definiens: shall mean, with respect to a particular Licensed Product and on acountry - by - country basis, a generic pharmaceutical product that is marketed for sale by a ThirdParty ( not licensed, supplied or otherwise permitted by the [COMPANY] Group or the BPM Group)and that : ( i ) ( a ) contains the same or substantially the same active ingredient as theCollaboration Compound in such Licensed Product ; and ( b ) is approved for use in such countryby a Regulatory Authority through an Abbreviated New Drug Application as defined in the FDCA, and the regulations promulgated thereunder, pursuant to Article 10.1 of Directive 2001/83 / EC ofthe European Parliament and Council of 6 November 2001, or any enabling legislation thereof, orpursuant to any similar abbreviated route of approval in such country ; or ( ii ) ( a ) contains thesame or substantially the same active ingredient as the Collaboration Compound in suchLicensed Product ; and ( b ) is approved for use in such country by a Regulatory Authority througha regulatory pathway referencing clinical data first submitted by the [COMPANY] Group or the BPMGroup for obtaining Regulatory Approval for such Licensed Product