MACE Plus Study definition
MACE Plus Study means the component of the CVOT relating to the co-primary objective of assessing whether or not treatment with the Initial Product reduces the incidence of major adverse cardiovascular events including in totality or in part the following events: stroke or myocardial infarction; cardiovascular death or hospitalization for unstable angina or heart failure; or any coronary revascularization compared to placebo (“MACE Plus”), but excluding any component relating to the CVOT required by the FDA to be conducted in connection with the approval of the Initial Product. For clarity, if a component relates to assessing whether or not treatment with the Initial Product reduces the incidence of MACE Plus and some other component of the CVOT, it shall not be considered part of the MACE Plus Study for purposes of this Agreement.