Expanded Access Program

Rakuten Medical is focused on developing innovative and transformative products with the goal of obtaining regulatory approval so that these products can be made widely available to patients. The company conducts clinical trials to generate safety and efficacy information needed to obtain regulatory approval for its investigational products. More information about Rakuten Medical clinical trials can be found at clinicaltrials.gov. Outside of a clinical trial, access to Rakuten Medical’s investigational products would only be considered for the following circumstances:

• Rakuten Medical may provide access to its investigational products to patients with serious or life-threatening disease who do not have other treatment options, when enrollment into an active clinical trial for the investigational product is not feasible and when the potential benefits of the investigational product are greater than the know risks in the disease indication
• Rakuten Medical may provide continued access to its investigational products to trial participants once the clinical trial is complete

Rakuten Medical’s Expanded Access Program (EAP) review committee will consider requests from physicians, from countries where such access is permitted by law. The review committee will assess and approve expanded access for individual patients, on a case-by-case basis when the following criteria are met:

• The patient’s disease or condition is believed to be serious or life- threatening
• There are no comparable or satisfactory approved and available alternative treatments for the disease or condition
• The patient is ineligible or unable to participate in an ongoing clinical trial
• There is sufficient clinical evidence of safety and effectiveness in the indication and that the potential benefit to the patient justifies the potential risks
• The expanded access will not interfere with the clinical development of the product nor jeopardize the regulatory approval
• The expanded access will be available in countries where Rakuten Medical expects to file for regulatory approval for the product commercially in the country from which the request was received once it has been approved
• The treating physician must have prior product training and hands-on experience utilizing the investigational product
• There is adequate product supply to support the request, ongoing, active clinical trials and investigational treatment

Patients interested in seeking expanded access to a Rakuten Medical investigational product should speak with their physician. A treating physician may request information about applying for access by contacting the Global Medical Affairs Department at: [email protected]. Rakuten Medical’s EAP review committee will carefully review all expanded access requests in consideration of the above criteria. If an expanded access request is approved by the committee, the treating physician must agree to comply with the country- specific laws and regulations for administering investigational treatment, e.g., submission to and approval from the regulatory authority, submission to and approval from the Institutional Review Board or Ethics Committee from the treating hospital, obtaining informed consent, complying to safety reporting, receive product specific refresher training and the treating physician must understand any known product risks and agree to use the product as instructed by Rakuten Medical.

Consistent with the 21st Century Cures Act, the posting of policies by manufacturers shall not serve as a guarantee of access to any specific investigational product by any individual patient, and Rakuten Medical may update this policy at any time.