definiens: means, with respect to a particular Product, a product sold ( i ) by a Third Party ( who isnot authorized by [COMPANY] or any of its Affiliates and who neither Arena 11 * * * Confidential TreatmentRequestedConfidential nor any of its Affiliates has authorized at [COMPANY] ’s request ) or ( ii ) by Arena, any of its Affiliates or any Third Partyauthorized by Arena or any of its Affiliates ( provided, that the foregoing shall in no way be deemed or construed tolimit Arena ’s obligations under Section 2.3(a ) ) that, in each case ( ( i ) or ( ii ) ), ( a ) contains as an active pharmaceuticalagent the same Compound or Related Compound that such Product contains as an active pharmaceutical agent, and(b ) ( 1 ) if sold in the United States, has been approved for sales introduction into commerce in the United States byreference to the Regulatory Approval for such Product in the United States pursuant to Section 505(b)(2 ) or 505(j ) ofthe FFDCA ( or the successor thereof ) or ( 2 ) if sold in a country in the Additional Territory or the New Territory, hasbeen approved for sale in such country pursuant to an equivalent regulatory law or regulation, but excluding for clarityany Products sold by [COMPANY] or any of its Affiliates or Sub - distributors during the Term