Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 157

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 157
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 use when deciding to exercise march-in rights.
While march-in rights have not previously been exercised, given these actions, there can be no certainty that such rights will not be
exercised in the future.

Healthcare reform efforts have been and may continue
to be subject to scrutiny and legal challenge. For example, with respect to the ACA, tax reform legislation was enacted that eliminated
the tax penalty established for individuals who do not maintain mandated health insurance coverage beginning in 2019 and, in 2021, the
U.S. Supreme Court dismissed the latest judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality
of the ACA. As another example, revisions to regulations under the federal anti-kickback statute would remove protection for traditional
Medicare Part D discounts offered by pharmaceutical manufacturers to pharmacy benefit managers and health plans. Pursuant to court
order, the removal was delayed and recent legislation imposed a moratorium on implementation of the rule until January 2032. As another
example, the IRA drug price negotiation program has been challenged in litigation filed by various pharmaceutical manufacturers and industry
groups.

There have also been efforts by federal and state
government officials or legislators to implement measures to regulate prices or payment for pharmaceutical products, including legislation
on drug importation. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (SIP)
proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented,
United States or Canada. Other states have also submitted Section 804 Importation Program (“SIP”) proposals that are
pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered
by those programs. Recently, there has been considerable public and government scrutiny of pharmaceutical pricing and proposals to address
the perceived high cost of pharmaceuticals. There have also been recent state legislative efforts to address drug costs, which generally
have focused on increasing transparency around drug costs or limiting drug prices.

General legislative cost control measures may
also affect reimbursement for our product candidates. The Budget Control Act, as amended, resulted in the imposition of reductions in
Medicare (but not Medicaid) payments to providers in 2013 that remain in effect through 2032 unless additional Congressional action is
taken. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may
be implemented and/or any significant taxes or fees that may