Canada

Clinical Trial Application	n/a
Mandated Coverage	No
Standard Limits	Provided by US Master Product Liability policy. (If your study is being conducted in Quebec, please check with your CRO to confirm coverage under the US Master Product Liability policy is acceptable)
Tail Coverage	n/a
Data Required to Quote	Please submit an email request to our certificate team requesting a certificate at: techcertrequest@newfront.com and CC your Newfront Team. Include the following in your email: o Include in your email the following: RE: Protocol #, Country o Attach the Protocol and Informed Consent Form (ICF) documents, if not already provided to Newfront o If your CRO is requiring a local policy in Canada, please submit a Clinical Trial Liability Quote request and provide the estimated patient split per province for tax calculations.

Clinical Trial Application	Japan Clinical Trial Quote Request
Mandated Coverage	Yes
Standard Limits	50.000.000.00 JPY/patient 500.000.000.00 JPY/protocol
Tail Coverage	n/a
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) • Japan requires payment and wire payment confirmation PRIOR to release of documentation • Sponsor pays the carrier directly once invoice is provided • No refund for policy cancellation • Carrier will provide a pre-filled application form that will require Sponsor's signature THE PROCESS TO ISSUE DOCUMENTS IS SLOW. PLEASE ALLOW ENOUGH TIME AS WE ARE NOT ABLE TO EXPEDITE DOCUMENTS. It is very SLOW due to all of the intermediaries involved. Please allow a minimum 2 months before receipt of documentation.. Submission should be made to Newfront at least one month before documents are required