definiens: means the randomized, double - blind, plaxxxx - contro lled Clinical Trial to evaluate the effect of long - term treatment with Contrave on the incidence of MACE in obese and over weight subjects with cardiovascular disease that the FDA r equired in its Regulatory Approval of Contrave date d September 10, 2014, which study shall meet the foll owing requirements : ( a ) the primary objective of th is Clinical Trial shall be to demonstrate txxx the upp er bound of the 2 - sided confidence interval for the estimated risk ratio comparing the incidence of MACE observed with Contrave to that observed in the placebo grou p is less than 1.4 ; ( b ) the Clinical Trial shall be desi gned to provide sufficient data to reflect the cardiovascular risk associated with Contrave ; ( c ) t he Clinical Trial shall be designed in a manner tha t allows for completion in accordance with the timelines set by the FDA ; and ( d ) any other requirements for such Cl inical Trial set forth by the FDA or that the Parties mutu ally axxxx xx xnclude in such Clinical Trial