Regulatory Audit Sample Clauses

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. 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. 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. JV shall permit authorized representatives of any Regulatory Authority to inspect JV’s plant and production facilities relating to or used in connection with the manufacture of the Products and shall promptly notify Medifocus when JV receives notice of any such inspection. JV shall advise Medifocus of the findings of any regulatory inspection and shall take the steps necessary to correct promptly any compliance deficiencies found by the Regulatory Authority relating to the manufacture of the Products. JV further agrees to use its best efforts to provide to Medifocus such documentation or conduct such analyses as Medifocus may reasonably request in connection with any regulatory submission or audit.

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. 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. 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.

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.