Company: REVB
Filing Date: 2025-05-20
Form Type: S-1
Source: 0001213900-25-045828
Chunk: 33

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-20
Form: S-1
Chunk 33
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 third-party relationship, which may not be readily available or on acceptable terms, which would cause additional delay or increased expense and would thereby have a material adverse effect on our business, financial condition, results of operations and prospects. We do not have a long-term supply agreement with any third-party manufacturer. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufacture product candidates or products ourselves. For example, if we do not maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities in a timely manner or at all, which could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us, and there could be a substantial delay before new facilities could be qualified and registered with the FDA and other comparable foreign regulatory authorities. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

| ● | the possible failure of the third party to manufacture product                                                                          
 candidates according to our schedule, or at all, including if our third-party contractors give greater priority to the supply of other  
 products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and 
 them;                                                                                                                                   |

| ● | the possible breach of the manufacturing agreement by the                                                                               
 third party because of factors beyond our control (including a failure to manufacture product candidates in accordance with our product 
 specifications);                                                                                                                        |

| ● | the possible mislabeling of clinical supplies, potentially                                                  
 resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; |

| ● | the possibility of clinical supplies not being delivered                                                                               
 to clinical sites on time, leading to clinical study interruptions, or of drug supplies not being distributed to commercial vendors in 
 a timely manner, resulting in lost sales;                                                                                              |

| ● | the possible misappropriation of our proprietary information, 
 including our trade secrets and know-how;                     |

| ● | the possible termination or nonrenewal of the agreement by           
 the third party at a time that is costly or inconvenient for us; and |

| ● | reliance on the third party for regulatory compliance, quality 
 assurance and safety and pharmacovigilance reporting.          |

Certain raw materials necessary for the manufacture of our Program Products, such as our active