BUSINESS OVERVIEW 6 that is owed by pharmaceutical manufacturers who participate in Additional new laws may result in additional reductions in funding Medicare Part D and to close the coverage gap in most Medicare to Medicare and other federal health care programs. Further, drug plans, commonly referred to as the “donut hole.” Congress new laws may, among other things, increase drug rebates or could consider additional legislation to repeal or repeal and discounts owed under federal health care programs, impose replace certain elements of the ACA. additional reporting or compliance obligations, and/or otherwise In addition, other legislative changes have been proposed and put additional downward pressure on drug prices or increase the adopted since the ACA was enacted. On August 2, 2011, then- burden of compliance on pharmaceutical manufacturers. President President Obama signed into law the Budget Control Government Regulation Outside of the European Union and the Act of 2011, which, among other things, created the Joint Select United States Committee on Deficit Reduction to recommend to Congress In addition to regulations in the European Union and the proposals in spending reductions. The Joint Select Committee United States, we wil l be subject to a variety of regulations in did not achieve a targeted deficit reduction of at least $1.2 trillion other jurisdictions governing, among other things, clinical trials, for the years 2013 through 2021, triggering the legislation’s commercial sales and distribution of our products, and pricing automatic reduction to several government programs. This and reimbursement. The requirements and process governing includes reductions to Medicare payments to providers of 2% the conduct of clinical trials, product licensing, pricing and per fiscal year, which went into effect on April 1, 2013 and, due reimbursement vary from country to country. If we fail to comply to subsequent legislation, including the BBA, will remain in effect with applicable national regulatory requirements, we may be through 2027 unless additional Congressional action is taken. subject to, among other things, fines, suspension or withdrawal On January 2, 2013, then-President President Obama signed of regulatory approvals, product recal ls, seizure of products, into law the American Taxpayer Relief Act of 2012, which, among operating restrictions and criminal prosecution. other things, reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. 100– GENSIGHT BIOLOGICS – 2017 Registration Document