Preclinical Plan Sample Clauses
The Preclinical Plan clause defines the requirements and expectations for conducting preclinical studies before advancing to clinical trials. It typically outlines the scope of research, timelines, and deliverables that must be met, such as specific animal studies or laboratory tests to assess safety and efficacy. By establishing clear guidelines for preclinical work, this clause ensures that both parties understand the necessary steps and standards, thereby reducing the risk of miscommunication and helping to ensure regulatory compliance before further development.
Preclinical Plan. (a) The Preclinical Development Program will be carried out in accordance with a written research plan (the “Preclinical Plan”). The purpose of the Preclinical Plan is to detail the responsibilities and activities of CytomX and BMS with respect to carrying out the Preclinical Development Program. The Preclinical Plan will include a description of the specific activities to be performed by CytomX in support of the Preclinical Development Program, the number of qualified CytomX FTEs to perform the activities in support of the Preclinical Development Program, projected timelines for completion of such activities and, as applicable, provisions for the supply of Compound by CytomX to BMS. The Preclinical Plan will also include a budget for the BMS-funded CytomX FTEs (based on the number of BMS-funded CytomX FTEs and the FTE Rate) and any projected Third Party Costs, with such budget to be update periodically by the JRC (the “Budget”), with such Budget to be updated in advance for each calendar quarter by the JRC, subject to this Section 3.3 and Section 3.4. As part of this calendar quarter update to the Budget, the JRC shall specify in writing for the coming calendar quarter period the number of CytomX FTEs assigned to the Preclinical Development Program (in accordance with Section 3.4), a summary of their activities, a listing of the CytomX scientists comprising such FTEs and their percentage of time devoted to working on the Preclinical Development Program. If BMS has concerns regarding any specific scientist assigned to the Preclinical Development Program, such concerns shall be communicated to the JRC for its consideration. In accordance with the Preclinical Plan, CytomX will develop and optimize Masks, Substrates and Compounds, and will deliver such Masks, Substrates and Compounds to BMS. Such Masks, Substrates and Compounds may be further modified by BMS, provided no substantive changes shall be made to the Mask or Substrate of such Compound. Examples of permitted modifications to Mask or Substrate include modifications in the course of optimizing a Compound or a Product, provided that BMS may make any changes to the Antibody portion of the Compound or Product. The initial Preclinical Plan that has been agreed to by the Parties as of the Execution Date is attached as Exhibit E.
Preclinical Plan. Year 1: Identify other cancer targets for ENV105 - Year 2: Study biomarkers for ENV105 - Clinical Plan: - Year 1: Develop Phase 2 clinical trial for ENV105 combination with darolutamide for castrate resistance prostate cancer patients - Year 2: Begin accrual for ENV105 clinical trial - Year 2: Develop Phase 1 clinical trial for external beam irradiation for localized ER+ breast cancer with ENV105. - Year 3: Complete accrual for ENV105 clinical trial THIS EXCLUSIVE LICENSE AGREEMENT (“Agreement”) is entered into as of this 16th day of March 2020 (“Effective Date”) by and between CEDARS-SINAI MEDICAL CENTER, a California nonprofit public benefit corporation (“CSMC”), with offices at 8▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, Los Angeles, California 90048-1865, and ENVIRO THERAPEUTICS, INC.., a C Corporation (“Licensee”), with offices at 2▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇. #▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇.
Preclinical Plan. Section 3.3(a) is hereby deleted in its entirety and replaced with the following: