Notice of Adverse Reactions. Each Party shall provide prompt notice to the other Party of any information it receives concerning serious side effects, injury, toxicity, or sensitivity reaction associated with the Product, whether or not determined to be attributable to the Product. Further, each Party shall notify the other Party in writing within 3 business days of the time such Party first becomes aware of a circumstance that might necessitate expedited notification of relevant Regulatory Authorities or significant change in the labeling of the Product.
Appears in 4 contracts
Samples: Asset Transfer and License Agreement, Asset Transfer and License Agreement (Avenue Therapeutics, Inc.), Asset Transfer and License Agreement (Avenue Therapeutics, Inc.)