definiens: shall mean the occurrence of any of the following : any RegulatoryAuthority in the Territory pursuing an enforcement action ( i ) against [COMPANY] or its Affiliates(to the extent that such Affiliates are offering the Test pursuant this Agreement in theTerritory ) that impacts the ability to commercialize the Test or ( ii ) directly related to the Test;or any Regulatory Authority in the Territory issuing a warning letter against ( i ) [COMPANY] or itsAffiliates ( to the extent that such Affiliates are providing services to [COMPANY] pursuant tothis Agreement in the Territory ) that impacts the ability to commercialize the Test or(ii ) directly related to the Test ; and ( b ) shall mean a Regulatory Event that both ( a ) materially andadversely affects the ability of the parties to commercialize the Test in the Territory wherethe Regulatory Event occurs, and ( b ) leads to the actual average monthly volume of FNAsreceived by [COMPANY] for the Test in the Territory during the six ( 6 ) months following the dateof the occurrence of the Regulatory Event being at least fifty percent ( 50 % ) less than theaverage monthly volume for the six ( 6 ) months prior to such date