediation and other requirements of ISRA, including without limitation all requirements of N.J.S.A. 13:1K-9(b) through and including (l).


(B) The parties acknowledge and agree that, except as provided in subparagraph (D) below, pursuant to ISRA, Tenant shall be, and is hereby, designated the party responsible (the "Responsible Person") to comply with the requirements of ISRA with respect to the Premises, and that as a result, the NJDEP may compel Tenant to so comply. In addition, any failure of Tenant to provide any information and submission as required under Sections 13:1K-9 or 13:1K-11of ISRA shall constitute a default under this Lease. Any assignee or subtenant of Tenant shall be deemed to have, and by entering into such assignment or sublease, and/or by entering into possession of the Premises, does hereby, acknowledge that they shall be the Party Responsible, jointly and severally with Tenant, under the provisions of this Lease.

 
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(C) In the event that Tenant is not obligated to comply with Article 9(b)(A) of this Lease for any reason, including without limitation inapplicability of ISRA to Tenant, then prior to the expiration or sooner termination of this Lease or any subletting of any portion of the Premises, Tenant shall, at Tenant's expense, and at Landlord's option:

(i) File with NJDEP an ISRA Applicability/Nonapplicability Affidavit seeking confirmation that the proposed termination, assignment or subletting shall not be subject to the requirements of ISRA. Any representation or certification made by Tenant in connection with the non-applicability letter request shall constitute a representation and warranty by Tenant in favor of Landlord and any misrepresentation or breach of warranty contained in Tenant's request shall constitute a default under this Lease; provided, however, if a non-applicability letter is not issued due to factors relating solely to the Premises or parties other than Tenant, then Tenant shall be deemed to have complied with this provision.

(ii) If reasonably indicated by a reputable environmental consultant engaged by Landlord, at Landlord's expense, Tenant shall remove "hazardous waste" attributable to Tenant's occupancy at the Premises in a manner which complies with NJDEP requirements under ISRA, at Tenant's expense, as if ISRA applied to Tenant and/or the Premises.

(D)  In the event that Tenant is obligated, under this Article or otherwise, to perform and/or cooperate in performing any ISRA obligations and/or obtain and/or cooperate in obtaining any ISRA approval, by way of a non-applicability letter, "negative declaration", the performance of an approved remedial action work plan, the obtaining of a no further action letter, the performance under a remediation agreement and/or otherwise (collectively the "ISRA Obligations") and, prior to fully performing such ISRA Obligations, there occurs the scheduled expiration of the Term of this Lease or any other termination of this Lease other than as a consequence of Landlord’s breach hereof (collectively, a "Lease Termination"), and in the event (i) Landlord is obligated to deliver possession to a new tenant and (ii) Landlord is prevented from being able to deliver lawful possession because of such failure of Tenant to fully perform same, then Tenant shall, following such Lease Termination, pay, at the time and in the manner Fixed Rent payments were due during the term, an amount equal to: (i) Fixed Rent at twice the rate in effect immediately prior to such Lease Termination; and (ii) Additional Rent as provided under the Lease until such time as all such ISRA Obligations have been fully completed.

(E) Any failure by Landlord to provide Tenant or NJDEP with any information in Landlord’s actual possession including, without limitation, ownership and operations history of the Premises since December 31, 1983 within thirty (30) days after written request therefor, or to consent, in a timely manner, to NJDEP’s entry onto the Premises for ISRA related purposes shall constitute a default under this Lease and such default shall excuse Tenant’s failure to obtain any documentation required under subparagraph (D) above.
 
 
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(c)  
Other Tenant Requirements.

In addition, upon written request of Landlord, Tenant shall cooperate with Landlord in obtaining Applicable Environmental Laws approval of any transfer of the Premises to the extent that such approvals are required by law. Specifically in that regard, Tenant agrees that it shall (1) execute and deliver all affidavits, reports, responses to questions, applications or other filings required by Applicable Environmental Laws and related to Tenant's activities at the Premises, (2) allow reasonable inspections and testing of the Premises during normal business hours, and (3) as respects the Premises, perform any requirement of Applicable Environmental Laws necessary for the receipt of approvals under Applicable Environmental Laws, provided the foregoing shall be at no out-of-pocket cost or expense to Tenant except for clean-up and remediation costs arising from Tenant's violation of this Article 9.
 
(d) Additional Terms. In the event of Tenant's failure to comply in full with this Article, Landlord may, after written notice to Tenant and Tenant's failure to cure within thirty (30) days of its receipt of such notice, at Landlord's option, perform any and all of Tenant's obligations as aforesaid and all costs and expenses incurred by Landlord in the exercise of this right shall be deemed to be Additional Rent payable on demand and with interest at the Default Rate. This Article 9 shall survive the expiration or sooner termination of this Lease.

 
10.
TENANT'S ALTERATIONS.

(a) Except as set forth below, Tenant will not make alterations, improvements or physical additions (collectively, "Alterations") of any kind to any part of the Building or the Premises without first obtaining the written consent of Landlord, such consent not to be unreasonably withheld, conditioned or delayed Landlord shall be deemed to have been reasonable in withholding its consent to any structural Alterations or Alterations to the Building systems including, without limitation, electrical, plumbing, heating, ventilation, air-conditioning and life safety systems if Landlord determines, in its sole discretion, that such Alterations will have a material and adverse affect on the structure and/or such systems or if such Alterations will diminish the value of the Premises (unless, only in the case of the value of the Premises being diminished, Tenant agrees or is otherwise required to (i) remove such Alterations upon the expiration or sooner termination of this Lease, and (ii) upon such removal, also restore the subject portion of the Building, and/or the Premises to its original condition in accordance with the terms hereof). Notwithstanding anything contained in this Article to the contrary, Landlord’s consent shall not be required in connection with any Minor Alteration or any Decorative Alteration. The term “Minor Alteration”, as used herein, means an Alteration which (i) is non-structural in nature; (ii) shall not affect the exterior or any structural portions or components of the Building or the Premises; (iii) shall not adversely affect the usage or proper functioning of any of the Building systems (including, without limitation, the heating, ventilation, air conditioning, plumbing, electrical, fire, health and life safety, sprinkler or security systems serving the Building or the Premises; (iv) shall not jeopardize health safety or life safety; (v) shall not require a change to the certificate of occupancy for the Building or Premises; (vi) shall not cause the Building or the Premises to be in violation of any applicable laws, codes, rules and regulations and (vii) costs less than $50,000.00 to perform. The term “Decorative Alteration”, as used herein, means any Alteration that is merely decorative in nature such as painting, wallpapering and carpeting or any Alteration involving low voltage cabling or data and telephone installations. If Landlord approves Tenant's Alterations and agrees to permit Tenant's contractors to do the work, Tenant, prior to the commencement of labor or supply of any materials, must furnish to Landlord (i) a duplicate or original policy or certificates of insurance evidencing (a) general public liability insurance for personal injury and property damage in the minimum amount of $1,000,000.00 combined single limit, (b) statutory workman's compensation insurance, and (c) employer's liability insurance from each contractor to be employed (all such policies shall be non-cancelable without thirty (30) days prior written notice to Landlord and shall be in amounts and with companies satisfactory to Landlord); (ii) construction documents prepared and sealed by a registered New Jersey architect if such alteration causes the aggregate of all Alterations to be in excess of $50,000.00; (iii) all applicable building permits required by law; and (iv) an executed, effective Waiver of Mechanics Liens from such contractors and all sub-contractors in states allowing for such waivers or the cost of such alteration must be bonded by Tenant. In connection with all Alterations performed by Landlord, Landlord shall be entitled to collect the charges described in Article 4(b) above. In connection with all Alterations not performed by Landlord, Landlord shall be entitled to collect a supervisory fee equal to 1% of the cost of the Alteration in connection with Landlord’s services in supervising and review of such Alterations. Any approval by Landlord permitting Tenant to do any or cause any work to be done in or about the Premises or the Building shall be and hereby is conditioned upon Tenant's work being performed by workmen and mechanics working in harmony and not interfering with labor employed by Landlord, Landlord's mechanics or their contractors at the Premises. If at any time any of the workmen or mechanics performing any Alterations shall be unable to work in harmony or shall interfere with any labor employed by Landlord or its respective mechanics and contractors at the Premises, then the permission granted by Landlord to Tenant permitting Tenant to do or cause such Alterations to be done in or about the Premises or the Building, may be withdrawn by Landlord upon forty-eight (48) hours written notice to Tenant.

 
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(b)  All Alterations (whether temporary or permanent in character) made in or upon the Premises or the Building, either by Landlord or Tenant, shall be Landlord's property upon installation and shall remain on the Premises or the Building, as applicable, without compensation to Tenant unless Landlord provides written notice to Tenant promptly after Tenant notifies Landlord of its intent to perform such Alterations to remove same at the expiration of this Lease, in which event Tenant shall promptly remove such Alterations and restore the Premises or the Building, as applicable, to good order and condition. All furniture, movable trade fixtures and equipment (including laboratory equipment, telephone, security and communication equipment system wiring and cabling) and other Alterations that Landlord required be removed at the time such Alterations were approved by Landlord shall be removed by Tenant at the termination of this Lease. All such installations, removals and restoration shall be accomplished in a good and workmanlike manner so as not to damage the Building. If Tenant fails to remove any items required to be removed pursuant to this Article, Landlord may do so and the reasonable costs and expenses thereof shall be deemed Additional Rent hereunder and shall be reimbursed by Tenant to Landlord within thirty (30) business days of Tenant’s receipt of an invoice therefor from Landlord.
 
 
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11.
CONSTRUCTION LIENS.

Tenant will not suffer or permit any contractor's, subcontractor's or supplier's lien (a "Construction Lien") to be filed against the Building or any part thereof by reason of work, labor services or materials supplied or claimed to have been supplied to Tenant; and if any Construction Lien shall at any time be filed against the Premises or any part thereof, Tenant, within thirty (30) days after notice of the filing thereof, shall cause it to be discharged of record by payment, deposit, bond, order of a court of competent jurisdiction or otherwise. If Tenant shall fail to cause such Construction Lien to be discharged within the period aforesaid, then in addition to any other right or remedy, Landlord may, but shall not be obligated to, discharge it either by paying the amount claimed to be due or by procuring the discharge of such lien by deposit or by bonding proceedings. Any amount so paid by Landlord, plus all of Landlord's costs and expenses associated therewith (including, without limitation, reasonable legal fees), shall constitute Additional Rent payable by Tenant under this Lease and shall be paid by Tenant to Landlord on demand with interest from the date of advance by Landlord at the Default Rate.

12. ASSIGNMENT AND SUBLETTING.

(a) Subject to the remaining subsections of Article 12, except as expressly permitted pursuant to this section, Tenant shall not, without the prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned or delayed, assign, transfer or hypothecate this Lease or any interest herein or sublet the Premises or any part thereof. Any of the foregoing acts without such consent shall be void. Subject to Article 12(i) below, this Lease shall not, nor shall any interest herein, be assignable as to the interest of Tenant by operation of law or by merger, consolidation or asset sale, without the written consent of Landlord, which consent shall not be unreasonably withheld, conditioned or delayed. Notwithstanding anything contained herein to the contrary, Landlord’s consent shall not be required in connection with any Minor Sublease, provided the terms and conditions of such Minor Sublease comply with the remaining provisions of this Lease and Tenant otherwise provides Landlord with written notice of all such subleases. The term “Minor Sublease”, as used herein, shall mean any proposed sublease which, when considered together with all other subleases that will be in effect on the commencement date of such proposed sublease, covers less than 35,000 rentable square feet of the Premises.

 
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(b) If at any time or from time to time during the term of this Lease Tenant desires to assign this Lease or sublet all or any part of the Premises, except for a Minor Sublease or as permitted under paragraph (i) below, Tenant shall give notice to Landlord of such desire, including the name, address and contact party for the proposed assignee or subtenant, a description of such party’s business history, the effective date of the proposed assignment or sublease (including the proposed occupancy date by the proposed assignee or sublessee), and in the instance of a proposed sublease, the square footage to be subleased, a floor plan professionally drawn to scale depicting the proposed sublease area, and a statement of the duration of the proposed sublease (which shall in any and all events expire by its terms prior to the scheduled expiration of this Lease, and immediately upon the sooner termination hereof). Landlord may, at its option, and in its sole and absolute discretion, exercisable by notice given to Tenant within fifteen (15) business days next following Landlord’s receipt of Tenant’s notice (which notice from Tenant shall, as a condition of its effectiveness, include all of the above-enumerated information), elect to recapture the Premises if Tenant is proposing to sublet or assign the Premises or such portion as is proposed by Tenant to be sublet, and terminate this Lease with respect to the space being recaptured.   The foregoing right of recapture shall not apply with respect to (i) any sublease that is to expire prior to the last six (6) months of the term or any Extension Term (as hereinafter defined), if Tenant has previously exercised its right to extend the term pursuant to the terms hereof, or (ii) any Minor Sublease or assignment or sublease to an Affiliate or any sublease with a Business Group.

(c) If Landlord elects to recapture the Premises or a portion thereof as aforesaid, then from and after the effective date thereof as approved by Landlord, after Tenant shall have fully performed such obligations as are enumerated herein to be performed by Tenant in connection with such recapture, and except as to obligations and liabilities accrued and unperformed (and any other obligations expressly stated in this Lease to survive the expiration or sooner termination of this Lease), Tenant shall be released of and from all lease obligations thereafter otherwise accruing with respect to the Premises (or such lesser portion as shall have been recaptured by Landlord). The Premises, or such portion thereof as Landlord shall have elected to recapture, shall be delivered by Tenant to Landlord free and clear of all furniture, furnishings, personal property and removable fixtures, with Tenant repairing and restoring any and all damage to the Premises resulting from the installation, handling or removal thereof, and otherwise in the same condition as Tenant is, by the terms of this Lease, required to redeliver the Premises to Landlord upon the expiration or sooner termination of this Lease. In the event of a sublease of less than all of the Premises, the cost, in connection with such recapture, of erecting any required demising walls, entrances and entrance corridors, and any other or further improvements required in connection therewith, including without limitation, modifications to HVAC, electrical, plumbing, fire, life safety and security systems (if any), painting, wallpapering and other finish items as may be acceptable to or specified by Landlord shall be paid by Landlord. All of the foregoing improvements shall be made in accordance with applicable legal requirements and Landlord’s then-standard base building specifications and shall be performed by Landlord’s contractors. Upon the completion of any recapture and termination as provided herein, Tenant’s Fixed Rent, Recognized Expenses and other monetary obligations hereunder shall be adjusted pro-rated based upon the reduced rentable square footage then comprising the Premises.

 
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(d) If Landlord provides written notification to Tenant electing not to recapture the Premises (or so much thereof as Tenant had proposed to sublease), then Tenant may proceed to market the designated space and may complete such transaction and execute an assignment of this Lease or a sublease agreement (in each case in form acceptable to Landlord) within a period of five (5) months next following Landlord’s notice to Tenant that it declines to recapture such space, provided that Tenant shall have first obtained in any such case the prior written consent of Landlord to such transaction. If, however, Tenant shall not have assigned this Lease or sublet the Premises with Landlord’s prior written consent as aforesaid within five (5) months next following Landlord’s notice to Tenant that Landlord declines to recapture the Premises (or such portion thereof as Tenant initially sought to sublease), then in such event, Tenant shall again be required to request Landlord’s consent to the proposed transaction, whereupon Landlord’s right to recapture the Premises (or such portion as Tenant shall desire to sublease) shall be renewed upon the same terms and as otherwise provided in subsection (b) above.

For purposes of this Article 12, and without limiting the basis upon which Landlord may withhold its consent to any proposed assignment or sublease, the parties agree that it shall not be unreasonable for Landlord to withhold its consent to such assignment or sublease if: (i) the proposed assignee or sublessee shall have no reliable credit history or an unfavorable credit history, or other reasonable evidence exists that the proposed assignee or sublessee will experience difficulty in satisfying its financial or other obligations under this Lease; (iii) the portion of the Premises requested to be subleased renders the balance of the Premises unleasable as a separate area; (iv) the proposed assignee or subtenant is an existing tenant of Landlord or an affiliate of Landlord or is an entity or person with whom Landlord or its affiliate is negotiating a lease, or (v) the nature of such party’s proposed business operation would or might reasonably permit or require the use of the Premises in a manner inconsistent with the “Permitted Use” specified herein, would or might reasonably otherwise be in conflict with express provisions of this Lease.

(e) Any sums or other economic consideration received by Tenant as a result of any subletting, assignment or license (except rental or other payments received which are attributable to the amortization of the cost of leasehold improvements made to the sublet or assigned portion of the premises by Tenant for subtenant or assignee, and other reasonable expenses incident to the subletting or assignment, including standard leasing commissions) whether denominated rentals under the sublease or otherwise, which exceed, in the aggregate, the total sums which Tenant is obligated to pay Landlord under this Lease (prorated to reflect obligations allocable to that portion of the premises subject to such sublease or assignment) shall be divided evenly between Landlord and Tenant with Landlord’s portion being payable to Landlord as Additional Rental under this Lease without affecting or reducing any other obligation of Tenant hereunder. Notwithstanding anything contained in this Lease to the contrary, Landlord shall not be entitled to share in such amounts in connection with a sublease of less than thirty (30%) percent of the rentable area of the Building or with respect to any assignment or sublease to an Affiliate or any sublease with a Business Group .

 
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(f) Regardless of Landlord's consent, except as otherwise specifically set forth herein, no subletting or assignment shall release Tenant of Tenant's obligation or alter the primary liability of Tenant to pay the Rent and to perform all other obligations to be performed by Tenant hereunder. The acceptance of rental by Landlord from any other person shall not be deemed to be a waiver by Landlord of any provision hereof. Consent to one assignment or subletting shall not be deemed consent to any subsequent assignment or subletting. In the event of default by any assignee of Tenant or any successor of Tenant in the performance of any of the terms hereof, Landlord may proceed directly against Tenant without the necessity of exhausting remedies against such assignee or successor. Notwithstanding the foregoing, in the event that Tenant assigns its interest in this Lease to an entity (i) whose creditworthiness is equal to or greater than the creditworthiness of Tenant as of the date of this Lease, as determined by Landlord, in its reasonable discretion, and (ii) satisfactory to any Landlord’s Mortgagee and, provided Landlord maintains sufficient security or collateral for such entity’s obligations under this Lease, as determined by Landlord, in its reasonable discretion, then Landlord shall provide Tenant with written notice that the above conditions have been satisfied and, , Tenant shall be relieved of liability under this Lease from and after the date of such assignment.

(g) In the event that (i) the Premises or any part thereof are sublet and Tenant is in default under this Lease, or (ii) this Lease is assigned by Tenant, then, Landlord may collect Rent from the assignee or subtenant and apply the net amount collected to the rent herein reserved; but no such collection shall be deemed a waiver of the provisions of this Article 12 with respect to assignment and subletting, or the acceptance of such assignee or subtenant as Tenant hereunder, or a release of Tenant from further performance of the covenants herein contained.

(h) In connection with each proposed assignment or subletting of the Premises by Tenant, Tenant shall pay to Landlord (i) an administrative fee of $250 per request (including requests for non-disturbance agreements and Landlord’s or its lender’s waivers) in order to defer Landlord's administrative expenses arising from such request, plus (ii) Landlord’s reasonable attorneys’ fees.

(i) Tenant may, after notice to, but without the consent of Landlord, assign this Lease to an affiliate, parent or subsidiary corporation of Tenant or to a corporation to which it sells or assigns all of substantially all of its assets or stock or with which it may be consolidated or merged ("Affiliate"), provided that if Tenant shall not be the surviving entity such purchasing, consolidated, merged, affiliated or subsidiary corporation shall, in writing, assume and agree to perform all of the obligations of Tenant under this Lease. Tenant shall deliver a copy of the assignment of this Lease to Landlord within ten (10) days thereafter. Tenant shall not be released or discharged from any liability under this Lease by reason of such assignment, except as otherwise provided in Article 12(f) above. Subject to the further provisions of this Article 12, Tenant may also, after notice to, but without the consent of Landlord, sublease up to 15,000 square feet of space in the Premises to a Business Group. For purposes of this Lease, the term “Business Group” shall mean any entity which has an active and ongoing business relationship or other strategic partnership or alliance with Tenant.

 
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(j)  Landlord shall respond to Tenant’s request for consent to an assignment of this Lease or a sublet of all or a portion of the Premises within fifteen (15) business days of Landlord’s receipt of Tenant’s written request for such consent, together with all documentation required hereunder. If Landlord shall fail to respond to Tenant’s request for such consent within said fifteen (15) business day period, then Tenant shall send Landlord a second request for consent (the “Second AS Request”). If Landlord shall fail to respond to the Second AS Request within five (5) days of its receipt of the Second AS Request, Landlord shall be deemed to have granted consent to the subject assignment or subletting, provided the Second AS Request shall expressly state in bold letters (of at least 14-point type face) that Landlord’s failure to timely respond thereto shall be deemed consent to the subject assignment or subletting.
 
 
13.
LANDLORD'S RIGHT OF ENTRY.
 
Landlord and persons authorized by Landlord may enter the Premises at all reasonable times upon reasonable advance notice (except in the case of an emergency in which case only prior notice reasonable under the circumstances is necessary) for the purpose of inspections, repairs, alterations to adjoining space, appraisals, or other reasonable purposes; including enforcement of Landlord's rights under this Lease. Landlord shall not be liable for inconvenience to or disturbance of Tenant by reason of any such entry; provided, however, that in the case of repairs or work, such shall be done, so far as practicable, so as to not unreasonably interfere with Tenant's use of the Premises. Such efforts shall not require Landlord to use overtime labor unless Tenant shall pay for the increased costs to be incurred by Landlord for such overtime labor. Landlord also shall have the right to enter the Premises at all reasonable times after giving prior oral notice to Tenant, to exhibit the Premises to any prospective purchaser and/or mortgagee. Landlord also shall have the right to enter the Premises at all reasonable times after giving prior oral notice to Tenant, to exhibit the Premises to any prospective tenants during the last twelve (12) months of the term hereof, unless Tenant has previously exercised the renewal option in accordance with the provisions of Article 34 hereof.

 
14.
REPAIRS AND MAINTENANCE.

(a) Except as specifically otherwise provided in subparagraphs (b) and (c) and (g) of this Article, Tenant, at its sole cost and expense and throughout the Term of this Lease, shall keep and maintain the interior portions of the Building leased by Tenant from time to time under this Lease in good order and condition, free of accumulation of dirt and rubbish, and shall promptly make all non-structural repairs necessary to keep and maintain such good order and condition. Tenant shall have the option of replacing lights, ballasts, tubes, ceiling tiles, outlets and similar equipment itself or it shall have the ability to advise Landlord of Tenant's desire to have Landlord make such repairs. If requested by Tenant, Landlord shall make such repairs to the Premises within a reasonable time of notice to Landlord and shall charge Tenant for such services at Landlord's standard rate. When used in this Article 14, the term "repairs" shall include replacements and renewals when necessary. All repairs made by Tenant shall utilize materials and equipment which are at least equal in quality and usefulness to those originally used in constructing the Building and the Premises.

 
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(b) Landlord, throughout the Term of this Lease and at Landlord's sole cost and expense (except to the extent provided in Article 6 hereof), shall make all necessary repairs to the footings and foundations, roof and all other structural portions of the Building.

(c) Landlord shall maintain all HVAC systems, plumbing and electric systems serving the Building and the Premises in good order, condition and repair. Notwithstanding anything in this Article 14(c) or elsewhere in this Lease to the contrary, all maintenance, repair and replacement of the HVAC systems servicing the laboratory, laboratory support and pilot plant space in the Premises (the “LP HVAC Systems”) shall be performed by Landlord, but all costs related thereto shall not be included as Recognized Expenses and shall be borne entirely by Tenant. Tenant however, upon not less than sixty (60) days prior written notice to Landlord, may assume the obligation of maintaining, repairing and replacing the LP HVAC Systems. In such case, Tenant shall obtain and keep in full force and effect for the benefit of Landlord and Tenant with a licensed company a service, repair and maintenance contract with respect to the LP HVAC Systems.  Tenant's Allocated Share of Landlord's cost for HVAC (other than with respect to the costs relating to the LP HVAC Systems, which shall be paid for by Tenant as provided above), electric and plumbing service, maintenance, repairs and replacements shall be included as a portion of Recognized Expenses to the extent provided in Article 6 hereof.
 
(d) Landlord, throughout the Term of this Lease, shall maintain, repair and replace as necessary all portions of the exterior of the Building, including the roof, walls, exterior portions of the Premises and the Building, utility lines, equipment and other utility facilities in the Building and to any driveways, sidewalks, curbs, loading, parking and landscaped areas, and other exterior improvements for the Building. Tenant shall pay its Allocated Share of the cost of all repairs and partial replacements to be performed by Landlord pursuant to this Article 14(d) as Additional Rent to the extent provided in Article 6 hereof.
 
(e) Landlord shall keep and maintain all exterior areas of the Premises and any sidewalks, parking areas, curbs and access ways adjoining the Premises in a clean and orderly condition, free of accumulation of dirt, rubbish, snow and ice, and shall keep and maintain all landscaped areas in a neat and orderly condition acceptable to Tenant in its reasonable discretion. Tenant shall pay its Allocated Share of the cost of all work to be performed by Landlord pursuant to this Article 14(e) as Additional Rent to the extent provided in Article 6 hereof.
 
(f) Notwithstanding anything herein to the contrary, repairs to the Premises or the Building and its appurtenant common areas made necessary by a negligent or willful act or omission of Tenant or any employee, agent, contractor, or invitee of Tenant shall be made at the sole cost and expense of Tenant, except as otherwise provided in Section 15(d).

 
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(g) Landlord shall provide Tenant with janitorial services for the Premises (excluding the laboratory, laboratory support and high bay areas in the Premises) Monday through Friday each week, except for Holidays, in accordance with the guidelines set forth in Exhibit “F” attached hereto and any changes from time to time requested, or agreed to, by Tenant. It is further understood and agreed that Landlord’s obligation to provide building maintenance personnel at the Premises shall be limited to eight hours a day Monday through Friday, except for Holidays at reasonable times to be mutually agreed to by the parties. Should Tenant require building maintenance services in excess of the hours provided for above, Tenant shall be responsible for all actual costs incurred for such additional services. For purposes of this Lease, the term “Holidays” shall mean New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and Christmas Day. Notwithstanding the foregoing, Tenant, at its sole cost and expense, shall be solely responsible for the proper and legal removal and disposal of all medical, biomedical, toxic and other Hazardous Substances from the Premises. Landlord shall have no obligation or liability to any person or entity in this regard. Tenant shall, at its sole cost and expense, contract with a licensed company for the removal and disposal of all such items.

(h) Notwithstanding anything contained herein to the contrary, in the event of an Abatement Event (as hereinafter defined), Tenant may be entitled to an Abatement (as hereinafter defined), subject to the following provisions and conditions of this subparagraph (d). An Abatement Event shall be deemed to have occurred when the Premises, or any portion thereof, have been rendered Untenantable (as hereinafter defined) as a direct result of the interruption of any Essential Service for a period of five (5) or more consecutive business days following the delivery by Tenant of an Abatement Notice (as hereinafter defined). The term “Essential Service”, as used herein, shall mean any service which is reasonably necessary for Tenant’s use and occupancy of or access to the Building, or any portion of the Premises, for the Permitted Uses and is a service under Landlord’s reasonable control (such as a service interruption that affects exclusively the Property as distinguished from conditions that affect an area that extends beyond the Property and specifically excluding any interruptions caused by a force majeure event). The term “Untenantable”, as used herein, shall be deemed to mean where the Premises, or any portion thereof, have been rendered wholly unsuitable for the Permitted Uses and Tenant has actually ceased to use the Premises, or a portion thereof, as a result of an Abatement Event. The term “ Abatement Notice” , as used herein, shall mean a written notice by Tenant delivered to Landlord which: (A)states that there has occurred an Abatement Event (describing with particularity, if known, the nature of such failure or denial of such access); and (B) notifies Landlord that if such Abatement Event is not remedied within five (5) business days following the effective delivery of the Abatement Notice, Tenant will pursue an Abatement in accordance with the provisions of this subparagraph. If an Abatement Event has occurred and has not been remedied within five (5) business days following effective delivery by Tenant of a Abatement Notice, then, unless Landlord reasonably objects thereto, there shall be deemed to have occurred an Abatement Event and Tenant shall be entitled to an abatement of the Fixed Rent and all items of Additional Rent becoming due hereunder (in the proportion that the Untenantable area of the Premises bears to the total area of the Premises) for a period commencing on the sixth business day following such effective delivery and expiring on the day on which such remedy or restoration has been effected (an “Abatement”). In the event of reasonable objection thereto by Landlord, Landlord may institute an expedited arbitration proceeding seeking an affirmative determination of the occurrence of an Abatement Event and Tenant’s entitlement to the Abatement, provided that Tenant shall be entitled to continue to abate rent until such determination has been made but only for so long as the Abatement Event continues (it being understood and agreed that should Landlord prevail in such arbitration proceeding and it is determined that Tenant had no reasonable basis to claim that an Abatement Event occurred, Tenant shall be liable for any damages which Landlord incurs (such as late fees due Landlord’s Mortgagee) pursuant to the provisions of Article 16 hereof). The arbitration shall be commenced and held in the County of Somerset (or the AAA (as hereinafter defined) office located nearest the Premises) and shall be conducted before a single, independent arbitrator pursuant to the then prevailing rules of the AAA. The arbitrator must be an individual with at least ten (10) years experience in the Somerset commercial real estate market. The sole issues before the arbitrator shall be whether there has occurred an Abatement Event, whether Tenant is entitled to an Abatement under the provisions of this subparagraph and whether Tenant had a reasonable basis to claim that an Abatement Event occurred. The decision of the arbitrator shall be final and binding upon Landlord and Tenant. Except for the determination of Tenant’s entitlement to an Abatement (if appropriate), the arbitrator shall not be empowered to award damages of any nature. The provisions of this subparagraph shall be inapplicable to any Abatement Event which (x) is attributable to the actions or omissions of Tenant, its Affiliate, a Business Group or any of their respective employees, agents, contractors, licensees or invitees, or (y) results from any fire or other casualty falling within the purview of Paragraph 18 of this Lease. The fees of any arbitration shall be shared equally by the parties.

 
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15. INSURANCE; SUBROGATION RIGHTS.

(a) Tenant shall obtain and keep in force at all times during the term hereof, at its own expense, commercial general liability insurance including contractual liability and personal injury liability and all similar coverage, with combined single limits of $3,000,000.00 on account of bodily injury to or death of one or more persons as the result of any one accident or disaster and on account of damage to property, or in such other amounts as Landlord may from time to time require. Tenant shall also require its movers to procure and deliver to Landlord a certificate of insurance naming Landlord as an additional insured.

(b) Tenant shall, at its sole cost and expense, maintain in full force and effect on all Tenant's trade fixtures, equipment and personal property on the Premises, a policy of "special form" property insurance covering the full replacement value of such property.

(c) All liability insurance required hereunder shall not be subject to cancellation without at least thirty (30) days prior notice to all insureds, and shall name Landlord and Landlord's Agent as additional insureds, as their interests may appear, and, if requested by Landlord, shall also name as an additional insured any mortgagee or holder of any mortgage which may be or become a lien upon any part of the Premises. Prior to the commencement of the Term, Tenant shall provide Landlord with certificates which evidence that the coverages required have been obtained for the policy periods. Tenant shall also furnish to Landlord throughout the term hereof replacement certificates at least thirty (30) days prior to the expiration dates of the then current policy or policies. All the insurance required under this Lease shall be issued by insurance companies authorized to do business in the State of New Jersey with a financial rating of at least an A-X as rated in the most recent edition of Best's Insurance Reports and in business for the past five years. The limit of any such insurance shall not limit the liability of Tenant hereunder. If Tenant fails to procure and maintain such insurance, Landlord may, but shall not be required to, procure and maintain the same, at Tenant's expense to be reimbursed by Tenant as Additional Rent within ten (10) days of written demand. Any deductible under such insurance policy or self-insured retention under such insurance policy in excess of Twenty Five Thousand ($25,000.00) Dollars must be approved by Landlord in writing prior to issuance of such policy. Tenant shall not self-insure without Landlord’s prior written consent. The policy limits set forth herein shall be subject to periodic review, and Landlord reserves the right to require that Tenant increase the liability coverage limits if, in the reasonable opinion of Landlord, the coverage becomes inadequate or is less than commonly maintained by tenants of similar buildings in the area making similar uses.

 
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(d) Each party hereto, and anyone claiming through or under them by way of subrogation, waives and releases any cause of action it might have against the other party and their respective employees, officers, members, partners, trustees and agents, on account of any loss or damage that is insured against under any insurance policy required to be obtained hereunder (to the extent that such loss or damage is recoverable under such insurance policy) that covers the Premises or the Building, Landlord's or Tenant's fixtures, personal property, leasehold improvements or business and which names Landlord or Tenant, as the case may be, as a party insured. Each party hereto agrees that it will cause its insurance carrier to endorse all applicable policies waiving the carrier's right of recovery under subrogation or otherwise against the other party. During any period while such waiver of right of recovery is in effect, each party shall look solely to the proceeds of such policies for compensation for loss, to the extent such proceeds are paid under such policies.

(e) Landlord shall maintain or cause to be maintained: (i) commercial general public liability insurance in respect of the Building and the land thereunder and the conduct and operation of its business therein and thereon, in amounts and with coverages as are generally kept by owners of substantially similar buildings in the area in which the Building is located; and (ii) fire and extended coverage insurance (including, without limitation, full replacement coverage and rent insurance) in respect of the Building (including, without limitation, the Common Areas) (except for the property Tenant is required to cover with insurance under this Lease and similar property of other tenants and occupants in the Building, if applicable).

16. INDEMNIFICATION.

(a) Tenant shall defend, indemnify and hold harmless Landlord and its employees and agents from and against any and all third-party claims, actions, damages, liability and expense (including all reasonable attorney’s fees, expenses and liabilities incurred in defense of any such claim or any action or proceeding brought thereon) arising from (i) any activity, work or things done, permitted or suffered by Tenant or its agents, licensees or invitees in or about the Premises or elsewhere contrary to the requirements of this Lease, (iii) any breach or default in the performance of any obligation of Tenant's part to be performed under the terms of this Lease, and (iii) any negligence or willful act of Tenant or any of Tenant's agents, contractors, employees or invitees. Without limiting the generality of the foregoing, Tenant’s obligations shall include any case in which Landlord shall be made a party to any litigation commenced by or against Tenant, its agents, subtenants, licensees, concessionaires, contractors, customers or employees, then Tenant shall defend, indemnify and hold harmless Landlord and shall pay all costs, expenses and reasonable attorney's fees incurred or paid by Landlord in connection with such litigation, after notice to Tenant and Tenant's refusal to defend such litigation, and upon notice from Landlord shall defend the same at Tenant's expense by counsel satisfactory to Landlord.

 
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(b) Landlord shall indemnify and save harmless Tenant from and against all liability, claims or costs, including reasonable legal fees, arising from (i) any injury or damage to person or property sustained by anyone in the Building or on the Premises resulting from any negligence or misconduct of Landlord or any of its employees and (ii) any breach or default in the performance of any obligation of Landlord’s part to be performed under the terms of this Lease. Except to the extent caused by or arising as a result of the negligence or misconduct of Landlord, Landlord shall not be liable for any injury or damage to the person, business, equipment, merchandise or other property of Tenant resulting from (i) fire, steam, electricity, water, gas or rain, (ii) leakage, obstruction or other defects of pipes, sprinklers, wires, plumbing, air conditioning, boilers or lighting fixtures; or (iii) any act or omission, negligent or otherwise, of any other occupant of the Premises, other than an assignee or subtenant of Tenant.

 
17.
QUIET ENJOYMENT.

Provided Tenant has performed all of the terms and conditions of this Lease, including the payment of Fixed Rent and Additional Rent, to be performed by Tenant, Tenant shall peaceably and quietly hold and enjoy the Premises for the Term, without hindrance from Landlord, or anyone claiming by through or under Landlord under and subject to the terms and conditions of this Lease.

 
18.
FIRE DAMAGE.

(a) Except as provided below, in case of damage to the Premises by fire or other insured casualty, Landlord shall repair the damage. Such repair work shall be commenced promptly following notice of the damage and completed with due diligence, taking into account the time required for Landlord to effect a settlement with and procure insurance proceeds from the insurer, except for delays due to governmental regulation, scarcity of or inability to obtain labor or materials, intervening acts of God or other causes beyond Landlord's reasonable control.

(b) Notwithstanding the foregoing, if (i) the damage is of a nature or extent that, based on a contractor’s estimate obtained by Landlord's (to be communicated to Tenant within forty-five (45) days from the date of the casualty, unless more than twenty (20%) percent of the total area of the Building is extensively damaged, then within ninety (90) days from the date of such casualty), the repair and restoration work would require more than three hundred sixty (360) consecutive days to complete after the casualty (assuming normal work crews not engaged in overtime), or (iii) the casualty occurs in the last Lease Year of the Term and Tenant has not exercised a renewal right, either party shall have the right to terminate this Lease and all the unaccrued obligations of the parties hereto, by sending written notice of such termination to the other within ten (10) days of Tenant's receipt of the notice from Landlord described above. Such notice is to specify a termination date no less than fifteen (15) days after its transmission.

 
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(c) In the event Landlord has not completed restoration of the Premises within three hundred and sixty (360) days from the date of casualty (subject to delay due to weather conditions, shortages of labor or materials or other reasons beyond Landlord's control, but in no event for more than an additional 90 days), Tenant may terminate this Lease by written notice to Landlord within thirty (30) business days following the expiration of such 360 day period (as extended for reasons beyond Landlord's control as provided above) unless, within thirty (30) business days following receipt of such notice, Landlord has substantially completed such restoration and delivered the Premises to Tenant for occupancy. Notwithstanding the foregoing, in the event Tenant is responsible for the aforesaid casualty as a result of its or its agents’ willful or intentional misconduct, Tenant shall not have the right to terminate this Lease if Landlord is willing to rebuild and restore the Premises or any portion thereof.

(d) In the event of damage or destruction to the Premises or any part thereof, Tenant's obligation to pay Fixed Rent and Additional Rent shall be equitably adjusted or abated.

 
19.
SUBORDINATION; RIGHTS OF MORTGAGEE.

(a) This Lease shall be subject and subordinate at all times to the lien of any mortgages now or hereafter placed upon the Building and/or Premises and land of which they are a part without the necessity of any further instrument or act on the part of Tenant to effectuate such subordination. Tenant further agrees to execute and deliver upon demand such further instrument or instruments evidencing such subordination of this Lease to the lien of any such mortgage and such further instrument or instruments of attornment as shall be desired by any mortgagee or proposed mortgagee or by any other person. Notwithstanding the foregoing, any mortgagee may at any time subordinate its mortgage to this Lease, without Tenant's consent, by notice in writing to Tenant, and thereupon this Lease shall be deemed prior to such mortgage without regard to their respective dates of execution and delivery and in that event such mortgagee shall have the same rights with respect to this Lease as though it had been executed prior to the execution and delivery of the mortgage.

(b) In the event Landlord shall be or is alleged to be in default of any of its obligations owing to Tenant under this Lease, Tenant agrees to give to the holder of any mortgage (collectively "Landlord’s Mortgagee") now or hereafter placed upon the Building and/or Premises, notice by overnight mail of any such default which Tenant shall have served upon Landlord, provided that prior thereto Tenant has been notified in writing (by way of Notice of Assignment of Rents and/or Leases or otherwise in writing to Tenant) of the name and addresses of any Landlord’s Mortgagee. Tenant shall not be entitled to terminate this Lease because of any default by Landlord without having given such notice to Landlord’s Mortgagee; and Tenant further agrees that Landlord’s Mortgagee shall have the same period afforded to Landlord hereunder, within which to cure such default, provided that if such default be such that the same could not be cured within such period and Landlord’s Mortgagee is diligently pursuing the remedies necessary to effectuate the cure (including but not limited to foreclosure proceedings if necessary to effectuate the cure); then Tenant shall not exercise any right or remedy as there may be arising because of Landlord's default, including but not limited to, termination of this Lease as may be expressly provided for herein or available to Tenant as a matter of law, if Landlord’s Mortgagee either has cured the default within such time periods, or as the case may be, has initiated the cure of same within such period and is diligently pursuing the cure of same as aforesaid.

 
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(c) Notwithstanding the foregoing, the subordination provided hereinabove shall be conditioned upon Landlord delivering to Tenant a subordination, attornment and nondisturbance agreement (“Nondisturbance Agreement”) from each future Landlord’s Mortgagee, substantially in the form attached hereto as Exhibit “G”. In the event a future mortgagee shall be unwilling to enter into a Nondisturbance Agreement as aforesaid, this Lease shall remain in full force and effect and the obligations of Tenant shall not in any manner be affected except that, anything to the contrary contained in this Lease notwithstanding, this Lease shall not be subject and subordinate to such future mortgage.

20. CONDEMNATION.

(a) If more than forty (40%) percent of the floor area of the Premises is taken or condemned for a public or quasi-public use (a sale in lieu of condemnation to be deemed a taking or condemnation for purposes of this Lease), this Lease shall, at either party's option, terminate as of the date title to the condemned real estate vests in the condemnor, and the Fixed Rent and Additional Rent herein reserved shall be apportioned and paid in full by Tenant to Landlord to that date and all rent prepaid for period beyond that date shall forthwith be repaid by Landlord to Tenant and neither party shall thereafter have any liability hereunder.

(b) If less than forty (40%) percent of the floor area of the Premises is taken or if neither Landlord nor Tenant have elected to terminate this Lease pursuant to the preceding sentence, Landlord shall do such work as may be reasonably necessary to restore the portion of the Premises not taken to tenantable condition for Tenant's uses, but shall not be required to expend more than the net award Landlord reasonably expects to be available for restoration of the Premises. If Landlord determines that the damages available for restoration of the Building and/or Premises will not be sufficient to pay the cost of restoration, or if the condemnation damage award is required to be applied on account of any mortgage which encumbers any part of the Building and/or Premises, Landlord may terminate this Lease by giving Tenant thirty (30) days prior notice specifying the termination date.

 
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(c) If this Lease is not terminated after any such taking or condemnation, the Fixed Rent and the Additional Rent shall be equitably reduced in proportion to the area of the Premises which has been taken for the balance of the Term.

(d) If a part or all of the Premises shall be taken or condemned, all compensation awarded upon such condemnation or taking shall go to Landlord and Tenant shall have no claim thereto other than Tenant's damages associated with Tenant’s leasehold interest, moving, storage and relocation; and Tenant hereby expressly waives, relinquishes and releases to Landlord any claim for damages or other compensation to which Tenant might otherwise be entitled because of any such taking and irrevocably assigns and transfers to Landlord any right to compensation of all or a part of the Premises.

21. ESTOPPEL CERTIFICATE.
 
Each party agrees at any time and from time to time, within ten (10) days after the other party's written request, to execute, acknowledge and deliver to the other party a written instrument in recordable form certifying all information reasonably requested, including but not limited to, the following: that this Lease is unmodified and in full force and effect (or if there have been modifications, that it is in full force and effect as modified and stating the modifications), the Commencement Date, the Expiration Date, the square footage of the Premises, the rental rates applicable to the Premises, the dates to which Rent, Additional Rent, and other charges have been paid in advance, if any, and stating whether or not to the best knowledge of the party signing such certificate, the requesting party is in default in the performance of any covenant, agreement or condition contained in this Lease and, if so, specifying each such default of which the signer may have knowledge. It is intended that any such certification and statement delivered pursuant to this Article may be relied upon by any prospective purchaser of the Premises or any mortgagee thereof or any assignee of Landlord's interest in this Lease or of any mortgage upon the fee of the Premises or any part thereof.

22. DEFAULT.

If:
(a) (i) Tenant fails to pay any installment of Fixed Rent or any amount of Additional Rent within five (5) business days from the date when due, (ii) Tenant fails to bond over a construction or mechanics lien within the time period set forth in Article 11; (iii) Tenant fails to observe or perform any of Tenant's other non-monetary agreements or obligations herein contained within thirty (30) days after written notice specifying the default, or the expiration of such additional time period as is reasonably necessary to cure such default, provided Tenant immediately commences and thereafter proceeds with all due diligence and in good faith to cure such default; (iv) Tenant makes any assignment for the benefit of creditors; (v) a petition is filed or any proceeding is commenced against Tenant or by Tenant under any federal or state bankruptcy or insolvency law and such petition or proceeding is not dismissed within ninety (90) days; (vi) a receiver or other official is appointed for Tenant or for a substantial part of Tenant's assets or for Tenant's interests in this Lease; (vii) any attachment or execution against a substantial part of Tenant's assets or of Tenant's interests in this Lease remains unstayed or undismissed for a period of more than ninety (90) days, or (viii) a substantial part of Tenant's assets or of Tenant's interest in this Lease is taken by legal process in any action against Tenant, then, in any such event, an Event of Default shall be deemed to exist and Tenant shall be in default hereunder.

 
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If an Event of Default shall occur, the following provisions shall apply and Landlord shall have, in addition to all other rights and remedies available at law or in equity, the rights and remedies set forth therein, which rights and remedies may be exercised upon or at any time following the occurrence of an Event of Default unless, prior to such exercise, Landlord shall agree in writing with Tenant that the Event(s) of Default has been cured by Tenant in all respects.

(b) Acceleration of Rent. By notice to Tenant, Landlord shall have the right to accelerate all Fixed Rent and all expense installments due hereunder and otherwise payable in installments over the remainder of the Term, and, at Landlord's option, any other Additional Rent to the extent that such Additional Rent can be determined and calculated to a fixed sum as follows: without further notice or demand for payment, the difference between the amount of accelerated rent to the termination date and the fair and reasonable rental value of the Premises for the period for which such installments were due, shall be due and payable by Tenant within five (5) days after Landlord has so notified Tenant. Such amount(s) collected from Tenant shall be discounted to present value using an interest rate of six percent (6%) per annum. Additional Rent which has not been included, in whole or in part, in accelerated rent, shall be due and payable by Tenant during the remainder of the Term, in the amounts and at the times otherwise provided for in this Lease.
 
Notwithstanding the foregoing or the application of any rule of law based on election of remedies or otherwise, if Tenant fails to pay the accelerated rent in full when due, Landlord thereafter shall have the right by notice to Tenant, (i) to terminate Tenant's further right to possession of the Premises and (ii) to terminate this Lease under subparagraph (c) below; and if Tenant shall have paid part but not all of the accelerated rent, the portion thereof attributable to the period equivalent to the part of the Term remaining after Landlord's termination of possession or termination of this Lease shall be applied by Landlord against Tenant's obligations owing to Landlord, as determined by the applicable provisions of subparagraphs (d) and (e) below.

(c) Termination of Lease. By notice to Tenant, Landlord shall have the right to terminate this Lease as of a date specified in the notice of termination and in such case, Tenant's rights, including any based on any option to renew, to the possession and use of the Premises shall end absolutely as of the termination date; and this Lease shall also terminate in all respects except for the provisions hereof regarding Landlord's damages and Tenant's liabilities arising prior to, out of and following the Event of Default and the ensuing termination.

 
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Following such termination and the notice of same provided above (as well as upon any other termination of this Lease by expiration of the Term or otherwise) Landlord immediately shall have the right to recover possession of the Premises; and to that end, Landlord may enter the Premises and take possession in accordance with applicable legal process, and in so doing Landlord may remove Tenant's property (including any improvements or additions to the Premises which Tenant made, unless made with Landlord's consent which expressly permitted Tenant to not remove the same upon expiration of the Term), as well as the property of others as may be in the Premises, and make disposition thereof in such manner as Landlord may deem to be commercially reasonable and necessary under the circumstances.

(d) Tenant's Continuing Obligations/Landlord's Reletting Rights. Unless and until Landlord shall have terminated this Lease under subparagraph (c) above, Tenant shall remain fully liable and responsible to perform all of the covenants and to observe all the conditions of this Lease throughout the remainder of the Term to the early termination date; and, in addition, Tenant shall pay to Landlord, upon demand and as Additional Rent, the total sum of all costs, losses, damages and expenses, including reasonable attorneys’ fees, as Landlord incurs, directly or indirectly, because of any Event of Default having occurred.

If Landlord either terminates Tenant's right to possession without terminating this Lease or terminates this Lease and Tenant's leasehold estate as above provided, then, subject to the provisions below, Landlord shall have the unrestricted right to relet the Premises or any part(s) thereof to such tenant(s) on such provisions and for such period(s) as Landlord may deem appropriate. If Landlord relets the Premises after such a default, the costs recovered from Tenant shall be reallocated to take into consideration any additional rent which Landlord receives from the new tenant which is in excess to that which was owed by Tenant.

(e) Landlord's Damages.

The damages which Landlord shall be entitled to recover from Tenant shall be the sum of:

(i) all Fixed Rent and Additional Rent accrued and unpaid as of the termination date; and

(ii) all costs and expenses incurred by Landlord in recovering possession of the Premises, including removal and storage of Tenant's property, the costs and expenses of restoring the Premises to the condition in which the same were to have been surrendered by Tenant as of the expiration of the Term, and the costs of reletting commissions; and

(iii) all Fixed Rent and Additional Rent (to the extent that the amount(s) of Additional Rent has been then determined) otherwise payable by Tenant over the remainder of the Term (including, without limitation, any accrued but unpaid Recognized Expenses) as reduced to present value;

 
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Less all Fixed Rent and Additional Rent which Landlord receives from other tenant(s) by reason of the leasing of the Premises or parts thereof during or attributable to any period falling within what would otherwise have been, but for the termination of this Lease, the remainder of the Term.

The damage sums payable by Tenant under the preceding provisions of this Article shall be payable on demand from time to time as the amounts are determined; and if from Landlord's subsequent receipt of rent as aforesaid from reletting, there be any excess payment(s) by Tenant by reason of the crediting of such rent thereafter received, the excess payment(s) shall be refunded by Landlord to Tenant, without interest.

Landlord may enforce and protect the rights of Landlord hereunder by a suit or suits in equity or at law for the specific performance of any covenant or agreement contained herein, and for the enforcement of any other appropriate legal or equitable remedy, including, without limitation, injunctive relief, and for recovery of consequential damages and all moneys due or to become due from Tenant under any of the provisions of this Lease.

(f) Landlord’s Right to Cure. Without limiting the generality of the foregoing, if an Event of Default shall occur, Landlord may (but shall not be obligated to do so), in addition to any other rights it may have in law or in equity, cure such default on behalf of Tenant, and Tenant shall reimburse Landlord upon demand for any sums paid or costs incurred by Landlord in curing such default, including reasonable attorneys' fees and other legal expenses, together with interest at the Default Rate.

(g) Interest on Damage Amounts. Any sums payable by Tenant hereunder, which are not paid after the same shall be due, shall bear interest from that day until paid at the rate of four (4%) percent over the then Prime Rate as published daily under the heading "Money Rates" in The Wall Street Journal, unless such rate be usurious as applied to Tenant, in which case the highest permitted legal rate shall apply (the "Default Rate").

(h) Landlord's Statutory Rights. Landlord shall have all rights and remedies now or hereafter existing at law or in equity with respect to the enforcement of Tenant's obligations hereunder and the recovery of the Premises. No right or remedy herein conferred upon or reserved to Landlord shall be exclusive of any other right or remedy, but shall be cumulative and in addition to all other rights and remedies given hereunder or now or hereafter existing at law. Landlord shall be entitled to injunctive relief in case of the violation, or attempted or threatened violation, of any covenant, agreement, condition or provision of this Lease, or to a decree compelling performance of any covenant, agreement, condition or provision of this Lease.

(i) Remedies Not Limited. Nothing herein contained shall limit or prejudice the right of Landlord to exercise any or all rights and remedies available to Landlord by reason of default or to prove for and obtain in proceedings under any bankruptcy or insolvency laws, an amount equal to the maximum allowed by any law in effect at the time when, and governing the proceedings in which, the damages are to be proved, whether or not the amount be greater, equal to, or less than the amount of the loss or damage referred to above.

 
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(j) No Waiver by Landlord. No delay or forbearance by Landlord in exercising any right or remedy hereunder, or Landlord's undertaking or performing any act or matter which is not expressly required to be undertaken by Landlord shall be construed, respectively, to be a waiver of Landlord's rights or to represent any agreement by Landlord to undertake or perform such act or matter thereafter. Waiver by Landlord of any breach by Tenant of any covenant or condition herein contained (which waiver shall be effective only if so expressed in writing by Landlord) or failure by Landlord to exercise any right or remedy in respect of any such breach shall not constitute a waiver or relinquishment for the future of Landlord's right to have any such covenant or condition duly performed or observed by Tenant, or of Landlord's rights arising because of any subsequent breach of any such covenant or condition nor bar any right or remedy of Landlord in respect of such breach or any subsequent breach. Landlord's receipt and acceptance of any payment from Tenant which is tendered not in conformity with the provisions of this Lease or following an Event of Default (regardless of any endorsement or notation on any check or any statement in any letter accompanying any payment) shall not operate as an accord and satisfaction or a waiver of the right of Landlord to recover any payments then owing by Tenant which are not paid in full, or act as a bar to the termination of this Lease and the recovery of the Premises because of Tenant's previous default.

(k) Landlord’s Default. Landlord shall be in default under this Lease in the event that written notice thereof has been given to Landlord and Landlord fails to complete such cure within thirty (30) days (provided, however, that such 30 day period shall be reasonably extended if such performance begins within such period and thereafter is continuously diligently pursued). If Landlord has failed to perform any obligation required under this Lease that materially and adversely affects Tenant’s use or occupancy of the Premises within the foregoing period of time, except in case of emergency, when such period shall only be the time reasonably needed to cure such condition, and if Landlord shall fail to either (i) respond to Tenant indicating its intention to cure (or disputing, in good faith, that Landlord is in default or otherwise that such cure by Landlord is required), or (ii) commence such cure, after Tenant shall have provided an additional ten (10) days’ written notice to Landlord expressly identifying the work that Tenant claims is required to cure such failure, then Tenant shall have the right to perform such obligation on Landlord’s behalf. In no event may Tenant exercise such rights if Landlord should dispute, in good faith, Tenant’s notice as aforesaid. Any dispute under this subparagraph (k) shall be resolved by an expedited arbitration proceeding in the same manner as set forth in Article 14(h) hereof. Landlord shall reimburse Tenant for all of Tenant’s reasonable, third-party out-of-pocket costs, including reasonable attorney’s fees, associated with effecting such cure which Tenant has the right to prosecute under this Paragraph. Such amounts shall be due and payable by Landlord to Tenant within thirty (30) days of Landlord’s receipt of bills and/or invoices with respect to same. In the event Landlord shall default in its obligation to reimburse such costs to Tenant, Tenant shall have the right to offset such costs plus interest at the Default Rate, against the monthly installments of Fixed Rent thereafter due under this Lease, on a month-to-month basis, to the extent of ten (10%) percent of such monthly installment of Fixed Rent until Tenant shall have collected the full amount due under this subparagraph. In the event Landlord shall dispute the reasonableness of the costs incurred by Tenant, such dispute shall also be resolved by an expedited arbitration proceeding as provided above.

 
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23. INTENTIONALLY OMITTED.

24. LANDLORD'S REPRESENTATIONS AND WARRANTIES.

Landlord represents and warrants to Tenant that: (a) Landlord has the authority to enter into this Lease and (b) the person executing this Lease is duly authorized to execute and deliver this Lease on behalf of Landlord.

25. SURRENDER.
 
Tenant shall, at the expiration of the Term, promptly quit and surrender the Premises in good order and condition and in conformity with the applicable provisions of this Lease, excepting only reasonable wear and tear and damage by fire or other insured casualty. Tenant shall have no right to hold over beyond the expiration of the Term and in the event Tenant shall fail to deliver possession of the Premises as herein provided, such occupancy shall not be construed to effect or constitute other than a tenancy at sufferance. During any period of occupancy beyond the expiration of the Term (i) the amount of rent owed to Landlord by Tenant shall automatically become for the first sixty (60) days of such period one hundred fifty percent (150%) of the sum of the Rent as those sums are at that time calculated under the provisions of the Lease, and, following such sixty (60) day period, the amount of Rent owed to Landlord shall become two hundred (200%) percent of the sum of the Rent as those are sums at that time calculated under the provisions of the Lease, (ii) Tenant shall be liable to Landlord for any payment or rent concession which Landlord may be required to make to any tenant in order to induce such tenant not to terminate an executed lease covering all or any portion of the Premises by reason of the holdover by Tenant, and (iii) Tenant shall be liable to Landlord for any damages suffered by Landlord as the result of Tenant's failure to surrender the Premises. The acceptance of rent by Landlord or the failure or delay of Landlord in notifying or evicting Tenant following the expiration or sooner termination of the Term shall not create any tenancy rights in Tenant and any such payments by Tenant may be applied by Landlord against its costs and expenses, including attorney's fees, incurred by Landlord as a result of such holdover.

26. RULES AND REGULATIONS.

Tenant agrees that at all times during the terms of this Lease (as same may be extended) it, its employees, agents, invitees and licenses shall comply with all rules and regulations specified on Exhibit "H" attached hereto and made a part hereof, together with all reasonable Rules and Regulations as Landlord may from time to time promulgate. Tenant's right to dispute any changes in or additions to the Rules and Regulations shall be deemed waived unless asserted to Landlord within ten (10) business days after Landlord shall have given Tenant written notice of any such adoption or change. In case of any conflict or inconsistency between the provisions of this Lease and any Rules and Regulations, the provisions of this Lease shall control. Landlord shall have no duty or obligation to enforce any Rule and Regulation, or any term, covenant or condition of any other lease, against any other tenant, and Landlord's failure or refusal to enforce any Rule or Regulation or any term, covenant of condition of any other lease against any other tenant shall be without liability of Landlord to Tenant. However, if Landlord does enforce Rules or Regulations, Landlord shall endeavor to enforce same equally in a non-discriminatory manner.

 
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27. GOVERNMENTAL REGULATIONS.

(a) Tenant shall, in the use and occupancy of the Premises and the conduct of Tenant's business or profession therein, at all times comply with all applicable laws, ordinances, orders, notices, rules and regulations of the federal, state and municipal governments, or any of their departments and the regulations of the insurers of the Building and/or Premises.

(b) Without limiting the generality of the foregoing, Tenant shall (i) obtain, at Tenant's expense, before engaging in Tenant's business or profession within the Building, all necessary licenses and permits including (but not limited to) state and local business licenses or permits, and (ii) remain in compliance with and keep in full force and effect at all times all licenses, consents and permits necessary for the lawful conduct of Tenant's business or profession at the Building. Tenant shall pay all personal property taxes, income taxes and other taxes, assessments, duties, impositions and similar charges which are or may be assessed, levied or imposed upon Tenant and which, if not paid, could be liened against the Building or against Tenant's property therein or against Tenant's leasehold estate.

(c) Except as otherwise provided in this Article 27, Landlord shall be responsible for compliance with all applicable laws with respect to the Premises, including, without limitation, Title III of the Americans with Disabilities Act of l990, 42 U.S.C. '12181 et seq. and its regulations, (collectively, the "ADA") as to the design and construction of exterior common areas (e.g. sidewalks and parking areas). Except as set forth above in the initial sentence hereto, Tenant shall be responsible for compliance with the ADA in all other respects concerning the use and occupancy of the Premises, which compliance shall include, without limitation (i) provision for full and equal enjoyment of the goods, services, facilities, privileges, advantages or accommodations of the Premises as contemplated by and to the extent required by the ADA, (ii) compliance relating to requirements under the ADA or amendments thereto arising after the date of this Lease and (iii) compliance relating to the design, layout, renovation, redecorating, refurbishment, alteration, or improvement to the Premises made or requested by Tenant.

28. NOTICES.

Wherever in this Lease it shall be required or permitted that notice or demand be given or served by either party to this Lease to or on the other party, such notice or demand shall be deemed to have been duly given or served if in writing and either: (i) personally served; (ii) delivered by pre-paid nationally recognized overnight courier service (e.g. Federal Express) with evidence of receipt required for delivery; or (iii) forwarded by Registered or Certified mail, return receipt requested, postage prepaid; in all such cases addressed to the parties at the addresses set forth in Article 1(m) hereof (provided, however, that from and after the Commencement Date any notices delivered to Tenant shall be delivered to the Premises). Each such notice shall be deemed to have been given to or served upon the party to which addressed on the date the same is delivered or delivery is refused. Either party hereto may change its address to which said notice shall be delivered or mailed by giving written notice of such change to the other party hereto, as herein provided.

 
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29. BROKERS.
 
Landlord and Tenant each represents and warrants to the other that such party has had no dealings, negotiations or consultations with respect to the Premises or this transaction with any broker or finder other than the Broker identified in Article 1(l); and that otherwise no broker or finder called the Premises to Tenant's attention for lease or took any part in any dealings, negotiations or consultations with respect to the Premises or this Lease. Each party agrees to indemnify and hold the other harmless from and against all liability, cost and expense, including attorney's fees and court costs, arising out of any misrepresentation or breach of warranty under this Article. Landlord shall pay the Broker the commission or fee due in connection with this Lease pursuant to the terms of a separate agreement.

30. INTENTIONALLY OMITTED.

31. LANDLORD'S LIABILITY.

Landlord's obligations hereunder shall be binding upon Landlord only for the period of time that Landlord is in ownership of the Building; and, upon termination of that ownership, Tenant, except as to any obligations which are then due and owing, shall look solely to Landlord's successor in interest in the Building for the satisfaction of each and every obligation of Landlord hereunder. Landlord shall have no personal liability under any of the terms, conditions or covenants of this Lease and Tenant shall look solely to the equity of Landlord in the Building of which the Premises form a part and the rents and net, undistributed proceeds and other income therefrom for the satisfaction of any claim, remedy or cause of action accruing to Tenant as a result of the breach of any section of this Lease by Landlord. In addition to the foregoing, no recourse shall be had for an obligation of Landlord hereunder, or for any claim based thereon or otherwise in respect thereof, against any past, present or future trustee, member, partner, shareholder, officer, director, partner, agent or employee of Landlord, whether by virtue of any statute or rule of law, or by the enforcement of any assessment or penalty or otherwise, all such other liability being expressly waived and released by Tenant with respect to the above-named individuals and entities.

32. AUTHORITY.

Tenant represents and warrants that (a) Tenant is duly organized, validly existing and legally authorized to do business in the State of New Jersey and, (b) the persons executing this Lease are duly authorized to execute and deliver this Lease on behalf of Tenant.

 
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33. NO OFFER.

The submission of the Lease by Landlord to Tenant for examination does not constitute a reservation of or option for the Premises or of any other space within the Building or in other buildings owned or managed by Landlord or its affiliates. This Lease shall become effective as a Lease only upon the execution and legal delivery thereof by both parties hereto.

34. EXTENSION OPTION.  

(a) Provided that no Event of Default has occurred that remains uncured, and the Lease is in full force and effect, Tenant shall have the right to renew this Lease for two (2) terms of five (5) years each beyond the end of the initial Term (each, an "Extension Term"). Tenant shall furnish written notice of intent to renew twelve (12) months prior to the expiration of the initial Term or the first Extension Term, as applicable, failing which, such renewal right shall be deemed waived; time being of the essence.

(b) The terms and conditions of this Lease during each Extension Term shall remain unchanged except that the annual Fixed Rent for the first Extension Term shall be ninety-five (95%) percent of Fair Market Rent (as such term is hereinafter defined) and the annual Fixed Rent for the second Extension Term shall be ninety-five (95%) percent of Fair Market Rent. All factors regarding Additional Rent shall remain unchanged, and no Tenant Allowance shall be included in the absence of further agreement by the parties. Anything herein contained to the contrary notwithstanding, Tenant shall have no right to renew the term hereof other than or beyond the two (2) consecutive five (5) year terms hereinabove described.

(c) For purposes of this Lease, "Fair Market Rent" shall mean the base rent for comparable space in similar buildings in the area of the Building where the use of such space is similar to the Permitted Use taking into consideration all relevant factors. In the event Tenant disputes Landlord's determination of Fair Market Rent, Tenant, by written demand served upon Landlord within thirty (30) days after Landlord notifies Tenant of Landlord’s determination of Fair Market Rent, may commence arbitration strictly in accordance with the terms and conditions of this Article. If Tenant shall fail to demand arbitration as set forth above within said thirty (30) day period, Tenant shall be deemed to have accepted Landlord’s determination of Fair Market Rent. The sole issue to be determined by such arbitration shall be the Fair Market Rent in accordance with this Article. Such written demand shall contain the name and address of the arbitrator appointed by Tenant. Within ten (10) days after its receipt of the written demand, Landlord will give Tenant written notice of the name and address of its arbitrator. Within ten (10) days after the date of the appointment of the second arbitrator, the two (2) arbitrators will meet. If the two (2) arbitrators are unable to agree on the Fair Market Rent as provided herein within ten (10) days after their first meeting, they will select a third arbitrator. The third arbitrator will be designated as chairman and will immediately give Landlord and Tenant written notice of its appointment. The three (3) arbitrators will meet within ten (10) days after the appointment of the third arbitrator. If they are unable to agree on the Fair Market Rent within ten (10) days after their first meeting, the third arbitrator will select a time, date and place for a hearing and will give Landlord and Tenant thirty (30) days prior written notice of it. The date for the hearing will not be more than sixty (60) days after the date of appointment of the third arbitrator. The arbitrators must be licensed real estate appraisers with at least five (5) years experience in the Somerset County real estate market. No arbitrator may be an active real estate broker. The arbitration will be governed by the laws of the State of New Jersey and, when not in conflict with such law, by the general procedures in the commercial arbitration rules of the American Arbitration Association. The arbitrators will not have the power to add to, modify, detract from or alter in any way the provisions of this Lease or any amendments or supplements to this Lease. The arbitrators will not have any power to decide or consider anything other than the specific issue of the Fair Market Rent in accordance with the terms of this Lease. The written decision of at least two (2) arbitrators will be conclusive and binding upon Landlord and Tenant. No arbitrator is authorized to make an award for damages of any kind including, without limitation, an award for punitive, exemplary, consequential or incidental damages. Landlord and Tenant will pay for the services of its appointees, attorneys and witnesses plus one-half of all other proper costs relating to the arbitration. The decision of the arbitrators will be final and non-appealable and may be enforced according to the laws of the State of New Jersey. Notwithstanding anything to the contrary contained herein, in the event Tenant disputes Landlord's determination of the Fair Market Rent, Tenant shall nevertheless continue to pay Rent at the same rate then being paid under this Lease. In the event the Rent as determined hereunder is at variance with the Rent being paid by Tenant, Tenant shall either pay the difference in a lump sum or receive a credit, as the case may be.
 
 
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35.
OPTION TO PURCHASE.

(a) Subject to the conditions of this Article 35, Tenant shall have the option to purchase (the “Purchase Option”) from Landlord all of Landlord’s interest in the Premises for the Purchase Price (as determined in accordance with the provisions of Article 35(b) below), provided (i) no Event of Default shall have occurred that remains uncured as of the date of exercise of the Purchase Option or as of the date of closing of the purchase of the Premises, (ii) Tenant delivers to Landlord, on or before the last day of the forty-second (42nd) full calendar month of the Term (the “Purchase Notice Date”), written notice (“Tenant’s Purchase Notice”) of Tenant’s desire to exercise the Purchase Option, and (iii) Tenant delivers to Landlord a contract deposit in the amount of $750,000.00 (to be held pursuant to the terms of the contract of sale referenced below) when required pursuant to the provisions of subparagraph (c) below.

(b) The “Purchase Price” shall be equal to the sum of (i) Landlord’s Acquisition, Financing Leasing and Sale Costs (as hereinafter defined) plus (ii) $900,000.00. The term “Landlord’s Acquisition, Financing, Leasing and Sale Costs” shall mean any and all costs and expenses incurred by Landlord in acquiring, financing, leasing and selling the Premises including, without limitation, the following: (A) with respect to the acquisition, all due diligence costs, such as engineering, environmental, title and survey costs, any downpayment or deposit paid under the contract for Landlord’s purchase of the Premises, the purchase price for the purchase of the Premises, if applicable, and all closing costs, such as title charges, title premiums, recording fees and the like, (B) with respect to the financing, commitment fees, application fees, rate lock-in fees, lender’s due diligence fees, lender’s legal fees, prepayment fees and/or premiums and other closing costs related thereto, whether incurred in connection with the initial financing of the Premises or in connection with the assumption of the Loan by Tenant, (C) with respect to the leasing, any costs incurred by Landlord in connection with tenant improvement work performed at the Premises, such as architectural, permitting and construction costs and any brokerage fees, (D) with respect to the sale, fees for the assumption of Landlord’s loan, conveyance taxes, whether or not Landlord is responsible to pay same under applicable law, and any other closing costs related thereto, and (E) in all cases, all legal, accounting and other similar fees incurred by Landlord in connection with the acquisition, financing, leasing, and sale of the Premises.
 
 
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(c) Upon the calculation of the Purchase Price, Landlord shall prepare and deliver to Tenant a contract of sale for the purchase and sale of the Premises, which contract of sale will be on a mutually acceptable form. Provided Tenant has timely and properly delivered Tenant’s Purchase Notice (and otherwise satisfied the conditions of Article 35(a) above), (i) Tenant shall execute the contract of sale and return same to Landlord within five (5) days after Landlord first tenders the contract of sale to Tenant; (ii) Landlord shall countersign and return a fully-executed original of the contract of sale to Tenant within ten (10) days after Landlord’s receipt of same from Tenant; and (iii) the date for closing of the purchase and sale of the Premises shall occur within six (6) months of Landlord’s receipt of Tenant’s Purchase Notice, but in no event earlier than the date Landlord’s lockout period expires under Landlord’s Mortgagee’s loan documents. Landlord shall advise Tenant of the lockout period expiration date and the corresponding earliest date for closing under the terms hereof as soon as such information becomes available to Landlord. Tenant shall be obligated to deliver the contract deposit described in subparagraph (a) above by no later than six (6) months prior to said closing date. For purposes of this Article, the lockout period expiration date shall mean the earlier to occur of: (A) two (2) years from the “start-up day” of the REMIC (i.e., securitization of Landlord’s loan for the purchase of the Premises), and (B) three (3) years from the date the closing of the transfer of title to the Premises to Landlord occurs.

(d) Time shall be of the essence as to all dates and time periods set forth in this Article.

(e) In the event Tenant shall fail to deliver Tenant’s Purchase Notice on or before the Purchase Notice Date or shall fail or refuse, for any reason, to execute or deliver the contract of sale submitted by Landlord to Tenant, at the time and in the manner required in this Article, or shall fail or refuse, for any reason, to close the transfer of title to the Premises in accordance with the terms of the contract of sale, the Purchase Option hereunder shall be null and void, and Tenant shall have no right whatsoever to purchase or otherwise acquire the Premises.

(f) In the event Tenant shall timely and properly exercise the Purchase Option hereunder, Tenant shall continue to pay Fixed Rent and all items of Additional Rent under this Lease, and the provisions of this Lease shall continue to govern the relationship of Landlord and Tenant with respect to the Premises, until the closing of title for the Premises. Effective as of closing of title to the Premises, this Lease shall immediately and automatically terminate. The parties hereby agree that once exercised, Tenant shall not have the right to revoke or rescind its exercise of this Purchase Option.

 
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(g) The Purchase Option is personal to DOV Pharmaceutical, Inc., and is non-transferable by operation of law or otherwise.
 
36. CONTINGENCY.

(a) Landlord and Tenant each acknowledge and agree that, as of the date of this Lease, Landlord is negotiating the purchase of the Premises from the current owner and has not yet acquired title to the Premises. Landlord and Tenant each further agree to cooperate with the other party in order to structure a mutually satisfactory and assignable financing arrangement for the Premises which will facilitate any exercise by Tenant of the Purchase Option contained in Article 35 of this Lease. Notwithstanding anything to the contrary contained in this Lease, the parties acknowledge and agree that this Lease is contingent upon the purchase by Landlord of the Premises from the current owner and, in the event Landlord has not so acquired title on or before the date which is seven (7) months from the date of this Lease  then either party may cancel this Lease upon fifteen (15) days written notice to the other party. If this Lease is canceled pursuant to this Article, Landlord shall thereafter return to Tenant any Letter of Credit or amounts prepaid by Tenant to Landlord under this Lease and thereafter this Lease shall be of no further force or effect.

(b) Landlord acknowledges that the Tenant’s ability to secure economic development incentives from state and local municipalities is material to Tenant’s decision to enter this Lease and locate its operations at the Property. In the event that Tenant is unable to secure state and local economic development incentives acceptable to Tenant, in its sole discretion, Tenant shall have the right to terminate the Lease by providing Landlord with written notice thereof prior to December 28, 2005 (the “Termination Deadline Date”). TIME SHALL BE OF THE ESSENCE as to Tenant’s obligation to deliver such written termination notice by the Termination Deadline Date. In the event Tenant does not elect to terminate this Lease pursuant to this paragraph by the Termination Deadline Date, Tenant’s right to terminate the Lease pursuant to this paragraph shall be deemed automatically waived. If the Tenant elects to terminate this Lease pursuant to this provision, Tenant shall reimburse Landlord for Landlord’s actual, documented out-of-pocket expenses incurred in furtherance of this Lease and Landlord’s acquisition and financing of the Property. Such amounts shall be due and payable by Tenant to Landlord by no later than ten (10) days following the Termination Deadline Date.

37. RIGHT OF OFFER FOR PURCHASE RIGHT OF OFFER FOR PURCHASE OF REAL PROPERTY

(a)   If Landlord decides to sell the Premises (as a single building/property sale) to an unaffiliated third party, following the lockout period under Landlord’s Mortgagee’s loan documents, then, provided at such time no Event of Default shall have occurred that remains uncured and before offering the Premises for sale to such a third party, Landlord shall notify Tenant ("Landlord's ROFO Notice") of the purchase price for which it would be willing to sell the Premises. The parties specifically acknowledge and agree that Tenant’s Right of Offer set forth in this Article 37 shall not apply to a sale or proposed sale of the Premises by Landlord made in conjunction with the sale of the Premises together with one or more additional properties to the same third party. Tenant shall, within seven (7) business days after receipt of Landlord's ROFO Notice, (i) notify Landlord in writing ("Tenant's ROFO Notice") of its intention to exercise Tenant's right to purchase the Premises (which Tenant’s ROFO Notice shall be effective only if sent by Tenant to Landlord, via certified mail, return receipt requested), at Landlord’s address set forth in this lease), and (ii) simultaneously with delivery of the Tenant’s ROFO Notice, deliver to Landlord a contract deposit in an amount equal to ten (10%) of the purchase price set forth by Landlord in Landlord’s ROFO Notice (to be held pursuant to the terms of the contract of sale referenced below). If Tenant does not give such Tenant's ROFO Notice within such seven (7) business day period as required above, then this Right of Offer will lapse and be of no further force and effect and Landlord shall have the right to sell the Premises to a third party (or parties) on the same or any other terms and conditions, whether or not such terms and conditions are more or less favorable than those offered to Tenant, and Landlord shall not be required at any other time, to re-offer the Premises to Tenant.

 
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(b)  Upon timely receipt of Tenant’s ROFO Notice, Landlord shall prepare and deliver to Tenant a contract of sale for the purchase and sale of the Premises. Assuming timely and proper delivery of the Tenant’s ROFO Notice, (i) Tenant shall execute the contract of sale and return same to Landlord within five (5) days after Landlord first tenders the contract of sale to Tenant; (ii) Landlord shall countersign and return a fully-executed original of the contract of sale to Tenant; and (iii) the date for closing of the purchase and sale of the Premises shall be set at the date that is sixty (60) days following the date on which Landlord first tenders such contract of sale to Tenant; time being of the essence with respect to such closing date. The contract of sale shall provide that Tenant, as purchaser, is accepting the Premises in its then current “as is” condition, without any contingency for financing.

(c)  In the event Tenant shall fail to deliver Tenant’s ROFO Notice within the time period provided above or shall fail or refuse, for any reason to execute or deliver the contract of sale submitted by Landlord to Tenant, at the time and in the manner required in this Article, or shall fail or refuse, for any reason, to close in accordance with the terms of the contract of sale, this Right of Offer shall be null and void. Landlord shall thereafter be free to sell the Premises to any third party. Notwithstanding the foregoing, if the economic terms of such sale to a third party shall be less than ninety (90%) percent of those set forth in Landlord’s ROFO Notice, the Premises shall again be subject to Tenant’s rights under this Article 37.

(d)  In the event Tenant shall timely and properly exercise this Right of Offer hereunder, Tenant shall continue to pay Fixed Rent and all items of additional rent under this Lease, and the provisions of this Lease shall continue to govern the relationship of Landlord and Tenant until the closing of title for the Premises. Effective as of closing of title in the sale of the Premises to Tenant, this lease shall immediately and automatically terminate as if the date of such closing of title were the date originally set forth herein as the Expiration Date.

 
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(e)  Time shall be of the essence with respect to all of Tenant’s obligations under this Article 37.

(f) This Right of Offer or First Refusal is personal to DOV Pharmaceutical, Inc., and is non-transferable by operation of law or otherwise.

38. TENANT FINANCIAL INFORMATION.
 
If Tenant is not a publicly-traded company, any time and from time to time during the Term (but not more than once during any twelve month period) upon not less than thirty (30) days prior written request from Landlord, Tenant shall deliver to Landlord: (i) an accurate, complete and detailed quarterly financial statement of Tenant, in the form customarily prepared by Tenant in the ordinary course of its business, prepared in accordance with generally accepted accounting principles consistently applied and certified by the Chief Financial Officer of Tenant to be a fair and true presentation of Tenant's current financial position; (ii) a current, accurate, complete and detailed financial statements of Tenant audited by an independent certified public accountant for the last available calendar year. Landlord shall keep all information provided hereunder strictly confidential in accordance with a separate confidentiality agreement to be executed by Landlord and Tenant.

39. MISCELLANEOUS PROVISIONS.

(a) Successors. The respective rights and obligations provided in this Lease shall bind and inure to the benefit of the parties hereto, their successors and assigns; provided, however, that no rights shall inure to the benefit of any successors or assigns of Tenant unless Landlord's written consent for the transfer to such successor and/or assignee has first been obtained as provided in Article 12 hereof.

(b) Governing Law. This Lease shall be construed, governed and enforced in accordance with the laws of the State of New Jersey, without regard to principles relating to conflicts of law.
 
(c) Severability. If any provisions of this Lease shall be held to be invalid, void or unenforceable, the remaining provisions hereof shall in no way be affected or impaired and such remaining provisions shall remain in full force and effect.

(d) Captions. Marginal captions, titles or exhibits and riders and the table of contents in this Lease are for convenience and reference only, and are in no way to be construed as defining, limiting or modifying the scope or intent of the various provisions of this Lease.

(e) Gender. As used in this Lease, the word "person" shall mean and include, where appropriate, an individual, corporation, partnership or other entity; the plural shall be substituted for the singular, and the singular for the plural, where appropriate; and the words of any gender shall mean to include any other gender.

 
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(f) Entire Agreement. This Lease, including the Exhibits and any Riders hereto (which are hereby incorporated by this reference, except that in the event of any conflict between the printed portions of this Lease and any Exhibits or Riders, the term of such Exhibits or Riders shall control), supersedes any prior discussions, proposals, negotiations and discussions between the parties and the Lease contains all the agreements, conditions, understandings, representations and warranties made between the parties hereto with respect to the subject matter hereof, and may not be modified orally or in any manner other than by an agreement in writing signed by both parties hereto or their respective successors in interest. Without in any way limiting the generality of the foregoing, this Lease can only be extended pursuant to the terms hereof, and in Tenant’s case, with the terms hereof, with the due exercise of an option (if any) contained herein pursuant to a written agreement signed by both Landlord and Tenant specifically extending the term. No negotiations, correspondence by Landlord or offers to extend the term shall be deemed an extension of the termination date for any period whatsoever.

(g) Counterparts. This Lease may be executed in any number of counterparts, each of which when taken together shall be deemed to be one and the same instrument. 

(h) Telefax Signatures. The parties acknowledge and agree that notwithstanding any law or presumption to the contrary a telefaxed signature of either party whether upon this Lease or any related document shall be deemed valid and binding and admissible by either party against the other as if same were an original ink signature.

(i)  Calculation of Time. In computing any period of time prescribed or allowed by any provision of this Lease, the day of the act, event or default from which the designated period of time begins to run shall not be included. The last day of the period so computed shall be included, unless it is a Saturday, Sunday or a legal holiday, in which event the period runs until the end of the next day which is not a Saturday, Sunday, or legal holiday. Unless otherwise provided herein, all Notices and other periods expire as of 5:00 p.m. EST on the last day of the Notice or other period.
 
(j) No Merger. There shall be no merger of this Lease or of the leasehold estate hereby created with the fee estate in the Premises or any part thereof by reason of the fact that the same person, firm, corporation, or other legal entity may acquire or hold, directly or indirectly, this Lease of the leasehold estate and the fee estate in the Premises or any interest in such fee estate, without the prior written consent of Landlord’s mortgagee.

(k) Time of the Essence. TIME IS OF THE ESSENCE IN ALL PROVISIONS OF THIS LEASE, INCLUDING ALL NOTICE PROVISIONS TO BE PERFORMED BY OR ON BEHALF OF TENANT.

(l) Recordation of Lease. Tenant shall not record this Lease without the written consent of Landlord. However, either party may record a memorandum of this Lease in the public land records, provided the parties simultaneously execute and deliver to each other a release of such memorandum in recordable form, which release may be automatically recorded by Landlord in the applicable land records upon the expiration or sooner termination of this Lease.
 
 
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(m) Accord and Satisfaction. No payment by Tenant or receipt by Landlord of a lesser amount than any payment of Fixed Rent or Additional Rent herein stipulated shall be deemed to be other than on account of the earliest stipulated Fixed Rent or Additional Rent due and payable hereunder, nor shall any endorsement or statement or any check or any letter accompanying any check or payment as Rent be deemed an accord and satisfaction. Landlord may accept such check or payment without prejudice to Landlord’s right to recover the balance of such Rent or pursue any other right or remedy provided for in this Lease, at law or in equity.

(n) No Partnership. Landlord does not, in any way or for any purpose, become a partner of Tenant in the conduct of its business, or otherwise, or joint venturer or a member of a joint enterprise with Tenant. This Lease establishes a relationship solely of that of a landlord and tenant.

(o) No Presumption Against Drafter. Landlord and Tenant understand, agree, and acknowledge that: (i) this Lease has been freely negotiated by both parties; and (ii) that, in the event of any controversy, dispute, or contest over the meaning, interpretation, validity, or enforceability of this Lease, or any of its terms or conditions, there shall be no inference, presumption, or conclusion drawn whatsoever against either party by virtue of that party having drafted this Lease or any portion thereof.

(p) Force Majeure.  If by reason of strikes or other labor disputes, fire or other casualty (or reasonable delays in adjustment of insurance), accidents, orders or regulations of any Federal, State, County or Municipal authority, or any other cause beyond Landlord’s reasonable control, Landlord is unable to furnish or is delayed in furnishing any utility or service required to be furnished by Landlord under the provisions of this Lease or is unable to perform or make or is delayed in performing or making any installations, decorations, repairs, alterations, additions or improvements, or is unable to fulfill or is delayed in fulfilling any of Landlord’s other obligations under this Lease, no such inability or delay shall constitute an actual or constructive eviction, in whole or in part, or entitle Tenant to any abatement or diminution of Fixed Rent, or relieve Tenant from any of its obligations under this Lease, or impose any liability upon Landlord or its agents, by reason of inconvenience or annoyance to Tenant, or injury to or interruption of Tenant’s business, or otherwise.

40. WAIVER OF TRIAL BY JURY.

LANDLORD AND TENANT WAIVE THE RIGHT TO A TRIAL BY JURY IN ANY ACTION OR PROCEEDING BASED UPON, OR RELATED TO, THE SUBJECT MATTER OF THIS LEASE. THIS WAIVER IS KNOWINGLY, INTENTIONALLY, AND VOLUNTARILY MADE BY TENANT AND TENANT ACKNOWLEDGES THAT NEITHER LANDLORD NOR ANY PERSON ACTING ON BEHALF OF LANDLORD HAS MADE ANY REPRESENTATIONS OF FACT TO INDUCE THIS WAIVER OF TRIAL BY JURY OR IN ANY WAY TO MODIFY OR NULLIFY ITS EFFECT. TENANT FURTHER ACKNOWLEDGES THAT IT HAS BEEN REPRESENTED (OR HAS HAD THE OPPORTUNITY TO BE REPRESENTED) IN THE SIGNING OF THIS LEASE AND IN THE MAKING OF THIS WAIVER BY INDEPENDENT LEGAL COUNSEL, SELECTED OF ITS OWN FREE WILL, AND THAT IT HAS HAD THE OPPORTUNITY TO DISCUSS THIS WAIVER WITH COUNSEL. TENANT FURTHER ACKNOWLEDGES THAT IT HAS READ AND UNDERSTANDS THE MEANING AND RAMIFICATIONS OF THIS WAIVER PROVISION AND AS EVIDENCE OF SAME HAS EXECUTED THIS LEASE.

 
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41. CONSENT TO JURISDICTION.

Tenant hereby consents to the exclusive jurisdiction of the state courts located in Somerset County and to the federal courts located in the District of New Jersey.

 
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IN WITNESS WHEREOF, the parties hereto have executed this Lease, the day and year first above written.

LANDLORD:

PARAGON 150 PIERCE STREET, L.L.C.  


By: /s/ Mark Schaevitz   
                              Name: Mark Schaevitz
      Title: Manager

TENANT:
 
DOV PHARMACEUTICAL, INC.


By /s/ J. Robert Horton   
                 Name: J. Robert Horton
                      Title: Sr. Vice President and General Counsel
 
 
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EXHIBIT "A"


The certain piece or parcel of land known as Lot 2.02, Block 468.08 located in Franklin Township, Somerset County, New Jersey.

[FINAL SURVEY TO BE INSERTED AT OR PRIOR TO CLOSING]

 
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EXHIBIT "B" - CONFIRMATION OF LEASE TERM

THIS MEMORANDUM is made as of the ___ day of _________, 2005, between PARAGON 150 PIERCE STREET, L.L.C., a New Jersey limited liability company, with an office at One Paragon Drive, Suite 145, Montvale, New Jersey 07645 ("Landlord") and DOV PHARMACEUTICAL, INC., a Delaware corporation, with its principal place of business at Continental Plaza, 433 Hackensack Avenue, Hackensack, New Jersey 07601 ("Tenant"), who entered into a lease, dated for reference purposes as of ___________ __, 2005 (the “Lease”), covering certain premises located at 150 Pierce Street, Franklin Township, New Jersey. All capitalized terms, if not defined herein, shall be defined as they are defined in the Lease.

1. The Parties to this Memorandum hereby agree that the date of ______________, 200_ is the "Commencement Date" of the Lease and the date _________ is the Expiration Date.

2. Tenant hereby confirms that: (a) it has accepted possession of the Premises pursuant to the terms of the Lease; (b) there are no offsets or credits against rentals, and the Letter of Credit has been delivered as provided in the Lease; and (c) there is no default by Landlord or Tenant under the Lease and the Lease is in full force and effect.

3. This Memorandum, each and all of the provisions hereof, shall inure to the benefit, or bind, as the case may require, the parties hereto, and their respective successors and assigns, subject to the restrictions upon assignment and subletting contained in the Lease.

LANDLORD:

PARAGON 150 PIERCE STREET, L.L.C.  


By: _____________________________________
Name:
Title:

TENANT:
 
DOV PHARMACEUTICAL, INC.


By _____________________________________
Name:
Title:

 
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EXHIBIT "C" - WIRING INSTRUCTIONS

TO BE PROVIDED FOLLOWING THE EXECUTION OF THIS LEASE

 
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EXHIBIT “D” - LETTER OF CREDIT



[LETTERHEAD OF ISSUER OF LETTER OF CREDIT]

 
_______________, 200_


Paragon 150 Pierce Street, L.L.C.
One Paragon Drive, Suite 145
Montvale, New Jersey 07645


REF: IRREVOCABLE LETTER OF CREDIT NO. __________

GENTLEMEN:

WE HEREBY OPEN OUR UNCONDITIONAL IRREVOCABLE CLEAN LETTER OF CREDIT NO. __________ IN YOUR FAVOR AVAILABLE BY YOUR DRAFT(S) AT SIGHT FOR AN AMOUNT NOT TO EXCEED IN THE AGGREGATE $2,807,406.00 EFFECTIVE IMMEDIATELY.

ALL DRAFTS SO DRAWN MUST BE MARKED “DRAWN UNDER IRREVOCABLE LETTER OF CREDIT OF [ISSUING BANK], NO. __________, DATED __________, 200_.”

THIS LETTER OF CREDIT IS ISSUED, PRESENTABLE AND PAYABLE AT OUR OFFICE AT ________________, NEW JERSEY [MUST BE IN SOMERSET COUNTY] OR SUCH OTHER OFFICE IN ______________, NEW JERSEY [SOMERSET COUNTY] AS WE MAY DESIGNATE BY WRITTEN NOTICE TO YOU, AND EXPIRES WITH OUR CLOSE OF BUSINESS ON __________. IT IS A CONDITION OF THIS LETTER OF CREDIT THAT IT SHALL BE AUTOMATICALLY EXTENDED FOR ADDITIONAL TWELVE MONTH PERIODS THROUGH __________ [60 DAYS AFTER LEASE EXPIRATION DATE], UNLESS WE INFORM YOU IN WRITING BY CERTIFIED OR REGISTERED MAIL DISPATCHED BY US AT LEAST 60 DAYS PRIOR TO THE THEN EXPIRATION DATE OF THIS LETTER OF CREDIT THAT THIS LETTER OF CREDIT SHALL NOT BE EXTENDED. IN THE EVENT THIS LETTER OF CREDIT IS NOT EXTENDED FOR AN ADDITIONAL PERIOD AS PROVIDED ABOVE, YOU MAY DRAW HEREUNDER. SUCH DRAWING IS TO BE MADE BY MEANS OF A DRAFT ON US AT SIGHT WHICH MUST BE PRESENTED TO US BEFORE THE THEN EXPIRATION DATE OF THIS LETTER OF CREDIT. THIS LETTER OF CREDIT CANNOT BE MODIFIED OR REVOKED WITHOUT YOUR CONSENT. THIS LETTER OF CREDIT IS PAYABLE IN MULTIPLE DRAFTS AND SHALL BE TRANSFERABLE BY YOU WITHOUT ADDITIONAL CHARGE.

 
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WE HEREBY DO UNDERTAKE TO PROMPTLY HONOR YOUR SIGHT DRAFT OR DRAFTS DRAWN ON US, INDICATING OUR LETTER OF CREDIT NO. _________, FOR THE AMOUNT AVAILABLE TO BE DRAWN ON THIS LETTER OF CREDIT UPON PRESENTATION OF YOUR SIGHT DRAFT IN THE FORM OF SCHEDULE A ATTACHED HERETO DRAWN ON US AT OUR OFFICES SPECIFIED ABOVE DURING OUR USUAL BUSINESS HOURS ON OR BEFORE THE EXPIRATION DATE HEREOF.

EXCEPT AS EXPRESSLY STATED HEREIN, THIS UNDERTAKING IS NOT SUBJECT TO ANY AGREEMENTS, REQUIREMENTS OR QUALIFICATION. OUR OBLIGATION UNDER THIS LETTER OF CREDIT IS OUR INDIVIDUAL OBLIGATION AND IS IN NO WAY CONTINGENT UPON REIMBURSEMENT WITH RESPECT THERETO OR UPON OUR ABILITY TO PERFECT ANY LIEN, SECURITY INTEREST OR ANY OTHER REIMBURSEMENT.

IN THE EVENT THE APPLICANT BECOMES A DEBTOR IN A CASE UNDER TITLE 11 OF THE UNITED STATES CODE (THE “BANKRUPTCY CODE”), OR IN ANY OTHER INSOLVENCY OR SIMILAR PROCEEDING, OUR OBLIGATIONS TO THE BENEFICIARY HEREUNDER SHALL NOT BE REDUCED, LIMITED, IMPAIRED, DISCHARGED, DEFERRED, SUSPENDED, STAYED, TERMINATED OR OTHERWISE AFFECTED BY REASON THEREOF OR BY REASON OF ANY PROVISIONS OF THE BANKRUPTCY CODE (INCLUDING BUT NOT LIMITED TO, SECTIONS 362 AND 502(B) OF THE BANKRUPTCY CODE), OR THE PROVISIONS OF ANY OTHER INSOLVENCY OR SIMILAR LAW.

THIS LETTER OF CREDIT IS SUBJECT TO THE INTERNATIONAL STANDBY PRACTICES 1998, INTERNATIONAL CHAMBER OF COMMERCE PUBLICATION NO. 590, AND SHALL BE DEEMED TO BE A CONTRACT MADE THEREUNDER, AND AS TO MATTERS NOT GOVERNED BY THE INTERNATIONAL STANDBY PRACTICES, SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK AND APPLICABLE U.S. LAW.


[ISSUER OF LETTER OF CREDIT]
 

________________________________

 
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SCHEDULE A TO LETTER OF CREDIT

FOR VALUE RECEIVED

PAY AT SIGHT BY WIRE TRANSFER IN IMMEDIATELY AVAILABLE FUNDS TO _______________ THE SUM OF U.S. _______________ DRAWN UNDER IRREVOCABLE LETTER OF CREDIT NO. _______________ DATED _______________, 200_ ISSUED BY __________.

TO: ________________________ [ISSUER OF LETTER OF CREDIT]


________________, NEW JERSEY[LOCATION OF ISSUER IN SOMERSET COUNTY]

 
57

 

EXHIBIT “E”

 
INTENTIONALLY DELETED
 
 
58

 

EXHIBIT “F” - CLEANING SPECIFICATIONS


Landlord shall clean the Premises substantially in accordance with the following:

Office/Administrative and Lobby Areas

·  
All carpeting shall be vacuumed nightly. Carpet shall be spot cleaned as required. Carpet shampooing is excluded.
·  
Dust furniture & window sills nightly.
·  
Empty and dust all waste receptacles nightly and removed from the demised premises waste paper and waste materials incidental to normal office usage.
·  
Empty and clean ashtrays and sand urns nightly.
·  
Clean water fountains and coolers nightly.
·  
Dust telephones, lighting fixtures and ventilating louvers as required.
·  
Dust under desk equipment as required.
·  
Dust baseboards 2 times per month.
·  
Sweep and/or mop (non-carpeted) areas with appropriately treated brooms, mops or cloths nightly.
·  
Sweep & dust stairwell landings and handrails 2 times per week.
·  
Sweep, vacuum and/or mop floors of elevator cab nightly.
·  
Strip and reseal stairwell landing once annually.
·  
Strip and reseal VCT flooring twice annually.

Lavatory Areas

·  
Wash all lavatory floors nightly using proper disinfectants.
·  
Clean all mirrors, powder shelves, sinks and counters nightly.
·  
Clean and disinfect basins, bowls, and urinals and flushometers nightly.
·  
Wash toilet seats nightly.
·  
Clean partitions, tile, dispenses and receptacles nightly.
·  
Empty paper towel receptacles and sanitary disposal receptacles nightly.
·  
Fill toilet tissue holders, soap dispensers and paper towel dispensers nightly.

Laboratory/Laboratory Support/High Bay Areas

·  
Cleaning specifications for all laboratory/laboratory support and Pilot Plant areas shall be established by Tenant. Landlord shall perform such cleaning as directed by Tenant, at Tenant’s sole cost and expense.
 
 
59

 

EXHIBIT “G” - FORM SNDA

 
60

 

EXHIBIT “H” - RULES AND REGULATIONS
 
Landlord hereby promulgates the following Rules and Regulations with respect to the Premises:

1. No awnings, signs or other projections shall be attached to the outside walls of the Building without the prior written consent of Landlord. The foregoing rule and regulation shall be subject however, to the provisions of Article 8(a) of the Lease.

2. Restrooms and other plumbing fixtures shall not be used for any purpose other than those for which they were constructed and no debris, rubbish, rags or other substances shall be thrown therein. Only standard toilet tissue may be flushed in commodes. All damage resulting from any misuse of these fixtures shall be the responsibility of Tenant who, or whose employees agents, visitors, clients, or licensees shall have caused same.

3. Tenant shall not construct or maintain, use or operate in any part of the Premises any apparatus or sound/communication system which will be heard outside the Premises at a level objectionable to neighboring properties.

4. Tenant shall not cause or permit any objectionable odors to be produced at a level objectionable to neighboring properties.

5. Tenant shall provide keys/codes and/or security access cards to all locks or bolts of any kind upon any door or window of the Building. Tenant must, upon the termination of tenancy, return to Landlord all keys for the Building, either furnished to or otherwise procured by Tenant, and all security access cards to the Building, where applicable.

The foregoing rules and regulations may be amended, modified or supplemented by Landlord, from time to time, pursuant to the provisions of Article 26 of this Lease.
 
 
61

 
 
LEASE MODIFICATION AGREEMENT

AGREEMENT made as of the 28th day of February, 2006 by and between PARAGON 150 PIERCE STREET, L.L.C., a New Jersey limited liability company, having its principal office at One Paragon Drive, Suite 145, Montvale, New Jersey 07645 (hereinafter called "Landlord")and DOV PHARMACEUTICAL, INC., a Delaware corporation, having its principal office at Continental Plaza, 433 Hackensack Avenue, Hackensack, New Jersey 07601 (hereinafter called "Tenant").

RECITALS

WHEREAS, Landlord and Tenant entered into a Lease dated December 20, 2005 (the "Lease") for the lease of land and the entire building and other improvements from time to time located at 150 Pierce Street, Franklin Township, New Jersey; and

WHEREAS, Landlord and Tenant desire to amend and modify certain terms and conditions of the Lease regarding Landlord’s Work (as such term is defined in the Lease).

NOW, THEREFORE, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

ARTICLE I
Definitions

1.1 The recitals are specifically incorporated into the body of this Agreement and shall be binding upon the parties hereto.  
1.2 Unless expressly set forth to the contrary and except as modified by this Agreement, all capitalized or defined terms shall have the meanings ascribed to them in the Lease.
 
ARTICLE II
Lease Modifications

2.1 Construction By Landlord. The fourth full sentence of Article 4(c) of the Lease is hereby deleted in its entirety and the following provisions are inserted in lieu thereof:

 
62

 
 
“In no event shall Tenant be entitled to receive a rent credit if Landlord fails to substantially complete Landlord’s Work by the agreed to Stated Completion Date. It is agreed however, that in the event Landlord does not substantially complete Landlord’s Work by the agreed to Stated Completion Date, subject to Force Majeure and Tenant Delay, Tenant may deliver a thirty (30) day written notice to Landlord of Tenant’s intention to perform or cause the performance of those aspects of Landlord’s Work which have not been substantially completed by the agreed to Stated Completion Date (the “Remaining Work”). Following the delivery of such written notice, Landlord shall take whatever commercially reasonable additional measures as are necessary (such as the use of overtime labor) so that the Remaining Work is substantially completed by the expiration of said thirty (30) day period. If the Remaining Work is still not substantially completed by the expiration of said thirty (30) day period, then Tenant may perform or cause the performance of the Remaining Work. In such case, Tenant shall be entitled to draw down the Tenant Allowance monies, or so much thereof as there is then remaining, directly from Landlord’s Mortgagee in accordance with the procedures set forth in the loan documents entered into by Landlord and Landlord’s Mortgagee. In addition, Landlord shall reimburse Tenant for any incremental additional costs actually incurred by Tenant by reason of assuming the performance of such work”

2.2 Letter of Credit. Article 5(c)(ii)(C) of the Lease is hereby modified by adding the following provision at the end of said Article: “For so long as CIBC Inc. or its successors or assigns (“Lender”) is Landlord’s Mortgagee, the Letter of Credit shall name Lender, or its designee, as the beneficiary under the Letter of Credit and Lender shall be entitled to draw down the Letter of Credit and apply the proceeds thereof in the same manner as Landlord would be entitled.”

2.3 Option to Purchase. Article 35(c) of the Lease is hereby modified as follows:

(a) The words “lockout period expires” in the tenth line of said Article 35(c) are hereby deleted in their entirety and the words “defeasance period commences” are inserted in lieu thereof; and

 
63

 
 
(b) The words “lockout expiration date” in the eleventh and fifteenth lines of said Article 35(c) are hereby deleted in their entirety and the words “defeasance period commencement date” are hereby inserted in lieu thereof.
 
ARTICLE III
Ratification

3.1 The parties hereby ratify and confirm all of the terms, covenants and conditions of the Lease, except to the extent that those terms, covenants and conditions are amended, modified or varied by this Agreement. If there is a conflict between the provisions of the Lease and the provisions of this Agreement, the provisions of this Agreement shall control.  

3.2 This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and/or assigns.     
 
 
64

 

IN WITNESS WHEREOF, the parties have executed this Lease Modification Agreement as of the day and year first above written.


PARAGON REALTY GROUP, L.L.C.
By: Paragon 150 Inc., Its Manager

By: /s/ Mark Schaevitz 
Name: Mark Schaevitz
Title: President

 
DOV PHARMACEUTICAL, INC.

By: /s/ Barbara Duncan 
                                                                                Name: Barbara Duncan
Title: Chief Financial Officer
 
 
65

 
 
SECOND LEASE MODIFICATION AGREEMENT

AGREEMENT made as of the 28th day of February, 2006 by and between PARAGON 150 PIERCE STREET, L.L.C., a New Jersey limited liability company, having its principal office at One Paragon Drive, Suite 145, Montvale, New Jersey 07645 (hereinafter called "Landlord")and DOV PHARMACEUTICAL, INC., a Delaware corporation, having its principal office at Continental Plaza, 433 Hackensack Avenue, Hackensack, New Jersey 07601 (hereinafter called "Tenant").

RECITALS
 
WHEREAS, Landlord and Tenant entered into a Lease dated December 20, 2005 (the "Original Lease") for the lease of land and the entire building and other improvements from time to time located at 150 Pierce Street, Franklin Township, New Jersey; and

WHEREAS, the Original Lease was modified by a certain Letter Agreement dated December 20, 2006 between Landlord and Tenant (the “Letter Agreement”) and by a certain Lease Modification Agreement dated February 28, 2006 between Landlord and Tenant (the “First Modification”, together with the Original Lease and the Letter Agreement are hereinafter collectively referred to as the “Lease”); and

WHEREAS, Landlord and Tenant desire to amend and modify certain terms and conditions of the Lease regarding the Annual Fixed Rent (as such term is defined in the Lease).

NOW, THEREFORE, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

ARTICLE I
Definitions

1.1 The recitals are specifically incorporated into the body of this Agreement and shall be binding upon the parties hereto.  
1.2 Unless expressly set forth to the contrary and except as modified by this Agreement, all capitalized or defined terms shall have the meanings ascribed to them in the Lease.
 
 
66

 

ARTICLE II
Lease Modifications

2.1 The Fixed Rent amount, as set forth in Section 1 of the Lease, Summary of Defined Terms, is hereby deleted in its entirety and the following inserted in its place:


 
LEASE YEAR
MONTHLY INSTALLMENTS
ANNUAL FIXED RENT
       
 
Years 1-5
$237,404.05
$2,848,848.65
       
 
Years 6-10
$260,799.10
$3,129,589.25

3.1 The parties hereby ratify and confirm all of the terms, covenants and conditions of the Lease, except to the extent that those terms, covenants and conditions are amended, modified or varied by this Agreement. If there is a conflict between the provisions of the Lease and the provisions of this Agreement, the provisions of this Agreement shall control.  

3.2 This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and/or assigns.     
 
[NO FURTHER TEXT ON THIS PAGE]

 
67

 

IN WITNESS WHEREOF, the parties have executed this Second Lease Modification Agreement as of the day and year first above written.


PARAGON REALTY GROUP, L.L.C.
By: Paragon 150 Inc., Its Member

By: /s/ Mark Schaevitz 
Name: Mark Schaevitz
Title: President

 
DOV PHARMACEUTICAL, INC.

By: /s/ Barbara Duncan  
Name: Barbara Duncan
Title: Chief Financial Officer
 
 
 
68

 
EX-21.1 8 v037548_ex21-1.htm
Exhibit 21.1

SUBSIDIARIES OF REGISTRANT

Nascime Limited (an Irish private limited company managed in Luxembourg)

DOV Pharmaceutical Luxembourg S.a.r.l. (a Luxembourg private company)

 
 

 
EX-23.1 9 v037548_ex23-1.htm
Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (No. 333-101297), the Registration Statement on Form S-3 originally filed on Form S-1 (No. 333-112727), and the Registration Statements on Form S-3 (Nos. 333-130139 and 333-123693) of DOV Pharmaceutical, Inc. of our report dated March 14, 2006 relating to the financial statements, management’s assessment of the effectiveness of internal control over financial reporting and the effectiveness of internal control over financial reporting, which appears in this Form 10-K.

/s/ PricewaterhouseCoopers LLP

Florham Park, New Jersey
March 14, 2006


EX-31.1 10 v037548_ex31-1.htm
Exhibit 31.1

Certification by the Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002

I, Leslie Hudson, certify that:

1. I have reviewed this annual report on Form 10-K of DOV Pharmaceutical, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of registrant as of, and for, the periods presented in this report;
 
4. Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for registrant and have:

a)  
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)  
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)  
Evaluated the effectiveness of registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)  
Disclosed in this report any change in registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, registrant’s internal control over financial reporting; and
 
5. Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

a)  
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting that are reasonably likely to adversely affect registrant’s ability to record, process, summarize and report financial information; and

b)  
Any fraud, whether or not material, that involves management or other employees who have a significant role in registrant’s internal control over financial reporting.
 
Date: March 14, 2006
 
/s/ Leslie Hudson
----------------------------------------------------------
Leslie Hudson
Director, Chief Executive Officer and President
 
 
 

 
EX-31.2 11 v037548_ex31-2.htm
Exhibit 31.2

Certification by the Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002

I, Barbara Duncan, certify that:

1. I have reviewed this annual report on Form 10-K of DOV Pharmaceutical, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of registrant as of, and for, the periods presented in this report;
 
4. Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for registrant and have:

a)  
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)  
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)  
Evaluated the effectiveness of registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)  
Disclosed in this report any change in registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, registrant’s internal control over financial reporting; and
 
5. Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

a)  
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting that are reasonably likely to adversely affect registrant’s ability to record, process, summarize and report financial information; and

b)  
Any fraud, whether or not material, that involves management or other employees who have a significant role in registrant’s internal control over financial reporting.
 
Date: March 14, 2006
 
/s/ Barbara Duncan
---------------------------------
Barbara Duncan
Chief Financial Officer
 
 
 

 
EX-32 12 v037548_ex32.htm
Exhibit 32

Certification by the Chief Executive Officer Pursuant to 18 U. S. C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U. S. C. Section 1350, I, Leslie Hudson, hereby certify that, to the best of my knowledge, the Annual Report on Form 10-K of DOV Pharmaceutical, Inc. for the year ended December 31, 2005 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of DOV Pharmaceutical, Inc.

A signed original of this written statement required by Section 906 has been provided to DOV and will be retained by DOV and furnished to the Securities and Exchange Commission or its staff upon request.
 
/s/ Leslie Hudson
------------------------------------------------------------------------

Leslie Hudson
Director, Chief Executive Officer and President
March 14, 2006


Certification by the Chief Financial Officer Pursuant to 18 U. S. C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U. S. C. Section 1350, I, Barbara Duncan, hereby certify that, to the best of my knowledge, the Annual Report on Form 10-K of DOV Pharmaceutical, Inc. for the year ended December 31, 2005 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of DOV Pharmaceutical, Inc.

A signed original of this written statement required by Section 906 has been provided to DOV and will be retained by DOV and furnished to the Securities and Exchange Commission or its staff upon request.
 
/s/ Barbara Duncan 
------------------------------------------------------------------------

Barbara Duncan
Chief Financial Officer
March 14, 2006

These certifications accompany this Report on Form 10-K pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by such Act, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act, except to the extent that the Company specifically incorporates it by reference.
 
 
 

 

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