COLLABORATION AGREEMENT
by and between:
ARRAY BIOPHARMA INC.,
a Delaware corporation; and
VERTEX PHARMACEUTICALS INCORPORATED,
a Massachusetts corporation.
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Dated as of August 1, 2001
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TABLE OF CONTENTS
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---- ARTICLE 1 DEFINITIONS.....................................................................................1
ARTICLE 2 RESEARCH COLLABORATION..........................................................................5
Section 2.1 Goal...................................................................................5
Section 2.2 Targets............................................................................... 5
Section 2.3 Research Plan..........................................................................6
Section 2.4 General Resources and Responsibilities.................................................6
Section 2.5 Research Collaboration Staffing........................................................7
Section 2.6 Research Term..........................................................................8
Section 2.7 Third Party Licenses...................................................................8
Section 2.8 Record Maintenance.....................................................................8
Section 2.9 Exclusivity............................................................................8
Section 2.10 Access to Diversity Library Compounds..................................................9
Section 2.11 Delivery...............................................................................9
ARTICLE 3 MANAGEMENT.....................................................................................10
Section 3.1 Joint Research Committee..............................................................10
Section 3.2 Membership............................................................................10
Section 3.3 Meetings..............................................................................10
Section 3.4 Minutes...............................................................................10
Section 3.5 Decision Making.......................................................................11
Section 3.6 Program Managers......................................................................11
Section 3.7 Records and Reporting.................................................................11
ARTICLE 4 LICENSES.......................................................................................12
Section 4.1 Exclusive License under Collaboration Technology......................................12
Section 4.2 Exclusive License under Joint Technology..............................................12
Section 4.3 Non-Exclusive License under Array Technology..........................................12
Section 4.4 Research Use License..................................................................13
Section 4.5 License to Vertex for Diversity Library Compounds.....................................13
Section 4.6 No Implied Licenses...................................................................13
Section 4.7 No Products Other than Products.......................................................13
Section 4.8 Development and Commercialization.....................................................13
ARTICLE 5 PAYMENTS.......................................................................................14
Section 5.1 Initial Payment.......................................................................14
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Section 5.2 Research Collaboration Funding........................................................14
Section 5.3 Milestones............................................................................15
ARTICLE 6 PAYMENT METHOD; BOOKS AND RECORDS..............................................................16
Section 6.1 Payment Methods.......................................................................16
Section 6.2 Records; Inspection...................................................................16
ARTICLE 7 DUE DILIGENCE..................................................................................17
Section 7.1 Due Diligence.........................................................................17
ARTICLE 8 INTELLECTUAL PROPERTY..........................................................................17
Section 8.1 Ownership of Inventions; Disclosure...................................................17
Section 8.2 Patent Prosecution....................................................................17
Section 8.3 Cooperation...........................................................................18
Section 8.4 Infringement Defense..................................................................18
ARTICLE 9 CONFIDENTIALITY AND NON-USE....................................................................19
Section 9.1 Confidential Information..............................................................19
Section 9.2 Non-Use Obligations...................................................................20
Section 9.3 Permitted Use and Disclosures.........................................................20
Section 9.4 Termination of Prior Agreement........................................................20
Section 9.5 Nondisclosure of Terms................................................................21
Section 9.6 Publication...........................................................................21
ARTICLE 10 REPRESENTATIONS AND WARRANTIES.................................................................22
Section 10.1 Vertex................................................................................22
Section 10.2 Array.................................................................................22
Section 10.3 Disclaimer............................................................................22
ARTICLE 11 INDEMNIFICATION................................................................................23
Section 11.1 Vertex................................................................................23
Section 11.2 Array.................................................................................23
Section 11.3 Indemnification Procedures............................................................23
ARTICLE 12 TERM AND TERMINATION...........................................................................24
Section 12.1 Term..................................................................................24
Section 12.2 Termination for Breach................................................................24
Section 12.3 Termination for Insolvency............................................................24
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Section 12.4 Early Termination of Research Collaboration by Vertex.................................24
Section 12.5 Termination Upon Acquisition..........................................................25
Section 12.6 Effect of Breach or Termination.......................................................25
Section 12.7 Survival..............................................................................25
ARTICLE 13 MISCELLANEOUS..................................................................................26
Section 13.1 Governing Laws........................................................................26
Section 13.2 Waiver................................................................................26
Section 13.3 Assignment............................................................................26
Section 13.4 Independent Contractors...............................................................26
Section 13.5 Compliance with Laws..................................................................26
Section 13.6 Notices...............................................................................27
Section 13.7 Severability..........................................................................27
Section 13.8 Advice of Counsel.....................................................................28
Section 13.9 Performance Warranty..................................................................28
Section 13.10 Force Majeure.........................................................................28
Section 13.11 Complete Agreement....................................................................28
Section 13.12 Consultation..........................................................................28
Section 13.13 Headings..............................................................................28
Section 13.14 Counterparts..........................................................................28
EXHIBIT A RESEARCH PLAN
EXHIBIT b DIVERSITY LIBRARY COMPOUND SPECIFICATIONS
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COLLABORATION AGREEMENT
This COLLABORATION AGREEMENT (the "Agreement"), effective as of August 1, 2001 (the "Effective Date"), is made by and between Array BioPharma Inc., a Delaware corporation, having a principal place of business at 1885 33rd Street, Boulder, Colorado 80301 ("Array"), and Vertex Pharmaceuticals Incorporated, a Massachusetts corporation, having a principal place of business at 130 Waverly Street, Cambridge, Massachusetts 02139-4242 ("Vertex").
BACKGROUND
A. Array has developed novel and proprietary methods for the generation of Compounds, has synthesized a Diversity Library (as defined below) and has skills, expertise and experience in identification, generation, selection and optimization of lead compounds to produce clinical candidates from drug discovery programs.
B. Vertex is a pharmaceutical company involved in the research, development, manufacture and sale of new and useful pharmaceutical products, and has identified biological models and assays that have the potential to be used as the basis for drug discovery programs for specific Targets (as defined below).
C. Vertex and Array desire to collaborate to identify Compounds with activity against the Targets, with the goal of delivering Compounds with desired activity and selectivity.
NOW, THEREFORE, for and in consideration of the covenants, conditions and undertakings hereinafter set forth, it is agreed by and between the Parties as follows:
ARTICLE 1
DEFINITIONS
As used herein, the following terms will have the meanings set forth below:
1.1 "Affiliate" shall mean any corporation or other entity which is directly or indirectly controlling, controlled by or under common control of a Party hereto for so long as such control exists. For the purposes of this Section 1.1, "control" shall mean the direct or indirect ownership of at least fifty percent (50%) of the outstanding shares or other voting rights of the subject entity having the power to vote on or direct the affairs of the entity, or if not meeting the preceding, the maximum voting right that may be held by the particular Party under the laws of the country where such entity exists.
1.2 "Array Technology" shall mean Array Patent Rights, Diversity Library Compounds, and all other technology including, but not limited to, trade secrets, know-how, inventions,
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information (including structure-activity data) and materials, whether patentable or not, directed to processes, formulations and/or methods discovered, developed, owned, licensed or acquired by Array in the Field prior to the commencement date of the Research Collaboration. Notwithstanding the foregoing, it is understood that Array Technology shall not include any patent or other rights to high-speed synthesis technology, methods or compound libraries. For the avoidance of doubt, it is intended that Array Technology shall exclude Vertex Technology, Collaboration Technology and Joint Technology.
1.2.1 "Array Patent Rights" shall mean (i) all patents and patent applications that claim a Diversity Library Compound, or method of use or process for the synthesis thereof or composition-of-matter containing such Diversity Library Compound, for which the earliest effective filing date is prior to the Effective Date, and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, or extensions to the extent the same have an earliest effective filing date prior to the date described in (i) above, and any substitutions, confirmations, or registrations of any of the foregoing, in each case, which is owned by Array (solely or jointly), to the extent Array has the right to license or sublicense the same.
1.3 "Array Researchers" shall have the meaning set forth in Section 2.5 below.
1.4 "Diversity Library Compound Information" shall have the meaning set forth in Section 2.11.1 below.
1.5 "Chemical Class" shall mean those chemical entities [***].
1.6 "Collaboration Technology" shall mean all technology including, but not limited to, trade secrets, know-how, inventions, information (including structure-activity data) and materials (excluding Compounds), whether patentable or not, directed to processes, formulations and/or methods a) discovered, developed, owned, licensed or acquired by Array (whether or not with funding support by Vertex) arising out of or in connection with the conduct of the Research Collaboration; or (b) discovered, developed, owned, licensed or acquired by Array Researcher(s) funded by Vertex in the course of performing activities under the Research Plan. For the avoidance of doubt, it is intended that Collaboration Technology shall exclude Vertex Technology, Array Technology and Joint Technology.
1.7 "Compound" shall mean any chemical entity synthesized by Array and disclosed to Vertex in the course of performing or in connection with the Research Collaboration that is identified as having that level of activity against a Target in the applicable assay as set forth in the Research Plan. For the purposes hereof, a prodrug shall also constitute a "Compound", provided that the active component of such prodrug has the level of activity specified in the Research Plan. Notwithstanding the foregoing, it is understood and agreed that no Diversity Library Compound shall be deemed a Compound. The Parties agree that the Research Plan shall specify an enzymatic inhibition activity level no greater than [***].
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1.8 "Consumer Price Index" or "CPI" means the Consumer Price Index, All Urban Consumers, as published by the U.S. Bureau of Labor Statistics.
1.9 "Diversity Library" shall mean the collection of chemical entities that Array makes available on a non-exclusive basis to Third Parties contained within 96-well plates. The Diversity Library shall contain between [***] and [***] chemical entities.
1.10 "Diversity Library Compound" shall mean any chemical entity that is contained in the Diversity Library.
1.11 "Field" shall mean the discovery, development and commercialization of small molecules for the therapeutic or prophylactic treatment of diseases and conditions in humans, wherein the mechanism of action of such small molecules is to modulate the activity of a Target.
1.12 "First Commercial Sale" shall mean, with respect to each Product, the first bona fide FDA-approved commercial sale of such Product in the United States by or under authority of Vertex, its Affiliates or Licensees.
1.13 "FTE" shall mean a full-time person dedicated to the Research Collaboration, or in the case of less than a full-time, dedicated person, a full-time, equivalent person year, based upon a total of [***] hours per year of work in connection with the Research Collaboration.
1.14 "Inactive Chemical Entity" shall mean a chemical entity, (other than a Compound, or a chemical entity in the Chemical Class, or a Diversity Library Compound) synthesized and screened by Array in the course of performing, or in connection with, the Research Collaboration.
1.15 "JRC" or "Joint Research Committee" shall have the meaning set forth in Section 3.1.
1.16 "Joint Technology" shall mean all technology including, but not limited to, trade secrets, know-how, inventions, information (including structure-activity data) and materials (excluding Compounds), whether patentable or not, directed to products, processes, formulations and/or methods that are developed by Array using Vertex Technology or are discovered, developed, licensed or acquired jointly by Array and Vertex in performance of the Research Collaboration or thereafter until termination of the Agreement. For the avoidance of doubt, it is intended that Joint Technology shall exclude Vertex Technology, Array Technology and Collaboration Technology.
1.17 "Licensed Technology" shall mean, collectively, Collaboration Technology, Joint Technology, and Array Technology licensed to Vertex under this Agreement.
1.18 "Licensee" shall mean, with respect to a particular Product, a Third Party to whom Vertex has granted a license or other right under the Licensed Technology to make and sell such Product. As used in this Agreement, "Licensee" shall also include a Third Party to whom Vertex has granted the right to distribute such Product, provided that such Third Party has responsibility for
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marketing and promotion of such Product within the field or territory for which such distribution rights are granted.
1.19 "NDA" shall mean a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.
1.20 "Net Sales" shall mean the gross invoice price by Vertex or its Affiliates or Licensees, as the case may be, for all Products sold by Vertex, its Affiliates or Licensees ("Selling Party"), under this Agreement in arm's length sales to Third Parties less deductions allowed to the Third Party customer by the Selling Party on such sales for: (a) trade, quantity, and cash discounts; (b) credits, rebates (including those to managed-care entities and government agencies), and allowances or credits to customers on account of rejection or returns (including, but not limited to, wholesaler and retailer returns) or on account of retroactive price reductions affecting such Product; (c) freight, postage and duties; and (d) sales and excise taxes, other consumption taxes, customs duties and compulsory payments to governmental authorities and any other governmental charges imposed upon the sale of such Product to Third Parties. In addition, the Selling Party may exclude from Net Sales a reasonable provision for uncollectible accounts, to the extent such reserve is determined in accordance with generally accepted accounting standards, consistently applied across all product lines of the particular Party, until such amounts are actually collected. Notwithstanding the foregoing, Net Sales shall not include sales among Vertex, its Affiliates and Licensees for resale, provided that such resale shall be included within Net Sales.
1.21 "Party" or "Parties" shall mean, respectively, Array or Vertex individually, or Array and Vertex collectively.
1.22 "Phase IIb" shall have the meaning attributed to such term in 21 CFR 312.21.
1.23 "Phase III" shall mean human clinical trials, the principal purpose of which is to establish safety and efficacy of one or more particular doses in patients being studied, and which will (or are intended to) satisfy the requirements of a pivotal trial for purposes of obtaining approval of a Product in a country by the health regulatory authority in such country to market such Product for an application in the Field, and more specifically, shall have the meaning attributed to such term in 21 CFR 312.21.
1.24 "Product" shall mean any diagnostic, therapeutic or prophylactic product for use in the Field, incorporating as an active ingredient at least one of the following (i) a Compound, or (ii) a chemical entity in the same Chemical Class as a Compound. For the avoidance of doubt, a Product will be considered a single Product and not a separate Product, even if multiple marketing approvals are or would be required by the FDA (or the relevant competent authority), if the multiple marketing approvals are solely due to changes to or variations of (a) the inactive ingredient(s) and/or concentration of the active ingredient(s), (b) the method of delivery (e.g., tabular versus injectable forms, modified dosage forms, treatment modalities), and/or (c) prodrug moieties.
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1.25 "Research Collaboration" shall mean the research activities undertaken by the Parties pursuant to this Agreement.
1.26 "Research Plan" shall mean the written research plan, adopted by the Parties promptly after the Effective Date, governing the joint effort of the Parties in conducting the Research Collaboration in the Field. The Research Plan may be amended from time to time by the Joint Research Committee as it deems necessary or appropriate and shall specify the Array personnel to conduct activities with respect to the Research Collaboration, such personnel to be proposed by Array. The initial Research Plan shall be attached hereto as Exhibit A.
1.27 "Research Term" shall mean the term of the Research Collaboration, as provided in Section 2.6 below.
1.28 "Research Year" shall mean a twelve (12) month period during the term of the Research Collaboration. The first Research Year hereunder shall be deemed to have commenced on the Effective Date.
1.29 "Target(s)" and "Substitute Targets" shall mean those molecular targets which the parties agree are the subject of the Research Collaboration pursuant to Section 2.2 below.
1.30 "Third Party" shall mean any person or entity other than Array and Vertex, and their respective Affiliates.
1.31 "Vertex Technology" shall mean all technology including, but not limited to, trade secrets, know-how, inventions and information (including test data, protocols and screening methodology), and materials, whether patentable or not, directed to products, processes, formulations and/or methods that Vertex discovers, develops, identifies, licenses or acquires independently of Array (i.e., without the use of the Confidential Information of Array), and Compounds, pharmaceutical compositions containing a Compound, chemical entities in a Chemical Class, or the use of a Compound or a composition containing a Compound for therapeutic purposes. For the avoidance of doubt, it is intended that Vertex Technology shall exclude Array Technology, Collaboration Technology and Joint Technology.
ARTICLE 2
RESEARCH COLLABORATION
2.1 Goal. The goal of the Research Collaboration is to identify Compounds that will serve as lead classes against the Targets.
2.2 Targets.
2.2.1 General. The Research Collaboration shall be focused on identifying chemical entities that have activity against the following two (2) phosphatase Targets: [***].
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2.2.2 Abandonment and Substitution of Targets. The JRC may decide to discontinue research activities with respect to one or more Targets (each a "De-Selected Target"). In such event, any Compound directed to a De-Selected Target and any chemical entity in the same Chemical Class as such Compound directed to a De-Selected Target shall remain subject to this Agreement; provided, however, that if during the Research Term research activities are discontinued with respect to a particular De-Selected Target because Vertex elects to cease all research and development activities with respect to such De-Selected Target (an "Abandoned Target"), then (i) Vertex shall so notify Array in writing, and (ii) Arrays' obligations under Section 2.9 below with respect to such Abandoned Target shall terminate [***] a ...
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