definiens: means, with respect to the Product in the United States, after Regulatory Approval of theProduct in the United States, any other biological product designated for human use which ( i ) contains the same principalmolecular structural features as ( but not necessarily all of the same structural features as ) the Product, ( ii ) has a purity, potency and safety proﬁle that has no clinically meaningful diﬀerence from the purity, potency and safety proﬁle of theProduct, ( iii ) is approved for use pursuant to a regulatory approval process in the United States that is based on reliance, atleast in part, on the Product, whether or not such regulatory approval was based upon data generated by either Party ﬁledwith the applicable Governmental Authority in the United States or was obtained using an abbreviated, expedited or otherprocess, and ( iv ) is sold in the United States by any Third Party