Xx Debarment. I understand that FivePrime is engaged in the biotechnology business, which is regulated by the United States Food and Drug Administration ("FDA"}, among other governmental agencies. I represent and warrant to FivePrime that I am not, and have never been, debarred by the FDA or any other governmental agency, including of jurisdictions outside the United States, associated with the regulation of pharmaceuticals or biologics, including with respect to clinical and non-clinical research, development, manufacturing, marketing and sales. If at any time during my employment with FivePrime I become the subject of any proceeding for disqualification, debarment, delisting or exclusion, I will immediately inform FivePrime of such proceeding.
Xx Debarment. Each Party will use reasonable efforts to not use, in any capacity in connection with the Collaboration or the performance of its obligations under this Agreement, any Person that has been debarred pursuant to Section 306 of the FD&C Act, as amended, or that is the subject of a conviction described in such section. Each Party agrees to inform the other Party in writing immediately if it or any Person that is performing activities in the Collaboration or under this Agreement, is debarred or is subject to debarment or is the subject of a conviction described in Section 306 of the FD&C Act, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of the notifying Party’s knowledge, is threatened, relating to the debarment or conviction of the notifying Party or any Person or entity used in any capacity by such Party or any of its Affiliates in connection with the Collaboration or the performance of its other obligations under this Agreement.
Xx Debarment. Institution warrants and represents that neither the Institution nor the Institution’s employees or agents who will perform Study services hereunder (including without limitation the Principal Investigator and all other Study investigators and personnel) (i) are debarred, disqualified or deemed ineligible to conduct clinical research or to receive investigational drugs or devices as a clinical investigator under any applicable laws or regulations, including without limitation, subsections 306(A) and 306(B) of the Generic Drug Enforcement Act of 1992, or (ii) is under investigation by any government agency in relation to clinical research, including, without limitation FDA debarment. Institution further covenants and agrees that during the term of this Agreement, Institution shall immediately provide Sponsor with written notice if Institution or any of its employees or agents becomes debarred, disqualified or deemed ineligible by any court or regulatory agency or becomes subject to any pending or threatened proceedings or actions regarding the same, together with any other information known to Institution that is relevant to such debarment or disqualification proceedings or actions. Institution shall promptly notify the Sponsor if any research in which the Principal Investigator has been involved in was terminated for cause or allegations of misconduct and an explanation of the circumstances that led to termination and to promptly notify the Sponsor if ongoing research is terminated for cause or allegations of misconduct and an explanation of the circumstances that led to such termination.
