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. 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. 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. 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.
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. 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 can negotiate further remuneration.
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. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Changes to the Protocol. No change in the Protocol shall be made by the Institution or the Principal Investigator, subject to any Applicable Laws relating to the safety of Subjects that require a deviation from the Protocol, in which case 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 five (5) days’ advance written notice to the Institution; provided, however, that, unless the changes are required by Applicable Laws, do not materially increase the cost of performance of the Study by the Institution or are otherwise agreed to by the Institution, the Institution may terminate this Agreement pursuant to Section 24.
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 Parties will address any material changes to the protocols by negotiating an Amended Statement of Work addressing any such changes. University Department Fiscal Manager Children’s Hospital Colorado By: By: Title: Title: Email: Email: Date: Date: Marketplace Payment Voucher
