definiens: shall mean, with respect to any Country, the occurrence of any ofthe following : ( 1 ) any Regulatory Authority in that Country pursuing an enforcement action(i ) against [COMPANY] or its Affiliates ( to the extent that such Affiliates are offering the Testpursuant this Agreement in such Country ) that impacts the ability to commercialize the Testor ( ii ) directly related to the Test ; or ( 2 ) any Regulatory Authority in that Country issuing awarning letter ( i ) against [COMPANY] or its Affiliates ( to the extent that such Affiliates areproviding services to 41 [COMPANY] pursuant to this Agreement in such Country ) that impacts the ability tocommercialize the Test or ( ii ) directly related to the Test ; andrd ( b ) shall mean a Country Regulatory Event that both(a ) materially and adversely affects the ability of the parties to commercialize the Test in theCountry where the Country Regulatory Event occurs, and ( b ) leads to the actual averagemonthly volume of FNAs received by [COMPANY] for the Test in such Country during the six(6 ) months following the date of the occurrence of the Country Regulatory Event being atleast fifty percent ( 50 % ) less than the average monthly volume for the six ( 6 ) months prior tosuch date