definiens: shall mean, with respect to a country and a Product, a product that ( a ) is not produced, licensed or owned by the Buyer or any of its Affiliates, ( b ) is, according to the relevant Government Entity responsibility for Marketing Auth orization for such country ( a ), highly similar with respect to such Pr oduct, notwithstanding minor differences in clinica lly inactive components, and with no meaningful differe nces between the Biosimilar Product and such Product in terms of the efficacy, safety, purity an d potency of the product, ( c ) is approved through a n abbreviated regulatory pathway and ( d ) has the same amino acid sequence as the API in the Product . For countries or jurisdictions where no explicit biosim ilar regulations exist, a Biosimilar Product means any product that ( i ) has been deemed to be a biosimilar to such Product by a Governmental Entity with the relevant authority in another country or jurisdicti on or ( ii ) has the same amino acid sequence as the API in the Product