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EXHIBIT 10.1 EXCLUSIVE LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

License Agreement

EXHIBIT 10.1 EXCLUSIVE LICENSE, DEVELOPMENT AND

                           COMMERCIALIZATION AGREEMENT | Document Parties: DOV PHARMACEUTICAL INC |  MSD WARWICK (MANUFACTURING) LTD. You are currently viewing:
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DOV PHARMACEUTICAL INC | MSD WARWICK (MANUFACTURING) LTD.

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Title: EXHIBIT 10.1 EXCLUSIVE LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Governing Law: New Jersey     Date: 9/22/2004
Industry: Biotechnology and Drugs     Sector: Healthcare

EXHIBIT 10.1 EXCLUSIVE LICENSE, DEVELOPMENT AND

                           COMMERCIALIZATION AGREEMENT, Parties: dov pharmaceutical inc ,  msd warwick (manufacturing) ltd.
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                                                                    EXHIBIT 10.1

 

***Confidential   treatment has been requested for portions of this exhibit.   The

copy   filed   herewith   omits   the   information   subject   to the   confidentiality

request.   Omissions are designated as [***]. A complete   version of this exhibit

has been filed separately with the Securities and Exchange Commission.

 

 

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EXECUTION COPY

 

 

                       EXCLUSIVE LICENSE, DEVELOPMENT AND

                           COMMERCIALIZATION AGREEMENT

 

                                 BY AND BETWEEN

 

                        MSD WARWICK (MANUFACTURING) LTD.

 

                                       AND

 

                            DOV PHARMACEUTICAL, INC.

 

 

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         EXCLUSIVE LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

      THIS AGREEMENT   (including all exhibits,   schedules and other attachments,

this   "Agreement"),   effective as of the Closing Date   (defined   below),   by and

between MSD WARWICK   (MANUFACTURING)   LTD., a corporation organized and existing

under the laws of Bermuda   ("MERCK"),   with a   principal   place of   business   at

Chesney    House,    96   Pitts   Bay   Road,    Pembroke   HM   08,    Bermuda   and   DOV

Pharmaceutical,   Inc., a corporation   organized   and existing   under the laws of

Delaware,   with   a   principal   place   of   business   at   433   Hackensack   Avenue,

Hackensack, NJ 07601 ("DOV").

 

                                    RECITALS:

 

       WHEREAS,   DOV has developed DOV Know-How (as hereinafter   defined) and has

rights to DOV Patent Rights (as hereinafter defined); and

 

      WHEREAS, MERCK and DOV desire to enter into a collaboration to develop the

Compound   (as   hereinafter   defined)   upon the   terms and   conditions   set forth

herein; and

 

      WHEREAS, MERCK desires to obtain a license under the DOV Patent Rights and

DOV Know-How,   upon the terms and conditions set forth herein and DOV desires to

grant such a license; and

 

      WHEREAS,   MERCK   desires to obtain a right of first   refusal to obtain the

rights to develop DOV 102,677 for the   treatment   and/or   prevention   of anxiety

and/or depression;

 

      NOW, THEREFORE,   in consideration of the foregoing premises and the mutual

covenants herein contained, the Parties hereby agree as follows:

 

1.     DEFINITIONS

 

      Unless specifically set forth to the contrary herein, the following terms,

whether used in the singular or plural,   shall have the respective   meanings set

forth below:

 

1.1    "ACT" shall mean, as applicable,   the United States Federal Food, Drug and

      Cosmetic   Act,   21 U.S.C.   ss.ss.   301 et seq.,   and/or the Public   Health

      Service   Act, 42 U.S.C.   ss.ss.   262 et seq.,   as such may be amended from

      time to time.

 

1.2    "AFFILIATE"   shall mean, in relation to a Party, any corporation or entity

      that,   directly   or   indirectly   owns,   is   owned   by or is   under   common

      ownership with such Party. For purposes of this definition, the term "own"

       (as used in the terms   "owns,"   "owned by" and "under   common   ownership")

      means direct or indirect   beneficial   or legal   ownership of fifty percent

      (50%) or more of the voting interest in, or fifty percent (50%) or more of

      the equity of or the right to appoint   fifty   percent (50%) or more of the

      directors or managers of that   corporation or other business entity or the

      power to direct or cause the direction of the   management   and policies of

      such   corporation or entity,   whether   pursuant to the ownership of voting

      securities, by contract or otherwise.

 

 

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1.3    "ASYMMETRIC PROCESS" shall mean, (i) with regard to the manufacture of DOV

      21,947 , a process whereby no significant amount of DOV 102,677 is created

      and (ii) with regard to the manufacture of DOV 102,677,   a process whereby

      no significant amount of DOV 21,947 is created.

 

1.4    "BANKRUPTCY EVENT" is defined in Section 9.3.2.

 

1.5    "CALENDAR   QUARTER"   shall   mean   the   respective   periods   of   three   (3)

      consecutive   calendar months ending on March 31, June 30, September 30 and

      December 31.

 

1.6    "CALENDAR   YEAR" shall mean each   successive   period of twelve (12) months

      commencing on January 1 and ending on December 31.

 

1.7    "CHANGE OF CONTROL" is defined in Section 12.2.

 

1.8    "CLINICAL   TRIAL" shall mean a Phase I Clinical   Trial,   Phase II Clinical

      Trial, Phase III Clinical Trial and/or Phase IV Clinical Trial.

 

1.9    "CLOSING DATE" shall mean the date upon which the HSR Conditions have been

      met.

 

1.10   "COLLABORATION   TERM"   shall mean the   duration of the   Collaboration,   as

      described more fully in Section 2.7.

 

1.11   "COLLABORATION" shall mean the activities undertaken by the Parties hereto

      as set forth in Article 2.

 

1.12   "COMBINATION   DRUG" shall mean a Product that   includes one or more active

      ingredients   other   than   Compound   in   combination   with   Compound.    All

      references   to   Product   in this   Agreement   shall be   deemed   to   include

      Combination Drug.

 

1.13   "COMMERCIALLY   REASONABLE   EFFORTS" shall mean with respect to the efforts

      to be   expended   by a Party   with   respect to any   objective,   reasonable,

      diligent,   good faith efforts to accomplish   such   objective as such Party

      would   normally   use to   accomplish   a   similar   objective   under   similar

      circumstances,   it being   understood   and agreed that with   respect to the

      research,   development or commercialization   of Compound or Product,   such

      efforts shall be   substantially   equivalent to those efforts and resources

      commonly used by a Party for a similar   pharmaceutical product owned by it

      or to which it has   rights,   which   product   is at a similar   stage in its

      development or product life and is of similar market potential taking into

      account   efficacy,   safety,   approved   labeling,   the   competitiveness   of

      alternative products in the marketplace,   the patent and other proprietary

      position of the product,   the likelihood of regulatory   approval given the

      Regulatory Authority involved,   the profitability of the product including

      the   royalties   payable   to   licensors   of   patent   or other   intellectual

      property   rights,    alternative    products   and   other   relevant   factors.

      Expenditures   by MERCK for development of the Product or Compound that are

      comparable to expenditures by MERCK for similar products or compounds at a

      similar   commercial   value and stage of   development   shall be evidence of

      Commercially Reasonable Efforts.   Commercially Reasonable Efforts shall be

      determined on a market-by-market and Indication-by-Indication   basis for a

      particular   Compound or Product,   and it is anticipated   that the level of

      effort will be different for different markets, and will change over time,

      reflecting   changes   in   the   status   of the   Product   and   the   market(s)

      involved.   The   royalties   and other   payments made or required to be made

      hereunder or under the Wyeth Agreement shall not be factors in determining

      whether   a Party has used   Commercially   Reasonable   Efforts,   (that is, a

      Party may not apply lesser resources or efforts in support of a Product or

      Compound because such Product or Compound is subject to a royalty on sales

      or to any other payments under this Agreement or the Wyeth Agreement).

 

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1.14   "COMMITTEE"   shall mean the joint   development   committee   established   to

      facilitate the Collaboration, as more fully described in Section 2.3.1.

 

1.15   "COMPOUND"   shall mean DOV 21,947,   and/or DOV 216,303.   For   avoidance of

      doubt, "Compound" does not include DOV 102,677.

 

1.16   "CONFIDENTIAL   INFORMATION" shall mean any Information disclosed by either

      Party that such Party has either marked as confidential or proprietary, or

      has identified in writing as   confidential   or   proprietary   within thirty

      (30) days of   disclosure   to the other   Party ;   provided,   however,   that

      (subject   in all cases to Article 4 below,   including   without   limitation

      Sections   4.2 and   4.4)   information   regarding   the   Collaboration,   or a

      disclosing Party's business plans, strategies, technology,   manufacturing,

      research   and   development,   and   products   or   services   shall be   deemed

      Confidential   Information of the disclosing Party even if not so marked or

      identified.

 

1.17   "CONTROL",   "CONTROLS" OR "CONTROLLED   BY" shall mean, with respect to any

      item of or right   under DOV Patent   Rights,   DOV   Know-How,   MERCK   Patent

      Rights,   MERCK Know-How or MERCK Termination   Know-How,   the possession of

      (whether by ownership or license,   other than pursuant to this Agreement),

      or the ability of a Party and/or its Controlled Affiliates to grant access

      to, or a license or   sublicense   of,   such item or right as   provided   for

      herein without   violating the terms of any agreement or other   arrangement

      with any Third   Party   existing   at the time such Party   would be required

      hereunder   to grant the other Party such access or license or   sublicense.

      For avoidance of doubt,   intellectual   property rights that are Controlled

      by a Controlled   Affiliate of a Party shall be deemed to be   Controlled by

      such Party.

 

1.18   "CONTROLLED AFFILIATE" shall mean, in relation to a Party, any corporation

      or entity that,   directly or indirectly   controls,   is controlled by or is

      under common control with such Party. For purposes of this definition, the

      term   "control"   (as used in the   terms   "controls,"   "controlled   by" and

      "under   common   control")   means   direct or indirect   beneficial   or legal

      ownership of more than fifty percent   (50%) of the voting   interest in, or

      more than   fifty   percent   (50%) of the   equity of or the right to appoint

      more   than   fifty   percent   (50%) of the   directors   or   managers   of that

      corporation or other   business   entity or the power to direct or cause the

      direction of the   management   and policies of such   corporation or entity,

      whether   pursuant to the   ownership of voting   securities,   by contract or

      otherwise.

 

1.19   "CO-PROMOTION   AGREEMENT" shall have the meaning provided for in paragraph

      2 of Schedule 3.7.

 

1.20   "CRO" is defined in Section 2.2.1 hereof.

 

1.21   "DDMAC" shall mean the United States Food and Drug Administration Division

      of Drug Marketing, Advertising, and Communications.

 

1.22   "DETAIL" shall mean a product presentation in a face-to-face meeting in an

      individual   or   group   practice   setting   between   a   professional    sales

      representative   and a Target   Prescriber   in which one or more key product

      benefits are verbally   presented in a balanced   manner.   For   avoidance of

      doubt,   a Detail does not include a reminder or sample   drop.   "Detailing"

      shall mean the act of presenting a Detail.

 

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1.23   "DOV    21,947"    shall   mean   the    compound    having   a    chemical    name

      (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane,      including     all

      solvates, Prodrugs, salts and polymorphs thereof.

 

1.24   "DOV    102,677"    shall   mean   the    compound    having   a   chemical    name

      (-)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane,      including     all

      solvates, Prodrugs, salts and polymorphs thereof.

 

1.25   "DOV    216,303"    shall   mean   the    compound    having   a   chemical    name

      (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane,      including     all

      solvates, Prodrugs, salts and polymorphs thereof.

 

1.26   "DOV INFORMATION AND INVENTIONS" shall mean all protocols, formulas, data,

      Inventions, know-how and trade secrets, patentable or otherwise, resulting

      from the Collaboration developed or invented solely by employees of DOV or

      other persons not employed by MERCK acting on behalf of DOV.

 

1.27   "DOV KNOW-HOW" shall mean all information and materials, including but not

      limited   to   discoveries,   improvements,   processes,   methods,   protocols,

      formulas,   data   (including   data and results from   research,   preclinical

       development and Clinical Trials), inventions (including without limitation

      DOV   Information   and   Inventions   and DOV's and/or any of its   Controlled

      Affiliates'   rights in Joint   Information   and   Inventions),   know-how and

      trade   secrets,   patentable or otherwise,   which (i) are Controlled by DOV

      and/or any of its   Controlled   Affiliates as of the Closing Date or become

      Controlled by DOV and/or its Controlled Affiliates during the term of this

      Agreement,   (ii) are not generally known and (iii) are necessary or useful

      to   MERCK   in   connection    with   the    Collaboration    or   the   research,

      development, manufacture, marketing, use or sale of Compound or Product in

      the Territory, excluding, however, any MERCK Know-How.

 

1.28   "DOV PATENT RIGHTS" shall mean any and all Patent Rights Controlled by DOV

      or its Controlled   Affiliates as of the Closing Date or become   Controlled

      by DOV and/or its Controlled   Affiliates during the term of this Agreement

      that (i) would be practiced by the manufacture,   use, sale, offer for sale

      or   importation   of   Compound   or   Product;   or (ii)   claim or   cover   DOV

      Information   and Inventions,   including,   but not limited to, those Patent

      Rights listed on Schedule 1.28.

 

1.29   "DRUG    DEVELOPMENT    PLAN"   shall   mean   the    preclinical   and   clinical

      development   plan for Compound(s) and Product(s),   developed in accordance

      with the Collaboration as described in Article 2.

 

1.30   "EMEA"   shall mean the   European   Agency for the   Evaluation   of Medicinal

      Products (a cross-national Regulatory Authority in the European Union) and

      any   successor    Governmental   Authority   having   substantially   the   same

      function.

 

1.31   "EXECUTION DATE" shall mean the date of last execution by both Parties.

 

1.32   "FDA" shall mean the United States Food and Drug   Administration,   and any

      successor Governmental Authority having substantially the same function.

 

1.33   "FIELD"   shall mean (i) in the case of DOV   21,947,   the use of DOV 21,947

      and/or pharmaceutical preparations in final form containing DOV 21,947 for

      the   treatment   and/or   prevention   and/or   diagnosis   of diseases   and/or

      medical conditions in humans and/or animals; and (ii) in the case of

 

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      DOV 216,303, the use of DOV 216,303 and/or pharmaceutical   preparations in

      final form   containing   DOV 216,303 for the   treatment   and/or   prevention

      and/or   diagnosis of   depression,   anxiety or   addiction in humans   and/or

      animals.

 

1.34   "FILING" of an NDA shall mean the acceptance by a Regulatory   Authority of

      an NDA for filing.

 

1.35   "FIRST COMMERCIAL SALE" shall mean, with respect to any Product, the first

      sale by   MERCK   or a   Related   Party   for end use or   consumption   of such

      Product in a country,   excluding,   however, any sale or other distribution

      for use in a Clinical Trial.

 

1.36   "FIRST POSITION DETAIL" shall mean a Detail where key product messages and

      benefits are   presented   in the first   position and at least [***]% of the

      time available is spent on this presentation.

 

1.37   "GLP" or "GOOD LABORATORY PRACTICE" shall mean the applicable then-current

      standards for laboratory activities for pharmaceuticals or biologicals, as

      set forth in the Act and any regulations or guidance documents promulgated

      thereunder,   as   amended   from   time to time,   together   with any   similar

      standards of good   laboratory   practice as are required by any   Regulatory

      Authority in the Territory.

 

1.38   "GMP"   OR   "GOOD    MANUFACTURING    PRACTICE"   shall   mean   the   applicable

      then-current standards for United States Good Manufacturing   Practices, as

       specified   in the   United   States   Code   of   Federal   Regulations   and any

      regulations or guidance documents promulgated thereunder,   as amended from

      time to time,   together with any similar   standards of good   manufacturing

      practice as are required by any Regulatory Authority in the Territory.

 

1.39   "GOVERNMENTAL   AUTHORITY" means any government,   any governmental   entity,

      department,   commission, board, agency or instrumentality,   and any court,

      tribunal or judicial or arbitral body,   whether   federal,   state or local,

      including, without limitation, the U.S. Federal Trade Commission.

 

1.40   "HSR ACT" means the Hart-Scott-Rodino   Antitrust Improvements Act of 1974,

      as amended, 15 U.S.C. ss.18A.

 

1.41   "HSR   CLEARANCE   DATE" means the   earliest   date on which both   Parties or

      their   Controlled   Affiliates   have actual   knowledge   that all applicable

      waiting   periods   under   the   HSR Act   with   respect   to the   transactions

      contemplated hereunder have expired or have been terminated.

 

1.42   "HSR CONDITIONS" shall have the meaning provided in Section 11.2.

 

1.43   "HSR FILING" means filings by MERCK or its   Controlled   Affiliates and DOV

      with the United States Federal Trade Commission and the Antitrust Division

      of the United States   Department of Justice of a   Notification   and Report

      Form for Certain Mergers and   Acquisitions (as that term is defined in the

      HSR Act) with respect to the matters set forth in this Agreement, together

      with all required documentary attachments thereto.

 

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1.44   "IND" shall mean an investigational   new drug application,   clinical study

      application,    clinical   trial   exemption,    or   similar    application   or

      submission   for approval to conduct human   clinical   investigations   filed

      with or   submitted   to a   Regulatory   Authority   in   conformance   with the

      requirements of such Regulatory Authority.

 

1.45   "INDICATION"   shall   mean   the   primary   prophylactic   and/or   therapeutic

      purpose for which a Product is   developed   specifically   directed   towards

      obtaining   Regulatory   Approval   for use of such   Product   pursuant   to an

      approved   label   claim.   A single   Indication   shall   include   the primary

      disease and variants or sub-divisions or   sub-classifications   within such

      primary disease.   For example,   for purposes of this Agreement,   treatment

      and/or   prevention   of   anxiety   is a single   Indication;   treatment   of a

      particular   phobia   would be   treated as a   sub-classification   within the

      single   Indication   of   anxiety.   Treatment   and   prophylaxis   of the same

      general   psychiatric   disorder   (e.g.   anxiety)   as   defined by the DSM-IV

      (i.e.,   Diagnosis   and   Statistical   Manual)   shall be treated as the same

      Indication.   However,   treatment of depression shall be deemed a different

      Indication from treatment of anxiety.

 

1.46   "INFORMATION"   shall   mean any and all   information   and   data,   including

      without   limitation all MERCK Know-How,   MERCK Termination   Know-How,   DOV

      Know-How,   and all other scientific,   preclinical,   clinical,   regulatory,

      manufacturing,   marketing,   financial and commercial   information or data,

      whether   communicated in writing or orally or by any other method, that is

      provided by one Party (or such Party's Controlled Affiliates) to the other

      Party in connection with this Agreement.

 

1.47   "INITIATES"    shall   mean,    with   respect   to   a   Clinical    Trial,    the

      administration of the first dose to a patient in such Clinical Trial.

 

1.48   "INVENTION" shall mean any process, method, composition of matter, article

      of manufacture,   discovery or finding that is (i) conceived as a result of

      the Collaboration; or (ii) is conceived as a result of the practice of DOV

      Patent Rights during or after the term of the Collaboration.

 

1.49   "JOINT   INFORMATION   AND INVENTIONS"   shall mean all protocols,   formulas,

      data,   Inventions,   know-how and trade   secrets,   patentable or otherwise,

      resulting from   collaborative   activities   occurring   prior to the Closing

      Date, or during the   Collaboration   or resulting   from the practice of the

      DOV Patent Rights during or after the term of the Collaboration   developed

      or   invented   jointly by   employees   of MERCK and DOV or others   acting on

      behalf of MERCK and DOV.

 

1.50   "JOINT   PATENT   RIGHTS" shall mean any and all Patent Rights that claim or

      cover any Joint Information or Inventions.

 

1.51   "LAUNCH   DATE" shall mean the date   subsequent   to receiving the necessary

      Regulatory   Approvals in the United   States when the Parties will initiate

      Detailing   activities in the United States,   as such date is determined by

      MERCK.

 

1.52   "MAJOR   MARKET"   shall   mean any one of the   following   countries:   United

      States, Japan, the United Kingdom, France, Germany, Italy or Spain.

 

1.53   "MARKETING   AUTHORIZATION"   shall   mean   (i) for the   United   States,   the

      approval of an NDA,   and (ii) for any foreign   jurisdiction,   the approval

      from the   relevant   Regulatory   Authority   necessary   to market and sell a

      Product in that country,   including,   without   limitation,   all applicable

      pricing and government reimbursement approvals.

 

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1.54   "MERCK   INFORMATION   AND INVENTIONS"   shall mean all protocols,   formulas,

      data,   Inventions,   know-how and trade   secrets,   patentable or otherwise,

      resulting   from the   Collaboration   or resulting   from the practice of DOV

      Patent Rights during or after the term of the Collaboration,   developed or

      invented solely by employees of MERCK or other persons not employed by DOV

      acting on behalf of MERCK.

 

1.55   "MERCK   KNOW-HOW" shall mean all information and materials,   including but

      not limited to discoveries,   improvements,   processes, methods, protocols,

      formulas,   data   (including   data and results from   research,   preclinical

      development and Clinical Trials), inventions (including without limitation

      MERCK   Information and Inventions and MERCK's and/or any of its Controlled

      Affiliates'   rights in Joint   Information   and   Inventions),   know-how and

      trade   secrets,   patentable   or   otherwise,   which during the term of this

      Agreement,   (i) are   Controlled   by   MERCK   and/or   any of its   Controlled

      Affiliates, (ii) are not generally known and (iii) are necessary or useful

      to DOV in connection with the Collaboration.

 

1.56   "MERCK PATENT   RIGHTS" shall mean any and all Patent Rights   Controlled by

      MERCK   and/or   any of   MERCK's   Controlled   Affiliates,   that (i) would be

      practiced by the manufacture,   use, sale, offer for sale or importation of

      Compound   or   Product;   or (ii)   claim   or   cover   MERCK   Information   and

      Inventions or MERCK's rights in Joint Information and Inventions.

 

1.57   "MERCK   TERMINATION   KNOW-HOW"   shall mean all   information and materials,

      including   but   not   limited   to   discoveries,    improvements,   processes,

      methods,   protocols,   formulas,   data   (including   data and   results   from

      research,    preclinical   development   and   Clinical   Trials),    inventions

      (including without limitation MERCK Information and Inventions and MERCK's

      and/or any of its Controlled   Affiliates'   rights in Joint Information and

      Inventions),   know-how and trade secrets,   patentable or otherwise,   which

      during the term of this Agreement,   (i) are Controlled by MERCK and/or any

      of MERCK's Controlled Affiliates,   (ii) are not generally known, and (iii)

      are necessary for the research, development,   manufacture,   marketing, use

      or sale of Compound or Product in the Territory,   excluding,   however, any

      DOV Know-How. The MERCK Termination Know-How shall include the information

       of the type set forth in Schedule 1.57.

 

1.58   "MOTHER   LIQUOR"   shall mean a liquid stream (i)   containing   the negative

      isomer after recovery of the desired positive   isomer,   or (ii) containing

      the positive isomer after recovery of the desired negative isomer.

 

1.59   "NDA" shall mean a New Drug Application or Biologics   License   Application

      submitted   to the FDA, or a   Worldwide   Marketing   Application,   Marketing

      Authorization   Application or similar   application filed with a Regulatory

      Authority to obtain approval for marketing a biological or   pharmaceutical

      product in a foreign country or group of countries.

 

1.60   "NET SALES" shall mean the gross invoice price of Product sold by MERCK or

      any   Related   Party to the first   Third   Party,   after   deducting,   if not

      previously deducted, from the amount invoiced or received:

 

      (a) trade and   quantity   discounts   actually   allowed or taken   other than

      early pay cash discounts;

 

      (b) amounts   allowed or taken by reason of returns,   rebates,   chargebacks

      and other allowances;  

 

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      (c) retroactive   price reductions that are actually allowed or granted and

      that are specifically identifiable as relating to Products; and

 

      (d) a fixed amount equal to [***] percent   ([***]%) of the amount invoiced

      to cover bad debt,   sales or excise taxes,   early payment cash   discounts,

      custom duties, and other governmental   charges,   sales commissions paid to

      Third Party distributors and/or selling agents, and the cost of devices or

      delivery systems used for dispensing or administering Product;

 

      With respect to sales of Combination   Drugs, Net Sales shall be calculated

      on the basis of the gross invoice price of Product(s)   containing the same

      strength of Compound sold without other active   ingredients.   In the event

      that Product is sold only as a Combination   Drug,   (y) with respect to any

      Combination   Drug in which   Compound   is   combined   only   with one or more

      active   ingredients   the   manufacture,    use,   sale,   offer   for   sale   or

      importation   of which active   ingredient(s)   would not practice any Patent

      Right Controlled by MERCK, MERCK's Controlled Affiliates or a Third Party,

      Net Sales shall be   calculated   on the basis of the gross invoice price of

      the Combination Drug and (z) with respect to any Combination Drug in which

      Compound   is   combined   only   with   one or   more   active   ingredients   the

      manufacture,   use sale,   offer   for sale or   importation   of which   active

      ingredient(s) would practice any Patent Right Controlled by MERCK, MERCK's

      Controlled Affiliates, or a Third Party, DOV and MERCK shall, prior to any

      sales   of such   Combination   Drug,   negotiate   in good   faith   to agree in

      writing on the relative value of Compound and each other active ingredient

      in such Combination   Drug, which   determination   shall be based upon sales

       prices for comparable   products.   Such relative   value(s) shall be used in

      calculating Net Sales.   The deductions set forth in paragraphs (a) through

      (d) above will be applied in calculating Net Sales for a Combination Drug.

 

1.61   "PARTY" shall mean MERCK and DOV,   individually,   and "PARTIES" shall mean

      MERCK and DOV, collectively.

 

1.62   "PATENT   RIGHTS"   shall   mean   patents   and   patent   applications   in   the

      Territory   (which for the   purposes of this   Agreement   shall be deemed to

      include   certificates of invention and   applications   for   certificates of

      invention),     including     provisionals,      divisions,     continuations,

      continuations-in-part,    reissues,   renewals,   extensions,    supplementary

      protection   certificates,   and the like of any   such   patents   and   patent

      applications,   and foreign equivalents   thereof, and shall include patents

      whose term has been   extended   by   statutory   patent term   adjustments   or

      extensions in any jurisdiction in the Territory, including but not limited

      to those patent term   adjustments   and extensions   granted under 37 C.F.R.

      ss.ss. 1.701 - 1.705, 35 U.S.C. ss. 154(b), or 35 U.S.C. ss. 156.

 

1.63   "PIVOTAL   CLINICAL   TRIAL"   shall   mean an   adequate   and   well-controlled

      Clinical Trial designed to demonstrate   efficacy of a Product   intended to

      form the basis of Filing an NDA .

 

1.64   "PHASE I CLINICAL   TRIAL" shall mean a human clinical trial in any country

      that would satisfy the requirements of 21 CFR 312.21(a).

 

1.65   "PHASE II CLINICAL TRIAL" shall mean a human clinical trial in any country

      that would satisfy the requirements of 21 CFR 312.21(b).

 

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1.66   "PHASE   III   CLINICAL   TRIAL"   shall   mean a human   clinical   trial in any

      country that would satisfy the requirements of 21 CFR 312.21(c).

 

1.67   "PHASE IV CLINICAL   TRIAL" shall mean a human clinical trial following the

      approval   of an NDA,   including   any human   clinical   trial in any country

      consistent with the description set forth in 21 CFR 312.85.

 

1.68   "PRODRUG" shall mean a compound that, upon metabolism   within the body, is

      converted   to DOV   21,947,   DOV   216,303   or   DOV   102,677,   the   in   vivo

       pharmacological   activity of which substantially   derives from the in vivo

      presence of the DOV 21,947, DOV 216,303 or DOV 102,677, respectively, into

      which the compound is converted.

 

1.69   "PRODUCT(S)"   shall mean any   pharmaceutical   preparation   in final   form,

      including without limitation any Combination Drug, containing Compound (i)

      for sale by prescription,   over-the-counter   or any other method,   or (ii)

      for administration to human patients in a Clinical Trial.

 

1.70   "REGULATORY   AUTHORITY"   shall mean any applicable   government   regulatory

      authority,   including   the FDA in the   United   States   and the EMEA in the

      European   Union,   involved in granting   approvals   for   manufacturing   and

      marketing a Product in the United States, or for manufacturing, marketing,

      reimbursement   and/or   pricing   of a Product   in any other   country in the

      Territory.

 

1.71   "RELATED   PARTY"   shall   mean each of   MERCK,   its   Affiliates,   and their

      respective   sublicensees (which term does not include distributors to whom

      MERCK sells,   without   restriction,   Product or Compound),   as applicable;

      provided, however, that a manufacturer that is sublicensed by MERCK solely

      for the purpose of   manufacturing   (and not for the purpose of developing,

      marketing   or   selling)   Compound   or Product   for MERCK and whose   Patent

      Rights are not Controlled by Merck shall not be deemed a "Related Party".

 

1.72   "SPECIALIST"   shall   mean a   psychiatrist   or   neurologist,   or such other

      specialist   medical or health care   professional   authorized   to prescribe

      Product under the laws of the jurisdiction in which such medical or health

      care   professional   is practicing,   to the extent that such   psychiatrist,

      neurologist or other specialist is approved by MERCK.

 

1.73   "SPECIALTY SALES   REPRESENTATIVES"   shall mean employees of DOV performing

      the sales promotion of pharmaceutical products to Target Prescribers.

 

1.74   "SUCCESSFUL   COMPLETION"   of a   Pivotal   Clinical   Trial   shall   mean   the

      achievement of a [***] and [***].

 

1.75   SYMMETRIC   PROCESS" shall mean, (i) with regard to the   manufacture of DOV

      21,947, a process whereby a significant amount of DOV 102,677 is made, and

      (ii) with regard to the   manufacture of DOV 102,677,   a process   whereby a

      significant amount of DOV 21,947 is made

 

1.76   "TARGET PRESCRIBER" shall mean a Specialist   identified as a member of the

      target   audience to whom DOV shall direct a Detail as   determined by MERCK

      in its marketing plans for Product.

 

1.77   "TERRITORY"   shall   mean all of the   countries   in the   world,   and   their

      territories and possessions.

 

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1.78   "THIRD   PARTY"   shall   mean an entity   other   than   MERCK and its   Related

       Parties, and DOV and its Affiliates.

 

1.79   "VALID   PATENT   CLAIM"   shall   mean a claim of an issued   patent   included

      within the DOV Patent Rights or Joint Patent Rights that claims the use or

      composition   of matter of   Compound   or   Product,   or a claim of an issued

      patent   included   within the MERCK Patent Rights that claims a composition

      of matter of Compound or Product,   the term and statutory   extensions,   if

      any,   of which   patent   have not yet   expired,   which   claim   has not been

      revoked or held unenforceable or invalid by a decision of a court or other

      governmental   agency of   competent   jurisdiction   (which   decision   is not

      appealable or has not been   appealed   within the time allowed for appeal),

      and which claim has not been disclaimed,   denied or admitted to be invalid

      or   unenforceable    through   reissue,    re-examination   or   disclaimer   or

      otherwise.

 

1.80   "WYETH" shall mean Wyeth Holdings Corporation, a Maine corporation.

 

1.81   "WYETH   AGREEMENT"   shall mean the certain   Amended and   Restated   License

      Agreement between DOV and Wyeth, effective as of May 29, 1998, relating to

      the license of DOV 216,303, as amended and restated on February 25, 2004.

 

2.     COLLABORATION

 

2.1    DRUG DEVELOPMENT PLAN.

 

      DOV and   MERCK   shall   engage   in the   Collaboration   upon the   terms   and

conditions set forth in this   Agreement.   The activities to be undertaken in the

course of the Collaboration   shall be set forth in the Drug Development Plan set

forth as Schedule 2.1 and incorporated by reference herein. The Drug Development

Plan is subject to   modification   by MERCK,   subject in all   respects   to and in

accordance with the terms and conditions of this Agreement.   MERCK shall present

any   modifications   (and if timing permits proposed   modifications)   of the Drug

Development Plan to the Committee for review and discussion,   and shall consider

in   good   faith   DOV's   input   with   regard   to   such   modifications.   The   Drug

Development   Plan shall include the preclinical   development   and   pre-Marketing

Authorization   Clinical Trials that MERCK plans to conduct,   and shall include a

plan describing with specificity the Clinical Trials to be undertaken to achieve

the Development   Milestones and Product Profile Milestones set forth in Sections

5.3 and 5.4,   and the   projected   time   frame for   these   Clinical   Trials.   For

avoidance   of doubt,   MERCK   shall have the right to   reasonably   determine   the

appropriate   Clinical Trials to be performed to achieve   Development   Milestones

and Product Profile Milestones. Notwithstanding anything herein to the contrary,

the Drug   Development   Plan shall   provide for   conducting   Clinical   Trials the

successful   outcome of which will result in the   achievement   of the   milestones

provided for in Sections   5.3(a) and 5.4 of this   Agreement,   where the Clinical

Trials   are   adequately   designed   and   powered   to   provide   data that has both

statistical and clinical significance.

 

2.2    CONDUCT OF COLLABORATION.

 

2.2.1 MERCK shall be responsible for all formulation,   preclinical   development,

      clinical   development and regulatory   work, and   manufacturing of clinical

      supplies    pursuant   to   the   Drug   Development    Plan.   Merck   shall   use

      Commercially   Reasonable   Efforts to perform   the Drug   Development   Plan.

      MERCK shall be responsible   for all regulatory   activities,   both prior to

      and after   obtaining   Marketing   Authorization,   including   global   safety

      reporting.   MERCK   shall be   entitled   to utilize   the   services   of Third

      Parties to   perform   its   Collaboration   activities.   To the extent   MERCK

      determines to use DOV as a Contract Research   Organization   ("CRO"),   such

      activities   shall be pursuant to an agreement   containing   customary terms

      and conditions and commercial   terms   negotiated in good faith between the

      Parties.   Pursuant to such an agreement, DOV shall use only Clinical Trial

      facilities   approved in advance by MERCK, and shall be entitled to utilize

      the service of Third Parties to perform its   activities as a CRO only upon

      MERCK's   prior written   consent.   Notwithstanding   any such consent,   each

      Party   shall   remain   at   all   times   fully   liable   for   its    respective

      responsibilities under the Collaboration.

 

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2.2.2 DOV and MERCK shall   conduct any   activities   that either   Party   performs

      pursuant to the   Collaboration   in compliance   with all   applicable   laws,

      rules and   regulations,   including,   without   limitation,   Good Laboratory

      Practice and Good Manufacturing Practice, to the extent applicable.   It is

      not   contemplated   that DOV shall use animals in performing its activities

      under the   Collaboration.   Each   Party   hereby   certifies   that it has not

      employed   or   otherwise   used in any   capacity,   and   will not   employ   or

      otherwise use in any capacity,   the services of any person   debarred under

      United States law,   including but not limited to 21 U.S.C. ss. 335(a),   in

      performing any portion of the Collaboration.

 

2.3    JOINT DEVELOPMENT   COMMITTEE.   The Parties hereby establish a committee to

      facilitate the Collaboration as follows:

 

2.3.1 COMPOSITION OF THE JOINT DEVELOPMENT COMMITTEE. The Collaboration shall be

      conducted   under   the   direction   of a joint   development   committee   (the

      "Committee")   comprised   of   three   representatives   of   MERCK   and   three

      representatives   of DOV. Each Party may change its   representatives to the

       Committee from time to time, in its sole discretion, effective upon notice

      to the   other   Party of such   change.   These   representatives   shall   have

      appropriate technical credentials,   experience and knowledge,   and ongoing

      familiarity   with   the    Collaboration.    Additional    representatives   or

      consultants   may from time to time, by mutual   consent of the Parties,   be

      invited to attend Committee meetings,   subject to such representative's or

      consultant's   written agreement to comply with the requirements of Article

      4. The Committee shall be chaired by a representative   of MERCK, and MERCK

      will have final   decision   making   authority on all issues   related to the

      research,     development,     regulatory    approval,     manufacturing    and

      commercialization   of Compounds   and   Products.   DOV shall have a right to

      review and provide comments on the Drug Development Plan, and in the event

      DOV has a substantive   dispute in regard to the Drug Development Plan, the

      Parties' representatives may refer the issue in dispute to the appropriate

      Executive Vice President,   MERCK Research Laboratories,   for MERCK and the

      Chief   Executive   Officer   for DOV.   In the   event   that   the   appropriate

      Executive   Vice   President   of MERCK   Research   Laboratories   or the Chief

      Executive Officer of DOV requests, in writing within fifteen (15) business

      days after the   referral   of the dispute to such   parties,   or within such

       extended period agreed upon by such executives, such executives shall meet

      in-person   to attempt to resolve the   dispute.   If   unresolved,   the final

      resolution   and/or   course   of   conduct   shall be   determined   by   MERCK's

      President,    MERCK   Research    Laboratories,    in   such   executive's   sole

      discretion.   Each   Party   shall   bear   its   own   expenses   related   to the

      attendance   of such   meetings   by its   representatives.   Each Party   shall

      provide   Committee   members with reasonable access during regular business

      hours   to   all   its   records   and   documents    that   are   related   to   the

      Collaboration or to the development of the Product.

 

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2.3.2 MEETINGS.    The   Committee   shall   meet   in   accordance   with   a   schedule

      established   by   mutual   written   agreement   of the   Parties,   but no less

      frequently   than once per   Calendar   Quarter,   with the   location for such

      meetings   alternating   between   DOV and MERCK   facilities   (or such   other

      location   as   may be   determined   by the   Committee).   Alternatively,   the

      Committee may meet by means of   teleconference,   videoconference   or other

      similar communications equipment. The Committee shall confer regarding the

      status of the Collaboration,   review relevant data and the progress of the

      Drug   Development   Plan,   consider and advise on any technical issues that

      arise   relating to the   Collaboration   that may be referred to, or invited

      for referral by, the Committee.   MERCK will provide DOV with copies of any

      minutes taken of Committee meetings.

 

2.4 EXCHANGE OF   INFORMATION.   DOV shall   transfer   copies of all   documents and

materials   Controlled by DOV or DOV's   Controlled   Affiliates   embodying the DOV

Know-How and the subject   matter of the DOV Patent Rights to MERCK within thirty

(30) days after the Closing   Date of this   Agreement   (the   "Initial   Transition

Period") and provide MERCK reasonable   technical   support from DOV technical and

scientific   personnel during this the Initial   Transition Period relating to the

use of such DOV Know-How and the practice of such DOV Patent   Rights,   solely to

the extent permitted under the licenses   granted to MERCK herein.   Following the

Initial   Transition Period,   from time to time upon MERCK's reasonable   request,

DOV shall provide reasonable technical support from DOV technical and scientific

personnel,   relating to the use of DOV   Know-How   and the practice of DOV Patent

Rights,   solely to the   extent   permitted   under the   licenses   granted to MERCK

herein.   In furtherance of the foregoing,   DOV shall   cooperate with MERCK,   and

shall cause its Controlled Affiliates and Third Party manufacturers to cooperate

with   MERCK,   in order to   accomplish   an orderly   transition   of   manufacturing

technology for Compound to MERCK.

 

2.5    RECORDS AND REPORTS.

 

2.5.1 DOV RECORDS.   If DOV is utilized as a CRO, DOV shall maintain records,   in

      sufficient detail and in good scientific manner appropriate for patent and

      regulatory purposes,   which shall fully and properly reflect all work done

      and results achieved in the performance of the Collaboration by DOV.

 

2.5.2 COPIES AND   INSPECTION   OF   RECORDS.   MERCK   shall have the right,   during

      normal business hours and upon reasonable   notice, to inspect and copy all

      such records of DOV   referred to in Section   2.5.1.   MERCK shall   maintain

      such   records   and the   information   disclosed   therein in   confidence   in

      accordance with Section 4.1. MERCK shall have the right to arrange for its

      employees   and/or   consultants   involved   in the   activities   contemplated

      hereunder   to visit the   offices   and   laboratories   of DOV and any of its

      Third Party   contractors   as   permitted   under   Section 2.2 during   normal

      business hours and upon reasonable   notice,   to discuss the   Collaboration

      work and its   results   in   detail   with the   technical   personnel   and any

      permitted Third Party contractors of DOV. Upon request,   DOV shall provide

      copies of the records described in Section 2.5.1.

 

2.5.3 QUARTERLY REPORTS.   The Parties shall each prepare a written report, which

      shall be delivered to the other Party at least   fifteen (15) days prior to

      each   quarterly   meeting of the   Committee,   which report shall inform the

      Committee of the work performed to date on the Collaboration, evaluate the

      work performed in relation to the goals of the   Collaboration   and provide

      such other information as may be reasonably   requested by the Committee (a

      "Collaboration   Quarterly   Report").   The   MERCK   Collaboration   Quarterly

      Report shall include   Information in sufficient detail that performance by

      MERCK of the Drug Development Plan and progress achieved in performing the

      Drug Development Plan may be ascertained.

 

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2.5.4 LDRC AND EDRC   REPORTS.   Only to the extent   applicable   to Compounds   and

      Products,   during   the   Collaboration   Term,   MERCK   shall   provide to DOV

      progress   reports   provided in accordance   with MERCK's   regular   business

      practices to MERCK's Early Development   Review Committee ("EDRC") and Late

      Development   Review Committee   ("LDRC"),   or the respective   successors to

      such   committees,   in order to keep DOV   informed   of the   progress of the

      conduct of activities under the   Collaboration   and the development of the

      Compounds and Products.

 

2.6    INFORMATION AND INVENTIONS. The entire right, title and interest in:

 

      (a)    DOV Information and Inventions shall be owned solely by DOV;

 

      (b)    MERCK Information and Inventions shall be owned solely by MERCK; and

 

      (c)    Joint   Information and Inventions   shall be owned jointly by DOV and

            MERCK.   Each of the   Parties,   as owners   of a joint   and   undivided

            interest in the Joint   Information   and   Inventions and Joint Patent

            Rights, shall have the right to exploit and to grant licenses in and

            to such Joint Information and Inventions and/or Joint Patent Rights,

            without an accounting or   obligation   to, or other consent   required

            from, the other Party, unless otherwise specified in this Agreement.

            Each Party   further   agrees to execute   such   documents as the other

            Party may   reasonably   require to give   effect to the intent of this

            Section   2.6(c).   For avoidance of doubt,   this Section 2.6(c) shall

            not   supersede   the licenses and other   rights   granted   pursuant to

            Article 3.

 

      Each Party shall   promptly   disclose to the other Party,   in writing,   the

      development,    making,   conception   or   reduction   to   practice   of   Joint

      Information    and   Inventions   or,    respectively,    DOV   Information   and

      Inventions and MERCK Information and Inventions.

 

2.7 COLLABORATION TERM AND TERMINATION. Except as otherwise provided herein, the

term of the Collaboration   shall commence on the Closing Date and continue until

approval of the NDA by the FDA for the first Product.

 

2.8 DEVELOPMENT REPORTS FOLLOWING TERMINATION OF COLLABORATION.   Notwithstanding

any   other   provision   of   this   Agreement,   following   the   termination   of the

Collaboration,   MERCK   shall   provide a   development   report   to DOV upon   DOV's

request no more frequently than   semianually,   which report shall include (i) an

update describing the development efforts of MERCK and its Controlled Affiliates

pertaining to the Compound and the Product,   and (ii) a description   of clinical

studies   commenced   to   achieve    Development    Milestones   or   Product   Profile

Milestones as described in Section 5.3 or Section 5.4, respectively.

 

3.     LICENSE; EXCHANGE OF INFORMATION; DEVELOPMENT AND COMMERCIALIZATION

 

3.1    LICENSE GRANT.

 

3.1.1 DOV hereby grants to MERCK an exclusive license (even as to DOV, except as

      set forth in   Section   3.1.2   below)   in the   Territory   under DOV   Patent

      Rights,   DOV's   and its   Controlled   Affiliates'   rights   in Joint   Patent

      Rights, and DOV Know-How, with a right to sublicense,   to make, have made,

      use,   offer to sell,   sell or import   Compound(s)   and   Product(s)   in the

      Field.   For the avoidance of doubt,   DOV reserves all rights not expressly

      licensed to MERCK under this   Agreement   (e.g.,   DOV reserves the right to

      make,   use,   sell,   offer to sell and   import DOV   216,303   outside of the

      Field).

 

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3.1.2 DOV hereby retains the right in the Territory   under DOV Patent Rights and

      DOV   Know-How,   to make or have made DOV   21,947 for the   purposes   of (i)

      making,   having made, using,   offering for sale,   selling or importing DOV

      102,677 and/or any pharmaceutical   preparation or preparations   containing

      DOV 102,667 and (ii) conforming to any   then-applicable   requirements of a

      Regulatory   Authority,   provided   that DOV may not use DOV   21,947 for any

      other   purposes or provide DOV 21,947 to any other   person   other than for

      the purpose of having DOV 102,677 made, and any DOV 21,947 in DOV's or any

      of its   Controlled   Affiliates'   or any   Third   Party's   possession   after

      completion   of the   process   of   making   DOV   102,677   shall   be   promptly

      destroyed.

 

3.2.   NON-EXCLUSIVE LICENSE GRANTS.

 

3.2.1 In the event that the making,   having made,   use, offer for sale,   sale or

      import by MERCK, or MERCK's Related Parties,   of Compound(s) or Product(s)

      in the Field would   infringe   during the term of this Agreement a claim of

      an issued patent Controlled by DOV or its Controlled   Affiliates and which

      patent is not covered by the grant in Section   3.1,   DOV hereby   grants to

      MERCK,   to the   extent   DOV is   legally   able to do so,   a   non-exclusive,

      sublicensable, royalty-free license in the Territory under any such issued

      patent for MERCK and   MERCK's   Related   Parties to make,   have made,   use,

      sell,   offer   for   sale   or   import   Compound(s)   and   Product(s)   in   the

      Territory.

 

3.2.2 DOV hereby grants to MERCK a non-sublicenseable,   non-exclusive license to

      use DOV   102,677 for the purpose of   developing   an assay   relating to DOV

      21,947 that   quantifies the level,   if any, of DOV 102,677   present in DOV

      21,947 in vitro or in vivo.

 

3.2.3 MERCK hereby grants to DOV a non-sublicenseable,   non-exclusive license to

      use DOV 21,947 for the   purpose of   developing   an assay   relating   to DOV

      102,677 that   quantifies   the level,   if any, of DOV 21,947 present in DOV

      102,677 in vitro or in vivo.

 

3.3.   SUBLICENSES.

 

3.3.1 MERCK may grant   written   sublicenses   of the   licenses   granted   it under

      Sections 3.1 and 3.2 above (each,   a   "Sublicense   Agreement"),   provided,

      however,   that no sublicense   granted under this Agreement   shall be valid

      unless each sublicensee (a "MERCK   Sublicensee") agrees in writing in such

       Sublicense Agreement:

 

      (i)    to exercise its rights under the   sublicense in accordance   with the

            applicable terms of this Agreement;

 

      (ii)   to maintain   records   that Merck   would be required to retain   under

            this Agreement and to permit auditors of DOV to inspect such records

            on the same basis as such records   could be inspected if retained by

            MERCK;

 

      (iii) to, in the event of a Bankruptcy Event affecting MERCK, (a) transfer

            to   DOV   any   MERCK    Termination    Know-How   to   which   such   MERCK

            Sublicensee   has access no later   than 60 days   after the   effective

            date of such Bankruptcy   Event,   (b) transfer to DOV any Information

            or Joint   Information and Inventions to which such MERCK Sublicensee

            has access and that is necessary or useful to the prosecution of DOV

            Patent Rights or Joint Patent Rights no less than 30 days before any

            application   deadline   applicable   to any DOV Patent   Right or Joint

            Patent   Right;   (c) transfer to DOV title to or   sponsorship   of any

            IND, NDA or other   regulatory   filing held in the name of such MERCK

            Sublicensee   pertaining   to the Compound or the Product,   or if such

            transfer   is not   legally   permissible   or such   items do not relate

            solely to Compound

 

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            or Product,   to grant DOV the right,   with right to   sublicense,   to

            access,   use and   cross-reference   such data,   filings and approvals

            from   Regulatory    Authorities,    which   right   shall   be   exclusive

            (including as to the MERCK   Sublicensee) with respect to Compound or

            Product;   and (d) provide to DOV reasonable   technical   support from

             technical and scientific   personnel to effect the complete   transfer

            of MERCK   Termination   Know-How to which such MERCK   Sublicensee has

            access,   including   Information   necessary   for the use of any MERCK

            Termination Know-How and the practice of any MERCK Patent Rights and

            Joint   Patent   Rights in relation   to   Compound or Product;   and (e)

            provide   that all of the   provisions   of the   foregoing   clauses (a)

            through   (d)   shall   survive   any    termination   of   the   applicable

            Sublicense Agreement;

 

      (iv)   to observe all other applicable terms of this Agreement; and

 

      (v)    that (a) DOV shall be a third party beneficiary under the applicable

            Sublicense   Agreement solely for purposes of enforcing its rights in

            the event of a Bankruptcy   Event   affecting   MERCK;   and (b) that in

            such a Bankruptcy   Event,   if the   Sublicense   Agreement by MERCK is

            rejected   and the   MERCK   Sublicensee   does not   elect to treat   the

            Sublicense   Agreement   as   terminated,   then the   MERCK   Sublicensee

            shall, at DOV's option,   enter into a license   agreement with DOV on

            the   same   terms   and   conditions   as   the    applicable    Sublicense

            Agreement.

 

3.3.2 (a) Contemporaneously with the execution of a Sublicensee Agreement, MERCK

      shall obtain from each MERCK   Sublicensee a written   acknowledgement   (the

      "Sublicensee   Acknowledgement")   stating   that   the   Sublicense   Agreement

      executed    between   such   MERCK    Sublicensee   and   MERCK   contains   those

      provisions   required by Section 3.3.1 of this Agreement.   During the first

      twelve months following the Closing Date, MERCK shall promptly provide DOV

      with a copy of each   Sublicense   Acknowledgement.   Thereafter,   MERCK will

      provide DOV with copies of any additional Sublicense Acknowledgements upon

      request, but no more frequently than once per year.

 

      (b)   MERCK   shall   maintain   a list of MERCK   Sublicensees   and a   general

      description   of the   subject   matter   of each   Sublicense   Agreement   (the

      "Sublicensee   List").    During   the   first   twelve   months   following   the

      Execution   Date, the Sublicensee   List shall be updated   contemporaneously

      upon the execution of each Sublicense   Agreement and provided   promptly to

      DOV   following   the execution of each   Sublicense   Agreement.   Thereafter,

      MERCK will   provide DOV with a copy of the updated   Sublicensee   List upon

      request, but no more frequently than once per year. .

 

3.3.3 MERCK unconditionally guarantees the performance of all MERCK Sublicensees

      in   accordance   with   the   terms of this   Agreement,   and   MERCK   shall be

      responsible   for enforcing the provisions of any   sublicense   agreement to

      ensure   that   the   MERCK   Sublicensees   do not   breach   the   terms of this

      Agreement.

 

3.3.4 In the event of a Bankruptcy Event affecting MERCK, any and all Sublicense

      Agreements shall immediately terminate.

 

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3.4.   RIGHT OF FIRST REFUSAL FOR DOV 102,677.

 

3.4.1.RIGHT OF FIRST REFUSAL. In the event that DOV desires to commercialize DOV

      102,677 or a Product   containing it for the treatment and/or prevention of

      depression   and/or   anxiety in humans   and/or   animals,   MERCK will have a

      right of first refusal with regard to obtaining   exclusive   rights to such

      commercialization.   In such a circumstance, DOV shall present a good faith

      offer for the commercialization rights for DOV 102,677.   Thereafter, after

      a sixty   (60) day period of good faith   negotiation,   if it is   reasonably

      apparent that the Parties are unable to reach agreement with regard to the

      terms and   conditions   under   which MERCK may obtain   exclusive   rights to

      commercialize    DOV   102,677   for   the   treatment   and/or    prevention   of

      depression and/or anxiety in humans and/or animals, then DOV shall be free

      to   commercialize   DOV 102,677   itself or to negotiate   with Third Parties

      with   respect   to   the    commercialization    of   DOV   102,677    through   a

      collaboration or by such Third Party,   provided,   however,   that

      prior to entering into an agreement   granting   rights to a Third Party for

      commercializing   DOV 102,677 for lesser compensation than DOV's last offer

      to MERCK,   DOV shall offer the   compensation   and other relevant   material

      terms to MERCK in writing.   If MERCK does not accept such compensation and

      other   relevant   material in writing   within   thirty (30) days, it will be

      deemed to have waived its rights.

 

3.5.   NO IMPLIED   LICENSES.   Except as specifically set forth in this Agreement,

      neither   Party shall   acquire any license or other   intellectual   property

      interest, by implication or otherwise,   in any Information disclosed to it

      under   this   Agreement   or   under   any   patents   or   patent    applications

      Controlled by the other Party or its Controlled Affiliates.

 

3.6.   DEVELOPMENT AND COMMERCIALIZATION.

 

      MERCK    shall   use    Commercially    Reasonable    Efforts   to   develop   and

commercialize   a Product   containing   at least one of the   Compounds   at its own

expense.   For   avoidance   of doubt,   a temporary   suspension,   not to exceed six

months,   of the   development   or   commercialization   of a Product due to MERCK's

reasonable determination that the Product is materially unsafe for use in humans

shall not cause MERCK to be in breach of this Section 3.6. For the   avoidance of

doubt, in the event of any such   suspension,   the provisions of Article 10 shall

apply.

 

3.7.   OPTION FOR DOV TO CO-PROMOTE PRODUCTS IN UNITED STATES.

 

3.7.1.MERCK hereby grants DOV an option to co-promote   the Product in the United

      States   only   (the    "Co-promotion    Option")   by   Detailing    Product   to

      Specialists   designated   by MERCK as Target   Prescribers,   subject   to the

      provisions of this Section 3.7, and   conditioned on DOV and MERCK entering

      into a   Co-Promotion   Agreement on terms and   conditions   consistent   with

      Schedule 3.7.

 

3.7.2.MERCK shall   determine the Launch Date of the Product,   and shall keep DOV

      apprised at quarterly   Committee   meetings of any changes in the projected

      Launch   Date for the   Product,   so that DOV has   reasonable   notice of the

      projected   Launch Date.   DOV will notify MERCK in writing of its intent to

      exercise   the   Co-Promotion   Option   twenty-four   (24) months prior to the

      projected Launch Date as communicated by MERCK (the "Exercise   Date").   If

      DOV chooses to exercise the Co-Promotion   Option, MERCK and DOV will enter

      into a Co-Promotion Agreement consistent with the terms and conditions set

      forth in Schedule 3.7 no later than eighteen (18) months before the Launch

      Date.

 

3.7.3.If DOV   exercises   the   Co-Promotion   Option,   DOV   shall be   required   to

      commence   Detailing   on the   Launch   Date for the   Product,   and   shall be

      required to deploy a sufficient number of Specialty

 

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      Sales   Representatives   as   determined   by   MERCK,   based on the reach and

      frequency of Detailing   that MERCK   determines   is desirable to the Target

      Prescribers.   For   avoidance   of doubt,   DOV shall be required to deploy a

      minimum of [***] and, unless otherwise   agreed upon in writing,   a maximum

      of [***] Specialty Sales Representatives, with the specific number of such

      Specialty   Sales   Representatives   to be   determined by MERCK based on the

      desired   reach and   frequency   of   Detailing   to Target   Prescribers,   and

      communicated   by MERCK to DOV at least sixty (60) days before the Exercise

      Date. In the event that DOV has an existing   sales force that is detailing

       a   DOV   product   to   the   same   Target    Prescribers    and   employs    more

      representatives     than    the    required    number    of    Specialty    Sales

      Representatives as determined by MERCK, MERCK shall consider in good faith

      utilizing such existing DOV sales force.   Compensation   in any event shall

      be as described in Paragraph 2(e) of Schedule 3.7.

 

3.7.4. The Co-Promotion Option shall lapse if:

 

      (a)    DOV does not notify   MERCK in writing of its intent to exercise   the

             Co-Promotion Option by the Exercise Date; or

 

      (b)    DOV cannot   provide the number of   Specialty   Sales   Representatives

            provided for in Section   3.7.3,   unless   otherwise   agreed to by the

            Parties; or

 

      (c)    The Agreement is terminated pursuant to Article 9.

 

3.8.   SUPPLY BY MERCK TO DOV OF MOTHER LIQUOR CONTAINING DOV 102, 677.

 

3.8.1.In   the   event   that   MERCK    develops   an   Asymmetric    Process   for   the

      manufacture of DOV 21,947, MERCK shall have no obligation to supply to DOV

      Mother Liquor containing DOV 102,677. In the event that MERCK manufactures

      DOV 21,947 using a Symmetric Process,   MERCK shall, upon DOV's request and

      subject to the terms and   conditions   of this Section   3.8,   supply to DOV

      such   quantities   of the Mother   Liquor   containing   DOV 102,677   that are

      obtained   by MERCK and its   Controlled   Affiliates   in the   course of such

      manufacturing   process   (except   such small   quantities   of Mother   Liquor

      needed by MERCK for   development of assays,   analytical   methods and other

      similar purposes).

 

3.8.2.Any   quantities of such Mother Liquor   supplied by MERCK shall be supplied

      "where is" and "as is",   with no   warranty as to the quality of the Mother

      Liquor   or its   fitness   for use for any   purpose.   Title and risk of loss

      shall shift to DOV upon delivery by MERCK at MERCK's site of   manufacture.

      DOV shall   develop   appropriate   packaging   and   labeling   for such Mother

      Liquor, and provide such packaging and labeling to MERCK.

 

3.8.3.DOV shall pay for any   transportation   or insurance costs   associated with

      the delivery of such   quantities   of Mother   Liquor,   and shall   reimburse

      MERCK for out of pocket costs incurred by MERCK in the recovery,   storage,

      packaging and labeling of such Mother Liquor.

 

3.8.4.DOV   shall   have   reasonable   access to   MERCK's   and   MERCK's   Controlled

      Affiliates'   data in   order   to   support   its   submissions   to   Regulatory

      Authorities relating to DOV 102,677;   provided,   however, that such access

      shall be   limited   to   employees   of DOV,   and   shall not be   extended   to

      consultants,   partners,   agents,   licensees or other Third Parties,   other

      than those   consultants   or   independent   Third Parties   involved with the

      analysis   of   studies   being   conducted   or data being   collected   for the

      purpose   of   gaining   Marketing    Authorization,    or   involved   with   the

      preparation   or   submission of materials to   Regulatory   Authorities;   and

      provided,   further   that   MERCK   shall   be   reimbursed   for   its   and   its

      Controlled    Affiliates'    fully    allocated   costs   for   supporting   such

      submissions to Regulatory Authorities.

 

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3.8.5.Any   obligation of MERCK or its Controlled   Affiliates   under this Section

      3.8 to supply Mother Liquor to DOV shall immediately cease upon any Change

      of Control in which a Major   Pharma   Entity (as   defined in Section   12.2)

      obtains   control   of   DOV by   acquiring   DOV's   assets   or   voting   equity

      securities (by asset purchase,   merger,   consolidation,   reorganization or

      otherwise), or upon the granting by DOV to any Third Party of any license,

      promotion   rights,   distribution   rights or other   rights   relating to DOV

      102,677.

 

3.9.   ASYMMETRIC TECHNOLOGY.   (a) In the event that MERCK develops an Asymmetric

      Process for   manufacture   of DOV 21,947,   MERCK shall so notify DOV. MERCK

      shall   thereafter,   upon   DOV's   request,   provide   technical   information

      necessary to permit DOV to manufacture   DOV 102,677 using such   Asymmetric

      Process ("MERCK Asymmetric   Technology").   To the extent DOV utilizes such

      MERCK Asymmetric   Technology,   and to the extent that the use of the MERCK

      Asymmetric   Technology   in the making or having made of DOV 102,677   would

      infringe   during the term of this   Agreement   a claim of an issued   patent

      Controlled by MERCK or its Controlled   Affiliates,   MERCK hereby grants to

      DOV, to the extent MERCK or its Controlled   Affiliates are legally able to

      do so, a non-exclusive, fully paid-up, sublicensable, royalty-free license

      in the Territory under the MERCK Asymmetric Technology and any such issued

       patent for DOV, DOV's Controlled Affiliates and its and their sublicensees

      to make or have made DOV 102,677 in the Territory.

 

      (b) In the event that DOV develops an Asymmetric   Process for   manufacture

of DOV 102,677,   DOV shall so notify MERCK. DOV shall   thereafter,   upon MERCK's

request,   provide technical information necessary to permit MERCK to manufacture

DOV 21,947 using such Asymmetric Process ("DOV Asymmetric   Technology").   To the

extent   MERCK   or   its   Controlled    Affiliates   utilizes   such   DOV   Asymmetric

Technology,   and to the extent that the use of the DOV Asymmetric   Technology in

the making or having made of DOV 21,947 would   infringe   during the term of this

Agreement   a claim   of an   issued   patent   Controlled   by DOV or its   Controlled

Affiliates,   DOV hereby   grants to MERCK,   to the   extent DOV or its   Controlled

Affiliates   are   legally   able   to   do   so,   a   non-exclusive,    fully   paid-up,

sublicensable,   royalty-free   license in the Territory   under the DOV Asymmetric

Technology and any such issued pate


 
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