Regulatory Audit. In addition to the rights set out above, each Party acknowledges and agrees that certain government departments and regulatory, statutory and other entities, committees and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate, investigate or influence any matters within this Agreement or any other affairs of the other Party (collectively, “Regulatory Bodies”) from time to time require the right, whether by virtue of Law, regulation, code of conduct or otherwise, to investigate the affairs of such other Party; and accordingly each Party agrees to provide such access as is referred to in Section 5.4 and all such other access, information and assistance as such Regulatory Bodies properly require in order to fulfill such requirements. If a Party considers that any requirement relates to information which is confidential to such Party, such Party will be entitled to disclose the information directly to the Regulatory Body without having to disclose it to the other Party.
Regulatory Audit. If a Regulatory Authority notifies a Party that it plans to conduct an inspection or audit of such Party’s facility or a Subcontractor of such Party (to the extent permitted under the applicable agreement with such Subcontractor) with regard to any Product, then such Party will notify the other Party [*] of such notification of such audit or inspection and provide such other Party with copies of any materials provided to it by the applicable Regulatory Authority, provided that the first Party will not be required to notify the other Party of audits or inspections that do not relate to any Product, except where such audits result in communications or actions of such Regulatory Authority which have an impact upon any Product. In addition, if a Regulatory Authority conducts an unannounced inspection or audit of a Party or a Subcontractor or such Party (to the extent permitted under the applicable agreement with such Subcontractor) with regard to any Product, then such Party will notify the other Party [*]. The inspected Party will cooperate, and will [*] to cause the applicable Subcontractor to cooperate, with such Regulatory Authority during such inspection or audit. Without limiting Section 6.1, following any such inspection or audit, (a) such Party will provide the other Party with a copy of any inspection or audit observations of such Regulatory Authority, [*] upon its receipt thereof, and copies of any other written communications received from Regulatory Authorities with respect to such inspections or audits (to the extent such written communications relate to any Product or the Manufacture thereof) in a timely manner after its receipt thereof, and (b) such Party will provide the other Party with a copy of any proposed response to any such observations or communications and will implement such other Party’s reasonable comments with respect to such proposed response. The inspected Party agrees to conform its activities under this Agreement to any commitments made in such a response.
Regulatory Audit. Terumo shall notify IceCure promptly and any event no later than five (5) Business Days after becoming aware of a Regulatory Authority audit or inspection of Terumo or its Affiliates with respect to the Product. The Parties agree to cooperate during the preparation and conduct of any audit by a Regulatory Authority.
Regulatory Audit. Supplier will permit authorized representatives of any Regulatory Authority to inspect Supplier’s plant and production facilities relating to or used in connection with the manufacture of Company Product and will promptly notify BioForm when Supplier receives notice of any such inspection. Supplier will advise BioForm of the findings of any regulatory inspection and will promptly take the necessary steps to correct any compliance deficiencies found by the Regulatory Authority relating to the production of Company Product. Supplier further agrees to use its reasonable best efforts to provide to BioForm such documentation or conduct such analyses as BioForm may reasonably request in connection with any regulatory submission or audit concerning Company Product. BioForm will permit authorized representatives of any Regulatory Authority to inspect BioForm’s facilities relating to distribution of Company Product and will promptly notify Supplier when BioForm receives notice of any such inspection. BioForm will advise Supplier of the findings of any regulatory inspection and will promptly take the necessary steps to correct any compliance deficiencies found by the Regulatory Authority relating to BioForm’s activities with Company Product.
Regulatory Audit. LICENSEE will permit authorized representatives of any REGULATORY AUTHORITY to inspect LICENSEE’S or its manufacturers’ plant and production facilities relating to or used in connection with the manufacture of the LICENSED PRODUCTS and will promptly notify HONEYWELL when LICENSEE receives notice of any such inspection. LICENSEE will advise HONEYWELL of the findings of any regulatory inspection and will promptly take the necessary steps to correct any compliance deficiencies found by the REGULATORY AUTHORITY relating to the production of the LICENSED PRODUCTS. LICENSEE further agrees to use commercially reasonable efforts to provide to HONEYWELL such documentation or conduct such analyses as HONEYWELL may reasonably request in connection with any regulatory submission or audit concerning the LICENSED PRODUCTS.
Regulatory Audit. In addition to the annual audit, CUSTOMER shall be entitled to request, authorize or conduct (or have it done on its behalf) any necessary additional audit required pursuant to any notification from a governmental or regulatory authority to conduct an inspection of the Facility (or other facility) used in the development, manufacturing, storage or handling of the Product. Under such circumstances, NOVASEP will, without charge, permit governmental or regulatory authority bodies (together with CUSTOMER’s designated representatives) to enter those areas of NOVASEP premises (including the Facility) used for the performance of the Works for the purpose of observing and inspecting the performance of the Works and those records of NOVASEP specific to the Works. During any such regulatory inspections, NOVASEP will provide reasonable assistance as requested by the relevant governmental or regulatory authority and shall promptly permit access to and copy and verify records and reports in NOVASEP’s possession, custody or control relating to the Works. In addition to the above, NOVASEP shall immediately notify CUSTOMER of any audit or inspection undertaken at the Facility by any authority or regulatory body that raises any issues, deviations, defects, actions or concerns with respect to the operation of the Facility. NOVASEP’s personnel or record keeping, and shall provide full details of the same to CUSTOMER together with the remedial plan and updates as to NOVASEP’s progress to resolving all issues, deviations, defects, actions or concerns.
Regulatory Audit. Each Party shall notify the other Party after becoming aware of a Regulatory Authority audit or inspection of such Party or its Affiliates with respect to the Product in accordance with the Regulatory Plan. The Parties agree to cooperate during the preparation, conduct and follow-up of any audit by a Regulatory Authority in accordance with the Regulatory Plan.
Regulatory Audit. Brightcove shall reasonably assist and support Company in the event of an investigation by a data protection regulator or similar authority, if and to the extent that such investigation relates to Brightcove’s Processing of Personal Data.
Regulatory Audit. In addition to the rights set out above, Primerica acknowledges and agrees that certain government departments and regulatory, statutory and other entities, committees and bodies which, whether under Law or codes of practice or otherwise, are entitled to regulate, investigate or influence any matters within this Agreement or any other affairs of CitiLife (collectively, “Regulatory Bodies”) from time to time require the right, whether by virtue of Law or code of practice or otherwise, to investigate the affairs of Primerica; and, accordingly, Primerica agrees to provide such access as is referred to in Section 5.4 and all such other access, information and assistance as such Regulatory Bodies properly require in order to fulfill such requirements. CitiLife shall bear any reasonable, out-of pocket costs incurred by Primerica in providing such access, information and assistance. If Primerica considers that any requirement relates to information which is confidential to Primerica, Primerica will be entitled to disclose the information directly to the Regulatory Body without having to disclose it to CitiLife.
Regulatory Audit. JazzHR shall reasonably assist and support Customer in the event of an investigation by a data protection regulator or similar authority, if and to the extent that such investigation relates to JazzHR’s Processing of Customer Data.
