Global Development Plan; Development Leads Sample Clauses

Global Development Plan; Development Leads. (a) It is contemplated that from and after the Effective Date, the Clinical Studies and Post Approval Studies for the Licensed Product, where practicable and without any obligation to amend the initial Development Plan, shall be structured so as to support the filing of Drug Approval Applications for the Licensed Product in the United States and European Union. (b) Except as otherwise provided in the Development Plan, (i) Licensee shall be the Development Lead with respect any Clinical Studies, Post Approval Studies and other Development activities for the Licensed Product that are conducted solely in support of Regulatory Approvals for the Licensed Product or Commercialization of the Licensed Product in the Licensee Territory, including any Development activities that constitute Unilateral Activities of Licensee pursuant to Section 2.5.2 (collectively, the “Licensee Activities”), and (ii) GPC Biotech shall be the Development Lead with respect to all other Clinical Studies, Post Approval Studies and other Development activities for the Licensed Product, including any Development activities that constitute Unilateral Activities of GPC Biotech pursuant to Section 2.5.2 (collectively, “GPC Biotech Activities”).