definiens: shall mean a product owned or controlled by a Third Party that ( a ) is in oral dosageform, ( b ) contains as its only APIs per single daily dose, TDF equivalent to 300 mg Tenofovir Disoproxil Fumarate and FTC equivalent to200 mg Emtricitabine, and ( c ) is approved ( or sought to be approved ) in the Field either : ( i ) pursuant to14 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.CONFIDENTIAL TREATMENT REQUESTEDUNDER 17 C.F.R. § § 200.80(b)(4 ) AND 240.24B-2Section 505(j ) of the Act ( 21 U.S.C. 355(j ) ) or a foreign equivalent thereof by reference to a Marketing Approval of Truvada or any FTCProduct or TDF Product, or ( ii ) pursuant to any other law or regulation where such approval is based on a demonstration of bio - equivalence or biosimilarity to any of the foregoing products