definiens: means, with respect to a par ticular Licensed Product in a country, a generic pharmaceutical product that : ( a ) contains the same active ingredient as the Licensed Compound in the s ame chemical form as in such Licensed Product ; and ( b ) is approved for use in such country by a Regulatory Authority through an Abbreviated New Drug Applicati on as defined in the FD&C Act, pursuant to Article 10.1 of Directive 2001/83 / EC of the European Parliament and Council of 6 November 2001, or any enabling legislation thereof, or pursuant to any similar abb reviated route of approval in any other countries i n the Territory ; or ( c ) ( i ) contains the same active ingr edient as the Licensed Compound in such Licensed Pr oduct ; and ( ii ) is approved for use in such country by a Regul atory Authority through a regulatory pathway refere ncing clinical data first submitted by Licensee or its Af filiates or Sublicensees for obtaining Regulatory A pproval for such Licensed Product