definiens: means, with respect to a given Product in a given country, any biological product that ( i ) is sold by a Third Party that is n ot a Licensee or Affiliate of iTeos and without the consent of iTeos, under a marketing approval granted by a regu latory authority to such Third Party ; ( ii ) is highl y similar to such Product, notwithstanding minor differences in clinically inactive components ; ( iii ) shows no clin ically meaningful differences when compared to the Product, in terms of safety, purity and potency and ( iv ) s uch generic product is approved in reliance on or with reference to a prior Marketing Approval of such Pro duct or an equivalent process for Marketing Approval in any co untry outside the United States, or any other equiv alent provision that comes into force, or is the subject of a notice with respect to such Product under 42 U .S.C. § 262(1)(2 ) or any other equivalent provision that co mes into force in such country . By way of example, in the United States this would include a product that is submitted to U.S. Food and Drug Administration as a biosimilar via a Biologics License Application unde r Section 262(k ) of Title 42 of the United States C ode, as may be amended from time to time, for which the Pro duct is the reference product