definiens: means, with respect to a Product ( but specificall y 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, Zai or any of its Affiliates or Sublicensees ; ( b ) contains the same or similar amino acid sequen ce as the applicable Product ; and ( c ) with respect to a Regio n or Country of the Territory, has been granted Reg ulatory Approval as a biosimilar or interchangeable biologi cal product by the applicable Regulatory Authority in such Region or Country according to a biosimilar regulat ory pathway that is materially equivalent to that o f Section 351(k ) of the US Public Health Service Act ( 42 U.S.C. § 262(k ) ), as may be amended, or any sub sequent or superseding law, statute or regulation