definiens: means, with respect to the Licensed Products, all INDs, NDAs, and other regulatory applicationssubmitted to any Regulatory Authority, Regulatory Approvals, pre - clinical and clinical data and information, regulatory materials, drug dossiers, masterﬁles ( including Drug Master Files, as deﬁned in 21 C.F.R. 314.420 and any non - United States equivalents ), and any other reports, records, regulatorycorrespondence, and other materials relating to the Licensed Product, or required to Develop, Manufacture, or Commercialize the Licensed Products, including any information that relates to pharmacology, toxicology, chemistry, Manufacturing and controls data, batch records, safety and eﬃcacy, andany safety database . For clarity, Regulatory Documentation includes all documentation and correspondence with the FDA or any other GovernmentalAuthority with respect to the Licensed Products