definiens: means, with resp ect to a Licensed Product, the date on which a Settlement Sublicensee or a Third Party without a l icense or authorization from [COMPANY], any of its Aff iliates or any Sublicensee launches a pharmaceutical product w ith respect to which such Third Party has received Regulatory Approval for a BLA for such product as a biosimilar to, or that is interchangeable with, such Licensed Product ( a ) under Section 351(k ) of the PHSA in the United Stat es ( or any successor provisions thereto ) or under A rticle 10(4 ) of Directive 2001/83 / EC in the European Union or an y member state thereof ( or any successor provisions thereto ), in each case citing such Licensed Product as the re ference product or ( b ) for which the BLA otherwise references or relies on such Licensed Product under applicable Law in any other country in the Territory