Common use of Development Activities Clause in Contracts

Development Activities. During the Development Term for a particular Development Program and subject to Section 4.7, each Party shall be responsible for, and shall use Commercially Reasonable Efforts to perform, the Development activities 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 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 a copy of the protocols and other material documentation and information related to such Clinical Trial for review and comment by the other Party, which comments shall be considered in good faith by the Party conducting the Clinical Trial prior to Initiation of such Clinical Trial. Each Party shall have the right to conduct any Development activities in the other Party’s 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 applicable Licensed Product or related Diagnostic Products in such country, and the Development Costs related to such Development activities shall be Territory-Specific Development Costs of such Party. Further, in the event a Party desires to clinically Develop a Licensed Compound or Licensed Product for non-oncology Indication(s), the Parties shall mutually agree upon the clinical Development of such Licensed Product for non-oncology Indication(s) prior to the 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 a Party.

Development Activities. During 2.1 The Steering Committee shall be comprised of [*Certain information has been omitted under a request for 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 Steering Committee members. The functions of the Steering Committee shall be to oversee the collaborative research and joint development activities, including monitoring progress under the Development Term for a particular Development Program and subject to Section 4.7, each Party shall be responsible forActivities, and engaging in exchanges of information and joint planning activities. The Steering Committee shall use Commercially Reasonable Efforts to perform, the Development activities 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)also appoint task forces or subcommittees, to the extent reasonably possibleit may find it convenient or appropriate, satisfy regulatory requirements in both with the United States objective of keeping each Party aware of relevant issues and Europe. During decisions relating to the collaborative research and joint development under the Development Term for a particular Activities. The Steering Committee may propose from time to time, during the term of this Agreement, to amend or augment the Development ProgramActivities hereunder including the addition of statements of work to update or improve any Developed Intellectual Property hereunder. Each such amendment or additional statement of work shall be developed and approved by the Steering Committee, each Party shall provide written notice and, to the other Party of each Clinical Trial it will conduct at least [**] days prior extent mutually agreeable to the Initiation Parties, shall be executed by the Parties and become a part of such Clinical Trialthis Agreement as an exhibit attached hereto. Notwithstanding the foregoing, together with a copy 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 protocols activities of the Steering Committee shall give it authority to direct the Development Activities or otherwise to infringe upon the appropriate authority of the Principal Investigator in undertaking the Development Activities. 2.2 Mount Sinai and other material documentation and information related LifeMap will commence the Development Activities after the Effective Date of this Agreement. The Parties will use reasonable efforts to such Clinical Trial for review and comment by undertake the other Party, which comments shall be considered Development Activities substantially in good faith by the Party conducting the Clinical Trial prior to Initiation of such Clinical Trial. Each Party shall have the right to conduct any Development activities in the other Party’s territory, subject to accordance with the terms and conditions of this Agreement. Notwithstanding anything the foregoing, LifeMap acknowledges that Mount Sinai will have the freedom to conduct the contrary 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 may conduct any Development or Commercialization activities with respect terminate this Agreement upon written notice thereof to its territory that the FDA or equivalent Regulatory Authority other Party, subject to the provisions of Article 11. Termination of this Agreement in such Party’s territory requires such Party event shall not be considered a termination for breach. In order to conduct to obtain Regulatory Approval ▇▇▇▇▇▇ the collaborative nature of the applicable Licensed Product Development Activities, the Parties acknowledge that LifeMap will request that Mount Sinai host, during the term of this Agreement, LifeMap employees or related Diagnostic Products contractors in such countryMount 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 Development Costs related to 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 Development activities LifeMap Visiting Scientists shall be Territorysubject 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-Specific Development Costs 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 such Partynon-limiting example, New York law, including N.Y. Pub. FurtherHealth 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 work outlined in the event a Party desires Development Activities, obligates Mount Sinai to clinically Develop a Licensed Compound sequence direct consumer patient biological samples in its New York State laboratory facilities or Licensed Product otherwise provide genetic testing for nonsuch direct-oncology Indication(s)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 mutually agree upon be at its sole discretion. 2.5 Except to the clinical Development extent reasonably agreed to by LifeMap, Mount Sinai shall use good faith efforts to avoid utilizing in the LMN Engine (i) 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 make Source Code or object code available to third parties (collectively, “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 Licensed Product for non-oncology Indication(s) Open Source Code in the LMN Engine, it shall discuss in good faith with LifeMap such need and follow the processes specified by the LifeMap Chief Technology Officer, or other LifeMap officer, as appointed by the LifeMap Chief Technology Officer, prior to incorporating any such Open Source Code in the 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 a PartyLMN Engine.

Development Activities. During 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 (including Development activities with respect to which a Party has paid the Buy-in Amount in accordance with Section 5.4.2(b)(iv)) pursuant to the Development Term for a particular Development Program and Plan: (a) subject to Section 4.75.5.2, Servier shall be responsible for *** and MacroGenics shall be responsible for *** of all Development Costs as well as the costs of clinical supply of the Program DART and/or Licensed Product used in connection with such Development (in each case, whether incurred by Servier or MacroGenics or their respective Affiliates). 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 be responsible for, and shall use Commercially Reasonable Efforts to perform, the Development activities 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 Party shall provide written notice 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 each Clinical Trial it will conduct at least [Licensed Program within **] days prior to the Initiation of such Clinical Trial, together with a copy of the protocols and other material documentation and information related to such Clinical Trial for review and comment by the other Party, which comments shall be considered in good faith by the Party conducting the Clinical Trial prior to Initiation of such Clinical Trial. Each *; (c) each Party shall have the right to conduct any use all clinical data and related Regulatory Documentation Controlled by either Party and generated in the course of such Manufacturing process development activities and Development activities in order to Develop, obtain Regulatory Approval for and Commercialize Licensed Products in the Field in such Party’s territory, in accordance with the terms of this Agreement; and (d) each Party hereby grants to the other Party a Right of Reference or Use to any and all such Regulatory Documentation with respect to Licensed Products in the Field in the other Party’s territory, subject and agrees 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 applicable Licensed Product or related Diagnostic Products in such countrysign, and the Development Costs related cause its Affiliates to sign, any instruments reasonably requested by such Development activities shall be Territory-Specific Development Costs of other Party in order to effect such Party. Further, in the event a Party desires to clinically Develop a Licensed Compound or Licensed Product for non-oncology Indication(s), the Parties shall mutually agree upon the clinical Development of such Licensed Product for non-oncology Indication(s) prior to the 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 a Partygrant.

Development Activities. During (i) The Commercializing Party shall be responsible for conducting all Development activities as may be contemplated under the Development Term 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 particular 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 Program and subject 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 4.72.8(b)). (iv) With respect to each Split Program, each Party shall be responsible forentitled 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, and 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 perform, the Development activities 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 Party shall provide written notice to ensure the other Party of each Clinical Trial it will conduct at least [**] days prior has access to the Initiation of such Clinical Trialdata and results, together including, if appropriate, providing for such access in any agreement with a copy of the protocols and other material documentation and information related to such Clinical Trial for review and comment by the other Party, which comments shall be considered in good faith by the Third Party conducting the Clinical Trial prior to Initiation of such Clinical Trial. Each Party shall have the right to conduct any Development activities in the other Party’s 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 applicable Licensed Product or related Diagnostic Products in such country, and the Development Costs related to such Development activities shall be Territory-Specific Development Costs of such Party. Further, in the event a Party desires to clinically Develop a Licensed Compound or Licensed Product for non-oncology Indication(s), the Parties shall mutually agree upon the clinical Development of such Licensed Product for non-oncology Indication(s) prior to the 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 a PartyContractor.

Development Activities. During the Development Term for a particular Development Program and subject to Section 4.7, each Party shall (i) Inspire will be responsible for, for undertaking the Inspire Development Activities and shall will use Commercially Reasonable Efforts to perform, perform the Inspire Development Activities in accordance with the Development activities assigned Timeline. Faes will be responsible for undertaking the Faes Development Activities and will use Commercially Reasonable Efforts to such Party under perform the applicable Faes Development Activities in accordance with the Development Timeline. The Joint Project Team will monitor each Party’s respective obligations and progress towards achieving the goals set forth in the Development Plan. Unless otherwise agreed by Each Party acknowledges and agrees that the Partiesdrug development process is a process of scientific discovery and as such is inherently unpredictable and delays to the Development Timeline may occur for reasons beyond a Party’s control as Subject Products are developed, Pivotal Clinical Trial(sand that the drug development process is subject to a high level of governmental regulation and the requirements of the regulatory process of seeking drug approval may result in delays beyond a Party’s control and that such delays or other similar delays beyond a Party’s control, without evidence of some other lack of Commercially Reasonable Efforts, are not a breach of this Section 3.2(b)(i). (ii) conducted pursuant to each Development Plan Without limiting Section 3.2(b)(i), Inspire shall be designed so that such Pivotal responsible, at Inspire’s sole cost and expense, for conducting all Phase 3 Clinical Trial(s), to the extent reasonably possible, satisfy regulatory requirements Trials in both the United States on the Compound as necessary to obtain Regulatory Approval in the United States of a Principal Product for the Primary Indication. (iii) Without limiting Section 3.2(b)(i), Faes shall be responsible, at Faes’s sole cost and Europeexpense, for continuing and completing the Definitive QT Study in accordance with current good clinical practices and any comments received from the FDA. During Promptly upon completion of the Development Term Definitive QT Study, Faes shall report the results thereof to Inspire. Faes shall prepare or cause to be prepared, at its sole cost and expense, a final, audited study report with respect to the Definitive QT Study in compliance with applicable guidelines and suitable for a particular Development Programsubmission to the FDA, each Party and Faes shall provide written notice such report to the other Party of each Clinical Trial it will conduct at least [**] Inspire within sixty (60) days prior to the Initiation after completion of such Clinical Trial, together with a copy of the protocols and other material documentation and information related to such Clinical Trial for review and comment by the other Party, which comments shall be considered in good faith by the Party conducting the Clinical Trial prior to Initiation of such Clinical Trialstudy. Each Party Inspire shall have the right to conduct any Development activities in the other Party’s territory, subject use and refer to the terms and conditions of Definitive QT Study solely in connection with Inspire’s permitted activities under 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 applicable Licensed Product or related Diagnostic Products in such country, and the Development Costs related to such Development activities shall be Territory-Specific Development Costs of such Party. Further, in the event a Party desires to clinically Develop a Licensed Compound or Licensed Product for non-oncology Indication(s), the Parties shall mutually agree upon the clinical Development of such Licensed Product for non-oncology Indication(s) prior to the 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 a Party.

Development Activities. During Allergan shall take the lead in and control the Development Term 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 a particular the Development Program of the Co-Co Products through the first Phase 1/2 Clinical Trial for the Initial Co-Co Product, including executing the protocol and subject to Section 4.7managing 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, for conducting and shall use Commercially Reasonable Efforts to perform, conduct the Development activities assigned to such Party under the applicable Development Plan. Unless otherwise agreed by the Parties, Pivotal Clinical Trial(s) conducted pursuant to it in each Development Plan under the direction and supervision of the Core Team, provided, that neither Party shall be designed so 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 such Pivotal Clinical Trial(s), each Party has approved and consented to the extent reasonably possible, satisfy regulatory requirements in both the United States Initial Development Plan and Europe. During the Development Term for a particular Development Program, each 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 a copy of the protocols and other material documentation and information related to such Clinical Trial for review and comment by the other Party, which comments shall be considered in good faith by the Party conducting the Clinical Trial prior to Initiation of such Clinical TrialBudget. Each Party shall have the right be responsible for selection and supervision of its personnel assigned to conduct any tasks related to Development activities in the other Party’s territory, subject activities. Subject to the terms role of Core Team, the ADB shall be responsible for making, and conditions have authority to make, all decisions, and undertake any actions necessary as a result of this Agreement. Notwithstanding anything to the contrary such decisions, regarding Development (including additional preclinical and clinical Development and testing) and preparing and filing BLAs and any other applications for Regulatory Approval, all in a manner consistent with this Agreement, a Party may conduct any the 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 applicable Licensed Product or related Diagnostic Products in such country, Plan and the Development Costs related to such Development activities shall be Territory-Specific Development Costs of such Party. Further, in the event a Party desires to clinically Develop a Licensed Compound or Licensed Product for non-oncology Indication(s), the Parties shall mutually agree upon the clinical Development of such Licensed Product for non-oncology Indication(s) prior to the 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 a PartyGDS.