P rotocol Sample Clauses

P rotocol. The Protocol given to Institution and Investigator by Idorsia is incorporated herein by reference. Any amendments to the Protocol must be agreed to by Idorsia and the Ethics committee in writing. All such amendments shall be automatically incorporated as part of this Agreement. Except solely to the extent necessary to protect the safety, rights, or welfare of Subjects (defined below) due to an emergent medical condition, Institution and Investigator shall not deviate from the Protocol, without prior written consent from Idorsia and the Ethics committee. Notwithstanding the foregoing, to the extent a deviation from the Protocol occurs during the Study, Institution or Investigator shall promptly report such deviation and the reason therefore to Idorsia or to the Ethics committee. 1.3
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