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.
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Related to Clinical Development Information

  • Technology Research Analyst Job# 1810 General Characteristics

  • Staff Development As part of their induction, new staff will be made aware of this policy and will be asked to ensure compliance with its procedures at all times.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members. (b) Information collected as part of this program shall be the sole property of the faculty member. This information or any judgments arising from this program shall not be used to determine non-renewal or termination of a faculty member's contract, suspension or dismissal of a faculty member, denial of advancement on the salary scale, nor affect any other administrative decisions pertaining to the promotion or employment status of the faculty member. (c) A joint advisory committee consisting of three regular faculty members who shall be elected by and are P.D. Committee Chairpersons and three administrators shall make recommendations for the operation, financing and management of the Professional Development Program.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • Research Independence The Company acknowledges that each Underwriter’s research analysts and research departments, if any, are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriter’s research analysts may hold and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of its investment bankers. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against such Underwriter with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriter’s investment banking divisions. The Company acknowledges that the Representative is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short position in debt or equity securities of the Company.