39 Since the ACA’s enactment, there have been numerous challenges to the ACA. For example, President Trum r p signed several Executive Orders and other directives designed to delay the implementation of certain provisions of the ACA. Concurrently, Congress considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing penalties, starting January r 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance and delaying the implementation of certain ACA-mandated fees. On June 17, 2021, the U.S. Supr u eme Court dismissed a challenge on procedur d al grounds that argued that the ACA is unconstitutional in its entirety because the individual mandate was repealed by Congress. Further, prior to the U.S. Supr u eme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purpos r es of obtaining health insurance coverage through the ACA marketpl t ace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is possible that the ACA will be subj u ect to judicial or Congressional challenges in the future. Further, on August 16, 2022, President Biden signed the IRA R into law, which among other things, extends enhanced subs u idies for individuals purchasing health insurance coverage in ACA marketpl t aces through plan year 2025. The IRA R also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary r maximum out-of-pocket cost through a newly establ a ished manufact f ur t er discount program. It is unclear how any such challenges and any additional healthcare reform measures of the Biden administration will impact the ACA and our business. In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unabl a e to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effe f ct in 2013, and due to subs u equent legislative amendments to the statut t e, including the Infrastructure Investment and Jobs Act and Consolidated Appropriations Act of 2023, will remain in effe f ct until 2032 unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012 further reduced Medicare payments to several providers, including hospitals and cancer treatment centers, and increased the statut t e of limitations period for the government to recover overpayments to providers from three to five years. Further, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statut t ory r Medicaid drug r rebate cap for single source and innovator multiple source drugs r , beginning January 1, 2024. There have been, and likely will continue to be, legislative and regulatory r proposals at the foreign, federal and state levels directed at containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing effo f rts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affe f ct: • the demand for our product candidates, if we obtain regulatory r approval; • our ability to receive or set a price that we believe is fair for our products; • our ability to generate revenue and achieve or maintain profit f ability; • the level of taxes that we are required to pay; and • the availabi a lity of capital.