Common use of Development Activities Clause in Contracts

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 (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 Plan: (a) subject to Section 5.5.2, 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 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 Licensed Program 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 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, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by such other Party in order to effect such grant.

Development Activities. 5.5.1 Except (i) The Commercializing Party shall be responsible for conducting all Development activities conducted by a Party at its own expense pursuant to Section 5.4.2(b)(ii), 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 conducted for any Split Program outside such Party’s portion of the primary purpose Territory (even if such Development activities are for purposes of obtaining or maintaining Regulatory Approval for Licensed Products both 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 Servier Territory and in the MacroGenics Territory applicable Development Plan. (including ii) The Parties will share all Global Development activities with respect to which a Party has paid the Buy-in Amount Costs in accordance with Section 5.4.2(b)(iv9.4(b)) pursuant ; provided that Celgene shall not be responsible for any of Agios’ Global Development Costs prior to the Development Plan: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. (aiii) subject If either Party proposes to Section 5.5.2, 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 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 undertake any Development activities for each Licensed a Split Program 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 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 portion of the terms of this Agreement; and (d) each Party hereby grants to Territory that the other Party reasonably determines are reasonably likely to have a Right material adverse impact on the Development or Commercialization of Reference Split Compounds or Use to any and all such Regulatory Documentation with respect to Licensed Split Products in the Field in the other Party’s territoryportion 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 agrees 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 signthe 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 cause its Affiliates to sign, any instruments reasonably requested by such 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 order to effect such grantany agreement with a Third Party Contractor.

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 (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 During the Development Plan: (a) Term for a particular Development Program and subject to Section 5.5.24.7, Servier each Party shall be responsible for *** for, and MacroGenics 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 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 designed so that such Development (in each casePivotal Clinical Trial(s), 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 reasonably possible, satisfy regulatory requirements in both the United States and Europe. During the Development Costs are Term for Phase 2 Clinical Trials; (b) On a Licensed Program by Licensed Program basis particular Development Program, each Party shall disclose provide written notice to the other Party all clinical data and related Regulatory Documentation Controlled by such Party and generated in of each Clinical Trial it will conduct at least [**] days prior to the course Initiation of such Manufacturing process development activities Clinical Trial, together with a copy of the protocols and Development activities other material documentation and information related to such Clinical Trial for each Licensed Program within ***; (c) each 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 use all clinical data and related Regulatory Documentation Controlled by either Party and generated in the course of such Manufacturing process development activities and conduct any 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 to the terms and agrees conditions of this Agreement. Notwithstanding anything to signthe 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 cause its Affiliates the Development Costs related to signsuch Development activities shall be Territory-Specific Development Costs of such Party. Further, any instruments reasonably requested by 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 other Party in order Licensed Product for non-oncology Indication(s) prior to effect the commencement of the first such grantnon-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. 5.5.1 Except for 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 conducted by a Party at its own expense pursuant and responsibilities to Section 5.4.2(b)(ii)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 respect to any Development activities conducted Allergan 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 Plan: (a) subject to Section 5.5.2, 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 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 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 1/2 Clinical Trials; (b) On a Licensed Program by Licensed Program basis each Party shall 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 Licensed Program 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 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 territoryTrial, in accordance with the terms applicable Development Plan. Without limiting the generality of the foregoing, each Party shall be responsible for conducting and shall use Commercially Reasonable Efforts to conduct the 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 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 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; and (d) each Party hereby grants to , the other Party a Right of Reference or Use to any Development Plan and all such Regulatory Documentation with respect to Licensed Products in the Field in the other Party’s territory, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by such other Party in order to effect such grantGDS.

Development Activities. 5.5.1 Except (i) Inspire will be responsible for undertaking the Inspire Development activities conducted by Activities and will use Commercially Reasonable Efforts to perform the Inspire Development Activities in accordance with the Development Timeline. Faes will be responsible for undertaking the Faes Development Activities and will use Commercially Reasonable Efforts to perform the 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. Each Party acknowledges and agrees that the drug development process is a Party 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, and 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) Without limiting Section 3.2(b)(i), Inspire shall be responsible, at Inspire’s sole cost and expense, for conducting all Phase 3 Clinical Trials in 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 expense, for continuing and completing the Definitive QT Study in accordance with current good clinical practices and any comments received from the FDA. Promptly upon completion of the Definitive QT Study, Faes shall report the results thereof to Inspire. Faes shall prepare or cause to be prepared, at its own expense pursuant to Section 5.4.2(b)(ii)sole cost and expense, a final, audited study report with respect to any Development activities conducted the Definitive QT Study in compliance with applicable guidelines and suitable 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 submission to the Development Plan: FDA, and Faes shall provide such report to Inspire within sixty (a60) subject to Section 5.5.2, 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 disclose to the other Party all clinical data and related Regulatory Documentation Controlled by such Party and generated in the course days after completion of such Manufacturing process development activities and Development activities for each Licensed Program within ***; (c) each Party study. Inspire shall have the right to use all clinical data and related Regulatory Documentation Controlled by either Party and generated refer to the Definitive QT Study solely in the course of such Manufacturing process development connection with Inspire’s permitted 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 under 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, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by such other Party in order to effect such grant.