Common use of Adverse Event Reporting Clause in Contracts

Adverse Event Reporting. Either party shall adhere, and shall require that its Affiliates, Sublicensees, co-marketers and distributors adhere, to all requirements of applicable law and regulations that relate to the reporting and investigation of any adverse event. In the event that either party becomes aware of any adverse event relating to either the Licensed Product or Captisol, the party shall timely inform the other party of any such adverse event.

Adverse Event Reporting. Either party (a) Each Party agrees to comply with any and all Laws that are applicable to it as of the Effective Date and thereafter during the Term relating to Licensed Product safety data collection and reporting (and, if applicable, recalls). Each Party shall adhere, and shall require that its Affiliates, Sublicensees, co-marketers and distributors adhere, to all requirements of applicable law and regulations that relate provide annually to the reporting and investigation other Party a listing of any adverse event. In the event that either party becomes aware of any adverse event relating to either the each serious untoward medical occurrence in a patient or subject who is administered a Licensed Product or Captisoland shall, the party shall timely inform the should such other party Party expressly so request, provide such other Party with additional detail as to such ones of any such adverse eventoccurrences as such other Party may designate.

Adverse Event Reporting. Either party Each Party shall adherebe responsible for reporting to the relevant Governmental Authorities all adverse events with respect to the Licensed Products (whether within or outside the Territory), to the extent required by and shall require in accordance with Law. Each Party will ensure that its Affiliates, Sublicenseespermitted sublicensees and licensees, co-marketers and distributors adhereas applicable, comply with all such reporting obligations. Each Party will designate a safety liaison to all requirements of applicable law and regulations that relate to be responsible for communicating with the other Party regarding the reporting and investigation of any adverse event. In the event that either party becomes aware of any adverse event relating events with respect to either the a Licensed Product or Captisol, the party shall timely inform the other party of any such adverse eventProduct.