Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes

Key Inclusion Criteria:

- Have a medically documented diagnosis of hemophilia A or B that is being treated
prophylactically with a factor replacement product not designed to have a prolonged
half-life and satisfy a therapeutic indication for rFVIIIFc/rFIXFc per the approved
local label

- Have at least 50 prior exposure days (EDs) to any combination of factor replacement
products

- Have documented pre-study data available that confirm fulfillment of the eligibility
criteria

- Have no measurable inhibitor activity in a sample obtained within 4 weeks prior to the
Baseline visit, and absence of clinical signs or symptoms of decreased response to the
current factor replacement product

Key Exclusion Criteria:

- Have a diagnosis of any bleeding disorder other than hemophilia A or hemophilia B or
an additional coagulation disorder(s) in addition to hemophilia A or hemophilia B

- Have a prior history of anaphylaxis associated with any factor VIII (FVIII)/ factor IX
(FIX) or intravenous immunoglobin administration

- Had an inhibitor within 5 years before the Baseline visit. Note: A family history of
inhibitors will not exclude the patient.

- Past or current treatment with any factor replacement product with a prolonged
half-life, including an Fc product, for the treatment of hemophilia

NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.