Data and Safety Monitoring Board (DSMB) Sample Clauses

Data and Safety Monitoring Board (DSMB). If a DSMB is constituted for the Clinical Trial, NHLBI will notify Company in advance of any DSMB review. Company may participate in and will receive the open session reports of the DSMB. The recommendations derived from the closed sessions will also be communicated to Company. Prior to the Completion of the Clinical Trial, data and reports distributed for DSMB review will be used only for the purposes of the DSMB meeting and will be held in confidence by the DMSB.
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Data and Safety Monitoring Board (DSMB). If a DSMB is constituted for the Clinical Trial, the NIAID will notify the Company in advance of any DSMB review. The Company may participate in and will receive the open session reports of the DSMB. The recommendations derived from the closed sessions will also be communicated to the Company. Prior to the Completion of the Clinical Trial, data and reports distributed for DSMB review will be used only for the purposes of the DSMB meeting and will be held in confidence by the DMSB. [OPTIONAL TEXT WHEN COMPANY IS THE ONLY IND HOLDER AND ANY PORTION OF THE CLINICAL TRIAL IS CONDUCTED AT THE NIH [Comment: Review of the NIH Office of Human Subjects Protections by the Association for the Accreditation of Human Research Protections Programs (AAHRPP) requires the addition of this term to agreements involving clinical trials. This language was approved by AAHRPP, the NIH OHSRP and the NIH Technology Transfer Policy Board.]: “During and for a period of two years after the completion of a Protocol, the Company shall promptly provide to the NIAID any information that Company has reasonably determined could directly affect the health or safety of past or current Human Subjects or influence the conduct of the Protocol. Such information may arise from any source, for example, safety reports provided to the FDA, study results, information in site monitoring reports or data safety monitoring committee reports. NIAID shall be free to communicate the relevant safety information to each Human Subject and the IRB.”]
Data and Safety Monitoring Board (DSMB). Company will notify NIAID in advance of any DSMB review. NIAID may participate in and will receive the open session reports of the DSMB. Prior to the Completion of the Clinical Trial, data and reports distributed for DSMB review will be used only for the purposes of the DSMB meeting and will be held in confidence by the DSMB.

Related to Data and Safety Monitoring Board (DSMB)

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Environmental, Health and Safety i. Environment, Health and Safety Performance. Seller acknowledges and accepts full and sole responsibility to maintain an environment, health and safety management system ("EMS") appropriate for its business throughout the performance of this Contract. Buyer expects that Seller’s EMS shall promote health and safety, environmental stewardship, and pollution prevention by appropriate source reduction strategies. Seller shall convey the requirement of this clause to its suppliers. Seller shall not deliver goods that contain asbestos mineral fibers.

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

  • Health and Safety C8.1 The Contractor shall promptly notify the Authority of any health and safety hazards which may arise in connection with the performance of the Contract. The Authority shall promptly notify the Contractor of any health and safety hazards which may exist or arise at the Authority’s Premises and which may affect the Contractor in the performance of the Contract.

  • Environment, Health, and Safety 24.4.1. The Supplier and its staff (and/or any sub-supplier and/or subcontractor) shall comply with the laws and regulations in force related to protection of the environment, the health and safety instructions applicable to the Goods and Services performed pursuant to the Contract and especially, if appropriate, to the Goodsand Services performedon any Site by a third company.

  • Environmental, Health and Safety Laws There does not exist any violation by the Borrower or any Subsidiary of any applicable federal, state or local law, rule or regulation or order of any government, governmental department, board, agency or other instrumentality relating to environmental, pollution, health or safety matters which will or threatens to impose a material liability on the Borrower or a Subsidiary or which would require a material expenditure by the Borrower or such Subsidiary to cure. Neither the Borrower nor any Subsidiary has received any notice to the effect that any part of its operations or properties is not in material compliance with any such law, rule, regulation or order or notice that it or its property is the subject of any governmental investigation evaluating whether any remedial action is needed to respond to any release of any toxic or hazardous waste or substance into the environment, the consequences of which non-compliance or remedial action could constitute an Adverse Event.

  • Change Management BellSouth provides a collaborative process for change management of the electronic interfaces through the Change Control Process (CCP). Guidelines for this process are set forth in the CCP document as amended from time to time during this Agreement. The CCP document may be accessed via the Internet at xxxx://xxx.xxxxxxxxxxxxxxx.xxxxxxxxx.xxx.

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