definiens: means with respect to a Licensed Product in a par ticular country any product ( i ) that is sold in such particular country by a Third Party who is not a Sublicensee or a Distributor selling such product under authorization from MedImmune or its A ffiliates, ( ii ) that has received Regulatory Approval necessary for sale in such country, ( iii ) that ( a ) is 12 substantially the same as the Licensed Product in d osage form, strength, route of administration, qual ity and performance characteristics, and intended use o r ( b ) has received Regulatory Approval based on a reference to a Regulatory Approval of the Licensed Product held by MedImmune, its Affiliates, or Sublicensees, and ( iv ) that contains as an active i ngredient the same compound or substantially the sa me compound ( such as a biosimilar ) ( or, solely for pro ducts that are described by subsection ( iii)(b ), an equivalent or biosimilar thereof ), as is contained in such Licensed Product