definiens: means the first day of the first full quarter to occur afterthe Effective Date.1.10 means for Batches of Drug Substance that Spark CommencesManufacturing in the Calendar Years [ * * ], a fee not exceeding [ * * ] US Dollars ( US$ [ * * ] ) perannum, and for Batches of Drug Substance that Spark Commences Manufacturing in each of thenext [ * * ] Calendar Years ( the period from [ * * ], the ), a fee equalto [ * * ] percent ( [ * * ] % ) of the Fixed Manufacturing Cost ( regardless of whether [COMPANY] orders anyDrug Substance or Resulting Vials of Drug Product in those [ * * ] Calendar Years ), provided that:(a ) if, during the Term, the Parties agree in writing to allocate additional Batchesof Drug Substance to [COMPANY] pursuant to Section 3.2(b ), then:(i ) if [COMPANY] orders [ * * ] Batches of Drug Substance, or the Resulting Vialsof Drug Product corresponding to [ * * ] Batches of Drug Substance, and the Calendar Yearthat Spark Commences Manufacturing of such Batches of Drug Substance is any of [ * * ], the Fixed Facility Fee shall not exceed US$ [ * * ] for such Calendar Year ; and(ii ) if [COMPANY] orders [ * * ] Batches of Drug Substance, or the Resulting Vialsof Drug Product corresponding to [ * * ] Batches of Drug Substance, and is delivered thesame in any of the next [ * * ] Calendar Years, the Fixed Facility Fee shall be [ * * ] percent([**]% ) of Spark ’s actual Fixed Manufacturing Cost for the Calendar Year in which SparkCommences Manufacturing of such Batches of Drug Substance ; and(iii ) if [COMPANY] orders [ * * ] Batches of Drug Substance, or the Resulting Vialsof Drug Product corresponding to [ * * ] Batches of Drug Substance, and is the CalendarYear that Spark Commences Manufacturing of such Batches of Drug Substance is any of [ * * ], the Fixed Facility Fee shall not exceed US$ [ * * ] ; and(iv ) if [COMPANY] orders [ * * ] Batches of Drug Substance, or the Resulting Vialsof Drug Product corresponding to [ * * ] Batches of Drug Substance, and is delivered thesame in any of the next [ * * ] Calendar Years, the Fixed Facility Fee shall be [ * * ] percent([**]% ) of Spark ’s actual Fixed Manufacturing Cost for the Calendar Year in which SparkCommences Manufacturing of such Batches of Drug Substance ; ( b ) if, during the Term, the capacity of the Spark Facility increases beyond [ * * ] Batches of Drug Substance or the Resulting Vials of Drug Product corresponding to such numberof Batches of Drug Substance per Calendar Year, Spark shall adjust the [ * * ], unless the Partiesagree otherwise in the Capacity Plan;(c ) if, during the Term, the Manufacture of the Drug Substance is transferred toNovartis or its designated Affiliate or a Third Party contract manufacturer, the Fixed Facility Feeshall be [ * * ] from the date of the last delivery to Novartis;(d ) if in any [ * * ] during the Term, [COMPANY] fails to place at least [ * * ] PurchaseOrders requiring Manufacture of a Batch of Drug Substance in that [ * * ], then the Fixed FacilityFee shall [ * * ], provided that:(i ) without prejudice to any other rights or remedies [COMPANY] may haveunder this Agreement, the Fixed Facility Fee for such [ * * ] shall be reduced by [ * * ] percent([**]% ) if [COMPANY] orders [ * * ] of Drug Substance and reduced by [ * * ] percent ( [ * * ] % ) ifNovartis orders [ * * ] of Drug Substance, where [COMPANY] ( acting reasonably ) withholds oneor more Purchase Orders or delays the proposed delivery date for such PurchaseOrder(s ), as a result of ( A ) the occurrence of a Supply Failure event, or ( B ) the Parties(acting reasonably ) agreeing that there is a reasonable likelihood that the Batches of DrugSubstance or Resulting Vials of Drug Product will not conform with the Product Warranty(with any dispute as to the likelihood of conformity to be escalated to the JSC);(ii ) without prejudice to any other rights or remedies [COMPANY] may haveunder this Agreement, the Fixed Facility Fee for a [ * * ] shall be reduced by [ * * ] percent([**]% ) if [COMPANY] orders [ * * ] of Drug Substance and reduced by [ * * ] percent ( [ * * ] % ) ifNovartis orders [ * * ] of Drug Substance, where [COMPANY] ( acting reasonably ) withholds oneor more Purchase Orders or delays the proposed delivery date for such Purchase Ordersas a result of a failure or delay by Spark in obtaining EU Regulatory Approval, except thatif Spark subsequently obtains EU Regulatory Approval and the Products Manufacturedpursuant to Sections 3.1 and 3.3 comply with the Product Warranty, then the Fixed FacilityFee shall not be so reduced and [COMPANY] shall pay to Spark the remaining portion of theFixed Facility Fee that it is has not yet paid for such [ * * ] to Spark ; and(iii ) Spark shall reduce the Fixed Facility Fee by [ * * ] percent ( [ * * ] % ) if it uses [ * * ] the vacant manufacturing slots for itself or Third Parties and by [ * * ] percent ( [ * * ] % ) if ituses [ * * ] the vacant manufacturing slots for itself or Third Parties ( with any such use to beagreed with [COMPANY] in writing in advance )