definiens: means, with respect to a Licensed Product in a country or jurisdiction, any product : ( a ) sold by a Third Party that has not obtained the rights to such product as a Sublicensee or distributor of, or through any other contractual relationship with, Jazz or any of its Affiliates or Sublicensees and that ( b ) has the same or substantially the same active pharmaceutical ingredient(s ) or biological material as the Licensed Product and ( c)(i ) has been licensed as a biosimilar or interchangeable product by the U.S. FDA pursuant to Section 351(a ) or 351(k ) of the PHSA citing the Licensed Product as the reference product, ( ii ) has been licensed as a similar biological medicinal product by EMA pursuant to Directive 2001/83 / EC, as may be amended, or any subsequent or superseding law, statute or regulation, referencing or relying on such Licensed Product, ( iii ) is authorized for sale in the United States pursuant to Section 505(j ) of the FFDCA ( 21 U.S.C. 355(j ), respectively ), or ( iv ) has otherwise received Regulatory Approval as a generic, biosimilar or interchangeable product from another applicable Regulatory Authority in such country or jurisdiction, including by referencing Regulatory Approvals ( or data therein ) of 2 such L icensed Product and ( d ) is approved for sale for at least one Indication that is the same as an Indication for which such Licensed Product is approved for sale in such country or jurisdiction . For the avoidance of doubt, no Authorized Biosimilar / Generic of a Licensed Product shall be deemed to be a Biosimilar / Generic Product for the purpose of this definition . For this purpose, the term means any biological product that is sold under an NDA or BLA filed by Jazz, its Affiliate or any Sublicensee for such Licensed Product