Fully Burdened Manufacturing Cost

Fully Burdened Manufacturing Cost. Shall mean Manufacturer's total cost to manufacture including materials, direct labor, indirect labor and materials, manufacturing overhead and yield losses, costs associated with Product testing and required retains, as measured and adjusted on a semi-annual basis. Manufacturing overhead shall include expenses directly related to improving or enhancing performance specifications, quality, reliability, lifetime and/or usability of manufactured Products and expenses associated with the... continuous improvements of the manufacturing process. View More

Fully Burdened Manufacturing Cost. Shall mean the cumulative cost of a Product and shall include the direct and indirect cost of procuring and/or producing the Product in accordance with generally accepted accounting principles applied on a consistent basis by Biotronik. Direct costs shall include direct labor (including fringe benefits), direct materials (including taxes and duties) and third-party contract and licensing costs required to manufacture the Product, as well as all costs related to the approval process. Indirect... costs (to be allocated to the production effort) shall include, but not be limited to, items treated as ‘manufacturing overhead,' such as indirect labor and materials, reasonable fringe benefits, occupancy costs, depreciation of property, plant and equipment used in the manufacturing process and other costs reasonably allocable to the manufacturing process, to the extent that the foregoing are directly related to the production effort. For purposes of this Agreement, unless otherwise stated in the applicable Statement of Work, indirect costs shall be deemed to equal 40% of direct costs. Included in the cost of Product shall be manufacturing variances, including inventory reserves and non-conforming production runs. The Fully Burdened Manufacturing Costs for each Product shall be as set forth in the applicable Statement of Work. View More

Fully Burdened Manufacturing Cost. Halozyme's fully burdened cost to manufacture (or acquire from its third party manufacturer) and supply API, including without limitation costs for testing, packaging, shipping and an allocable share of corporate and overhead costs

Fully Burdened Manufacturing Cost. The actual cost of Manufacture by Aquila of the Adjuvant under a Manufacturing Process in compliance with cGMPs, if applicable, which actual cost shall be comprised of the cost of goods produced as determined in accordance with United States generally accepted accounting principles, and shall include direct labor, direct material and allocable manufacturing overhead but shall exclude selling, general and administrative, research and development and interest expenses. Fully-Burdened... Manufacturing Cost shall include, to the extent applicable, the cost to Aquila of having some portion or all of the Manufacturing Process performed by a third party View More

Fully Burdened Manufacturing Cost. Means the consolidated fully burdened cost incurred by AMAG in the Manufacture of Product, calculated in accordance with GAAP and with AMAG's accounting practices applied on a normal and customary basis by AMAG consistent with its practices, which shall equal [***]