definiens: shall mean, with respect to any Product, the fully - burdened cost to a party ( expressed on a perunit basis ) of manufacturing or having manufactured such Product, together with the packaging thereof, including the cost ofmaterials, direct labor, quality control, warranty parts and labor ( only as to Blood Screening Instruments manufactured by Gen - Probe ), and overhead ( but excluding royalties paid or payable to Third Parties ), all as determined in accordance with suchparty ’s standard accounting practices for other products manufactured . For the avoidance of doubt, Manufacturing Cost shallinclude the cost of dry ice for frozen or refrigerated products . An estimate of Manufacturing Cost for each Product shall beestablished by the manufacturing party and provided to the other party on an annual basis . Within seventy - five ( 75 ) days ofthe close of each calendar year the manufacturing party will provide the other party with a detailed report of the aggregate ofall actual Manufacturing Costs incurred for Products, on a product - by - product basis . In the event the aggregate of all actualManufacturing Costs for a Product manufactured in the calendar year exceeds, or is less than, the estimate set and used todetermine the Applicable Purchase Price paid for such Products sold during such calendar year, the parties will theaggregate Applicable Purchase Price paid for such Products accordingly