External Termination Factor

External Termination Factor. Means one or more of the following events or circumstances with respect to the Product: (a) failure to achieve the primary end points in a clinical study for the Product; (b) receipt of any materially adverse written communication from any Regulatory Authority regarding the approvability or approval of the Product; (c) decisions by any Regulatory Authority not to approve the NDA for the Product or a material delay in such approval; or (d) material changes in applicable laws or regulations... relating to the development, manufacture or commercialization of the Product. 2 [6] View More