Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 153

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 153
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 being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages
or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine
or pharmacy.

Pursuant to national laws, industry codes or professional
codes of conduct payments made to physicians in certain EU member states and the UK must be publicly disclosed. Moreover, agreements with
physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional
organization and/or the regulatory authorities of the individual EU member states, or the UK (as applicable). Failure to comply with these
requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

The advertising and promotion of medicinal products
is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising
and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary
of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines
is also prohibited in the EU and the UK. Although general requirements for advertising and promotion of medicinal products are established
under Directive 2001/83/EC, which was transposed into national law in the UK via the Human Medicines Regulations 2012, the details
are governed by regulations in each European jurisdiction and can differ from one country to another.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage
and reimbursement status of any product candidates for which we may seek regulatory approval by the FDA or other government authorities.
In the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs
associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid,
and commercial payors is critical to new product acceptance. Our ability to successfully commercialize our product candidates will depend
in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government
health authorities or programs, private health insurers and other organizations. Even if coverage is provided, the approved reimbursement
amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

Government authorities and other third-party payors,
such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement
levels. Additionally, coverage and