Spontaneous Report Sample Clauses

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.
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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. A communication describing an adverse event or reaction in a patient given a medicinal product which does not derive from a study.

Related to Spontaneous Report

  • Status Report Recognizing that both parties may find it necessary to establish to third parties, such as accountants, banks, mortgagees, ground lessors, or the like, the then current status of performance hereunder, either party, on the request of the other made from time to time, will promptly furnish to Landlord, or the holder of any mortgage or ground lease encumbering the Premises, or to Tenant, as the case may be, a statement of the status of any matter pertaining to this Lease, including, without limitation, acknowledgment that (or the extent to which) each party is in compliance with its obligations under the terms of this Lease.

  • Status Reports The Grantee shall submit status reports quarterly, unless otherwise specified in the Attachments, on Exhibit A, Progress Report Form, to Department’s Grant Manager describing the work performed during the reporting period, problems encountered, problem resolutions, scheduled updates, and proposed work for the next reporting period. Quarterly status reports are due no later than twenty (20) days following the completion of the quarterly reporting period. For the purposes of this reporting requirement, the quarterly reporting periods end on March 31, June 30, September 30 and December 31. The Department will review the required reports submitted by Grantee within thirty (30) days.

  • CMI/RAI MDS Report Recognizing the mutual objective of quality resident care, the Employer agrees to meet through the Union Management Committee with the Union as soon as practicable after the receipt of the annual CMI/RAI MDS report. The Employer agrees to provide the Union with staffing levels, and staffing mix information; the impact of related payroll costs on staffing levels and a written notice of the CMI/RAI MDS report for the facility. The purpose of this meeting is to discuss the impact of the CMI/RAI MDS report on the staffing levels in the Home, quality resident care, and provide the Union with an opportunity to make representation in that regard. The parties shall meet as necessary to discuss other changes or workload issues. The parties may invite additional participants to attend the meeting to support constructive review and discussion.

  • Progress Report By March 1 of each year, ***** will submit a written annual report to Stanford covering the preceding calendar year. The report will include information sufficient to enable Stanford to satisfy reporting requirements of the U.S. Government and for Stanford to ascertain progress by ***** toward meeting this Agreement’s diligence requirements. Each report will describe, where relevant: *****’s progress toward commercialization of Licensed Product, including work completed, key scientific discoveries, summary of work-in-progress, current schedule of anticipated events or milestones, market plans for introduction of Licensed Product, and significant corporate transactions involving Licensed Product. ***** will specifically describe how each Licensed Product is related to each Licensed Patent.

  • Progress Reporting 5. The IP will submit to UNICEF narrative progress reports against the planned activities contained in the Programme Document, using the PDPR. Unless otherwise agreed between the Parties in writing, these reports will be submitted at the end of every Quarter. The final report will be submitted no later than thirty (30) calendar days after the end the Programme and will be provided together with the FACE form.

  • 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.

  • Adverse Report The Employer shall notify an employee in writing of any expression of dissatisfaction concerning his work within ten (10) working days of the event of the complaint, with a copy to the Union. This notice shall include particulars of the work performance which led to such dissatisfaction. If this procedure is not followed, such expression of dissatisfaction shall not become a part of his work record for use against him at any time. This Article shall be applicable to any complaint or accusation which may be detrimental to an employee's advancement or standing with the Employer, whether or not it relates to his work. The employee's reply to such complaint, accusation or expression of dissatisfaction shall become part of his record. The record of an employee shall not be used against him at any time after twelve (12) months following the serving of a suspension or disciplinary action, including letters of reprimand or any adverse reports.

  • 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.

  • COST REPORT 27 A. CONTRACTOR shall submit separate individual and/or consolidated Cost Reports for Period 28 One, Period Two, and Period Three, or for a portion thereof, to COUNTY no later than sixty (60) 29 calendar days following the period for which they are prepared or termination of this Agreement. 30 CONTRACTOR shall prepare the individual and/or consolidated Cost Report in accordance with all 31 applicable federal, state and COUNTY requirements, GAAP and the Special Provisions Paragraph of 32 this Agreement. CONTRACTOR shall allocate direct and indirect costs to and between programs, cost 33 centers, services, and funding sources in accordance with such requirements and consistent with prudent 34 business practice, which costs and allocations shall be supported by source documentation maintained 35 by CONTRACTOR, and available at any time to ADMINISTRATOR upon reasonable notice. In the 36 event CONTRACTOR has multiple Agreements for mental health services that are administered by 37 HCA, consolidation of the individual Cost Reports into a single consolidated Cost Report may be 1 required, as stipulated by ADMINISTRATOR. CONTRACTOR shall submit a consolidated Cost 2 Report to COUNTY no later than five (5) business days following approval by ADMINSTRATOR of 3 all individual Cost Reports to be incorporated into a consolidated Cost Report. 4 1. If CONTRACTOR fails to submit an accurate and complete individual and/or consolidated 5 Cost Report within the time period specified above, ADMINISTRATOR shall have sole discretion to 6 impose one or both of the following: 7 a. CONTRACTOR may be assessed a late penalty of five hundred dollars ($500) for each 8 business day after the above specified due date that the accurate and complete individual and/or 9 consolidated Cost Report is not submitted. Imposition of the late penalty shall be at the sole discretion 10 of the ADMINISTRATOR. The late penalty shall be assessed separately on each outstanding individual 11 and/or consolidated Cost Report due COUNTY by CONTRACTOR. 12 b. ADMINISTRATOR may withhold or delay any or all payments due CONTRACTOR 13 pursuant to any or all agreements between COUNTY and CONTRACTOR until such time that the 14 accurate and complete individual and/or consolidated Cost Report is delivered to ADMINISTRATOR. 15 2. CONTRACTOR may request, in advance and in writing, an extension of the due date of the 16 individual and/or consolidated Cost Report setting forth good cause for justification of the request.

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