definiens: means any of the following in relation to a Verified Compound orProduct:(a ) significant research activity related to a Verified Compound or Product orrelated to biological processes that a Verified Compound or Product would or could affect, including, but not limited to, animal studies;(b ) active preclinical work required for a planned clinical trial, includingtoxicology or pharmacokinetic work;(c ) active planning of a clinical trial ( or in the event of issues arising with aregulatory agency in relation to a clinical trial, active negotiation with the regulatory agencyand / or replanning of the clinical trial);(d ) actively seeking to obtain the necessary IND or IRB / ethics committee or otherapprovals to carry out a clinical trial;(e ) active enrollment of patients into, or participation of patients in, a clinical trial, where relevant in accordance with the protocol in order to determine if the primary end point hasbeen met;'li ■ jText ~nnrlccd with an * has bcEn omitted and 171ed s ~ arat ~ c~~ with the Securities and Exchange Commission.lREDACTED CONFIDENTIAL(~ active monitoring, analysis or reporting on the data arising from a clinical trialwhere relevant in accordance with the protocol in order to determine if the primary end point hasbeen met;(g ) manufacture or formulation of a Verified Compound or Product for use in aclinical trial, including active process development work in support of planned manufacture ; and(h ) preparation for and making submissions to regulatory agencies for an NDA orawaiting the outcome of such submission