Clinical Safety Reports Sample Clauses

Clinical Safety Reports. Immediately following the notification of occurrence of a “Serious Adverse Event,” as defined under Applicable Standards (as defined in Section 5.2) and in the applicable Protocol relating to a Clinical Trial (but in no event more than 24 hours thereafter), TKL shall inform in writing Sponsor and/or any other body designated by Sponsor of such occurrence. At a minimum, Serious Adverse Event reports shall include the patient’s initials/study identifier, the reporter’s name, and a description of the event and any other information required by the Protocol. Sponsor shall then prepare and provide to the appropriate regulatory authorities all written safety reports and telephone reports within the timeframes and containing the information required under Applicable Standards (as defined in Section 5.2). TKL shall prepare all the documents required by the clinical site’s IRB or other ethics committee for submission by the investigator in the occurrence of a Serious Adverse Event. ****Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. TKL shall prepare and submit to Sponsor all annual reports containing the description of such adverse events as required under Applicable Standards (as defined in Section 5.2). Sponsor will provide TKL with a copy of each such report submitted to the regulatory authorities for distribution to the clinical site and from there to the IRB or other similar ethics, safety, or medical committee. Sponsor and/or its designee may, at its option, communicate directly with any clinical site and investigator about any Serious Adverse Event or other adverse event. For the avoidance of doubt, Sponsor will remain responsible for reporting of Serious Adverse Events as the named sponsor, but will discharge that responsibility with the assistance of TKL.

Clinical Safety Reports. Within twenty-four (24) hours of the notification of occurrence of a serious adverse experience, as defined under FDA regulations, including without limitation 21 CFR § 312.32 (“Serious Adverse Experience”), relating to the Clinical Trial, JSW shall inform Axonyx of such occurrence. At a minimum, serious adverse event reports shall include the patient’s initials/study identifier, the reporter’s name, and a description of the event. Axonyx shall prepare and provide to the FDA all written IND safety reports and telephone reports within the timeframes and containing the information required under FDA regulations, including without limitation 21 CFR § 312.32. For all adverse events relating to the Clinical Trial other than any Serious Adverse Experiences, JSW shall provide Axonyx in a timely manner all information relating to such adverse events. Axonyx shall prepare and submit to the FDA all annual reports containing the description of such adverse experiences as required under FDA regulations, including without limitation 21 CFR § 312.33. Axonyx will provide JSW with a copy of each such report submitted to the FDA. Axonyx may, at its option, communicate directly with any clinical site and investigator about any Serious Adverse Experience or other adverse event.