definiens: means, with respect to a particular Licensed Product and on acountry - by - country basis, a generic pharmaceutical product that is marketed for sale by a Third Party(not licensed, supplied or otherwise permitted by [COMPANY] or BPM in accordance with this Agreement)and that : ( a)(i ) contains the same or substantially the same active ingredient as the Compound insuch Licensed Product ; and ( ii ) is approved for use in such country by a Regulatory Authority throughan Abbreviated New Drug Application as deﬁned in the FDCA, and the regulations promulgatedthereunder, pursuant to Article 10.1 of Directive 2001/83 / EC of the European Parliament and Councilof 6 November 2001, or any enabling legislation thereof, or pursuant to any similar abbreviated routeof approval in such country ; or ( b)(i ) contains the same or substantially the same active ingredient asthe Compound in such Licensed Product ; and ( ii ) is approved for use in such country by a RegulatoryAuthority through a regulatory pathway referencing clinical data ﬁrst submitted by or on behalf ofRoche or BPM for obtaining Regulatory Approval for such Licensed Product