Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 154

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 154
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lower the cost of drugs, promote accessibility and improve quality of care. Further, in December 2023, the Biden administration
announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act (which
allow the government, in specified circumstances, to grant or require a patent-holder of technology funded by the federal government
to grant a license to certain third parties). The announcement was followed by publication of Draft Interagency Guidance Framework for
Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can 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