Role of Site Investigator Ensure subject safety is protected & well-managed Full compliance with requirements of Good Clinical Practice (GCP) Conduct the study in compliance with the protocol

Acknowledge and retain responsibility for study conduct Personally conduct or supervise the clinical study Ensure that all study staff are informed of their obligations (Delegation of Authority) Maintain records of staff qualifications Ensure that mechanisms are in place to ensure that site staff receive the appropriate information throughout the study Ensure that appropriate medical coverage is identified for any planned absences (holiday, attending a conference, etc.) Allow monitoring, auditing & regulatory inspections Notify CERU asap of any planned regulatory inspections Interact with the CERU monitor during monitoring visits Investigator Responsibilities (cont)

Highlighted Responsibilities Site Investigator/sub-I delegate should sign/date all documentation to make the following assessments: Confirmation of patient eligibility SAE Identification & Assessment Ensure adherence to reporting requirements & timelines Provide causality assessment Determine relationship to investigational product Perform Severity of Burn and Grafting Assessments

GRAFTING ASSESSMENT (Post-Enrollment) Initial Grafting Assessment (to be completed after consent is obtained) Deep Partial/Full Thickness Burn expected to require grafting: __________%TBSA Final Grafting Assessment (to be completed at the end of study duration) Total Body Surface Area that actually required grafting: __________%TBSA

Any untoward medical event that: Results in death, Is life-threatening, Requires hospitalization or prolongation of hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, A medically important event (e.g. one that may result in an intervention to prevent one of above outcomes) Serious Adverse Events (SAEs)

SAE Identification Unexpected event - is NOT expected due to the progression of the underlying disease or co-morbid illnesses. Not all deaths – only unexpected. Related to the Study Intervention defined as: Possibly Related: suggests that the association of this SAE with the study supplement is unknown and the event is not reasonable supported by other conditions. Probably Related: suggests that a reasonable temporal sequence of this SAE with study supplement administration exists and the association of the event with the study supplement seems likely. Report SERIOUS Adverse Events that are: 1. Unexpected – regardless of relationship to intervention 2. Related to Intervention – regardless of expectedness

Subject Withdrawal A subject may be withdrawn from IP at any time: at SDM or her/his own request, or at the discretion of the investigator for safety, behavioral or administrative reasons. A subject may withdraw (or be withdrawn) from the study prematurely for the following reasons: Serious Adverse Event related to intervention Termination of the study by the sponsor Other (must be specified)

Delegation of Authority Logs “The Investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties (ICH section 4.1.5)” Completed Log to be sent to CERU before start of trial