definiens: means, with respect to a given Calendar Year with respect to aPfizer Licensed Product in any country, that during such Calendar Year, one ( 1 ) or more Third Parties havereceived Regulatory Approval to sell in such country a Biosimilar Biologic Product, such Biosimilar BiologicProduct(s ) will be commercially available in such country and such Biosimilar Biologic Product(s ) will have, in the aggregate . A product will be a with respect to a [COMPANY] LicensedProduct if such product ( 1 ) has been licensed as a biosimilar or interchangeable product by FDA pursuant toSection 351(k ) of the Public Health Service Act ( 42 U.S.C. 262(k ) ), as may be amended, or any subsequentor superseding law, statute or regulation, ( 2 ) has been licensed as a similar biological medicinal product byEMA pursuant to Directive 2001/83 / EC, as may be amended, or any subsequent or superseding law, statuteor regulation, or ( 3 ) has otherwise achieved analogous Regulatory Approval from another applicableRegulatory Authority