Regulatory Correspondence. Each Party shall promptly (and in any event, within five (5) Business Days of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any material correspondence received from a Governmental Authority in the Territory. In the event that a Party receives any material regulatory letter requiring a response, the other Party will cooperate fully with the receiving Party in preparing such response and will promptly provide the receiving Party with any data or information required by the Receiving Party in preparing any such response.
Regulatory Correspondence. Each Party shall promptly (and in any event, within five (5) Business Days of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any material correspondence received from a Governmental Authority in Canada. In the event that a Party receives any material regulatory letter requiring a response, the other Party will cooperate fully with the receiving Party in preparing such response and will promptly provide the receiving Party with any data or information required by the Receiving Party in preparing any such response.
Regulatory Correspondence. Rugby and HMRI shall make available (or cause to be made available) to each other within three (3) days of receipt of regulatory correspondence regarding regulatory letters, withdrawal of Product, and correspondence bearing on the safety and efficacy of the Product.
Regulatory Correspondence. Each Party shall notify the other Party within [***] of its receipt of information that: (i) raises any concern regarding the safety of any Sublicensed Product(s); (ii) concerns suspected or actual tampering, counterfeiting or contamination or other similar problems with respect to any Sublicensed Product(s); (iii) is reasonably likely to lead to a Recall or market withdrawal of any Sublicensed Product(s); or (iv) concerns any ongoing or potential investigation, inspection, detention, seizure or injunction by a Regulatory Authority involving any Sublicensed Product(s). Each Party shall provide the other Party with copies of any such information. In the event that a Party receives any material regulatory letter requiring a response, the other Party will cooperate fully with the receiving Party in preparing such response and will promptly provide the receiving Party with any data or information reasonably required by the receiving Party in preparing any such response.
Regulatory Correspondence. CPL shall notify OptiNose [***]) of any correspondence, any inspections, and the result of any inspection(s) with the FDA or any Regulatory Authority related to the Product. CPL shall send a draft to OptiNose of all correspondence related to the Product that CPL intends to send to any Regulatory Authority. All correspondence with a [***] 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 Authority related to the Product shall be subject to OptiNose’s review and comment. OptiNose shall have [***] ([***]) business days to review the draft correspondence and provide its comments. CPL shall, acting reasonably, determine whether to incorporate such comments into the final correspondence. If OptiNose fails to review and/or provide comments to such correspondence within [***] ([***]) business days, OptiNose shall be deemed to have no comments to the correspondence. In no event shall OptiNose cause CPL to be late in responding to any Regulatory Authority. With respect to all correspondence and reports provided to OptiNose pursuant to this Section 6.4, CPL shall be entitled to redact any information that is specific to its customers other than OptiNose and is not directly related to the Product, and OptiNose agrees that such correspondence and reports shall constitute Confidential Information of CPL.
Regulatory Correspondence. The Company has made available to the Parent ------------------------- true and correct copies of any and all material correspondence from or to any federal governmental or regulatory agencies or bodies since January 1, 1997, including, without limitation, all significant correspondence with the Securities and Exchange Commission, the National Association of Securities Dealers and the United States Justice Department.
Regulatory Correspondence. COPLEY and HMRI shall make availaxxx xx each other, within three (3) days of receipt, regulatory correspondence covering the following issues: regulatory letters, Product recalls, withdrawal of Product, and correspondence bearing on the safety and efficacy of the Product.
Regulatory Correspondence. The trial site and trial-related documents may be subject to review by the institutional review board IRB/IEC, and/or to quality assurance audits performed by VIVUS, Inc., and/or to inspection by the FDA and/or applicable foreign health authorities. The investigator will notify VIVUS, Inc. within *** working days following any FDA or other regulatory agency contact with the investigative site regarding this study. The investigator will provide VIVUS, Inc. with copies of all correspondence with the FDA or other regulatory agency which may affect the review of the current study (e.g., Form 483, Inspection Observations) or their qualification as an investigator in studies conducted by VIVUS, Inc. (e.g., warning letters).
Regulatory Correspondence. CyDex shall deliver to Hospira all copies of correspondence after the Effective Date between CyDex and any Regulatory Authorities that concern Captisol. CyDex shall deliver such correspondence to Hospira within [***] of distributing or receiving such correspondence, as the case may be. CyDex may redact such correspondence to delete the name of any of its other customers or other customers’ products or any Third Party’s Intellectual Property or proprietary information that is not included in the CyDex Intellectual Property.
Regulatory Correspondence. Ximedica shall notify OptiNose in accordance with the Quality Agreement of any notice, correspondence, and the result of any inspection(s) by or with the FDA or any Regulatory Authority (including without limitation any 483, warning letter, or similar correspondence) concerning an actual or potential regulatory deficiency, noncompliance or problem that directly or indirectly relates to the manufacturing of the LDSAs or any of the services provided by Ximedica under this Agreement. Ximedica shall notify OptiNose in accordance with the Quality Agreement of any other notice or correspondence, and the result of any inspection(s), with the FDA or any Regulatory Authority that is reasonably likely to impact or directly relates to the manufacture of LDSAs or other performance under this Agreement. In all of the foregoing notifications, Ximedica shall provide OptiNose with copies of any such notices, correspondences, or results of inspection in accordance with the Quality Agreement. Furthermore, Ximedica shall send a draft to OptiNose of all correspondence Ximedica intends to send to any Regulatory Authority with any substantial relation to LDSAs. For all correspondence with a Regulatory Authority related to LDSAs that is in response to any 483, warning letter, regulatory deficiency or other problem relating to the manufacture of LDSAs, Ximedica shall consult with, and reasonably consider the input of, OptiNose on the draft correspondence before such correspondence is sent to the Regulatory Authorities. Regarding all interactions with Regulatory Authorities, both parties shall make [***] to act expeditiously in cooperating with each other and responding to Regulatory Authorities.
