definiens: means, with respect to a Licensed Product in a co untry or jurisdiction, any product sold by a Third Party tha t ( a ) is subject to a license under Section 351(a ) or 351(k ) of the PHSA and ( i ) is authorized by the FDA as being ( as defined in Section 351(i)(3 ) of t he PHSA ) to such Licensed Product, or ( ii ) is authorized by the FDA as being a ( as defined in Sect ion 351(i)(2 ) of the PHSA ) regardless of whether such product has been found to be ( as defined in Section 351(i)(3 ) of the PHSA ) to such Licensed Product, ( b ) has been granted a marketing authorization by the European Commission as a similar biological medicinal produc t pursuant to Article 10 of Directive 2001/83 / EC, a s may be amended, or any subsequent or superseding law, stat ure or regulation or ( c ) has otherwise received Reg ulatory Approval as a generic, biosimilar or interchangeabl e product from another applicable Regulatory Author ity in such country or jurisdiction, including by referencing o r otherwise relying on Regulatory Approvals ( or dat a therein ) of such Licensed Product