definiens: shall mean, with respect to any Country, the occurrence of any of thefollowing : any Regulatory Authority in that Country pursuing an enforcement action ( i ) againstVeracyte or its Affiliates ( to the extent that such Affiliates are offering the Test pursuant thisAgreement in such Country ) that impacts the ability to commercialize the Test or ( ii ) directlyrelated to the Test ; or any Regulatory Authority in that Country issuing a warning letter againstVeracyte or its Affiliates ( to the extent that such Affiliates are providing services to Genzymepursuant to this Agreement in such Country ) that impacts the ability to commercialize the Test or(ii ) directly related to the Test ; and 39 ( 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 average monthlyvolume of FNAs received by [COMPANY] for the Test in such Country during the six ( 6 ) monthsfollowing the date of the occurrence of the Country Regulatory Event being at least fifty percent(50 % ) less than the average monthly volume for the six ( 6 ) months prior to such date