Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 144

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 144
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primands, 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 reimbursement for drug products can differ significantly from payor to payor. One third-party
payor’s decision to cover a particular drug product or service does not ensure that other payors will also provide coverage for
the drug product, or will provide coverage at an adequate reimbursement rate. Coverage policies and third-party reimbursement rates may
change at any time. Even if favorable coverage and reimbursement status is attained for one or more product candidates for which we receive
regulatory approval from one or more third party payors, less favorable coverage policies and reimbursement rates may be implemented
in the future. Additionally, if a companion diagnostic test is developed for use with a drug product, any coverage and reimbursement
for