Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 159

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 159
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 report certain financial interactions with physicians, certain non-physician practitioners and teaching hospitals to the federal government for re-disclosure to the public; |

| ● | the U.S. Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things, U.S. companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees 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 may seek FDA approval for Nano-Mupirocin
under the 505(b)(2) regulatory pathway, which is subject to FDA discretion, and there can be no assurance that this pathway will be available
or sufficient for approval. The 505(b)(2) pathway could potentially allow reliance on existing data for an approved active ingredient
while supporting innovation in formulation or route of