definiens: means ( a ) costs directly attributable to Manufacturing, qualityassurance and quality control related to a unit of Product on a per tablet basis, including, but not limited to, direct labor and beneﬁt expenses for Manufacturing, and consumable bulk and other product materials, asdetermined in accordance with United States generally accepted cost accounting practices consistentlyapplied, plus ( b ) ﬁxed Manufacturing overhead costs allocable to the Product based on the actual percentageutilization ( including start - up-2- and shut - down time ) of the capacity of the manufacturing facility, including, but not limited to, direct beneﬁtand labor expenses for technical services and support services, depreciation, maintenance and repairs andinsurance costs associated with such utilization of the manufacturing facility, as determined in accordancewith United States generally accepted cost accounting practices consistently applied . In no event shall chargesfor ( i ) idle capacity or underutilized facilities or ( ii ) any Direct Development Costs be included in DirectManufacturing Costs