Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 158

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 158
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 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, which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |

| ● | the FDCA, which among other things, strictly regulates drug marketing, prohibits manufacturers from marketing such products for off-label use and regulates the distribution of samples; |

| ● | federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; |

| ● | the so-called “federal sunshine” law, which requires pharmaceutical and medical device companies to monitor and