Recall of Product Sample Clauses

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. 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: (a) will immediately advise the Purchaser in writing (at the address specified in Article 30 of these Terms and Conditions) and take all reasonable steps to minimize the Purchaser’s risk and to remedy the situation, all at the Supplier’s sole cost and expense, which steps will include: (i) in respect of Equipment, the provision of loaner Products to the Purchaser until the remedy of the situation; (ii) the delivery and installation of any and all Software and hardware as may be necessary to rectify the situation; (iii) the coordination with the Purchaser of the removal and replacement of, or the repair of, the affected Products; (iv) the provision of new, and/or extension of existing, warranties as set out in Article 11 hereof; (v) in respect of Consumables, the provision of alternative or substitute Products, acceptable to the Purchaser, in its sole discretion; and (vi) the provision of training, in accordance with Article 6 hereof, as may be requested by the Purchaser during, or after rectification of, the situation. (b) upon the Purchaser’s request, will provide the Purchaser with all technical data in the Supplier’s possession or control relating to the Product recalled and the reason for the Product recall, including; (i) in respect of Consumables, the lot number, product code number, description of the Products affected by the recall or alert,; and (ii) in respect of Equipment, the manufacturer, the model number(s), and the serial number(s) of the Products affected by the recall or alert; (c) upon the Purchaser’s request, will accept return by the Purchaser of all recalled Products for full refund; (d) if the Purchaser determines, in its sole discretion, that it must obtain the Product or a product similar to the Product from an alternative supplier, will immediately reimburse the Purchaser for any additional costs incurred by the Purchaser in obtaining such products, which costs shall include, without limitation, any price for a Product or similar product paid by the Purchaser in excess of the price of any such recalled Product set forth in the Agreement and any costs associated with obtaining any other item that is necessary for the use of the replacement Product; and (e) will be responsible for and will pay all costs and expenses incurred b...

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. 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. (a) In the event DARA should be required or should voluntarily decide to initiate a Recall, DARA shall timely notify ONXEO and provide a copy of its recall letter and in no event later than twenty-four (24) hours of such decision by DARA. In conjunction with such Recall, ONXEO shall provide assistance in any investigation reasonably required to determine the cause and extent of the problem causing the Recall. (b) In the event that ONXEO independently believes that a Recall may be necessary or appropriate, ONXEO shall timely notify DARA, and in no event later than forty-eight (48) hours of such decision by ONXEO, and reasonably cooperate with DARA concerning the necessity and nature of such action; provided, however, that ONXEO shall not contact the FDA regarding a Recall of the Product without first consulting with DARA. (c) All coordination of any Recall activities involving a Product shall be handled by DARA whether or not such action was initiated by DARA. (d) In the event that the Product is Recalled as a result of (i) the supply by ONXEO of the Product that does not conform to the requirements set forth in this Supply Agreement or the Quality Agreement, (ii) ONXEO’s breach of this Supply Agreement or the Commercialization Agreement, including all Schedules thereto, or (iii) the grossly negligent or intentionally wrongful act of ONXEO or its representatives (including any Third Party Manufacturer), then ONXEO shall bear all of the costs and expenses of such Recall, including, without limitation, expenses related to communications and meetings with all required Regulatory Authorities, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal amount of replacement Product to those same customers. In the event that any Product is recalled for any other reason, then DARA shall bear all of the costs and expenses of such recall, including without limitation expenses related to communications and meetings with all required Regulatory Authorities, expenses of replacement stock, the costs of notifying customers and costs associated with shipment of recalled ...

Recall of Product. 16.1 Dynavax will be responsible for coordinating any recall of Product pursuant to the Quality Agreement. Baxter shall cooperate with Dynavax in connection with any recall, at Dynavax’s expense. Dynavax will be responsible for all of the costs and expenses of all Product recalls (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those persons whom Dynavax deems appropriate).

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. 16.1 Each party promptly shall notify the other if any Batch of Product is alleged or proven to be the subject of a recall, market withdrawal or correction. CLIENT shall be responsible for coordinating any recall, market withdrawal or field correction of Product, and recall, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. CLIENT shall provide BAXTER with a copy of all documents relating to such recall, market withdrawal or field correction. BAXTER shall cooperate with CLIENT (including providing CLIENT with all data, information and documents requested by CLIENT) in connection with such recall, market withdrawal or field correction, at CLIENT's expense. Unless such recall is [CONFIDENTIAL TREATMENT REQUESTED] , CLIENT shall be responsible for all of the costs and expenses of such recall, market withdrawal or field correction. In the event a recall, market withdrawal or field correction is necessary because both (i) BAXTER has delivered a non-conforming Product to CLIENT, and (ii) such non-conformity is [CONFIDENTIAL TREATMENT REQUESTED], BAXTER will bear all reasonable costs associated with such recall, market 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 CLIENT deems appropriate) in accordance with and up to a cumulative total maximum amount set forth in the chart below: In the event a recall, market withdrawal or field correction is necessary because both (i) BAXTER has delivered a non-conforming Product to CLIENT, and (ii) such non-conformity is due [CONFIDENTIAL TREATMENT REQUESTED], or [CONFIDENTIAL TREATMENT REQUESTED] XXXXXX'x breach of its warranties or obligations under this Agreement, BAXTER additionally will be responsible for the replacement cost of all returned Kits which are the subject of such recall, market withdrawal or field correction [CONFIDENTIAL TREATMENT REQUESTED]. 16.2 This Article 16 sets forth the entire liability of BAXTER in the event of a recall, market withdrawal, or field correction.

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; 7.2. Without prejudice to any other rights QUOIN as appropriate may have against the Distributor, the Distributor shall at all times maintain adequate control procedures to permit complete recall of any of the Product, including the implementation of a traceability system which allows traceability data to be retrieved within a maximum of twenty-four (24) hours. 7.3. If QUOIN determines or becomes aware that the Product fails in any respect to meet the relevant Specifications or the standards of quality and appearance required by QUOIN or applicable law, QUOIN shall be entitled by notice to the Distributor to require the Distributor to take all necessary action to recall immediately any such Product (including any such Product sold to Purchasers of the Distributor) and cease all further supply of such Product on a Named Patient Supply or Compassionate Supply basis until QUOIN can satisfy itself that the cause of the failure has been detected and rectified. The Product must be clearly marked and kept separate from other products and must be handled and disposed of in accordance with QUOIN’ instructions. Save as required by law, the D...

Recall of Product. 13.1 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 without limitation, Health Canada, the Supplier: (a) will immediately advise the safety alerts coordinator of AHS in writing (at the address specified in Section 29 of these Terms and Conditions) and take all reasonable steps to minimize AHS’ risk and to remedy the situation, all at the Supplier’s sole cost and expense; (b) upon AHS’ request, will provide AHS with all technical data in the Supplier’s possession or control relating to the reason for the Product recall and any proposed solution of the Supplier to the issue identified in the Product recall; (c) upon AHS’ request, will accept return by AHS of all recalled Products for full refund; (d) if AHS determines, in its sole discretion, that it must obtain the Product or a product similar to the Product from an alternative supplier, will immediately reimburse AHS for any additional costs incurred by AHS in obtaining such products, which costs shall include, without limitation, any price for a Product or similar product paid by AHS in excess of the price of any such recalled Product set forth in the Purchase Order and any costs associated with obtaining any other item that is necessary for the use of the replacement product; and (e) will be responsible for and will pay all expenses incurred with respect to any of the foregoing, including labour, return freight, insurance and packaging. This Section 13 shall survive the expiry or early termination of the Purchase Order.