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. 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. BSD may propose additional clinical research to support enhanced marketing claims for Products. BSD will work with BTI to make any study generally supportive of the efficacy of the technology. If BTI agrees with the study protocol, clinical expenses will be shared 50/50%. Ownership of the research will be shared.
Clinical Research. Process of search, experimental evaluation of a product, substance, drug, medical device, diagnostic or therapeutic technique in human beings, where the objective of evaluation is safety and efficacy, always taking care of the bioethical and confidentiality aspects of the study subjects.Source: ACROM website, http://www.acrom. org.mx/?page_id=38
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 research, studies and tests conducted by or on behalf of the Company (collectively, “Studies”), if any, have been and, if still pending, are being conducted with reasonable care and in accordance with experimental protocols, procedures and controls pursuant to all Health Care Laws and Health Care Authorizations. Except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any research, studies or tests, the results of which the Company believes reasonably call into question the research, study or test results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described; the Company has made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. or foreign government or medical device regulatory agency, or health care facility institutional review board (collectively, the “Regulatory Agencies”). The Company has not received any correspondence from any Governmental Entity requiring the termination, suspension or material modification of any research, study or test conducted by or on behalf of the Company. To the knowledge of the Company, there have been no material adverse episodes or complications resulting from any research, study or test conducted by or on behalf of the Company. The Company has operated and currently is in compliance in all material respects with all applicable rules, regulations and policies of the Governmental Entity.
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: