This section contains the financial certification and disclosure information for the covered clinical studies supporting this BLA, as required by 21 CFR part 54. Form FDA 3454 (Certification) and Form FDA 3455 (Disclosure) are provided.

Summary of Disclosed Interests:
- A total of 35 investigators participated in the pivotal trials. Of these, four investigators were identified as having financial interests as defined in 21 CFR 54.2(a).
- Investigators with Interests: Jean Bennett, M.D., Ph.D.; Albert M. Maguire, M.D.; Daniel C. Chung, D.O.; Stephen R. Russell, M.D.
- Nature of Interests: Interests included grants to institutions, consulting fees, equity interests, and patent ownership.
- Steps to Minimize Bias: As detailed in the submitted Form FDA 3455s, steps were taken to minimize potential bias. Drs. Bennett and Maguire have waived any financial interest in the patents related to the product. Dr. Chung discontinued his role as a clinical investigator upon becoming a full-time employee of Spark Therapeutics. All study data were subject to independent monitoring and scoring by masked evaluators to ensure objectivity. A subgroup analysis of the primary endpoint by study site shows no evidence of bias influencing the efficacy outcome at the site with the principal investigators holding financial interests. We conclude that these arrangements have not introduced bias into the study outcomes.