definiens: means the aggregate of:(a ) the Cost of Drug Substance ; and(b ) the internal and external costs of Spark and its Affiliates to perform all fill, finishand packaging processes relating to the Batch of Drug Substance to produce the Resulting Vialsof Drug Product ( such fill, finish and packaging processes collectively, the ), all as calculated in accordance with Accounting Standards and which aredirectly related to the performance of Drug Product Finishing Activities, including:(i ) all fees and costs directly relating to the purchase of Materials, [ * * ] ; ( ii ) the applicable categories and components thereof identified in ColumnB of Exhibit A attached hereto ( excluding all other columns ), which categories andcomponents shall serve as the general basis for calculating for anyCalendar Year, subject to ( A ) the JSC ’s discussion and input as to the specific units andallocation methodologies to be used to calculate the costs for each such category andcomponents thereof for a particular Calendar Year, ( B ) the provision of supporting detailson cost allocations to the Cost of Drug Product, and ( C ) the Parties ’ understanding that insome Calendar Years, it is possible that a category or any of its components thereof mayinclude no costs ; and(iii ) any other items as mutually agreed between the Parties in writing fromtime to time