definiens: means, with respect to a particular Product ( the ), one or more product(s ) sold by a Third Party that is not a licensee or Sub licensee of [COMPANY] pursuant to a license, sublicens e or subcontract pursuant to which [COMPANY] receives a royalty, profit share or other consideration directly as a result of the sales of such product where such product(s ) ( a ) have the sam e active pharmaceutical ingredient as such Referenc e Product, are approved in reliance, in whole or in part, on a prior Regulatory Approval of the Reference Product, and are determined by a Regulatory Authority to be substitu table for the Reference Product or ( b ) are approved by the Regulatory Authority as a substitutable generic or substitutable biosimilar for such Reference Product or otherwise are approved in a manner that relies on or incorpor ates data submitted by [COMPANY] or its Affiliates in connection with the regulatory filings for such Reference Prod uct through an ANDA or 505(b)(2 ) pathway, or any en abling legislation thereof, or any equivalent process wher e bioequivalence to such Reference Product has been asserted