Common use of Global Development Plan Clause in Contracts

Global Development Plan. During the License Term for each Licensed Program, the Development of Licensed Products under this Agreement under such Licensed Program shall be conducted pursuant to a reasonably comprehensive written research and development plan (each, a “Global Development Plan”), which shall include a detailed budget for all Development Costs and Manufacturing Process Development Costs (each, a “Development Budget”), and which shall include the resource allocations for the Parties based upon the general principle that the allocation shall endeavor to take advantage of the respective resources, capabilities and expertise of MacroGenics and Servier, respectively. Within *** after the License Grant Date, the JRDC shall prepare an initial draft of the Global Development Plan for approval by the JSC for such Licensed Program. Each Global Development Plan also shall set forth the specific activities (including non-clinical and clinical studies to be conducted by each Party) and the estimated timeline for Development of Licensed Products licensed under such Licensed Program in order to obtain the data that the Parties intend will be useful, by both Parties, to obtain Regulatory Approvals of the Licensed Products in both the United States, and the EU. Servier shall be the sponsor of all clinical studies conducted in the Servier Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the Servier Territory, and MacroGenics shall be the sponsor of all clinical studies conducted in the MacroGenics Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the MacroGenics Territory. The JRDC shall discuss which Party(ies) shall be the sponsor of all clinical studies conducted in countries of both the MacroGenics Territory and the Servier Territory under such Licensed Program.

Global Development Plan. During the License Term for each Licensed ProgramTerm, the Development of Licensed Products under this Agreement under such Licensed Program shall be conducted pursuant to a reasonably comprehensive written research and development plan (each, a “Global Development Plan”), which shall include a detailed budget for all Development Costs and Manufacturing Process Development Costs (each, a “Development Budget”), and which shall include the resource allocations for the Parties based upon the general principle that the allocation shall endeavor to take advantage of the respective resources, capabilities and expertise of MacroGenics and Servier, respectively. Within *** after the License Grant Date, the JRDC shall prepare an initial draft of the Global Development Plan for approval by the JSC for such Licensed ProgramJSC. Each The Global Development Plan also shall set forth the specific activities (including non-clinical and clinical studies to be conducted by each Party) Party and the estimated timeline for Development of Licensed Products licensed under such Licensed Program in order to obtain the data that the Parties intend will be useful, by both Parties, to obtain Regulatory Approvals of the Licensed Products licensed Product in both the United States, and the EU. , Servier shall be the sponsor of all clinical studies conducted in the Servier Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the Servier Territory, and MacroGenics shall be the sponsor of all clinical studies conducted in the MacroGenics Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the MacroGenics Territory. The JRDC shall discuss which Party(ies) shall be the sponsor of all clinical studies conducted in countries of both the MacroGenics Territory and the Servier Territory under such Licensed ProgramTerritory.

Global Development Plan. During the License Term for each Licensed ProgramExcept with respect to [***]as specified below, Company shall use Commercially Reasonable Efforts to conduct the Development of Licensed the Products under this Agreement under such Licensed Program shall be conducted pursuant to a reasonably comprehensive written research and development plan (each, a “for the Territory in accordance with the Global Development Plan”, at its own expense (subject to MacroGenics’ sharing of expenses upon its exercise of the Co-Funding Option). Company shall have the right to make amendments to the Global Development Plan, which shall include a detailed budget for all be consistent with Company’s Development Costs and Manufacturing Process Development Costs (each, a “Development Budget”obligations set forth in Section 4.2(a), and which each amended Global Development Plan shall include all material Development activities anticipated to be required to obtain Regulatory Approval for Products in [***], as well as timelines regarding such activities, including the resource allocations plans and timelines for preparing the Parties based upon necessary Regulatory Materials. The Global Development Plan shall include any Development activities with respect to [***] that Company elects to conduct, provided that Company shall have no obligation to conduct Development or to seek Regulatory Approval for Products in [***]. Beginning with the general principle that the allocation shall endeavor to take advantage delivery of the respective resourcesCo-Funding Materials and continuing through the Co-Funding Option Deadline (if MacroGenics does not exercise the Co-Funding Option) and the Co-Funding Termination Date (if MacroGenics exercises the Co-Funding Option), capabilities and expertise of MacroGenics and Servier, respectively. Within *** after the License Grant Date, the JRDC Company shall prepare an initial draft of update the Global Development Plan to include a then-current, non-binding budget for approval by any Global Development Costs. During the JSC for such Licensed Program. Each Co-Funding Term, Company shall update and amend, as appropriate, the then-current Global Development Plan also and shall set forth submit such updates and/or amendments for review to the specific activities (including non-clinical JSC. While the Global Development Plan shall not require the approval of the JSC, Company shall review and clinical studies consider all comments to be conducted by each Party) and the estimated timeline for Global Development of Licensed Products licensed under such Licensed Program Plan received from MacroGenics at the JSC in order to obtain good faith. Company will consider including, in the data that Global Development Plan, Clinical Trials using the Parties intend will be useful, by both PartiesInitial Product [***], to obtain Regulatory Approvals of the Licensed Products in both the United Statesextent that Company reasonably determines that such Clinical Trials are feasible from a medical, scientific, regulatory and the EU. Servier shall be the sponsor of all clinical studies conducted in the Servier Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the Servier Territory, and MacroGenics shall be the sponsor of all clinical studies conducted in the MacroGenics Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the MacroGenics Territorycommercial perspective. The JRDC Parties acknowledge and agree that Company’s ability to conduct such Clinical Trials may be subject to [***] and that Company shall discuss which Party(ies) shall be have no obligation to conduct such Clinical Trials unless the sponsor conduct of all clinical studies conducted in countries of both the MacroGenics Territory and the Servier Territory under such Licensed ProgramClinical Trials is [***].