Adverse Reaction Reporting and Regulatory Matters Sample Clauses

The "Adverse Reaction Reporting and Regulatory Matters" clause establishes the obligations of parties to promptly report any negative or unexpected reactions associated with a product, typically in the context of pharmaceuticals or medical devices. It outlines the procedures for documenting, communicating, and escalating such incidents to relevant regulatory authorities, and may specify timelines, responsible parties, and required documentation. This clause ensures compliance with legal and regulatory requirements, helps protect public safety, and facilitates transparent communication between parties and regulators.
Adverse Reaction Reporting and Regulatory Matters. (a) Interneuron shall notify Wyeth-Ayerst within twenty-four (24) hours if Interneuron receives any notice of a serious or unexpected adverse drug experience associated with the use of REDUX. The terms "serious," "unexpected," and "adverse drug experience" as used in this Section 9(a) shall have the same meaning as the definitions set forth in Title 21 of the Code of Federal Regulations, Section 314.80(a), and in effect at the time of Interneuron's notice of report to Wyeth-Ayerst. Interneuron shall notify Wyeth-Ayerst immediately upon receiving notice of (1) information concerning any incident that causes REDUX or its labeling to be mistaken for, or applied to, another article; or (2) information concerning any change or deterioration in REDUX. Any repeated failure to notify Wyeth-Ayerst under this provision shall be grounds for termination, at Wyeth-Ayerst's option. (b) Interneuron shall report monthly to Wyeth-Ayerst all other significant information concerning any complaint of any kind regarding REDUX, its labeling, quality or packaging, including but not limited to, any adverse drug experience not reported pursuant to Section 9(a) above. (c) It is understood and agreed that the reporting requirements set forth in this Section 9 are based on Wyeth-Ayerst policies and procedures and regulatory reporting requirements. Accordingly, in the event of changes to regulatory requirements or Wyeth-Ayerst policies and procedures for adverse experience reporting, Interneuron agrees to comply with all reasonable revised notification procedures as requested in writing by Wyeth-Ayerst. (d) Wyeth-Ayerst shall evaluate all adverse drug experiences associated with REDUX, including those reported to Wyeth-Ayerst by Interneuron, and appropriately report serious or unexpected adverse drug experiences to FDA.
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Adverse Reaction Reporting and Regulatory Matters. (A) During the term of this Agreement, PSS shall notify Client in writing within twenty four hours of any information that PSS obtains concerning any Product or package complaint or any adverse event associated with the clinical use or marketing of the Product(s), whether or not determined to be attributable to the Product(s), in accordance with Client's written procedures delivered to PSS at the time a Supplement for the Product is signed. (B) During the term of this Agreement and for one year thereafter, PSS shall notify Client in writing within one business day of any information PSS receives regarding any threatened or pending action by any regulatory agency or other government authority which may affect the Product(s). PSS shall reasonably cooperate with Client in responding to such action, provided that any costs incremental to those provided for in the Supplement will be at Client's expense. In no event shall PSS itself respond to any such regulatory action without the prior written consent of Client.
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Adverse Reaction Reporting and Regulatory Matters 
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Related to Adverse Reaction Reporting and Regulatory Matters

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • 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, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; 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 inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.