definiens: means ( A ) failure of the JPT ( orJSC, as applicable ) to agree upon or determine the applicable specifications, protocols to be provided to such manufacturer, the quantities to be supplied or delivery schedule in sufficient advance of such delivery schedule to reasonably permit suchsupply or ( B ) any change requested by [COMPANY], required or approved by and applicable Committee, or required by applicableRegulatory Authority or applicable Law in applicable specifications, protocols, quantities or delivery schedule, ( C ) delays inapproval of the applicable Approved [COMPANY] CMO under Section 6.1.1(a ), or ( D ) [COMPANY] ’ disapproval of, or delay inapproving, ( x ) a proposal by [COMPANY] to engage an Approved [COMPANY] CMO, ( y ) a proposal to enter into ( or make a materialmodification to ) a supply agreement with an Approved [COMPANY] CMO, or ( z ) a proposal by [COMPANY] to include in theBudget ( or [COMPANY] ’ disapproval or delay in approving a Budget proposed by [COMPANY] containing ) appropriate and timelypayments to an Approved [COMPANY] CMO for such Product ( provided that the foregoing items in ( D ) shall constitute a only if and to the extent that ( I ) in connection with the proposals described in ( x ), ( y ) and ( z ) above, Maxygenprovided notice to the JSC ( either within the Supplies Requirement Plan or otherwise ) as to when a delay or failure in theapplicable approval would likely lead to delays or an inability to supply Product as required above, and ( II ) the deliveryschedule in the Supplies Requirement Plan is not adjusted to accommodate the applicable delay in approval, or disapproval, by [COMPANY] )