definiens: . For purposes of Sections 5.4(a ) or 5.4(b ), shall mean ( i ) the occurrence orexistence of a condition or event relating to the manufacture of Product which constitutes a [ * ], ( ii ) [COMPANY] ’s or Alexza’sreceipt of a deficiency or warning letter related to the manufacture of the Product or any components of the Product listed inthe NDA or MAA from any Regulatory Authority, ( iii ) a [ * ] of the Product, ( iv ) a [ * ] of any Regulatory Requirements in themanufacture of the Product, ( v ) follow up to a prior audit where substantive violations of the Quality Agreement or therelevant Regulatory Requirements were identified and not rectified to the reasonable satisfaction of [COMPANY], or ( vi ) the [ * ] ofany [ * ] based on the manufacture of the Product or any components of the Product listed in the NDA or MAA by Alexza orany Supplier, which, in any case, could reasonably be expected to materially affect the Product, any components of theProduct listed in the NDA or MAA or the ability of Alexza or [COMPANY] to exercise its rights or perform its obligations under thisAgreement