Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 149

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 149
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 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 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