Adverse Event Information Clause Samples

The Adverse Event Information clause defines the obligations of parties to report and share information regarding any negative or unintended medical occurrences that arise during the course of a clinical trial or product use. Typically, this clause outlines the types of events that must be reported, the timelines for notification, and the procedures for documenting and communicating such events to relevant authorities or stakeholders. Its core practical function is to ensure prompt and transparent handling of safety information, thereby protecting patient welfare and maintaining regulatory compliance.
Adverse Event Information. WCCI shall provide notice to Paratek of any Adverse. Events that occur during the Term, including without limitation, all filings made with Regulatory Authorities with respect to Adverse Events promptly after making such filings. WCCI shall make available to Paratek for review and copy at Paratek’s expense, upon reasonable request, all Adverse Event information and product complaint information relating to Lead Candidates and Products as compiled, prepared and filed by WCCI with the FDA or similar Regulatory Authorities in the normal course of business in connection with the Development, Commercialization or sale of any Lead Candidates or Products. Paratek acknowledges and agrees that such information shall be the Confidential Information of WCCI and subject to the provisions of Article 6 hereof.
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Adverse Event Information. Within six months after the commencement of the Development Phase, MMD will establish a protocol for the timely handling and transmission of adverse event information. MMD and TKT shall promptly notify each other of any adverse event information relating to GA-EPO in accordance with such protocol.
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Adverse Event Information. In addition to the updates described in Section 2.3.1, AMBION shall provide ROSETTA with copies of all adverse and product complaint information relating to Collaboration Products and/or Collaboration Services as such information is compiled or prepared by AMBION in the normal course of business in connection with the Development or Commercialization of any Collaboration Product and/or Collaboration, Service and, in any event, within time frames consistent with reporting obligations under Applicable Laws.
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Adverse Event Information. Aegis will provide Opiant with copies of all reports of any adverse event which Aegis must report to a Regulatory Authority under applicable Law or which is serious, such as any adverse event involving Materials that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in disability, congenital anomaly or is medically important (i.e., may require other medical or surgical intervention to prevent other serious criteria from occurring), and which Aegis has reason to believe is associated with any or all Materials as soon as reasonably practicable, but in no event more than forty-eight (48) hours following receipt of notice thereof by Aegis, including without limitation from Aegis’ Contract Manufacturer or customers. Each Party shall promptly advise the other Party of any complaints, adverse reaction reports, safety issues or toxicity issues relating to any Material of which it becomes aware. If either Party determines that any Material causes an adverse event, such Party shall notify the other Party as soon as reasonably practicable, but in no event more than forty-eight (48) hours following such determination.
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Related to Adverse Event Information

  • Event Information Number: 210301 Title: Academic Curriculum and Instructional/Educational Goods, Materials, and Services Type: Request for Proposal Issue Date: 3/4/2021 Deadline: 4/16/2021 03:00 PM (CT) Notes: Vendors that currently hold and are satisfied with TIPS Contract 200903 Books, Library, and Educational Materials do not need to respond to this solicitation unless they desire to hold and manage multiple TIPS Contracts that cover the same offerings. Vendors that currently hold TIPS Contract 180902 Classroom and Teaching Aids Goods and Services may want to consider responding to this solicitation as it covers the same offerings and TIPS Contract 180902 is expiring this year. If 180902 Vendors choose not respond here, they will be required to respond to a replacement solicitation in September 2021 to replace their expiring 180902 contract instead. Address: Region 8 Education Service Center ▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Phone: +▇ (▇▇▇) ▇▇▇-▇▇▇▇ Email: ▇▇▇▇@▇▇▇▇-▇▇▇.▇▇▇ Contact: ▇▇▇▇ ▇▇▇▇ Address: ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Road Suite 304 Red Bank, NJ 07701 Phone: (▇▇▇) ▇▇▇-▇▇▇▇ Fax: (▇▇▇) ▇▇▇-▇▇▇▇ Email: ▇▇▇▇▇▇▇▇.▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ By submitting your response, you certify that you are authorized to represent and bind your company. The vendor must download the Vendor Agreement from the attachment tab, fill in the requested information and upload the completed agreement. DO NOT UPLOAD encrypted or password protected files. If you have not taken exception or deviation to the agreement language in the solicitation attributes, download the AGREEMENT SIGNATURE FORM from the "ATTACHMENTS" tab. This PDF document is a fillable form. Download the document to your computer, fill in the requested company information, print the file, SIGN the form, SCAN the completed and signed AGREEMENT SIGNATURE FORM, and upload here. If you have taken exception to any of the agreement language and noted the exception in the deviations section of the attributes for the agreement, complete the AGREEMENT SIGNATURE FORM, but DO NOT SIGN until those deviations have been negotiated and resolved with TIPS management. Upload the unsigned form here, because this is a required document. The vendor must download the PRICING SPREADSHEET SHEET from the attachment tab, fill in the requested information and upload the completed spreadsheet. DO NOT UPLOAD encrypted or password protected files. The vendor must download the PRICING SPREADSHEET SHEET from the attachment tab, fill in the requested information and upload the completed spreadsheet. DO NOT UPLOAD encrypted or password protected files.

  • Patient Information Each Party agrees to abide by all laws, rules, regulations, and orders of all applicable supranational, national, federal, state, provincial, and local governmental entities concerning the confidentiality or protection of patient identifiable information and/or patients’ protected health information, as defined by any other applicable legislation in the course of their performance under this Agreement.

  • 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.

  • Client Information Protected Health Information in any form including without limitation, Electronic Protected Health Information or Unsecured Protected Health Information (herein “PHI”);

  • 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.