Facility Audits. Upon commercially reasonable notice (to be provided not less than [***] days in advance) and during Miltenyi’s normal business hours, but not more often than [***] every [***] during the Term of this Agreement, Autolus or Autolus’ Licensees duly authorized representatives may inspect those portions of Miltenyi’s and its Affiliates’ and Subcontractors’ Facilities that are used to manufacture, store or conduct testing of Miltenyi Products to determine compliance with Applicable Laws, Regulatory Laws, Agreed Standards, the Quality Agreement and Product Specifications. Such representatives shall comply with the applicable rules and regulations for workers at such Facilities and shall enter into reasonable confidentiality and non-use agreements if so requested by Miltenyi, as a representative of Autolus or such Licensee (and not in an individual capacity). All audits shall be conducted in a manner that is intended to minimize disruption to the operations at such Facilities. Miltenyi shall promptly address and correct any deficiencies from Agreed Standards identified in connection with such inspections. Notwithstanding anything herein, Autolus or Autolus’ Licensees duly authorized representatives may conduct additional “for cause” audits to investigate a failure or potential failure of Miltenyi to adhere to the Applicable Laws, Regulatory Laws, Agreed Standards, the Quality Agreement or Product Specifications.
Appears in 3 contracts
Sources: Supply Agreement (Autolus Therapeutics LTD), Supply Agreement (Autolus Therapeutics LTD), Supply Agreement (Autolus Therapeutics LTD)