definiens: means, with respect to the Program DARTs or Licensed Products, all INDs, BLAs, andother regulatory applications submitted to any Regulatory 11 * * * = Portions of this exhibit have been omitted pursuant to a request for confidential treatment . An unredactedversion of this exhibit has been filed separately with the Commission . Authority, copies of Regulatory Approvals, regulatory materials, drug dossiers, master files ( including Drug Master Files, asdefined in 21 C.F.R. § 314.420 and any non - United States equivalents ), and any other reports, records, regulatorycorrespondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval of the Program DARTsor Licensed Products ( including any underlying safety and effectiveness data whether or not submitted to any RegulatoryAuthority ), or required to manufacture, distribute or sell Licensed Products including any information that relates topharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and any safetydatabase required to be maintained for Regulatory Authorities