definiens: means, with respect to a Royalty Product, any pha rmaceutical product that : ( a ) is sold by a Third Party under a Drug Approval Application granted by a Regulatory Authority to su ch Third Party, which Third Party is not a licensee or subli censee of Reata or its Affiliates, or any of their licensees or sublicensees, and has not obtained such Royalty Pro duct from a chain of distribution including Reata, its Affiliates or any of their licensees or sublicensees, ( b ) cont ains the applicable Compound as an active pharmaceu tical ingredient ( or the same active moiety ) ; and ( c ) is approved in reliance, in whole or in part, on the p rior approval of such Royalty Product as determined by the applic able Regulatory Authority ( pursuant to 21 U.S.C. 35 5(b)(2 ), an ANDA, a separate NDA, compendia listing, other d rug approval application or otherwise, including fo reign equivalents of the foregoing )