Audits by Regulatory Authorities. Institution shall make available to regulatory authorities, the Study site, the Study Staff, and, subject to Applicable Law relating to patient confidentiality, all Study Materials for purposes of review and audit upon reasonable advance notice during regular business hours. Institution recognizes that the Study and the Institution is subject to inspection by regulatory agencies worldwide, including the FDA. The Institution/Principal Investigator shall provide the Sponsor prompt, advance notification of any audit by a regulatory authority, which audit is directly related to the Study (or, when advance notification is impracticable, prompt notification of any completed audit). To the extent possible, the Institution/Principal Investigator shall permit the Sponsor to review and comment in advance on any written communication from the Institution/Principal Investigator to the regulatory authority in connection with such an audit; provided, however, that such review does not have a material adverse impact on the timeliness of the Institution/Principal Investigator’s response to the regulatory authority. The Institution/Principal Investigator shall promptly provide the Sponsor with copies of all communications between the Institution/Principal Investigator and the regulatory authority related to such audit unless prohibited from so doing by the regulatory authority, and shall promptly take action to correct any deficiencies found by the regulatory authority during the audit. With respect to a pending audit directly related to the Study by the FDA, the EMEA, or by any comparable foreign regulatory authority with jurisdiction over drug approval, the Institution/Principal 2.7 Audity regulačnými orgánmi. Inštitúcia poskytne regulačným orgánom prístup na pracovisko skúšania, k personálu skúšania a podľa platných právnych predpisov týkajúcich sa ochrany súkromia pacientov ku všetkým materiálom skúšania na účely preskúmania a auditu na základe primeraného oznámenia vopred počas riadnych úradných hodín. Inštitúcia uznáva, že klinické skúšanie a inštitúcia podliehajú inšpekcii zo strany regulačných orgánov na celom svete vrátane FDA. Inštitúcia/zodpovedný skúšajúci bezodkladne zadávateľovi vopred oznámia akýkoľvek audit regulačným orgánom, ak audit priamo súvisí s klinickým skúšaním (alebo ak oznámenie vopred nie je prakticky možné, tak bezodkladne xxxxxxx xxxxx xxxxxxxxx audit). Do tej miery, ako to je možné, inštitúcia/zodpovedný skúšajúci povolia zadávateľovi vopred ...
Audits by Regulatory Authorities. In addition to access as provided in Sections 8.1 (Bank Audit Rights and Obligations) and 8.2 (EFS Audit Rights and Obligations), each Party, at its own expense, will permit, in accordance with Applicable Law, any Regulatory Authority to visit its facilities related to the Program. Each Party will also permit, in accordance with Applicable Law, any Regulatory Authority to review and obtain copies of the books and records in its possession or under its control relating to the Program. The access granted under this Section 8.3 shall occur during normal business hours with reasonable advance notice unless otherwise required by any such Regulatory Authority and Applicable Law.
Audits by Regulatory Authorities. Each Party shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Collaboration Activities are conducted pursuant to this Agreement by or on behalf of such Party, whether such site or facility is such Party’s, an Affiliate’s, or a subcontractor’s (each, an “Audited Site”). Such Party shall inform the other Party as promptly as practicable and in any event within [ * ] of receiving notice of such a Regulatory Authority audit and shall provide daily updates to the other Party regarding the audit status. In the event that any Audited Site is found to be non-compliant with one or more of GLP, GCP, GMP, current standards for pharmacovigilance and safety reporting, or requirements related to the protection of human subjects, and such non-compliance relates to or impacts any Collaboration Activities, the audited Party shall submit to the other Party proposed CAPA within [ * ] after the audited Party, its Affiliate, or its subcontractor receives notification of such non-compliance from the relevant Regulatory Authority. The other Party shall have the right to review and comment on such CAPA, which comments the audited Party shall consider in good faith. The audited Party shall use Diligent Efforts to implement such CAPA promptly after review and comment by the other Party.
Audits by Regulatory Authorities. The Institution shall provide the Sponsor prompt, advance notification of any audit by a regulatory authority, which audit is directly related to the Study (or, when advance notification is impracticable, prompt notification of any completed audit). To the extent possible, the Institution shall permit the Sponsor to review and comment in advance on any written communication designated for the regulatory authority in connection with such an audit; provided, however, that such review does not have a material adverse impact on the timeliness of the Institution’s response to the regulatory authority. The Institution shall promptly provide the Sponsor with copies of all communications between the Institution and the regulatory authority related to such audit unless prohibited from so doing by the regulatory authority, and shall promptly take action to correct any deficiencies found by the regulatory authority during the audit. With respect to a pending audit directly related to the Study by the FDA or by any comparable regulatory authority (e.g. SÚKL), the Institution shall permit the Sponsor’s representatives to be present at such audit unless prohibited from so doing by Applicable Law. With respect to any 2.7 Audity, které provádějí kontrolní úřady. Zdravotnické zařízení neprodleně zadavateli předem oznámí jakýkoliv audit ze strany kontrolního úřadu, který se bude přímo týkat studie (nebo, jestliže oznámení předem není možné, neprodleně oznámí jakýkoliv provedený audit). V míře, v jaké to bude možné, umožní zdravotnické zařízení zadavateli předem zkontrolovat jakékoliv písemné sdělení určené kontrolnímu úřadu v souvislosti s takovým auditem a vyjádřit se k němu, ovšem za předpokladu, že tato kontrola nebude mít podstatný nežádoucí dopad na včasnost odpovědi zdravotnického zařízení kontrolnímu úřadu. Zdravotnické zařízení zadavateli neprodleně poskytne kopie veškeré komunikace mezi zdravotnickým zařízením a kontrolním úřadem, která se bude takového auditu týkat, pokud mu to kontrolní úřad nezakáže, a neprodleně podnikne kroky k nápravě veškerých nedostatků, které kontrolní úřad během auditu zjistí. Pokud jde o dosud nedokončený audit, který se bude přímo týkat studie, ze strany FDA nebo jiného srovnatelného kontrolního úřadu (např. SÚKL), umožní zdravotnické zařízení zástupcům zadavatele, aby byli u takového auditu přítomni, pokud jejich účast nebude zakázána podle příslušných zákonů. Pokud audit by any regulatory authority, which audit is not directly related...
Audits by Regulatory Authorities. Licensee shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Trials or other Development activities or Manufacturing activities are conducted pursuant to this Agreement by Licensee or on its behalf, whether such site or facility is Licensee’s, an Affiliate’s, or a subcontractor’s (each, an “Audited Site”). Licensee shall inform Xxxxxxx as promptly as practicable and in any event within forty-eight (48) hours of receiving notice of such a Regulatory Authority audit and shall provide daily updates regarding the audit status. In the event that any Audited Site is found to be non-compliant with one or more of GLP, GCP, GMP, current standards for pharmacovigilance and safety reporting, or requirements related to the protection of human subjects, and such non-compliance relates to or impacts any Licensed Product, Licensee shall submit to Xxxxxxx proposed CAPA within thirty (30) days after Licensee, its Affiliate, or its subcontractor receives notification of such non-compliance from the relevant Regulatory Authority. Xxxxxxx shall have the right during the License Term, to review and comment on such CAPA, which comments Licensee shall consider in good faith. Licensee shall use Commercially Reasonable Efforts to implement such CAPA promptly after review and comment by Xxxxxxx.
Audits by Regulatory Authorities. Each Party shall inform the other Party within 48 hours following its receipt of notice of an inspection of an Audited Site of such Party (including such Party) by a Regulatory Authority that relates to any Research Plan Activity conducted at such Audited Site (“Regulatory Audit”). Each Party shall cooperate in good faith with the Regulatory Authority during a Regulatory Audit of such Party. Each Party shall provide daily updates to the other Party regarding its knowledge of the status of a Regulatory Audit and, to the extent not prohibited by Applicable Law, provide any materials received by such Party from the Regulatory Authority or an Audited Site in relation thereto.
Audits by Regulatory Authorities. Each Party shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility of the other Party or its Affiliates or subcontractors where Collaboration Activities or other activities with respect to the Product are conducted pursuant to this Agreement by or on behalf of such Party (each, an “Audited Site”). Such Party shall inform the other Party as promptly as practicable and in any event within forty-eight (48) hours of receiving notice of such a Regulatory Authority audit and shall provide reasonable updates to the other Party regarding the audit status. In the event that any Audited Site is found to be non-compliant with one or more of GLP, GCP, GMP, current standards for pharmacovigilance and safety reporting, or requirements related to the protection of human subjects, and such non-compliance relates to or impacts any Collaboration Activities, the audited Party shall submit to the other Party proposed CAPA within forty-five (45)) days after the audited Party, its Affiliate, or its subcontractor receives notification of such non-compliance from the relevant Regulatory Authority. The other Party shall have the right to review and comment on such CAPA, which comments the audited Party shall consider in good faith. The audited Party shall use Commercially Reasonable Efforts to implement such CAPA.
Audits by Regulatory Authorities. The Institution shall provide the Sponsor prompt, advance notification of any audit by a regulatory authority, which audit is directly related to the Study (or, when advance notification is impracticable, prompt notification of any completed audit). To the extent possible, the Institution shall permit the Sponsor to review and comment in advance on any written communication from the Institution to the regulatory authority in connection with such an audit; provided, however, that such review does not adversely impact the timeliness of the Institution’s response to the regulatory authority. The Institution shall promptly provide the Sponsor with copies of all communications between the Institution and the regulatory authority related to such audit unless prohibited from so doing by the regulatory authority, and shall promptly take action to correct any deficiencies found by the regulatory authority during the audit. With respect to a pending audit directly related to the Study by the FDA or by any comparable foreign regulatory authority with jurisdiction over drug/device approval, the Institution shall permit the Sponsor’s representatives to be present at such audit unless prohibited from so doing by the FDA or such foreign regulatory authority. With respect to any audit by any regulatory authority, which audit is not directly related to the Study, the Institution shall promptly notify the Sponsor of any findings of such an audit that would be likely to have an adverse effect on the Institution’s ability to conduct the Study.
Audits by Regulatory Authorities. If legally permissible, Institution will notify Abbott within two business days upon receipt of any requests by a regulatory authority to inspect or have access to Study documents and will promptly provide Abbott with a copy of any such request, to include copies of any documents received from or provided to regulatory authorities. If legally permissible, Abbott may attend or request to be present during any inspection. Abbott agrees not to alter or interfere with any documentation or practice of Institution. Upon receipt of a regulatory citation or notice relating to this Agreement, Institution agrees to produce a summary within 10 business days that includes an explanation of the issues identified by the regulatory authority and any response thereto.
Audits by Regulatory Authorities. Institute shall, to the extent permitted by Applicable Law, including any confidentiality, peer review, or legal privileges that may attach, provide Company reasonable advance notification of any audit by a regulatory authority to the extent the audit is directly related to the Study being conducted hereunder (each a “Regulatory Study Audit”). If advance notification is impracticable, Institute will provide Company notification of any completed Regulatory Study Audit.
