Supply Coordination. The Manufacture of Tirasemtiv and Product, including all process and formulation development in connection therewith, including CMC Activities, shall be overseen and coordinated by the JMC and conducted pursuant to the Manufacturing plan included in the Development Plan and the Commercialization Plan. At each regularly scheduled JMC meeting, each Party shall provide the JMC with reports summarizing its Manufacturing activities and the results of such activities and [*] Tirasemtiv and Product [*] by such Party under this Agreement [*]. The Parties shall discuss expansion of the worldwide Manufacturing capacity over time and, in any event, in the event that Cytokinetics’ current Manufacturing capacity is unable to meet the Parties’ anticipated or actual requirement for Tirasemtiv and Product. The terms and conditions of such supply ([*] for the supply of bulk drug substance of Tirasemtiv or [*] for the supply of finished Product, as applicable) shall be set forth in a separate supply agreement to be agreed by the Parties. In case Astellas desires to change the specification or manufacturing method of the Product for the use of its Development or Commercialization of the Product in Astellas Territory, JMC discuss the allocation of activities necessary for the CMC activities necessary for the change. For clarity, [*] the specification or manufacturing method of the Product for the use of its Development or Commercialization of the Product [*].
Appears in 2 contracts
Sources: License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc)