Product Recall. (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.
(b) To the extent a recall is required by applicable Law, or due to a potential safety hazard, non-compliance or Serial Defect, which is caused by Supplier, Supplier shall indemnify and hold Buyer harmless from all reasonable costs and expenses incurred in connection with any recall, repair, replacement or refund program, including all costs related to: (i) investigating and/or inspecting the affected goods; (ii) notifying Buyer’s customers; (iii) repairing, or where repair of the goods is impracticable or impossible, repurchasing or replacing the recalled goods; (iv) packing and shipping the recalled goods; and (v) media notification. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall, potential safety hazard, non- compliance or Serial Defect, except where such consultation would prevent timely notification required by Law.
Product Recall. In the event product delivered has been recalled, seized, or embargoed and/or has been determined to be misbranded, adulterated, or found to be unfit for human consumption by the packer, processor, manufacturer or by any State or Federal regulatory agency, the Contractor shall be responsible to notify the State through DAS, Office of State Purchasing and all ordering agencies/entities within two business days after notice has been given. Contractor shall, at the option of the ordering agency, either reimburse the purchase price or provide an equivalent replacement product at no additional cost. Contractor shall be responsible for removal and/or replacement of the affected product within a reasonable time as determined by the ordering agency. At the option of the ordering agency, Contractor may be required to reimburse storage and/or handling fees to be calculated from time of delivery and acceptance to actual removal. Contractor will bear all costs associated with the removal and proper disposal of the affected product. Failure to reimburse the purchase price or provide equivalent replacement product will be considered a default.
Product Recall. 15.1 Product may be recalled by XDx for any of the following reasons:
(A) where required by Applicable Laws and Regulations;
(B) following an order to recall by any Regulatory Authority; or
(C) where XDx determines that recall is necessary or advisable for safety reasons. Diaxonhit shall administer all aspects of any Product recall in accordance with provisions of this clause 15.
15.2 If Diaxonhit determines that any Product should be recalled, or if Diaxonhit becomes aware that a recall is required by law, then Diaxonhit shall notify XDx in writing within twenty-four (24) hours of such determination and shall consult with XDx regarding the most appropriate course of action. XDx shall review the written notice and provide a written response to Diaxonhit within twenty-four (24) hours of receipt of Diaxonhit’s notice of such determination. Diaxonhit shall give XDx notice of any life endangering situation or requirement for a recall of any Product mandated by any Regulatory Authority promptly.
15.3 If XDx determines that any Product should be recalled because of safety reasons, XDx shall notify Diaxonhit in writing within twenty four (24) hours of such determination and the reason for such recall and Diaxonhit shall proceed with the recall in accordance with Diaxonhit’s recall procedures and any reasonable instructions provided by XDx.
15.4 Following the decision to recall any Product, XDx shall provide Diaxonhit with a prepared statement for use in response to any inquiries regarding any recall of the Product. Diaxonhit shall use such prepared statement to respond to any inquiries received with regard to the recall and shall not make any other statement regarding such recall.
15.5 Subject to a cap of 100% of the Royalties actually received by XDx in the Sales Year in which a recall occurs, if any Product is recalled, XDx shall reimburse Diaxonhit for the direct out-of-pocket costs of activities incurred as a result of the recall, (e.g., travel, transportation, destruction and publicity costs) except those internal costs directly incurred and necessary to administer the recall; provided, however, that XDx shall not reimburse any costs associated with the recall to the extent that such recall is due to the fault, negligence, recklessness or wrong-doing of Diaxonhit or any of Diaxonhit’s Affiliates or Sales Agents, or their directors, officers, employees or agents or due to a breach of this Agreement by Diaxonhit.
15.6 In addition to its obligations under claus...
Product Recall. In the event that any of the goods are found by the Contractor, the State, any governmental agency, or court having jurisdiction to contain a defect, serious quality or performance deficiency, or not to be in compliance with any standard or requirement so as to require or make advisable that such goods be reworked or recalled, the Contractor will promptly communicate all relevant facts to the State Entity and undertake all corrective actions, including those required to meet all obligations imposed by laws, regulations, or orders, and shall file all necessary papers, corrective action programs, and other related documents, provided that nothing contained in this section shall preclude the State Entity from taking such action as may be required of it under any such law or regulation. The Contractor shall perform all necessary repairs or modifications at its sole expense except to any extent that the Contractor and the State Entity shall agree to the performance of such repairs by the State Entity upon mutually acceptable terms.
Product Recall. (a) If a recall is required by applicable Law, or Buyer or Supplier reasonably determines that a recall is advisable based on the fact that that the goods create a potential safety hazard, the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. Supplier and Xxxxx agree to cooperate and work together to ensure that the Corrective Action Plan is acceptable to both parties. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard to users of the goods or cause either party to be non-compliant with applicable Law. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings.
(b) To the extent a recall is determined to have been caused by a defect, non-conformance or non-compliance, which is the responsibility of Supplier, Supplier shall indemnify and hold harmless Buyer from all reasonable costs and expenses incurred in connection with any recall, repair, replacement or refund program, including all costs related to: (i) investigating and/or inspecting the affected goods; (ii) notifying Buyer’s customers; (iii) repairing, or where repair of the goods is impracticable or impossible, repurchasing or replacing the recalled goods; (iv) packing and shipping the recalled goods; and (v) media notification. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall or potential safety hazards, except where such consultation would prevent timely notification required by Law.
Product Recall. If this Contract includes the provision of goods and in the event that any of the goods are found by the Contractor, the State, any governmental agency, or court having jurisdiction to contain a defect, serious quality or performance deficiency, or not to be in compliance with any standard or requirement so as to require or make advisable that such goods be reworked or recalled, the Contractor will promptly communicate all relevant facts to the State Entity and undertake all corrective actions, including those required to meet all obligations imposed by laws, regulations, or orders, and shall file all necessary papers, corrective action programs, and other related documents, provided that nothing contained in this section shall preclude the State Entity from taking such action as may be required of it under any such law or regulation. The Contractor shall perform all necessary repairs or modifications at its sole expense except to any extent that the Contractor and the State shall agree to the performance of such repairs by the State upon mutually acceptable terms.
Product Recall. In the event that any of the goods provided by Contractor pursuant to this Agreement are found by the Contractor, the District, any governmental agency, or any court of competent subject matter jurisdiction adjudicating a dispute arising out of this Agreement or arising out of any other contract between Contractor and a third party for the same or substantially similar goods, to contain a defect, serious quality or performance deficiency, or to otherwise not be in compliance with any standards or requirement so as to require or make advisable that such goods be reworked or recalled, Contractor, will promptly communicate all relevant facts to the District’s School Nutrition Program and undertake all necessary corrective actions, including those required to meet all obligations imposed by laws, regulations or orders, and shall file all necessary papers, corrective action programs, and other related documents, provided that nothing contained in this section shall preclude the District from taking any such action as may be required of it under such law or regulation or as the District, in its sole discretion, deems reasonably necessary for the health, safety, and welfare of District’s students, staff, and visitors. The District will not accept any goods that have been reworked or recalled, the Contractor will reimburse the District for any previously delivered goods that have been recalled. The Contractor will further indemnify and hold harmless the District from any and all third party claims arising out of the Contractor’s provision of recalled goods as provided in this Agreement.
Product Recall. If any Governmental Entity issues a recall or takes similar action in connection with the Products, or if MEC determines that an event, incident or circumstance has occurred which may require a recall or market withdrawal, MEC shall advise Distributor of the circumstances by telephone or facsimile. MEC shall have the right to control the arrangement of any Product recall, and Distributor shall cooperate in the event of a Product recall with respect to the reshipment, storage or disposal of recalled Products, the preparation and maintenance of relevant records and reports, and notification to any recipients or end users. MEC shall pay all reasonable expenses incurred by Distributor of such a recall, including the costs of destroying Products. Distributor, shall promptly refer to MEC for exclusive response to all customer or consumer complaints involving the health, safety, quality, composition or packaging of the Products, or which in any way could be detrimental to the image or reputation of MEC or the Products, and shall notify MEC of any governmental, customer or consumer inquiries regarding the Products about which Distributor becomes aware.
Product Recall. (a) Distributor will maintain or cause to be maintained such traceability records as are necessary to permit a recall, market withdrawal or field correction of the Product, including inventory withdrawal in connection with any of the foregoing (each a “Recall”).
(b) Each Party shall promptly (but in any case, not later than twenty-four (24) hours of receipt) notify the other Party in writing of any information which indicates a Recall of any Product may be necessary, any safety or regulatory concerns, or any order, request or directive of a court or other Regulatory Authority requesting or requiring a Recall.
(c) To the extent permitted by circumstances, the Parties will confer before initiating any Recall. If the Parties do not agree on the need for or the extent of such a Recall, either Party may authorize the Recall.
(d) Each Party will cooperate fully with the other Party in connection with any Recall efforts.
(e) Distributor shall be responsible for the carrying out of any and all Recalls in accordance with applicable Laws.
(f) If any Recall is required (I) due to the failure of the Product to conform to the Specifications at the time title is transferred to Distributor, as subsequently confirmed by a mutually acceptable Third Party laboratory, or (II) due to the fact that Product samples (both retention and stability) stored under controlled conditions at the time of title transfer to Distributor no longer conform to the Specifications at any time tested thereafter until the Product expiration date is reached as confirmed by Cipher or its Approved Manufacturer (for stability samples) or a mutually acceptable Third Party laboratory (for retention samples), Cipher will be responsible for the direct costs of such Recall, will reimburse Distributor, its Affiliates, and SubDistributors within ten (10) Business Days after receipt of an invoice with supporting detail for all of their direct out-of-pocket costs and direct expenses related to such Recall. Any Minimum Net Sales Requirements set forth in Schedule D and promotional commitments in Section 3.1 shall be held in abeyance during such time as said Recall materially interferes with the Wholesalers’ ability to fulfill its customers’ orders, provided that such interruption shall not be deemed to occur so long as Distributor holds one week or more of saleable inventory. The Parties shall promptly discuss whether to credit or refund the Purchase Price of any Product subject to the Recall and, if the Partie...
Product Recall. No Product (or any component thereof) has been recalled, suspended, withdrawn, seized, discontinued or the subject of a refusal to file, clinical hold, deficiency or similar action letter (including any correspondence questioning data integrity) as a result of any action by any Governmental Entity, by the Seller or any of its Affiliates; nor are any such actions pending or under consideration (or any facts, conditions, or circumstance known) by the Seller or any of its Affiliates, or, to the Seller’s Knowledge, by any Governmental Entity. There is not, to the Seller’s Knowledge, pending or threatened litigation anywhere in the world seeking the recall, withdrawal, suspension, seizure or discontinuance of any of the Products.
