Deviation Investigations. Cardinal Health reserves the right to expend up to […***…] per Critical Deviation (as defined in the Quality Agreement) to complete all required investigational work (such as OOS investigations, trouble shooting chromatographic methods, etc.) without prior approval from the Xencor. If the additional work requires going beyond […***…], the Xencor will be contacted prior to continuation. The additional work will be performed based on verbal agreement from the Xencor and will be documented on a Cardinal Health Telephone Conversation Record (TCR). Cardinal Health shall […***…], in which case Xencor shall […***…] within thirty (30) days after receipt of an invoice and appropriate supporting documentation from Cardinal Health.
Appears in 4 contracts
Samples: Development and Manufacturing Services Agreement (Xencor Inc), Development and Manufacturing Services Agreement (Xencor Inc), Development and Manufacturing Services Agreement (Xencor Inc)
