Spontaneous Report Sample Clauses

Spontaneous Report. A communication describing an adverse event or reaction in a patient given a medicinal product which does not derive from a study.
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Spontaneous Report. Licensee shall provide to Oncolytics information of Spontaneous Reports in the Territory in writing, using any mutually agreed format within the timeframes defined in Section 8.3. The reporting form shall include all the information provided by the Spontaneous Source. All Spontaneous Reports received from consumers or health care professionals are considered as suspected Adverse Drug Reactions. Cases originating from the internet where the website is under management or responsibility of Licensee or any Third Party which holds Marketing Authorization for Licensed Product, should be screened for potential Adverse Events by the appropriate Party.
Spontaneous Report. Unsolicited communication by a Healthcare Professional or Consumer to a company, regulatory authority or other organisation that describes one or more Adverse Events or Adverse Drug Reactions in a patient given one or more medicinal products and does not derive from a study or any organised data collection scheme.

Related to Spontaneous Report

  • Status Reports DSI will issue to Depositor and Preferred Beneficiary a report profiling the account history at least semi-annually. DSI may provide copies of the account history pertaining to this Agreement upon the request of any party to this Agreement.

  • Progress Report 10.1 If required, you shall submit progress reports in connection with the Service (“Report”) on at least a monthly basis, or as we may require. The Report shall include a summary of the activities and accomplishments during the previous reporting period.

  • Information Package On each Reporting Date the Master Servicer shall deliver to the Administrative Agent and each Purchaser Agent, on behalf of such Purchaser Agent’s Purchaser Group, the relevant Information Package.

  • Information Packages As soon as available and in any event not later than two (2) Business Days prior to each Settlement Date, an Information Package as of the most recently completed Fiscal Month.

  • 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.

  • Progress Reports The Recipient shall submit to the OPWC, at the OPWC's request, summary reports detailing the progress of the Project pursuant to this Agreement and any additional reports containing such information as the OPWC may reasonably require.

  • Report A report delivered by the Servicer to the Trustee or the Certificate Administrator pursuant to Section 3.10.

  • Management Report Promptly upon receipt thereof, copies of all detailed financial and management reports submitted to Borrower or any other Loan Party by independent auditors in connection with each annual or interim audit made by such auditors of the books of Borrower or any other Loan Party.

  • Monthly Report A. A Monthly Report shall be submitted within ten (10) calendar days of the end of each calendar month of the Period of Operation. Each Monthly Report shall be signed, dated, and certified by Concessionaire, Concessionaire’s Bookkeeper, or Accountant, and contain a Statement of Total Gross Receipts, excluding New Jersey State Sales Tax, derived by Concessionaire from operation of the Concession during the previous month. Each Monthly Report shall be based on the daily “Z” tapes or Point-of-Service (POS) device equivalent for that same month showing each day’s sales activity. Failure on the part of Concessionaire to provide the Monthly Report, when due, shall constitute a material breach of this Agreement subject to Suspension of Operations and/or Termination, in accordance with the terms and conditions set forth in Paragraphs 9 and 10. Concessionaire shall provide Department with any additional written clarification and/or information necessary to confirm the accuracy of any or all of Concessionaire’s Monthly Reports.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

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