Common use of Initial GDP Clause in Contracts

Initial GDP. (a) Notwithstanding Section 4.1.1, the initial GDP attached to this Agreement as Exhibit C (“Initial GDP”) includes all Clinical Studies that, as of the Effective Date, the Parties believe are reasonably necessary to support Marketing Approval of a Product for the indications contemplated by the GDP in the Major Market Countries. For clarity, each Clinical Study described in the Initial GDP is a Clinical Study of the Initial Product for the Field. Promptly following the Effective Date, the JDC will prepare and the JSC shall approve a comprehensive GDP that includes all Development activities that are reasonably necessary to support Marketing Approval and Commercialization of such Product for each indication in the Initial GDP in the U.S., ▇▇▇▇▇▇▇ Territory and Greater China. Unless otherwise agreed by the Parties, such comprehensive GDP shall be consistent with the Initial GDP. (b) Notwithstanding Section 4.1.1, the Initial GDP includes an initial Development Budget (“Initial Development Budget”) for Calendar Years [***]. Promptly following the Effective Date, the JDC will prepare and the JSC shall approve a comprehensive Development Budget [***] in connection with the preparation of the comprehensive GDP pursuant to Section 4.1.2(a). Such comprehensive Development Budget for each such Calendar Year shall be consistent with the Initial Development Budget for the applicable Calendar Year [***]. [***] (c) The initial GDP includes the initial Development Budget Forecast [***] (the “Initial Development Budget Forecast”). Promptly following the Effective Date, the JDC will prepare and the JSC shall approve a comprehensive Development Budget Forecast [***] in connection with the preparation of the comprehensive GDP pursuant to Section 4.1.2(a) and Development Budget pursuant to Section 4.1.2(b). Such Development Budget Forecast shall be consistent with the Initial Development Budget Forecast [***]. (d) The initial GDP includes [***] of the Initial Product to be conducted in [***]. [***] as soon as possible after the following criteria have been satisfied: (i) [***] the Initial Product has been [***]; and (ii) the Parties have received guidance from [***].