Clinical Development Information Clause Samples

Clinical Development Information. The Parties acknowledge that the Phase III clinical studies in the Development Plan will not be initiated without available clinical supply manufactured in the facility expected to produce the commercial supply. The Parties currently agree that the available safety database at BLA filing shall contain [*] (currently contemplated to be approximately [*]. If the Parties identify that, due to factors such as drop-out rate, changes in the Development Plan, or other factors, the number of treated patients in the safety database at filing will be less than [*], then the JDC will propose amendments to the Development Plan to ensure that the safety database contains [*]. Roche and PDL recognize that the ideal assessment of Daclizumab [*] would accurately determine clinically relevant [*] responses to Daclizumab for the proposed asthma indication within this particular patient population. Clinically relevant responses reflect issues related to [*]. The [*] plan should be discussed on a regular basis with regulatory authorities especially at the end of phase II meeting.