definiens: means, with respect to a given Shared Antigen TCR Product, any drug, biological product or Cell Therapy t hat : ( i ) is subject to review under an abbreviated approval pathway as a biosimilar, follow -on biologic or generic biological product, as those terms are commonly understood under the FD&C Act, 21 C.F.R. § § 210, 211 and 600 et seq . and under the PHS Act, 2 1 C.F.R. § § 600 -610 and related rules and regulations, or the corresponding or similar laws, rules and regulations of any other jurisdiction ; ( ii ) is approved as, in each case of clauses ( i ) and ( ii ), of the relevant Shared Antigen TCR Product ( s ) ; or ( iii ) is subject to review under an abbreviated approval pathway as a ( or substantially similar nomenclature therefor ) in reliance on or by reference to the Marketing Approval for the relevant Shared Antigen TCR Product, in the ev ent Regulatory Authorities promulgate such rules and regulations under the FD&C Act, or the corresponding or similar laws, rules and regulations of any other jurisdiction ; provided, that in each instance under clauses ( i ) -(iii ), which Biosimilar is sold by a Third Party that is not a licensee or sublicensee of [COMPANY] ( or any of its Affiliates ) and that has not otherwise been authorized, directly or indirectly, by [COMPANY] ( or any of its Affiliates ) to market and sell such product