Regulatory Inspections. WuXi ATU will allow representatives of any Regulatory Agency to inspect the relevant parts of the Facility where the Manufacture of the Product is carried out and to inspect the master production record and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify Graphite of the scheduling of any such inspection relating to the Manufacture of Product. The Parties shall cooperate in good faith with respect to the conduct of any such inspections. WuXi ATU shall permit the attendance of Graphite at any such regulatory inspections in accordance with the Parties' Quality Agreement. WuXi ATU will promptly send to Graphite a copy of any reports, citations, or warning letters or other written communication received from such Regulatory Authority in connection with such visit or inspection, and any written communication received from any Regulatory Authority relating to any Product, the Facility (if it specifically relates to or adversely affects the Development and/or Manufacture of any Product) or the Graphite Process, within ​ Business

Regulatory Inspections.Access to Facility. At agreed-upon dates and times, WuXi ATU will allowpermit Graphite or its duly authorized representatives # to observe and consult with WuXi ATU during the performance of Services under this Agreement, including the Manufacturing of any Regulatory AgencyBatch of Product, and # to inspect the relevant partsFacility and Graphite Process to ascertain compliance by WuXi ATU with the terms of this Agreement, including inspection of # the Facility where the Manufacture of the Product is carried out and to inspect the master production record and Batch Records to verify compliance with cGMPGraphite Equipment and other practices or regulationsequipment, and will promptly notify Graphite Materials and raw materials used in the performance of Services; # the scheduling of anyholding facilities for such inspectionGraphite Materials and raw materials; and # all Records relating to such Services and the Manufacture of Product. The Parties shall cooperate in good faith with respect to the conduct of any such inspections. WuXi ATU shall permit the attendance of Graphite at any such regulatory inspections in accordance with the Parties' Quality Agreement. WuXi ATU will promptly send to Graphite a copy of any reports, citations, or warning letters or other written communication received from such Regulatory Authority in connection with such visit or inspection, and any written communication received from any Regulatory Authority relating to any Product, the Facility (if it specifically relates to or adversely affects the Development and/or Manufacture of any Product) or the Graphite Process, within ​ Business