Mexico

Mexico

Mexico

Mexico

Clinical Trial Application

Mexico Clinical Trial Quote Request

Mandated Coverage

Yes

Standard Limits

n/a

Tail Coverage

n/a

Data Required to Quote

THE PROCESS IN MEXICO IS SLOW. PLEASE ALLOW UP TO TWO MONTHS FOR DOCUMENTS TO BE PROCESSED. Please provide all documentation outlined below otherwise the process is further delayed.

PLEASE PROVIDE THE FOLLOWING INFORMATION
• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English and Spanish
• Protocol Title in Spanish
• The following documents to be provided by the Sponsor:
(i) Copy ID of the legal representative of the Sponsor (this should be the same as the person completing the form)
(ii) Proof of address of the sponsor (not older than 3 months)
(iii) Document confirming the legal establishment of the sponsor --->
Legal representative details of the Sponsor in Mexico
Note the Legal Representative will be responsible for providing the following documents:
(i) Copy of the Memorandum of Association registered upon the Property & Commerce Public registry
(ii) Copy of the Fiscal Identification Schedule (RFC)
(iii) Copy of an Official Identification and Notary’s Testimony of the local CRO
(iv) Copy of a Domicile Voucher

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