definiens: means, with respect to the Program DARTs or Licensed Products, all INDs, BLAs, andother regulatory applications submitted to any Regulatory Authority, copies of Regulatory Approvals, regulatory materials, 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 DARTs or Licensed Products ( including any underlying safety andeffectiveness data whether or not submitted to any Regulatory Authority ), or required to Develop, Manufacture orCommercialize Licensed Products including any information that relates to pharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and any safety database required to be maintained forRegulatory Authorities