Common use of Changes to the Protocol Clause in Contracts

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. 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 increases 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. 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 increases the cost of performance of the Study Trial by the Institution, SPONSOR and Institution will work together to amend the Study Trial 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.