Company: REVB
Filing Date: 2025-05-23
Form Type: S-1/A
Source: 0001213900-25-047104
Chunk: 62

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-23
Form: S-1/A
Chunk 62
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 be made by CMS on a publicly available website.                                                           |

| ● | Analogous state, local or foreign laws, such as state anti-kickback                                                                     
 and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state   
 and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements;    
 state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines     
 and the relevant compliance guidance promulgated by the federal government; state and local laws that require licensure or registration 
 by sales and marketing agents of a pharmaceutical company; state laws that require disclosure of information related to drug pricing;   
 and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from 
 each other in significant ways and may not have the same effect as HIPAA.                                                               |

36 Pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of promotional and marketing activities, such as: providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion; and submitting inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. The global data protection landscape is rapidly evolving, and we may be affected by or subject to new, amended or existing laws and regulations in the future, including as our operations continue to expand or if we operate in foreign jurisdictions. Several foreign jurisdictions, including the EU, its member states, the United Kingdom, Japan and Australia, among others, have adopted legislation and regulations that increase or change the requirements governing the collection, use, disclosure and transfer of the personal information of individuals in these jurisdictions. Additionally, certain countries have passed or are considering passing laws that require local data residency and/or restrict the international transfer of data. These laws have the potential to increase costs of compliance, risks of noncompliance and penalties for noncompliance. If our operations are found to be in violation of any of these laws or any other