Common use of Manufacture of API Clause in Contracts

Manufacture of API. DPC will manufacture API in accordance with cGMPs and other applicable rules and regulations of the FDA. If NovaCardia requires API for distribution of product outside the U.S., then NovaCardia shall so notify DPC, and the parties shall agree on any additional costs and activities required to comply with such foreign governmental or regulatory agencies with jurisdiction over the manufacture, use or sale of such API, as then in effect. In accordance with cGMPs and during the term of this Agreement, DPC shall (i) take all steps necessary to ensure that any API that may be produced by it pursuant to this Agreement shall be free of cross-contamination from any other manufacturing or similar activities and (ii) be responsible for validated cleaning and changeover procedures prior to manufacturing any API for NovaCardia. Both parties shall promptly notify each other of any new instructions or specifications required by the FDA or the Act, and of other applicable domestic or foreign rules and regulations, and shall confer with each other with respect to the best means to comply with such requirements and shall allocate any costs of implementing such changes on an equitable basis. DPC and NovaCardia shall agree on the schedule for manufacture and delivery of API and Pre-Commercial Lots. Unless otherwise agreed by DPC, NovaCardia shall provide at least [. . .***. . .] notice prior to the required shipment date for delivery of product hereunder, or [. . .***. . .].