Japan

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

Clinical Trial Application	Australia Clinical Trial Quote Request
Mandated Coverage	No, but is typically preferred by EC
Standard Limits	AUD 10M or AUD 20M depending on territory where study is taking place. PLEASE CONFIRM WITH YOUR CRO for limit required
Tail Coverage	12 months but 72 months in respect of Western Australia and/or Queensland.
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO or Institution name (Contact Person Name, Address, Telephone Number and E-Mail Address) • Local CRO GST (Goods and Services Tax) Number. ABN (Australian Business Number) is also sufficient If Sponsor has a local entity to be listed without the Local CRO on policy, a Goods & Services Tax (GST) will be required for the local sponsor entity. If none available, there is a tax implication. The same trial in New Zealand can be added to this policy for additional premium. Please check with your CRO beforehand to advise if a shared policy is acceptable.