definiens: means, with respect to the Program Antibodies or Licensed Products, all INDs, BLAs, and other regulatory applications submitted to any Regulatory Authority, copies of Regulatory Approvals, regulatorymaterials, drug dossiers, master files ( including Drug Master Files, as defined in 21 C.F.R. § 314.420 and any non - United Statesequivalents ), and any other reports, records, regulatory correspondence, meeting minutes, telephone logs, and other materialsrelating to Regulatory Approval of the Program Antibodies or Licensed Products ( including any underlying safety andeffectiveness data whether or not submitted to any Regulatory Authority ), or required to manufacture, distribute or sellLicensed Products including any information that relates to pharmacology, toxicology, chemistry, manufacturing and controlsdata, batch records, safety and efficacy, and any safety database required to be maintained for Regulatory Authorities