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. 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. DBS will grant reasonable access to its facilities, records and personnel to regulatory authorities for the purpose of auditing the Exchanges.
Regulatory Audits. The Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Studies or Manufacturing of Collaboration Product in the Field are conducted by or on behalf a Party pursuant to this Agreement, whether such site or facility is such Party’s or its Affiliate’s or Subcontractor’s (each an “Audited Site”). Taiho shall be given a reasonable opportunity, at its own cost, (taking into account the timing and notice provided by the applicable Regulatory Authority) to assist in the preparation of Cxxxxxxx’x and its Subcontractors’ Audited Sites for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of such Audited Sites, and the summary, or wrap-up, meeting with a Regulatory Authority at the conclusion of such inspection. Each Party will provide to the other Party a copy of the report resulting from any Regulatory Authority audit of such Party’s or its Affiliate’s or Subcontractor’s Audited Site. If providing such report would result in the disclosure to the other Party of Confidential Information unrelated to the subject matter of this Agreement, the Parties shall enter into a reasonable and customary confidentiality agreement covering such unrelated subject matter. In the event that any Audited Site of a Party, its Affiliate or its Subcontractor is found to be non-compliant with one or more Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice or current standards for pharmacovigilance practice, such Party shall submit to the other Party a proposed recovery plan or Corrective and Preventative Actions (“CAPA”) within [*****] Business Days after such Party, its Affiliate or its Subcontractor receives notification of such non-compliance from the relevant Regulatory Authority and such Party shall use Commercially Reasonable Efforts to implement such recovery plan or CAPA promptly after submission.
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. If a Regulatory Authority desires to conduct an inspection or audit of a Party with regard to a Licensed Product in the Field, each Party agrees to cooperate with the other and the Regulatory Authority during such inspection or audit. Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the receiving Party will promptly provide to the other Party), the Party in receipt of the observations will prepare any appropriate responses; provided that the JSC, to the extent practicable, shall have the right to review and comment on such responses to the extent they cover or may be reasonably expected to adversely impact any Co-Promote Product in the U.S., and the Party that received the observations shall consider in good faith the comments made by the JSC. Without limiting the foregoing, if any audited site is found to be non-compliant with one or more GLP, GMP, or current standards of good pharmacovigilance standards, the applicable Party shall, within [***] Business Days of receipt of notification of such non-compliance, submit to the other Party a proposed remedy plan or Corrective and Preventative Action (“CAPA”), which for clarity [***] and shall implement such remedy plan or CAPA. Any follow-up documentation to implement or substantiate a proposed remedy plan or CAPA, which for clarity, [***], shall be promptly shared, including, where a Regulatory Authority does not accept the applicable CAPA, or requests further information regarding any such remedy plan or CAPA, and the additional steps shall be agreed between the Parties. Without limiting the foregoing, each Party (and its Subcontractors) shall notify the other Party as promptly as reasonably practicable, but no later than within [***] Business Days, upon receipt of a notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities used or proposed to be used for the Manufacture of Co-Promote Products under the Core Commercialization Plan. Notwithstanding the foregoing, the rights and obligations of a Party under this Section 4.4.4 shall be [***].
