definiens: means any supra - national, national ( e.g., the FDA ), state, provincial.or local regulatory agency, department, bureau, commission, council or other governmental entity involved in or responsible for regulation of the manufacture, promotion andlor sale of medicinal products in the Field that are intended for human use in the applicable country or regulatory jurisdiction, 1.32 means ( a ) all INDs, NDAs and equivalent foreign applications or registrations for authority to conduct clinical trials on the Product or for Regulatory Approval, anywhere in the Territory ; ( b ) all Regulatory Approvals and any other technical, medical and scientific registrations, authorizations and approvals ( including approvals ofNDAs or foreign equivalents, supplements and amendments, pre - and post - approvals, pricing and Third Party reimbursement approvals, and labeling approvals ) of any Regulatory Authority necessary for or applicabJe to the Development ( including the conduct of clinical trials ), Commercialization, manufacture, distribution, marketing, promotion, offer for sale, use, import, reimbursement, export Or sale of a Product in any regulatory jurisdiction in the Territory, together with all related correspondence to or from any Regulatory Authority and all documents f;I ' " CERTAIN CONI'IDENTIAI . INFORMATIONCONTAINEl > IN TillS DOClIl\U : NT, MARKl : l > BY BRACKETS AND HIGIII.IGIITED, IS FILED WiTlI TilE SECliRITIES AND EXCHANGE COMMISSIONPliRSUANT 1'0 . RULE : 24n-2 OF TilE SEClJRITIES EXCHANGE ACT OF 1934, AS AMENDED