Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 156

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 156
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 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 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