Recall of Product. In the event that: (a) any regulatory authority issues a request, directive or order that the Product be recalled or retrieved; (b) a court of competent jurisdiction orders that the Product be recalled or retrieved; or (c) AFP determines that the Product should be recalled or retrieved, AFP shall promptly notify MannKind, in writing, of such event and shall conduct such activity and take appropriate corrective actions, at AFP’s expense.
Recall of Product. In the event PRAECIS shall be required to recall any Product Produced hereunder because such Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Product Specifications, or in the event that PRAECIS elects to institute a voluntary recall, PRAECIS shall be responsible for coordinating such recall. PRAECIS promptly shall notify BAXTER if any Product Produced hereunder is the subject of a recall and provide BAXTER with a copy of all documents relating to such recall. BAXTER shall cooperate with PRAECIS in connection with any such recall. PRAECIS shall be responsible for all of the costs and expenses of any such recall unless such recall is caused *** APPROXIMATELY 3 LINES OMITTED *** , in which case BAXTER will bear all reasonable costs associated with such recall, product withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom PRAECIS deems appropriate); provided however that solely in respect of administrative and operating costs and expenses, XXXXXX'x liability for conducting the recall shall be in accordance with and up to a cumulative total maximum amount set forth in the chart below. Notwithstanding the foregoing, in no event shall XXXXXX'x liability for costs associated with such recall, product withdrawal or field correction exceed the Purchase Price for the Product which is the subject of such recall, product withdrawal or field correction. ADMINISTRATIVE NUMBER OF COST CAPS BY CONSIGNEES RECALL CLASS --------------------------------------- I II III ------------------------------------------------------- *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** ***
Recall of Product. 14.1 In the event of a medical alert, consumer alert or other form of Product recall issued by the Supplier, the manufacturer of the Product or by any qualified authority, including Health Canada, the Supplier:
Recall of Product. For any Product, in the event that: (a) any Regulatory Authority in the Territory issues a request, directive or order that Product be recalled or retrieved; (b) a court of competent jurisdiction orders that Product be recalled or retrieved; or (c) Sanofi reasonably determines, after reasonable, good faith discussion with MannKind, that Product should be recalled or retrieved, Sanofi shall promptly notify MannKind of such event (to the extent time allows) and shall conduct such activity and take appropriate corrective actions, and MannKind shall provide such assistance to Sanofi as is reasonably necessary to carry out such activities. All reasonable costs and expenses of such recall and corrective actions shall be equitably allocated between the Parties taking into account the relative fault of Sanofi and the relative fault of MannKind.
Recall of Product. 11.1 In the event Chiron shall be required to recall any Product because such Product may violate any relevant laws or regulations or the Product Specifications, Chiron shall be responsible for coordinating such recall. Chiron shall promptly notify Rhein Biotech and GCVC if any Product is the subject of a recall. Rhein Biotech and GCVC shall cooperate with Chiron in connection with any recall. Chiron shall be responsible for all of the costs and expenses of such recall unless (a) such recall is caused solely by Rhein Biotech and GCVC’s breach of this Agreement, in which case, Rhein Biotech and GCVC shall be responsible for the costs and expenses of such recall or (b) such recall is the result of an adverse event the cause of which cannot be attributed solely to any act or omission of Rhein Biotech and GCVC or any third party, in which case, the Parties shall share the costs and expenses of such recall.
Recall of Product. In the event either Party believes a recall, field alert, product withdrawal or field correction, may be necessary with respect to Product provided under this Agreement, such Party shall immediately notify the other Party in writing. Neither Party shall act to initiate a recall, field alert, Product withdrawal or field correction, without the express prior written approval of the other Party, unless required by applicable law. Both Parties shall cooperate with one another with respect to such recall, field alert, product withdrawal or field correction. Alfacell shall be responsible for conducting any recall, field alert, product withdrawal or field correction; provided, however, that the cost of any such recall, field alert, product withdrawal or field correction shall be borne equally by the Parties, except to the extent such recall, field alert, Product withdrawal or field correction is caused by a breach by either Alfacell or Par of its respective warranties, representations or obligations under this Agreement, the License Agreement or applicable law or its gross negligence or willful misconduct, in which case such cost shall be borne by the responsible Party. For purposes hereof, such cost shall be limited to reasonable, actual and documented costs incurred by the Parties for such recall, field alert, product withdrawal or field correction, and for the replacement of the Product to be recalled. In the event of a recall, Par shall provide to Alfacell copies of distribution records in its control and shall otherwise reasonably cooperate with Alfacell in respect of any such recall.
Recall of Product. 7.1. In the event (a) any Regulatory Authority issues a directive or order that the Product be recalled, (b) a court of competent jurisdiction orders such a recall, or (c) QUOIN communicates that the Product should be recalled for any reason, the Parties shall promptly implement a recall for such Product to the extent distributed under this Agreement in accordance with applicable SOPs and QUOIN’s reasonable requirements. QUOIN shall, unless the recall has been caused by the negligence of the Distributor in its handling the Product, be responsible for all reasonable costs and expenses of recalling and destroying the Product (e.g. destruction charges (upon provision of evidence of destruction), man-hours and other costs incurred by Distributor in assisting QUOIN in arranging and coordinating a recall). QUOIN or Third-Party Designee on behalf of QUOIN as appropriate will be responsible for all returns, except as set forth in the applicable SOP, and all aspects of any recall (subject to the provision by the Distributor of requested reasonable assistance). Any recalled Product will be destroyed in accordance with Applicable Local Law requirements. QUOIN shall use reasonable commercial endeavors to replace or procure in good faith and if feasible the replacement of such recalled Product with conforming Product within thirty (30) days;
Recall of Product. (s) manufactured under this agreement by IHF shall be effected after consultation with the Company. If a recall of any Products is initiated by IHF or the Company, either voluntarily or by order of any court, the Company will assist IHF in developing a recall strategy and will work with IHF and all applicable governmental agencies in monitoring the recall operation and in preparing such reports as may be required in connection therewith. In such event, the Company will immediately issue a full credit or refund, as the case may be, excluding the shipping charges therefor which shall be paid by the Company and will promptly replace such Products with conforming Products, and ship the same, at the Company's risk and expense, to the location(s) designated by IHF; provided, however, the obligations imposed on Company by this sentence shall not apply in the event such recall does not result from the negligence of the Company. The Price for any such replacement Products shall be the lesser of: (i) the Price established as of the date the Products were originally ordered by IHF pursuant to Section 6, or (ii) the Price for the replacement Products as of the date they are shipped by the Company. The Company will provide IHF with written instructions regarding the disposition of all Products which have been recalled, and any costs incurred for such will be borne by the Company.
Recall of Product. Recall. The handling of field alerts, recalls and market withdrawals (collectively, “Recalls”) of all Product shall be within the sole discretion of Portola and Portola will notify Hovione promptly of any Recall of Product. Notification to any Regulatory Authority and the conduct of such Recall shall be the sole responsibility of Portola. Hovione shall (a) cooperate fully with Portola in the event of any such Recall and (b) provide such assistance in connection therewith as Portola may reasonably request. Portola shall bear all expenses of any Recall unless and to the extent such Recall directly results from Hovione’s negligence or willful misconduct, in which case Hovione shall (i) bear the actual, documented and reasonable expenses of the parties in carrying out the Recall and (ii) use commercially reasonable efforts to replace the Product subject to such Recall with conforming Product as soon as reasonably practicable at Hovione’s expense. In all events, [*] under this Section 5.5 for such Recall [*] to the [*] for such [*] applicable [*].
Recall of Product. DARA shall be responsible for any recall, market withdrawal or field correction of the Product (a “Recall”; when used as a verb, “Recall” means to engage in a Recall). ONXEO shall cooperate with DARA in the event of any Recall and provide such assistance in connection therewith as DARA may reasonably request.
