Common use of Process Development; Manufacturing Approvals Clause in Contracts

Process Development; Manufacturing Approvals. The Parties will use commercially reasonable and diligent efforts to develop a process for the manufacture of each Collaboration Product and to scale up that process to a scale sufficient to manufacture and supply (a) the anticipated demand for preclinical studies and clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (b) the anticipated market demand for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the Program Management Team. The Parties will use commercially reasonable and diligent efforts, and will cause any approved Third Party supplier, to make filings necessary to obtain approval of any license application for the New Facility which may be required as part of any Regulatory Approval for the first Collaboration Product.

Process Development; Manufacturing Approvals. The Parties will use commercially reasonable and diligent efforts to develop a process for the manufacture of each Collaboration Product and to scale up that process to a scale sufficient to manufacture and supply (ai) the anticipated demand for preclinical studies and clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (bii) the anticipated market demand for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the Program Management Team. The Parties will use commercially reasonable and diligent efforts, and will cause any approved Third Party supplier, to make filings necessary to obtain approval of any license application for the New Dedicated Facility which may be required as part of any Regulatory Approval for the first Collaboration Product.