Common use of Adverse Experience Reporting Clause in Contracts

Adverse Experience Reporting. Each Party will promptly report to the other Party any information of which it becomes aware concerning any adverse drug experience in connection with the use of the Product, including the incidence and the severity thereof. Each Party shall be responsible for reporting adverse experiences in accordance with applicable Legal Requirements; provided, however, that NEW ALPHA will bear all reasonable expenses incurred by GENERICO and NEW ALPHA in connection therewith. NEW ALPHA will provide to GENERICO copies of any reports submitted to the FDA and/or Regulatory Authority relating to any adverse drug experiences that are reasonably significant. GENERICO shall be responsible for receiving and documenting any complaint regarding the Product, as well as forwarding the complaint information to the applicable Facility quality unit and responding to the customer.