Provisions Generally Applicable to Development Plans. The activities and key milestones to occur with respect to each Development Plan may include, but are not limited to, the following activities or topics: (i) technical feasibility assessment, (ii) formulation and analytical development, (iii) Facility improvements, (iv) equipment and Material purchases, (v) clinical scale production, (vi) stability studies and Product batch production to support Regulatory Submissions, (vii) Regulatory Submissions, (viii) Regulating Groups’ review and approval, and (ix) Product launch readiness activities and other pre-commercial activities. If different from the Product Specifications, specifications applicable to Product to be manufactured under each Development Plan will be set forth in each such plan, subject to refinement from time to time based upon the results of the Development Plan, the results of ongoing activities under other Development Plans, and requirements of Regulating Groups. While Product and Formulation specifications, and any changes thereto, must be agreed to in writing by both Parties, Cadence will be responsible for and must provide final approval of all Product specifications and any Formulation specifications included in Development Plans, and all changes thereto prior to implementation. During the Term of the Agreement, Cadence will be responsible for performing certain Cadence activities as set forth in each Development Plan, including but not limited to, the following: (i) providing technical information about the API and the manufacturing process for Product, (ii) unless otherwise agreed in writing by a duly authorized representative of each Party, timely providing the API and applicable reference standards required for implementation of the activities described in the Development Plans, (iii) unless otherwise agreed between the Parties, compliance with Regulatory Submission reporting requirements regarding manufacture and control of the API, (iv) timely review, drafting and filing of all necessary submissions with Regulating Groups, and (v) payment of development fees and other fees and expenses as set forth in Section 4.2.3. In general, during the Term of the Agreement, Baxter will be responsible for performing certain activities as set forth in each Development Plan, including but not limited to, the following: (a) conducting development studies identified as a Baxter Development Deliverable in each Development Plan, (b) maintaining inventories of excipients, applicable reference standards ...
