Common use of Clause 11 Clause in Contracts

Clause 11. 7.1 of the Commercialisation and Supply Agreement is deleted and replaced by the following: 11.7.1 pounds sterling (£***) upon the Successful Completion of the Relevant Clinical Trial for treatment of spasticity associated with multiple sclerosis; “Successful Completion of the Relevant Clinical Trial” shall mean presentation of the Headline Results Document and the fully Quality Controlled tables and listings for the GW Pharma’s Phase III Clinical Trial n° GWSP0604 (being the “Relevant Clinical Trial”) for the relief of spasticity associated with multiple sclerosis which show that such clinical trial has successfully met its primary end point set out in the clinical trial protocol for that clinical trial meaning for 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 Almirall notifies within five (5) days of receipt of the above mentioned Headline Results Document and fully Quality Controlled tables and listings that in Almirall’s opinion the results and data are not sufficient for use as a pivotal trial for filing a MAA, then it will be considered that Successful Completion of the Relevant Clinical Trial has not been achieved, unless and until such time that GW Pharma and Almirall further agree that a Successful Completion of the Relevant Clinical Trial has been achieved and that the corresponding MAA can be filed.” *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Appears in 2 contracts

Sources: Product Commercialisation and Supply Agreement (Gw Pharmaceuticals PLC), Product Commercialisation and Supply Agreement (Gw Pharmaceuticals PLC)