definiens: means, with respect to a given Product in a given country of the Territory, any biological product that ( a ) is sold after the E ffective Date by a Third Party that is not a Sublic ensee of [COMPANY] and without the consent of [COMPANY], unde r a 3 Marketing Approval granted by a Competent Authority to such Third Party ; ( b ) is similar to such Product in terms of quality characteristics, biolog ical activity, safety and efficacy, notwithstanding minor differences and considered in the United Stat es under 42 USC § 262(i)(2 ) or its foreign equivalen t applicable Law, on a country - by - country basis where such Product is marketed, as a product provided that such applicable Law exists ; a nd ( c ) is approved in reliance in whole or in part, on ( i ) a prior Marketing Approval ( or on any safety or efficacy data submitted in support of prior Market ing Approval ) of such Product or reference to other pub licly available clinical data with respect to such Product, or ( ii ) a demonstration of biosimilarity t o or interchangeability with such Product