Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 130

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 130
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 the label, including “boxed” warnings,                                                 
 or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information 
 about the product;                                                                                                                               |

| ● | we may be required to change the way the product is administered or conduct additional clinical studies 
 or post-approval studies;                                                                               |

| ● | we may be required to create a risk evaluation and mitigation strategy or similar risk management measures,   
 which could include a medication guide outlining the risks of such side effects for distribution to patients; |

| ● | we may be required to modify promotional materials and labeling and/or issue corrective information; |

| ● | we may be subject to fines, warning letters, or untitled letters; |

| ● | we may be subject to holds on clinical trials, |

| ● | regulatory authorities may refuse to approve applications or supplements to approved applications, or 
 suspend or revoke product approvals;                                                                  |

| ● | we may be subject to product seizure or detention, refusal to permit the import or export of products,                                
 injunctions, the imposition of civil or criminal penalties or consent decrees, corporate integrity agreements, debarment or exclusion 
 from federal healthcare programs;                                                                                                     |

| ● | we may be subject to fines, injunctions or the imposition of criminal penalties; |

| ● | we could be sued and held liable for harm caused to patients; and |

| ● | our reputation may suffer. |

| 53 |

Any of these
events could prevent us from achieving or maintaining approval, certification or market acceptance of the particular product candidate,
and could materially and adversely impact or seriously harm our business, operating results, prospects or financial condition.

We will be dependent on
attracting, retaining and developing key management, clinical, scientific, regulatory, quality, marketing and other expert personnel,
and losing these personnel could impair the development and sales of our products or product candidates.

We are highly
dependent on our senior management and other key personnel. Our success depends on our continued ability to attract, retain, develop and
motivate highly qualified management, clinical, scientific and sales and marketing personnel. Although we expect to enter into new employment
agreements with its key personnel following the consummation of the Business Combination, our employees, including our executive officers,
are and will be employed “at will,” and each employee can terminate his or her employment with us at any time. We also do
not maintain “key person” insurance policies on any of our officers or our other employees. The