definiens: means ( a ) with respect to th ... J.S. Territory, the conduct by King and its Affiliates of additional clinical studies of a Product that has previously received Regulatory Approval from the FDA, which additional clinical studies are conducted using CTM that is in the same formulation and dosage form as the Product for which Regulatory Approval was previously obtained, and ( b ) with respect to the ROW, the conduct by King, its Affiliates, or its Sublicensees of clinical studies of a Product, which additional clinical studies are conducted using CTM that is in the same formulation and dosage form as the Product for which Regulatory Approval was previously obtained in the U.S. Territory ( or if Regulatory Approval has not yet been obtained in the U.S. Territory, then using CTM in the same formulation(s ) and dosage form(s ) then being utilized by PTI under the Development Plan for such Product in the U.S