DRUG DISCOVERY AND DEVELOPMENT AGREEMENT

Development Agreement

You are currently viewing:

This Development Agreement involves

ARRAY BIOPHARMA INC | 3200 Walnut, Boulder, CO | Celgene Corporation

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.

Title: DRUG DISCOVERY AND DEVELOPMENT AGREEMENT
Governing Law: New York Date: 11/6/2007
Industry: BIOTRX Sector: Healthcare

Search Development Agreement by:

EXHIBIT 10.1

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

EXECUTION COPY

DRUG DISCOVERY AND DEVELOPMENT AGREEMENT

THIS DRUG DISCOVERY AND DEVELOPMENT AGREEMENT (the “Agreement”) is made effective as of September 21, 2007 (“Effective Date”) by and between Array BioPharma Inc., a Delaware corporation, having its principal offices located at 3200 Walnut, Boulder, CO 80301 (“Array”), and Celgene Corporation, a Delaware corporation, having its principal offices located at 86 Morris Avenue, Summit, NJ 07901 (“Celgene”).

BACKGROUND

A. Array has skills, expertise and technology relating to the discovery and development of therapeutics that modulate molecular targets involved in oncology and other disease areas.

B. Celgene is engaged in the discovery, development and commercialization of therapeutics in the fields of oncology and immunological diseases.

C. Celgene and Array desire to establish a collaboration to apply Array’s expertise and technology to the discovery, optimization and development of small molecule compounds that directly bind and modulate certain molecular targets, and to provide for the development and commercialization of certain products based on such compounds, all on the terms and conditions set forth in this Agreement.

NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

ARTICLE I
DEFINITIONS

The following terms shall have the following meanings as used in this Agreement:

1.1 “**[ * ]” shall mean those [ * ]** previously agreed by the Parties.

1.2 “Affiliate” of a Party shall mean any person, corporation or other entity that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party, as the case may be, for so long as such control exists. As used in this Section 1.1, “control” shall mean: (a) to possess, directly or indirectly, the power to direct the management and policies of such person, corporation or other entity, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) direct or indirect beneficial ownership of at least fifty percent (50%) (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital in such person, corporation or other entity.

1.3 “Analog” shall mean, with respect to a specific Development Compound, Development Back-Up Compound, Collaboration Compound, Collaboration Back-Up Compound or Abandoned Compound, molecules (a) that have the same core structure (meaning exact atom arrangement that makes up the original core structure present in the structure of such specific chemical compound, minus any substituent R groups) as such specific Development Compound, Development Back-Up Compound, Collaboration Compound, Collaboration Back-Up Compound or Abandoned Compound; (b) that modulates the Target to which such Development Compound, Development Back-Up Compound, Collaboration Compound, Collaboration Back-Up Compound or Abandoned Compound is directed, the mechanism of action of which is a specific interaction with such Target; and (c) that has a **[ * ]**.

1.4 “Annual Net Sales” shall mean total Net Sales of Licensed Products in a particular calendar year, as derived from audited financial statements of Celgene (or the applicable Affiliate or Sublicensee), provided, however, that Celgene shall use U.S. generally accepted accounting principles to calculate in good faith the Net Sales from any entities that are not audited or have not completed their audit within seventy-five (75) days of the end of the preceding calendar year.

1.5 “Array Technology” shall mean the Array Patents and Array Know-How.

1.5.1 “Array Know-How” shall mean any and all Information Controlled by Array and created prior to the Effective Date that: (a) covers a Collaboration Compound or a Collaboration Back-Up Compound (including the composition of matter, or manufacture or any use thereof); and (b) is necessary for Celgene to exercise the rights licensed to it under the Agreement or perform its obligations with respect to Collaboration Compounds, Collaboration Back-Up Compounds and Licensed Products under the Agreement. For the purposes of the license granted in Section 5.1.2, Array Know-How shall also include any and all Information Controlled by Array and created prior to the Effective Date that is necessary for, or specifically pertains to, the discovery, development or use of Compounds, Development Compounds and Development Back-Up Compounds.

1.5.2 “Array Patents” shall mean all Patents owned or Controlled by Array (a) as of the Effective Date, or (b) during the Term of this Agreement to the extent that such Patents claim Array Know-How, in each case that: (i) claim a Collaboration Compound or a Collaboration Back-Up Compound (including the composition of matter, or manufacture or any use thereof); and (ii) are necessary for Celgene to exercise the rights licensed to it under the Agreement or perform its obligations with respect to Collaboration Compounds, Collaboration Back-Up Compounds and Licensed Products under the Agreement. For the purposes of the license granted in Section 5.1.2, Array Patents shall also include all Patents owned or Controlled by Array as of the Effective Date covering inventions that are necessary for the discovery, development, or use of Compounds, Development Compounds and Development Back-Up Compounds.

Notwithstanding Sections 1.5.1 and 1.5.2 above, the Array Technology shall not include Collaboration Patents or Collaboration Know-How.

1.6 “Celgene Compound” shall mean a chemical entity provided to Array by Celgene, in Celgene’s sole discretion, and agreed on by the JRC as evidenced by written notice that such chemical entity is provided for research and development purposes under this Agreement.

1.7 “Celgene Technology” shall mean the Celgene Patents and Celgene Know-How.

1.7.1 “Celgene Know-How” shall mean any and all Information Controlled by Celgene and (a) created prior to the Effective Date or during the Option Term that is necessary for the discovery, development, manufacture, use or sale of Compounds, Development Compounds and Back-Up Compounds directed to each Target for which Celgene does not exercise the Celgene Product Option, and (b) which is contributed by Celgene during the Option Term, in Celgene’s sole discretion, to the collaboration hereunder, as evidenced by written notice from Celgene to Array and agreed on by the JRC or JDC.

1.7.2 “Celgene Patents” shall mean all Patents owned or Controlled by Celgene (a) prior to the Effective Date or during the Option Term covering inventions that are necessary for the discovery, development, manufacture, use or sale of Compounds, Development Compounds and Back-Up Compounds directed to each Target for which Celgene does not exercise the Celgene Product Option, and (b) which are contributed by Celgene during the Option Term, in Celgene’s sole discretion, the collaboration hereunder, as evidenced by written notice from Celgene to Array and agreed on by the JRC or JDC.

Notwithstanding Sections 1.7.1 and 1.7.2 above, the Celgene Technology shall not include Collaboration Patents or Collaboration Know-How.

1.8 “Collaboration Compound” means each Development Compound for which Celgene has exercised its Celgene Product Option under Section 3.5 of this Agreement and which is identified in the written notice given by Celgene to effect such exercise.

1.9 “Collaboration Technology” shall mean the Collaboration Patents and Collaboration Know-How.

1.9.1 “Collaboration Know-How” shall mean any Information generated, solely or jointly, by employees, consultants or agents of Array and/or Celgene in the course of performing activities under the Discovery Program or in accordance with the applicable Development Plan, or, solely with respect to Array, activities directed to the development, manufacture and/or use of Compounds, Development Compounds, Collaboration Compounds, Back-Up Compounds,

Development Back-Up Compounds, Collaboration Back-Up Compounds, Licensed Products, in each case during the Option Term.

1.9.2 “Collaboration Patents” shall mean all Patents covering inventions conceived or created, solely or jointly, by employees, consultants or agents of Array and/or Celgene in the course of performing activities under the Discovery Program or in accordance with the applicable Development Plan, or, solely with respect to Array, activities directed to the development, manufacture and/or use of Compounds, Development Compounds, Collaboration Compounds, Back-Up Compounds, Development Back-Up Compounds, Collaboration Back-Up Compounds or Licensed Products, in each case during the Option Term.

1.10 “Combination Product” shall mean a Licensed Product that is a pharmaceutical preparation for human use incorporating two or more therapeutically active ingredients and including a Collaboration Compound as one of its active ingredients. Notwithstanding the foregoing, drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “therapeutically active ingredients,” and their presence shall not be deemed to create a Combination Product under this Section 1.10.

1.11 “Compound” shall mean a small molecule chemical entity (a) that is (i) synthesized and/or assayed against a Target by Array prior to the Effective Date, (ii) first synthesized and/or assayed by or on behalf of a Party in the course of performing activities under the Discovery Program, or (iii) a Celgene Compound; (b) that modulates one or more Target(s), the mechanism of action of which is a specific interaction with such Target; and (c) that has **[ * ]**.

1.12 “Control” (including any variations, such as “Controlled” or “Controlling”), with respect to any Compound or intellectual property rights, shall mean rights to a Compound or intellectual property sufficient to grant the applicable license under this Agreement, without violating the terms of any agreement or other arrangement with any Third Party or, without the other Party’s written consent, requiring any payment to a Third Party.

1.13 “Derivative” shall mean a molecule (a) that is synthesized using the same synthetic route such that such molecule is derived from the Development Compound by one synthetic step and such that any compound modifications (i.e., differences between such molecule and the corresponding Development Compound) are readily determined to be related to or derived from the Development Compound, and (b) that has **[ * ]**.

1.14 “Development Back-Up Compound” shall mean, with respect to each Compound designated as a Development Compound, additional Lead Compounds suitable for clinical development designated in accordance with Section 3.5.3 below.

1.15 “Development Compound” shall mean a Compound that is designated for further development in clinical trials, in accordance with Section 3.5.2 below.

1.16 “Diligent Efforts” shall mean the carrying out of obligations or tasks in a manner consistent with the efforts a Party devotes to a product or a research, development or marketing project at a similar stage of research or development that is of similar market potential, profit potential or strategic value resulting from its own research efforts, but in no event using less than the commercially reasonable standards applied by other public biotechnology companies to their pharmaceutical products at a similar stage of research or development that is of similar market potential, profit potential or strategic value.

1.17 “FDA” shall mean the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

1.18 “FD&C Act” shall mean the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the regulations promulgated thereunder, as amended from time to time.

1.19“ FTE” shall mean a full-time person employed by Array, dedicated full-time to the Discovery Program, or in the case of less than a full-time dedicated person, a full-time, equivalent

person year, based upon a total of one thousand eight hundred eighty (1,880) hours per year of work on the Discovery Program.

1.20 “GAAP” shall mean generally accepted accounting principles as applicable in the United States of America.

1.21 “IND” shall mean any Investigational New Drug Application filed with the FDA pursuant to 21 C.F.R. § 312 before the commencement of clinical trials involving a Development Compound, a Development Back-Up Compound, a Collaboration Compound or a Collaboration Back-Up Compound (or any Licensed Product incorporating a Collaboration Compound or Collaboration Back-Up Compound), or any comparable filings with any Regulatory Authority in any other jurisdiction.

1.22 “Information” shall mean materials, data and other information relating to the subject matter of this Agreement and including: (a) techniques and data, including screens, models, inventions, methods, test data (including, pharmacological, toxicological and clinical test data), analytical and quality control data, marketing, pricing, distribution, costs, and sales data, manufacturing information, and patent and legal data or descriptions (to the extent that disclosure thereof would not result in loss or waiver of privilege or similar protection); (b) compositions of matter, including compounds, biological materials and assays; and (c) the subject matter and content of all JRC, JDC, JMC and JCC discussions and meetings. As used herein, “clinical test data” shall be deemed to include all information related to the clinical or preclinical testing of a Compound or Licensed Product, including patient report forms, investigators’ reports, biostatistical, pharmaco-economic and other related analyses, regulatory filings and communications, and the like.

1.23 “Initiation” of a particular clinical trial shall be deemed to occur upon the date of first dosing of the first subject in such trial.

1.24 “Licensed Product” shall mean a product that incorporates a Collaboration Compound or a Collaboration Back-Up Compound as an active ingredient.

1.25 “Marketing Approval” shall mean all approvals, licenses, registrations or authorizations of a Regulatory Authority in a country necessary for the manufacture, use, storage, import, marketing and sale of a Licensed Product in such country.

1.26 “Marketing Approval Application” or “MAA” shall mean a New Drug Application (as defined in 21 C.F.R. § 314.50 et. seq.) or a comparable application for Marketing Approval (not including pricing or reimbursement approval) in another jurisdiction, in each case with respect to a Licensed Product.

1.27 “Marketing Exclusivity” shall mean, with respect to a Licensed Product that the Licensed Product has been granted marketing exclusivity afforded approved drug products pursuant to (a) Sections 505(c), 505(j), and 505A of the FD&C Act or its equivalent in a country other than the United States, or (b) the orphan drug exclusivity afforded approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the FD&C Act or its equivalent in a country other than the United States, or (c) applicable law covering the Licensed Product which precludes the Regulatory Authority in a country from granting Marketing Approval for another product that contains the same active ingredient as that which is contained in the applicable Licensed Product.

1.28 “Net Sales” shall mean the gross amounts billed or invoiced by Celgene, its Affiliates or Sublicensees to non-Sublicensee Third Parties for the sale or other commercial disposition of Licensed Products less deductions from such amounts calculated in accordance with GAAP, so as to arrive at reported Net Product Sales under GAAP, and further reduced by write offs of accounts receivable or increased for collection of accounts that were previously written off.

Sales between Celgene and its Affiliates or Sublicensees and Licensed Products provided to Third Parties at no cost, or below direct manufacturing cost, in connection with research and development, clinical trials, compassionate sales or indigent programs or for use as samples shall be excluded from the computation of Net Sales, and no payments will be payable on such sales or no-cost transfers except where such Affiliates or Sublicensees are end users. If a Licensed Product is sold or transferred for consideration other than cash, or in a transaction not at arm’s length, the Net

Sales from such sale or transfer shall be deemed the then-fair market value of such Licensed Product.

In the event a Licensed Product is sold which is a Combination Product, for purposes of determining royalty payments due Array under Section 6.5, Net Sales of Combination Products shall be calculated by multiplying the Net Sales of the Combination Product during the applicable reporting period by the fraction A/(A+B), in which “A” is the average sales price of the Licensed Product when such Licensed Product comprising a single Collaboration Compound or Collaboration Back-Up Compound as the sole therapeutically active ingredient is sold separately in substantial quantities, and “B” is the average sales price of the other therapeutically active ingredients contained in the Combination Product sold separately in substantial quantities; in each case during the applicable reporting period. In the event that no separate sales of either the Licensed Product comprising a single Collaboration Compound or Collaboration Back-Up Compound, as the case may be, as the sole therapeutically active ingredient or the other therapeutically active ingredients of the Combination Product are made during the applicable reporting period, or if the average sales price for a particular therapeutically active ingredient cannot be determined for the applicable reporting period, the respective average sales prices during the most recent reporting period in which sales of both occurred shall be used. In the event that either or both of A or (and) B is (are) not available, then Net Sales of Combination Products for the purposes of determining royalty payments hereunder shall be reasonably allocated based on the relative values contributed by each component, and agreement by the Parties to such allocation shall not be unreasonably withheld or delayed.

1.29 “Option Term” shall have the meaning set forth in Section 4.1.1(a).

1.30 “Party” or “Parties” shall mean Array and/or Celgene.

1.31 “Patent” shall mean any patents and patent applications, together with all additions, divisions, continuations, continuations-in-part, substitutions, reissues, re-examinations, extensions, registrations, patent term extensions, supplemental protection certificates and renewals of any of the foregoing.

1.32 “Phase I” shall mean a human clinical trial conducted on a limited number of study subjects for the purpose of gaining evidence of the safety and tolerability of, and information regarding pharmacokinetics and, with respect to applicable oncology trials, potential pharmacological activity for, a product or compound, as described in 21 C.F.R.§ 312.21(a) (including any such clinical study in any country other than the United States).

1.33 “Phase II” shall mean a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy and/or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

1.34 “Phase III” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in study subjects with the disease or condition being studied, as further described in 21 C.F.R. §312.21(c) (including any such clinical study in a country other than the United States), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of a MAA for the indication being studied.

1.35 “Regulatory Authority” shall mean the FDA, or a regulatory body with similar regulatory authority in any jurisdiction outside the United States.

1.36 “Sales Representative” shall mean a professional pharmaceutical sales representative engaged or employed by either Party to conduct sales activities and other promotional efforts with respect to a Co-Promoted Product.

1.37 “Sublicensee” shall mean, with respect to a particular Collaboration Compound, a Collaboration Back-Up Compound or Licensed Product, a Third Party to whom Celgene has granted a license or sublicense to make and sell such Collaboration Compound, Collaboration Back-Up Compound or Licensed Product; and a “sublicense” shall mean any agreement or arrangement between Celgene and a Sublicensee granting such rights.

1.38 “Target” shall mean those targets listed on Schedule 1.38 attached hereto, or any substitute for such a target mutually agreed by the Parties in accordance with Section 3.2 below or selected by Array from two (2) proposed substitute targets in accordance with Section 3.5.1 below.

1.39 “Third Party” shall mean any entity other than Array, Celgene and their respective Affiliates.

1.40 “Valid Claim” shall mean (a) a claim of an issued and unexpired Patent (including the term of any patent term extension, supplemental protection certificate, renewal or other extension) which has not been held unpatentable, invalid or unenforceable in a final decision of a court or other government agency of competent jurisdiction from which no appeal may be or has been taken, and which has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; or (b) a claim of a patent application, which claim has been pending less than five (5) years from the original filing date of such claim in a given country, unless or until such claim thereafter issues as a claim of an issued Patent (from and after which time the same shall be deemed a Valid Claim subject to paragraph (a) above).

1.41 Additional Definitions. Each of the following terms shall have the meaning described in the corresponding section of this Agreement below.

Term		Section Defined
Abandoned Product		12.3.2
Array Indemnitees		11.4.2
*[ ]**		*[ ]**
*[ ]**		*[ ]**
Celgene Indemnitees		11.4.1
Celgene Product Option		4.1
Clinical Candidate Guidelines		3.5.1
Collaboration Back-Up Compound		4.1.1(b)

Commercialization Plan		8.1.2
Compound Improvement		9.2.2
Confidential Information		10.1
Cooperating Party		10.4.2
Co-Promoted Product		8.2.1
Co-Promotion Option		8.2.1
Co-Promotion Plan		8.2.2
Development Back-Up Compound		3.5.2
Development Milestone		6.3.1
Development Plan		3.6.1
Discovery Milestone		6.2
Discovery Program		3.1
Dispute		13.1
Escalation Notice		2.2.3
Exclusivity Period		5.6.2
force majeure event		13.4
Indemnify		11.4
JCC		2.1
JDC		2.1
JMC		2.1
JRC		2.1
*[ ]**		*[ ]**
Losses		11.4.1
Prosecution and Maintenance		9.5.1(a)
Prosecuting Party		9.5.1(b)
Requesting Party		10.4.2
Subject Transaction		13.3.2

Third-Party Claim		11.4.1
Trial Design Guidelines		2.3

ARTICLE II
GOVERNANCE

2.1 General. The Parties shall establish (i) a Joint Research Committee (“JRC”) to oversee and coordinate activities under the Discovery Program; (ii) a Joint Development Committee (“JDC”) for each Development Compound to oversee and coordinate clinical development of such Development Compound; (iii) a Joint Manufacturing Committee (“JMC”) to oversee and coordinate CMC activities with respect to each Development Compound and Development Back-Up Compounds; and (iv) if applicable, a Joint Commercialization Committee (“JCC”) for each Co-Promoted Product. Each Committee may from time to time establish sub-committees to handle matters within the scope of its authority.

2.1.1 Joint Research Committee. Within thirty (30) days following the Effective Date, Array and Celgene shall establish a Joint Research Committee.

(a) Duties. The JRC shall:

(i) establish, oversee, review and coordinate the Discovery Program, including assigning activities to be performed by each Party under the Discovery Program (subject to Section 3.1), which may require the Parties to enter into material transfer and other appropriate agreements in connection with such activities;

(ii) discuss designation of Compounds as Development Compounds and Back-Up Compounds in accordance with Section 3.5;

(iii) provide a forum for the Parties: (1) to discuss the objectives of the Discovery Program; and (2) to exchange and review scientific information and data relating to

the activities being conducted under, and the then-current progress of, the Discovery Program, including the exchange and review of data, Compound structures and the like resulting from the Discovery Program;

(iv) determine when and for which general disease area (specifically, cancer or inflammatory disease) an IND will be filed on each Development Compound; provided, however, that the Parties shall mutually agree which general disease area the IND will be filed for a Development Compound directed to a cancer/inflammation Target; and

(v) make any such decisions as are expressly allocated to the JRC under this Agreement.

(b) Termination of JRC. The JRC, on a Target-by-Target basis, shall exist until the end of the Option Term for such Target.

2.1.2 Joint Development Committee. Promptly but no later than thirty (30) days following the Effective Date, Array and Celgene shall establish a Joint Development Committee.

(a) Duties. The JDC shall:

(i) Establish and direct the strategy for the worldwide development of each Development Compound and corresponding Development Back-Up Compounds, if any, and products containing each Development Compound or a corresponding Development Back-Up Compound;

(ii) Review and finalize the applicable Development Plan for each Development Compound and, if applicable a corresponding Development Back-Up Compound, and propose revisions to each Development Plan as needed, but no less frequently than annually;

(iii) Subject to and within the parameters of each Development Plan: (1) oversee the implementation of the such Development Plan (including approval of clinical trial protocols and review of the conduct of clinical trials conducted pursuant to the Development

Plan); and (2) review and approve the overall strategy and positioning of all material submissions and filings with the applicable Regulatory Authorities; and

(iv) Perform such other duties as are specifically assigned to such JDC under this Agreement.

(b) Termination of JDC. The JDC shall exist, on a Target-by-Target basis, until the end of the Option Term for such Target.

2.1.3 Joint Manufacturing Committee. Promptly but no later than thirty (30) days following the designation of the first Development Compound, Array and Celgene shall establish a Joint Manufacturing Committee.

(a) Duties. The JMC shall:

(i) oversee, review and coordinate the studies required for the preparation of the CMC section of an IND for filing with the FDA for each Development Compound and, if applicable, Development Back-Up Compounds, including studies relating to analytical methods and purity analysis, and formulation and manufacturing development studies, together with associated regulatory activities;

(ii) oversee, review and coordinate process research and development activities (including manufacturing scale-up) and formulation development activities; and

(iii) Perform such other duties as are specifically assigned to such JMC under this Agreement.

(b) Termination of JMC. The JMC shall exist, on a Target-by-Target basis, until the end of the Option Term for such Target.

2.1.4 Joint Commercialization Committee. Within thirty (30) days following a request by either Party after Array’s exercise of the Co-Promotion Option, Array and Celgene shall establish a Joint Commercialization Committee, which at Celgene’s option may be split into separate Joint Commercialization Committees for each Co-Promoted Product. The JCC shall have as its overall purpose oversight of the commercialization of Co-Promoted Products in the United States.

(a) Duties: The JCC shall:

(i) Review and approve the Co-Promotion Plan for each Co-Promoted Product developed in accordance with Section 8.2.2 below;

(ii) Subject to and within the parameters of the Co-Promotion Plan, oversee the implementation of the Co-Promotion Plan; and

(iii) Perform such other duties as are specifically assigned to such JCC under this Agreement.

2.2 General Committee Membership and Procedures.

2.2.1 Committee Membership. Each Committee shall each be composed of three (3) representatives from each of Celgene and Array. Each Party may replace any of its representatives on any Committee at any time with prior written notice to the other Party; provided that such replacement is of comparable standing and authority within that Party’s organization as the person he or she is replacing.

2.2.2 Committee Meetings. The JRC and JDC shall hold an initial joint meeting within forty-five (45) days of the Effective Date or as otherwise agreed by the Parties. Thereafter, each Committee shall meet at least once every calendar quarter, unless the respective Committee members otherwise agree. All Committee meetings may be conducted by telephone, video-conference or in person as determined by the applicable Committee; provided, however, that each Committee shall meet in person at least once each calendar year, unless the Parties mutually agree to

meet by alternative means. Unless otherwise agreed by the Parties, all in-person meetings for each Committee shall be held on an alternating basis between Array’s facilities and Celgene’s facilities. With the consent of the Parties (not to be unreasonably withheld or delayed), a reasonable number of other representatives of a Party may attend any Committee meeting as non-voting observers (provided that such additional representatives are under obligations of confidentiality and non-use applicable to the Confidential Information of the other Party that are at least as stringent as those set forth in Article 10). Each Party shall be responsible for all of its own personnel and travel costs and expenses relating to participation in Committee meetings.

2.2.3 Decision-Making. Decisions of each Committee with decision-making authority shall be made by unanimous vote. In the event such Committee fails to reach unanimous agreement with respect to a particular matter within its decision-making authority, then, either Party may, by written notice to the other Party (an “Escalation Notice”), have such matter referred to the following individuals of each Party or his/her designee (the “Negotiators”): for disputes originating in the JRC, the heads of research of each Party shall serve as Negotiators; and