definiens: means, with respect to a give n 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 r egulatory authority to such Third Party ; ( ii ) is hi ghly similar to such Product, notwithstanding minor diff erences in clinically inactive components ; ( iii ) sh ows no clinically meaningful differences when compared to the Product, in terms of safety, purity and potency and ( iv ) such generic product is approved in reliance o n or with reference to a prior Marketing Approval o f such Product or an equivalent process for Marketing Approval in any country outside the United States, or any other equivalent provision that comes into forc e, or is the subject of a notice with respect to su ch Product under 42 U.S.C. § 262(l)(2 ) or any other equivalent provision that comes into force in such country