SUSAR reporting Sample Clauses

SUSAR reporting. Unexpected adverse reactions are all untoward and unintended responses to an investigational product related to any dose administered These reactions are SUSARs if the following two conditions are met: 1) the event must be serious (see section 9.3.2); 2) there must be a certain degree of probability that the event is a harmful and an undesirable reaction to the medicinal product under investigation, regardless of the administered dose; NovImmune will report directly or through delegation to a third party all SUSARs to the investigators and the relevant Ethics Committees, in writing as soon as practical, but at least within 15 days. Fatal and life-threatening suspected SUSARs will be reported within 7 calendar days, with another 8 days for completion of the report. NovImmune will report all SUSARs to the EMA's EudraVigilance database within 15 days, as well as to the relevant National Competent Authorities when required. Fatal and life-threatening suspected SUSARs will be reported within 7 calendar days, with another 8 days for completion of the report.
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SUSAR reporting. Pfizer will provide Suspected Unexpected Serious Adverse Reactions (“SUSAR”) cases to Institution. Principal Investigator will receive SUSAR reports via the sponsor's SIRIUS system and save them as appropriate keeping in mind that they should be readily available if inspected by either Pfizer or 19.15
SUSAR reporting. Unexpected adverse reactions are all untoward and unintended responses to an investigational product related to any dose administered These reactions are SUSARs if the following three conditions are met: 1) the event must be serious (see Section 8.2.2 above); 2) there must be a certain degree of probability that the event is a harmful and an undesirable reaction to the medicinal product under investigation, regardless of the administered dose; 3) the event is not listed as an expected serious reaction in the Reference Safety Information (RSI) of the IB.Under 21 CFR 312.32(c), the Sponsor (directly or through a delegated third party) is required to notify FDA and all participating Investigators in an IND safety report (i.e. 7- or 15-day expedited report) of potentially serious risks from clinical trials or any other source as soon as possible, but no later than 7 calendar days for fatal or life-threatening events and 15 calendar days for all other events, after the Sponsor receives the safety information and determines that the information qualifies for reporting. US Investigators are required to promptly report to the Institutional Review Board (IRB) all unanticipated problems involving risk to human subjects or others, including adverse events that should be considered unanticipated problems (21 CFR 312.66), such as IND safety reports. Sobi AG will also report all SUSARs to the EMA's EudraVigilance database within 15 days, as well as to the relevant National Competent Authorities when required. Fatal and life-threatening SUSARs will be reported within 7 calendar days, with another 8 days for completion of the report.

Related to SUSAR reporting

  • Monthly Reporting Within twenty (20) calendar days following the end of each calendar month, Registry Operator shall deliver to ICANN reports in the format set forth in Specification 3 attached hereto (“Specification 3”).

  • Management Reporting (a) Provide periodic reports, in accordance with agreed upon frequency and content parameters, to the Funds. As reasonably requested by the Funds, the Transfer Agent shall furnish ad hoc reports to the Funds.

  • Other Reporting Upon request, the School shall provide the Commission any other information determined by the Commission to be relevant to any term or condition of this Contract.

  • Information Reporting We may report your performance under this Agreement to credit reporting agencies, including your failure to make minimum payments on time. A negative credit report may significantly harm your ability to obtain credit from other sources. We may also obtain follow-up credit reports on you (for example, when we review your Account for a credit line increase). We may exchange information about you or your Account with our affiliates, and, to the extent permitted by law, with other third parties. However, if you prefer that we not share such information with our affiliate companies, just call us at (000) 000-0000 or outside the Albuquerque area, 0-000-000-0000. You may also write to us at Nusenda Federal Credit Union, P.O. Box 8530, Albuquerque, New Mexico 87198. Closing Your Account. You may close your Account at any time by notifying us in writing. However, you remain responsible to pay the balance according to the terms of this Agreement. We may close your Account or suspend your Account privileges at any time without prior notice. We may also reissue a different Card, Account number, or different checks at any time. You must return the Card or the checks to us upon request. Lost or Stolen Cards. If any Card, Account Number or PIN is lost or stolen, or if you think someone used or may use them without your permission, notify us at once by calling the telephone number shown on the billing statement or by calling 0-000-000-0000. We may require you to provide certain information in writing to help us find out what happened. Do not use the Card after we've been notified, even if it is found or returned. You will not be liable for any unauthorized purchases or cash advances made after we've been notified of the loss or the theft; however, you must identify for us the charges on the billing statement that were not made by you or someone authorized by you, and from which you received no benefit. Credit Authorizations. We are not responsible if we do not approve a purchase or cash advance on your Account, or if a third party refuses to accept or honor the Card, even if you have sufficient credit available. We may limit the number of purchases or cash advances which may be approved in one day. If we detect unusual or suspicious activity on your Account, we may temporarily suspend your credit privileges until we can verify the activity. We may approve purchases or cash advances that cause the balance to exceed your credit line without waiving any of our rights under the Agreement. Waiver. Our failure to exercise, or our delay in exercising any of our rights under this Agreement for any reason does not mean that we will be unable to exercise these rights later.

  • Rule 144 Reporting With a view to making available the benefits of certain rules and regulations of the Commission that may permit the sale of the Restricted Securities to the public without registration, the Company agrees to use its commercially reasonable efforts to: (a) Make and keep adequate current public information with respect to the Company available in accordance with Rule 144 under the Securities Act, at all times from and after ninety (90) days following the effective date of the first registration under the Securities Act filed by the Company for an offering of its securities to the general public; (b) File with the Commission in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act at any time after it has become subject to such reporting requirements; and (c) So long as a Holder owns any Restricted Securities, furnish to the Holder forthwith upon written request a written statement by the Company as to its compliance with the reporting requirements of Rule 144 (at any time from and after ninety (90) days following the effective date of the first registration statement filed by the Company for an offering of its securities to the general public), and of the Securities Act and the Exchange Act (at any time after it has become subject to such reporting requirements), a copy of the most recent annual or quarterly report of the Company, and such other reports and documents so filed as a Holder may reasonably request in availing itself of any rule or regulation of the Commission allowing a Holder to sell any such securities without registration.

  • Periodic Reporting (a) The Company will promptly deliver to each Blackstone Entity when available one copy of each annual report on Form 10-K and quarterly report on Form 10-Q of the Company, as filed with the SEC. In the event the Company is not required to file an annual report on Form 10-K or quarterly report on Form 10-Q, the Company may, in lieu of the requirements of the preceding sentence, deliver, or cause to be delivered, the following to each Blackstone Entity: (i) as soon as available, but not later than ninety (90) days after the end of each fiscal year of the Company, a copy of the audited consolidated balance sheet of the Company and its Subsidiaries as of the end of such fiscal year and the related statements of operations and cash flows for such fiscal year, setting forth in each case in comparative form the figures for the previous year, all in reasonable detail; (ii) commencing with the fiscal period ending after September 30, 2010, as soon as available, but in any event not later than forty five (45) days after the end of each of the first three fiscal quarters of each fiscal year, the unaudited consolidated balance sheet of the Company and its Subsidiaries, and the related statements of operations and cash flows for such quarter and for the period commencing on the first day of the fiscal year and ending on the last day of such quarter; (b) The Company shall deliver or cause to be delivered to each Blackstone Entity: (i) to the extent otherwise prepared by the Company, operating and capital expenditure budgets and periodic information packages relating to the operations and cash flows of the Company and its Subsidiaries; and (ii) such other reports and information as may be reasonably requested by any Blackstone Entity; provided, however, that the Company shall not be required to disclose any privileged information of the Company so long as the Company has used its best efforts to enter into an arrangement pursuant to which it may provide such information to the Blackstone Entities without the loss of any such privilege.

  • Quarterly Reporting If reporting is on a quarterly basis, the AGENCY shall submit to the Orange County Citizens’ Commission for Children a complete, accurate, and programmatic Quarterly Report, in a format as provided by the COUNTY, on or before the 10th of the month following the close of the quarter, as well as supporting documentation. The Quarterly Reports shall, if applicable to the Scope of Work in Attachment “A”, list “Units of Service” provided (i.e.: hourly, per session, etc.) and/or any other pertinent outcome measurements outlined in Attachment “A”.

  • Tax Reporting (1) Prepare and file on a timely basis appropriate federal and state tax returns including, without limitation, Forms 1120/8613, with any necessary schedules. (2) Prepare state income breakdowns where relevant. (3) File Form 1099 for payments to disinterested Trustees and other service providers. (4) Monitor wash sale losses. (5) Calculate eligible dividend income for corporate shareholders.

  • EDD Independent Contractor Reporting Requirements Effective January 1, 2001, the County of Orange is required to file in accordance with subdivision (a) of Section 6041A of the Internal Revenue Code for services received from a “service provider” to whom the County pays $600 or more or with whom the County enters into a contract for $600 or more within a single calendar year. The purpose of this reporting requirement is to increase child support collection by helping to locate parents who are delinquent in their child support obligations. The term “service provider” is defined in California Unemployment Insurance Code Section 1088.8, subparagraph B.2 as “an individual who is not an employee of the service recipient for California purposes and who received compensation or executes a contract for services performed for that service recipient within or without the state.” The term is further defined by the California Employment Development Department to refer specifically to independent Contractors. An independent Contractor is defined as “an individual who is not an employee of the ... government entity for California purposes and who receives compensation or executes a contract for services performed for that ... government entity either in or outside of California.” The reporting requirement does not apply to corporations, general partnerships, limited liability partnerships, and limited liability companies. Additional information on this reporting requirement can be found at the California Employment Development Department web site located at xxxx://xxx.xxx.xx.xxx/Employer_Services.htm

  • 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.

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