Adverse Experience Clause Samples

The Adverse Experience clause defines what constitutes an adverse event or negative outcome related to the use of a product, service, or participation in a study. It typically outlines the types of incidents that must be reported, such as unexpected side effects, injuries, or other harmful occurrences, and may specify the procedures for documenting and communicating these events to relevant parties. This clause is essential for ensuring that all parties are aware of and respond appropriately to potential risks, thereby promoting safety, regulatory compliance, and transparency.
Adverse Experience. During the Term, each Party shall promptly notify the other Party of any significant adverse events that relate to the Product or are required in accordance with the regulations of relevant Governmental Entities, including adverse drug experiences and governmental inquiries, and each Party shall cooperate with the other Party in connection therewith as reasonably requested by the other Party and as follows: (a) Serious Adverse Events for the Product of which one (1) Party becomes aware shall be submitted to the other Party within three (3) business days but no more than four (4) calendar days from the date the first-mentioned Party first became aware of such Serious Adverse Event. Non-Serious Adverse Events for the Product that are reported to one (1) Party shall be submitted to the other Party no more than one (1) month from the date received by the first-mentioned Party; provided, however, that medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent a Serious Adverse Event outcome. BMS shall timely provide to the Company any and all data in BMS’ possession relating to the Product manufactured for the Company by BMS or its Affiliate which is necessary for the Company to timely complete and submit any adverse event report. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. (b) Until the reporting procedures referenced in Section 8.03(d) herein have been instituted by the Parties, a “Serious Adverse Event” for the Product shall have the meaning set forth in 21 C.F.R. § 314.80(a), as amended from time to time, and a “Non-Serious Adverse Event” for the Product is defined as an untoward medical occurrence at any dose of the Product that is not a Serious Adverse Event.
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Adverse Experience. 8.1. DOV shall keep (and DOV shall cause its sublicensees to keep under terms and conditions equal to those set forth in this Article 8.0) Wyeth, during the term of this Agreement, promptly and fully informed of all pharmaceutical, toxicological and clinical findings relating to adverse experience of the Product or Marketed Product. 8.2. DOV undertakes to notify Wyeth promptly with written confirmation by immediate telecopy of any information concerning any serious adverse event as defined by C.I.O.M.S. or the F.D.A. or by the Ministry of Health & Welfare in Japan, as applicable, reasonably associated with clinical studies or attributed to the use or application of the Product or Marketed Product. In any event the above notification shall be made within two (2) working days after DOV first learns or is advised of all relevant information with respect to such serious adverse event. 8.3. DOV shall also forward regularly (and usually every six months unless the parties agree on another period) to Wyeth any information on all other adverse effects or any difficulty associated with the clinical use, studies, investigations, tests and prescription of the Product or Marketed Product. 8.4. DOV shall provide upon request the information on estimated patient days of exposure. 8.5. DOV shall inform Wyeth, without delay, of any governmental action, correspondence or reports to or from governmental authorities that may affect the situation of the Product or Marketed Product and furnish Wyeth with copies of any relevant documents relating thereto.
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Adverse Experience. During the Term, each Party shall promptly notify the other Party of any significant event(s) that affect the marketing of the Products, including, but not limited to, adverse drug experiences and governmental inquiries. WC shall have the reporting responsibility for such events to applicable regulatory health authorities in the Territory, and BMSLC shall cooperate with WC in connection therewith as requested by WC.
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Adverse Experience. 9.1 As stated in Sections 9.2 and 9.3, EYEFITE shall keep (and EYEFITE shall cause its sublicensees to keep under terms and conditions equal to those set forth in this Section 9) CANFITE, during the term of this Agreement, promptly and fully informed of all pharmaceutical, toxicological and clinical findings relating to adverse experience of the Licensed Product or Licensed Compound. CANFITE shall be permitted to share with PHS all data and information provided under this Article 9 by EYEFITE.
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Adverse Experience. Duke shall promptly, in accordance with applicable laws and regulations, advise Sponsor of any adverse reactions or side effects occurring during the conduct of any Study that become known to Duke.
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Adverse Experience. Any adverse experience information obtained by ▇▇▇▇▇▇ shall be reported to OraSure, by telephone or by facsimile within three (3) business days after ▇▇▇▇▇▇’▇ initial receipt of any such information: provided, however, any report of a serious adverse event or any report of a death shall be reported to OraSure by telephone within twenty-four (24) hours after ▇▇▇▇▇▇’▇ receipt of the information and by facsimile within forty-eight (48) hours after ▇▇▇▇▇▇’▇ receipt of the information. Reports under this Section 6.5 shall be sent to OraSure’s Vice President, Regulatory Affairs and Quality.
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Adverse Experience. 8.1 DOV shall keep (and DOV shall cause its sublicensees to keep under terms and conditions equal to those set forth in this Article 8) ACY during the term of this Agreement, promptly and fully informed of all pharmaceutical, toxicological and clinical findings relating to adverse experience of the Product and Marketed Product. 8.2 DOV undertakes to notify ACY promptly with written confirmation by immediate telecopy of any information concerning any serious adverse event as defined by C.I.O.M.S. or the F.D.A. or by the Ministry of Health & Welfare in Japan, as applicable, reasonably associated with clinical studies or attributed to the use or application of the Product and Marketed Product. In any event the above notification shall be made within two working days after DOV should first learn or be advised of all relevant information with respect to such adverse event. 8.3 DOV shall also forward regularly (and usually every six months unless the parties agree on another period) to ACY any information on all other adverse effects or any difficulty associated with the clinical use, studies, investigations, tests and prescription of the Product. 8.4 DOV shall provide upon request the information on patient exposure: estimated patient-days of exposure. 8.5 DOV shall inform ACY without delay, of any governmental action, correspondence or reports to or from governmental authorities which may affect the situation of the Product and furnish ACY with copies of any relevant documents relating thereto.
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Adverse Experience. An adverse experience is any unfavorable and unintended change in the structure, function or chemistry of an animal or human being and includes any injury, side-effect, toxicity or sensitivity reaciton that may be associated with the use of a Merck animal health product, whether or not the experience is considered to be causally related ot the Merck product. For a marketed product, this would also include any failure of the marketed Merck product to exhibit its expected pharmacological activity in the animal. Reports of an adverse experience may originate from a variety of sources such as: Merck or extramural research personnel, veterinarians, animal health professionals, agricultural workers, pet and livestock owners, distributors, sales personnel, marketing staffs, etc. Three important classes of adverse experiences have special reporting requirements. These are:
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Related to Adverse Experience

  • Work Experience A sabbatical leave may be granted for contracted work or externship with other educational institutions, government agencies, corporations, or foundations related to the applicant’s discipline. A detailed, specific plan must be submitted by the applicant and approved by the Salary and Leaves Committee as likely to improve the applicant’s teaching effectiveness, strengthen the College’s academic program, or otherwise bring a clear benefit to students.

  • 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.

  • 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.

  • Teaching Experience Recognized Years of Experience: Uncredited Experience:

  • Adverse Developments Since June 30, 2009, there has been no material adverse change in the business, operations or condition (financial or otherwise) of the Company; nor has there been since such date, any damage, destruction or loss, whether covered by insurance or not, materially or adversely affecting the business, properties or operations of the Company.