Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 42

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 42
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 our product candidates.

    ●
    Third-party
    manufacturers might be unable to timely manufacture our product candidates or produce the quantity and quality required to meet our
    clinical and commercial needs, if any.

    ●
    Third-party
    manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately.

    ●
    Third-party
    manufacturers may not perform as agreed, may not devote sufficient resources to our product candidates or may not remain in the contract
    manufacturing business for the time required to supply our clinical trials or to successfully produce, store, and distribute our
    products, if any.

    ●
    Manufacturers
    are subject to ongoing periodic unannounced inspection by the FDA and corresponding state or foreign agencies to ensure strict compliance
    with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’
    compliance with these regulations and standards.

    ●
    We
    may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in
    the manufacturing processes for our product candidates.

    ●
    Our
    third-party manufacturers could breach or terminate their agreements with us, and we may be required to pay fees upon suspension
    or termination of the agreement even if the manufacturers do not deliver adequate supply of the product candidates or their components.

    ●
    Raw
    materials and components used in the manufacturing processes, particularly those for which we have no other source or supplier, may
    not be available or may not be suitable or acceptable for use due to factors beyond our control.

    ●
    Our
    third-party manufacturers may have unacceptable or inconsistent product quality success rates and yields, and we have no direct control
    over their ability to maintain adequate quality control, quality assurance and qualified personnel.

46

Each
of these risks could delay or prevent the completion of our clinical trials or the approval of any of our product candidates by the FDA,
result in higher costs or adversely impact commercialization of our product candidates. In addition, we will rely on third parties to
perform certain specification tests on our product candidates prior to delivery to patients. If these tests are not appropriately done
and test data are not reliable, patients could be put at risk of serious harm and the FDA could place significant restrictions on our
company until deficiencies are remedied. Furthermore, our or a third party’s failure to execute on our manufacturing requirements,
to do so on commercially reasonable