# EDGAR Filing Document

**Accession Number:** 0002070577
**File Stem:** 0001520138-25-000280
**Filing Date:** 2025-9
**Character Count:** 729562
**Document Hash:** 3c2bff6f7ab990e07a80c78e1341b65e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001520138-25-000280.hdr.sgml**: 20260123

**ACCESSION NUMBER**: 0001520138-25-000280

**CONFORMED SUBMISSION TYPE**: DRS

**PUBLIC DOCUMENT COUNT**: 3

**FILED AS OF DATE**: 20250905

**DATE AS OF CHANGE**: 20250909

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Option Therapeutics Inc.
- **CENTRAL INDEX KEY:** 0002070577
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 334884057
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** DRS
- **SEC ACT:** 1933 Act
- **SEC FILE NUMBER:** 377-08426
- **FILM NUMBER:** 251297294

**BUSINESS ADDRESS:**
- **STREET 1:** 680 W NYE LN STE 201
- **CITY:** CARSON CITY
- **STATE:** NV
- **ZIP:** 89703
- **BUSINESS PHONE:** 775-446-0517

**MAIL ADDRESS:**
- **STREET 1:** 680 W NYE LN STE 201
- **CITY:** CARSON CITY
- **STATE:** NV
- **ZIP:** 89703

**As submitted confidentially to the Securities and Exchange Commission on September 5, 2025.**

**This draft registration statement has not been publicly filed with the Securities and Exchange Commission** 

**and all information herein remains strictly confidential.**

**Registration No. 333-** 

**UNITED STATES<br> SECURITIES AND EXCHANGE COMMISSION<br> Washington, D.C. 20549**

**FORM S-1**

**REGISTRATION STATEMENT<br> UNDER<br> THE SECURITIES ACT OF 1933**

**OPTION THERAPEUTICS INC.** 

*(Exact name of registrant as specified in its charter)*

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| | | |
|:---|:---|:---|
| **Delaware** | **2834** | 33-4884057 |
| *(State or other jurisdiction of<br> incorporation or organization)* | *(Primary Standard Industrial<br> Classification Code Number)* | *(I.R.S. Employer <br> Identification Number)* |

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**680 W Nye Lane, Suite 201**

**Carson City, Nevada 89703** 

**(775) 888-1664**

*(Address, including zip code, and telephone number, including area code, of registrant's principal executive offices)*

**Cuong Do<br> c/o BioVie Inc.**

**Chief Executive Officer**

**680 W Nye Lane, Suite 201**

**Carson City, Nevada 89703** 

**(775) 888-3162**

*(Name, address, including zip code, and telephone number, including area code, of agent for service)*

*Copies to:*

 

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| | |
|:---|:---|
| **Stephen E. Older, Esq.**<br> **Carly E. Ginley, Esq.**<br> **McGuireWoods LLP**<br> **1251 Avenue of the Americas**<br> **20th Floor**<br> **New York, New York, 10020**<br> **(212) 548-2100** | **Jeffrey J. Fessler, Esq.**<br> **Stephen A. Cohen, Esq.**<br> **Sheppard, Mullin, Richter & Hampton LLP**<br> **30 Rockefeller Plaza**<br> **New York, New York 10112**<br> **(212) 653-8700** |

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**Approximate date of commencement of proposed sale to the public:** As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ <br> Non-accelerated filer ☒ Smaller reporting company ☒ <br> Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

**The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.**

**The information contained in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted**.

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| | | |
|:---|:---|:---|
| **PRELIMINARY PROSPECTUS** | **SUBJECT TO COMPLETION** | **DATED SEPTEMBER 5, 2025** |

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**Shares** 

**Common Stock** 

**Option Therapeutics Inc.**

This is the initial public offering of shares of common stock, $0.001 par value per share ("common stock") of Option Therapeutics Inc., a Delaware corporation, which is currently a wholly owned subsidiary of BioVie Inc., a Nevada corporation ("BioVie"). We are offering shares of our common stock. Prior to this offering, there has been no public market for our common stock. We anticipate that the initial public offering price of shares of our common stock will be between $ and $ per share.

We intend to apply to list our common stock on NYSE American ("NYSE") under the symbol " ". If our common stock is not approved for listing on NYSE, we will not consummate this offering.

In connection with this offering, we will issue shares of our common stock representing not more than % of our outstanding common stock, with BioVie maintaining ownership of at least % of our outstanding common stock. As a result, we will be a "controlled company" as defined under the corporate governance rules of NYSE upon completion of this offering and will be exempt from certain corporate governance requirements of such rules. See "Management—Controlled Company Exemption."

We are an "emerging growth company" and a "smaller reporting company" under the federal securities laws and may elect to comply with certain reduced public company reporting requirements. See "Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company."

**Investing in our common stock is involves a high degree of risk. See "Risk Factors" beginning on page 15.**

**Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.**

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| | | |
|:---|:---|:---|
|  | **Per Share** | **Total** |
| Initial public offering price | $| $|
| Underwriting discounts and commissions<sup>(1)</sup> | $| $|
| Proceeds to us, before expenses | $| $|

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&nbsp;&nbsp;&nbsp;&nbsp;(1) We refer you to "Underwriting" beginning on page 97 for additional information regarding
 the underwriters' compensation.

We have granted a 45-day option to the underwriters to purchase up to additional shares of common stock at the initial public offering price, less underwriting discounts and commissions, solely to cover over-allotments, if any.

The underwriters expect to deliver the shares to purchasers on or about , 2025.

**ThinkEquity**

The date of this prospectus is , 2025.

**TABLE OF CONTENTS**

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| | |
|:---|:---|
| [ABOUT THIS PROSPECTUS](#a_001) | [1](#a_001) |
| [FORWARD-LOOKING STATEMENTS](#a_002) | [3](#a_002) |
| [PROSPECTUS SUMMARY](#a_003) | [4](#a_003) |
| [RISK FACTORS](#a_004) | [15](#a_004) |
| [USE OF PROCEEDS](#a_005) | [52](#a_005) |
| [DIVIDEND POLICY](#a_006) | [53](#a_006) |
| [CAPITALIZATION](#a_007) | [54](#a_007) |
| [DILUTION](#a_008) | [55](#a_008) |
| [BUSINESS](#a_009) | [57](#a_009) |
| [MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](#a_010) | [67](#a_010) |
| [MANAGEMENT](#a_011) | [70](#a_011) |
| [EXECUTIVE COMPENSATION](#a_012) | [76](#a_012) |
| [CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS](#a_013) | [77](#a_013) |
| [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENTS](#a_014) | [83](#a_014) |
| [DESCRIPTION OF OUR SECURITIES](#a_015) | [84](#a_015) |
| [SHARES ELIGIBLE FOR FUTURE SALE](#a_016) | [90](#a_016) |
| [MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES FOR NON-U.S. HOLDERS](#a_017) | [93](#a_017) |
| [UNDERWRITING](#a_018) | [97](#a_018) |
| [LEGAL MATTERS](#a_019) | [105](#a_019) |
| [EXPERTS](#a_020) | [105](#a_020) |
| [WHERE YOU CAN FIND MORE INFORMATION](#a_021) | [105](#a_021) |
| [INDEX TO FINANCIAL STATEMENTS](#a_022) | [F-1](#a_022) |

---

**ABOUT THIS PROSPECTUS**

This prospectus is part of a registration statement on Form S-1 that we filed with the U.S. Securities and Exchange Commission (the "SEC"). You should read this prospectus carefully. This prospectus contains important information you should consider when making your investment decision.

You should only rely on information contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus that we may authorize to be delivered or made available to you. Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other than the information contained in this prospectus, any amendment or supplement to this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we may have referred you. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the underwriters have not authorized any other person to provide you with different or additional information. Neither we nor the underwriters are making an offer to sell shares of our common stock in any jurisdiction where the offer or sale is not permitted. This offering is being made in the United States and elsewhere solely based on the information contained in this prospectus. Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus. This prospectus is not an offer to sell or the solicitation of an offer to buy our common stock in any circumstances under which such offer or solicitation is unlawful. The information contained in this prospectus, any amendment or supplement to this prospectus or any applicable free writing prospectus is current only as of its date, regardless of the time of delivery of this prospectus, any amendment or supplement to this prospectus or any applicable free writing prospectus or any sale of the shares. Our business, financial condition, results of operations and prospects may have changed since such date.

For investors outside the United States: neither we nor the underwriters have done anything that would permit this offering or the possession or distribution of this prospectus in any jurisdiction where action for those purposes is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, this offering of common stock and the distribution of this prospectus outside the United States.

**Background**

In connection with this offering, we will issue shares of our common stock representing not more than % of our outstanding common stock, with BioVie maintaining ownership of at least % of our outstanding common stock. We describe in this prospectus the business that will be contributed to us by BioVie as part of our separation from BioVie as if it were our business for all historical periods described.

Except as otherwise indicated, references in this prospectus to (1) the "Separation" refer to the separation of our business from BioVie's business, along with the effectiveness of various agreements between us and BioVie and (2) the "Company," "Option," "we," "us" and "our" refer to Option Therapeutics Inc., a Delaware corporation, assuming the completion of the Separation; and (3) "BioVie" refer to BioVie Inc., a Nevada corporation.

Please see the section titled "The Separation Transaction" for a description of the Separation.

**Market, Industry and Other Data**

This prospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our products. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.

In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled "Risk Factors." These and other factors could cause our future performance to differ materially from our assumptions and estimates. See "Forward-Looking Statements."

**Presentation of Financial Information**

The financial information included in this prospectus has been prepared from BioVie's historical accounting records and is derived from the financial statements of BioVie to present the Company as if it had been operating on a standalone basis. The historical carve-out financial statements (together with the notes thereto, the "financial statements") reflect our financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States ("U.S. GAAP"). The carve-out financial statements include the assets, liabilities, and expenses based on our legal entity structure as well as direct and indirect costs that are attributable to our operations. Indirect costs are the costs of support functions that are partially provided on a centralized basis by BioVie, which include finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance, and other professional services. Indirect costs have been allocated to us for the purposes of preparing the carve-out financial statements based on a specific identification basis or, when specific identification is not practicable, a proportional cost allocation method, primarily based on individuals identified that contributed to the Company's operations or other allocation methodologies that are considered to be a reasonable reflection of the utilization of services provided or the benefit received by us during the periods presented, depending on the nature of the services received.

The financial information included in this prospectus may not necessarily reflect what our financial condition, results of operations, or cash flows would have been had we been a standalone company during that will occur in our operations and capital structure as a result of this offering and the Separation. In addition, the financial information included in this prospectus may not necessarily reflect what our financial condition, results of operations, and cash flows may be in the future. See "Risk Factors—Risks Related to the Separation and Our Relationship with BioVie—We have no recent history of operating as a standalone public company, and our historical financial information may not necessarily reflect the results that we would have achieved as a standalone public company or what our results may be in the future."

**FORWARD-LOOKING STATEMENTS**

Certain statements contained in this prospectus constitute forward-looking information or forward-looking statements under applicable securities laws. These statements relate to future events or future performance, business prospects or opportunities of the Company. All statements other than statements of historical fact may be forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, or future events or performance (often, but not always, using words or phrases such as "seek," "anticipate," "plan," "continue," "estimate," "expect," "may," "will," "project," "predict," "forecast," "potential," "targeting," "intend," "could," "might," "should," "believe," and similar expressions) are not statements of historical fact and may be "forward-looking statements."

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking statements. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. These forward-looking statements involve risks and uncertainties relating to, among others: our limited operating history; our ability to raise the substantial capital needed to fund our operations and research and development; risks associated with clinical development and our ability to successfully complete pre-clinical and clinical testing and be granted regulatory approval for our products to be sold and marketed in the United States or elsewhere; our ability to achieve the expected benefits of and successfully execute the Separation; our status as a controlled company, and the possibility that BioVie's interests or those of certain of our executive officers and directors may conflict with the interests of our other stockholders; our reliance on third parties to conduct our clinical trials and manufacture our product candidates; our ability to establish and/or maintain intellectual property rights covering our product candidates; competition; future dilution and liquidity of our common stock; the global economic, political and financial market conditions; and our reliance on a limited number of product candidates.

The Company believes that the expectations reflected in any forward-looking statements are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking statements included in, or incorporated by reference into, this prospectus should not be unduly relied upon. These statements speak only as of the date of this prospectus and the Company does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. Actual results may differ materially from those expressed or implied by such forward-looking statements.

**PROSPECTUS SUMMARY**

*This summary contains basic information about us and our business but does not contain all of the information that is important to your investment decision and is qualified in its entirety by the more detailed information and financial statements included elsewhere in this prospectus. You should carefully read this summary together with the more detailed information contained elsewhere in this before making an investment decision. Investors should carefully consider the information set forth under the caption "Risk Factors" appearing elsewhere in this prospectus.*

**Overview**

We are a clinical-stage company developing innovative drug therapies to treat chronic debilitating liver disease through our investigational drug candidate BIV201 (continuous infusion terlipressin). BIV201 has been granted both FDA Fast Track designation status and FDA Orphan Drug Status and is being evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by non-alcoholic steatohepatitis ("NASH"), hepatitis, and alcoholism. BIV201 is administered as a patent-pending liquid formulation with patents issued, to date, in the U.S., China, Japan, Chile, and India .

**About Liver Cirrhosis**

Liver cirrhosis causes a heavy global burden. There are an estimated 4.8 million people diagnosed with chronic liver disease and cirrhosis in the United States and 54,803 deaths annually, ranking 10<sup>th</sup> in causes of death. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity. Between 2012 and 2018, the prevalence of liver cirrhosis doubled among insured patients in the United States, alcohol-related and NASH cirrhosis were the most significant contributors to this increase. Additionally, the number of deaths from alcoholic cirrhosis more than tripled between 1999 and 2019, rising from 3.3 deaths per 100,000 to 10.6 deaths per 100,000.

Individuals with cirrhosis are at high risk of developing complications which include ascites, variceal bleeding, hepatic encephalopathy, acute kidney injury ("AKI"), and bacterial infections, the development of which define decompensated cirrhosis, and the increased prevalence of cirrhosis is expected to result in increased incidence of cirrhosis complications. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. Decompensated cirrhosis is an advanced stage of cirrhosis often associated with liver failure and is associated with worse survival rates (2-4 years) compared with compensated cirrhosis (10-15 years). The majority of decompensated patients have ascites and are frequently hospitalized for complications. In 2014 approximately 100,000 individuals with cirrhosis and ascites were hospitalized in the United States with about one quarter being readmitted within 30 days. Assuming at least a doubling of this population in the past 10 years, as was seen from 2012 to 2018, the estimated target population is about 200,000. Those with ascites and AKI experience higher readmission rates and have a poor prognosis: the development of AKI is strongly associated with mortality and can increase risk of death 5-fold.

Decompensated liver cirrhosis currently has no approved therapeutic options other than liver transplantation. There is thus a major gap in effective, long-term, and accessible treatments for patients with decompensated liver disease and ascites. The paradigm for the treatment of these patients is now changing from attempts to control ascites towards the goal of preventing further decompensation and mortality. The recent news that the PRECIOSA study, evaluating whether albumin infusions improve mortality, transplant-free survival, and disease-related outcomes in decompensated patients, failed to meet its primary endpoint, most certainly highlights the urgent need for more research and investment in this challenging population.

**The Need for Therapy**

A reduction in complications in decompensated patients could lead to a decrease in the risk of hospitalization, reducing health care burden and costs, and increase the chance of survival. In addition, these complications may make this population ineligible for liver transplantation. There is currently no approved drug treatment to reduce ascites and complications and preserve renal function in patients with cirrhosis and ascites. A recent Phase 3 study evaluating the potential for frequent albumin infusions to improve outcomes transplant-free survival, mortality and complications in this patient population failed to meet its primary endpoint.

U.S. treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $5 billion annually. Treating decompensated cirrhosis and complications like ascites and AKI increase the costs of treatment significantly in the first year.

**Pathophysiology of Decompensated Cirrhosis**

Most experts agree that ascites and other complications develop as a consequence of high blood pressure in the vein that supplies blood to the liver. This so-called "portal hypertension" occurs as increasing liver damage (fibrosis) impedes blood flow through the liver. This causes vasodilation and blood pooling in the central or "splanchnic" region of the body and low blood volume in the arteries. The decrease in effective blood volume activates a signaling pathway ("neurohormonal systems") which tells the kidneys to retain large amounts of salt and water in an effort to increase blood volume. Ultimately the retention of excess sodium and water leads to the formation of ascites as these substances "weep" from the liver and lymph system and collect in the patient's abdomen as ascites. Portal hypertension also leads to the development of hepatic encephalopathy, gastrointestinal bleeding, and hepatorenal syndrome and increases the risk of AKI.

**BIV201 Proposed Mechanism of Action**

The vasoconstrictor terlipressin, an agonist of vasopressin receptors, reduces splanchnic vasodilation associated with portal hypertension in patients with cirrhosis and can lead to a decrease in ascites production by reducing portal hypertension, increasing effective blood volume and decreasing the activity of the renin-angiotensin-aldosterone system (RAAS). Increasing evidence suggests that terlipressin, administered as a continuous infusion on an outpatient basis, can be a well-tolerated effective treatment to improve clinical outcomes in patients with cirrhosis requiring paracentesis. By targeting the pathophysiology that predisposes these patients to AKI and by reducing potential triggers for AKI (paracentesis, SBP, portal-hypertension-related GI bleeding and reduction in the need for diuretics), BIV201 can potentially reduce ascites and the incidence of further decompensation events, including AKI, and subsequently improving patient outcomes.

In liver disease, the initial target for BIV201 therapy was refractory ascites in patients with cirrhosis. These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.

BIV201 is a continuous infusion of terlipressin, a drug used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal varices) that was approved in the U.S. in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function) but is not approved in Japan. With its novel room temperature stable formulation in a pre-filled syringe and potentially other containers, we believe BIV201 could potentially provide a superior terlipressin drug delivery system throughout the world. The goal of BIV201 therapy is to target the pathophysiology that contributes to ascites production, AKI, and complications of cirrhosis that are associated with significant mortality.

After two Phase 2 studies BioVie received guidance from the FDA in June 2023 and December 2024, regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites. The Company is currently finalizing the protocol for a randomized, placebo-controlled Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from AKI. This patient population is not limited to those having refractory ascites.

In an open-label Phase 2a trial (NCT03107091) initiated in 2017, six patients with cirrhosis and refractory ascites received a continuous IV infusion of terlipressin 2 mg/day escalating to 4 mg/d during a 7-day inpatient period, followed by 21 days as outpatients. The PK and safety/tolerability and effects on the need for and volume of paracentesis were evaluated. Four of 6 patients enrolled experienced ≥50% increase in the interval between large volume paracenteses (LVP) with terlipressin. Three (50.0%) patients reported treatment-related adverse events, but none were serious. Based on this study, continuous IV infusion of terlipressin improved control of refractory ascites with an acceptable safety and predictable PK profile and further evaluation of terlipressin was deemed warranted in a randomized controlled trial for treating refractory ascites and related complications of cirrhosis.

In June 2021, BioVie initiated a randomized (2:1), open-label Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 for the treatment of refractory ascites. Patients with cirrhosis and refractory ascites were randomly assigned (2:1) to receive two 28-day cycles of continuous infusion BIV201 plus standard of care (SOC) separated by a ≤56-day washout (n=10), or SOC alone (n=5).The primary endpoints of the study were the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period. By October 12, 2022, there were 15 patients enrolled for treatment and the last patient completed treatment on May 8, 2023. In March 2023, enrollment was paused and that data from the first 10 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period. Final data analysis was limited by the small sample size and confounded by a potential interaction with gabapentinoids in the BIV201+SOC group. Nonetheless, there were differences in favor of BIV201+SOC versus SOC in the coprimary efficacy endpoints and several QoL assessments. The beneficial effects of BIV201 on liver complications (mean: 90% CI; BIV201-completers=2.87: 1.51; 5.46 vs. SOC=2.38: 1.20; 4.73) and the change in cumulative ascites (mean; 90% CI; BIV201-completers=-10.76: -26.51; 5.00 vs. SOC=-4.99: -21.95; 11.97) were more pronounced versus SOC in the 5 BIV201+SOC patients who completed both treatment cycles. There were also greater improvements in exploratory QoL assessments and the percent change in TPs with BIV201+SOC (-27.94±41.80) versus SOC (-16.67±45.64). Despite the high rate of hyponatremia in the BIV201+SOC group (4/10 patients), the safety profile suggested that continuous BIV201 infusion was well tolerated. These findings support further development of BIV201 in confirmatory trials.

Our proprietary novel liquid formulation of terlipressin is designed to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute the current powder version of terlipressin. To date, analytical testing results have confirmed room temperature stability of the prefilled syringe in storage for 2 years. Room temperature storage presents a key product differentiation versus terlipressin products in countries where the drug is approved. To the best of the Company's knowledge, all other terlipressin products sold globally must be stored under refrigeration and there is no prefilled syringe format of terlipressin available for treating patients in these countries. BioVie has also filed a Patent Cooperation Treaty ("PCT") application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and to date patents have been granted in the U.S. (Patent No. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68965), China (Patent No. ZL 202080050758.X), and Japan (7579811).

We believe BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis, and alcoholism. The FDA has granted Fast-Track status and Orphan Drug designation for ascites (due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical need. Patients with cirrhosis and ascites account for an estimated 116,000 U.S. hospital discharges annually, with frequent early readmissions. According to the HCUP Nationwide Readmissions Database 2016, those requiring paracentesis (removal of ascites fluid) experience an average hospital stay lasting eight days incurring over $86,000 in medical costs. This translates into a total potentially addressable ascites market size for BIV201 therapy exceeding $650 million based on Company estimates. The Company's forecasts for BIV201 shows peak annual sales of $1.2 billion in U.S. sales for refractory ascites, and the agreed-upon approach for conducting the registrational Phase 3 would lead to earlier treatment of patients and expand the market opportunity further.

The FDA has never approved any drug specifically for treating ascites. After receiving guidance from FDA in 2023 and again in 2025, the Company is finalizing the protocol design for a Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from AKI.

The BIV201 development program was initiated by LAT Pharma LLC. On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. Pursuant to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will be obligated to pay 5.0% on net sales of BIV201 to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

**Future Possible BIV201 Indications**

Based on international investigative studies of the active agent in BIV201, terlipressin, we believe our drug candidate has potential future applications in other life-threatening conditions due to liver cirrhosis that are Orphan indications including HRS-AKI and bleeding esophageal varices. Orhan drugs in this therapeutic area command premium pricing with Terlivaz costing more than $20,000 for 6 days of treatment for HRS-AKI. Securing marketing approvals for any of these new uses will require well-controlled clinical trials to satisfy the FDA and/or other countries' regulatory requirements, none of which have commenced at this time.

**The Separation**

We currently are, and at all times prior to the completion of this offering will be, a wholly owned subsidiary of BioVie, and all of our outstanding shares of common stock are owned by BioVie. As a result, we have never operated as a standalone company. Upon the completion of this offering, we expect that BioVie will own % of our outstanding common stock (or % if the underwriters' over-allotment option is exercised in full). As a result, BioVie will be able to exercise control over all matters requiring stockholder approval, including the election of our directors and approval of significant corporate transactions.

Prior to the completion of this offering, we will enter into various agreements with BioVie that provide for certain transactions and arrangements to effect the Separation and provide a framework for our relationship with BioVie following the Separation, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;· *Separation Agreement —* We and BioVie will enter into a separation agreement that will
set forth the agreements between us and BioVie regarding the principal transactions required to effect the Separation and this offering,
and other agreements governing the relationship between BioVie and us following the completion of this offering.

&nbsp;&nbsp;&nbsp;&nbsp;· *Management Services Agreement —* We and BioVie will enter into a management services agreement that will address certain services to be
performed by BioVie and certain of its executive officers and other employees to support our operations following the completion of this
offering in exchange for a quarterly fee.

&nbsp;&nbsp;&nbsp;&nbsp;· *Registration Rights Agreement —* We and BioVie will enter into a registration rights
agreement, pursuant to which we will grant BioVie and its affiliates certain registration
rights with respect to shares of our common stock owned by them.

See "Certain Relationships and Related Party Transactions—Agreements to be Entered into in Connection with the Separation" for a more detailed discussion of the agreements described above.

All agreements relating to the Separation will be made in the context of a parent-subsidiary relationship and will be entered into in the overall context of the Separation. The terms of these agreements may be more or less favorable to us than if they had been negotiated with unaffiliated third parties. See "Risk Factors—Risks Related to the Separation and Our Relationship with BioVie—We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with BioVie."

We believe that a distribution of our shares by BioVie to BioVie shareholders may be advantageous to the market for our shares by increasing liquidity, would accelerate our ability to become independent from BioVie by decreasing BioVie's ownership of our common stock, and would be beneficial for BioVie's shareholders who would have a direct opportunity to participate in our value proposition. BioVie has advised us that, following the completion of this offering and subject to the expiration of any applicable lock-up periods or other agreements we have or may have with BioVie described herein, it does not have any near-term plans to distribute our shares held by BioVie to BioVie shareholders. The decision to conduct any such distribution is at the sole discretion of BioVie's board of directors. There is no assurance that such a distribution will ever occur. Presently, it is expected that any potential distribution will be taxable to BioVie and its shareholders. We refer to any such potential distribution as a "Distribution."

See "The Separation Transaction" for further information.

**Corporate Information**

We were incorporated as a Delaware corporation on May 1, 2025. Our principal executive offices are located at 680 W Nye Lane, Suite 201, Carson City, Nevada 89703 and our telephone number is (775) 888-1664. Our principal website address is . Information contained in, or accessible through, our website is not part of, and is not incorporated into, this prospectus, and you should not rely on any such information in making an investment decision to purchase shares of our common stock.

**Implications of Being a "Controlled Company"**

Upon completion of this offering, BioVie will own more than a majority of the voting power of our common stock eligible to vote in the election of our directors. As a result, we will be a "controlled company" as defined under the corporate governance rules of and, therefore, will qualify for exemptions from certain corporate governance requirements of NYSE. Accordingly, we will not be required to have a majority of "independent directors" on the Board as defined under the rules of NYSE, and we will not be required to have a compensation committee or a nominating and corporate governance committee, in each case composed entirely of independent directors. We intend to take advantage of one or more of these exemptions following the completion of this offering and do not intend to have a compensation committee. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all the corporate governance requirements of NYSE. See "Management— Controlled Company Exemption."

**Implications of Being an Emerging Growth Company and a Smaller Reporting Company**

We are an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). As an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. These include, but are not limited to:

&nbsp;&nbsp;&nbsp;&nbsp;· being permitted to provide only two years of audited financial statements, in addition to any required
unaudited interim financial statements, with correspondingly reduced "Management's Discussion and Analysis of Financial Condition
and Results of Operations" disclosure;

&nbsp;&nbsp;&nbsp;&nbsp;· not being required to comply with the auditor attestation requirements in the assessment of our internal
control over financial reporting;

&nbsp;&nbsp;&nbsp;&nbsp;· not being required to comply with any requirement that may be adopted by the Public Company Accounting
Oversight Board regarding mandatory audit firm rotation or a supplement to the auditors' report providing additional information
about the audit and the financial statements;

&nbsp;&nbsp;&nbsp;&nbsp;· reduced disclosure obligations regarding executive compensation; and

&nbsp;&nbsp;&nbsp;&nbsp;· exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder
approval of any golden parachute payments not previously approved.

Additionally, under the JOBS Act, an emerging growth company can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We irrevocably elected to avail ourselves of this exemption from new or revised accounting standards, and, therefore, are not subject to the same new or revised accounting standards as public companies who were not emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of June 30th of that fiscal year, (ii) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have issued more than $1 billion in non-convertible debt in the prior three-year period, and (iv) the last day of the fiscal year following the fifth anniversary of the date of the first sale of equity securities in our initial public offering, or December 31, 2030.

We are also a "smaller reporting company" as defined in the Exchange Act of 1934, as amended (the "Exchange Act"). We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

**Summary Risk Factors**

Our business is subject to a number of risks which you should be aware before making an investment decision. You should carefully consider all of the information set forth in this prospectus and, in particular, should evaluate the specific factors set forth under "Risk Factors" in deciding whether to invest in our securities. These risks include but are not limited to the following:

*Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements*

&nbsp;&nbsp;&nbsp;&nbsp;· We have a limited operating history, have incurred significant operating losses since our inception and
expect to incur significant operating losses for the foreseeable future. We have a high risk of never generating revenue or becoming profitable
or, if we achieve profitability, we may not be able to sustain it.

&nbsp;&nbsp;&nbsp;&nbsp;· Even if this offering is successful, we will require
substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms,
or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.

&nbsp;&nbsp;&nbsp;&nbsp;· Raising additional capital may cause dilution to
our stockholders, including purchasers of common stock in this offering, restrict our operations or require us to relinquish rights to
our technologies or product candidates. In addition, any capital obtained by us may be obtained on terms that are unfavorable to us, our
investors, or both.

*Risks Related to Our Business and Industry*

&nbsp;&nbsp;&nbsp;&nbsp;· We rely and will continue to rely on third parties
to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines
or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize
our product candidates.

&nbsp;&nbsp;&nbsp;&nbsp;· We have no products approved for commercial sale,
have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations.

&nbsp;&nbsp;&nbsp;&nbsp;· If the FDA or comparable foreign regulatory authorities
approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not 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.

&nbsp;&nbsp;&nbsp;&nbsp;· Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many
of which are outside of our control. Consequently, we can provide no assurance that our product candidates will obtain regulatory approval,
and if we are unsuccessful or fail to timely develop new drugs, we could be forced to discontinue our operations.

&nbsp;&nbsp;&nbsp;&nbsp;· We must comply with significant and complex government regulations, compliance with which may delay or
prevent the commercialization of our product candidates, which could have a material adverse effect on our business, financial condition
and results of operations.

&nbsp;&nbsp;&nbsp;&nbsp;· We will depend upon BioVie's management, and their loss or unavailability could put us at a competitive
disadvantage which could have a material adverse effect on our business, financial condition and results of operations.

&nbsp;&nbsp;&nbsp;&nbsp;· The biotechnology and biopharmaceutical industries are characterized by rapid technological developments
and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us, which
could cause us to curtail or cease operations.

&nbsp;&nbsp;&nbsp;&nbsp;· There may be conflicts of interest among our officers, directors and stockholders.

*Risks to Our Intellectual Property*

&nbsp;&nbsp;&nbsp;&nbsp;· We may be unable to obtain or protect intellectual property rights relating to our product candidates,
which could have a material adverse effect on our business, financial condition and results of operations.

&nbsp;&nbsp;&nbsp;&nbsp;· We may not be able to protect our intellectual property rights throughout the world.

&nbsp;&nbsp;&nbsp;&nbsp;· We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated
or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.

&nbsp;&nbsp;&nbsp;&nbsp;· Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes
the market price of shares of our common stock to decline.

*Risks Related to the Separation and Our Relationship with BioVie*

&nbsp;&nbsp;&nbsp;&nbsp;· We have no recent history of operating as a standalone public company,
and our historical financial information may not necessarily reflect the results that we would have achieved as a standalone public company
or what our results may be in the future.

&nbsp;&nbsp;&nbsp;&nbsp;· We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely
affect our business, financial condition and results of operations.

&nbsp;&nbsp;&nbsp;&nbsp;· Following the completion of this offering, BioVie will continue to control the direction of our business,
and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.

&nbsp;&nbsp;&nbsp;&nbsp;· We will be a "controlled company" within the meaning of the NYSE rules and, as a result, we
will qualify for, and intend to rely on, exemptions from certain corporate governance requirements.

&nbsp;&nbsp;&nbsp;&nbsp;· We will incur significant charges in connection with the Separation and incremental costs as a standalone
public company.

&nbsp;&nbsp;&nbsp;&nbsp;· After this offering, our directors and executive officers may have actual or potential conflicts of interest
because of their current BioVie positions or their equity ownership in BioVie.

&nbsp;&nbsp;&nbsp;&nbsp;· Potential indemnification obligations to BioVie in connection with the Separation could adversely affect
our business, financial condition and results of operations.

&nbsp;&nbsp;&nbsp;&nbsp;· We may have received better terms from unaffiliated third parties than the terms we will receive in our
agreements with BioVie.

&nbsp;&nbsp;&nbsp;&nbsp;· Following this offering, we will continue to
depend on BioVie to provide us with certain services for our business.

&nbsp;&nbsp;&nbsp;&nbsp;· The assets and resources that we acquire from
BioVie in the Separation may not be sufficient for us to operate as a stand-alone company, and we may experience difficulty in separating
our assets and resources from BioVie.

*Risks Related to this Offering and Ownership of Our Common Stock*

&nbsp;&nbsp;&nbsp;&nbsp;· You will experience immediate and substantial dilution as a result of this offering.

&nbsp;&nbsp;&nbsp;&nbsp;· There is no liquid public market for our common stock and we do not know whether one will develop to provide
you with adequate liquidity. If our share price fluctuates after this offering, you could lose a significant part of your investment.

&nbsp;&nbsp;&nbsp;&nbsp;· We have no operating experience as a public company.

&nbsp;&nbsp;&nbsp;&nbsp;· The market price and trading volume of our common stock may be volatile.

&nbsp;&nbsp;&nbsp;&nbsp;· Our common stock may experience extreme stock price volatility unrelated to our actual or expected operating
performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our
common stock.

&nbsp;&nbsp;&nbsp;&nbsp;· We are an emerging growth company within the meaning of the Securities Act and may take advantage of certain
reduced reporting requirements applicable to other public companies that are not emerging growth companies.

&nbsp;&nbsp;&nbsp;&nbsp;· We are considered a smaller reporting company that is exempt from certain disclosure requirements, which
could make our stock less attractive to potential investors.

&nbsp;&nbsp;&nbsp;&nbsp;· Because we do not intend to pay any cash dividends on our common stock, our stockholders will not be able
to receive a return on their shares unless they sell them.

&nbsp;&nbsp;&nbsp;&nbsp;· The provisions of our amended and restated certificate of incorporation will require exclusive forum in
certain courts in the State of Delaware or the federal district courts of the U.S. for certain types of lawsuits may have the effect of
discouraging lawsuits against our directors and officers.

**The Offering**

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| | |
|:---|:---|
| **Common stock offered by us** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;shares. |
| **Assumed public offering price** | $ per share (which is the midpoint of the price range set forth on the cover page of this prospectus). |
| **Common stock outstanding immediately after giving effect to this offering** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;shares (or shares if the underwriters exercise their over-allotment option to purchase additional shares in full). |
| **Common stock to be held by BioVie immediately after giving effect to this offering** | Upon completion of this offering, BioVie will own approximately % of our outstanding common stock (or approximately % if the underwriters exercise their over-allotment option to purchase additional shares in full). |
| **Option to purchase additional shares** | We have granted the underwriters an option to purchase up to additional shares of common stock from us. The underwriters can exercise this option at any time within 45 days from the closing of this offering solely to cover over-allotments. |
| **Use of proceeds** | We estimate the net proceeds from this offering to us will be approximately $ million, or approximately $ million if the underwriters exercise their over-allotment option to purchase additional shares in full, assuming an initial public offering price of $ per share (which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.<br>We intend to use the net proceeds from this offering to commercialize our investigational drug candidate BIV201 (continuous infusion terlipressin) and for other general corporate purposes.<br>See the section of this prospectus titled "Use of Proceeds." |
| **Representative's Warrants** | Upon the closing of this offering, we have agreed to issue to the Representative (as defined below) warrants (the "Representative Warrants") to purchase shares of our common stock. The Representative's Warrants will be exercisable at an exercise price of $(representing 125% of the public offering price of $ per share. The Representative's Warrants are immediately exercisable and will expire on the four- and one-half year anniversary of the date that is 180 days from the commencement of sales of the securities issued in this offering. See "Underwriting" for more information. |
| **Lock-up agreements**<br>| Each of our directors and executive officers have agreed, without the prior written consent of the Representative, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of six months after the closing of this offering, subject to certain exceptions. We and any of our successors have also agreed, without the prior written consent of the Representative, among other things, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of four months after the closing of this offering, subject to certain exceptions. See "Underwriting" for more information. |

---

---

| | |
|:---|:---|
| **Controlled Company** | Upon completion of this offering, BioVie will own more than a majority of the voting power of our common stock eligible to vote in the election of our directors. As a result, we will be a "controlled company" as defined under the corporate governance rules of and, therefore, will qualify for exemptions from certain corporate governance requirements of NYSE. Accordingly, we will not be required to have a majority of "independent directors" on the Board as defined under the rules of NYSE and we will not be required to have a compensation committee or a nominating and corporate governance committee, in each case composed entirely of independent directors. We intend to take advantage of one or more of these exemptions following the completion of this offering and do not intend to have a compensation committee. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all the corporate governance requirements of NYSE. See "Management—Controlled Company Exemption."<br>As long as BioVie beneficially owns a majority of the voting power of our outstanding shares of common stock, BioVie will generally be able to control the outcome of matters submitted to our stockholders for approval, including the election of directors, without the approval of our other stockholders. See "Risk Factors—Risks Related to the Separation and Our Relationship with BioVie—Following the completion of this offering, BioVie will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions."  |
| **Risk factors**<br>| Investing in our common stock involves a high degree of risk. See the section titled "Risk Factors" and other information included in this prospectus for a discussion of factors you should consider before investing in our common stock. |
| **Proposed listing** | We intend to apply to list to list our common stock on NYSE under the symbol " ". |

---

Unless otherwise indicated, the information presented in this prospectus:

&nbsp;&nbsp;&nbsp;&nbsp;· gives effect to the transactions described under "The Separation Transaction";

&nbsp;&nbsp;&nbsp;&nbsp;· gives effect to our amended and restated certificate of incorporation and our amended and restated
bylaws, which will be in effect immediately prior to the completion of this offering and forms of which have been filed as exhibits
to the registration statement of which this prospectus is a part; and

&nbsp;&nbsp;&nbsp;&nbsp;· assumes no exercise of the underwriters' over-allotment option to purchase additional shares.

**Summary Historical Financial Information**

The following table sets forth our summary historical financial information. You should read the summary historical financial information in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations*,*" our audited carve-out financial statements and related notes. We have derived the summary historical financial information as of and for the years ended June 30, 2025 and 2024 from our audited carve-out financial statements included elsewhere in this prospectus.

Our historical carve-out financial statements may not be reflective of our financial position, results of operations and cash flows had we operated as a stand-alone public company during all periods presented. Prior to June 30, 2025, we operated as part of BioVie and not as a separate stand-alone entity. Our financial statements prior to June 30, 2025 have been prepared on a "carve-out" basis from the financial statements of BioVie to represent our financial position and performance as if we had existed on a stand-alone basis during each of the fiscal years presented in the financial statements. Our historical carve-out financial statements were prepared on a standalone basis in accordance with GAAP.

Our historical carve-out financial statements include the assets, liabilities, and operating expenses based on our legal entity structure as well as direct and indirect costs that are attributable to our operations. Indirect costs are the costs of support functions that are partially provided on a centralized basis by BioVie, which include finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance and other professional services. Indirect costs have been allocated to us for the purposes of preparing the carve-out financial statements based on a specific identification basis or, when specific identification is not practicable, a proportional cost allocation method, primarily based on headcount or other allocation methodologies that are considered to be a reasonable reflection of the utilization of services provided or benefit received by us during the periods presented, depending on the nature of the services received.

---

| | | |
|:---|:---|:---|
|  | **June 30,** | **June 30,** |
|  | **2025** | **2024** |
| Cash | $- | $- |
| Current Assets | $493075 | $62810 |
| Goodwill and Intangibles | $524052 | $753429 |
| Total Assets | $1017127 | $816239 |
| Total Liabilities | $127217 | $12845 |
| Parent's net investment | $889910 | $803394 |
| Operating expenses | $1223839 | $1939727 |
| Net loss | $(1223839) | $(1939727) |

---

**RISK FACTORS**

*You should carefully consider the risks described below and all other information contained in this prospectus before making an investment decision. If any of the following risks actually occur, individually or in the aggregate, they could have a material adverse effect on our business, financial condition and results of operations. In that event, the trading price of our securities could decline, and you may lose all or part of your investment. This prospectus also contains forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including, but not limited to, the risks described below and elsewhere in this prospectus. See "Forward Looking Statements."*

**Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements**

***We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future. We have a high risk of never generating revenue or becoming profitable or, if we achieve profitability, we may not be able to sustain it.***

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stage biopharmaceutical company with a relatively limited operating history upon which you can evaluate our business and prospects. We were incorporated in May 2025 and have not generated revenue. Therefore, there is limited historical financial or operational information upon which to evaluate our performance. Our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. Many if not most companies in our industry at our stage of development never become profitable and are acquired or go out of business before successfully developing any product that generates revenue from commercial sales or enables profitability.

We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future as we continue the clinical development of, seek regulatory approval for and potentially commercialize BIV201 and any future product candidates, as well as operate as a public company. The amount of future losses and when, if ever, we will become profitable are uncertain. We do not have any products that have generated any revenues from commercial sales and do not expect to generate revenues from the commercial sale of products in the near future, if ever. If we are unable to successfully develop, obtain requisite approval for and commercialize BIV201 or any future product candidates, we may never generate revenue. Our ability to generate revenue and achieve profitability will depend on, among other things, successful completion of the development of our product candidates; obtaining necessary regulatory approvals from the FDA and international regulatory agencies; establishing manufacturing, sales, and marketing arrangements with third parties; obtaining adequate reimbursement by third-party payers; and raising sufficient funds to finance our activities. If we are unsuccessful at some or all of these undertakings, they could have a material adverse effect on our business, financial condition, and results of operations.

To become and remain profitable, we must succeed in developing, obtaining regulatory approvals for, and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing human clinical trials of BIV201 and any future product candidates, acquiring or developing additional product candidates, obtaining regulatory approval for BIV201 and any future product candidates, and manufacturing, marketing, and selling any products for which we may obtain regulatory approval. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never generate revenue that is significant enough to achieve profitability. In addition, we have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry. Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable may have an adverse effect on the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product candidates, achieve our strategic objectives or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

**Even if this offering is successful, we will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our development programs, commercialization efforts, or other operations.**

The development of biopharmaceutical product candidates, including conducting preclinical studies and clinical trials, is a very time-consuming, capital-intensive and uncertain process. Our operations have consumed substantial amounts of cash since inception. We expect our expenses to substantially increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned clinical trials of BIV201 and potentially seek regulatory approval for BIV201 and any future product candidates we may develop. In addition, if we are able to progress BIV201 through development and commercialization, we expect to be required to make milestone and royalty payments pursuant to various license or collaboration agreements with third parties. If we obtain regulatory approval for BIV201 or any future product candidates, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution. Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of capital necessary to successfully complete the development and commercialization of BIV201 or any future product candidates. Furthermore, following the completion of this offering, we expect to incur additional costs associated with operating as a public company.

We believe the amount of net proceeds from this offering will be sufficient to fund BIV201 through Phase 3 clinical development. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. We will need to raise substantial additional funds to complete registration trials before we can expect to commercialize any products, if approved. We may satisfy our future cash needs through the sale of equity securities, debt financings, working capital lines of credit, corporate collaborations or license agreements, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources. The amount and timing of our actual expenditures will depend upon numerous factors, including the status and results of our clinical trials.

Our ability to raise additional funds may be adversely impacted by global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, or even cease operations. We expect to finance our cash needs through public or private equity or debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop BIV201 or any future product candidates.

Our future capital requirements will depend on many factors, including without limitation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· the initiation, type, number, scope, progress, expansions, results, costs, and timing of clinical trials
and preclinical studies of BIV201 and any future product candidates we may choose to pursue, including the costs of modification to clinical
development plans (including an increase in the number, size, duration and/or complexity of a trial) based on feedback that we may receive
from regulatory authorities and any third-party products used as combination agents in our clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· the costs and timing of manufacturing for BIV201 or any future product candidate, including commercial
manufacturing at sufficient scale and encountering higher than expected costs to manufacture our current and future active pharmaceutical
ingredients, if any product candidate is approved, including as a result of inflation, any supply chain issues or component shortages;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· slower than expected progress in developing BIV201 or a future product candidate, including without limitation,
additional costs caused by such program delays;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· the costs, timing and outcome of regulatory meetings and reviews of BIV201 and developing certain formulations
of BIV201 or any future product candidates in any jurisdictions in which we or our current or any future collaborators may seek approval
for BIV201 or any future product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as
a public company, including enhanced internal control over financial reporting;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· the timing and payment of milestone, royalty or other payments we must make pursuant to our existing and
potential future license or collaboration agreements with third parties;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· the costs and timing of establishing or securing sales and marketing capabilities and commercial compliance
programs if BIV201 or any future product candidate is approved;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· higher than expected personnel, consulting or other costs, such as adding personnel or industry expert
consultants or pursuing the licensing/acquisition of additional assets;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· higher than expected costs to obtain, maintain, enforce and protect our patents and other intellectual
property and proprietary rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party
payors and adequate market share and revenue for any approved products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· our ability and strategic decision to develop future product candidates other than BIV201, and the timing
of such development, if any;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· patient willingness to pay out-of-pocket for any approved products in the
absence of coverage and/or adequate reimbursement from third-party payors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements;
and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· our ability to raise sufficient funds when and if required.

Conducting clinical trials and preclinical studies and potentially identifying future product candidates is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize BIV201 or any future product candidates. If approved, BIV201 and any future product candidates may not achieve commercial success. We expect that our commercial revenue, if any, will initially be derived from sales of BIV201, which we do not expect to be commercially available for several years, if at all. Commercial success in the United States may depend upon acceptance and coverage by federal healthcare program and third-party payors, and it can be time consuming and costly to demonstrate that any of our products should be covered.

Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability, market-wide liquidity shortages, geopolitical events, or otherwise.

**Raising additional capital may cause dilution to our stockholders, including purchasers of common stock in this offering, restrict our operations or require us to relinquish rights to our technologies or product candidates. In addition, any capital obtained by us may be obtained on terms that are unfavorable to us, our investors, or both.**

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements. We do not have any committed external source of funds. If we attempt to raise additional financing, there can be no assurance that we will be able to secure such additional financing in sufficient quantities or at all. We may be unable to raise additional capital for reasons including, without limitation, our operational and/or financial performance, investor confidence in us and the biopharmaceutical industry, credit availability from banks and other financial institutions, the status of current projects, and our prospects for obtaining any necessary regulatory approvals. Potential investors' capital investments may have shifted to other opportunities with perceived greater returns and/or lower risk thereby reducing capital available to us, if available at all.

In addition, any additional financing might not be available, and even if available, may not be available on terms favorable to us or our then-existing investors. We may seek to raise funds through public or private equity offerings, debt financings, corporate collaboration or licensing arrangements, mergers, acquisitions, sales of intellectual property, or other financing vehicles or arrangements. To the extent that we raise additional capital by issuing equity securities or other securities (including convertible debt), our then-existing investors will experience dilution, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. If we raise funds through debt financings or bank loans, we may become subject to restrictive covenants, such as incurring additional debt, making capital expenditures or declaring dividends. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan. Moreover, if we raise funds through debt financings or bank loans, our assets may be pledged as collateral for the debt, and the interests of our then-existing investors would be subordinated to the debt holders or banks. In addition, our use of and ability to exploit assets pledged as collateral for debt or loans may be restricted or forfeited. To the extent that we raise additional funds through collaboration or licensing arrangements, we may be required to relinquish valuable rights to our future revenue streams, product candidates, research programs, intellectual property or proprietary technology, or grant licenses on terms that are not favorable to us and/or that may reduce the value of our common stock. If we are not able to raise needed funding when needed under acceptable terms or at all, then we would be required to delay, limit, reduce, curtail, abandon or terminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we might otherwise prefer to develop and market ourselves, or on less favorable terms than we would otherwise choose, or sell assets, or cease operations entirely.

**Risks Related to Our Business and Industry**

***We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.***

We depend, and will continue to depend, on third parties, including, but not limited to, contract research organizations ("CROs"), clinical trial sites and clinical trial principal investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials, including those for our drug candidate BIV201. We rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities. Nevertheless, we retain ultimate responsibility for ensuring that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and regulations, and our reliance on third parties does not relieve the Company of our regulatory responsibilities. We and these third parties are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct of clinical trials on product candidates in clinical development. Regulatory authorities enforce cGCPs through periodic inspections and for-cause inspections of clinical trial principal investigators and trial sites. If, due to the failure of either the Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA's IND requirements, other applicable regulatory requirements, or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical trials to support our marketing applications, which would delay the regulatory approval process.

Although we design the clinical trials for our product candidates, our CROs are tasked with facilitating and monitoring these trials. As a result, many aspects of our clinical development programs, including site and investigator selection, and the conduct, timing, and monitoring of the study, is outside our direct control, either partially or in whole. Our reliance on third parties to conduct clinical trials also results in less direct control over the collection, management, and quality of data developed through clinical trials than would be the case if we were relying entirely upon our own employees. Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Our business may be impacted if any of these third parties violates applicable federal, state, or foreign laws and/or regulations, including but not limited to FDA's IND regulations, cGCPs, fraud and abuse or false claims laws, healthcare privacy and data security laws, or provide the Company or government agencies with inaccurate, misleading, or incomplete data.

***Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.***

Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons. Pre-clinical study results may show the product candidate to be less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic side effects. Product candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies; length of time to achieve study endpoints; additional time requirements for data analysis; IND and later new drug application preparation; discussions with the FDA; an FDA request for additional pre-clinical or clinical data; unexpected safety or manufacturing issues; manufacturing costs; pricing or reimbursement issues; clinical sites deviating from the trial protocol, committing scientific misconduct, or other violations of regulatory requirements - which can render data from those sites unusable in support of regulatory approval; or other factors that make the product not economical. Proprietary rights of others and their competing products and technologies may also prevent the product from being commercialized.

Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next and may be difficult to predict. There can be no assurance that any of our products will develop successfully, and the failure to develop our products could have a material adverse effect on our business, financial condition and results of operations, which could cause you to lose all of your investment.

***We may be subject to similar or other litigation in the future, all of which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes, which could have a material adverse effect on our business, financial condition and results of operations and negatively affect the price of our common stock.***

We may in the future become, subject to various legal proceedings and claims that arise in or outside the ordinary course of business. It is possible that lawsuits will be filed, or allegations received from stockholders, with respect to matters related to our business and also naming us and/or our officers and directors as defendants. Such lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of such lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense of the pending lawsuit and any additional lawsuits, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with such lawsuits. We currently are not able to estimate the possible cost to us from this matter, as the pending lawsuit is currently at an early stage, and we cannot be certain how long it may take to resolve the pending lawsuit or the possible amount of any damages that we may be required to pay. Monitoring, initiating and defending against legal actions is time-consuming for our management, is likely to be expensive and may detract from our ability to fully focus our internal resources on our business activities. We could be forced to expend significant resources in the settlement or defense of the pending lawsuit and any potential future lawsuits, and we may not prevail in such lawsuits.

Our insurance coverage may be insufficient, and our assets may be insufficient to cover any amounts that exceed our insurance coverage, and we may have to pay damage awards or otherwise may enter into a settlement arrangement in connection with such claim. A decision adverse to our interests in the pending lawsuit, or in similar or related litigation, could result in the payment of substantial damages, or possibly fines, and could have a material adverse effect on our business, financial condition and results of operations. We have not established any reserve for any potential liability relating to the pending lawsuit or any potential future lawsuits. Any such payments or settlement arrangements in current or future litigation could have a material adverse effect on our business, financial condition and results of operation. In addition, such lawsuits may make it more difficult to finance our operations and affect our ability to make payments for damages.

***We have no products approved for commercial sale, have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations.***

We have no products approved for commercial sale and, to date, we have not generated any revenue. Our ability to generate revenue depends heavily on (a) successful completion of one or more development programs demonstrating in human clinical trials that BIV201, our product candidate, is safe and effective; (b) our ability to seek and obtain regulatory approvals, including, without limitation, with respect to the indications we are seeking; (c) successful commercialization of our product candidate; and (d) market acceptance of our product. There are no assurances that we will achieve any of the forgoing objectives. Furthermore, our product candidate is in the development stage and has not been fully evaluated in human clinical trials. If we do not successfully develop and commercialize our product candidate, we will not achieve revenues or profitability in the foreseeable future, if at all. If we are unable to generate revenues or achieve profitability, we may be unable to continue our operations.

***We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment.***

We are a development stage biopharmaceutical company with a potential therapy that has not been fully evaluated in clinical trials, and our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited to the absence of an operating history, the lack of commercialized products, insufficient capital, expected substantial and continual losses for the foreseeable future, limited experience in dealing with regulatory issues, the lack of manufacturing experience and limited marketing experience, possible reliance on third parties for the development and commercialization of our proposed products, a competitive environment characterized by numerous, well-established and well capitalized competitors and reliance on key personnel.

Since inception, we have not established any revenues or operations that would provide financial stability in the long term, and there can be no assurance that we will realize our plans on our projected timetable in order to reach sustainable or profitable operations.

Investors are subject to all the risks incident to the creation and development of a new business and each investor should be prepared to withstand a complete loss of his, her or its investment. Furthermore, the accompanying financial statements have been prepared assuming that we will continue as a going concern. We have not emerged from the development stage and may be unable to raise further equity. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements included elsewhere in this prospectus do not include any adjustments that might result from the outcome of this uncertainty.

Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our Company. Our ability to become profitable depends primarily on our ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our research and development ("R&D") efforts, including the timing and cost of clinical trials; and our ability to enter into favorable alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution.

Even if we successfully develop and market BIV201, we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations and cause you to lose all of your investment.

***If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not 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.***

Once an NDA is approved, the product covered thereby becomes a "reference listed drug" ("RLD"), in the FDA's publication, "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the Orange Book. Other manufacturers may seek approval of generic versions of reference listed drugs through submission of abbreviated new drug applications ("ANDAs") in the United States. In support of an ANDA, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to the same extent as the RLD. Generic products may be significantly less costly to bring to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower prices. Moreover, generic versions of RLDs are often automatically substituted for the RLD by pharmacies when dispensing a prescription written for the RLD. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

The FDA may not approve an ANDA for a generic product until any applicable period of non-patent exclusivity for the reference listed drug has expired. The FDCA provides a period of five years of non-patent exclusivity for a new drug containing a new chemical entity ("NCE"). An NCE is an active ingredient that has not previously been approved by FDA in any other NDA. BIV201 does not qualify for NCE because FDA approved an NDA in 2022 that contained a powdered form of terlipressin as the active ingredient. In cases where a five-year NCE exclusivity has been granted, an ANDA may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug. If an ANDA is submitted to FDA with a Paragraph IV Certification, the generic applicant must also provide a "Paragraph IV Notification" to the holder of the NDA for the RLD and to the owner of the listed patent(s) being challenged by the ANDA applicant, providing a detailed written statement of the basis for the ANDA applicant's position that the relevant patent(s) is invalid or would not be infringed. If the patent owner brings a patent infringement lawsuit against the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA will be automatically stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application was filed between 4 years and 5 years after the NDA approval. Any such stay will be terminated earlier if the court rules that the patent is invalid or would not be infringed.

Competition that our products may face from generic versions of our products could have a material adverse effect on our business, financial condition, results of operations and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

***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, which may reduce the length of time that we can prevent competitors from selling generic versions of BIV201.***

We have obtained Orphan Drug Designation for BIV201 (terlipressin) in the U.S. for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites (due to all etiologies except cancer) on September 8, 2016. Under the Orphan Drug Act, the FDA may designate a product as an Orphan Drug if it is a drug intended to treat a rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the U.S. In the European Union ("EU"), Orphan Drug designation may be granted to drugs intended to treat, diagnose or prevent a life-threatening or chronically debilitating disease having a prevalence of no more than five in 10,000 people in the EU, and which meet other specified criteria. The company that first obtains FDA approval for a designated Orphan Drug for the associated rare disease may receive a seven-year period of marketing exclusivity during which time FDA may not approve another application for the same drug for the same orphan disease or condition, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care or in instances of drug supply issues. Orphan Drug exclusivity does not prevent FDA approval of another application for the same drug for a different disease or condition, or of an application for a different drug for the same rare disease or condition. Orphan Drug exclusive marketing rights may be lost under several circumstances, including a later determination by the FDA that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the EU with a ten-year period of market exclusivity.

Even though BioVie has obtained two Orphan Drug Designations for its lead product candidate, BIV201 (terlipressin), for treatment of ascites and for treatment of hepatorenal syndrome, and may seek other Orphan Drug Designations for BIV201, there is no assurance that we will be the first to obtain marketing approval for any particular rare indication or be able to demonstrate clinical superiority. In 2004, Mallinckrodt Hospital Products IP Limited received Orphan Drug designation for its product candidate, Terlivaz (terlipressin) for injection for the treatment of hepatorenal syndrome. In September 2022, FDA approved the product to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. As the first FDA-approved medication for hepatorenal syndrome, Mallinckrodt's product was granted a seven-year period of marketing exclusivity. Consequently, FDA may not be able to approve an application for BIV201 (terlipressin) for hepatorenal syndrome unless we generate evidence of BIV201 being clinical superior to Terlivaz by means of greater effectiveness, greater safety, or providing a major contribution to patient care.

Even though we have obtained Orphan Drug Designations for our lead product candidate, or even if we obtain Orphan Drug Designation for other potential product candidates, such designation may not effectively protect us from competition because different drugs can be approved for the same condition and the same drug can be approved for different conditions and potentially used off-label in the Orphan indication. Even after an Orphan Drug is approved, as noted above, the FDA can subsequently approve another competing drug with the same active ingredient for the same condition for several reasons, including, if the FDA concludes that the later drug is clinically superior due to being safer or more effective or because it makes a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

In addition, other companies have received Orphan Drug designations for terlipressin for indications other than hepatorenal syndrome. PharmaIN Corporation received Orphan Drug Designation in 2012 for PGC-C12E-terlipressin for treatment of ascites due to all etiologies except cancer. In addition, Ferring Pharmaceuticals Inc. received Orphan Drug Designation in 1986 for terlipressin for the treatment of bleeding esophageal varices. If one of those or any other company with Orphan Drug Designation for the same drug as ours for the same proposed disease or condition receives FDA approval and Orphan Drug exclusivity before our product is approved, approval of our drug(s) for the orphan indication may be blocked for seven years by the other company's Orphan exclusivity and they may obtain a competitive advantage even after the exclusivity period expires associated with being the first to market.

***We will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms, which could have a material adverse effect on our business, financial condition and results of operations.***

Developing biopharmaceutical products, including conducting pre-clinical studies and clinical trials and establishing manufacturing capabilities, requires substantial funding. Additional financing will be required to fund the research and development of our product candidates. We have not generated any product revenues, and do not expect to generate any revenues until, and only if, we develop and receive approval to sell our product candidates from the FDA and other regulatory authorities for our product candidates.

We may not have the resources to complete the development and commercialization of any of our proposed product candidates. We will require additional financing to further the clinical development of our product candidates. In the event that we cannot obtain the required financing, we will be unable to complete the development necessary to file an NDA with the FDA for BIV201. This will delay or require termination of research and development programs, preclinical studies and clinical trials, material characterization studies, regulatory processes, the establishment of our own laboratory or a search for third party marketing partners to market our products for us, which could have a material adverse effect on our business, financial condition and results of operations.

The amount of capital we may need will depend on many factors, including the progress, timing and scope of our research and development programs, the progress, timing and scope of our preclinical studies and clinical trials, the time and cost necessary to obtain regulatory approvals, the time and cost necessary to establish our own marketing capabilities or to seek marketing partners, the time and cost necessary to respond to technological and market developments, changes made or new developments in our existing collaborative, licensing and other commercial relationships, and new collaborative, licensing and other commercial relationships that we may establish.

Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings, or corporate collaboration and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts. In addition, we could be forced to discontinue product development and reduce or forego attractive business opportunities. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

Our fixed expenses, such as rent and other contractual commitments, will likely increase in the future, as we may enter into leases for new facilities and capital equipment and/or enter into additional licenses and collaborative agreements. Therefore, if we fail to raise substantial additional capital to fund these expenses, we could be forced to cease operations, which could cause you to lose all of your investment.

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

We have never successfully developed a new drug and brought it to market. Our management and clinical teams have experience in drug development, but they may not be able to successfully develop any drugs. Our ability to achieve revenues and profitability in our business will depend on, among other things, our ability to develop products internally or to obtain rights to them from others on favorable terms; complete laboratory testing and human studies; obtain and maintain necessary intellectual property rights to our products; successfully complete regulatory review to obtain requisite governmental agency approvals; enter into arrangements with third parties to manufacture our products on our behalf; and enter into arrangements with third parties to provide sales and marketing functions. If we are unable to achieve these objectives, we will be forced to cease operations and you will lose all of your investment.

***Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control. Consequently, we can provide no assurance that our product candidates will obtain regulatory approval, and if we are unsuccessful or fail to timely develop new drugs, we could be forced to discontinue our operations.***

Development and extensive testing will be required to determine the technical feasibility and commercial viability of BIV201. Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs on a timely basis. Drugs that we may develop are not likely to be commercially available, at a minimum, for several years, if ever. Our drug product candidate, BIV201, was cleared by the FDA to undergo testing in a mid-stage (Phase 2b) clinical trial for the treatment of refractory ascites due to cirrhosis. On June 24, 2021, we announced that the first patient has been enrolled in this study. In March 2023, the open-label trial was stopped after 15 of the planned 30 patients were enrolled, and an evaluation of those completed patients assessed. Encouraging data from these patients appeared to show that treatment with BIV201 plus the current standard of care resulted in a reduction in ascites fluid accumulation during treatment versus pre-treatment. In June 2023, BioVie requested and subsequently received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. Over three years since the initial enrollment of this clinical trial, BioVie is continuing to finalize protocol designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

Any delay or further delay in the development, introduction or marketing of our product candidates could result either in such drugs being marketed at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term nature of our projects and other risk factors described elsewhere in this document, we may not be able to successfully complete the development or marketing of any drugs, which could cause us to cease operations.

From time to time, the FDA may have feedback on our clinical trial designs, including for example certain of our endpoints and outcome measures. As a result, we may consider revisions to our protocols which may delay progress in implementing our trials. We may fail to successfully develop and commercialize our product candidate(s) if it is found to be unsafe or ineffective in clinical trials; does not receive necessary approval from the FDA or foreign regulatory agencies; fails to conform to a changing standard of care for the disease it seeks to treat; or is less effective or more expensive than current or alternative treatment methods.

Drug development failure can occur at any stage of clinical trials and as a result of many factors, there can be no assurance that we or our collaborators will reach our anticipated clinical targets. Even if the trials are successfully completed, clinical data are often susceptible to varying interpretations and analyses, and we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. We cannot guarantee that the FDA or comparable foreign regulatory authorities will view our product candidates as having efficacy even if positive results are observed in clinical trials. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols, and the rate of dropout among clinical trial participants. If the results of our ongoing or future clinical trials are inconclusive with respect to the efficacy of our product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates, we may be delayed in obtaining marketing approval, if at all. Additionally, any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications. We also do not know what the long-term effects of exposure to our product candidates will be. Furthermore, our product candidates may be used in combination with other treatments and there can be no assurance that such use will not lead to unique or unexpected safety issues.

Failure to complete clinical trials or to prove that our product candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations, which could cause you to lose all of your investment.

***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.***

Because we have limited human capital and financial resources, we focus on research programs and drug candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities. Our spending on current and future research and development programs and drug candidates for specific indications may not yield any commercially viable drugs. If we do not accurately evaluate the commercial potential or target market for a particular drug candidate, we may relinquish valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such drug candidate.

At any time and for any reason, we may determine that one or more of our discovery programs or preclinical or clinical drug candidates or programs does not have sufficient potential to warrant the allocation of resources toward such program or drug candidate. Accordingly, we may choose not to develop a potential drug candidate or elect to suspend, deprioritize or terminate one or more of our discovery programs or preclinical or clinical drug candidates or programs. When we suspend, deprioritize or terminate a program or drug candidate in which we have invested significant resources, we will have expended resources on a program that will not provide a full return on our investment and may have missed the opportunity to have allocated those resources to potentially more productive uses, including existing or future programs or drug candidates.

***We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a material adverse effect on our business, financial condition and results of operations.***

We have never manufactured products in the highly regulated environment of pharmaceutical manufacturing, and our team has limited experience in the manufacture of drug therapies. There are numerous regulations and requirements that must be maintained to obtain licensure and permitting required prior to the commencement of manufacturing, as well as additional requirements to continue manufacturing pharmaceutical products. We currently do not own or lease facilities that could be used to manufacture any products that might be developed by us and have contracted with an experienced Contract Manufacturing Organization ("CMO") to perform the manufacturing of BIV201. In addition, we do not have the resources at this time to acquire or lease suitable facilities. If we or our CMO fail to comply with regulations, to obtain the necessary licenses and knowhow or to obtain the requisite financing in order to comply with all applicable regulations and to own or lease the required facilities in order to manufacture our products, we could be forced to cease operations, which would cause you to lose all of your investment.

In addition, the FDA and other regulatory authorities require that product candidates and drug products be manufactured according to the FDA's current Good Manufacturing Practices regulations ("cGMP"). Any failure by our third-party manufacturers to comply with cGMP could lead to a shortage of BIV201. In addition, such failure could be the basis for action by the FDA to withdraw approval, if granted to us, and for other regulatory enforcement action, including Warning Letters, product seizure, injunction or other civil or criminal penalties.

BIV201 and any other product candidates that we develop may have to compete with other products and product candidates for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. If we need to find another source of drug substance or drug product manufacturing for BIV201, we may not be able to identify, or reach agreement with, commercial-scale manufacturers on commercially reasonably terms, or at all. If we are unable to do so, we will need to develop our own commercial-scale manufacturing capabilities, which would: impact commercialization of BIV201 in the U.S. and other countries where it may be approved; require a capital investment by us that could be quite costly; and increase our operating expenses.

If our existing third-party manufacturers, or the third parties that we engage in the future to manufacture a product for commercial sale or for our clinical trials, should cease to continue to do so for any reason, we likely would experience significant delays in obtaining sufficient quantities of product for us to meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers. If for any reason we are unable to obtain adequate supplies of BIV201 or any other product candidate that we develop, or the drug substances used to manufacture it, it will be more difficult for us to compete effectively, generate revenue, and further develop our products. In addition, if we are unable to assure a sufficient quantity of the drug for patients with rare diseases or conditions, we may lose any Orphan Drug exclusivity to which the product otherwise would be entitled.

***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 material adverse effect on our business, financial condition and results of operations.***

We are an early-stage development company with limited resources. Even if we had products available for sale, which we currently do not, we have not secured sales and marketing staff at this early stage of operations to sell products. We cannot generate sales without sales or marketing staff and must rely on others to provide any sales or marketing services until such personnel are secured, if ever. If we fail to hire and retain the requisite expertise in order to market and sell our products or fail to raise sufficient capital in order to afford to pay such sales or marketing staff, then we could be forced to cease operations, and you could lose all of your investment.

***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, which could have a material adverse effect on our business, financial condition and results of operations.***

If we were to successfully develop approvable drugs, before we can begin selling these drugs, we must obtain regulatory approval of our manufacturing facility and process or the manufacturing facility and process of the third party or parties with whom we may outsource our manufacturing activities. In addition, the manufacture of our products must comply with the FDA's current Good Manufacturing Practices regulations (cGMPs) The cGMP regulations govern quality control and documentation policies and procedures. Our manufacturing facilities, if any in the future, and the manufacturing facilities of our third-party manufacturers will be continually subject to inspection by the FDA and other state, local and foreign regulatory authorities, before and after product approval. We cannot guarantee that we, or any potential third-party manufacturer of our products, will be able to comply with the cGMP regulations or other applicable manufacturing regulations. The failure to comply with all necessary regulations could have a material adverse effect on our business, financial condition and results of operations and could force us to cease operations and you could lose all of your investment.

***We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates, which could have a material adverse effect on our business, financial condition and results of operations.***

The R&D, manufacture and marketing of drug product candidates are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries. These national agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including testing in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and promotion of the product that we are developing. Noncompliance with applicable requirements can result in various adverse consequences, including approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations, revocation of approvals previously granted, warning letters, fines, criminal prosecution, recalls or seizures of products, injunctions against shipping drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts.

The process of obtaining FDA approval is costly and time consuming. Current FDA requirements for a new human drug or biological product to be marketed in the United States include, among other things: (a) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain preliminary information on the product's safety; (b) filing with the FDA of an IND application to conduct human clinical trials for drugs or biologics; (c) the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy of the product for its recommended use; and (d) filing by a company and acceptance and approval by the FDA of a NDA for a drug product or a BLA for a biological product to allow commercial distribution of the drug or biologic. A delay in one or more of the procedural steps outlined above could be harmful to us in terms of getting our product candidates through clinical testing and to market, which could have a material adverse effect on our business, financial condition and results of operations.

The FDA, clinical investigators, Data Safety Monitoring Boards, and IRBs review the ongoing conduct of, and emerging safety information from, clinical trials and may order the temporary or permanent discontinuation of clinical trials at any time if it believes the product candidate exposes clinical subjects to an unacceptable health risk. Investigational drugs used in clinical studies must be produced in compliance with cGMP rules pursuant to FDA regulations.

Development, approval, and sales outside the United States of products that we develop will also be subject to regulatory requirements governing human clinical trials and marketing for drugs and biological products and devices. The requirements vary widely from country to country, but typically the registration and approval process takes several years and requires significant resources.

If we experience delays or discontinuations of our clinical trials by the FDA or comparable authorities in other countries, or if we fail to obtain registration or other approvals of our products or devices then we could be forced to cease our operations and you will lose all of your investment.

Even if we are successful in developing BIV201, our product candidate, we have limited experience in conducting or supervising clinical trials that must be performed to obtain data to submit in concert with applications for approval by the FDA. The regulatory process to obtain approval for drugs for commercial sale involves numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA. In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such trials to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be approved for sale which could have a material adverse effect on our business, financial condition and results of operations.

***We will depend upon BioVie's management, and their loss or unavailability could put us at a competitive disadvantage which could have a material adverse effect on our business, financial condition and results of operations.***

Pursuant to the terms of the management services agreement, BioVie will provide us with the services of certain of its executive officers and other employees to support our operations following the completion of this offering in exchange for a quarterly fee. All salaries and compensation to such persons will be paid by BioVie. We will have no executive officers or other employees directly employed by us upon the consummation of this offering. As a result, we will depend upon the efforts and abilities of BioVie's executive officers and other employees. The loss or unavailability of the services of any of these individuals for any significant period of time could have a material adverse effect on our business, financial condition and results of operations which may cause you to lose all of your investment. We have not obtained, do not own, nor are we the beneficiary of key-person life insurance.

***We may not be able to attract and retain highly skilled personnel, which could have a material adverse effect on our business, financial condition and results of operations.***

Our ability to attract and retain highly skilled personnel is critical to our operations and expansion. We face competition for these types of personnel from other pharmaceutical companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than us. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or at all. If we are not successful in attracting and retaining these personnel, this could cause a material adverse effect on our business, financial condition and results of operations.

***The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us, which could cause us to curtail or cease operations.***

The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain government approval for testing, manufacturing and marketing.

We compete with biopharmaceutical firms in the United States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations. Many biopharmaceutical companies have focused their development efforts in the human therapeutics area. Many major pharmaceutical companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies. These companies, as well as academic institutions, government agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital to us.

Although there are not currently any drug therapies approved by the FDA specifically for the treatment of ascites due to liver cirrhosis, we still face significant competitive and market risk. Other companies are developing therapies for severe complications of advanced liver cirrhosis, which may in the future be developed for the treatment of ascites, and these therapies could compete indirectly or directly with our product candidate. Sequahana Medical, for instance, announced in December 2024 that FDA had approved the company's active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis. There may be other competitive development programs of which we are unaware. Even if our product candidate is ultimately approved by the FDA, there is no guarantee that once it is on the market doctors will adopt them in favor of current ascites treatment procedures such as diuretics and paracentesis with respect to BIV201. These competitive and market risks could have a material adverse effect on our business, financial condition and results of operations which may cause you to lose all of your investment.

Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing of the market introduction of some of our potential product candidate or of competitors' products may be an important competitive factor. Accordingly, the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply commercial quantities to market are important competitive factors. We expect that competition among drugs approved for sale will be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.

The successful development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon the development of our product candidates.

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

Certain of our executive officers and directors and their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons. Neither we nor any of our stockholders will have any rights in these ventures or their income or profits. In particular, our executive officers or directors or their affiliates may have an economic interest in or other business relationship with partner companies that invest in us or are engaged in competing drug development. Our executive officers or directors may have conflicting fiduciary duties to us and third parties. The terms of transactions with third parties may not be subject to arm's length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm's length negotiations. Although we have established an audit committee comprised solely of independent directors to oversee transactions between us and our insiders, we do not have any formal policies in place to deal with such conflicting fiduciary duties should such a conflict arise.

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

Our amended and restated certificate of incorporation and our amended and restated bylaws will require us to indemnify our officers and directors against claims associated with carrying out the duties of their offices. We will also be required to advance the costs of certain legal defenses upon the indemnitee undertaking to repay such expenses to the extent it is determined that such person was not entitled to indemnification of such expenses. Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended (the "Securities Act"), may be permitted to our officers, directors, or control persons, the SEC has advised that such indemnification is against public policy and is therefore unenforceable.

**Risks Related to Our Intellectual Property**

***We may be unable to obtain or protect intellectual property rights relating to our product candidates, which could have a material adverse effect on our business, financial condition and results of operations.***

Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies. We cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent applications will result in granted patents with respect to the technology owned by us or licensed to us. Further, we cannot predict how long it will take for such patents to issue, if at all. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated or circumvented.

We have five granted and eight pending patent applications for our liquid formulations of terlipressen that claim priority to PCT/US2020/034269 filed on May 22, 2020 and published as WO2020/237170. We also have thirteen issued U.S. patents, five pending U.S. applications, three pending Patent Cooperation Treaty applications four issued foreign patents and eight pending foreign patent applications directed to protecting bezisterm (NE3107) and related compounds and methods of making and using thereof. However, there can be no assurance that our pending patent applications will result in issued patents, or that any issued patent claims from pending or future patent applications will be sufficiently broad to protect BIV201, bezisterim (NE3107), or any other product candidates or to provide us with competitive advantages.

We can provide no assurance that any issued patents will provide us with any competitive advantage. We cannot be certain that there is no invalidating prior art of which we and the patent examiner are unaware or that our interpretation of the relevance of prior art is correct. If a third-party patent or patent application is determined to have an earlier priority date, it may prevent our patent applications from issuing at all or issuing in a form that provides any competitive advantage for our drug candidates. Failure to obtain additional issued patents could have a material adverse effect on our ability to develop and commercialize our drug candidates. Even if our patent applications do issue as patents, third parties may be able to challenge the validity and enforceability of our patents on a variety of grounds, including that such third party's patents and patent applications have an earlier priority date, and if such challenges are successful, we may be required to obtain one or more licenses from such third parties, if available on commercially reasonable terms, or be prohibited from commercializing our drug candidates.

We seek to protect our proprietary positions by, among other things, filing patent applications in the United States and abroad related to our current drug candidates and other drug candidates that we may identify. Obtaining, maintaining, defending and enforcing pharmaceutical patents is costly, time-consuming and complex, and we may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce and license any patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, under certain of our license or collaboration agreements, we may not have the right to control the preparation, filing, prosecution and maintenance of patent applications, or to maintain the rights to patents licensed to or from third parties.

We currently are the assignee of a number of U.S. provisional patent applications. U.S. provisional patent applications are not eligible to become issued patents until, among other things, we file a non-provisional patent application within 12 months of filing one or more of our related provisional patent applications. With regard to such U.S. provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications. Further, in the event that we do timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any such patent applications will result in the issuance of patents or if such issued patents will provide us with any competitive advantage.

As to our material inventions, trade secrets, and intellectual property, our employees, consultants, and advisors execute confidentiality agreements and agree to disclose and assign to us all inventions conceived during the workday, using our property, or which relate to our business. However, any of these parties may breach these agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Further, we may not be aware of all third-party intellectual property rights potentially relating to our drug candidates. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal, technological and factual questions and has, in recent years, been the subject of much debate and litigation throughout the world. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa. The standards that the United States Patent and Trademark Office (the "USPTO") (and foreign countries) use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. The issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. The subject matter claimed in a patent application can be significantly reduced or eliminated before the patent issues, if at all, and its scope can be reinterpreted or narrowed after issuance. Therefore, our pending and future patent applications may not result in patents being issued in relevant jurisdictions that protect our drug candidates, in whole or in part, or that effectively prevent others from commercializing competitive drug candidates, and even if our patent applications issue as patents in relevant jurisdictions, they may not issue in a form that will provide us with any meaningful protection for our drug candidates or technology, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Additionally, our competitors may be able to circumvent our patents by challenging their validity or by developing similar or alternative drug candidates or technologies in a non-infringing manner.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. We may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, *inter partes* review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others, or other proceedings in the USPTO or applicable foreign offices that challenge priority of invention or other features of patentability. An adverse determination in any such submission, proceeding or litigation could result in loss of exclusivity or ability to sell our products free from infringing the patents of third parties, patent claims being narrowed, invalidated or held unenforceable, in whole or in part, and limitation of the scope or duration of the patents directed to our drug candidates, all of which could limit our ability to stop others from using or commercializing similar or identical drug candidates or technology to compete directly with us, without payment to us, or result in our inability to manufacture or commercialize drug candidates or approved products (if any) without infringing third-party patent rights. In addition, if the breadth or strength of the claims of our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future drug candidates, or could have a material adverse effect on our ability to raise funds necessary to continue our research programs or clinical trials. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us.

In addition, given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products or technology similar or identical to ours for a meaningful amount of time, or at all. Moreover, some of our licensed patents and owned or licensed patent applications may in the future be co-owned with third parties. If we are unable to obtain exclusive licenses to any such co-owners' interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

Further, we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the technology. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, there could be a material adverse effect on our business, financial condition and results of operations. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant problems in protecting our proprietary rights in these countries.

Our success depends in significant part on our ability to obtain, maintain, enforce and defend patents and other intellectual property rights with respect to our drug candidates and technology and to operate our business without infringing, misappropriating, or otherwise violating the intellectual property rights of others. If we are unable to obtain and maintain sufficient intellectual property protection for our drug candidates or other drug candidates that we may identify, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors and other third parties could develop and commercialize drug candidates similar or identical to ours, and our ability to successfully commercialize our drug candidates and other drug candidates that we may pursue may be impaired.

***Confidentiality agreements may not adequately prevent disclosure of trade secrets and other proprietary information and disclosure of our trade secrets or proprietary information could compromise any competitive advantage that we have, which could have a material adverse effect on our business, financial condition and results of operations.***

Our success will depend, in part, on our ability to protect our proprietary rights to the technologies used in our product candidates. We will depend heavily upon confidentiality agreements with BioVie's executive officers and other employees, any of our future executive officers and other employees, consultants and subcontractors to maintain the proprietary nature of our technology. These measures may not afford us complete or even sufficient protection and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential information. If we fail to protect and/or maintain our intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property. In addition, others may independently develop technology similar to ours, otherwise avoiding the confidentiality agreements, or produce patents, which could have a material adverse effect on our business, financial condition and results of operations, in which event you could lose all of your investment.

***We may enter into licensing and collaboration agreements with third parties. If we fail to comply with our obligations in the agreements under which we license intellectual property rights to or from third parties, or these agreements are terminated, or we otherwise experience disruptions to our business relationships with our licensors or licensees, our competitive position, business, financial condition, results of operations and prospects could be harmed.***

It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our products (if approved), in which case we would be required to obtain a license from these third parties. The licensing of third-party intellectual property rights is a competitive area, and more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. More established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to license such technology, or if we are forced to license such technology on unfavorable terms, there could be a material adverse effect on our business, financial condition and results of operations.

We may fail to obtain any of these licenses or intellectual property rights on commercially reasonable terms. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. Licenses may not provide us with exclusive rights to use the applicable intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our drug candidates, products (if approved) and technology in the future. In that event, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could have a material adverse effect on our business, financial condition and results of operations, and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors, and we may not be able to prevent competitors from developing and commercializing competitive products or technologies.

In addition, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications or to maintain, defend and enforce the patents that we license to or from third parties, and we may have to rely on our partners to fulfill these responsibilities. If our current or future licensors, licensees or collaborators fail to prepare, file, prosecute, maintain, enforce, and defend licensed patents and other intellectual property rights, such rights may be reduced or eliminated, and our right to develop and commercialize any of our drug candidates or technology that are the subject of such licensed rights could be adversely affected. In addition, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor's rights.

If we fail to comply with our obligations, including the obligation to make various milestone payments and royalty payments, under any of the agreements under which we license intellectual property rights from third parties, the licensor may have the right to terminate the license. If any of our license agreements is terminated, the underlying licensed patents fail to provide the intended exclusivity or we otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business or be prevented from developing and commercializing our drug candidates, and competitors could have the freedom to seek regulatory approval of, and to market, products identical to ours. Termination of these agreements or reduction or elimination of our rights under these agreements may also result in our having to negotiate new or reinstated agreements with less favorable terms, cause us to lose our rights under these agreements, including our rights to important intellectual property or technology, or impede, delay or prohibit the further development or commercialization of one or more drug candidates that rely on such agreements. It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources to redesign our drug candidates or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.

Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues and certain provisions in intellectual property license agreements may be susceptible to multiple interpretations. Disputes may arise between us and our licensing partners regarding intellectual property subject to a license agreement, including:

&nbsp;&nbsp;&nbsp;&nbsp;· the scope of rights granted under the license agreement and other interpretation-related issues;

&nbsp;&nbsp;&nbsp;&nbsp;· whether and the extent to which technology and processes of one party infringe intellectual property of
the other party that are not subject to the licensing agreement;

&nbsp;&nbsp;&nbsp;&nbsp;· rights to sublicense patent and other rights to third parties;

&nbsp;&nbsp;&nbsp;&nbsp;· any diligence obligations with respect to the use of the licensed technology in relation to development
and commercialization of our drug candidates, and what activities satisfy those diligence obligations;

&nbsp;&nbsp;&nbsp;&nbsp;· the ownership of inventions and know-how resulting from the joint creation or use of intellectual property;

&nbsp;&nbsp;&nbsp;&nbsp;· rights to transfer or assign the license; and

&nbsp;&nbsp;&nbsp;&nbsp;· the effects of termination.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could harm our business, financial condition, results of operations and prospects. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms or at all, we may be unable to successfully develop and commercialize the affected drug candidates. Moreover, any dispute or disagreement with our licensing partners may result in the delay or termination of the research, development or commercialization of our drug candidates or any future drug candidates, and may result in costly litigation or arbitration that diverts management attention and resources away from our day-to-day activities, which may adversely affect our business, financial condition, results of operations and prospects.

Furthermore, current and future collaborators or strategic partners may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations. Competing products, either developed by our collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for our drug candidates. Any of these developments could harm our product development efforts.

In addition, if our licensors fail to abide by the terms of the license, if the licensors fail to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable there could be a material adverse effect on our business, financial condition and results of operations.

***Some of our intellectual property may be subject to federal regulations such as "march-in" rights, certain reporting requirements and a preference for U.S.-based companies if it is determined that our intellectual property has been discovered through government-funded programs. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.***

Some of the intellectual property rights we have acquired or licensed or may acquire or license in the future may have been generated through the use of U.S. government funding and may therefore be subject to certain federal regulations. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as "march-in rights"). The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products relating to such intellectual property. To the extent any of our future intellectual property is also generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

***Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time.***

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents directed to our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to competition from competitive medications, including generic versions. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration and conditions of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act, and similar legislation in the EU and certain other countries. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for the applicable drug candidate will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and nonclinical data and launch their product earlier than might otherwise be the case, which could have a material adverse effect on our business, financial condition and results of operations.

***We may not be able to protect our intellectual property rights throughout the world.***

Filing, prosecuting, maintaining, defending and enforcing patents on our drug candidates in all countries throughout the world would be prohibitively expensive, and consequently our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and may export otherwise infringing products to territories where we have patents, but enforcement rights are not as strong as those in the United States. These products may compete with our drug candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries do not favor the enforcement or protection of patents, trade secrets and other intellectual property, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Many foreign countries, including some EU countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of the applicable patents and limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license, which could adversely affect our business, financial condition, results of operations and prospects.

In 2012, the European Patent Package, or EU Patent Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court ("UPC"), for litigation involving European patents. Implementation of the EU Patent Package occurred in 2023. Under the UPC, all European patents, including those issued prior to ratification of the European Patent Package, will by default automatically fall under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents and allow for the possibility of a competitor to obtain pan-European injunctions. It will be several years before we will understand the scope of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC. Under the EU Patent Package as currently proposed, we will have the right to opt our patents out of the UPC over the first seven years of the court's existence, but doing so may preclude us from realizing the benefits of the new unified court.

***Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates.***

Obtaining and enforcing patents in the pharmaceutical industry is inherently uncertain, due in part to ongoing changes in the patent laws. For example, in the United States, depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents, and interpretation thereof, could change in unpredictable ways that could weaken our and our collaborators' or licensors' ability to obtain new patents or to enforce existing or future patents. For example, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Therefore, there is increased uncertainty with regard to our and our collaborators' or licensors' ability to obtain patents in the future, as well as uncertainty with respect to the value of patents once obtained.

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our and our collaborators' or licensors' patent applications and the enforcement or defense of our or our collaborators' or licensors' issued patents. For example, assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the "Leahy-Smith Act"), enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications are prosecuted and may also affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, *inter partes* review and derivation proceedings. The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, particularly the first inventor-to-file provisions. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our or our licensors' patent applications and the enforcement or defense of our or our licensors' issued patents. Similarly, statutory or judicial changes to the patent laws of other countries may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Any of the foregoing could harm our business, financial condition, results of operations and prospects.

***We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents directed towards our technology and drug candidates could be found invalid or unenforceable if challenged.***

We are not aware that our patents directed to BIV201 are infringed by third parties. However, there can be no assurance that our patents will not be found in the future to be infringed by others. Any patents we do obtain may be challenged by reexamination or otherwise invalidated or eventually found unenforceable. Both the patent application process and the process of managing patent disputes can be time-consuming and expensive.

Significantly, our pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Our ability to enforce patent rights also depends on our ability to identify infringement. It may be difficult to identify infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor's or potential competitor's product or service. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents or that our patents are invalid or unenforceable. In a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent's claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology. An adverse result in any litigation proceeding could put one or more of our owned or licensed patents at risk of being invalidated, held unenforceable or interpreted narrowly. We may find it impractical or undesirable to enforce our intellectual property against some third parties.

If we were to initiate legal proceedings against a third party to enforce a patent directed to our drug candidates, or one of our future drug candidates, the defendant could counterclaim that our patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or insufficient written description. Grounds for a presentability assertion could be an allegation that someone connected with prosecution of the patent withheld material information from the USPTO or made a misleading statement during prosecution. Third parties may also raise similar claims before the USPTO or an equivalent foreign body, even outside the context of litigation. Potential proceedings include reexamination, post-grant review, *inter partes* review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our technology or any drug candidates that we may develop. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution. These assertions may also be based on information known to us or the USPTO. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights directed towards the applicable drug candidates or technology related to the patent rendered invalid or unenforceable. Such a loss of patent rights could have a material adverse effect on our business, financial condition and result of operations.

Interference proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. If the prevailing party does not offer us a license on commercially reasonable terms or at all there could be a material adverse effect on our business, financial condition and results of operations.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

The pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Moreover, the cost to us of any litigation or other proceeding relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management's efforts. We may not have sufficient resources to bring any such action to a successful conclusion. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations and you could lose all of your investment.

Some of our competitors are larger than we are and have substantially greater resources. They are, therefore, likely to be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or otherwise violating our intellectual property. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims could result in substantial costs and diversion of management resources, which could harm our business. In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal research programs, or in-license needed technology or other drug candidates. There could also be public announcements of the results of the hearing, motions, or other interim proceedings or developments. If securities analysts or investors perceive those results to be negative, it could cause the price of shares of our common stock to decline. Any of the foregoing events could harm our business, financial condition, results of operation and prospects.

***We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our drug candidates.***

We cannot guarantee that any of our or our licensors' patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of our drug candidates in any jurisdiction. For example, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the United States remain confidential until patents issue. As mentioned above, patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our drug candidates could have been filed by third parties without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our drug candidates or the use of our drug candidates. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent's prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our drug candidates. We may incorrectly determine that our drug candidates are not covered by a third-party patent or may incorrectly predict whether a third party's pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our drug candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our drug candidates.

In addition, if we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, which may be significant, we may be temporarily or permanently prohibited from commercializing any of our drug candidates that are held to be infringing. We might, if possible, also be forced to redesign drug candidates so that they no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business and could adversely affect our business, financial condition, results of operations and prospects.

***Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.***

Our commercial success depends upon our ability to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in the pharmaceutical industry. We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our drug candidates and their manufacture and our other technology, including reexamination, interference, post-grant review, *inter partes* review or derivation proceedings before the USPTO or an equivalent foreign body. Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our drug candidates. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit.

We do not believe that BIV201 infringes the patents of any third parties. However, there can be no assurance that our technology will not be found in the future to infringe the patents of others. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products or product candidates infringe. For example, pending applications may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes.

Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of claim scope, infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable and infringed, which could have a material adverse effect on our ability to commercialize any drug candidates we may develop and any other drug candidates or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent.

If we are found to infringe, misappropriate or otherwise violate a third party's intellectual property rights, and we are unsuccessful in demonstrating that such rights are invalid or unenforceable, we could be required to obtain a license from such a third party in order to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be or may become non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business operations. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys' fees for willful infringement, pay royalties and other fees, redesign our infringing drug candidate or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

***We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.***

Many of our employees were previously employed at other biotechnology or pharmaceutical companies. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual's former employer. We may also be subject to claims that patents and applications we have filed to protect inventions made on our behalf by our employees, consultants and advisors, even those related to one or more of our drug candidates, are rightfully owned by their former or concurrent employer. Litigation may be necessary to defend against these claims.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs, delay development of our drug candidates and be a distraction to management. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

***We may be subject to claims challenging the inventorship of our patents and other intellectual property.***

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest (including co-ownership or ownership) in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we or our licensors or collaborators may have inventorship disputes arising from conflicting obligations of employees, consultants or others who are involved in developing our drug candidates. While it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing or may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors' or collaborators' ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our licensors or collaborators fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our drug candidates. Even if we are successful in defending against such claims, these claims may create considerable distraction to management and other employees of the company. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.

***Intellectual property rights do not necessarily address all potential threats.***

The degree of future protection, if any, afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

&nbsp;&nbsp;&nbsp;&nbsp;· others may be able to make products that are similar to any drug candidates we may develop or utilize
similar technology but that are not covered by the claims of the patents that we license or may own in the future;

&nbsp;&nbsp;&nbsp;&nbsp;· we, or our current or future licensors or collaborators, might not have been the first to make the inventions
covered by the issued patent or pending patent application that we license or may own in the future;

&nbsp;&nbsp;&nbsp;&nbsp;· we, or our current or future licensors or collaborators might not have been the first to file patent applications
covering certain of our or their inventions;

&nbsp;&nbsp;&nbsp;&nbsp;· we, or our current or future licensors or collaborators might not have been the first to file patent applications
covering certain of our or their inventions;

&nbsp;&nbsp;&nbsp;&nbsp;· others may independently develop similar or alternative technologies or duplicate any of our technologies
without infringing our owned or licensed intellectual property rights;

&nbsp;&nbsp;&nbsp;&nbsp;· it is possible that our pending owned or licensed patent applications or those that we may own or license
in the future will not lead to issued patents;

&nbsp;&nbsp;&nbsp;&nbsp;· issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal
challenges by our competitors;

&nbsp;&nbsp;&nbsp;&nbsp;· our competitors might conduct research and development activities in countries where we do not have patent
rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

&nbsp;&nbsp;&nbsp;&nbsp;· we may develop additional proprietary technologies that are patentable;

&nbsp;&nbsp;&nbsp;&nbsp;· the intellectual property rights of others may harm our business; and

&nbsp;&nbsp;&nbsp;&nbsp;· we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third
party may subsequently file a patent directed to such intellectual property.

Should any of these events occur, they could harm our business, financial condition, results of operations and prospects.

***Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our common stock to decline.***

During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished. Accordingly, the market price of shares of our common stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business, financial condition and results of operations.

**Risks Related to the Separation and Our Relationship with BioVie**

***After this offering, we will depend on BioVie to provide us with certain services for our business. Accordingly, we are subject to the business risks of BioVie.***

After the Separation, BioVie will continue to manage and support our business. Therefore, any event that adversely effects BioVie's business, financial condition or results of operations, may adversely affect us.

Accordingly, we are subject to the business risks of BioVie, including, but not limited to:

&nbsp;&nbsp;&nbsp;&nbsp;· third party contractors not successfully carrying out contractual duties or meeting deadlines, therefore
unable to obtain regulatory approval or commercialize product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;· uncertainty of successful development of biopharmaceuticals;

&nbsp;&nbsp;&nbsp;&nbsp;· concentration of assets within certain financial institutions;

&nbsp;&nbsp;&nbsp;&nbsp;· securities class action litigation;

&nbsp;&nbsp;&nbsp;&nbsp;· lack of products for commercial sale and revenue;

&nbsp;&nbsp;&nbsp;&nbsp;· approval of generic versions of any product candidates that receive marketing approval;

&nbsp;&nbsp;&nbsp;&nbsp;· failure to maintain Orphan Drug exclusivity for BIV201;

&nbsp;&nbsp;&nbsp;&nbsp;· raising substantial additional capital in the future to fund operations;

&nbsp;&nbsp;&nbsp;&nbsp;· limited experience in drug development;

&nbsp;&nbsp;&nbsp;&nbsp;· development of pharmaceuticals being time consuming;

&nbsp;&nbsp;&nbsp;&nbsp;· expenditure of limited resources to pursue a particular drug candidate;

&nbsp;&nbsp;&nbsp;&nbsp;· lack of manufacturing experience;

&nbsp;&nbsp;&nbsp;&nbsp;· lack of sales and marketing personnel to sell products;

&nbsp;&nbsp;&nbsp;&nbsp;· failure to comply with manufacturing regulations;

&nbsp;&nbsp;&nbsp;&nbsp;· complying with significant and complex government regulations;

&nbsp;&nbsp;&nbsp;&nbsp;· loss of availability of management;

&nbsp;&nbsp;&nbsp;&nbsp;· inability to attract and retain highly skilled personnel; and

&nbsp;&nbsp;&nbsp;&nbsp;· conflicts of interest among officers, directors and stockholders.

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Please see Item 1A, "Risk Factors" in BioVie's Annual Report on Form 10-K for the year ended June 30, 2025 (which is not, and shall not be deemed to be, incorporated by reference herein) for a full discussion of the risks associated with BioVie's business.

***We have no recent history of operating as a standalone public company, and our historical financial information may not necessarily reflect the results that we would have achieved as a standalone public company or what our results may be in the future.***

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Since our inception, we have been a wholly owned subsidiary of BioVie. The financial information included in this prospectus has been prepared from BioVie's historical accounting records and is derived from the financial statements of BioVie to present the Company as if it had been operating on a standalone basis. Accordingly, this information may not necessarily reflect what our financial condition, results of operations or cash flows would have been had we been a standalone company during the periods presented or what our financial condition, results of operations and cash flows may be in the future, primarily because of the following factors:

&nbsp;&nbsp;&nbsp;&nbsp;· Prior to the Separation, our business has been operated by BioVie as part of its broader corporate organization,
rather than as a standalone company. BioVie or one of its affiliates performed various corporate functions for us, including finance,
human resources, benefits administration, procurement support, information technology, legal, corporate governance and other professional
services.

&nbsp;&nbsp;&nbsp;&nbsp;· Our historical financial results reflect the direct and indirect costs for the services historically provided
by BioVie to us. Pursuant to a management services agreement, BioVie will provide us with the services of certain of its executive officers
and other employees to support our operations following the completion of this offering in exchange for a quarterly fee. See "Certain
Relationships and Related Party Transactions—Agreements to be Entered into in Connection with the Separation—Management Services
Agreement."

&nbsp;&nbsp;&nbsp;&nbsp;· Our working capital requirements and capital expenditures have historically been satisfied as part of
BioVie's corporate-wide cash management and centralized funding programs, and our cost of debt and other capital may differ significantly
from the historical amounts reflected in our historical carve-out financial statements.

&nbsp;&nbsp;&nbsp;&nbsp;· Currently, our business is under common ownership with the other businesses of BioVie, and we benefit
from BioVie's size and scale, including with respect to costs, employees and relationships with customers and third-party partners.
Although we will enter into a management services agreement with BioVie in connection with the Separation, these arrangements will not
fully capture the benefits that we have enjoyed as a result of being under common ownership with BioVie, and the costs we will incur as
a standalone public company may significantly exceed comparable costs we would have incurred as part of BioVie.

For additional information about the past financial performance of our business and the presentation of financial information of the historical carve-out financial statements of our business included in this prospectus, see "Presentation of Financial Information" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our carve-out financial statements included elsewhere in this prospectus.

***We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely affect our business, financial condition and results of operations.***

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We may not be able to achieve the full strategic and financial benefits expected to result from the Separation, or the benefits may be delayed or not occur at all. We expect that the Separation will improve our strategic and operational flexibility; provide the executive leadership and board the opportunity to focus solely on our business; provide us with a unique and more efficiently valued equity currency to commercialize our drug candidates and other capital needs; allow us to adopt the capital structure, investment policy and dividend policy best suited to our financial profile and business needs; provide us with a more effective tool for employee compensation; and enable investors to invest directly in us.

We may not achieve these and other anticipated benefits of the Separation following the completion of this offering for a variety of reasons, including:

&nbsp;&nbsp;&nbsp;&nbsp;· the Separation will require significant amounts of management's time and effort, which may divert
management's attention from operating and growing our business;

&nbsp;&nbsp;&nbsp;&nbsp;· we may be more susceptible to economic downturns and other
adverse events than we were prior to the Separation;

&nbsp;&nbsp;&nbsp;&nbsp;· our business will be less diversified than BioVie's businesses
prior to the Separation;

&nbsp;&nbsp;&nbsp;&nbsp;· the cost of capital for our business may be higher than BioVie's
cost of capital prior to the Separation;

&nbsp;&nbsp;&nbsp;&nbsp;· certain costs and liabilities that were otherwise less significant
to BioVie as a whole will be more significant to us as a standalone company; and

&nbsp;&nbsp;&nbsp;&nbsp;· other actions required to separate the respective businesses could disrupt our operations.

If we fail to achieve some or all of the benefits expected to result from the Separation, or if the benefits are delayed, our business, financial condition and results of operations could be adversely affected.

***Until the Separation is completed, BioVie has sole discretion to change the terms of the Separation in ways that may be unfavorable to us.***

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Until the Separation is completed, we will be a wholly-owned subsidiary of BioVie. Accordingly, BioVie will effectively have the sole and absolute discretion to determine and change the terms of the Separation. These changes could be unfavorable to us. In addition, BioVie may decide at any time not to proceed with the Separation.

***Following the completion of this offering, BioVie will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.***

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Upon completion of this offering, BioVie will own approximately % of our outstanding common stock (or approximately % if the underwriters exercise their over-allotment option to purchase additional shares of common stock in full). Investors in this offering generally will not be able to affect the outcome of any matter submitted to our stockholders for approval as long as BioVie or its successor-in-interest beneficially owns a majority of the total voting power of our outstanding shares of common stock.

As long as BioVie beneficially owns a majority of the voting power of our outstanding shares of common stock, BioVie will generally be able to control the outcome of matters submitted to our stockholders for approval without the approval of our other stockholders, including:

&nbsp;&nbsp;&nbsp;&nbsp;· determinations with respect to our business direction and policies, including the election and removal
of directors and the appointment and removal of officers;

&nbsp;&nbsp;&nbsp;&nbsp;· determinations with respect to corporate transactions, such as mergers, business combinations or dispositions
of assets;

&nbsp;&nbsp;&nbsp;&nbsp;· our financing and dividend policies;

&nbsp;&nbsp;&nbsp;&nbsp;· our compensation and benefit programs and other human resources policy decisions;

&nbsp;&nbsp;&nbsp;&nbsp;· termination of, changes to or determinations under our agreements with BioVie relating to the Separation;

&nbsp;&nbsp;&nbsp;&nbsp;· determinations with respect to tax matters; and

&nbsp;&nbsp;&nbsp;&nbsp;· changes to any other agreements that may adversely affect us.

If BioVie does not dispose of its remaining equity interest in our company, or if BioVie purchases shares of our common stock in the open market following the completion of this offering, it could remain our controlling stockholder for an extended period of time or indefinitely. Even if BioVie were to beneficially own less than a majority of the total voting power of our outstanding shares of common stock, BioVie may be able to influence the outcome of corporate actions requiring stockholder approval for as long as it owns a significant portion of our common stock.

BioVie's interests may not be the same as, or may conflict with, the interests of our other stockholders. Actions that SMC takes with respect to us, as a controlling or significant stockholder, may not be favorable to us or our other stockholders.

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***We will be a "controlled company" within the meaning of the NYSE rules and, as a result, we will qualify for, and intend to rely on, exemptions from certain corporate governance requirements.***

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Upon completion of this offering, BioVie will own more than a majority of the voting power of our shares of common stock eligible to vote in the election of our directors. As a result, we will be a "controlled company" within the meaning of the NYSE corporate governance standards. Under the NYSE rules, a company of which more than 50% of the voting power is held by an individual, group or another company is a "controlled company" and may elect not to comply with certain NYSE corporate governance standards, including:

&nbsp;&nbsp;&nbsp;&nbsp;· the requirement that a majority of the board consist of independent directors;

&nbsp;&nbsp;&nbsp;&nbsp;· the requirement to have a compensation committee that is composed entirely of independent directors with
a written charter addressing the committee's purpose and responsibilities;

&nbsp;&nbsp;&nbsp;&nbsp;· the requirement to have a nominating and governance committee that is composed entirely of independent
directors with a written charter addressing the committee's purpose and responsibilities, or otherwise have director nominees selected
by vote of a majority of the independent directors; and

&nbsp;&nbsp;&nbsp;&nbsp;· the requirement for an annual performance evaluation of the nominating and governance and compensation
committees.

We intend to take advantage of one or more of these exemptions following the completion of this offering and do not intend to have a compensation committee. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all the corporate governance requirements of NYSE.

***Following the completion of this offering, we and our stockholders may have conflicts of interest with BioVie.***

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Conflicts of interest may arise between BioVie and us after the offering, since BioVie will continue to engage in transactions with us. Further, BioVie may, from time to time, acquire and hold interests in, or maintain business relationships with, businesses that compete directly or indirectly with us. In general, BioVie could pursue business interests or exercise its voting power as stockholder in ways that are detrimental to us but beneficial to themselves or to other companies in which they invest or with whom they have relationships.

In addition, adverse publicity, regulator scrutiny and pending investigations by regulators or law enforcement agencies involving BioVie could negatively impact our reputation due to our relationship with BioVie, which could have a material adverse effect on our business, financial condition and results of operations.

***A Distribution may not occur and your investment in our securities may be adversely affected if BioVie does not distribute the shares of our common stock owned by BioVie.***

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BioVie has advised us that, following the completion of this offering and subject to the expiration of any applicable lock-up periods or other agreements we have or may have with BioVie, it does not have any near-term plans to distribute the shares of our common stock held by BioVie shareholders. Whether a Distribution is conducted in the future will depend on many factors, including BioVie's cash position, market capitalization, BioVie's investment opportunities, taxation to BioVie and BioVie's shareholders and our status and prospects. In addition, the liquidity of the market for our common stock may be constrained for as long as BioVie continues to hold a significant position in our common stock. Additionally, without a Distribution, there will be limited liquidity in the market for our common stock, which will impact our stockholders and our stock price. A lack of liquidity in the market for our common stock may adversely affect our stock price and therefore, our ability to raise additional funds in the public markets, which could have a material adverse effect on our ability to grow our business.

***We will incur significant charges in connection with the Separation and incremental costs as a standalone public company.***

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We expect the separation process to be complex, time-consuming and costly. We will need to establish or expand our own corporate functions, including finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance and other professional services. We will also need to make investments or hire additional employees to operate without the same access to BioVie's existing operational and administrative infrastructure. We expect to incur one-time costs to replicate, or outsource from other providers, these corporate functions to replace the corporate services that BioVie historically provided to us prior to the Separation. Any failure or significant downtime in our own financial, administrative or other support systems, or in the BioVie financial, administrative or other support systems during the transitional period during which BioVie provides us with support, could adversely affect our business, financial condition and results of operations, such as by preventing us from paying our suppliers and employees, executing business combinations and foreign currency transactions, or performing administrative or other services on a timely basis. Due to the scope and complexity of the underlying projects related to the Separation, the amount of total costs could be materially higher than our estimate, and the timing of the incurrence of these costs is subject to change.

In addition, our financial statements include the assets, liabilities, revenue and expenses that management has determined are specifically or primarily identifiable to us, as well as direct and indirect costs that are attributable to our operations. Indirect costs are the costs of support functions that are provided on a centralized basis by BioVie and its affiliates. Indirect costs have been allocated to us for the purposes of preparing our historical carve-out financial statements based on a specific identification basis or, when specific identification is not practicable, a proportional cost allocation method, primarily based on headcount or other allocation methodologies that are considered to be a reasonable reflection of the utilization of services provided or the benefit received by us during the periods presented, depending on the nature of the services received. The value of the assets and liabilities we assume in connection with the Separation could ultimately be materially different than these attributions, which could adversely affect our business, financial condition and results of operations.

 ****

 **

***After this offering, our directors and executive officers may have actual or potential conflicts of interest because of their current BioVie positions or their equity ownership in BioVie.***

 **

Each of our directors and executive officers have been, and are expected to continue to be, BioVie directors and executive officers. In addition, because of their current BioVie positions, our directors and executive officers own BioVie common stock or other equity compensation awards. For some of these individuals, their individual holdings may be significant compared to their total assets. These relationships and financial interests may create, or may create the appearance of, conflicts of interest when these directors and officers are faced with decisions that could have different implications for BioVie and us. For example, potential conflicts of interest could arise over matters such as the desirability of changes in our business and operations, funding and capital matters, regulatory matters, matters arising with respect to the separation agreement and other agreements with BioVie relating to the Separation or otherwise, employee retention or recruiting or our dividend policy. We expect that provisions relating to certain relationships and transactions in our amended and restated certificate of incorporation will address certain actual or potential conflicts of interest between us, on the one hand, and BioVie and its directors and officers who are our directors and officers on the other hand. By becoming our stockholder, you will be deemed to have notice of, and consented to, these provisions of our amended and restated certificate of incorporation. For example, we are expected to renounce any interest or expectancy of ours in any corporate opportunities that are presented to our directors and officers who are also directors and officers of BioVie, and such director or officer will have no duty to communicate or present such corporate opportunity to us, in each case so long as such corporate opportunity was not expressly offered to such person solely in their capacity as our director or officer. Although these provisions are designed to resolve certain conflicts of interest between us and BioVie fairly, we cannot assure you that any conflicts of interest will be so resolved.

***Certain contracts used in our business will need to be replaced, or assigned from BioVie or its affiliates to the Company in connection with the Separation, which may require the consent of the counterparty to such an assignment, and failure to obtain such replacement contracts or consents could increase the Company's expenses or otherwise adversely affect our results of operations.***

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Our separation from BioVie requires us to replace shared contracts and, with respect to certain contracts that are to be assigned from BioVie or its affiliates to us or our affiliates, to obtain consents and assignments from third parties. It is possible that, in connection with the replacement or consent process, some parties may seek more favorable contractual terms from the Company. If we are unable to obtain such replacement contracts or consents, as applicable, we may be unable to obtain some of the benefits, assets and contractual commitments that are intended to be allocated to the Company as part of the Separation. If the Company is unable to obtain such replacement contracts or consents, the loss of these contracts could increase the Company's expenses which could have a material adverse effect on our business, financial condition and results of operations.

***If BioVie sells a controlling equity interest in our company to a third party in a private transaction, you may not realize any change-of-control premium on your shares of our common stock and we may become subject to the control of a currently unknown third party.***

Upon completion of this offering, BioVie will own approximately % of our outstanding common stock (or approximately % if the underwriters exercise their over-allotment option to purchase additional shares of common stock in full). BioVie will have the ability, should it choose to do so, to sell some or all of its shares of our common stock in a privately negotiated transaction, which, if sufficient in size, could result in a change of control of us.

The ability of BioVie to privately sell its shares of our common stock, with no requirement for a concurrent offer to be made to acquire all of the shares of our common stock that will be publicly traded following the completion of this offering, could prevent you from realizing any change-of-control premium on your shares of our common stock that may otherwise accrue to BioVie on its private sale of shares of our common stock. In addition, if BioVie privately sells its controlling equity interest in our company, we may become subject to the control of a currently unknown third party. The interests of this third party may not be the same as, or may conflict with, the interests of our other stockholders. Furthermore, if BioVie sells a controlling equity interest in our company to a third party, our future indebtedness may be subject to acceleration, and our other commercial agreements and relationships, including any remaining agreements with BioVie, could be impacted. The occurrence of any of these events could adversely affect our business, financial condition and results of operations.

 ****

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***Potential indemnification obligations to BioVie in connection with the Separation could adversely affect our business, financial condition and results of operations.***

The separation agreement will provide for indemnification obligations (for uncapped amounts, reduced by any insurance proceeds or other third-party proceeds that the party being indemnified receives) designed to make us financially responsible for substantially all liabilities that may exist relating to our business activities, whether incurred prior to or following the completion of this offering. In addition, we will agree to indemnify BioVie under certain additional circumstances pursuant to certain other agreements we will enter into with BioVie in connection with the Separation. If we are required to indemnify BioVie under the circumstances set forth in these agreements, we may be subject to substantial liabilities, which could adversely affect our business, financial condition and results of operations.

***In connection with the Separation, BioVie will indemnify us for certain liabilities. However, we cannot assure you that the indemnity will be sufficient to insure us against the full amount of such liabilities or that BioVie's ability to satisfy its indemnification obligation will not be impaired in the future.***

Pursuant to the separation agreement and certain other agreements we will enter into with BioVie in connection with the Separation, BioVie will agree to indemnify us for certain liabilities. However, third parties could also seek to hold us responsible for any of the liabilities that BioVie has agreed to retain and we cannot assure you that the indemnity from BioVie will be sufficient to protect us against the full amount of such liabilities, or that BioVie will be able to fully satisfy its indemnification obligations. In addition, pursuant to the separation agreement, BioVie's self-funded insurance policies will not be available to us, and BioVie's third-party insurance policies may not be available to us, for liabilities associated with occurrences of indemnified liabilities prior to the Separation, and in any event BioVie's insurers may deny coverage to us for liabilities associated with certain occurrences of indemnified liabilities prior to the Separation. Moreover, even if we ultimately succeed in recovering from BioVie or its insurance providers any amounts for which we are held liable, we may be temporarily required to bear these losses. The occurrence of any of these events could adversely affect our business, financial condition and results of operations.

***We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with BioVie.***

The agreements we will enter into with BioVie in connection with the Separation were prepared in the context of our separation from BioVie while we were still part of BioVie. Accordingly, during the period in which these agreements were prepared, we did not have a separate or independent board of directors or a management team that was separate from or independent of BioVie. The terms of these agreements, including the fees charged for services provided under these agreements, were primarily determined by BioVie and, as a result, may not necessarily reflect terms that would have resulted from arm's-length negotiations between unaffiliated third parties or from arm's-length negotiations between BioVie and an unaffiliated third party in another form of transaction, such as a buyer in a sale of a business transaction**.**

***Approval of commercial terms between us and BioVie does not preclude the possibility of stockholder litigation, including but not limited to derivative litigation nominally against BioVie and against its directors and officers and also against us and our directors and officers.***

The commercial terms of the separation agreement and management services agreement that we will enter into with BioVie have not been negotiated on behalf of BioVie by persons consisting solely of disinterested BioVie directors. Notwithstanding the foregoing, we have no basis for believing that the terms of these agreements will not be in the best interests of both BioVie and its stockholders and also us and our stockholders. Nonetheless, no assurance can be given that any stockholder of BioVie will not claim in a lawsuit that such terms in fact are not in the best interests of BioVie and its stockholders, that the directors and officers of BioVie breached their fiduciary duties in connection with such agreements and that any disclosures by BioVie to its stockholders regarding these agreements and the relationship between BioVie and us did not satisfy applicable requirements. In any such instance, we and our directors and officers may also be named as defendants and we would have to defend ourselves and our directors and officers. While we will seek indemnification from BioVie under the terms of these agreements against any damages or other costs, which could be substantial, no such indemnification has yet been agreed to or may be agreed to and be in effect. Further, any such litigation would be time-consuming and would divert focus and resources from the development of our product candidates and our business, including but not limited to possibly delaying our clinical trials due to our management having to spend time and attention on such litigation.

***Following this offering, we will continue to depend on BioVie to provide us with certain services for our business.***

We are currently a wholly owned subsidiary of BioVie. Certain administrative services required by us for the operation of our business will be provided by BioVie, including certain finance, accounting, compliance and regulatory services. At our election, or if BioVie does not or is unable to perform its obligations under the management services agreement, we will be required to provide these services ourselves or to obtain substitute arrangements with other third parties. We may be unable to provide these services because of financial or other constraints or be unable to implement substitute arrangements on a timely basis on terms that are favorable to us, or at all.

We will exercise no control over the activities of BioVie other than the contractual rights we will have pursuant to our management services agreement. Because of our historical relationship with BioVie, our reputation is also tied to BioVie. We may be subject to reputational harm, or our relationships with existing and potential clients, third-party research organizations, consultants and other business partners could be harmed if BioVie or any of its affiliates, previously, or in the future, among other things, engages in poor business practices, restructures or files for bankruptcy, becomes subject to litigation or otherwise damages its reputation or business prospects. Any of these events might in turn adversely affect our reputation, revenues and/or business prospects, and may also adversely affect our access to BioVie's collaborative services.

Furthermore, certain individuals conducting services on our behalf are not our employees, and except for remedies available to us under our agreements with BioVie, we cannot control whether or not they devote sufficient time, skill and resources to our ongoing development programs. We also cannot ensure that BioVie retains sufficient resources of personnel or otherwise to conduct its operations. BioVie may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting research and development activities, which could impede their ability to devote appropriate time to our research and development programs. In addition, if we fail to comply with our diligence, payment or other obligations under the agreements, any such collaboration may terminate or we may not be able to successfully negotiate agreements for future product candidates or collaborations with BioVie.

***The assets and resources that we acquire from BioVie in the Separation may not be sufficient for us to operate as a stand-alone company, and we may experience difficulty in separating our assets and resources from BioVie.***

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Because we have not operated as a standalone company in the past, we may have difficulty doing so. We may need to acquire assets and resources in addition to those provided by BioVie to us, and in connection with the Separation, may also face difficulty in separating our resources from BioVie's and integrating newly acquired assets into our business. For example, we may need to hire additional personnel to assist with administrative and technical functions and acquire other office and laboratory equipment for use in the ordinary course operations of our business. If we have difficulty operating as a stand-alone company, fail to acquire assets that we need to run our operations, or incur unexpected costs in separating our business from BioVie's business or in integrating newly acquired assets into our business, our financial condition and results of operations will be adversely affected.

**Risks Related to this Offering and Ownership of Our Common Stock**

***You will experience immediate and substantial dilution as a result of this offering.***

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the assumed sale by us of shares of common stock at an assumed public offering price of $ per share of common stock (excluding the exercise of the underwriters' over-allotment option to purchase additional shares and after deducting underwriting discounts, commissions and estimated offering expenses payable by us), investors in this offering can expect an immediate dilution of $ per share of common stock. In addition, you may experience further dilution if the underwriters exercise their over-allotment option.

***There is no liquid public market for our common stock and we do not know whether one will develop to provide you with adequate liquidity. If our share price fluctuates after this offering, you could lose a significant part of your investment.***

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Prior to this offering, there has not been a liquid public market for our common stock. If an active trading market does not develop, you may have difficulty selling any of our common stock that you buy. We cannot predict the extent to which investor interest in the Company will lead to the development of an active trading market on the U.S. Exchange or otherwise or how liquid that market might become. The initial public offering price for our common stock will be determined by negotiations between us and the underwriters and may not be indicative of prices that will prevail in the open market following this offering. Consequently, you may not be able to sell our common stock at prices equal to or greater than the price paid by you in this offering. In addition to the risks described above, the market price of our common stock may be influenced by many factors, some of which are beyond our control, including actual or anticipated variations in our operating results; the failure of financial analysts to cover our common stock after this offering or changes in financial estimates by financial analysts, or any failure by us to meet or exceed any of these estimates or changes in the recommendations of any financial analysts that elect to follow our common stock or the shares of our competitors; announcements by us or our competitors of significant contracts or acquisitions; technological innovations by us or our competitors; future sales of our common stock; and investor perceptions of us and the market in which we operate.

***Management will have broad discretion as to the use of the proceeds from this offering, and may not use the proceeds effectively.***

Our management will have broad discretion as to the use of the net proceeds from any offering by us and could use them for purposes other than those contemplated at the time of this offering. Accordingly, you will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return for our company.

***We have no operating experience as a public company.***

We have no operating experience as a public company. Although the individuals who now constitute our management team have experience managing a public company, there is no assurance that the past experience of our management team will be sufficient to operate our company as a public company, including timely compliance with the disclosure requirements of the SEC. Following the completion of this offering, we will be required to develop and implement internal control systems and procedures in order to satisfy the periodic and current reporting requirements under applicable SEC regulations and comply with the NYSE listing standards. These requirements will place significant strain on our management team, infrastructure and other resources. In addition, our management team may not be able to successfully or efficiently manage our company as a public reporting company that is subject to significant regulatory oversight and reporting obligations.

***The market price and trading volume of our common stock may be volatile.***

The market price and trading volume of our common stock has been volatile. We expect that the market price of our common stock will continue to fluctuate significantly for many reasons, including in response to the risk factors described in this prospectus or for reasons unrelated to our specific performance. In recent years, the stock market has experienced extreme price and volume fluctuations. This volatility has affected the market prices of securities issued by many companies for reasons unrelated to their operating performance and may adversely affect the market price and trading volume of our common stock. Prices for our common stock may also be influenced by the depth and liquidity of the market for our common stock, investor perceptions about us and our business, our future financial results, the absence of cash dividends on our common stock and general economic and market conditions. In the past, securities class action litigation has often been instituted against companies following periods of volatility in their stock price. This type of litigation could result in substantial costs and could divert our management and other resources.

***We cannot assure you that we will be able to comply with the minimum bid price requirement of NYSE.***

Although we expect our stock price will meet such minimum bid price requirements prior to the effective date of the registration statement of which this prospectus forms a part, there is no guarantee that the price of our common stock will stay above the minimum requirements for the time period required by NYSE. Further, there can be no assurance that the market price of our common stock will remain at the level required for continuing compliance with the minimum price requirements. It is not uncommon for the market price of a company's common stock to decline in the period following a reverse stock split. If the market price of our common were to experience such a decline, or if other factors unrelated to the number of shares of our common stock outstanding, such as negative financial or operational results, adversely affect the market price of our common stock, that may jeopardize our ability to meet or maintain the minimum bid price requirement of the exchange on which our common stock is listed.

***Our inability to comply with NYSE's continued listing requirements could result in our common stock being delisted, which could affect the market price and liquidity of our securities and reduce our ability to raise capital.***

We intend to apply for listing of our common stock on NYSE under the symbol " ". No assurance can be given that our application will be approved. However, if such listing is approved, upon completion of this offering, we will be required to meet certain qualitative and financial tests to maintain the listing of our common stock on NYSE. If we do not maintain compliance with NYSE's continued listing requirements within specified periods and subject to permitted extensions, our common stock may be recommended for delisting (subject to any appeal we would file). No assurance can be provided that we will comply with these continued listing requirements. NYSE has broad discretionary authority over the continued listing of securities, which it could exercise with respect to the listing of our common stock. If our common stock were delisted, it could be more difficult to buy or sell our common stock and to obtain accurate quotations, and the price of our securities could suffer a material decline. Delisting would also impair our ability to raise capital.

***An investment in our securities involves significant risks.***

Additional risks and uncertainties not presently known to us or that we currently consider immaterial may also impair our business and operations and cause the trading price of our securities to decline, which could have a material adverse effect on our business, financial condition and results of operations. In that event, the trading price of our securities could decline and security holders could lose all or part of their investment. There is no assurance that risk management steps taken will avoid future loss due to the occurrence of the risks described below or other unforeseen risks.

***Our common stock may experience extreme stock price volatility unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock.***

Recently, there have been instances of extreme stock price run-ups followed by rapid price declines and strong stock price volatility with a number of recent initial public offerings, especially among companies with relatively smaller public floats. As a relatively small-capitalization company with relatively small public float, we may experience greater stock price volatility, extreme price run-ups, lower trading volume and less liquidity than large-capitalization companies. In particular, our common stock may be subject to rapid and substantial price volatility, low volumes of trades and large spreads in bid and ask prices. Such volatility, including any stock-run up, may be unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock.

In addition, if the trading volumes of our common stock are low, persons buying or selling in relatively small quantities may easily influence prices of our common stock. This low volume of trades could also cause the price of our common stock to fluctuate greatly, with large percentage changes in price occurring in any trading day session. Holders of our common stock may also not be able to readily liquidate their investment or may be forced to sell at depressed prices due to low volume trading. If high spreads between the bid and ask prices of our common stock exist at the time of a purchase, the stock would have to appreciate substantially on a relative percentage basis for an investor to recoup their investment. Broad market fluctuations and general economic and political conditions may also adversely affect the market price of our common stock.

As a result of this volatility, investors may experience losses on their investment in our common stock. A volatile market price of our common stock also could adversely affect our ability to issue additional common stock or other securities and our ability to obtain additional financing in the future.

***Any failure to maintain effective internal control over financial reporting could harm us.***

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. generally accepted accounting principles ("GAAP"). Under standards established by the Public Company Accounting Oversight Board ("PCAOB"), a deficiency in internal control over financial reporting exists when the design or operation of a control does not allow management or personnel, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis. The PCAOB defines a material weakness as a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented, or detected and corrected, on a timely basis.

If we are unable to assert that our internal control over financial reporting is effective, or when required in the future, if our independent registered public accounting firm is unable to express an unqualified opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could be adversely affected and we could become subject to litigation or investigations by the stock exchange on which our securities are listed, the SEC or other regulatory authorities, which could require additional financial and management resources.

***We are an emerging growth company within the meaning of the Securities Act and may take advantage of certain reduced reporting requirements applicable to other public companies that are not emerging growth companies.***

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We will be an "emerging growth company" as defined in section 3(a) of the Exchange Act (as amended by the JOBS Act), and will continue to qualify as an emerging growth company until the earliest of: (a) the last day of the fiscal year during which we have total annual gross revenues of at least $1.235 billion; (b) the last day of our fiscal year following the fifth anniversary of the completion of this offering; (c) the date on which we have, during the preceding three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a "large accelerated filer" under the Exchange Act, which would occur if the market value of our shares of common stock that are held by non-affiliates exceeds $700 million.

For so long as we remain an emerging growth company, we are permitted to and may rely upon exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include not being required to comply with the auditor attestation requirements of Section 404. We cannot predict whether investors will find our securities less attractive because we rely upon certain of these exemptions. If some investors find the securities less attractive as a result, there may be a less active trading market for our securities and the price of our securities may be more volatile. On the other hand, if we no longer qualify as an emerging growth company, we would be required to divert additional management time and attention from development and other business activities and incur increased legal and financial costs to comply with the additional associated reporting requirements, which could negatively impact our business, financial condition and results of operations.

***We are considered a smaller reporting company that is exempt from certain disclosure requirements, which could make our stock less attractive to potential investors.***

Rule 12b-2 of the Exchange Act defines a "smaller reporting company" as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Had a public float of less than $250 million as of the last business day of its most recently completed
fiscal quarter, computed by multiplying the aggregate number of worldwide number of shares of its voting and non-voting common equity
held by non-affiliates by the price at which the common equity was last sold, or the average of the bid and asked prices of common equity,
in the principle market for the common equity; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· In the case of an initial registration statement under the Securities Act or the Exchange Act for shares
of its common equity, had a public float of less than $250 million as of a date within 30 days of the date of the filing of the registration
statement, computed by multiplying the aggregate worldwide number of such shares held by non-affiliates before the registration plus,
in the case of a Securities Act registration statement, the number of such shares included in the registration statement by the estimated
public offering price of the shares; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· In the case of an issuer who had annual revenue of less than $100 million during the most recently completed
fiscal year for which audit financial statements are available, had a public float as calculated under paragraph (1) or (2) of this definition
that was either zero or less than $700 million.

As a "smaller reporting company" we are not required and may not include a Compensation Discussion and Analysis section in our proxy statements; we provide only 3 years of business development information; and have other "scaled" disclosure requirements that are less comprehensive than issuers that are not "smaller reporting companies" which could make our stock less attractive to potential investors, which could make it more difficult for you to sell your shares.

***Because we do not intend to pay any cash dividends on our common stock, our stockholders will not be able to receive a return on their shares unless they sell them.***

We intend to retain any future earnings to finance the development and expansion of our business. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. Unless we pay dividends, our stockholders will not be able to receive a return on their shares of common stock unless they sell them. There is no assurance that stockholders will be able to sell their shares of common stock when desired.

***We will be authorized to issue "blank check" preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities.***

Our amended and restated certificate of incorporation will authorize us to issue up to shares of blank check preferred stock. Any preferred stock that we issue in the future may rank ahead of our common stock in terms of dividend priority or liquidation premiums and may have greater voting rights than our common stock. Any preferred stock issued may contain provisions allowing those shares to be converted into shares of common stock, which could dilute the value of our common stock to current stockholders and could adversely affect the market price, if any, of our common stock. The preferred stock could be utilized, under certain circumstances, as a method of discouraging, delaying, or preventing a change in control of our company. Although we have no present intention to issue any shares of our authorized preferred stock, there can be no assurance that we will not do so in the future.

***Anti-takeover provisions in our organizational documents and Delaware law might discourage or delay acquisition attempts for us that you might consider favorable.***

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Our amended and restated certificate of incorporation and our amended and restated bylaws that will become effective immediately prior to the consummation of this offering will contain provisions that may make a merger with or acquisition of our Company or changes in our management more difficult without the approval of our board of directors. Among other things, these provisions:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· permit the board of directors to establish the number of directors and fill any vacancies and newly created
directorships;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· provide that, from and after the Trigger Event, a director may be removed only for cause and only by the
affirmative vote of the holders of at least 66 2/3% in voting power of all the then-outstanding shares of our common stock entitled to
vote thereon, voting together as a single class;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· provide that, from and after the Trigger Event, the affirmative vote of the holders of at least 66 2/3%
in voting power of all the then-outstanding shares of our common stock entitled to vote thereon, voting together as a single class, is
required in order to amend certain provisions of our amended and restated certificate of incorporation regarding the amendment of our
amended and restated certificate of incorporation, the composition and authority of our board of directors, the election and removal of
directors, limitations of director liability, stockholder meetings, corporate opportunities, choice of forum and the interpretation of
our amended and restated certificate of incorporation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· authorize the board of directors to amend our bylaws without the assent or vote of stockholders, provided
that, from and after the Trigger Event, stockholders may amend the bylaws with the affirmative vote of the holders of at least 66 2/3%
in voting power of all the then-outstanding shares of our common stock entitled to vote thereon, voting together as a single class from,
and after the Trigger Event and with the exception of actions required or permitted to be taken by the holders of preferred stock, prohibit
stockholder action by written consent unless such action is recommended by all directors in office, instead requiring stockholder actions
to be taken at a meeting of our stockholders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· permit our board of directors, without further action by our stockholders, to fix the rights, preferences,
privileges and restrictions of preferred stock, the rights of which may be greater than the rights of our common stock;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· restrict the forum for certain litigation against us to Delaware;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· establish advance notice requirements for nominations for election to our board of directors or for proposing
matters that can be acted upon by stockholders at annual stockholder meetings; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· provide for a staggered board.

Further, as a Delaware corporation, we are subject to provisions of Delaware law, which may impede or discourage a takeover attempt that our stockholders may find beneficial. These anti-takeover provisions and other provisions under Delaware law could discourage, delay or prevent a transaction involving a change in control of our Company, including actions that our stockholders may deem advantageous, or negatively affect the trading price of our common stock. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing and to cause us to take other corporate actions you desire. For further discussion of these and other such anti-takeover provisions, see "Description of Our Securities—Anti-Takeover Effects of Various Provisions of Delaware Law, Our Amended and Restated Certificate of Incorporation and Our Amended and Restated Bylaws."

***The provisions of our amended and restated certificate of incorporation will require exclusive forum in certain courts in the State of Delaware or the federal district courts of the U.S. for certain types of lawsuits may have the effect of discouraging lawsuits against our directors and officers.***

 ****

Our amended and restated certificate of incorporation will provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will, to the fullest extent permitted by law, be the sole and exclusive forum for: (i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a breach of fiduciary duty owed by any of our directors, officers, other employees or stockholders to us or our stockholders, creditors or other constituents, or a claim of aiding and abetting any such breach of fiduciary duty; (iii) any action asserting a claim against us or our directors or officers arising pursuant to any provision of the Delaware General Corporation Law (the "DGCL") or our amended and restated certificate of incorporation or the bylaws (as either may be amended and/or restated from time to time) or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware; (iv) any action to interpret, apply, enforce or determine the validity of our amended and restated certificate of incorporation or bylaws (as either may be amended and/or restated from time to time); (v) any action asserting a claim against us or our directors or officers that is governed by the internal affairs doctrine; or (vi) any action asserting an "internal corporate claim" as that term is defined in Section 115 of the DGCL; provided, however, that, in the event that the Court of Chancery of the State of Delaware lacks subject matter jurisdiction over any such action or proceeding, any other state court of the State of Delaware, or if no state court of the State of Delaware has subject matter jurisdiction, the federal district court for the District of Delaware, will be the forum. The foregoing provision will not apply to claims arising under the Securities Act or the Exchange Act.

Any person or entity purchasing or otherwise acquiring any interest in any shares of our capital stock shall be deemed to have notice of and to have consented to the forum provisions in the amended and restated certificate of incorporation. Although we believe these exclusive forum provisions benefit us by providing increased consistency in the application of Delaware law and federal securities laws in the types of lawsuits to which each applies, the exclusive forum provisions may limit a stockholder's ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers or stockholders or result in increased costs for a stockholder to bring a claim, which may discourage lawsuits with respect to such claims.

Further, in the event a court finds either exclusive forum provision contained in our amended and restated certificate of incorporation to be unenforceable or inapplicable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, financial condition and results of operations.

**USE OF PROCEEDS**

We estimate that the net proceeds from this offering will be approximately $ million, or approximately $ million if the underwriters exercise their over-allotment option to purchase additional shares of common stock in full, assuming an initial public offering price of $ per share (which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

We intend to use the net proceeds from this offering to commercialize our investigational drug candidate BIV201 (continuous infusion terlipressin) and for other general corporate purposes.

We believe that the net proceeds from this offering, together with our existing cash, cash equivalents and investments, will be sufficient to fund our current operations for at least twelve months from the date of this prospectus. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. We believe the amount of net proceeds from this offering will be sufficient to fund BIV201 through Phase 3 clinical development. We will need to raise substantial additional funds to complete registration trials before we can expect to commercialize any products, if approved. We may satisfy our future cash needs through the sale of equity securities, debt financings, working capital lines of credit, corporate collaborations or license agreements, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources. The amount and timing of our actual expenditures will depend upon numerous factors, including the status and results of our clinical trials.

The amounts and timing of our actual expenditures will depend on numerous factors, including the success of our research and development efforts, the FDA process, the amounts of proceeds actually raised in this offering and the amount of cash generated by our operations. Our management will have broad discretion to allocate the net proceeds from this offering.

Each $1.00 increase (decrease) in the assumed public offering price of $ per share of common stock would increase (decrease) net proceeds to us by approximately $ million (or $ million if the underwriters exercise their over-allotment option to purchase additional shares of common stock in full), assuming the number of shares of common stock we sell, as set forth on the cover page of this prospectus, remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us. Similarly, each increase (decrease) of shares of common stock offered by us would increase (decrease) the net proceeds to us by $ million, assuming the assumed public offering price remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us.

**DIVIDEND POLICY**

We have not declared or paid any cash dividends on our common stock to date. We may retain future earnings, if any, for future operations, expansion and debt repayment and have no current plans to pay cash dividends for the foreseeable future. Any decision to declare and pay dividends in the future will be made at the discretion of our board of directors and will depend on, among other things, our results of operations, financial condition, cash requirements, contractual restrictions and other factors that the board may deem relevant and subject to applicable laws and the restrictions contained in any future financing instruments. We do not anticipate declaring any cash dividends to holders of our common stock in the foreseeable future.

**CAPITALIZATION**

The following table sets forth our capitalization as of June 30, 2025:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· on an actual basis; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· on an as adjusted basis to give effect to the sale of 
shares of common stock in this offering (excluding the exercise of the underwriters' over-allotment option to purchase additional
shares of common stock) at the assumed public offering price of $
per share of common stock (which is the midpoint of the price range set forth on the cover page of this prospectus) and the application
of the net proceeds therefrom, after deducting the underwriting discounts and commissions and the estimated offering expenses.

 

The cash and capitalization information in the following table may not necessarily reflect what our cash and capitalization would have been had we been operating as a standalone company as of June 30, 2025. In addition, the cash and capitalization information in the following table may not necessarily reflect what our cash and capitalization may be in the future.

This table should be read in conjunction with the "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Use of Proceeds" sections, as well as our audited carve-out financial statements, included elsewhere in this prospectus.

---

| | | |
|:---|:---|:---|
|  | **As of June 30, 2025** | **As of June 30, 2025** |
|  | **Actual<br> (audited)** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**As adjusted**<br> &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(unaudited)** |
| Cash and cash equivalents | $— | $|
| Total Liabilities | 127217 |  |
| Stockholders' Equity: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Common stock |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in capital |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive loss |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accumulated deficit |  |  |
| Total parent's net investment/stockholders' equity | $889910 | $|
| Total capitalization | $1017127 | $|

---

**DILUTION**

If you invest in our common stock in this offering, your interest will be immediately diluted to the extent of the difference between the public offering price per share of common stock in this offering and the adjusted net tangible book value per share of common stock after this offering. Dilution results from the fact that the public offering price per share of common stock is substantially in excess of the net tangible book value per share of common stock. As of June 30, 2025, we had a net tangible book value of $ per share of common stock. Our net tangible book value per share represents total tangible assets less total liabilities, divided by the number of shares of common stock outstanding on June 30, 2025.

After giving effect to the sale of common stock in this offering at an assumed public offering price of $ per share of common stock (which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the estimated underwriting discounts and commissions and estimated offering expenses, our as adjusted net tangible book value as of June 30, 2025 would have been $ per share of common stock. This represents an immediate decrease in as adjusted net tangible book value of $ per share of common stock to our existing stockholder, BioVie, and immediate dilution of $ per share of common stock to new investors.

The following table illustrates this dilution per share of common stock:

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| | |
|:---|:---|
| Assumed public offering price per share of common stock | $|
| Historical net tangible book value per share of common stock as of June 30, 2025 | $— |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Decrease as adjusted net tangible book value per share of common stock after this offering | $— |
| As adjusted net tangible book value per share of common stock after this offering | $|
| Dilution per share of common stock to new investors participating in this offering | $|

---

If the underwriters' over-allotment option to purchase additional shares of common stock is exercised in full, the as adjusted net tangible book value will increase to $ per share of common stock, representing an immediate increase in further as adjusted net tangible book value to the existing stockholder, BioVie, of $ per share of common stock and an immediate dilution of $ per share of common stock to new investors participating in this offering.

We may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our equity holders.

The dilution information discussed above is illustrative only and will change based on the actual initial public offering price and other terms of this offering determined at pricing. A $ increase in the assumed public offering price of $ per share of common stock would increase our as adjusted net tangible book value after this offering by $ per share of common stock and would increase dilution to new investors by $ per share of common stock. An increase of in the number of shares of common stock we are offering would increase our as adjusted net tangible book value after this offering by $ per share and would decrease dilution to new investors by $ per share of common stock, assuming the assumed public offering price per share remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us. A decrease of in the number of shares of common stock we are offering would increase our as adjusted net tangible book value after this offering by $ per share of common stock and would decrease dilution to new investors by $ per share of common stock, assuming the assumed public offering price per share remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us.

The following table summarizes, on the as adjusted basis described above as of June 30, 2025, the differences between the number of shares of common stock purchased from us, the total consideration and the price per share paid by our existing stockholder, BioVie, and by investors participating in this offering at an assumed initial public offering price of $ per share of common stock (the midpoint of the price range set forth on the cover page of this prospectus), before deducting the underwriting discount and estimated offering expenses payable by us.

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
|  | **Shares Purchased** | **Shares Purchased** | **Total Consideration<br> (In thousands)** | **Total Consideration<br> (In thousands)** | |
|  | **Number** | **Percent** | **Amount** | **Percent** | **Weighted-<br> Average<br> Price Per**<br>**Share** |
| Existing stockholder, BioVie (1)% |  |  | $— | —% | $— |
| Investors participating in this offering |  | % | $— | 100.0% | $— |
| Total |  | 100.0% | $— | 100.0% | $— |

---

(1) Total consideration represents the pro forma book value of
the net assets being transferred to us by BioVie in connection with the Separation.

A $ increase in the assumed initial public offering price of $ per share of common stock would increase total consideration paid by new investors by $ million, assuming that the number of shares offered by us remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us. An increase of in the number of shares of common stock we are offering would increase total consideration paid by new investors by $ million, assuming that the assumed initial public offering price remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us.

The table above assumes no exercise of the underwriters' over-allotment option in this offering. If the underwriters' over-allotment option is exercised in full, the number of common shares held by new investors purchasing common stock in this offering would be increased to % of the total number of shares of common stock outstanding after this offering, and the number of shares of common stock held by existing stockholders would be reduced to % of the total number of shares of common stock outstanding after this offering.

To the extent that we issue additional common stock in the future, there will be future dilution to investors participating in this offering. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

**BUSINESS**

**Overview**

We are a clinical-stage company developing innovative drug therapies to treat chronic debilitating liver disease through our investigational drug candidate BIV201 (continuous infusion terlipressin). BIV201 has been granted both FDA Fast Track designation status and FDA Orphan Drug Status and is being evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by non-alcoholic steatohepatitis ("NASH"), hepatitis, and alcoholism. BIV201 is administered as a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile and India, to date.

**About Liver Cirrhosis**

Liver cirrhosis causes a heavy global burden. There are an estimated 4.8 million people diagnosed with chronic liver disease and cirrhosis in the United States and 54,803 deaths annually, ranking 10<sup>th</sup> in causes of death. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity. Between 2012 and 2018, the prevalence of liver cirrhosis doubled among insured patients in the United States, alcohol-related and NASH cirrhosis were the most significant contributors to this increase. Additionally, the number of deaths from alcoholic cirrhosis more than tripled between 1999 and 2019, rising from 3.3 deaths per 100,000 to 10.6 deaths per 100,000.

Individuals with cirrhosis are at high risk of developing complications which include ascites, variceal bleeding, hepatic encephalopathy, AKI and bacterial infections, the development of which define decompensated cirrhosis, and the increased prevalence of cirrhosis is expected to result in increased incidence of cirrhosis complications. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. Decompensated cirrhosis is an advanced stage of cirrhosis often associated with liver failure and is associated with worse survival rates (2-4 years) compared with compensated cirrhosis (10-15 years). The majority of decompensated patients have ascites and are frequently hospitalized for complications. In 2014 approximately 100,000 individuals with cirrhosis and ascites were hospitalized in the United States with about one quarter being readmitted within 30 days. Assuming at least a doubling of this population in the past 10 years, as was seen from 2012 to 2018, the estimated target population is about 200,000. Those with ascites and AKI experience higher readmission rates and have a poor prognosis: the development of AKI is strongly associated with mortality and can increase risk of death 5-fold.

Decompensated liver cirrhosis currently has no approved therapeutic options other than liver transplantation. There is thus a major gap in effective, long-term, and accessible treatments for patients with decompensated liver disease and ascites. The paradigm for the treatment of these patients is now changing from attempts to control ascites towards the goal of preventing further decompensation and mortality. The recent news that the PRECIOSA study, evaluating whether albumin infusions improve mortality, transplant-free survival, and disease-related outcomes in decompensated patients, failed to meet its primary endpoint, most certainly highlights the urgent need for more research and investment in this challenging population.

**The Need for Therapy**

A reduction in complications in decompensated patients could lead to a decrease in the risk of hospitalization, reducing health care burden and costs, and increase the chance of survival. In addition, these complications may make this population ineligible for liver transplantation. There is currently no approved drug treatment to reduce ascites and complications and preserve renal function in patients with cirrhosis and ascites. A recent Phase 3 study evaluating the potential for frequent albumin infusions to improve outcomes transplant-free survival, mortality and complications in this patient population failed to meet its primary endpoint.

U.S. treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $5 billion annually. Treating decompensated cirrhosis and complications like ascites and AKI increase the costs of treatment significantly in the first year.

**Pathophysiology of Decompensated Cirrhosis**

Most experts agree that ascites and other complications develop as a consequence of high blood pressure in the vein that supplies blood to the liver. This so-called "portal hypertension" occurs as increasing liver damage (fibrosis) impedes blood flow through the liver. This causes vasodilation and blood pooling in the central or "splanchnic" region of the body and low blood volume in the arteries. The decrease in effective blood volume activates a signaling pathway ("neurohormonal systems") which tells the kidneys to retain large amounts of salt and water in an effort to increase blood volume. Ultimately the retention of excess sodium and water leads to the formation of ascites as these substances "weep" from the liver and lymph system and collect in the patient's abdomen as ascites. Portal hypertension also leads to the development of hepatic encephalopathy, gastrointestinal bleeding, and hepatorenal syndrome and increases the risk of AKI.

**BIV201 Proposed Mechanism of Action**

The vasoconstrictor terlipressin, an agonist of vasopressin receptors, reduces splanchnic vasodilation associated with portal hypertension in patients with cirrhosis and can lead to a decrease in ascites production by reducing portal hypertension, increasing effective blood volume and decreasing the activity of the renin-angiotensin-aldosterone system (RAAS). Increasing evidence suggests that terlipressin, administered as a continuous infusion on an outpatient basis, can be a well-tolerated effective treatment to improve clinical outcomes in patients with cirrhosis requiring paracentesis. By targeting the pathophysiology that predisposes these patients to AKI and by reducing potential triggers for AKI (paracentesis, SBP, portal-hypertension-related GI bleeding and reduction in the need for diuretics), BIV201 can potentially reduce ascites and the incidence of further decompensation events, including AKI, and subsequently improving patient outcomes.

In liver disease, the initial target for BIV201 therapy was refractory ascites in patients with cirrhosis. These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.

BIV201 is a continuous infusion of terlipressin, a drug used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal varices) that was approved in the U.S. in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function) but is not approved in Japan. With its novel room temperature stable formulation in a pre-filled syringe and potentially other containers, we believe BIV201 could potentially provide a superior terlipressin drug delivery system throughout the world. The goal of BIV201 therapy is to target the pathophysiology that contributes to ascites production, AKI and complications of cirrhosis that are associated with significant mortality.

After two Phase 2 studies BioVie received guidance from the FDA in June 2023 and December 2024, regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites. The Company is currently finalizing the protocol for a randomized, placebo-controlled Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from AKI. This patient population is not limited to those having refractory ascites.

In an open-label Phase 2a trial (NCT03107091) initiated in 2017, six patients with cirrhosis and refractory ascites received a continuous IV infusion of terlipressin 2 mg/day escalating to 4 mg/d during a 7-day inpatient period, followed by 21 days as outpatients. The PK and safety/tolerability and effects on the need for and volume of paracentesis were evaluated. Four of 6 patients enrolled experienced ≥50% increase in the interval between large volume paracenteses (LVP) with terlipressin. Three (50.0%) patients reported treatment-related adverse events, but none were serious. Based on this study, continuous IV infusion of terlipressin improved control of refractory ascites with an acceptable safety and predictable PK profile and further evaluation of terlipressin was deemed warranted in a randomized controlled trial for treating refractory ascites and related complications of cirrhosis.

In June 2021, BioVie initiated a randomized (2:1), open-label Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 for the treatment of refractory ascites. Patients with cirrhosis and refractory ascites were randomly assigned (2:1) to receive two 28-day cycles of continuous infusion BIV201 plus standard of care (SOC) separated by a ≤56-day washout (n=10), or SOC alone (n=5).The primary endpoints of the study were the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period. By October 12, 2022, there were 15 patients enrolled for treatment and the last patient completed treatment on May 8, 2023. In March 2023, enrollment was paused and that data from the first 10 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period. Final data analysis was limited by the small sample size and confounded by a potential interaction with gabapentinoids in the BIV201+SOC group. Nonetheless, there were differences in favor of BIV201+SOC versus SOC in the coprimary efficacy endpoints and several QoL assessments. The beneficial effects of BIV201 on liver complications (mean: 90% CI; BIV201-completers=2.87: 1.51; 5.46 vs. SOC=2.38: 1.20; 4.73) and the change in cumulative ascites (mean; 90% CI; BIV201-completers=-10.76: -26.51; 5.00 vs. SOC=-4.99: -21.95; 11.97) were more pronounced versus SOC in the 5 BIV201+SOC patients who completed both treatment cycles. There were also greater improvements in exploratory QoL assessments and the percent change in TPs with BIV201+SOC (-27.94±41.80) versus SOC (-16.67±45.64). Despite the high rate of hyponatremia in the BIV201+SOC group (4/10 patients), the safety profile suggested that continuous BIV201 infusion was well tolerated. These findings support further development of BIV201 in confirmatory trials.

Our proprietary novel liquid formulation of terlipressin is designed to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute the current powder version of terlipressin. To date, analytical testing results have confirmed room temperature stability of the prefilled syringe in storage for 2 years. Room temperature storage presents a key product differentiation versus terlipressin products in countries where the drug is approved. To the best of the Company's knowledge, all other terlipressin products sold globally must be stored under refrigeration and there is no prefilled syringe format of terlipressin available for treating patients in these countries. BioVie has also filed a Patent Cooperation Treaty ("PCT") application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and to date patents have been granted in the U.S. (Patent No. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68965), China (Patent No. ZL 202080050758.X), and Japan (7579811).

We believe BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis, and alcoholism. The FDA has granted Fast-Track status and Orphan Drug designation for ascites (due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical need. Patients with cirrhosis and ascites account for an estimated 116,000 U.S. hospital discharges annually, with frequent early readmissions. According to the HCUP Nationwide Readmissions Database 2016, those requiring paracentesis (removal of ascites fluid) experience an average hospital stay lasting eight days incurring over $86,000 in medical costs. This translates into a total potentially addressable ascites market size for BIV201 therapy exceeding $650 million based on Company estimates. The Company's forecasts for BIV201 shows peak annual sales of $1.2 billion in U.S. sales for refractory ascites, and the agreed-upon approach for conducting the registrational Phase 3 would lead to earlier treatment of patients and expand the market opportunity further.

The FDA has never approved any drug specifically for treating ascites. After receiving guidance from FDA in 2023 and again in 2025, the Company is finalizing the protocol design for a Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from AKI.

The BIV201 development program was initiated by LAT Pharma LLC. On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. Pursuant to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will be obligated to pay 5.0% on net sales of BIV201 to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

**Future Possible BIV201 Indications**

Based on international investigative studies of the active agent in BIV201, terlipressin, we believe our drug candidate has potential future applications in other life-threatening conditions due to liver cirrhosis that are Orphan indications including HRS-AKI and bleeding esophageal varices. Orhan drugs in this therapeutic area command premium pricing with Terlivaz costing more than $20,000 for 6 days of treatment for HRS-AKI. Securing marketing approvals for any of these new uses will require well-controlled clinical trials to satisfy the FDA and/or other countries' regulatory requirements, none of which have commenced at this time.

**Intellectual Property**

BioVie relies on a combination of patent, trade secret, other intellectual property laws (such as FDA data exclusivity), nondisclosure agreements, and other measures to protect our proposed products. We require our employees, consultants, and advisors to execute confidentiality agreements and to agree to disclose and assign to us all inventions conceived during the workday, using our property, or which relate to our business. Despite any measures taken to protect our intellectual property (IP), unauthorized parties may attempt to copy aspects of our products or to obtain and use information that we regard as proprietary.

BIV201 was awarded Orphan Drug Designations in the U.S. for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites due to all etiologies except cancer on September 8, 2016. We also filed a PCT application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and are seeking patent protection in U.S., Europe, China, Japan and other jurisdictions. To date patents have been granted in U.S. (Patent No. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68965), China (Patent No. ZL 202080050758.X), and Japan (7579811). Also, we own U.S. Patent 11,364,277, and European patent EP3347032, which is directed to a method of treating ascites with BIV201, and we are pursuing additional patent coverage in U.S., Japan, Europe, and China.

**Government Regulation**

Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of products such as those we are developing. Any pharmaceutical candidate that we develop must be approved by the FDA before it may be legally marketed in the United States and by the appropriate foreign regulatory agency before it may be legally marketed in foreign countries.

***United States Drug Development Process***

In the United States, the FDA regulates the development of drugs and biologic products under the Federal Food, Drug and Cosmetic Act ("FDCA") and the Public Health Services Act ("PHSA"), respectively. Drugs, biologics and medical devices are also subject to other federal, state and local statutes and regulations.

Biologics are subject to regulation by the FDA under the FDCA, the PHSA and related regulations, and other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require 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.

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 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 inspections 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 control. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject inclusion and exclusion criteria, and the parameters to be used to monitor subject safety. Each protocol must be submitted to the FDA as part of the IND. Clinical trials must be conducted in accordance with the FDA's cGCP requirements. Further, each clinical trial must be reviewed and approved by an independent institutional review board ("IRB"), at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until it is completed.

Human clinical trials prior to approval are typically conducted in three sequential phases that may overlap or be combined:

*●* *Phase 1.* The drug or biologic is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients having the specific disease.

*●* *Phase 2.* The drug or biologic is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine optimal dosage and dosing schedule for patients having the specific disease.

*●* *Phase 3.* Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials, which usually involve more subjects than earlier trials, are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or BLA.

Post-approval studies, or Phase 4 clinical trials, may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication and may be required by the FDA as part of the approval process.

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA by the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's requirements or if the drug or biologic has been associated with unexpected serious harm to patients.

Concurrent with clinical trials, companies usually complete additional animal studies and develop additional information about the chemistry and physical characteristics of the drug or biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug or biological candidate and, among other things, must include methods for testing the identity, strength, quality and purity of the final drug or biologic. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug or biological candidate does not undergo unacceptable deterioration over its shelf life.

***U.S. Review and Approval Processes***

The results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug or biologic, proposed labeling and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market the product. The submission of an NDA or BLA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain limited circumstances.

The FDA reviews all NDAs and BLAs submitted before it accepts them for filing and may request additional information rather than accepting an NDA or BLA for filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA or BLA.

After the NDA or BLA submission is accepted for filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product's identity, strength, quality and purity. The FDA reviews a BLA to determine, among other things, whether the product is safe, pure and potent and the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product's continued safety, purity and potency. In addition to its own review, the FDA may refer applications for novel drug or biological products or drug or biological products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the approval process, the FDA also will determine whether a risk evaluation and mitigation strategy, or REMS, is necessary to assure the safe use of the drug or biologic. If the FDA concludes that a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS; the FDA will not approve the NDA or BLA without a REMS, if required.

Before approving an NDA or BLA, the FDA will inspect the facilities at which the product is to be manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with cGMP. If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable it will outline the deficiencies in the submission and often will request additional testing or information.

The NDA or BLA review and approval process is lengthy and difficult and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical data or other information. Even if such data and information is submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA will issue a "complete response" letter if the agency decides not to approve the NDA or BLA. The complete response letter describes all of the specific deficiencies in the NDA or BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant might take to place the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

If a product receives regulatory approval, the approval may be limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. In addition, the FDA may require Phase 4 testing which involves clinical trials designed to further assess a product's safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.

***Orphan Drug Designation***

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product. Orphan product designation must be requested before submitting an NDA or BLA. After the FDA grants orphan product designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

If a product that has Orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Competitors, however, may receive approval of different products for the indication for which the Orphan product has exclusivity or obtain approval for the same product but for a different indication for which the Orphan product has exclusivity. Orphan product exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval of the same drug or biological product as defined by the FDA or if our drug or biological candidate is determined to be contained within the competitor's product for the same indication or disease. If a drug or biological product designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan product exclusivity. Orphan Drug status in the European Union has similar but not identical benefits in the European Union.

***Expedited Development and Review Programs***

The FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new drug and biological products that meet certain criteria. Specifically, new drug and biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. Unique to a Fast Track product, the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA or BLA, the FDA agrees to accept sections of the NDA or BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA or BLA.

Any product submitted to the FDA for marketing approval, including those submitted to a Fast Track program, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. Any product is eligible for priority review if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention of a disease compared with marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new drug or biological product designated for priority review in an effort to facilitate the review. Additionally, a product may be eligible for accelerated approval. Drug or biological products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval, which means that they may be approved on the basis of adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA generally requires that a sponsor of a drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies to establish safety and efficacy for the approved indication. Failure to conduct such studies or conducting such studies that do not establish the required safety and efficacy may result in revocation of the original approval. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch or subsequent marketing of the product. Fast Track designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process.

***Post-Approval Requirements***

Any drug or biological products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information on an annual basis or as required more frequently for specific events, product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, prohibitions against promoting drugs and biologics for uses or in patient populations that are not described in the drug's or biologic's approved labeling (known as "off-label use"), rules for conducting industry-sponsored scientific and educational activities, and promotional activities involving the internet. Failure to comply with FDA requirements can have negative consequences, including the immediate discontinuation of noncomplying materials, adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties. Although physicians may prescribe legally available drugs and biologics for off-label uses, manufacturers may not market or promote such off-label uses.

We will need to rely on third parties for the production of our product candidates. Manufacturers of our product candidates are required to comply with applicable FDA manufacturing requirements contained in the FDA's cGMP regulations. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of comprehensive records and documentation. Drug and biologic manufacturers and other entities involved in the manufacture and distribution of approved drugs and biologics are also required to register their establishments and list any products made there with the FDA and comply with related requirements in certain states, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in serious and extensive restrictions on a product, manufacturer, or holder of an approved NDA or BLA, including suspension of a product until the FDA is assured that quality standards can be met, continuing oversight of manufacturing by the FDA under a "consent decree," which frequently includes the imposition of costs and continuing inspections over a period of many years, and possible withdrawal of the product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

The FDA also may require post-marketing testing, known as Phase 4 testing, risk minimization action plans and surveillance to monitor the effects of an approved product or place conditions on an approval that could otherwise restrict the distribution or use of the product.

**Human Capital Resources**

Pursuant to the terms of the management services agreement, BioVie will provide us with the services of certain of its executive officers and other employees in exchange for a quarterly fee. All salaries and compensation to such persons will be paid by BioVie. We will have no executive officers or other employees directly employed by us upon the consummation of this offering. We will also rely on a team of highly experienced scientific, medical, and regulatory consultants to conduct product development activities.

**Properties**

The Company pays an annual rent of $1,800 for its headquarters at 680 W. Nye Lane, Suite 201, Carson City, Nevada 89703. The rental agreement is for a one-year term that commenced on May 1, 2025. We consider this facility adequate for our current operations.

**Corporate History**

We were incorporated as a Delaware corporation on May 1, 2025. Our principal executive offices are located at 680 W. Nye Lane, Suite 201, Carson City, Nevada 89703 and our telephone number is (775) 888-1664. Our principal website address is . Information contained in, or accessible through, our website is not part of, and is not incorporated into, this prospectus, and you should not rely on any such information in making an investment decision to purchase shares of our common stock.

**Legal Proceedings**

From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. We are not party to or aware of any proceedings that we believe could have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors.

**THE SEPARATION TRANSACTION**

We currently are, and at all times prior to the completion of this offering will be, a wholly owned subsidiary of BioVie, and all our outstanding shares of common stock are owned by BioVie. As a result, we have never operated as a standalone company. Upon the completion of this offering, we expect that BioVie will own % of our outstanding common stock (or % if the underwriters' over-allotment option is exercised in full).

Prior to the completion of this offering, we will enter into various agreements with BioVie that provide for certain transactions and arrangements to effect the Separation and provide a framework for our relationship with BioVie following the Separation, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;· *Separation Agreement —* We and BioVie will enter into a separation agreement that will
set forth the agreements between us and BioVie regarding the principal transactions required to effect the Separation and this offering,
and other agreements governing the relationship between BioVie and us following the completion of this offering.

&nbsp;&nbsp;&nbsp;&nbsp;· *Management Services Agreement —* We and BioVie will enter into a management services agreement that will address
certain services to be performed by BioVie and certain of its executive officers and other employees to support our operations following
the completion of this offering in exchange for a quarterly fee.

&nbsp;&nbsp;&nbsp;&nbsp;· *Registration Rights Agreement —* We and BioVie will enter into a registration rights agreement, pursuant to which
we will grant BioVie and its affiliates certain registration rights with respect to shares of common stock owned by them.

See "Certain Relationships and Related Party Transactions—Agreements to be Entered into in Connection with the Separation" for a more detailed discussion of the agreements described above.

All agreements relating to the Separation will be made in the context of a parent-subsidiary relationship and will be entered into in the overall context of the Separation. The terms of these agreements may be more or less favorable to us than if they had been negotiated with unaffiliated third parties. See "Risk Factors—Risks Related to the Separation and Our Relationship with BioVie—We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with BioVie."

We believe, and BioVie has advised us that it believes, that the Separation and this offering will provide a number of benefits to our business and BioVie's business. These intended benefits include:

&nbsp;&nbsp;&nbsp;&nbsp;· improving the strategic and operational flexibility of each company;

&nbsp;&nbsp;&nbsp;&nbsp;· providing each company with a unique and more efficiently valued equity currency to commercialize their
respective drug candidates and other capital needs;

&nbsp;&nbsp;&nbsp;&nbsp;· allowing each company to adopt the capital structure, investment policy and dividend policy best suited
to its financial profile and business needs; and

&nbsp;&nbsp;&nbsp;&nbsp;· enabling investors to invest directly in each company.

However, we cannot assure you that we will be able to achieve these and other anticipated benefits of the Separation, and the benefits of the Separation may be delayed or not occur at all. See "Risk Factors—Risks Related to the Separation—We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely affect our business, results of operations or financial condition."

**MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS**

*The following discussion and analysis of the financial condition and results of our operations should be read in combination with our financial statements and the notes to those statements appearing elsewhere in this prospectus. This discussion and analysis contains forward-looking statements reflecting our management's current expectations that involve risks, uncertainties and assumptions. See the section entitled "Forward-Looking Statements." Our actual results and the timing of events may differ materially from those described in or implied by these forward-looking statements due to a number of factors, including those discussed below and elsewhere in this prospectus, particularly those set forth under "Risk Factors."*

**Overview**

We are a clinical-stage company developing innovative drug therapies to treat chronic debilitating liver disease through our investigational drug candidate BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.

**The Separation**

Prior to the completion of this offering, we will enter into various agreements with BioVie that provide for certain transactions and arrangements to effect the Separation and provide a framework for our relationship with BioVie following the Separation, as further described in the section of this prospectus entitled "Certain Relationships and Related Party Transactions—Agreements to be Entered into in Connection with the Separation."

**Results of Operations**

***Comparison of the Years Ended June 30, 2025 and 20****24*

 

*Net Loss*

The net loss was approximately $1.2 million and $1.9 million for the years ended June 30, 2025 and 2024, respectively. The decrease in net loss of approximately $716,000 was comprised primarily of decreased research and development expenses of approximately $674,000.

Total operating expenses were the same as the net loss of approximately $1.2 million and $1.9 million for the years ended June 30, 2025 and 2024, respectively.

*Research and Development Expenses*

Research and development expenses were approximately $488,000 and $1.2 million for the year ended June 30, 2025, and 2024, respectively. The net decrease of approximately $674,000, was primarily attributed to the Phase 2b Ascites study that completed in the prior fiscal year.

*General and Administrative Expenses*

General and administrative expenses were approximately $507,000 for the year ended June 30, 2025 and was comparable to $549,000 for the year ended June 30, 2024.

**Capital Resources and Liquidity**

As of June 30, 2025, the Company had working capital of approximately $366,000, and BioVie's net investment was approximately $890,000. Additionally, the Company had a net loss of approximately $1.2 million and net cash used in operating activities of approximately $1.2 million during the year ended June 30, 2025, which was funded by BioVie. In addition, the Company has not generated any revenues to date and no revenues are expected in the foreseeable future. Following the Separation, our capital structure and sources of liquidity will change from our historical capital structure. The Company's future operations are dependent on the success of the Company's ongoing development and commercialization efforts, as well as its ability to secure additional financing as needed. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

Although management continues to pursue the Company's strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company's ability to continue as a going concern. The financial statements included elsewhere in this prospectus do not include any adjustments that might result from the outcome of this uncertainty.

**Emerging Growth Company Accounting Election**

Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can choose not to take advantage of the extended transition period and comply with the requirements that apply to non-emerging growth companies, and any such election to not take advantage of the extended transition period is irrevocable. The Company is an "emerging growth company" as defined in Section 2(A) of the Securities Act and has elected to take advantage of the benefits of this extended transition period.

The Company expects to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public business entities and non-public business entities until the earlier of the date the Company (a) is no longer an emerging growth company or (b) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. This may make it difficult or impossible to compare the Company's financial results with the financial results of another public company that is either not an emerging growth company or is an emerging growth company that has chosen not to take advantage of the extended transition period exemptions because of the potential differences in accounting standards used.

In addition, the Company may rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, if, as an emerging growth company, the Company relies on such exemptions, the Company will not be required to, among other things: (a) provide an auditor's attestation report on the Company's system of internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; (b) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act; (c) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements (auditor discussion and analysis); or (d) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer's compensation to median employee compensation.

The Company will remain an emerging growth company under the JOBS Act until the earliest of (a) the last day of the Company's first fiscal year following the fifth anniversary of its initial public offering, (b) the last date of the Company's fiscal year in which the Company has total annual gross revenue of at least $1.235 billion, (c) the date on which the Company is deemed to be a "large accelerated filer" under the rules of the SEC with at least $700.0 million of outstanding securities held by non-affiliates or (d) the date on which the Company has issued more than $1.0 billion in non-convertible debt securities during the previous three years.

**Contractual Obligations and Commitments**

*Royalty Agreements*

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, by and between BioVie's predecessor entities, LAT Pharma and NanoAntibiotics, Inc., BioVie was obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. The assignment of this royalty agreement to the Company will be effected upon completion of this offering.

Pursuant to the Technology Transfer Agreement entered into on July 25, 2016, by and between BioVie and the University of Padova (Italy), BioVie was obligated to pay a low single digit royalty on net sales of all terlipressin products covered by US patent No. 9,655,645 and any future foreign issuances, capped at a maximum of $200,000 per year. The assignment of this technology transfer agreement to the Company will be effected upon completion of this offering.

**Critical Accounting Policies and Estimates**

*Allocation of Shared Expenses*

 

Management adopted a proportional cost method to carve-out BioVie expenses to the Company. The method calculates the appropriate share of general and administrative expenses to be allocated based on activities directly related to BIV201 relative to other BioVie activities. The Company believes the methodology used was reasonable and has been consistently applied, and results in an appropriate reflection of costs of the activities for the periods presented in the accompanying financial statements. However, these costs may not be indicative of the total costs the Company would have incurred had the Company been a stand-alone entity, or not indicative of future costs required to operate the Company.

*Research and Development Expenses*

 

Research and development expenses consist primarily of costs associated with the clinical trial of the BIV201 drug candidate, compensation for third party contractors, consultants and personal, Chemistry, Manufacturing and Controls, and other expenses for research and development.

In preparation of the carve-out financial statements, the process involved reviewing vendor agreements and invoices and identifying all vendors directly related to the BIV201 clinical study. The last patient treatment in the BIV201 Phase 2 trial was in May 2023, and the costs incurred since that date were costs involved with the wrap-up of final patient visits, data analysis and evaluation, reports of the study, and the preparation and development of the next phase clinical study for the BIV201 drug candidate. The process included identifying the direct services performed and allocating shared cost, primarily consisting of personnel costs, which were determined by communicating with its personnel and evaluating their level of BIV201 involvement during the reporting periods.

**MANAGEMENT**

**Executive Officers and Directors**

Pursuant to the terms of the management services agreement, BioVie will provide us with the services of certain of its executive officers and other employees to support our operations following the completion of this offering, including its executive officers listed in the table below, in exchange for a quarterly fee. We will have no executive officers or other employees directly employed by us upon the consummation of this offering. The following table also sets forth certain information concerning the individuals who are expected to serve as our directors upon completion of this offering. Unless otherwise stated, the business address of our executive officers and directors is our corporate office of the Company located at 680 W Nye Lane, Suite 201, Carson City, Nevada 89703.

---

| | | |
|:---|:---|:---|
| **Name** | **Age** | **Position** |
| ***Executive Officers:*** |  |  |
| Cuong Do | 59 | Chief Executive Officer of BioVie Inc., Director |
| Joanne Wendy Kim | 70 | Chief Financial Officer of BioVie Inc. |
| Joseph Palumbo | 65 | Chief Medical Officer of BioVie Inc. |
| ***Independent Director Nominees*** |  |  |
| Jim Lang | 60 | Chairman of the Board Nominee |
| Sigmund Rogich | 81 | Independent Director Nominee |
|  |  | Independent Director Nominee |

---

***Cuong Do (Chief Executive Officer of BioVie Inc. and Director)***

Mr. Do has served on BioVie's board of directors since 2016 and was appointed BioVie's Chief Executive Officer ("CEO") and President in 2021. He previously served as President, Global Strategy Group at Samsung from 2015 to 2020. Mr. Do helped set the strategic direction for Samsung's diverse business portfolio. Prior to that, he was the Chief Strategy Officer for Merck from 2011 to 2014, Tyco Electronics from 2009 to 2011, and Lenovo from 2007 to 2009. Mr. Do is a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech and corporate finance practices. He holds a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth.

Mr. Do's qualifications to serve on our Board of Directors are primarily based on his decades of experience as an executive in the pharma, biotech, and other high technology industries and his extensive experience in strategy, corporate finance practice and the development of companies in all stages.

***Joanne Wendy Kim (Chief Financial Officer of BioVie Inc.)***

Ms. Kim has served as BioVie's Chief Financial Officer since 2018. Ms. Kim previously served as Chief Financial Officer ("CFO") for several companies throughout her career, previously with Landmark Education Enterprises, and prior to that, other public entities in the entertainment and financial services industry sectors. She provided interim CFO services to various organizations through Group JWK from 2016 to 2018. In her various roles, Ms. Kim oversaw corporate finance and operational groups, closed eight acquisitions, secured bank financings, developed and implemented new business strategies, managed risk and implemented new financial policies and procedures. As a CPA professional, she advised on accounting transactions, SEC reporting matters and other regulatory matters to clients serving as a Director at BDO USA, LLP's National Office SEC Department and sat the US desk in London for BDO LLP UK Firm in 2008-2016 and as a Senior Manager at KPMG in earlier part of her career. She brings more than 40 years of accounting and finance experience to this position. Ms. Kim earned her BSA in accounting and finance at California State University, Long Beach.

***Joseph Palumbo (Chief Medical Officer of BioVie Inc.)***

Dr. Palumbo has served as our Chief Medical Officer ("CMO") since 2021. Formerly he served as the CMO at Zynerba Pharmaceuticals from July 2019 to October 2021, responsible for clinical operations, development, regulatory, and medical affairs. Prior to his time at Zynerba, Dr. Palumbo held senior worldwide governance roles at Mitsubishi Tanabe Pharma in both the United States and Japan from April 2012 to June 2019, where he led medical science and translational research across multiple therapeutic areas, and guided successful registrational programs for Radicava® (edaravone) for the treatment of Amyotrophic Lateral Sclerosis. From April 2003 to March 2012, Dr. Palumbo was Global Head and Franchise Medical Leader for Psychiatry, and the Interim Head of Global Neuroscience at Johnson & Johnson, where he led the medical teams who achieved successful global registrations for Risperdal® (risperidone); Concerta® (methylphenidate HCL); and Invega® (paliperidone). He was Head of Psychiatry and Neurology at Pharmanet for from April 2002 to April 2003. Dr Palumbo previously held industry positions in European Pharma with Sanofi-Synthelabo from April 1999 to April 2002, Biotech at Cephalon, from April 1997 to April 1998, and from July 1989 to April 2002, he held senior leadership and hospital administration roles at prestigious academic research institutions including Yale, Cornell, and the University of Pennsylvania. He holds a Bachelor of Arts at the University of Pennsylvania and received his Doctor of Medicine at the George Washington University School of Medicine. He was a Biological Sciences Training Program Fellow of the National Institutes of Health and Chief Resident for the Abraham Ribicoff Clinical Neuroscience Research Unit at Yale University. Dr Palumbo has received Board Certification in Psychiatry and Addiction Psychiatry.

***Jim Lang (Independent Director Nominee)***

 ****

Mr. Lang has served as BioVie's Chairman of the Board of Directors since 2023 and has served as BioVie's director since 2016. He is currently CEO of EVERSANA, the leading commercialization services company for the life sciences industry. In five years since he founded EVERSANA, it is now over $1B in revenue, with >7000 employees across 40 global locations. He formerly served as the CEO of Decision Resources Group (DRG), which he transformed into a leading healthcare data and analytics firm. Prior to that, Jim was CEO of IHS Cambridge Energy Research Associates (IHS CERA), a recognized leader in energy industry subscription information products, and formerly the President of Strategic Decisions Group (SDG), a leading global strategy consultancy. Mr. Lang holds a BS summa cum laude in electrical and computer engineering from the University of New Hampshire and an MBA with Distinction from the Tuck School of Business. Jim Lang currently also serves as a Director at OptimizeRX (OPRX), a Nasdaq listed Company.

Mr. Lang's qualifications to serve as Chairman of our Board of Directors are primarily based on his decades of experience as a strategy consultant, broad industry expertise, and senior-level management experience running several healthcare and information technology companies.

***Sigmund Rogich (Independent Director Nominee)***

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Mr. Rogich has served as a director of BioVie since 2020. He is the CEO and President of The Rogich Communications Group and serves on the Board of Keep Memory Alive, a philanthropic organization which raises awareness about brain disorders and Alzheimer's disease. Keep Memory Alive funds clinical trials to advance new treatments for patients with Alzheimer's, Huntington's and Parkinson's disease, as well as multiple sclerosis. Mr. Rogich was formerly the U.S. Ambassador to Iceland. He has served as a senior consultant to Presidents Ronald Reagan and George H.W. Bush. Mr. Rogich serves on multiple boards of directors for charitable causes.

Mr. Rogich's qualifications to serve on our Board of Directors are primarily based on his experience in the Communications sector and philanthropic organization raising awareness about brain disorders. His experience in service as a senior consultant to candidates of the highest office.

***(Independent Director Nominee)***

 ****

**Family Relationships**

There are no familial relationships among our directors and executive officers. Except as described above, none of our other directors or officers is or has been a director or has held any form of directorship in any other U.S. reporting companies. None of our directors or officers has been affiliated with any Company that has filed for bankruptcy within the last five years. We are not aware of any proceedings to which any of our officers or directors, or any associate of any such officer or director, is a party that are adverse to the Company. We are also not aware of any material interest of any of our officers or directors that is adverse to our own interests.

**Board Composition**

Our business and affairs are organized under the direction of the Board. Our amended and restated bylaws will provide that the Board will consist of not less than three members nor more than seven members, the actual number to be determined by the Board from time to time. Upon completion of this offering, the Board will consist of four members. The primary responsibilities of the Board are to provide oversight, strategic guidance, counseling, and direction to our management.

In all elections for directors, every stockholder will have the right to vote the number of shares owned by such stockholders for each director to be elected. A director or the entire Board may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at the election of directors. Vacancies in the Board may be filled by a majority of the directors or by an election either at an annual meeting or at a special meeting of the stockholders called for that purpose. Any directors elected by the stockholders to fill the vacancy shall hold office for the balance of the term for which he or she was elected. A director appointed by the Board to fill the vacancy shall serve until the next meeting of stockholders at which directors are elected.

**Leadership Structure**

Upon completion of this offering, Mr. Jim Lang will serve as Chairman of the Board. Having an independent Chair ensures a greater role for non-management directors in the oversight of the Company and active participation of these directors in setting agendas and establishing priorities and procedures for the work of the Board. In addition, this structure allows the Chief Executive Officer to focus his attention on implementing our strategic plans, while a separate Chair can devote full attention to Board leadership functions. The Board will periodically review our leadership structure and may make such changes in the future as it deems appropriate and in the best interests of the Company and its stockholders. While the Board does not have a lead independent director, the independent directors will meet in executive session regularly without the presence of management.

**Independence of the Board of Directors**

We intend to apply to list our common stock on NYSE under the trading symbol " ". The Board of Directors has determined that three of the members of the Board of Directors qualify as "independent," as defined by the listing standards of NYSE. Consistent with these considerations, after review of all relevant transactions and relationships between each director, or any of the director's family members, and the Company, its senior management and its independent auditors, the Board has determined further that Messrs. Lang, Rogich and are independent under the listing standards of NYSE. In making this determination, the Board of Directors considered that there were no new transactions or relationships between its current independent directors and the Company, its senior management and its independent auditors since last making this determination.

**Controlled Company Exemption**

Upon completion of this offering, BioVie will own more than a majority of the voting power of our issued and outstanding shares of common stock eligible to vote in the election of our directors. As a result, we will be a "controlled company" as defined under the corporate governance rules of and, therefore, will qualify for exemptions from certain corporate governance requirements of NYSE. Accordingly, we will not be required to have a majority of "independent directors" on the Board as defined under the rules of NYSE and we will not be required to have a compensation committee or a nominating and corporate governance committee, in each case composed entirely of independent directors. We intend to take advantage of one or more of these exemptions following the completion of this offering and do not intend to have a compensation committee. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all the corporate governance requirements of NYSE.

The "controlled company" exemption does not modify the independence requirements for the Audit Committee, and we intend to comply with the applicable requirements of the Exchange Act and NYSE within the applicable transition periods.

In the event that we cease to be a "controlled company," we will be required to fully implement the corporate governance requirements of NYSE within the applicable transition periods specified in the rules of NYSE.

**Committees of the Board of Directors**

Upon completion of this offering, the Board will have two standing committees: an audit committee and a nominating and corporate governance committee. Each of our committees will be composed solely of independent directors. The Board will adopt a written charter for each committee and each committee will have the composition and responsibilities described below. The charter of each committee will be available on our website.

***Audit Committee***

Upon completion of this offering, the members of our audit committee will be Messrs. Lang, Rogich and , each of whom is an independent director within the meaning of NYSE rules. Mr. Lang will serve as chair of the audit committee and qualifies as an "audit committee financial expert" as defined by Item 401(h)(2) of Regulation S-K.

The principal functions of the audit committee will include:

&nbsp;&nbsp;&nbsp;&nbsp;· assisting board oversight of (1) the integrity of our financial statements, (2) our compliance
with legal and regulatory requirements, (3) our independent auditor's qualifications and independence, and (4) the performance of
our internal audit function and independent auditors; the appointment, compensation, retention, replacement, and oversight of the work
of the independent auditors and any other independent registered public accounting firm engaged by us;

&nbsp;&nbsp;&nbsp;&nbsp;· pre-approving all audit and non-audit services to be provided by the independent auditors or any other
registered public accounting firm engaged by us, and establishing pre-approval policies and procedures; reviewing and discussing with
the independent auditors all relationships the auditors have with us in order to evaluate their continued independence;

&nbsp;&nbsp;&nbsp;&nbsp;· setting clear policies for audit partner rotation in compliance with applicable laws and regulations;

&nbsp;&nbsp;&nbsp;&nbsp;· obtaining and reviewing a report, at least annually, from the independent auditors describing (1) the
independent auditor's internal quality-control procedures and (2) any material issues raised by the most recent internal quality-control
review, or peer review, of the audit firm, or by any inquiry or investigation by governmental or professional authorities, within the
preceding five years respecting one or more independent audits carried out by the firm and any steps taken to deal with such issues;

&nbsp;&nbsp;&nbsp;&nbsp;· meeting to review and discuss our annual audited financial statements and quarterly financial statements
with management and the independent auditor, including reviewing our specific disclosures under "Management's Discussion and
Analysis of Financial Condition and Results of Operations"; reviewing and approving any related party transaction required to be
disclosed pursuant to Item 404 of Regulation S-K promulgated by the SEC prior to us entering into such transaction; and

&nbsp;&nbsp;&nbsp;&nbsp;· reviewing with management, the independent auditors, and our legal advisors, as appropriate, any legal,
regulatory or compliance matters, including any correspondence with regulators or government agencies and any employee complaints or published
reports that raise material issues regarding our financial statements or accounting policies and any significant changes in accounting
standards or rules promulgated by the Financial Accounting Standards Board, the SEC or other regulatory authorities.

**Compensation Committee Interlocks and Insider Participation**

None of our officers currently serves, or in the past year has served, as a member of the compensation committee of any entity that has one or more officers serving on the Board.

***Nominating and Corporate Governance Committee***

Upon completion of this offering, the members of our nominating and corporate governance committee will be and , each of whom is an independent director within the meaning of NYSE rules. will serve as chair of the nominating and corporate governance committee.

The principal functions of the nominating and corporate governance committee will include:

&nbsp;&nbsp;&nbsp;&nbsp;· identifying, screening and reviewing individuals qualified to serve as directors, consistent with criteria
approved by the Board of Directors, and recommending to the Board of Directors candidates for nomination for election at the annual meeting
of stockholders or to fill vacancies on the Board of Directors;

&nbsp;&nbsp;&nbsp;&nbsp;· developing and recommending to the Board of Directors and overseeing implementation of our corporate governance
guidelines;

&nbsp;&nbsp;&nbsp;&nbsp;· coordinating and overseeing the annual self-evaluation of the Board of Directors, its committees, individual
directors and management in the governance of the company; and

&nbsp;&nbsp;&nbsp;&nbsp;· reviewing on a regular basis our overall corporate governance and recommending improvements as and when
necessary.

The charter will also provide that the nominating and corporate governance committee may, in its sole discretion, retain or obtain the advice of, and terminate, any search firm to be used to identify director candidates, and will be directly responsible for approving the search firm's fees and other retention terms.

We have not formally established any specific, minimum qualifications that must be met or skills that are necessary for directors to possess. In general, in identifying and evaluating nominees for director, the Board considers educational background, diversity of professional experience, knowledge of our business, integrity, professional reputation, independence, wisdom, and the ability to represent the best interests of our stockholders. Prior to our initial business combination, holders of our public shares will not have the right to recommend director candidates for nomination to the Board.

**Board Oversight of Risk**

The Board's primary function will be one of oversight. The Board as a whole will work with our management team to promote and cultivate a corporate environment that incorporates enterprise-wide risk management into strategy and operations. Management will periodically report to the Board about the identification, assessment and management of critical risks and management's risk mitigation strategies. Each committee of the Board will be responsible for the evaluation of elements of risk management based on the committee's expertise and applicable regulatory requirements. In evaluating risk, the Board and its committees will consider whether our programs adequately identify material risks in a timely manner and implement appropriately responsive risk management strategies throughout the organization. The audit committee will focus on assessing and mitigating financial risk, including risk related to internal controls, and receives at least quarterly reports from management on identified risk areas. The nominating and corporate governance committee will consider areas of potential risk within corporate governance and compliance. Each of the committees will report to the Board as a whole as to their findings with respect to the risks they are charged with assessing.

**Code of Ethics**

Prior to the completion of this offering, the Board will adopt a code of conduct and ethics meeting the requirements of Section 406 of the Sarbanes-Oxley Act of 2002. Our code of conduct and ethics will be designed to deter wrongdoing and promote honest and ethical conduct; provide full, fair, accurate, timely and understandable disclosure in public reports; comply with applicable laws; ensure prompt internal reporting of violations; and provide accountability for adherence to the provisions of the code of ethic. Our code of ethics will be accessible on our website. Disclosure regarding any amendments to, or waivers from, provisions of the code of ethics will be included in a Current Report on Form 8-K that will be filed with the SEC within four business days following the date of the amendment or waiver.

**Corporate Governance Guidelines**

Prior to the completion of this offering, the Board will adopt corporate governance guidelines to assist it in guiding our governance practices. Our corporate governance guidelines will be reviewed annually by the nominating and corporate governance committee and may be amended by the Board from time to time. Our corporate governance guidelines will address a number of topics, including responsibilities of the Board, director qualifications, rights of the Board, election of directors, Board committees, Board and Board committee performance evaluations, director orientation, continuing education, executive performance evaluations and succession planning. Our corporate governance guidelines will be available on our website.

**Clawback Policy**

We intend to adopt a compensation recovery policy that is compliant with NYSE rules and regulations, as required by the Dodd-Frank Act, to be effective upon the completion of this offering.

**Stockholder and Interested Party Communications**

Stockholders and interested parties may communicate with the Board, any committee or committee chairperson or the independent directors as a group by writing to the Board, committee, committee chairperson or independent directors in care of the Chairman of the Board at 680 W Nye Lane, Suite 201, Carson City, Nevada 89703. Each communication will be forwarded, depending on the subject matter, to the Board, the appropriate committee or committee chairperson or all independent directors.

**EXECUTIVE COMPENSATION**

We and BioVie will enter into a management services agreement that will address certain services to be performed by BioVie and certain of its executive officers and other employees to support our operations following the completion of this offering in exchange for a quarterly fee. All salaries and compensation to such persons will be paid by BioVie. We will have no executive officers or other employees directly employed by us upon the consummation of this offering. The cost of these services will be negotiated between us and BioVie and may not necessarily be reflective of prices that we could have obtained for similar services from an independent third party. We believe that the terms and conditions of the management services agreement will be more favorable and cost effective to us than if we hired the full staff to operate the Company.

We expect that the executive officers of BioVie will allocate their time between managing our business and managing the businesses of BioVie. Since all of the executive officers will be employed by BioVie, the responsibility and authority for compensation-related decisions for the executive officers will reside with the compensation committee of the board of directors of BioVie. BioVie has the ultimate decision-making authority with respect to the total compensation of the executive officers that are employed by BioVie. Any such compensation decisions will not be subject to any approvals by the board of directors of the Company or any committee thereof.

The terms of the management services agreement and payments to be made by us thereunder are described under "Certain Relationships and Related Party Transactions—Agreements to be Entered into in Connection with the Separation—Management Services Agreement."

**Director Compensation**

There are no arrangements pursuant to which our directors are or will be compensated in the future for any services provided to the Company.

**CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS**

The following includes a summary of transactions since July 1, 2024 and any currently proposed transactions, to which we were or are to be a participant, in which (i) the amount involved exceeded or will exceed the lesser of $120,000 or one percent of the average of our total assets at year-end for the last two completed fiscal years; and (ii) any of our directors, executive officers or holders of more than 5% of our capital stock, or any affiliate or member of the immediate family of the foregoing persons, had or will have a direct or indirect material interest, other than compensation and other arrangements that are described under the section of this prospectus titled "Executive Compensation."

**Relationship with BioVie**

We currently are, and at all times prior to the completion of this offering will be, a wholly owned subsidiary of BioVie, and all our outstanding shares of common stock are owned by BioVie. As a result, we have never operated as a standalone company. Upon the completion of this offering, we expect that BioVie will own % of our outstanding common stock (or % if the underwriters' over-allotment option is exercised in full).

For as long as BioVie continues to control more than 50% of our outstanding common stock, BioVie or its successor-in-interest will be able to direct the election of all the members of our board of directors. Similarly, BioVie will have the power to determine matters submitted to a vote of our stockholders without the consent of our other stockholders, will have the power to prevent a change in control of us and will have the power to take certain other actions that might be favorable to BioVie.

The financial statements include the assets, liabilities, revenue and expenses based on our legal entity structure as well as direct and indirect costs that are attributable to our operations. Indirect costs are the costs of support functions that are partially provided on a centralized basis by BioVie and its affiliates, which include finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance, and other professional services. Indirect costs have been allocated to us for the purposes of preparing the financial statements based on a specific identification basis or, when specific identification is not practicable, a proportional cost allocation method, primarily based on headcount or other allocation methodologies that are considered to be a reasonable reflection of the utilization of services provided or the benefit received by us during the periods presented, depending on the nature of the services received. However, these allocations may not necessarily be indicative of the actual expenses we would have incurred as an independent company during the periods prior to the offering or of the costs we will incur in the future.

Following the completion of this offering, we expect that BioVie and its affiliates will continue to provide certain services related to these functions pursuant to a management services agreement. Upon completion of this offering, we will assume responsibility for all of our standalone public company costs, including the costs of corporate services provided by BioVie and its affiliates to us prior to the Separation.

**Agreements to be Entered into in Connection with the Separation**

Prior to the completion of this offering, we will enter into various agreements with BioVie that provide for certain transactions and arrangements to effect the Separation and provide a framework for our relationship with BioVie following the Separation, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;· Separation Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;· Management Services Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;· Registration Rights Agreement.

These agreements will govern various interim and ongoing relationships between us and BioVie following the completion of this offering. The material terms of the agreements we will enter into with BioVie in connection with the Separation are summarized below. Certain of these agreements that we believe are material agreements have been filed as exhibits to the registration statement of which this prospectus is a part.

***Separation Agreement***

 ****

We and BioVie will enter into a separation agreement that will set forth the agreements between us and BioVie regarding the principal transactions required to effect the Separation and this offering, and other agreements governing the relationship between BioVie and us following the completion of this offering.

*The Separation* 

The separation agreement will identify assets to be transferred, liabilities to be assumed and contracts to be assigned to us as part of the Separation, and will provide for when and how these transfers, assumptions and assignments will occur. In particular, the separation agreement will provide, among other things, that, subject to certain exceptions and the terms and conditions contained therein:

&nbsp;&nbsp;&nbsp;&nbsp;· the assets exclusively related to BIV201 as well as certain other assets
mutually agreed upon by us and BioVie will be transferred to us;

&nbsp;&nbsp;&nbsp;&nbsp;· certain liabilities (including whether accrued, contingent or otherwise)
arising out of or resulting from BIV201, and other liabilities related to our businesses and operations will be retained by or transferred
to us; and

&nbsp;&nbsp;&nbsp;&nbsp;· all other assets and liabilities (including whether accrued, contingent
or otherwise) will be retained by or transferred to BioVie.

Except as may expressly be set forth in the separation agreement or any other transaction agreements, all assets will be transferred on an "as is," "where is" basis, and the respective transferees will bear the economic and legal risks that (1) any conveyance will prove to be insufficient to vest in the transferee good title, free and clear of any security interest, and (2) any necessary consents or governmental approvals are not obtained or that any requirements of laws or judgments are not complied with.

*Further Assurances* 

The separation agreement will provide that, in addition to the actions specifically provided for in the separation agreement, the Company and BioVie will use their reasonable best efforts, prior to, on and after the Separation, to take, or cause to be taken, all actions, and to do, or cause to be done, all things, reasonably necessary, proper or advisable under applicable laws, regulations and agreements to consummate and make effective the transactions contemplated by the separation agreement and all related agreements.

*Releases* 

The separation agreement will provide that, except as otherwise provided in the separation agreement or any other transaction agreement, each party will release and forever discharge the other party and its respective subsidiaries and affiliates from all liabilities existing or arising from any acts or events occurring or failing to occur or alleged to have occurred or to have failed to occur or any conditions existing or alleged to have existed on or before the Separation, including in connection with the transactions and all other activities to implement the Separation.

*Indemnification* 

In addition, the separation agreement will provide for cross-indemnities principally designed to place financial responsibility for the obligations and liabilities of our business with us and financial responsibility for the obligations and liabilities of BioVie's business with BioVie. Specifically, each party will indemnify, defend and hold harmless the other party and its respective officers, directors, employees and agents (collectively, the "indemnified parties") for any losses arising out of or otherwise in connection with:

&nbsp;&nbsp;&nbsp;&nbsp;· the failure of either party to pay, perform or otherwise promptly discharge any of the BioVie Liabilities
or the Company Liabilities, respectively, in accordance with their terms, whether prior to, at or after the Separation;

&nbsp;&nbsp;&nbsp;&nbsp;· the liabilities that each such party assumed or retained pursuant to
the separation agreement (which, in our case, would include the Company Liabilities and the operation of the Company Business, and in
the case of BioVie, would include the BioVie Liabilities and the operation of the BioVie Business); and

&nbsp;&nbsp;&nbsp;&nbsp;· any breach by such party of the separation agreement or the other transaction agreements. .

The Company will also indemnify, defend and hold harmless the BioVie indemnified parties for any losses arising out of or otherwise in connection with any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, with respect to all information contained in any registration statement, including the registration statement of which this prospectus is a part, or any information statement, prospectus, periodic report or similar disclosure document, whether or not filed with the SEC or any other governmental authority, in each case which describes the Separation, this offering or the Company or primarily relates to the transactions contemplated by the separation agreement.

BioVie will also indemnify, defend and hold harmless the Company indemnified parties for any losses arising out of or otherwise in connection with any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, with respect to all information contained in any registration statement, including the registration statement of which this prospectus is a part, or any information statement, prospectus, periodic report or similar disclosure document, whether or not filed with the SEC or any other governmental authority, in each case which describes the Separation, this offering or the Company or primarily relates to the transactions contemplated by the separation agreement.

The separation agreement also specifies procedures with respect to claims subject to indemnification and related matters.

*Other Provisions* 

The separation agreement will also govern other matters related to the consummation of this offering, the provision and retention of records, access to information, confidentiality, cooperation with respect to governmental filings and third-party consents and insurance.

*Termination* 

The separation agreement may be terminated at any time prior to the Separation by BioVie. After the Separation, the separation agreement may not be terminated except by an agreement in writing signed by each of BioVie and the Company.

***Management Services Agreement***

 ****

We and BioVie will enter into a management services agreement that will address certain management and administrative services to be performed by BioVie and certain of its executive officers and other employees to support our operations following the completion of this offering.

Pursuant to the management services agreement, BioVie will provide us with services following the completion of this offering, including, but not limited to, the following:

&nbsp;&nbsp;&nbsp;&nbsp;· supervising and implementing our general strategies and business initiatives;

&nbsp;&nbsp;&nbsp;&nbsp;· technical, marketing, investor relations and business support services;

&nbsp;&nbsp;&nbsp;&nbsp;· accounting, budgeting, forecasting, financial planning and analysis services;

&nbsp;&nbsp;&nbsp;&nbsp;· services for the administration of certain treasury functions as may be requested from time to time, which
may include but shall not be limited to managing capital structure, investment and debt portfolios, financing for operations, securities
offerings, credit lines and facilities, and compliance with covenants;

&nbsp;&nbsp;&nbsp;&nbsp;· clinical development, clinical trial support and operations services related to the development of BIV201;

&nbsp;&nbsp;&nbsp;&nbsp;· accounting and reporting services, which includes the preparation for our annual audit and quarterly reviews
by our auditors of our annual financial statements and quarterly interim financial statements (including notes thereto);

&nbsp;&nbsp;&nbsp;&nbsp;· services in connection with any applications, filings or notices required to be filed with any governmental
authority under the provisions of any applicable laws, rules or regulations;

&nbsp;&nbsp;&nbsp;&nbsp;· support services as relating to corporate finance matters; and

&nbsp;&nbsp;&nbsp;&nbsp;· administrative services relating to managing human resources activities, external legal support and information
technology support.

The management services agreement will specify the fee to be paid by us for these services, which will be negotiated between us and BioVie and may not necessarily be reflective of prices that we could have obtained for similar services from an independent third party. We believe that the terms and conditions of the management services agreement will be more favorable and cost effective to us than if we hired the full staff to operate the Company.

***Registration Rights Agreement***

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Prior to the completion of this offering, we expect to enter into a registration rights agreement with BioVie with customary representations, warranties and covenants, pursuant to which we will grant BioVie and its affiliates certain registration rights with respect to shares of our common stock owned by them. We refer to these shares as "registrable securities," and we refer to the holders of these registrable securities as "holders."

The registration rights agreement will provide that each holder is entitled to unlimited piggyback registration rights with respect to its registrable securities, such that each holder can include its registrable securities in registration statements filed by us, including registration effected by us for security holders other than holders, subject to certain limitations. The registration rights agreement will also grant BioVie and its subsidiaries that hold registrable securities demand registration rights requiring that we register registrable securities held by holders and take all actions reasonably necessary or desirable to expedite or facilitate the disposition of registrable securities. BioVie and its subsidiaries that hold registrable securities may request up to registrations in any -month period, subject to certain limitations. Our obligation to effect demand registration rights will not be relieved to the extent we effect piggyback registration rights.

We will pay the costs incident to our compliance with the registration rights agreement, but the holders will pay for any underwriting discounts or commissions or transfer taxes associated with all such registrations.

Pursuant to the registration rights agreement, we will agree to indemnify BioVie and its subsidiaries that hold registrable securities (and their directors, officers, agents and, if applicable, each other person who controls such holder under Section 15 of the Securities Act) registering shares pursuant to the registration rights agreement against certain losses, expenses and liabilities under the Securities Act, common law or otherwise. Holders will similarly indemnify us, but such indemnification will be limited to an amount equal to the net proceeds received by such holder under the sale of registrable securities giving rise to the indemnification obligation.

**Review and Approval of Transactions with Related Persons**

The Board will adopt a policy on transactions with related persons upon completion of this offering. The policy will require the approval or ratification by the audit committee of any transaction or series of transactions exceeding $120,000 in which we are a participant and any related person that has a direct or indirect material interest (other than solely as a result of being a director or trustee or less than 10% owner of another entity). Related persons include our directors and executive officers and their immediate family members and persons sharing their households as well as persons controlling more than 5% of our outstanding shares of common stock.

Once a related person transaction has been identified, the audit committee will review all of the relevant facts and circumstances and approve or disapprove entry into the transaction. The audit committee will consider, among other factors, whether the transaction is on terms no more favorable than terms generally available to an unaffiliated third party under the same or similar circumstances and the extent of the related person's interest in the transaction. If it is not feasible to obtain advance approval of a transaction from the audit committee, the transaction will be considered for ratification at the next regularly scheduled meeting of the audit committee.

The policy on transactions with related persons will not be in effect at the time we enter into the agreements described above under "Agreements to be Entered into in Connection with the Separation." Each of the agreements between us and BioVie that has been entered into prior to the completion of this offering, and any transactions contemplated thereby, will be deemed to be approved and not subject to the terms of the policy on transactions with related persons.

**Lock-Up Agreements**

Each of our directors and executive officers have agreed, without prior written consent of the Representative, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of six months after the closing of this offering, subject to certain exceptions. We and any of our successors have also agreed, among other things, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of four months after the closing of this offering, subject to certain exceptions. See "Underwriting" for more information.

**Indemnification Agreements** 

We intend to enter into indemnification agreements with each of our executive officers and directors upon completion of this offering. Our amended and restated certificate of incorporation and our amended and restated bylaws will provide that we will indemnify our directors and officers to the fullest extent permitted by applicable law.

**SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT**

The following table sets forth information regarding the actual beneficial ownership of our common stock as of , 2025 by:

&nbsp;&nbsp;&nbsp;&nbsp;· each person or group of affiliated persons known by us to be the beneficial owner of more than 5% of the
outstanding shares of our common stock;

&nbsp;&nbsp;&nbsp;&nbsp;· each of BioVie's named executive officers and our director nominees; and

&nbsp;&nbsp;&nbsp;&nbsp;· all of BioVie's executive officers and our director nominees as a group.

Percentage of beneficial ownership in the following table is based on shares of our common stock outstanding immediately prior to the completion of this offering and shares of our common stock outstanding upon completion of this offering, assuming no exercise of the underwriters' over-allotment option.

Beneficial ownership is determined according to the rules of the SEC, which generally provide that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power over that security, including options and warrants that are currently exercisable or exercisable within 60 days.

Applicable percentage ownership is based on shares of common stock outstanding on , 2025.

Unless otherwise indicated, we believe that all persons named in the table have sole voting and investment power with respect to all our common stock beneficially owned by them.

Unless otherwise indicated, the address of each person listed on the table is 680 W Nye Lane, Suite 201, Carson City, Nevada 89703.

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| | | | |
|:---|:---|:---|:---|
| | | **Percentage of Shares Beneficially Owned** | **Percentage of Shares Beneficially Owned** |
| <br>**Name and Address of Beneficial Owner** | <br>**Number of<br> Shares<br> Beneficially<br> Owned** | **Before<br> Offering** | **After<br> Offering** |
| *Named Executive Officers and Director Nominees* |  |  |  |
| &nbsp;&nbsp;&nbsp;Cuong Do |  |  |  |
| &nbsp;&nbsp;&nbsp;Joanne Wendy Kim |  |  |  |
| &nbsp;&nbsp;&nbsp;Joseph Palumbo |  |  |  |
| &nbsp;&nbsp;&nbsp;Jim Lang |  |  |  |
| &nbsp;&nbsp;&nbsp;Sigmund Rogich |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;All executive officers and director nominees (6 individuals) |  |  |  |
| *5% Stockholders* |  |  |  |
| BioVie, Inc. |  | 100% | % |

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\* Represents beneficial ownership less than 1%.

**DESCRIPTION OF OUR SECURITIES**

In connection with this offering, we will amend and restate our certificate of incorporation and our bylaws. The following description summarizes the material terms of our amended and restated certificate of incorporation and our amended and restated bylaws, which will be in effect prior to the completion of this offering, as well as relevant sections of the DGCL.

The following description is not complete and is qualified by reference to the full text of our amended and restated certificate of incorporation and our amended and restated bylaws, forms of which have been filed as exhibits to the registration statement of which this prospectus is a part, as well as the applicable provisions of the DGCL.

**General**

Upon completion of this offering, our authorized capital stock will consist of:

&nbsp;&nbsp;&nbsp;&nbsp;· shares of common stock, par value $0.01 per share.

&nbsp;&nbsp;&nbsp;&nbsp;· shares of preferred stock, par value $0.01 per share

Upon completion of this offering, there will be shares of our common stock outstanding (or shares if the underwriter exercise their over-allotment option to purchase additional shares in full).

**Common Stock**

Holders of shares of our common stock will be entitled to the rights set forth below.

***Voting Rights***

Each holder of shares of our common stock will be entitled to one vote per share of our common stock on all matters which may be submitted to the holders of shares of our common stock. At any meeting of our stockholders, the holders of a majority of the issued and outstanding shares entitled to vote at such meeting must be present in person or represented by proxy in order to constitute a quorum.

At any meeting of our stockholders, all questions, except as otherwise expressly provided by statute, our amended and restated certificate of incorporation or our amended and restated bylaws, will be determined by vote of the holders of a majority of the issued and outstanding shares present in person or represented by proxy at such meeting and entitled to vote. Except as otherwise required by law, a nominee for election as a director will be elected to the Board at a meeting at which a quorum is present if the number of votes cast, in person or by proxy, by the holders of shares entitled to vote thereon, "for" such nominee's election exceeds the number of votes cast "against" such nominee's election; provided that, if the number of director nominees exceeds the number of directors to be elected, then each nominee will be elected by a plurality of the votes cast, in person or by proxy, by the holders of shares entitled to vote thereon, at the meeting at which a quorum is present.

Our amended and restated bylaws will provide that any director may be removed from office at any time, with or without cause, by vote of the holders of a majority of the issued and outstanding shares entitled to vote thereon.

***Dividend Rights***

Each holder of shares of our common stock will be entitled to receive ratably the dividends, if any, as may be declared from time to time by the Board out of any assets lawfully available for the payment of dividends.

***Liquidation, Dissolution and Winding-Up Rights***

In the event of a liquidation, dissolution or winding-up of the Company, each holder of shares of our common stock will be entitled to ratable distribution of our net assets that remain after the payment in full of all liabilities.

***Other Rights***

Holders of shares of our common stock will have no preemptive or conversion rights to purchase, subscribe for or otherwise acquire any shares of our common stock or other securities. There are no redemption or sinking fund provisions applicable to the shares of our common stock.

**Anti-Takeover Effects of Various Provisions of Delaware Law, Our Amended and Restated Certificate of Incorporation and Our Amended and Restated Bylaws** 

Provisions of the DGCL, our amended and restated certificate of incorporation and our amended and restated bylaws could make it more difficult to acquire us by means of a tender offer, a proxy contest or otherwise, or to remove incumbent directors. These provisions, summarized below, are expected to discourage certain types of coercive takeover practices and takeover bids that the Board may consider inadequate and to encourage persons seeking to acquire control of us to first negotiate with the Board. We believe the benefits of increased protection of the Board's ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging takeover or acquisition proposals, including because negotiation of these proposals could result in an improvement of the terms of the proposals.

***Delaware Anti-Takeover Statute***

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We will be subject to Section 203 of the DGCL. Section 203 of the DGCL generally prohibits a Delaware corporation from engaging in a "business combination" with an "interested stockholder" for a period of three years following the time that such stockholder became an interested stockholder, unless:

&nbsp;&nbsp;&nbsp;&nbsp;· prior to such time, the board of directors of the corporation approved either the business combination
or the transaction which resulted in the stockholder becoming an interested stockholder;

&nbsp;&nbsp;&nbsp;&nbsp;· upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder,
the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder)
those shares (1) owned by persons who are directors and also officers and (2) held in employee stock plans in which employee participants
do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer;
or

&nbsp;&nbsp;&nbsp;&nbsp;· at or subsequent to such time, the business combination is approved by the board of directors of the corporation
and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least two-thirds
of the outstanding voting stock of the corporation which is not owned by the interested stockholder.

Generally, a "business combination" includes a merger, asset or stock sale or other transaction resulting in a financial benefit to the interested stockholder. Generally, an "interested stockholder" is a person who, together with its affiliates and associates, owns (or within three years prior to the determination of interested stockholder status did own) 15% or more of a corporation's voting stock.

The existence of Section 203 of the DGCL would be expected to have an anti-takeover effect with respect to transactions not approved in advance by the Board, including discouraging takeover attempts that might result in a premium over the then-prevailing market price for the shares of our common stock held by our stockholders.

A Delaware corporation may "opt out" of Section 203 of the DGCL by including a provision expressly electing not to be governed by Section 203 of the DGCL in its original certificate of incorporation or in its certificate of incorporation or bylaws resulting from amendments approved by holders of at least a majority of the corporation's outstanding voting stock. We will not elect to "opt out" of Section 203 of the DGCL.

However, BioVie and its affiliates have been approved by the Board as an interested stockholder (as defined in Section 203 of the DGCL) and therefore will not be subject to Section 203 of the DGCL. So long as BioVie beneficially owns a majority of the voting power of shares of our common stock, and therefore has the ability to direct the election of all the members of the Board, directors designated by BioVie to serve on the Board would have the ability to pre-approve other parties, including potential transferees of BioVie's shares of our common stock, so that Section 203 of the DGCL would not apply to such other parties.

***Size of Board and Vacancies***

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Our amended and restated bylaws will provide that the Board will consist of not less than three nor more than seven directors, the actual number to be determined by the Board from time to time. Upon completion of this offering, the Board will consist of four directors.

Our amended and restated bylaws will provide that any vacancies in the Board, however created, will be filled by appointment made by a majority of the remaining directors. In addition, our amended and restated certificate of incorporation will provide that any directorship to be filled by reason of an increase in the number of directors on the Board may be filled by election by a majority of the directors then in office.

***Special Stockholder Meetings***

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Our amended and restated bylaws will provide that a special meeting of our stockholders may be called at any time by (1) our Chief Executive Officer or (2) a majority of the Board.

***Stockholder Action by Written Consent***

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Our amended and restated certificate of incorporation will provide that (1) until such time as BioVie ceases to beneficially own a majority of the voting power of our shares of common stock, holders of shares of our common stock will be permitted to act by written consent without a duly called annual or special meeting of our stockholders if such written consent is signed by holders of shares of our common stock having at least the minimum number of votes necessary to authorize such action and (2) from and after the time that BioVie ceases to beneficially own a majority of the voting power of our shares of common stock, holders of shares of our common stock will not be able to act by written consent without a duly called annual or special meeting of our stockholders.

 **

***Requirements for Advance Notification of Stockholder Proposals***

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Our amended and restated bylaws will establish advance notice procedures for business (including any nominations for director) to be properly brought by a stockholder before an annual or special meeting of our stockholders. In addition, our amended and restated bylaws will require that, in order to submit a nomination for director, a stockholder must also submit all information relating to such person that is required to be disclosed in solicitations of proxies as well as certain other information.

***No Cumulative Voting***

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The DGCL provides that stockholders of a company are denied the right to cumulate votes in the election of directors unless the company's certificate of incorporation provides otherwise. Our amended and restated certificate of incorporation will not provide for cumulative voting.

***Undesignated Preferred Stock***

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The authority that the Board will possess to issue preferred stock, as described under "Preferred Stock," could potentially be used to discourage attempts by third parties to obtain control of us through a merger, tender offer or proxy contest or otherwise by making such attempts more difficult or more costly. The Board may be able to issue preferred stock with voting rights or conversion rights that, if exercised, could adversely affect the voting power of the holders of shares of our common stock.

***Amended and Restated Certificate of Incorporation***

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Our amended and restated certificate of incorporation will provide that our amended and restated certificate of incorporation may only be amended by vote of the holders of 66.67% of the issued and outstanding shares of common stock entitled to vote thereon.

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***Amended and Restated Bylaws***

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Our amended and restated bylaws will provide that the Board will have the power to make, alter, amend or repeal any bylaw, including a bylaw designating the number of directors; provided that the Board may not make, alter, amend or repeal any bylaw designating the qualification or term of office of any member or members of the then-existing Board.

Our amended and restated bylaws will further provide that our amended and restated bylaws may be amended, altered, changed, added to or repealed at any annual meeting of our stockholders, or at any special meeting of our stockholders, or by the Board at any regular or special meeting of the Board, if notice of the proposed amendment, alteration, change, addition or repeal is contained in the notice of such meeting; provided, however, that action taken by our stockholders intended to supersede action taken by the Board in making, amending, altering, changing, adding to or repealing any bylaws will supersede prior action of the Board and will deprive the Board of further jurisdiction in the premises to the extent indicated in the statement, if any, of the stockholders accompanying such action of our stockholders. Our amended and restated bylaws also provide that our bylaws may be amended, altered or repealed by stockholder action by written consent if in accordance with the amended and restated certificate of incorporation.

**Conflicts of Interest; Corporate Opportunities**

In order to address potential conflicts of interest between us and BioVie, our amended and restated certificate of incorporation will include certain provisions regulating and defining the conduct of our affairs to the extent that they may involve BioVie and its directors or officers and our rights, powers, duties and liabilities and those of our directors, officers and stockholders in connection with our relationship with BioVie. These provisions generally recognize that we and BioVie may engage in the same or similar business activities and lines of business or have an interest in the same areas of corporate opportunities and that we and BioVie will continue to have contractual and business relations with each other.

Following the completion of this offering and for as long as BioVie (1) beneficially owns at least a majority of our issued and outstanding shares of common stock with respect to the election of directors or (2) has any directors, officers or employees who serve on our Board, our Board is expected, in accordance with Section 122(17) of the DGCL, to renounce any interest or expectancy of ours in any corporate opportunities that are presented to BioVie or any of its directors, officers or employees.

**Registration Rights**

Upon the completion of this offering, BioVie will be entitled to rights with respect to the registration of the sale of our common stock under the Securities Act. Registration of the sale of these shares under the Securities Act would result in these shares becoming fully tradable without restriction under the Securities Act immediately upon the effectiveness of the registration, except for shares purchased by affiliates. See the section titled "*Certain Relationships and Related Party Transactions—Relationship with BioVie—Arrangements between BioVie and the Company—Registration Rights Agreement*."

**Limitation on Liability and Indemnification of Officers and Directors and Insurance**

The DGCL authorizes corporations to limit or eliminate the personal liability of directors or officers to corporations and their stockholders for monetary damages for breaches of fiduciary duties as directors or officers. Our amended and restated certificate of incorporation will include such an exculpation provision. Our amended and restated certificate of incorporation and our amended and restated bylaws will include provisions that indemnify, to the fullest extent allowable under the DGCL, the personal liability of directors or officers for monetary damages for actions taken as our director or officer, or for serving at our request as a director or officer or another position at another corporation or enterprise, as the case may be. Our amended and restated certificate of incorporation and our amended and restated bylaws will also provide that we must indemnify and advance reasonable expenses to our directors and, subject to certain exceptions, officers, subject to our receipt of an undertaking from the indemnified party as may be required under the DGCL. Our amended and restated certificate of incorporation will expressly authorize us to carry directors' and officers' insurance to protect us, our directors, officers and certain employees for some liabilities.

The limitation of liability and indemnification provisions that will be in our amended and restated certificate of incorporation and our amended and restated bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duty. These provisions may also have the effect of reducing the likelihood of derivative litigation against our directors and officers, even though such an action, if successful, might otherwise benefit us and our stockholders. However, these provisions will not limit or eliminate our rights, or those of any stockholder, to seek non-monetary relief such as injunction or rescission in the event of a breach of a director's duty of care. The limitation of liability and indemnification provisions that will be in our amended and restated certificate of incorporation will not alter the liability of directors under the federal securities laws. In addition, your investment may be adversely affected to the extent that, in a class action or direct suit, we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.

There is currently no pending material litigation or proceeding against us or any of our directors, officers or employees for which indemnification is sought.

**Exclusive Forum**

Our amended and restated certificate of incorporation will provide, in all cases to the fullest extent permitted by law, that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery located within the State of Delaware will be the sole and exclusive forum for:

&nbsp;&nbsp;&nbsp;&nbsp;· any derivative action or proceeding brought on our behalf;

&nbsp;&nbsp;&nbsp;&nbsp;· any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, employees
or stockholders to us or our stockholders;

&nbsp;&nbsp;&nbsp;&nbsp;· any action asserting a claim arising pursuant to any provision of the DGCL or as to which the DGCL confers
jurisdiction on the Court of Chancery located within the State of Delaware;

&nbsp;&nbsp;&nbsp;&nbsp;· any action asserting a claim governed by the internal affairs doctrine; or

&nbsp;&nbsp;&nbsp;&nbsp;· any action asserting a claim arising pursuant to any provision of our amended and restated certificate
of incorporation or our amended and restated bylaws.

However, if the Court of Chancery located within the State of Delaware does not have jurisdiction over any such action, the action may be brought instead in the United States District Court for the District of Delaware.

In addition, our amended and restated certificate of incorporation will provide that the foregoing provision will not apply to claims arising under the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States will be the sole and exclusive forum for the resolution of any action asserting a claim arising under the Securities Act.

These exclusive forum provisions may impose additional costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware and may limit the ability of a stockholder to bring a claim in a judicial forum that such stockholder finds favorable for disputes with us or any of our directors, officers or stockholders, which may discourage lawsuits with respect to such claims. Our stockholders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations thereunder as a result of these exclusive forum provisions.

**Authorized but Unissued Shares**

Our authorized but unissued shares of common stock will be available for future issuance without further vote or action by our stockholders. We may use additional shares for a variety of purposes, including to raise additional capital, to fund acquisitions and as employee compensation. The existence of authorized but unissued shares of common stock could also discourage attempts by third parties to obtain control of us through a merger, tender offer or proxy contest or otherwise by making such attempts more difficult or more costly.

**Transfer Agent**

Upon the completion of this offering, the transfer agent and registrar for our common stock will be West Coast Stock Transfer, Inc. The transfer agent's address is 721 N. Vulcan Ave., 1<sup>st</sup> Floor, Encinitas, CA 92024.

**Listing**

We intend to apply to list our common stock on NYSE under the trading symbol " ".

**SHARES ELIGIBLE FOR FUTURE SALE**

Prior to this offering, there has been no public market for our common stock, and a liquid trading market for our common stock may not develop or be sustained after this offering. Future sales of our common stock, including shares issued upon the exercise of outstanding options, in the public market after the completion of this offering, or the perception that those sales may occur, could adversely affect the prevailing market price for our common stock from time to time or impair our ability to raise equity capital in the future. As described below, only a limited number of shares of our common stock will be available for sale in the public market for a period of several months after the completion of this offering due to contractual and legal restrictions on resale described below. Future sales of our common stock in the public market either before or after restrictions lapse, or the perception that those sales may occur, could adversely affect the prevailing market price of our common stock at such time and our ability to raise equity capital at a time and price we deem appropriate.

**Sale of Restricted Shares** 

Upon the closing of this offering and assuming no exercise of the underwriters' over-allotment option, we will have outstanding an aggregate of approximately shares of common stock.

Subject to any contractual restrictions, including under the lock-up agreements described below under "Lock-Up Agreements," all of the shares of our common stock sold in this offering will be freely tradable in the public market without restriction or further registration under the Securities Act, unless the shares are held by any of our "affiliates" as such term is defined in Rule 144 or subject to lock-up agreements.

All remaining shares of common stock held by existing stockholders immediately prior to the consummation of this offering will be "restricted securities," as such term is defined in Rule 144. These restricted securities were issued and sold by us in private transactions and are eligible for public sale only if registered under the Securities Act or if they qualify for an exemption from registration under the Securities Act, including the exemptions provided by Rule 144 or Rule 701, which rules are summarized below.

As a result of the lock-up agreements referred to below and the provisions of Rule 144 and Rule 701 under the Securities Act, based on the number of shares of our common stock outstanding (calculated as of June 30, 2025 on the basis of the assumptions described above and assuming no exercise of the underwriters' option to purchase additional shares, if any, and no exercise of outstanding options), the shares of our common stock (excluding the shares sold in this offering) that will be available for sale in the public market are as follows:

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| | |
|:---|:---|
| **Approximate Number of Shares** | **First Date Available for Sale Into Public Market** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;shares | 181 days after the date of this prospectus, upon expiration of the lock-up agreements referred to below, subject in some cases to applicable volume, manner of sale and other limitations under Rule 144 and Rule 701. |

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We may issue shares of common stock from time to time as consideration for future acquisitions, investments or other corporate purposes. In the event that any such acquisition, investment or other transaction is significant, the number of shares of common stock that we may issue may in turn be significant. We may also grant registration rights covering those shares of common stock issued in connection with any such acquisition and investment.

**Rule 144** 

In general, persons who have beneficially owned restricted shares of our common stock for at least six months, and any affiliate of the company who owns shares of our common stock, are entitled to sell their securities without registration with the SEC under an exemption from registration provided by Rule 144.

Under Rule 144, as currently in effect, once we have been subject to the public company reporting requirements of the Exchange Act for at least 90 days, and we are current in our Exchange Act reporting at the time of sale, a person (or persons whose shares are required to be aggregated) who is not deemed to have been one of our "affiliates" for purposes of Rule 144 at any time during the 90 days preceding a sale and who has beneficially owned restricted securities within the meaning of Rule 144 for at least six months, including the holding period of any prior owner other than one of our "affiliates," is entitled to sell those shares in the public market (subject to the lock-up agreement referred to below, if applicable) without complying with the manner of sale, volume limitations or notice provisions of Rule 144, but subject to compliance with the public information requirements of Rule 144. If such a person has beneficially owned the shares proposed to be sold for at least 12 months, including the holding period of any prior owner other than "affiliates," then such person is entitled to sell such shares in the public market without complying with any of the requirements of Rule 144 (subject to the lock-up agreement referred to above, if applicable).

In general, under Rule 144, as currently in effect, once we have been subject to the public company reporting requirements of the Exchange Act for at least 90 days, our "affiliates," as defined in Rule 144, who have beneficially owned the shares proposed to be sold for at least six months, are entitled to sell in the public market, upon expiration of any applicable lock-up agreements and within any three-month period, a number of those shares of our common stock that does not exceed the greater of:

&nbsp;&nbsp;&nbsp;&nbsp;· 1% of the number of shares of common stock then outstanding, which will equal approximately 
shares of common stock immediately upon the closing of this offering (calculated as of ,
2025 on the basis of the assumptions described above and assuming no exercise of the underwriters' over-allotment option to purchase
additional shares and no exercise of outstanding options); or

&nbsp;&nbsp;&nbsp;&nbsp;· the average weekly trading volume of our common stock on NYSE during the four calendar weeks preceding
the filing of a notice on Form 144 with respect to such sale.

Such sales under Rule 144 by our "affiliates" or persons selling shares on behalf of our "affiliates" are also subject to certain manner of sale provisions, notice requirements and to the availability of current public information about us. Notwithstanding the availability of Rule 144, the holders of substantially all of our restricted securities have entered into lock-up agreements as referenced above and their restricted securities will become eligible for sale (subject to the above limitations under Rule 144) upon the expiration of the restrictions set forth in those agreements.

**Rule 701**

In general, under Rule 701 as currently in effect, any of our employees, directors, officers, consultants or advisors who acquired common stock from us in connection with a written compensatory stock or option plan or other written agreement in compliance with Rule 701 before the effective date of the registration statement of which this prospectus is a part (to the extent such common stock is not subject to a lock-up agreement) and who are not our "affiliates" as defined in Rule 144 during the immediately preceding 90 days, is entitled to rely on Rule 701 to resell such shares beginning 90 days after the date of this prospectus in reliance on Rule 144, but without complying with the notice, manner of sale, public information requirements or volume limitation provisions of Rule 144. Persons who are our "affiliates" may resell those shares beginning 90 days after the date of this prospectus without compliance with minimum holding period requirements under Rule 144 (subject to the terms of the lock-up agreement referred to below, if applicable).

**Lock-Up Agreements**

Each of our directors and executive officers have agreed, without prior written consent of the Representative, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of six months after the closing of this offering, subject to certain exceptions. We and any of our successors have also agreed, among other things, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of four months after the closing of this offering, subject to certain exceptions. See "Underwriting" for more information.

**Registration Rights**

Upon the completion of this offering, BioVie will be entitled to rights with respect to the registration of the sale of our common stock under the Securities Act. Registration of the sale of these shares under the Securities Act would result in these shares becoming fully tradable without restriction under the Securities Act immediately upon the effectiveness of the registration, except for shares purchased by affiliates. See the section titled "*Certain Relationships and Related Party Transactions—Relationship with BioVie—Arrangements between BioVie and the Company—Registration Rights Agreement*."

**MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES FOR NON-U.S. HOLDERS**

The following is a summary of the material U.S. federal income tax consequences for non-U.S. holders (as defined below) of the acquisition, ownership and disposition of our common stock issued pursuant to this offering. This discussion is not a complete analysis of all potential U.S. federal income tax consequences relating thereto, does not address the potential application of the Medicare contribution tax on net investment income, and does not address any estate or gift tax consequences or any tax consequences arising under any state, local or foreign tax laws, or any other U.S. federal tax laws. This discussion is based on the Internal Revenue Code of 1986, as amended (the Code), and applicable Treasury Regulations promulgated thereunder, judicial decisions and published rulings and administrative pronouncements of the Internal Revenue Service (IRS), all as in effect as of the date hereof. These authorities are subject to differing interpretations and may change, possibly retroactively, resulting in U.S. federal income tax consequences different from those discussed below. We have not requested a ruling from the IRS with respect to the statements made and the conclusions reached in the following summary, and there can be no assurance that the IRS or a court will agree with such statements and conclusions.

This discussion is limited to non-U.S. holders who purchase our common stock pursuant to this offering and who hold our common stock as a "capital asset" within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all of the U.S. federal income tax consequences that may be relevant to a particular holder in light of such holder's circumstances. This discussion also does not consider any specific facts or circumstances that may be relevant to holders subject to special rules under the U.S. federal income tax laws, including:

&nbsp;&nbsp;&nbsp;&nbsp;· certain former citizens or long-term residents of the United States;

&nbsp;&nbsp;&nbsp;&nbsp;· partnerships or other pass-through entities (and investors therein);

&nbsp;&nbsp;&nbsp;&nbsp;· "controlled foreign corporations;"

&nbsp;&nbsp;&nbsp;&nbsp;· "passive foreign investment companies;"

&nbsp;&nbsp;&nbsp;&nbsp;· corporations that accumulate earnings to avoid U.S. federal income tax;

&nbsp;&nbsp;&nbsp;&nbsp;· banks, financial institutions, investment funds, insurance companies, brokers, dealers or traders in securities;

&nbsp;&nbsp;&nbsp;&nbsp;· tax-exempt organizations and governmental organizations;

&nbsp;&nbsp;&nbsp;&nbsp;· tax-qualified retirement plans;

&nbsp;&nbsp;&nbsp;&nbsp;· "qualified foreign pension funds" as defined in Section 897(l)(2) of the Code and entities
all of the interests of which are held by qualified foreign pension funds

&nbsp;&nbsp;&nbsp;&nbsp;· persons subject to the alternative minimum tax;

&nbsp;&nbsp;&nbsp;&nbsp;· persons that own, or have owned, actually or constructively, more than 5% of our common stock at any time;

&nbsp;&nbsp;&nbsp;&nbsp;· accrual-method taxpayers subject to special tax accounting rules under Section 451(b) of the Code; and

&nbsp;&nbsp;&nbsp;&nbsp;· persons holding our common stock as part of a hedging or conversion transaction, straddle, synthetic security,
constructive sale, or other risk reduction strategy or integrated investment.

If an entity or arrangement that is classified as a partnership for U.S. federal income tax purposes holds our common stock, the U.S. federal income tax treatment of a partner in the partnership will generally depend on the status of the partner, the activities of the partnership and certain determinations made at the partner level. Partnerships holding our common stock and the partners in such partnerships are urged to consult their tax advisors about the particular U.S. federal income tax consequences to them of holding and disposing of our common stock.

THIS DISCUSSION IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT TAX ADVICE. PROSPECTIVE INVESTORS SHOULD CONSULT THEIR TAX ADVISORS REGARDING THE PARTICULAR U.S. FEDERAL INCOME TAX CONSEQUENCES TO THEM OF ACQUIRING, OWNING AND DISPOSING OF OUR COMMON STOCK, AS WELL AS ANY TAX CONSEQUENCES ARISING UNDER ANY STATE, LOCAL OR FOREIGN TAX LAWS AND ANY OTHER U.S. FEDERAL TAX LAWS.

**Definition of Non-U.S. Holder** 

For purposes of this discussion, a non-U.S. holder is any beneficial owner of our common stock that is not a "U.S. person" or a partnership (including any entity or arrangement treated as a partnership) for U.S. federal income tax purposes. A U.S. person is any person that, for U.S. federal income tax purposes, is or is treated as any of the following:

&nbsp;&nbsp;&nbsp;&nbsp;· an individual who is a citizen or resident of the United States;

&nbsp;&nbsp;&nbsp;&nbsp;· a corporation (or entity treated as a corporation for U.S. federal income tax purposes) created or organized
in or under the laws of the United States, any state thereof or the District of Columbia;

&nbsp;&nbsp;&nbsp;&nbsp;· an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

&nbsp;&nbsp;&nbsp;&nbsp;· a trust (i) whose administration is subject to the primary supervision of a U.S. court and which has one
or more U.S. persons who have the authority to control all substantial decisions of the trust or (ii) that has a valid election in effect
under applicable Treasury Regulations to be treated as a U.S. person.

**Distributions on Our Common Stock** 

We have never declared or paid any cash dividends on our capital stock and we do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. However, if we do make cash or other property distributions on our common stock, such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return of capital and will first be applied against and reduce a holder's tax basis in our common stock, but not below zero. Any excess will be treated as gain realized on the sale or other disposition of our common stock and will be treated as described under the section titled "Gain on Sale, Exchange or Other Taxable Disposition of Our Common Stock" below.

Subject to the discussions below regarding effectively connected income, backup withholding and Sections 1471 through 1474 of the Code (commonly referred to as FATCA), dividends paid to a non-U.S. holder of our common stock generally will be subject to U.S. federal withholding tax at a rate of 30% of the gross amount of the dividends or such lower rate specified by an applicable income tax treaty. To receive the benefit of a reduced treaty rate, a non-U.S. holder must furnish us or our paying agent with a valid IRS Form W-8BEN or IRS Form W-8BEN-E (or applicable successor form) and satisfy applicable certification and other requirements. This certification must be provided to us or our paying agent before the payment of dividends and must be updated periodically. If the non-U.S. holder holds the stock through a financial institution or other agent acting on the non-U.S. holder's behalf, the non-U.S. holder will be required to provide appropriate documentation to the agent, which then will be required to provide certification to us or our paying agent, either directly or through other intermediaries. Prospective investors should consult their tax advisors concerning whether they may benefit from an applicable income tax treaty.

Non-U.S. holders that do not provide the required certification on a timely basis, but that qualify for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS.

If a non-U.S. holder holds our common stock in connection with the conduct of a trade or business in the United States, and dividends paid on our common stock are effectively connected with such holder's U.S. trade or business (and are attributable to such holder's permanent establishment in the United States if required by an applicable tax treaty), the non-U.S. holder will be exempt from U.S. federal withholding tax. To claim the exemption, the non-U.S. holder must generally furnish a valid IRS Form W-8ECI (or applicable successor form) to the applicable withholding agent.

However, any such effectively connected dividends paid on our common stock generally will be subject to U.S. federal income tax on a net income basis at the regular U.S. federal income tax rates in the same manner as if such holder were a resident of the United States. A non-U.S. holder that is a foreign corporation also may be subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of its effectively connected earnings and profits for the taxable year, as adjusted for certain items. Non-U.S. holders should consult their tax advisors regarding any applicable income tax treaties that may provide for different rules.

**Gain on Sale, Exchange or Other Taxable Disposition of Our Common Stock**

Subject to the discussions below regarding backup withholding and FATCA, a non-U.S. holder generally will not be subject to U.S. federal income tax on any gain realized on the sale, exchange or other taxable disposition of our common stock, unless:

&nbsp;&nbsp;&nbsp;&nbsp;· the gain is effectively connected with the non-U.S. holder's conduct of a trade or business in the
United States, and if required by an applicable income tax treaty, is attributable to a permanent establishment maintained by the non-U.S.
holder in the United States;

&nbsp;&nbsp;&nbsp;&nbsp;· the non-U.S. holder is a nonresident alien individual present in the United States for 183 days or more
during the taxable year of the disposition, and certain other requirements are met; or

&nbsp;&nbsp;&nbsp;&nbsp;· our common stock constitutes a "United States real property interest" by reason of our status
as a United States real property holding corporation (USRPHC) for U.S. federal income tax purposes at any time within the shorter of the
five-year period preceding the disposition or the non-U.S. holder's holding period for our common stock, and our common stock is
not "regularly traded" on an established securities market (as defined by applicable Treasury Regulations).

Determining whether we are a USRPHC depends on the fair market value of our U.S. real property interests relative to the fair market value of our other trade or business assets and our foreign real property interests. We believe that we are not currently and do not anticipate becoming a USRPHC for U.S. federal income tax purposes, although there can be no assurance we will not in the future become a USRPHC. If we are or become a USRPHC and the "regularly traded" exception noted above does not apply to the disposition, a non-U.S. holder will generally be taxed on any gain in the same manner as gain that is effectively connected with the conduct of a U.S. trade or business, except that the branch profits tax generally will not apply. Prospective investors are encouraged to consult their own tax advisors regarding the possible consequences to them if we are, or were to become, a USRPHC.

Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis at the regular U.S. federal income tax rates in the same manner as if such holder were a resident of the United States. A non-U.S. holder that is a foreign corporation also may be subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of its effectively connected earnings and profits for the taxable year, as adjusted for certain items. A non-U.S. holder described in the second bullet point above will be subject to U.S. federal income tax at a flat 30% rate (or such lower rate specified by an applicable income tax treaty) on gain realized upon the sale or other taxable disposition of our common stock, but may be offset by certain U.S.-source capital losses (even though the individual is not considered a resident of the United States), provided that the non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses. Non-U.S. holders should consult their tax advisors regarding any applicable income tax treaties that may provide for different rules.

**Information Reporting and Backup Withholding** 

Annual reports are required to be filed with the IRS and provided to each non-U.S. holder indicating the amount of distributions on our common stock paid to such holder and the amount of any tax withheld with respect to those distributions. These information reporting requirements apply even if no withholding was required because the distributions were effectively connected with the holder's conduct of a U.S. trade or business, or withholding was reduced or eliminated by an applicable income tax treaty. This information also may be made available under a specific treaty or agreement with the tax authorities in the country in which the non-U.S. holder resides or is established. Backup withholding, currently at a 24% rate, generally will not apply to payments to a non-U.S. holder of dividends on or the gross proceeds of a disposition of our common stock provided the non-U.S. holder furnishes the required certification for its non-U.S. status, such as by providing a valid IRS Form W-8BEN, W-8BEN-E or W-8ECI, or certain other requirements are met. Backup withholding may apply if the payor has actual knowledge, or reason to know, that the holder is a U.S. person.

Backup withholding is not an additional tax. If any amount is withheld under the backup withholding rules, the non-U.S. holder should consult with a U.S. tax advisor regarding the possibility of and procedure for obtaining a refund or a credit against the non-U.S. holder's U.S. federal income tax liability, if any.

**Withholding on Foreign Entities** 

FATCA imposes a U.S. federal withholding tax of 30% on certain payments made to a "foreign financial institution" (as specially defined under these rules) unless such institution enters into an agreement with the U.S. government to withhold on certain payments and to collect and provide to the U.S. tax authorities certain information regarding certain U.S. account holders of such institution (which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners) or an exemption applies. FATCA also generally imposes a U.S. federal withholding tax of 30% on certain payments made to a non-financial foreign entity unless such entity provides the withholding agent a certification identifying certain direct and indirect U.S. owners of the entity or an exemption applies. An intergovernmental agreement between the United States and an applicable foreign country may modify these requirements. FATCA currently applies to dividends paid on our common stock. Although withholding under FATCA would have applied also to payments of gross proceeds from the sale or other disposition of our common stock, proposed Treasury Regulations eliminate FATCA withholding on payments of gross proceeds entirely. Taxpayers generally may rely on these proposed Treasury Regulations until final Treasury Regulations are issued. Under certain circumstances, a non-U.S. holder might be eligible for refunds or credits of such taxes.

Prospective investors should consult with their own tax advisors regarding the potential implications of FATCA on their investment in our common stock.

**The preceding discussion of U.S. federal tax considerations is for general information only. It is not tax advice. Each prospective investor should consult its tax advisor regarding the particular U.S. federal, state and local and non-U.S. tax consequences of purchasing, holding and disposing of our common stock, including the consequences of any proposed change in applicable laws.**

**UNDERWRITING**

We have entered into an underwriting agreement dated with ThinkEquity LLC, as the representative of the underwriters (the "Representative"), with respect to the securities sold in this offering. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriters named below, and the underwriters have agreed, severally and not jointly, to purchase from us the securities set forth opposite each underwriters' name in the following table at the public offering price less the underwriting discounts set forth in the cover page of this prospectus:

---

| | |
|:---|:---|
| **Underwriter** | **Number of**<br> **Shares** |
| ThinkEquity LLC |  |
| Total |  |

---

The underwriters have committed to purchase all of the securities offered by us other than those covered by the over-allotment option described below, if they purchase any securities. The obligations of the underwriters may be terminated upon the occurrence of certain events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement, the underwriters' obligations are subject to customary conditions, representations and warranties contained in the underwriting agreement, such as receipt by the underwriters of officers' certificates and legal opinions.

The underwriters are offering the securities, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions contained in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, or to contribute to payments the underwriters may be required to make in respect of those liabilities.

**Over-Allotment Option**

We have granted a 45-day option to the underwriters to purchase up to additional shares of common stock, solely to cover over-allotments, if any. The underwriters may exercise this option one or more times in whole or in part for 45 days from the closing of this offering. If any of these additional shares of common stock are purchased, the underwriters will offer the additional shares on the same terms as those on which the shares of common stock were initially offered.

**Underwriting Discount, Commissions and Expenses**

Pursuant to the underwriting agreement, we will pay the underwriters, concurrently with the closing of this offering, a underwriting fee equal to 7.5% of the aggregate number of shares sold in this offering. We have also agreed to pay a non-accountable expense allowance to the Representative equal to 1% of the gross proceeds received in this offering.

The underwriters propose initially to offer the shares of common stock to the public at the public offering price set forth on the cover page of this prospectus and to dealers at that price less a concession not in excess of $ per share. If all of the shares of common stock offered by us are not sold at the public offering price, the underwriters may change the public offering price and other selling terms by means of a supplement to this prospectus.

The following table shows the public offering price, underwriting discounts and proceeds, before expenses, to us. The information assumes either no exercise or full exercise by the underwriters of their over-allotment option to purchase additional shares of common stock.

---

| | | | |
|:---|:---|:---|:---|
|  | **Per Share** | **Total Assuming No Exercise of**<br> **Over- Allotment**<br> **Option** | **Total Assuming Full Exercise of**<br> **Over- Allotment**<br> **Option** |
| Public offering price | $| $| $|
| Underwriting discounts and commissions (7.5%) | $| $| $|
| Proceeds, before expense, to us | $| $| $|

---

We will be responsible for and pay all expenses relating to this offering, including, without limitation, (a) all filing fees and communication expenses relating to the registration of the shares to be sold in this offering (including the over-allotment shares) with the SEC; (b) all filing fees and expenses associated with the review of this offering by FINRA; (c) all fees and expenses relating to the listing of our shares on NYSE or on such other stock exchange as the Company and the Representative together determine, including any fees charged by The Depository Trust Company (DTC) for new securities; (d) all fees, expenses and disbursements relating to the registration or qualification of the shares of common stock under the "blue sky" securities laws of such states, if applicable, and other jurisdictions as the Representative may reasonably designate; (e) all fees, expenses and disbursements relating to the registration, qualification or exemption of the shares under the securities laws of such foreign jurisdictions as the Representative may reasonably designate; (f) the costs of all mailing and printing of the underwriting documents (including, without limitation, the underwriting agreement, any Blue Sky Surveys and, if appropriate, any agreement among underwriters, selected dealers' agreement, underwriters' questionnaire and power of attorney), registration statements, prospectuses and all amendments, supplements and exhibits thereto and as many preliminary and final prospectuses as the Representative may reasonably deem necessary; (g) the costs and expenses of the public relations firm; (h) the costs of preparing, printing and delivering certificates representing the shares of common stock; (i) fees and expenses of the transfer agent for our common stock; (j) stock transfer and/or stamp taxes, if any, payable upon the transfer of securities from us to the Representative; (k) the costs associated with post-closing advertising this offering in the national editions of the Wall Street Journal and New York Times; (l) the costs associated with bound volumes of the public offering materials as well as commemorative mementos and lucite tombstones, each of which the Company or its designee will provide within a reasonable time after the Closing in such quantities as the Representative may reasonably request, in an amount not to exceed $3,000; (n) the fees and expenses of the Company's accountants; (o) the fees and expenses of the Company's legal counsel and other agents and representatives; (p) the fees and expenses of the Representative's legal counsel not to exceed $125,000; (q) the $29,500 cost associated with the use of Ipreo's book building, prospectus tracking and compliance software for this offering; (r) $10,000 for data services and communications expenses; (s) up to $10,000 of the Representative's actual accountable "road show" expenses; and (t) up to $30,000 of the Representative's market making and trading, and clearing firm settlement expenses for the Offering. Such reimbursement shall be paid at each closing (to the extent not paid at a prior closing) from the gross proceeds of the shares of common stock.

The Representative may also ask other FINRA member broker-dealers that are registered with the SEC to participate as soliciting dealers for this offering.

We have paid an expense deposit of $50,000 to the Representative, which will be applied against the out-of-pocket accountable expenses that will be paid by us to the underwriters in connection with this offering and will be reimbursed to us to the extent not actually incurred in compliance with FINRA Rule 5110(g)(4)(A).

Our total estimated expenses of the offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding underwriting discounts and commissions and excluding the non-accountable expense allowance, are approximately $.

**Representative's Warrants**

Upon the closing of this offering, we have agreed to issue Representative's Warrants to the Representative to purchase shares of common stock. The Representative's Warrants will be exercisable at an exercise price of $(representing 125% of the public offering price of $ per share. The Representative's Warrants are immediately exercisable and will expire on the four- and one-half year anniversary of the date that is 180 days from the commencement of sales of the securities issued in this offering.

The Representative's Warrants have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule 5110(e)(1)(A) of FINRA. The Representative (or permitted assignees under Rule 5110(e)(2)) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will they engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a period of 180 days following the commencement of sales of the securities issued in this offering. In addition, the Representative's Warrants provide for registration rights upon request, in certain cases. The sole demand registration right provided will not be greater than five years from the commencement of sales of the securities issued in this offering in compliance with FINRA Rule 5110(g)(8)(C). The piggyback registration rights provided will not be greater than seven years from the commencement of sales of the securities issued in this offering in compliance with FINRA Rule 5110(g)(8)(D). We will bear all fees and expenses attendant to registering the securities issuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The exercise price and number of shares issuable upon exercise of the Representative's Warrants may be adjusted in certain circumstances including in the event of a stock dividend or our recapitalization, reorganization, merger or consolidation. However, the Representative's Warrant exercise price or underlying shares will not be adjusted for issuances of shares of our common stock at a price below the warrant exercise price.

**Lock-Up Agreements**

We have agreed that, for a period of four months from the closing of this offering, without prior written consent of the Representative, we will not (a) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any shares of our common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock; (b) file or caused to be filed any registration statement with the SEC relating to the offering of any shares of our common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock; (c) complete any offering of debt securities of our Company, other than entering into a line of credit with a traditional bank or (d) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of our common stock, whether any such transaction described in clause (a), (b), (c) or (d) above is to be settled by delivery of shares of our common stock or such other securities, in cash or otherwise, subject to certain exceptions.

Moreover, pursuant to "lock-up" agreements, our executive officers and directors have agreed for a period of six months from the closing of this offering, subject to customary exceptions, without the prior written consent of the Representative, not to, directly or indirectly (a) offer, sell, agree to offer or sell, solicit offers to purchase, grant any call option or purchase any put option with respect to, pledge, encumber, assign, borrow or otherwise dispose of any shares of our common stock, any warrant or option to purchase such shares or any other of our securities or of any other entity that is convertible into, or exercisable or exchangeable for, shares of our common stock or any other of our equity securities (each a "Relevant Security" and collectively, "Relevant Securities"), in each case owned beneficially owned by them or otherwise publicly disclose the intention to do so, or (b) establish or increase any "put equivalent position" or liquidate or decrease any "call equivalent position" with respect to any Relevant Security (in each case within the meaning of Section 16 of the Exchange Act with respect to any Relevant Security or otherwise enter into any swap, derivative or other transaction or arrangement that transfers to another, in whole or in part, any economic consequence of ownership of a Relevant Security, whether or not such transaction is to be settled by the delivery of Relevant Securities, other securities, cash or other consideration, or otherwise publicly disclose the intention to do so.

**Right of First Refusal**

Upon closing of this offering which results in not less than $10 million in net proceeds to us, we will grant the Representative a right of first refusal, for a period of twelve months from the closing of this offering, to act as sole investment banker, back-runner and/or sole placement agent for any and all future public or private equity offering, including all equity-linked or debt offerings during such twelve month period of the Company, or any successor to or any subsidiary of the Company. We have agreed not to offer to retain any entity or person in connection with any such offering on terms more favorable than terms on which we offer to retain the Representative. Such offer shall be made in writing in order to be effective. The Representative shall notify us within ten business days of its receipt of the written offer contemplated above as to whether it agrees to accept such retention. If the Representative should decline such retention, we shall have no further obligations to the Representative with respect to this offering for which it has offered to retain the Representative.

**Indemnification**

We have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act and to contribute to payments that the underwriters may be required to make for these liabilities.

**Discretionary Accounts**

The underwriters do not intend to confirm sales of the shares of our common stock offered hereby to any accounts over which they have discretionary authority.

**Electronic Distribution**

This prospectus in electronic format may be made available on websites or through other online services maintained by one or more of the underwriters, or by their affiliates. Other than this prospectus in electronic format, the information on any underwriter's website and any information contained in any other website maintained by an underwriter is not part of this prospectus, has not been approved and/or endorsed by us or any underwriter in its capacity as underwriter, and should not be relied upon by investors.

**Determination of Offering Price**

The offering price has been negotiated between the Representative and us. In determining the offering price of the securities, the following factors were considered:

● prevailing market conditions;

● our historical performance and capital structure;

● estimates of our business potential and earnings prospects;

● an overall assessment of our management; and

● the consideration of these factors in relation to market valuation of companies in related businesses.

**Listing Application**

We intend to apply for our common stock to be listed on NYSE under the symbol " ". The consummation of this offering is contingent upon the approval of our listing on NYSE, however, it is unlikely we would meet the initial listing standards of NYSE unless this Offering is consummated. If our listing application is not approved by NYSE, we will not consummate this offering and will terminate this offering.

**Stabilization**

● Stabilizing transactions permit bids to purchase securities so long as the stabilizing bids do not exceed a specified maximum and are engaged in for the purpose of preventing or retarding a decline in the market price of the securities while the offering is in progress.

● Over-allotment transactions involve sales by the underwriters of securities in excess of the number of securities the underwriters are obligated to purchase. This creates a syndicate short position which may be either a covered short position or a naked short position. In a covered short position, the number of securities over-allotted by the underwriters is not greater than the number of securities that they may purchase in the over-allotment option. In a naked short position, the number of securities involved is greater than the number of securities in the over-allotment option. The underwriters may close out any short position by exercising their over-allotment option and/or purchasing securities in the open market.

● Syndicate covering transactions involves purchases of securities in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of securities to close out the short position, the underwriters will consider, among other things, the price of securities available for purchase in the open market as compared with the price at which they may purchase securities through exercise of the over-allotment option. If the underwriters sell more securities than could be covered by exercise of the over-allotment option and, therefore, have a naked short position, the position can be closed out only by buying securities in the open market. A naked short position is more likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the securities in the open market that could adversely affect investors who purchase in the offering.

● Penalty bids permit the underwriters to reclaim a selling concession from a syndicate member when the securities originally sold by that syndicate member are purchased in stabilizing or syndicate covering transactions to cover syndicate short positions.

These stabilizing transactions, over-allotment transactions, syndicate covering transactions, and penalty bids may have the effect of raising or maintaining the market price of our securities or preventing or retarding a decline in the market price of our securities. As a result, the price of our securities in the open market may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the price of our securities. These transactions may be affected on NYSE, in the over-the-counter market or otherwise and, if commenced, may be discontinued at any time.

**Passive Market Making**

In connection with this offering, underwriters and selling group members may engage in passive market making transactions in our securities on NYSE in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the securities and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker's bid, then that bid must then be lowered when specified purchase limits are exceeded.

**Other Relationships**

The underwriters and certain of their affiliates are full service financial institutions engaged in various activities, which may include securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment, hedging, financing and brokerage activities. The underwriters and certain of their affiliates have, from time to time, performed, and may in the future perform, various commercial and investment banking and financial advisory services for the issuer and its affiliates, for which they received or may in the future receive customary fees and expenses.

**Selling Restrictions**

Other than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.

**European Economic Area**

In relation to each member state of the European Economic Area that has implemented the Prospectus Directive (each, a relevant member state), with effect from and including the date on which the Prospectus Directive is implemented in that relevant member state (the relevant implementation date), an offer of securities described in this prospectus may not be made to the public in that relevant member state other than:

● to any legal entity which is a qualified investor as defined in the Prospectus Directive;

● to fewer than 100 or, if the relevant member state has implemented the relevant provision of the 2010 PD Amending Directive, 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the relevant Dealer or Dealers nominated by us for any such offer; or

● in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of securities shall require us or any underwriter to publish a prospectus pursuant to Article 3 of the Prospectus Directive.

For purposes of this provision, the expression an "offer of securities to the public" in any relevant member state means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, as the expression may be varied in that member state by any measure implementing the Prospectus Directive in that member state, and the expression "Prospectus Directive" means Directive 2003/71/EC (and amendments thereto, including the 2010 PD Amending Directive, to the extent implemented in the relevant member state) and includes any relevant implementing measure in the relevant member state. The expression 2010 PD Amending Directive means Directive 2010/73/EU.

The sellers of the securities have not authorized and do not authorize the making of any offer of securities through any financial intermediary on their behalf, other than offers made by the underwriters with a view to the final placement of the securities as contemplated in this prospectus. Accordingly, no purchaser of the securities, other than the underwriters, is authorized to make any further offer of the securities on behalf of the sellers or the underwriters.

***United Kingdom***

This prospectus is only being distributed to, and is only directed at, persons in the United Kingdom that are qualified investors within the meaning of Article 2(1)(e) of the Prospectus Directive that are also (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (each such person being referred to as a "relevant person"). This prospectus and its contents are confidential and should not be distributed, published or reproduced (in whole or in part) or disclosed by recipients to any other persons in the United Kingdom. Any person in the United Kingdom that is not a relevant person should not act or rely on this document or any of its contents.

***Switzerland***

The securities may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange (the "SIX") or on any other stock exchange or regulated trading facility in Switzerland. This document does not constitute a prospectus within the meaning of and has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketing material relating to the securities or the offering may be publicly distributed or otherwise made publicly available in Switzerland.

Neither this document nor any other offering or marketing material relating to the offering, the Company, the securities have been or will be filed with or approved by any Swiss regulatory authority. This document will not be filed with, and the offer of securities will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA (the "FINMA"), and the offer of securities has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes (the "CISA"). The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of securities.

***Canada***

The securities may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser's province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser's province or territory for particulars of these rights or consult with a legal advisor.

***Israel***

The securities offered by this prospectus have not been approved or disapproved by the Israeli Securities Authority (the "ISA"), nor have such securities been registered for sale in Israel. The securities may not be offered or sold, directly or indirectly, to the public in Israel, absent the publication of a prospectus. The ISA has not issued permits, approvals or licenses in connection with the offering or publishing the prospectus; nor has it authenticated the details included herein, confirmed their reliability or completeness, or rendered an opinion as to the quality of the securities being offered. Any resale in Israel, directly or indirectly, to the public of the securities offered by this prospectus is subject to restrictions on transferability and must be effected only in compliance with the Israeli securities laws and regulations.

***United Arab Emirates***

Neither this document nor the securities have been approved, disapproved or passed on in any way by the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab Emirates, nor has the Company received authorization or licensing from the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab Emirates to market or sell the securities within the United Arab Emirates. This document does not constitute and may not be used for the purpose of an offer or invitation. No services relating to the securities, including the receipt of applications and/or the allotment or redemption of such securities, may be rendered within the United Arab Emirates by the Company.

No offer or invitation to subscribe for securities is valid or permitted in the Dubai International Financial Centre.

***Singapore***

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of our securities may not be circulated or distributed, nor may the securities be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor (as defined under Section 4A of the Securities and Futures Act, Chapter 289 of Singapore (the "SFA")) pursuant to Section 274 of the SFA, (ii) to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A), and in accordance with the conditions specified in Section 275 of the SFA or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA, in each case subject to conditions set forth in the SFA.

Where our securities are subscribed or purchased under Section 275 by a relevant person which is a corporation (which is not an accredited investor as defined in Section 4A of the SFA) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor, the securities or securities-based derivatives contracts (each as defined in Section 2(1) of the SFA) of that corporation shall not be transferable for six months after that corporation has acquired our securities under Section 275 except: (a) to an institutional investor under Section 274 of the SFA or to a relevant person, (b) where such transfer arises from an offer in that corporation's securities pursuant to Section 275(1A) of the SFA, and in accordance with the conditions, specified in Section 275 of the SFA; (c) where no consideration is or will be given for the transfer; (d) where such transfer is by operation of law; or (e) as specified in Section 276(7) of the SFA.

Where the securities are subscribed or purchased under Section 275 of the SFA by a relevant person which is a trust (where the trustee is not an accredited investor (as defined in Section 4A of the SFA)) whose sole purpose is to hold investments and each beneficiary of the trust is an accredited investor, the beneficiaries' rights and interest (howsoever described) in that trust shall not be transferable for six months after that trust has acquired the securities under Section 275 of the SFA except: (1) to an institutional investor under Section 274 of the SFA or to a relevant person, (2) where such transfer arises from an offer that is made on terms that such rights or interest are acquired at a consideration of not less than S$200,000 (or its equivalent in a foreign currency) for each transaction (whether such amount is to be paid for in cash or by exchange of securities or other assets), (3) where no consideration is or will be given for the transfer, (4) where the transfer is by operation of law, or (5) as specified in Section 276(7) of the SFA.

***Hong Kong***

Our securities may not be offered or sold by means of any document other than (i) in circumstances which do not constitute an offer to the public within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong), (ii) to "professional investors" within the meaning of the Securities and Futures Ordinance (Cap.571, Laws of Hong Kong) and any rules made thereunder or (iii) in other circumstances which do not result in the document being a "prospectus" within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong), and no advertisement, invitation or document relating to the securities may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), which is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the laws of Hong Kong) other than with respect to the securities which are or are intended to be disposed of only to persons outside Hong Kong or only to "professional investors" within the meaning of the Securities and Futures Ordinance (Cap.571, Laws of Hong Kong) and any rules made thereunder.

***Australia***

This prospectus is not a disclosure document under Chapter 6D of the Australian Corporations Act, has not been lodged with the Australian Securities and Investments Commission and does not purport to include the information required of a disclosure document under Chapter 6D of the Australian Corporations Act. Accordingly, (i) the offer of the securities under this prospectus is only made to persons to whom it is lawful to offer the securities without disclosure under Chapter 6D of the Australian Corporations Act under one or more exemptions set out in section 708 of the Australian Corporations Act, (ii) this prospectus is made available in Australia only to those persons as set forth in clause (i) above, and (iii) the offeree must be sent a notice stating in substance that by accepting this offer, the offeree represents that the offeree is such a person as set forth in clause (i) above, and, unless permitted under the Australian Corporations Act, agrees not to sell or offer for sale within Australia any of the securities sold to the offeree within 12 months after its transfer to the offeree under this prospectus.

***Japan***

The securities have not been and will not be registered under Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948), as amended (the "FIEL"), pursuant to an exemption from the registration requirements applicable to a private placement of securities to Qualified Institutional Investors (as defined in and in accordance with Article 2, paragraph 3 of the FIEL and the regulations promulgated thereunder). Accordingly, the securities may not be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan other than Qualified Institutional Investors. Any Qualified Institutional Investor who acquires securities may not resell them to any person in Japan that is not a Qualified Institutional Investor, and acquisition by any such person of securities is conditional upon the execution of an agreement to that effect.

***People's Republic of China***

The information in this document does not constitute a public offer of the securities, whether by way of sale or subscription, in the People's Republic of China (excluding, for purposes of this paragraph, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan). The securities may not be offered or sold directly or indirectly in the PRC to legal or natural persons other than directly to "qualified domestic institutional investors."

**LEGAL MATTERS**

The validity of the securities offered by this prospectus will be passed upon for us by McGuireWoods LLP, New York, New York. Sheppard, Mullin, Richter & Hampton LLP, New York, New York is acting as counsel for the underwriters.

**EXPERTS**

The carve-out balance sheets of Option Therapeutics Inc. as of June 30, 2025 and 2024, and the related carve-out statements of operations, changes in Parent's net investment, and cash flows for each of the years then ended, have been audited by EisnerAmper LLP, independent registered public accounting firm, as stated in their report which is incorporated herein, which report includes an explanatory paragraph about the existence of substantial doubt concerning the Company's ability to continue as a going concern. Such financial statements have been incorporated herein in reliance on the report of such firm given upon their authority as experts in accounting and auditing.

**WHERE YOU CAN FIND MORE INFORMATION**

We have filed with the SEC a registration statement (including amendments and exhibits to the registration statement) on Form S-1 under the Securities Act. This prospectus, which is part of the registration statement, does not contain all of the information set forth in the registration statement. For further information, we refer you to the registration statement and the exhibits and schedules filed as part of the registration statement. If a document has been filed as an exhibit to the registration statement, we refer you to the copy of the document that has been filed. Each statement in this prospectus relating to a document filed as an exhibit is qualified in all respects by the filed exhibit. You should read this prospectus and the documents that we have filed as exhibits to the registration statement of which this prospectus is a part completely.

You may read our SEC filings, including this registration statement, over the Internet at the SEC's website at www.sec.gov. Upon the closing of this offering, we will be subject to the information reporting requirements of the Exchange Act and we will file reports, proxy statements and other information with the SEC. These reports, proxy statements and other information will be available for review on the web site of the SEC referred to above. We also maintain a website at , at which, following the completion of this offering, you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.

**INDEX TO FINANCIAL STATEMENTS**

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| | |
|:---|:---|
|  | **Page** |
| [Report of Independent Registered Public Accounting Firm (EisenAmper LLP PCAOB identification number 274)](#fin_001) | [F-2](#fin_001) |
| [Carve-Out Balance Sheets as of June 30, 2025 and 2024](#fin_002) | [F-3](#fin_002) |
| [Carve-Out Statements of Operations for the Years ended June 30, 2025 and 2024](#fin_003) | [F-4](#fin_003) |
| [Carve-Out Statements of Changes in Parent's Net Investment for the years ended June 30, 2025 and 2024](#fin_004) | [F-5](#fin_004) |
| [Carve-Out Statements of Cash Flows for the Years ended June 30, 2025 and 2024](#fin_005) | [F-6](#fin_005) |
| [Notes to Financial Statements](#fin_006) | [F-7](#fin_006) |

---

**Report of Independent Registered Public Accounting Firm**

To the Board of Directors and Stockholder of

Option Therapeutics Inc.

***Opinion on the Financial Statements***

We have audited the accompanying carve-out balance sheets of Option Therapeutics Inc. (the "Company") as of June 30, 2025 and 2024, and the related carve-out statements of operations, changes in Parent's Net Investment, and cash flows for each of the years then ended, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30, 2025 and 2024, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.

***Going Concern***

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company's recurring losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern. Management's plans regarding these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

***Basis for Opinion***

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ EisnerAmper LLP

We have served as the Company's auditor since 2025.

EISNERAMPER LLP

Iselin, New Jersey

September 5, 2025

 **Option Therapeutics Inc.**

**Carve-Out Balance Sheets**

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| | | |
|:---|:---|:---|
|  | **June 30, <br> 2025** | **June 30,<br> 2024** |
| **ASSETS** |  |  |
| **CURRENT ASSETS:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaid and other current assets | $- | $62810 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Deferred offering costs | 493075 | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 493075 | 62810 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Intangible assets, net | 178341 | 407718 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Goodwill | 345711 | 345711 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total non-current assets | 524052 | 753429 |
| **TOTAL ASSETS** | $1017127 | $816239 |
| **LIABILITIES AND PARENT'S NET INVESTMENT** |  |  |
| **CURRENT LIABILITIES:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts payable and accrued expenses | $127217 | $12845 |
| **Total liabilities** | 127217 | 12845 |
| Commitments and Contingencies (see Note 8) |  |  |
| **Parent's net investment** | 889910 | 803394 |
| **TOTAL LIABILITIES AND PARENT'S NET INVESTMENT** | $1017127 | $816239 |

---

See accompanying notes to carve-out financial statements

 

 

**Option Therapeutics Inc.**

**Carve-Out Statements of Operations**

---

| | | |
|:---|:---|:---|
|  | **Year Ended June 30,**<br>**2025** | **Year Ended June 30,**<br>**2024** |
| **OPERATING EXPENSES:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Amortization of intangible assets | $229377 | $229377 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Research and development expenses | 487858 | 1161743 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;General and administrative expenses | 506604 | 548607 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**TOTAL OPERATING EXPENSES** | $1223839 | $1939727 |
| **NET LOSS** | $(1223839) | $(1939727) |

---

See accompanying notes to carve-out financial statements

**Option Therapeutics Inc.**

**Carve-Out Statements of Changes in Parent's Net Investment**

---

| | |
|:---|:---|
| Parent's net investment as of July 1, 2023 | $576012 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net Loss | (1939727) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Stock based compensation | 300286 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net contribution from Parent | 1866823 |
| Parent's net investment as of June 30, 2024 | 803394 |
| &nbsp;&nbsp;&nbsp;Net Loss | (1223839) |
| &nbsp;&nbsp;&nbsp;Stock based compensation | 153131 |
| &nbsp;&nbsp;&nbsp;Net contribution from Parent | 1157224 |
| Parent's net investment as of June 30, 2025 | $889910 |

---

See accompanying notes to carve-out financial statements

**Option Therapeutics Inc.**

**Carve-Out Statements of Cash Flows**

---

| | | |
|:---|:---|:---|
|  | **Year ended June 30,**<br>**2025** | **Year ended June 30,**<br>**2024** |
| **CASH FLOWS FROM OPERATING ACTIVITIES:** |  |  |
| &nbsp;&nbsp;&nbsp;Net loss | $(1223839) | $(1939727) |
| &nbsp;&nbsp;&nbsp;Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Amortization of intangible assets | 229377 | 229377 |
| &nbsp;&nbsp;&nbsp;Stock based compensation | 153131 | 300286 |
| &nbsp;&nbsp;&nbsp;Changes in operating assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaid and other current assets | 62810 | (62810) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Deferred offering costs | (493075) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts payable and accrued expenses | 114372 | (393949) |
| &nbsp;&nbsp;&nbsp;Net cash used in operating activities | (1157224) | (1866823) |
| **CASH FLOWS FROM FINANCING ACTIVITIES:** |  |  |
| &nbsp;&nbsp;&nbsp;Contributions from parent | 1157224 | 1866823 |
| &nbsp;&nbsp;&nbsp;Net cash flows provided by financing activities | 1157224 | 1866823 |
| Net change in cash and cash equivalents |  |  |
| **Cash and cash equivalents, beginning of period** | - | - |
| **Cash and cash equivalents, end of period** | $- | $- |

---

See accompanying notes to carve-out financial statements

**Option Therapeutics Inc.**

**Notes to Carve-out Financial Statements**

**For the Years Ended June 30, 2025 and 2024**

&nbsp;&nbsp;&nbsp;&nbsp;**1.** **Background Information** 

Option Therapeutics Inc. (the "Company") was incorporated under the law of the state of Delaware on May 1, 2025 as a wholly-owned subsidiary of BioVie Inc. ("Parent"). The Company will commence operations upon the effective date of the Initial Public Offering ("IPO"). The Company is a clinical-stage company developing innovative drug therapies to overcome unmet medical needs in chronic debilitating conditions in advanced liver disease. As of June 30, 2025, the Company is authorized to issue 100 shares of its common stock, and 100 shares are issued and outstanding, all owned by Parent.

The Parent has been developing the Company's investigational drug candidate BIV201 (continuous infusion terlipressin), which was granted both FDA Fast Track designation status and FDA Orphan Drug Status, is being evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism. The initial target for BIV201 therapy was refractory ascites.

After receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting a broader ascites patient population. The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury. This patient population is not limited to those having refractory ascites. BIV201 is administered as a patent-pending liquid formulation with patents issued in United States, China, Japan, Chile and India to date.

In June 2021, the Parent initiated a Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment cycles) combined with standard-of-care ("SOC"), compared to SOC alone, for the treatment of refractory ascites. The primary endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period. By October 2022, there were 15 patients enrolled for treatment and the last patient completed treatment in May 2023.

In March 2023, enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period.

The BIV201 development program was initiated by LAT Pharma LLC. On April 11, 2016, BioVie Inc. ("BioVie") acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. Pursuant to the Separation Agreement to be entered into between the Company and BioVie upon completion of the initial public offering, the Company will assume the royalty agreement and will be obligated to pay the low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

&nbsp;&nbsp;&nbsp;&nbsp;**2.** **Liquidity and Going Concern** 

The Company's operations are subject to a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company's products; the Company's ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company's ability to raise capital. The Company's financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of June 30, 2025, the Company had working capital of approximately $366,000. The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future. The Company's future operations are dependent on the success of the Company's ability to secure additional financing and ongoing development and commercialization efforts, as well as Parent's ability to continue to fund the Company's operations.

The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

Although management continues to pursue the Company's strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company's ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

&nbsp;&nbsp;&nbsp;&nbsp;**3.** **Significant Accounting Policies** 

*Basis of Presentation* 

The Company has historically operated as part of the Parent and not as a standalone company. The accompanying carve-out financial statements represent the historical operations of the Parent's BIVI201 activities and have been derived from the Parent's historical accounting records. The Company's carve-out financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented. The carve-out financial statements may not be indicative of what the carve-out business would have been as a stand-alone entity.

*Use of Estimates*

 

The preparation of carve-out financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of expenses reported for each of the periods presented in the statements of operations are affected by estimates and assumptions, which are used for, but not limited to, accounting for clinical accruals, the inputs used in the valuation of goodwill and intangible assets in connection with impairment testing and the allocation of indirect expenses. Actual results could differ from those estimates.

*Research and Development*

 

Research and development expenses consist primarily of costs associated with the clinical trial of the BIV201 drug candidate, compensation for third party contractors, consultants and personal, Chemistry, Manufacturing and Controls ("CMC") and other expenses for research and development.

In preparation of the carve-out financial statements, the process involved reviewing vendor agreements and invoices and identifying all vendors directly related to the BIV201 clinical study. The last patient treatment in the BIV201 Phase 2 trial was in May 2023 and the costs incurred since that date were costs involved with the wrap-up of final patient visits, data analysis and evaluation, reports of the study and the preparation and development of the next phase clinical study for the BIV201 drug candidate. The process included identifying the direct services performed and allocating shared cost, primarily consisting of personnel costs including stock-based compensation for relevant personnel of approximately $71,500 and $162,300 for the years ended June 30, 2025 and 2024, respectively, which were determined by communicating with its personnel and evaluating their level of BIV201 involvement during the reporting periods.

When accruing research and development expenses, the Company estimated the time period over which services will be performed and the level of effort to be expended for the period, and the progress of the study. Historically, the estimated accrued research and development expenses have approximated the actual expense incurred.

*General and Administrative Expenses*

General and administrative expenses represent salaries, benefits and other personnel-related costs, including stock-based compensation of approximately $81,600 and $138,000 for the years ended June 30, 2025 and 2024, respectively, and professional and legal fees.

*Deferred offering costs*

Deferred offering costs represent legal and other fees directly related to the cost of issuance of common stock from the anticipated capital raise and will be offset against the gross proceeds of the raise upon the close.

*Goodwill and Intangible Assets*

 

Goodwill and intangible assets resulted from the Parent's purchase of LAT Pharma. On April 11, 2016, the Parent entered into and consummated an Agreement and Plan of Merger (the "Merger Agreement"), with LAT Acquisition Corp., a Nevada corporation and wholly-owned subsidiary of the Parent ("Acquisition") and LAT Pharma, LLC an Illinois limited liability company ("LAT"). Pursuant to the terms of the Merger Agreement, Acquisition merged with and into LAT in a statutory triangular merger (the "Merger") with LAT surviving as a wholly-owned subsidiary of the Parent. Following the merger, the Parent continued to development the low dose continuous infusion of Terlipressin known as BIV201 and has completed two phase 2 clinical studies. The Parent did not recognize any impairments of goodwill or the acquired intellectual properties. The Company recorded the goodwill and intangible assets at the Parent's amortized cost as of July 1, 2023.

The Company's impairment review process compares the fair value of the reporting unit to its carrying value, including the goodwill related to its one reporting unit, which is performed at least annually, or more frequently if an event or other circumstance indicates that the Company may not be able to recover the carrying amounts of the net assets of the reporting unit. The Company may use various approaches including an asset or cost approach, market approach or income approach or any combination thereof to determine the fair value of the reporting unit. The estimates and assumptions used are reviewed periodically and are typically developed as part of the Company's routine business planning and forecasting process. While the Company believes its estimates and assumptions are reasonable, variations from those estimates could produce materially different results.

*Impairment of Long-Lived Assets*

 

Long-lived assets, including intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset.

If the carrying amount of an asset exceeds its undiscounted estimated future cash flows, an impairment review is performed. An impairment charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset. Generally, fair value is determined using valuation techniques such as expected discounted cash flows or appraisals, as appropriate. Assets to be disposed of would be separately presented in the balance sheet and reported at the lower of the carrying amount or fair value less costs to sell and are no longer depreciated or amortized. The assets and liabilities of a disposed group classified as held for sale would be presented separately in the appropriate asset and liability sections of the balance sheet.

*Income Taxes*

The financial data included in the accompanying carve-out financial statements was derived from the general ledger of the Parent as of and for the years ended June 30, 2025 and 2024. As such, all income taxes were reported in the Parent's consolidated financial statements and tax returns and are excluded from these carve-out financial statements. The Company will provide for income taxes on a separate company basis and will continue to be a part of the Parent's consolidated tax return.

The Company uses the asset and liability method of accounting for deferred income taxes. Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards and to the differences between the financial reporting and tax bases of assets and liabilities. Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.

The Company recognizes uncertainty in income taxes in the financial statements using a recognition threshold and measurement attribute of a tax position taken or expected to be taken in a tax return. The Company applies the "more-likely-than-not" recognition threshold to all tax positions, commencing at the inception date of the Company which resulted in no unrecognized tax benefits as of such date. Additionally, there have been no material unrecognized tax benefits subsequent to adoption.

*Segment Reporting*

Upon commencement of operations on the effective date of the IPO, the Company will operate as one operating segment with a focus on its efforts to develop drug therapies for advanced liver disease. The Company's Chief Executive Officer ("CEO"), as the chief operating decision maker, will manage and allocate resources to the operations of the Company based on the line items included within these financial statements and segment performance will be evaluated based on net loss. This will enable the CEO to assess the overall level of available resources and determine how best to deploy these resources across functions, clinical trials, and development projects in line with the long-term company-wide strategic goals. The measurement of segment assets is reported on the carve-out balance sheet as total assets.

*Emerging Growth Company Status*

 

The Company intends to operate as an emerging growth company ("EGC"), as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). Under the JOBS Act, EGCs can delay adopting new or revised accounting standards as of effective dates for private companies. The Company historically operated as part of BioVie and adopted new accounting pronouncements using the same timeline as BioVie. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an EGC or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBs Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

*Recent Accounting Pronouncements*

The Company considers the applicability and impact of all Accounting Standards Updates ("ASUs").

ASU 2023-07: Segment Reporting Topic 280 - Improvements to Reportable Segment Disclosures. This update requires expanded annual and interim disclosures for significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss. This update is effective for fiscal years beginning after December 15, 2023. The Company adopted ASU 2023-07 in the current fiscal year.

In December 2023, the FASB issued ASU 2023-09, "Income Taxes (Topic 740): Improvements in Income Tax Disclosures" to enhance the transparency and decision usefulness of income tax disclosures. This amendment requires public companies to disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. Additionally, under the amendment entities are required to disclose the amount of income taxes paid disaggregated by federal, state and foreign taxes, as well as disaggregated by material individual jurisdictions. Finally, the amendment requires entities to disclose income from continuing operations before income tax expense disaggregated between domestic and foreign and income tax expense from continuing operations disaggregated by federal, state and foreign. The new rules are effective for annual periods beginning after December 15, 2024. The standard will be adopted on a prospective basis and is not expected to have a material impact to the Company's financial statements or disclosures.

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses ("DISE"), which will require additional disclosure of the nature of expenses included in the income statement in response to longstanding requests from investors for more information about an entity's expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. The new standard will be effective for public companies for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2024-03 on its financial statements and disclosures.

&nbsp;&nbsp;&nbsp;&nbsp;**4.** **Intangible Assets** 

The Company's intangible assets consist of intellectual property that the Parent had acquired from LAT Pharma, Inc. and are amortized over their estimated useful lives.

The following is a summary of the Company's intangible assets:

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| | | |
|:---|:---|:---|
|  | **June 30, 2025** | **June 30, 2024** |
| Intellectual Property | $2293770 | $2293770 |
| Less: Accumulated Amortization | (2115429) | (1886052) |
| Intangible assets, net | $178341 | $407718 |

---

Amortization expense was $229,377 for the years ended June 30, 2025 and 2024. The Company amortizes intellectual property over the expected original useful lives of 10 years.

Estimated future amortization expense is as follows:

---

| | |
|:---|:---|
| Year ending June 30, 2026 | $178341 |

---

&nbsp;&nbsp;&nbsp;&nbsp;**5.** **Related Party Transactions** 

Management adopted a proportional cost method to carve-out Parent expenses to the Company. The method calculates the appropriate share of general and administrative costs to be allocated based on activities and usage directly related to BIV201 relative to the other Parent activities. As a result, approximately 5.9% and 6.2% of the Parent's general and administrative expenses were allocated to the Company for the years ended June 30, 2025 and 2024, respectively. The Company believes the methodology used was reasonable and has been consistently applied, and results in an appropriate reflection of costs of the activities for the periods presented. However, these costs may not be indicative of the total costs the Company would have incurred had the Company been a stand-alone entity, or not indicative of future costs required to operate the Company. The Parent carved-out approximately $507,000 and $549,000 of its general and administrative costs to the Company for the years ended June 30, 2025 and 2024, respectively. The Parent carved-out approximately $488,000 and $1.2 million of research and development costs to the Company for the years ended June 30, 2025 and 2024, respectively. Such amounts will not be cash settled and are included in the calculation of the Parent's net investment. The Parent carved-out approximately $153,000 and $300,000 of stock-based compensation that is included in both research and development and general and administrative costs to the Company for the years ended June 30, 2025 and 2024, respectively. Such amounts will not be cash settled and are deemed contributions from the Parent and included as a component of the Parent's net investment.

&nbsp;&nbsp;&nbsp;&nbsp;**6.** **Investment by Parent** 

The Company was dependent upon the Parent for all of its working capital and financing requirements as the Parent has historically used a centralized approach for cash management and financing its operations. The financial transactions relating to the Company were reflected through the Parent's net investment account. The Parent's net contributions to the Company as a result of the carve-out process were approximately $1,157,000 and 1,867,000 for the years ended June 30, 2025 and 2024, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;**7.** **Leases** 

*Office Leases* 

The Company pays an annual rent of $1,800 for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703. The rental agreement was for a one-year term, commenced on May 1, 2025.

&nbsp;&nbsp;&nbsp;&nbsp;**8.** **Commitments and Contingencies** 

*Royalty Agreements*

 

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, by and between the Parent's predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Parent was obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. The assignment of this royalty agreement to the Company will be effected upon completion of the IPO.

Pursuant to the Technology Transfer Agreement entered into on July 25, 2016, by and between the Parent and the University of Padova (Italy), the Parent was obligated to pay a low single digit royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances, capped at a maximum of $200,000 per year. The assignment of this technology transfer agreement to the Company will be effected upon completion of the IPO.

*Legal Proceedings*

 

From time to time the Parent and the Company may be involved in various claims and legal actions arising in the ordinary course of our business.

On January 19, 2024, a purported shareholder class action complaint, captioned *Eric Olmstead v. BioVie Inc. et al.*, No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming BioVie Inc. and certain of its officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned *Way v. BioVie Inc. et al.*, No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption *In re BioVie Inc. Securities Litigation*, No. 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the BioVie Inc.'s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the BioVie Inc.'s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney's fees. The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and that motion was fully briefed as of December 5, 2024. On March 27, 2025, the court denied the defendants' motion to dismiss, and the parties are now engaged in the early stages of fact discovery.

On December 30, 2024, a shareholder derivative lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder Andrew Hulm, allegedly on behalf of the BioVie Inc., that piggy-backs on the securities class action also pending in that court. The derivative complaint names certain current and former officers and directors as defendants and generally alleges that they breached their fiduciary duties by causing or failing to prevent the securities violations alleged in the securities class action. The derivative complaint also alleges claims for unjust enrichment, waste of corporate assets, gross mismanagement, and abuse of control as against all defendants. On March 18, 2025, the court ordered the Hulm derivative lawsuit stayed, pending resolution of the motion to dismiss the securities class action described above.

On April 28, 2025, a second shareholder derivative lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder William Settel, allegedly on behalf of the BioVie Inc., that likewise piggy-backs on the securities class action. The Settel derivative complaint alleges essentially the same claims as the Hulm derivative action against the same defendants based on the same alleged conduct.

BioVie Inc. believes that the claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Shares of Common Stock**

**Option Therapeutics Inc.**

**PROSPECTUS**

**ThinkEquity**

, 2025

Through and including , 2025 (the 25<sup>th</sup> day after the date of this offering), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer's obligation to deliver a prospectus when acting as underwriters and with respect to an unsold allotment or subscription.

**PART II**

**INFORMATION NOT REQUIRED IN PROSPECTUS**

**Item 13. Other Expenses of Issuance and Distribution.**

The estimated expenses in connection with the sale of the securities being registered hereby, are as follows:

---

| | |
|:---|:---|
| SEC registration fee | $\* |
| Accounting fees and expenses | \* |
| FINRA filing fee | \* |
| NYSE listing fee | \* |
| Printing expenses | \* |
| Legal fees and expenses | \* |
| Transfer agent fees and expenses | \* |
| Miscellaneous expenses | \* |
| Total | $\* |

---

\* To be filed by amendment

**Item 14. Indemnification of Directors and Officers.**

Section 102(b)(7) of the DGCL permits a corporation to provide in its certificate of incorporation that a director or officer of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director or officer, except: a director or officer for any breach of the director's or officer's duty of loyalty to the corporation or its stockholders, a director or officer for acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law, a director for willful or negligent payment of unlawful dividends, stock repurchases, or redemptions, a director or officer for any transaction from which the director derived an improper personal benefit, or an officer in any action by or in the right of the corporation.

Section 145 of the DGCL ("Section 145") provides, among other things, that a Delaware corporation may indemnify any person who was, is, or is threatened to be made party to any threatened, pending, or completed action, suit, or proceeding, whether civil, criminal, administrative, or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person is or was an officer, director, employee, or agent of such corporation or is or was serving at the request of such corporation as a director, officer, employee, or agent of another corporation or enterprise against expenses (including attorneys' fees), judgments, fines, and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit, or proceeding, provided such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation's best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who were or are a party to any threatened, pending, or completed action or suit by or in the right of the corporation by reason of the fact that such person is or was a director, officer, employee, or agent of another corporation or enterprise against expenses (including attorneys' fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit, provided such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation's best interests, provided further that no indemnification is permitted without judicial approval if the officer, director, employee, or agent is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the expenses such officer or director has actually and reasonably incurred.

Section 145 also provides that the expenses incurred by a director, officer, employee, or agent of the corporation or a person serving at the request of the corporation as a director, officer, employee, or agent of another corporation or enterprise in defending any action, suit, or proceeding may be paid in advance of the final disposition of the action, suit, or proceeding, subject, in the case of current officers and directors, to the corporation's receipt of an undertaking by or on behalf of such officer or director to repay the amount so advanced if it shall be ultimately determined that such person is not entitled to be indemnified.

Section 145 further authorizes a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee, or agent of the corporation or is or was serving at the request of the corporation as a director, officer, employee, or agent of another corporation or enterprise, against any liability asserted against such person and incurred by such person in any such capacity, or arising out of his or her status as such, whether or not the corporation would otherwise have the power to indemnify him or her under Section 145.

In addition, our amended and restated certificate of incorporation will provide that we must indemnify our directors and officers to the fullest extent authorized by law. Under our amended and restated bylaws, we are also expressly required to advance certain expenses to our directors and officers and we are permitted to, and currently intend to, carry directors' and officers' insurance providing indemnification for our directors and officers for some liabilities. We believe that these indemnification provisions and the directors' and officers' insurance are useful to attract and retain qualified directors and officers.

The indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter acquire under any statute, provision of our amended and restated certificate of incorporation, provision of our amended and restated bylaws, agreement, vote of stockholders or disinterested directors, or otherwise.

We expect to maintain standard policies of insurance that provide coverage (1) to our directors and officers against loss arising from claims made by reason of breach of duty or other wrongful act and (2) to us with respect to indemnification payments that we may make to such directors and officers.

We intend to enter into indemnification agreements with our directors and executive officers. These agreements will require us to indemnify these individuals to the fullest extent permitted under Delaware law against liabilities that may arise by reason of their service to us, and to advance expenses incurred as a result of any proceeding against them as to which they could be indemnified. Insofar as indemnification for liabilities arising under the Securities Act, may be permitted to directors or executive officers, we have been informed that, in the opinion of the Securities and Exchange Commission, such indemnification is against public policy and is therefore unenforceable.

The proposed form of Underwriting Agreement to be filed as Exhibit 1.1 to this registration statement provides for indemnification of our directors and officers signing this registration statement by the underwriters against certain liabilities.

**Item 15. Recent Sales of Unregistered Securities.**

The registrant has not issued or sold any securities within the past three years that have not been registered under the Securities Act.

**Item 16. Exhibits**

***(a) Exhibits.***

 

The exhibits listed below are filed as part of this registration statement.

---

| | |
|:---|:---|
| **Exhibit<br> Number** | **Description of Document** |
| 1.1\* | Form of Underwriting Agreement |
| 3.1\* | Form of Amended and Restated Certificate of Incorporation |
| 3.2\* | Form of Amended and Restated Bylaws |
| 4.1\* | Form of Common Stock Certificate of the registrant |
| 4.2\* | Form of Representative's Warrant |
| 5.1\* | Opinion of McGuireWoods LLP |
| [10.1](opti_drsex10z1.htm) | [Form of Separation Agreement](opti_drsex10z1.htm) |
| [10.2](opti_drsex10z2.htm) | [Form of Management Services Agreement](opti_drsex10z2.htm) |
| 10.3\* | Form of Registration Rights Agreement |
| 10.4\*+ | Form of Indemnification Agreement for Directors and Officers |
| 23.1\* | Consent of EisnerAmper LLP, Independent Registered Public Accounting Firm |
| 23.2\* | Consent of McGuireWoods LLP (included in Exhibit 5.1) |
| 24.1\* | Power of Attorney (included on signature page) |
| 99.1\* | Form of Audit Committee Charter |
| 99.2\* | Form of Nominating and Corporate Governance Committee Charter |
| 99.4\* | Code of Business Conduct and Ethics of the Registrant. |
| 99.5\* | Consent of Jim Lang, to be named as a director |
| 99.6\* | Consent of Sigmund Rogich, to be named as a director |
| 99.7\* | Consent of , to be named as a director |
| 107\* | Filing Fee Table |

---

\* To be filed by amendment.

+ Indicates management contract or compensatory plan

**Item 17. Undertakings**

The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described in Item 6, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) For the purposes of determining liability under the Securities
Act to any purchaser in the initial distributions of the securities, the undersigned registrant undertakes that in a primary offering
of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell
the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications,
the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Any preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule 424;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant
or used or referred to by the undersigned registrant;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) The portion of any other free writing prospectus relating to the offering containing material information
about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) For purposes of determining any liability under the Securities Act, the information omitted from the form
of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the
registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement
as of the time it was declared effective.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) For the purpose of determining any liability under the Securities Act, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering
of such securities at that time shall be deemed to be the initial bona fide offering thereof.

**SIGNATURES**

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, on the day of , 2025.

---

| | |
|:---|:---|
| **OPTION THERAPEUTICS INC.** | **OPTION THERAPEUTICS INC.** |
| By: |  |
| Name: | Cuong Do |
| Title: | President |

---

**POWER OF ATTORNEY**

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Cuong Do as his or her true and lawful attorneys-in-fact, with full power of substitution and re-substitution, for him and in his name, place and stead, in any and all capacities to sign any and all amendments (including post-effective amendments) to this registration statement and to sign a registration statement pursuant to Section 462(b) of the Securities Act of 1933, and to file the same with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.

---

| | | | |
|:---|:---|:---|:---|
| **Name** | **Name** | **Position** | **Date** |
| By: |  | President and Director | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;, 2025 |
|  | Cuong Do | (Principal Executive Officer) |  |
| By: |  | Treasurer, Secretary and Director | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;, 2025 |
|  | Joanne Wendy Kim | (Principal Financial and Accounting Officer) |  |

---

## Exhibit 10.1

Exhibit 10.1

FORM OF

SEPARATION AGREEMENT

BY AND BETWEEN

BIOVIE INC.

AND

OPTION THERAPEUTICS INC.

DATED AS OF [⚫], 2025

**TABLE OF CONTENTS**

---

| | | |
|:---|:---|:---|
|  |  | **Page** |
| ARTICLE I DEFINITIONS | ARTICLE I DEFINITIONS | 2 |
| ARTICLE II THE SEPARATION | ARTICLE II THE SEPARATION | 11 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1 | Transfer of Assets and Assumption of Liabilities | 11 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2 | SpinCo Assets | 12 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3 | SpinCo Liabilities | 14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4 | Transfer of Excluded Assets; Assumption of Excluded Liabilities | 15 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5 | Approvals and Notifications | 16 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6 | Novation of SpinCo Liabilities | 18 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.7 | Novation of Excluded Liabilities | 18 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8 | Intercompany Agreements and Arrangements | 19 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.9 | Treatment of Shared Contracts | 20 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.10 | Bank Accounts; Cash Balances; Collection of Accounts Receivable | 21 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.11 | Ancillary Agreements | 21 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.12 | Disclaimer of Representations and Warranties | 21 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.13 | Intellectual Property | 22 |
| ARTICLE III THE IPO; OTHER TRANSACTIONS | ARTICLE III THE IPO; OTHER TRANSACTIONS | 22 |
| ARTICLE IV MUTUAL RELEASES; INDEMNIFICATION | ARTICLE IV MUTUAL RELEASES; INDEMNIFICATION | 23 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1 | Release of Pre-Separation Claims | 23 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2 | Indemnification by SpinCo | 25 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3 | Indemnification by BioVie | 26 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4 | Procedures for Indemnification of Third-Party Claims | 26 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5 | Additional Matters | 27 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6 | Remedies Cumulative | 28 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.7 | Survival of Indemnities | 28 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.8 | Guarantees, Letters of Credit or Other Obligations | 28 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.9 | Contribution | 29 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.10 | Covenant Not to Sue | 29 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.11 | Taxes | 29 |
| ARTICLE V INSURANCE | ARTICLE V INSURANCE | 30 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1 | Insurance Matters | 30 |
| ARTICLE VI CERTAIN OTHER MATTERS | ARTICLE VI CERTAIN OTHER MATTERS | 30 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1 | No Right to Use Regulatory Information | 30 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2 | Late Payments | 31 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3 | Inducement | 31 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4 | Post-Effective Time Conduct | 31 |

---

i

---

| | | |
|:---|:---|:---|
| ARTICLE VII EXCHANGE OF INFORMATION; CONFIDENTIALITY | ARTICLE VII EXCHANGE OF INFORMATION; CONFIDENTIALITY | 31.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1 | Agreement for Exchange of Information; Archives | 31.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2 | Ownership of Information | 31.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3 | Compensation for Providing Information | 32.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4 | Record Retention | 32.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5 | Limitations of Liability | 32.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.6 | Production of Witnesses; Records; Cooperation | 32.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.7 | Confidentiality | 33.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.8 | Protective Arrangements | 34.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9 | Privileged Matters | 34.0 |
| ARTICLE VIII DISPUTE RESOLUTION | ARTICLE VIII DISPUTE RESOLUTION | 36.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1 | Disputes | 36.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2 | Negotiation and Mediation | 36.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3 | Arbitration | 36.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4 | Interim Relief | 37.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.5 | Remedies | 37.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.6 | Expenses | 37.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.7 | Continuation of Services and Commitments | 38.0 |
| ARTICLE IX FURTHER ASSURANCES AND ADDITIONAL COVENANTS | ARTICLE IX FURTHER ASSURANCES AND ADDITIONAL COVENANTS | 38.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1 | Further Assurances | 38.0 |
| ARTICLE X TERMINATION | ARTICLE X TERMINATION | 38.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1 | Termination | 38.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2 | Effect of Termination | 38.0 |
| ARTICLE XI MISCELLANEOUS | ARTICLE XI MISCELLANEOUS | 39.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1 | Counterparts; Entire Agreement; Corporate Power | 39.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2 | Governing Law | 39.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3 | Assignability | 39.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.4 | Third-Party Beneficiaries | 40.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.5 | Notices | 40.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6 | Severability | 40.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.7 | Force Majeure | 40.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.8 | Publicity | 41.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.9 | Expenses | 41.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.10 | Headings | 41.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.11 | Survival of Covenants | 41.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12 | Waivers of Default | 41.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.13 | Specific Performance | 41.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.14 | Amendments | 41.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.15 | Interpretation | 42.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.16 | No Set Off | 42.0 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.17 | Limitations of Liability | 42.0 |

---

ii

<u>SCHEDULES</u>:

---

| | |
|:---|:---|
| Schedule 1.1 | SpinCo Contracts |
| Schedule 1.2 | SpinCo Employment Contracts and Arrangements |
| Schedule 1.4 | SpinCo Intellectual Property |
| Schedule 1.6 | SpinCo Products |
| Schedule 2.2(a)(x) | SpinCo Actions |
| Schedule 2.2(b)(ii) | Excluded Assets |
| Schedule 2.3(b)(iii) | Excluded Liabilities |
| Schedule 2.9(a) | Shared Contracts |
| Schedule 4.8(b) | Guarantee Release |

---

<u>EXHIBITS</u>:

Exhibit A Form of Amended and Restated Certificate of Incorporation of SpinCo <br>Exhibit B Form of Amended and Restated Bylaws of SpinCo

iii

**SEPARATION AGREEMENT**

This **SEPARATION AGREEMENT**, dated as of [⚫], 2025 (this "<u>Agreement</u>"), is made and entered into by and between BIOVIE INC., a Nevada corporation ("<u>BioVie</u>"), and OPTION THERAPEUTICS INC., a Delaware corporation ("<u>SpinCo</u>"). BioVie and SpinCo are referred to together as the "<u>Parties</u>" and individually as a "<u>Party</u>." Capitalized terms used herein shall have the respective meanings assigned to them in <u>Article I</u> or elsewhere in this Agreement.

RECITALS

**WHEREAS**, BioVie, directly or indirectly, currently owns and operates both the BioVie Business and the SpinCo Business;

**WHEREAS**, the board of directors of BioVie (the "<u>BioVie Board</u>") has determined that it is in the best interests of BioVie and its shareholders to create a new publicly traded company that shall operate the SpinCo Business;

**WHEREAS**, SpinCo has been incorporated for these purposes and has not engaged in activities except those incidental to its formation and in preparation for the transactions described herein;

**WHEREAS**, in furtherance of the foregoing, the BioVie Board and the board of directors of SpinCo (the "<u>SpinCo Board</u>") have determined that it is appropriate and desirable for BioVie to transfer the SpinCo Assets to SpinCo and have SpinCo assume the SpinCo Liabilities, in each case as more fully described in this Agreement and the Ancillary Agreements (the "<u>Separation</u>");

**WHEREAS**, the BioVie Board has further determined that it is appropriate and desirable, on the terms and conditions contemplated hereby, for SpinCo to make an offer and sale to the public of a limited number of SpinCo Common Shares, pursuant to a registration statement on Form S-1, as more fully described in this Agreement and the Ancillary Agreements (the "<u>IPO</u>"), immediately following which offering and sale BioVie will own more than 50% of the outstanding SpinCo Common Stock (the "<u>Retained Shares</u>");

**WHEREAS**, after the IPO, if effected, BioVie may (i) effect a disposition of Retained Shares pursuant to one or more public offering(s) or private transaction(s) or (ii) continue to hold its interest of the Retained Shares;

**WHEREAS**, the Parties intend the Separation to qualify for non-recognition treatment for U.S. federal income tax purposes;

**WHEREAS**, each of BioVie and SpinCo has determined that it is appropriate and desirable to set forth the principal corporate transactions required to effect the Separation and to set forth certain other agreements that shall govern certain matters relating to the Separation and the relationship of BioVie, and SpinCo following the Separation and IPO (the "<u>Transactions</u>"); and

**WHEREAS**, the Parties acknowledge that this Agreement and the Ancillary Agreements represent the integrated agreement of BioVie and SpinCo relating to the Transactions, are being entered into together, and would not have been entered into independently.

**NOW, THEREFORE**, in consideration of the mutual agreements, provisions and covenants contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:

**ARTICLE I<br> DEFINITIONS**

For purposes of this Agreement, the following terms shall have the following meanings:

"<u>Action</u>" shall mean any demand, action, claim, dispute, suit, countersuit, arbitration, settlement, inquiry, subpoena, proceeding (including any administrative proceeding) or investigation of any nature (whether criminal, civil, legislative, administrative, regulatory, prosecutorial or otherwise) by or before any federal, state, local, foreign or international Governmental Authority or any arbitration or mediation tribunal.

"<u>Affiliate</u>" shall mean, when used with respect to a specified Person, a Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such specified Person. For the purpose of this definition, "<u>control</u>" (including with correlative meanings, "<u>controlled by</u>" and "<u>under common control with</u>"), when used with respect to any specified Person shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities or other interests, by contract, agreement, obligation, indenture, instrument, lease, promise, arrangement, release, warranty, commitment, undertaking or otherwise. [It is expressly agreed that, prior to, on and after the Separation Date, for purposes of this Agreement and the Ancillary Agreements, (1) SpinCo shall not be deemed to be an Affiliate of BioVie and (2) BioVie shall not be deemed to be an Affiliate of SpinCo.]

"<u>Agreement</u>" shall have the meaning set forth in the Preamble.

"<u>Ancillary Agreements</u>" shall mean all agreements (other than this Agreement) entered into by the Parties in connection with the Transactions, including the Management Services Agreement, the Registration Rights Agreement and the Transfer Documents.

"<u>Approvals or Notifications</u>" shall mean any consents, waivers, approvals, permits or authorizations to be obtained from, notices, registrations or reports to be submitted to, or other filings to be made with, any third-party, including any Governmental Authority.

"<u>Assets</u>" shall mean, with respect to any Person, the assets, properties, claims and rights (including goodwill) of such Person, wherever located (including in the possession of vendors or other Third-Parties or elsewhere), of every kind, character and description, whether real, personal or mixed, tangible, intangible or contingent, in each case whether or not recorded or reflected or required to be recorded or reflected on the books and records or financial statements of such Person, including the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) all accounting and other books, records and files whether in paper, microfilm, microfiche, computer tape or disc, magnetic tape, electronic or any other form;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) all apparatus, computers and other electronic data processing and communications equipment, fixtures, machinery, equipment, furniture, office equipment, automobiles, trucks, vessels, motor vehicles and other transportation equipment and other tangible personal property;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) all inventories of materials, parts, raw materials, components, supplies, works-in-process and finished goods and products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) all interests in real property of whatever nature, including easements, whether as owner, mortgagee or holder of a Security Interest in real property, lessor, sublessor, lessee, sublessee or otherwise;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) (i) all interests in any capital stock or other equity interests of any Subsidiary, Affiliate or any other Person, (ii) all bonds, notes, debentures or other securities issued by any Subsidiary, Affiliate or any other Person, (iii) all loans, advances or other extensions of credit or capital contributions to any Subsidiary, Affiliate or any other Person and (iv) all other investments in securities of any Person;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) all license agreements, leases of personal property, open purchase orders for raw materials, supplies, parts or services and other contracts, agreements or commitments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) all deposits, letters of credit and performance and surety bonds;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) all written (including in electronic form) or oral technical information, data, specifications, research and development information, engineering drawings and specifications, operating and maintenance manuals, and materials and analyses prepared by consultants and other Third-Parties;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) all Intellectual Property and Technology;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j) all Software;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(k) all cost information, sales and pricing data, customer prospect lists, supplier records, customer and supplier lists, customer and vendor data, correspondence and lists, product data and literature, artwork, design, formulations and specifications, quality records and reports and other books, records, studies, surveys, reports, plans and documents;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(l) all prepaid expenses, trade accounts and other accounts and notes receivable;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(m) all rights under insurance policies and all rights in the nature of insurance, indemnification or contribution;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(n) all rights under contracts, consent decrees, orders or agreements, all claims or rights against any Person arising from the ownership of any Asset, all rights in connection with any bids or offers and all claims, choses in action or similar rights, whether accrued or contingent;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(o) all licenses, permits, approvals and authorizations that have been issued by any Governmental Authority;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(p) all cash or cash equivalents, bank accounts, lock boxes and other deposit arrangements; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(q) all interest rate, currency, commodity or other swap, collar, cap or other hedging or similar agreements or arrangements.

"<u>BioVie</u>" shall have the meaning set forth in the Preamble.

"<u>BioVie Board</u>" shall have the meaning set forth in the Recitals.

"<u>BioVie Business</u>" shall mean the businesses and operations of BioVie other than the SpinCo Business.

"<u>BioVie Disclosure Portions</u>" shall mean the information set forth in the IPO Registration Statement or any other Disclosure Document, in each case solely to the extent relating exclusively to (a) BioVie, (b) the BioVie Business, (c) BioVie's intentions with respect to the Separation, or (d) the terms of the Transactions, including the form, structure and terms of any transaction(s) to effect the Separation and the timing of and conditions to the consummation of the Transactions.

"<u>BioVie Indemnitees</u>" shall have the meaning set forth in <u>Section 4.2</u>.

"<u>BioVie Intellectual Property</u>" shall mean all Intellectual Property that is owned or licensed by BioVie, other than the SpinCo Intellectual Property.

"<u>BioVie Released Party</u>" shall have the meaning set forth in <u>Section 4.1(a)</u>.

"<u>BioVie Technology</u>" shall mean all Technology that is owned or licensed by BioVie or SpinCo, other than the SpinCo Technology.

"<u>BioVie Transfer Documents</u>" shall have the meaning set forth in <u>Section 2.1(b)</u>.

"<u>Business Day</u>" shall mean any day that is not a Saturday, a Sunday or other day that is a statutory holiday under the federal Laws of the United States. In the event that any action is required or permitted to be taken under this Agreement on or by a date that is not a Business Day, such action may be taken on or by the Business Day immediately following such date.

"<u>Code</u>" shall mean the Internal Revenue Code of 1986, as amended, and the regulations promulgated thereunder.

"<u>Confidential Information</u>" shall have the meaning set forth in <u>Section 7.7(a)</u>.

"<u>CPR</u>" shall have the meaning set forth in <u>Section 8.2</u>.

"<u>Disclosing Group</u>" shall have the meaning set forth in <u>Section 7.7(a)</u>.

"<u>Disclosing Party</u>" shall have the meaning set forth in <u>Section 7.7(a)</u>.

"<u>Disclosure Document</u>" shall mean any registration statement (including the IPO Registration Statement) filed with the SEC by or on behalf of either Party or any of its controlled Affiliates, and also includes any information statement, prospectus, periodic report or similar disclosure document, whether or not filed with the SEC or any other Governmental Authority, in each case which describes the Separation or the IPO or SpinCo or primarily relates to the Transactions.

"<u>Dispute</u>" shall have the meaning set forth in <u>Section 8.1(b)</u>.

"<u>Dispute Notice</u>" shall have the meaning set forth in <u>Section 8.2</u>.

"<u>Effective Time</u>" shall mean the time at which the Separation occurs on the Separation Date, which shall be deemed to be 12:01 a.m., Eastern Time, on the Separation Date, or such other time as BioVie may determine in its sole discretion.

"<u>Environmental Law</u>" shall mean any Law relating to pollution, protection or restoration of or prevention of harm to the environment or natural resources, including the use, handling, transportation, treatment, storage, disposal, Release or discharge of Hazardous Materials or the protection of or prevention of harm to human health and safety.

"<u>Environmental Liabilities</u>" shall mean all Liabilities relating to, arising out of or resulting from any Hazardous Materials, Environmental Law or contract or agreement relating to environmental, health or safety matters (including all removal, remediation or cleanup costs, investigatory costs, response costs, natural resources damages, equipment upgrades or replacements, asbestos survey and removal costs, property damages, personal injury damages, costs of compliance, including with any product take back requirements, or with any settlement, judgment or other determination of Liability and indemnity, contribution or similar obligations) and all costs and expenses, interest, fines, penalties or other monetary sanctions in connection therewith.

"<u>Exchange</u>" shall mean the NYSE American or such other nationally recognized stock exchange as SpinCo shall select for the listing of the SpinCo Common Stock to be issued in the IPO.

"<u>Exchange Act</u>" shall mean the U.S. Securities Exchange Act of 1934, as amended, together with the rules and regulations promulgated thereunder.

"<u>Excluded Assets</u>" shall have the meaning set forth in <u>Section 2.2(b)</u>.

"<u>Excluded Liabilities</u>" shall have the meaning set forth in <u>Section 2.3(b)</u>.

"<u>Force Majeure</u>" shall have the meaning set forth in <u>Section 11.7</u>.

"<u>GAAP</u>" means United States generally accepted accounting principles, consistently applied.

"<u>Governmental Approvals</u>" shall mean any notices, reports or other filings to be made, or any consents, registrations, approvals, permits or authorizations to be obtained from, any Governmental Authority.

"<u>Governmental Authority</u>" shall mean any nation or government, any state, municipality or other political subdivision thereof, and any entity, body, agency, commission, department, board, bureau, court, tribunal or other instrumentality, whether federal, state, local, domestic, foreign or multinational, exercising executive, legislative, judicial, regulatory, administrative or other similar functions of, or pertaining to, government and any executive official thereof.

"<u>Guarantee Release</u>" shall have the meaning set forth in <u>Section 4.8(b)</u>.

"<u>Hazardous Materials</u>" shall mean any chemical, radiological isotope, material, substance, waste, pollutant, emission, discharge, release or contaminant that could result in liability under, or that is prohibited, limited or regulated by or pursuant to, any Environmental Law, and any natural or artificial substance (whether solid, liquid or gas, noise, ion, vapor or electromagnetic) that could cause harm to human health or the environment, including petroleum, petroleum products and byproducts, asbestos and asbestos-containing materials, urea formaldehyde foam insulation, electronic, medical or infectious wastes, polychlorinated biphenyls, radon gas, radioactive substances, chlorofluorocarbons and all other ozone-depleting substances.

"<u>Indemnifying Party</u>" shall have the meaning set forth in <u>Section 4.4(a)</u>.

"<u>Indemnitee</u>" shall have the meaning set forth in <u>Section 4.4(a)</u>.

"<u>Information</u>" shall mean information, whether or not patentable or copyrightable, in written, oral, electronic or other tangible or intangible forms, whether or not stored in any medium that has existed, now exists or will exist, including studies, reports, records, books, contracts, instruments, surveys, discoveries, ideas, concepts, know-how, techniques, designs, specifications, drawings, blueprints, diagrams, models, prototypes, samples, flow charts, data, computer data, disks, diskettes, tapes, computer programs or other Software, marketing plans, customer names, communications by or to attorneys (including attorney-client privileged communications), memos and other materials prepared by attorneys or under their direction (including attorney work product), and other technical, financial, employee or business information or data.

"<u>Insurance Proceeds</u>" shall mean those monies (a) received by an insured from an insurance carrier, including due to premium adjustments, whether or not retrospectively rated, or (b) paid by an insurance carrier on behalf of an insured, in either case net of any applicable premium deductible or self-insured retention. For the avoidance of doubt, "Insurance Proceeds" shall be calculated net of any costs or expenses incurred by a Party in pursuing insurance coverage.

"<u>Intellectual Property</u>" shall mean all of the following whether arising under the Laws of the United States or of any other foreign or multinational jurisdiction: (a) patents, patent applications (including patents issued thereon) and statutory invention registrations, including reissues, divisions, continuations, continuations in part, substitutions, renewals, extensions and reexaminations of any of the foregoing, and all rights in any of the foregoing provided by international treaties or conventions (the foregoing, collectively, "Patents"), (b) trademarks, service marks, trade names, service names, trade dress, logos and other source or business identifiers, including all goodwill associated with any of the foregoing, and any and all common law rights in and to any of the foregoing, registrations and applications for registration of any of the foregoing, all rights in and to any of the foregoing provided by international treaties or conventions, and all reissues, extensions and renewals of any of the foregoing (the foregoing, collectively, "Trademarks"), (c) Internet domain names, (d) copyrightable works, copyrights, moral rights, mask work rights, database rights and design rights, in each case, other than Software, whether or not registered, and all registrations and applications for registration of any of the foregoing, and all rights in and to any of the foregoing provided by international treaties or conventions, (e) confidential and proprietary Information, including trade secrets, invention disclosures, processes and know-how, in each case, other than Software, (f) intellectual property rights arising from or in respect of any Technology, and (g) rights to enforce any past, present or infringement or misappropriation of any of the foregoing.

"<u>Intercompany Agreements</u>" shall mean the agreements listed on <u>Schedule 1.7</u>.

"<u>IPO</u>" shall have the meaning set forth in the Recitals.

"<u>IPO Effective Date</u>" shall mean the date of the closing of the IPO.

"<u>IPO Registration Statement</u>" shall mean the effective registration statement on Form S-1 to be filed under the Securities Act, pursuant to which the SpinCo Common Stock to be issued in the IPO will be registered under the Securities Act, together with all amendments thereto.

"<u>IRS</u>" shall mean the United States Internal Revenue Service.

"<u>IRS Ruling</u>" shall have the meaning set forth in <u>Section 3.3(a)(i)</u>.

"<u>Law</u>" shall mean any national, supranational, federal, state, provincial, local or similar law (including common law), statute, code, order, ordinance, rule, regulation, treaty (including any income tax treaty), license, permit, authorization, approval, consent, decree, injunction, binding judicial or administrative interpretation or other requirement, in each case, enacted, promulgated, issued or entered by a Governmental Authority.

"<u>Liabilities</u>" shall mean any and all debts, guarantees, assurances, commitments, liabilities, responsibilities, Losses, Taxes, remediation, deficiencies, reimbursement obligations in respect of letters of credit, damages, fines, penalties, settlements, sanctions, costs, expenses, interest and obligations of any nature or description, whether accrued or fixed, absolute or contingent, matured or unmatured, accrued or not accrued, asserted or unasserted, liquidated or unliquidated, foreseen or unforeseen, known or unknown, reserved or unreserved, or determined or determinable, including those arising under any Law, claim (including any Third-Party Claim), demand, Action, or order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority or arbitration tribunal, and those arising under any contract, agreement, obligation, indenture, instrument, lease, promise, arrangement, release, warranty, commitment or undertaking, or any fines, damages or equitable relief that is imposed, in each case, including all costs and expenses relating thereto.

"<u>Losses</u>" shall mean any and all damages, losses, deficiencies, Liabilities, Taxes, obligations, penalties, judgments, settlements, claims, payments, fines, charges, interest, costs and expenses, whether or not resulting from Third-Party Claims, including the costs and expenses of any and all Actions and demands, assessments, judgments, settlements and compromises relating thereto and the costs and expenses of attorneys', accountants', consultants' and other professionals' fees and expenses incurred in the investigation or defense thereof or the enforcement of rights hereunder.

"<u>Management Services Agreement</u>" shall mean the Management Services Agreement, dated as of the date hereof, by and between BioVie and SpinCo, as such Management Services Agreement may be amended from time to time.

"<u>Parties</u>" or "<u>Party</u>" shall have the meaning set forth in the Preamble.

"<u>Patents</u>" shall have the meaning set forth in the definition of Intellectual Property.

"<u>Person</u>" shall mean an individual, a general or limited partnership, a corporation, a trust, a joint venture, an unincorporated organization, a limited liability entity, any other entity or any Governmental Authority.

"<u>Policies</u>" shall mean insurance policies and insurance contracts of any kind (other than life and benefits policies or contracts), including primary, excess and umbrella policies, comprehensive general liability policies, director and officer liability, fiduciary liability, automobile, aircraft, marine, property and casualty, workers' compensation and employee dishonesty insurance policies, bonds and self-insurance and captive insurance company arrangements, together with the rights, benefits and privileges thereunder.

"<u>Privileged Information</u>" means any information, in written, oral, electronic or other tangible or intangible forms, including any communications by or to attorneys (including attorney-client privileged communications), memoranda and other materials prepared by attorneys or under their direction (including attorney work product), as to which a Party would be entitled to assert or have asserted a privilege, including the attorney-client and attorney work product privileges.

"<u>Receiving Group</u>" shall have the meaning set forth in <u>Section 7.7(a)</u>.

"<u>Receiving Party</u>" shall have the meaning set forth in <u>Section 7.7(a)</u>.

"<u>Registrable IP</u>" shall mean all Patents, registered Trademarks (including all goodwill associated therewith), registered Internet domain names and copyright registrations.

"<u>Registration Rights Agreement</u>" shall mean the Registration Rights Agreement, dated as of the date hereof, by and between BioVie and SpinCo, as such Registration Rights Agreement may be amended from time to time.

"<u>Release</u>" shall mean any release, spill, emission, discharge, leaking, pumping, pouring, dumping, injection, deposit, disposal, dispersal, leaching or migration of Hazardous Materials into the environment (including ambient air, surface water, groundwater and surface or subsurface strata).

"<u>Representatives</u>" shall mean, with respect to any Person, any of such Person's directors, officers, employees, agents, consultants, advisors, accountants, attorneys or other representatives.

"<u>Retained Shares</u>" shall have the meaning set forth in the Recitals.

"<u>SEC</u>" shall mean the U.S. Securities and Exchange Commission.

"<u>Securities Act</u>" shall mean the Securities Act of 1933, as amended, together with the rules and regulations promulgated thereunder.

"<u>Security Interest</u>" shall mean any mortgage, security interest, pledge, lien, charge, claim, option, right to acquire, voting or other restriction, right-of-way, covenant, condition, easement, encroachment, restriction on transfer or other encumbrance of any nature whatsoever.

"<u>Separation</u>" shall have the meaning set forth in the Recitals.

"<u>Separation Date</u>" shall mean the IPO Effective Date or such other date as BioVie and SpinCo may mutually agree upon in writing.

"<u>Shared Contract</u>" shall have the meaning set forth in <u>Section 2.9(a)</u>.

"<u>Software</u>" shall mean any and all (a) computer programs, including any and all software implementation of algorithms, models and methodologies, whether in source code, object code, human readable form or other form, (b) databases and compilations, including any and all data and collections of data, whether machine readable or otherwise, (c) descriptions, flow charts and other work products used to design, plan, organize and develop any of the foregoing, (d) screens, user interfaces, report formats, firmware, development tools, templates, menus, buttons and icons, and (e) documentation, including user manuals and other training documentation, relating to any of the foregoing.

"<u>SpinCo</u>" shall have the meaning set forth in the Preamble.

"<u>SpinCo Accounts</u>" shall have the meaning set forth in <u>Section 2.10(a)</u>.

"<u>SpinCo Assets</u>" shall have the meaning set forth in <u>Section 2.2(a)</u>.

"<u>SpinCo Balance Sheet</u>" shall mean the unaudited pro forma balance sheet of the SpinCo Business, as of [DATE], including the notes thereto, as reflected in the applicable Disclosure Document.

"<u>SpinCo Board</u>" shall have the meaning set forth in the Recitals.

"<u>SpinCo Business</u>" shall mean: (a) (i) the business and operations of SpinCo and (ii) such other businesses and operations relating thereto carried on by SpinCo and (b) except as otherwise expressly provided herein, any terminated, divested or discontinued businesses or operations that at the time of termination, divestiture or discontinuation exclusively or primarily related to the SpinCo Business (as described in the foregoing clause (a)) as then conducted, excluding, in the case of each of clauses (a) and (b), the businesses and operations primarily related to the Excluded Assets.

"<u>SpinCo Bylaws</u>" shall mean the Amended and Restated Bylaws of SpinCo, substantially in the form of <u>Exhibit B</u> attached hereto, as reasonably amended in a manner consistent with then-market terms at the advice of the Underwriters to enhance marketability and, subsequent to the IPO Effective Date, shall mean such document as it may be amended from time to time.

"<u>SpinCo Cash</u>" shall have the meaning set forth in <u>Section 2.2(a)(ix)</u>.

"<u>SpinCo Certificate of Incorporation</u>" shall mean the Amended and Restated Certificate of Incorporation of SpinCo, substantially in the form of <u>Exhibit A</u> attached hereto, as reasonably amended in a manner consistent with then-market terms at the advice of the Underwriters to enhance marketability and, subsequent to the IPO Effective Date, shall mean such document as it may be amended from time to time.

"<u>SpinCo Common Shares</u>" shall mean the shares of common stock, par value $0.01 per share, of SpinCo.

"<u>SpinCo Contracts</u>" shall mean the following contracts and agreements to which BioVie is a party or by which BioVie or its Assets is bound, whether or not in writing, in each case immediately prior to the Separation, except for any such contract or agreement that is contemplated to be retained by BioVie pursuant to any provision of this Agreement or any Ancillary Agreement (including pursuant to <u>Section 2.2(b)(ii)</u>):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) any customer, distribution, supply or vendor contracts or agreements entered into prior to the Effective Time that relate exclusively or primarily to the SpinCo Business, including the contracts set forth on <u>Schedule 1.1</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) any other contract or agreement that relates exclusively or primarily to the SpinCo Business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) any joint venture agreement or, subject to <u>Section 2.13</u>, any license agreement that relates exclusively or primarily to the SpinCo Business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) any guarantee, indemnity, representation, warranty or other Liability of SpinCo or BioVie in respect of any other SpinCo Contract, any SpinCo Liability or the SpinCo Business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) any employment, change of control, retention, consulting, indemnification, termination, severance or other similar agreements with any SpinCo Employee or consultants of SpinCo that are in effect as of the Separation Date, except for the arrangements listed on <u>Schedule 1.2</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) any consent order, decree or agreement with any third party including Governmental Authorities that relates exclusively or primarily to the SpinCo Business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) any contract or agreement that is otherwise expressly contemplated pursuant to this Agreement or any of the Ancillary Agreements to be assigned to SpinCo; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) any interest rate, currency, commodity or other swap, collar, cap or other hedging or similar agreements or arrangements that relate exclusively or primarily to the SpinCo Business.

"<u>SpinCo Employee</u>" shall have the meaning set forth in the Management Services Agreement.

"<u>SpinCo Indemnitees</u>" shall have the meaning set forth in <u>Section 4.3</u>.

"<u>SpinCo Intellectual Property</u>" shall mean (a) all Registrable IP set forth on <u>Schedule 1.4</u> and (b) all Intellectual Property, other than Registrable IP, that is owned by BioVie or SpinCo and that is used or held for use exclusively or primarily in the SpinCo Business as of the Separation Date, in each case other than any Registrable IP or other Intellectual Property that is contemplated to be retained by BioVie pursuant to any provision of this Agreement or any Ancillary Agreement (including pursuant to <u>Section 2.2(b)(ii)</u>).

"<u>SpinCo Liabilities</u>" shall have the meaning set forth in <u>Section 2.3(a)</u>.

"<u>SpinCo Products</u>" shall mean the products and product candidates listed on <u>Schedule 1.6</u>.

"<u>SpinCo Released Party</u>" shall have the meaning set forth in <u>Section 4.1(b)</u>.

"<u>SpinCo Software</u>" shall mean all Software owned or licensed by BioVie or SpinCo that is exclusively or primarily used or held for use in the SpinCo Business as of the Separation Date, other than any Software that is contemplated to be retained by BioVie pursuant to any provision of this Agreement or any Ancillary Agreement (including pursuant to <u>Section 2.2(b)(ii)</u>).

"<u>SpinCo Technology</u>" shall mean all Technology owned or licensed by BioVie or SpinCo that is exclusively or primarily used or held for use in the SpinCo Business as of the Separation Date, other than any Technology that is contemplated to be retained by BioVie pursuant to any provision of this Agreement or any Ancillary Agreement (including pursuant to <u>Section 2.2(b)(ii)</u>).

"<u>SpinCo Transfer Documents</u>" shall have the meaning set forth in <u>Section 2.4(b)</u>.

"<u>Subsidiary</u>" shall mean, with respect to any Person, any corporation, limited liability company, joint venture or partnership of which such Person (a) beneficially owns, either directly or indirectly, more than fifty percent (50%) of (i) the total combined voting power of all classes of voting securities of such Person, (ii) the total combined equity interests or (iii) the capital or profit interests, in the case of a partnership, or (b) otherwise has the power to vote, either directly or indirectly, sufficient securities to elect a majority of the board of directors or similar governing body.

"<u>Tax Matters Agreement</u>" shall mean the Tax Matters Agreement, dated as of the date hereof, by and between BioVie and SpinCo, as such Tax Matters Agreement may be amended from time to time.

"<u>Tax Return</u>" shall have the meaning set forth in the Tax Matters Agreement.

"<u>Taxes</u>" shall have the meaning set forth in the Tax Matters Agreement.

"<u>Technology</u>" shall mean all technology, designs, formulae, algorithms, procedures, methods, discoveries, processes, techniques, ideas, know-how, research and development, technical data, tools, materials, specifications, processes, inventions (whether patentable or unpatentable and whether or not reduced to practice), apparatus, creations, improvements, works of authorship in any media, confidential, proprietary or nonpublic information, and other similar materials or Information, and all recordings, graphs, drawings, reports, analyses and other writings, and other tangible embodiments of the foregoing in any form whether or not listed herein, in each case, other than Software.

"<u>Third-Party Claim</u>" shall have the meaning set forth in <u>Section 4.4(a)</u>.

"<u>Trademarks</u>" shall have the meaning set forth in the definition of Intellectual Property.

"<u>Transactions</u>" shall have the meaning set forth in the Recitals.

"<u>Transfer Documents</u>" shall have the meaning set forth in <u>Section 2.4(b)</u>.

"<u>Transition Committee</u>" shall have the meaning set forth in <u>Section 2.14</u>.

"<u>Underwriters</u>" shall mean the managing underwriters for the IPO.

"<u>Underwriting Agreement</u>" shall mean the underwriting agreement to be entered into by and among BioVie, SpinCo and the Underwriters as representatives of the several underwriters named therein with respect to the IPO.

"<u>Unreleased Excluded Liability</u>" shall have the meaning set forth in <u>Section 2.7(b)</u>.

"<u>Unreleased SpinCo Liability</u>" shall have the meaning set forth in <u>Section 2.6(b)</u>.

**ARTICLE II<br> THE SEPARATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1 <u>Transfer of Assets and Assumption of Liabilities</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) On or prior to the Effective Time, which may be amended at any time prior to the Effective Time by BioVie in its sole and absolute discretion:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) <u>Transfer and Assignment of SpinCo Assets</u>. BioVie shall contribute, assign, transfer, convey and deliver to SpinCo, and SpinCo shall accept from BioVie, all of BioVie's right, title and interest in and to all of the SpinCo Assets; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) <u>Acceptance and Assumption of SpinCo Liabilities</u>. SpinCo shall be deemed to have accepted, and shall assume and agree faithfully to perform, discharge and fulfill all of the SpinCo Liabilities in accordance with their respective terms. SpinCo shall be responsible for all SpinCo Liabilities, if any, regardless of when or where such SpinCo Liabilities arose or arise, or whether the facts on which they are based occurred prior to or subsequent to the Effective Time, regardless of where or against whom such SpinCo Liabilities are asserted or determined (including any SpinCo Liabilities arising out of claims made by BioVie's or SpinCo's respective directors, officers, employees, agents, Subsidiaries or Affiliates against BioVie or SpinCo) or whether asserted or determined prior to the date hereof, and regardless of whether arising from or alleged to arise from negligence, recklessness, violation of Law, fraud or misrepresentation by BioVie or SpinCo, or any of their respective directors, officers, employees, agents, Subsidiaries or Affiliates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) In furtherance of the assignment, transfer, conveyance and delivery of the SpinCo Assets and the assumption of the SpinCo Liabilities in accordance with <u>Sections 2.1(a)(i)</u> and <u>2.1(a)(ii)</u>, on or before the date that such SpinCo Assets are assigned, transferred, conveyed or delivered or such SpinCo Liabilities are assumed (i) BioVie shall execute and deliver such bills of sale, quitclaim deeds, stock powers, certificates of title, assignments of contracts and other instruments of transfer, conveyance and assignment as and to the extent necessary to evidence the transfer, conveyance and assignment of all of BioVie's right, title and interest in and to the SpinCo Assets to SpinCo, and (ii) SpinCo shall execute and deliver such assumptions of contracts and other instruments of assumption as and to the extent necessary to evidence the valid and effective assumption of the SpinCo Liabilities by SpinCo. All of the foregoing documents contemplated by this <u>Section 2.1(b)</u> shall be referred to collectively herein as the "<u>BioVie Transfer Documents</u>."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) In the event that, in connection with the Separation, any Party shall receive or otherwise possess any Asset or Liability that is allocated to any other Person pursuant to this Agreement or any Ancillary Agreement, such Party shall promptly transfer, or cause to be transferred, such Asset or Liability, as the case may be, to the Person entitled to such Asset or responsible for such Liability, as the case may be. Prior to any such transfer, the Person receiving, possessing or responsible for such Asset or Liability shall be deemed to be holding such Asset or Liability, as the case may be, in trust for any such other Person.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) SpinCo hereby waives compliance by BioVie with the requirements and provisions of any "bulk-sale" or "bulk-transfer" Laws of any jurisdiction that may otherwise be applicable with respect to the transfer or sale of any or all of the SpinCo Assets.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) BioVie hereby waives compliance by SpinCo with the requirements and provisions of any "bulk-sale" or "bulk-transfer" Laws of any jurisdiction that may otherwise be applicable with respect to the transfer or sale of any or all of the Excluded Assets.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2 <u>SpinCo Assets</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) For the purposes of this Agreement, "<u>SpinCo Assets</u>" shall mean (without duplication):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) all Assets that are expressly provided by this Agreement or any Ancillary Agreement (including for the avoidance of doubt the Schedules hereto or thereto) as Assets to be transferred to SpinCo;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) all of the SpinCo Contracts and all rights, interests or claims of either BioVie or SpinCo thereunder;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) all Assets reflected as assets of SpinCo and its Subsidiaries on the SpinCo Balance Sheet, subject to any dispositions of such Assets subsequent to the date of the SpinCo Balance Sheet; <u>provided</u> that the amounts set forth on the SpinCo Balance Sheet with respect to any Assets shall not be treated as minimum amounts or limitations on the amount of such Assets that are included in the definition of SpinCo Assets pursuant to this subclause (iii);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) all Assets that are of a nature or type that would have resulted in such Assets being included as Assets on a pro forma balance sheet of SpinCo as of the Effective Time (were such balance sheet to be prepared on a basis consistent with the determination of the Assets included on the SpinCo Balance Sheet), it being understood that the SpinCo Balance Sheet shall be used to determine the types of, and methodologies used to determine, those Assets that are included in the definition of SpinCo Assets pursuant to this subclause (iv);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v) all rights, interests and claims of either BioVie or SpinCo to any SpinCo Intellectual Property, SpinCo Software and SpinCo Technology;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi) all other rights, interests and claims of either Party or any of its Subsidiaries with respect to Information that is exclusively or primarily related to the SpinCo Assets, the SpinCo Liabilities or the SpinCo Business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vii) solely to the extent provided in <u>Article V</u>, rights under any Policies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(viii) subject to <u>Section 2.10</u>, all cash or cash equivalents of SpinCo (the "<u>SpinCo Cash</u>");

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ix) any cash or cash equivalents withdrawn from BioVie Accounts in accordance with <u>Section 2.10(c)</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(x) all actions, claims, causes of action, rights of recovery, choses in action and rights of setoff with respect to the Actions listed on <u>Schedule 2.2(a)(x)</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(xi) all books and records which relate exclusively or primarily to the SpinCo Assets, the SpinCo Liabilities or the SpinCo Business (<u>provided</u> that BioVie shall have the right to retain copies of all such books and records to the extent related to the BioVie Business);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(xii) all pre-clinical and clinical data related exclusively or primarily to the SpinCo Assets, the SpinCo Liabilities or the SpinCo Business and which is contained in BioVie's databases or is otherwise in BioVie's possession or control; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(xiii) except as contemplated by <u>Section 2.5(b)</u>, any and all Assets, other than Intellectual Property, Software and Technology, owned and used or held for use immediately prior to the Effective Time by BioVie or any of its Subsidiaries that are used exclusively or primarily in the SpinCo Business. The intention of this clause (xv) is only to rectify any inadvertent omission of transfer or conveyance of any Assets that, had the Parties given specific consideration to such Asset as of the date hereof, would have otherwise been classified as a SpinCo Asset. No Asset shall be deemed to be a SpinCo Asset solely as a result of this clause (xv) if such Asset is within the category or type of Asset expressly covered by the terms of this Agreement or an Ancillary Agreement unless the Party claiming entitlement to such Asset can establish that the omission of the transfer or conveyance of such Asset was inadvertent.

Notwithstanding the foregoing, the SpinCo Assets shall not in any event include the Excluded Assets referred to in <u>Section 2.2(b)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) For the purposes of this Agreement, "<u>Excluded Assets</u>" shall mean (without duplication):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) any and all Assets that are expressly contemplated by this Agreement or any Ancillary Agreement (or the Schedules hereto or thereto) as Assets to be retained by BioVie;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) the Assets described on <u>Schedule 2.2(b)(ii)</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) any cash or cash equivalents withdrawn from SpinCo Accounts in accordance with <u>Section 2.10(c)</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) all rights, interests and claims of either Party or any of its Subsidiaries to any BioVie Intellectual Property;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v) any and all Shared Contracts (other than SpinCo Assets arising under any Shared Contracts in accordance with <u>Section 2.9</u>);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi) except as otherwise provided in <u>Article V</u>, any and all rights under any Policies; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vii) subject to <u>Section 2.2(a)(xv)</u>, any and all Assets of BioVie that are not SpinCo Assets.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3 <u>SpinCo Liabilities</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) For the purposes of this Agreement, "<u>SpinCo Liabilities</u>" shall mean (without duplication):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) all Liabilities, including any Environmental Liabilities and any Liability relating to the protection of human and occupational health and safety, the protection or restoration of, or prevention of harm to, the environment or natural resources, relating to, arising out of or resulting from:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A) the operation or ownership of the SpinCo Business, as conducted at any time prior to, on or after the Separation Date (including any Liability relating to, arising out of or resulting from any act or failure to act by any Representative (whether or not such act or failure to act is or was within such Person's authority) and including (for the avoidance of doubt) any Liability with respect to any products sold by the SpinCo Business under an BioVie label, whether prior to, on or after the Separation Date);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B) the operation or ownership of any business conducted by SpinCo at any time after the Effective Time (including any Liability relating to, arising out of or resulting from any act or failure to act by any Representative (whether or not such act or failure to act is or was within such Person's authority));

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(C) any SpinCo Assets (including any SpinCo Contracts and any SpinCo Assets arising under any Shared Contracts, to the extent related to the SpinCo Business, and any real property and leasehold interests) in any such case whether arising before, on or after the Separation Date; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(D) any product liability claims or other claims of third parties relating to any product developed, manufactured, marketed, distributed, licensed or sold by the SpinCo Business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) all Liabilities that are expressly provided by this Agreement or any Ancillary Agreement (or the Schedules hereto or thereto) as Liabilities to be assumed by or otherwise the responsibility of SpinCo and all agreements, obligations and Liabilities of SpinCo under this Agreement or any of the Ancillary Agreements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) all Liabilities relating to, arising out of or resulting from any of the terminated, divested or discontinued businesses and operations of the SpinCo Business, including the businesses listed on <u>Schedule 2.3(a)(iii)</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) all Liabilities reflected as liabilities or obligations of SpinCo and its Subsidiaries on the SpinCo Balance Sheet, subject to any discharge of such Liabilities subsequent to the date of the SpinCo Balance Sheet; <u>provided</u> that the amounts set forth on the SpinCo Balance Sheet with respect to any Liabilities shall not be treated as minimum amounts or limitations on the amount of such Liabilities that are included in the definition of SpinCo Liabilities pursuant to this subclause (iv);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v) all Liabilities that are of a nature or type that would have resulted in such Liabilities being included as Liabilities on a pro forma balance sheet of SpinCo as of the Effective Time (were such balance sheet to be prepared on a basis consistent with the determination of the Liabilities included on the SpinCo Balance Sheet), it being understood that the SpinCo Balance Sheet shall be used to determine the types of, and methodologies used to determine, those Liabilities that are included in the definition of SpinCo Liabilities pursuant to this subclause (v);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi) all Liabilities relating to, arising out of or resulting from the Actions listed on <u>Schedule 2.2(a)(x)</u>; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vii) all Liabilities arising out of claims made by BioVie's or SpinCo's current or former respective directors, officers, shareholders, employees, agents, Subsidiaries or Affiliates against BioVie or SpinCo to the extent relating to, arising out of or resulting from the (x) SpinCo Business or (y) the other businesses, operations, activities or Liabilities referred to in clauses (i) through (vi) above, inclusive.

Notwithstanding the foregoing, the SpinCo Liabilities shall not include the Excluded Liabilities referred to in <u>Section 2.3(b)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) For the purposes of this Agreement, "<u>Excluded Liabilities</u>" shall mean (without duplication):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) any and all Liabilities that are expressly contemplated by this Agreement or any Ancillary Agreement (or the Schedules hereto or thereto) as Liabilities to be retained or assumed by BioVie or any other member of BioVie, and all agreements and obligations of BioVie under this Agreement or any of the Ancillary Agreements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) any and all Liabilities of BioVie to the extent relating to, arising out of or resulting from any Excluded Assets (other than Liabilities arising under any Shared Contracts to the extent such Liabilities relate to the SpinCo Business);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) the Liabilities described on <u>Schedule 2.3(b)(iii)</u>; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) any and all Liabilities of BioVie that are not SpinCo Liabilities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4 <u>Transfer of Excluded Assets; Assumption of Excluded Liabilities</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) To the extent any Excluded Asset is transferred or assigned to, or any Excluded Liability is assumed by, SpinCo upon consummation of the Separation or is owned or held by SpinCo after the Effective Time, from and after the Separation Date:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) SpinCo shall promptly assign, transfer, convey and deliver to BioVie, and BioVie shall accept from SpinCo, all of SpinCo's right, title and interest in and to such Excluded Assets; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) BioVie shall promptly accept, assume and agree faithfully to perform, discharge and fulfill all such Excluded Liabilities in accordance with their respective terms.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) In furtherance of the assignment, transfer, conveyance and delivery of Excluded Assets and the assumption of Excluded Liabilities set forth in <u>Sections 2.1(a)(iii)</u>, <u>2.1(a)(iv)</u>, <u>2.4(a)(i)</u> and <u>2.4(a)(ii)</u> and without any additional consideration therefor: (i) SpinCo shall execute and deliver, and shall cause its applicable Subsidiaries to execute and deliver, such bills of sale, quitclaim deeds, stock powers, certificates of title, assignments of contracts and other instruments of transfer, conveyance and assignment as and to the extent necessary to evidence the transfer, conveyance and assignment of all of SpinCo's and its applicable Subsidiaries' right, title and interest in and to the Excluded Assets to BioVie and its applicable Subsidiaries, and (ii) BioVie shall execute and deliver, and shall cause its applicable Subsidiaries to execute and deliver, such assumptions of contracts and other instruments of assumption as and to the extent necessary to evidence the valid and effective assumption of the Excluded Liabilities by BioVie and such Subsidiaries. All of the foregoing documents contemplated by this <u>Section 2.4(b)</u> shall be referred to collectively herein as the "<u>SpinCo Transfer Documents</u>" and, together with the BioVie Transfer Documents, the "<u>Transfer Documents</u>."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5 <u>Approvals and Notifications</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) To the extent that the transfer or assignment of any Excluded Assets or the assumption of any Excluded Liabilities requires any Approvals or Notifications, the Parties shall use their commercially reasonable efforts to obtain or make such Approvals or Notifications as soon as reasonably practicable; <u>provided</u>, <u>however</u>, that, except to the extent expressly provided in this Agreement or any of the Ancillary Agreements or as otherwise agreed between BioVie and SpinCo, neither BioVie nor SpinCo shall be obligated to contribute capital or pay any consideration in any form (including providing any letter of credit, guaranty or other financial accommodation) to any Person, or agree to any material undertaking, in order to obtain or make such Approvals or Notifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) If and to the extent that the valid, complete and perfected transfer or assignment to BioVie of any Excluded Assets or the assumption by BioVie of any Excluded Liabilities would be a violation of applicable Law, or require any Approvals or Notifications that has not been obtained or made on or before the Separation Date, then, unless the Parties shall otherwise mutually determine, the transfer or assignment to BioVie of such Excluded Assets or the assumption by BioVie of such Excluded Liabilities, as the case may be, shall be automatically deemed deferred and any such purported transfer, assignment or assumption shall be null and void until such time as all legal impediments are removed or such Approvals or Notifications have been obtained or made. Notwithstanding the foregoing, any such Excluded Assets or Excluded Liabilities shall continue to constitute Excluded Assets or Excluded Liabilities for all other purposes of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) If any transfer or assignment of any Excluded Asset or any assumption of any Excluded Liability not intended to be transferred, assigned or assumed hereunder, as the case may be, is consummated on or prior to the Separation Date, then, insofar as reasonably possible, SpinCo shall thereafter hold such Excluded Asset or Excluded Liability, as the case may be, for the use and benefit of BioVie (at the expense of BioVie). In addition, SpinCo shall, insofar as reasonably possible and to the extent permitted by applicable Law, treat such Excluded Asset or Excluded Liability in the ordinary course of business in accordance with past practice and take such other actions as may be reasonably requested by BioVie in order to place BioVie in a substantially similar position as if such Excluded Asset or Excluded Liability had not been so transferred, assigned or assumed and so that all the benefits and burdens relating to such Excluded Asset or Excluded Liability, as the case may be, including use, risk of loss, potential for gain, and dominion, control and command over such Excluded Asset or Excluded Liability, as the case may be, and all costs and expenses related thereto, shall inure from and after the Separation Date to BioVie.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) If and when the Approvals or Notifications, the absence of which caused the deferral of transfer or assignment of any Excluded Asset or the deferral of assumption of any Excluded Liability, are obtained or made, and, if and when any other legal impediments for the transfer or assignment of any Excluded Asset or the assumption of any Excluded Liability have been removed, the transfer or assignment of the applicable Excluded Asset or the assumption of the applicable Excluded Liability, as the case may be, shall be effected in accordance with the terms of this Agreement and/or the applicable Ancillary Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) In the event SpinCo retains an Excluded Asset or Excluded Liability due to the deferral of the transfer or assignment of such Excluded Asset or the deferral of the assumption of such Excluded Liability, as the case may be, shall not be obligated, in connection with the foregoing, to expend any money unless the necessary funds are advanced (or otherwise made available) by BioVie entitled to the Excluded Asset or Excluded Liability, other than reasonable out-of-pocket expenses, attorneys' fees and recording or similar fees, all of which shall be promptly reimbursed by BioVie or the member of BioVie entitled to such Excluded Asset or Excluded Liability.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) To the extent that the transfer or assignment of any SpinCo Asset, the assumption of any SpinCo Liability, the Separation or the Separation requires any Approvals or Notifications, the Parties shall use their commercially reasonable efforts to obtain or make such Approvals or Notifications as soon as reasonably practicable; <u>provided</u>, <u>however</u>, that, except to the extent expressly provided in this Agreement or any of the Ancillary Agreements or as otherwise agreed between BioVie and SpinCo, neither BioVie nor SpinCo shall be obligated to contribute capital or pay any consideration in any form (including providing any letter of credit, guaranty or other financial accommodation) to any Person, or agree to any material undertaking, in order to obtain or make such Approvals or Notifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) If and to the extent that the valid, complete and perfected transfer or assignment to SpinCo of any SpinCo Asset or assumption by SpinCo of any SpinCo Liability would be a violation of applicable Law, or require any Approvals or Notifications in connection with the Separation or the Separation that have not been obtained or made on or before the Separation Date, then, unless the Parties shall otherwise mutually determine, the transfer or assignment to SpinCo of such SpinCo Assets or the assumption by SpinCo of such SpinCo Liabilities, as the case may be, shall be automatically deemed deferred and any such purported transfer, assignment or assumption shall be null and void until such time as all legal impediments are removed or such Approvals or Notifications have been obtained or made. Notwithstanding the foregoing, any such SpinCo Assets or SpinCo Liabilities shall continue to constitute SpinCo Assets and SpinCo Liabilities for all other purposes of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) If any transfer or assignment of any SpinCo Asset or any assumption of any SpinCo Liability intended to be transferred, assigned or assumed hereunder, as the case may be, is not consummated on or prior to the Separation Date, whether as a result of the provisions of <u>Section 2.5(g)</u> or for any other reason, then, insofar as reasonably possible BioVie shall thereafter hold such SpinCo Asset or SpinCo Liability, as the case may be, for the use and benefit of SpinCo (at SpinCo's expense). In addition, BioVie shall, insofar as reasonably possible and to the extent permitted by applicable Law, treat such SpinCo Asset or SpinCo Liability in the ordinary course of business in accordance with past practice and take such other actions as may be reasonably requested by SpinCo, in order to place SpinCo in a substantially similar position as if such SpinCo Asset or SpinCo Liability had been transferred, assigned or assumed as contemplated hereby and so that all the benefits and burdens relating to such SpinCo Asset or SpinCo Liability, as the case may be, including use, risk of loss, potential for gain, and dominion, control and command over such SpinCo Asset or SpinCo Liability, as the case may be, and all costs and expenses related thereto, shall inure from and after the Separation Date to SpinCo.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) If and when the Approvals or Notifications, the absence of which caused the deferral of transfer or assignment of any SpinCo Asset or the deferral of assumption of any SpinCo Liability pursuant to <u>Section 2.5(g)</u>, are obtained or made, and, if and when any other legal impediments for the transfer or assignment of any SpinCo Asset or the assumption of any SpinCo Liability have been removed, the transfer or assignment of the applicable SpinCo Asset or the assumption of the applicable SpinCo Liability, as the case may be, shall be effected in accordance with the terms of this Agreement and/or the applicable Ancillary Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j) BioVie retaining a SpinCo Asset or SpinCo Liability due to the deferral of the transfer or assignment of such SpinCo Asset or the deferral of the assumption of such SpinCo Liability, as the case may be, shall not be obligated, in connection with the foregoing, to expend any money unless the necessary funds are advanced (or otherwise made available) by SpinCo, other than reasonable out-of-pocket expenses, attorneys' fees and recording or similar fees, all of which shall be promptly reimbursed by SpinCo.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(k) Notwithstanding anything to the contrary in this Agreement, the Parties' respective obligations under <u>Sections 2.5(a)</u>, <u>2.5(c)</u>, <u>2.5(f)</u> and <u>2.5(h)</u> shall terminate on the first anniversary of the Separation Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6 <u>Novation of SpinCo Liabilities</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Each Party, at the request of the other, shall use its commercially reasonable efforts to obtain, or to cause to be obtained, as soon as reasonably practicable, any consent, substitution, approval or amendment required to novate or assign all obligations under agreements, leases, licenses and other obligations or Liabilities of any nature whatsoever that constitute SpinCo Liabilities, or to obtain in writing the unconditional release of all parties to such arrangements other than SpinCo, so that, in any such case, SpinCo will be solely responsible for such Liabilities; <u>provided</u>, <u>however</u>, that, except as otherwise expressly provided in this Agreement or any of the Ancillary Agreements, neither BioVie nor SpinCo shall be obligated to contribute any capital or pay any consideration in any form (including providing any letter of credit, guaranty or other financial accommodation) to any third-party from whom any such consent, substitution, approval, amendment or release is requested or to agree to any material undertaking in connection therewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) If BioVie or SpinCo is unable to obtain, or to cause to be obtained, any such required consent, substitution, approval, amendment or release and the applicable member of BioVie continues to be bound by such agreement, lease, license or other obligation or Liability (each, an "<u>Unreleased SpinCo Liability</u>"), SpinCo shall, to the extent not prohibited by Law, as indemnitor, guarantor, agent or subcontractor for such member of BioVie, as the case may be, (i) pay, perform and discharge fully all the obligations or other Liabilities of such member of BioVie that constitute Unreleased SpinCo Liabilities from and after the Separation Date and (ii) use its commercially reasonable efforts to effect such payment, performance, or discharge prior to any demand for such payment, performance, or discharge is permitted to be made by the obligee thereunder on BioVie. If and when any such consent, substitution, approval, amendment or release shall be obtained or the Unreleased SpinCo Liabilities shall otherwise become assignable or able to be novated, BioVie shall promptly assign, or cause to be assigned, and SpinCo shall assume, such Unreleased SpinCo Liabilities without exchange of further consideration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.7 <u>Novation of Excluded Liabilities</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Each Party, at the request of the other Party, hereby agrees to use its commercially reasonable efforts to obtain, or to cause to be obtained, as soon as reasonably practicable, any consent, substitution, approval or amendment required to novate or assign all obligations under agreements, leases, licenses and other obligations or Liabilities for which BioVie and SpinCo are jointly or severally liable and that constitute Excluded Liabilities, or to obtain in writing the unconditional release of all parties to such arrangements other than BioVie, so that, in any such case, BioVie will be solely responsible for such Liabilities; <u>provided</u>, <u>however</u>, that, except as otherwise expressly provided in this Agreement or any of the Ancillary Agreements, neither BioVie nor SpinCo shall be obligated to contribute any capital or pay any consideration in any form (including providing any letter of credit, guaranty or other financial accommodation) to any third-party from whom any such consent, substitution, approval, amendment or release is requested or to agree to any material undertaking in connection therewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) If BioVie or SpinCo is unable to obtain, or to cause to be obtained, any such required consent, substitution, approval, amendment or release and SpinCo continues to be bound by such agreement, lease, license or other obligation or Liability (each, an "<u>Unreleased Excluded Liability</u>"), BioVie shall, to the extent not prohibited by Law, as indemnitor, guarantor, agent or subcontractor for SpinCo, as the case may be, (i) pay, perform and discharge fully all the obligations or other Liabilities of SpinCo that constitute Unreleased Excluded Liabilities from and after the Separation Date and (ii) use its commercially reasonable efforts to effect such payment, performance, or discharge prior to any demand for such payment, performance, or discharge is permitted to be made by the obligee thereunder on SpinCo. If and when any such consent, substitution, approval, amendment or release shall be obtained or the Unreleased Excluded Liabilities shall otherwise become assignable or able to be novated, SpinCo shall promptly assign, or cause to be assigned, and BioVie shall assume, such Unreleased Excluded Liabilities without exchange of further consideration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8 <u>Intercompany Agreements and Arrangements</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Except as set forth in <u>Section 2.8(b)</u>, in furtherance of the releases and other provisions of <u>Section 4.1</u> hereof, SpinCo, on the one hand, and BioVie, on the other hand, hereby terminate any and all agreements, arrangements, commitments or understandings, whether or not in writing, between or among SpinCo and BioVie, effective as of the Effective Time. No such terminated agreement, arrangement, commitment or understanding (including any provision thereof which purports to survive termination) shall be of any further force or effect after the Effective Time. Each Party shall, at the reasonable request of any other Party, take, or cause to be taken, such other actions as may be necessary to effect the foregoing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) The provisions of <u>Section 2.8(a)</u> shall not apply to any of the following agreements, arrangements, commitments or understandings (or to any of the provisions thereof): (i) this Agreement and the Ancillary Agreements (and each other agreement or instrument expressly contemplated by this Agreement or any Ancillary Agreement to be entered into by any of the Parties or to be continued following the Effective Time); (ii) any agreements, arrangements, commitments or understandings to which any Person other than the Parties and their respective Affiliates is a party; (iii) any intercompany accounts payable or accounts receivable accrued as of the Effective Time that are reflected in the books and records of the Parties or otherwise documented in writing in accordance with past practices, which shall be settled in the manner contemplated by <u>Section 2.8(d)</u>; (iv) any agreements, arrangements, commitments or understandings to which any non-wholly owned Subsidiary of BioVie or SpinCo, as the case may be, is a party (it being understood that directors' qualifying shares or similar interests will be disregarded for purposes of determining whether a Subsidiary is wholly owned); (v) any Shared Contracts; (vi) any agreements, arrangements, commitments or understandings relating to the purchase and sale of products in the ordinary course of business between SpinCo and BioVie; (vii) the Reorganization Agreements; and (viii) any other agreements, arrangements, commitments or understandings that this Agreement or any Ancillary Agreement expressly contemplates will survive past the Effective Time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) The Parties acknowledge and agree that all of the Intercompany Balances as of [DATE] have been repaid, settled or otherwise eliminated by means of cash payments, a dividend, capital contribution, a combination of the foregoing or otherwise, as determined by BioVie.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) All Intercompany Balances outstanding as of the date hereof shall, as promptly as practicable after the Effective Time, be repaid, settled or otherwise eliminated by means of cash payments, a dividend, capital contribution, a combination of the foregoing or otherwise, as determined by BioVie.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.9 <u>Treatment of Shared Contracts</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Without limiting the generality of the obligations set forth in <u>Section 2.1</u>, unless the Parties otherwise agree or the benefits of any contract, agreement, arrangement, commitment or understanding described in this <u>Section 2.9</u> are expressly conveyed to the applicable Party pursuant to this Agreement or an Ancillary Agreement, (i) any contract, agreement, arrangement, commitment or understanding that is listed on <u>Schedule 2.9(a)</u> shall be assigned in part to the applicable Party, if so assignable, or appropriately amended prior to, on or after the Separation Date, so that each Party shall, as of the Separation Date, be entitled to the rights and benefits, and shall assume the related portion of any Liabilities, inuring to its respective businesses, in each case, in accordance with the allocation of benefits and burdens set forth on <u>Schedule 2.9(a)</u>, and (ii) (A) any contract, agreement, arrangement, commitment or understanding that is an Excluded Asset or Excluded Liability but, prior to the Effective Time, inured in part to the benefit or burden of SpinCo (other than any such contract, agreement, arrangement, commitment or understanding covering substantially the same services or arrangements that are covered by a contract, agreement, arrangement, commitment or understanding entered into by SpinCo in connection with the Separation), and (B) any contract, agreement, arrangement, commitment or understanding that is a SpinCo Asset or a SpinCo Liability but, prior to the Effective Time, inured in part to the benefit or burden of BioVie (other than any such contract, agreement, arrangement, commitment or understanding covering substantially the same services or arrangements that are covered by a contract, agreement, arrangement, commitment or understanding entered into by a member of BioVie in connection with the Separation), shall be assigned in part to the applicable Party, if so assignable, or appropriately amended prior to, on or after the Separation Date, so that each Party shall, as of the Separation Date, be entitled to the rights and benefits, and shall assume the related portion of any Liabilities, inuring to its respective businesses (any contract, agreement, arrangement, commitment or understanding referred to in clause (i) or (ii) above, a "<u>Shared Contract</u>"); <u>provided</u>, <u>however</u>, that, in the case of each of clause (i) and (ii), (1) in no event shall any Party be required to assign (or amend) any Shared Contract in its entirety or to assign a portion of any Shared Contract which is not assignable (or cannot be amended) by its terms (including any terms imposing consents or conditions on an assignment where such consents or conditions have not been obtained or fulfilled) and (2) if any Shared Contract cannot be so partially assigned by its terms or otherwise, or cannot be amended or if such assignment or amendment would impair the benefit the Parties thereto derive from such Shared Contract, then the Parties shall take such other reasonable and permissible actions (including by providing prompt notice to the other Party with respect to any relevant claim of Liability or other relevant matters arising in connection with a Shared Contract so as to allow such other Party the ability to exercise any applicable rights under such Shared Contract) to cause SpinCo or BioVie, as the case may be, to receive the rights and benefits of that portion of each Shared Contract that relates to the SpinCo Business or the businesses retained by BioVie, as the case may be (in each case, to the extent so related), as if such Shared Contract had been assigned to (or amended to allow) SpinCo or BioVie to bear the burden of the corresponding Liabilities (including any Liabilities that may arise by reason of such arrangement), as if such Liabilities had been assumed pursuant to this <u>Section 2.9</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Each of Party shall (i) treat for all Tax purposes the portion of each Shared Contract inuring to their respective businesses as Assets owned by, and/or Liabilities of, as applicable, such Party, or its subsidiaries, as applicable, not later than the Separation Date, and (ii) neither report nor take any Tax position (on a Tax Return or otherwise) inconsistent with such treatment (unless required by applicable Law).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Nothing in this <u>Section 2.9</u> shall require any Party to make any payment (except to the extent advanced, assumed or agreed in advance to be reimbursed by such Party), incur any obligation or grant any concession for the benefit of the other Party in order to effect any transaction contemplated by this <u>Section 2.9</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.10 <u>Bank Accounts; Cash Balances; Collection of Accounts Receivable</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Each Party agrees to take, on the Separation Date (or such earlier time as BioVie and SpinCo may agree), all actions necessary to amend all contracts or agreements governing each bank and brokerage account owned by SpinCo (collectively, the "<u>SpinCo Accounts</u>") and all contracts or agreements governing each bank or brokerage account owned by BioVie (collectively, the "<u>BioVie Accounts</u>") so that each such SpinCo Account and BioVie Account, if currently linked (whether by automatic withdrawal, automatic deposit or any other authorization to transfer funds from or to) to any BioVie Account or SpinCo Account, respectively, is delinked from such BioVie Account or SpinCo Account, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) With respect to any outstanding payments initiated by BioVie or SpinCo prior to the Effective Time, such outstanding payments shall be honored following the Effective Time by the Party owning the account from which the payment was initiated.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) As between BioVie and SpinCo all payments made and reimbursements received after the Effective Time by either Party that relate to a business, Asset or Liability of the other Party shall be held by such Party in trust for the use and benefit of the Party entitled thereto and, promptly following receipt by such Party of any such payment or reimbursement, such Party shall pay over to the other Party the amount of such payment or reimbursement without right of set-off.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) From and after the Effective Time, BioVie shall be solely responsible for the collection efforts of any and all accounts receivable of BioVie or SpinCo outstanding as of the Effective Time. Promptly following the collection of any such account receivable by BioVie, but solely to the extent that such account receivable constitutes a SpinCo Asset, BioVie shall forward to SpinCo the amount so collected.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.11 <u>Ancillary Agreements</u>. Effective on or prior to the Separation Date, each of BioVie and SpinCo will execute and deliver all Ancillary Agreements to which it is a party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.12 <u>Disclaimer of Representations and Warranties</u>. EACH OF PARTY UNDERSTANDS AND AGREES THAT, EXCEPT AS EXPRESSLY SET FORTH HEREIN, IN ANY REORGANIZATION AGREEMENT OR IN ANY ANCILLARY AGREEMENT, NO PARTY TO THIS AGREEMENT, ANY ANCILLARY AGREEMENT, ANY REORGANIZATION AGREEMENT OR ANY OTHER AGREEMENT OR DOCUMENT CONTEMPLATED BY THIS AGREEMENT, ANY ANCILLARY AGREEMENT, ANY REORGANIZATION AGREEMENT OR OTHERWISE, IS REPRESENTING OR WARRANTING IN ANY WAY AS TO THE ASSETS, BUSINESSES OR LIABILITIES TRANSFERRED OR ASSUMED AS CONTEMPLATED HEREBY OR THEREBY, AS TO ANY CONSENTS, NOTIFICATIONS OR APPROVALS REQUIRED IN CONNECTION HEREWITH OR THEREWITH, AS TO THE VALUE OR FREEDOM FROM ANY SECURITY INTERESTS OF, OR ANY OTHER MATTER CONCERNING, ANY ASSETS OF SUCH PARTY, OR AS TO THE ABSENCE OF ANY DEFENSES OR RIGHT OF SETOFF OR FREEDOM FROM COUNTERCLAIM WITH RESPECT TO ANY CLAIM OR OTHER ASSET, INCLUDING ANY ACCOUNTS RECEIVABLE, OF ANY PARTY, OR AS TO THE LEGAL SUFFICIENCY OF ANY ASSIGNMENT, DOCUMENT OR INSTRUMENT DELIVERED HEREUNDER TO CONVEY TITLE TO ANY ASSET OR THING OF VALUE UPON THE EXECUTION, DELIVERY AND FILING HEREOF OR THEREOF. EXCEPT AS MAY EXPRESSLY BE SET FORTH HEREIN, IN ANY REORGANIZATION AGREEMENT OR IN ANY ANCILLARY AGREEMENT, ALL SUCH ASSETS ARE BEING TRANSFERRED ON AN "AS IS," "WHERE IS" BASIS, AND EXCLUDING ALL WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR TITLE, AND THE RESPECTIVE TRANSFEREES SHALL BEAR THE ECONOMIC AND LEGAL RISKS THAT (A) ANY CONVEYANCE WILL PROVE TO BE INSUFFICIENT TO VEST IN THE TRANSFEREE GOOD AND MARKETABLE TITLE, FREE AND CLEAR OF ANY SECURITY INTEREST, AND (B) ANY NECESSARY APPROVALS OR NOTIFICATIONS ARE NOT OBTAINED OR MADE OR THAT ANY REQUIREMENTS OF LAWS OR JUDGMENTS ARE NOT COMPLIED WITH.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.13 <u>Intellectual Property</u>. Notwithstanding anything to the contrary in this Agreement or any Ancillary Agreement, BioVie will retain all licenses, rights and royalty payments in and to any and all existing Intellectual Property license agreements with third parties, including the sole right to amend or modify such agreements, except for Intellectual Property related agreements which (a) relate exclusively or primarily to the SpinCo Business, (b) were executed or entered into by the SpinCo Business and (c) do not otherwise constitute Excluded Assets.

**ARTICLE III<br> THE IPO; OTHER TRANSACTIONS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1 <u>Sole and Absolute Discretion; Cooperation</u>. Following the date hereof and subject to the terms of the Underwriting Agreement, BioVie may, in its sole and absolute discretion, determine (a) whether and when to proceed with the IPO, if at all and (b) the terms of the IPO, including the form, structure and terms of any transaction(s) or offering(s) to effect the IPO and the timing and conditions to the consummation of the IPO. In addition, subject to the terms of the Underwriting Agreement, BioVie may, at any time and from time to time until the consummation of the IPO, modify or change the terms of the IPO, including by accelerating or delaying the timing of the consummation of all or part of the IPO or terminating the IPO. SpinCo shall cooperate with BioVie to accomplish the IPO and any concurrent private placement(s) and shall, at BioVie's direction, promptly take any and all actions necessary or desirable to effect the IPO and any concurrent private placement(s), including, without limitation, the registration under the Securities Act of the SpinCo Common Stock on appropriate registration form(s) to be designated by BioVie. For the avoidance of doubt, BioVie may determine, at any point prior to the IPO Effective Date, to not proceed with and terminating the IPO.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2 <u>Actions Prior to the IPO</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) If BioVie determines in accordance with <u>Section 3.1</u> to proceed with the IPO, BioVie and SpinCo shall use their reasonable best efforts to consummate the IPO. Such actions shall include, but not necessarily be limited to, those specified in this <u>Section 3.2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Registration Statements</u>. SpinCo shall prepare and file the IPO Registration Statement, and such amendments or supplements thereto, and use its reasonable best efforts to cause the same to become and remain effective as required by Law or by the Underwriting Agreement, including, but not limited to, filing such amendments to the IPO Registration Statement as may be required by the Underwriting Agreement, the SEC or federal, state or foreign securities Laws. BioVie and SpinCo shall also cooperate in preparing, filing with the SEC and causing to become effective a registration statement registering the SpinCo Common Stock under the Exchange Act, and any registration statements or amendments thereof which are required to reflect the establishment of, or amendments to, any employee benefit and other plans necessary or appropriate in connection with the IPO or the other transactions contemplated by this Agreement and the Ancillary Agreements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Underwriting Activities</u>. BioVie and SpinCo shall enter into the Underwriting Agreement, in form and substance reasonably satisfactory to BioVie and shall comply with its obligations thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>IPO Consultation</u>. BioVie and SpinCo shall consult with each other and the Underwriters regarding the timing, pricing and other material matters with respect to the IPO.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Securities Law Matters</u>. To the extent required under applicable Law, BioVie and SpinCo will prepare, and SpinCo will file with the SEC, any such documentation and any requisite no-action letters which BioVie determines are necessary or desirable to effectuate the IPO, and BioVie and SpinCo shall each use its reasonable best efforts to obtain all necessary approvals from the SEC with respect thereto as soon as practicable. Each of BioVie and SpinCo shall use its reasonable best efforts to take all such action as may be necessary or appropriate under state securities and blue sky laws of the United States (and any comparable Laws under any foreign jurisdictions) in connection with the IPO.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) <u>Exchange Listing</u>. SpinCo shall prepare, file and use reasonable best efforts to seek to make effective, an application for listing of the SpinCo Common Stock to be issued in the IPO on the Exchange, subject to official notice of issuance.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) <u>Preparation of Materials</u>. SpinCo shall participate in the preparation of materials and presentations as BioVie or the Underwriters shall deem necessary or desirable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) <u>IPO Costs</u>. Other than the SEC registration fee and the FINRA fee, SpinCo shall pay all third-party costs, fees and expenses relating to the IPO, all of the reimbursable expenses of the Underwriters pursuant to the Underwriting Agreement, all of the costs of producing, printing, mailing and otherwise distributing the Prospectus, as well as the Underwriters' discount as provided in the Underwriting Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) <u>SpinCo Directors and Officers</u>. Prior to the IPO Effective Date, BioVie and SpinCo shall take all necessary actions so that, as of the IPO Effective Date, (i) the directors and executive officers of SpinCo shall be those set forth in the IPO Registration Statement, unless otherwise agreed by the Parties; (ii) each individual referred to in clause (i) shall have resigned, if requested by BioVie at BioVie's sole discretion, from his or her position, if any, as a member of the BioVie Board or as an executive officer of BioVie; and (iii) SpinCo shall have such other officers as SpinCo shall appoint. Until the Disposition Date, the chair of the SpinCo Board shall not be an officer of SpinCo.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j) <u>SpinCo Certificate of Incorporation and SpinCo Bylaws</u>. Prior to the IPO Effective Date, BioVie and SpinCo shall each take all actions that may be required to provide for the adoption by SpinCo of the SpinCo Certificate of Incorporation and SpinCo Bylaws, in each case, to be effective as of the IPO Effective Date.

**ARTICLE IV<br> MUTUAL RELEASES; INDEMNIFICATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1 <u>Release of Pre-Separation Claims</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Except as provided in (i) <u>Sections 4.1(c)</u> and <u>4.1(d)</u> or (ii) any Ancillary Agreement, effective as of the Effective Time, SpinCo does hereby, for itself and its Affiliates (other than BioVie), successors and assigns, and all Persons who at any time prior to the Effective Time have been shareholders, directors, officers, agents or employees of SpinCo (in each case, in their respective capacities as such), remise, release and forever discharge BioVie and its Affiliates (other than SpinCo), successors and assigns, and all Persons who at any time prior to the Effective Time have been shareholders, directors, officers, agents or employees of BioVie (in each case, in their respective capacities as such), and their respective heirs, executors, administrators, successors and assigns (the "<u>BioVie Released Parties</u>"), from any and all Liabilities whatsoever, whether at law or in equity (including any right of contribution), whether arising under any contract or agreement, by operation of Law or otherwise, existing or arising from any acts or events occurring or failing to occur or alleged to have occurred or to have failed to occur or any conditions existing or alleged to have existed at or before the Effective Time, including in connection with the transactions and all other activities to implement the Separation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Except as provided in (i) <u>Sections 4.1(c)</u> and <u>4.1(d)</u> and (ii) any Ancillary Agreement, effective as of the Effective Time, BioVie does hereby, for itself and its Affiliates (other than SpinCo), successors and assigns, and all Persons who at any time prior to the Effective Time have been shareholders, directors, officers, agents or employees of BioVie (in each case, in their respective capacities as such), remise, release and forever discharge SpinCo and its Affiliates (other than BioVie), successors and assigns, and all Persons who at any time prior to the Effective Time have been shareholders, directors, officers, agents or employees of SpinCo (in each case, in their respective capacities as such), and their respective heirs, executors, administrators, successors and assigns (the "<u>SpinCo Released Parties</u>"), from any and all Liabilities whatsoever, whether at law or in equity (including any right of contribution), whether arising under any contract or agreement, by operation of Law or otherwise, existing or arising from any acts or events occurring or failing to occur or alleged to have occurred or to have failed to occur or any conditions existing or alleged to have existed at or before the Effective Time, including in connection with the transactions and all other activities to implement the Separation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Nothing contained in <u>Section 4.1(a)</u> or <u>(b)</u> shall impair any right of any Person to enforce this Agreement, any Ancillary Agreement or any agreements, arrangements, commitments or understandings that are specified in <u>Section 2.8(b)</u> or the applicable Schedules thereto not to terminate as of the Effective Time, in each case in accordance with its terms. Nothing contained in <u>Section 4.1(a)</u> or <u>(b)</u> shall release any Person from:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) any Liability provided in or resulting from any agreement between the Parties that is specified in <u>Section 2.8(b)</u> or the applicable Schedules thereto as not to terminate as of the Effective Time, or any other Liability specified in such <u>Section 2.8(b)</u> as not to terminate as of the Effective Time;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) any Liability, contingent or otherwise, assumed, transferred, assigned or allocated to a Party in accordance with, or any other Liability of any Party under, this Agreement or any Ancillary Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) any Liability that the Parties may have with respect to indemnification or contribution pursuant to this Agreement, any Ancillary Agreement or otherwise for claims brought against the Parties by Third-Parties, which Liability shall be governed by the provisions of this <u>Article IV</u> and <u>Article V</u> and, if applicable, the appropriate provisions of the Ancillary Agreements; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) any Liability solely to the extent such Liability is the basis of a claim against any Person that is not a SpinCo Released Party or a BioVie Released Party.

In addition, nothing contained in <u>Section 4.1(a)</u> shall release BioVie from honoring its existing obligations to indemnify any director, officer or employee of SpinCo who was a director, officer or employee of BioVie on or prior to the Separation Date, to the extent such director, officer or employee is or becomes a named defendant in any Action with respect to which such director, officer or employee was entitled to such indemnification pursuant to then-existing obligations; it being understood that, if the underlying obligation giving rise to such Action is a SpinCo Liability, SpinCo shall indemnify, or procure from a Subsidiary the effective indemnification of, BioVie for such Liability (including BioVie's costs to indemnify the director, officer or employee) in accordance with the provisions set forth in this <u>Article IV</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) SpinCo shall not make any claim or demand, or commence any Action asserting any claim or demand, including any claim of contribution or any indemnification, against BioVie or any other member of BioVie, or any other Person released pursuant to <u>Section 4.1(a)</u>, with respect to any Liabilities released pursuant to <u>Section 4.1(a)</u>. BioVie shall not make, and shall not permit BioVie to make, any claim or demand, or commence any Action asserting any claim or demand, including any claim of contribution or any indemnification against SpinCo or any other Person released pursuant to <u>Section 4.1(b)</u>, with respect to any Liabilities released pursuant to <u>Section 4.1(b)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) It is the intent of each of Party, by virtue of the provisions of this <u>Section 4.1</u>, to provide for a full and complete release and discharge of all Liabilities existing or arising from all acts and events occurring or failing to occur or alleged to have occurred or to have failed to occur and all conditions existing or alleged to have existed on or before the Separation Date, between or among SpinCo and BioVie (including any contractual agreements or arrangements existing or alleged to exist between or among any such members on or before the Separation Date), except as expressly set forth in <u>Section 4.1(c)</u>. From time to time, at the request of any other Party, each Party shall execute and deliver releases reflecting the provisions hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) Any breach of the provisions of this <u>Section 4.1</u> by either BioVie or SpinCo shall entitle the other Party to recover reasonable fees and expenses of counsel in connection with such breach or any Action resulting from such breach.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2 <u>Indemnification by SpinCo</u>. SpinCo shall indemnify, defend and hold harmless BioVie and each of its directors, officers, employees and agents, in each case in their respective capacities as such, and each of the heirs, executors, successors and assigns of any of the foregoing (collectively, the "<u>BioVie Indemnitees</u>"), from and against any and all Liabilities of the BioVie Indemnitees relating to, arising out of or resulting from, directly or indirectly, any of the following items (without duplication):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) the failure of SpinCo or any other Person to pay, perform or otherwise promptly discharge any SpinCo Liabilities or SpinCo Contract in accordance with its respective terms, whether prior to, on or after the Separation Date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) the SpinCo Business (except to the extent it constitutes an Excluded Liability), any SpinCo Liability or any SpinCo Contract;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) any breach by SpinCo of this Agreement or any of the Ancillary Agreements, unless any such Ancillary Agreement expressly provides for separate indemnification therein, in which case any claim for indemnification for breach thereof shall be made exclusively pursuant to (and subject to the terms and conditions of) the indemnification provisions therein;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) except to the extent it constitutes an Excluded Liability, any guarantee, indemnification obligation, letter of credit reimbursement obligation, surety, bond or other credit support agreement, arrangement, commitment or understanding for the benefit SpinCo by BioVie that survives following the Separation; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, contained in the IPO Registration Statement or any other Disclosure Document, in each case, as amended or supplemented, except in each case solely to the extent such statement or omission constitutes an BioVie Disclosure Portion.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3 <u>Indemnification by BioVie</u>. BioVie shall indemnify, defend and hold harmless SpinCo and each of its directors, officers, employees or agents, in each case in their respective capacities as such, and each of the heirs, executors, successors and assigns of any of the foregoing (collectively, the "<u>SpinCo Indemnitees</u>"), from and against any and all Liabilities of the SpinCo Indemnitees relating to, arising out of or resulting from, directly or indirectly, any of the following items (without duplication):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) the failure of BioVie or any other Person to pay, perform or otherwise promptly discharge any Excluded Liabilities in accordance with their terms, whether prior to, on or after the Separation Date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) the Excluded Liabilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) the BioVie Business (except to the extent it constitutes a SpinCo Liability and other than the conduct of business, operations or activities for the benefit of SpinCo pursuant to any Ancillary Agreement);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) any breach by BioVie of this Agreement or any of the Ancillary Agreements, unless any such Ancillary Agreement expressly provides for separate indemnification therein, in which case any claim for indemnification for breach thereof shall be made exclusively pursuant to (and subject to the terms and conditions of) the indemnification provisions therein; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, contained in the IPO Registration Statement or any other Disclosure Document, in each case, as amended or supplemented, and in each case solely to the extent such statement or omission constitutes a BioVie Disclosure Portion.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4 <u>Procedures for Indemnification of Third-Party Claims</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) If any Person entitled to indemnification hereunder (an "<u>Indemnitee</u>") shall receive notice or otherwise learn of the assertion by a third-party (including any Governmental Authority) of any claim or of the commencement by any such Person of any Action (collectively, a "<u>Third-Party Claim</u>") with respect to which any Party (an "<u>Indemnifying Party</u>") may be obligated to provide indemnification to such Indemnitee pursuant to <u>Section 4.2</u> or <u>4.3</u>, or any other Section of this Agreement or any Ancillary Agreement, such Indemnitee shall give such Indemnifying Party written notice thereof as promptly as practicable (and no later than thirty (30) days or sooner, if the nature of the Third-Party Claim so requires) after becoming aware of such Third-Party Claim. Any such notice shall describe the Third-Party Claim in reasonable detail and include copies of all notices and documents (including court papers) received by the Indemnitee relating to the Third-Party Claim. Notwithstanding the foregoing, the failure of an Indemnitee to provide notice in accordance with this <u>Section 4.4(a)</u> shall not relieve an Indemnifying Party of its indemnification obligations under this Agreement, except to the extent to which the Indemnifying Party is actually materially prejudiced by the Indemnitee's failure to provide notice in accordance with this <u>Section 4.4(a)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) An Indemnifying Party may elect to defend (and, unless the Indemnifying Party has specified any reservations or exceptions, to seek to settle or compromise), at such Indemnifying Party's own expense, any Third-Party Claim with outside counsel satisfactory to the Indemnitee. Within thirty (30) days after the receipt of notice from an Indemnitee in accordance with <u>Section 4.4(a)</u> (or sooner, if the nature of such Third-Party Claim so requires), the Indemnifying Party shall notify the Indemnitee of its election whether the Indemnifying Party will assume responsibility for defending such Third-Party Claim, which election shall specify any reservations or exceptions. After notice from an Indemnifying Party to an Indemnitee of its election to assume the defense of a Third-Party Claim, such Indemnitee shall have the right to employ separate counsel and to participate in (but not control) the defense, compromise or settlement thereof, but the fees and expenses of such counsel shall be the expense of such Indemnitee except as otherwise set forth in this <u>Section 4.4</u>. Notwithstanding the foregoing or anything else to the contrary in this Agreement, the Indemnifying Party shall not be entitled to defend (or settle or compromise) any Third-Party Claim that involves any Governmental Authority or potential criminal liability or that seeks injunctive or other non-monetary relief.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) In the event that the Indemnifying Party is permitted by the terms of this Agreement, and has elected, to assume the defense of the Third-Party Claim but has specified, and continues to assert, any reservations or exceptions in such notice, then, in any such case, the reasonable fees and expenses of one (1) separate counsel for all Indemnitees shall be borne by the Indemnifying Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) If an Indemnifying Party is not permitted by this terms of this Agreement or elects not to assume responsibility for defending a Third-Party Claim, or fails to notify an Indemnitee of its election as provided in <u>Section 4.4(b)</u>, such Indemnitee may defend such Third-Party Claim at the cost and expense of the Indemnifying Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) Unless the Indemnifying Party has failed or is not permitted by the terms of this Agreement to assume the defense of the Third-Party Claim in accordance with the terms of this Agreement, no Indemnitee may settle or compromise any Third-Party Claim, or admit to any wrongdoing in connection therewith, without the consent of the Indemnifying Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) In the case of a Third-Party Claim, no Indemnifying Party shall consent to entry of any judgment or enter into any settlement of the Third-Party Claim, or admit to any wrongdoing in connection therewith, without the consent of the Indemnitee; provided, however, that the Indemnifying Party may, without the consent of the Indemnitee, consent to any settlement of a Third-Party Claim that (i) does not require or result in any payment by the Indemnitee, (ii) does not include any admission of wrongdoing by the Indemnitee or any of its Affiliates, (iii) does not provide for any injunctive or non-monetary relief against the Indemnitee or any of its Affiliates and (iv) includes a complete and unconditional release of the Indemnitee and its Affiliates with respect to such Third-Party Claim.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) The party controlling the defense of any Third-Party Claim shall keep the other party fully informed of the status of such Third-Party Claim and the defense thereof and shall consider in good faith recommendations made by the other party with respect thereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) For the avoidance of doubt, the provisions of this <u>Article IV</u> shall apply to Third-Party Claims that have already been asserted as well as Third-Party Claims asserted after the date hereof, and there shall be no requirement under this <u>Section 4.4</u> to give notice with respect to any Third-Party Claims that have already been asserted as of the Effective Time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5 <u>Additional Matters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Indemnification payments in respect of any Liabilities for which an Indemnitee is entitled to indemnification under this <u>Article IV</u> shall be paid by the Indemnifying Party to the Indemnitee as such Liabilities are incurred upon demand by the Indemnitee, including reasonably satisfactory documentation setting forth the basis for the amount of such indemnification payment, including documentation with respect to calculations made and consideration of any Insurance Proceeds that actually reduce the amount of such Liabilities. The indemnity agreements contained in this <u>Article IV</u> shall remain operative and in full force and effect, regardless of (i) any investigation made by or on behalf of any Indemnitee, (ii) the knowledge by the Indemnitee of Liabilities for which it might be entitled to indemnification hereunder and (iii) any termination of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Any claim on account of a Liability which does not result from a Third-Party Claim shall be asserted by written notice given by the Indemnitee to the related Indemnifying Party. Such Indemnifying Party shall have a period of thirty (30) days after the receipt of such notice within which to respond thereto. If such Indemnifying Party does not respond within such thirty (30)-day period, such Indemnifying Party shall be deemed to have refused to accept responsibility to make payment. If such Indemnifying Party does not respond within such thirty (30)-day period or rejects such claim in whole or in part, such Indemnitee shall be free to pursue such remedies as may be available to such party as contemplated by this Agreement and the Ancillary Agreements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) In the event of payment by or on behalf of any Indemnifying Party to any Indemnitee in connection with any Third-Party Claim, such Indemnifying Party shall be subrogated to and shall stand in the place of such Indemnitee as to any events or circumstances in respect of which such Indemnitee may have any right, defense or claim relating to such Third-Party Claim against any claimant or plaintiff asserting such Third-Party Claim or against any other Person. Such Indemnitee shall cooperate with such Indemnifying Party in a reasonable manner, and at the cost and expense of such Indemnifying Party, in prosecuting any subrogated right, defense or claim.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) In the event of an Action in which the Indemnifying Party is not a named defendant, if either the Indemnitee or Indemnifying Party shall so request, the Parties shall endeavor to substitute the Indemnifying Party for the named defendant. If such substitution or addition cannot be achieved for any reason or is not requested, the named defendant shall allow the Indemnifying Party to manage the Action as set forth in this <u>Section 4.5</u>, and the Indemnifying Party shall fully indemnify the named defendant against all costs of defending the Action (including court costs, sanctions imposed by a court, attorneys' fees, experts fees and all other external expenses), the costs of any judgment or settlement and the cost of any interest or penalties relating to any judgment or settlement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) For all claims as to which indemnification or contribution is provided under this <u>Article IV</u>, other than Third-Party Claims (as to which <u>Section 4.4</u> shall apply), the reasonable fees and expenses of counsel to the Indemnitee for the enforcement of the indemnity obligations shall be borne by the Indemnifying Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6 <u>Remedies Cumulative</u>. The remedies provided in this <u>Article IV</u> shall be cumulative and, subject to the provisions of <u>Article VIII</u>, shall not preclude assertion by any Indemnitee of any other rights or the seeking of any and all other remedies against any Indemnifying Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.7 <u>Survival of Indemnities</u>. The rights and obligations of each of BioVie and SpinCo and their respective Indemnitees under this <u>Article IV</u> shall survive the sale or other transfer by any Party of any Assets or businesses or the assignment by it of any Liabilities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.8 <u>Guarantees, Letters of Credit or Other Obligations</u>. In furtherance of, and not in limitation of, the obligations set forth in <u>Section 2.6</u> and this <u>Article IV</u>:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) On or prior to the Separation Date or as soon as practicable thereafter, SpinCo shall (with the reasonable cooperation of the applicable member(s) of BioVie) use its reasonable best efforts to have any member(s) of BioVie removed as guarantor of or obligor for any SpinCo Liability to the extent that they constitute SpinCo Liabilities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) On or prior to the Separation Date, to the extent required to obtain a release from a guarantee or letter of credit, including the guarantees listed on <u>Schedule 4.8(b)</u> (a "<u>Guarantee Release</u>"), of BioVie, SpinCo shall execute a guarantee agreement in the form of the existing guarantee or letter of credit, as applicable, or such other form as is agreed to by the relevant parties to such guarantee agreement or letter of credit, except to the extent that such existing guarantee or letter of credit contains representations, covenants or other terms or provisions either (i) with which SpinCo would be reasonably unable to comply or (ii) which would be reasonably expected to be breached.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) If the Parties are unable to obtain, or to cause to be obtained, any such required removal as set forth in clauses (a) and (b) of this <u>Section 4.8</u>, (i) SpinCo shall indemnify, defend and hold harmless each of the BioVie Indemnitees for any Liability arising from or relating to such guarantee and shall, as agent or subcontractor for BioVie, pay, perform and discharge fully all the obligations or other Liabilities of BioVie, and (ii) SpinCo shall not agree to renew or extend the term of, increase any obligations under, or transfer to any third-party, any loan, guarantee, letter of credit, lease, contract or other obligation for which a member of BioVie is or may be liable unless all obligations of BioVie with respect thereto are thereupon terminated by documentation satisfactory in form and substance to BioVie in its sole and absolute discretion.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.9 <u>Contribution</u>. If the indemnification provided for in <u>Section 4.2</u> is unavailable to, or insufficient to hold harmless, any Indemnitee under this <u>Article IV</u> with respect to any Liabilities (other than in accordance with the terms of this Agreement, in which case this <u>Section 4.9</u> shall not apply), then the Indemnifying Party, in lieu of indemnifying such Indemnitee, shall contribute to the amount paid or payable by such Indemnitee as a result of such Liabilities in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party and the Indemnitee in connection with the conduct, statements or omissions that resulted in such Liabilities. The relative fault of any BioVie Indemnitee, on the one hand, and of any SpinCo Indemnitee, on the other hand, in the case of any Liabilities arising out of or related to information contained in the IPO Registration Statement or any other Disclosure Document shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission of a material fact relates to information supplied by a SpinCo Indemnitee or a BioVie Indemnitee, it being understood that (a) the BioVie Disclosure Portions shall in all cases be deemed supplied by BioVie and the BioVie Indemnitees and (b) all other information in the IPO Registration Statement or any other Disclosure Document shall in all cases be deemed supplied by SpinCo and the SpinCo Indemnitees.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.10 <u>Covenant Not to Sue</u>. Each Party hereby covenants and agrees that none of it, its Affiliates or any Person claiming through it shall bring suit or otherwise assert any claim against any Indemnitee, or assert a defense against any claim asserted by any Indemnitee, before any court, arbitrator, neutral mediator or administrative agency anywhere in the world, alleging that: (a) the assumption of any SpinCo Liabilities by SpinCo on the terms and conditions set forth in this Agreement and the Ancillary Agreements is void or unenforceable for any reason; (b) the retention of any BioVie Liabilities by BioVie on the terms and conditions set forth in this Agreement and the Ancillary Agreements is void or unenforceable for any reason; or (c) the provisions of this <u>Article IV</u> are void or unenforceable for any reason.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.11 <u>Taxes</u>. The provisions of this Agreement, including this <u>Article IV</u>, shall not apply to any matters relating to Taxes to the extent such matters are addressed in the Tax Matters Agreement or the Management Services Agreement. In the case of any conflict between this Agreement and either the Tax Matters Agreement or the Management Services Agreement in relation to any matters related to Taxes, the Tax Matters Agreement or the Management Services Agreement, as applicable, shall prevail.

**ARTICLE V<br> INSURANCE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1 <u>Insurance Matters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) SpinCo acknowledges and agrees that, from and after the Effective Time, SpinCo shall not have any rights to or under BioVie's insurance policies, except as expressly provided in this Agreement or any Ancillary Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Notwithstanding <u>Section 5.1(a)</u>, from and after the Effective Time, with respect to any Liability incurred by SpinCo prior to the Effective Time, to the extent reasonably possible, BioVie will, or will cause the applicable insurance companies to (i) continue to provide SpinCo with access to and coverage under the applicable insurance policies, and (ii) reasonably cooperate with SpinCo and take commercially reasonable actions as may be necessary or advisable to assist SpinCo in submitting such claims under the applicable insurance policies; <u>provided that</u> SpinCo shall be responsible for any and all applicable deductibles, self-insured retentions, retrospective premiums, claims-handling charges, co-payments or any other charge or fee legally due and owing relating to such claims and neither BioVie nor the insurance company shall be required to maintain such insurance policies. For the avoidance of doubt, if an occurrence date is after the Effective Time, then no payment for any damages, costs of defense, or other sums with respect to such claim shall be available to SpinCo under such insurance policies. SpinCo shall not, in connection with making a claim under any insurance policy of BioVie pursuant to this <u>Section 5.1(b)</u>, shall take any action that would be reasonably likely to: (A) have an adverse impact on the then-current relationship between BioVie and the applicable insurance company; (B) result in the applicable insurance company terminating or reducing coverage, or increasing the amount of any premium owed by BioVie under the applicable insurance policy; or (C) otherwise compromise, jeopardize or interfere with the rights of BioVie under the applicable insurance policy. At all times, each Party shall cooperate with reasonable requests for information by the other Party or the insurance companies regarding any such insurance policy claim.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) At the Effective Time, SpinCo shall have in effect all insurance programs required to comply with SpinCo's statutory and contractual obligations and such other insurance policies as reasonably necessary or customary for companies operating a business similar to the SpinCo Business. Such insurance programs include general liability, commercial auto liability, workers' compensation, employers liability, product liability, property, cargo, employment practices liability, employee dishonesty/crime, directors' and officers' liability and fiduciary liability.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) BioVie shall not have any obligation to secure extended reporting for any claims under BioVie's claims-made or occurrence-reported liability policies for any acts or omissions of SpinCo incurred prior to the Effective Time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) This Agreement shall not be considered as an attempted assignment of any policy of insurance or as a contract of insurance and shall not be construed to waive any right or remedy of BioVie in respect of any of the BioVie insurance policies and programs or any other contract or policy of insurance.

**ARTICLE VI<br> CERTAIN OTHER MATTERS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1 <u>No Right to Use Regulatory Information</u>. BioVie shall not have a right of reference to, or otherwise be entitled to use, the regulatory filings or other regulatory information that is owned or controlled by SpinCo and exclusively relate to any SpinCo Products; and (b) SpinCo shall not have a right of reference to or otherwise be entitled to use the regulatory filings or other regulatory information owned or controlled by BioVie.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2 <u>Late Payments</u>. Except as expressly provided to the contrary in this Agreement or in any Ancillary Agreement, any amount not paid when due pursuant to this Agreement or any Ancillary Agreement (and any amounts billed or otherwise invoiced or demanded and properly payable that are not paid within forty-five (45) days of such bill, invoice or other demand) shall accrue interest at a rate per annum equal to eight percent (8%) (or, if lower, the maximum rate permitted by applicable Law).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3 <u>Inducement</u>. SpinCo acknowledges and agrees that BioVie's willingness to cause, effect and consummate the Separation has been conditioned upon and induced by SpinCo's covenants and agreements in this Agreement and the Ancillary Agreements, including SpinCo's assumption of the SpinCo Liabilities pursuant to the Separation and the provisions of this Agreement and SpinCo's covenants and agreements contained in <u>Article IV</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4 <u>Post-Effective Time Conduct</u>. The Parties acknowledge that, after the Effective Time, each Party shall be independent of the other Party, with responsibility for its own actions and inactions and its own Liabilities relating to, arising out of or resulting from the conduct of its business, operations and activities following the Effective Time, except as may otherwise be provided herein or in any Ancillary Agreement, and each Party shall (except as otherwise provided in <u>Article IV</u>, including <u>Section 4.2</u> and <u>Section 4.3</u>) use commercially reasonable efforts to prevent such Liabilities from being inappropriately borne by the other Party.

**ARTICLE VII<br> EXCHANGE OF INFORMATION; CONFIDENTIALITY**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1 <u>Agreement for Exchange of Information; Archives</u>. Subject to <u>Section 7.7</u> and any other applicable confidentiality obligations, each Party agrees to provide, or cause to be provided, to the other Party, at any time before, on or after the Separation Date, as soon as reasonably practicable after written request therefor, any Information in the possession or under the control of such Party which the requesting Party reasonably needs (i) to comply with reporting, disclosure, filing or other requirements imposed on the requesting Party (including under applicable securities or Tax Laws) by a Governmental Authority having jurisdiction over the requesting Party, (ii) for use in any other judicial, regulatory, administrative, Tax or other proceeding or in order to satisfy audit, accounting, claims, regulatory, litigation, Tax or other similar requirements, in each case other than claims or allegations that one Party to this Agreement has against the other, or (iii) subject to the foregoing clause (ii), to comply with its obligations under this Agreement or any Ancillary Agreement; <u>provided</u>, <u>however</u>, that, in the event that any Party determines that any such provision of Information could be commercially detrimental, violate any Law or agreement, or waive any privilege otherwise available under applicable Law, including the attorney-client privilege, the Parties shall take all reasonable measures to permit the compliance with such obligations in a manner that avoids any such harm or consequence. For the avoidance of doubt, the rights and obligations of any Party described in this <u>Section 7.1</u> with respect to the sharing of Information related to Taxes are subject to the rights and obligations described in the Tax Matters Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2 <u>Ownership of Information</u>. Any Information owned by a Party that is provided to a requesting Party pursuant to <u>Section 7.1</u> or <u>Section 7.6</u> shall be deemed to remain the property of the providing Party. Unless specifically set forth herein, nothing contained in this Agreement shall be construed as granting or conferring rights of license or otherwise in any such Information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3 <u>Compensation for Providing Information</u>. The Party requesting Information agrees to reimburse the other Party for the reasonable out-of-pocket costs, if any, of creating, gathering and copying such Information, to the extent that such costs are incurred for the benefit of the requesting Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4 <u>Record Retention</u>. To facilitate the possible exchange of Information pursuant to this <u>Article VII</u> and other provisions of this Agreement after the Effective Time, the Parties agree to use their reasonable best efforts to retain all Information in their respective possession or control on the Separation Date in accordance with the policies of BioVie as in effect on the Separation Date or such other policies as may be adopted by BioVie after the Effective Time (<u>provided</u>, in the case of SpinCo, that BioVie notifies SpinCo of any such material change). Neither Party will destroy, or permit any of its Subsidiaries to destroy, any Information which the other Party may have the right to obtain pursuant to this Agreement prior to the end of the retention period set forth in such policies without first notifying the other Party of the proposed destruction and giving the other Party the opportunity to take possession of such information prior to such destruction; <u>provided</u>, <u>however</u>, that in the case of any Information relating to Taxes, employee benefits or Environmental Liabilities, such retention period shall be extended to the expiration of the applicable statute of limitations (giving effect to any extensions thereof). Notwithstanding the foregoing, <u>Section 5.01</u> of the Tax Matters Agreement shall govern the retention of Tax Records (as defined in the Tax Matters Agreement).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5 <u>Limitations of Liability</u>. Neither Party shall have any liability to the other Party in the event that any Information exchanged or provided pursuant to this Agreement which is an estimate or forecast, or which is based on an estimate or forecast, is found to be inaccurate in the absence of willful misconduct by the Party providing such Information. Neither Party shall have any liability to the other Party if any Information is destroyed after reasonable best efforts by such Party to comply with the provisions of <u>Section 7.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.6 <u>Production of Witnesses; Records; Cooperation</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) After the Effective Time, except in the case of an adversarial Action by one Party against the other Party, each Party shall use its commercially reasonable efforts to make available to the other Party, upon written request, the former, current and future directors, officers, employees, other personnel and agents of the members of such Party as witnesses and any books, records or other documents within its control or which it otherwise has the ability to make available, to the extent that any such Person (giving consideration to business demands of such directors, officers, employees, other personnel and agents) or books, records or other documents may reasonably be required in connection with any Action in which the requesting Party may from time to time be involved, regardless of whether such Action is a matter with respect to which indemnification may be sought hereunder. Without limiting any indemnification obligations of the non-requesting Party pursuant to <u>Article IV</u>, the requesting Party shall bear all costs and expenses in connection therewith. For the avoidance of doubt, the rights and obligations of any Party described in this <u>Section 7.6</u> are subject to the rights and obligations described in the Tax Matters Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) If an Indemnifying Party chooses to defend or to seek to compromise or settle any Third-Party Claim, the other Party shall make available to such Indemnifying Party, upon written request, the former, current and future directors, officers, employees, other personnel and agents of such Party as witnesses and any books, records or other documents within its control or which it otherwise has the ability to make available, to the extent that any such person (giving consideration to business demands of such directors, officers, employees, other personnel and agents) or books, records or other documents may reasonably be required in connection with such defense, settlement or compromise, or such prosecution, evaluation or pursuit, as the case may be, and shall otherwise cooperate in such defense, settlement or compromise, or such prosecution, evaluation or pursuit, as the case may be.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Without limiting the foregoing, the Parties shall cooperate and consult to the extent reasonably necessary with respect to any Actions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Without limiting any provision of this <u>Section 7.6</u>, each of the Parties agrees to cooperate with each other in the defense of any infringement or similar claim with respect to any Intellectual Property and shall not claim to acknowledge, the validity or infringing use of any Intellectual Property of a third Person in a manner that would hamper or undermine the defense of such infringement or similar claim.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) The obligation of the Parties to provide witnesses pursuant to this <u>Section 7.6</u> is intended to be interpreted in a manner so as to facilitate cooperation and shall include the obligation to provide as witnesses inventors and other officers (subject to the exception set forth in the first sentence of <u>Section 7.6(a)</u>).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) In connection with any matter contemplated by this <u>Section 7.6</u>, the Parties will enter into, in accordance with <u>Section 7.9</u>, a mutually acceptable joint defense agreement so as to maintain to the extent practicable any applicable attorney-client privilege or work product immunity of each Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.7 <u>Confidentiality</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Subject to <u>Section 7.1</u> and <u>7.8</u>, each of BioVie and SpinCo (each, a "<u>Receiving Party</u>"), on behalf of itself and its Affiliates (collectively, the relevant "<u>Receiving Group</u>"), agrees to hold, and to cause its respective Representatives to hold, in strict confidence, with at least the same degree of care that applies to BioVie's confidential and proprietary information pursuant to policies in effect as of the Separation Date (and in no event less than a reasonable degree of care), all confidential or proprietary Information ("<u>Confidential Information</u>") concerning each such other Group or any of its members (collectively, the "<u>Disclosing Group</u>", and the relevant Party in such Group, the "<u>Disclosing Party</u>") that is either in the possession of any member of the Receiving Group or any of its respective Representatives (including such Confidential Information in its possession prior to the date hereof) or furnished by any member of the Disclosing Group or its respective Representatives at any time pursuant to this Agreement, any Ancillary Agreement or otherwise, and shall not use any such Confidential Information other than for such purposes as shall be expressly permitted hereunder or under any Ancillary Agreement, except, in each case, to the extent that such Confidential Information (i) is as of the date hereof or at any time thereafter in the public domain or generally known to the public through no fault of any member of the Receiving Group or any of their respective Representatives, (ii) is after the Separation Date lawfully acquired by any member of the Receiving Group from sources, other than any member of the Disclosing Group or any of its respective Representatives, which sources are not themselves bound by a confidentiality obligation, or (iii) is independently generated by a member of the Receiving Group without reference to any Confidential Information of the Disclosing Group. Each Party shall maintain, and shall cause its respective Group members and Representatives to maintain, policies and procedures, and develop such further policies and procedures as will from time to time become necessary or appropriate, to ensure compliance with this <u>Section 7.7</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) SpinCo acknowledges that it may have in its possession Confidential Information of third-parties that was received under a confidentiality or nondisclosure agreement with such parties while SpinCo was part of BioVie. SpinCo will, and will cause its Representatives to, hold in strict confidence the Confidential Information of third-parties to which SpinCo has access, in accordance with the terms of any agreements entered into prior to the Effective Time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Each Receiving Party, on behalf of itself and the other members of its Receiving Group, agrees not to release, communicate or disclose, or permit to be released, communicated or disclosed, directly or indirectly, any Confidential Information of the Disclosing Group to any other Person, except its Representatives who need to know such Confidential Information (who shall be advised of their obligations hereunder with respect to such Confidential Information), except in compliance with <u>Section 7.8</u>. Without limiting the foregoing, when any such Confidential Information is no longer needed for the purposes contemplated by this Agreement or any Ancillary Agreement, each Receiving Party will promptly after request of the Disclosing Party either return to the Disclosing Party all such Confidential Information in a tangible form (including all copies thereof and all notes, extracts or summaries based thereon) or certify to the Disclosing Party that it has destroyed such Confidential Information (and such copies thereof and such notes, extracts or summaries based thereon).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Each Party shall be liable for any failure by its Representatives, to comply with the restrictions on use and disclosure of Confidential Information contained in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.8 <u>Protective Arrangements</u>. In the event that any Receiving Party either determines on the advice of its counsel that it is required to disclose any Confidential Information of the Disclosing Group pursuant to applicable Law or receives any demand under lawful process or from any Governmental Authority to disclose or provide Confidential Information of the Disclosing Party, such Receiving Party shall notify the Disclosing Party (if legally permissible under the circumstances) prior to disclosing or providing such Confidential Information and shall cooperate at the expense of the Disclosing Party in seeking any reasonable protective arrangements requested by the Disclosing Party. Subject to the foregoing, the member of the Receiving Group that received such request may thereafter disclose or provide the Disclosing Group's Confidential Information to the extent required by such Law (as so advised by counsel) or by lawful process or such Governmental Authority. The Receiving Party shall promptly provide the Disclosing Party with a copy of the Confidential Information so disclosed, in the same form and format so disclosed, together with a list of all Persons to whom such Confidential Information was disclosed, in each case if legally permissible under the circumstances.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9 <u>Privileged Matters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) The Parties recognize that the legal and other professional services that have been and will be provided prior to the Effective Time have been and will be rendered for the collective benefit of the Parties, and that each Party should be deemed to be the client with respect to such services for the purposes of asserting all privileges and immunities that may be asserted under applicable Law in connection therewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) The Parties agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) BioVie shall be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to the BioVie Business, whether or not the Privileged Information is in the possession or under the control of any member of BioVie or SpinCo. BioVie shall also be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to any BioVie Liabilities resulting from any Actions that are now pending or may be asserted in the future, whether or not the Privileged Information is in the possession or under the control of BioVie or SpinCo.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) SpinCo shall be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to the SpinCo Business, whether or not the Privileged Information is in the possession or under the control of BioVie or SpinCo. SpinCo shall also be entitled, in perpetuity, to control the assertion or waiver of all privileges and immunities in connection with any Privileged Information that relates solely to any SpinCo Liabilities resulting from any Actions that are now pending or may be asserted in the future, whether or not the Privileged Information is in the possession or under the control of BioVie or SpinCo.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) If BioVie and SpinCo do not agree as to whether certain information is Privileged Information, then the information shall be treated as Privileged Information, and the Party who believes such information is Privileged Information shall be entitled to control the assertion or waiver of all privileges and immunities in connection with any such information unless the Parties otherwise agree. The Parties shall utilize the procedures set forth in <u>Article VIII</u> to resolve any disputes as to whether any information relates solely to the BioVie Business, solely to the SpinCo Business, or to both the BioVie Business and the SpinCo Business.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Subject to <u>Section 7.9(d)</u> and <u>Section 7.9(e)</u>, the Parties agree that they shall have a shared privilege or immunity with respect to all privileges not allocated pursuant to <u>Section 7.9(b)</u> and all privileges and immunities relating to any Actions or other matters that involve both Parties and in respect of which both Parties have Liabilities under this Agreement, and that no such shared privilege or immunity may be waived by either Party without the consent of the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) If any dispute arises between BioVie and SpinCo regarding whether a privilege or immunity should be waived to protect or advance the interests of either Party, each Party agrees that it shall (i) negotiate with the other Party in good faith; (ii) endeavor to minimize any prejudice to the rights of the other Party; and (iii) not unreasonably withhold consent to any request for waiver by the other Party. Further, each Party specifically agrees that it shall not withhold its consent to the waiver of a privilege or immunity for any purpose except to protect its own legitimate interests.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) Upon receipt by SpinCo of any subpoena, discovery or other request that may reasonably be expected to result in the production or disclosure of information subject to a shared privilege or immunity or as to which BioVie has the sole right hereunder to assert a privilege or immunity, or if SpinCo obtains knowledge that any current or former directors, officers, agents or employees of SpinCo have received any subpoena, discovery or other requests that may reasonably be expected to result in the production or disclosure of such Privileged Information, SpinCo shall promptly provide notice to BioVie of the existence of the request (which notice shall be delivered to BioVie no later than five (5) Business Days following the receipt of any such subpoena, discovery or other request) and shall provide BioVie a reasonable opportunity to review the information and to assert any rights it or they may have, including under this <u>Section 7.9</u> or otherwise, to prevent the production or disclosure of such Privileged Information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) Upon receipt by BioVie of any subpoena, discovery or other request that may reasonably be expected to result in the production or disclosure of information subject to a shared privilege or immunity or as to which SpinCo has the sole right hereunder to assert a privilege or immunity, or if BioVie obtains knowledge that any current or former directors, officers, agents or employees of BioVie have received any subpoena, discovery or other requests that may reasonably be expected to result in the production or disclosure of such Privileged Information, BioVie shall promptly provide notice to SpinCo of the existence of the request (which notice shall be delivered to SpinCo no later than five (5) Business Days following the receipt of any such subpoena, discovery or other request) and shall provide SpinCo a reasonable opportunity to review the information and to assert any rights it or they may have, including under this <u>Section 7.9</u> or otherwise, to prevent the production or disclosure of such Privileged Information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) The Parties agree that they have or may in the future have common legal interests in the BioVie Liabilities and any corresponding legal rights, in the SpinCo Liabilities and any corresponding legal rights, in the Privileged Information and in the preservation of the protected status of the Privileged Information. The Parties have disclosed and exchanged and will disclose and exchange certain Privileged Information between and among themselves in order to further the Parties' common legal interests.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) Any furnishing of, or access to, information pursuant to this Agreement is made in reliance on the agreement of BioVie and SpinCo set forth in this <u>Section 7.9</u> and in <u>Section 7.7</u> to maintain the confidentiality of Privileged Information and to assert and maintain all applicable privileges and immunities. The Parties further agree that (i) the exchange by one Party to the other Party of any Privileged Information that should not have been transferred pursuant to the terms of this <u>Article VII</u> shall not be deemed to constitute a waiver of any privilege or immunity that has been or may be asserted under this Agreement or otherwise with respect to such Privileged Information; and (ii) the Party receiving (or for which a Subsidiary has received) such Privileged Information shall promptly return such Privileged Information to the Party (or its applicable Subsidiary) who has the right to assert the privilege or immunity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) In furtherance of, and without limitation to, the Parties' agreement under this <u>Section 7.9</u>, BioVie and SpinCo shall use reasonable efforts to maintain their respective separate and joint privileges and immunities, including by executing joint defense and/or common interest agreements where necessary or useful for this purpose.

**ARTICLE VIII<br> DISPUTE RESOLUTION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1 <u>Disputes</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Except as otherwise provided in <u>Section 8.1(b)</u>, any controversy or claim arising out of or relating to this Agreement or any Ancillary Agreements, or the breach thereof, shall be resolved by BioVie in its sole and absolute discretion.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Any controversy or claim arising after the Effective Time and arising out of or relating to this Agreement or any Ancillary Agreements, or the breach thereof (a "<u>Dispute</u>"), shall be resolved: (a) first, by negotiation by the applicable local or functional leads (if applicable to any Dispute), and then (if there remains a Dispute) negotiation by and among the members of the Transition Committee, with the possibility of mediation as provided in <u>Section 8.2</u>; and (b) then, if negotiation and mediation fail, by binding arbitration as provided in <u>Section 8.3</u>. Each Party agrees on behalf of itself and each of its Subsidiaries that the procedures set forth in this <u>Article VIII</u> shall be the exclusive means for resolution of any Dispute. The initiation of mediation or arbitration hereunder will toll the applicable statute of limitations for the duration of any such proceedings.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2 <u>Negotiation and Mediation</u>. If either party serves written notice of a Dispute upon the other party (a "<u>Dispute Notice</u>"), the parties will first attempt to resolve such Dispute by direct discussions and negotiation (including as set forth in <u>Section 8.1</u> above or, as applicable, in accordance with the applicable Ancillary Agreement). If the parties to the Dispute agree, the parties may also attempt to resolve the Dispute by a mediation administered by the International Institute for Conflict Prevention & Resolution ("<u>CPR</u>") under its Mediation Procedure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3 <u>Arbitration</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) If a Dispute is not resolved within 45 days (or later if mutually agreed by the Parties) after the service of a Dispute Notice, either Party shall have the right to commence arbitration. The arbitration shall be administered by the CPR pursuant to its Arbitration Rules and Procedures. References herein to any arbitration rules or procedures mean such rules or procedures as amended from time to time, including any successor rules or procedures, and references herein to the CPR include any successor thereto. The arbitration shall be before three (3) arbitrators. Each Party shall designate one arbitrator in accordance with the "screened" appointment procedure provided in Rule 5.4 of the CPR Rules. The two Party-appointed arbitrators will select the third, who will serve as the panel's chair or president. This arbitration provision, and the arbitration itself, shall be governed by the Laws of the State of Delaware and the Federal Arbitration Act, 9 U.S.C. §§ 1-16.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Consistent with the expedited nature of arbitration, each Party will, upon the written request of the other Party, promptly provide the other with copies of documents on which the producing Party may rely in support of or in opposition to any claim or defense. At the request of a Party, the arbitrators shall have the discretion to order examination by deposition of witnesses to the extent the arbitrator deems such additional discovery relevant and appropriate. Depositions shall be limited to a maximum of five per Party and shall be held within 45 days of the grant of a request. Additional depositions may be scheduled only with the permission of the arbitrators, and for good cause shown. Each deposition shall be limited to a maximum of one day's duration. All objections are reserved for the arbitration hearing except for objections based on privilege and proprietary or confidential information. The Parties shall not utilize any other discovery mechanisms, including international processes and U.S. federal statutes, to obtain additional evidence for use in the arbitration. Any Dispute regarding discovery, or the relevance or scope thereof, shall be determined by the arbitrators, which determination shall be conclusive. All discovery shall be completed within 60 days following the appointment of the arbitrators. All costs and fees relating to the retrieval, review and production of electronic discovery shall be paid by the Party requesting such discovery.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) The panel of arbitrators shall have no power to award non-monetary or equitable relief of any sort. The arbitrators shall have no power or authority, under the CPR Rules for Non-Administered Arbitration or otherwise, to relieve the Parties from their agreement hereunder to arbitrate or otherwise to amend or disregard any provision of this Agreement or any Ancillary Agreement. The award of the arbitrators shall be final, binding and the sole and exclusive remedy to the Parties. Either Party may seek to confirm and enforce any final award entered in arbitration, in any court of competent jurisdiction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Absent fraud or manifest error, any arbitral award issued hereunder shall be final and binding on the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) Except as may be required by Law or any applicable rules and regulations of any stock exchange, neither a Party nor an arbitrator may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4 <u>Interim Relief</u>. At any time during the resolution of a Dispute between the Parties, either Party has the right to apply to any court of competent jurisdiction for interim relief, including pre-arbitration attachments or injunctions, necessary to preserve the Parties' rights or to maintain the Parties' relative positions until such time as the arbitration award is rendered or the Dispute is otherwise resolved.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.5 <u>Remedies</u>. The arbitrators shall have no authority or power to limit, expand, alter, amend, modify, revoke or suspend any condition or provision of this Agreement or any Ancillary Agreement nor any right or power to award punitive, exemplary or treble damages (or other multiple damages that are not actual damages).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.6 <u>Expenses</u>. Each Party shall bear its own costs, expenses and attorneys' fees in pursuit and resolution of any Dispute; <u>provided</u>, <u>however</u>, that, in the event of any arbitration with respect to any Dispute pursuant to <u>Section 8.3</u> in which the arbitrator issues an arbitral award in an amount that is within ten percent (10%) of the amount of the most recent *bona fide* written settlement offer submitted by a Party and rejected by a Party in connection with such Dispute, then the Party that rejected such settlement offer shall bear both Parties' costs, expenses and attorneys' fees incurred in connection with such arbitration (including the fees and expenses of any arbitrator).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.7 <u>Continuation of Services and Commitments</u>. Unless otherwise agreed in writing, the Parties shall continue to honor all commitments under this Agreement and each Ancillary Agreement to the extent required by such agreements during the course of dispute resolution pursuant to the provisions of this <u>Article VIII</u> with respect to all matters related to such Dispute.

**ARTICLE IX<br> FURTHER ASSURANCES AND ADDITIONAL COVENANTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1 <u>Further Assurances</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) In addition to the actions specifically provided for elsewhere in this Agreement, each of the Parties shall use its reasonable best efforts, prior to, on and after the Separation Date, to take, or cause to be taken, all actions, and to do, or cause to be done, all things, reasonably necessary, proper or advisable under applicable Laws, regulations and agreements to consummate and make effective the transactions contemplated by this Agreement and the Ancillary Agreements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Without limiting the foregoing, prior to, on and after the Separation Date, each Party hereto shall cooperate with the other Party, and without any further consideration, but at the expense of the requesting Party, to execute and deliver, or use its reasonable best efforts to cause to be executed and delivered, all instruments, including instruments of conveyance, assignment and transfer, and to make all filings with, and to obtain all Approvals or Notifications of, any Governmental Authority or any other Person under any permit, license, agreement, indenture or other instrument (including any consents or Governmental Approvals), and to take all such other actions as such Party may reasonably be requested to take by any other Party from time to time, consistent with the terms of this Agreement and the Ancillary Agreements, in order to effectuate the provisions and purposes of this Agreement and the Ancillary Agreements and the transfers of the SpinCo Assets and the assignment and assumption of the SpinCo Liabilities and the other transactions contemplated hereby and thereby. Without limiting the foregoing, each Party will, at the reasonable request, cost and expense of any other Party, take such other actions as may be reasonably necessary to vest in such other Party good and marketable title to the Assets allocated to such Party under this Agreement or any of the Ancillary Agreements, free and clear of any Security Interest.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) On or prior to the Separation Date, BioVie and SpinCo shall each ratify any actions which are reasonably necessary or desirable to be taken by to effectuate the transactions contemplated by this Agreement and the Ancillary Agreements.

**ARTICLE X<br> TERMINATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1 <u>Termination</u>. This Agreement may be terminated by BioVie at any time, in its sole and absolute discretion, prior to the Effective Time. After the Effective Time, this Agreement may not be terminated except by an agreement in writing signed by each of the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2 <u>Effect of Termination</u>. In the event of any termination of this Agreement prior to the Effective Time, no Party (or any of its directors or officers) shall have any Liability or further obligation to any other Party.

**ARTICLE XI<br> MISCELLANEOUS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1 <u>Counterparts; Entire Agreement; Corporate Power</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) This Agreement and each Ancillary Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when one or more counterparts have been signed by each of the Parties and delivered to the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) This Agreement, the Ancillary Agreements, the Exhibits, the Schedules and appendices hereto and thereto contain the entire agreement between the Parties with respect to the subject matter hereof, supersede all previous agreements, negotiations, discussions, writings, understandings, commitments and conversations with respect to such subject matter and there are no agreements or understandings between the Parties other than those set forth or referred to herein or therein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) BioVie and SpinCo each represents as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) each such Person has the requisite corporate or other power and authority and has taken all corporate or other action necessary in order to execute, deliver and perform each of this Agreement and each Ancillary Agreement to which it is a party and to consummate the transactions contemplated hereby and thereby; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) this Agreement and each Ancillary Agreement to which it is a party has been duly executed and delivered by it and constitutes a valid and binding agreement of it enforceable in accordance with the terms thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Each Party acknowledges that it and each other Party is executing certain of the Ancillary Agreements by facsimile, stamp or mechanical signature. Each Party expressly adopts and confirms each such facsimile, stamp or mechanical signature made in its respective name as if it were a manual signature, agrees that it will not assert that any such signature is not adequate to bind such Party to the same extent as if it were signed manually and agrees that at the reasonable request of any other Party at any time it will as promptly as reasonably practicable cause each such Ancillary Agreement to be manually executed (any such execution to be as of the date of the initial date thereof).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2 <u>Governing Law</u>. This Agreement and, unless expressly provided therein, each Ancillary Agreement, shall be governed by and construed and interpreted in accordance with the Laws of the State of Delaware, irrespective of the choice of Laws and principles, as to all matters, including matters of validity, construction, effect, enforceability, performance and remedies.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3 <u>Assignability</u>. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Except as otherwise provided for in this Agreement, this Agreement shall not be assignable, in whole or in part, directly or indirectly, by either Party without the express written consent of the other Party, and any attempt to assign any rights or obligations arising under this Agreement without such consent shall be void. Notwithstanding the foregoing, no such consent shall be required for the assignment of a Party's rights and obligations under this Agreement (i) in connection with the merger of such Party, or the sale, transfer or other divestiture of all or substantially all of an entire product line, Affiliate, division or other business unit of such Party, or (ii) to any Affiliate of such Party; <u>provided</u>, <u>however</u>, that in connection with each such assignment or delegation, the assigning Party provides a guarantee to the non-assigning Party for any liability or obligation assigned or delegated pursuant to this <u>Section 11.3</u>; <u>provided</u>, <u>further</u>, that SpinCo shall only be entitled to assign its rights or delegate its obligations under this Agreement with the prior written consent of BioVie.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.4 <u>Third-Party Beneficiaries</u>. Except (a) for the indemnification rights under this Agreement of any BioVie Indemnitee or SpinCo Indemnitee in their respective capacities as such and (b) as expressly set forth in any Ancillary Agreement, (i) the provisions of this Agreement and each Ancillary Agreement are solely for the benefit of the Parties and are not intended to confer upon any Person except the Parties any rights or remedies hereunder, and (ii) there are no third-party beneficiaries of this Agreement or any Ancillary Agreement and neither this Agreement nor any Ancillary Agreement shall provide any third party with any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement or any Ancillary Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.5 <u>Notices</u>. All notices, requests, claims, demands or other communications under this Agreement and, to the extent applicable and unless otherwise provided therein, under each of the Ancillary Agreements shall be in writing and shall be given or made (and shall be deemed to have been duly given or made upon receipt) by delivery in person, by overnight courier service, by facsimile or electronic transmission with receipt confirmed (followed by delivery of an original via overnight courier service) or by registered or certified mail (postage prepaid, return receipt requested) to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this <u>Section 11.5</u>):

If to BioVie, to:

Biovie Inc.

680 W Nye Lane

Suite 204

Carson City, Nevada 89703

Attention: Cuong Do

If to SpinCo to:

Option Therapeutics Inc.

680 W Nye Lane

Suite 204

Carson City, Nevada 89703

Attention: Joanne Wendy Kim

A Party may, by notice to the other Party, change the address and contact person to which any such notices are to be given or made.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6 <u>Severability</u>. If any provision of this Agreement or any Ancillary Agreement or the application thereof to any Person or circumstance is determined by a court of competent jurisdiction to be invalid, void or unenforceable, the remaining provisions hereof or thereof, or the application of such provision to Persons or circumstances or in jurisdictions other than those as to which it has been held invalid or unenforceable, shall remain in full force and effect and shall in no way be affected, impaired or invalidated thereby. Upon such determination, the Parties shall negotiate in good faith in an effort to agree upon such a suitable and equitable provision to effect the original intent of the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.7 <u>Force Majeure</u>. No Party shall be deemed in default of this Agreement or any Ancillary Agreement to the extent that any delay or failure in the performance of its obligations under this Agreement or any Ancillary Agreement, other than a delay or failure to make a payment, results from any cause beyond its reasonable control and without its fault or negligence, such as acts of God, acts of civil or military authority, embargoes, epidemics, war, riots, insurrections, fires, explosions, earthquakes, floods, unusually severe weather conditions, labor problems or unavailability of parts, or, in the case of computer systems, any failure in electrical or air conditioning equipment (each such cause, a "<u>Force Majeure</u>"). In the event of any such excused delay, the time for performance shall be extended for a period equal to the time lost by reason of the delay.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.8 <u>Publicity</u>. Prior to the Effective Time, each of SpinCo and BioVie shall consult with each other prior to issuing any press releases or otherwise making public statements with respect to the Separation or any of the other Transactions contemplated hereby or under any Ancillary Agreement and prior to making any filings with any Governmental Authority with respect thereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.9 <u>Expenses</u>. Except as expressly set forth in this Agreement (or in any Ancillary Agreement), all fees, costs and expenses incurred in connection with the preparation, execution, delivery and implementation of this Agreement and any Ancillary Agreement, and with the consummation of the transactions contemplated hereby and thereby, will be borne by the Party incurring such fees, costs or expenses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.10 <u>Headings</u>. The article, section and paragraph headings contained in this Agreement and in the Ancillary Agreements are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement or any Ancillary Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.11 <u>Survival of Covenants</u>. Except as expressly set forth in this Agreement or any Ancillary Agreement, the covenants, representations and warranties contained in this Agreement and each Ancillary Agreement, and liability for the breach of any obligations contained herein, shall survive the Separation and shall remain in full force and effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12 <u>Waivers of Default</u>. Waiver by a Party of any default by the other Party of any provision of this Agreement or any Ancillary Agreement shall not be deemed a waiver by the waiving Party of any subsequent or other default, nor shall it prejudice the rights of the other Party. No failure or delay by any Party in exercising any right, power or privilege under this Agreement or any Ancillary Agreement shall operate as a waiver thereof nor shall a single or partial exercise thereof prejudice any other or further exercise thereof or the exercise of any other right, power or privilege.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.13 <u>Specific Performance</u>. Subject to the provisions of <u>Article VIII</u>, in the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement or any Ancillary Agreement, the Party or Parties who are, or are to be, thereby aggrieved shall have the right to specific performance and injunctive or other equitable relief in respect of its or their rights under this Agreement or such Ancillary Agreement, in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative. The Parties agree that the remedies at law for any breach or threatened breach, including monetary damages, are inadequate compensation for any loss and that any defense in any action for specific performance that a remedy at law would be adequate is waived. Any requirements for the securing or posting of any bond with such remedy are waived by each of the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.14 <u>Amendments</u>. No provisions of this Agreement or any Ancillary Agreement shall be deemed waived, amended, supplemented or modified by any Party, unless such waiver, amendment, supplement or modification is in writing and signed by the authorized representative of the Party against whom it is sought to enforce such waiver, amendment, supplement or modification.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.15 <u>Interpretation</u>. In this Agreement and any Ancillary Agreement, (a) words in the singular shall be held to include the plural and vice versa and words of one gender shall be held to include the other genders as the context requires; (b) the terms "hereof," "herein," and "herewith" and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement (or the applicable Ancillary Agreement) as a whole (including all of the Schedules, Exhibits and Appendices hereto and thereto) and not to any particular provision of this Agreement (or such Ancillary Agreement); (c) Article, Section, Exhibit, Schedule and Appendix references are to the Articles, Sections, Exhibits, Schedules and Appendices to this Agreement (or the applicable Ancillary Agreement) unless otherwise specified; (d) the word "including" and words of similar import when used in this Agreement (or the applicable Ancillary Agreement) shall mean "including, without limitation"; (e) the word "or" shall not be exclusive; (f) unless expressly stated to the contrary in this Agreement or in any Ancillary Agreement, all references to "the date hereof," "the date of this Agreement," "hereby" and "hereupon" and words of similar import shall all be references to [⚫], 2025, regardless of any amendment or restatement hereof; (g) the verb "will" means "shall"; and (h) except where the context otherwise requires, references to Subsidiaries of SpinCo refers to Persons that will be Subsidiaries of SpinCo upon consummation of the Separation. BioVie and SpinCo have each participated in the negotiation and drafting of this Agreement and if an ambiguity or question of interpretation should arise, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or burdening either Party by virtue of the authorship of any of the provisions in this Agreement or any interim drafts of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.16 <u>No Set Off</u>. Except as set forth in any Ancillary Agreement or as otherwise mutually agreed to in writing by the Parties, neither Party nor any of its Subsidiaries shall have any right of set off or other similar rights with respect to (a) any amounts received pursuant to this Agreement or any Ancillary Agreement; or (b) any other amounts claimed to be owed to the other Party or any of its Subsidiaries arising out of this Agreement or any Ancillary Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.17 <u>Limitations of Liability</u>. Notwithstanding anything in this Agreement to the contrary, neither SpinCo or its Affiliates, on the one hand, nor BioVie or its Affiliates, on the other hand, shall be liable under this Agreement to the other for any special, punitive, exemplary or similar damages in connection with the transactions contemplated hereby (other than any such liability with respect to a Third-Party Claim), whether or not advised of the possibility of such damages and whether or not such damages are reasonably foreseeable.

*[Signature Page Follows]*

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed on the date first written above by their duly authorized representatives.

---

| |
|:---|
| BIOVIE INC. |
| By: |
| Name: |
| Title: |
| OPTION THERAPEUTICS INC. |
| By: |
| Name: |
| Title: |

---

## Exhibit 10.2

Exhibit 10.2

**FORM OF MANAGEMENT SERVICES AGREEMENT**

This **MANAGEMENT SERVICES AGREEMENT** (this "<u>Agreement</u>") is made and entered into as of [•], 2025 by and between Option Therapeutics Inc., a Delaware corporation ("<u>Service Recipient</u>"), and BioVie Inc., a Nevada corporation ("<u>Parent</u>"), effective as of completion of the Separation (as defined below) or such other date as Service Recipient and Parent may mutually agree upon in writing (the "<u>Effective Time</u>"). Service Recipient and Parent shall be referred to collectively as the "<u>Parties</u>" and, individually, as a "<u>Party</u>".

WITNESSETH:

**WHEREAS,** Service Recipient is currently a direct, wholly owned subsidiary of Parent;

**WHEREAS,** Parent and Service Recipient have entered into a separation agreement substantially concurrently with this Agreement (such agreement, as amended, restated or modified from time to time, the "<u>Separation Agreement</u>"), pursuant to which Service Recipient will spin-off from Parent into a separately operated company (the "<u>Separation</u>"); and

**WHEREAS**, upon the Separation, Parent desires to provide to Service Recipient, and Service Recipient desires to receive from Parent, the services described in <u>Schedule A</u> attached hereto as may be requested from time to time by Service Recipient (each a "<u>Service</u>" and together the "<u>Services</u>").

**NOW, THEREFORE**, in consideration of the foregoing recitals and the mutual covenants and agreements contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, agree as follows:

<u>TERMS AND CONDITIONS</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. <u>Agreement to Provide Services</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1. <u>Agreement</u>. Upon the terms and subject to the conditions contained herein, Parent shall provide to Service Recipient the Services. Each of the Services shall be provided and accepted in accordance with the terms, limitations and conditions set forth herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2. <u>Review of Services; Additional Services</u>. The scope, frequency and manner of delivery of the Services are subject to periodic review by the Parties. Changes to any of the Services (including the addition or deletion of services) may be made at any time as mutually agreed to by each Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3. <u>Service Providers</u>. Parent shall perform the Services through its officers and employees identified on <u>Schedule B</u> attached hereto or any replacement officers and other employees serving in substantially similar roles (each a "<u>Service Provider</u>" and together the "<u>Service Providers</u>"). Additional officers and employees of Parent may become Service Providers under this Agreement, as mutually agreed to by each Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.4. <u>Standards for Performance of Service</u>. Parent shall perform its obligations hereunder in a prudent and efficient manner and in accordance with applicable law and good industry practice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. <u>Fees</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1. <u>Management Fee</u>. In lieu of any other compensation to, or reimbursement of payroll expenses incurred by, Parent hereunder, commencing with the first fiscal quarter ending after the Effective Time, Service Recipient shall pay a quarterly fee to Parent (the "<u>Fee</u>") equal to one hundred seven thousand dollars ($107,000), plus any out-of-pocket expenses (the "<u>Direct Expenses</u>") incurred in relation to the development and commencement of drug candidate BIV201 and the Services. The Fee and the Direct Expenses shall be paid on or prior to the fifteenth (15<sup>th</sup>) day after the end of such quarter. The Parties shall initially reassess the Fee for the Services within ten (10) days after Service Recipient receives funding in an amount sufficient for the continued development and commencement of BIV201 and within ten (10) days after the end of each quarter thereafter. The Parties may amend this <u>Section 2.1</u> to reflect any updated Fee as mutually agreed to by each Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2. <u>Books and Records; Access</u>. Parent shall keep and maintain accurate books and records related to Service Recipient's operations and business. Parent hereby agrees that, upon reasonable notice from Service Recipient, it shall make its books and records with respect to Service Recipient available to Service Recipient and its representatives for inspection during normal business hours at Parent's principal place of business.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. <u>Access to Employees</u>. At the request of Service Recipient, Parent shall, and shall cause its affiliates, to use its reasonable best efforts to provide for consultation with Service Recipient the applicable Service Provider. At the request of Service Recipient, Parent shall, and shall cause its affiliates to, make available information relating to the Parent's business and operations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. <u>Force Majeure</u>. No Party shall be liable for any failure of performance attributable to acts, events or causes (including, but not limited to, war, riot, rebellion, civil disturbances, power failures, failure of telephone lines and equipment, flood, storm, fire and earthquake or other acts of God or conditions or events of nature, or any law, order, proclamation, regulation, ordinance, demand or requirement of any Governmental Authority) beyond its control that prevent in whole or in part performance by such Party hereunder. The affected provisions and/or other requirements of this Agreement shall be suspended during the period of such disability and Parent shall not have any liability to Service Recipient or any other party in connection therewith with respect to the period of such disability. Parent shall make all reasonable efforts to remove such disability as soon as and to the extent reasonably possible and to assist Service Recipient in finding third parties to provide affected Services during the period of such disability.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. <u>Indemnification</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1. Service Recipient shall indemnify, defend and hold harmless Parent, its affiliates, its officers, directors, employees, agents and representatives from and against any and all losses, liabilities, claims, damages, actions, fines, penalties, expenses or costs (including court costs and reasonable attorneys' fees) ("<u>Losses</u>") suffered or incurred by any such person arising from or in connection with Parent's performance of any covenant, agreement or obligation of Parent hereunder, other than by reason of Parent's or any of its affiliates' gross negligence, willful misconduct or bad faith. This <u>Section 5.1</u> shall survive any termination or expiration of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2. Parent shall indemnify, defend and hold harmless Service Recipient, its affiliates, its officers, directors, employees, agents and representatives from and against any and all Losses suffered or incurred by any such person arising from or in connection with Parent's gross negligence, willful misconduct or bad faith. This <u>Section 5.2</u> shall survive any termination or expiration of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. <u>Term and Termination</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1. <u>Term of Services</u>. The term of this Agreement shall be two (2) years beginning at the Effective Time; *provided*, *however*, that such term shall renew automatically for successive terms of one (1) year thereafter unless Parent or Service Recipient provides written notice to the other that this Agreement shall not be renewed at least ninety (90) days prior to the expiration of the then current term.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2. <u>Termination by Service Recipient for Material Breach</u>. This Agreement may be terminated by Service Recipient if Parent breaches its obligations hereunder and such breach remains uncured for thirty (30) days after Parent receives written notice of the breach from Service Recipient.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3. <u>Termination by Parent for Material Breach</u>. This Agreement may be terminated by Parent if Service Recipient breaches its obligations hereunder and such breach remains uncured for thirty (30) days after Service Recipient receives written notice of the breach from Parent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4. <u>Automatic Termination</u>. This Agreement shall terminate automatically, without any notice or other action whatsoever on the part of any party hereto, if either Parent or Service Recipient becomes the subject of an involuntary petition in bankruptcy or any other involuntary proceeding relating to insolvency, receivership, liquidation, or composition for the benefit of creditors, if such petition or proceeding is not dismissed within ninety (90) days of the filing or initiation thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5. <u>Effect if Effective Time Does Not Occur</u>. If the Separation Agreement is terminated prior to the Effective Time, then this Agreement shall terminate and all actions and events that are, under this Agreement, to be taken or occur effective immediately prior to or as of the Effective Time or otherwise in connection with the Separation shall not be taken or occur except to the extent mutually agreed to by each Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. <u>General Provisions</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1. <u>Assignment</u>. This Agreement will bind and inure to the benefit of each Party, its successors and assigns. The rights granted to each Party hereunder will be personal to it and may not, without the prior written consent of the other Party, be transferred or assigned to any other person and any assignment or transfer in violation of the foregoing shall be null, void and without effect. Notwithstanding the foregoing, Parent may assign its rights and obligations under this agreement to a subsidiary or affiliate under common control; *provided* such assignee is reasonably deemed capable of providing the Services. Parent may assign this Agreement, without Service Recipient's consent, including without limitation, its interests in and under this Agreement, to lenders and their administrative agents as collateral security for the obligations of Parent and its affiliates under bank, institutional or commercial financing and any renewal, extension or refinancing thereof. Notwithstanding anything in this Agreement to the contrary, any transfer of assets or equity to a transferee resulting from an exercise by any such lender or administrative agent of rights in respect of collateral security will be a permitted assignment hereunder and will not be deemed an event entitling Parent or Service Recipient to terminate this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2. <u>Remedies</u>. Except as otherwise expressly provided herein, none of the remedies set forth in this Agreement is intended to be exclusive, and each Party shall have all other remedies now or hereafter existing at law or in equity or by statute or otherwise, and the election of any one or more remedies shall not constitute a waiver of the right to pursue other available remedies.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3. <u>Interpretation; Definitions</u>. The headings contained in this Agreement or in any schedule attached hereto are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. The terms defined in the singular shall have a comparable meaning when used in the plural and vice versa. This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the party drafting or causing any instrument to be drafted. When a reference is made in this Agreement to articles, sections or schedules, such reference shall be to an article, section of or schedule to this Agreement unless otherwise indicated. Whenever the words "include," "includes" or "including" are used in this Agreement, they shall be deemed to be followed by the words "without limitation". The phrases "the date of this Agreement," "the date hereof' and terms of similar import, unless the context otherwise requires, shall be deemed to refer to the date set forth in the first paragraph of this Agreement. The words "hereof," "hereby," "herein," "hereunder" and similar terms in this Agreement shall refer to this Agreement as a whole (including the schedules attached hereto) and not to any particular section in which such words appear.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4. <u>Amendments</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. No amendment to this Agreement (or any schedule attached hereto) shall be effective unless it is mutually agreed to in writing by each Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. This Agreement shall not be amended in any manner materially adverse to the creditors of or debt providers to Parent or Service Recipient.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5. <u>Cooperation</u>. Service Recipient will provide all information that Parent reasonably requests for performance of the Services, and Parent will cooperate with any reasonable request of Service Recipient in connection with performance of the Services.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.6. <u>Counterparts</u>. This Agreement and any amendments hereto may be executed by facsimile and in one or more counterparts, all of which shall be considered one and the same agreement and shall become effective when one or more such counterparts have been signed by each of the Parties and delivered to the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.7. <u>Severability</u>. If any provision of this Agreement or the application of any such provision to any person or circumstance shall be held invalid, illegal or unenforceable in any respect by a court of competent jurisdiction, such invalidity, illegality or unenforceability shall not affect any other provision hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.8. **<u>GOVERNING LAW AND TIME; WAIVER OF JURY TRIAL</u>. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK WITHOUT REGARD TO THE PRINCIPLES OF CONFLICTS OF LAWS. SPECIFIED TIMES OF DAY REFER TO NEW YORK CITY TIME. EACH PARTY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9. **<u>CONSENT TO JURISDICTION</u>. EACH PARTY HEREBY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE STATE AND FEDERAL COURTS SITTING IN THE CITY OF NEW YORK, BOROUGH OF MANHATTAN, FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION WITH ANY TRANSACTION CONTEMPLATED HEREBY, AND HEREBY IRREVOCABLY WAIVES, AND AGREES NOT TO ASSERT IN ANY SUIT, ACTION OR PROCEEDING, ANY CLAIM THAT IT IS NOT PERSONALLY SUBJECT TO THE JURISDICTION OF ANY SUCH COURT, THAT SUCH SUIT, ACTION OR PROCEEDING IS BROUGHT IN AN INCONVENIENT FORUM OR THAT THE VENUE OF SUCH SUIT, ACTION OR PROCEEDING IS IMPROPER. EACH PARTY HEREBY IRREVOCABLY WAIVES PERSONAL SERVICE OF PROCESS AND CONSENTS TO PROCESS BEING SERVED IN ANY SUCH SUIT, ACTION OR PROCEEDING BY MAILING A COPY THEREOF (CERTIFIED OR REGISTERED MAIL, RETURN RECEIPT REQUESTED) TO SUCH PARTY AT THE ADDRESS IN EFFECT FOR NOTICES TO IT UNDER THIS AGREEMENT AND AGREES THAT SUCH SERVICE SHALL CONSTITUTE GOOD AND SUFFICIENT SERVICE OF PROCESS AND NOTICE THEREOF. NOTHING CONTAINED HEREIN SHALL BE DEEMED TO LIMIT IN ANY WAY ANY RIGHT TO SERVE PROCESS IN ANY MANNER PERMITTED BY LAW.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.10. <u>Waiver</u>. Except as otherwise provided in this Agreement, any failure of any of the Parties hereto to comply with any obligation, covenant, agreement or condition herein may be waived by the Party entitled to the benefits thereof only by a written instrument signed by the Party granting such waiver, but such waiver or failure to insist upon strict compliance with such obligation, covenant, agreement or condition shall not operate as a waiver of, or estoppel with respect to, any subsequent or other failure. Any consent given by any Party pursuant to this Agreement shall be valid only if contained in a written consent signed by such party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. <u>Notices</u>. Any notices required or permitted under this Agreement will be considered duly made if delivered to the intended Party by certified or registered mail (return receipt requested), any reputable international courier service, or by facsimile (with a confirming copy sent by any of the other options) at the following address. Notice will be deemed given on the date of receipt.

With respect to Parent:

BioVie Inc.

680 W Nye Lane, Suite 201

Carson City, Nevada 89703

Attention: Cuong Do and Joanne Wendy Kim

Email: cdo@bioviepharma.com

wkim@bioviepharma.com

With respect to Service Recipient:

Option Therapeutics Inc.

680 W Nye Lane, Suite 201

Carson City, Nevada 89703

Attention: Cuong Do and Joanne Wendy Kim

Email: cdo@bioviepharma.com

wkim@bioviepharma.com

With a copy in any case to:

McGuireWoods LLP

1251 Avenue of the Americas, 20<sup>th</sup> Floor

New York, New York 10020

Attn: Stephen E. Older and Carly E. Ginley

Email: solder@mcguirewoods.com

cginley@mcguirewoods.com

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1. <u>Authority</u>. None of the Parties hereto shall act or represent or hold itself out as having authority to act as an agent or partner of the other Party, or in any way bind or commit the other party to any obligations. Nothing contained in this Agreement shall be construed as creating a partnership, joint venture, agency, trust or other association of any kind, each Party being individually responsible only for its obligations as set forth in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2. <u>Confidentiality</u>. Each Party acknowledges that it may have access to certain confidential and proprietary information of the other Party. No Party, or their directors, officers, employees or agents, will publicize, disclose or use (except as provided in this Agreement) any such confidential or proprietary information that is the property of the other Party that is disclosed to such Party pursuant to this Agreement. It is agreed that neither Party will be under any obligation to maintain confidentiality regarding information that: (i) was already known to the recipient at the time of its receipt; (ii) was publicly known or becomes so through no fault of the recipient; (iii) is required to be disclosed by law; (iv) was received from a third party not in breach of a confidentiality obligation; or (v) was independently developed by the recipient without use of the disclosing Party's confidential information. Each Party may make disclosure to attorneys, agents and accountants of each Party on a need-to-know basis, *provided* that such Party shall remain liable for any breaches of this <u>Section 8.2</u> by any such persons. The obligations set forth in this <u>Section 8.2</u> will survive the termination of this Agreement for a period of two (2) years. Upon termination of this Agreement, each Party will return to the other all confidential materials belonging such other Party that were delivered during the term of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3. <u>Miscellaneous</u>. This Agreement is the product of arms' length negotiations between parties knowledgeable of its subject matter who have had the opportunity to consult counsel concerning the terms and conditions of this Agreement prior to the execution of this Agreement and any rule of law that would cause interpretation of any provision against the Party responsible for its inclusion herein will have no effect on the interpretation of this Agreement. If any part of this Agreement shall be declared invalid or unenforceable by a duly appointed arbitrator, it shall not affect the validity of the balance of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4. <u>Significance of Headings</u>. Paragraph headings contained herein are solely for the purpose of aiding in speedy location of subject matter and are not in any sense to be given weight in the construction of this Agreement. Accordingly, in case of any question with respect to the construction of this Agreement, it is to be construed as though such paragraph headings had been omitted.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.5. <u>Schedules</u>. All schedules attached hereto or referred to herein are hereby incorporated in and made a part of this Agreement as if set forth in full herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.6. <u>Entire Agreement</u>. This Agreement constitutes the entire agreement and understanding between the Parties hereto with respect to the subject matter hereof and their affiliates and terminate and supersedes any prior agreement or understanding relating to the subject matter of such agreement. None of the provisions of this Agreement can be waived or modified except as mutually agreed to in writing and signed by each Party, and there are no representations, promises, agreements, warranties, covenants or undertakings other than those contained herein.

*[Signature Page Follows]*

 

**IN WITNESS WHEREOF**, the Parties hereto have duly executed this Agreement as of the date first above mentioned.

---

| |
|:---|
| **Service Recipient:** |
| **OPTION THERAPEUTICS INC.** |
| By: |
| Name: |
| Title: |
| **Parent:** |
| **BIOVIE INC.** |
| By: |

---

[SIGNATURE PAGE TO MANAGEMENT SERVICES AGREEMENT]

**<u>Schedule A</u>**

**Services**

**1.**  **<u>General Management Support</u>** 

Parent shall supervise and implement the general strategies and business initiatives of Service Recipient and as otherwise required in connection with the provision of the Services.

**2.**  **<u>Support Services</u>** 

Parent shall provide technical, marketing, investor relations, public relations and business support services and assistance.

**3.**  **<u>Financial and Treasurer Services</u>** 

Parent shall provide accounting, budgeting, forecasting, financial planning and analysis services.

Parent shall provide services for the administration of treasury functions, including managing capital structure, investment and debt portfolios, financing for operations, securities offerings, credit lines and facilities, and compliance with covenants.

**4.**  **<u>Clinical Development and Operations Services</u>** 

Parent shall provide clinical development, clinical trial support and operations services related to the development of BIV201. Parent shall also oversee and supervise related activities performed by third-party vendors and consultants.

**5.**  **<u>Financial Statements</u>** 

Parent shall provide to Service Recipient the accounting and reporting services for Service Recipient, which includes the preparation for the annual audit and quarterly reviews by its auditors of the annual financial statements and quarterly interim financial statements (including notes thereto). The financial statements will be prepared in accordance with U.S. GAAP and comply with reports and filings required under U.S. Securities Exchange Act of 1934 ("34 Act").

**6.**  **<u>Regulatory Services</u>** 

Parent shall prepare any applications, filings or notices required to be filed by Service Recipient with any governmental authority under the provisions of any applicable laws, rules or regulations, including any filings or reports required pursuant to the 34 Act, and in connection with maintaining compliance with all permits, licenses and governmental approvals necessary or desirable for the conduct of Service Recipient's business.

**8.**  **<u>Corporate Finance Services</u>** 

Parent shall provide finance management services, including relating to corporate strategy development, mergers, acquisitions, joint ventures, and other business combination facilitation.

Parent shall provide planning and analysis services, including corporate monthly reporting, forecasting and budgeting; facilitation of capital initiatives; consolidated financials, forecasts and budgets; technical accounting support and external audit facilitation; allocations.

**9. <u>Administrative Support</u>**

Parent shall provide administrative services, including relating to managing human resources activities, external legal support and information technology support.

**<u>Schedule B</u>**

**Officers and Other Employees**

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| | |
|:---|:---|
| **Name** | **Title** |
| Cuong Do | President and Chief Executive Officer |
| Joanne Wendy Kim | SVP, Chief Financial Officer, Secretary & Treasurer |
| Dr. Joseph Palumbo | EVP, Chief Medical Officer |
| David Morse | SVP, Chief Regulatory Officer |
| Penelope Markham | SVP, Liver Disease Programs and Strategic Initiatives |
| Clarence Ahlem | SVP, Operations - CMC Head of Parkinson Program |
| Joe Djan | VP, Clinical Operations |
| Flynn Eldred | VP, Head of Quality |
| Arvind Patel | Quality Assurance Documentation and Training Manager |
| Sujin Yim | Chief of Staff |

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