Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 90

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 90
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 the expenditure of substantial
time and financial resources. Failure to comply with the applicable United States requirements at any time during the product development
process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include
refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures,
total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement
or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

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The process required by the FDA before a drug
or biological product may be marketed in the United States generally involves the following:

| · | Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory 
 Practices or other applicable regulations;                                                                      |

| · | Submission to the FDA of an Investigational New Drug Application (“IND”), which must become 
 effective before human clinical trials may begin;                                           |

| · | Performance of adequate and well-controlled human clinical trials according to the FDA’s GCPs, to 
 establish the safety and efficacy of the proposed drug or biologic for its intended use;          |

| · | Submission to the FDA of a New Drug Application (an “NDA”), for a new drug product, or a Biologics 
 License Application (a “BLA”), for a new biological product;                                       |

| · | Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug                             
 or biologic is to be produced to assess compliance with the FDA’s current good manufacturing practice standards, or cGMP, to assure 
 that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and         
 purity;                                                                                                                             |

| · | Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of 
 the NDA or BLA; and                                                                                   |

| · | FDA review and approval of the NDA or BLA. |

The lengthy process of seeking required approvals
and the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial resources. There
can be no certainty that approvals will be granted.

Clinical trials involve the administration of
the drug or biological candidate to healthy volunteers or patients having the disease being studied under the supervision of qualified
investigators, generally physicians not employed by or under the trial sponsor’s