definiens: means the weighted average price as determined by ( a ) [ * * * ] and ( b ) [ * * * ] . 1.21 means, with respect to a product, a biological me dicinal product or biological product for human use which : ( a ) is highly similar to such product notwithstandi ng minor differences in clinically inactive components ; ( b ) has no clinical ly meaningf ul differences with regard to such product in terms of safety, purity, or potency, as determin ed by Applicable Law or any applicable Regulatory Authority ; and ( c ) is approved for use ( i ) in the U .S., under 42 U.S.C § 262(k ) as a biosimilar biological product ( as defined in 42 U.S.C. § 262(i)(1 ), ( 2 ) ) and for which such product is the r eference product ( as defined in 42 U.S.C. § 262(i)(4 ) ) or ( ii ) in any other country or jurisdic tion, pursuant to an equivalent regime in such country or jurisdiction, and for whi ch such product is the reference product