ICF, Case Report Forms and Site Agreement Templates Sample Clauses

ICF, Case Report Forms and Site Agreement Templates. BMS and Compugen will create an agreed upon (through the JDC) template informed consent form (“ICF”) and template case report form (“CRF”) for each Combined Therapy Study and a template Study Site agreement (“Site Agreement”); provided that ICFs, CRFs and Site Agreements for the CGEN Phase 1 Study will be those entered into or finalized by Compugen prior to the Effective Date for the CGEN Phase 1 Study (the “Prior Study Agreements”) as disclosed to BMS as set forth in Section 10.12. The Sponsoring Party shall have the authority to modify the template ICF, CRF and template Site Agreement (or amend any Prior Study Agreement) based on its negotiations with Study Sites, provided there are no substantive changes relative to, and the ICF and Site Agreement remains otherwise generally consistent with, the original template (or the Prior Study Agreement), and provided the ICF shall: (i) include risks and discomforts associated with Compound(s) of the Other Party substantially similar to those identified in the safety information made available by the Other Party; and (ii) include consent from the Study patients to collect and use the Samples for research and development of the BMS Compound, the Compugen Compound and the Combined Therapy and for performing the PVRIG Inhibitor Biomarker Testing and the PD-L1 Expression Testing, and that the patient waives any rights he/she may have to such Samples after collection. Without limiting the foregoing, neither Party, in its capacity as the Sponsoring Party, shall, without the prior written approval of the JDC, make changes to the template ICF and template Site Agreement (or any Prior Study Agreement) based on its negotiation with the Study Sites where such changes (A) impose a new obligation, whether direct, indirect or contingent, upon the Other Party, (B) confer a benefit upon Sponsoring Party that is not also conferred upon the Other Party or (C) relate to use of Samples, other than for the performance of the PVRIG Inhibitor Biomarker Testing and the PD-L1 Expression Testing, or to the information to be disclosed in the form ICF or under the Site Agreement regarding the Other Party’s Compound. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1
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ICF, Case Report Forms and Site Agreement Templates. BMS and the Company will create agreed upon templates for the informed consent form (“ICF”), the case report form (“CRF”), and the Study Site agreement (“Site Agreement”) for each Combined Therapy Study. The Sponsoring Party shall have the authority to modify the template ICF, the template CRF and template Site Agreement based on its negotiations with Study Sites unless such modification includes a Template Substantive Changes, in which case written approval by the Other Party[***], shall be required. Notwithstanding any modification of the ICF, the Sponsoring Party shall ensure that in all cases the ICF includes: (i) disclosure of the risks and discomforts associated with Compounds of the Other Party that is substantially similar to those identified in the safety information made available by the Other Party, and (ii) consent from the Combined Therapy Study patients to collect and use the Samples for research and development of the BMS Compound, the Company Compound and the Combined Therapy, and to perform Biomarker Testing and PD-L1 Expression Testing, and (iii) that the patient waives any rights he or she may have to such Samples after collection.
Sample 1

Related to ICF, Case Report Forms and Site Agreement Templates

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  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

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  • Periodic Review of Compliance Policies and Procedures During the Term, Transfer Agent shall periodically assess its compliance policies and procedures (the “Policies”). Transfer Agent shall provide, (i) no less frequently than annually, electronic access to its Policies to the chief compliance officer of the Fund (the “Chief Compliance Officer”), and/or any individual designated by the Fund or such Chief Compliance Officer, including but not limited to members of the internal compliance and audit departments of Federated Investors, Inc., and any advisory board constituted by the Fund provided that the Transfer Agent may reasonably require any members of such advisory board that are not employees of the Fund or its Affiliates to execute a confidentiality agreement with respect to such information; (ii) at such reasonable times as he or she shall request, access by such Chief Compliance Officer to such individuals as may be necessary for the Chief Compliance Officer to conduct an annual review of the operation of such Policies for purposes of making his or her annual report to the Board of the Fund (the “Annual Report”), (iii) promptly upon enactment, notification of, and a copy of, any material change in such Policies, and (iv) promptly upon request, such other information as may be reasonably requested by such Chief Compliance Officer for purposes of making such Annual Report.

  • Software License Agreement McDATA agrees that all Licensed Software will be distributed to Customers subject to a Software License Agreement (including warranty statement), along with a McDATA Manual, in a manner which is (a) no less protective of BROCADE's Intellectual Property Rights in the Licensed Software than the form attached hereto as Exhibit D, and (b) legally enforceable in the jurisdictions in which the Licensed Software, as incorporated into the McDATA Products, is distributed.

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