CLINICAL RESEARCH. These Clinical Terms apply to all contracts that involve clinical research. The Government shall have unlimited rights to all protocols, data generated from the execution of these protocols, and final reports, funded by the Government under this contract, as defined in Rights in Data Clause in FAR 52.227-14. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form, to ensure the Government has the ability to review and distribute the deliverables, as the Government deems necessary.
CLINICAL RESEARCH. The parties recognize the benefits of participation in clinical research projects. The Union will be notified prior to implementation of any clinical research that impacts working conditions of bargaining unit employees. Participation in research projects will be voluntary, consistent with staff rights/policy and the Department’s right to assign work. Employees will receive training and written instructions regarding the intent and requirements of the research project prior to implementation. Staff involved in clinical research may be recognized for their participation/contribution to the project by the annual performance evaluation and other means; for example, monetary awards, acknowledgment in papers.
CLINICAL RESEARCH. DISTRIBUTOR shall not engage in, support or contribute to any clinical research and/or studies of any of the Products without the prior written consent of OTI and OTI’s prior review and written approval of the protocol for such clinical research or study.
CLINICAL RESEARCH. Preparation of the final clinical study report for L-FMAU-102 is ongoing and is expected to be complete in March 2004. • Study L-FMAU-102B will continue until the last patient completes the study (currently targeted for Nov. 23, 2003). The final database lock is scheduled for December 31, 2003. The final data from this study will be provided. • Study FTCB-204 will continue until the last patient completes the study (currently targeted for June 2004). The final database lock is scheduled for July 22, 2004. The final data from this study will be provided. • All activities for study CLV-202 are being terminated. • The regulatory process for study CLV-205 in Turkey is ongoing. The possibility to transfer this filing to Bukwang to be discussed.
CLINICAL RESEARCH. Essential Elements:
CLINICAL RESEARCH a. Patient-oriented research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient- oriented research may include: Mechanisms of human disease; Therapeutic interventions; Clinical trials; Development of new technologies.2 1
CLINICAL RESEARCH. To the extent that any Network Participant desires to perform any human clinical testing and experimentation in performance or furtherance of the Research, the Network Participant must first acquire FLQ’s express written consent, not to be unreasonably withheld, provided that, the Network Participant (i) certifies that it will comply with all applicable legal requirements and good clinical practice applicable to Network Participant and to clinical research in the jurisdiction in which the clinical research is performed; (ii) provides evidence of satisfactory levels of insurance or self-insurance applicable to the clinical activity, and (iii) unless otherwise prohibited by law, FLQ has been expressly named as an additional insured under such insurance policies.
CLINICAL RESEARCH. Drug Development and Manufacturing . Recognizing that SPARTA and RTP are both young companies with a need to cooperate in order to maximize economies of scale and to avoid duplicate efforts related to drug development and manufacturing of applications utilizing same drug delivery technologies, SPARTA and RTP agree that:
CLINICAL RESEARCH. Except as otherwise provided in the agreement effective November 27, 1991 by and between SPARTA and CRL, to the extent requested by SPARTA and to the extent available by RTP and its affiliates, Cato Research Ltd. ("CRL") and Cato Pharma Canada, Ltd., RTP will make available its staff or that of said affiliates, to conduct ongoing clinical research activities related to the Applications being developed by SPARTA as requested by SPARTA and at SPARTA's expense, as mutually agreed by the applicable parties.
CLINICAL RESEARCH. 51 Section 14.1. Responsibilities of the Parties...................51 Section 14.2. Clinical Protocol; Selection of Sites.............52 Section 14.3. Japan Studies.....................................53 ---------------- [**]Confidential Information omitted and filed separately with the Securities and Exchange Commission.
