Adverse Event Reporting. Licensee shall advise Vital Images, by telephone or facsimile, within twenty-four (24) hours after it becomes aware of any adverse event from the use of any Product or malfunction of any Product. Unless otherwise required by applicable local laws, Licensee shall advise Vital Images of any such adverse event prior to any report or filing being made with the U.S. Food and Drug Administration (“FDA”) or any other comparable regulatory body elsewhere in the world.
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Samples: Product Distribution Agreement (Vital Images Inc), Development, Supply, Marketing and Distribution Agreement (Vital Images Inc), Product Distribution Agreement (Vital Images Inc)
Adverse Event Reporting. In the event that Vital Images has granted Licensee the right to use the Products under this License Agreement in its business activities, Licensee shall advise Vital Images, by telephone or facsimile, within twenty-four (24) hours after it becomes aware of any adverse event from the use of any Product or malfunction of any Product. Unless otherwise required by applicable local laws, Licensee shall advise Vital Images of any such adverse event prior to any report or filing being made with the U.S. Food and Drug Administration (“FDA”) or any other comparable regulatory body elsewhere in the world.
Appears in 2 contracts
Samples: Development, Supply, Marketing and Distribution Agreement (Vital Images Inc), Development, Supply, Marketing and Distribution Agreement (Vital Images Inc)
Adverse Event Reporting. In the event that Vital Images has granted Licensee the right to use the Products under this License Agreement in its business activities, Licensee shall advise Vital Images, by telephone or facsimile, within twenty-four (24) hours after it becomes aware of any adverse event from the use of any Product or malfunction of any Product. Unless otherwise required by applicable local laws, Licensee shall advise Vital Images of any such adverse event prior to any report or filing being made with the U.S. Food and Drug Administration (“"FDA”") or any other comparable regulatory body elsewhere in the world.
Appears in 1 contract
Adverse Event Reporting. Licensee shall advise inform Vital Images, by telephone or facsimile, within twentyforty-four eight (2448) hours after it becomes aware of any adverse event from the Licensee concludes that use of or errors in any Product may threaten human safety or malfunction of any Productlife, describing in reasonable detail the facts giving rise to such perceived threat. Unless otherwise required by applicable local laws, Licensee shall advise Vital Images of any such adverse event threat prior to making any report or filing being made with the U.S. Food and Drug Administration (“"FDA”") or any other comparable regulatory body elsewhere in the worldother countries.
Appears in 1 contract
Samples: Software License Agreement