Company: REVB
Filing Date: 2025-04-04
Form Type: DRS
Source: 0001213900-25-029022
Chunk: 31

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-04-04
Form: DRS
Chunk 31
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 and clinical programs. We currently rely on a third -partymanufacturer for the production of our clinical study materials., our Product Candidates have been and for the near -termwill be manufactured by a single third -partymanufacturer. 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 -partymanufacturers may not be able to produce Program Products that meet the quality requirements. In the event that this third -partymanufacturer 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 -partymanufacturer, 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 -partyrelationship, 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 -termsupply agreement with any third -partymanufacturer. Reliance on third -partymanufacturers 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 -partymanufacturers, reliance on third -partymanufacturers 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 -partycontractors 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); 17 •the possible mislabeling of clinical supplies, potentially resulting in the wrong