Manufacturing Overhead definition

Manufacturing Overhead consists of a [***] associated with the manufacture of quantities of Product, for supply to Unity[***] (A) [***], (B) [***], (C) [***], (D) [***], (E) [***], (F) [***], and (G) [***].
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Manufacturing Overhead shall include all operating expenses incurred by and in support of the particular manufacturing cost centers, purchasing department and quality assurance operations, with respect to a Product, including indirect labor, related payroll taxes, employee benefits, depreciation, taxes, insurance, rent, repairs and maintenance, supplies, utilities, and factory administrative expenses. The allocable portion of the operating expenses shall be determined by taking the total output of a Product during the applicable period divided by Interpharm's total solid oral dosage manufactured products and multiplying the result by the total amount of solid oral dosage products manufacturing overhead for the applicable period. Manufacturing Overhead shall exclude selling, general and administrative, research and development, and, to the extent not included by Interpharm in cost of goods sold, interest expenses and all debt service payments of Interpharm (it being understood that only interest expenses and debt service payments which are related to manufacturing may be included in Manufacturing Overhead).
Sample 1
Manufacturing Overhead means a reasonable allocation of other Manufacturing expenses associated with the Manufacture of quantities of such Finished Product, including (i) Faes personnel supporting the direct Manufacturing of such Finished Product, including labor and materials for quality control, quality assurance, raw material acquisition and acceptance, document control, calibration/validation of equipment used in the Manufacture of such Finished Product and other similar expenses, (ii) depreciation of or rent/lease expenses for property, plant or equipment used in the Manufacture of such Finished Product, (iii) direct plan management (e.g., supervisors and purchasing), (iv) plant services (e.g., engineering and production planning) associated with the Manufacture of such Finished Product, (v) plant maintenance, (vi) costs of plant fire insurance coverage, and (vii) other direct Manufacturing costs associated with the Manufacture of such Finished Product, in each case to the extent incurred by Faes in connection with the Manufacture of such Finished Product and reasonably allocable to the Manufacture of such Finished Product. For purposes of this Agreement, Cost of Goods Sold shall be calculated in accordance with IFRS and shall be consistent from year-to-year during the Manufacturing Term. The methodology to be used in making the allocations of any costs included in Cost of Goods Sold shall upon Marathon’s request be reviewed by the Parties. As of the Effective Date, the Cost of Goods Sold with respect to a Unit manufactured and commercialized by Faes without complying with applicable U.S. FDA standards is €[**] per Unit. This Cost of Goods Sold may vary substantially if new investments or new procedures have to be implemented in the production process in order to comply with the applicable U.S. FDA standards or in case of modifications of certain specifications mutually agreed by the Parties. ActiveUS 164142681
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Examples of Manufacturing Overhead in a sentence

  • However, there is no certainty that we will be able to realize any gains from efficiencies.For 2021 and 2022, our costs of goods sold included as part of Manufacturing Overhead a 1% royalty paid to Build IP, a company controlled by our founder and CEO, Paolo Tiramani, under the terms of our exclusive license agreement to utilize the patented technology necessary to produce and deliver our Boxes.

  • Additional Bluebird IP Section 10.7(a) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F [***] [***] Bluebird Indemnitees Section 11.6(a) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Term Section 12.1 Celgene Indemnitees Section 11.6(b) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • EXECUTION COPY SCHEDULE 1.48 CALCULATION OF MANUFACTURING COSTS Manufacturing Cost with respect to a Party's or its Affiliates' cost to manufacture and/or Label the Product in finished form shall be calculated as the sum of [Actual Cost of Raw Materials] + [Actual Direct Labor Costs] + [Manufacturing Overhead Costs], where: ACTUAL COST OF RAW MATERIALS.

  • AB shall send AMBI a monthly invoice as of the first day of each calendar month setting forth the Monthly Manufacturing Overhead Fee for such month.

  • Manufacturing Overhead The cost of required manufacturing support services and supplies.

  • The price for Products shall be composed of Monthly Manufacturing Overhead Fee and price per gram of Product sold, as set forth on Exhibit B.

  • For purposes of this (S)2(c), the following terms shall have the meanings set forth below: "Fixed Manufacturing Overhead and Selling, General and Administrative Costs" ("FMO;SGA") for each period shall mean all costs other than Cost of Sales.


More Definitions of Manufacturing Overhead

Manufacturing Overhead attributable to such Product (in bulk or finished form) shall mean [***].”
Sample 1
Manufacturing Overhead means the following indirect costs, (a) all of which shall be determined in accordance with allocation principles established by mutual agreement of the Parties (b) shall be in accordance with generally accepted accounting principles and consistently applied, (c) shall be allocated to products based on methodologies consistently applied in the cost accounting system mutually agreed upon by the finance representatives from the Parties: (i) Manufacturing facility overhead including depreciation of capital, indirect supplies, indirect labor (such as product quality assurance and maintenance) utilities, insurance, property taxes and other facility costs, and all other indirect costs of the manufacturing facility including utilities, manufacturing. "Marketing Expenses" means the actual costs and expenses incurred by a Party or for its account specifically attributable to the marketing of a Licensed Product, to the extent generally consistent with the then-current Commercialization Plan and Commercialization Budget, including but not limited to [ * ] and other similar activities related to the Licensed Products and approved by the Steering Committee or its designee. Such costs will include [ * ]. "Marketing Expenses" shall also include activities related to [ * ]. "Marketing Expenses" will specifically exclude the [ * ]. "Medical Education Expenses" means the actual costs and expenses incurred by a Party or for its account specifically attributable to [ * ] to the extent generally consistent with the then-current Commercialization Plan and Commercialization Budget, including but not limited to [ * ]. "Net Sales" means the amount invoiced by SangStat or its Affiliates for sales or other commercial disposition of Licensed Product to a Third Party less deductions for (a) [ * ] and (b) [ * ]. "Ongoing Phase II/III Clinical Trial" means the Phase II/III clinical trial for ABX-CBL ABX-CB-9906 entitled "A Phase II/III, Multicenter, Open Label, Randomized Clinical Trial evaluating ABX-CBL when compared to AtgamÒ as Second Line Therapy in Patients with Steroid Resistant Acute Graft versus Host Disease" as amended from time to time, being conducted by Abgenix in the United States as of the Effective Date. "Other Operating Income/Expense" means other operating income or expense from or to Third Parties which is not part of the primary business activity of the Collaboration, but is considered and approved by the Steering Committee (or its designee) as income or expense for ...
Sample 1
Manufacturing Overhead means, with respect to the Products, the amounts accrued by Sweetheart from the Operations Date through the end of the relevant fiscal period for the overhead items described in Exhibit F, with any components of Fixed Overhead being determined in accordance with the Applicable Budget.
Sample 1

Related to Manufacturing Overhead

  • Manufacturing Costs means [***].

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Manufacturing Cost means [***].

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Manufacturing Process means any process for—

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • SOPs has the meaning set forth in Section 3.7.

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.