“Independent Data Monitoring Committee” means the committee responsible for reviewing the accrued safety and efficacy data during the Phase III Clinical Trial, monitoring the overall progress of the trial, and providing advice on the conduct of the Phase III Clinical Trial to the Trial Steering Committee.
“Programme Liaison Group” means the body responsible for the overall co-ordination of the Programme on a day to day basis, overseeing finances and administration.
“Programme Management Board” means the body responsible for the overall management of the Programme.
“Trial Management Group” means the body charged with the general management of the activities relating to the Phase III Clinical Trial.
“Trial Steering Committee” means the committee to be established prior to the Phase III Clinical Trial to review progress of the trial.
(E) Confidentiality, publication of data and intellectual property rights
Access to and publication of data
26. Indevus will be represented on the Trial Management Group and will be entitled to attend (although not vote at) Programme Management Board and Trial Steering Committee meetings. Indevus will receive analyses of the Trial Data (blinded) in the normal course of their membership of the Trial Management Group i.e., simultaneously with the clinical investigator members of that Group.
Settlement of disputes
49. MRC and Indevus will attempt to settle by mutual agreement all disputes arising under this Agreement with the assistance of the Programme Management Board.
50. This Agreement is to be governed by and adjudicated in accordance with English law.