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.
Appears in 6 contracts
Samples: License Agreement (Spectrum Pharmaceuticals Inc), Licensing Agreement, Licensing Agreement
Adverse Event Reporting. Either party Each Party shall adhere, and shall require that its Affiliates, Sublicensees, co-marketers and distributors adhere, provide the other Party with all information necessary for such other Party to receive in order to comply with all requirements of applicable law and regulations that relate Applicable Law relating to adverse event reporting with respect 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 eventProducts.
Appears in 2 contracts
Samples: License Agreement (Aridis Pharmaceuticals, Inc.), License Agreement (Aridis Pharmaceuticals, Inc.)
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.
Appears in 1 contract
Samples: License Agreement (Amgen Inc)