definiens: means any pharmaceutical product that is distributed by a Third Party ( that is not licensed or otherwisepermitted by KHK or its Affiliates or its Sublicensees ) in the Territory ( i ) under a Regulatory Approval approved by a Regulatory Authority inreliance, in whole or in part, on the Regulatory Approval for the Product, including any product authorized for sale ( a ) in the United Statespursuant 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 ofDirective 2001/83 / EC as amended, or ( c ) in the Territory all equivalents of such provisions in ( a ) and ( b ), and ( ii ) which product ( a ) containsthe same active pharmaceutical ingredient(s ) as the Product, ( b ) is approved based in significant part upon clinical data generated and usedfor obtaining Regulatory Approval of the Product and ( c ) is approved for at least one of the same Indication(s ) as the Product in the Territory