Manufacturing Costs definition
Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.
Manufacturing Costs means [***].
Manufacturing Costs means, with respect to Existing Products or Improved Products, as the case may be, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs of a Party or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (1) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (2) manufacturing scale-up; (3) in-process testing, stability testing and release testing; (4) quality assurance/quality control development; (5) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (6) packaging development and final packaging and labeling; (7) shipping configurations and shipping studies; and (8) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (a) to the extent that any such Existing Product or Improved Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by such Party or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by such Party or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (b) to the extent that any such Existing Product or Improved Product is manufactured by such Party or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP.
Examples of Manufacturing Costs in a sentence
All costs of manufacturing shall be either Fixed Manufacturing Costs (as defined below) or Variable Manufacturing Costs (as defined below).
The Manufacturing Costs for such supply shall be reimbursed by Alimera in accordance with Section 3.1.2 and shall be Direct Development Costs (except that the Manufacturing Costs associated with the wet AMD trial, the vein occlusion trial and the additional marketing support trial shall be deemed Direct Commercialization Costs to the extent such trials are Non-NDA Trials).
Notwithstanding the terms of Section 3.6(b), all Manufacturing Costs necessary to produce Product in sufficient volumes and quality necessary for conduct of the first Phase I Study of the first Product in the Field will be borne [*] percent ([*]%) by Alexion and [*] percent ([*]%) by XOMA.
Except as set forth in Section 6.10 (Manufacturing Costs) and the foregoing sentence, the non-terminating Party shall have no claim against the terminating Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement.
The Parties shall have quarterly meetings to discuss the Manufacturing Costs and make any adjustments, as agreed upon by the Parties, to such Manufacturing Costs.
More Definitions of Manufacturing Costs
Manufacturing Costs means, with respect to ZIOPHARM Products, the FTE costs (under a reasonable accounting mechanism to be agreed upon by the Parties and out-of-pocket costs of a Party or any of its Affiliates incurred in manufacturing such ZIOPHARM Products, including costs and expenses incurred in connection with (1) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (2) manufacturing scale-up; (3) in-process testing, stability testing and release testing; (4) quality assurance/quality control development; (5) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (6) packaging development and final packaging and labeling; (7) shipping configurations and shipping studies; and (8) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include:
(a) to the extent that any such ZIOPHARM Product is Manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by such Party or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by such Party or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and
(b) to the extent that any such ZIOPHARM Product is manufactured by such Party or any of its Affiliates, direct material and direct labor costs attributable to such ZIOPHARM Product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP.
Manufacturing Costs means (i) all direct and indirect costs related to the manufacture by Bayer or its Affiliates of Products, including costs for personnel, materials, quality control, regulatory compliance, administrative expenses, subcontractors, fixed and variable manufacturing overhead costs and business unit or division costs reasonably allocable to the manufacture of Products, as determined and allocated in accordance with generally accepted accounting principles, consistently applied, excluding costs for excess manufacturing capacity not reasonably related to projected demand for Products, or (ii) with respect to Products purchased from a third party vendor, reasonable amounts actually paid to the vendor for such Products in arm's length transactions.
Manufacturing Costs means [*****]:
Manufacturing Costs means costs for manufacturing a Compound or Product provided by one Party to the other Party which is (a) manufactured and supplied by a Third Party or (b) manufactured directly by the supplying Party or its Affiliate; in each case to the extent such costs are reasonably allocable to the Compound or Product supplied, and calculated in accordance with the supplying Party’s internal accounting policies and principles, so long as such Party’s calculations are in accordance with GAAP. For costs under clause (a) above, Manufacturing Costs means: (i) the amount paid by a Party or its Affiliates to such a Third Party in connection with the manufacture and supply of such Compound or Product (including expenses related to storage, QA and QC (including testing), shipping, handling, insurance, customs duties or excise taxes), plus (ii) a Party’s FTE costs (measured at the applicable FTE Rate) and other direct out-of-pocket costs recorded as an expense in accordance with its customary accounting practices (so long as the same are consistent with GAAP) in connection with such manufacture and supply, including supply chain management, payments owed to Third Parties on account of Third Party intellectual property licensed to a Party that is used in the course of such manufacture and supply, management of agreements with Third Party manufacturers for such Compound or Product and expenses related to storage, QA and QC (including testing), shipping, handling, insurance, customs duties or excise taxes. For costs under clause (b) above, Manufacturing Costs means the standard cost of goods sold. For purposes of this definition, “standard costs of goods sold” include materials (such as active ingredients, intermediates, semi-finished materials, excipients, primary and secondary packaging), and conversion costs (such as direct labor, equipment costs and quality testing), and an allocation of general site and manufacturing support costs (including an appropriate allocation of utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities and including capital improvements in the form of depreciation, other equipment costs (where such costs are expensed by a Party in accordance with its customary practices)), customs duties or excise taxes, and sales taxes incurred on purchased Product; provided, however, that no allocation shall be made for unused plant capacity. All components of Manufacturing Costs shall be allocated on a ba...
Manufacturing Costs has the meaning set forth in Exhibit B.
Manufacturing Costs means [***]
Manufacturing Costs means the manufacturing costs of goods determined in accordance with regulation 25;