definiens: means, with respect to a particular Licensed Prod uct in a particular country, a product on the market in such country commercialize d by any Third Party that is not a Sublicensee and that did not purchase such product in a chain of distributio n that included any of Sanofi or its Affiliates or Sublicensees, that ( a ) is approved by the applicable Regulatory A uthority, under any then - existing Applicable Laws p ertaining to approval of generic products, which approval is based on all or part of the clinical data reference d in any Regulatory Approval for the Licensed Product or whi ch otherwise relies on the Regulatory Authority ’s f inding 12 of safety or effectiveness for the Licensed Product, or ( b ) is otherwise recognized as an product by the applicable Regulatory Authority . For clarity, A uthorized Generics will not be classified as Generi c Products for purposes of this Agreement