definiens: means, with respect to a Licensed Product, a product sold by a Third Party that ( a ) contains aCompound as an active ingredient, and ( b ) has been approved for sales introduction into interstate commerce by reference to suchLicensed Product pursuant to ( i ) Section 505(b)(2 ) or Section 505(j ) of the FFDCA ( 21 U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j),respectively ), ( ii ) Articles 10(1 ), 10(2 ), 10(3 ), 10(4 ) or 10a of Directive 2001/83 / EC of the European Parliament and of theCouncil of 6 November 2001 on the Community code relating to medicinal products for human use, each as amended, or ( iii)any similar approval in any country, which similar approval is based on reference to the Health Registration Approval for suchLicensed Product in such country and a demonstration of bio - equivalence or similarity to such Licensed Product, but excludingfor clarity all Licensed Products, including Opioid Combination Products and Authorized Generic Versions, sold by [COMPANY], its Affiliates, Sublicensees and Distributors