Audit Support. Patheon shall provide, at no cost to Zogenix, support for [***] per annum by Zogenix of Patheon’s quality and compliance systems at the Facility in accordance with the provisions set out in the Quality Agreement. In the event that Zogenix requests that Patheon provide support for more than [***] per annum at the Facility and such additional audits are not required to address legitimate quality concerns and the Parties have not mutually agreed otherwise, Zogenix shall reimburse Patheon as set out in Schedule B. For the avoidance of doubt, audits by third parties of the Facility that are requested by Zogenix shall be considered a Zogenix audit for the purposes of this Section. For the further avoidance of doubt, inspections by Regulatory or Governmental Authorities or due diligence visits by prospective licensees of the Product shall not be considered a quality audit for the purposes of this Section; *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (Zogenix, Inc.), Manufacturing Services Agreement (Zogenix, Inc.)