Company: REVB
Filing Date: 2025-05-20
Form Type: S-1
Source: 0001213900-25-045828
Chunk: 125

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 125
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 above, are the following:

| ● | an annual, nondeductible fee on any entity that manufactures                                                                           
 or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market 
 share in some government healthcare programs that began in 2011;                                                                       |

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| ● | a Medicare Part D coverage gap discount program, in                                                                                     
 which manufacturers must agree to offer 50% point-of-sale discounts, which through subsequent legislative amendments, will be increased 
 to 70%, starting in 2019, off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period,   
 as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D;                                             |

| ● | extension of manufacturers’ Medicaid rebate liability                                              
 to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |

| ● | expansion of eligibility criteria for Medicaid programs by,                                                                                     
 among other things, allowing states to offer Medicaid coverage to additional individuals beginning in 2014 and by adding new mandatory          
 eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ 
 Medicaid rebate liability;                                                                                                                      |

| ● | expansion of the entities eligible for discounts under the 
 340B Drug Discount Program;                                |

| ● | a Patient-Centered Outcomes Research Institute to oversee,                                                             
 identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; |

| ● | expansion of healthcare fraud and abuse laws, including the                                                       
 FCA and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; |

| ● | a new methodology by which rebates owed by manufacturers                                                                      
 under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; |

| ● | a requirement to annually report certain information regarding          
 drug samples that manufacturers and distributors provide to physicians; |

| ● | a licensure framework for follow on biologic products. |

Since its enactment, there have been executive, legal and Congressional challenges to certain aspects of the ACA. On June 17, 2021 the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Further, prior to the U.S. Supreme Court ruling, President Biden issued an executive order that initiated a special enrollment period from February 15,