definiens: means, with respect to a Royalty Product, any pharmaceutical or biological product that is distributed by a Third Party under a Drug Approval Application approved by a Regulator y Authority that references or otherwise relies, in w hole or in part, on the prior approval ( or on safet y or efficacy data submitted in support of the prior approval ) of such Royalty Product, including any product author ized for sale : ( a ) in the U.S. pursuant to ( i ) Section 505(b ) ( 2 ) or Section 505(j ) of the FFDCA ( 21 U.S.C. § 355 ( b)(2 ) and 21 U.S.C. § 355(j ), respectively ) or ( ii ) Section 35 1(k ) of the PHSA ( 42 U.S.C. § 262(k ) ) as interchange able with such Royalty Product in accordance with Section 351 ( k)(4 ) of the PHSA ( 42 U.S.C. § 262(k)(4 ) ) ; ( b ) in t he EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC as a mended ( including an application under Article 6.1 of Parl iament and Council Regulation ( EC ) No 726/2004 that relies for its content on any such provision ) ; or ( c ) in a ny other country or jurisdiction pursuant to an equ ivalent of such provisions