definiens: means, with respect to a pharmaceutical product in a country or regulatoryjurisdiction, the act of a Regulatory Authority necessary for the marketing and sale of such product in such country orregulatory jurisdiction, including, where required in order to make the marketing and sale of such product commerciallypracticable, Pricing Approval,1.46 means any applicable government regulatory authority involved in granting approvalsfor the marketing and/or pricing of a pharmaceutical product in a country or regulatory jurisdiction including the FDA, and foreign equivalents thereof,1.47 means, with respect to a Product Candidate or Licensed Product, all INDs, NDAs, and other 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.FJL § 314.420 andany non - United States equivalents ), and any other reports, records, regulatory correspondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval of Product Candidates or Licensed Products(including any underlying safety and effectiveness data whether or not submitted to any Regulatory Authority ), orrequired to manufacture, distribute or sell the Licensed Product including any information that relates topharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and anysafety database required to be maintained for Regulatory Authorities