Netherlands

Clinical Trial Application	Netherlands Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. www.ccmo.nl/en/insurance
Standard Limits	450.000 €/patient 3.500.000 €/protocol Effective July 1, 2015, new limits required are: 650.000 €/patient 5.000.000 €/protocol
Tail Coverage	4 years from the end of patient treatment
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Dutch - There are TWO insurance requirements. - Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO - The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy - Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate

Clinical Trial Application	Bulgaria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	50.000 BGN/patient 1.000.000 BGN/protocol
Tail Coverage	1 year
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Bulgarian • Site List in Bulgarian and English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code • Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) Once coverage is bound and Policy documents are issued to the Sponsor, Sponsor must review for accuracy, sign and then mail original wet-inked documents to the carrier. Carrier will countersign and send to Local CRO along with the Certificates. Newfront will provide the carrier contact information separately for mailing documentation.