definiens: means, with respect to a Competing Product, anypharmaceutical or biological product that ( i ) is distributed by a Person under a Drug ApprovalApplication approved by a Regulatory Authority in reliance, in whole or in part, on the priorapproval ( or on safety or efficacy data submitted in support of the prior approval ) of suchCompeting Product, including any product authorized for sale ( a ) in the U.S. pursuant to Section505(b)(2 ) or Section 505(j ) of the FFDCA ( 21 U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j),respectively ), ( b ) in the European Union pursuant to a provision of Articles 10, 10a or 10b ofParliament and Council Directive 2001/83 / EC as amended ( including an application underArticle 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content onany such provision ) or ( c ) in any other country or jurisdiction pursuant to all equivalents of suchprovisions or ( ii ) is otherwise substitutable under Applicable Law for such Competing Productwhen dispensed without the intervention of a physician or other health care provider withprescribing authority