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

  • 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.

  • 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.

  • 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.

  • 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.

  • Each Clinical Development Plan shall include, for each Approved Study and Contingent Approved Study (other than any Clinical Study that was included in a Clinical Development Plan prior to the date of this Amendment No. 2), all information required by Exhibit 1.20, including a Clinical Budget.

  • Unless and until the Modified Clinical Budget is approved in accordance with the Commercial Agreement, the Existing Clinical Budget shall remain in effect.

  • The Development Committee shall decide on all changes in the Management Plan and the Management Budget that are subject to approval pursuant to Section 2 of the Management Services Agreement, and all changes in the Clinical Plan and Clinical Budget that are subject to approval pursuant to Sections 4.2 and 8.3 of the Amended and Restated Research and Development Agreement (each such change, a “Material Change” to the Development Plan or Development Budget, as applicable).

  • The Development Committee shall promptly thereafter amend the Clinical Plan to reflect such discontinuation or abandonment and amend the Clinical Budget to reallocate to any or all of the remaining Protocols the funds previously allocated to the discontinued or abandoned Protocol (with any funds not then allocated to another Protocol to be held for reallocation by the Development Committee at another time).

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


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 2.2.

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

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

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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 WTL, 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 Finalised 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 WTL. 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 a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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 Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a 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.

  • 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.