Access to Facility. At agreed-upon dates and times, WuXi ATU will permit 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 Batch of Product, and # to inspect the Facility and Graphite Process to ascertain compliance by WuXi ATU with the terms of this Agreement, including inspection of # the Graphite Equipment and other equipment, and Graphite Materials and raw materials used in the performance of Services; # the holding facilities for such Graphite Materials and raw materials; and # all Records relating to such Services and the Product.

Performance of Manufacturing. WuXi ATU will perform all Services at the Qualified Facility, provide all staff necessary to perform the Services in accordance with the terms of the applicable Work Order, this Agreement and the Quality Agreement (as applicable), and hold at such Qualified Facility all Graphite Equipment and Graphite Materials and other items used in the Services. For Manufacturing Services performed, WuXi ATU will not use any additional facility (other than the Qualified Facility or the facilities of Permitted Subcontractors) for the performance of Services under this Agreement without timely (meaning with regard to the agreed manufacturing schedule) prior written notice to, and prior written consent from, Graphite, which consent will not be unreasonably withheld or delayed (it being understood and agreed that Graphite may withhold consent

Person in Facility. Subject to WuXi ATU’s safety procedures, access control SOPs, and confidentiality limitations, WuXi ATU will permit Graphite’s representatives during the Term of this Agreement, to visit the Facility at mutually agreed upon times, to provide advice to support technology transfer and/or observe procedures and processes at mutually agreed upon times with reasonable advance notification to WuXi ATU. Graphite will give WuXi ATU reasonable advanced notice of any proposed visit, but no fewer than ​ Business Days’ prior notice for the first visit and ​ weeks prior notice for subsequent visits. Graphite shall identify the individuals who will be in attendance. All visits will be during WuXi ATU’s normal business hours on weekdays at the Facility and conducted consistent with WuXi ATU’s person-in-plant SOPs, and in a manner that does not unreasonably interfere with WuXi ATU’s Services and does not otherwise unreasonably interfere with normal business activities.

Inspection and Audit Rights. Except as may otherwise be provided for in a Work Order or the Quality Agreement or unless the audit is for cause, Graphite and/or Graphite's representative shall have the right, up to ​ period and at agreed-upon dates and times, to access the Facilities of WuXi ATU where the Services are performed, to inspect the Records and facilities and interview staff related to the Product Manufacture. Graphite and Graphite’s employees or other representatives conducting such inspections will abide by the confidentiality provisions set forth in Article 14, below.

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

Licenses and Permits. WuXi ATU will be responsible for obtaining and maintaining, at its expense, any Facility or other regulatory licenses, permits, or approvals required for the performance of Services by WuXi ATU under this Agreement. At Graphite's written request, WuXi ATU will provide Graphite with copies of such licenses, permits and approvals. Graphite may use such provided regulatory licenses, permits, and approval in connection with Graphite’s regulatory submissions and/or commercial development of the Product.