definiens: shall mean [ the United Kingdomor the Netherlandsl . If subsequently the IND or such other application is successfully filed byCVT under this Agreement, then FHI shall within two ( 2 ) business days thereafter either ( a)repay CVT by wire transfer the full amount of the IND Payment or ( b ) terminate this Agreementunder Section 12.2 ( including the notice provision therein ), in which event FHI shall be entitledto keep the IND Payment previously refunded by CVT . Under this Section 5.3, a IND or such other application shall mean that ( i ) if an IND was filed with the FDA, aperiod of thirty ( 30 ) days has passed from CVT 's receipt of a notice from the FDA that the FDAhas received such IND, and during such thirty ( 30 ) day period the FDA has not put a clinicalhold on such IND ( or did so but CVT has subsequently received a notice from the FDAconfirming that the clinical hold has been removed ), or ( ii ) if an application was filed outside theU.S. in one of the Permitted Countries to permit human clinical testing, such application hasbeen accepted by the appropriate Regulatory Authority, or CVT is otherwise able to commencehuman clinical testing thereunder as provided under applicable laws and regulations . If withinthiny ( 30 ) days after the expiration of such twelve ( 12 ) month period, FHI in good faith believest7CONFIDENTIAL TREATMENT, FOR TEXT IN BRACKETS, REQUESTED BY CV THERAPEUTICS, INC.that CVT is in material breach of its obligations to file the IND or such other application underthis Section 5.3, either Party may initiate arbitration pursuant to Section 14.2 below