5-2 承保範圍及不保事項 - ACE Group

circumstance, situation, transaction, event, advice, or decision will be deemed to be a single “clinical studyincident”.D. “Clinical studies” means any use or handling of the insured’s products or products of othersfurnished by the insured in connection with any “human clinical trial” and in compliance with a writtenprotocol for such research, clinical evaluation, testing, study or analysis, and includes “compassionateuse” of the insured’s “pharmaceuticals”, “biologics”, or “medical devices” in connection with the insured’s“human clinical trials”.E. “Compassionate use” means the emergency use of your “pharmaceutical”, “biologic”, or “medicaldevice” in a “human clinical trial” on a human subject when:1. such subject is incapable of giving informed consent, either directly or through an authorizedrepresentative;2. there is insufficient time to obtain proper pre-approval from the appropriate authorities; and3. such use is in strict compliance with all applicable laws, rules and regulations.F. “Employee” includes a “leased worker”. “Employee” does not include a “temporary worker”.G. “Executive officer” means a person holding any of the officer positions created by your charter,constitution, by-laws or any other similar governing document.H. “Hazardous properties” includes radioactive, toxic or explosive properties of “nuclear materials”,“radioactive materials” and/or “waste materials”.I. “Human clinical trial” means any organized research, clinical evaluation, testing, study or analysisof products or procedures, which adheres to a written protocol for the same and which provides clinicaldata for the assessment of the effects of a “pharmaceutical”, “biologic”, or “medical device” on humans.J. “Leased worker” means a person leased to you by a labor leasing firm under an agreementbetween you and the labor leasing firm, to perform duties related to the conduct of your business.“Leased worker” does not include a “temporary worker”.K. “Medical device” means any product, other than a “pharmaceutical” or “biologic”, that has anapplication in therapeutic or diagnostic medicine.L. “Nuclear material” means “source material”, “special nuclear material” and “byproduct material”.181