Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 16

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 16
---
 grant our products sufficient, or any, periods of exclusivity before 
 approving generic versions of our products, the sales of our products could be adversely affected.                                          |

| · | If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential 
 marketing exclusivity and on our intellectual property rights.                                               |

| · | We will need to raise substantial additional capital in the future to fund our operations, which could 
 have a materially adverse effect on our business.                                                      |

| · | We have limited experience in drug development and may not be able to successfully develop any drugs, 
 which would cause us to cease operations.                                                             |

| · | Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many 
 of which are outside of our control.                                                                   |

| · | We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize       
 on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success. |

| · | We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations 
 and requirements could have a materially adverse effect on our business.                                     |

| · | We do not currently have the sales and marketing personnel necessary to sell products, and the failure 
 to hire and retain such staff could have a materially adverse effect on our business.                  |

| · | Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we 
 or our third-party manufacturers fail to comply with manufacturing regulations.                         |

| · | We must comply with significant and complex government regulations, compliance with which may delay or 
 prevent the commercialization of our product candidates.                                               |

| · | We may face business disruption and related risks if there is another pandemic. |

| · | The loss or unavailability of our management could put us at a competitive disadvantage. |

| · | We may not be able to attract and retain highly skilled personnel. |

| · | We may be unable to compete with enterprises in the highly competitive biotechnology and biopharmaceutical 
 industries and those equipped with more substantial resources than us.                                     |

| · | There may be conflicts of interest among our officers, directors and stockholders. |

| · | We indemnify our officers and directors against liability to us and our security holders, and such indemnification 
 could increase our operating costs.                                                                                |

<div align='center'>6</div>

R