Quality Testing. Alliance shall perform quality control tests and assays on the Product manufactured by it pursuant to Section 9.01 in accordance with the requirements of the applicable Drug Approval Application. Alliance shall provide Schering with a copy of the batch record, a certificate of analysis and a certificate of compliance for each batch of Product delivered to Schering either in advance of or contemporaneous with the delivery of each batch of Product to Schering. The certificate of compliance shall certify that each batch was reviewed and meets all regulatory requirements. The certificate of analysis shall certify that each batch was tested and meets all specifications.
Appears in 2 contracts
Sources: License Agreement (Alliance Pharmaceutical Corp), License Agreement (Alliance Pharmaceutical Corp)