Regulatory Authorities definition
Examples of Regulatory Authorities in a sentence
The NHS CI Employer acknowledges that Regulatory Authorities may inspect its, and the Chief Investigator’s, activities and records related to the Clinical Trial, subject to compliance with Data Protection Laws and Guidance.
Ionis will promptly notify Ono if Ionis is required to make any material changes to such performance (a) to comply with any changes in Applicable Law, (b) to comply with specific requirements imposed by Regulatory Authorities, or (c) as Ionis reasonably determines in good faith are necessary for safety reasons.
Without limiting Section 8.4 (Regulatory Submissions) and Section 8.8 (No Harmful Actions), Xxx will not be required to delay any submission, correspondence, or communication with any Regulatory Authorities in a manner that affects Xxx’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in such jurisdiction.
For the avoidance of doubt, the restrictions in this Section 6(h) shall not prevent any disclosure to Regulatory Authorities contemplated under Section 6(i).
While Ono is providing Transition Services, Xxx and Xxxxx will mutually agree on talking points and a communication plan to key stakeholders, including customers, specialty pharmacies, physicians, Regulatory Authorities, patient advocacy groups, payors, and clinical study investigators, and Xxx will make all such communication to such entities and individuals in accordance with the mutually agreed talking points.