definiens: means, with respect to a Li censed Product, a biological medicinal product for human use which : ( a ) is highl y similar to such Licensed Product ; ( b ) has no clin ically meaningful differences with regard to such Licensed Product in terms of safety, purity, or potency, as determined by Applicable Law or any applicable Regulatory Auth ority ; ( c ) is approved for use in the United States under 42 U.S.C § 262(k ) as a biosimilar biological product ( as defined in 42 U.S.C. § 262(i)(1 ), ( 2 ) ) or under any other jurisdiction pursuant to an equivalent regime in su ch jurisdiction, and ( d ) for which the Licensed Pro duct is the reference product ( as defined in 42 U.S.C. § 262(i ) ( 4 ) or equivalent code reference in the applicable jurisdiction and regulatory regime )