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LICENSE AND RESEARCH COLLABORATION AGREEMENT

Collaboration Agreement

LICENSE AND RESEARCH COLLABORATION AGREEMENT | Document Parties: DECODE GENETICS INC | MERCK & CO., INC. You are currently viewing:
This Collaboration Agreement involves

DECODE GENETICS INC | MERCK & CO., INC.

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Title: LICENSE AND RESEARCH COLLABORATION AGREEMENT
Governing Law: New Jersey     Date: 3/15/2004
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AND RESEARCH COLLABORATION AGREEMENT, Parties: decode genetics inc , merck & co.  inc.
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                                                                   Exhibit 10.33

 

[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CONFIDENTIAL INFORMATION CONTAINED

IN THIS DOCUMENT. THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

                  LICENSE AND RESEARCH COLLABORATION AGREEMENT

 

                                     BETWEEN

 

                                 MERCK & CO., INC.

 

                                       AND

 

                              DECODE GENETICS, EHF.

 

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                  LICENSE AND RESEARCH COLLABORATION AGREEMENT

 

         THIS RESEARCH COLLABORATION AND LICENSE AGREEMENT (this "Agreement"),

which shall be effective as of February 25, 2004 (the "Effective Date"), is

entered into by and between deCODE genetics, Ehf., a corporation organized under

the laws of Iceland ("deCODE") and Merck & Co., Inc., a corporation organized

under the laws of the State of New Jersey, having an office located at One Merck

Drive, Whitehouse Station, New Jersey 08889 ("MERCK").

 

                             PRELIMINARY STATEMENTS

 

A.        deCODE has expertise in conducting research in the field of human

genetics and genomics and in the conduct of clinical trials.

 

B.        MERCK has certain expertise in drug development and in the design and

conduct of clinical trials to demonstrate the safety and efficacy of its

pharmaceutical products.

 

C.        deCODE and MERCK wish to collaborate on the design and conduct of

Information Rich Clinical Trials (terms with initial capitals as hereafter

defined) on selected MERCK compounds in specified Disease Areas in accordance

with the attached Work Plan.

 

D.         deCODE Parent (as hereinafter defined) and MERCK are simultaneously

entering into a separate Stock and Warrant Purchase Agreement whereby MERCK

shall purchase shares of stock of deCODE Parent pursuant to the terms and

conditions set forth in that agreement.

 

NOW, THEREFORE, in consideration of the foregoing Preliminary Statements and the

mutual agreements and covenants set forth herein, 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       "AFFILIATE" shall mean as to deCODE or MERCK, as the case may be (i)

         any corporation or business entity of which fifty percent (50%) or more

         of the securities or other ownership interests representing the equity,

         the voting stock or general partnership interest are owned, controlled

         or held, directly or indirectly, by MERCK or deCODE; or (ii) any

          corporation or business entity which, directly or indirectly, owns,

         controls or holds fifty percent (50%) (or the maximum ownership

         interest permitted by law) or more of the securities or other ownership

         interests representing the equity, the voting stock or, if applicable,

         the general partnership interest, of MERCK or deCODE.

 

1.2       "ASSOCIATED INFORMATION" shall mean information about [CONFIDENTIAL

         TREATMENT REQUESTED] in an IRCT performed as part of the Research

         Program which [CONFIDENTIAL TREATMENT REQUESTED] in an Exclusive

         Disease Area or a Non-exclusive Disease Area where the [CONFIDENTIAL

         TREATMENT REQUESTED] is associated with the [CONFIDENTIAL TREATMENT

         REQUESTED] within the Disease Area being studied in that IRCT.

 

1.3       "BUDGET" shall mean the projected expenditures for the upcoming year

         set out in Schedule 2.6

 

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         and more fully described in Section 2.6.

 

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

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

         and December 31.

 

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

         commencing on January 1 and ending on December 31.

 

1.6       A "CHANGE IN CONTROL" shall mean the occurrence of any of the

         following:

 

         (a) An acquisition of any voting securities of deCODE Parent (the

          "Voting Securities") by any "Person" (as the term "person" is used for

         purposes of Section 13(d) or 14(d) of the Securities Exchange Act of

         1934, as amended (the "Exchange Act")), immediately after which such

         Person has "Beneficial Ownership" (within the meaning of Rule 13d-3

         promulgated under the Exchange Act) of more than fifty percent (50%) of

         (1) the then-outstanding shares of common stock of deCODE Parent (or

         any other securities into which such shares of common stock are changed

         or for which such shares of common stock are exchanged) (the "Shares")

         or (2) the combined voting power of deCODE Parent's then-outstanding

         Voting Securities;

 

         (b) The individuals who, as of Effective Date, are members of the board

         of directors of deCODE Parent (the "Incumbent Board"), following a

         Merger (as hereinafter defined), do not for any reason constitute at

         least a majority of the members of the board of directors of (x) the

         corporation resulting from such Merger (the "Surviving Corporation"),

         if fifty percent (50%) or more of the combined voting power of the

         then-outstanding voting securities of the Surviving Corporation is not

         Beneficially Owned, directly or indirectly, by another Person (a

         "Parent Corporation") or (y) if there is one or more than one Parent

         Corporation, the ultimate Parent Corporation; PROVIDED, HOWEVER, that,

         any individual becoming a director subsequent to the date hereof whose

         election, or nomination for election by such company's shareholders,

         was approved by a vote of at least a majority of the directors then

         comprising the Incumbent Board shall be considered as though such

         individual were a member of the Incumbent Board, but excluding, for

         this purpose, any such individual whose initial assumption of office

         occurs as a result of an actual or threatened election contest with

         respect to the election or removal of directors or other actual or

         threatened solicitation of proxies or consents by or on behalf of a

         Person other than the board of directors of deCODE Parent (a "Proxy

         Contest"), including by reason of any agreement intended to avoid or

         settle any Proxy Contest;

 

         (c) At least eighty (80%) percent of voting securities of deCODE are no

         longer owned directly or indirectly by deCODE Parent; or

 

         (d) The consummation of:

 

                 (i)    A merger, consolidation or reorganization (1) with or

         into deCODE Parent or a direct or indirect subsidiary of deCODE Parent

         or (2) in which securities of deCODE Parent are issued (both

          1.5(c)(i)(1) and (2) are defined as a "Merger"), unless such Merger is

         a "Non-Control Transaction." A "Non-Control Transaction" shall mean a

         Merger in which:

 

                              (A) the stockholders of deCODE Parent immediately

         before such Merger own directly or indirectly immediately following

         such Merger at least fifty percent (50%) of the combined voting power

         of the outstanding voting securities of (x) the Surviving Corporation,

         if there is no Parent Corporation or (y) if there is one or more than

         one Parent Corporation, the

 

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         ultimate Parent Corporation;

 

                              (B) the individuals who were members of the

         Incumbent Board immediately prior to the execution of the agreement

         providing for such Merger constitute at least a majority of the members

         of the board of directors of (x) the Surviving Corporation, if there is

         no Parent Corporation, or (y) if there is one or more than one Parent

         Corporation, the ultimate Parent Corporation; and

 

                              (C) no Person other than (1) deCODE Parent, or

         (2) any Person who, immediately prior to the Merger had Beneficial

         Ownership of fifty percent (50%) or more of the then outstanding Shares

         or Voting Securities, has Beneficial Ownership, directly or indirectly,

         of fifty percent (50%) or more of the combined voting power of the

         outstanding voting securities or common stock of (x) the Surviving

         Corporation, if fifty percent (50%) or more of the combined voting

         power of the then outstanding voting securities of the Surviving

         Corporation is not Beneficially Owned, directly or indirectly by a

         Parent Corporation, or (y) if there is one or more than one Parent

         Corporation, the ultimate Parent Corporation; PROVIDED, HOWEVER, that

         any Person described in clause (2) of this subsection (C) may not,

         immediately following the Merger, Beneficially Own more than thirty

         percent (30%) of the combined voting power of the outstanding voting

         securities of the Surviving Corporation or the Parent Corporation, as

         applicable, for the Merger to constitute a Non-Control Transaction.

 

                              (ii) A complete liquidation or dissolution of

         deCODE Parent; or

 

                              (iii) The sale or other disposition of all or

         substantially all of the assets of deCODE Parent and its Subsidiaries

         taken as a whole to any Person (other than (x) a transfer under

         conditions that would constitute a Non-Control Transaction, with the

         disposition of assets being regarded as a Merger for this purpose or

         (y) the distribution to deCODE Parent's stockholders of any other

         assets).

 

         Notwithstanding the foregoing, a Change in Control shall not be deemed

         to occur solely because any Person (the "Subject Person") acquired

         Beneficial Ownership of more than the permitted amount of the then

         outstanding Shares or Voting Securities as a result of the acquisition

         of Shares or Voting Securities by deCODE Parent which, by reducing the

         number of Shares or Voting Securities then outstanding, increases the

         proportional number of shares Beneficially Owned by the Subject

         Persons; provided that if a Change in Control would occur (but for the

         operation of this sentence) as a result of the acquisition of Shares or

         Voting Securities by deCODE Parent and, after such share acquisition by

         deCODE Parent, the Subject Person becomes the Beneficial Owner of any

          additional Shares or Voting Securities and such Beneficial Ownership

         increases the percentage of the then outstanding Shares or Voting

         Securities Beneficially Owned by the Subject Person, then a Change in

         Control shall occur.

 

1.7       "COLLABORATION DATE" shall be February 25, 2004.

 

1.8       "COLLABORATION INFORMATION AND INVENTION" shall mean any discoveries,

         Improvements, processes, methods, protocols, formulas, data,

         inventions, know-how and trade secrets, patentable or otherwise, that

         arise from the Research Program.

 

1.9       "COLLABORATION PATENTS" shall mean any and all patents and patent

         applications in the Territory (which for the purposes of this Agreement

         shall be deemed to include certificates of invention

 

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         and applications for certificates of invention) that a Party or its

         Affiliates owns, Controls or through license or otherwise acquires

         rights during the term of this Agreement which claim, cover or relate

         to Collaboration Information and Inventions or are divisions,

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

         supplementary protection certificates, utility, models and the like of

         any such patents and patent applications and foreign equivalents

         thereof.

 

1.10      "COMBINATION PRODUCT" shall mean a Product which includes one or more

         active ingredients other than IRCT Compound or Related IRCT Compound in

         combination with IRCT Compound or Related IRCT Compound. All references

         to Product in this Agreement shall be deemed to include Combination

         Product.

 

1.11      "COMPETITIVE PRODUCT" shall mean a product containing the IRCT Compound

         or Related IRCT Compound which has or attains on a Calendar Year basis

         a market share of [CONFIDENTIAL TREATMENT REQUESTED] or more in a

         country of sale as measured by prescriptions or other similar

         information in the country of sale.

 

1.12      "COMPETITOR" shall mean a company in the pharmaceutical business sector

         with reported annual gross revenues from the sale of pharmaceuticals in

         excess [CONFIDENTIAL TREATMENT REQUESTED] for each of its [CONFIDENTIAL

         TREATMENT REQUESTED].

 

1.13      "CONTROL", "CONTROLS" OR "CONTROLLED BY" shall mean either (a) being an

         Affiliate of either MERCK or deCODE; or (b) with respect to any item of

         or right under Collaboration Patents, Patents or Know-How, the

         possession of (whether by ownership or license, other than pursuant to

         this Agreement) or the ability of a Party to grant access to, or a

         license or sublicense of, such items 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.

 

1.14      "deCODE INFORMATION AND INVENTIONS" shall mean all Collaboration

         Information and Inventions developed or invented solely by employees of

         deCODE or other persons not employed by MERCK acting on behalf of

          deCODE.

 

1.15      "deCODE KNOW-HOW" shall mean all secret, substantial and identified

         information and materials, including, but not limited to, discoveries,

         Improvements, processes, formulas, data, inventions(including without

          limitation deCODE's Information and Inventions and deCODE's rights in

         Joint Information and Inventions), know-how and trade secrets,

         patentable or otherwise, which arise from the Research Program and

         during the term of this Agreement (i) are in deCODE's possession or

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

         to MERCK in connection with the Research Program or the research,

         development, manufacture, marketing, use or sale of IRCT Compound,

         Related IRCT Compound, Tests or Product in the

 

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         Territory.

 

1.16      "deCODE COLLABORATION PATENTS" shall mean Collaboration Patents that

         claim, cover or relate to deCODE Information and Inventions excluding

         deCODE Information and Inventions relating to deCODE Generalized

         Technology.

 

1.17      "deCODE COMPOUNDS" shall mean compounds[CONFIDENTIAL TREATMENT

         REQUESTED].

 

1.18      "deCODE GENERALIZED TECHNOLOGY" shall mean any Technical Information

         relating to generalized methods for conducting genomics research and

         characterizing the function of genes or any raw data useful in

         generalized genomics research tools which at any time is owned or

         controlled by deCODE or its Affiliates (provided deCODE or its

         Affiliates have the right to license or otherwise make available such

         Technical Information to MERCK).

 

1.19      "deCODE GENOMICS DATA" shall mean (a) [CONFIDENTIAL TREATMENT

         REQUESTED] as may be created, developed or acquired by deCODE from time

         to time during the term of this Agreement or as may be existing or have

         been created as of the Effective Date, and (b) deCODE's proprietary

         inventions, processes and other assets directly relating to the use,

         creation, maintenance, development, operation, access, analysis,

         reporting, storage, protection, and/or transmission of such proprietary

          databases, including proprietary methods, procedures and techniques,

         procedure manuals, personal and scientific data, computer technical

         expertise and software, in each case independently developed by or on

         behalf of deCODE and such software useful for the analysis of the

         information included in such databases.

 

1.20      "deCODE PARENT" shall mean deCODE genetics, Inc., a corporation

         organized and existing under the laws of the State of Delaware.

 

1.21      "deCODE PATENTS" shall mean Patents, that deCODE or its Affiliates

         Control prior to the Effective Date or during the term of this

         Agreement, including but not limited to those listed on Schedule 1.21,

         that are necessary or useful to MERCK in connection with the Research

         Program or the research, development, manufacture, marketing, use or

         sale of IRCT Compound, Tests or Product in the Territory including

         Patents claiming deCODE Genomics Data but excluding any part of Patents

         claiming deCODE Generalized Technology.

 

1.22      "deCODE PRIOR KNOW-HOW" shall mean all secret, substantial and

         identified information and materials, including, but not limited to,

         discoveries, Improvements, processes, formulas, data, inventions,

         know-how and trade secrets, patentable or otherwise, which existed

         prior to the Effective Date and during the term of this Agreement (i)

         are in deCODE's possession or control, (ii) are not generally known and

         (iii) are necessary or useful to MERCK in connection with the

 

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         Research Program or the research, development, manufacture, marketing,

         use or sale of IRCT Compound, Tests or Product in the Territory

         including deCODE Genomics Data but excluding deCODE Generalized

         Technology and deCODE Know-How.

 

1.23      "DISEASE AREAS" shall mean Exclusive Disease Areas and Non-exclusive

         Disease Areas.

 

1.24      "EXCLUSIVE DISEASE AREAS" shall mean at least one of the following:

         [CONFIDENTIAL TREATMENT REQUESTED].

 

1.25      [CONFIDENTIAL TREATMENT REQUESTED]

 

1.26      [CONFIDENTIAL TREATMENT REQUESTED]

 

1.27      [CONFIDENTIAL TREATMENT REQUESTED]

 

1.28      "NON-EXCLUSIVE DISEASE AREAS" shall mean [CONFIDENTIAL TREATMENT

         REQUESTED].

 

1.29      [CONFIDENTIAL TREATMENT REQUESTED]

 

1.30      "ELECTED DISEASE" shall have the meaning set out in Section 3.1(d).

 

1.31      "EXCLUSIVE LICENSE FEE" shall have the meaning set out in Section

         3.1(d).

 

1.32      "EXECUTIVE COMMITTEE" shall mean the committee made up of one senior

         executive of each Party as more fully described in Section 2.5.1.

 

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

         of an NDA for filing.

 

1.34      "FIRST COMMERCIAL SALE" shall mean, with respect to any Product or

         Test, the first sale for end use or consumption of such Product or Test

         in a country after all required approvals, including Marketing

         Authorization, have been granted by the Regulatory Authority of such

         country.

 

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1.35      "FULL TIME EQUIVALENT" or "FTE" shall mean the equivalent of a

         full-time scientist's work time over a twelve-month period (including

         normal vacations, sick days and holidays). The portion of an FTE year

         devoted by a scientist to the Research Program shall be determined by

         dividing the number of full days during any twelve-month period devoted

         by such employee to the Research Program by the total number of working

         days during such twelve-month period.

 

1.36      "IMPROVEMENT" shall mean any enhancement, whether or not patentable, in

         the manufacture, formulation, ingredients, preparation, presentation,

         means of delivery, dosage or packaging of IRCT Compound, Related IRCT

         Compound, Tests or Product.

 

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

         without limitation all MERCK Know-How, deCODE Know-How, and all other

         scientific, pre-clinical, clinical, regulatory, manufacturing,

         marketing, financial and commercial information or data, whether

         communicated in writing or orally or by any other method, which is

         provided by one Party to the other Party in connection with this

         Agreement.

 

1.38      "INFORMATION RICH CLINICAL TRIAL OR IRCT" shall mean a clinical trial

         which includes the following, as specified in the protocol for such

         clinical trial: [CONFIDENTIAL TREATMENT REQUESTED]

 

1.39      "INVENTION" means any process, method, composition of matter, article

         of manufacture, discovery or finding that is conceived and reduced to

         practice.

 

1.40      "IRCT COMPOUND" shall mean a Selected Compound that has [CONFIDENTIAL

         TREATMENT REQUESTED] in accordance with the Agreement.

 

1.41      "JOINT INFORMATION AND INVENTIONS" shall mean all discoveries,

         Improvements, processes, methods, protocols, formulas, data,

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

         arising from the Research Program developed or invented jointly by

         employees of MERCK and deCODE or others acting on behalf of MERCK and

         deCODE.

 

1.42      "JOINT COLLABORATION PATENTS" shall mean Collaboration Patents that

         claim, cover or relate to Joint Information and Inventions.

 

1.43      "MARKETING AUTHORIZATION" shall mean any approval (including without

         limitation all applicable pricing and governmental reimbursement

         approvals) necessary to receive permission from the relevant Regulatory

         Authority to market and sell a Product or Test in any country.

 

1.44      "MERCK COMPOUND OPTION" shall have the meaning set out in Section

         3.1(e) (i).

 

1.45      "MERCK COMPOUND PATENT" shall mean any Patent that claims, covers or

         relates to an IRCT Compound, Related IRCT Compound, Test or Product

         Controlled by MERCK.

 

1.46      "MERCK EXERCISE NOTICE" shall have the meaning set out in Section

         3.1(e) (iii).

 

1.47      "MERCK INFORMATION AND INVENTIONS" shall mean all discoveries,

         Improvements, processes,

 

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         methods, protocols, formulas, data, Inventions, know-how and trade

         secrets, patentable or otherwise, arising from the Research Program

         developed or invented solely by employees of MERCK or other persons not

         employed by deCODE acting on behalf of MERCK.

 

1.48      "MERCK KNOW-HOW" shall mean any information and materials, including

         but not limited to, discoveries, Improvements, processes, methods,

         protocols, formulas, data, inventions (including without limitation

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

         Information and Inventions), know-how and trade secrets, patentable or

         otherwise, which arise from the Research Program and during the term of

         this Agreement, (i) are in MERCK's possession or control, (ii) are not

         generally known and (iii) are in MERCK's opinion necessary to deCODE in

         the performance of its obligations under the Research Program.

 

1.49      "MERCK COLLABORATION PATENTS" shall mean Collaboration Patents that

         claim, cover or relate to MERCK Information and Inventions.

 

1.50      "MERCK PATENTS" shall mean Patents Controlled by MERCK prior to the

         Effective Date or during the term of this Agreement (provided MERCK has

         the right to license or otherwise make available such Patents to

         deCODE) and are necessary or useful to deCODE in connection with the

         Research Program.

 

1.51      "MERCK PRIOR KNOW-HOW" shall mean any information and materials,

         including but not limited to, discoveries, Improvements, processes,

         methods, protocols, formulas, data, inventions, know-how and trade

         secrets, patentable or otherwise, which existed prior to the Effective

         Date and during the term of this Agreement, (i) are in MERCK's

         possession or control, (ii) are not generally known and (iii) are in

         MERCK's opinion necessary to deCODE in the performance of its

         obligations under the Research Program excluding MERCK Know-How.

 

1.52      "MERCK SHARE" [CONFIDENTIAL TREATMENT REQUESTED].

 

1.53      "NET SALES" shall mean the gross invoice price of Product or Tests sold

         by MERCK or its Related Parties to the first Third Party after

         deducting, if not previously deducted, from the amount invoiced or

         received:

 

         (a)      trade and quantity discounts other than early pay cash

                 discounts;

 

         (b)      returns, rebates, chargebacks and other allowances;

 

         (c)      retroactive price reductions that are actually allowed or

         granted;

 

         (d)      sales commissions paid to Third Party distributors and/or

         selling agents;

 

         (e)       a fixed amount equal to [CONFIDENTIAL TREATMENT REQUESTED] of

         the amount invoiced to cover bad debt, sales or excise taxes, early

         payment cash discounts, transportation and insurance, custom duties,

         and other governmental charges; and

 

         (f)      the standard inventory cost of devices or delivery systems used

         for dispensing or administering Product or Tests, as applicable. With

         respect to sales of Combination Products, Net Sales shall be calculated

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

         same strength of IRCT Compound or Related IRCT Compound sold without

         other active ingredients. In the event that Product is sold only as a

         Combination Product, Net Sales shall be calculated on the basis of the

         gross invoice price of the

 

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         Combination Product multiplied by a fraction, the numerator of which

         shall be the inventory cost of IRCT Compound or Related IRCT Compound

         in the Product and the denominator of which shall be the inventory cost

         of all of the active ingredients in the Combination Product. Inventory

         cost shall be determined in accordance with MERCK's regular accounting

         methods, consistently applied. The deductions set forth in paragraphs

         (a) through (f) above will be applied in calculating Net Sales for a

         Combination Product. In the event that Product is sold only as a

         Combination Product and either Party reasonably believes that the

         calculation set forth in this Paragraph does not fairly reflect the

         value of the Product relative to the other active ingredients in the

         Combination Product, the Parties shall negotiate, in good faith, other

         means of calculating Net Sales with respect to Combination Products.

 

1.54      "PARTY OR PARTIES" shall mean either MERCK or deCODE or both as the

         context requires.

 

1.55      "PATENT RIGHTS" shall mean deCODE Collaboration Patents, and deCODE's

         interest in Joint Collaboration Patents.

 

1.56      "PATENTS" shall mean any and all 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) that a Party owns, Controls or through license or otherwise

         acquires rights prior to the Effective Date or during the term of this

         Agreement which: (i) claim, cover or relate to a Selected Compound,

         Test and/or Product; or (ii) claim, cover or relate to Inventions; or

         (iii) are divisions, continuations, continuations-in-part, reissues,

         renewals, extensions, supplementary protection certificates, utility,

         models and the like of any such patents and patent applications and

         foreign equivalents thereof.

 

1.57      "PRODUCT(s)" shall mean any therapeutic preparation in final form

          containing (a) an IRCT Compound for sale by prescription,

         over-the-counter or any other method for any and all uses that arise

         from the [CONFIDENTIAL TREATMENT REQUESTED] in the Disease Area or (b)

         a Related IRCT Compound, including without limitation in the case of

         either 1.57(a) or (b) any Combination Product.

 

1.58      "RELATED PARTIES" shall mean a Party's Affiliates or sublicensees, but

         shall not mean a Party's distributors.

 

1.59      "REGULATORY AUTHORITY" shall mean any applicable government regulatory

         authority involved in granting approvals for the manufacturing,

         marketing, reimbursement and/or pricing of a Product or Test, as

         applicable, in the Territory, including, in the United States, the

         United States Food and Drug Administration and any successor

         governmental authority having substantially the same function.

 

1.60      "RELATED IRCT COMPOUND" shall mean a compound Controlled by MERCK that

         [CONFIDENTIAL TREATMENT REQUESTED].

 

1.61      "RESEARCH PROGRAM TERM" shall mean the duration of the Research Program

         and "Extended Research Program Term" shall mean any period of the

         Research Program as it may be extended by mutual agreement of the

         Parties, as described more fully in Section 2.10.

 

1.62      "RESEARCH PROGRAM" shall mean the research activities undertaken by the

         Parties hereto as set forth in Article 2 and Attachment 2.1.

 

1.63      "SELECTED COMPOUND" shall mean any compound proposed by MERCK and

         accepted by the

 

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         Operating Committee to be evaluated in Information Rich Clinical

         Trials.

 

1.64      "OPERATING COMMITTEE" shall mean the joint research committee

         established to facilitate the Research Program as more fully described

         in Section 2.5.1.

 

1.65      "SUCCESSFUL CLINICAL RESULT" shall mean result(s) [CONFIDENTIAL

         TREATMENT REQUESTED].

 

1.66      "TECHNICAL INFORMATION" shall mean information, data or know-how

         (whether patentable or unpatentable), including without limitation,

         formulas, manufacturing methods, procedures, designs, compositions of

         matter, plans, applications, specifications, drawings, techniques,

         materials (including without limitation biological materials such as

         tissue samples, plasma samples, cell lines, RNA, DNA, DNA fragments,

         organisms, proteins, polypeptides, plasmids, vectors and the like),

         compounds, samples, inventions, discoveries, and the like, as well as

         improvements related thereto.

 

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

         territories and possessions.

 

1.68      "THERAPEUTIC FIELD" shall mean any and all application of technology to

         [CONFIDENTIAL TREATMENT REQUESTED].

 

1.69      "TESTS" shall mean pharmacogenomic tests aimed at predicting the

         response or non-response and side-effects to an IRCT Compound that are

         developed, discovered or identified through the Research Program.

 

1.70      "THIRD PARTY" shall mean an entity other than MERCK and its Affiliates,

         and deCODE and its Affiliates.

 

1.71      "VALID PATENT CLAIM" shall mean a claim of an issued and unexpired

         patent included within the MERCK Compound Patent which claims IRCT

         Compound, Related IRCT Compound, Tests or Product as a composition of

         matter, which has not been revoked or held unenforceable or invalid by

         a decision of a court or other governmental agency of competent

         jurisdiction, and which is not appealable or has not been appealed

         within the time allowed for appeal, and which has not been disclaimed,

         denied or admitted to be invalid or unenforceable through reissue,

         re-examination or disclaimer or otherwise.

 

1.72      "WORK PLAN" shall mean Schedule 2.1-X describing the tasks to be

         performed by each of the Parties in furtherance of the Research

          Program. It is anticipated that there will be separate work plans

         relating to each IRCT conducted by the Parties which shall be appended

         to the Agreement in sequential order.

 

2.        RESEARCH PROGRAM

 

2.1       GENERAL

 

         deCODE and MERCK shall engage in the Research Program upon the terms

         and conditions set forth in this Agreement. The activities to be

         undertaken in the course of each IRCT pursuant to the Research Program

         will be set forth in a Work Plan (Schedule 2.1-X) wherein X shall begin

         with 1 continue in succession. Prior to the initiation of any IRCT

         herein the Parties shall agree in writing signed by members of the

         Executive Committee or their designees on what is a Successful Clinical

         Result and the signed writing shall become part of the corresponding

         Work

 

                                        4

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         Plan for that IRCT. The Work Plan may be amended from time to time upon

          the mutual written agreement by authorized representatives of the

         Parties. All Work Plans including Schedule 2.1-0 attached hereto are

         part of the Agreement. Notwithstanding any provision of the Agreement

         to the contrary, neither Party shall be obligated to conduct any

         activities which it reasonably believes would be in violation of any

         statute, regulation, law, or terms of any ongoing deCODE project in a

         Non-exclusive Disease Area.

 

2.2       CONDUCT OF RESEARCH

 

         deCODE and MERCK each shall conduct the Research Program in good

         scientific manner, and in compliance in all material respects with all

         requirements of applicable laws, rules and regulations and all

         applicable good laboratory practices to attempt to achieve their

         objectives efficiently and expeditiously. deCODE and MERCK each shall

         proceed diligently with the work set out in the Work Plan by using

         their respective good faith efforts to allocate sufficient time,

         effort, equipment and facilities to the Research Program and to use

         personnel with sufficient skills and experience as are required to

         accomplish the Research Program in accordance with the terms of this

         Agreement and Work Plan.

 

         deCODE and MERCK shall be entitled to utilize the services of their

         Affiliates to perform their respective Research Program activities.

         Each Party shall also be entitled to utilized the services of Third

         Parties to perform their respective Research Program activities only

         upon the prior written consent of the other Party or as specifically

         set forth in Work Plan. Notwithstanding any such consent, both Parties

          shall remain at all times fully liable for its respective

         responsibilities under the Research Program.

 

2.3       INFORMATION RICH CLINICAL TRIALS

 

         Each IRCT shall be conducted in accordance with the Work Plan and a

         detailed protocol. A proposed protocol and a draft proposal for what a

         Successful Clinical Result will be, shall be prepared initially by the

         Operating Committee. These draft proposals shall be further reviewed

         internally by the appropriate committees within MERCK and deCODE. The

         draft proposals, with any changes or revisions made by MERCK or deCODE,

         shall then be considered and revised by the Operating Committee for

         submission to the Executive Committee. deCODE shall be obligated to

         provide support needed to conduct no more than five (5) IRCTs

         concurrently at any time during the Research Program. Each IRCT shall

         be conducted under the direction and control of the Operating Committee

          in accordance with the terms and conditions set forth in Schedule 2.3

         and a Study Protocol for that Selected Compound. In any given IRCT that

         is conducted under this Agreement the Parties may modify and/or

         supplement the terms and conditions set forth in Schedule 2.3 in

         accordance with Section 10.7 herein. All data and results pertaining to

         any Selected Compound may be used by MERCK in filings with Regulatory

         Authorities and all other rights to any intellectual property that are

         embodied by those data and results shall be governed by Article 3.

 

2.4       COMPOUND SELECTION

 

         MERCK shall nominate MERCK compounds during the Research Program for

         which Information Rich Clinical Trials shall be conducted by the

         Parties according to the Work Plan. deCODE shall be given the

         opportunity to review each proposed compound to confirm that deCODE's

         conduct of one or more IRCTs on such compound under this Agreement

         would not

 

                                        4

<Page>

 

         conflict with any other ongoing deCODE project(s). The Operating

         Committee shall select which MERCK nominated compounds will become

         Selected Compounds; PROVIDED, HOWEVER, that solely with respect to

         compounds in the Non-exclusive Disease Area, deCODE shall not be

         obligated to perform development efforts with respect to any such

         compounds if it reasonably believes that the performance of such

         efforts will conflict with any ongoing deCODE project(s).

 

2.5       GOVERNANCE OF THE COLLABORATION.

 

         The Parties hereby establish process to govern the conduct of the

         Research Program and each party's contribution to the Research Program

         as follows:

 

2.5.1     MANAGERIAL OVERSIGHT.

 

         There will be two levels of managerial oversight of the Research

         Program. There will be an Executive Committee and an Operating

         Committee. In addition each Party shall designate Project Leaders for

         the Research Program.

 

                 (a)    EXECUTIVE COMMITTEE

 

                 The Executive Committee shall consist of one senior executive

                 from each of MERCK and deCODE. The Executive Committee shall

                 have the ultimate authority for decisions regarding the

                 Research Program. The matters that require approval by the

                 Executive Committee shall include approval of financial

                  statements such as the Budget and approval of the Work Plan.

 

                       (i)     Any disputes where the Executive Committee cannot

                       reach a mutually acceptable decision within thirty (30)

                       days after the matter was referred to them shall be

                       decided by the President of MERCK Research Laboratories

                       and the final determination of the issue that shall be

                       binding on the Parties and the Research Program;

                       PROVIDED, HOWEVER, as set forth below in Section 2.5.1

                       (a)(ii) regarding implementation of such decisions and in

                       all cases that to the extent such disputes materially

                        affect the rights or obligations of the Parties under

                       this Agreement, MERCK shall consult with deCODE and the

                       Parties shall agree on a course of action to lawfully

                       avoid or minimize such effects upon the rights or

                       obligations of the Parties, to the extent practicable.

 

                       (ii)    Any disputes arising with respect to the manner in

                       which decisions of the Operating Committee, the Executive

                       Committee or the President of Merck Research Laboratories

                       will be implemented that will affect relations with

                       patients participating in the Research Program, research

                       sites, consultants, investigators or vendors all of which

                       are in Iceland, or any governmental authority in Iceland

                       ("Implementation Disputes"), shall be decided by the

                        Chief Executive Officer of deCODE (or his designee) and

                       the final determination of the issue that shall be

                       binding on the Parties and the Research Program, who

                       shall give good faith consideration to the comments of

                       MERCK's Executive Committee member (or their respective

                       designees) in resolving such matter; PROVIDED, HOWEVER,

                       that to the extent such disputes materially affect the

                       rights or obligations of the Parties under this

                       Agreement, deCODE shall consult with MERCK and the

                       Parties shall agree on a course of action to lawfully

                        avoid or minimize such effects upon the rights or

                       obligations of the Parties, to the extent practicable.

 

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<Page>

 

                 (b)    OPERATING COMMITTEE

 

                        The Operating Committee shall be based in Iceland and

                       composed of MERCK representatives and deCODE

                       representatives and shall exist for [**] after

                       termination or expiration of the Research Program Term.

                       The Operating Committee shall perform the following

                       functions (i) approve and, as the need arises, determine

                       the necessity to remove personnel working on the Research

                        Program, (ii) prepare the Budget, (iii) formulate and

                       adjust Work Plans, (iv) select Compounds; (v) oversee

                       progress of the Research Program and exchange of data

                       between the Parties; and (vi) appoint sub-committees of

                       equal representation to fulfill any of the enumerated

                       tasks set forth in this Section 2.5.1(b). Each Party

                       shall have 1 vote. Each Party shall appoint its

                       representatives to the Operating Committee from time to

                       time, and may substitute one or more of its

                       representatives, in its sole discretion, effective upon

                        notice to the other Party of such change. These

                       representatives shall have, individually or collectively,

                       appropriate technical credentials, experience and

                       knowledge, and ongoing familiarity with the Research

                       Program. Additional representatives or consultants may

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

                       invited to attend Operating Committee meetings, in the

                       case of consultants subject to such consultant's written

                       agreement to comply with the requirements of Section 4.1.

                       Any member of the Operating Committee may designate a

                        substitute to attend and perform the functions of that

                       member at any meeting of the Operating Committee. A

                       chairperson and secretary of the Operating Committee

                       shall serve co-terminus one (1) year terms, commencing on

                       the Collaboration Date or an anniversary thereof, as the

                       case may be. deCODE shall have the right to name the

                       chairperson and MERCK shall have the right to name the

                       secretary of the Operating Committee. Decisions of the

                       Operating Committee shall be made unanimously by the

                       members. In the event that the Operating Committee cannot

                       or does not, after good faith efforts, reach agreement on

                       an issue, the resolution and/or course of conduct shall

                       be referred to the Executive Committee. Each Party shall

                        bear its own expenses related to the attendance of such

                       meetings by its representatives and invitees.

 

2.5.2     MEETINGS AND MINUTES.

 

         Meetings of the Operating Committee require the participation of at

         least one member of the Operating Committee from each Party. During the

         Research Program Term, the Operating Committee shall meet in person at

         least once during every Calendar Year. From time to time, a Party may

         give the other Party reasonable notice of its desire to hold a meeting

         of the Operating Committee. Unless otherwise agreed by the Parties,

         meetings of the Operating Committee shall be held in person and shall

         alternate between the offices of the Parties, or meet in such other

         place as agreed by the Parties. Instead of meeting in person, the

         members of the Operating Committee may, for purposes of holding a

         Operating Committee meeting, convene or be polled or consulted from

         time to time by means of telecommunications, video conferences,

         electronic mail or correspondence, as deemed necessary or appropriate

         by the Parties.

 

         With the sole exception of specific items of the meeting minutes to

         which the chairperson and the secretary cannot agree and which are

         escalated as provided below, definitive minutes of all Operating

         Committee meetings shall be finalized promptly after the meeting to

         which the minutes pertain, as follows:

 

         Promptly after each Operating Committee meeting, the secretary shall

         prepare and distribute to all members of the Operating Committee draft

         minutes of the meeting. Such minutes shall provide a description, in

         reasonable detail, of the discussions at the meeting and a list of any

         actions,

 

                                        4

<Page>

 

         decisions or determinations approved by the Operating Committee and a

         list of any issues to be resolved by the Executive Officers.

 

         The chairperson shall then promptly after receiving such draft minutes

         collect comments thereon from the members of his or her Party and

         provide them to the secretary.

 

         The chairperson and the secretary of the Operating Committee shall then

         discuss each other's comments and finalize the minutes. The secretary

         and chairperson shall each sign and date the final minutes. The

         signature of the chairperson and the secretary upon the final minutes

         shall indicate each Party's assent to the minutes.

 

         If at any time during the preparation and finalization of the Operating

         Committee meeting minutes, the secretary and the chairperson do not

         agree on any issue with respect to the minutes, such issue shall be

         resolved by the decision making process as provided in Section

         2.5.1(a). The decision resulting from the decision making process shall

         be recorded by the secretary in amended finalized minutes for said

         meeting.

 

2.5.3     PROJECT LEADERS.

 

         MERCK and deCODE each shall appoint a person (a "Project Leader") from

         the Operating Committee to coordinate its part of the Research Program.

         The Project Leaders shall be the primary contact between the Parties

         and the Operating Committee with respect to the Research Program. Each

         Party shall notify the other within thirty (30) days of the date of the

         Agreement of the appointment of its Project Leader and shall notify the

         other Party as soon as practicable upon changing this appointment.

 

2.6       ANNUAL BUDGET .

 

         All costs in personnel time, expenses, goods and Third Party services

          shall be estimated in advance for the subsequent Calendar Year

         according to the Budget to be set forth in Schedule 2.6. The Budget

         shall be prepared by the Project Leaders under the direction and

         control of the Operating Committee by September 30th of the year

         preceding the Calendar Year of the Budget.

 

2.7       RECORDS AND REPORTS

 

2.7.1     RECORDS.

 

         Each Party 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 Research Program by that Party.

 

2.7.2     COPIES AND INSPECTION OF RECORDS.

 

         (a) MERCK shall have the right, during normal business hours and upon

         reasonable notice, to inspect and copy all such records of deCODE

         referred to in Section 2.7.1. 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 deCODE and any of its Third Party

         contractors as permitted under Section 2.2 during normal business hours

         and upon reasonable notice, and to discuss the Research Program work

         and its results in

 

                                        4

<Page>

 

         detail with the technical personnel and consultants of deCODE. Upon

         request, deCODE shall provide copies of the records described in

         Section 2.7.1 above.

 

         (b) At least once per Calendar Year during the term of the Agreement,

          MERCK shall provide deCODE with information about the status of any

         IRCT Compounds in development at MERCK including a review of any

         significant developmental milestones achieved or setbacks encountered

         since the previous year's review and such other information as may be

         reasonably requested by deCODE so as to enable deCODE to monitor or

         confirm MERCK's compliance with the provisions of Section 3.4 hereof.

         deCODE shall have the right, during normal business hours and upon

         reasonable notice, to inspect and copy all such records of MERCK

         referred to in Section 2.7.1 that are necessary to deCODE to perform

         its obligations under this Agreement. deCODE shall maintain such

          records and the information disclosed therein in confidence in

         accordance with Section 4.1.

 

2.8       COMPLIANCE

 

         deCODE shall conduct the Research in accordance with all applicable

         laws, rules and regulations, including, without limitation, all current

         governmental regulatory requirements concerning Good Laboratory

         Practices. In addition, if animals are used in research hereunder,

         deCODE will comply with the Animal Welfare Act or any other applicable

         local, state, national and international laws or regulations relating

         to the care and use of laboratory animals. MERCK encourages deCODE to

         use the highest standards, such as those set forth in the Guide for the

         Care and Use of Laboratory Animals (NRC, 1996), for the humane

         handling, care and treatment of such research animals. Any animals

         which are used in the course of the Research, or products derived from

         those animals, such as eggs or milk, will not be used for food

         purposes, nor will these animals be used for commercial breeding

         purposes. deCODE shall notify MERCK in writing of any deviations from

         applicable regulatory or legal requirements. deCODE hereby certifies

         that it will not and has not employed or otherwise used in any capacity

         the services of any person debarred under Section 21 USC 335a in

         performing any services hereunder.

 

2.9       RESEARCH PROGRAM TERM

 

         Except as otherwise provided herein, the term of the Research Program

         shall commence on the Collaboration Date and continue for a period of

         seven (7) years. Following the initial seven (7) year term, the

         Research Program will renew annually for successive one (1) year terms

         ("Extended Research Term") unless either Party sends a written notice

         of termination at any time to the other Party PROVIDED, HOWEVER, that

         MERCK may send such written notice of termination at any time beginning

         five (5) years after the Collaboration Date. Such notice of termination

         shall be sent at least [**] prior to the date of termination. In the

         event that deCODE exercises its right to terminate under this Section

          2.9, such termination shall not affect any ongoing IRCTs which shall be

         completed at MERCK's discretion, PROVIDED HOWEVER that deCODE shall not

         be obligated to begin any new IRCT which has been approved by the

         Operating Committee but not yet begun. From time-to-time, the Parties

         shall amend the Work Plan as applicable. In the event of a Change of

         Control pursuant to which a Competitor Controls deCODE, MERCK shall

         have the right to terminate the Research Program at any time on written

         notice to deCODE. In the event that the term of the Research Program

         expires or the Research Program is terminated during the pendency of an

         IRCT or in the event that the Parties elect to abandon or terminate any

         IRCT during the course of the Research Program, the Parties shall

         arrange for orderly completion or

 

                                        4

<Page>

 

         early termination of such IRCT over a reasonable period of at least 90

         days, including making provision for payment for all non-cancelable

         expenses associated therewith.

 

2.10      EXCLUSIVE EFFORTS

 

         (a) During the Research Program Term, deCODE shall work exclusively

         with MERCK in efforts to conduct IRCT [CONFIDENTIAL TREATMENT

         REQUESTED] and shall not otherwise facilitate or assist any Third Party

         to conduct IRCT [CONFIDENTIAL TREATMENT REQUESTED] by providing rights

         to, either through license or any agreement to forgo enforcement of,

         deCODE Patents or deCODE Prior Know-How. This Agreement does not

         prohibit deCODE from (i) conducting IRCT [CONFIDENTIAL TREATMENT

         REQUESTED]; or (ii) conducting clinical trials [CONFIDENTIAL TREATMENT

         REQUESTED]. In the event that MERCK and deCODE begin an IRCT with a

         Selected Compound in a Non-exclusive Disease Area, deCODE shall not

         commence any IRCT with [CONFIDENTIAL TREATMENT REQUESTED].

 

         (b) Beginning after the first anniversary of the Effective Date, if

         during any [**] period the Parties do not commence or continue an IRCT

         in any one of the Exclusive Disease Areas, and if during such two-year

         period the Operating Committee neither plans nor conducts at least five

         concurrent IRCT's during at least [**] of such [**] period, then such

         specific Disease Area shall thereafter become a Non-Exclusive Disease

         Area for all purposes under this Agreement. Notwithstanding the

         preceding sentence, the Parties may agree to create exceptions to, or

         the tolling of, the foregoing for special circumstances.

 

2.11      EXCHANGE OF INFORMATION

 

         During the Research Term, deCODE promptly shall disclose on an ongoing

         basis to MERCK in English and in writing all deCODE Know-How. MERCK

         shall promptly disclose to deCODE during the Research Program Term all

         MERCK Know-How.

 

2.12      USE OF HUMAN MATERIALS

 

         With respect to any human cell lines, tissue, human clinical isolates

         or similar human-derived materials that have been or are to be

         collected and/or used in the Research Program ("Human Materials"), each

         Party represents and warrants (i) that it has complied, or shall

         comply, with all applicable laws, guidelines and regulations relating

         to the collection and/or use of the Human Materials and (ii) that it

         has obtained, or shall obtain, all necessary approvals and appropriate

         informed consents, in writing, for the collection and/or use of such

         Human Materials. deCODE shall provide documentation of such approvals

         and consents upon MERCK's request. Each Party further represents and

         warrants that such Human Materials may be used as contemplated in this

         Agreement without any obligations to the individuals or entities

         ("Providers") who contributed the Human Materials, including, without

         limitation, any obligations of compensation to such Providers or any

         other Third Party for the intellectual property associated with, or

         commercial use of, the Human Materials for any purposes.

 

2.13      PHARMACOGENOMICS TESTS.

 

         (a) TESTS FOR USE IN CLINICAL TRIALS. MERCK shall have the sole and

         exclusive right to direct and control the development and

         commercialization of Tests for use with Selected Compounds. deCODE

         shall have the first right to perform the work needed to develop such

         Tests for use in the

 

                                        4

<Page>

 

         conduct of IRCT's under this Agreement as set forth below. MERCK shall

         identify and prioritize the Tests it wishes to have developed and Merck

          shall have the right to solicit bids from Third Parties including

         deadlines for the achievement of defined events in the development of

         suc


 
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