definiens: means with respect to a Licensed Product sold in a country, a product in such country that : ( a ) is marketed by a Third Party that has not obtained the rights to such product as a s ublicensee or distributor of, or through any other contractual re lationship with, [COMPANY] or any of its Affiliates or sublicensees ; ( b ) contains any biologically active molecule that is the same as or highly similar to the applicable Licensed Product Compound notwithstanding minor differences in clinically inactive components ; ( c ) has no clini cally meaningful differences from the applicable Licensed Product in terms of safety, purity, and potency ; ( d ) for which Regulatory Approval is obtained by referencin g Regulatory Materials of such Licensed Product ; an d ( e ) that is approved for use in such country ( or re gion ) pursuant to a Regulatory Approval process gov erning approval of interchangeable or biosimilar biologics as described in 42 U.S.C. § 262, or a similar proc ess for Regulatory Approval in any country ( or region ) outs ide the United States