Common use of PSC Development Responsibilities Clause in Contracts

PSC Development Responsibilities. Each PSC shall have the following responsibilities with respect to the Development of the Split Territory Licensed Program and Split Territory Licensed Products for which it is responsible: (a) reviewing, commenting on and approving the initial Split Territory Global Development Plan for such Split Territory Licensed Product in accordance with Section 5.2.2 (Split Territory Global Development Plans); (b) preparing, reviewing, commenting on and approving updates and amendments to the Split Territory Global Development Plan and Split Territory Global Development Budget for such Split Territory Licensed Product in accordance with Section 5.2.4 (Updates and Amendments to the Split Territory Global Development Plans and Split Territory Global Development Budgets); (c) monitoring the implementation of the Split Territory Global Development Plan for such Split Territory Licensed Product, including the Split Territory Global Development Activities set forth in such Split Territory Global Development Plan; (d) monitoring any Global Clinical Study performed by a contract research organization retained by a Party to perform such Global Clinical Study, against the criteria and timelines in such Split Territory Global Development Plan; (e) reviewing, commenting on and approving the initial Genzyme Territory Development Plan and the initial Voyager Territory Development Plan for such Split Territory Licensed Product in accordance with Section 5.2.6 (Voyager Territory Development Plan) and Section 5.2.7 (Genzyme Territory Development Plan); (f) reviewing, commenting on and approving updates and amendments to the Genzyme Territory Development Plan in accordance with Section 5.2.6 (Voyager Territory Development Plan) and Section 5.2.7 (Genzyme Territory Development Plan), and providing each Party with feedback regarding the same; (g) reviewing and discussing updates provided by each Party regarding the Development of such Split Territory Licensed Product in accordance with Section 5.5.1.1 (Development Activities Reports), and providing each Party with feedback regarding the same; (h) monitoring and coordinating Development activities in the Genzyme Territory and the Voyager Territory for such Split Territory Licensed Product, regulatory strategy, and regulatory and pharmacovigilance requirements and matters; (i) reviewing and discussing updates provided by each Party regarding any Split Territory Global Development Activities in accordance with the Split Territory Global Development Plan for such Split Territory Licensed Product (including the Split Territory Global Development Budget); (j) overseeing any manufacturing and supply relationship between the Parties with respect to the Manufacture of such Split Territory Licensed Product for Development activities (subject to the provisions of any Supply Agreement); (k) approving a global list of clinical sites for each Global Clinical Study for such Split Territory Licensed Product; (l) approving the appointment of a global contract research organization to manage any Clinical Study for such Split Territory Licensed Product; (m) reviewing and approving any Additional Development Proposals pursuant to Section 5.2.5 (Secondary Indications); and (n) performing such other activities as the Parties agree in writing shall be the responsibility of such PSC or that are otherwise assigned to such PSC under this Agreement.