definiens: means ( a ) in respect of a Product sold in the United States, a biological productapproved under the Public Health Service Act section 351(k ) that is highly similar to such Product, notwithstandingminor differences in clinically inactive components, and for which there are no clinically meaningful differencesbetween such biological product and the Product in terms of the safety, purity and potency ; ( b ) in respect of a Productsold in the European Union, a biological product approved under Article 10(4 ) of Directive 2001/83 / EC and Section 4,Part II, Annex I to such Directive based on the demonstration of the similar nature of such biological product and theProduct ; and ( c ) in respect of a Product sold outside the United States and the European Union, a biological productapproved under a similar pathway to ( a ) or ( b ) if such pathway exists and, if such pathway does not exist, a marketingapproval granted by a regulatory authority to such Third Party with reference to such Product