Regulatory Documentation

Regulatory Documentation. With respect to the Licensed Compound and Licensed Products, all INDs, NDAs, and other regulatory applications submitted to any Regulatory Authority, Regulatory Approvals, pre-clinical and clinical data and information, 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 other reports, records, regulatory correspondence, and other materials relating to Development or Regulatory Approval... of the Licensed Compound or a Licensed Product, or required to manufacture, distribute, or sell the Licensed Products, including any information that relates to pharmacology, toxicology, chemistry, manufacturing, and controls data, batch records, safety and efficacy, and any safety database View More