Clinical Supply Cost definition

Clinical Supply Cost means the sum of (a) the cost of Product and placebos of Product utilized in activities in accordance with the Development Plan, as determined in accordance with Section 4.8, (b) out-of-pocket costs and expenses incurred in purchasing comparator drug and in packaging comparator drug and/or the Product and/or placebos of Product, shipping clinical supplies to centers and/or disposal of clinical supplies, and (c) actual costs of packaging comparator and Product if done by USL or Orion.
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Clinical Supply Cost means (i) the Manufacturing Cost of Clinical Supply Requirements, as set forth in Schedule 1.101, and (ii) the Out-of-Pocket Cost for purchasing, or Manufacturing Cost to manufacture, as the case may be, comparator agent or placebo requirements.
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Clinical Supply Cost means (a) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture Formulated Bulk Product for Clinical Supply Requirements under the applicable Global Development Plan, (b) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture, comparator agent or placebo requirements for activities contemplated under the applicable Global Development Plan, (c) the Out-of-Pocket Cost and/or the Manufacturing Cost for filling, packaging, labeling and delivery of such Clinical Supply Requirements, comparator agent, combination agent and/or placebo, as the case may be, for activities contemplated under the applicable Global Development Plan and (d) any irrecoverable VAT or similar taxes actually paid with respect to the Manufacture or delivery of Clinical Supply Requirements. To the extent that manufacturing cost for comparator agent, combination agent or placebo includes any markup over Manufacturing Cost to the benefit of one of the Parties or its Affiliates, such markup shall be deducted in the calculation of Clinical Supply Cost.
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Examples of Clinical Supply Cost in a sentence

  • Regeneron shall supply such Clinical Supply Requirements of the Trap-1 Product at Regeneron's Clinical Supply Cost for such product.

  • Novartis shall also use Commercially Reasonable Efforts to provide an adequate supply of properly forecast Clinical Supply Requirements of the Trap-1 Product post first Launch in the Territory during the applicable Term of this Agreement at Novartis' Clinical Supply Cost for such product.

  • Clinical Supply Requirements of the Trap-2 Product -55- <PAGE> shall be provided at Novartis' Clinical Supply Cost for such product.

  • The budgets for NA Development Cost and NA/Ex-NA Development Cost for the current and next succeeding calendar years shall be specified in more detail to include, without limitation, on a study-by-study or activity-by-activity basis any (i) investigator fees and expert fees, (ii) CRO costs, lab fees and scientific service fees, (iii) FTE Cost and (iv) Clinical Supply Cost.

  • On each purchase order, LILLY will designate the amount of API to be billed at the API Clinical Supply Cost versus the API Commercial Supply Price, pursuant to section 5.1(a).

  • Novartis shall supply such Clinical Supply Requirements of the IL-1 Antibody Product at Novartis' Clinical Supply Cost for such product.

  • Clinical Supply Requirements of the Trap-2 Product shall be provided at Novartis' Clinical Supply Cost for such product.

  • JPI shall pay Legend the Clinical Supply Cost and Commercial Supply Cost for Product within [***] after receipt of an invoice.


More Definitions of Clinical Supply Cost

Clinical Supply Cost means (a) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture Formulated Bulk Product for Clinical Supply Requirements under the Development Plans, (b) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture, comparator agent or placebo requirements for activities contemplated under the Development Plans, (c) the Out-of-Pocket Cost and/or the Manufacturing Cost for filling, packaging and labeling such Clinical Supply Requirements, comparator agent and/or placebo, as the case may be, for activities contemplated under the Development Plans and (d) any VAT or similar taxes actually paid with respect to the Manufacture or delivery of Clinical Supply Requirements.
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Clinical Supply Cost means, with respect to Clinical Supply Requirements of a particular IL-1 Product, the manufacturing Party's Fully Burdened Manufacturing Cost (in this instance the definition of Fully Burdened Manufacturing Cost shall apply to Regeneron as a manufacturing party as well) for the particular IL-1 Product.
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Clinical Supply Cost means (a) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture Formulated Bulk Product for Clinical Supply Requirements under the Development Plans, (b) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to Manufacture comparator agent or placebo requirements for activities contemplated under the Development Plans, (c) the Out-of-Pocket Cost and/or the Manufacturing Cost for filling, packaging and labeling Clinical Supply Requirements, comparator agent and/or placebo, as the case may be, for activities contemplated under the Development Plans and (d) any VAT and/or similar taxes actually paid with respect to the Manufacture or delivery of Clinical Supply Requirements.
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Related to Clinical Supply Cost

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • 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.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • 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.

  • 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:

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

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Medical supplies means items for medical use that are suitable for use in a health care facility or in the home and that are disposable or semi-disposable and are non-reusable.

  • 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.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • 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:

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • 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.

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

  • 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.

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

  • 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;

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

  • Development Expenses means, with respect to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.), usual and customary operating and financial costs, such as the compliance monitoring fee, the financial monitoring fee, replacement reserves, the servicing fee and the debt service reserves. As it relates to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.) and to the application of Development Cash Flow described in subsections 67-48.010(5) and (6), F.A.C., as it relates to SAIL Developments or in paragraph 67-48.020(3)(b), F.A.C., as it relates to HOME Developments, the term includes only those expenses disclosed in the operating pro forma on an annual basis included in the final credit underwriting report, as approved by the Board, and maximum of 20 percent Developer Fee per year.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

  • Commercial Supply Agreement has the meaning set forth in Section 5.2.