Common use of Required Time-Sensitive Notification Clause in Contracts

Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's representative (COR) as follows: 1. Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative within 24 hours of FDA notification. 2. Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification. 3. IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification. 4. Expedited safety reports – shall be sent to the COR concurrently with the report to FDA. 5. Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the COR annually. In case of problems or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed. Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.

Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's ’s representative (COR) as follows: 1. Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's ’s Representative within 24 hours of FDA notification. 2. Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification. 3. IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification. 4. Expedited safety reports – shall be sent to the COR concurrently with the report to FDA. 5. Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the COR BARDA annually. In case of problems or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed. Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.

Required Time-Sensitive Notification. a. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's BARDA representative (COR) or the COR as follows: 1. : Expedited safety report of unexpected or life-threatening experience or death – death. A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative BARDA representative or COR within 24 hours of FDA notification. 2. Expedited safety reports of serious and unexpected adverse experiences – experiences. A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative BARDA representative or COR within 24 hours of FDA notification. 3. IDE reports of unanticipated adverse device effect – effect. A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative BARDA representative or COR within 24 hours of FDA notification. 4. Expedited safety reports – shall be sent reports. Sent to BARDA representative or the COR concurrently with the report to FDA. 5. Other adverse events documented during the course of the trial shall should be included in the annual IND or IDE report and reported to the COR BARDA annually. In case of problems . b. Safety reporting for research not performed under an IND or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed. Ongoing IDE: Final decisions regarding ongoing safety reporting requirements for research not performed under an IND or IDE shall must be mutually agreed upon made jointly by the Contracting Officer’s Representative BARDA PO or the COR and the Contractor. In case of problems or issues the COR will contact the Contractor within ten (10) working days by email or fax, followed within thirty (30) calendar days by an official letter to the Contractor’s Project Manager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed.

Required Time-Sensitive Notification. a. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's BARDA representative (or the COR) /ACOR /ACOR as follows: 1. : Expedited safety report of unexpected or life-threatening experience or death – death. A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative BARDA representative or COR/ACOR /ACOR within 24 hours of FDA notification. 2. Expedited safety reports of serious and unexpected adverse experiences – experiences. A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative BARDA representative or COR/ACOR /ACOR within 24 hours of FDA notification. 3. IDE reports of unanticipated adverse device effect – effect. A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative BARDA representative or COR/ACOR /ACOR within 24 hours of FDA notification. 4. Expedited safety reports – shall be sent reports. Sent to BARDA representative or the COR COR/ACOR /ACOR concurrently with the report to FDA. 5. Other adverse events documented during the course of the trial shall should be included in the annual IND or IDE report and reported to the COR BARDA annually. In case of problems . b. Safety reporting for research not performed under an IND or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed. Ongoing IDE: Final decisions regarding ongoing safety reporting requirements for research not performed under an IND or IDE shall must be mutually agreed upon made jointly by the Contracting Officer’s Representative BARDA PO or the COR/ACOR /ACOR and the Contractor. In case of problems or issues the COR/ACOR /ACOR will contact the Contractor within ten (10) working days by email or fax, followed within thirty (30) calendar days by an official letter to the Contractor’s Project Manager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed.

Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible BARDA Contracting Officer's representative (COR) as follows: 1. Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s 's receipt of the information, must be submitted to the BARDA program officer or the Contracting Officer's Representative within 24 hours of FDA notification. 2. Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s 's receipt of the information, must be submitted to the BARDA Contracting Officer’s 's Representative within 24 hours of FDA notification. 3. IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the BARDA Contracting Officer’s 's Representative within 24 hours of FDA notification. 4. Expedited safety reports – shall be sent to the BARDA COR concurrently with the report to FDA. 5. Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the COR BARDA annually. In case of problems or issues, the BARDA COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed. Safety reporting for research not performed under an IND. Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the BARDA Contracting Officer’s 's Representative and the Contractor.

Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's representative ’s Representative (COR) as follows: 1. i. Expedited safety report of unexpected or life-threatening experience or death – death: A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative COR within 24 hours of FDA notification. 2ii. Expedited safety reports of serious and unexpected adverse experiences – experiences: A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative COR within 24 hours of FDA notification. For medical devices, adverse events should be reported under the MedWatch (MDR) program with reporting timelines of 5 days for serious adverse events or 30 days for reportable events. 3iii. IDE reports of unanticipated adverse device effect – effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative COR within 24 hours of FDA notification. 4iv. Expedited safety reports – shall be sent reports: Sent to the COR concurrently with the report to FDA. 5. v. Other adverse events documented during the course of the trial shall should be included in the annual IND or IDE report and reported to the COR BARDA annually. In case of problems or issues, the COR Contracting Officer’s Representative will contact the Contractor within 10 working ten (10) business days by emailemail or fax, followed within 7 thirty (30) calendar days by an official letter to the Contractor. The Contractor shall forward the official letter ’s Project Manager, with a copy to the principal investigator institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed. Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.

Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's representative ’s Representative (COR) as follows: 1. i. Expedited safety report of unexpected or life-threatening experience or death – death: A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days [***] after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative COR within 24 hours [***] of FDA notification. 2ii. Expedited safety reports of serious and unexpected adverse experiences – experiences: A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days [***] after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative COR within 24 hours [***] of FDA notification. For medical devices, adverse events should be reported under the MedWatch (MDR) program with reporting timelines of 5 days for serious adverse events or 30 days for reportable events. 3iii. IDE reports of unanticipated adverse device effect – effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative COR within 24 hours [***] of FDA notification. 4iv. Expedited safety reports – shall be sent reports: Sent to the COR concurrently with the report to FDA. 5. v. Other adverse events documented during the course of the trial shall should be included in the annual IND or IDE report and reported to the COR BARDA annually. In case of problems or issues, the COR Contracting Officer’s Representative will contact the Contractor within 10 working ten (10) business days by emailemail or fax, followed within 7 thirty (30) calendar days by an official letter to the Contractor. The Contractor shall forward the official letter ’s Project Manager, with a copy to the principal investigator institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed. Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.

Required Time-Sensitive Notification. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's representative ’s Representative (COR) as follows: 1. i. Expedited safety report of unexpected or life-threatening experience or death – death: A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven [**] days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative COR within 24 hours [**] of FDA notification. 2ii. Expedited safety reports of serious and unexpected adverse experiences – experiences: A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days [**] day after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative COR within 24 hours [**] of FDA notification. 3iii. IDE reports of unanticipated adverse device effect – effect: A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative COR within 24 hours [**] of FDA notification. 4iv. Expedited safety reports – shall be sent reports: Sent to the COR concurrently with the report to FDA. 5. v. Other adverse events documented during the course of the trial shall should be included in the annual IND or IDE report and reported to the CO and the COR annually. In case of problems or issues, the COR Contracting Officer’s Representative will contact the Contractor within 10 [**] working days by emailemail or fax, followed within 7 [**] calendar days by an official letter to the Contractor. The Contractor shall forward the official letter ’s Project Manager, with a copy to the principal investigator institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed. Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.

Required Time-Sensitive Notification. a. Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's BARDA representative (COR) or the COR as follows: 1. : Expedited safety report of unexpected or life-threatening experience or death – death. A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative representative or COR within 24 hours of FDA notification. 2. Expedited safety reports of serious and unexpected adverse experiences – experiences. A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative BARDA representative or COR within 24 hours of FDA notification. 3. IDE reports of unanticipated adverse device effect – effect. A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative BARDA representative or COR within 24 hours of FDA notification. 4. Expedited safety reports – shall be sent reports. Sent to BARDA representative or the COR concurrently with the report to FDA. 5. Other adverse events documented during the course of the trial shall should be included in the annual IND or IDE report and reported to the COR BARDA annually. In case of problems . b. Safety reporting for research not performed under an IND or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed. Ongoing IDE: Final decisions regarding ongoing safety reporting requirements for research not performed under an IND or IDE shall must be mutually agreed upon made jointly by the Contracting Officer’s Representative BARDA PO or the COR and the Contractor. In case of problems or issues the COR will contact the Contractor within ten (10) working days by sponsored programs, listing issues and appropriate actions to be discussed.