definiens: means, with respect to a Product ( but specifically excluding any MGA012 component thereof ) sold in a Country or Region, a p roduct that : ( a ) is marketed by a Third Party that has not obtained the rights to such product as a Sublicense e or distributor of, or through any other contractu al relationship with, I - MAB or any of its Affiliates o r Sublicensees ; contains the same or substantially similar amino acid sequence as the applicable Product ; and with respect to a Region or Country of the Territor y, has been granted Regulatory Approval as a biosimilar or interchangeable biological product by the applicab le Regulatory Authority in such Region or Country acco rding to a biosimilar regulatory pathway that is ma terially equivalent to that of Section 351(k ) of the US Publ ic Health Service Act ( 42 U.S.C. § 262(k ) ), as may be amended, or any subsequent or superseding law, stat ute or regulation