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COMPETING PHARMACEUTICAL COMPANIES | Pharmacopeia Drug Discovery, Inc | Wyeth Pharmaceuticals. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here. |
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Exhibit 10.43 Portions of this Exhibit were omitted and filed separately with the Secretary of the Commission pursuant to an application for confidential treatment filed with the Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934. Such omissions are designated as **. CONFIDENTIAL Execution Copy RESEARCH AND LICENSE AGREEMENT by and among WYETH, acting through its WYETH PHARMACEUTICALS DIVISION, and PHARMACOPEIA DRUG DISCOVERY, INC. Dated as of December 22, 2006 TABLE OF CONTENTS
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vi Schedules and Exhibits Schedules Schedule 1.8 Competing Pharmaceutical Companies Schedule 1.10 Compound Selection Criteria Schedule 1.22 Discovery Compound Criteria Schedule 1.62 Pharmacopeia Compounds Schedule 1.75 Primary Prosecution Countries Schedule 3.7 Approved Subcontractors Schedule 8.2 Disclosure Schedules Exhibits Exhibit A Research Plan Outline RESEARCH AND LICENSE AGREEMENT
This Research and License Agreement (the “Agreement” ) is entered into as of December 22, 2006 (the “Effective Date” ), by and between Wyeth, together with its Affiliates (as defined below), acting through its Wyeth Pharmaceuticals Division, a corporation organized and existing under the laws of the State of Delaware and having a place of business at 500 Arcola Road, Collegeville, Pennsylvania 19426 (collectively, “Wyeth” ) and Pharmacopeia Drug Discovery, Inc., a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 3000 Eastpark Blvd., Cranbury, NJ 08512 (together with its Affiliates, if any, “Pharmacopeia” ). Wyeth and Pharmacopeia may each be referred to herein individually as a “Party” and collectively as the “Parties . ” WHEREAS, Wyeth is engaged in the research, development and commercialization of pharmaceutical and health care products; WHEREAS, Pharmacopeia is engaged in the research and development of pharmaceutical and health care products, and has developed and owns proprietary rights to certain technology for optimizing compounds for use in products having applicability in the Fields (defined below); WHEREAS, Pharmacopeia has identified certain JAK-3 Kinase Inhibitors (as defined below), and Wyeth and Pharmacopeia desire to collaborate to discover and research additional JAK-3 Kinase Inhibitors; and WHEREAS, Wyeth desires to obtain from Pharmacopeia, and Pharmacopeia desires to grant to Wyeth, exclusive rights to research, develop, manufacture and commercialize certain compounds and products. NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows: 1. DEFINITIONS. 1.1. “Affiliate(s) ” means, with respect to any Person or entity, any other Person or entity which controls, is controlled by or is under common control with such Person or entity. A Person or entity will be regarded as in “control” of another entity if it owns or controls at least fifty percent (50%) of the equity securities of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority); provided , however , that the term “Affiliate” will not include subsidiaries or other entities in which a Party or its Affiliates owns a majority of the ordinary voting power necessary to elect a majority of the board of directors or other governing board, but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect. 1.2. “Agreement Compound” means a Pharmacopeia Compound, a Wyeth Compound, a Collaboration Compound, or a Derivative Compound. Notwithstanding the preceding sentence, Agreement Compounds shall not include any Non-Licensed Compounds. For purpose of clarity, compounds that are synthesized (i) as part of the Research Collaboration by either Party or its Affiliates or (ii) by Wyeth during the Derivative Tail, but that in either case ((i) and (ii)) are not JAK-3 Kinase Inhibitors, will not be Agreement Compounds. 1.3. “Calendar Quarter ” means each respective period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect. 1.4. “Change of Control Transaction” means, with respect to any Party, an event in which: (a) any person (as the term “person” is used for purposes of Section 13(d) or 14(d) of the Exchange Act) not then beneficially owning more than fifty percent (50%) of the voting power of the outstanding securities of such Party or any of its controlling Affiliates acquires or otherwise becomes the beneficial owner (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of securities of such Party or any of its controlling Affiliates representing more than fifty percent (50%) of the voting power of the then outstanding securities of such Party with respect to the election of directors of such Party; (b) such Party (i) consummates a merger, consolidation or similar transaction with another Person where the voting securities of such Party or any of its controlling Affiliates outstanding immediately preceding such transaction (or the voting securities issued with respect to the voting securities of such Party or any of its controlling Affiliates outstanding immediately preceding such transaction) represent less than fifty percent (50%) of the voting power of such Party or any of its controlling Affiliates or surviving entity, as the case may be, following such transaction, (ii) sells or otherwise transfers to any Person(s) in one or more related transactions more than fifty percent (50%) of its consolidated total assets, or assets from which more than fifty percent (50%) of its consolidated operating income for its most recent financial year was derived, (iii) disposes by sale, assignment, exclusive license or otherwise of all or substantially all of its intellectual property rights, except for licenses under such intellectual property rights in the ordinary course of business and any isolated sale or assignment of specific items of intellectual property, or (iv) liquidates, dissolves or winds-up; or (c) with respect to any Party having equity securities registered under the Exchange Act, any “person” (as the term “person” is used for the purposes of Sections 13(d) or 14(d) of the Exchange Act) other than the other Party acquires forty percent (40%) or more of the voting power of the then-outstanding voting securities of such Party or any of its controlling Affiliates. For the purposes of this definition, a “Controlling Affiliate” is an Affiliate that “controls”: a Party, as such term is used in the definition of “Affiliate” in Section 1.1 (Affiliate). 2 1.5. “Collaboration Compound” means any JAK-3 Kinase Inhibitor, other than a Pharmacopeia Compound or a Wyeth Compound, that is (a) conceived or synthesized by either Party alone or jointly with the other Party in the course of the Research Collaboration during the Research Term; or (b) within the scope of (i.e., is covered by) a composition of matter claim of a Patent Right that has a priority date after the Effective Date and is Controlled solely by Pharmacopeia or Wyeth (or any of their Affiliates) or jointly by Pharmacopeia and Wyeth, which Patent Right also claims any compound in category (a) as a composition of matter. In the event that the Research Collaboration is terminated by Wyeth pursuant to Section 9.4.1 (Termination Without Cause) prior to the **, Collaboration Compounds will include any JAK-3 Kinase Inhibitor (other than a Pharmacopeia Compound or a Wyeth Compound) that is derived from a Pharmacopeia Compound, a Wyeth Compound or another Collaboration Compound by Wyeth during the period from the **. For purposes of this definition, a compound will be deemed to have been “derived” from a compound if it: (i) is **, (ii) is otherwise **, (iii) is based **, or (iv) is within the scope of ** category (i), (ii) or (iii) above as a composition of matter. 1.6. “Commercialization” or “Commercialize ” means activities directed to obtaining pricing and reimbursement approvals, marketing, promoting, Manufacturing for commercial purposes, distributing, importing or selling a Product. Commercialization will not include any activities related to Development. 1.7. “Commercially Reasonable Efforts ” means (i) with respect to the efforts to be expended by any Party other than as provided in subsection (ii) or (iii) below, those **; (ii) with respect to the ** , and (iii) with respect to the **. 1.8. “Competing Pharmaceutical Company ” means ** . 1.9. “Compound Classification Disputes” has the meaning set forth in Section 3.4.6(a) (Compound Classification Disputes). 1.10. “ Compound Selection Criteria ” means those procedures and criteria not materially inconsistent with the criteria that a Party uses to make decisions regarding whether to advance compounds for further studies in its ** . Wyeth’s initial Compound Selection Criteria for advancing a compound from a **, and from a ** are set forth on Schedule 1.10 (Compound Selection Criteria). Pharmacopeia’s initial Compound Selection Criteria for selection of ** and for advancing a ** will be provided by Pharmacopeia to the JRC **. Each Party’s Compound Selection Criteria may, upon written notice to the JRC, be amended by such Party in the course of conducting its overall business from time to time. 1.11. “Confidential Information” of a Party means all Know-How or other information regarding such Party’s technology, products, business information 3 or objectives, whether or not designated as confidential by the disclosing Party at the time any such Know-How or other information is disclosed by the disclosing Party to the other Party . 1.12. “Control” or “Controlled ” means with respect to any Know-How, information, compound, product or intellectual property right, the possession (whether by ownership or license, other than pursuant to this Agreement) by a Party of the ability to grant to the other Party access or a license as provided herein under such item or right without violating the terms of any agreement or other arrangements with any Third Party. 1.13. “Copyright” means the copyright in any work of authorship used in connection with the Commercialization of a Product. 1.14. “Core Structure” means a **. 1.15. “Derivative Compound” means any JAK-3 Kinase Inhibitor, other than a Pharmacopeia Compound, a Wyeth Compound, a Collaboration Compound, that is derived from a Pharmacopeia Compound, a Wyeth Compound or a Collaboration Compound by Wyeth during the Derivative Tail. For purposes of this Section, a compound will be deemed to have been “derived” from a compound if it: (i) is **, (ii) is otherwise **, (iii) is **, or (iv) is within the scope of ** category (i), (ii) or (iii) above; in each case wherein ** JAK-3 Kinase Inhibitor. 1.16. “Derivative Tail” means the ** period beginning at the later of (a) the end of the Research Collaboration or (b) the ** of the start of the Research Term. 1.17. “Development” or “Develop ” means (i) Research and (ii) clinical research and drug development activities, including without limitation clinical toxicology, Manufacturing process development, quality assurance and quality control development, statistical analysis, clinical studies (including pre- and post-approval studies), Manufacturing for clinical studies, regulatory affairs, pharmacovigilance and Regulatory Approval, and clinical study regulatory activities (including regulatory activities other than those directed to obtaining pricing and reimbursement approvals). 1.18. “Development Compound” means a Pre-Development Compound designated by a Party, at its sole discretion in accordance with its Compound Selection Criteria, for inclusion ** (e.g., **). 1.19. “Diligence Failure” has the meaning set forth in Section 9.3 (Termination for Cause). 1.20. “Disclosing Party” has the meaning set forth in Section 7.1 (Confidentiality) hereof. 4 1.21. “Discovery Compounds” means Pharmacopeia Compounds, Wyeth Compounds or Collaboration Compounds that meet the **, as determined by the JRC during the Research Term. 1.22. “Discovery Compound Criteria” means the criteria attached as Schedule 1.22 to the Agreement, as may be amended from time to time by the JRC during the Research Term. 1.23. “Effective Date ” has the meaning set forth in the Preamble. 1.24. “Exchange Act” means the Securities Exchange Act of 1934, as amended. 1.25. “Executive Officers” means the President of Wyeth Pharmaceuticals (or an executive officer of Wyeth designated by such President of Wyeth Pharmaceuticals) and the Chief Executive Officer of Pharmacopeia (or an executive officer of Pharmacopeia designated by such Chief Executive Officer). 1.26. “FDA ” means the United States Food and Drug Administration or any successor agency thereto. 1.27. “FD&C Act ” means the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the rules and regulations promulgated thereunder. 1.28. “Fields” means the Wyeth Field and the Pharmacopeia Field. 1.29. “First Commercial Sale” means, in any particular country in the Territory, the first sale in that country for use by the general public of a Product after Regulatory Approval of such Product has been granted by the Regulatory Authority of that country. 1.30. “FTE ” means the full time equivalent effort of one scientist with either a ** or equivalent degree consisting of ** done by such an employee of Pharmacopeia or of a subcontractor approved in advance by the JRC in accordance with Section 3.7 (Subcontracting) on or directly related to and in support of the Research Plan. 1.31. “IND ” means an Investigational New Drug Application, as defined in the FD&C Act, that is required to be filed with the FDA before beginning clinical testing of a Product in human subjects, or an equivalent foreign filing. 1.32. “Indemnified Party” has the meaning set forth in Section 10.3 (Procedure) hereof. 1.33. “Indemnifying Party” will have the meaning set forth in Section 10.3 (Procedure) hereof. 5 1.34. “Initial Term” has the meaning set forth in Section 3.3.1 (Research Term). 1.35. “JAK-3 Exclusivity Period” means **. 1.36. “JAK-3 Joint Patent Right” means **. 1.37. “JAK-3 Kinase Inhibitor” means a molecule that has JAK-3 Kinase Inhibitory Activity at an **. 1.38. “JAK-3 Kinase Inhibitory Activity” means, when used to describe a compound, that the compound binds to the protein tyrosine kinase enzyme known as Janus Activating Kinase 3 (JAK-3). 1.39. “Joint IP” means Joint Patent Rights and Joint Know-How. 1.40. “ Joint Know-How ” means any Know-How that is jointly owned by the Parties in accordance with Section 6.1 (Ownership). 1.41. “Joint Patent Right(s)” means those Patent Right(s) that claim Joint Know-How. 1.42. “Joint Research Committee” has the meaning set forth in Section 3.4 (Joint Research Committee) hereof. 1.43. “JRC” means the Joint Research Committee. 1.44. “Know-How ” means proprietary information or other know-how, whether or not patentable, and whether stored or transmitted in oral, documentary, electronic, or other form, including without limitation, ideas, concepts, formulas, methods, procedures, designs, compositions, plans, documents, data, inventions, discoveries, developments, works of authorship, biological and chemical materials, and any information relating to research and development plans, experiments, results, compounds, therapeutic leads, candidates, products, preclinical and clinical data, trade secrets, chemical synthesis, scale-up and manufacturing, toxicology, regulatory, stability, and any other information relevant to the **. 1.45. “Lead Developer” means (i) Wyeth for all Wyeth Available Compounds that Wyeth has designated as ** pursuant to ** or selected for Development from among the Passed Compounds pursuant to Section 3.2.4 (Compound Selection) and (ii) Pharmacopeia for all Pharmacopeia Available Compounds, on an Agreement Compound-by-Agreement Compound basis, upon selection by Pharmacopeia of such Agreement Compound pursuant to Section 3.2.4 (Compound Selection). 1.46. “Liability” has the meaning set forth in Section 10.1 (Indemnification by Wyeth) hereof. 6 1.47. “License Verification Notice” has the meaning set forth in Section 3.8 (Notice of Compounds). 1.48. “ Major Market Countries ” means the United States, France, Germany, United Kingdom, Italy, Spain, and Japan. 1.49. “Manufacturing” or “Manufacture” means activities directed to producing, manufacturing, processing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and storage of a Product. 1.50. “Material Structural Feature” means a **. 1.51. “NDA” means a “New Drug Application” filed with the FDA as described in 21 CFR §314, or any corresponding application for Regulatory Approval in any country other than the U.S. 1.52. “ Net Sales ” means, **. It is understood that ** is made. Notwithstanding the foregoing, Net Sales will not include **. Additionally, for the sake of clarity, sales of a **. Notwithstanding the foregoing, if a **. In the event that Wyeth or its sublicensees **. In the event that Wyeth or its sublicensees**. 1.53. “Non-Assert IP” means any Patent Rights Controlled by a Party or its Affiliates that claim (a) the **, or (b) a **. For clarity, the foregoing does not include any **. 1.54. “ Non-Licensed Compounds ” has the meaning set forth in Section 3.9 (License Verification). 1.55. “ Non-Licensed Compound Notice ” has the meaning set forth in Section 3.9 (License Verification). 1.56. “Passed Compounds ” means any Pharmacopeia Compound or Collaboration Compound that has become a “Passed Compound” pursuant to Section 3.2 (Compound Selection and Reversion) and is available for selection by the Parties for Development pursuant to Section 3.2 (Compound Selection and Reversion). Passed Compounds do not include **. 1.57. “Patent Rights ” means any and all (a) patents, (b) pending patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all 7 patents granted thereon, (c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof (d) inventor’s certificates, and (e) all United States and foreign counterparts of any of the foregoing. 1.58. “PCT” means the Patent Cooperation Treaty. 1.59. “Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government. 1.60. “Pharmacopeia Available Compound” means: (a) any Pharmacopeia Compound or Collaboration Compound selected by Pharmacopeia for Development in accordance with Section 3.2.4 (Compound Selection) and for which Pharmacopeia is fulfilling the diligence obligations required under Section 3.2.4 (Compound Selection); and (b) any Pharmacopeia Compound or Collaboration Compound with respect to which Pharmacopeia has undertaken Development in the Wyeth Field if permitted under Section 4.1 and for which Pharmacopeia is fulfilling the diligence obligations required under Section 3.2.4 (Compound Selection). 1.61. “ Pharmacopeia Change of Control Transaction ” means a Change of Control Transaction where Pharmacopeia is the Party undergoing change of control. 1.62. “Pharmacopeia Compounds” means all JAK-3 Kinase Inhibitors that: (a) are identified on Schedule 1.62, or (b) are synthesized by Pharmacopeia or Wyeth in the course of the Research Collaboration from compounds in category ** and (i) are **; (ii) are otherwise ** (iii) are based on ** (a) above; provided , however , **; or (c) are synthesized by Pharmacopeia during the Research Term (but excluding any JAK-3 Kinase Inhibitor identified by Pharmacopeia utilizing information obtained in the Research Collaboration); or (d) come into Control of Pharmacopeia ** 8 (e) were Controlled by Pharmacopeia **, as substantiated by reasonable documentation, but were not listed on Schedule 1.62. Pharmacopeia Compounds further will include isomers, enantiomers, prodrugs, hydrates, solvates, metabolites and all pharmaceutically acceptable salts of the foregoing. 1.63. “Pharmacopeia Field” means all uses of a Product in non-human animals, and all topical uses of a Product for the treatment or prevention of skin and eye diseases in humans where such Product would be applied directly to the skin or eye and would have its therapeutic effect at or near a target site on the skin or eye. 1.64. “Pharmacopeia Indemnified Party” has the meaning set forth in Section 10.1 (Indemnification by Wyeth). 1.65. “Pharmacopeia IP” means Pharmacopeia Patent Rights and Pharmacopeia Know-How. 1.66. “Pharmacopeia Know-How” means all Know-How Controlled by Pharmacopeia ** . It is understood that Pharmacopeia Know-How shall not include any **. 1.67. “ Pharmacopeia Patent Right ” means all Patent Rights Controlled by Pharmacopeia **. It is understood that Pharmacopeia Patent Rights shall not include any **. 1.68. “Pharmacopeia Product ” means a pharmaceutical preparation containing a Pharmacopeia Available Compound. For purposes of clarity, any pharmaceutical preparations containing the same Pharmacopeia Available Compound will be deemed to be the same Pharmacopeia Product. 1.69. “Pharmacopeia Third Party Agreement(s)” means any (i) **, and (ii) any other ** by Pharmacopeia. 1.70. “Phase I Clinical Study ” means a study of an Agreement Compound or Product in human patients with the endpoint of determining initial tolerance, safety and/or pharmacokinetic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens. 1.71. “Phase II Clinical Study ” means a study of an Agreement Compound or Product in human patients to determine initial efficacy and dose range finding before embarking on Phase III Clinical Studies. 1.72. “Phase III Clinical Study ” means a pivotal study in human patients with a defined dose or a set of defined doses of an Agreement Compound or Product designed to ascertain efficacy and safety of such Agreement Compound for the 9 purpose of preparing and submitting applications for Regulatory Approval to the competent Regulatory Authorities in a country of the world. 1.73. “Pre-Development Compound” means an Agreement Compound selected by a Party, at its sole discretion in accordance with its Compound Selection Criteria, for further Development studies prior to being considered for advancement as a Development Compound. 1.74. “Pre-IND” means any Development studies conducted after compound discovery that are intended to obtain information needed to assess, according to a Party’s applicable Compound Selection Criteria, whether to file an IND for a particular compound. 1.75. “Primary Prosecution Countries” means the countries set forth on Schedule 1.75. 1.76. “Product(s)” means Pharmacopeia Product(s) or Wyeth Product(s), as the case may be. 1.77. “Project Team” has the meaning set forth in Section 3.4.1 (Composition) 1.78. “Regulatory Approval ” means the technical, medical and scientific licenses, registrations, authorizations and approvals (including, without limitation, approvals of NDAs, supplements and amendments, pre- and post- approvals, pricing approvals, and labeling approvals) of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the commercial Manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of Product(s) in a regulatory jurisdiction. For the sake of clarity, Regulatory Approval will not be deemed to have been obtained in a country until any applicable governmental pricing and governmental reimbursement approvals (other than those required by Medicaid or Medicare) have also been obtained in such country. 1.79. “Regulatory Authorit(y/ies) ” means any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Agency for the Evaluation of Medicinal Products), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the granting of Regulatory Approval for the Product. 1.80. “Research” means those discovery and preclinical activities undertaken by or on behalf of a Party or its Affiliates with respect to an Agreement Compound, or Product incorporating such Agreement Compound, prior to conducting clinical studies using such Agreement Compound or Product, including, without limitation, medicinal chemistry and synthesis, purification and other discovery efforts, test method development and stability testing, delivery 10 system development, pharmacology, preclinical toxicology, and formulation of such Agreement Compound or Product. 1.81. “Research Plan ” means the written plan for the conduct of the Research Collaboration described in Section 3.5 (Research Plan). 1.82. “Research Collaboration ” has the meaning set forth in Section 3.1 (Scope). 1.83. “Research Term ” has the meaning set forth in Section 3.3.1 (Research Term). 1.84. “Royalty Term” means, **, the period **. 1.85. “SEC” means the United States Securities and Exchange Commission. 1.86. “Selection Conditions” means the occurrence of both of the following events (a) ** and (b) **. 1.87. “Selection Notice” means written notice to the JRC or the other Party, as applicable, nominating a **, as applicable. 1.88. “Term” has the meaning set forth in Section 9.2 (Term). 1.89. “Territory ” means the entire world. 1.90. “Third Part(y/ies) ” means any Person(s) other than Wyeth, Pharmacopeia or their respective Affiliates. 1.91. “Third Party IP Rights” will have the meaning set forth in Section 6.2.3(b) (Option to Negotiate) hereof. 1.92. “Third Party Suit” has the meaning set forth in Section 6.2.3(c) (Third Party Infringement Suit). 1.93. “Top 10 Pharmaceutical Company ” means, **. 1.94. “Trademarks ” means those registered and unregistered trademarks used in connection with the Commercialization of any Product by a Party or its Affiliates or sublicensees hereunder. 1.95. “Unpatented Product” means a Wyeth Product, the making, use, sale, offering for sale, or importation of which does not infringe at least one Valid Claim of a Pharmacopeia Patent Right or Joint Patent Right in the particular country where the sale of such Wyeth Product has occurred. 1.96. “Valid Claim” means a claim of any issued, unexpired U.S. or foreign patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time 11 allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise. 1.97. “Wyeth Available Compound” means: (a) during the Research Term, all Agreement Compounds other than Pharmacopeia Available Compounds and Non-Licensed Compounds; and (b) after the Research Term, (i) **, and (ii) **, in each case ((i) and (ii)) other than **. 1.98. “Wyeth Compounds” means JAK-3 Kinase Inhibitors that (a) Wyeth, in its sole discretion, contributes to the Research Collaboration for evaluation by the JRC pursuant to Section 3.2.1 (Discovery Compounds) and which are Controlled by Wyeth as of the Effective Date of the Agreement or come into Control of, or are synthesized by, Wyeth during the Research Term (but excluding any JAK-3 Kinase Inhibitor identified by Wyeth utilizing information obtained in the Research Collaboration), or (b) are synthesized by Wyeth or Pharmacopeia in the course of the Research Collaboration from compounds in category (a) above and are (i) **; (ii) otherwise obtained ** (iii) based on ** (a) above; provided , however , **. Wyeth Compounds further will include isomers, enantiomers, prodrugs, hydrates, solvates, metabolites and all pharmaceutically acceptable salts of the foregoing. Notwithstanding the foregoing, **. Furthermore, **. 1.99. “Wyeth Development Track” means **. 1.100. “Wyeth Field” means all human therapeutic and prophylactic uses of a Product other than uses included within the Pharmacopeia Field. 1.101. “Wyeth Indemnified Party” has the meaning set forth in Section 10.2 (Indemnification by Pharmacopeia) hereof. 1.102. “Wyeth IP ” means Wyeth Patent Rights and Wyeth Know-How. 1.103. “Wyeth Know-How” means any Know-How Controlled by Wyeth **. 1.104. “Wyeth Patent Right” means all Patent Rights Controlled by Wyeth **. 1.105. “Wyeth Product” means a pharmaceutical preparation containing a Wyeth Available Compound. For purposes of clarity, any pharmaceutical preparations containing the same Wyeth Available Compound will be deemed to be the same Wyeth Product. For the avoidance of doubt, a Wyeth Product will not be considered to be separate, distinct and different from another Wyeth Product solely on the basis of its use for a different indication, method of production or manufacture, method of delivery or dosage level. 12 2. LICENSES. 2.1. Licenses to Wyeth. 2.1.1. ** License. Subject to the terms and conditions of this Agreement, Pharmacopeia hereby grants Wyeth a **, as determined by the JRC. 2.1.2. ** Licenses. Subject to the terms and conditions of the Agreement, including the rights reserved by Pharmacopeia under Section 2.3 (Retained Rights) and Section 2.12 (Pharmacopeia Third Party Activities): (a) ** Period. Pharmacopeia hereby grants Wyeth **; (b) ** Rights. Subject to Section 4.1 (Product Development), Pharmacopeia hereby grants Wyeth **; and (c) ** Compounds. Pharmacopeia hereby grants Wyeth **. 2.2. Licenses to Pharmacopeia. 2.2.1. ** License. Subject to the terms and conditions of this Agreement, Wyeth hereby grants Pharmacopeia **, as determined by the JRC. 2.2.2. ** License. Subject to the terms and conditions of this Agreement, with respect to **, Wyeth hereby grants Pharmacopeia **. 2.3. Retained Rights. 2.3.1. ** Period . After the **. 2.3.2. ** Retained Rights . **. 2.4. Sublicensing . Wyeth may grant to its Affiliates and to Third Parties sublicenses of the rights granted to it under Section 2.1.2(c) (Development and Commercialization License) at any time at its sole discretion; provided that, within thirty (30) days following the execution of any such sublicense, Wyeth shall provide Pharmacopeia with at least the following information with respect to each sublicensee: (i) the identity of the sublicensee; (ii) a description of the Product, and the rights granted to the sublicensee; and (iii) the territory in which the Product will be sold. Each such sublicense will be subject to the requirements of 35 U.S.C. § 200 et seq. and implementing regulations, and shall be subject and subordinate to, and consistent with, the terms and conditions of this Agreement, and Wyeth shall remain responsible to Pharmacopeia for the compliance of each such sublicensee with the financial and other obligations due under this Agreement. No sublicense granted by Wyeth may be assigned, transferred or further sublicensed to any Third Party without the prior written consent of Pharmacopeia. 13 2.5. Direct Licenses to Affiliates. Wyeth may at any time request and authorize Pharmacopeia to grant licenses directly to Affiliates of Wyeth by giving written notice designating to whom a direct license is to be granted. Upon receipt of any such notice, Pharmacopeia will enter into and sign a separate direct license agreement with such designated Affiliate of Wyeth and will enter into and sign an amendment to this Agreement as may be necessary to reflect entry into such direct license. All such direct license agreements will be consistent with the terms and conditions of this Agreement, except for such modifications as may be required by the laws and regulations in the country in which the direct license will be exercised; provided , however , that Pharmacopeia will have no obligation to enter into any such direct license agreement if the effect of entering into such agreement (and continuing as a party to this Agreement) would be to increase the level of obligations owed by Pharmacopeia, or decrease the consideration owed to Pharmacopeia, relative to the obligations owed by or consideration owed to Pharmacopeia under this Agreement. In countries where validity of the direct license agreement requires prior government approval or registration, such direct license agreement will not become binding between the parties thereto until such approval or registration is granted, which approval or registration will be obtained by Wyeth. All costs of making a direct license, including Pharmacopeia’s reasonable attorneys fees, under this Section 2.5 will be borne by Wyeth. 2.6. Restrictions. 2.6.1. ** Restrictions. Subject to Section 2.1.2 (Wyeth's ** License) and Section 2.2.2 (Pharmacopeia's ** License), **. During the **. 2.6.2. Pharmacopeia Restrictions. (a) ** JAK-3 Compounds. Subject to Section 2.2.2 (** License), during the **. (b) ** Licenses . Subject to Section 2.2.2 (** License), during the **. (c) Joint Patent Rights . Subject to the rights retained by Pharmacopeia under clauses (i), (iii), and (iv) of Section 2.3.2 (** Retained Rights) and Section 4.1 (Product Development), Pharmacopeia will not **. (d) ** Compounds . Subject to the rights retained by Pharmacopeia under clauses (i) and (iii) of Section 2.3.2 (** Retained Rights), **. (e) ** Compounds. Except in the exercise of Pharmacopeia’s right under Section 4.1 (Product Development) to **, Pharmacopeia will not **. 14 2.6.3. Wyeth Restrictions. During the **. 2.6.4. Termination of Restrictions. Without limiting any remedy that a Party may have under this Agreement, in equity or at law, in the event that either Party rejects this Agreement under Section 365 of the Bankruptcy Code, the covenants set forth in this Section 2.6 (Restrictions) shall terminate and cease to restrict the non-bankrupt Party. 2.7. Covenant Not to Sue. Subject to any ** granted by either Party under any agreement with a Third Party entered into in compliance with the terms of this Agreement: (a) Covenant by each Party. Each Party hereby ** covenants and warrants that it will not (and will cause its Affiliates, successors, and assigns not to) **; and (b) Covenant by Pharmacopeia. Pharmacopeia **. (c) Limitation on Covenant. Nothing in Section 2.7(a) (Covenant by Each Party) or 2.7(b) (Covenant by Pharmacopeia) shall be construed to **. (d) Successors and Assigns . The covenants in Section 2.7(a) (Covenant by Each Party) will inure to the benefit of and will bind the respective successors and permitted assigns of the Parties and their Affiliates. 2.8. Right of Reference. Each Party hereby grants to the other Party a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled by such Party or its Affiliates that relates to any Agreement Compound or Product for which the other Party is the Lead Developer, and such Party will provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3). 2.9. 365(n) of Bankruptcy Code. All rights and licenses now or hereafter granted under or pursuant to any Section of this Agreement, are rights to “intellectual property” (as defined in Section 101(35A) of Title 11 of the United States Code, as amended (such Title 11, the “Bankruptcy Code”)). Each Party hereby grants to other Party and all Affiliates of such other Party a right of access and to obtain possession of, and to benefit from copies of, (i) pre-clinical and clinical research data and results, (ii) laboratory and compound samples required by the JRC to be delivered to Wyeth to the extent not previously delivered and to the extent still available to Pharmacopeia, all of which ((i) and (ii)) constitute “embodiments” of intellectual property pursuant to Section 365(n) of the Bankruptcy Code), and (iii) all other embodiments of such intellectual property, whether any of the foregoing are in the granting Party’s possession or control or in the possession and control of Third Parties. 15 Each Party agrees not to interfere with the other Party’s and other Party’s Affiliates exercise of rights and licenses to intellectual property licensed hereunder and embodiments thereof in accordance with this Agreement and agrees to use reasonable efforts to assist such other Party and Affiliates to obtain such intellectual property and embodiments thereof in the possession or control of Third Parties as reasonably necessary or desirable for such other Party and Affiliates to exercise such rights and licenses in accordance with this Agreement. The Parties acknowledge and agree that all payments payable under this Agreement will constitute “royalties” within the meaning of Bankruptcy Code Section 365(n) other than FTE payments payable to Pharmacopeia under Section 3.6 (Funding of the Research Collaboration) and Designation Payments payable to Pharmacopeia under Section 5.2 (Designation Payments). Furthermore, the Parties agree that **, Designation Payments payable to Pharmacopeia under Section 5.2 (Designation Payments) will also constitute “royalties” within the meaning of Bankruptcy Code Section 365(n). 2.10. Know-How Transfer. 2.10.1. Disclosure of Pharmacopeia Know-How. Pharmacopeia will disclose the Pharmacopeia Know-How to Wyeth during the Research Term. Without limiting the generality of the foregoing, at Wyeth’s request within a reasonable time not to exceed ** days from the date of Wyeth’s request, Pharmacopeia will deliver to Wyeth, as ** or as otherwise contemplated under a Research Plan, copies (for documentation and information) or samples (for tangible materials) of any documents, files, diagrams, plans, specifications, designs, recipes, schematics, reports, notes, data, models, prototypes, chemical or biological materials, or other documentation or tangible materials recording or embodying the Pharmacopeia Know-How in Pharmacopeia’ possession. In addition, at Wyeth’s request, and on a commercially reasonable schedule and at a commercially reasonable venue **, technically qualified scientists and engineers from each Party will meet and/or participate in telephone conference calls as reasonably necessary to exchange knowledge necessary to fully transfer all such Pharmacopeia Know-How. 2.10.2. Disclosure and Transfer of Joint Know-How. Each Party will promptly disclose any Joint Know-How to the other Party. Any such Joint Know-How transfer will be accomplished through reciprocal delivery of documentation and meetings/telephone calls in like manner as provided in Section 2.10.1 (Disclosure of Pharmacopeia Know-How). 2.11. No Implied Rights. Except as expressly provided in this Agreement, neither Party will be deemed by estoppel or implication to have granted the other Party 16 any license or other right with respect to any intellectual property of such Party. 2.12. Pharmacopeia Third Party Activities. It is understood that **. Accordingly, so long as **. 2.13. No Obligation To Disclose Non-Agreement Compounds . For the avoidance of doubt, nothing in this Agreement will require Pharmacopeia to disclose to Wyeth any compound other than Agreement Compounds. 3. RESEARCH COLLABORATION. 3.1. Scope. During the Research Term, Wyeth and Pharmacopeia will engage in a research collaboration to Research and evaluate JAK-3 Kinase Inhibitors in the appropriate assays and pre-clinical models of **, and to select ** through the selection procedures set forth in this Article 3 and pursuant to the other terms and conditions of this Agreement (the “Research Collaboration” ). The Research Collaboration will be conducted in accordance with the Research Plan. The JRC will have the sole authority to determine the activities to be undertaken by Pharmacopeia FTEs and Wyeth personnel working in the Research Collaboration during the Research Term. In general, the Parties agree that medicinal chemistry and primary, in vitro biology will be undertaken by Pharmacopeia, and that in vivo biology and animal pharmacology will be undertaken by Wyeth. **. 3.2. Compound Selection. 3.2.1. Discovery Compounds . The JRC will establish a procedure under which ** will be evaluated to determine whether such compounds meet the Compound Selection Criteria for **. The JRC will follow such procedures in making determinations regarding whether a compound meets such Compound Selection Criteria. If the JRC reasonably believes that it does not have sufficient data to determine whether a compound meets such Compound Selection Criteria, it may request that reasonable further data for such compound be generated pursuant to a Research Plan, in order to make such determination. At the ** the JRC following the provision of such reasonable further data to the JRC, the JRC will make a final determination as to the status of the compound in question. Subject to Section 3.4.6 (Dispute Resolution), if the JRC does not determine ** at that time, **. Any such Wyeth Compound will remain **. 3.2.2. Pre-Development Compounds . Within ** of an Agreement Compound being designated as a ** pursuant to Section 3.2.1 (Discovery Compounds), Wyeth will have the ** by providing written notice of such designation to the JRC. Any ** that is not **. Wyeth may also designate a ** as a ** prior to the expiration of such ** 17 period by providing written notice to Pharmacopeia of such designation. At the end of the Research Term, any **. 3.2.3. Development Compounds . Wyeth may, at any time and at its sole discretion, designate as ** any ** that meet the applicable Compound Selection Criteria. 3.2.4. Compound Selection . (a) General Selection Procedures During the Research Term . (i) Selection by Pharmacopeia . During the Research Term, for any **. (ii) Selection by Either Party . Any ** for purposes of this Agreement. (iii) ** Pre-Development Compounds . Notwithstanding the other provisions of this Section 3.2.4 (Compound Selection), **. (b) Passed Compounds at End of Research Term . At the end of the Research Term, all **. Notwithstanding the foregoing, if at the end of the Research Term any **. (c) Selection of Agreement Compounds After Research Term . (i) Selection by Pharmacopeia . After the Research Term, all **. (ii) Wyeth Compounds . After the Research Term, all **. (iii) Collaboration Compounds Invented Solely by Wyeth . After the Research Term, all **. (iv) Collaboration Compounds Invented Jointly . If the **. (v) Pharmacopeia Compounds and Collaboration Compounds Invented by Pharmacopeia . If the **. (d) Effect of Selection . If a ** with respect to such compound. If a ** by either Party. (e) Diligence . Pharmacopeia will use **. If Pharmacopeia fails to do so for any **. Such compound’s becoming ** for a breach by Pharmacopeia of this Section 3.2.4(e) (Diligence). 18 3.2.5. Notice of Designation. Both during and after the **, each Party will promptly notify the other in writing upon designating ** pursuant to this Agreement. Such notice shall include a **. 3.2.6. No Simultaneous Development of the Same Agreement Compound. For clarity, in no event may **, at the same time, under any circumstances. For example, ** of a topical ** treatment must be undertaken with a ** of an oral or injectable **. 3.2.7. ** After Research Term. Each Party may **. For example, such **. Notwithstanding the foregoing, neither Party shall be obligated to ** contemplated by this Section. 3.2.8. Pharmacopeia Compound Selection Criteria. Prior to selecting a Passed Compound pursuant to Section 3.2.4 (Compound Selection), Pharmacopeia will submit to the JRC reasonable Compound Selection Criteria that will be used by Pharmacopeia for selecting a compound as a Pre-Development Compound and for advancing a Pre-Development Compound to a Development Compound, which Compound Selection Criteria will be consistent with industry standards and generally comparable, where applicable, to the Compound Selection Criteria used by Wyeth taking into account the requirements of a therapeutic product for the indications and routes of delivery in the Pharmacopeia Field. 3.3. Term of the Research Collaboration. 3.3.1. Research Term. Unless earlier terminated in accordance with Section 9 (Government Approvals; Term and Termination), the term of the Research Collaboration will ** (the “Initial Term” ) and for the duration of any extension described in Section 3.3.2 (Extensions) (the entire period being the “Research Term” ). 3.3.2. Extensions . Wyeth will have the option, exercisable in its sole discretion, by providing written notice to Pharmacopeia ** prior to the end of the Initial Term, to extend the Research Collaboration for an additional year. In addition, the Parties will be entitled to extend the Research Term for additional ** upon mutual agreement. 3.4. Joint Research Committee. 3.4.1. Composition. Within thirty (30) days after the Effective Date, the Parties will establish a Joint Research Committee (the “ Joint Research Committee ” or “ JRC ”) to oversee and govern the Research Collaboration. The JRC will be in effect only during the Research Term. The JRC will be composed of three (3) representatives from each Party and will be co-chaired by one representative of each Party. Each Party may replace any of its 19 representatives at any time upon written notice to the other Party. From time to time, the JRC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JRC decides. ** (each such **) **. During the Research Term, **. Each Project Team shall include **. 3.4.2. Responsibilities. The JRC’s responsibilities will be to (i) create the Research Plan and update it within ninety (90) days of the end of each year of the Research Term; (ii) manage the implementation of the Research Plan, including but not limited to implementing the chemistry and biology activities associated with Agreement Compounds to be evaluated thereunder; (iii) either directly or through **, direct the chemistry efforts carried out by both Parties and determine the division of labor under the Research Plan including the activities to which all Pharmacopeia ** and all Wyeth ** allocated; (iv) determine whether Agreement Compounds have achieved the Compound Selection Criteria for **, if appropriate; (v) manage the process of the Agreement Compound selection by the Parties, as described in Section 3.2 (Compound Selection and Reversion); (vi) maintain an up-to-date list of ** and Agreement Compounds selected by either Party for Development pursuant to a Selection Notice, which list will specify whether each compound is a **. All Compound Classification Disputes, as well as any dispute as to whether an Agreement Compound meets the **, will be resolved in accordance with the procedures set forth in Section 3.4.6 (Dispute Resolution). However, the procedures set forth in Section 3.4.6 (Dispute Resolution) **. 3.4.3. Meetings. The JRC will meet at least four (4) times annually, face-to-face, unless otherwise agreed by the co-chairs, and may arrange other meetings as the co-chairs deem necessary by teleconference or video. At the first meeting of the JRC, to be held within thirty (30) days of the Effective Date, the JRC will agree to an initial Research Plan for the Research Collaboration and will evidence such Research Plan by attaching it to the minutes of such meeting. Each Party will have the right, upon thirty (30) days prior written notice to the other Party, to call a special meeting of the JRC to vote on any issue subject to the JRC’s jurisdiction, either in-person by teleconference, or video, as the co-chairs of the JRC may agree. Project Teams will maintain continuous and open communication through in-person meetings, teleconferences and e-mail. 3.4.4. End of Jurisdiction. After the Research Term, or on an Agreement Compound-by-Agreement Compound basis, at such time as an Agreement Compound is designated by a Party as a ** , the JRC will have no further jurisdiction, and all activities for further research and 20 Development of such ** will be managed by the Lead Developer with respect to such **. 3.4.5. Voting . Decisions of the JRC will be made by unanimous consent, with each Party having one vote. The JRC may act without a meeting if an action by unanimous written consent is signed by all members of the JRC. 3.4.6. Dispute Resolution. (a) ** Disputes . If a dispute regarding ** cannot be resolved at the JRC within fifteen (15) business days, the matter will be resolved by, first, referring the ** Dispute to a team of legal counsel, the team consisting of two lawyers having experience in chemistry, with one selected by each Party. If the team of legal counsel is unable to resolve the matter within fifteen (15) business days, the matter will then be referred for resolution to an independent patent lawyer having experience in chemistry who is acceptable to both members of the team of legal counsel. The decision of the mutually agreed outside legal counsel will be binding on the Parties. (b) If, pursuant to Section 3.4.2 (Responsibilities) a dispute, **, cannot be resolved at the JRC within fifteen (15) business days, the matter will be brought by the JRC co-chairs to the Executive Vice President, Wyeth Discovery Research, and the Chief Scientific Officer, Pharmacopeia. If agreement cannot be reached between these two individuals within fifteen (15) business days, then the matter will be brought to the President, Wyeth Research and the CEO, Pharmacopeia for good faith discussion and timely resolution. 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