Regulatory Inquiries. If the Company receives an inquiry from any governmental or regulatory agency regarding products supplied hereunder that could reasonably be expected to impact a Member or require a response from or action by a Member, the Company shall immediately notify such Member in writing.
Regulatory Inquiries. Novavax will [***] notify SIIPL in writing of any governmental or regulatory inquiries, inspections, or audits directly related to the Vaccine Components and Licensed Know-How and any findings related to the same. SIIPL will permit such governmental or regulatory body to inspect and audit its facilities and documents, including facilities and documents of its contract manufacturer(s), related to Vaccine Components at [***] cost and expense, and notify and update Novavax of such inquiries, inspections and audits.
Regulatory Inquiries. Without limiting any provision of the License Agreement, upon being contacted (and, in the case of CCT, upon any Permitted Subcontractor being contacted) by any Regulatory Authority for any regulatory purpose pertaining to this Agreement or to the Manufactured Products, including notice of the initiation of any inquiries, notices or inspection activity by any such agency, a Party shall immediately notify the other Party and provide the other Party with (a) a reasonable description of any such inquiries and related documentation, (b) an opportunity to advise and comment with respect thereto and (c) if appropriate, an opportunity to participate with respect thereto to the extent such matters relate to the Manufactured Products in the Territory.
Regulatory Inquiries. Alexza shall notify Teva and if applicable, provide Teva with copies of any investigation, inquiry, regulatory action, or other material notice or communication from FDA related to the Product (or any component thereof) or the manufacturing, promptly, but in no case later than [ * ] Business Days after Alexza becomes aware of such investigation, inquiry, regulatory action, notice or communication. Alexza shall comply in a timely manner with any request for information received from FDA relating to the manufacture of the Product or components of the Product.
Regulatory Inquiries. Agency agrees to give its full and complete cooperation in responding to any regulatory complaint or inquiry and shall promptly respond in writing directly to Insurer upon its request. Agency shall notify Insurer immediately upon becoming aware of any regulatory complaint or dispute involving Agency or its Outsourced Service Providers.
Regulatory Inquiries. Each of the Custodian and the Servicer agree to (a) provide access to the Loan Notes and related documentation in its possession for inspection by governmental regulatory agencies and (b) assist in the preparation of any routine reports required by regulatory bodies, if any.
Regulatory Inquiries. Correspondent and NFS will each respond to the inquiries they receive from regulatory authorities. Each will cooperate with the other in production of information or documentation as necessary to respond to such inquiry in a timely and complete manner.
Regulatory Inquiries. Licensee shall as soon as reasonably possible and in any event within two (2) calendar days inform Oncolytics of any inquiries from any Regulatory Authority involving Safety Issues or Signals in relation to the Licensed Product.
Regulatory Inquiries. Each Party shall promptly inform the other Party of the existence and substance of any inquiry or investigation related to Products initiated by any government authority or certification agency that may reasonably be anticipated to affect either Party’s ability to fulfill their obligations hereunder or that may reasonably be related to potential end user or patient safety concerns.
Regulatory Inquiries. Novavax will [***] notify SIIPL in writing of any governmental or regulatory inquiries, inspections, or audits directly related to the Vaccine Components and Licensed Know–How and any findings related to the same. SIIPL will [***] notify Novavax in writing of any governmental or regulatory inquiries, inspections, or audits directly related to the Drug Substance and any findings related to the same. SIIPL will permit such governmental or regulatory body to inspect and audit its facilities and documents, including facilities and documents of its contract manufacturer(s), related to Vaccine Components at [***] cost and expense, and notify and update Novavax of such inquiries, inspections and audits.”
14. Article 5, Clause 5.1 of the Agreement shall stand amended and modified as under–
