Protocol Changes. MSK and / or Investigator-Sponsor will not make any changes to the Protocol without first informing Company of any such change and obtaining the written approval of the appropriate regulatory entity, IRB and of Company, unless such changes are required for the health and safety of Study subjects, in which case such Protocol change shall not be considered a breach of this Agreement by MSK nor a cause for termination by Company. If these changes affect the cost of conducting the Study, MSK will submit to Company a written estimate of such changes for prior written approval. MSK will provide Company with a copy of all Protocols approved by the IRB, including Protocol(s) approved prior to the Effective Date of this Agreement and any later versions, which will be revised in accordance with this Section 6.
Protocol Changes. The District will continue to meet with Public Health – Seattle & King County and display COVID prevention strategies for the 2021-2022 school year that are linguistically accessible and visible at all school and district worksites. Any changes communicated to the District from PHSKC that necessitate modifications to COVID protocols will be communicated in the LMC and to impacted SEA staff before implementation. The protocol changes will also be incorporated into the District website for community members to view.
Protocol Changes. This form can be used only for simple modifications of the experimental protocol such as disinfectant changes, use of same agent in a different form, or changes in vector or host organisms that do not alter classification of the experiment or safety of the protocol. Major protocol adjustments such as changes/additions to chemical or biological agents, changes in animal model, or use of vector or host organisms that change classification of the experiment require completion of a new MUA.
Protocol Changes. The managers shall have no authority to modify or amend the terms of this Agreement. The managers may establish or change other provisions in the Protocol goals to the extent such changes are consistent with the terms of this Agreement. Changes made to a Protocol, if any, shall be limited to those changes that have been reviewed and approved by both managers in accordance with the following procedure: (a) either manager may submit a request to the other describing the proposed change and the rationale for such change; (b) both managers shall assess the impact that the proposed change may have on the price and timing of the Protocol; and (c) acceptance of the proposed change shall require the written approval by both managers acknowledging their acceptance of amended tasks, timetable adjustments, and estimated cost adjustments for each task.
