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).

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.

Examples of Clinical Budget in a sentence

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

• 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.

• 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.

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

• 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.

• 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: ▇▇▇▇▇▇ 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.

• Clinical Budget for: Sponsor: P▇▇▇▇▇ Compound: N/A Study: Integrated **** Safety Database PCN: KO1604 A.

• 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).

• Exelixis shall be fully compensated for all amounts to which Sections 8.3(b) and 8.3(c) do not apply and all amounts that are approved pursuant to Section 8.3(b) or are included in an amended Clinical Budget.

More Definitions of Clinical Budget

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