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.
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Samples: Agreement, Agreement (Reliant Pharmaceuticals, Inc.), Agreement (Reliant Pharmaceuticals, Inc.)