Voluntary Recall. Auxilium shall have the right, acting reasonably, to initiate a Voluntary Recall. In case of a voluntary recall initiated by Auxilium, Auxilium shall immediately give written notice to the Distributor of such action and all particulars thereof and review with the Distributor the proposed manner in which the recall is to be carried out. In the event that Distributor believes that a voluntary recall should be initiated, Auxilium shall be consulted prior to the decision of (i) whether a voluntary recall or other removal of Product shall be made; and (ii) the manner of communicating and executing any voluntary Product recall or withdrawal. In the event Distributor reasonably believes a voluntary Product recall or withdrawal in the Territory should be made for reasons of patient safety, Distributor shall promptly notify Auxilium of its belief ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. in writing and provide Auxilium with all supporting information or documentation. Auxilium’s approval must be obtained in writing, within a time period reasonable in the specific circumstance, for any recall and any notice of, or letters relating to, any recall. In the event that distributor and Auxilium cannot agree that a voluntary recall should be made for safety reasons, Distributor shall have the right to terminate the Agreement, remove the Product bearing its trademarks from the market within a reasonable time and to notify its customers that the Product will no longer be distributed by Distributor.
Voluntary Recall. In the event that DEBIOTECH or IMED reasonably believes that any Product or Accessory violates any provision of applicable law, rule or regulation or should be recalled due to health or safety considerations, DEBIOTECH and IMED shall consult in good faith concerning the necessity for implementing any action and the means of implementing the same and shall mutually agree to take such action in respect thereof as is necessary. In such an event, the Voluntary Recall shall be treated in accordance with Article 11.3(a) hereabove, including, without limitation, calculation of costs.
Voluntary Recall. If Company voluntarily recalls an item for any reason (a “Voluntary Recall”), Company will (a) immediately notify Intermountain’s recall center at (000) 000-0000, and xxxxxxx@xxxxx.xxx; (b) within 24 hours of the Voluntary Recall, provide Intermountain a written proposal of the corrective action to be taken by Company as a result of the Voluntary Recall , which corrective action is subject to Intermountain’s review and approval; (c) perform the corrective action approved by Intermountain; and (d) within 30 days of Intermountain’s request, reimburse Intermountain for any costs it incurs as a result of the Voluntary Recall.
Voluntary Recall. If a Party believes that a voluntary withdrawal or recall of a Product is necessary both Parties will mutually agree to the need for a recall. If the Parties cannot agree, they will use an independent third party qualified to assess the need for a recall and will follow the recommendation of the third party. INO-T will assist AGA, to the extent necessary in implementing the withdrawal or recall. Any and all costs related to the recall should be paid by the Party which is responsible for the recall.
Voluntary Recall. In the event that either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party desiring such recall or similar action shall, within twenty-four (24) hours, advise the other Party thereof by telephone (and confirm by email or facsimile), email or facsimile. Following notification of a voluntary recall in the Territory, the Parties shall decide through the JSC whether to conduct a recall and the manner in which any such recall shall be conducted. In any case of dispute, Section 3.4 shall apply.
Voluntary Recall. If either Party desires to recall OT-fentanyl Products shipped prior to the Repurchase Date for non-conformities with Specifications (other than such non-conformities that would require recall pursuant to the requirements of applicable laws or regulations), it shall so notify the other Party. If the other Party does not agree that the relevant OT-fentanyl Products do not comply with Specifications, the dispute shall be settled as set forth in Section 4.7(c). If the Parties agree as to such non-conformity or such non-conformity is determined pursuant to Section 4.7(c), then the Party desiring the recall shall administer the recall in a commercially reasonable manner with the other Party's cooperation. If one Party's actions were the sole cause of the non-conformity with Specifications, such Party shall bear all costs and expenses of the recall.
Voluntary Recall. (a) If a Party believes that a voluntary withdrawal or recall of a Product is necessary, both Parties shall promptly use their respective commercially reasonable efforts to agree whether it is necessary. If the Parties agree that it is necessary, in respect of the Linde Territories, AGA shall carry out that withdrawal or recall and, in respect of countries outside the Linde Territories and the Existing ROW Territories, INO-T shall carry out that withdrawal and recall. If the Parties cannot agree, in respect of a proposed voluntary withdrawal or recall:
Voluntary Recall. If either Party establishes a need to recall a Product for non-conformities with the Product specifications therefor (other than such non-conformities that would require recall pursuant to the requirements of applicable laws or regulations), it shall so notify the other Party. If the other Party does not agree that the relevant Product does not comply with such specifications, the dispute shall be settled as set forth in Clause 5.10. If the Parties agree as to such non-conformity or such non-conformity is determined pursuant to Clause 5.10, then a decision shall be made mutually as to the appropriate Party that will lead/coordinate the recall in a commercially reasonable manner with the other Party's full cooperation. The lead/coordination role shall typically be taken by the holder of the Regulatory Approval in the country in which the recall is to take place with full consultation by the other Party. A joint recall administration team shall be established with an equal number of nominated individuals from both Parties participating. A final report must be completed by the recall administration team and delivered promptly to the other Party.
Voluntary Recall. When an employee voluntarily agrees to work on scheduled days off, hours shall be paid as hours worked.
