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. Institu- tion or Investigator will promptly notify Idorsia if any Regulatory Authority begins to con- duct, or gives notice of its intent to conduct, an inspection pertaining to the Study or that could affect the Study. During such inspec- tion, Institution and Investigator shall coop- erate with Regulatory Authorities. To the ex- tent allowed by Applicable Law, Institution or Investigator shall provide Idorsia with copies of all pertinent information and documenta- tion issued by any Regulatory Authority and any proposed response, and Idorsia and/or its Representatives shall have the right to re- view and approve any responses that pertain to the Study. In any event, no such response shall contain any false or misleading infor- mation with respect to the Study or Idorsia. 3.3
Regulatory Inspections and Audits. Poskytovatel a/nebo hlavní zkoušející neprodleně vyrozumí společnost PPD, pokud to není zakázáno platnými předpisy, pokud RÚ/MEK a/nebo LEK s ohledem na klinické hodnocení (a) kontaktuje poskytovatele nebo hlavního zkoušejícího, (b) provádí nebo oznámí svůj záměr provést inspekci na kterémkoliv řešitelském centru nebo (c) nebo oznámí svůj záměr přijmout další regulační opatření ve vztahu k jakékoli činnosti poskytovatele, LEK nebo hlavního zkoušejícího. a. Institution and/or Principal Investigator shall promptly notify PPD unless prevented from doing so by applicable law, if any RA/MEC and/or LEC, with respect to the Study (a) contacts the Institution or the Principal Investigator, (b) conducts, or gives notice of its intent to conduct, an inspection at any Study site or (c) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of the Institution, the LEC or the Principal Investigator.
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 inspection pertaining to the Study or that could affect the Study. During such inspection, Institution and Investigator shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Institution or Investigator shall provide Idorsia with 3.3
Regulatory Inspections and Audits. Upon reasonable prior notice, BIO-RAD shall afford access to its facilities during normal business hours to the FDA and any other state, federal or foreign regulatory agency having jurisdiction over CIPHERGEN’s business operations in the Clinical Diagnostics Market and/or the PRODUCTS sold by CIPHERGEN to: (a) inspect the BIO-RAD facilities where PRODUCTS are manufactured including, without limitation, work-in-progress and finished inventory, and (b) audit any records maintained by BIO-RAD in accordance with Section 8.1 above. CIPHERGEN shall bear all out-of-pocket costs associated with such audits.
Regulatory Inspections and Audits. 12.1 Covance shall during and up to ***** after the term of the Agreement, permit the Sponsor or its representatives (which shall not be a competitor of Covance) to: (a) audit and examine Covance’s principal facilities, operations and quality systems and documentation that are used or that are intended to be used in the performance of the Services or a Study; and (b) audit and copy the Results, regardless of location. The provisions of this Section shall also apply to Study sites managed by Covance.
Regulatory Inspections and Audits. 7.1. Supplier shall be solely responsible for obtaining, and shall obtain in a timely manner, and maintain in good standing, all necessary licenses, registrations, notifications, certificates, approvals, authorizations or permits required under Applicable Law, whether de novo documents or modifications to existing documents, which are necessary to perform the Services, and Supplier shall bear all costs and expenses associated therewith, and Supplier shall provide copies of such documents to Zogenix upon request by Zogenix.
Regulatory Inspections and Audits. 12.1 Except as otherwise provided in the additional terms and conditions of each Company Affiliate that apply to the services provided by a Company Affiliate (and any Work Orders thereunder) under Exhibit A, the terms of this section shall apply to Services provided under this Agreement and any applicable Work Order.
Regulatory Inspections and Audits. Provider will promptly notify Actelion if any Regulatory Authority begins to conduct, or gives notice of its intent to conduct, an inspection pertaining to the Study or that could affect the Study. During such inspection, Provider shall cooperate with Regulatory Authorities. To the extent allowed by Applicable Law, Provider shall provide Actelion with copies of all pertinent information and documentation issued by any Regulatory Authority and any proposed response, and Actelion and/or its Representatives shall have the right to review and approve any responses that pertain to the 3.3
Regulatory Inspections and Audits
