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.
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 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 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)
Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with Relaxin Licensed Compound or the Product, or if either Party party determines that an event, incident or circumstance has occurred which may result in the need for a recall or market withdrawal, the Party party notified of or wishing to call such recall or similar action shall, within twenty-four (24) hours[*], advise the other Party party of notification or its determination by telephone or facsimile, after which the Parties parties shall promptly discuss and work together to effect an appropriate course of action; provided, however, that either Party party may initiate a recall or market withdrawal thereafter if it deems such action necessary or appropriate. Connetics ImmunoGen shall be responsible for notification to FDA (or such other applicable Regulatory Authority with respect to countries other than Authorities outside the United States and the Territory) Territory and compliance with applicable laws outside the Territory in conducting such recall. Faulding BB shall be responsible for notification to the applicable Regulatory Authority Authorities 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 (Immunogen Inc)
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 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)
Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with Relaxin or the 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. Connetics As between the Parties, Soltec shall be responsible for notification to FDA (or such other the applicable Regulatory Authority with respect to countries other than those in the United States and the Territory) Territory and compliance with applicable laws outside the Territory in conducting such recall. Faulding 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