Company: REVB
Filing Date: 2025-05-23
Form Type: S-1/A
Source: 0001213900-25-047104
Chunk: 33

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-05-23
Form: S-1/A
Chunk 33
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 to independently manufacture Program Products for our planned preclinical and clinical programs. We currently rely on a third-party manufacturer for the production of our clinical study materials., our Product Candidates have been and for the near-term will be manufactured by a single third-party manufacturer. This manufacturer may not be able to scale production to the larger quantities required for large clinical studies and to commercialize our Product Candidates, if approved. Also, the third-party manufacturers may not be able to produce Program Products that meet the quality requirements. In the event that this third-party manufacturer does not successfully carry out its contractual duties, meet expected deadlines or manufacture our products in accordance with regulatory requirements or if there are disagreements between us and this third-party manufacturer, we will not be able to complete, or may be delayed in completing, the clinical studies required. In such instances, we may need to locate an appropriate replacement 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