CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. 11.1. The Clinical Study Sites and Principal Investigators shall perform the Study in strict accordance with the protocol, and any subsequent amendments thereto, applicable federal, state, and local laws, regulations and guidelines, good clinical practices (“GCP”), and instructions provided by Nordic Bioscience. The Clinical Study Sites and Principal Investigators shall permit Nordic Bioscience and agencies such as the FDA to inspect Study records including the Subjects’ medical records. The subject informed consent form signed by the Subjects shall provide for access to the Subjects’ medical records by Nordic Bioscience and by agencies such as the FDA.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. A. The Institution shall perform the Services (i) in a professional manner; (ii) in conformance with that level of care and skill ordinarily exercised by other professional institutions in similar circumstances; and (iii) in compliance with all applicable local, state and federal laws and regulations.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. A. The Group shall perform the Study in substantial conformance with generally accepted standards of good clinical practice, with the Protocol, and with all applicable local, state and federal laws and regulations governing the performance of clinical investigations including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the FDA applicable to cooperative group clinical trials.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. Immtech shall perform the Research in conformance with generally accepted standards of good clinical practice, with the Protocol, with instructions provided by UNC-CH's Institutional Review Board and Scientific Advisory Boards, and with all applicable local, state and federal or national laws and regulations governing the performance of the Protocol and Research in the countries involved in the clinical trials, including, but not limited to, the Swiss Tropical Institute. Immtech shall retain all records resulting from the Research for the time required by applicable regulations, and shall allow for inspection by UNC-CH (during normal business hours and upon reasonable advance notice, unless an emergency medical condition exists with respect to a Research Subject) of all such records, including the Research Subjects' medical records.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. In performing their respective obligations hereunder, the Parties shall comply, as applicable, with generally accepted standards of clinical practice, with the Protocol, and with all Applicable Law governing the performance of clinical investigations as applicable to the Study.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. The Institution and the Principal Investigators shall perform the Study in conformance with the Protocol, instruction provided by Analytical Biosystems, good clinical practice guidelines, state and federal laws, guidelines of the Institution, and patient consent requirements.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. Pacific Data Design, Inc. shall perform its obligations under this Agreement in conformance with generally accepted standards of good clinical practice, with any applicable protocols, and with all applicable local, state and federal laws and regulations governing the performance of clinical investigations including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration ("FDA"). Pacific Data Design. Inc. agrees to retain all records resulting from the Services for the time required by applicable regulations and furnish copies to CLIENT of such records, or allow CLIENT to inspect all such records as permitted or required by applicable law. CLIENT will notify Pacific Data Design, Inc. of the FDA Application filing and approval status. ________________________________________________________________________________ *Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. Pacific Data Designs, Inc. Master Agreement -------------------------------------------------------------------------------- [LOGO FOR PACIFIC DATA] PROJECT AGREEMENT Protocol DUR01-03 Between Pacific Data Designs, Inc. and Durect Corporation ________________________________________________________________________________ *Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. Pacific Data Designs, Inc. Master Agreement -------------------------------------------------------------------------------- Pacific Data Designs, Inc. and Durect Corporation ("CLIENT") agree that Pacific Data Designs, Inc. will perform the services described below beginning July 2000. Unless otherwise specified, the general terms and conditions for work performed under this Project Agreement, are those specified under the Master Agreement, which is incorporated herein by this reference. Changes to this Agreement may only be made by mutual written agreement of the parties. Pacific Data Designs, Inc.: CLIENT: By:______________________________ By:___________________________ Name: Xxxxx X. Xxxxxx Name:_________________________ ---------------------------- Title: President Title:________________________ --------------------------- Date:____________________________ Date:_________________________ ________________________________________________________________________________ *Material has been omitted pursuant to a r...
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. 11.1 The Institution and the Principal Investigator shall perform the Study in compliance with generally accepted standards of GCP as set forth in Title 21 of the U.S. Code of Federal Regulations (“C.F.R.”), the Protocol, instructions provided by Amgen and all applicable local, state and federal laws and regulations governing the performance of clinical investigations including but not limited to the Federal Food, Drug, and Cosmetic Act, regulations and guidances of the FDA; all applicable export control and economic sanctions regulations as well as the Foreign Corrupt Practices Act and other applicable anti-bribery laws (the “Applicable Law”). The Principal Investigator shall provide Amgen with sufficient accurate financial information to allow Amgen to submit complete and accurate certification or disclosure statements as required under 21 C.F.R. Part 54. The Principal Investigator shall also promptly update this information if any relevant changes occur during the course of the Study and for […***…] following the completion of the Study. The Institution and Principal Investigator shall comply with all recordkeeping requirements under 21 C.F.R. Part 312 and shall retain any records mutually agreed to by Amgen, the Institution and/or Principal Investigator resulting from the Study for the time required by applicable federal regulations, and to allow for inspection of all such records including the Subjects’ medical records. The subject informed consent form signed by the Subjects shall provide for access to the Subjects’ medical records by Amgen and by agencies such as the FDA. The Institution and the Principal Investigator shall ensure that the most up to date and relevant safety information regarding Study Drug is disclosed in the informed consent form. Amgen will provide the Institution and the Principal Investigator with such safety information, as updated from time to time.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. CLINIMETRICS shall perform its obligations under this Agreement in conformance with generally accepted standards of good clinical practice, with the Protocol, and with all applicable local, state and federal laws and regulations governing the performance of clinical investigations including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration ("FDA"). CLINIMETRICS agrees to retain all records resulting from the Research for the time required by applicable regulations and furnish copies to CLIENT of such records including the medical records of any subject participating in the Research, or allow CLIENT to inspect all such records as permitted or required by applicable law. CLIENT will notify CLINIMETRICS of the FDA Application filing and approval status.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE. The Institution shall perform the Research in conformance with generally accepted standards of good clinical practice, with the Protocol, instructions provided by Sponsor and with all applicable local, state and federal laws and regulations governing the performance of clinical investigations including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration. The Institution shall retain all records resulting from the Research for the time required by applicable federal regulations (the Sponsor will notify the Institution of the FDA Application filing and approval status), and to allow for inspection of all such records including the Research Subjects medical records. The Informed Consent form signed by the Research Subjects shall provide for access to the Research Subjects medical records by the Sponsor and by agencies such as the FDA.
