definiens: means a product in a particularcountry or regulatory jurisdiction that : ( a ) contains the same active pharmaceutical ingredient(s ) as such product utilizing theCompound or is otherwise comparable to such product in dosage form, strength, route of administration, pharmacokinetic profile, quality and performance characteristics and intended use ; ( b ) is approved in reliance, in whole or in part, on a prior approval ( or onsafety or efficacy data submitted in support of a prior approval ) of such product as determined by the applicable regulatory authority, including any product authorized for sale ( i ) in the U.S. pursuant to Section 505(j ) of the U.S. Federal Food, Drug, and Cosmetic Act(21 U.S.C. Section 355(j ) ), ( ii ) in the European Union pursuant to a provision of Articles 10, 10a or 10b of Parliament and CouncilDirective 2001/83 / EC as amended ( including an application under Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004that relies for its content on any such provision ), or ( iii ) in any other country or jurisdiction pursuant to all equivalents of such provisions, including any amendments and successor statutes with respect to the subsections ( i ) through ( iii ) thereto ; and ( c ) is sold in suchcountry or regulatory jurisdiction by a Third Party that is not a sublicensee of Context or an Affiliate of Context, and is not otherwiseauthorized by Context or its Affiliates or Context ’s sublicensees to sell such product