definiens: means, with respect to the Licensed Compoundsand Licensed Products, all INDs, NDAs and other regulatory applications submitted to anyRegulatory Authority, Regulatory Approvals, pre - clinical and clinical data and information, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONPURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.15EXECUTION VERSION regulatory materials, drug dossiers, master files ( including Drug Master Files, as defined in 21C.F.R. 314.420 and any non - United States equivalents ), and any other reports, records, regulatory correspondence and other materials relating to Development or Regulatory Approvalof a Licensed Compound or Licensed Product, or required to manufacture, distribute or sell theLicensed Products, including any information that relates to pharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and any safety database