definiens: means, with respect to a Product ( the ), anypharmaceutical product in a particular regulatory jurisdiction that ( a ) ( i ) contains the same activepharmaceutical ingredients as the Reference Product ; ( ii ) is bioequivalent to the ReferenceProduct as determined by the applicable Regulatory Authority in such jurisdiction ; and ( iii ) hasone or more Regulatory Authority - approved Indications in such jurisdiction equivalent to any ofthe Regulatory Authority - approved Indications for the Reference Product in such jurisdiction(except that the references to in this subsection ( iii ) means, with respect toRegulatory Authority - approved Indications in the Territory, any one or more countries in theTerritory ) ; and ( b ) is sold in such jurisdiction by a Third Party that is not a Sublicensee ofLicensee or its Affiliates, and is not otherwise authorized by Licensee or any of its Affiliates, Sublicensees or distributors to sell such product