Cuba

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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.

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Switzerland Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

CHF 10,000,000
CHF 1,000,000 Per Patient

20 years

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in German, French or Italian
• Legal Representative Details of Sponsor (Contact Person Name, Address, Telephone Number and E-Mail Address) in Switzerland are are now required unless your CRO states this is NOT a requirement for your study.

- Switzerland has always required non-Swiss sponsored studies to have engaged a Swiss-based legal representative, but most Sponsors have not been required to comply in recent years.
- Due to current demands for the Legal Representative to be shown, please check with your CRO PRIOR to binding coverage.

- Swiss Ethics have released certificate/policy templates that must be followed. As part of this new format, Swiss Ethics require that the Insurers include in all policies the classification of the medicinal product i.e. Category A, B or C.
- Insurers do not hold descriptions for each class and cannot provide any advice on how a trial should be categorized.
- Categorization is considered to be a technical, medical and scientific decision, and if in any doubt over which category the trial should fall into, the Sponsor should seek advice from the Ethics Committees in such cases