SPONTANEOUS REPORTS Sample Clauses

SPONTANEOUS REPORTS. SERIOUS ADRS YAMANOUCHI will forward by fax all reports of serious ADRs in CIOMS I format to CONNETICS within the same day for all fatal and life-threatening ADRs. All other serious ADRs should be forwarded no later than five (5) calendar days after receipt by YAMANOUCHI. The type of report (spontaneous), clock date, seriousness and case assessment (causality / expectedness) and company medical evaluation are printed on the CIOMS form. Where possible copies of the original reporter's report should be forwarded too, together with a translation into English if the original report is written in another language. The type of report (spontaneous), clock date, seriousness, case assessment (causality/expectedness) and company medical evaluation will be printed on the CIOMS form or on the covering letter. NON-SERIOUS ADRS YAMANOUCHI will provide CONNETICS with all reports of non-serious spontaneous ADRs in CIOMS I format on at least a monthly basis. CONNETICS will incorporate all such data in the Periodic Safety Update Reports.
Sample 1
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SPONTANEOUS REPORTS. In general, the principle of the implied positive causality shall be applied to all spontaneously reported AEs. Each Party shall assess each of the expectedness, labelling and listedness issues for each report as appropriate and according to their internal SOPs.
Sample 1
SPONTANEOUS REPORTS. (FROM ANY SOURCE) GlaxoSmithKline Canada and Corixa will exchange spontaneous AE data (foreign and domestic) with BEXXAR therapy according to the timelines below: Redacted
Sample 1
SPONTANEOUS REPORTS. Teva agrees to provide Supplier with all Adverse Event reports related to Product. The format is not necessarily that of CIOMS I but should contain all data elements to be able to generate a CIOMS I report. Source documents should remain locally for inspection purposes and should be provided on request. Case exchange is preferably done by email Each party agrees to provide the other party with copies of all Adverse Events reports within 3 business days of submission. Both parties agree to answer in a reasonably exhaustive manner all questions that the other party might raise that affect case evaluation or regulatory reporting with regard to exchanged cases. The date of receipt by the original recipient of any Adverse Event report must be recorded on each report exchanged.
Sample 1

Related to SPONTANEOUS REPORTS

  • 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 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Records Reports To maintain records and to prepare and file reports required by law to be filed by the Trustee or required by agreement with the Company;

  • 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.

  • Sales Reports On or before the twentieth (20th) day of each calendar month after the First Month, Tenant shall submit to City a report (the “Sales Report”) showing all Gross Revenues achieved with respect to the prior month by location, segregated by each source or general type of article sold or service rendered. Such report shall be certified as being true and correct by Tenant and shall otherwise be in form and substance satisfactory to Director. As described below, City shall have the right, in addition to all other rights herein, to impose a fine in the event Tenant shall fail to submit such Sales Report timely.

  • 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.

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