Common use of Notification and Recall Clause in Contracts

Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with a 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. As between the Parties, Soltec shall be responsible for notification to the applicable Regulatory Authority with respect to countries other than those in the Territory and compliance with applicable laws outside the Territory in conducting such recall. Connetics 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.

Appears in 1 contract

Samples: Agreement (Connetics Corp)

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Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with a 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. As between the Parties, Soltec Connetics shall be responsible for notification to the FDA (or such other applicable Regulatory Authority with respect to countries other than those in the Territory United States and the Territory) and compliance with applicable laws outside the Territory in conducting such recall. Connetics 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.

Appears in 1 contract

Samples: Development, Commercialization and License Agreement (Connetics Corp)

Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with a 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. As between the Parties, Soltec Connetics shall be responsible for notification to the FDA (or such other applicable Regulatory Authority with respect to countries other than those in the Territory United States and the Territory) and compliance with applicable laws outside the Territory in conducting such recall. Connetics Paladin 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.

Appears in 1 contract

Samples: License Agreement (Connetics Corp)

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Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with a 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. As between the Parties, Soltec Connetics shall be responsible for notification to the FDA (or such other applicable Regulatory Authority with respect to countries other than those in the Territory United States and the Territory) and compliance with applicable laws outside the Territory in conducting such recall. Connetics Medeva 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.

Appears in 1 contract

Samples: Development, Commercialization and License Agreement (Connetics Corp)

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