Direct Manufacturing Cost means the costs directly attributable to manufacturing Product (i.e. those costs whose total will vary with quantity of production but which are relatively fixed with respect to a unit of production), including, but not limited to, direct labor and benefit expenses and consumable raw materials and other production materials, determined in accordance with generally accepted cost accounting standards.
Direct Manufacturing Cost of an ALL Component means the actual, direct cost per unit, for clarity excluding overhead, of manufacture of such ALL Component, as determined in accordance with GAAP and ALL’s auditable, DCAA approved rate structure.
Direct Manufacturing Cost means (a) costs directly attributable to Manufacturing, quality assurance 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, as determined in accordance with United States generally accepted cost accounting practices consistently applied, plus (b) fixed Manufacturing overhead costs allocable to the Product based on the actual percentage utilization (including start-up and shut-down time) of the capacity of the manufacturing facility, including, but not limited to, direct benefit and labor expenses for technical services and support services, depreciation, maintenance and repairs and insurance costs associated with such utilization of the manufacturing facility, as determined in accordance with United States generally accepted cost accounting practices consistently applied. In no event shall charges for (i) idle capacity or underutilized facilities or (ii) any Direct Development Costs be included in Direct Manufacturing Costs.
Examples of Direct Manufacturing Cost in a sentence
The remaining 50% of the Direct Manufacturing Cost of such product shall be due and payable at the time such Product is delivered to DISTRIBUTOR.
DISTRIBUTOR shall remit payment, at the time of placing an order, in an amount equal to 50% of the Direct Manufacturing Cost of Product ordered.
Such process shall be initially conducted six (6) months following the First Commercial Sale of a Consumable Licensed Product or Instrument Licensed Product incorporating an ALL Component to determine the initial Direct Manufacturing Cost Cap, and thereafter no more than once per calendar year promptly following each anniversary of the execution of the Supply Agreement.
For clarity, Inflation Adjustment cannot be used to reduce the Direct Manufacturing Cost or any element thereof.
NOVARTIS may, upon written request and at its expense (except as provided for in Clause 12.2), cause an internationally-recognized independent accounting firm selected by it (except one to whom GW has a reasonable objection), (the “Audit Team”) to audit during ordinary business hours, at such place or places as they are customarily kept, the books and records of GW and its Affiliates for a given Contract Year and the correctness of the Direct Manufacturing Cost in such year.
More Definitions of Direct Manufacturing Cost
Direct Manufacturing Cost shall include the sum of manufacturing fees; raw materials; direct labor; quality, release and in-process control costs; charges for reasonable spoilage, scrap or rework costs; freight and duty, and factory overhead costs that can be directly attributed to such Compound, including but not limited to equipment maintenance and repair, supplies, ongoing stability program costs, other plant services, indirect labor and depreciation on direct capital assets.
Direct Manufacturing Cost means any direct costs, expenses or expenditures incurred by the Company Entities and the Purchaser Entities in the manufacture of Wireless Sensing Products, including, without limitation, materials, subcontract assembly testing, shipping, quality assurance and configuration. To the extent the manufacture of Wireless Sensing Products is not outsourced to a third party, Direct Manufacturing Cost shall also include any overhead charges reasonably allocated to labor, plant and equipment costs directly associated with the manufacture, testing, shipping, quality control and configuration of Wireless Sensing Products.
Direct Manufacturing Cost means the direct out-ofpocket costs actually incurred by Sucampo or its Third Party contract manufacturer for the manufacturing, Labeling and Packaging of the Product, including API, excipients, Packaging and Labeling components, internal direct labor, and quality control and assurance testing that are a necessary part of manufacturing.
Direct Manufacturing Cost of MacroPore with respect to a Product for a particular period means MacroPore's per unit average direct material, direct labor and variable manufacturing overhead costs for such Product during such period.
Direct Manufacturing Cost means all costs of […***…] incurred with respect to […***…], but shall not include […***…]. Absent the requirements of applicable law, the FDA or any Regulatory Agency or the occurrence of any circumstances covered by the language of […***…].
Direct Manufacturing Cost means all costs of [***] incurred with respect to the manufacture hereunder of any particular volume of Naltrexone Hydrochloride, but shall not include any [***]. Absent the requirements of applicable law, the FDA or any Regulatory Agency or the occurrence of any circumstances covered by the language of this Section 2.2 above, MALLINCKRODT shall not change the Specifications unless OREXIGEN has agreed in writing to such change in advance [***], and any increase or decrease in the Direct Manufacturing Cost to MALLINCKRODT associated with any such change proposed by MALLINCKRODT shall [***].
Direct Manufacturing Cost means (a) costs directly attributable to manufacturing, quality assurance and quality control related to a unit of Product (i.e., those costs which vary with production), including, but not limited to, direct labor and benefit expenses for manufacturing, and consumable bulk and other product materials, as determined in accordance with United States generally accepted cost accounting practices consistently applied, plus (b) fixed manufacturing overhead costs allocable to the product based on the actual percentage utilization (including start-up and shut-down time) of the capacity of the manufacturing facility, including, but not limited to, direct benefit and labor expenses for technical services and support services, depreciation, maintenance and repairs and insurance costs associated with such utilization of the manufacturing facility, as determined in accordance with Untied States generally accepted costs accounting practices consistently applied. In no event shall charges for idle capacity or under utilized facilities be included in Direct Manufacturing Cost.