definiens: means, with respect to any Compound or Product, all INDs, NDAs, and other regulatory applications submitted to any Regulatory Authority, copies of Regulatory Approval s, regulatory materials, drug dossiers, master files ( including Drug Master Files, as defined in 21 C.F.R . § 314.420 and any non - United States equivalents ), and any oth er reports, records, regulatory correspondence, mee ting minutes, telephone logs, and other materials relati ng to Regulatory Approval of such Compound or Produ ct ( including any underlying safety and effectiveness data whether or not submitted to any Regulatory Aut hority ), or required to Research, Develop, Manufacture or Comme rcialize such Compound or Product, including any information that relates to pharmacology, toxicolog y, chemistry, manufacturing and controls data, batc h records, safety and efficacy, and any safety database requir ed to be maintained for Regulatory Authorities