Manufacturing Costs definition
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 the costs of Processing that generate Manufacturing Proceeds received by Grantor.
Manufacturing Costs means [***].
Examples of Manufacturing Costs in a sentence
For Manufacturing Costs that constitute shared Development Costs under Section 6.2, the Party initially incurring such costs under an agreement with a Third-Party CMO in accordance with the applicable Development Plan (subject to Section 4.4) may elect to have the other Party reimburse the incurring Party’s applicable share of such Development Costs using the process set forth in this Section 7.1(c) in lieu of utilizing the quarterly invoicing process set forth in Section 7.1(a).
All Manufacturing Costs incurred during the Term in regard to a Collaboration Product in the Field will be included in either Development Costs (and therefore allocated between the Parties in accordance with Section 4.3 (Development Costs)) or Commercialization Costs (and therefore allocated between the Parties via their inclusion in Proceeds in accordance with Section 7.3 (Proceeds)), as applicable.
More Definitions of Manufacturing Costs
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 has the meaning set forth in Exhibit J.
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 means [***]
Manufacturing Costs means, with respect to (a) the Gorilla IL-12 Products in the HPV Field, or (b) the Gorilla IL-12 Products in the Field, but outside of the HPV Field, the costs of manufacturing such Gorilla IL-12 Product which Gorilla IL-12 Product is either: (x) supplied to a Party by a Third Party; or (y) manufactured directly by a Party or its Affiliate, in each case to the extent such costs are directly allocable to the Development or Commercialization of such Gorilla IL-12 Product in the Territory, as further described below and in accordance with generally accepted accounting principles in the U.S. (“US GAAP”). Manufacturing Costs shall be included in Commercialization Costs on a “cost of sales” basis as such Gorilla IL-12 Product is sold, or Development Costs on a usage basis as clinical supplies are used, as the case may be, in each case via standard costs and reconciliation for variances to standard cost and inventory write-offs. In the event that a Party performs any of its manufacturing and supply obligations through one or more Affiliates, any inter-company amounts or fees paid for any such services for Gorilla IL-12 Product or any intermediate used therein by such Party shall not be included in calculating Manufacturing Costs and only those costs directly incurred by such Affiliate shall be so included.
(i) For costs in subsection (x), Manufacturing Costs means: (1) the amount paid to such a Third Party (excluding any Third Party Payments); plus (2) the relevant manufacturing Party’s reasonable direct and identifiable internal costs and out-of-pocket costs, incurred or accrued (including any prepayments) by the manufacturing Party in connection with inventory write-offs, variances, manufacturing process improvements, storage, freight, manufacturing scale-up, manufacturing site qualification, materials, quality assurance and quality control (including testing), supply chain management, capital equipment, similar activities comprising the manufacturing Party’s oversight of the manufacturing process of the Third Party, and any value-added tax or similar tax due for amounts paid to such Third Party, but excluding costs otherwise included within Development Costs.
(ii) For costs in subsection (y), Manufacturing Costs means the “standard cost” per unit, including variances to standard costs and inventory write-offs. This
Manufacturing Costs means the manufacturing costs of goods determined in accordance with regulation 25;