definiens: means a pharmaceutical preparation which ( i ) either ( x ) is not produced, licensed, orowned by Buyer or any of Buyer ’s Controlled Affiliates, successors, assigns, or its or their respective sub - licenseesor ( y ) is not authorized by Buyer or any of Buyer ’s Controlled Affiliates or its or their respective successors, assigns, or sublicensees by license, covenant not to sue, settlement agreement, release or by any other arrangement ormeans ( including with respect to ANDAs ), and ( ii ) is automatically substitutable for the branded Product at the retailpharmacy level or is approved in reliance on the prior approval of the Product as determined by the applicableRegulatory Authority(ities ) in any country on the basis of being comparable to and substitutable for the Product;provided that Generic Product shall in no event include any pharmaceutical preparation that is marketed, distributedand sold by or on behalf of Buyer or any of Buyer ’s Controlled Affiliates, successors, assigns, or its or theirrespective sub - licensees ( e.g., an authorized generic )