definiens: means the aggregate of the internal and external costs ofSpark that directly relate to the Manufacture of a Batch of Drug Substance ( but, for clarity, withoutperforming any Drug Product Finishing Activities ), all as calculated in accordance withAccounting Standards, including:(a ) all fees and costs relating to the purchase of Materials, [ * * ] ; ( b ) the applicable categories and components thereof identified in Column B ofExhibit A attached hereto, which categories and components shall serve as the general basis(excluding all other columns ) for calculating for any Calendar Year, subject to ( i ) the JSC ’s discussion and input as to the specific units and allocation methodologiesto be used to calculate the costs for each such category and components thereof for a particularCalendar Year, ( ii ) the provision of supporting details on cost allocations to the Cost of DrugSubstance, and ( ii ) the Parties ’ understanding that in some Calendar Years, it is possible that acategory or any of its components thereof may include no costs ; and(c ) any other items as mutually agreed between the Parties in writing from time totime