Clinical Manufacturing Costs definition

Clinical Manufacturing Costs means the out-of-pocket costs incurred by a Party or by the Parties jointly to one or more Third Parties in connection with the manufacture, supply, testing, shipment, release and other activities relating to the procurement of the Product(s), placebos and comparator drugs used in the Development of the Products. Clinical Manufacturing Costs excludes internal costs; this means that if a Party procures or has procured the Product from a Third Party manufacturer, the Clinical Manufacturing Costs shall mean the costs incurred by such Party in connection with the procurement, testing, storage, shipping and releasing such Product but shall exclude the internal costs incurred by such Party in connection with the management of the contractual relationship with such Third Party manufacturer.
Sample 1
Clinical Manufacturing Costs means the (a) external costs and expenses and (b) internal direct costs (including labor), to Manufacture the Nektar Assets and BMS Assets and all other costs and expenses, as agreed by the JMC and JFC, in each case that are incurred by a
Sample 1
Clinical Manufacturing Costs means the (a) external costs and expenses and (b) internal direct costs (including labor), to Manufacture the Nektar Assets and BMS Assets and all other costs and expenses, as agreed by the JMC and JFC, in each case that are incurred by a [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Party or its Affiliates for the Manufacture and supply of the Nektar Assets and BMS Assets for clinical purposes (including out-of-pocket external and internal costs, in each case, for process development, scale up, stability studies, qualification lots, validation lots and post-launch studies that may be required in connection with a conditional Regulatory Approval), in each case to the extent incurred in accordance with this Agreement in relation to a Collaboration Study, Independent Study or other Joint Development Plan activities. Without limiting the generality of the preceding, Schedule 1.34 (Clinical Manufacturing Costs), which may be amended from time to time by the JMC and approved by the JDC, sets forth a schedule of certain costs and expenses acknowledged and agreed by the Parties (x) to be included in the Clinical Manufacturing Costs, and (y) to be excluded from the Clinical Manufacturing Costs. For clarity, Clinical Manufacturing Costs exclude general overhead beyond what is already included in the FTE Rate, costs associated with failed lots (due to a Party’s negligence) and other unabsorbed costs related to idle plant capacity.
Sample 1

Examples of Clinical Manufacturing Costs in a sentence

  • Subject to Section 6.1, the Development Costs (other than Clinical Manufacturing Costs) for Combined Therapy Collaboration Studies shall be allocated to, and be the responsibility of the Parties, in accordance with Schedule 6.3 (Combined Therapy Collaboration Study Development Cost Allocation), in each case to the extent that such Development Costs are incurred in accordance with this Agreement and the applicable Development Budget.

  • In the event a Party uses any Clinical Supply in its Independent Studies and the Clinical Manufacturing Costs for such Clinical Supply have been paid by each Party equally, such Party using such Clinical Supply for its Independent Studies shall pay to the other Party fifty percent (50%) of the Clinical Manufacturing Costs of the portion of the Clinical Supply so used by such Party for such Independent Studies.

  • In such event, Norgine will reimburse Tranzyme for the Clinical Manufacturing Costs of procuring such supply in accordance with Section 7.3. Otherwise, each Party shall be solely responsible for the procurement of clinical supply for Product for its Independent Studies.

  • Concurrent with the issuance of each such invoice for a particular lot of finished Product, Tranzyme shall also invoice Norgine for fifty percent (50%) of the Clinical Manufacturing Costs incurred by Tranzyme prior to the Effective Date in connection with the procurement of the Existing Inventory incorporated into such lot of finished Product.

  • The Company and the Executive may terminate this Agreement at any time.

  • Such Party shall be solely responsible for the Clinical Manufacturing Costs for such Independent Studies, [***].

Related to Clinical Manufacturing Costs

  • Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • Manufacturing Cost means ***

  • 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;

  • 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.

  • 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.

  • 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 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.

  • 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 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.

  • 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.

  • 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 Process means any process for—

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

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

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Distillery manufacturing license means a license issued in accordance with

  • 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.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • 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.

  • 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.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • 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.

  • 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.

  • 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: