Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 30

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 30
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 Company is reliant upon third parties to manufacture and supply components of certain substances necessary to manufacture its product candidates.

The Company is reliant on several third-party CMOs for the manufacture and supply of components and substances for all of the product candidates the Company is developing. In addition, certain component materials are currently available from a single supplier, or a small number of suppliers. The Company cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of its competitors or another company that is not interested in continuing to manufacture these materials for the Company. The Company cannot assure that, if required, the Company will be able to identify alternate sources with the desired scale and capability and establish relationships with such sources. A loss of any CMO or component supplier and delay in establishing a replacement could delay Innate's clinical development and regulatory approval process.

Its production costs may be higher than the Company currently estimates.

Innate's product candidates are manufactured according to manufacturing best practices applicable to drugs for clinical trials and to specifications approved by the applicable regulatory authorities. If any of its products were found to be non-compliant, the Company would be required to manufacture the product again, which would entail additional costs and may prevent delivery of the product to patients on time.

Other risks inherent in the production process may have the same effect, such as:

• contamination of the controlled atmosphere area;

• unusable premises and equipment;

• new regulatory requirements requiring a partial and/or extended stop to the production unit to meet the requirements;

• unavailable qualified personnel;

• power failure of extended duration; and

• logistical error.

Should any of these risks materialize, this could have a material adverse effect its business, prospects, financial condition and results of operations.

The Company relies on third parties to supply key materials used in its research and development, to provide services to Innate and to assist with clinical studies.

The Company makes considerable use of third-party suppliers for the key materials used in its business. The failure of third-party suppliers to comply with regulatory standards could result in the imposition of sanctions on the Company. These sanctions could include fines, injunctions, civil penalties, refusal by regulatory organizations to grant approval to conduct clinical trials or marketing authorization for its products, delays, suspension or withdrawal of approvals, license revocation, seizure or recalls of its products, operating restrictions and legal proceedings. Furthermore, the presence of non-conformities, as detected in regulatory toxicology studies, could result in delays in the development of one or more of its product candidates and would require