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. Essential Elements:
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. 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. 1
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. 3.19 BSC shall present clinical information regarding BSC Surgical Mesh in a truthful, non-misleading manner and with a balanced presentation of risks in relation to benefits.
3.20 BSC shall not, when citing to any clinical study, clinical data, or preclinical data regarding Surgical Mesh, misrepresent the result or scope of the cited information.
3.21 BSC shall register all BSC-Sponsored studies regarding its BSC Surgical Mesh with XxxxxxxxXxxxxx.xxx as required by 42 CFR Part 11.
3.22 BSC shall, when submitting a study or clinical data regarding BSC Surgical Mesh for publication, disclose BSC’s role as a Sponsor and any potential conflict of interest with BSC of which BSC is aware for any author consistent with the disclosure requirements for International Committee of Medical Journal Editors (ICMJE).
3.23 In relation to BSC Surgical Mesh, BSC shall not, in Marketing Materials, use, rely on, or cite to any clinical study, clinical data or preclinical data where it had control or possession of underlying scientific materials, documents, or raw data on or after November 15, 2012 but does not retain the same for the three-year period following the last date such Marketing Materials are distributed by BSC. This prohibition will not apply if BSC has not retained such underlying scientific materials, documents, or raw data if (1) it was not permitted to retain the underlying scientific materials, documents, or raw data; or (2) the study/data was published in a peer-reviewed journal or has otherwise entered the public domain.
3.24 In relation to BSC Surgical Mesh, BSC shall not, in Marketing Materials, use, rely on, or cite to any clinical study, clinical data, preclinical data, research, or article, (1) for which BSC has not complied with the disclosure requirements in paragraph 3.22, unless BSC provides the disclosure detailed in paragraph 3.22 in the Marketing Material that uses, relies on, or cites such clinical study, clinical data, preclinical data, research, or article, (2) Sponsored by BSC for which the institution or investigator has not complied with the disclosure requirements set forth in paragraph 3.17, unless BSC provides the disclosure detailed in paragraph 3.17 in the Marketing Material that uses, relies on, or cites such clinical study, clinical data, preclinical data, research, or article, or (3) Supported by BSC for which any author/consultant/investigator has not complied with the disclosure requirements set forth in paragraphs 3.16 or 3.18,...
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.
CLINICAL RESEARCH. The Educational Institution will not permit dissemination or publication of any clinical research without prior consent of the Agency, which consent shall not be unreasonably withheld. Notwithstanding the foregoing, student may participate in Clinical Research in accordance with the appropriate professional and legal standards (as per the Use and Disclosure of Research section of The Health Information and Protection Act) to further Students’ academic standard including uses in theses, case studies, Student discussions, papers, research work and other similar academic activities.
