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.
Access to Facility. At agreed-upon dates and times,Performance of Manufacturing. WuXi ATU will permitperform 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 or its duly authorized representatives # to observeEquipment and consult withGraphite Materials and other items used in the Services. For Manufacturing Services performed, WuXi ATU duringwill not use any additional facility (other than the Qualified Facility or the facilities of Permitted Subcontractors) for the performance of Services under this Agreement, includingAgreement without timely (meaning with regard to the Manufacturing of any Batch of Product,agreed manufacturing schedule) prior written notice to, and # to inspect the Facilityprior written consent from, Graphite, which consent will not be unreasonably withheld or delayed (it being understood and agreed that 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.may withhold consent
AccessPerson in Facility. Subject to Facility. At agreed-upon datesWuXi ATU’s safety procedures, access control SOPs, and times,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 or its duly authorized representatives # to observe and consult withwill give WuXi ATU during the performance of Services under this Agreement, including the Manufacturingreasonable advanced notice of any Batch of Product,proposed visit, but no fewer than Business Days’ prior notice for the first visit and # to inspect 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 Graphite Process to ascertain compliance byconducted consistent with WuXi ATUATU’s person-in-plant SOPs, and in a manner that does not unreasonably interfere 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 suchWuXi ATU’s Services and the Product.does not otherwise unreasonably interfere with normal business activities.
AccessInspection 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 Facility. At period and at agreed-upon dates and times, to access the Facilities of WuXi ATU will permit Graphite or its duly authorized representatives # to observe and consult with WuXi ATU duringwhere the performance of Services under this Agreement, including the Manufacturing of any Batch of Product, and #are performed, to inspect the FacilityRecords and facilities and interview staff related to the Product Manufacture. Graphite Process to ascertain complianceand Graphite’s employees or other representatives conducting such inspections will abide by WuXi ATU with the terms of this Agreement, including inspection of # the Graphite Equipment and other equipment, and Graphite Materials and raw materials usedconfidentiality provisions set forth 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.Article 14, below.
Access to Facility. At agreed-upon dates and times,Regulatory Inspections. WuXi ATU will permit Graphite or its duly authorizedallow 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 #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 Processof the scheduling of any such inspection relating to ascertain compliance bythe 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 termsParties' Quality Agreement. WuXi ATU will promptly send to Graphite a copy of this Agreement, including inspectionany 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 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.Process, within Business
Access to Facility. At agreed-upon datesLicenses and times,Permits. WuXi ATU will permit Graphitebe responsible for obtaining and maintaining, at its expense, any Facility or its duly authorized representatives # to observe and consult with WuXi ATU duringother regulatory licenses, permits, or approvals required for 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 under this Agreement. At Graphite's written request, WuXi ATU will provide Graphite with the termscopies of this Agreement, including inspectionsuch 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 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.
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