India

Clinical Trial Application	India Specific Clinical Trial Quote Request
Mandated Coverage	Yes
Standard Limits	From 1 to 5 Million USD in aggregate
Tail Coverage	6 months (up to 1 year available for an additional premium)
Data Required to Quote	• Country-specific Application and Application must be printed and signed PRIOR to binding coverage • Protocol and Informed Consent Form in English • A local entity must be named as the Policyholder (Investigator or CRO) - No refund for policy cancellation - India requires payment to the carrier PRIOR to release of certificate To bind coverage: • provide Permanent Account Number (PAN) of the Local CRO. PAN number is a ten-digit alphanumeric number, issued in the form of a laminated card by the Income Tax Department • provide Good and Services Tax (GST) number of the Local CRO Please allow additional time for processing. Please allow at least one month before issuance of policy documents

Clinical Trial Application	Nigeria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. It is recommended that Sponsor use an experienced or local CRO in Nigeria
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	Process is SLOW in Nigeria. Please allow for additional time. Submission should be made at least one month before documents are required • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address) • Completed, signed and dated Clinical Trial Proposal form (To be provided separately) • Provide completed Anti-Money Laundering document which is required (To be provided separately) - Regulatory Approval (RA) from the National Agency for Food & Drugs Administration and Control (NAFDAC), which can be provided after release of the policy documents, but is absolutely required unless the Sponsor does not have approval at the time of submission - Nigeria requires a local quotation so the premium will be subject to change by the local Nigerian office - Nigeria is a cash before cover country, which means Policy documents only released after premium payment received by the carrier; Sponsor pays the Carrier directly once invoice is provided and Carrier will confirm receipt of funds - No refunds for policy cancellation