definiens: . Re&TUlatory Documentation means, with respect to the Licensed Compound or the 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 CF.R. § 314,420 and any non~ United States equivalents ), and any other reports, records, regulatory c011'espondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval of the Licensed Compound or the Licellsed Product ( including any underlying safety and effectiveness data whether or not submitted to any Regulatory Authority ), or required to manufacture, distribute or sell the Licensed Product 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 for Regulatory Authorities