definiens: shall mean a generic version of a product containing an active component ( including the Licensed Compound)of a [COMPANY] Combination Product or Licensed Product that is approved for marketing by a Third Party in the Field either : ( i ) pursuant toSection 505(j ) of the FD&C Act ( 21 U.S.C. 355(j ) ), 505(b)(2 ) of the FD&C Act, ( 21 U.S.C. 355(b)(2 ) ), or a foreign equivalent of either, byreference to a Regulatory Approval of such product, or ( ii ) pursuant to any other law or regulation where such approval is based on ademonstration of bio - equivalence or biosimilarity to such product . Under no circumstances shall a product be considered a Generic Product ifGilead or its Affiliates or its Sublicensees ( a ) transferred a Regulatory Approval of such product to such Third Party, ( b ) transferred anapplication for Regulatory Approval of such product to such Third Party, or ( c ) provided a Right of Reference to such Third Party in order toenable such Third Party to commercialize such product, except for a right of reference limited to qualifying the generic version for agovernment and/or nonprofit entity ’s program for providing medicines at no or low cost to countries in the Access Territory