Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment

This is a multi-center, open label study to evaluate the long term safety of everolimus in
patients with TSC and refractory seizures currently being treated in the Novartis-sponsored
study EXIST-3 study and are judged by their parent study investigator as benefiting from the
current study treatment. The study is expected to remain open for approximately 10 years (or
until 31-Dec-2022 in the UK) from First Patient First Visit (FPFV).

Patients will continue to be treated in this study until they are no longer benefiting from
their everolimus treatment as judged by the Investigator or until one of the protocol defined
discontinuation criteria is met or everolimus becomes commercially available according to
local regulations.

Key Inclusion Criteria:

- Patient is currently enrolled in the Novartis-sponsored EXIST-3 study, receiving
everolimus, and has fulfilled all its requirements

- Patient is currently benefiting from treatment with everolimus, as determined by the
Investigator.

- Patient has demonstrated compliance, as assessed by the Investigator,with the parent
study protocol requirements.

- Patient is willing and able to comply with scheduled visits and treatment plans.

- Written informed consent/adolescent assent obtained prior to enrolling into the
roll-over study.

Key Exclusion Criteria:

- Patient has been permanently discontinued from everolimus study treatment in EXIST-3
study

- Everolimus is approved for patients with TSC and refractory seizures and is reimbursed
in the local country.

- Patients who are receiving everolimus in combination with unapproved or experimental
treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose
of seizure control.