Regulatory Audits. BNY Mellon shall, upon reasonable prior notice when possible, make all books and records available to the applicable Voya or Voya Fund regulators and state government representatives or their designees to audit, evaluate and inspect BNY Mellon’s books and records for Voya and such Voya Fund. BNY Mellon agrees to reasonably cooperate with and assist Voya in meeting any regulatory requirements related to audits or inspections imposed upon Voya to the extent that Voya notifies BNY Mellon of such requirements.
Regulatory Audits. In addition to the reasonable quality assurance audits contemplated under Section 2.11, if MTPC or ADCT receives a notice that a Regulatory Authority desires to conduct an inspection or audit of any of facilities regarding Licensed Compounds and/or Products, then such Party shall promptly notify the other Party of such inspection or audit. The Parties shall discuss in good faith the response to such notice of an inspection or audit from Regulatory Authority. The inspected Party shall permit such inspection or audit, or obtain consent by such contracted facility for such inspection or audit, and cooperate with the Regulatory Authority for such inspection and audit. Upon the reasonable written request of the inspected Party, the other Party shall assist the inspected Party in connection with such inspection or audit and cooperate with the Regulatory Authority in the Territory for such inspection and audit. Following receipt of the inspection or audit observations of such Certain confidential information contained in this document, marked by [**], has been omitted because ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) is the type that ADCT customarily and actually treats as private or confidential. Regulatory Authority in writing (a copy of which the inspected Party will promptly provide to the other Party), the inspected Party, as applicable, shall prepare the response to any such observations, if necessary, and shall provide a copy of such response to the other Party, if any. If the Regulatory Authority requires MTPC to do additional testing following such inspection and audit, which MTPC is unable to conduct on its own, ADCT shall reasonably assist MTPC in conducting such additional testing and the details and costs associated with such testing shall be determined under an update to the MTPC Development Plan that is approved through the Governance Mechanism. ADCT’s obligations under this Section 6.4.3 are subject to the terms of ADCT’s agreements with its contractors, including contract manufacturing organizations.
Regulatory Audits. DBS will grant reasonable access to its facilities, records and personnel to regulatory authorities for the purpose of auditing the Exchanges.
Regulatory Audits. If a Regulatory Authority in the Territory desires to conduct an inspection or audit of a Party’s facility, or a facility under contract with a Party, with regard to a POZEN Product, then such Party will promptly notify the other Party and permit and cooperate with such inspection or audit, and will cause the contract facility to permit and cooperate with such Regulatory Authority and such other Party during such inspection or audit. Licensee will have the right upon request (which request shall not be unreasonably withheld) to have a representative observe such inspection or audit with respect to a POZEN facility, or a facility under contract with POZEN. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which the audited Party will immediately provide to the other Party), the audited Party will prepare the response to any such observations, and will provide a copy of such response to the other Party. The audited Party agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable Laws.
Regulatory Audits. If a Regulatory Authority desires to conduct an inspection or audit of a Party’s facility, or a facility under contract with a Party, with regard to a Collaboration Product, then such Party shall promptly notify the other Party and permit and cooperate with such inspection and audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which the audited Party will immediately provide to the other Party), the audited Party shall prepare the response to any such observations and shall provide a copy of such response to the other Party.
Regulatory Audits. Within thirty (30) days of its receipt, Servicer shall provide FMC with a summary of any audit results performed by a federal or state regulator concerning the Services provided under this Agreement, including but not limited to the Department of Education. The content of any such summary shall be subject to Servicer’s reasonable security requirements. When the regulatory auditor’s procedures reveal exceptions or control deficiencies, then Servicer shall take steps to correct the control design deficiency or operating effectiveness deficiency in all material respects. If such audit reveals that the services provided by Servicer do not cause Servicer’s operations to meet the auditor’s recommendation, then Servicer shall provide such further services as are necessary to bring its operations into conformance with the auditor’s recommendations to such level and degree, at no cost to FMC.
Regulatory Audits. Each Party shall permit the other Party reasonable access to its regulatory records, no more than once in any twelve (12) month period, to permit the auditing Party to determine that regulatory obligations are being met. The auditing Party shall provide ten (10) days prior written notice of such an audit.
Regulatory Audits. Flextronics shall promptly notify Customer when an FDA inspection of its facilities, or an inspection by third parties in accordance with FDA regulations, or inspection by a Notified Body, related to the Product(s) is expected and/or underway. Flextronics shall also provide the Customer the option of attending the Audit if it pertains to Customer’s products. Flextronics shall promptly provide Customer with copies of all related correspondence, including without limitation audit reports, Form FDA 483s, Warning Letters, and any related correspondence with FDA or the Notified Body, as applicable.
Regulatory Audits. To the extent that Cephalon’s participation is requested by FBIO, the Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Trials or Manufacturing of Licensed Products in the Field are conducted pursuant to this Agreement, whether such site or facility is FBIO’s or its Affiliate’s or a permitted subcontractor’s.
Regulatory Audits. Achillion shall cooperate in good faith in the event any Regulatory Authority inspects any site where clinical studies or Manufacturing of clinical supplies of Licensed Products are conducted by or on behalf of Achillion pursuant to this Agreement, whether such audited site is Achillion’s or its Affiliate’s or contractor’s (such as under an Existing Third Party Agreement), as permitted by and subject to the terms and conditions of any applicable Existing Third Party Agreement of Achillion or as otherwise expressly permitted by the applicable Third Party. Achillion shall notify Xxxxxxx within [**] Business Days after receiving notification of any Regulatory Authority inspection at any site where clinical studies or Manufacturing of clinical supplies of any Achillion Single APIs and/or Licensed Products are conducted. Taking into account the timing and notice provided by the applicable Regulatory Authority, Applicable Law, and the terms of any applicable Existing Third Party Agreement, Xxxxxxx shall be given a reasonable opportunity to assist in the preparation of Achillion’s audited site for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the audited site, and the summary, or wrap-up, meeting with a Regulatory Authority at the conclusion of such inspection. If such attendance would result in the disclosure of Achillion’s or its audited site’s Confidential Information not related to the subject matter of this Agreement, the Parties shall enter into a confidentiality agreement covering such unrelated subject matter. In the event that any audited site is found to be non-compliant with one or more Applicable Laws, Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, or current standards for pharmacovigilance practice, Achillion or its applicable contractor under an Existing Third Party Agreement shall submit to Xxxxxxx a CAPA plan within [**] Business Days after receiving notification of such non-compliance from the non-compliant audited site and shall use commercially reasonable efforts to cause such non-compliant audited site to implement such CAPA plan promptly after submission.
