Company: TELO
Filing Date: 2025-11-20
Form Type: PREM14A
Source: 0001493152-25-024463
Chunk: 158

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-11-20
Form: PREM14A
Chunk 158
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.9.2 There are no Legal Proceedings pending, including any Form FDA-483 observations, demand letter, warning letter, untitled letter, or, to the Knowledge of Company, threatened with respect to an alleged material violation by the Company or Merger Sub of the FDCA, FDA regulations adopted thereunder, the PHSA, the FDCA or any other similar Law administered or promulgated by any Drug Regulatory Agency, or there is no act, omission, event, or circumstance of which the Company or Merger Sub 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.

4.9.3 All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which Company or its respective current products or product candidates have participated, were and, if still pending, are being conducted (collectively “ Company Clinical Trials”) in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2023, neither the Company nor Merger Sub has received any written notices, correspondence, or other written communications from any Drug Regulatory Agency requiring, or to the Knowledge of Company or Merger Sub threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Company or in which Company or its current products or product candidates have participated. All Company Clinical Trials are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including the Good Clinical Practice regulations under 21 C.F.R. Parts 50, 54, 56, 312 and 314 and Good Laboratory Practice regulations under 21 C.F.R. Part 58.

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4.9.4 Company and Merger Sub are not the subject of any pending or, to the Knowledge of Company or Merger Sub, threatened investigation in respect of their business