definiens: shall mean all of the follow ing related to a given Lot : ( a ) with respect to API, Certificates of Analysis and Compliance, a summary list of Discrepancy Reports, and the actual Discrepancy Reports upon request by [COMPANY] where required to release Filled Product in the Territory and ( b ) with respect to Filled Product, Certificates of Analysis and Compliance, batch production records, Discrepancy Reports, lot disposition form(s ) signed by [COMPANY] and customs related documentation required to export from the country of manufacture . In any e vent, [COMPANY] shall provide [COMPANY] all documentation required by the Regulatory Authorities . If actual Discrepancy Reports are necessary for [COMPANY] to comply with the requirements of the Regulatory Authorities in the Territory and [COMPANY] has submitted such request to [COMPANY], thereafter, [COMPANY] shall provide with each Lot the actual Discrepancy Reports ( not merely the summaries thereof )