definiens: means, with respect to the Products, all documentation comprisingthe Purchased Regulatory Approvals related to the Products and the Territory : ( a ) original NDAs and associatedamendments, any post - approval correspondence and any official correspondence and reports submitted to or receivedfrom Governmental Authorities ( including minutes and official contact reports relating to any communications with anyGovernmental Authority ) ; ( b ) copies of all clinical studies performed in association and in support of the PurchasedRegulatory Approvals, ( c ) copies of all periodic safety reports ( PBRER, PSUR or PADERs ) submitted to the FDA, ( d)relevant supporting documents with respect to such correspondence and reports, including all regulatory drug lists, materials submitted to FDA under FDA Form 2253, final versions of advertising and promotion materials, and adversedrug experience reports ( periodic and expedited ), and ( e ) the Purchased Information, in each case, ( x ) to the extent inthe possession or Control of Sellers or any of their respective Affiliates as of the Closing Date and ( y ) excluding theExcluded Items and all intellectual property rights of Sellers or their respective Affiliates or their respective licensorscontained or depicted therein