Fully Loaded Manufacturing Cost definition

Fully Loaded Manufacturing Cost means the Party’s direct out-of-pocket costs actually incurred for the manufacturing, labeling, and packaging of an Authorized Generic or a Licensed Product, including API, excipients, packaging components, labeling components, internal direct labor, and quality control and assurance testing that are a necessary part of manufacturing. […***…].
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Fully Loaded Manufacturing Cost means, with respect to each Product, a Party's internal and external costs, determined in accordance with such Party's Applicable Accounting Standards, as consistently applied by such Party in accordance with its past practice and in the ordinary course of its business for products other than Products and all taxes related thereto, incurred in manufacturing, acquiring raw materials, including active pharmaceutical ingredient ("API"), excipients and other materials consumed in the manufacture of Products, packaging, insuring, transporting and/or storing such Product (including product testing activities relating to quality assurance, quality control and regulatory compliance), and reasonably allocated administrative and overhead expenses associated with the Products, in each case to the extent related and allocable to the Product.
Sample 1
Fully Loaded Manufacturing Cost means, with respect to Finished Product, Xxxx’x internal and external costs, determined in accordance with United States generally accepted accounting principles, as consistently applied by Xxxx in accordance with its past practice and in the ordinary course of its business, incurred in manufacturing, acquiring, packaging, transporting and/or storing such Finished Product (including product testing activities relating to quality assurance, quality control and regulatory compliance), in each case to the extent related and allocable to the Finished Product supplied to Xxxxx hereunder. Fully Loaded Manufacturing Cost shall not include any cost attributable to general corporate activities, including, by way of example, executive management, investor relations, business development, legal affairs and finance. Attached as Schedule 1.20 is a non-binding sample calculation of Fully Loaded Manufacturing Cost.
Sample 1

Examples of Fully Loaded Manufacturing Cost in a sentence

  • The invoices shall reflect the supply of Finished Product to Xxxxx at a price per unit equal to two (2) times the Fully Loaded Manufacturing Cost for each SKU of Finished Product (other than Professional Samples) and the supply of Professional Samples to Xxxxx at a price per unit equal to one and a quarter (1.25) times the Fully Loaded Manufacturing Cost for such Professional Sample.

  • Xxxxx shall have the right to have a nationally recognized independent public accounting firm audit, but in any case no more than once per calendar year, Xxxx’x books and records relating to the Processing Activities, for the sole purpose of verifying Xxxx’x calculation of Fully Loaded Manufacturing Cost.

  • Kos shall bear the full cost of such audit, unless such audit discloses **** from Xxxx'x calculation of its Fully Loaded Manufacturing Cost (based on the aggregate Fully Loaded Manufacturing Cost for all Finished Product hereunder, and not one Finished Product individually), in which event, Xxxx shall bear the full cost of such audit.

  • Kos shall have the right to have a nationally recognized independent public accounting firm audit, no more than once per calendar year during the Term and for one (1) year thereafter, Xxxx'x books and records relating to the Processing Activities, for the sole purpose of verifying Xxxx'x calculation of its Fully Loaded Manufacturing Cost.

  • Each Party shall keep complete and accurate records of information required for the determination of Fully Loaded Manufacturing Cost, Transfer Price and Gross Profit, as applicable to such Party, and shall retain such records for a period of at least [**] from the date of the information reported therein.

  • Sepracor shall use commercially reasonable efforts to ensure that the Contract Manufacturer manufactures, packages, labels, stores, and ships the Products in accordance with (i) the Packaging Requirements, the cost of such packaging to be included in the Fully Loaded Manufacturing Cost of the Products, (ii) cGMPs, and (iii) the Specifications set forth in the NDA.

  • Xxxxx shall bear the full cost of such audit, unless such audit discloses a variance of more than 5% from Xxxx’x calculation of its Fully Loaded Manufacturing Cost (based on the aggregate Fully Loaded Manufacturing Cost for all Finished Product hereunder, and not one Finished Product individually), in which event, Xxxx shall bear the full cost of such audit.


More Definitions of Fully Loaded Manufacturing Cost

Fully Loaded Manufacturing Cost means, with respect to each Licensed Product, Xxxx'x internal and external costs, determined in accordance with United States generally accepted accounting principles, as consistently applied by Xxxx in accordance with its past practice and in the ordinary course of its business for products other than Licensed Products, incurred in manufacturing, acquiring, packaging, transporting and/or storing such Licensed Product (including product testing activities relating to quality assurance, quality control and regulatory compliance), in each case to the extent related and allocable to the Licensed Product.
Sample 1
Fully Loaded Manufacturing Cost means (a) costs [ * ] [ * ] Confidential Treatment Requested by Affymetrix, Inc.
Sample 1
Fully Loaded Manufacturing Cost means (a) costs [ * ] including but not limited to, [ * ] on account of the manufacture of the Licensed DNA Probe Arrays to the extent that [ * ] plus [ * ] being determined in accordance with United States generally accepted cost accounting practices, and shall additionally include amounts [ * ] if the Parties so elect. 1.17 "High Density Probe Array" means (i) a DNA Probe Array having a Probe density of equal to or greater than [ * ] Probes per square centimeter (Probes/cm(2)), or (ii) a DNA Probe Array having such lesser number of Probes/cm(2), such Probe Array the subject of an applicable Valid Patent Claim included in the AFFX Licensed Core Technology issued to AFFX for the United States, by the European Patent Office of the European Union or for Japan, or (iii) a DNA Probe Array having fewer
Sample 1
Fully Loaded Manufacturing Cost means the Party’s direct out-of-pocket costs actually incurred for the manufacturing, labeling, and packaging of a Rescula® Product, including API, excipients, packaging components, labeling components, internal direct labor, and quality control and assurance testing that are a necessary part of manufacturing.
Sample 1
Fully Loaded Manufacturing Cost means, with respect to Finished Product, Xxxx'x internal and external costs, determined in accordance with United States generally accepted accounting principles, as consistently applied by Xxxx in accordance with its past practice and in the ordinary course of its business for products other than Licensed Products manufactured for Third Parties, incurred in manufacturing, acquiring, packaging, transporting and/or storing such Finished Product (including product testing activities relating to quality assurance, quality control and regulatory compliance), in each case to the extent related and allocable to the Finished Product supplied to Kos hereunder; provided, however, that in no event will Fully Loaded Manufacturing Cost include: (i) the cost of any royalties or other amounts due to Third Parties for any intellectual property rights required for the manufacture and supply of any Licensed Product hereunder; or (ii) the cost of freight, shipping or insurance for the delivery of any Licensed Product to Kos' designated facility pursuant to Section 5.3.
Sample 1

Related to Fully Loaded Manufacturing Cost

  • 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 [***].

  • Manufacturing Cost means ***

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) 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; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty 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 AquaBounty 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 (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty 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 AquaBounty or its Affiliates maintained in accordance with US GAAP.

  • Fully Loaded Cost means the direct cost of good or service plus all applicable indirect charges and overheads.

  • COGS means the cost of goods sold as determined in accordance with U.S.GAAP;

  • Development Cost means the total of all costs incurred in the completion of a Development excluding Developer Fee, operating deficit reserves, and total land cost as typically shown in the Development Cost line item on the development cost pro forma.

  • 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.

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

  • FTE Cost means, for any period, the FTE Rate multiplied by the number of FTEs in such period.

  • 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.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Cost of Goods Sold means [ * ].

  • Bondable stranded costs rate order means one or more

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

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

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Cost of Goods means the fully burdened cost to manufacture Compound or Drug Product, as applicable, (the “Supplied Product”) which means: (a) [ * ]; and (b) in the case of [ * ]. Actual unit costs shall consist of [ * ].

  • The Contract Price/Project Cost means the price payable to the Vendor under the Contract for the full and proper performance of its contractual obligations.

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

  • 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.

  • Product Group or “the Group” means a group of lotteries that has joined together to offer a product pursuant to the terms of the Multi-State Lottery Agreement and the Product Group’s own rules.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • embedded generator means a generator who is not a market participant and whose generation facility is connected to a distribution system of a distributor, but does not include a generator who consumes more electricity than it generates;