Common use of Development Activities Clause in Contracts

Development Activities. (i) The Commercializing Party shall be responsible for conducting all Development activities as may be contemplated under the Development Plan for each Split Program with respect to such Commercializing Party’s portion of the Territory (i.e., the US Territory for Agios and the ROW Territory for Celgene). Neither Commercializing Party shall conduct any Development activities for any Split Program outside such Party’s portion of the Territory (even if such Development activities are for purposes of Development in such Party’s portion of the Territory), unless the JDC by Mutual Consent approves of such activities, including any protocol associated with a Clinical Trial, and such activities are reflected in the applicable Development Plan. (ii) The Parties will share all Global Development Costs in accordance with Section 9.4(b); provided that Celgene shall not be responsible for any of Agios’ Global Development Costs prior to the Development Cost Initiation Date. For clarity, Celgene’s obligation to share Global Development Costs shall not include any Development Costs incurred prior to the Development Cost Initiation Date or any Development Costs related to any Clinical Trial for which the FPD occurred prior to the Development Cost Initiation Date even if completed following the Development Cost Initiation Date; instead, Celgene’s obligations will be limited to Development activities related to any company-sponsored Phase II Studies or later stages of Development. (iii) If either Party proposes to undertake any Development activities for a Split Program in such Party’s portion of the Territory that the other Party reasonably determines are reasonably likely to have a material adverse impact on the Development or Commercialization of Split Compounds or Split Products in the other Party’s portion of the Territory, such proposing Party shall not proceed with such Development activities unless approved by the JDC (with any disputes resolved in accordance with the dispute resolution procedure of Section 2.8, including the Lead Party having the final decision-making authority to the extent provided in Section 2.8(b)). (iv) With respect to each Split Program, each Party shall be entitled to use the data and results (including clinical data) from all Development activities conducted by the other Party; provided that a Party shall not interpret such data or results in a different manner than the Party who performed the Development activity giving rise to the data or results without the performing Party’s prior written consent (which may be given through the Party’s representatives on the JDC). In furtherance thereof, each Commercializing Party shall update the other Party pursuant to Section 3.8(c) on the status of all Development activities for Split Programs, including a summary of relevant data. Each Commercializing Party will use Commercially Reasonable Efforts to ensure the other Party has access to such data and results, including, if appropriate, providing for such access in any agreement with a Third Party Contractor.

Development Activities. (i) 2.1 The Commercializing Party Steering Committee shall be responsible comprised of [*Certain information has been omitted under a request for conducting confidential treatment, and the omitted information has been filed with the Commission]. The Steering Committee shall meet at least bi-monthly at mutually agreeable dates and places, including meeting by teleconference or other electronic means if agreed upon by all Development activities as may Steering Committee members. The functions of the Steering Committee shall be contemplated to oversee the collaborative research and joint development activities, including monitoring progress under the Development Plan for Activities, and engaging in exchanges of information and joint planning activities. The Steering Committee shall also appoint task forces or subcommittees, to the extent it may find it convenient or appropriate, with the objective of keeping each Split Program with respect Party aware of relevant issues and decisions relating to the collaborative research and joint development under the Development Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development Activities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such Commercializing Party’s portion amendment or additional statement of work shall be developed and approved by the Steering Committee, and, to the extent mutually agreeable to the Parties, shall be executed by the Parties and become a part of this Agreement as an exhibit attached hereto. Notwithstanding the foregoing, nothing contained herein shall obligate either Party to undertake additional or expanded activities. Notwithstanding the foregoing provisions of this Section 2.1, none of the Territory (i.e., the US Territory for Agios and the ROW Territory for Celgene). Neither Commercializing Party shall conduct any Development activities for any Split Program outside such Party’s portion of the Territory (even if such Steering Committee shall give it authority to direct the Development activities are for purposes of Development in such Party’s portion Activities or otherwise to infringe upon the appropriate authority of the Territory), unless Principal Investigator in undertaking the JDC by Mutual Consent approves of such activities, including any protocol associated with a Clinical Trial, and such activities are reflected in the applicable Development PlanActivities. (ii) 2.2 Mount Sinai and LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will share all Global Development Costs in accordance with Section 9.4(b); provided that Celgene shall not be responsible for any of Agios’ Global Development Costs prior use reasonable efforts to undertake the Development Cost Initiation Date. For clarity, Celgene’s obligation to share Global Development Costs shall not include any Development Costs incurred prior to the Development Cost Initiation Date or any Development Costs related to any Clinical Trial for which the FPD occurred prior to the Development Cost Initiation Date even if completed following the Development Cost Initiation Date; instead, Celgene’s obligations will be limited to Development activities related to any company-sponsored Phase II Studies or later stages of Development. (iii) If either Party proposes to undertake any Development activities for a Split Program in such Party’s portion of the Territory that the other Party reasonably determines are reasonably likely to have a material adverse impact on the Development or Commercialization of Split Compounds or Split Products in the other Party’s portion of the Territory, such proposing Party shall not proceed with such Development activities unless approved by the JDC (with any disputes resolved Activities substantially in accordance with the dispute resolution procedure terms and conditions of Section 2.8this Agreement. Notwithstanding the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the Development Activities in a manner consistent with Mount Sinai’s educational and research missions. 2.3 If the services of the Principal Investigator become unavailable to Mount Sinai for any reason, Mount Sinai shall notify LifeMap and shall undertake reasonable efforts to designate [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or another member of its faculty who is acceptable to both Parties to serve as the Principal Investigator of the Development Activities. If a substitute Principal Investigator has not been designated within ninety (90) days after the original Principal Investigator ceases his or her services under this Agreement, LifeMap may request an additional ninety (90) days, which extension must be granted, to identify an acceptable replacement Mount Sinai faculty member to serve as Principal Investigator and which replacement shall not be unreasonably objected to by Mount Sinai. During the extended search period, Mount Sinai may suspend its activities under this Agreement until a suitable replacement Principal Investigator has been identified and has agreed to take on the role of Principal Investigator, and Mount Sinai has agreed in writing to the new Principal Investigator. The Parties agree nothing contained herein shall obligate Mount Sinai to cause any Mount Sinai faculty member to act as Principal Investigator against such faculty member’s wishes. If a mutually acceptable replacement cannot be found within the foregoing time periods, only then may either Party terminate this Agreement upon written notice thereof to the other Party, subject to the provisions of Article 11. Termination of this Agreement in such event shall not be considered a termination for breach. In order to ▇▇▇▇▇▇ the collaborative nature of the Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or contractors in Mount Sinai facilities solely for the purpose of conducting the Development Activities (“LifeMap Visiting Scientists”). The Parties agree that hosting of any LifeMap Visiting Scientists in Mount Sinai facilities shall only be by the prior written agreement of the Parties and shall be limited to no more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] LifeMap Visiting Scientists in cumulative total during the term of this Agreement. The Parties further agree that all such LifeMap Visiting Scientists shall be subject to Mount Sinai’s policies regarding facility entrance and usage and that all said LifeMap Visiting Scientists shall be required to sign the Visiting Scientist Agreement, attached hereto as Attachment C, prior to being hosted at Mount Sinai. Notwithstanding the foregoing, nothing contained herein obligates Mount Sinai to host, or to continue to host, any LifeMap Visiting Scientists in its facilities. Procedures and details regarding the day-to-day collaborative environment and hosting shall be jointly created by Mount Sinai and LifeMap to the extent such procedures and details do not violate any Mount Sinai policies. 2.4 The Parties acknowledge the evolving regulatory landscape surrounding direct-to-consumer patient genetic testing and that certain permit(s) and/or approval(s) may be necessary for such testing. By way of non-limiting example, New York law, including N.Y. Pub. Health Law § 574, Article 5, Title V, prohibits direct-to-consumer genetic testing in New York State and testing of samples obtained in New York State. As such, nothing contained herein, including the Lead Party having work outlined in the final decisionDevelopment Activities, obligates Mount Sinai to sequence direct consumer patient biological samples in its New York State laboratory facilities or otherwise provide genetic testing for such direct-making authority to-consumer patient samples in contravention of any applicable law. Should LifeMap desire Mount Sinai to sequence patient biological samples or otherwise provide genetic testing, the Parties will discuss, in good faith, potential avenues for Mount Sinai’s participation in such activities that comply with the letter and spirit of applicable law, should Mount Sinai be agreeable to such participation, which agreement shall be at its sole discretion. 2.5 Except to the extent provided reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in Section 2.8(b)). the LMN Engine (ivi) With respect any open source, free, community, or similar software, including any libraries or software licensed under the General Public License or any other license agreement or arrangement obliging a Party to each Split Programmake Source Code or object code available to third parties (collectively, each Party “Open Source Code”) or (ii) any code that requires the use of any Open Source Code in order to function in its intended fashion. Should Mount Sinai reasonably believe it needs to utilize such Open Source Code in the LMN Engine, it shall be entitled to use discuss in good faith with LifeMap such need and follow the data and results (including clinical data) from all Development activities conducted processes specified by the LifeMap Chief Technology Officer, or other Party; provided that a Party shall not interpret LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such data or results Open Source Code in a different manner than the Party who performed the Development activity giving rise to the data or results without the performing Party’s prior written consent (which may be given through the Party’s representatives on the JDC). In furtherance thereof, each Commercializing Party shall update the other Party pursuant to Section 3.8(c) on the status of all Development activities for Split Programs, including a summary of relevant data. Each Commercializing Party will use Commercially Reasonable Efforts to ensure the other Party has access to such data and results, including, if appropriate, providing for such access in any agreement with a Third Party ContractorLMN Engine.

Development Activities. 5.5.1 Except for Development activities conducted by a Party at its own expense pursuant to Section 5.4.2(b)(ii), with respect to any Development activities conducted for the primary purpose of obtaining or maintaining Regulatory Approval for Licensed Products both in the Servier Territory and in the MacroGenics Territory (iincluding Development activities with respect to which a Party has paid the Buy-in Amount in accordance with Section 5.4.2(b)(iv)) The Commercializing Party pursuant to the Development Plan: (a) subject to Section 5.5.2, Servier shall be responsible for conducting *** and MacroGenics shall be responsible for *** of all Development activities Costs as may be contemplated under well as the Development Plan for each Split Program with respect to such Commercializing Party’s portion costs of clinical supply of the Territory Program DART and/or Licensed Product used in connection with such Development (i.e.in each case, the US Territory for Agios and the ROW Territory for Celgenewhether incurred by Servier or MacroGenics or their respective Affiliates). Neither Commercializing For purposes of clarity, MacroGenics may seek reimbursement from Servier under Section 5.4.3(c) to apply to Development Costs for which MacroGenics is responsible under this Section 5.5.1(a) to the extent such Development Costs are for Phase 2 Clinical Trials; (b) On a Licensed Program by Licensed Program basis each Party shall conduct any disclose to the other Party all clinical data and related Regulatory Documentation Controlled by such Party and generated in the course of such Manufacturing process development activities and Development activities for any Split each Licensed Program outside within ***; (c) each Party shall have the right to use all clinical data and related Regulatory Documentation Controlled by either Party and generated in the course of such Party’s portion of the Territory (even if such Manufacturing process development activities and Development activities are in order to Develop, obtain Regulatory Approval for purposes of Development and Commercialize Licensed Products in the Field in such Party’s portion of the Territory)territory, unless the JDC by Mutual Consent approves of such activities, including any protocol associated with a Clinical Trial, and such activities are reflected in the applicable Development Plan. (ii) The Parties will share all Global Development Costs in accordance with Section 9.4(b)the terms of this Agreement; provided that Celgene shall not be responsible for any of Agios’ Global Development Costs prior to the Development Cost Initiation Date. For clarity, Celgene’s obligation to share Global Development Costs shall not include any Development Costs incurred prior to the Development Cost Initiation Date or any Development Costs related to any Clinical Trial for which the FPD occurred prior to the Development Cost Initiation Date even if completed following the Development Cost Initiation Date; instead, Celgene’s obligations will be limited to Development activities related to any company-sponsored Phase II Studies or later stages of Development.and (iiid) If either each Party proposes hereby grants to undertake any Development activities for a Split Program in such Party’s portion of the Territory that the other Party reasonably determines are reasonably likely a Right of Reference or Use to have a material adverse impact on any and all such Regulatory Documentation with respect to Licensed Products in the Development or Commercialization of Split Compounds or Split Products Field in the other Party’s portion of the Territoryterritory, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by such proposing Party shall not proceed with such Development activities unless approved by the JDC (with any disputes resolved in accordance with the dispute resolution procedure of Section 2.8, including the Lead Party having the final decision-making authority to the extent provided in Section 2.8(b)). (iv) With respect to each Split Program, each Party shall be entitled to use the data and results (including clinical data) from all Development activities conducted by the other Party; provided that a Party shall not interpret such data or results in a different manner than the Party who performed the Development activity giving rise to the data or results without the performing Party’s prior written consent (which may be given through the Party’s representatives on the JDC). In furtherance thereof, each Commercializing Party shall update the other Party pursuant in order to Section 3.8(c) on the status of all Development activities for Split Programs, including a summary of relevant data. Each Commercializing Party will use Commercially Reasonable Efforts to ensure the other Party has access to effect such data and results, including, if appropriate, providing for such access in any agreement with a Third Party Contractorgrant.

Development Activities. (i) The Commercializing During the Development Term for a particular Development Program and subject to Section 4.7, each Party shall be responsible for conducting all for, and shall use Commercially Reasonable Efforts to perform, the Development activities as may be contemplated assigned to such Party under the applicable Development Plan. Unless otherwise agreed by the Parties, Pivotal Clinical Trial(s) conducted pursuant to each Development Plan shall be designed so that such Pivotal Clinical Trial(s), to the extent reasonably possible, satisfy regulatory requirements in both the United States and Europe. During the Development Term for a particular Development Program, each Split Program Party shall provide written notice to the other Party of each Clinical Trial it will conduct at least [**] days prior to the Initiation of such Clinical Trial, together with respect a copy of the protocols and other material documentation and information related to such Commercializing Clinical Trial for review and comment by the other Party’s portion , which comments shall be considered in good faith by the Party conducting the Clinical Trial prior to Initiation of the Territory (i.e., the US Territory for Agios and the ROW Territory for Celgene)such Clinical Trial. Neither Commercializing Each Party shall have the right to conduct any Development activities for any Split Program outside such Party’s portion of the Territory (even if such Development activities are for purposes of Development in such Party’s portion of the Territory), unless the JDC by Mutual Consent approves of such activities, including any protocol associated with a Clinical Trial, and such activities are reflected in the applicable Development Plan. (ii) The Parties will share all Global Development Costs in accordance with Section 9.4(b); provided that Celgene shall not be responsible for any of Agios’ Global Development Costs prior to the Development Cost Initiation Date. For clarity, Celgene’s obligation to share Global Development Costs shall not include any Development Costs incurred prior to the Development Cost Initiation Date or any Development Costs related to any Clinical Trial for which the FPD occurred prior to the Development Cost Initiation Date even if completed following the Development Cost Initiation Date; instead, Celgene’s obligations will be limited to Development activities related to any company-sponsored Phase II Studies or later stages of Development. (iii) If either Party proposes to undertake any Development activities for a Split Program in such Party’s portion of the Territory that the other Party reasonably determines are reasonably likely to have a material adverse impact on the Development or Commercialization of Split Compounds or Split Products in the other Party’s portion territory, subject to the terms and conditions of this Agreement. Notwithstanding anything to the contrary in this Agreement, a Party may conduct any Development or Commercialization activities with respect to its territory that the FDA or equivalent Regulatory Authority in such Party’s territory requires such Party to conduct to obtain Regulatory Approval of the Territoryapplicable Licensed Product or related Diagnostic Products in such country, such proposing Party shall not proceed with and the Development Costs related to such Development activities unless approved by shall be Territory-Specific Development Costs of such Party. Further, in the JDC (with any disputes resolved in accordance with event a Party desires to clinically Develop a Licensed Compound or Licensed Product for non-oncology Indication(s), the dispute resolution procedure Parties shall mutually agree upon the clinical Development of Section 2.8, including the Lead Party having the final decisionsuch Licensed Product for non-making authority oncology Indication(s) prior to the extent provided in Section 2.8(b)). (iv) With commencement of the first such non-oncology Clinical Trial of such Licensed Product, regardless if such Clinical Trial incurs Global Development Costs or Territory-Specific Development Costs, and regardless of whether a Business Combination occurs with respect to each Split Program, each Party shall be entitled to use the data and results (including clinical data) from all Development activities conducted by the other a Party; provided that a Party shall not interpret such data or results in a different manner than the Party who performed the Development activity giving rise to the data or results without the performing Party’s prior written consent (which may be given through the Party’s representatives on the JDC). In furtherance thereof, each Commercializing Party shall update the other Party pursuant to Section 3.8(c) on the status of all Development activities for Split Programs, including a summary of relevant data. Each Commercializing Party will use Commercially Reasonable Efforts to ensure the other Party has access to such data and results, including, if appropriate, providing for such access in any agreement with a Third Party Contractor.

Development Activities. (i) The Commercializing Allergan shall take the lead in and control the Development of the Co-Co Products. Without limiting the generality of the foregoing, Allergan shall, in good faith, assign reasonable activities and responsibilities to Editas in all phases of the Development of the Co-Co Products taking into consideration, and commensurate with, Editas’ capabilities and experience and the nature of such activities or responsibilities, including, without limitation, Editas’ scientific, financial and regulatory capabilities, expertise and experience, the cost of Editas performing any such activity or such responsibility compared to Allergan’s cost and any other requirements of the relevant activity or responsibility. Editas shall be jointly responsible with Allergan for the Development of the Co-Co Products through the first Phase 1/2 Clinical Trial for the Initial Co-Co Product, including executing the protocol and managing and overseeing the clinical research organizations that may be conducting such Phase 1/2 Clinical Trial, in accordance with the applicable Development Plan. Without limiting the generality of the foregoing, each Party shall be responsible for conducting all Development activities as may be contemplated under the Development Plan for each Split Program with respect to such Commercializing Party’s portion of the Territory (i.e., the US Territory for Agios and the ROW Territory for Celgene). Neither Commercializing Party shall conduct any Development activities for any Split Program outside such Party’s portion of the Territory (even if such Development activities are for purposes of Development in such Party’s portion of the Territory), unless the JDC by Mutual Consent approves of such activities, including any protocol associated with a Clinical Trial, and such activities are reflected in the applicable Development Plan. (ii) The Parties will share all Global Development Costs in accordance with Section 9.4(b); provided that Celgene shall not be responsible for any of Agios’ Global Development Costs prior to the Development Cost Initiation Date. For clarity, Celgene’s obligation to share Global Development Costs shall not include any Development Costs incurred prior to the Development Cost Initiation Date or any Development Costs related to any Clinical Trial for which the FPD occurred prior to the Development Cost Initiation Date even if completed following the Development Cost Initiation Date; instead, Celgene’s obligations will be limited to Development activities related to any company-sponsored Phase II Studies or later stages of Development. (iii) If either Party proposes to undertake any Development activities for a Split Program in such Party’s portion of the Territory that the other Party reasonably determines are reasonably likely to have a material adverse impact on the Development or Commercialization of Split Compounds or Split Products in the other Party’s portion of the Territory, such proposing Party shall not proceed with such Development activities unless approved by the JDC (with any disputes resolved in accordance with the dispute resolution procedure of Section 2.8, including the Lead Party having the final decision-making authority to the extent provided in Section 2.8(b)). (iv) With respect to each Split Program, each Party shall be entitled to use the data and results (including clinical data) from all Development activities conducted by the other Party; provided that a Party shall not interpret such data or results in a different manner than the Party who performed the Development activity giving rise to the data or results without the performing Party’s prior written consent (which may be given through the Party’s representatives on the JDC). In furtherance thereof, each Commercializing Party shall update the other Party pursuant to Section 3.8(c) on the status of all Development activities for Split Programs, including a summary of relevant data. Each Commercializing Party will use Commercially Reasonable Efforts to ensure conduct the other activities assigned to it in each Development Plan under the direction and supervision of the Core Team, provided, that neither Party shall be assigned obligations under such Development Plan without such Party’s prior written approval, which shall not be unreasonably withheld, delayed or conditioned, it being understood that each Party has access approved and consented to the Initial Development Plan and Budget. Each Party shall be responsible for selection and supervision of its personnel assigned to tasks related to Development activities. Subject to the role of Core Team, the ADB shall be responsible for making, and have authority to make, all decisions, and undertake any actions necessary as a result of such data decisions, regarding Development (including additional preclinical and resultsclinical Development and testing) and preparing and filing BLAs and any other applications for Regulatory Approval, includingall in a manner consistent with this Agreement, if appropriate, providing for such access in any agreement with a Third Party Contractorthe Development Plan and the GDS.