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.

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.

Graphite has the right to supply the Graphite Materials and the Graphite Information to WuXi ATU and the necessary rights to license or permit WuXi ATU to use the same for the purpose of the Services; and Graphite shall not do or cause anything to be done which would adversely affect their ownership or entitlement to use the same for those purposes.

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