definiens: means any of the following in relation to a Licens ed Product : i. significant research activity related to biologi cal processes that a Licensed Product would or could affect, including, but not limited to, animal studies ; ii . active preclinical work required for any contem plated clinical trial, including any toxicology or pharmacokinetic work ; iii . active planning of a clinical trial ( or in the even t of issues arising with a Competent Authority in relation to a clinical trial, active negotiation with such Competent Authority and/or replanning of the clinical trial ) ; iv . actively seeking to obta in the necessary IND, other regulatory approvals or other approvals to carry out a clinical trial ; v. active enrolment of patients into, or participation of patients in, a clinical trial, where relevant in accordance with the protocol in order to det ermine if the primary end point has been met ; vi . active monitoring, analysis or reporting on the dat a arising from a clinical trial where relevant in accordance with the protocol in order to determi ne if the primary end point has been met ; vii . manufacture or formulation of a Licensed Produ ct for use in a clinical trial, including active process development work in support of planned manu facture ; and - 10 - EXECUTION VERSION CONFIDENTIAL viii