Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 155

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 155
---
 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 be imposed on us could have an adverse impact on our results of operations.

Adoption of new legislation at the federal or
state level could affect demand for, or pricing of, any future products if approved for sale. We cannot, however, predict the ultimate
content, timing or effect of any federal and state reform efforts. There is no assurance that federal or state healthcare reform will
not adversely affect our future business and financial results.

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Other Healthcare Laws

Pharmaceutical companies are subject to additional
healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they
conduct their business that may constrain how we conduct our business, including the financial arrangements and relationships through
which we research, as well as sell, market and distribute any products for which we obtain marketing authorization. Restrictions under
applicable federal and state healthcare laws and regulations, some of which will apply only if and when we receive marketing approval
for a product candidate, include the following:

| ● | federal                                                                                                                                  
 healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, 
 directly or indirectly, to induce either the referral of an individual for an item or service or the purchasing or ordering of a         
 good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;                          |

| ● | federal                                                                                                                               
 false claims, false statements and civil monetary penalties laws which prohibit, among other activities, any person from knowingly    
 presenting, or causing to be presented, a false claim for payment of government funds or knowingly making, or causing to be made,     
 a false statement to get a false claim paid and may be implicated if claims are submitted that result from a violation of the federal 
 anti-kickback statute;                                                                                                                |

| ● | HIPAA,