Clinical Study. The term “
Clinical Study. The term “Clinical Study” shall mean a Phase I, Phase II, Phase III Study, as applicable.
Clinical Study. Hospital and Investigator agree to use their best efforts and professional expertise to perform the Clinical Study according to the Protocol as set forth in Exhibit A. Hospital agrees to provide such qualified personnel, equipment, materials (except materials to be provided by Sponsor as hereinafter set forth) and facilities as are necessary to perform the Clinical Study. Hospital and Investigator agree to comply with all applicable laws and regulations relating to the use of such equipment, materials and facilities and to the employment of such personnel.
Clinical Study. A research study using human subjects or data from living human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. Two types of clinical studies are interventional studies (or clinical trials) and observational studies. 6 45 CFR 164.504(e): Uses and disclosures: Organizational requirements: xxxx://xxx.xxxx.xxx/cgi-bin/text- idx?SID=938e08839465e82e2c30c3bd4a359ce2&node=pt45.1.164&rgn=div5%23se45.1.164_1402#se4 5.1.164_1504 8 10 CFR 1045.21 Privately Generated Restricted Data: xxxxx://xxx.xxx.xxx/fdsys/granule/CFR-1999-title10- vol4/CFR-1999-title10-vol4-sec1045-21 9 Executive Order 12958: 32 CFR 701.23 xxxxx://xxx.xxx.xxxxxxx.xxx/cfr/text/32/701.23 10 Classified National Security Information, April 17, 1995: Executive Order 13526 xxxxx://xxx.xxxxxxxxxx.xxx/the-press-office/executive-order-classified-national-security-information 11 Atomic Energy Act of 1954: Nuclear Regulatory Legislation, 109th Congress: Session NUREG-0980 Vol. 1, Mo. 7. Office of the General Counsel, U.S. Nuclear Regulatory Commission: xxxx://xxxxxxx.xxxxxx.xxx/~/media/bes/pdf/nureg_0980_v1_no7_june2005.pdf A codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government in the United States. • 21 CFR Part 50 Protection of Human Subjects12 • 21 CFR Part 54 Financial Disclosure by Clinical Investigators13 • 21 CFR Part 56 Institutional Review Boards14 • 21 CFR Part 312 Investigational New Drug Application15 • 21 CFR Part 314 Applications for FDA Approval to Market an New Drug or an Antibiotic16 • 21 CFR Part 320 Bioavailability and Bioequivalence Requirements17 • 45 CFR Part 46 Protection of Human Subjects (Common Rule)18 See Data Classification The federal rule that governs most federally funded research conducted on living human subjects and aims to ensure that the rights of human subjects are protected during the course of a research project, historically focusing on protection from physical and mental harm by stressing autonomy and consent.19 See Regulatory Authorities When referring to a study participant addresses the issue of how personal data that have been collected for one approved person may be held and used by the organization that collected the data, what other secondary or further uses may be made of the data, and when the permission of the individual is required for such uses.20 This term in this context is specific to data use agreemen...
Clinical Study. A. The Manufacturer is involved in a clinical study consisting of at least two hundred (200) patients (the "Clinical Study") being conducted by Dr. Virgilio Sacchini ("Dr. Sacchinx"), xx xxx xxxxxxx or Xxxxxxxxxxxxst working with Dr. Sacchini. Pursuant to Paragrxxxx "X" xxx "B" of Article "3" of the Definitive Agreement, an aggregate of at least two hundred thousand ($200,000) dollars and not more than two hundred twenty five thousand ($225,000) dollars shall be paid by the Distributor towards the completion of the Clinical Study.
Clinical Study. A. Within five (5) days and within sixty (60) days after the date of the December 3, 2004 execution of this Agreement, Life Medical shall give one hundred thousand ($100,000) dollars and an additional one hundred thousand ($100,000) dollars, respectively, to Scantek, which funds shall be utilized by Scantek for the completion of a clinical study consisting of at least two hundred (200) patients (the "Clinical Study") by Dr. Virgilio Sacchini ("Dr. Sacchixx") xx xx xxx xxxxxxx or xxxxxxxxxxxxst working with Dr. Sacchini, if Dr. Sacchini is not xxxxxxxxx xor anx xxxxxx.
B. After the two hundred thousand ($200,000) dollars set forth in Paragraph "A" of this Article "3" of this Agreement has been utilized by Scantek, Scantek shall be responsible for all additional costs with respect to the Clinical Study; provided, however, that if Scantek incurs additional costs of the Clinical Study beyond the two hundred thousand ($200,000) set forth in Paragraph "A" of this Article "3" of this Agreement, Life Medical shall pay to Scantek 50% of such additional costs, up to a maximum payment of twenty-five thousand ($25,000) dollars in the event that Scantek pays at least fifty thousand ($50,000) in additional costs, within thirty (30) days after notification by Scantek that Scantek has paid said additional costs. If, for example, the Clinical Study costs an additional forty thousand ($40,000) dollars beyond the two hundred thousand ($200,000) dollars paid by Life Medical pursuant to Paragraph "A" of this Article "3" of this Agreement, Life Medical shall pay $20,000 to Scantek.
C. Life Medical shall not be responsible for any costs with respect to the Clinical Study in excess of the aggregate of two hundred twenty five thousand ($225,000) dollars set forth in Paragraphs "A" and "B" of this Article "3" of this Agreement.
Clinical Study. During the Pre-Closing Period, the Company shall continue to conduct its Ongoing IMPT-314 Clinical Trial in the Ordinary Course of Business consistent with past practices, including by using its reasonable best efforts [*] for the Ongoing IMPT-314 Clinical Trial as soon as reasonably practicable. The Company will keep Parent reasonably informed of the status of the Ongoing IMPT-314 Clinical Trial, and promptly notify Parent of (i) any new data or findings, including any new safety reports or imaging results, (ii) any deviations from the Company’s existing development plan or (iii) any other material changes, including any changes to the conduct of the study, events (including any reported Serious Adverse Events) circumstances or conditions, in each case, with respect to the Ongoing IMPT-314 Clinical Trial. The Company shall promptly following the availability thereof provide Parent with all meeting minutes, including minutes of any safety review meetings, regarding any with respect to actions or changes made by the Company with respect to the Ongoing IMPT-314 Clinical Trial; provided that such material may be (A) redacted as necessary to comply with contractual arrangements or address legal privilege or (B) designated as “outside counsel only,” which materials and the information contained therein shall be given only to outside counsel and previously agreed upon outside consultants; provided further that, in the case of clause (A) above, the Company shall use its reasonable best efforts to obtain any required consents or take such other action (such as the entry into a joint defense or common interest agreement or other arrangement to avoid loss of attorney client privilege) to permit such access or disclosure. The Company shall not take any material actions or make material changes with respect to the Ongoing IMPT-314 Clinical Trial without Parent’s consent (with such consent not to be unreasonably withheld, conditioned or delayed). The Company shall also use its reasonable best efforts with respect to the entry and cleaning of data for the anticipated presentation at [*].
Clinical Study. Through the use of the Principal Investigator and its Study Staff, the Institution shall undertake and complete in a timely fashion the Study within the agreed period for performance in strict accordance with this Agreement, the Protocol (including all amendments hereto) and the budget outlined in Exhibit A hereto (the “Budget”). Institution shall not subcontract any of the services to be performed by it in accordance with the Study, the Protocol, or this Agreement, without the prior written consent of CRO.
Clinical Study. Through the use of the Study Staff, the Site shall undertake and complete in a timely fashion the Study within the agreed period for performance in strict accordance with this Agreement, the Protocol (including all amendments hereto) and the budget outlined in Exhibit A hereto (the “Budget”). Site shall not subcontract any of the services to be performed by it in accordance with the Study, the Protocol, or this Agreement, without the prior written consent of CRO.
