Phase III Development Costs definition

Phase III Development Costs means all development costs incurred by either Party with TSD’s prior approval under the Collaboration Agreement for (a) direct support of the performance of a Phase III Trial or (b) process development for a Product in a Phase III Trial. For clarity, Phase III Development Costs include costs to formulate and manufacture Phase III Trial CTM.
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Phase III Development Costs shall have the meaning defined in Section 3.5.3.
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Phase III Development Costs with respect to a particular Co-Funded Product shall mean, to the extent incurred in accordance with the Co-Development Plan and Budget then in effect and to the extent not reimbursed by a Third Party, [ * ] of Phase III Development of the particular Co- Funded Product.
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Examples of Phase III Development Costs in a sentence

  • Array shall have the right, on a Licensed Product-by-Licensed Product basis, to elect to fund [ * ] of the Phase III Development Costs of such Licensed Product, all in accordance with this Section 3.5 (the “Co-Funding Option”).

  • Within [ * ] days after Array’s receipt of such statement, Array shall [ * ] AZ [ * ] of the Phase III Development Costs [ * ] such quarterly period in accordance with the statement for such Co-Funded Product; provided, however, that Array shall not be required to [ * ] AZ for [ * ].

  • AZ agrees to keep Array informed on an ongoing basis as to the actual Phase III Development Costs incurred to date as compared to the Phase III Development Costs reflected in the Co-Development Plan and Budget.

  • Industrial Magistrate Flynn found that the ordinary meaning of 'referral' in a medical context is the introduction of a patient by one medical practitioner to another medical practitioner for treatment.

  • In the event Array exercises its Co-Funding Option with respect to a Licensed Product, Array shall be obligated to [ * ] AZ for [ * ] of such Phase III Development Costs for such Licensed Product, subject to the provisions of this Section 3.5.

  • Should AZ have [ * ] Phase III Development Costs in the period prior to Array’s termination of its Co-Funding Option AZ shall invoice Array in respect of [ * ] of costs within [ * ] of such costs being [ * ] and such payments shall be due [ * ] of receipt of invoice by Array.

  • Pursuant to and in accordance with Section 2.4 and Section 3.6 of the Lease, the Parties hereby acknowledge and agree that the actual Development Costs for Landlord’s Phase III Work are $12,020,912, and that such amount shall be used in reference to Phase III Development Costs and the Phase III Budget in all instances in the Lease.

  • In contrast, annual growth in rents for the market outside Dublin was more subdued, recording growth of 0.8% when compared to the first quarter of 2013.

  • Promptly after Roche exercises the Option with respect to an Option Compound, Roche shall provide Memory with its complete and correct copy of its then current internal budget, to the extent it exists, for the estimated global Phase III Development Costs for such Option Compound, together with any other material information then available to Roche relating to the estimated amount thereof, to assist Memory in determining whether to exercise its co-promotion right.


More Definitions of Phase III Development Costs

Phase III Development Costs means all Development Costs with respect to Landlord’s
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Related to Phase III 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:

  • 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.

  • 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 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.

  • Total Development Cost means the total of all costs incurred in the completion of a Development, all of which shall be subject to the review and approval by the Credit Underwriter and the Corporation pursuant to this rule chapter, and as further described in Rule 67-48.0075, F.A.C.

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

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

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

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

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

  • Improvement Costs means any additional expenditure on a fixed asset that materially increases the capacity of the asset or materially improves its functioning or represents more than 10% of the initial depreciation base of the asset;

  • Project Costs means the costs of the construction, acquisition or equipping of the Project, as further described in the Project Budget, and such other costs as may be approved in writing by the Department, provided such costs are permitted by the Act.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

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

  • 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.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Development Fee means a fee for the packaging of a Property, including negotiating and approving plans, and undertaking to assist in obtaining zoning and necessary variances and necessary financing for the Property, either initially or at a later date.

  • 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;

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Project area budget means a multiyear projection of annual or cumulative

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

  • Development Area means that area to which a development plan is applicable.

  • Redevelopment project means a specific construction project

  • 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.