Urgent Safety Measures or Serious Breaches. If either Party becomes aware of (a) any urgent safety measures taken by a Clinical Investigator to protect Subjects against any immediate hazard or (b) any serious breaches of the Development Plan or any Applicable Laws (including GCP guidelines), such Party will immediately inform the JDC.
Appears in 3 contracts
Samples: Development and Commercialization License Agreement (Opko Health, Inc.), Development and Commercialization License Agreement, Development and Commercialization License Agreement (Opko Health, Inc.)
Urgent Safety Measures or Serious Breaches. If either Party becomes aware of (a) any urgent safety measures taken by a Clinical Investigator to protect Subjects against any immediate hazard or (b) any serious breaches of the Development Plan Protocol or any Applicable Laws (including ICH GCP guidelines), such Party will immediately inform the JDC.
Appears in 1 contract
Samples: Co Development Agreement (PhaseBio Pharmaceuticals Inc)
