definiens: means, with respect to any Licensed Product ina given country, any biopharmaceutical product that is sold by a Third Party that is not aSublicensee of CytomX or its Affiliates and such Third Party product ( a ) contains both ( i)an Antibody or Probody that specifically binds to the Licensed Target, and ( ii ) the sameLinker and Cytotoxic Compound as the relevant Licensed Product, or ( b ) ( i ) has beenlicensed as a biosimilar or interchangeable biological product by FDA pursuant toSection 351(k ) of the PHSA or any subsequent or superseding law, statute or regulation,(ii ) has been licensed as a similar biological medicinal product by the EuropeanMedicines Agency pursuant to Directive 2001/83 / EC, as may be amended, or anysubsequent or superseding law, statute or regulation, or ( iii ) has otherwise achievedanalogous regulatory marketing approval in reliance on the prior approval of the LicensedProduct from another applicable Regulatory Authority where in the case of each ofsubclauses ( i ), ( ii ) or ( iii ) of clause ( b ) above, the Licensed Product is the referenceproduct for purposes of determining ( bio)similarity or interchangeability of the Third Partyproduct