definiens: means the regulator y registrations, applications, authorizations and approvals ( including approvals of NDAs, BLAs, 510(k ) s, PMAs, supplements and amendments, pre- and post -approvals, pricing and Third Party reimbursement ap provals, and labeling approvals ), Regulatory Approv als or other submissions made to or with any Regulatory Au thority necessary for the research, development ( in cluding the conduct of clinical studies ), manufacture, or c ommercialization of a Development Candidate, Licens ed Product or Diagnostic Product in a regulatory juris diction, together with all related correspondence t o or from any Regulatory Authority and all documents referenc ed in the complete regulatory chronology for each N DA, including all Drug Master File(s ) ( if any ), IND, CT A, MAA and supplemental new drug applications ( sNDA s ) or foreign equivalents of any of the foregoing