Sponsor will establish a plan with sites to provide or arrange for prompt diagnosis and medical treatment of any Research Injury experienced by a Study subject. Sponsor agrees to inform subjects who is responsible to pay the actual cost of diagnostic procedures and medical treatment necessary to treat a Research Injury.

Sponsor agrees: (a) to promptly notify the IRB of any Principal Investigator(s), of (i) non-compliance with the study protocol or applicable laws, particularly those laws related to human research subjects, that could impact the safety or welfare of participating subjects, (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Clinical Trial at any site, (iii) unanticipated problems in the Clinical Trial at any site that could relate to risks to participating subjects, and (iv) circumstances that could affect subjects’ willingness to continue to participate in the Clinical Trial or the IRB’s continuing approval of the Clinical Trial.

Sponsor agrees to provide data and safety monitoring plans for review by the IRB prior to its approval of the research, and agrees to provide routine safety monitoring reports at continuing review, and urgent reports immediately.

Sponsor agrees to follow DOH agency policies concerning publication.

Sponsor agrees to develop with the Investigator a plan of communication to subjects that is acceptable to the DOH /IRB when new findings or results of the Study might impact the willingness of subjects to continue to participate in the Study or directly affect their current or future safety or medical care.