Common use of Notification of Inspection Clause in Contracts

Notification of Inspection. In the event the FDA or other Regulatory Authority notifies Manufacturer that it intends to visit or inspect its facilities relating to the manufacture of Product, the following shall apply: (a) Manufacturer shall immediately provide notice of such visit or inspection to Company; (b) Manufacturer shall permit a representative of Company to be present at the facility during such visit or inspection; (c) Manufacturer shall permit such representative of Company to be present at, and participate in, each daily wrap up session for such inspection and the post-inspection wrap up session for such inspection; (d) Manufacturer promptly shall provide Company with copies of all written materials received by Manufacturer relating to such inspection; (e) Manufacturer shall provide Company with advance copies of all proposed responses, shall permit Company reasonable opportunity to review and comment on each such response, shall reasonably consider Company’s reasonable comments thereon and shall provide Company with copies of each such response as submitted; and (f) Manufacturer agrees to allow the FDA or other relevant Regulatory Authorities to conduct such audit and reasonably cooperate with the FDA and other Regulatory Authorities in connection therewith. In addition, Manufacturer shall advise Company immediately if an authorized agent of the FDA or other Regulatory Authority visits any Manufacturer facilities relating to the manufacture of Product without prior notice. Manufacturer shall furnish to Company the report by such agency of any such visit within thirty (30) days of Manufacturer’s receipt of such report.

Notification of Inspection. In the event the FDA or other Regulatory Authority notifies Manufacturer Hospira that it intends to visit or inspect its facilities relating to the manufacture of ProductProduct or storage of API, the following shall apply: (a) Manufacturer Hospira shall immediately provide notice of such visit or inspection to CompanyMediciNova; (b) Manufacturer Hospira shall permit a representative of Company MediciNova to be present at the facility during such visit or inspection; (c) Manufacturer Hospira shall permit such representative of Company MediciNova to be present at, and participate in, each daily wrap up session for such inspection and the post-inspection wrap up session for such inspection; (d) Manufacturer Hospira promptly shall provide Company MediciNova with copies of all written materials materials, including, without limitation, copies of any Notice of Inspection (FDA Form 482), other notice of inspection, notice of violation, other similar notice or Inspectional Observations (FDA Form 483) received by Manufacturer Hospira relating to such inspection; and (e) Manufacturer Hospira shall provide Company MediciNova with advance copies of all proposed responsesresponses to any such inspections, notices or actions, shall permit Company MediciNova reasonable opportunity to review and comment on each such response, shall reasonably consider CompanyMediciNova’s reasonable comments thereon and shall provide Company MediciNova with copies of each such response as submitted; and (f) Manufacturer agrees to allow the FDA or other relevant Regulatory Authorities to conduct such audit and reasonably cooperate with the FDA and other Regulatory Authorities in connection therewith. In addition, Manufacturer Hospira shall advise Company MediciNova immediately if an authorized agent of the FDA or other Regulatory Authority visits any Manufacturer Hospira facilities relating to the manufacture of Product or storage of API without prior notice. Manufacturer Hospira shall furnish to Company MediciNova the report by such agency of any such visit within thirty (30) days of ManufacturerHospira’s receipt of such report.

Notification of Inspection. In the event the FDA or other Regulatory Authority notifies Manufacturer that it intends to visit or inspect its facilities relating to the manufacture of Product, the following shall apply: (a) Manufacturer shall immediately provide notice of such visit or inspection to Company; (b) Manufacturer shall shall, to the extent permitted by law, permit a representative of Company to be present at the facility during such visit or inspectioninspection but only shall have access to portions of the facility directly related to the Products; (c) Manufacturer shall shall, to the extent permitted by law, permit such representative of Company to be present at, and participate in, each daily wrap up session for such inspection and the post-inspection wrap up session for such inspection; (d) Manufacturer promptly shall provide Company with copies of all written materials received by Manufacturer relating to such inspection; (e) Manufacturer shall provide Company with advance copies of all proposed responses, shall permit Company reasonable opportunity to review and comment on each such response, shall reasonably consider Company’s reasonable comments thereon and shall provide Company with copies of each such response responses as submitted; and (f) Manufacturer agrees to allow the FDA or other relevant Regulatory Authorities to conduct such audit and reasonably cooperate with the FDA and other Regulatory Authorities in connection therewith. In addition, Manufacturer shall advise Company immediately promptly if an authorized agent of the FDA or other Regulatory Authority visits any Manufacturer facilities relating to the manufacture of Product without prior notice. Manufacturer shall furnish to Company the report by such agency of any such visit within thirty (30) business days of Manufacturer’s receipt of such report.