France

Clinical Trial Application	France Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	1.000.000 €/patient 6.000.000 €/protocol 10.000.000 €/year
Tail Coverage	10 years
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in French • Site List in English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents. • Local CRO or EU Representative details (Contact Person Name and Telephone Number). Will be referenced on the Policy declaration page and the Certificate • Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol

Clinical Trial Application	Ukraine Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	Limit per protocol = 10.000 USD x number of patients
Tail Coverage	3 years
Data Required to Quote	The process is SLOW. Please allow additional time for processing. Typically up to 3 weeks • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Ukrainian • Certificate of Incorporation of Sponsor (for new Sponsors in Ukraine only) • Name and Title of Authorized Signatory who will countersign policy • Name of document which gives the Signatory the authorization to countersign the policy. (i.e. Charter, Power of Attorney, Resolution by the Board of Directors) - Ukraine requires payment and payment confirmation documentation PRIOR to release of certificate - No refund for policy cancellation - Original documents are not required to be delivered to the local CRO. Only require copy of the Certificate which is issued by the carrier once the premium has been received