Common use of Development Plan and Development Budget Clause in Contracts

Development Plan and Development Budget. As early as necessary in each year beginning with the first full Fiscal Year after the Effective Date, the Parties shall update and prepare the U.S. Development Plan and Development Budget for the Product for the following Fiscal Year to take into account completion, commencement or cessation of U.S. Development activities not contemplated by the then-current U.S. Development Plan, and submit such proposed U.S. Development Plan to the JSC no later than November 1 of such year, as follows: (a) Affymax, in consultation with Takeda, shall update the U.S. Development Plan for Regulatory Approval of the Product in the Renal Indications; and (b) Takeda shall update the U.S. Development Plan for Regulatory Approval of the Product in the Oncology Indications in consultation with Affymax. The JSC shall have the right to approve updates to the U.S. Development Plan and Development Budget, subject to the final decision-making authority described in Section 2.5(c) above. The JSC shall endeavor to finalize its approval of each updated U.S. Development Plan by December 15 of each year.