Device Recall Sample Clauses

Device Recall. As between the Parties, CDEX shalx xxve the sole right to initiate a voluntary withdrawal from the market of any Device. In the event any Device is recalled by any Regulatory Agency or withdrawn by CDEX in the Territory or a field correction or other correction action ("Device Action") takes place, except to the extent caused solely by Baxa or any of its resellers or distributors, CDEX shall bear all expxxxxs relating to such Device Action and shall reimburse Baxa, its resellers and distributors for any commercially reasonable xxxxnses any of them incurs directly as a result of processing return of Devices to CDEX and customer notification (excluding Baxa's internal costs). Otherwise, Baxa shall reimburse CDEX for any xxxxxxcially reasonable expenses it xxxurs directly as a result of processing return of Devices to CDEX and customer notification (excluding CDEX's internal costs). Prior to any such Device Action, CDEX shall advise Baxa of the situation. CDEX shall provide Baxa with a prepared statemxxx, subject to Baxa's approval, for use ix xxsponse to inquiries regarding a Device Xxxxxx that Baxa shall provide to all Baxa Representatives promoting the affected Xxxice. Baxa and the Baxa Xxxresentatives shall use only such prepared statemxxx to responx xx any inquiries received with regard to any Device Action.

Device Recall. (a) In the event any governmental agency having applicable jurisdiction shall order any corrective action with respect to any Product or Device supplied hereunder, customer notice, restriction, change, corrective action or market action or the Product or Device change, [**] particular Product or Device shall be established to be [**] hereunder. (b) In the event that [**] recall of the Product or Device supplied hereunder [**], customer notice, restriction, change, corrective action or market action or any Product change, [**] particular Product or Device shall be established to be [**] hereunder. (c) Any such recalls shall be implemented and administered by CPC and Closure Medical in a manner which is appropriate and reasonable under the circumstances and in conformity with any requests or orders of the FDA as well as accepted trade practices. Each Party shall give immediate notice by telephone (to be confirmed in writing) to the other Party upon discovery that any Product or Device should be recalled, corrected or withdrawn from the market, or may be required to be recalled, corrected or withdrawn from the market. The obligations under this section shall survive the complete or partial termination of this Agreement. (d) If both Parties share responsibility with respect to a recall, the costs shall [**]. (e) CPC undertakes to use reasonable efforts to establish a batch tracing and recall system which will enable CPC, to the extent reasonably possible, to identify, as quickly as possible, customers within the Territory who have been supplied with Devices of any particular batch, and to recall such Devices from such customers.