definiens: means, with respect to a given Calendar Year with respect to an [COMPANY] Licensed Product in anycountry, that during such Calendar Year, one ( 1 ) or more Third Parties have received Regulatory Approval to sell insuch country a Biosimilar Biologic Product, such Biosimilar Biologic Product(s ) will be commercially available in suchcountry and such Biosimilar Biologic Product(s ) will have, in the aggregate . A product will be a with respect to an [COMPANY] Licensed Product if such product ( 1 ) has been licensed as a biosimilar orinterchangeable product by FDA pursuant to Section 351(k ) of the Public Health Service Act ( 42 U.S.C. 262(k ) ), asmay be amended, or any subsequent or superseding law, statute or regulation, ( 2 ) has been licensed as a similarbiological medicinal product by EMA pursuant to Directive 2001/83 / EC, as may be amended, or any subsequent orsuperseding law, statute or regulation, or ( 3 ) has otherwise achieved analogous Regulatory Approval from anotherapplicable Regulatory Authority