Pre-Clinical Activities

Pre-Clinical Activities. Those activities required by the FDA to be undertaken in order to file an IND.

Pre-Clinical Activities. Those activities required to be undertaken in order to file an IND application with the United States Food and Drug Administration ("FDA") or an equivalent application to a similar foreign regulatory agency in another jurisdiction, which may include, inter alia, managing animal studies, as well as toxicology studies. Pre-Clinical Activities shall not include testing, experimentation or other use in human patients.

Pre-Clinical Activities. Those activities required to be undertaken in order to file an IND with the FDA or an equivalent application to a similar foreign regulatory agency in another jurisdiction in the Primary EU Markets or EMA, which may include, inter alia, drug discovery and development, managing animal studies, as well as toxicology studies.