definiens: means, with respect to a Licensed Product that has received Regulatory Approval in a country or region in the Territory, a biologictherapeutic sold in the Territory not authorized by or on behalf of [COMPANY], ( a ) which has been licensed as a biosimilar or interchangeable product by FDApursuant to Section 351(k ) of the Public Health Service Act ( 42 U.S.C. 262(k ) ) or considered by the applicable Regulatory Authority as a pursuant to EU Directive 2001/83 / EC, in each case, as may be amended, or any subsequent or superseding law, statute or regulation, or ( b ) [ * * * ] means a Biologics License Application submitted to the FDA pursuant to 21 U.S.C. § 601.2, for purposes of obtaining Regulatory Approval for anew biologic in the United States, or any equivalent filing in a country or regulatory jurisdiction other than the United States