ICF, Case Report Forms and Site Agreement Templates Sample Clauses

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.
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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.

Related to ICF, Case Report Forms and Site Agreement Templates

  • Implementation Report Within 150 days after the Effective Date, Ensign Group shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, address, phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names and positions of the members of the Board of Directors who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3; 4. a copy of Ensign Group’s Code of Conduct required by Section III.B.1; 5. the number of individuals required to complete the Code of Conduct certification required by Section III.B.1, the percentage of individuals who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG upon request); 6. a summary of all Policies and Procedures required by Section III.B (copies of the Policies and Procedures shall be made available to OIG upon request); 7. the following information regarding each type of training required by Section III.C: a. a description of such training, including a summary of the topics covered, the length of sessions, and a schedule of training sessions; b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation of any exceptions. A copy of all training materials and the documentation supporting this information shall be made available to OIG upon request. 8. a description of the Disclosure Program required by Section III.E; 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between Ensign Group and the IRO; and (e) a certification from the IRO regarding its professional independence and objectivity with respect to Ensign Group; 10. a description of the process by which Ensign Group fulfills the requirements of Section III.F regarding Ineligible Persons; 11. a list of all of Ensign Group’s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location’s Medicare and state Medicaid program provider number and/or supplier number(s); and the name and address of each Medicare and state Medicaid program contractor to which Ensign Group currently submits claims; 12. a description of Ensign Group’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and

  • Preparatory Contract Negotiations Meetings Where operational requirements permit, the Employer will grant leave without pay to an employee to attend preparatory contract negotiations meetings.

  • Project Implementation Manual The Recipient, through the PCU, shall: (i) take all action required to carry out Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4 (ii) of the Project in accordance with the provisions and requirements set forth or referred to in the Project Implementation Manual; (ii) submit recommendations to the Association for its consideration for changes and updates of the Project Implementation Manual as they may become necessary or advisable during Project implementation in order to achieve the objective of Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4(ii) of the Project; and (iii) not assign, amend, abrogate or waive the Project Implementation Manual or any of its provisions without the Association’s prior agreement. Notwithstanding the foregoing, if any of the provisions of the Project Implementation Manual is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall prevail and govern.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • GRIEVANCE REPORT FORM Grievance # School District Distribution of Form 1. Superintendent

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Integration; Modification This Construction Services Agreement represents the entire understanding of District and Contractor as to those matters contained herein, and supersedes and cancels any prior oral or written understanding, promises or representations with respect to those matters covered herein, and it shall not be amended, altered or changed except by a written agreement signed by the parties hereto.

  • Modifications and Updates to the Wire Center List and Subsequent Transition Periods 5.4.6.1 In the event AT&T identifies additional wire centers that meet the criteria set forth in Sections 5.4.2.1 or 5.4.2.2 above, but that were not included in the Master List of Unimpaired Wire Centers or AT&T’s List of Unimpaired Wire Centers, AT&T shall include such additional wire centers in a CNL. Each such list of additional wire centers shall be considered a Subsequent Wire Center List. AT&T will follow any limitations on the frequency with which it may issue such lists and notification procedures set forth in applicable Commission orders. 5.4.6.2 TWTC shall have thirty (30) business days to dispute the additional wire centers listed on AT&T’s CNL. Absent such dispute, effective thirty (30) business days after the date of a AT&T CNL providing a Subsequent Wire Center List, AT&T shall not be required to provide DS1 and DS3 Dedicated Transport, as applicable, in such additional wire center(s), except pursuant to the self-certification process as set forth in Section 1.9.1 of this Attachment. 5.4.6.3 For purposes of Section 5.4.6.1 above, AT&T shall make available DS1 and DS3 Dedicated Transport that were in service for TWTC in a wire center on the Subsequent Wire Center List as of the thirtieth (30th) business day after the date of AT&T’s CNL identifying the Subsequent Wire Center List (Subsequent Embedded Base) until one hundred eighty (180) days after the thirtieth (30th) business day Version: 4Q06 Standard ICA 11/30/06 from the date of AT&T’s CNL identifying the Subsequent Wire Center List (Subsequent Transition Period). 5.4.6.4 The rates set forth in Exhibit B shall apply to the Subsequent Embedded Base during the Subsequent Transition Period. 5.4.6.5 No later than one hundred eighty (180) days from AT&T’s CNL identifying the Subsequent Wire Center List, TWTC shall submit an LSR(s) or spreadsheet(s) as applicable, identifying the Subsequent Embedded Base of circuits to be disconnected or converted to other AT&T services. 5.4.6.5.1 In the case of disconnection, the applicable disconnect charges set forth in this Agreement shall apply. 5.4.6.5.2 If TWTC chooses to convert DS1 and/or DS3 Dedicated Transport to special access circuits in existence as of the Effective Date of this Agreement, AT&T will include such DS1 and/or DS3 Dedicated Transport within TWTC’s total special access circuits, and apply any discounts to which TWTC is entitled from the transition period of 3/11/2006 to the conversion date. Conversions will be subject to the switch-as-is charge set forth in Exhibit A to this Attachment 2. 5.4.6.5.3 AT&T shall not impose disconnect or nonrecurring installation charges when transitioning the Subsequent Embedded Base of DS1 and DS3 Dedicated Transport in existence as of the Effective Date of this Agreement. 5.4.6.6 If TWTC fails to submit the LSR(s) or spreadsheet(s) for all of its Subsequent Embedded Base by one hundred eighty (180) days after the date of AT&T’s CNL identifying the Subsequent Wire Center List, AT&T will identify TWTC’s remaining Subsequent Embedded Base, if any, and will transition such circuits to the equivalent tariffed AT&T service(s), or in the case of Georgia, to the equivalent 271 service(s) set forth in Exhibit 1. In the states of Florida, Kentucky, Mississippi and South Carolina, those circuits identified and transitioned by AT&T shall be subject to the applicable disconnect charges as set forth in this Agreement and the full nonrecurring charges for installation of the equivalent tariffed AT&T service as set forth in AT&T’s tariffs. In the states of Alabama, Georgia, North Carolina and Tennessee, those circuits identified and transitioned by AT&T shall be subject to the applicable switch-as-is rates set forth in Exhibit A of Attachment

  • Proposed Policies and Procedures Regarding New Online Content and Functionality By October 31, 2017, the School will submit to OCR for its review and approval proposed policies and procedures (“the Plan for New Content”) to ensure that all new, newly-added, or modified online content and functionality will be accessible to people with disabilities as measured by conformance to the Benchmarks for Measuring Accessibility set forth above, except where doing so would impose a fundamental alteration or undue burden. a) When fundamental alteration or undue burden defenses apply, the Plan for New Content will require the School to provide equally effective alternative access. The Plan for New Content will require the School, in providing equally effective alternate access, to take any actions that do not result in a fundamental alteration or undue financial and administrative burdens, but nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the same benefits or services as their nondisabled peers. To provide equally effective alternate access, alternates are not required to produce the identical result or level of achievement for persons with and without disabilities, but must afford persons with disabilities equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement, in the most integrated setting appropriate to the person’s needs. b) The Plan for New Content must include sufficient quality assurance procedures, backed by adequate personnel and financial resources, for full implementation. This provision also applies to the School’s online content and functionality developed by, maintained by, or offered through a third-party vendor or by using open sources. c) Within thirty (30) days of receiving OCR’s approval of the Plan for New Content, the School will officially adopt, and fully implement the amended policies and procedures.

  • COMPTROLLER’S REPORT ON CHAPTER 313 AGREEMENTS During the term of this Agreement, both Parties shall provide the Comptroller with all information reasonably necessary for the Comptroller to assess performance under this Agreement for the purpose of issuing the Comptroller’s report, as required by Section 313.032 of the TEXAS TAX CODE.

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