definiens: means, with respect to a particular Product, a product sold ( i ) by a Third Party ( who is notauthorized by [COMPANY] or any of its Affiliates and who neither Arena nor any of its Affiliates has authorized at [COMPANY] ’s request ) or(ii ) by Arena, any of its Affiliates or any Third Party authorized by Arena or any of its Affiliates ( provided that the foregoingshall in no way be deemed or construed to limit Arena ’s obligations under Section 2.3(a ) ) that, in each case ( ( i ) or ( ii)),(a ) contains as an active pharmaceutical agent the same Compound or Related Compound that such Product contains as anactive pharmaceutical agent, and ( b ) ( 1 ) if sold in the United States, has been approved for sales introduction into commerce inthe United States by reference to the Regulatory Approval for such Product in the United States pursuant to Section 505(b)(2)or 505(j ) of the FFDCA ( or the successor thereof ) or ( 2 ) if sold in a country in the Additional Territory, has been approved forsale in such country pursuant to an equivalent regulatory law or regulation, but excluding for clarity any Products sold byEisai or any of its Affiliates or Sub - distributors during the Term