definiens: means, with respect to a particular Licensed Prod uct in a particular country in the Territory, any pharmaceut ical or biological product that ( a ) is distributed by a Third Party under a Drug Approval Application or Abbrevia ted New Drug Application ( or similar applications ) approved by a Regulatory Authority in reliance, in whole or in part, on the prior Drug Approval Applic ation ( or on safety or efficacy data submitted in support of the prior approval ) of such Licensed Product, inclu ding any product authorized for sale ( i ) in the U.S. pursuan t to Section 505(b)(2 ) or Section 505(j ) of the FFD CA ( 21 U.S.C. § 355(b)(2 ) and 21 U.S.C. § 355(j ), respecti vely ), ( ii ) in the EU pursuant to a provision of Ar ticles 10, 10a or 10b of Parliament and Council Directive 2001 /83 / EC as amended ( including an application under Article 6.1 of Parliament and Council Regulation ( E C ) No . 726/2004 that relies for its content on any such provision ) or ( iii ) in any other country pursuant t o an equivalent of such provisions or ( b ) is substi tutable under Applicable Law for such Licensed Product when dispe nsed without the intervention of a physician or oth er health care provider with prescribing authority