Research Collaboration and License Agreement

EXHIBIT 10.62

Execution Copy


RESEARCH COLLABORATION AND LICENSE AGREEMENT


between


Genome Therapeutics Corp.


and

Amgen Inc.

RESEARCH COLLABORATION AND LICENSE AGREEMENT

This Research Collaboration and License Agreement (this "Agreement") is effective as of December 20, 2002 (the "Effective Date") by and between Genome Therapeutics Corp. ("GENE"), 100 Beaver Street, Waltham, Massachusetts 02453 and Amgen Inc. ("Amgen"), One Amgen Center Drive, Thousand Oaks, California 91320-1799. Amgen and GENE are sometimes referred to herein individually as a "Party" and collectively as the "Parties."


WITNESSETH:

WHEREAS, GENE is engaged in the discovery of novel genes related to high bone density;


WHEREAS Amgen is engaged in the discovery, development and commercialization of human therapeutics; and

WHEREAS GENE and Amgen desire to enter into a collaborative relationship to discover and develop human therapeutics for the treatment of osteoporosis and other diseases, on the terms and subject to the conditions set forth herein.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

1.1 "Affiliate" means any corporation, company, partnership, joint venture and/or firm which controls, is controlled by, or is under common control with a Party. For purposes of this definition, "control" shall be presumed to exist if one of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities.

1.2 "Amgen Background Know-How" means all Information and Materials, other than ***** and Amgen Program Know-How related to the Research Field but including Amgen Program Know-How not related to the Research Field, Controlled by Amgen as of the Effective Date or during the term of this Agreement that is necessary for the purpose of conducting the Research Program or for Developing, manufacturing or Commercializing Product(s).


1 1.3 "Amgen Background Patent Rights" means all Patent Rights Controlled by Amgen as of the Effective Date or during the term of this Agreement that claim Amgen Background Know-How.

1.4 "Amgen Technology" means, collectively, Amgen Background Patent Rights, Amgen Background Know-How, Amgen Program Patent Rights, Amgen Program Know-How and Amgen's interest in the Joint Patent Rights and Joint Know-How.

1.5 "Calendar Quarter" means, with respect to the first such Calendar Quarter, the period beginning on the Effective Date and ending on December 31, 2002, and thereafter each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.

1.6 "Calendar Year" means each successive period of twelve (12) months commencing on January 1 and ending on December 31. 1.7 "Change of Control of GENE" means the acquisition, directly or indirectly, by a Competitive Entity of fifty percent (50%) or more of the shares of GENE's voting capital stock, the holders of which have general voting power under ordinary circumstances to elect at least a majority of GENE's Board of Directors or equivalent body. 1.8 "Clinical Milestone Payments" means those amounts payable by Amgen to GENE pursuant to Section 8.5. 1.9 "Co-Detail" means the employment by Amgen and GENE of Representatives to jointly Detail the same Product under the same Product Trademark in the United States and/or Canada (as appropriate), under the coordination and direction of Amgen.

1.10 "Commercialization" or "Commercialize" means any and all activities (whether before or after Regulatory Approval) directed to the marketing, Detailing and promotion of a Product after Regulatory Approval for commercial sale has been obtained and shall include pre-launch and post-launch marketing, manufacturing for commercial sale, promoting, Detailing, distributing, offering to sell and selling a Product, importing a Product for sale, conducting Marketing Clinical Studies (but not Development clinical studies), and interacting with Regulatory Authorities regarding the foregoing. When used as a verb, "Commercializing" means to engage in Commercialization and "Commercialized" shall have a corresponding meaning.

1.11 "Commercialization Expense" has the meaning set forth in Exhibit X.

1.12 "Commercialization Plan" means the summary plan (which shall include a summary strategy and proposed timelines), and any updates thereto, to be prepared by Amgen pursuant to Section 6.2 for the Commercialization of any Product in the United States and/or Canada (as appropriate).


2 1.13 "Commercially Reasonable Efforts" means a level of efforts and resources consistent with good business practice and standards that a company in the research-based pharmaceutical industry would devote to research, develop or commercialize (as appropriate) a product for a similar use and of similar market potential at a similar stage in its product life as that of a Product, taking into account efficacy, the competitiveness of alternative Third Party products and product candidates in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval given the regulatory structure involved, the profitability of the product including the royalties payable to licensors of patent rights and other relevant factors. Commercially Reasonable Efforts shall be determined on a country-by-country basis for a particular Product, and it is anticipated that the level of effort will change over time, reflecting changes in the status of the Product and the country involved.

1.14 "Competitive Entity" means a company that at the time of a Change of Control of GENE (i) has a market capitalization in excess of US$*****, or (ii) has one or more compounds in development (in Phase I clinical trials or later) or approved for marketing that have among their proposed or actual indications the prophylactic, therapeutic or palliative treatment of disorders of bone metabolism, bone disease or bone repair, or (iii) is a company with respect to which Amgen can reasonably demonstrate is or was involved in litigation in which Amgen is or was an adverse party, or within the ***** immediately preceding the Change of Control was involved in a material dispute with Amgen.

1.15 "Confidential Information" means (a) all tangible embodiments of Information produced or developed by either Party in the Research Program, and (b) all Information received by either Party (the "receiving Party") from the other Party (the "disclosing Party") pursuant to this Agreement, other than that portion of such Information which: (a) is publicly disclosed by the disclosing Party, either before or after it becomes known to the receiving Party; (b) was known to the receiving Party, without obligation to keep it confidential, prior to when it was received from the disclosing Party, as shown by written documentation; (c) is subsequently disclosed to the receiving Party by a Third Party lawfully in possession thereof without obligation to keep it confidential; (d) has been publicly disclosed other than by the disclosing Party and without breach of an obligation of confidentiality with respect thereto; or (e) has been independently developed by the receiving Party without the aid, application or use of Confidential Information, as shown by written documentation. 1.16 "Contract Year" means the period beginning on the Effective Date and ending on the first anniversary thereof, and each succeeding twelve (12) month period thereafter.

1.17

"Control" or "Controlled" means with respect to any (a) Material or Information or (b) intellectual property right, in each case the possession (whether by ownership, license or other right, other than pursuant to this Agreement) by a Party or its


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Affiliates of the ability to grant the other Party access and/or a license or (sublicense) to such Material or Information or intellectual property rights as provided for herein without violating the terms (in existence at the time of such Party or its Affiliates acquiring such ownership, license or other right) of any agreement or other arrangement between such Party (or its Affiliates) and any Third Party.

1.18 "Creighton License" means that certain agreement between GENE and Creighton University, effective April 3, 1997, and any amendments thereto.

1.19 "Detail" means, with respect to a Product, an interactive face-to-face contact (including a live video presentation) of a Representative with (a) a medical professional with prescribing authority or (b) an office nurse with influence over the pharmaceutical treatment of a patient, in each case in an effort to increase physician prescribing preferences of such Product for its approved uses. When used as a verb, Detailing means performing Details. When used as an adjective, Detailing means of or related to performing Details.

1.20 "Development" or "Develop" means, with respect to a Product, all clinical and other activities undertaken to obtain Regulatory Approval of such Product, in accordance with this Agreement, after the first filing of an IND for such Product and prior to Regulatory Approval of such Product. These activities shall include clinical drug development activities, including, among other things: test method development and stability testing, toxicology, animal studies, formulation, process development, manufacturing, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control development, statistical analysis and report writing, participation in Joint Development Committees, clinical trial design and operations, obtaining Regulatory Approvals, and regulatory affairs related to the foregoing. When used as a verb, "Developing" means to engage in Development and "Developed" shall have a corresponding meaning.

1.21 "Development Costs" means (a) with respect to Amgen, the cost of any and all activities performed by Amgen and specifically attributable to the Development of a Product consistent with the Development Plan, including, without limitation: (i) all out-of-pocket costs, milestones, royalties and expenses incurred by Amgen on an arm's-length basis (calculated in accordance with GAAP) and paid to Third Parties (or accrued therefor) to the extent not included in the FTE Cost described in (a)(ii) below, (ii) the FTE Cost of such activities, (iii) the cost of Materials used in such activities to the extent not included in the FTE Cost described in (a)(ii) above, and (iv) marketing expenses incurred prior to the first approval of a Drug Approval Application in a Major Market Country; and (b) with respect to GENE, the FTE Costs incurred by GENE in order to participate in the Joint Development Committee pursuant to Section 4.10. For the avoidance of doubt, Development Costs excludes Clinical Milestone Payments made by Amgen to GENE pursuant to Section 8.5.

1.22

"Development Plan" means the summary plan (which shall include a summary strategy and proposed timelines), and any updates thereto, to be prepared by Amgen


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for the Development of any indication for a Product pursuant to Sections 4.2, 4.3 and 4.5 including, without limitation, the research, clinical and regulatory activities required to obtain Regulatory Approval(s) in the Territory.

1.23 "Diligent Inquiry" has the meaning set forth in Section 8.4(a).

1.24 "Drug Approval Application" means an application for any Regulatory Approval required before commercial sale or use of a Product as a drug or biologic or to treat a particular indication in a regulatory jurisdiction, including: (a) (i) a Biologics License Application (" BLA") pursuant to 21 C.F.R. 601.2 (or any successor application or procedure) or a New Drug Application (" NDA") pursuant to 21 C.F.R. 314.5 (or any successor application or procedure) submitted to the FDA; and (ii) any counterpart of a U.S. BLA or NDA in any other country in the Territory; and (b) all supplements and amendments that may be filed with respect to the foregoing.

1.25 "Early Development Costs" means the Development Costs associated with Early Stage Development of a Product for an indication. Early Development Costs include the cost of manufacturing a Product for Early Stage Development even if such Product is manufactured before the filing of an IND for the Product. The cost of manufacturing a Product for Late Stage Development shall be deemed an Early Development Cost if such Product is manufactured during Early Stage Development; provided however , if GENE elects not to contribute to Late Stage Development pursuant to Sections 4.3 or 4.5.b., Amgen shall reimburse GENE within sixty (60) days of GENE notifying Amgen in writing of such election any Development Costs actually paid by GENE to Amgen for such manufacturing and, further provided, if such Product does not proceed to Late Stage Development, Amgen shall have no obligation to reimburse GENE for such manufacturing Development Costs, regardless of GENE's election. Early Development Costs also include the Development Costs associated with the analysis of Phase II Clinical Study results, even if such analysis continues during Late Stage Development.

1.26 "Early Stage Development" means, with respect to any indication for a Product, all post-IND filing Development commencing on the first filing of an IND for such indication and continuing up to and including the completion of Phase II Studies or commencement of Pivotal Studies, whichever is earlier for such indication.

1.27 "Effective Date" means the first date set forth hereinabove.

1.28 "Fair Market Value" means the average closing stock price over the period of time ***** for which the equity is being issued. 1.29 "FDA" means the United States Food and Drug Administration and any successor thereto. 1.30 "Field of Use" means all uses, including human therapeutic, prophylactic, palliative and, pursuant to Section 9.2(c), diagnostic uses.

5 1.31 "First Commercial Sale" means, with respect to any Product, the first sale for end-use or consumption of such Product in a country after the governing health regulatory authority of such country has granted Regulatory Approval. Sale to an Affiliate or sublicensee will not constitute a First Commercial Sale unless the Affiliate or sublicensee is the last entity in the distribution chain of the Product.

1.32 "Force Majeure" means any occurrence beyond the reasonable control of a Party that prevents or substantially interferes with the performance by the Party of any of its obligations hereunder, if such occurs by reason of any act of God, flood, fire, explosion, earthquake, breakdown of plant, shortage of critical equipment, loss or unavailability of manufacturing facilities or material, strike, lockout, labor dispute, casualty or accident, or war, revolution, civil commotion, acts of public enemies, blockage or embargo, or any injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or of any subdivision, authority or representative of any such government, inability to procure or use materials, labor, equipment, transportation or energy sufficient to meet manufacturing needs without the necessity of allocation, or any other cause whatsoever, whether similar or dissimilar to those above enumerated, beyond the reasonable control of such Party, if and only if the Party affected shall have used reasonable efforts to avoid such occurrence and to remedy it promptly if it shall have occurred.

1.33 "FTE" means the equivalent of the work of one employee working full time on the Research Program or Development of a Product *****. No one person shall be permitted to account for more than one FTE.

1.34 "FTE Cost" means, for any Calendar Quarter, the FTE Rate multiplied by the sum of the number of days (calculated by adding the full and partial percentage of days) actually spent in that Calendar Quarter by FTEs of a Party (as per their time sheets) working directly on the Research Program or Development of a Product under the terms of this Agreement and dividing the result thereof *****.

1.35 "FTE Rate" means the amount to be charged per FTE. ***** Dollars ($*****), subject to adjustment on an annual basis as of January 1 of each year beginning in 2004 by a factor which reflects changes in the Consumer Price Index as reported as of January 1 in each applicable year when compared to the comparable statistic for January 1 of the preceding year. 1.36 "GAAP" means United States generally accepted accounting principles.

1.37 "GENE Background Know-How" means all Information and Materials, other than GENE ***** and GENE Program Know-How related to the Research Field but including GENE Program Know-How not related to the Research Field, Controlled by GENE as of the Effective Date or during the term of this Agreement that is necessary for the purpose of conducting the Research Program.

6 1.38 "GENE Background Patent Rights" means all Patent Rights Controlled by GENE as of the Effective Date or during the term of this Agreement that claim GENE Background Know-How.

1.39 "GENE *****" means all Information and Materials Controlled by GENE as of the Effective Date that is related to the Research Field.

1.40 "GENE *****" means those Patent Rights as set forth in Exhibit 2, and all other Patent Rights Controlled by GENE during the term of this Agreement that claim GENE *****.

1.41 "GENE Technology" means, collectively, GENE *****, GENE *****, GENE Background Patent Rights, GENE Background Know-How, GENE Program Patent Rights, GENE Program Know-How and GENE's interest in the Joint Patent Rights and Joint Know-How.

1.42 "IND" means (i) an Investigational New Drug Application (as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended from time to time, and the regulations promulgated thereunder) that is required to be filed with the FDA before beginning clinical testing of a Product in human subjects, or any successor application or procedure and (ii) any counterpart of a U.S. Investigational New Drug Application in any other country in the Territory.

1.43 "Information" means all tangible and intangible techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, conclusions, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms.

1.44 Joint Know-How means all Information and Materials characterized, conceived, developed, derived, discovered, generated or identified jointly by employees of or consultants to GENE and employees of or consultants to Amgen in the conduct of the Research Program.

1.45 "Joint Patent Rights" means Patent Rights that are Controlled during the term of this Agreement by Amgen and GENE and claim Joint Know-How.

1.46 "Joint Research Committee" means the committee formed pursuant to Section 2.1.

1.47 "Joint Steering Committee" means the committee formed pursuant to Section 2.4.

1.48 "Large Molecule" means a polypeptide , protein, antibody (or any similar molecule which is produced by introduction of recombinant DNA into appropriate hosts) and nucleic acid molecules (e.g., DNA encoding such molecules, antisense oligonucleotides).


7 1.49 "Large Molecule Manufacturing Technology" means all Information and materials Controlled by Amgen and used in Amgen's Large Molecule manufacturing. Manufacturing for this purpose includes without limitation expression, purification and formulations.

1.50 "Late Development Costs" means the Development Costs associated with Late Stage Development of a Product for an indication, other than the Development Costs explicitly included in Early Development Costs.

1.51 "Late Stage Development" means, with respect to any indication for a Product, all Development following the completion of Phase II Studies or commencement of Pivotal Studies, whichever is earlier for such indication, up to and including filing of the first Drug Approval Application for such indication in any jurisdiction and including any supplementary Development necessary or required by a Regulatory Authority (a) in order to obtain the first Regulatory Approval for such indication; or (b) to satisfy any conditions of the first Regulatory Approval in that jurisdiction.

1.52 "Losses" means liabilities, damages, expenses, costs and/or losses, including without limitation reasonable legal expenses and attorneys' fees for outside counsel.

1.53 "Materials" has the meaning provided in Section 3.7.

1.54 "Major Market Country" shall mean the United States, United Kingdom, Italy, Germany, France, Japan, Canada and Spain. 1.55 "Net Sales" has the meaning set forth in Exhibit X.

1.56 "Patent Rights" means (a) valid and enforceable United States patents, re-examinations, reissues, renewals, extensions and term restorations, and foreign counterparts thereof, and (b) pending applications for United States patents including, without limitation, provisional applications, continuations, continuations-in-part, divisional and substitute applications including, without limitation, inventors' certificates, and foreign counterparts thereof.

1.57 "Phase I Study" means a clinical trial that is designed to determine the metabolism, pharmacologic actions (including pharmacodynamics) and pharmacokinetics of a drug in humans, the tolerability and any potential side effects of the drug associated with increasing doses and that satisfy the requirements of 21 CFR 312.21(a), or its successor regulation, or its equivalent in any other jurisdiction.

1.58 "Phase II Study" means a clinical trial that is designed to establish the safety and preliminary efficacy of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed and that satisfy the requirements of 21 CFR 312.21(b) (or its successor regulation), or its equivalent in any other jurisdiction.


8 1.59 Pivotal Study(ies)" means those clinical trials on sufficient numbers of patients that, if the defined end-points are met, are designed (and agreed to by the FDA, or other Regulatory Authorities in the Territory) based upon existing data in the same patient population as of the start of the trial to definitively establish that a drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed, and which provide pivotal data supporting Regulatory Approval of such drug or label expansion of such drug and that satisfy the requirements of 21 CFR 321.21(c), or its successor regulation, or an equivalent foreign clinical trial.

1.60 "Product Contribution" has the meaning set forth in Exhibit X.

1.61 "Product(s)" means a Small Molecule pharmaceutical(s) and/or a Large Molecule pharmaceutical(s) *****. 1.62 "Product Trademark(s)" means any trademarks and trade names, whether or not registered, and any trademark applications, renewals, extensions or modifications thereto in the Territory together with all goodwill associated therewith, trade dress and packaging which are applied to or used with Products or any promotional materials relating thereto. 1.63 "Program Know-How" means all Information and Materials characterized, conceived, developed, derived, discovered, generated or identified by employees of or consultants to either Party in the conduct of the Research Program. Amgen Program Know-How means that portion of Program Know-How characterized, conceived, developed, derived, discovered, generated or identified solely by employees of or consultants to Amgen. GENE Program Know-How means that portion of Program Know-How characterized, conceived, developed, derived, discovered, generated or identified solely by employees of or consultants to GENE. 1.64 "Program Patent Rights" means all Patent Rights that are Controlled during the Agreement by Amgen or GENE and claim Program Know-How. In particular, Amgen Program Patent Rights means that portion of Program Patent Rights Controlled by Amgen and GENE Program Patent Rights means that portion of Program Patent Rights Controlled by GENE.

1.65 "Regulatory Approval" means any approvals (including supplements, amendments, pre- and post-approvals and price approvals), licenses, registrations or authorizations (including any designations of an indication for a Product as an "Orphan Product" under the Orphan Drug Act), howsoever called, of any Regulatory Authority, which are necessary for the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing and/or sale of a Product in a regulatory jurisdiction. Regulatory Approval shall not include any site license for an Amgen manufacturing facility.

9 1.66 "Regulatory Authority" means the FDA or any counterpart of the FDA outside the United States, or other national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing and/or sale of a Product.

1.67 "Regulatory Filings" means, collectively, INDs, BLAs, establishment license applications (ELAs) and drug master files (DMFs), applications for designation of a Product as an "Orphan Product(s)" under the Orphan Drug Act or any other similar filings (including any foreign equivalents and further including any related correspondence and discussions), and all data contained therein, as may be required by the FDA or equivalent foreign Regulatory Authorities for the Development, manufacture or Commercialization of a Product.

1.68 "Regulatory Plan" means the list of all Regulatory Filings and Regulatory Approvals regarding Products, and any updates thereto. 1.69 "Research Field" means (i) the identification and characterization of the *****, protein products of the ***** or other members of the ***** and (ii) the discovery and development of compounds which modulate and/or bind to the foregoing.

1.70 "Research Plan" means the written plan for conducting the Research Program attached hereto as Exhibit 1, as amended from time to time by the Joint Research Committee.

1.71 "Research Program" means the program of collaborative research to be carried out by the Parties pursuant to Article 3 and the activities related thereto as described in the Research Plan.

1.72 *****

1.73

"Royalty Term" means, in the case of any Product, and on a country-by-country basis, the period of time commencing on the First Commercial Sale of such Product and ending upon the later of (a) the expiration of the last to expire of the GENE ***** Patent Rights, GENE ***** Patent Rights related to the Research Field or Joint Patent Rights having one or more Valid Claims which would, but for the licenses granted under this Agreement, be infringed by the selling of such Product in the country of sale by Amgen, its Affiliates or sublicensees, or (b) ten (10) years after the date of First Commercial Sale of the first Product in the first Major Market Country; provided however , the Royalty Term for purposes of this ***** shall be extended for so long a period of time as (i) the active ingredient of such Product is claimed by ***** or the use of such Product in the approved indication is claimed by *****, in either case contained within Amgen Program Patent Rights in such country, and (i ...