definiens: means ( a ) with respect to a country in the Territory, any and all approvals, licenses, registrations or authorizations of anyGovernmental Authority issued to or received by any of Seller, Seller Sub or anyof their respective Affiliates as of the Execution Date, or that are issued toor received by any of Seller, Seller Sub or any of their respective Affiliatesafter the Execution Date but on or prior to the Closing Date, that are necessaryfor the manufacture, use or Distribution of the Products in such country(including any BLAs, NDAs, INDs or foreign equivalents thereof, any pricing orreimbursement approvals, non - clinical and clinical study authorizations, pre - and post - approval marketing authorizations and Labeling approvals ), and anyregistrations or applications for, supplements or amendments to, the foregoing;(b ) all supporting files, writings, data, studies, reports and other writtenmaterials filed as part of, or referenced in, such approvals, registrations, applications or notifications, or maintained by any of Seller, Seller Sub or anyof their respective Affiliates and relating to such approvals, registrations, applications or notifications ; and ( c ) all correspondence to or with the FDA, EMEA or any other Governmental Authority with respect to the Products or theProduct Line Business