Adverse Experience Sample Clauses

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.
Sample 1Sample 2See All (6)
AutoNDA by SimpleDocs
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.
Sample 1Sample 2Sample 3See All (5)
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 WSP shall cooperate with WC in connection therewith as requested by WC.
Sample 1Sample 2See All (4)
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.
Sample 1Sample 2
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:
Sample 1
Adverse Experience. Any adverse experience information obtained by Xxxxxx shall be reported to OraSure, by telephone or by facsimile within three (3) business days after Xxxxxx’x 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 Xxxxxx’x receipt of the information and by facsimile within forty-eight (48) hours after Xxxxxx’x receipt of the information. Reports under this Section 6.5 shall be sent to OraSure’s Vice President, Regulatory Affairs and Quality.
Sample 1
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.
Sample 1
AutoNDA by SimpleDocs
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.
Sample 1

Related to Adverse Experience

  • Work Experience Formula hour equivalents will be given on the basis of the following number of students enrolled at fourth week census: 5-14 students enrolled = 1 (one) formula hour 15-24 students enrolled = 2 (two) formula hours 25-34 students enrolled = 3 (three) formula hours

  • 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.

  • Adverse Weather Shall be only weather that satisfies all of the following conditions: (1) unusually severe precipitation, sleet, snow, hail, or extreme temperature or air conditions in excess of the norm for the location and time of year it occurred based on the closest weather station data averaged over the past five years, (2) that is unanticipated and would cause unsafe work conditions and/or is unsuitable for scheduled work that should not be performed during inclement weather (i.e., exterior finishes), and (3) at the Project.

  • Experience A minimum of 1 year of IT work experience in computer systems or support with demonstrated working knowledge of basic hardware and software products and problem solving/troubleshooting skills.

  • Previous Experience 31.01 New employees will be classified according to previous comparable experience for the purpose of establishing wage rates. The Co-operative shall not be required to recognize previous experience of new employees who have not worked in the same or similar business in the past two (2) years. Recognized credit for previous experience shall be applicable to qualifying employees commencing with the first working day following completion of said employee's probationary period. 31.02 It shall be the responsibility of the employee to supply proof of their previous experience prior to the completion of their probationary period. Otherwise, all claim for credit for previous experience shall be forfeited by the employee. 31.03 In the event of any disagreement as to credit granted for previous experience, such disagreement shall be considered a grievance, and the Grievance Procedure provided in the Agreement shall apply.

  • Reverse Engineering The Customer must not reverse assemble or reverse compile or directly or indirectly allow or cause a third party to reverse assemble or reverse compile the whole or any part of the software or any products supplied as a part of the Licensed System.

  • Knowledge and Experience The Purchaser has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of an investment in the Securities and of protecting its interests in connection with an acquisition of the Securities.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!