Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 130

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 130
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NY. None of SKNY or its properties or assets are subject to any material outstanding Order, whether temporary, preliminary, or permanent.

3.10 Compliance With Applicable Law

3.10.0 SKNY is and has been in compliance in all material respects with all Applicable Laws applicable to SKNY; and SKNY has not received notice from any Governmental Entity of any violation, alleged violation or potential violation of any such Applicable Laws.

3.10.1 To the Knowledge of SKNY, no event has occurred, and no condition exists, that would reasonably be expected to (with or without notice or lapse of time) constitute or result in a material violation by SKNY of any Applicable Law applicable to SKNY or its business.

3.10.2 There are no Proceedings pending, including any Form FDA-483 observations, demand letter, warning letter, untitled letter, or, to the Knowledge of SKNY, threatened with respect to an alleged material violation by SKNY of the FDCA, FDA regulations adopted thereunder, the Public Health Service Act (“ PHSA”), the Federal Food, Drug and Cosmetic Act (“ FDCA”) or any other similar Law administered or promulgated by any drug regulatory agency (the “ Drug Regulatory Agency”), or there is no act, omission, event, or circumstance of which SKNY has Knowledge that would reasonably be expected to give rise to or form the basis for any Legal Proceedings, Form FDA-483 observation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws administered or promulgated by any Drug Regulatory Agency.

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3.10.3 SKNY has so far conducted no clinical, pre-clinical or other studies and tests ofs its product candidates.

3.10.4 SKNY is not the subject of any pending or, to the Knowledge of SKNY, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of SKNY, it has not has committed any acts, made any statement, or has not failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fra