definiens: shall mean ( a ) all correspondence and submissions between Seller or any ofthe Divesting Entities and any United States Governmental Authority, including the FDA and the DEA, with respect tothe Transferred Governmental Authorizations, including any reports, filings, or notices submitted to any GovernmentalAuthority to support, maintain or obtain such Transferred Governmental Authorizations ; and ( b ) records and data fromall clinical and pre - clinical studies and trials conducted or being conducted by or on behalf of Seller or any of theDivesting Entities, which concern the Products and are ( i ) described in the Governmental Authorizations, ( ii ) thesubject of a post - marketing requirement as imposed by the FDA or the subject of a post - marketing commitment to theFDA, or ( iii ) listed on Section 1.01(e ) of the Disclosure Schedules ; in each case of ( a ) and ( b ) to the extent not alreadyin the possession or control of Purchaser . For the avoidance of doubt, Regulatory Information shall include a completecopy of the Product NDAs