Common use of Regulatory Inspections and Audits Clause in Contracts

Regulatory Inspections and Audits. Institution or Investigator will promptly notify Idorsia if any Regulatory Authority begins to conduct, or gives notice of its intent to conduct, an in- spection pertaining to the Study or that could affect the Study. During such inspection, In- stitution and Investigator shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Institution or Investigator shall provide Idorsia with copies of all perti- nent information and documentation issued by any Regulatory Authority and any pro- posed response, and Idorsia and/or its Rep- resentatives shall have the right to review and approve any responses that pertain to the Study. In any event, no such response shall contain any false or misleading information with respect to the Study or Idorsia. 3.3

Regulatory Inspections and Audits. Institution or Investigator will promptly notify Idorsia if any Regulatory Authority begins to conduct, or gives notice of its intent to conduct, an in- spection inspection pertaining to the Study or that could affect the Study. During such inspection, In- stitution Institution and Investigator shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Institution or Investigator shall provide Idorsia with copies of all perti- nent pertinent information and documentation issued by any Regulatory Authority and any pro- posed proposed response, and Idorsia and/or its Rep- resentatives Representatives shall have the right to review and approve any responses that pertain to the Study. In any event, no such response shall contain any false or misleading information with respect to the Study or Idorsia. 3.3

Regulatory Inspections and Audits. Institution or Investigator will promptly notify Idorsia if any Regulatory Authority begins to conduct, or gives notice of its intent to conduct, an in- spection inspection pertaining to the Study or that could affect the Study. During such inspection, In- stitution Institution and Investigator shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Institution or Investigator shall provide Idorsia with copies of all perti- nent pertinent information and documentation issued by any Regulatory Authority and any pro- posed proposed response, and Idorsia Xxxxxxx and/or its Rep- resentatives Representatives shall have the right to review and approve any responses that pertain to the Study. In any event, no such response shall contain any false or misleading information with respect to the Study or Idorsia. 3.3

Regulatory Inspections and Audits. Institution or Investigator will promptly notify Idorsia Actelion if any Regulatory Authority begins to conduct, or gives notice of its intent to conduct, an in- spection inspection pertaining to the Study or that could affect the Study. During such inspection, In- stitution Institution and Investigator shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Institution or Investigator shall provide Idorsia Actelion with copies of all perti- nent pertinent information and documentation issued by any Regulatory Authority and any pro- posed proposed response, and Idorsia Actelion and/or its Rep- resentatives Representatives shall have the right to review and approve any responses that pertain to the Study. In any event, no such response shall contain any false or misleading information with respect to the Study or IdorsiaActelion. 3.33.4

Regulatory Inspections and Audits. Institution or Investigator will promptly notify Idorsia Actelion if any Regulatory Authority begins to conduct, or gives notice of its intent to conduct, an in- spection inspection pertaining to the Study or that could affect the Study. During such inspection, In- stitution Institution and Investigator shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Institution or Investigator shall provide Idorsia Actelion with copies of all perti- nent pertinent information and documentation issued by any Regulatory Authority and any pro- posed proposed response, and Idorsia Actelion and/or its Rep- resentatives Representatives shall have the right to review and approve any responses that pertain to the Study. In any event, no such response shall contain any false or misleading information with respect to the Study or Idorsia. 3.3Actelion.

Regulatory Inspections and Audits. Institution or Investigator will promptly notify Idorsia if any Regulatory Authority begins to conduct, or gives notice of its intent to conduct, an in- spection pertaining to the Study or that could affect the Study. During such inspection, In- stitution and Investigator shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Institution or Investigator shall provide Idorsia with copies of all perti- nent information and documentation issued by any Regulatory Authority and any pro- posed response, and Idorsia and/or its Rep- resentatives shall have the right to review and approve comment any responses that pertain to the Study. In any event, no such response shall contain any false or misleading information with respect to the Study or Idorsia. 3.3