definiens: means a generic versio n of a Licensed Product that ( a ) in the United States, is approved under 21 U.S.C. 505(j ) ( or the equivalent of such statute if amended ) or ( b ) in countries of the European Union, is authorized to be placed on the market in accordance with Article 10(1)(a ) ( iii ) of Directive 2001/83 / EC ( or the equivalent of such statute if amended ), or ( c ) in countries of the Territory other than the United States and countries of the European Union, a generic version of the Licensed Product that ( i ) contains the same active pharmaceutical ingredient as the Licensed Compound in the Licensed Product and ( ii ) is approved by an abbreviated process that relies in whole or in part on safety and efficacy data generated for the first approval of the Licensed Product and ( iii ) has th e same or substantially the same labeling as the Licensed Product for at least one indication of the Licensed Product