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. 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 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. 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. 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 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. Commencing on the Effective Date with respect to all countries in the Territory, POINT shall use Commercially Reasonable Efforts in respect of the Product as the primary interface with and shall otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory activities related to the Product in the Field in the Territory, and POINT shall be responsible for preparing and filing any and all Regulatory Materials for the Product in the Field in the Territory at its sole expense.
Regulatory Correspondence. After the Effective Date of the Assignment and Assumption Agreement, NovaMedica will be granted access to the information above in a “Dropbox” folder, with the right to download copies of the documents subject to the provisions of Article 8 of this Agreement. After review the appropriate members of the Company will be available by phone to address any questions. Dropbox folder will contain the following information, but not limited to: Name Business Related Commercial Assessment (EMERGE) - Brazil MiniDeck vf.pptx (EMERGE) - China MiniDeck vf.pptx (EMERGE) - Initial Assessment vf.pptx (EMERGE) - Japan MiniDeck vf.pptx (EMERGE) - Russia MiniDeck vf.pptx (EMERGE) - SouthKorea MiniDeck vf.pptx 2009 10 09 Reckon II LCM Opportunities vf.ppt 20091120_ESSENTIAL Deck vf.pptx 2011-01-21 Project Restore_Discussion Document v3.ppt 2011-07-01 Radio Summary Findings vF.docx 20120614 REG VALUE vf.ppt Project Reckon Mkt Rsch 20090121_vF.ppt Regado Final Document_OHS and TAVI Assessment_Feb 15 2011.ppt Corporate Presentation Regado Investor Presentation_ MAR2012.pdf General Commercial
Regulatory Correspondence. 5.6.1 Each Party shall immediately and within [***] notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (a) receipt of a regulatory letter, warning letter, Form 483 (Inspectional Observations) or similar item, from the FDA or any other Regulatory Authority directed to the Manufacture or distribution of Collaboration Product by BioNTech or in connection with any general cGMP inspections applicable to the Facility; (b) any recall, market withdrawal or correction of any Collaboration Product Manufactured, tested, packaged, stored or distributed hereunder, where the recall, market withdrawal or correction is attributable to any Manufacturing or distribution activities by or on behalf of BioNTech; and (c) receipt of a regulatory letter, warning letter or similar item from the FDA or any other Regulatory Authority directed to or any regulatory comments related to Collaboration Product Manufactured or distributed hereunder where the comments relate or are attributable to any Manufacturing, testing, packaging, storage or distribution activities by or on behalf of BioNTech.
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.
