Notification and Recall. The handling of recalls and withdrawals of Finished Products shall be within the sole discretion of Santarus, unless otherwise required by Applicable Laws. If any Government Authority issues or requests a recall or takes similar action in connection with Finished Product, or if Santarus determines that an event, incident or circumstance has occurred which may reasonably result in the need for a recall or market withdrawal (collectively, "RECALLS"), Santarus shall, within *** hours, advise Patheon thereof by telephone or facsimile, after which the Parties shall promptly discuss and work together to effect an appropriate course of action. Notification to FDA (or such other Foreign Regulatory Authority or Government Authority) and conducting such Recall shall be the responsibility of Santarus. Patheon shall (a) cooperate fully with Santarus in the event of any such Recall, withdrawal and/or related disposition of any affected Finished Products in Patheon's possession and (b) provide such assistance in connection therewith as Santarus may reasonably request.
Notification and Recall. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Female Product, or in the event 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 notified of or desiring such recall or similar action shall, within twenty-four (24) hours, advise the other party thereof by telephone or facsimile. Following notification of a recall, within seventy-two (72) hours, Xxxxxxxx shall decide whether to conduct a recall (except in the case of a government-mandated recall) and the manner in which any such recall shall be conducted.
Notification and Recall. In the event that any Regulatory Authority issues or requests a recall or market withdrawal or takes similar action in connection with any Product sold or distributed by Licensee or its sub-distributors, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of any Product sold or distributed by Licensee or its sub-distributors, the Party notified of or desiring such recall or similar action shall, within twenty-four (24) hours, advise the other Party thereof by telephone or facsimile. Following such notification, within seventy-two (72) hours, Supplier shall decide in its sole discretion whether to conduct a recall or market withdrawal (except in the case of a government-mandated recall) and the manner in which any such recall or market withdrawal shall be conducted. Licensee shall cooperate with Supplier as reasonably requested by Licensee in the implementation of any recall or market withdrawal.
Notification and Recall. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with the Product, or in the event either party hereto determines an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the party notified of or determining the need for such recall or similar action shall, within twenty-four (24) hours, advise the other party thereof by telephone or facsimile. Following notification of a recall, within forty-eight (48) hours, the parties shall discuss whether or not to conduct a recall, and if so, the timing of the recall, the breadth, extent and level of customer to which the recall shall reach, the strategies and notifications to be used, and other related issues. In the event that the parties cannot agree on any such decision, the issue shall be resolved by Schering.
Notification and Recall. In the event that any governmental agency or authority issues or requests a recall or takes similar action in connection with the Product, or in the event either party determines that an event, incident or circumstance has occurred which may result in the need for a recall or market withdrawal, the party notified of or wishing to call such recall or similar action shall, within twenty-four (24) hours, advise the other party thereof by telephone or facsimile, after which the parties shall promptly discuss an appropriate course of action; provided, however, *** CONFIDENTIAL TREATMENT REQUESTED. 36 that either party may initiate a recall or market withdrawal thereafter if it deems such action necessary or appropriate.
Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with Relaxin or the Product, or if either Party determines that an event, incident or circumstance has occurred which may result in the need for a recall or market withdrawal, the Party notified of or wishing to call such recall or similar action shall, within twenty-four (24) hours, advise the other Party of notification or its determination by telephone or facsimile, after which the Parties shall promptly discuss and work together to effect an appropriate course of action; provided, however, that either Party may initiate a recall or market withdrawal thereafter if it deems such action necessary or appropriate. Connetics shall be responsible for notification to FDA (or such other applicable Regulatory Authority with respect to countries other than the United States and the Territory) and compliance with applicable laws outside the Territory in conducting such recall. Faulding shall be responsible for notification to the applicable Regulatory Authority with respect to countries in the Territory and compliance with applicable laws in the Territory in conducting such recall.
Notification and Recall. In the event that any governmental agency or authority issues or requests a recall or takes similar action in connection with the Product, or in the event either party determines that an event, incident or circumstance has occurred which may result in the need for a recall or market withdrawal, the party notified of or wishing to call such recall or similar action shall, within twenty-four (24) hours, advise the other party thereof by telephone or facsimile, after which the parties shall promptly discuss and work together to effect an appropriate course of action; provided, however, that either party may initiate a recall or market withdrawal thereafter if it deems such action necessary or appropriate. Notification to the FDA and compliance with applicable law in conducting such recall shall be the responsibility of Anthra.
Notification and Recall. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Licensed Product or in the event 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 notified of or desiring such recall or similar action will, within twenty-four (24) hours, advise the other Party thereof by telephone (and confirmed by email or facsimile), email or facsimile. Selecta will have the sole right to decide, in its discretion, whether to conduct a recall, at its expense, of a Licensed Product in the Territory, and the manner in which any such recall will be conducted. 3SBio will have the sole right to decide, in its discretion, whether to conduct a recall, at its expense, of a Licensed Product outside the Territory, and the manner in which any such recall will be conducted.
Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with the Product, or if either Party determines that an event, incident or circumstance has occurred which may result in the need for a recall or market withdrawal, the Party notified of or wishing to call such recall or similar action shall, within ***, advise the other Party of notification or its determination by telephone or facsimile, after which the Parties shall promptly discuss and work together to effect an appropriate course of action; provided, however, that either Party may initiate a recall or market withdrawal thereafter if it deems such action necessary or appropriate. SM shall be responsible for notification to FDA and compliance with applicable laws in conducting such recall.
Notification and Recall. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Licensed Product in the Field in the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of the Licensed Product in the Field, the Party notified of or desiring such recall or market withdrawal shall, within [***], advise the other Party thereof by telephone or facsimile. Following such notice, either Party may decide whether a recall or withdrawal shall be conducted in a Class I Situation with respect to any Licensed Product (except in the case of a government-mandated recall), and in the event of a disagreement between the Parties with respect to whether a recall or withdrawal shall be conducted, either Party may require such recall or withdrawal. The Party that holds the NDA shall decide the manner in which any such recall or withdrawal shall be conducted. Following such notice, the Party that holds the NDA with respect to the applicable Licensed Product may decide whether to conduct a recall or withdrawal in any situation which is not a Class I Situation (except in the case of a government-mandated recall) and the manner in which any such recall or withdrawal shall be conducted. For clarity, nothing contained in this Section 9.1 is intended or shall be construed to permit the Party other than the Party that holds the NDA to determine whether to cause a permanent recall or withdrawal of a Product from the market.
