definiens: shall mean presentation of the Headline Results Document and the fully Quality Controlled tables andlistings for the GW Pharma ’s Phase III Clinical Trial n ° GWSP0604 ( being the ) for the relief of spasticity associated with multiple sclerosis which show that such clinical trial hassuccessfully met its primary end point set out in the clinical trial protocol for that clinical trial meaningfor clarity that such clinical trial has shown a statistically significant difference compared with placebo, provided further that the clinical efficacy results, together with related safety data available at that time, are sufficient for use as a pivotal trial for filing a MAA . It is agreed that if [COMPANY] notifies within five(5 ) days of receipt of the above mentioned Headline Results Document and fully Quality Controlledtables and listings that in [COMPANY] ’s opinion the results and data are not sufficient for use as a pivotal trialfor filing a MAA, then it will be considered that Successful Completion of the Relevant Clinical Trial hasnot been achieved, unless and until such time that GW Pharma and [COMPANY] further agree that a SuccessfulCompletion of the Relevant Clinical Trial has been achieved and that the corresponding MAA can befiled . ” * * * Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with theCommission