Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 155

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 155
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 future relaxation of laws that
presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

In addition, in some foreign countries, the proposed
pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country
to country. For example, the EU provides options for its member states to restrict the range of medicinal products for which their national
health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain reimbursement
or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular
medicinal product candidate to currently available therapies. A member state may approve a specific price for the medicinal product or
it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the
market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will
allow favorable reimbursement and pricing arrangements for any of our product candidates. Historically, products launched in the EU do
not follow price structures of the U.S. and generally prices tend to be significantly lower.

Healthcare Reform

Payors, whether domestic or foreign, or governmental
or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically
adapted for therapies addressing rare diseases such as those we are developing. In both the United States and certain foreign jurisdictions,
there have been a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell our product
candidates profitably if and when approved for marketing. In particular, in 2010, the ACA was enacted, which, among other things, subjected
biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers
under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased
the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program
to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual
fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers
must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage
gap period, as a condition for the