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	Spain Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	Minimum 2.500.000 €/protocol per year 250.000 €/patient
Tail Coverage	2 years
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Spanish • Site List in Spanish, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s) Foundation/Site Location(s) Address(es) with Area Code • Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in the Protocol