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. 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 ***CONFIDENTIAL TREATMENT REQUESTED conduct such analyses as HONEYWELL may reasonably request in connection with any regulatory submission or audit concerning the LICENSED PRODUCTS.
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.
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. Purchaser (inclusive of its employees and representatives) shall have the right to audit Seller’s facilities, as Purchaser deems necessary. Seller shall also cooperate with regulatory agency requests to audit Seller’s facility, provided, Purchaser shall not be entitled to be present during any regulatory agency inspection. However, exercise of such right shall be subject to the following conditions: (a) Purchaser or its representatives, as the case may be, must sign Seller’s standard confidentiality agreement (“Confidentiality Agreement”); (b) Purchaser shall be entitled to conduct only one audit per Contract Year unless additional audits are required by law or regulation or otherwise agreed or unless Purchaser can demonstrate that Seller has materially breached this Agreement; (c) Purchaser audits shall be conducted only after reasonable advance written notice of the audit is provided by Purchaser to Seller and then only at such time as is reasonably convenient to Seller; (d) all information gathered and data reviewed during any such audit shall be “Confidential Information” subject to the provisions of the Confidentiality Agreement; and (e) the scope of each such audit shall be limited to the production and delivery (copies of which shall not be removed from Seller’s premises) of the Products under this Agreement and all documentation, data, and other records relating solely thereto, including but not limited to, production standard operating procedures that are not proprietary (e.g., QC, testing, training, etc.), and records and data relating to raw materials. Seller shall cooperate with Purchaser in the performance of such audit. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Regulatory Audit. 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 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. Genzyme will have the right to have a representative observe such inspection or audit of a facility operated by Isis or under contract with Isis. 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 [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. observations, and will provide a copy of such response to the other Party.
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. In the event that, in connection with any investigation or review of Vista Outdoor, any Governmental Entity shall request from Orbital ATK or any of its Affiliates any access, information or assistance, Orbital ATK and its Affiliates shall reasonably cooperate therewith at Vista Outdoor’s expense. In the event that, in connection with any investigation or review of Orbital ATK, any Governmental Entity shall request from Vista Outdoor or any of its Affiliates any access, information or assistance, Vista Outdoor and its Affiliates shall reasonably cooperate therewith at Orbital ATK’s expense.
