External Delay Factor

External Delay Factor. Means one or more of the following events or circumstances with respect to the Product: (a) the effectiveness of any IND or protocol filed with a Regulatory Authority to conduct a clinical trial necessary or useful to obtain Regulatory Approval of the Product in Japan is delayed; (b) any clinical study of the Product necessary or useful to obtain Regulatory Approval of the Product in Japan is suspended, put on hold, or terminated as a result of any action by any Regulatory Authority,... institutional review board ("IRB") or independent data monitoring committee, or by or on behalf of Durata, its Affiliates or licensees based on IRB or independent data monitoring committee guidance; or (c) manufacturing or supply difficulties. View More