Common use of Recalls; Quality Agreement Clause in Contracts

Recalls; Quality Agreement. As further set forth in the Quality Agreement, PROTEON shall notify LONZA promptly (and in any event within three (3) Business Days of receipt of written notice) if any Drug Substance or resulting Product is the subject of a recall, market withdrawal, field correction or seizure (a “Recall”). PROTEON shall (i) bear the cost of and be responsible for conducting or responding, to all 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, if such Recall was solely 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 arbitrator selected using the procedure specified in Section 10.2, LONZA shall credit or refund PROTEON for the total amount paid by PROTEON to LONZA for the Drug Substance used to make such Recalled Product. Notwithstanding anything to the contrary contained herein, the foregoing obligation shall be LONZA’s sole liability and PROTEON’s sole remedy under this Agreement with respect to Recalls.

Recalls; Quality Agreement. As further set forth in the Quality Agreement, PROTEON shall notify LONZA promptly each Party will give prompt telephonic notice (and to be confirmed in any event within three (3writing pursuant to Section 20.1) Business Days of to the other Party upon receipt of written notice) if any information which indicates a recall, seizure or market withdrawal of any Drug Substance or resulting Product is the subject of a recall, market withdrawal, field correction or seizure (a “Recall”)) may be necessary. PROTEON 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, responding to all 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, if to the extent that such Recall was solely 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 arbitrator selected using the procedure specified in Section 10.2Third Party, LONZA shall credit or refund PROTEON Client for the total amount paid by PROTEON Client to LONZA for the Drug Substance used to make such Recalled ProductProduct and will reimburse Client for all of Client’s reasonable costs and expenses incurred in connection with a Recall. Notwithstanding anything to the contrary contained hereinExcept for liabilities arising under Section 15.2, the foregoing obligation shall be LONZA’s sole liability and PROTEONClient’s sole remedy under this Agreement with respect to Recalls.