Spontaneous reports Sample Clauses

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.
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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.
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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.
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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
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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.

  • 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 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.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • 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.

  • Late Reports If the General Partner does not fulfill its obligations under Section 14.2 within the time periods set forth therein, the General Partner, using its own funds, shall pay as damages the sum of $100 per day (plus interest at the rate established by Section 6.4 of this Agreement) to the Limited Partner until such obligations shall have been fulfilled. If the General Partner does not fulfill its obligations under Section 14.3 within the time periods set forth therein, the General Partner, using its own funds, shall pay as damages the sum of $100 per week (plus interest at the rate established by Section 6.4 of this Agreement) to the Limited Partner until such obligations shall have been fulfilled. If the General Partner shall so fail to pay, the General Partner and its Affiliates shall forthwith cease to be entitled to any fees hereunder (other than the Development Fee) and/or to the payment of any Net Operating Income or Sale or Refinancing Proceeds to which the General Partner may otherwise be entitled hereunder. Payments of fees and Distributions shall be restored only upon payment of such damages in full.

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