definiens: means losses of Canisters equal to or greater tha forty percent, ( 40 % ~ calculated over the period commencing on the Effective Date and ending on t e ay 3 I - PRl1242754.!O immediately prior to a Canister Shortage, such calculation to be made solely by taking into account the following factors : ( i ) normal process loss, ( ii ) loss due to human error of A ventis personnel or its subcontractor, ( iii ) loss due to Product rejected for failure to meet Specifications, ( iv ) deemed losses pursuant to Section 6.1 in the event, and solely to the extent, that a recall results from any cause or event as a result of the defective manufacture, testing, storage or handling of the Product by [COMPANY] or its Affiliates or its subcontactor and ( v ) any loss or use of Canisters for validation or other purposes pursuant to any Discretionary Manufacturing Change requested by A ventis, even if such Discretionary Manufacturing Change is consented to by Purchaser