definiens: means, with respect to a Royalty Product and a country, any pharmaceutical productthat is distributed by a Third Party ( that is not licensed by the relevant Selling Party ) in such country ( i ) under aRegulatory Approval approved by a Regulatory Authority in reliance, in whole or in part, on the Regulatory Approval forsuch Royalty Product, including any product authorized for sale ( a ) in the United States pursuant to Section 505(b)(2)or 505(j ) of the FD&C Act ( 21 U.S.C. 355(b)(2 ) and 355(j ), respectively ), ( b ) in the EU pursuant to Article 10(1 ), Article10(4 ) or Article 10a of Directive 2001/83 / EC as amended, or ( c ) in any other country or jurisdiction pursuant to allequivalents of such provisions in ( a ) and ( b ), and ( ii ) which product ( a ) contains the same active pharmaceuticalingredient(s ) as such Royalty Product, ( b ) is approved based in part upon clinical data generated and used forobtaining Regulatory Approval of such Product, and ( c ) solely with respect to a 505(j ) Regulatory Approval or foreignequivalent ( but expressly excluding 505(b)(2 ) or its foreign equivalent ) is approved for at least one of the sameindication(s ) as such Royalty Product in such country and is approved for the same method of administration as suchRoyalty Product in such country