definiens: means, with respect to a particular Product, on a country - by - country basis, anypharmaceutical product that ( i ) contains substantially the same chemical composition, approximate chemical formula, andapparent molecular weight as the Product and has the same pharmaceutical form as the Product, ( ii ) obtains regulatoryapproval by reference to the Product pursuant to Article 10 ( as applicable ) of Directive 2001/83 / EC and Article 3(3 ) ofRegulation EC/726/2004 of the European Parliament and of the Council on the Community code relating to medicinalproducts for human use, as amended, or any similar approval in any country of the Licensed Territory that is based onreference to the Regulatory Approval for such Product in such country and a demonstration of therapeutic equivalence orsimilarity to such Product, and ( iii ) is sold in the same country as such Product by a Third Party that is not a sublicensee ofTakeda or its Affiliates and did not purchase such product in a chain of distribution that included any of [COMPANY] or itsAffiliates or sublicensees