Adverse Event Reporting Requirements Sample Clauses

Adverse Event Reporting Requirements. Connetics shall be solely responsible for submitting Adverse Event Reports to the FDA, except to the extent (if at all) that MGI may be required by law to make such reports itself. During the Term of this Agreement, MGI shall promptly forward to Connetics at the address set forth in Section 11.3 any reports MGI receives of adverse events (distinguished as serious and non-serious by FDA regulations), concerning side effects, injury, toxicity or sensitivity reaction including unexpected increased incidence and severity associated with commercial or clinical uses, studies, investigations or test with the Product (animal or human), throughout the world, whether or not determined to be attributable to the Product. For purposes of this Section 7.3, "promptly" means as soon as practicable, but in no event later than (a) five business days for serious adverse events after receipt of complete information regarding such events, or (b) thirty calendar days for non-serious adverse events after receipt of complete information regarding such events. Connetics shall transmit adverse event reports to MGI on a periodic basis, but no less often than once every six (6) months; provided, however, that Connetics shall promptly notify MGI of any adverse event report requiring the cessation or substantial alteration of detailing activities by the MGI Sales Force. MGI shall hold all such communications in the strictest confidence and subject to the terms of Section 11.1 of this Agreement.
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Adverse Event Reporting Requirements. The investigator is responsible for the detection and documentation of events meeting the criteria and definition of an adverse event (AE) or a serious adverse event (SAE), as provided in this protocol. Routine, adverse events of special interest (AESI), and expedited adverse event report forms and their supporting documentation must be submitted to DSSM according to the instructions in Sections 10.3, 10.4 and 10.6.
Adverse Event Reporting Requirements. In the event that Supplier and its Employees, during the course of performing the Services, become aware of an Adverse Event or other reportable AE safety information (including but not limited to medication error, pregnancies, overdoses and laboratory parameters) reported by investigators or study site employees, Supplier is required to collect and submit within one business day from becoming aware, the appropriate information to AstraZeneca as described in the instructions provided in the applicable clinical study protocol. AstraZeneca is solely responsible for reporting AEs and other safety information to regulatory and government authorities.
Adverse Event Reporting Requirements. Because the Pfizer Product used in this interventional study is not yet approved for marketing in the U.S. for the indication under study, potential drug-induced liver injury as assessed by laboratory test values (“Hy’s Law Cases”) are reportable to Pfizer as discussed in the Reporting of Serious Adverse Events section of the Agreement.
Adverse Event Reporting Requirements. Because this [is a prospective non- interventional study] [is a retrospective non-interventional study] [Study involves the use of a Pfizer product that includes a device component] [Study involves the use of a Pfizer product that is a mature marketed oncology product with a well- established safety profile], the requirements for reporting serious adverse events (“SAEs”) to Pfizer differ somewhat from the standard interventional-study requirements included in the Agreement. Requirements applicable to this Study are as follows: [Insert the Adverse Event text appropriate to the circumstances]
Adverse Event Reporting Requirements. Connetics shall be solely responsible for submitting Adverse Event Reports to the FDA, except to the extent (if at all) that MGI may be required by law to make such reports itself. During the Term of this Agreement, MGI shall promptly forward to Connetics at the address set forth in SECTION 11.3 any reports MGI

Related to Adverse Event Reporting Requirements

  • 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.

  • Reporting Requirements The Company, during the period when the Prospectus is required to be delivered under the 1933 Act or the 1934 Act, will file all documents required to be filed with the Commission pursuant to the 1934 Act within the time periods required by the 1934 Act and the 1934 Act Regulations.

  • Additional Reporting Requirements Contractor agrees to submit written quarterly reports to H-GAC detailing all transactions during the previous three (3) month period. Reports must include, but are not limited, to the following information:

  • Reporting Requirement (1) In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, or the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are established procedures for reporting the information; in the case of the Department of Defense, the Contractor shall report to the website at xxxxx://xxxxxx.xxx.xxx. For indefinite delivery contracts, the Contractor shall report to the Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in the case of the Department of Defense, identify both the indefinite delivery contract and any affected orders in the report provided at xxxxx://xxxxxx.xxx.xxx.

  • 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 and Reporting Requirements 63 7.1 Financial and Business Information.........................................................63 7.2

  • Compliance with Reporting Requirements The Company is subject to and in full compliance with the reporting requirements of Section 13 or Section 15(d) of the Exchange Act.

  • Financial Reporting Requirements The Charter School shall follow the financial requirements of the Charter Schools Section of the Department’s Financial Management for Georgia Local Units of Administration Manual. The Charter School shall submit all information required by the State Accounting Office for inclusion in the State of Georgia Comprehensive Annual Financial Report.

  • Account Reporting Information Italian residents who, at any time during the fiscal year, hold foreign financial assets (including cash and shares of Common Stock) which may generate income taxable in Italy are required to report these assets on their annual tax returns (UNICO Form, RW Schedule) for the year during which the assets are held, or on a special form if no tax return is due. These reporting obligations will also apply to Italian residents who are the beneficial owners of foreign financial assets under Italian money laundering provisions.

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