Development Committee Review Clause Samples

Development Committee Review. Notwithstanding Sections 5.1 or 5.2, all protocols for clinical trials to be conducted for Collaboration Products in any territory shall be submitted for review by the Development Committee prior to the initiation of such trials and filing such protocols with any health regulatory agency; and RPRP and Introgen will be bound by the recommendations of the Development Committee with respect to such protocols. In addition, Introgen and RPRP shall submit their product registration plans to the Development Committee for review and comment, and the recommendations of the Development Committee with respect to such plans shall be binding on Introgen and RPRP. It is understood, however, that this Section 5.5 only requires that each party abide by such recommendations as are agreed by the Development Committee, and does not require that the Development Committee approve protocols or registration plans.