France

France

France

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

Cuba

Cuba

Clinical Trial Application

n/a

Mandated Coverage

OFAC RESTRICTED COUNTRY - NO CLINICAL TRIAL COVERAGE ALLOWED

Significant sanctions remain in respect of Cuba. For example, Group remain subject to a range of financial, export, procurement, and other US sanctions if it:

(i) does business with Cuban or Cuba-related entities or individuals that appear on the US Treasury Department’s List of Specially Designated Nationals and Blocked Persons (known as the “SDN List”);
(ii) does business that involves movement of targeted goods between the US and Cuba.

Therefore the detailed characteristics of each and every transaction must be clearly understood, documented and checked against the full range of financial crime and sanctions tools before any assessment can be made as to whether business can be conducted.

No Group entity domiciled in the US, no US employee, citizen, permanent resident, shareholder, investor, or any other form of US business partner can be involved in any way in undertaking or engaging business with Cuba unless covered by a general license. No items relating to Cuba can be tabled or discussed with any such parties unless covered by a general license. It is Hyperion’s responsibility and, in particular, those undertaking such business transactions, to ensure that this prohibition is maintained.

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

n/a