definiens: means, on a country - by - country basis, any pharmaceutical product that ( a ) is sold by a Third Party undera Regulatory Approval granted by a Regulatory Authority to such Third Party ; ( b ) contains the identical active ingredient(s ) ( including an activemoiety ) as an approved Licensed Product of [COMPANY], its Affiliates or its Sublicensee ; and ( c ) is approved pursuant to ( i ) an abbreviated newdrug application or under Section 505(b)(2 ) of the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgatedthereunder, or any amended or successor abbreviated route of approval, ( ii ) Article 10.1 of Directive 2001/83 / EC of the European Parliamentand Council of 6 November 2001, or any enabling legislation thereof, or any amended or successor abbreviated route of approval, or ( iii ) anyLaws or abbreviated routes of approval in any other countries worldwide that are comparable to those described in subclause ( i ) or ( ii ) . Apharmaceutical product that is AB - rated or comparably rated in any jurisdiction outside the United States to the applicable Licensed Productshall be a Comparable Third Party Product with respect to such Licensed Product