Company: REVB
Filing Date: 2025-05-23
Form Type: S-1/A
Source: 0001213900-25-047104
Chunk: 67

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-23
Form: S-1/A
Chunk 67
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 product candidates. To obtain separate regulatory approvals in other countries, we may be required to comply with numerous and varying regulatory requirements of such countries regarding the safety and efficacy of our product candidates and governing, among other things, clinical studies and commercial sales, pricing and distribution of our product candidates, and we cannot predict success in these jurisdictions. We may not obtain foreign regulatory approvals on a timely basis, if at all. If we obtain approval of our product candidates and ultimately commercialize our product candidates in foreign markets, we would be subject to additional risks and uncertainties, including:

| ● | our customers’ ability to obtain reimbursement for 
 our product candidates in foreign markets;         |

| ● | our inability to directly control commercial activities if                                                                                     
 we are relying on third parties; the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements; |

| ● | different medical practices and customs in foreign countries 
 affecting acceptance in the marketplace;                     |

| ● | import or export licensing requirements; |

| ● | longer accounts receivable collection times; |

| ● | our ability to supply our product candidates on a timely 
 and large-scale basis in local markets;                  |

| ● | longer lead times for shipping which may necessitate local 
 manufacture of our product candidates;                     |

| ● | language barriers for technical training and the need for 
 language translations;                                    |

| ● | reduced protection of patent and other intellectual property 
 rights in some foreign countries;                            |

| ● | the existence of additional potentially relevant third-party 
 intellectual property rights;                                |

39

| ● | foreign currency exchange rate fluctuations; and |

| ● | the interpretation of contractual provisions governed by 
 foreign laws in the event of a contract dispute.         |

Foreign sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs. If any of our product candidates is approved for commercialization, we may selectively partner with third parties to market it in certain jurisdictions outside the United States. We expect that we will be subject to additional risks related to international pharmaceutical operations, including:

| ● | different regulatory requirements for drug approvals and                                                                            
 rules governing drug commercialization in foreign countries, including requirements specific to biologics or cell therapy products; |

| ● | reduced protection for patent and other intellectual property 
 rights;                                                       |

| ● | foreign reimbursement, pricing and insurance regimes; |

| ● | potential noncompliance with the U.S. Foreign Corrupt                                                                 
 Practices Act,