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. 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. (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.
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.
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. 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.
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.
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 Regulafions 21 CFR § 7.3 and 21 CFR§ 314, or other Applicable Law or regulafion of a country (a “Recall”), such Party shall advise and consult with the other Party regarding such event. MODERNA shall be responsible for implemenfing and administering any Recall, in its sole discrefion [***]. LONZA shall provide reasonable assistance to MODERNA in conducfing a recall or withdrawal, including providing MODERNA with all reasonably perfinent records and informafion. If the parfies dispute whether such Recall was primarily due to LONZA providing defecfive Product, then either party may seek the determinafion of whether the Product was defecfive Product in accordance with the relevant Statement of Work.
