Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 150

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 150
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 of public international organizations and foreign government       
 owned or affiliated entities, candidates for foreign political office, and foreign political       
 parties or officials thereof; and                                                                  |

| ● | analogous                                                                                            
 state and foreign laws and regulations, such as state anti-bribery, anti-kickback and false          
 claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental 
 third-party payors, including private insurers.                                                      |

Some state laws require pharmaceutical companies
to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers
or require pharmaceutical companies to report information related to payments to healthcare providers or marketing expenditures. Other
state laws may require pharmaceutical companies to file reports relating to pricing and marketing information, and state and local laws
may require registration of pharmaceutical sales representatives.

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Efforts to ensure that our business arrangements
with third parties comply with applicable healthcare laws and regulations will involve substantial costs. Given the breadth of the laws
and regulations, limited guidance for certain laws and regulations and evolving government interpretations of the laws and regulations,
governmental authorities may possibly conclude that our business practices may not comply with healthcare laws and regulations. If our
operations are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may
be subject to penalties, including significant civil and criminal penalties, damages, fines, exclusion from participation in government
healthcare programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of our operations, any of which
could adversely affect our business, financial condition, results of operations, and prospects.

Nano-Mupirocin Regulatory Strategy

United States

We plan to seek FDA approval for Nano-Mupirocin
via the 505(b)(2) regulatory pathway, which allows for reliance on existing data for an approved active ingredient while supporting innovation
in formulation or route of administration. Mupirocin is currently approved in the U.S. as a topical antibiotic (Bactroban) but is unsuitable
for systemic use due to rapid metabolism and high protein binding.

Nano-Mupirocin is a novel liposomal formulation
designed to enable parenteral administration of mupirocin, transforming it into a systemically active antibiotic. By encapsulating mupirocin
in the same liposomal composition used in the FDA-approved product Doxil (liposomal doxorubicin), the drug is protected in the bloodstream,
enhancing its bioavailability