Common use of Process Development Clause in Contracts

Process Development. The Parties will use, and shall cause their respective Permitted Subcontractors to 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 (plus a reasonable level of inventory) 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, and all changes to the manufacturing process shall be subject to the approval of the Program Management Team and any additional quality and regulatory personnel of the Parties whose approval is deemed necessary or desirable.

Process Development. The Parties will use, and shall cause their ------------------- respective Permitted Subcontractors to 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 (plus a reasonable level of inventory) 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, and all changes to the manufacturing process shall be subject to the approval of the Program Management Team and any additional quality and regulatory personnel of the Parties whose approval is deemed necessary or desirable.