definiens: means ( i ) the iRaBili~ ' Ie iRitia!e eliRis.1 trials HRae, the kIYestigatiaaal New D'Hg Appli •• I;.R fe, laflHeRRl ' liTHS T';'1aleRI IRasl;,'atea Sjllil Vi,;eR Vae.iRe aRa laeRtieal VaeeiRe .... itA ReaHeea Thim"rasal la IRe Paaa aJla DfHg AafRiRistralieR as set aLlt in that eeft.lA letter 8f Mareh 2g01 aRa refereaeea BB J - l > ID 11016 58 leRg as SHeA eliHi •• 1 llials .eHlemjll.lea By sHeh ' l'plieatieRA£I'ie ROt beea iRitiatea\. !, ( ii ) prohibitions for making or selling influenza vaccine imposed by Health Canada as a result of the first inspection after the Effective Date in respect of any of the Products ( other than in respect of any matter arising from the operation of the Business after the Effective Date ) as long as such prohibitions are in effect, ( iii ) any leases, licences, permits, approvals, consents and authorizations required for the conduct of the Business by [COMPANY] BioChem Inc, or [COMPANY] Biologics Inc, on the Effective Date, to the extent that [COMPANY] BioChem Inc, or [COMPANY] Biologics Inc, did not have such in place on the Effective Date, ( iv ) any regulation required to be complied with for the conduct of the Business by [COMPANY] BioChem Inc, on the Effective Date, to the extent that [COMPANY] BioChem Inc, was not complying therewith on the Effective Date, ( v ) any new conditions imposed by any Governmental Body upon the transfer, or as part of such Governmental Body 's consent to the transfer, of any licence, permit, approval, consent or authorization which is required to be transferred to IDB upon the purchase of the Business by IDB under the Asset Purchase Agreement, and ( vi ) any leases, licences, permits, approvals, consents, authorizations, regulations and other matters listed in Schedule 4,7 of the Disclosure Letter