Recall; Withdrawal Clause Samples
The Recall; Withdrawal clause establishes the right and procedures for a party to remove or take back products that have already been distributed or sold, typically due to safety, regulatory, or quality concerns. In practice, this clause outlines the circumstances under which a recall or withdrawal may be initiated, the responsibilities of each party in executing the recall, and the steps for notification, collection, and possible reimbursement or replacement of affected products. Its core function is to ensure a clear, coordinated response to product issues, thereby protecting consumers and minimizing legal or reputational risks for the parties involved.
Recall; Withdrawal. PRONOVA and RELIANT will each maintain or cause to be maintained such traceability records as are necessary to permit a recall, withdrawal or field correction of the Product (each, a “Recall”). Each Party will give telephonic notice (to be confirmed in writing) to the other within twenty-four (24) hours of the receipt of any information which indicates a Recall may be necessary. The decision to conduct and the right to control a Recall will be solely that of RELIANT, after appropriate consultation with PRONOVA. Each Party will cooperate fully with the other in connection with any Recall efforts. If any Recall is the result of the design, formulation or manufacture, storage or handling of the API by or on behalf of any PRONOVA Indemnitee (as defined in Section 16.2), PRONOVA will bear the cost of the Recall and replace API contained in recalled Product with conforming API at no additional charge hereunder and will reimburse RELIANT for all of RELIANT’s reasonable direct costs and expenses actually incurred by RELIANT in connection with the Recall including, but not limited to, direct costs of retrieving Product or Additional Products already delivered to customers and direct costs and expenses RELIANT is required to pay for notification, shipping and handling charges; provided, however, that for each such Recall (a) RELIANT will in good faith consult with PRONOVA and, to the extent commercially reasonable, implement PRONOVA’s recommendations on how best to conduct the Recall including, without limitation, the notification and retrieval of Product or Additional Product, and (b) prior to any reimbursement hereunder, RELIANT will provide PRONOVA with detailed supporting documentation of all costs and expenses for which reimbursement is being sought. If a Recall of Product or any Additional Product distributed is due to any act or omission of RELIANT, RELIANT will remain responsible for the costs of such Recall and will reimburse PRONOVA for all of the reasonable direct costs and expenses described above actually incurred by PRONOVA (if any) in connection with such Recall including, but not limited to, administration of the recall and such other reasonable direct costs as may be reasonably related to the Recall.
Recall; Withdrawal. As may be further set forth in the Quality Agreement, in the event that either Party determines an event, incident or circumstance has occurred which may result in the need for a “recall”, “market withdrawal” or “field alert” of Product, as such terms are defined in the United States Code of Federal Regulations 21 CFR § 7.3 and 21 CFR§ 314, or other Applicable Law or regulation of a country (a “Recall”), such Party shall advise and consult with the other Party regarding such event. MODERNA shall be responsible for implementing and administering any Recall, in its sole discretion [***]. LONZA shall provide reasonable assistance to MODERNA in conducting a recall or withdrawal, including providing MODERNA with all reasonably pertinent records and information. If the parties dispute whether such Recall was primarily due to LONZA providing defective Product, then either party may seek the determination of whether the Product was defective Product in accordance with the relevant Statement of Work.
Recall; Withdrawal. (a) Immediately upon execution of this Agreement, Supplier shall establish and HQ shall be notified by Supplier of its respective toll-free telephone number and contact name(s) for customers’ enquiries or questions.
(b) Supplier must provide supporting information or documentation to HQ for dissemination immediately and not later than twenty-four (24) hours by telephone and facsimile of a decision to Recall/Withdraw any of the Products.
(c) Subject to Sections 4.2 and 4.3, all costs of Recall/Withdrawal including all incremental costs incurred by the Parties, both internal and out of pocket, shall be the responsibility of and shall be paid by HQ if the causation is attributable to HQ or by Supplier if the causation is attributable to Supplier.
(d) Subject to Subsection 13.1(g), Supplier will provide the spokesperson on the specifics of the Recall/Withdrawal and shall provide an explanation as to why the Product was recalled/withdrawn unless the Withdrawal is initiated by HQ.
(e) Any notification to be given to HQ relative to a product recall/withdrawal must be faxed to the attention of the Director, Fractionation Products. The document must include the relevant product name, lot number(s) and a brief explanation of the reason justifying the recall/withdrawal. A statement confirming whether or not the targeted lot was distributed to HQ and/or within Canada must also be included.
(f) The transmission of a facsimile must be preceded by a telephone call to the fractionation products department (24 hours/ 7 days) Support Telephone line at (▇▇▇) ▇▇▇-▇▇▇▇ extension 6926, in order to inform HQ of the incoming facsimile in connection with a product recall/withdrawal.
(g) Any news release or disclosure relating to a removal from the market, quarantine, Recall or Withdrawal of a Product and referencing HQ must be reviewed and approved by HQ prior to release by Supplier.
(h) Any news release or disclosure, excluding customer cover letters, relating to a removal from the market, quarantine, Recall or Withdrawal of a Product and referencing Supplier must be reviewed and approved by Supplier prior to release by HQ.
Recall; Withdrawal. (a) Immediately upon execution of this Agreement, Supplier shall establish and CBS shall be notified by Supplier of its respective toll-free telephone number and contact name(s) for customers’ enquiries or questions.
(b) Supplier must provide supporting information or documentation to CBS for dissemination immediately and not later than twenty-four (24) hours by telephone and facsimile of a decision to Recall/Withdraw any of the Products.
(c) Subject to Sections 4.2 and 4.3, all costs of Recall/Withdrawal including all incremental costs incurred by the parties, both internal and out of pocket, shall be the responsibility of and shall be paid by CBS if the causation is attributable to CBS or by Supplier if the causation is attributable to Supplier.
(d) Subject to Subsection 11.1(e), Supplier will provide the spokesperson on the specifics of the Recall/Withdrawal and shall provide an explanation as to why the Product was recalled/withdrawn unless the Withdrawal is initiated by CBS.
(e) Any news release or disclosure relating to a removal from the market, quarantine, Recall or Withdrawal of a Product and referencing CBS must be reviewed and approved by CBS prior to release by Supplier.
(f) Any news release or disclosure, excluding customer cover letters, relating to a removal from the market, quarantine, Recall or Withdrawal of a Product and referencing Supplier must be reviewed and approved by Supplier prior to release by CBS.
Recall; Withdrawal. Without limiting Section 13.1, Egalet shall be fully responsible and pay for any recalls or Product withdrawals. If Egalet, in its discretion, recalls, detains or retains the Products (voluntarily or by order of a Regulatory Authority), Acura agrees to reasonably cooperate in such actions, at Egalet’s sole expense.
Recall; Withdrawal. 10.2.1 In the event that any Product sold pursuant to this Agreement should be alleged or proven not to meet its Specifications or other mandatory standards for the Product, either Party shall notify the other Party immediately, and both Parties shall cooperate fully regarding the investigation and disposition of any such matter. If Alpharma, in its discretion, recalls, detains or retains the Product (voluntarily or by order of a Regulatory Authority), Tris agrees to reasonably cooperate in such actions, at Alpharma's sole expense, except as set forth in Section 10.2.2.
10.2.2 In the event a recall, detention or retention action of the Product is due to any breach by Tris or its Affiliates of any warranty set forth herein or in the Commercial Supply Agreement, then and in such event, Tris shall bear all reasonable direct, documented costs associated with said action, including, without limitation, refund of the Commercial Transfer Price, and related royalty payments, of the quantity of Product so recalled, detained or retained, and shall bear the actual cost of conducting such action or withdrawal, including costs imposed by the applicable Regulatory Authority(ies) such as costs for detention and inspection, in accordance with the recall guidelines of the applicable Regulatory Authority(ies) or standard U.S. pharmaceutical industry practices. In the event the it cannot be determined after reasonable investigation whether a recall, detention or retention action is due to a Tris breach as referenced above, the costs of such action (as defined in the previous sentence) shall be shared equally by the Parties hereto.
Recall; Withdrawal. In the event that any Licensed Product should be alleged or proven not to meet the specifications or other mandatory standards for the Licensed Product in a country or legal jurisdiction in the applicable Territory, the Parties shall determine whether the unit of Licensed Product was sold prior to or after the Effective Date by reference to invoice information. River’s Edge shall have full responsibility to recall, detain or retain the Licensed Product (voluntarily or by order of a Regulatory Authority) for any Licensed Product sold after the Effective Date and DUSA shall have full responsibility to recall Licensed Product sold prior to the Effective Date.
Recall; Withdrawal. In the event that any Licensed Product should be alleged or proven not to meet the specifications or other mandatory standards for the Licensed Product in a country or legal jurisdiction in the applicable Territory, River’s Edge shall [C.I.] with any recall, or with respect to detaining or retaining the Licensed Product (voluntarily or by order of a Regulatory Authority). The [C.I.] will not in any way impact the [C.I.] under the terms of this Agreement except pursuant to Section 11.4 below.