The Production Record Sample Clauses

The Production Record. BSCP shall adhere to the Production Record in producing each Product, except to the extent that such Production Record conflicts with applicable law, in which event, BSCP will discuss the conflict with Client and attempt to resolve the issues before complying with applicable law. BSCP will maintain accurate records for the production of each Product and will provide all batch records approved by BSCP’s QA department at Client’s request. Client shall own the Production Records and Client Operating Documents relating to each Product produced for Client. BSCP shall own all BSCP Operating Documents, and shall make copies thereof available to Client upon Client’s request and at Client’s expense. BSCP Operating Documents shall remain BSCP Confidential Information. BSCP will provide to Client documentation regarding the production of purified bulk product for the Chemistry, Manufacturing and Controls (“CMC”) section required for a Biologics License Application (“CBLA”) or an analogous Marketing Authorization Application as required by the FDA or other authorized regulatory authority.