Saturday, March 18, 2017 1:26:53 PM
11.1 Recalls; Quality Agreement. As further set forth in the Quality Agreement, each Party will give prompt telephonic notice (to be confirmed in writing pursuant to Section 20.1) to the other Party upon receipt of any information which indicates a recall, seizure or market withdrawal of any Drug Substance or Product (a “Recall”) may be necessary. The decision to conduct and the right to control a Recall will be solely that of Client, following consultation with LONZA. Client shall (i) bear the cost of and be responsible for conducting or responding to Recalls of Drug Substance or Product, (ii) remain obligated to pay LONZA in accordance with this Agreement for any Drug Substance used to make such Recalled Product, and (iii) reimburse LONZA for its out-of-pocket expenses related to the Recall, if any. Notwithstanding the foregoing, to the extent that such Recall was attributable to LONZA’s breach of any of its warranties set forth in Section 14.2.1 hereof, upon substantiation of such causation by a mutually agreeable qualified independent Third Party, LONZA shall credit Client for the total amount paid by Client to LONZA for the Drug Substance used to make such Recalled Product and will reimburse Client for all of Client’s reasonable costs and expenses incurred in connection with a Recall. Except for liabilities arising under Section 15.2, the foregoing obligation shall be LONZA’s sole liability and Client’s sole remedy under this Agreement with respect to Recalls.
https://www.sec.gov/Archives/edgar/data/1290157/000119312508111792/dex1017.htm
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