Adverse Device Events definition
Adverse Device Events means any Product-related event that is reportable (or that Purchaser or Manufacturer determines after Best Efforts at mutual consultation should be reported) to (i) the FDA, or any local ethics committee ("LEC") responsible for approving the protocols for any clinical trials) conducted upon the Products in the Territory or any other ethics committee within the Territory with responsibilities analogous to a LEC; or (ii) to any other Governmental Authority responsible for the regulation of medical devices.