Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 150

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 150
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law in the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation,
endorsement, purchase, supply, order or use of medicinal products is also prohibited in the EU and the UK. The provision of benefits
or advantages to induce or reward improper performance generally is governed by the national anti-bribery laws of EU member states and
the Bribery Act 2010 in the UK. Infringement of these laws could result in substantial fines and imprisonment. Applicable law in Europe
further provides that, where medicinal products are 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