Common use of Notification and Recall Clause in Contracts

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.

Appears in 2 contracts

Samples: Manufacturing and Supply Agreement (Santarus Inc), Manufacturing and Supply Agreement (Santarus Inc)

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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"“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 ’s possession and (b) provide such assistance in connection therewith as Santarus may reasonably request.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Santarus Inc)

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 *** twenty four (24) hours, advise Patheon Manufacturer 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 Manufacturer shall (a) cooperate fully with Santarus in the event of any such Recall, withdrawal and/or related disposition of any affected Finished Products in PatheonManufacturer's possession and (b) provide such assistance in connection therewith as Santarus may reasonably request.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Santarus Inc)

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 *** twenty four (24) hours, advise Patheon Manufacturer 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 Manufacturer 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 Manufacturer’s possession and (b) provide such assistance in connection therewith as Santarus may reasonably request.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Salix Pharmaceuticals LTD)

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Notification and Recall. The handling of recalls and withdrawals of Finished Products Product 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"“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 Product in Patheon's ’s possession and (b) provide such assistance in connection therewith as Santarus may reasonably request.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Santarus Inc)

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