Common use of Regulatory Correspondence Clause in Contracts

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. CPL Hikma shall notify OptiNose immediately ([***]) of any correspondence, any inspections, and the result of any inspection(s) with the FDA or any Regulatory Authority related to the Product. CPL Hikma shall send a draft to OptiNose of all correspondence related to the Product that CPL Hikma 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 Hikma 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 Hikma 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 Hikma shall be entitled to redact any information that is specific to its customers other than OptiNose and or that is not directly related to the Product, and OptiNose agrees that such correspondence and reports shall constitute Confidential Information of CPLHikma.