definiens: means, with respect to a ny Product or any component thereof, all INDs, NDAs, and other Regulatory Applications submi tted to any Regulatory A-14 Authority, copies of Regulatory Approvals and other Governmental Approvals, regulatory materials, drug dossiers, master files ( including Drug Master Files, as defin ed in 21 C.F.R. § 314.420 and any non - United States equivalents ), and any other reports, records, regul atory correspondence, meeting minutes, telephone lo gs, and other materials relating to Regulatory Approval of such P roduct or any component thereof ( including any unde rlying safety and effectiveness data whether or not submit ted to any Regulatory Authority ), or required to re search, develop ( including Clinical Trials ), manufacture or commercialize such Product or any component thereo f, including any information that relates to pharmacol ogy, toxicology, chemistry, manufacturing and contr ols data, batch records, safety and efficacy, and any safety database required to be maintained for Regulatory A uthorities