definiens: means ( a ) any applications, filings, submissions, approvals, minutes of meetings or telephone conversations or corresponden ce between Seller or any of the Divesting Entities or any of their Affiliates and any Governmental Authority, th at relate to the Business or the Purchased Assets, including, all INDs, establishment license applications, drug master files, applications for designation as an under the Orphan Drug Act, for status under Section 506 of the FFDCA ( 21 U.S.C. § 356 ), for status under Secti on 506 of the FFDCA ( 21 U.S.C. § 356 ), as a under Section 529 of the FFDCA ( 21 U.S.C. 360ff ) or for a Special Protocol Assessment under Section 505(b)(5)(B ) and ( C ) of the FFDCA ( 21 U.S.C . § 355(b)(5)(B ) and ( C ) ), manufacturing approvals, technical, medical, and scientific licenses, and pr e - clinical, clinical and non - clinical study authori zation applications or notifications ), all amendments, sup plements, supporting files, data, studies, and repo rts relating thereto ( in hard and electronic form ) ; and ( b ) all technical and other information contained therein, and all correspondence with the FDA and other Governmental Authority relating to the foregoing, that, in each case, are in the possession of or controlled by, or held by o r for Seller, the Divesting Entities or their Affil iates, whether generated, filed or held by or for Seller, the Dive sting Entities or their Affiliates