Changes to the Protocol. In the event of a change to the Study Protocol that results in an increased cost, or if any increase in the compensation due for the conduct of the Study is necessary or appropriate, the Parties shall negotiate further remuneration and the, Sponsor shall provide written notice in the form of a budget increase letter.
Changes to the Protocol. The procedure to be followed when changes are made is set out in Clause 16.3 and if the change requires a revised financial schedule, this should be agreed, signed by the Parties and attached to the Agreement. The implementation of amendments requiring changes to the financial schedule should not be delayed until contract variation is completed. Instead, amendments should be implemented in a timely manner, whilst good faith negotiation between the parties continues to finalise and agree the variation.
Changes to the Protocol. No change in a Protocol shall be made by the Institution or the Principal Investigator without prior approval of SPONSOR and the IRB. Notwithstanding the foregoing, subject to any Applicable Laws relating to the safety of Subjects that may require a deviation from the Protocol, the Institution shall promptly notify SPONSOR and the IRB of the nature of the deviation and the facts necessitating such deviation as soon as the facts are known to the Institution. SPONSOR may at any time make changes in the Protocol upon written notice to the Institution, and Institution will act promptly to implement such changes once Institution’s IRB has approved such changes; provided, however, that, if the changes materially increase the cost of performance of the Study by the Institution, SPONSOR and Institution will work together to amend the Study Budget or the Institution may terminate this Agreement pursuant to Section 22. Notwithstanding the foregoing, Institution reserves the right to terminate this Agreement or any applicable SOW in the event that changes to the Protocol, in its sole discretion, materially change the terms and conditions of this Agreement or separate SOW.
Changes to the Protocol. 9.1. Subject to Section 9.2, any changes to the Protocol may be made only with the prior agreement of the Sponsor. If these changes will affect the cost of the Study, Nordic Bioscience shall provide the Clinical Study Sites with a written estimate of such change in Study cost.
9.2. If generally accepted standards of Good Clinical Practice relating to the safety of study subjects require a deviation from the Protocol, these standards will be followed. Any party who becomes aware of the need for a deviation from the Protocol will immediately notify the other parties to this Agreement and the Sponsor of the facts causing the deviation as soon as, the facts are known to that party but no such deviation or change shall be implemented without the prior written approval of Nordic Bioscience and Sponsor; Nordic Bioscience and Sponsor shall promptly confer and provide a prompt written response regarding any deviation proposed pursuant to this Section 9.2.
9.3. Clinical Study Site shall coordinate, and shall cause each Principal Investigator to coordinate, with the relevant institutional review board or ethics committee (the “EC”) to obtain the EC’s written approval of such Principal Investigator’s conduct of the Study at Clinical Study Site, including approval of the Protocol and informed consent form to be executed by all subjects enrolled by Principal Investigator in the Study (the “Informed Consent Form”). Clinical Study Site shall be responsible for providing Sponsor with a copy of each such approval, together with information about the members of the EC and all relevant correspondence with the EC. In addition, Clinical Study Site shall coordinate, and shall cause Principal Investigator to coordinate, with the EC to obtain review and approval in writing of any amendments made to a Protocol by the parties. In the event the EC requires changes in the Protocol or Informed Consent Form, such changes shall not be implemented until Sponsor and Nordic Bioscience are notified and Sponsor gives its written approval. In the event that the EC alters or withdraws its’ approval in any manner, Clinical Study Site shall promptly notify Sponsor and Nordic Bioscience. The Protocol and the Informed Consent Form shall not be revised without the prior written agreement of Sponsor, Nordic Bioscience and the EC. Clinical Study Site will use reasonable efforts to ensure that members of the EC agree to abide by the same obligations of confidentiality as apply to Clinical Study Site un...
Changes to the Protocol. Any amendment or modification of the Protocol must be agreed upon by both the Investigator and the Sponsor and documented in writing, however any such change shall not exempt the Sponsor of its liabilities and responsibilities hereunder.
Changes to the Protocol. The Group shall not modify the Protocol or make any addendum to the Protocol unless such modification or addendum is approved in advance by the NCI and the IRB; provided that administrative changes to the Protocol shall not require such approval. The NCI will provide notification to Company of changes to the Protocol pursuant to its CRADA, and input from the Company will be received in response to notices received from NCI. If at a future date changes in a Protocol appears desirable to the Group (a “Group Change”) and increase the costs for the Study and the Group wishes the Company to provide additional funding for the Study, the Group will submit to the Company for consideration the proposed Protocol amendment and a written estimate of all increased costs arising from the Group Change. Such additional funding shall be provided as agreed to by the Group and the Company. If such changes have not been requested by the Group (a “Company Change”), and increase the costs for the Study, the Group will submit to the Company a written estimate of all increased costs arising from the Company Change, and the Company shall pay such reasonable additional costs as required by the Group. All changes in the Protocol will be implemented immediately following NCI and IRB approval.
Changes to the Protocol. If at a future date changes in the Research or Protocol appear desirable, then such changes may be made through prior written agreement between UNC-CH and Immtech. In the event that UNC-CH and Immtech disagree regarding any such proposed change, then the Scientific Advisory Board appointed by UNC-CH to oversee the Research shall resolve such disagreement. If in the course of performing this Agreement, however, either of (a) generally accepted standards of clinical research and medical practice relating to the safety of Research Subjects, (b) a directive from the Institutional Review Board of UNC-CH with authority over the Research, or (c) a decision of the Scientific Advisory Board appointed by UNC-CH to oversee the Research, requires a deviation from the Protocol, then such standards will be followed. In such case, the party aware of the need for a deviation will immediately inform the other of the facts causing such deviation as soon as the facts are known to the party. If the aggregate amount of the costs of any and all required changes and/or deviations arising pursuant to clauses (b) or (c) of this Article 20 during the term of this Agreement, for which additional funding is not provided to Immtech by either the Bill & Melinda Gates Foundation, UNC-CH or any third party, exceed $000,000, xxxx Xxxxxch may terminate this Agreement upon thirty (30) days written notice to UNC-CH.
Changes to the Protocol. The Protocol may be amended only at the direction of Sponsor, subject to subsequent approval of the Ethics Committee and any applicable regulatory authorities. No financial adjustments shall be made because of such modifications unless the Parties hereto amend this Agreement accordingly. 19
Changes to the Protocol. 2.2.2.1 Any material change to the RESPONSE Protocol, including any country-specific appendices required by Applicable Law, and material changes made in response to any communications with any Regulatory Authorities that require a submission to a Regulatory Authority, an IRB or other ethics committee, will be diligently prepared by CymaBay in the form of draft amendments, and will require the ERC’s approval, which will not be unreasonably withheld or delayed and which will be communicated to the Parties as soon as reasonably practicable following the ERC’s receipt of the draft amendment from CymaBay.
Changes to the Protocol. The Parties will address any material changes to the protocols by negotiating an Amended Statement of Work addressing any such changes. By: By: Title: Title: Email: Email: Date: Date: Marketplace Payment Voucher
1. In Marketplace home page, scroll to bottom section “showcases” select Payment voucher form under “CU Purchasing & Payment Forms” and enter the following: - Supplier: “Children’s Hospital Colorado” Select a Different Fulfillment Center Select Location 366 Attn: Grants/Cash Management 00000 X 00xx Xxxxxx X000 Xxxxxx, XX 00000 XX - Payee type: Non-employee - Warrant Deliver Code: Regular mail - Payment is being authorized for: Service Fees to medical affiliates - Notes: Service for project, speedtype, PI, period of invoice - Commodity Code: 13 - Add invoice to payment voucher at the bottom using the add attachment button
2. Click “Add and go to cart” Add Speedtype and Account code: Use account code 535102-Medical Services, Click Calculate and Save
3. Click on Summary Tab
