11.1 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 LONZAs 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 LONZAs sole liability and PROTEONs sole remedy under this Agreement with respect to Recalls.
12.1 License to LONZA. During the Term, PROTEON hereby grants to LONZA a fully paid, non-exclusive license under any and all PROTEON Intellectual Property and any Project Intellectual Property owned solely by PROTEON that is necessary for LONZA to perform its obligations under this Agreement, including, without limitation, all rights necessary for the [ ]* the Manufacturing Process, and/or the PROTEON Confidential Information, for the sole and limited purpose of LONZAs performance of its obligations under this Agreement. For the avoidance of doubt, it is understood that LONZA may not sublicense its rights under this Section 12.1 without PROTEONs prior written consent, which consent shall be provided or denied in accordance with the procedure in Section 4.8.
12.2 License to PROTEON. (a) At the commencement of the development work contemplated by the Project Plan, PROTEON and LONZA shall review the LONZA Intellectual Property that they believe to be relevant to the Project Plan and shall determine which portions of such LONZA Intellectual Property may be useful for the development or manufacturing services contemplated by the Project Plan. The Parties shall agree upon: (i) a listing of the LONZA Intellectual Property to be utilized in such services; (ii) any limitations or restrictions upon the use, development and/or further improvement of such listed LONZA Intellectual Property; and (iii) the one-time fee (if any) applicable to such LONZA Intellectual Property in the event that PROTEON elects to make use of such LONZA Intellectual Property under the circumstances specified in Section 12.2(c), it being understood and agreed that such fee shall not exceed CHF [ ]* in the aggregate. LONZA shall not incorporate any LONZA Intellectual Property into the Drug Substance, the Product or the Manufacturing Process without the prior written consent of PROTEON. In the event and to the extent that any such
* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.