definiens: means, in a particular country with respect to aProduct regulated as a drug product, any drug product that : ( 1 ) contains the same active ingredient asthe Product ; ( 2 ) has received all necessary approvals by the applicable Regulatory Authoritiesauthorizing the marketing and sale of such product as a drug product ; ( 3 ) is marketed or sold by aThird Party that has not obtained the rights to market or sell such product as a licensee, sublicenseeor distributor of Sobi or any of its Aﬃliates or Sublicensees with respect to such product, other than asa result of settlement of any litigation ; and ( 4 ) is approved for use in such country pursuant to anabbreviated regulatory approval process governing approval of follow - on drug products based on thethen - current standards for regulatory approval in such country ( e.g., a non - U.S. equivalent to anabbreviated new drug application submitted pursuant to Section 505(j ) of the FD&C Act ( 21 U.S.C