Clinical Budget definition

Clinical Budget has the meaning set forth in Section 4.1 of the Amended and Restated Research and Development Agreement.
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Clinical Budget shall have the meaning assigned to such term in Section 4.3(a).
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Clinical Budget means (i) the budget for Development Costs for each Approved Study and Contingent Approved Study that is included in Exhibit B or C of the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2, as set forth in such Exhibit B or C, as the case may be, (ii) subject to Sections 4.3(b)(ii) and 4.3(h)(ii), each budget for Development Costs for each Approved Study and Contingent Approved Study that is included in Exhibit A of the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2 as set forth in such Exhibit A; and (iii) each budget for Development Costs for each Proposed Study or Emergency Study that becomes an Approved Study or a Contingent Approved Study that is not set forth in the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2 that is included in a subsequent Clinical Development Plan and that is approved in accordance with the provisions of this Agreement, in each case as such Clinical Budget may be modified or amended from time to time in accordance with the provisions of this Agreement. Each Clinical Budget shall set forth the approved aggregate Development Costs through completion for each Approved Study and each Contingent Approved Study included in the Clinical Development Plan (including the budgeted Development Costs for each such Approved Study and Contingent Approved Study for each calendar year included in the applicable Clinical Development Plan and the estimated Development Costs, if any, for each subsequent calendar year through completion) and shall include the other cost information required by Exhibit 1.20 for each Approved Study and each Contingent Approved Study included in the Clinical Development Plan.
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Examples of Clinical Budget in a sentence

  • Once a determination is made by the PDC with respect to the appropriate actions to be taken, the PDC shall review and re-evaluate the relevant Clinical Development Plan and the Clinical Budget and make any changes necessary to implement such actions.

  • The Clinical Budget and/or the relevant Marketing Budget shall be adjusted accordingly.

  • Upon receiving the approval of the JEC to undertake the additional clinical studies required by the FDA, the PDC shall be authorized to, and is hereby directed to, redirect (without increasing) the existing overall Clinical Budget as necessary to undertake such studies and to cause such studies to be undertaken.

  • DEFINITIONS / REQUIREMENTS Clinical: Budget at least 60% of the total award for clinical costs.

  • As soon as reasonably practicable after the meeting referred to in Section 3.1(a), the JMC shall meet to amend Exhibit 8.12 (B)(i) to the Commercial Agreement to reflect the Modified Clinical Budget.

  • The relatively smallproportion of U.S.-owned triadic patents and U.S. patents registered with the EPO is particularly signifi- cant.

  • Clinical Budget for: Sponsor: Xxxxxx Compound: PEP005 0.025%, and 0.05% get Study: Multi-centre, randomised, double-blind, double-dummy, parallel-group, vehicle-controlled comparison study to determine the efficacy of PEP005 0.25% and 0.5% get in patients with AK lesions.

  • UH Research SOP SP 202 describes the Coverage Analysis & Clinical Budget Development Process Flow.Certain investigational products must be added to the hospital charge master to assure compliant billing.

  • Each of the Parties agrees that Exelixis will work diligently and use commercially reasonable efforts to develop the Programs in a good scientific manner and, subject to Section 6.2 below, in accordance with the Clinical Plan, the Clinical Budget, and the terms of this Agreement.

  • Notwithstanding the foregoing, the number of full-time equivalents (“FTEs”) to be dedicated to the Programs by Exelixis shall be specified in the Clinical Budget, by function and work responsibilities, on a Program by Program basis.


More Definitions of Clinical Budget

Clinical Budget means that portion of the Budget that covers Clinical Development of a Product.
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Related to Clinical Budget

  • Research Budget has the meaning set forth in Section 3.2.

  • Development Budget shall have the meaning set forth in Section 3.3.

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

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Annual Budget means the operating budget, including all planned capital expenditures, for the Property prepared by Borrower for the applicable Fiscal Year or other period.

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

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Initial Budget has the meaning set forth in Section 7.06(a).

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Project Budget means the budget and project description included in the grant application. The Project Budget must succinctly describe all major elements of project work, the estimated cost of each, and clearly allocate requested grant funding and match contributions to each.

  • 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.

  • Budget means a resource, expressed in financial terms, proposed by the Board for the purpose of carrying out, for a specific period, any or all of the functions of the Trust.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Approved Project Budget means the most recent statement, approved by the FTA, of the costs of the Project, the maximum amount of Federal assistance for which the TJPA is currently eligible, the specific tasks (including specified contingencies) covered, and the estimated cost of each task.

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

  • Capital Budget has the meaning given in Section 3.11(a).

  • BASE budget means the minimum general fund budget of a district, which includes 80% of the basic

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Project Plans mean the plans for the Project that are attached to this Agreement as Exhibit “B.”

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Approved Budget means an annual budget-

  • Research Plan shall have the meaning set forth in Section 2.1.