definiens: or ( as such terms are defined in 21 C.F.R. 7.3 or other similar national, state or local law or regulation ) ( hereinafter refelTed to as a ) of a Product or any lot(s ) thereof Tracon shall be responsible for detennining whether and upon what tenns and conditions any Product shall be Recalled or otherwise withdrawn from sale to Third Parties within any country in the Territory . Tracon shall be responsible for discussions with Competent Authorities within the applicable country regarding all aspects of the Recall decision and the execution thereof If at any time ( i ) any Competent Authority in the TelTitory issues a request, directive or order for a Recall of a Product in the Tenitory or ( 1i ) a court of competent jurisdiction orders a Recall of any Product in the Territory, then Tracon shall be responsible for implementing such Recall . The expenses arising from such Recall shall be the responsibility of Tracon