Clinical Trial definition
Examples of Clinical Trial in a sentence
References herein to IND will include, to the extent applicable, any non-US counterpart of the foregoing filed with a Regulatory Authority for the investigation of a product in any country or group of countries (such as a Clinical Trial Application in the EU) outside the U.S. in conformance with the requirements of such Regulatory Authority.
To the extent required by applicable laws and regulations of the European Medicines Agency (the “EMA”), the Company has submitted to the EMA a Clinical Trial Authorization or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions, if any, were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the EMA with respect to any such submissions.
Neither Janux (nor any of its Affiliates, nor any Third Party on behalf of Janux or any of its Affiliates) is conducting (or has previously conducted prior to the Effective Date) any Clinical Trial for any Licensed Compound or Licensed Product.
The JSC will continue to exist until the earlier of (i) BMS’s election by written notice to discontinue the JSC (provided that BMS may not make such election until the study report for the first Phase I Clinical Trial under the Joint Development Plan has been drafted) and (ii) mutual agreement by the Parties to disband the JSC.