definiens: means, with respect to a Licensed Product, any pharmaceutical product comprising theCompound that ( a ) is distributed in the Licensed Territory by a Person other than [COMPANY] or itsAffiliates or any Person authorized by [COMPANY] or its Affiliates under a Marketing Authorizationissued by a Regulatory Authority based, in whole or in part, on bioequivalence andinterchangeability with such Licensed Product, including any product authorized for sale ( i ) in theEU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive2001/83 / EC as amended ( including an application under Article 6.1 of Parliament and CouncilRegulation ( EC ) No 726/2004 that relies for its content on any such provision ) or ( ii ) in any othercountry or jurisdiction pursuant to all equivalents of such provisions and ( b ) is substitutable underapplicable Laws for such Licensed Product when dispensed in the Licensed Territory without theintervention of a physician or other health care provider with prescribing authority