Product Development Costs definition

Product Development Costs means those out-of-pocket costs approved by the Development Committee incurred in connection with Product Development Activities defined in Section 5.4. Product Development Costs do not include any expenditures for studies commenced prior to the approval of the NDA unless specifically approved by DuPont. The amounts and reimbursement of Product Development Costs shall be determined in accordance with Sections 5.4 and 5.5.
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Product Development Costs means all external costs, including external product development costs, incurred by Centocor and Schering-Plough after the Effective Date in connection with the clinical development (including pre-clinical, toxicology, pharmacology and pharmacodynamic studies and clinical trials, except as limited by the last sentence of this definition) and clinical support of regulatory filings with respect to the Product. "Product Development Costs" also includes the cost of goods for material used in clinical trials, which cost will be calculated based on Centocor's Cost of Goods Sold, or, if Centocor contracts with a third party for manufacture of the Product, will be the actual cost paid by Centocor to that third party. "Product Development Costs" also includes such costs of the development of improvements of manufacturing and control processes as are incurred after the Product has received a first EMEA Approval. All internal costs of Centocor or Schering-Plough, including but not limited to salaries, payroll taxes, bonuses and benefits incurred with respect to their employees and office, administration and overhead expenses, are specifically excluded from the definition of "Product Development Costs," unless otherwise agreed by the parties. Excluded from "Product Development Costs" are costs incurred with respect to clinical trials or other studies undertaken solely to support applications for Regulatory Approval outside the Territory.
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Product Development Costs. ("PDC") is defined in Section 2.3(c) below.
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Examples of Product Development Costs in a sentence

  • Again, each of these is applicable in Jordan. Large-size real sector companies.

  • Each party will have the right, upon forty-five (45) days prior written notice and during normal business hours, through an independent third party representative (who will agree to be bound by confidentiality provisions to review and inspect the other party's books and records which relate to such other parties's operations under this Agreement including, but not limited to, records concerning Commercial Sales, Net Sales, Product Development Costs, sales presentations, and other costs.

  • Product Development Costs The Company capitalizes the costs associated with the development of new products.

  • To the extent that either party exceeds the agreed upon budgeted Product Development Costs for such activities without the prior written approval of the Product Committee, such party shall be solely responsible for such excess expenditures which shall be excluded from Product Development Costs.

  • To the extent that either party exceeds the agreed upon budgeted Product Development Costs for such activities without the prior written approval of the Product Committee, such party shall be solely responsible for such excess expenditures which shall be excluded from the calculation of any Excess Amount under Section 6.3(c).

  • In addition, for purposes of calculating the Development Balance, any Regeneron Shared ANG2 Product Development Costs shall be subtracted from Development Costs and any Collaboration Shared Excluded Ocular ANG2 Product Development Costs shall be added to Development Costs.

  • Further, all cost directly related to [****] shall be considered Shared ANG2 Product Development Costs.

  • DuPont shall be responsible for providing funding for 50% of Product Development Costs; provided, however, that neither DuPont nor Kos are obligated to agree to conduct Product Development Activities that in the aggregate would create Product Development Costs in excess of $********** during the Term.

  • The parties further agree that, subject to variances in patient accrual rates, the anticipated budget for Product Development Costs in calendar year 1999 for the clinical trials already in progress or ready to be started and for the ACCENT study is estimated at [***].

  • The Parties also recognize that such procedures may change from time to time and that any such changes may affect the definition of Incremental Product Development Costs and such other costs and expenses.


More Definitions of Product Development Costs

Product Development Costs means costs incurred for sample books, studio strike offs, design acquisition and development, printing cylinders, engraving and analogous items.
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Product Development Costs mean direct costs incurred by MSU in developing the Accessor.
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Product Development Costs means all external costs, including external product development costs, incurred by Centocor and Schering-Plough after the Effective Date in connection with the clinical development (including pre-clinical, toxicology, pharmacology and pharmacodynamic studies and clinical trials, except as limited by the last CONFIDENTIAL TREATMENT REQUESTED. sentence of this definition) and clinical support of regulatory filings with respect to the Product. "Product Development Costs" also includes the cost of goods for material used in clinical trials, which cost will be calculated based on Centocor's Cost of Goods Sold, or, if Centocor contracts with a third party for manufacture of the Product, will be the actual cost paid by Centocor to that third party. "Product Development Costs" also includes such costs of the development of improvements of manufacturing and control processes as are incurred after the Product has received a first EMEA Approval. All internal costs of Centocor or Schering-Plough, including but not limited to salaries, payroll taxes, bonuses and benefits incurred with respect to their employees and office, administration and overhead expenses, are specifically excluded from the definition of "Product Development Costs," unless otherwise agreed by the parties. Excluded from "Product Development Costs" are costs incurred with respect to clinical trials or other studies undertaken solely to support applications for Regulatory Approval outside the Territory.
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Product Development Costs as used herein refers to any cost incurred from activities related to Product Development.
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Product Development Costs means, in respect of any relevant testing period, the amount shown in respect of product development costs in the balance sheet comprising part of the Combined Pro-forma Accounts as at 31st December 1994;
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Related to Product Development Costs

  • 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:

  • 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.

  • 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.

  • 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.

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • Marketing Costs which means such reasonable charge for marketing of ores and concentrates sold or of concentrates tolled as is consistent with generally accepted industry marketing practices;

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • Program Costs means all necessary and incidental costs of providing program services.

  • 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.

  • Development Phase means the period before a vehicle type is type approved.

  • Patent Costs means the reasonable fees and expenses paid to outside legal counsel, and filing, maintenance and other reasonable out-of-pocket expenses paid to Third Parties, incurred in connection with the Prosecution and Maintenance of Patent Rights.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Research Budget has the meaning set forth in Section 2.2.

  • 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.

  • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Development Fees means fees imposed to offset capital costs of providing public infrastructure, public safety or other public services to a development and authorized pursuant to A.R.S. Section 9-463.05, A.R.S. Section 11-1102 or A.R.S. Title 48 regardless of the jurisdiction to which the fees are paid.

  • Development Plan has the meaning set forth in Section 3.2.

  • Manufacturing Cost means ***

  • Development Budget has the meaning set forth in Section 3.1.

  • Development Project means a project for the development of land within a project area.

  • FTE means full-time equated.