definiens: means, with respect to a particular Licensed Product in a country, ageneric pharmaceutical product that : ( a ) ( i ) contains the same or substantially the same active ingredient(including an active moiety that has the identical nucleic acid sequence and composition ) as the LicensedCompound in such Licensed Product ; and ( ii ) is approved for use in such country by a RegulatoryAuthority through an Abbreviated New Drug Application as defined in the United States of AmericaFederal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, pursuant to Article 10.1 of Directive 2001/83 / EC of the European Parliament and Council of 6 November2001, or any enabling legislation thereof, or pursuant to any similar abbreviated route of approval in anyother countries in the Territory ; or ( b ) ( i ) contains the same or substantially the same active ingredient(including an active moiety ) as the Licensed Compound in such Licensed Product ; and ( ii ) is approved foruse in such country by a Regulatory Authority through a regulatory pathway referencing clinical data firstsubmitted by Licensee or its Affiliates or Sublicensees for obtaining Regulatory Approval for suchLicensed Product