Converted by FileMerlin

As Filed With The U.S. Securities & Exchange Commission On August 18, 2005


Registration No. 333-


SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


FORM S-1

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933


HEPALIFE TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)


Florida

(State or other jurisdiction of

incorporation or organization)


3841

(Primary Standard Industrial

Classification Code Number)


58-2349413

(I.R.S. Employer Identification No.)


1628 West 1st Avenue, Suite 216,

Vancouver, British Columbia,  V6J 1G1

Telephone: (800) 518-4879

Facsimile: (604) 659-5029

(Address and telephone of registrant's executive office)


Mr. Harmel Rayat

1628 West 1st Avenue, Suite 216,

Vancouver, British Columbia,  V6J 1G1

Telephone: (800) 518-4879

Facsimile: (604) 659-5029

(Name, address and telephone number of agent for service)



Copies To:

Joseph Sierchio, Esq.

Sierchio Greco & Greco, LLP

720 Fifth Avenue

New York, New York 10019

Telephone: (212) 246-3030

Facsimile: (212) 246-2225


Approximate date of commencement of proposed sale to the public:  As soon as practicable after this registration statement becomes 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, please check the following box.   [X]


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


     

If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box.


CALCULATION OF REGISTRATION FEE


Title Of Each Class

Of Securities To Be Registered


Amount

To Be Registered

Proposed Maximum

Offering Price

Per Share(1)

Proposed Maximum

Aggregate

Offering Price (1)

Amount

Of Registration

Fee (2)

Common stock, par value $0.001per share (1)

 

10,711,598

$1.70

$18,209,717

$2,144

TOTAL (3)

 

10,711,598

$1.70

$18,209,717

$2,144


1.

Estimated solely for the purpose of computing the registration fee pursuant to Rule 457(c) under the Securities Act of 1933; the closing sale price of the registrant’s stock on August 12, 2005, as quoted on the National Association of Securities Dealers, Inc.’s Over the Counter Bulletin Board was $1.70. It is not known how many shares will be purchased under this registration statement or at what price shares will be purchased.


2.

These shares consist of the following: (i) 711,598 issued and outstanding shares issued to Fusion Capital Fund II, LLC; and (ii) 10,000,000 shares issuable to Fusion Capital Fund II, LLC in connection with the common stock purchase agreement.


3. The selling stockholder is offering all of the  10,711,598 share registered pursuant to this registration statement registered pursuant to this registration statement. Accordingly, this registration statement includes an indeterminate number of additional shares of common stock issuable for no additional consideration pursuant to the anti-dilution provisions of such warrants and by reason of any stock dividend, stock split, recapitalization or other similar transaction effected without the receipt of consideration, which results in an increase in the number of outstanding shares of our common stock. In the event of a stock split, stock dividend or similar transaction involving our common stock, in order to prevent dilution, the number of shares registered shall be automatically increased to cover the additional shares in accordance with Rule 416(a) under the Securities Act of 1933.



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 this Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

#






Subject to Completion, Dated August 18, 2005


The information in this 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 prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any state where the offer or sales is not permitted.


PROSPECTUS


Hepalife Technologies, Inc.


 10,711,598 Shares of Common Stock


This prospectus relates to the sale of up to 10,711,598 shares of our common stock by Fusion Capital Fund II, LLC.  


The prices at which Fusion Capital may sell its shares will be determined by the prevailing market price for the shares or in negotiated transactions. We will not receive proceeds from the sale of our shares by Fusion Capital.


Our common stock is quoted on the NASD’s Over-The-Counter Bulletin Board under the symbol “HPLF.”  On August 12, 2005, the closing sale price for our common stock as reported on the Over-the-Counter Bulletin Board, was $1.70 per share.


Investing in the common stock involves certain risks. See "Risk Factors" beginning on page 6 for a discussion of these risks.


Fusion Capital is an “underwriter” within the meaning of the Securities Act of 1933, as amended.


______________________


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.


______________________


The date of this prospectus _______, 2005










TABLE OF CONTENTS


PAGE

PROSPECTUS SUMMARY

3

RISK FACTORS

6

FORWARD-LOOKING STATEMENTS

18

MARKET FOR OUR COMMON STOCK

19

DIVIDEND POLICY

20

SELECTED CONSOLIDATED FINANCIAL INFORMATION

20

SUPPLEMENTARY FINANCIAL INFORMATION

22

USE OF PROCEEDS

23

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL

AND RESULTS OF OPERATIONS

23

BUSINESS

31

MANAGEMENT

42

THE FUSION CAPITAL TRANSACTION

52

PRINCIPAL STOCKHOLDERS

57

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

58

SELLING STOCKHOLDER

59

PLAN OF DISTRIBUTION

60

DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION

FOR SECURITIES ACT LIABILITIES

61

SHARES ELIGIBLE FOR RESALE

62

DESCRIPTION OF CAPITAL STOCK

63

EXPERTS

67

LEGAL MATTERS

67

AVAILABLE INFORMATION

67

FINANCIAL STATEMENTS

F-1


You should rely only on the information contained in this prospectus or any supplement hereto. We have not, and the selling stockholder has not, authorized anyone to provide you with different information. If anyone provides you with different information you should not rely on it. We are not, and the selling stockholder is not, making an offer to sell the common stock in any jurisdiction where the offer is not permitted. You should not assume that the information contained in this prospectus is accurate as of any date other than the date on the front cover of this prospectus or any supplement hereto, regardless of the date of delivery of this prospectus or any supplement hereto, or the sale of common stock. Our business, financial condition, results of operations and prospects may have changed since that date.


We obtained statistical data and certain other industry information and forecasts fused throughout this prospectus from market research, publicly available information and industry publications.  Industry publications generally state that they obtain their information from sources that they believe to be reliable, but they do not guarantee the accuracy and completeness of the information.  Similarly, while we believe that the statistical and industry data and forecasts and market research used herein are reliable, we have not independently verified such data.  We have not sought the consent of the sources to refer to their reports or articles in this prospectus.


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PROSPECTUS SUMMARY


This summary contains material information, about us and the offering, which is described in detail elsewhere in the prospectus.  Since it may not include all of the information you may consider important or relevant to your investment decision, you should read the entire prospectus carefully, including the more detailed information regarding our company, the risks of purchasing our common stock discussed under "Risk Factors" on page 6, and our financial statements and the accompanying notes.


Unless the context otherwise requires, the terms “we,” “our,” “us,” the “Company,” and “Hepalife” refer to Hepalife Technologies, Inc., a Florida and not to the selling stockholder.


Business


We are a Florida corporation, formed in 1997 under the name Zeta Corporation. We changed our name on April 17, 2003, to more accurately reflect our business.  We are authorized to issue up to 300,000,000 shares of common stock (of which 70,044,420 were issued and outstanding on July 12, 2005) and 1,000,000 shares of preferred stock (none of which has been issued).


Our principal executive offices are located at 1628 W. 1st Avenue, Suite 216, Vancouver, British Columbia V6J 1G1.  Our telephone number is 800-518-4879.  The address of our website is www.hepalife.com.  Information on our website is not part of this prospectus.


We are an early stage, research and development based biotechnology company focused on the identification, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease. Currently, we are concentrating our research and development efforts on developing an artificial liver device and in-vitro toxicology and pre-clinical drug testing platforms. Our sponsored research is being conducted pursuant to a Cooperative Research and Development Agreement (“CRADA”) with the United States Department of Agriculture’s (the “USDA”) Agricultural Research Service.


We currently do not have, and may never develop, any commercialized products.  We have not generated any revenue from our current operations and do not expect to do so for the foreseeable future.  On June 30, 2005, we had a cumulative deficit of $4,716,883.

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Artificial Liver Device


We are working towards optimizing the hepatic functionality of a porcine cell line, which we refer to as the “PICM-19 Cell Line.” The PICM-19 Cell Line was developed and patented by USDA’s Agricultural Research Service scientists.  The hepatic characteristics of the PICM-19 Cell Line have been demonstrated to have potential application in the production of an artificial liver device, which application was also developed and patented by USDA’s Agricultural Research Service scientists for potential use by human patients with liver failure.


In-Vitro Toxicology Testing


The PICM-19 Cell Line, grown in vitro, can synthesize liver specific proteins such as albumin and transferrin and display enhanced liver-specific functions, such as ureagenesis (conversion of ammonia to urea) and cytochrome P450 activity. The P-450 enzyme systems are key components in the overall hepatic detoxification pathway of drugs and other xenobiotics (toxic foreign chemicals which can be both man-made and natural chemicals, such as pesticides and pollutants). Likewise, ureagenesis is another important hepatic function since urea production is required for the detoxification of ammonia derived from the catabolism (breakdown of complex organic molecules into simpler components) of a number of nitrogen containing compounds. As a result, we believe the PICM-19 Cell Line could be an important element in developing in vitro toxicological and pre-clinical drug testing platforms that could more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.


The Offering


On July 8, 2005, we entered into a common stock purchase agreement with Fusion Capital Fund II, LLC, pursuant to which Fusion Capital has agreed, under certain conditions, to purchase on each trading day $25,000 of our common stock up to an aggregate of  $15.0 million over a 25 month period, subject to earlier termination at our discretion.  In our discretion, we may elect to sell more of our common stock to Fusion Capital than the minimum daily amount.  The purchase price of the shares of common stock will be equal to a price based upon the future market price of the common stock without any fixed discount to the market price.  Fusion Capital does not have the right or the obligation to purchase shares of our common stock in the event that the price of our common stock is less than $0.75.


Fusion Capital is offering for sale up to 10,711,598 shares of our common stock.

4


In connection with our entering into the stock purchase agreement, we authorized the sale to Fusion Capital of up to 10,000,000 shares of our common stock for up to  maximum proceeds of $15.0 million.  Assuming Fusion Capital purchases all $15.0 million of our common stock, we estimate that the maximum number of shares we will sell to Fusion Capital under the common stock purchase agreement will be 10,000,000 shares (exclusive of the 691,598 shares issued to Fusion Capital as the commitment fee and the 20,000 shares issued to Fusion Capital upon signing of a term sheet dated as of June 28, 2005).  Subject to approval by our board of directors, we have the right but not the obligation to sell more than 10,000,000 shares to Fusion Capital.  In the event we elect to sell more than the 10,000,000 shares, we will be required to file a new registration statement and have it declared effective by the U.S. Securities & Exchange Commission.  The number of shares ultimately offered for sale by Fusion Capital is dependent upon the number of shares purchased by Fusion Capital under the common stock purchase agreement.  


As of July 12, 2005, there were 70,044,420 shares outstanding. Included in our issued and outstanding shares are the 691,598 shares that we have issued to Fusion Capital as compensation for its purchase commitment and the 20,000 shares issued to Fusion Capital upon signing of the term sheet relating to the Fusion Capital transaction. Excluded from our issued and outstanding are the 10,000,000 shares offered by Fusion Capital pursuant to this prospectus, which it has not yet purchased from us. If all of shares offered by this prospectus were issued and outstanding as of the date hereof, the number of shares offered by this prospectus would represent approximately 13.6% of the total common stock outstanding as of July 12, 2005

5










RISK FACTORS


You should carefully consider the risks described below before purchasing shares of our common stock.  Our most significant risks and uncertainties are described below; however, they are not the only risks we face.  If any of the following risks actually occur, our business, financial condition, or results or operations could be materially adversely affected, the trading of our common stock could decline, and you may lose all or part of your investment therein.  You should acquire shares of our common stock only if you can afford to lose your entire investment.


RISKS ASSOCIATED WITH OUR BUSINESS


We Have Experienced Significant Losses And Expect Losses To Continue For The Foreseeable Future.


We have yet to establish any history of profitable operations.  We have incurred annual operating losses of $1,435,613, $1,102,723 and $375,472, respectively, during the past three fiscal years of operation.  As a result, at December 31, 2004, we had an accumulated deficit of $3,747,771.  We had an accumulated deficit of $4,716,883 at June 30, 2005. We had no revenues during the last five fiscal years and we do not expect to generate  revenues from our operations for the foreseeable future. Our profitability will require the successful completion of our research, development efforts and the subsequent commercialization of our products, if any, derived from our research and development activities regarding artificial liver device and in vitro toxicology testing methodologies.  No assurances can be given when this will occur or that we will ever be profitable.


We Currently Do Not Have, And May Never Develop, Any Commercialized Products.


We currently do not have any commercialized products or any significant source of revenue. We have invested substantially all of our time and resources over the last three years in identification, research and development of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease. The technologies, which are the subject of our ongoing research programs, will require additional development, clinical evaluation, regulatory approval, significant marketing efforts and substantial additional investment before they can provide us with any revenue. Our efforts may not lead to commercially successful products for a number of reasons, including:


-  we may not be able to obtain regulatory approvals or the approved indication may be narrower than we seek;

-  our technologies or products, if any, derived from our research and development efforts may not prove to be safe and effective in clinical trials;

-  physicians may not receive any reimbursement from third-party payors, or the level of reimbursement may be insufficient to support widespread adoption of any products derived from our research and development efforts;

-  any products that may be approved may not be accepted in the marketplace by physicians or patients;

-  we may not have adequate financial or other resources to complete the development and commercialization of products derived from our research and development efforts;

-  we may not be able to manufacture our products in commercial quantities or at an acceptable cost; and

-  rapid technological change may make our technologies and products derived from those technologies obsolete.

6


We Will Require Additional Financing To Sustain Our Operations And Without It We Will Not Be Able To Continue Operations.


Our independent auditors have added an explanatory paragraph to their audit opinion issued in connection with the financial statements for the years ended December 31, 2004 and 2003, relative to our ability to continue as a going concern. Our ability to obtain additional funding will determine our ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.


At June 30, 2005, we had a working capital deficit of $910,909. We have an operating cash flow deficit of $969,112 for the six months ended June 30, 2005, and have sustained operating cash flow deficits of $1,364,209 in 2004, $1,022,501 in 2003 and $108,129 in 2002. Although we believe that we have sufficient financial resources and commitments to sustain our current level of research and development activities through the end of 2005, any expansion, acceleration or continuation (beyond 2005) of such activities will require additional capital which may not be available to us, if at all, on terms and conditions that we find acceptable.


We only have the right to receive $25,000 per trading day under the agreement with Fusion Capital, unless our stock price equals or exceeds $2.00, in which case the daily amount may be increased under certain conditions as the price of our common stock increases.  Fusion Capital shall not have the right or the obligation to purchase any shares of our common stock on any trading days that the market price of our common stock is less than $0.75.  Since we initially registered 10,000,000 shares for sale by Fusion Capital pursuant to this prospectus, the selling price of our common stock to Fusion Capital will have to average at least $1.50 per share for us to receive the maximum proceeds of $15.0 million without registering additional shares of common stock.  Assuming a purchase price of $1.70 per share (the closing sale price of the common stock on August 10, 2005) and the purchase by Fusion Capital of 8,823,529 shares under the common stock purchase agreement, proceeds to us would be $15,000,000.  Subject to approval by our board of directors, we have the right but not the obligation to issue more than 10,000,000 shares to Fusion Capital.  In the event we elect to issue more than 10,000,000 shares offered hereby, we will be required to file a new registration statement and have it declared effective by the U.S. Securities & Exchange Commission.


Specifically, Fusion Capital does not have the right or the obligation to purchase any shares of our common stock on any trading days that the market price of our common stock is less than 0.75. If obtaining sufficient financing from Fusion Capital were to prove unavailable or prohibitively dilutive and if we are unable to develop and commercialize any products on the basis of our research and development program, we will need to secure another source of funding in order to satisfy our working capital needs. Even if we are able to access the full $15.0 million under the common stock purchase agreement with Fusion Capital, we may still need additional capital to fully implement our business, operating and development plans. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences would be a material adverse effect on our business, operating results, financial condition and prospects.

7


The extent we rely on Fusion Capital as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources, including other debt and equity financings.


The Success Of Our Research And Development Program Is Uncertain And We Expect To Be Engaged In Research And Development Efforts For A Considerable Period Of Time Before We Will Be In A Position, If Ever, To Develop And Commercialize Products Derived From Our Research Program.

 

We expect to continue our current research and development program through at least 2007. Research and development activities, by their nature, preclude definitive statements as to the time required and costs involved in reaching certain objectives. Actual costs may exceed the amounts we have budgeted and actual time may exceed our expectations. If our research and development requires more funding or time than we anticipate, then we may have to reduce technological development efforts or seek additional financing. There can be no assurance that we will be able to secure any necessary additional financing or that such financing would be available to us on favorable terms. Additional financings could result in substantial dilution to existing stockholders. Even if we are able to fully fund our research and development program, there is no assurance, that even upon successful completion of our program, that we will ever be able to commercialize products if any, derived from our research efforts or that we will be able to generate any revenues from operations.  


Our Research and Development Program Is In The Preliminary Development Stage And The Results We Attain May Not Prove To Be Adequate For Purposes of Developing and Commercializing Any Products Or Otherwise To Support A Profitable Business Venture.

 

Our research and development program is the preliminary development stage.  Our program is targeting specifically in vitro toxicology and drug testing platforms and the development of an artificial liver device. We will require significant further research, development, testing and regulatory approvals and significant additional investment before we will be in a position to attempt to commercialize products derived from our research and development program.


There can be no assurances that our early stage research will be successful. The ultimate results of our ongoing research program may demonstrate that the technologies being research by us may be ineffective, unsafe or unlikely to receive necessary regulatory approvals, if ever. If such results are obtained, we will be unable to create marketable products or generate revenues and we may have to cease operations.

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We have not submitted any products or any technologies that are the subject of, or result from, our research and development activities for regulatory approval or clearance. Even if our research is successful, the process of obtaining necessary U.S. Food and Drug Administration (“FDA”) approvals or clearances can take years and is expensive and full of uncertainties. Additionally, approved products are subject to continuing FDA requirements relating to quality control and quality assurance, maintenance of records, reporting of adverse events and product recalls, documentation, labeling and promotion of medical products. Compliance with such continued regulatory oversight may prove to be costly and may limit our ability to attain profitable operations.  


We May Not Be Granted An Exclusive License Under Our CRADA With The USDA’s Agricultural Research Service.  


We are a party to a CRADA with the USDA’s Agricultural Research Service which grants us an option to negotiate an exclusive license to any invention or other intellectual property conceived or reduced to practice under the Agreement which is patentable or otherwise protectable under Title 35 of the United States Code or under the patent laws of a foreign country. There can be no assurance that such a license will be granted to us or that we can obtain a license on terms favorable to us. If we do not obtain an exclusive license, our ability to generate revenue would be materially adversely affected.


We expect to enter into additional research agreements and licenses in the future that relate to important technologies that may be necessary for the development and commercialization of related and unrelated products. These agreements and licenses may impose various commercialization, indemnification, royalty, insurance and other obligations on us, which, if we fail to comply may result in the termination of these agreements and licenses or make the agreements and licenses non-exclusive, which could affect our ability to exploit important technologies that are required for successful development of products, if any, derived from our ongoing research and development programs.


Our CRADA With The USDA’s Agricultural Research Service May Be Terminated By Either Party At Any Time By Giving Written Notice Of Not Less Than Sixty Calendar Days Prior To The Desired Termination Date.


Our current research and development program is based entirely on our CRADA with the USDA’s Agricultural Research Service.  The CRADA provides that it may be terminated unilaterally by either us or the USDA’s Agricultural Research Service upon written notice of not less than sixty calendar days prior to the desired termination date.  This means that the USDA’s Agricultural Research Service could terminate the CRADA even if we are not in default under the terms of the Agreement.  If the USDA’s Agricultural Research Service were to do so our business and future prospects would be materially adversely affected.


We Will Not Directly Conduct Any Of Our Research And Development Activities And Therefore We Will Have Minimal Control Over Such Research.


We rely primarily on the USDA’s Agricultural Research Service to conduct, monitor and assess our research.  We will have no control over the specifics of and possible direction that the research may take.  Accordingly, there can be no assurance that the USDA’s Agricultural Research Service will conduct our research in a manner that will lead to the commercial development of any products.

9


We are also dependent upon the services of certain key scientific personnel who are not employed by us, including the principal investigators with respect to our on going research regarding both treatment of liver disease (and related conditions), including the development of an artificial liver device, and in vitro toxicology testing technologies. The loss of these services could have a materially adverse effect on us, unless qualified replacements could be found. We have no control over whether our principal investigators or other scientific personnel will choose to remain involved with our projects. Since these individuals are not bound by contract to us nor employed by us directly, they might move on to other research or positions.


We Are Subject To Substantial Government Regulation Which Could Materially Adversely Affect Our Business.


We have yet to develop any products for submission for regulatory approval. If any such products are submitted for approval, they must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process before they can be marketed. This process makes it longer, harder and more costly to bring any products to market; moreover, we cannot guarantee that approval will be granted. The pre-marketing approval process can be particularly expensive, uncertain and lengthy. Many products for which FDA have never been approved for marketing. In addition to testing and approval procedures, extensive regulations also govern marketing, manufacturing, distribution, labeling and record-keeping procedures. If we do not comply with applicable regulatory requirements, such violations could result in warning letters, non-approval, suspensions of regulatory approvals, civil penalties and criminal fines, product seizures and recalls, operating restrictions, injunctions and criminal prosecution.

 

Delays in, or rejection of, FDA or other government entity approval may also adversely affect our business. Such delays or rejection may be encountered due to, among other reasons, government or regulatory delays, lack of efficacy during clinical trials, unforeseen safety issues, slower than expected rate of patient recruitment for clinical trials, inability to follow patients after treatment in clinical trials, inconsistencies between early clinical trial results and results obtained in later clinical trials, varying interpretations of data generated by clinical trials, or changes in regulatory policy during the period of product development in the United States. In the United States more stringent FDA oversight in product clearance and enforcement activities could result in our experiencing longer approval cycles, more uncertainty, greater risk and significantly higher expenses. Even if regulatory approval for any product is granted, this approval may entail limitations on uses for which any such product may be labeled and promoted. It is possible, for example, that we may not receive FDA approval to market products based on our research and development efforts for broader or different applications or to market updated products that represent extensions of any such product. In addition, we may not receive FDA approval to export any such product in the future, and countries to which products are to be exported may not approve them for import.

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Any manufacturing facilities would also be subject to continual review and inspection. The FDA has stated publicly that compliance with manufacturing regulations will be scrutinized more strictly. A governmental authority may challenge our compliance with applicable federal, state and foreign regulations. In addition, any discovery of previously unknown problems with any of our research and development efforts or products derived from such research and development, or facilities may result in marketing, sales and manufacturing restrictions, being imposed, as well as possible enforcement actions.

 

From time to time, legislative or regulatory proposals are introduced that could alter the review and approval process relating to our research and development programs and products, if any, derived from such research. It is possible that the FDA will issue additional regulations further restricting the sale of our products, if any, derived from our research and development efforts. Any change in legislation or regulations that govern the review and approval process relating to could make it more difficult and costly to obtain approval, or to produce, market, and distribute such products, if any, derived from our research and development efforts, even if approved. 


We May Be Required To Comply With Rules Regarding Animal Testing and This May Limit the Success of Our Research and Development Program.


Our research and development efforts involve laboratory animals. We may be adversely affected by changes in laws, regulations or accepted procedures applicable to animal testing or by social pressures that would restrict the use of animals in testing or by actions against our collaborators or us by groups or individuals opposed to such testing.


Our Research and Development Program Uses Cells Derived From Pigs, Which Could Prevent The FDA Or Other Health Regulatory Agencies From Approving Products, If Any, Derived From Our Research and Development Efforts.


Because pigs carry genetic material of the porcine endogenous retrovirus (“PERV”), our use of cells derived from pigs carries a risk of transmitting viruses harmless to pigs, but deadly to humans. This may result in the FDA or other health regulatory agencies not approving products, if any, derived from our research and development efforts or subsequently banning any further use of any such products should health concerns arise after any such product was approved. At this time, it is unclear whether we will be able to obtain clinical and product liability insurance that covers the PERV risk.

11


We May Be Liable For Contamination Or Other Harm Caused By Materials That We Handle, And Changes In Environmental Regulations Could Cause Us To Incur Additional Expense.


Our research and development programs do not generally involve the handling of potentially harmful biological materials or hazardous materials, but they may occasionally do so. The USDA’s Agricultural Research Service and we are subject to federal, state and local laws and regulations governing the use, handling, storage and disposal of hazardous and biological materials. If violations of environmental, health and safety laws occur, we could be held liable for damages, penalties and costs of remedial actions. These expenses or this liability could have a significant negative impact on our business, financial condition and results of operations. We may violate environmental, health and safety laws in the future as a result of human error, equipment failure or other causes. Environmental laws could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We may be subject to potentially conflicting and changing regulatory agendas of political, business and environmental groups. Changes to or restrictions on permitting requirements or processes, hazardous or biological material storage or handling might require an unplanned capital investment or relocation. Failure to comply with new or existing laws or regulations could harm our business, financial condition and results of operations.


Even If We Were To Secure Regulatory Approval In The Future For Any Product Derived From Our Ongoing Research Efforts, We Lack Sales and Marketing Experience and Will Likely Rely On Third Parties For Such Services.


Our ability to achieve profitability is dependent in part on ultimately obtaining regulatory approvals for products, if any, which are derived from our research and development efforts, and then entering into agreements for the commercialization of any such products. There can be no assurance that such regulatory approvals will be obtained or such agreements will be entered into. The failure to obtain any such necessary regulatory approvals or to enter into any such necessary agreements could delay or prevent us from achieving profitability and would have a material adverse effect on the business, financial position and results of our operations. Further, there can be no assurance that our operations will become profitable even if products, if any, which are derived from our research and development efforts, are commercialized.


If FDA and other approvals are ultimately obtained with respect to any product submitted by us in the future for approval, we expect to market and sell any such product through distribution, co-marketing, co-promotion or sublicensing arrangements with third parties. We have no experience in sales, marketing or distribution of biotechnology products and our current management and staff is not trained in these areas. To date, we have no such agreements. To the extent that we enter into distribution, co-marketing, co-promotion or sublicensing arrangements for the marketing and sale of any such products, any revenues received by us will be dependent on the efforts of third parties. If any of such parties were to breach or terminate their agreement with us or otherwise fail to conduct marketing activities successfully, and in a timely manner, the commercialization of products, if any, derived from our research and development efforts would be delayed or terminated.

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We May Not Be Able To Attract And Retain Qualified Personnel Either As Employees Or As Consultants And, Without Such Personnel, We May Not Be Successful In Commercializing The Results Of Our Ongoing Research And Development Efforts.


Competition for qualified employees among companies in the biotechnology industry is intense. Our future success depends upon our ability to attract, retain and motivate highly skilled employees. Our present management has no clinical or other experience in the development of biotechnology products. Attracting desirable employees will require us to offer competitive compensation packages, including stock options. In order to successfully commercialize the results of our ongoing research and development efforts or products, if any, derived from our research program, we must substantially expand our personnel, particularly in the areas of clinical trial management, regulatory affairs, business development and marketing. There can be no assurance that we will be successful in hiring or retaining qualified personnel. Managing the integration of new personnel and our growth generally could pose significant risks to our development and progress. The addition of such personnel may result in significant changes in our utilization of cash resources and our development schedule.


We Expect To Operate In A Highly Competitive Market, We May Face Competition From Large, Well-Established Companies With Significant Resources, And We May Not Be Able To Compete Effectively.

 

Our commercial success will depend on our ability and the ability of our sublicensees, if any, to compete effectively in product development areas such as, but not limited to, safety, efficacy, ease of use, patient or customer compliance, price, and marketing and distribution. There can be no assurance that competitors will not succeed in developing products that are more effective than any products derived from our research and development efforts or that would render such products obsolete and non-competitive.


The biotechnology industry is characterized by intense competition, rapid product development and technological change. Most of the competition that we encounter will come from companies, research institutions and universities who are researching and developing technologies and potential products similar to or competitive with our own.


These companies enjoy numerous competitive advantages over us, including:


-  significantly greater name recognition;

-  established relations with healthcare professionals, customers and third-party payors;

-  established distribution networks;

-  additional lines of products, and the ability to offer rebates, higher discounts or incentives to gain a competitive advantage;

-  greater experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products, and marketing approved products; and

-  greater financial and human resources for product development, sales and marketing, and patent litigation.


As a result, we may not be able to compete effectively against these companies or their products.

13


We May Become Subject To Claims Of Infringement Or Misappropriation Of The Intellectual Property Rights Of Others, Which Could Prohibit Us From Commercializing Products Based On Our Research And Development Program, Require Us To Obtain Licenses From Third Parties Or To Develop Non-Infringing Alternatives, And Subject Us To Substantial Monetary Damages And Injunctive Relief.


We do not have any patents regarding any of our research and development activities. We may not be able to assert any rights, under our CRADA, to any patents held by the USDA’s Agriculture Research Service. Third parties could, in the future, assert infringement or misappropriation claims against us with respect to our current research and development program or future products, if any, derived from our research and development program. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Therefore, we cannot be certain that we have not infringed the intellectual property rights of such third parties.


Any infringement or misappropriation claim could cause us to incur significant costs, could place significant strain on our financial resources, divert management’s attention from our business and harm our reputation. If the relevant patents were upheld as valid and enforceable and we were found to infringe, we could be prohibited from continuing our research and development activities and from marketing or selling products, if any, derived from our research and development efforts unless we could obtain licenses to use the technology covered by the patent or are able to design around the patent. We may be unable to obtain a license on terms acceptable to us, if at all, and we may not be able to commercialize any products. A court could also order us to pay compensatory damages for such infringement, plus prejudgment interest and could, in addition, treble the compensatory damages and award attorney fees. These damages could be substantial and could harm our reputation, business, financial condition and operating results. Depending on the nature of the relief ordered by the court, we could become liable for additional damages to third parties.


We May Be Exposed To Product Liability Claims For Which We Do Not Have Any Insurance Coverage

 

Because we are researching and developing and will be testing new technologies, and in the future may be involved either directly or indirectly in the manufacturing and distribution of products, if any, derived from our research and development efforts, we may be exposed to the financial risk of liability claims in the event that the use of any such product results in personal injury, misdiagnosis or death. We may be subject to claims against us even if the apparent injury is due to the actions of others. There can be no assurance that we will not experience losses due to product liability claims in the future, or that adequate insurance will be available in sufficient amounts, at an acceptable cost, or at all. A product liability claim, product recall or other claim, or claims for uninsured liabilities or in excess of insured liabilities, may have a material adverse effect on our business, financial condition and results of operations. These liabilities could prevent or interfere with our product commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert management attention and might result in adverse publicity, which could result in the withdrawal of, or inability to recruit, clinical trial volunteers, or result in reduced acceptance of products derived from our research and development activities in the market.

14


We do not currently carry any insurance. If a claim against us results in a large monetary judgment, which we cannot pay, we may have to cease operations.


Failure To Obtain Third Party Reimbursement For Products Derived From Our Research and Development Efforts Could Limit Our Revenue.

 

In the United States, success in obtaining payment for a new product from third parties, such as insurers, depends greatly on the ability to present data which demonstrates positive outcomes and reduced utilization of other products or services, as well as cost data which shows that treatment costs using the new product are equal to or less than what is currently covered for other products. If we are unable to obtain favorable third party reimbursement and patients are unwilling or unable to pay for such products or services out-of-pocket, it could limit our revenue and harm our business.


Mr. Harmel S. Rayat, Our President, Chief Executive Officer, Chief Financial Officer, Principal Accounting Officer And  Director, Is Able To Substantially Influence All Matters Requiring Approval By Our Stockholders, Including The Election Of Directors.


     

As of July 12, 2005, Mr. Rayat beneficially owned approximately 79% of our outstanding common stock. Even if all of these shares offered hereby are sold, Mr. Rayat would still own approximately 67% of our then issued and outstanding shares. Accordingly, he is able to substantially influence virtually all matters requiring approval by our stockholders, including the election of directors. Our Articles of Incorporation do not provide for cumulative voting in the election of directors and, therefore, although they are able to vote, our other stockholders should not expect to be able to elect any directors to our board of directors.


We Rely On Our Management, The Loss Of Whose Services Could Have A Material Adverse Affect On Our Business.


We rely upon the services of our board of directors and management, in particular those of  Harmel S.Rayat, the loss of which could have a material adverse affect on our business and prospects.  Competition for qualified personnel to serve in a senior management position is intense.  If we are not able to retain our directors and management, or attract other qualified personnel, we may not be able to fully implement our business strategy; failure to do so would have a materially adverse impact on our future prospects.


We currently have no employment agreements with any of our officers and directors imposing any specific condition on our officers and directors regarding their continued employment by us.


Our officers and directors are also officers, directors and employees of other companies, and we may have to compete with such other companies for their time, attention and efforts.  Except for Mr. Rayat, none of our officers and directors is expected to spend  more than approximately five (5%) of his time on our business affairs. Mr. Rayat will not be spending his full time and effort on our business affairs because he is engaged in other business activities. We do not expect Mr. Rayat to spend more than twenty (20%) of his time on our business affairs.  If the demands of Mr. Rayat’s other business activities, from time to time, require more of Mr. Rayat’s time, he may have less time to spend on our business affairs and our operations could suffer as a result.  We do not maintain key man insurance on any of our directors or officers.

15


RISKS ASSOCIATED WITH THE OFFERING


 

The Sale Of Our Common Stock To Fusion Capital May Cause Dilution And The Sale Of The Shares Of Common Stock Acquired By Fusion Capital Could Cause The Price Of Our Common Stock To Decline.

 

The sale of shares pursuant to our common stock purchase agreement with Fusion Capital or any other future equity financing transaction will have a dilutive impact on our stockholders. As a result, our net income or loss per share could decrease in future periods, and the market price of our common stock could decline. In addition, the lower our stock price is, the more shares of common stock we will have to issue under the common stock purchase agreement with Fusion Capital in order to draw down the full amount. If our stock price were lower, then our existing stockholders would experience greater dilution. We cannot predict the actual number of shares of common stock that will be issued pursuant to the agreement with Fusion Capital or any other future equity financing transaction, in part, because the purchase price of the shares will fluctuate based on prevailing market conditions and we do not know the exact amount of funds we will need.


The purchase price for the common stock to be sold to Fusion Capital pursuant to the common stock purchase agreement will fluctuate based on the price of our common stock. All shares in this offering are freely tradable. Fusion Capital may sell none, some or all of the shares of common stock purchased from us at any time. We expect that the shares offered by this prospectus will be sold over a period of up to 25 months from the date of this prospectus. Depending upon market liquidity at the time, a sale of shares under this offering at any given time could cause the trading price of our common stock to decline. The sale of a substantial number of shares of our common stock under this offering, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.


Future Sales Of Our Common Stock May Decrease Our Stock Price.

 

We have previously issued a substantial number of shares of common stock, which are eligible for resale under Rule 144 of the Securities Act. In addition, we have also registered a substantial number of shares of common stock that are issuable upon the exercise of options. If holders of options or warrants choose to exercise their purchase rights and sell shares of common stock in the public market or if the selling stockholders whose shares are being registered pursuant to this prospectus sell or attempt to publicly sell such shares all at once or in a short time period, the prevailing market price for our common stock may decline. Future public sales of shares of common stock may adversely affect the market price of our common stock or our future ability to raise capital by offering equity securities.

16


Our Stock Price Historically Has Been Volatile And May Continue To Be Volatile.

 

The market price of our common stock has been and is expected to continue to be highly volatile. Factors, many of which are beyond our control, include, in addition to other risk factors described in this section, the  announcements of technological innovations by us or other companies, regulatory matters, new or existing products or procedures, concerns about our financial position, operating results, litigation, government regulation, developments or disputes relating to agreements, patents or proprietary rights, and general economic, industry and market conditions may have a significant impact on the market price of our stock. In addition, potential dilutive effects of future sales of shares of common stock by our stockholders and by us, including Fusion Capital pursuant to this prospectus and subsequent sale of common stock by the holders of warrants and options could have an adverse effect on the market price of our shares.

 

Volatility in the market price for particular companies has often been unrelated or disproportionate to the operating performance of those companies. Broad market factors may seriously harm the market price of our common stock, regardless of our operating performance. In addition, securities class action litigation has often been initiated following periods of volatility in the market price of a company's securities. A securities class action suit against us could result in substantial costs, potential liabilities, and the diversion of management's attention and resources. To the extent our stock price fluctuates and/or remains low, it could cause you to lose some or all of your investment and impair our ability to raise capital through the offering of additional equity securities.

 

Our Common Is A "Penny Stock" And Because "Penny Stock” Rules Will Apply, You May Find It Difficult To Sell The Shares Of Our Common Stock You Acquired In This Offering.


Our common stock is a “penny stock” as that term is defined under Rule 3a51-1 of the Securities Exchange Act of 1934. Generally, a "penny stock" is a common stock that is not listed on a securities exchange and trades for less than $5.00 a share. Prices often are not available to buyers and sellers and the market may be very limited. Penny stocks in start-up companies are among the riskiest equity investments. Broker-dealers who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the U.S. Securities & Exchange Commission. The document provides information about penny stocks and the nature and level of risks involved in investing in the penny stock market. A broker must also give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation, make a written determination that the penny stock is a suitable investment for the purchaser, and obtain the purchaser's written agreement to the purchase. Many brokers choose not to participate in penny stock transactions. Because of the penny stock rules, there is less trading activity in penny stock and you are likely to have difficulty selling your shares.

17


We Do Not Intend To Pay Dividends For The Foreseeable Future.


We currently intend to retain future earnings, if any, to support the development and expansion of our business and do not anticipate paying cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our board of directors after taking into account various factors, including but not limited to our financial condition, operating results, cash needs, growth plans and the terms of any credit agreements that we may be a party to at the time. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize their investment. Investors seeking cash dividends should not purchase the units offered by us pursuant to this prospectus.


FORWARD-LOOKING STATEMENTS


This prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended.  Such forward-looking statements include statements regarding, among other things, (a) our projected sales and profitability, (b) our growth strategies, (c) anticipated trends in our industry, (d) our future financing plans, and (e) our anticipated needs for working capital.  Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology.  This information may involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements.  These statements may be found under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” as well as in this prospectus generally.  Actual events or results may differ materially from those discussed in forward-looking statements as a result of various factors, including, without limitation, the risks outlined under “Risk Factors” and matters described in this prospectus generally.  In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur.  In addition to the information expressly required to be included in this filing, we will provide such further material information, if any, as may be necessary to make the required statements, in light of the circumstances under which they are made, not misleading.

18













MARKET FOR OUR COMMON STOCK


Our common stock trades on the Over-the-Counter Bulletin Board under the trading symbol “HPLF.” The quotations shown reflect inter-dealer prices, without retail mark-up, markdown or commission and may not necessarily represent actual transactions. Our high and low bid prices by quarter during fiscal years 2004, 2003 and 2002, and for the first two quarters of 2005, are presented as follows:

     

High

Low

2005


July 1 through July 31, 2005

$2.02

$1.55

Second Quarter 2005

$3.12

$1.80

First Quarter 2005

$4.97

$2.38


2004


Fourth Quarter 2004

$5.80

$2.06

Third Quarter 2004

$2.91

$1.95

Second Quarter 2004

$2.99

$1.47

First Quarter 2004

$3.62

$2.55


2003


Fourth Quarter 2003

$3.59

$1.74

Third Quarter 2003

$2.18

$1.51

Second Quarter 2003

$1.77

$0.44

First Quarter 2003

$0.70

$0.20


2002


Fourth Quarter 2002

$0.22

$0.05

Third Quarter 2002

$0.05

$0.05

Second Quarter 2002

$0.09

$0.06

First Quarter 2002

$0.04

$0.04


On August 12, 2005, the closing price of our common stock as reported on the Over-the-Counter Bulletin Board was $1.70 per share. On July 12, 2005, we had 65 stockholders of record holding our common stock.  Our stockholders have direct electronic access to all of our U.S. Securities & Exchange Commission filings via our website at www.hepalife.com, or via the U.S. Securities & Exchange Commission  website at www.sec.gov.  We send proxy filings to our stockholders as matters are voted on by all of our stockholders. When we do send information to our stockholders that relate to our annual meeting, our annual financial information contains audited information on which an opinion has been issued.

19


Securities Authorized for Issuance Under Equity Compensation Plans



We have reserved an aggregate of 40,000,000 shares of our common stock for issuance pursuant to our 2001 Stock Option Plan. The following table represents the number of shares issuable upon exercise and reserved for future issuance under this plan as of June 30,2005.


Securities Authorized for Issuance Under Equity Compensation Plans



Number of securities

remaining available for

Number of Securities to be

Weighted-average exercise

future issuance under

issued upon exercise of

price of outstanding

equity compensation plans

outstanding options,

options, warrants and

(excluding securities

warrants and rights

rights

reflected in column (a))

Plan Category

(a)

(b)

(c)

____________________________________________________________________________________________________________


Equity compensation plans

approved by security holders

17,133,000

$1.31

20,925,000


Equity compensation plans not

approved by security holders


____________________________________________________________________________________________________________

Total

17,133,000

$1.31

20,925,000



DIVIDEND POLICY


We have never declared or paid dividends on our common stock. Our dividend practices are determined by our board of directors and may be changed from time to time. We will base any issuance of dividends upon our earnings (if any), financial condition, capital requirements, acquisition strategies, and other factors considered important by our board of directors. Florida law and our articles of incorporation do not require our board of directors to declare dividends on our common stock. We expect to retain any earnings generated by our operations for the development and expansion of our business and do not anticipate paying any dividends to our common stockholders for the foreseeable future.



SELECTED FINANCIAL INFORMATION


The following summary statement of operations and summary balance sheet data are derived from our financial statements for the years ended December 31, 2004, 2003, 2002, 2001 and 2000 that were filed with the U.S. Securities & Exchange Commission on our Annual Reports on Form 10-K or Form 10-KSB, as applicable. This information should be read in conjunction with the audited consolidated financial statements and the related notes.

20










FIVE-YEAR STATEMENT OF OPERATIONS



  

Years Ended December 31

Six Months Ended June 30

  

2000

2001

2002

2003

2004

2005

Revenues

 

0

$0

$0

$0

$0

$0

        

General and administrative

       

   Management fees and consulting fees – Related party

 

62,000

144,000

144,600

28,500

9,500

11,051

   Investor Relations

 

-

-

119,500

960,003

1,016,916

679,215

   Other operating expense

 

28,877

21,936

21,823

73,767

259,572

150,223

   Research and Development

 

-

-

91,500

41,400

151,546

130,846

        

Total General and Administrative Expenses

 

90,877

165,936

377,423

1,103,670

1,437,534

971,335

        

Other Income

       

   Interest Income

 

(10,269)

(5,572)

(1,951)

(947)

(1,921)

(2,223)

        

Provision for Income Taxes

 

-

-

-

-

-

-

        

Net Loss Available to Common Stockholders

 

($80,608)

($160,364)

($375,472)

($1,102,723)

($1,435,613)

($969,112)

        

Basic and Diluted Loss Per Common Share

 

($0.002)

($0.004)

($0.007)

($0.019)

($0.020)

($0.014)

        

Weighted Average Common Shares Outstanding

 

41,200,000

45,409,680

52,723,277

57,817,305

64,610,777

67,841,064


21










SUPPLEMENTARY FINANCIAL INFORMATION


Certain quarterly financial information is set forth below.


 


March 31,

2003




June 30,

2003




September 30,

2003




December 31,

2003




Revenues

 

$0

$0

$0

$0

Gross Profit

 

$0

$0

$0

$0

Net Income (Loss)

 

$(13,385)

$(268,425)

$(365,248)

 $(455,665)

Net Income (Loss) Per Share (Basic)

 

$(0.000)

$(0.005)

$(0.006)

$(0.007)


     

 


March 31,

2004




June 30,

2004




September 30,

2004




December 31,

2004




Revenues

 

$0

$0

$0

$0

Gross Profit

 

$0

$0

$0

$0

Net Income (Loss)

 

$(96,164)

 $(142,767)

$(195,246)

$(1,001,436)

Net Income (Loss) Per Share (Basic)

 

$(0.002)

 $(0.002)

$(0.003)

$(0.015)


     

 


March 31,

2005





June 30,

2005




  

Revenues

 

$0

$0

  

Gross Profit

 

$0

$0

  

Net Income (Loss)

 

$(677,015)

$(292,098)

  

Net Income (Loss) Per Share (Basic)

 

$(0.010)

$(0.004)

  


22






#







USE OF PROCEEDS

 

This prospectus relates to shares of our common stock that may be offered and sold from time to time by the selling stockholder. We will receive no proceeds from the sale of shares of common stock in this offering. However, we may receive up to $15.0 million in proceeds from the sale of our common stock to Fusion Capital under the common stock purchase agreement. Any proceeds that we receive from Fusion Capital under the common stock purchase agreement will be used for working capital, loan repayments and general corporate purposes.



MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS


The following discussion and analysis is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, and should be read in conjunction with our financial statements and related notes. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. In addition, the following discussion and analysis contains forward-looking statements that involve risks and uncertainties, including, but not limited to, those discussed in “Risk Factors,” “Forward Looking Statements,” and elsewhere in this prospectus.


Overview 


We are an early stage, research based biotechnology company focused on the identification, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease. Currently, we are concentrating our efforts on developing an artificial liver device and in-vitro toxicology and pre-clinical drug testing platforms. Our sponsored research is being conducted pursuant to our CRADA with the USDA's Agricultural Research Service.


Artificial Liver Device


We are working towards optimizing the hepatic functionality of a porcine cell line, which we refer to as the “PICM-19 Cell Line.” The PICM-19 Cell Line was developed and patented by USDA Agricultural Research Service scientists.  The hepatic characteristics of the PICM-19 Cell Line have been demonstrated to have potential application in the production of an artificial liver device.

23


In-Vitro Toxicology Testing


The PICM-19 Cell Line, grown in vitro, can synthesize liver specific proteins such as albumin and transferrin and display enhanced liver-specific functions, such as ureagenesis (conversion to ammonia to urea) and cytochrome P450 activity. Consequently, we believe the PICM-19 Cell Line could be an important element in developing in vitro toxicological and pre-clinical drug testing platforms that could more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.


Critical Accounting Policies

 

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and related disclosures. We review our estimates on an ongoing basis.


We consider an accounting estimate to be critical if it requires assumptions to be made that were uncertain at the time the estimate was made; and changes in the estimate or different estimates that could have been made could have a material impact on our results of operations or financial condition. While our significant accounting policies are described in more detail in the notes to our financial statements included in this prospectus, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our financial statements.


General and Administrative Expenses


Our general and administrative expenses consist primarily of personnel related costs, legal costs, including intellectual property, investor relations, accounting costs, and other professional and administrative costs.


Research and Development Costs


Most of our operating costs to date have been for research and development activities. Research and development costs represent costs incurred to develop our technology incurred pursuant to our CRADA with the USDA’s Agricultural Research Service and include salaries and benefits for research and development personnel, allocated overhead and facility occupancy costs, contract services and other costs. We charge all research and development expenses to operations as they are incurred. We do not track research and development expenses by project.


Results of Operations


We have yet to establish any history of profitable operations.  We have not generated any revenues from operations during the past 5 years and do not expect to generate any revenues for the foreseeable future. We have incurred annual operating losses of $1,435,613, $1,102,723 and $375,472, respectively, during the past three fiscal years of operation.  As a result, at December 31, 2004, we had an accumulated deficit of $3,747,771.  Our profitability will require the successful completion of our research and development programs, and the subsequent commercialization of the results or of products derived from such research and development efforts.  No assurances can be given when this will occur or that we will ever be profitable.

24


Our independent auditors have added an explanatory paragraph to their audit opinion issued in connection with the financial statements for the years ended December 31, 2004 and 2003, relative to our ability to continue as a going concern. Our ability to obtain additional funding will determine our ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.



SIX MONTHS ended 2005, 2004 and 2003


  

        Six Months Ended June 30

  

2005

2004

2003

Revenues

 

$0

$0

$0

     

General and administrative

    

   Management fees and consulting fees – Related party

 

11,051

-

18,000

   Investor Relations

 

679,215

140,600

-

   Other operating expense

 

150,223

78,511

264,041

   Research and Development

 

130,846

20,700

-

     

Total General and Administrative Expenses

 

971,335

239,811

282,041

     

Other Income

    

   Interest Income

 

(2,223)

(880)

(231)

     

Provision for Income Taxes

 

-

-

-

     

Net Loss Available to Common Stockholders

 

($969,112)

($238,931)

($281,810)

     

Basic and Diluted Loss Per Common Share

 

($0.014)

($0.004)

($0.005)

     

Weighted Average Common Shares Outstanding

 

69,214,041

64,540,832

56,613,332



Six Months Ended June 30, 2005 and 2004


We had no revenues in the six months ended June 30, 2005 and 2004. Our general and administrative expenses increased 305% to $971,335 in the six months ended June 30, 2005, from $239,811 in the same period in 2004. This increase was primarily attributable to an increase of $538,615 in investor relations costs. We also had an increase of $110,146 in our research and development costs to $130,846, representing a 532% over the comparable expenses of $20,700 in 2004.  


Interest income increased 153% to $2,223 in the six months ended June 30, 2005, from $880 during the same period in 2004, reflecting higher average cash balances maintained during most of the quarterly period in 2005.


We incurred net losses of $969,112 and $238,931 during the six months ended June 30, 2005 and 2004, respectively. The increase in our net loss amounting to $730,181 was principally caused by the increase in our investor relations costs and research and development costs during the period.

25


Years Ended December 31, 2004 and 2003


We had no revenues in 2004 and 2003. Our general and administrative expenses increased 21% to $1,285,988 in 2004, from $1,062,270 in the same period in 2003. This increase was primarily attributable to an increase of $56,913 in investor relations costs to $1,016,916, as compared to $960,003 in 2003.


In 2004, we also incurred $151,546 in research and development expenses, an increase of 266%, compared to $41,400 of research and development costs that we incurred in 2003.  These expenses were incurred pursuant to our CRADA with the USDA’s Agricultural Research Service.


Interest income increased 103% to $1,921 in 2004, from $947 during the same period in 2004. This was the result of higher average cash balances maintained during 2004.


Our net loss in 2004 increased 30% to $1,435,613, from $1,102,723 in 2003. The increase in our net loss was principally caused by increased research and development expenses and investor relations costs as noted above.


Our operations in 2004 were funded from a loan in the amount of $275,000 from a related party and $1,391,620 from the proceeds from the sale of our common stock upon exercise of outstanding options and warrants. In addition, at December 31, 2004, we had a net operating loss carry forward for federal income tax purposes of approximately $570,000, which expires at various dates through 2024. The extent of any potential tax benefits to us from the operating loss carry forward is not presently ascertainable.

 

Years Ended December 31, 2003 and 2002


We had no revenues in 2003 and 2002. Our general and administrative expenses increased 272% to $1,062,270 in 2003, from $285,923 in the same period in 2002. This increase was primarily attributable to an increase of $840,503 in investor relations costs to $960,003, as compared to $ 119,500 in 2003.


Interest income decreased 52% to $947 in the year ended December 31, 2003, from $1,951 during the same period in 2002. This was a result of lower average cash balances maintained during 2003.


Our net loss in 2003 increased 194% to $1,102,723, from $375,472 in 2002. The increase in our net loss was principally caused by increased investor relations costs as noted above.


Our operations in 2003 were funded from a loan in the amount of $725,000 from a related party and $581,100 from the proceeds from the sale of our common stock upon exercise of outstanding options.


Liquidity and Capital Resources


Our operating activities use of cash for the twelve months ended December 31, 2004, 2003 and 2002, was $1,364,209, $1,022,501 and $108,129, respectively. Our operating activities use of cash for the six months ended June 30, 2005 and 2004 was $906,946 and $550,438, respectively.

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 Our working capital deficit was $539,779 as of December 31, 2004 and $910,909 as of June 30, 2005. Cash used by operations in the twelve months ended December 31, 2004, resulted primarily from increased research and development expenses and investor relations costs. Cash used by operations in the six months ended June 30, 2005, resulted primarily from our net loss from operations of $969,112, as well an increase in accounts payable of $61,885.

 

We have experienced losses during the last three fiscal years and expect to continue to incur losses for the foreseeable future.  Since inception these losses have amounted to $4,716,883 on a cumulative basis through June 30, 2005. Since we have yet to develop or commercialize any products and, accordingly, have generated no revenues, these losses have been funded primarily from proceeds from the sale of our common stock upon exercise of outstanding options and warrants and loans from our majority stockholder and director, as set forth in the following table.


Financing Source

Year Ending December 31,

Quarter Ending

 

2004

2003

2002

June 30,2005

Loans Incurred

$1,000,000

$725,000

$0

$250,000

Loans Repaid

$725,000

$0

$0

$300,000

Exercise of Options

$1,341,620

$398,600

$0

$260,500

Exercise of Warrants

$50,000

$182,500

$0

$31,250

Total

$1,666,620

$1,306,100

$0

$241,250



Contractual Obligations

     

 

As of December 31, 2004, we had the following contractual commitments (aggregating $654,228), to fund researchers and associated laboratory supplies, pursuant to our CRADA with the USDA's Agricultural Research Service, entered into on November 1, 2002, and amended on May 24, 2004:


Amount

Due Date


$65,422.80

on or before August 1, 2004;

$65,422.80

on or before November 1, 2004;

$65,422.80

on or before February 1, 2005;

$65,422.80

on or before May 1, 2005;

$65,422.80

on or before August 1, 2005;

$65,422.80

on or before November 1, 2005;

$65,422.80

on or before February 1, 2006;

$65,422.80

on or before May 1, 2006;

$65,422.80

on or before August 1, 2006;

$65,422.80

on or before November 1, 2006




As a result of delays incurred in the employment of personnel, we reached an agreement with the USDA’s Agricultural Research Service to modify the foregoing schedule so as to delay the payment of certain installments until funds are actually required.  Consequently, we paid $20,700 in February 2004, $65,423 in December 2004 and $65,423 in June 2005. During the balance of 2005, we expect to make two more payments, each for $65,422.80.     

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Additionally, we had the following loan repayment commitments to Mr. Harmel S. Rayat as at December 31, 2004:


Date of Loan

Amount

Interest Rate

Due Date

Amount to be Repaid


August 27, 2004

$300,000

7.5%

January 26, 2005

$309,432 (1)

March 2, 2005

$700,000

8.5%

September 1, 2006

$759,500

March 8, 2005

$250,000

8.5%

March 8, 2006

$271,250


(1) Repaid on January 26, 2005.


We do not currently have sufficient capital on hand to make the March 8, 2006 and September 2, 2006, loan payments. We have no understanding or agreements with Mr. Rayat regarding an extension of the due dates of these loans. We expect to repay these amounts, on the dates due, from the proceeds, if any, we receive under the common stock purchase agreement with Fusion Capital. If we do not do so, we will need to negotiate an extension of the due dates with Mr. Rayat. There is no assurance that we will be able to do so.


Except for our CRADA commitments and our loan repayment obligations, we have no other material capital expenditures planned during fiscal 2005.


We had cash and cash equivalents of $613,523, $312,201 and $28,602 as of December 31, 2004, 2003 and 2002, respectively.  The cash and cash equivalents as of June 30, 2005 and 2004 were $254,277 and $244,368, respectively.


In addition, pursuant to our common stock purchase agreement with Fusion Capital, we have the right to receive $25,000 per trading day under the agreement with Fusion Capital unless our stock price equals or exceeds $2.00, in which case the daily amount may be increased under certain conditions as the price of our common stock increases.  Fusion Capital shall not have the right nor the obligation to purchase any shares of our common stock on any trading days that the market price of our common stock is less than $0.75.  Since we initially registered 10,000,000 shares for sale by Fusion Capital pursuant to this Prospectus, the selling price of our common stock to Fusion Capital will have to average at least $1.50 per share for us to receive the maximum proceeds of $15.0 million without registering additional shares of common stock.  Assuming a purchase price of $1.70per share (the closing sale price of the common stock on August 10, 2005) and the purchase by Fusion Capital of 8,823,529 shares under the common stock purchase agreement, proceeds to us would be $15,000,000. Subject to approval by our board of directors, we have the right but not the obligation to issue more than 10,000,000 shares to Fusion Capital.  In the event we elect to issue more than 10,000,000 shares offered hereby, we will be required to file a new registration statement and have it declared effective by the U.S. Securities & Exchange Commission.

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Although we believe that we have sufficient cash on hand to satisfy our contractual commitments through 2005, we do not currently have sufficient cash on hand to sustain planned operating activities through 2006.  Our ability to continue as a going concern is substantially dependent upon future levels of funding from our funding sources, including Fusion Capital, which are currently uncertain as to amount and timing.


The extent to which we will rely on Fusion Capital as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources. Specifically, Fusion Capital shall not have the right or the obligation to purchase any shares of our common stock on any trading days that the market price of our common stock is less than $0.75. If obtaining sufficient financing from Fusion Capital were to prove unavailable or prohibitively dilutive and if we are unable to commercialize and sell products, if any, derived from our research and development efforts, we will need to secure another source of funding in order to satisfy our working capital needs. Even if we are able to access the full $15.0 million under the common stock purchase agreement with Fusion Capital, we may still need additional capital to fully implement our business, operating and development plans. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences would be a material adverse effect on our business, operating results, financial condition and prospects.


Related Party Transactions


For a description of our related party transactions, see the “Certain Relationships And Related Transactions” section of this prospectus and the related notes to our financial statements appearing at the end of this prospectus.


Off Balance Sheet Arrangements


We do not currently have, nor have we had, any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts. As such, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.


Qualitative and Quantitative Disclosures About Market Risk


Our exposure to market risk is confined to our cash equivalents and short-term investments. We invest in high-quality financial instruments; primarily money market funds, federal agency notes, and US Treasury obligations, with the effective duration of the portfolio within one year, which we believe, are subject to limited credit risk. We currently do not hedge interest rate exposure. Due to the short-term nature of our investments, we do not believe that we have any material exposure to interest rate risk arising from our investments.

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New Accounting Pronouncements


In December 2004, the Financial Accounting Standards Board (FASB) issued FASB Statement No. 123 (revised 2004), Share-Based Payment (“Statement 123(R)”), a revision of FASB Statement No. 123, Accounting for Stock-Based Compensation. Statement 123(R) supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and amends FASB Statement No. 95, Statement of Cash Flows. Statement 123(R), which we expect to adopt in the first quarter of 2006, is generally similar to Statement 123; however, it will require all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values. Thus, pro forma disclosure will no longer be an alternative to financial statement recognition. We do not believe the adoption of Statement 123(R) will have a material impact on our results of operations or financial position.


On April 14, 2005, the  U.S. Securities & Exchange Commission announced it would permit most registrants, subject to its oversight, additional time to implement the requirements in FASB Statement No. 123 (Revised 2004), Share-Based Payment. As originally issued by the FASB, public companies subject to U.S. Securities & Exchange Commission  oversight were required to implement Statement 123R as of the beginning of the first interim or annual reporting period that begins after June 15, 2005, or after December 15, 2005 for small business issuers.


As announced, the U.S. Securities & Exchange Commission  will permit companies to implement Statement 123R at the beginning of their next fiscal year, instead of the next reporting period as required by Statement 123R. That means a calendar year registrant, which is not a small business issuer, may continue to follow the guidance in FASB Statement No. 123, Accounting for Stock-Based Compensation, throughout 2005 and implement the new rules reflected in Statement 123R beginning January 1, 2006. The U.S. Securities & Exchange Commission  notes that if a company has a fiscal year that ends on June 30, 2005 and is not a small business issuer, it must still comply with Statement 123R beginning with its quarter beginning on July 1, 2005. In other words, such companies must comply with Statement 123R as originally issued by the FASB.


The U.S. Securities & Exchange Commission  announcement notes that it is not changing any of the accounting requirements in Statement 123R, rather only the required compliance date for certain registrants.


We understand the FASB has no current plans to amend or alter the guidance in Statement 123R to reflect the view of the U.S. Securities & Exchange Commission.

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#







BUSINESS

 

This description contains certain forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from the results discussed in the forward-looking statements as a result of certain of the risks set forth herein. We assume no obligation to update any forward-looking statements contained herein.


Overview


Through our CRADA with the USDA’s Agricultural Research Service, and incorporating the PICM-19 Cell Line developed and patented by USDA’s Agricultural Research Service scientists, we are currently concentrating our efforts on developing an artificial liver device and in-vitro toxicology and pre-clinical drug testing platforms through the application of the PICM-19 Cell Line.

 

At present, we have not submitted for, or received regulatory approval or commercialized any product. Since we have not yet submitted any product for regulatory approval, the statements contained in this prospectus regarding our ongoing research and development efforts and the results attained by us to-date have not been evaluated by the FDA or any other governmental or regulatory agency.


Material Agreements


On November 1, 2002, we entered into a CRADA with the USDA’s Agricultural Research Service and committed to pay a total of $292,727 to USDA’s Agricultural Research Service over a two-year period ending February 19, 2005


The payments are to fund salaries, equipment, travel and other indirect costs of a post-doctoral research associate.  The terms of the CRADA require our interaction  with USDA’s Agricultural Research Service personnel on the technical details involved with pig liver cell culture development, providing the necessary funds for the purpose above, preparing and filing any patent applications, and reviewing reports and implementing procedures for the development of an artificial liver device utilizing the pig liver cell line.  USDA’s Agricultural Research Service’s responsibilities include hiring the post-doctoral research associate for a two-year period, providing laboratory and office space for the research associate, providing experimental animals (pigs) and slaughter facilities, conducting the research, preparing progress reports on project objectives and preparing and submitting technical reports for publication.

 

Under the terms of the CRADA, all rights, title and interest in any subject invention made solely by USDA’s Agricultural Research Service employees are owned by USDA’s Agricultural Research Service, solely by us are owned by us, and any such inventions are owned jointly by us and USDA’s Agricultural Research Service if made jointly by USDA’s Agricultural Research Service and us. Under the CRADA, we have an option to negotiate an exclusive license in each subject invention owned or co-owned by USDA’s Agricultural Research Service for one or more field (s) of use encompassed by the CRADA. The option terminates when and if we fail to:

 

-  Submit a complete application for an exclusive license within sixty days of being notified by USDA’s Agricultural Research Service of an invention being available for licensing; or

-  submit a good faith written response to a written proposal of licensing terms within forty five days of such proposal.

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The USDA’s Agricultural Research Service has the first option to prepare and prosecute patent or Plant Variety Protection Certificate applications, on subject inventions that are owned or co-owned by the USDA’s Agricultural Research Service, which option may be waived in whole or in part.,


The CRADA is subject to termination at any time by mutual consent. However, either party may unilaterally terminate the entire agreement at any time by giving the other party written notice not less than sixty calendar days prior to the desired termination date. To date, we have neither given nor received any such written notice.


Current Research and Development Activities


Artificial Liver Device


We are working towards optimizing the hepatic functionality of a porcine cell line, which we refer to as the “PICM-19 Cell Line.” The PICM-19 Cell Line was developed and patented by USDA Agricultural Research Service scientists.  The hepatic characteristics of the PICM-19 Cell Line have been demonstrated to have potential application in the production of an artificial liver device, which application was also developed and patented by USDA Agricultural Research Service scientists for potential use by human patients with liver failure.


To help liver failure patients survive long enough to receive a liver transplant or recover without a transplant by exploiting the well known regenerative powers of the liver, a number of artificial liver devices are currently being developed and tested using living pig or human liver cells and various filtering or dialysis mechanisms. Since the liver is the only organ in the human body that can regenerate itself, artificial liver devices are intended to temporarily perform the function of a human liver, such as removing toxins from the body, thus giving the patient’s own liver valuable time to recover and regenerate.  Unfortunately, artificial liver technologies have not lived up to their initial promise as a consequence of problems relating to their inability to grow liver cells quickly and safely and with inconsistent results from filtering devices. Culturing and maintaining such cells have proven difficult; once removed from the body, they soon lose their normal functioning attributes.  


To date, the cellular components of artificial liver devices that are being tested have been based on freshly isolated porcine hepatocytes, human immortal tumor cells, or poorly defined stem-like cells prepared from fresh human adult liver tissue. It is widely recognized that the greatest hindrance to the development of a completely functional artificial liver device is the lack of an appropriately defined cell line that will provide the functions of an intact liver.


We believe the PICM-19 Cell Line has the required attributes to address the need for an appropriately defined cell line for incorporation into an artificial liver device. Key among these attributes is the PICM-19 Cell Line’s ability to differentiate into bile duct cells and hepatocytes (which comprise most of the liver and perform the vital metabolic and detoxification functions of the liver), which have been shown to have several liver specific functions such as the production of serum proteins and P450 enzymes (the key components in the overall hepatic detoxification pathway of drugs and other xenobiotics).

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In our view, the additional advantages of the PICM-19 Cell Line include, but are not limited to:


-  the PICM-19 Cell Line is not tumor-causing, a feature not only critical to nutrient metabolism research but one which the cell line has retained even after years in continuous culture;   

-  the PICM-19 cell line does what other cell lines do not do; it stops dividing and matures into functioning hepatocytes or bile ducts as normal cells do in the body (i.e., not cancerous in nature);

-  because the PICM-19 Cell Line is a cell line, it will grow (divide in two) over and over again so that a potentially unlimited number of cells can be created;

-  the ability of the PICM-19 Cell Line to continuously increase in number means that the cells can be studied to "define" their stability of form and function and defined also in being free of harmful agents such as toxins, viruses, bacteria, and fungi;

-  because the PICM-19 Cell Line is a growing population of cells, individuals (cells) within the population that have superior attributes can be searched for and isolated;

-  current methods of genetic engineering can be applied to the cells for the creation of derivative cell lines which are more advantageous in various ways for incorporation into an artificial liver device, and finally,  

-  the PICM-19 cell line could also be useful for toxicological studies as an alternative to animal testing where specific information is needed on how toxic various substances are to liver and bile duct cells.

 

In Vitro Toxicology and Drug Testing


Hepatocytes, the major cell type comprising the liver, perform the important task of metabolizing or detoxifying drug compounds that enter the body. This is accomplished primarily through cytochrome P450 enzymes that are abundantly expressed in hepatocytes. Therefore, hepatocytes grown in vitro have application for the rapid screening of multiple drug candidates to predict their potential liver toxicity and liver-specific pharmacological characteristics prior to clinical testing.


We believe the ability of the PICM-19 Cell Line, which is also concurrently being tested by us for use in an artificial liver device, to differentiate into either hepatocytes or bile duct cells (two key cell types of the liver) and to synthesize liver specific proteins, such as albumin and transferrin, as well as display enhanced liver-specific functions such as ureagenesis and cytochrome P450 activity, could be important to the development of  in vitro toxicological and pre-clinical drug testing platforms that could more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.


Our Strategy


Our current research is focused on optimizing the hepatic functionality of the PICM-19 Cell Line for use in the production of an artificial liver device for human patients with liver failure. The successful adaptation and application of an optimized PICM-19 Cell Line, along with the development of an artificial liver device, would allow us to target the estimated 25 million Americans that are or have been afflicted with liver and biliary disease.

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We anticipate that an artificial liver device, once approved for use by appropriate regulatory agencies, could be used either as a temporary artificial liver for patients awaiting a liver transplant, thus lengthening the time they have available while an organ donor is located, or it could provide support for post-transplantation patients until a grafted liver functions adequately to sustain the patient. Additionally, an artificial liver device could also be used as support for patients with chronic liver disease, thus allowing their own liver time to heal and regenerate, as well as providing immediate temporary support for those patients suffering from acute liver failure, as is the case with drug overdoses.


Assuming we succeed in our research and development efforts into the optimization of the PICM-19 Cell Line, the development of an artificial liver device incorporating the optimized PICM-19 Cell Line and in obtaining a license pursuant to our CRADA, we will explore a number of commercial opportunities, including, but not limited to: the outright sale of our technology, joint venture partnerships with health care companies, or the marketing and selling of the products, if any, derived from the research and development efforts ourselves.     


We are also targeting the toxicological and pre-clinical drug testing markets through the development of in vitro toxicological and pre-clinical drug testing platforms using the PICM-19 Cell Line.  Resulting in part from the limitations of current testing methodology, safety problems relating to drug usage are often discovered only during clinical trials, and unfortunately, sometimes after marketing. Hepatotoxicity, or liver damage caused by medications and other chemical compounds, is the single most common reason leading to drug withdrawal or refusal of drug approval by the FDA, generally resulting in substantial costs to the manufacturer.


Our commercial success will depend on our ability and the ability of our sublicensees, if any, to compete effectively in product development areas such as, but not limited to, safety, efficacy, and ease of use, patient or customer compliance, price, marketing and distribution. There can be no assurance that competitors will not succeed in developing products that are more effective than any that may ultimately be derived from our research and development efforts or that would render any such product obsolete and non-competitive. Accordingly, in addition to our research and development efforts, we have undertaken a program designed to establish “brand” name recognition early on in our corporate development; we intend to continue to develop and market our brand name pending commercialization, if ever, of the results of our research and development program or any products derived from our research development efforts. We believe our strategy will ultimately facilitate the commercialization of our targeted technologies and the marketing, distribution and public acceptance of products, if any, derived from our research and development efforts, if and when, regulatory approval is received.


Our Intended Markets


Assuming the results from our ongoing research and development efforts prove successful, and subject or our receiving regulatory approvals, we believe our Products Candidates have the potential to address two important market segments:

-  the liver disease market through the development of an artificial liver device and the toxicological; and

-  pre-clinical drug testing market through the development of in vitro toxicological and pre-clinical drug testing platforms that may more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.

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Liver Disease and the Need for an Artificial Liver Device


We believe that there is a demonstrated need for an effective artificial liver device. The National Institutes of Health (“NIH”) has estimated that one quarter of Americans will suffer from a liver or biliary disease at some point in their lifetime. These findings have been corroborated by other health organizations which have indicated that an estimated that 25 million Americans are or have been afflicted with liver or biliary diseases. Reportedly the 4th leading cause of death in the United States of adults between the ages of 45 and 54, it is estimated that expenses of approximately $10 billion annually are incurred in the treatment of liver disease and associated conditions.


It is estimated that liver disease accounts for 360,000 hospital discharges each year, and during 2002 alone, 27,257 people died in the United States as a consequence of cirrhosis and chronic liver disease.


Causes of liver disease and related conditions include:


Alcohol Abuse


Of the nearly 14 million estimated Americans that either abuse alcohol or are alcoholics, approximately 10 to 20% are expected to develop cirrhosis of the liver, one of the leading causes of death among young and middle-age adults in the United States. Individuals with cirrhosis are particularly prone to developing fatal bacterial infections and cancer of the liver.


Drug Induced Conditions


Adverse drug reactions are an increasingly important clinical problem in medicine today and rank among the ten most common causes of death. While drug induced liver injury occurs in all age groups, a greater percentage occurs in the elderly, where five out of six persons 65 and older are taking at least one medication and almost half are of the elderly take three or more.


Hepatitis


According to publicly available statistical information, approximately 15-25% (upwards of 312,500 Americans) of the estimated 1.25 million chronically infected hepatitis B sufferers will die from chronic liver disease. Globally, an estimated 300 million people are infected with hepatitis B, causing approximately 1,000,000 deaths per year.


Of the estimated 4.5 million Americans infected with hepatitis C, for which at this time there is no known cure, an estimated 70-80% will develop chronic liver disease and of these, approximately 20% will die. The annual health care costs for the affected U.S. population with chronic hepatitis C alone has been estimated to be as high as $9 billion, compared to annual cost of $360 million for hepatitis B sufferers.

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Other Medical Conditions


In addition to alcohol abuse, drug overdoses and hepatitis, other causes of liver disease include primary biliary cirrhosis, hemochromatosis, Wilson’s disease, alpha1-antitrypsin deficiency, glycogen storage disease, autoimmune hepatitis, cardiac cirrhosis and schistosomiasis.


For people with severe liver failure, orthotopic liver transplantation is the most prescribed and effective treatment therapy available today. At present, there are upwards of 17,000 adults and children medically approved and waiting for liver transplants in the United States. Unfortunately, there are just over 5,000 livers available for transplant annually. Due to a severe shortage of organ donors, the waiting time for potential liver recipients could be as long as two to three years, with 20-30% of these patients not surviving the waiting period.  


For persons who receive liver transplants, it is estimated that approximately 30% will die within 5 years of transplantation. The balance will require immunosuppressive drugs, rendering them susceptible to life threatening infections such as kidney failure and increased risk of cancer.


Because of limited treatment options, a low number of donor organs, the high price of transplants and follow up costs, a growing base of hepatitis, alcohol abuse, drug overdoses, and other factors that result in liver disease, we believe that a market opportunity for an artificial liver device able to remove toxins and improve immediate and long-term survival exists at this time.


The Need for Improved In Vitro Toxicology Testing


Hepatotoxicity, or liver damage caused by medications and other chemical compounds, is the single most common reason leading to drug withdrawal or refusal of drug approval by the FDA. In fact, about one third of all potential drugs fail pre-clinical or clinical trials due to the toxic nature of the compounds being tested, accounting for an estimated $70 million (20%) of total research and development costs per drug.

 

Despite efforts to develop better methods, many of the tools used for toxicology and human safety testing are decades old. In 2003, the inability to accurately predict toxicity early in drug development cost the pharmaceutical industry a record $8 billion. With the cost to develop an FDA approved drug approaching $1 billion and taking 10 to 15 years, a 10% improvement in predicting failures before clinical trials could save an estimated $100 million in development costs per drug.

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Competition


Industry


The biotechnology industry is characterized by intense competition, rapid product development and technological change. A number of companies, research institutions and universities are working on technologies and products that may be similar and/or potentially competitive with our own. In contrast to our PICM-19 Cell Line, the cellular components of other artificial liver devices being developed to-date have been based on freshly isolated porcine hepatocytes, cell lines established from human liver tumors, stem-cell-like cells prepared from fresh human adult liver tissue and human or pig liver cells ‘transformed’ or ‘immortalized’ by the addition of oncogenes (i.e., genes associated with cancer) through genetic engineering. While immortalized liver cells retain a high capacity for growth, they often have reduced or altered hepatocyte functions. In addition, PICM-19 Cell Line’s ability to synthesize liver specific proteins and display enhanced liver-specific functions is also important attributes to the development of in vitro toxicological and pre-clinical drug testing platforms.  


We face competition from a number of companies, many of which are substantially larger than we are and have access to resources far greater than ours. These companies enjoy numerous competitive advantages over us, including:


-  significantly greater name recognition;

-  established relations with healthcare professionals, customers and third-party payors;

-  established distribution networks;

-  additional lines of products, and the ability to offer rebates, higher discounts or incentives to gain a competitive advantage;

-  greater experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products, and marketing approved products; and

-  greater financial and human resources for product development, sales and marketing, and patent litigation.


As a result, we may not be able to compete effectively against these companies or their products.


The brief description of the products and technologies being developed or marketed by our competitors listed below have been taken from publicly available documents or reports filed by these companies; accordingly, there is no assurance that the descriptions set forth in the documents and reports filed by such companies are correct, accurate or complete; moreover, we make no assessment of the merits of the technologies underlying the products or treatments described.  


Competitors With Respect To Liver Device Technologies


-  Braun, Inc. – have developed an artificial liver device;


-  Arbios Systems, Inc. – developing artificial liver device incorporating liver cells obtained from pigs;


-  Vital Theraperies, Inc. – artificial liver device technology originally developed by VitaGen (formerly Hepatix) that uses a line of human liver cells cultivated from a hepatoblastoma, a type of liver tumor;


-  MultiCell Technologies, Inc. – supplies immortalized human hepatocytes for drug discovery and therapeutic applications, as well for inclusion in their artificial liver device, and


-  TeraKlin AG – developed a liver filtration system based on a dialysis principle to remove water-soluble and albumin bound toxins from the blood (acquired by Gambro).

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Competitors With Respect To In Vitro Toxicology Testing


-  Amphioxus Cell Technologies – is marketing toxicology testing kits incorporating an immortalized human liver cell line developed from a hepatoma (cancerous liver tumor);


-  BD Biosciences  - is marketing fully characterized, replatable, inducible cryopreserved human hepatocytes for P450 toxicity related studies;


-  Biotrin International – is marketing its Biotrin Rat Alpha GST EIA for hepatotoxicity investigations;


-  CellzDirect, Inc. – is marketing early cryopreserved human hepatocytes for in vitro screening, metabolism, hepatotoxicity, interaction studies, etc.;


-  Charles River Laboratories Discovery and Development Services – is marketing early toxicity information to pharmaceutical companies engaged in Discovery/Lead Optimization, utilizing numerous cryopreserved hepatocytes in its processes;


-  Geron Corporation – is developing a source of normal human liver cells for toxicity testing by applying its telomerase technology to immortalize primary human hepatocytes, and developing related procedures;


-  In Vitro Technologies, Inc. – is marketing plated hepatocytes from non-transplantable human livers for toxicology, enzyme induction, efficacy, and virology; also offers rat, monkey, and dog hepatocytes;


Personnel


Competition among biotechnology companies for qualified employees is intense, and there can be no assurance we will be able to attract and retain qualified individuals. If we fail to do so, this would have a material, adverse effect on the results of our operations.

 

We do not maintain any life insurance on the lives of any of our officers and directors. We are highly dependent on the services of our directors and officers, particularly on those of Harmel S. Rayat. If one or all of our officers or directors die or otherwise become incapacitated, our operations could be interrupted or terminated.

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Government Regulation


General


We are involved in a heavily regulated sector, and our ability to remain viable will depend on favorable government decisions at various points by various agencies. From time to time, legislation is introduced in the US Congress that could significantly change the statutory provisions governing our research and development processes as well as the approval, manufacture and marketing of any products derived from such research and development activities. Additionally, healthcare is heavily regulated by the federal government and by state and local governments. The federal laws and regulations affecting healthcare change constantly, thereby increasing the uncertainty and risk associated with any healthcare related venture, including our business. In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products, if any. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance, or interpretations changed, and what the impact of such changes, if any, may be.


The federal government regulates healthcare through various agencies, including but not limited to the following: (i) the FDA, which administers the Food, Drug, and Cosmetic Act (FD&C Act), as well as other relevant laws; (ii) CMS, which administers the Medicare and Medicaid programs; (iii) the Office of Inspector General (OIG) which enforces various laws aimed at curtailing fraudulent or abusive practices,  including by way of example, the Anti-Kickback Law, the Anti-Physician Referral Law, commonly referred to as Stark, the Anti-Inducement Law, the Civil Money Penalty Law, and the laws that authorize the OIG to exclude healthcare providers and others from participating in federal healthcare programs; and (iv) the Office of Civil Rights, which administers the privacy aspects of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). All of the aforementioned are agencies within United States Department of Health and Human Services (“HHS”).


Healthcare is also provided or regulated, as the case may be, by the Department of Defense through its TriCare program, the Public Health Service within HHS under the Public Health Service Act, the Department of Justice through the Federal False Claims Act and various criminal statutes, and state governments under Medicaid and other state sponsored or funded programs and their internal laws regulating all healthcare activities.


In addition to regulation by the FDA, in the future, we may be subject to general healthcare industry regulations. The healthcare industry is subject to extensive federal, state and local laws and regulations relating to:


-  billing for services;

-  quality of medical equipment and services;

-  confidentiality, maintenance and security issues associated with medical records and individually identifiable health information;

-  false claims; and

-  labeling products.


These laws and regulations are extremely complex and, in some cases, still evolving. In many instances, the industry does not have the benefit of significant regulatory or judicial interpretation of these laws and regulations. If our operations are found to be in violation of any of the federal, state or local laws and regulations that govern our activities, we may be subject to the applicable penalty associated with the violation, including civil and criminal penalties, damages, fines or curtailment of our operations. The risk of being found in violation of these laws and regulations is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action against us for violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s time and attention from the operation of our business.

39


Federal Food and Drug Administration (FDA) Regulation


We have yet to develop any products for submission for regulatory approval. The production and marketing of any product that may be developed by us and our ongoing research and development, preclinical testing and clinical trial activities will be subject to extensive regulation and review by numerous governmental authorities.


If any such products are submitted for approval, they must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process before they can be marketed. This process makes it longer, harder and more costly to bring any products to market; moreover, we cannot guarantee that approval will be granted. The pre-marketing approval process can be particularly expensive, uncertain and lengthy. A number of products for which FDA approval has been sought have never been approved for marketing. In addition to testing and approval procedures, extensive regulations also govern marketing, manufacturing, distribution, labeling and record-keeping procedures. If we do not comply with applicable regulatory requirements, such violations could result in warning letters, non-approval, suspensions of regulatory approvals, civil penalties and criminal fines, product seizures and recalls, operating restrictions, injunctions and criminal prosecution.

 

Delays in, or rejection of, FDA or other government entity approval may also adversely affect our business. Such delays or rejection may be encountered due to, among other reasons, government or regulatory delays, lack of efficacy during clinical trials, unforeseen safety issues, slower than expected rate of patient recruitment for clinical trials, inability to follow patients after treatment in clinical trials, inconsistencies between early clinical trial results and results obtained in later clinical trials, varying interpretations of data generated by clinical trials, or changes in regulatory policy during the period of product development in the United States. In the United States, more stringent FDA oversight in product clearance and enforcement activities could result in our experiencing longer approval cycles, more uncertainty, greater risk and significantly higher expenses. Even if regulatory approval for any product is granted, this approval may entail limitations on uses for which any such product may be labeled and promoted. It is possible, for example, that we may not receive FDA approval to market products based on our research and development efforts for broader or different applications or to market updated products that represent extensions of any such product. In addition, we may not receive FDA approval to export any such product in the future, and countries to which products are to be exported may not approve them for import.

 

 

Any manufacturing facilities would also be subject to continual review and inspection. The FDA has stated publicly that compliance with manufacturing regulations will be scrutinized more strictly. A governmental authority may challenge our compliance with applicable federal, state and foreign regulations. In addition, any discovery of previously unknown problems with any of our research and development efforts or products derived from such research and development, or facilities may result in marketing, sales and manufacturing restrictions, being imposed, as well as possible enforcement actions.

 

From time to time, legislative or regulatory proposals are introduced that could alter the review and approval process relating to our research and development programs and products derived from such research. It is possible that the FDA will issue additional regulations further restricting the sale of our proposed products derived from our research and development efforts. Any change in legislation or regulations that govern the review and approval process relating to could make it more difficult and costly to obtain approval, or to produce, market, and distribute such products, if any, derived from our research efforts, even if approved. 

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Environmental Regulation


Our research and development processes may involve the handling of potentially harmful biological materials as well as hazardous materials. The USDA's Agriculture Research Service and we are subject to federal, state and local laws and regulations governing the use, handling, storage and disposal of hazardous and biological materials and we incur expenses relating to compliance with these laws and regulations. If violations of environmental, health and safety laws occur, we could be held liable for damages, penalties and costs of remedial actions. These expenses or this liability could have a significant negative impact on our financial condition. We may violate environmental, health and safety laws in the future as a result of human error, equipment failure or other causes. Environmental laws could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We are subject to potentially conflicting and changing regulatory agendas of political, business and environmental groups. Changes to or restrictions on permitting requirements or processes, hazardous or biological material storage or handling might require an unplanned capital investment or relocation. Failure to comply with new or existing laws or regulations could harm our business, financial condition and results of operations.


Employees


In addition to the management services provided to us by Mr. Rayat, we have an administrative, clerical and office staff consisting of one full time and three part time employees.  All of our research and development activities are provided on our behalf by scientists and others employed by governmental agencies  with which we have agreements or by third party providers.


Legal Proceedings


We are not a party to any material legal proceedings and there are no material legal proceedings pending with respect to our property. We are not aware of any legal proceedings contemplated by any governmental authorities involving either our property or us. None of our directors, officers or affiliates is an adverse party in any legal proceedings involving us, or has an interest in any proceeding, which is adverse to us.

  

Property

 


Our principal office is located at 1628 West First Avenue, Suite 216, Vancouver, British Columbia, Canada, V6J 1G1. A private corporation controlled by Mr. Harmel S. Rayat, our president , chief executive and financial officer, principal accounting officer, director and majority stockholder owns these premises; the premises  are provided to us without charge.  We believe the premises are adequate for our operations.

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#








MANAGEMENT



The following table and text set forth the names and ages of all directors and executive officers of our company as of August 12, 2005. The Board of directors is comprised of only one class. All of the directors will serve until the next annual meeting of stockholders and until their successors are elected and qualified, or until their earlier death, retirement, resignation or removal. There are no family relationships between or among the directors, executive officers or persons nominated or charged by our company to become directors or executive officers. Executive officers serve at the discretion of the Board of directors, and are appointed to serve by the Board of directors.


Name


Age


Position


Held Position Since

Harmel S. Rayat (1)

44

President, Chief Executive Officer , Chief Financial Officer,  Principal Accounting Officer and Director

Director since December 4, 2000; President and Chief Executive Officer, Chief Financial Officer, and Principal Accounting Officer since August 11, 2005

    

Arian Soheili (1)

38

Secretary, Treasurer and Director

Secretary, Treasurer and Director since August 11, 2005 and a director since September 22, 2003

    

Jasvir S. Kheleh

31

Director

November 19, 2003



(1) On August 12, 2005 (i) Mr. Harmel S. Rayat was appointed our president, chief executive officer, chief financial officer, and principal accounting officer; and (ii) Mr.Soheili resigned as our president and chief executive officer and assumed positions as our secretary and treasurer on the same day. Prior to August 12, 2005, Mr. Soheili served as our president and chief financial officer since September 22, 2003.


The following is a brief description of the business experience of each director and executive officer during the past five years and an indication of directorships held by each director in other companies subject to the reporting requirements under the Federal securities laws.


Harmel S. Rayat, President, Chief Executive Officer, Chief Financial Officer,Principal Accounting Officer, Director


 Mr. Rayat has been in the brokerage and venture capital industry since 1981. Between January 1993 and April 2001, Mr. Rayat served as the president of Hartford Capital Corporation, a company that provided financial consulting services to a wide range of emerging growth corporations. From April 2001 through January 2002, Mr. Rayat acted as an independent consultant advising small corporations and since January 2002, he has been president of Montgomery Asset Management Corporation, a privately held firm providing financial consulting services to emerging growth corporations. Mr. Rayat has served, and continues to serve, as a director, executive officer and majority shareholder of a number of publicly traded and privately held corporations, including, Phytomedical Technologies, Inc., Entheos Technologies, Inc., and International  Energy, Inc. Mr. Rayat has served as one of our directors since December 4, 2000. In 2002 he was appointed secretary and treasurer. On August 12, 2005 he was appointed our president and chief executive and financial officer, as well as our principal accounting officer.

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Arian Soheili, Secretary, Treasurer, Director


 Mr. Soheili earned a Bachelor’s degree in Business Administration from Simon Fraser University in 1993 and brings over 20 years of industry and public practice experience with Grant Thornton, Deloitte and Touche, and others. Since 1999, Mr. Soheili has been the Managing Director at Cantatus Systems Group, Inc., a firm that specializes in enterprise solutions, technology infrastructure and systems integration services. Mr. Soheili joined us as a director and our President and Chief Executive Officer on September 22, 2003, positions from which he resigned on August 11, 2005. On that date, in addition to his services as a director, he assumed the positions of our secretary and treasurer.


Jasvir S. Kheleh, Director


 Mr. Kheleh received his Diploma in Financial Management majoring in Finance, from the British Columbia Institute of Technology (BCIT) in June 1995. From September 1995 to May 1996, Canada Trust, a subsidiary of the Toronto-Dominion Bank's, TD Bank Financial Group, employed Mr. Kheleh.  Since June 1996, Mr. Kheleh has been with the nation’s largest credit union institution, VanCity (Vancouver City Savings Credit Union) and is serving as Manager, Branch Services.  Mr. Kheleh joined us as a director on November 19, 2003.


There are no family relationships among or between any of our officers and directors.


Except as set forth below, during the past five years none of our directors, executive officers, promoters or control persons has been:


(a)

the subject of any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;


(b)

convicted in a criminal proceeding or is subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);


(c)

subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities; or


(d)

found by a court of competent jurisdiction (in a civil action), the Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law.

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On October 23, 2003, Mr. Harmel S. Rayat, EquityAlert.com, Inc., Innotech Corporation and Mr. Bhupinder S. Mann, a former part-time employee of ours, collectively the respondents, consented to a cease-and-desist order pursuant to Section 8A of the Securities Act of 1933. Without admitting or denying the findings of the U.S. Securities & Exchange Commission related to the public relation and stock advertising activities of EquityAlert.com, Inc. and Innotech Corporation, the respondents agreed to cease and desist , among other things, from committing or causing any violations and any future violations of Section 5(a) and 5(c) of the Securities Act of 1933.  EquityAlert.com, Inc. and Innotech Corporation agreed to pay disgorgement and prejudgment interest of $31,555.14.


On August 8, 2000, Mr. Harmel S. Rayat and EquityAlert.com, Inc., without admitting or denying the allegations of the U.S. Securities & Exchange Commission that EquityAlert did not disclose certain compensation received by it in connection with stock advertisements and promotions, consented to the entry of a permanent injunction enjoining them from, among other things, violating Section 17(b) of the Securities Act of 1933; in addition, each of Mr. Rayat and EquityAlert agreed to pay a civil penalty of $20,000.


Scientific Advisory Board


We use scientists, physicians and other professionals with expertise related to our technologies to advise us on scientific and medical matters. Currently, our scientific advisory board members are:


Prof. Michael Ott, MD, Ph.D


Dr. Michael Ott earned his medical and doctoral degrees from Germany’s largest medical training school, Westfälische-Wilhelms-University (Munster), receiving his medical license from the Ärztekammer des Landes Nordrhein-Westfalen (Germany) in 1987.  


From 1987 through 1989, Dr. Ott undertook his post-doctoral (equivalent) research at the University of Muenster (Germany) in the Molecular Biology and Pathophysiology Laboratory for Hemostasis and Microcirculation, and subsequently completed a three-year training program from 1990 through 1993 in Internal Medicine at the Johann-Wolfgang-Goethe University Medical Center in Frankfurt, Germany.  From 1993 to 1997, Dr. Michael Ott undertook further post-doctoral research at Marion Bessin Liver Research Center at the Albert Einstein College of Medicine, New York.  In 1997, Dr. Ott received his MD degree in Internal Medicine, and from 1997 through 2003, was a member of the Department of Gastroenterology, Hepatology and Endocrinology at the Hannover Medical School (Germany).  Since 2003, Dr. Michael Ott has tenured as Associate Professor for Experimental Hepatology at the Hannover Medical School.


Dr. Darryl J. Fleishman, MD


Dr. Darryl Fleishman is a Board Certified Emergency Medicine Specialist.  Dr. Fleishman earned his MD degree in 1991 from Boston University Medical School in Boston, MA, and in 1994 completed his Emergency Residency Program at Wayne State University in Detroit, MI. 

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From August 1994, through July 1997, Dr. Fleishman served at Holy Cross Hospital in Chicago, IL, while concurrently posted at the Level I Trauma Center at Mt. Sinai Hospital, Chicago, IL.  From October 1995 through March 1998, Dr. Darryl Fleishman tenured at Chicago’s Little Company of Mary and subsequently worked at St. Therese Hospital, Waukegan, IL from July 1997 through January 1998.  From January 1998 through May 1999, Dr. Fleishman served at the Level I Trauma Center in St. John’s Hospital in Springfield, IL and tenured at Ingalls Memorial Hospital, Harvey, IL  from September 1999 through July 2002.    From December 2002 through September 2004, Dr. Darryl Fleishman served at the Level I Trauma Center at Christ Hospital in Harvey, IL and since July 2004 has been in active emergency-medicine practice at St. Francis Hospital & Health Center’s Level I Trauma Center, Blue Island, IL.


Mr. John Bergman


Mr. John Bergmann attended Montclair State University, NJ where he earned a Bachelor of Arts degree in Biology in 1974 and his Master of Arts degree in Biology in 1977. From May 1976, through August 1978, Mr. Bergmann served as Research Associate and Director of Scientific Equipment, New Jersey Sea Grant, New Jersey Marine Science Consortium, Fort Hancock, NJ.  From September 1978 through August 1979, Mr. John Bergmann accepted a Research Associate position at National Oceanic Atmospheric Administration (NOAA), Northeast Fisheries Center, National Marine Fisheries Service, in Fort Hancock, NJ.  Subsequently, from September 1979 through December 1980, Mr. Bergmann worked at the University of Houston, Central Campus, Department of Biological Sciences, in Houston, TX.


Since December 1980, Mr. John Bergmann has undertaken research efforts at the University of Texas Medical Branch, Galveston, TX in numerous capacities:  Research Associate I, Department of Human Biological Chemistry and Genetics, Division of Biochemistry (December 1980 through February 1989); Research Associate II, Department of Human Biological Chemistry and Genetics, Division of Biochemistry (February 1989 through January 1991); Faculty Associate, graduate School of Biomedical Sciences and School of Medicine, Department of Pharmacology and Toxicology (January 1991 through April 1994); Research Associate II, Department of Pathology, Division of Clinical Microbiology and Immunology (April 1994 through May 1999); Research Associate II, Department of Human Biological Chemistry and Genetics (May 1999 through 2002); and Senior Research Associate and Laboratory Manager, Department of Human Biological Chemistry and Genetics.


Mr. Frank Menzler


Mr. Menzler earned a ‘Diplom-Ingenieur’ (Master’s of Science equivalent) in Mechanical and Biomedical Engineering from RWTH Aachen, Germany’s largest university of technology in 1996, and his Master’s degree in Business Administration (MBA) from Northwestern University’s, Kellogg School of Business in 2001.


In February 1998, Mr. Frank Menzler co-founded Impella Cardiotechnik AG, a medtech start up venture; designing, developing, and ultimately commercializing minimally-invasive cardiac assist systems for use in cardiology and cardiac surgery. Mr. Menzler served in executive positions at Impella until April 2002, and from May 2002 through July 2004 was in charge of marketing for Europe, Middle East, Africa and Canada at Guidant Corporation’s (NYSE: GDT) Cardiac Surgery Business Unit in Brussels, Belgium.


Since September 2004, Mr. Frank Menzler has been the General Manager for ABIOMED, Inc.’s European division, ABIOMED, B.V.

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Collaborating Scientists

Dr. Neil C. Talbot


With a Bachelor’s degree in biology, a Master of Science degree (viral immunology major) and a Doctorate in cellular and molecular oncology, Dr. Talbot has over 24 years of scientific research experience with the University of Maryland, Squibb Institute for Medical Research (E.R. Squibb and Sons, Inc.), National Institutes of Health and is currently employed by the U.S. Department of Agriculture, where Dr. Talbot received a Merit Award for superior performance on in vitro culture of embryonic cells in 1993 and a Scientist of the Year Award in 1996.


Dr. Talbot has extensive knowledge and experience in the following areas:


-  Research on nuclear cloning of cattle and embryonic stem cells of the pig, sheep and cow;

-  Oncogene and transformation suppression research with the isolation and characterization of oncogene resistant NIH/3T3 cell lines and v-Ki-ras suppressor genes;

-  Tyrosine Kinase oncogene suppression research with the analysis of the C127 mouse cell line's resistance to transformation by various oncogenes by transfection or infection;

-  Oncogene suppression research with the development of human HOS cell lines resistant to transformation by the v-Ki-ras oncogene.

-  Viral DNA analysis and production of monoclonal antibodies to equine herpesvirus type 1.

-  Immunoassays (ELISA, SN, CF, and cytotoxicity) for the evaluation of the antibody response in experimental infections of equine herpesvirus type1.


Dr. Talbot is widely published, with numerous research papers in such publications as: In Vitro Cellular and Developmental Biology; Cells Tissues Organs; Veterinary Immunology and Immunopathology; and Experimental Cell Research. Dr. Talbot is the co-inventor of the Hepatocyte Cell Line Derived from the Epiblast of Pig Blastocysts, U.S. Patent 5,532,156, issued July 2, 1996, and the Artificial Liver Device, U.S. Patent 5,866,420, issued February 2, 1999.


Dr. Thomas J. Caperna


With a Bachelor’s degree in Wildlife Biology and Zoology, a Master of Science degree in Biology (immunochemistry), and a PhD in Nutritional Biochemistry, Dr. Caperna has over 23 years of animal and cell research experience. Dr. Caperna has held research positions at Syracuse University and Virginia Polytechnic Institute and has been an associate and a research scientist at the U.S. Department of Agriculture since 1986.

46


Dr. Caperna’s expertise and research are in the following areas

-  Isolation and culture of rat and pig hepatic parenchymal and sinusoidal cells

-  Hepatocellular trace metal metabolism and metalloprotein biochemistry

-  Pig, chicken and bovine endocrinology

-  Nutrient-hormone interactions

-  Growth, development and energy metabolism in the pig with emphasis on the somatotropin axis

-  Stable isotope methodology in metabolic studies

-  Proteomics and Mass Spectrometry

Dr. Ayesha  Mahmood


Dr. Ayesha Mahmood holds a Bachelor's degree in Biochemistry, a Master of Science in Chemical Engineering and a PhD in Biomedical Engineering from Wayne State University (WSU), a biomedical engineering pioneer since 1939 and a recognized research innovator in small diameter blood vessel grafts, tissue engineering and biomaterials for tissue and organ replacement. Dr. Mahmood has published studies and delivered research presentations on biomaterials engineering, tissue engineering, chemical engineering and more, and has presented her findings to leading scientific peer review groups, including the Transactions of the Society for Biomaterials, American Institute of Chemical Engineers, Society of Biomaterials, and others.


Dr. Mahmood works at the U.S. Department of Agriculture’s Agricultural Research Service Growth Biology Laboratory located in Beltsville, MD.


Mr. Ryan Willard


Having completed his B.S. degree (cum laude) in Integrated Science and Technology/Biotechnology (ISAT) with a minor in Business at James Madison University in Harrison, VA, Mr. Ryan Willard subsequently undertook studies at the Department of Biology, University of Virginia (Charlottesville, VA). Among his broad scope of research experience, Mr. Willard has worked on genetic cloning and sequencing, protein purification, and the development of non-isotopic assays.


Most recently, Mr. Willard’s efforts as Senior Laboratory and Research Specialist at University of Virginia have focused on the development of a high-throughput assay for screening HIV anti-Rev compounds, testing positive compounds from the screen for efficacy and toxicity, and ultimately working towards elucidating a mechanism for each.


Mr. Willard works at the U.S. Department of Agriculture’s Agricultural Research Service Growth Biology Laboratory located in Beltsville, MD.

47


Compliance With Section 16(a) Of The Exchange Act


Based on information provided to us, we believe that all of our directors, executive officers and persons who own more than 10% of our common stock were in compliance with Section 16(a) of the Exchange Act of 1934 during the last fiscal year. During the year ended December 31, 2004, all of our directors, executive officers and persons who own more than 10% of our common stock were in compliance with section 16(a) of the Exchange Act of 1934, except as follows:


Directors


Our board of directors consists of three members. Directors serve for a term of one year and stand for election at our annual meeting of stockholders. Pursuant to our Bylaws, any vacancy occurring in the board of directors, including a vacancy created by an increase in the number of directors, may be filled by the stockholders or by the affirmative vote of a majority of the remaining directors though less than a quorum of the board of directors. A director elected to fill a vacancy shall hold office only until the next election of directors by the stockholders. If there are no remaining directors, the vacancy shall be filled by the stockholders.


We do not have any committee, nor do we have a member of the board of directors who would qualify as a financial expert.


At a meeting of stockholders, any director or the entire board of directors may be removed, with or without cause, provided the notice of the meeting states that one of the purposes of the meeting is the removal of the director. A director may be removed only if the number of votes cast to remove him exceeds the number of votes cast against removal.


Compensation of Directors


In 2004, 2003 and 2002, we incurred $9,500, $1,500 and $0, respectively, in fees to directors. Additionally, in 2003 and 2002, we paid $27,000 and 144,000, respectively to Harmel S. Rayat in management fees.


Standard Arrangements


Currently, we pay our directors for their services as directors a monthly stipend of $250 per month (except for Mr. Rayat, who receives $350 per month). In addition, each director receives $100 per board or committee meeting attended. We have no other arrangements pursuant to which any our directors was compensated during the year ended December 31, 2004, 2003 and 2002, for services as a director.  


Executive Compensation

     

Remuneration and Executive Compensation


The following table shows, for the three-year period ended December 31, 2004, the cash compensation paid by the Company, as well as certain other compensation paid for such year, to the Company's Chief Executive Officer and the Company's other most highly compensated executive officers. Except as set forth on the following table, no executive officer of the Company had a total annual salary and bonus for 2004 that exceeded $100,000.

48


Summary Compensation Table

                                                                                  

Securities

                                                                                 

Underlying

Name and                                                                         

Options       

All Other

Principal Position               Year      Salary     

Bonus        Other    

Granted     

Compensation


Harmel S. Rayat

2004

$0

$0       

$3,500      

    0

$0

President, CEO, CFO,     

2003    

$27,000

$0        

$0           

1,500,000            

$0

Principal Accounting

Officer and Director

2002    

$144,000       

$0        

$0           

5,500,000            

$0



Arian Soheili

 

2004

$0

$0       

$2,500      

    0

$0

Secretary, Treasurer

2003

$0

$0        

$1,150      

    0             

$0

and Director

2002

$0

       

$0        

$0           

    0             

$0



Jasvir Kheleh,             

2004

$0

$0       

$3,500      

    0

$0

Director

2003    

$0

$0        

$350         

    0             

$0

2002    

$0

       

$0        

$0           

    0             

$0


(1) On August 12, 2005 (i) Mr. Harmel S. Rayat was appointed our president, chief executive and financial officer, and principal accounting officer; and (ii) Mr.Soheili resigned as our president and chief executive officer and assumed positions as our secretary and treasurer. Prior to August 12, 2005, Mr. Soheili served as our president and chief financial officer since September 22, 2003.



Stock Option Grants in Last Fiscal Year


Shown below is further information regarding employee stock options awarded during 2004 to the named officers and directors:


   Number of

% of Total

   Securities

Options Granted

   Underlying

to Employees

Exercise

Expiration


Name

   Options

in 2004

Price ($/sh)

Date



Harmel Rayat

0

0

n/a

n/a

Arian Soheili

0

0

n/a

n/a

Jasvir Kheleh

0

0

n/a

n/a


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Aggregated Option Exercises During Last Fiscal Year and Year End Option Values


The following table shows certain information about unexercised options at year-end with respect to the named officers and directors:



Common Shares Underlying Unexercised

Value of Unexercised In-the-money    

Options on December 31, 2004     

Options on December 31, 2004      


Name  

Exercisable

     Unexercisable

Exercisable

Unexercisable


Harmel Rayat

5,166,667

1,833,333

20,201,668

7,168,332

Arian Soheili

0

0

0

0


Jasvir Kheleh

0

0

0

0



Employment Contracts and Change in Control Arrangements


We do not have any employment agreements with any of our officers and directors. There are no understandings or agreements known by management at this time, which would result in a change in control.  If such transactions are consummated, of which there can be no assurance, we may issue a significant number of shares of capital stock, which could result in a change in control and/or a change in our current management.


Stock Option Plans And Other Issuances


On July 12, 2001, our stockholders approved the 2001 Stock Option Plan, which has 40,000,000 shares reserved for issuance thereunder, all of which were registered under Form S-8 on May 8, 2003.  The objective of this plan is to attract and retain the best personnel, providing for additional performance incentives, and promoting our success by providing individuals the opportunity to acquire common stock.


On December 18, 2002, our board of directors agreed to grant 10,000,000 Non-Statutory Stock Options out of the 40,000,000 common shares available for issuance under our 2001 Stock Option Plan at $0.07 per share, the market price at the time of the grant. The terms and conditions, such as expiration dates and vesting periods are defined in the individual stock option agreements were finalized on February 10, 2003. The options are exercisable in three (3) equal instalments of thirty-three and one-third percent (33 1/3%), the first instalment being exercisable immediately, with an additional of thirty-three and one-third percent (33 1/3%) of the shares becoming exercisable on each of the two (2) successive anniversary dates. The options expire on February 10, 2013.  


On February 12, 2003, our board of directors authorized the grant of 75,000 options to purchase common stock to a director at $0.38 per share, being the approximate fair value at the date of grant and expiring ten (10) years from the grant date. The options become exercisable in two equal instalments of fifty percent (50%), with the first instalment becoming exercisable immediately and the balance becoming exercisable in 180 days from issuance.  On September 22, 2003, 37,500 of these options were cancelled due to the resignation of the director from our board of directors.

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On August 27, 2003, our board of directors authorized the grant of 3,000,000 options to purchase common stock to certain of our directors, officers and our employees at $2.11 per share.  The option price was based on the closing price of our common shares on August 27, 2003. The options become exercisable in two equal instalments of fifty percent (50%), with the first instalment becoming exercisable immediately and the balance becoming exercisable in 180 days from issuance.


We did not grant any stock options in 2004.  As of December 31, 2004, options to purchase 11,133,000 of our common stock at a weighted average exercise price of $0.48 per share were outstanding under the 2001 Stock Option Plan, of which 7,799,666 options to purchase shares were exercisable at December 31, 2004.


On March 7, 2005, our board of directors authorized the grant of 4,000,000 to purchase common stock to certain employees at $3.10 per share.  The option price was based on the closing price of our common shares on March 7, 2005.  The options become exercisable immediately.


On March 17, 2005, our board of directors authorized the grant of 2,000,000 to purchase common stock to certain employees at $2.38 per share.  The option price was based on the closing price of our common shares on March 17, 2005.  The options become exercisable immediately.

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#








THE FUSION CAPITAL TRANSACTION

 

General


On July 8, 2005, we entered into a common stock purchase agreement with Fusion Capital Fund II, LLC, pursuant to which Fusion Capital has agreed, under certain conditions, to purchase on each trading day $25,000 of our common stock up to an aggregate of $15.0 million over a 25 month period subject to earlier termination at our discretion.  In our discretion, we may elect to sell more of our common stock to Fusion Capital than the minimum daily amount.  The purchase price of the shares of common stock will be equal to a price based upon the future market price of the common stock without any fixed discount to the market price.  Fusion Capital does not have the right or the obligation to purchase shares of our common stock in the event that the price of our common stock is less than $0.75.


Fusion Capital, a selling stockholder under this prospectus, is offering for sale up to 10,711,598 shares of our common stock.  In connection with entering into the agreement, we authorized the sale to Fusion Capital of up to 10,000,000 shares of our common stock for maximum proceeds of $10.0 million.  Assuming Fusion Capital purchases all $15.0 million of common stock, we estimate that the maximum number of shares we will sell to Fusion Capital under the common stock purchase agreement will be 10,000,000 shares (exclusive of the 711,598 shares issued to Fusion Capital as the commitment fee).  Subject to approval by our board of directors, we have the right but not the obligation to issue more than 10,000,000 shares to Fusion Capital.  In the event we elect to issue more than 10,000,000 shares offered hereby, we will be required to file a new registration statement and have it declared effective by the U.S. Securities and Exchange Commission.  The number of shares ultimately offered for sale by Fusion Capital is dependent upon the number of shares purchased by Fusion Capital under the common stock purchase agreement.  

Purchase of Shares Under The Common Stock Purchase Agreement


Under the common stock purchase agreement, on each trading day Fusion Capital is obligated to purchase a specified dollar amount of our common stock.  Subject to our right to suspend such purchases at any time, and our right to terminate the agreement with Fusion Capital at any time, each as described below, Fusion Capital shall purchase on each trading day during the term of the agreement $25,000 of our common stock.  We may decrease this daily purchase amount at any time.  We also have the right to increase the daily purchase amount at any time, provided however, we may not increase the daily purchase amount above $25,000 unless our stock price is above $2.00 per share for five consecutive trading days.  The purchase price per share is equal to the lesser of:


the lowest sale price of our common stock on the purchase date; or


the average of the three (3) lowest closing sale prices of our common stock during the twelve (12) consecutive trading days prior to the date of a purchase by Fusion Capital.

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The purchase price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the trading days in which the closing bid price is used to compute the purchase price. Fusion Capital may not purchase shares of our common stock under the common stock purchase agreement if Fusion Capital, together with its affiliates, would beneficially own more than 9.9% of our common stock outstanding at the time of the purchase by Fusion Capital.  Fusion Capital has the right at any time to sell any shares purchased under the common stock purchase agreement, which would allow it to avoid the 9.9% limitation. Therefore, we do not believe that Fusion Capital will ever reach the 9.9% limitation.


The following table sets forth the amount of proceeds we would receive from Fusion Capital from the sale of shares of our common stock offered by this prospectus at varying purchase prices:


Assumed Average
Purchase Price

Number of Shares to be

Issued if Full Purchase

Percentage of Outstanding After Giving Effect to the Issuance to

Fusion Capital(1)

Proceeds from the Sale of 10,000,000 Shares to Fusion Capital Under the Common Stock Purchase Agreement

$0.75

10,000,000

13.4%

$7,500,000

$1.70 (2)

8,823,529

11.2%

$15,000,000

$2.50

6,000,000

8.0%

$15,000,000

$4.00

3,750,000

6.0%

$15,000,000

$4.50

3,333,333

5.5%

$15,000,000

$5.00

3,000,000

5.1%

$15,000,000



(1)

Based on 70,044,442 shares outstanding as of July 12, 2005 and  includes the issuance of 711,598 shares of common stock issued to Fusion Capital as a commitment fee, and the number of shares issuable at the corresponding assumed purchase price set forth in the adjacent column.

(2)

Closing sale price of our common stock on August 12, 2005.


In connection with entering into the agreement, we authorized the sale to Fusion Capital of up to 10,000,000 shares of our common stock.  We estimate that we will sell no more than 10,000,000 shares to Fusion Capital under the common stock purchase agreement (exclusive of the 711,598  shares issued to Fusion Capital as the commitment fee), all of which are included in this offering.  We have the right to terminate the agreement without any payment or liability to Fusion Capital at any time, including in the event that all 10,000,000 shares are sold to Fusion Capital under the common stock purchase agreement.  Subject to approval by our board of directors, we have the right but not the obligation to sell more than 10,000,000 shares to Fusion Capital.  In the event we elect to sell more than the 10,000,000 shares offered hereby, we will be required to file a new registration statement and have it declared effective by the U.S. Securities & Exchange Commission.  

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Minimum Purchase Price


Fusion Capital shall not have the right or the obligation to purchase any shares of our common stock in the event that the purchase price would be less the floor price. Specifically, Fusion Capital shall not have the right or the obligation to purchase shares of our common stock on any trading day that the market price of our common stock is below $0.75.

Our Right To Suspend Purchases


We have the unconditional right to suspend purchases at any time for any reason effective upon one trading day’s notice.  Any suspension would remain in effect until our revocation of the suspension. To the extent we need to use the cash proceeds of the sales of common stock under the common stock purchase agreement for working capital or other business purposes, we do not intend to restrict purchases under the common stock purchase agreement.

Our Right To Increase and Decrease the Amount to be Purchased


Under the common stock purchase agreement Fusion Capital has agreed to purchase on each trading day during the 25 month term of the agreement, $20,000 of our common stock or an aggregate of $20.0 million. We have the unconditional right to decrease the daily amount to be purchased by Fusion Capital at any time for any reason effective upon one trading day’s notice.  


In our discretion, we may elect to sell more of our common stock to Fusion Capital than the minimum daily amount.  First, in respect of the daily purchase amount, we have the right to increase the daily purchase amount as the market price of our common stock increases.  Specifically, for every $0.20 increase in Threshold Price above $2.00, the Company shall have the right to increase the daily purchase amount by up to an additional $2,000.  For example, if the Threshold Price were $4.00 we would have the right to increase the daily purchase amount to up to an aggregate of $50,000. The "Threshold Price" is the lowest sale price of our common stock during the five trading days immediately preceding our notice to Fusion Capital to increase the daily purchase amount.  If at any time during any trading day the sale price of our common stock is below the Threshold Price, the applicable increase in the daily purchase amount will be void.  


In addition to the daily purchase amount, we may elect to require Fusion Capital to purchase on any single trading day our shares in an amount up to $250,000, provided that our share price is above $2.50 during the ten trading days prior thereto.  The price at which such shares would be purchased will be the lowest Purchase Price (as defined above) during the previous fifteen (15) trading days prior to the date that such purchase notice was received by Fusion Capital.  We may increase this amount to $500,000 if our share price is above $4.00 during the ten trading days prior to our delivery of the purchase notice to Fusion Capital.  We may deliver multiple purchase notices; however at least ten (10) trading days must have passed since the most recent non-daily purchase was completed.  The daily purchases shall be suspended for ten (10) trading days each time any such notice is delivered.

Events of Default


Generally, Fusion Capital may terminate the common stock purchase agreement without any liability or payment to the Company upon the occurrence of any of the following events of default:

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the effectiveness of the registration statement of which this prospectus is a part of lapses for any reason (including, without limitation, the issuance of a stop order) or is unavailable to Fusion Capital for sale of our common stock offered hereby and such lapse or unavailability continues for a period of five (5) consecutive trading days or for more than an aggregate of twenty (20) trading days in any 365-day period;


suspension by our principal market of our common stock from trading for a period of three consecutive trading days;


the de-listing of our common stock from our principal market provided our common stock is not immediately thereafter trading on the Nasdaq National Market, the Nasdaq National SmallCap Market, the New York Stock Exchange or the American Stock Exchange;


 the transfer agent‘s failure for five trading days to issue to Fusion Capital shares of our common stock which Fusion Capital is entitled to under the common stock purchase agreement;


any material breach of the representations or warranties or covenants contained in the common stock purchase agreement or any related agreements which has or which could have a material adverse affect on us subject to a cure period of ten trading days;


any participation or threatened participation in insolvency or bankruptcy proceedings by or against us; or


a material adverse change in our business.

Our Termination Rights


We have the unconditional right at any time for any reason to give notice to Fusion Capital terminating the common stock purchase agreement.  Such notice shall be effective one trading day after Fusion Capital receives such notice.  

Effect of Performance of the Common Stock Purchase Agreement on Our Stockholders


All shares registered in this offering will be freely tradable. It is anticipated that shares registered in this offering will be sold over a period of up to 25 months from the date of this prospectus. The sale of a significant amount of shares registered in this offering at any given time could cause the trading price of our common stock to decline and to be highly volatile. Fusion Capital may ultimately purchase all of the shares of common stock registered in this offering, and it may sell some, none or all of the shares of common stock it acquires upon purchase. Therefore, the purchases under the common stock purchase agreement may result in substantial dilution to the interests of other holders of our common stock. However, we have the right at any time for any reason to: (1) reduce the daily purchase amount, (2) suspend purchases of the common stock by Fusion Capital and (3) terminate the common stock purchase agreement.

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No Short-Selling or Hedging by Fusion Capital


Fusion Capital has agreed that neither it nor any of its affiliates shall engage in any direct or indirect short-selling or hedging of our common stock during any time prior to the termination of the common stock purchase agreement.

Commitment Shares and Signing Shares Issued to Fusion Capital


Under the terms of the common stock purchase agreement Fusion Capital has received 691,598  shares of our common stock as a commitment fee.  We also issued 20,000 shares of our common stock to Fusion Capital upon its signing of the Term Sheet. We have agreed to issue additional shares of our common stock to Fusion Capital as a commitment fee in the event that the ten trading day average closing sale price of our common stock for the ten trading days prior to the date of this prospectus is less than $1.04.  The number of additional shares that may be issued to Fusion Capital is equal to the difference between (i) 1,350,000 divided by the ten day average closing sale price described above and (ii) the initial commitment shares.  Unless an event of default occurs, Fusion Capital must hold these shares until 25 months from the date of the common stock purchase agreement or the date the common stock purchase agreement is terminated.


No Variable Priced Financings


Until the termination of the common stock purchase agreement, we have agreed not to issue, or enter into any agreement with respect to the issuance of, any variable priced equity or variable priced equity-like securities unless we have obtained Fusion Capital’s prior written consent.

Participations Rights


For a period of 25 months from July 8, 2005, the date of the common stock purchase agreement, we have granted to Fusion Capital the right to participate in the purchase of any New Securities (as defined below) that we may, from time to time, propose to issue and sell in connection with any financing transaction to a third party.  In particular, Fusion Capital can purchase up to 50% of such New Securities at the same price and on the same terms as such other investor.  “New Securities” means any shares of our common stock, our preferred stock or any other of our equity securities or our securities convertible or exchangeable for our equity securities.  New Securities shall not include, (i) shares of our common stock issuable upon conversion or exercise of any securities outstanding as of the date of our agreement, (ii) shares, options or warrants for our common stock granted to officers, directors and employees of the company pursuant to stock option plans approved by our board of directors, (iii) shares of our common stock or securities convertible or exchangeable for our common stock issued pursuant to the acquisition of another company by consolidation, merger, or purchase of all or substantially all of the assets of such company or (iv) shares of our common stock or securities convertible or exchangeable into shares of our common stock issued in connection with a strategic transaction involving  us and issued to an entity or an affiliate of such entity that is engaged in the same or substantially related business as we are.  Fusion Capital rights shall not prohibit or limit us from selling any securities so long as we make the same offer to Fusion Capital.

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PRINCIPAL STOCKHOLDERS



The following table sets forth, as of July 12, 2005, the beneficial ownership of the Company's Common Stock by each director and executive officer of the Company and each person known by the Company to beneficially own more than 5% of the Company's Common Stock outstanding as of such date and the executive officers and directors of the Company as a group. The percentage ownership shown in such table is based upon the 70,024,430 common shares outstanding at July 12, 2005 and ownership by these persons of options or warrants exercisable within 60 days of such date.


Number of Shares

Person or Group

of Common Stock

Percent


Harmel S. Rayat (1)

46,463,056

68%

216-1628 West First Avenue

Vancouver, B.C. V6J 1G1 Canada


Harmel S. Rayat (2)

7,000,000

11%

216-1628 West First Avenue

Vancouver, B.C. V6J 1G1 Canada


Arian Soheili

0

0%

216-1628 West First Avenue

Vancouver, B.C.  V6J 1G1 Canada  

 

Jasvir Kheleh

0

0%

216-1628 West First Avenue

Vancouver, B.C.  V6J 1G1 Canada


Directors and Executive Officers

53,463,056

79%

as a group (3 persons)


(1)  Includes 3,203,194 shares held by Tajinder Chohan, Mr. Harmel S. Rayat's wife. Additionally, other members of Mr. Rayat's family hold shares. Mr. Rayat disclaims beneficial ownership of the shares beneficially owned by his wife and other family members.


(2)  Includes 5,500,000 stock options granted on February 10, 2003 and 1,500,000 stock options granted on August 27, 2003, which may be acquired pursuant to options granted and exercisable under the Company's stock option plans.

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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS


Management fees

During 2004 and 2003, we incurred $9,500 and $28,500, respectively, in management fees to our directors.   Management and consulting fees of $1,600 incurred in 2004 and $27,000 incurred in previous years are included in our accounts payable as at December 31, 2004.


Notes Payable


At a Board of directors meeting held on May 28, 2003, our Board of directors agreed to accept a loan commitment from Mr. Harmel S. Rayat, a director and our major stockholder agreed to loan us up to $750,000 on an “as needed basis.” The commitment was subsequently increased to $1,000,000. Proceeds from the loan are to fund our research and development commitments, legal and audit fees, ongoing investor and public relations costs and other working capital requirements.


In 2003, we drew down $725,000; the loan was reflected by unsecured promissory notes bearing interest at rates ranging from 7.00% to 7.25%. The loans and accrued interest in the amount of $51,500 were paid in 2004.


On August 27, 2004, we again drew down $300,000 from the loan commitment and issued an unsecured promissory note bearing an interest rate of 7.50%, due on August 27, 2005. Accrued interest on the note as at December 31, 2004, of $7,187 is included in accounts payable.  


In December 2004, Mr. Rayat advanced, on our behalf, $700,000.  We issued an unsecured promissory note bearing interest at a rate of prime  plus 3% per annum and due on September 1, 2006.


In March 2005, Mr. Rayat advanced, on our behalf, $250,000.  We issued an unsecured promissory note bearing interest at a rate of 8.50 % due on March 8, 2006.


Amounts payable to related parties


In 2004 we accrued $12,595 in payables to Mr. Harmel S. Rayat for miscellaneous of expenses (including travel expenses) paid or incurred on our behalf.  


Rent Expenses


The Company's office is located at Suite 216, 1628 West 1st Avenue, Vancouver, British Columbia, Canada. A private corporation controlled by Mr. Rayat, our president and chief executive officer, chief financial officer,  principal accounting officer and also one of our directors, owns these premises. We do not pay any rent for the premises. The fair value of the rent has not been included in our financial statements because the amount is immaterial.

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Warrants


Of the 4,700,000 and 2,700,000 stock purchase warrants outstanding as at December 31, 2003 and 2004, respectively, unaffiliated members of Mr. Rayat’s family held 2,700,000 and 2,700,000 stock purchase warrants, respectively, at a price of $0.025. In 2004, we received $50,000 from the exercise of 2,000,000 warrants by the holders of these warrants.


SELLING STOCKHOLDER


The following table presents information regarding the selling stockholder. Neither the selling stockholder or any affiliate thereof has held a position or office, or had any other material relationship, with us. Fusion Capital may acquire additional shares under the common stock purchase agreement.



Selling Stockholders

Shares

Beneficially Owned

Before Offering

Percentage of

Outstanding

Shares

Beneficially

Owned Before

Offering(A)

Shares to be Sold

in the Offering

Percentage of

Outstanding

Shares

Beneficially

Owned After

Offering(B)

Fusion Capital Fund II, LLC

222 Merchandise Mart Plaza

Suite 9-112

Chicago, IL 60654

711,598

.01%

10,711,598

0%

TOTAL

711,598

.01%

10,711,598

0%

     


A.

Percentage of outstanding shares is based on 70,044,420 shares of common stock outstanding as of July 12, 2005, which includes all shares of common stock beneficially owned by the selling stockholders before this offering.

B.

Percentage of outstanding shares is based on shares of common stock outstanding as of July 12, 2005, together with the 10,000,000 shares of common stock that may be purchased by Fusion Capital from us under the common stock purchase agreement. The shares to be issued to Fusion Capital under the common stock purchase agreement are treated as outstanding for the purpose of computing Fusion Capital's percentage ownership. Fusion Capital may not purchase shares of our common stock under the common stock purchase agreement if Fusion Capital, together with its affiliates, would beneficially own more than 9.9% of our common stock outstanding at the time of the purchase by Fusion Capital.  Fusion Capital has the right at any time to sell any shares purchased under the common stock purchase agreement, which would allow it to avoid the 9.9% limitation. Therefore, we do not believe that Fusion Capital will ever reach the 9.9% limitation.

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PLAN OF DISTRIBUTION


The selling stockholder are offering the common stock offered by this prospectus. The common stock may be sold or distributed from time to time by the selling stockholders only for cash directly to one or more purchasers or through brokers, dealers, or underwriters who may act solely as agents at market prices prevailing at the time of sale, at prices related to the prevailing market prices, at negotiated prices, or at fixed prices, which may be changed. The sale of the common stock offered by this Prospectus may be effected in one or more of the following methods:


-  Ordinary brokers’ transactions;

-  Transactions involving cross or block trades;

-  Transactions through brokers, dealers, or underwriters who may act solely as agents;

-  Transactions “at the market” into an existing market for the common stock;

-  Transactions not involving market makers or established trading markets, including direct sales to purchasers or sales effected through agents;

-  In privately negotiated transactions; or

-  Any combination of the foregoing.


In order to comply with the securities laws of certain states, if applicable, the shares may be sold only through registered or licensed brokers or dealers. In addition, in certain states, the shares may not be sold unless they have been registered or qualified for sale in the state or an exemption from the registration or qualification requirement is available and complied with.


Brokers, dealers, underwriters, or agents participating in the distribution of the shares as agents may receive compensation in the form of commissions, discounts, or concessions from the selling stockholders and/or purchasers of the common stock for whom the broker-dealers may act as agent. The compensation paid to a particular broker-dealer may be less than or in excess of customary commissions.


Fusion Capital, the selling stockholder, is an "underwriter" within the meaning of the Securities Act of 1933, as amended.


Neither the selling stockholder nor we can presently estimate the amount of compensation that any agent will receive. We know of no existing arrangements between the selling stockholder, any other stockholders, broker, dealer, underwriter, or agent relating to the sale or distribution of the shares. At the time a particular offer of shares is made, a prospectus supplement, if required, will be distributed that will set forth the names of any agents, underwriters, or dealers and any compensation from the selling stockholder and any other required information.


We will pay all of the expenses incident to the registration, offering, and sale of the shares to the public other than commissions or discounts of underwriters, broker-dealers, or agents. We have also agreed to indemnify Fusion Capital against specified liabilities, including liabilities under the Securities Act of 1933, as amended.


Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, may be permitted to our directors, officers, and controlling persons, we have been advised that in the opinion of the Securities and Exchange Commission this indemnification is against public policy as expressed in the Securities Act of 1933, as amended, and is therefore, unenforceable.

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Fusion Capital and its affiliates have agreed not to engage in any direct or indirect short selling or hedging of our common stock during the term of the common stock purchase agreement.


We have advised the selling stockholder that while they are engaged in a distribution of the shares included in this prospectus they are required to comply with Regulation M promulgated under the Securities Exchange Act of 1934, as amended. With certain exceptions, Regulation M precludes the selling stockholder, any affiliated purchasers, and any broker-dealer or other person who participates in the distribution from bidding for or purchasing, or attempting to induce any person to bid for or purchase any security which is the subject of the distribution until the entire distribution is complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price of a security in connection with the distribution of that security. All of the foregoing may affect the marketability of the shares offered hereby this prospectus.


This offering will terminate on the date that all shares offered by this prospectus by Fusion Capital have been sold.



DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR

SECURITIES ACT LIABILITIES


Our directors and officers are indemnified by our bylaws against amounts actually and necessarily incurred by them in connection with the defense of any action, suit or proceeding in which they are a party by reason of being or having been our directors or officers or of our subsidiaries. Our articles of incorporation provide that none of our directors or officers shall be personally liable for damages for breach of any fiduciary duty as a director or officer involving any act or omission of any such director or officer. Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, may be permitted to such directors, officers and controlling persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the U.S. Securities & 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 us of expenses incurred or paid by such director, officer or controlling person 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, we will, unless in the opinion of 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.

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SHARES ELIGIBLE FOR RESALE


Sales of substantial amounts of our common stock in the public market following this offering could negatively affect the market price of our common stock. Such sales could also impair our future ability to raise capital through the sale of our equity securities.


At the time of this Prospectus, we have outstanding 70,044,420 shares of our common stock. Of these shares, approximately 15,359,500 shares are freely tradable by persons, other than "affiliates", without restriction under the Securities Act of 1933, as amended; and 54,664,930 shares are "restricted" securities, within the meaning of Rule 144 under the Securities Act of 1933, as amended, and may not be sold in the absence of registration under the Securities Act of 1933, as amended, unless an exemption from registration is available, including the exemption provided by Rule 144. On July 12, 2005, our affiliates held 46,463,056 shares. Absent a registration statement covering the resale of such shares, the shares may only be sold pursuant to Rule 144. Mr. Rayat may purchase an additional 7,000,000 shares pursuant to outstanding stock options. Absent a registration statement covering the resale of such shares, when issued, these shares may be resold in a public transaction only pursuant to Rule 144.


In general, under Rule 144, a person or persons whose shares are aggregated, including any affiliate of ours who has beneficially owned restricted securities for at least one year, would be entitled to sell within any three-month period, a number of shares that does not exceed 1% of the number of common stock then outstanding.


     

Sales under Rule 144 are also subject to manner of sale and notice requirements and to the availability of current public information about us. Under Rule 144(k), a person who is not considered to have been an affiliate of ours at any time during the 90 days preceding a sale, and who has beneficially owned restricted securities for at least two years, including the holding period of any prior owner except an affiliate of ours, may sell these shares without following the terms of Rule 144.

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DESCRIPTION OF CAPITAL STOCK


General


We are authorized to issue 300,000,000 shares of common stock, $0.001 par value per share, and 1,000,000 shares of undesignated preferred stock, $0.10 par value per share. The following description of our capital stock does not purport to be complete and is subject to and qualified in its entirety by the provisions of applicable Florida law.


Common Stock


As of July 12, 2005, there were 70,044,420 shares of common stock outstanding, which were held of record by 65 stockholders. All of the issued and outstanding shares of common stock on July 12, 2005, were fully paid and non-assessable.


 The holders of our common stock are entitled to one vote per share on all matters to be voted on by the stockholders. Subject to preferences that may be applicable to any shares of preferred stock that may be outstanding from time to time, holders of common stock are entitled to receive ratably such dividends as may be declared by the board of directors out of funds legally available therefore. In the event we liquidate, dissolve or wind up, holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities and the liquidation preferences of any outstanding shares of preferred stock. Holders of common stock have no preemptive, conversion, or subscription rights. There are no redemption or sinking fund provisions applicable to the common stock. All then outstanding shares of common stock are, and all shares of common stock to be outstanding upon completion of this offering will be, fully paid and non-assessable.


Preferred Stock


Under our articles of incorporation, our board of directors has the authority, without further action by our stockholders, to issue up to 1,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges, qualifications and restrictions granted to or imposed upon such preferred stock, including dividend rights, conversion rights, voting rights, rights and terms of redemption, liquidation preference and sinking fund terms, any or all of which may be greater than the rights of the common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and reduce the likelihood that such holders will receive dividend payments and payments upon liquidation. Such issuance could have the effect of decreasing the market price of the common stock. The issuance of preferred stock or even the ability to issue preferred stock could also have the effect of delaying, deterring or preventing a change in control. We have no present plans to issue any shares of preferred stock.


Options and Warrants

 

As of June 30, 2005, 17,133,000 options for shares were outstanding under our approved stock option plan and 20,925,000 shares were available for future grants under our stock option plan. Holders of options do not have any of the rights or privileges of our stockholders, including voting rights, prior to exercise of the options and warrants. The number of shares of common stock for which these options and warrants are exercisable and the exercise price of these options and warrants are subject to proportional adjustment for stock splits and similar changes affecting our common stock. We have reserved sufficient shares of authorized common stock to cover the issuance of common stock subject to the options and warrants.

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Registrar and Transfer Agent


The registrar and transfer agent for our securities Holladay Stock Transfer, Inc., located at 2939 North 67th Place, Suite C, Scottsdale, AZ   85251.


Registration Rights


 In connection with the July 8, 2005, Fusion Capital transaction (See Fusion Capital Transaction), we entered into a registration rights agreement with Fusion Capital. Pursuant to the terms of the registration rights agreement, we are obligated to file a registration statement with the Securities and Exchange Commission covering shares which may be purchased by or which have been issued to Fusion Capital under the purchase agreement. 


Limitation of Liability; Indemnification


The Florida Business Corporation Act, or FBCA, permits a Florida corporation to indemnify any person who may be a party to any third party proceeding by reason of the fact that such person 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 entity, against liability incurred in connection with such proceeding (including any appeal thereof) if he or she acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.

 

The FBCA permits a Florida corporation to indemnify any person who may be a party to a derivative action if such person acted in any of the capacities set forth in the preceding paragraph, against expenses and amounts paid in settlement not exceeding, in the judgment of the board of directors, the estimated expenses of litigating the proceeding to conclusion, actually and reasonably incurred in connection with the defense or settlement of such proceeding (including appeals), provided that the person acted under the standards set forth in the preceding paragraph. However, no indemnification shall be made for any claim, issue, or matter for which such person is found to be liable unless, and only to the extent that, the court determines that, despite the adjudication of liability, but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnification for such expenses which the court deems proper.

 

The FBCA provides that any indemnification made under the above provisions, unless pursuant to a court determination, may be made only after a determination that the person to be indemnified has met the standard of conduct described above. This determination is to be made by a majority vote of a quorum consisting of the disinterested directors of the board of directors, by duly selected independent legal counsel, or by a majority vote of the disinterested stockholders. The board of directors also may designate a special committee of disinterested directors to make this determination. Notwithstanding the foregoing, the FBCA provides that a Florida corporation must indemnify any director, officer, employee or agent of a corporation who has been successful in the defense of any proceeding referred to above.

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Notwithstanding the foregoing, the FBCA provides, in general, that no director shall be personally liable for monetary damages to our company or any other person for any statement, vote, decision, or failure to act, regarding corporate management or policy, unless: (a) the director breached or failed to perform his duties as a director; and (b) the director’s breach of, or failure to perform, those duties constitutes (i) a violation of criminal law, unless the director had reasonable cause to believe his conduct was lawful or had no reasonable cause to believe his conduct was unlawful, (ii) a transaction from which the director derived an improper personal benefit, either directly or indirectly, (iii) an approval of an unlawful distribution, (iv) with respect to a proceeding by or in the right of the company to procure a judgment in its favor or by or in the right of a stockholder, conscious disregard for the best interest of the company, or willful misconduct, or (v) with respect to a proceeding by or in the right of someone other than the company or a stockholder, recklessness or an act or omission which was committed in bad faith or with malicious purpose or in a manner exhibiting wanton and willful disregard of human rights, safety, or property. The term “recklessness,” as used above, means the action, or omission to act, in conscious disregard of a risk: (a) known, or so obvious that it should have been known, to the directors; and (b) known to the director, or so obvious that it should have been known, to be so great as to make it highly probable that harm would follow from such action or omission.

 

The FBCA further provides that the indemnification and advancement of payment provisions contained therein are not exclusive and it specifically empowers a corporation to make any other further indemnification or advancement of expenses of any of its directors, officers, employees or agents under any bylaw, agreement, vote of stockholders or disinterested directors, or otherwise, both for actions taken in an official capacity and for actions taken in other capacities while holding such office. However, a corporation cannot indemnify or advance expenses if a judgment or other final adjudication establishes that the actions of the director, officer, employee, or agent were material to the adjudicated cause of action and the director, officer, employee, or agent (a) violated criminal law, unless the director, officer, employee, or agent had reasonable cause to believe his or her conduct was unlawful, (b) derived an improper personal benefit from a transaction, (c) was or is a director in a circumstance where the liability for unlawful distributions applies, or (d) engaged in willful misconduct or conscious disregard for the best interests of the corporation in a proceeding by or in right of the corporation to procure a judgment in its favor or in a proceeding by or in right of a stockholder.


We have adopted provisions in our articles of incorporation and bylaws providing that our directors, officers, employees, and agents shall be indemnified to the fullest extent permitted by Florida law. Additionally, our bylaws permit us to secure insurance on behalf of any officer, director, employee, or other agent for any liability arising out of his or her actions in connection with their services to us, regardless of whether our articles or incorporation or bylaws permit such indemnification. We have not yet obtained any such insurance.


Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors or officers pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities Exchange Commission, this indemnification is against public policy as expressed in the Securities Act, and is therefore unenforceable.

65


There is no pending litigation or proceeding involving any of our directors, officers, employees, or other agents as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director, officer, employee, or other agent.

 

Potential Anti-Takeover Effect of Provisions of Florida Law

 

We are subject to several anti-takeover provisions under Florida law that apply to public corporations organized under Florida law, unless the corporation has elected to opt out of those provisions in its articles of incorporation or bylaws. We have not elected to opt out of those provisions. The FBCA prohibits the voting of shares in a publicly-held Florida corporation that are acquired in a “control share acquisition” unless the holders of a majority of the corporation’s voting shares (exclusive of shares held by officers of the corporation, inside directors, or the acquiring party) approve the granting of voting rights as to the shares acquired in the control share acquisition. A “control share acquisition” is defined in the FBCA as an acquisition that immediately thereafter entitles the acquiring party to vote in the election of directors within each of the following ranges of voting power: one-fifth or more but less than one-third of such voting power, one-third or more but less than a majority of such voting power, and more than a majority of such voting power. However, an acquisition of a publicly held Florida corporation’s shares is not deemed to be a control-share acquisition if it is either (i) approved by such corporation’s board of directors, or (ii) made pursuant to a merger agreement to which such Florida corporation is a party.

 

The FBCA also contains an “affiliated transaction” provision that prohibits a publicly-held Florida corporation from engaging in a broad range of business combinations or other extraordinary corporate transactions with any person who, together with affiliates and associates, beneficially owns more than 10% of the corporation’s outstanding voting shares, otherwise referred to as an “interested stockholder,” unless:


-  the transaction is approved by a majority of disinterested directors before the person becomes an interested stockholder,

-  the interested stockholder has owned at least 80% of the corporation’s outstanding voting shares for at least five years, or

-  the transaction is approved by the holders of two-thirds of the corporation’s voting shares other than those owned by the interested stockholder.


Potential Anti-Takeover Effect of our Articles of Incorporation and Bylaws

 

Our articles of incorporation permits our board of directors to issue up to 1,000,000 shares of preferred stock, with such rights, preferences, privileges, and restrictions as are fixed by the board of directors. This gives our board of directors the ability to issue shares of preferred stock which could include the right to approve or not approve an acquisition or other transaction that could result in a change in control.

66






#







EXPERTS


Moore Stephens Ellis Foster Ltd., an independent registered public accounting firm, audited our balance sheets as of December 31, 2004 and 2003, and the statements of operations, stockholders' deficits and cash flows for the years ended December 31, 2004 and 2003. These financial statements are included in this prospectus in reliance on their report, given their authority as experts in accounting and auditing.


Clancy and Co., P.L.L.C., an independent registered public accounting firm, audited our statements of operations, stockholders' equity, and cash flows for the year ended December 31, 2002. These financial statements are included in this prospectus in reliance on their report, given their authority as experts in accounting and auditing.


LEGAL MATTERS


Sierchio Greco & Greco, LLP will pass upon the validity of the issuance of the common stock offered hereby for us.


AVAILABLE INFORMATION


We file current, quarterly and annual reports with the U.S. Securities & Exchange Commission on forms 8-K, 10-QSB and 10-KSB. We have filed with the U.S. Securities & Exchange Commission under the Securities Act of 1933 a registration statement on Form SB-2 with respect to the shares being offered in this offering. This prospectus does not contain all of the information set forth in the registration statement, certain items of which are omitted in accordance with the rules and regulations of the U.S. Securities & Exchange Commission. The omitted information may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission at http://www.sec.gov. Copies of such material can be obtained from the public reference section of the U.S. Securities & Exchange Commission at prescribed rates. Statements contained in this prospectus as to the contents of any contract or other document filed as an exhibit to the registration statement are not necessarily complete and in each instance reference is made to the copy of the document filed as an exhibit to the registration statement, each statement made in this prospectus relating to such documents being qualified in all respects by such reference.

 

For further information with respect to us and the securities being offered hereby, reference is hereby made to the registration statement, including the exhibits thereto and the financial statements, notes, and schedules filed as a part thereof.

67




#







FINANCIAL STATEMENTS


Index To Financial Statements


PAGE

UNAUDITED FINANCIAL STATEMENTS


UNAUDITED INTERIM BALANCE SHEET AS OF JUNE 30, 2005 AND

F-2

DECEMBER 31, 2004



UNAUDITED INTERIM STATEMENTS OF OPERATIONS FOR THE THREE

F-3

AND SIX MONTHS ENDED JUNE 30, 2005 AND 2004, AND FROM INCEPTION

(OCTOBER 21, 1997) TO JUNE 30, 2005


UNAUDITED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

F-4


UNAUDITED INTERIM STATEMENT OF CASH FLOWS FOR THE SIX MONTHS

F-8

ENDED JUNE 30, 2005 AND 2004 AND FROM INCEPTION (OCTOBER 21, 1997)

TO JUNE 30, 2005


UNAUDITED NOTES TO INTERIM FINANCIAL STATEMENTS (JUNE 30, 2005)

F-9


AUDITED FINANCIAL STATEMENTS


REPORT OF INDEPENDENT AUDITOR (MOORE STEPHENS ELLIS FOSTER)

F-13


REPORT OF INDEPENDENT AUDITOR (MOORE STEPHENS ELLIS FOSTER)

F-14


REPORT OF INDEPENDENT AUDITOR (CLANCY AND CO., PLLC)

F-15


BALANCE SHEET AS OF DECEMBER 31, 2004 AND 2003

F-16


STATEMENTS OF OPERATIONS FOR THE YEAR ENDED

F-17

DECEMBER 31, 2004, 2003 AND 2002


STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

F-18

(FROM INCEPTION TO DECEMBER 31, 2004)


STATEMENT OF CASH FLOWS FOR THE YEAR ENDED

F-21

DECEMBER 31, 2004, 2003 AND 2002


NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (DECEMBER 31, 2004)

F-22

F-1




#







In the opinion of management, the accompanying unaudited financial statements included in this Form 10-Q reflect all adjustments necessary for a fair presentation of the results of operations for the periods are presented.  The results of operations for the periods presented are not necessarily indicative of the results to be expected for the full year.


HEPALIFE TECHNOLOGIES, INC.

 (A Development Stage Company)

 INTERIM BALANCE SHEET

JUNE 30, 2005 AND DECEMBER 31, 2004

(Unaudited)

(Expressed in US Dollars)


BASIS OF PRESENTATION (NOTE 1)

ASSETS

June 30, 2005

Dec. 31, 2004

   

Current Assets      

  

   Cash

$254,277

$613,523

Total Current Assets

254,277

613,523

   

Equipment (Note 6)

$566

$828

   

Total Assets

$254,843

$614,351

   

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)

  
   

Current Liabilities

  

   Accounts Payable and Accrued Liabilities

$153,124

$100,243

   Accounts Payable and Accrued Liabilities, Related Party (Note 4)

62,062

53,059

   Notes Payable, Related Party, Unsecured (Note 4 )

950,000

1,000,000

Total Current Liabilities

1,165,186

1,153,302

   

Stockholders' Equity (Deficiency)

  

   Preferred Stock: $0.10 Par Value; Authorized Shares,

     1,000,000 shares; Issued and Outstanding, None


None

None

   Common Stock: $0.001 Par Value; Authorized Shares,

      300,000,000; Issued and Outstanding, 69,332,832 Shares


69,333

67,818

   Additional Paid In Capital

3,737,207

3,141,002

   Loss Accumulated During the Development Stage

(4,716,883)

(3,747,771)

Total Stockholders' Equity (Deficiency)

 (910,343)

(538,951)

   

Total Liabilities and Stockholders’ Equity (Deficiency)

$254,843

$614,351



The accompanying notes are an integral part of these financial statements.


F-2





#







HEPALIFE TECHNOLOGIES, INC.

 (A Development Stage Company)

INTERIM STATEMENTS OF OPERATIONS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2005 AND 2004,

AND FROM INCEPTION (OCTOBER 21, 1997) TO JUNE 30, 2005

(Unaudited)

(Expressed in US Dollars)


 



For The Three Months Ended

June 30, 2005



For The Three Months Ended June 30, 2004



For The Six Months Ended June 30, 2005



For The Six Months Ended June 30, 2004



From Inception (October 21, 1997) to

June 30, 2005

Revenues

$0

$0

$0

$0

$0

      

General and Administrative Expenses

     

   Management fees and consulting fees - Related party

5,098

0

11,051

0

920,365

   Investor Relations

151,267

92,389

679,215

140,600

2,775,634

   Other operating expense – Related Party

   (Note 4)

71,138

50,706

150,223

78,511

640,150

   Research and development expense

65,423

           0

130,846

  20,700

   415,292

      

Total selling, general and administrative expenses

292,926

143,095

971,335

239,811

4,751,441

      

Other Income

     

   Interest Income

(828)

(328)

(2,223)

(880)

(34,558)

      

Provision for income taxes

               0

           0

            0

            0

              0

      

Net loss available to common stockholders

$(292,098)

$(142,767)

$(969,112)

$(238,931)

$(4,716,883)

      

Basic loss per common share (Note 3)

$(0.004)

$(0.002)

$(0.014)

$(0.004)

$(0.105)

      

Basic weighted average common shares outstanding (Note 3)


69,214,041


64,540,832


67,841,064


64,540,832


45,073,047



The accompanying notes are an integral part of these financial statements.

F-3





#




STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)



       

Loss

 

Total

       

accumulated

 

stock-

    

Additional

 

during

 

holders'

 

Common shares

 

paid-in

development

 

equity

 

Shares

Amount

 

capital

 

stage

 

(deficiency)

          

Common stock issued for services rendered

         

  at $0.00025 per share, October 21, 1997

12,000,000

$

12,000

$

(9,000)

$

-

$

3,000

     


 


 


Common stock issued for cash at

    


 


 


$0.0625 per share during 1997

1,200,000

 

1,200

 

73,800

 

-

 

75,000

     


 


 


Comprehensive income

    


 


 


  Income from inception (October 21,

    


 


 


    1997) to December 31, 1997

-

 

-

 

-

 

42

 

42

     


 


 


Balance, December 31, 1997

13,200,000

 

13,200

 

64,800

 

42

 

78,042

     


 


 


Common stock issued for services rendered

    


 


 


  at $0. 025 per share, December 15, 1998

16,000,000

 

16,000

 

384,000

 

-

 

400,000

     


 


 


Comprehensive income (loss)

    


 


 


  Loss, year ended December 31, 1998

-

 

-

 

-

 

(471,988)

 

(471,988)

     


 


 


Balance, December 31, 1998

29,200,000

 

29,200

 

448,800

 

(471,946)

 

6,054

     


 


 


Common stock issued for cash at

    


 


 


  $0. 025 per share, March 1999

12,000,000

 

12,000

 

288,000

 

-

 

300,000

     


 


 


Comprehensive income (loss)

    


 


 


  Loss, year ended December 31, 1999

-

 

-

 

-

 

(121,045)

 

(121,045)

     


 


 


Balance, December 31, 1999

41,200,000

 

41,200

 

736,800

 

(592,991)

 

185,009

     


 


 


Comprehensive income (loss)

    


 


 


  Loss, year ended December 31, 2000

-

 

-

 

-

 

(80,608)

 

(80,608)

     


 


 


Balance, December 31, 2000

41,200,000

 

41,200

 

736,800

 

(673,599)

 

104,401

          

F-4






Conversion of debt to equity at $0.015

      


 


  per share, July 13, 2001

8,933,332

 

8,933

 

125,067

 

-

 

134,000

Comprehensive income (loss)

      


 


  Loss, year ended December 31, 2001

-

 

-

 

-

 

(160,364)

 

(160,364)

       


 


Balance, December 31, 2001

50,133,332

 

50,133

 

861,867

 

(833,963)

 

78,037

       


 


Common stock issued for services at

      


 


  $0.06 per share, April 23, 2002

10,000

 

10

 

590

 

-

 

600

       


 


Conversion of debt to equity at $0.05

      


 


  per share, April 26, 2002

2,160,000

 

2,160

 

105,840

 

-

 

108,000

       


 


Common stock issued for investor relations

      


 


  services at $0.05 per share, July 25 , 2002

2,390,000

 

2,390

 

117,110

 

-

 

119,500

       


 


Conversion of debt to equity at $0.05 per

      


 


  share, December 18, 2002

1,920,000

 

1,920

 

94,080

 

-

 

96,000

       


 


Comprehensive income (loss)

      


 


  Loss, year ended December 31, 2002

-

 

-

 

-

 

(375,472)

 

(375,472)

       


 


Balance, December 31, 2002

56,613,332

 

56,613

 

1,179,487

 

(1,209,435)

 

26,665

       


 


Common stock issued pursuant to

      


 


  exercise of stock options during the year

      


 


  at between $0.07 to $2.11 per share

282,500

 

283

 

398,317

 

-

 

398,600

       


 


Common stock issued pursuant to

      


 


  exercise of share purchase warrants in

      


 


  November 2003 at $0.025 per share

7,300,000

 

7,300

 

175,200

 

-

 

182,500

       


 


Comprehensive income (loss)

      


 


  Loss, year ended December 31, 2003

-

 

-

 

-

 

(1,102,723)

 

(1,102,723)

         


Balance, December 31, 2003

64,195,832

$

64,196

$

1,753,004

$

(2,312,158)

$

(494,958)

         


Common stock issued pursuant to exercise of

        


  stock options during the year

        


  at between $0.07 to $2.11 per share

1,622,000

 

1,622

 

1,339,998

   

1,341,620

         


Common stock issued pursuant to exercise of

        


  share purchase warrants in December 2004

        


  at $0.025 per share

2,000,000

 

2,000

 

48,000

   

50,000

         


Comprehensive income (loss)

        


  Loss, year ended December 31, 2004

      

(1,435,613)

 

(1,435,613)

         


Balance, December 31, 2004

67,817,832

$

67,818

$

3,141,002

$

(3,747,771)

$

(538,951)

         


Common stock issued pursuant to exercise of

        


  stock options during the quarter

        


  at between $2.11 to $3.10 per share

100,000

 

100

 

260,400

   

260,500

         


Common stock issued pursuant to exercise of

        


  share purchase warrants in March 2005

        


  at $0.025 per share

1,250,000

 

1,250

 

30,000

   

31,250

         


Comprehensive income (loss)

        


  Loss, month ended March 31, 2005

      

(677,015)

 

(677,015)

Balance, March 31, 2005

69,167,832

$

69,168

$

3,431,402

$

(4,424,785)

$

(924,215)

Common stock issued pursuant to exercise of

        


  stock options during the quarter

        


  at between $2.11 to $3.10 per share

145,000

 

145

 

305,805

   

305,950

         


Common stock issued pursuant to Confidential Term Sheet

20,000

 

20

 

0

   

20

         


Comprehensive income (loss)

        


  Loss, month ended June 30, 2005

      

(292,098)

 

(292,098)

Balance, June 30, 2005

69,332,832

$

69,333

$

3,737,207

$

(4,716,883)

$

(910,343)



The accompanying notes are an integral part of these financial statements.

F-7










HEPALIFE TECHNOLOGIES, INC.

(A Development Stage Company)

INTERIM STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED JUNE 30, 2005 AND 2004, AND

FOR THE PERIOD FROM INCEPTION (OCTOBER 21, 1997) TO JUNE 30, 2005   

(Unaudited)

(Expressed in US Dollars)


 



Six Months Ended June 30, 2005



Six Months Ended June 30, 2004

  

From Inception (October 21, 1997) to

June 30, 2005

Cash Flows From Operating Activities

   

   Net Loss

$(969,112)

$(238,931)

$ (4,716,883)

   Depreciation

261

0

3,993

   Common Stock Issued For Services

0

0

523,100

   Conversion of Debt to Equity

20

0

338,020

   Adjustments to Reconcile Net Loss to Net Cash Used

   By Operating Activities

   

   Changes in Assets and Liabilities

   

       Increase (Decrease) in Notes Payable

0

   (300,000)

0

       Increase (Decrease) in Accounts Payable

61,885

 (11,507)

215,187

   Total Adjustments

62,166

 (311,507)

1,080,301

Net Cash Flows Used In Operating Activities

(906,946)

(550,438)

(3,636,583)

            

   

Cash Flows From Investing Activities

   

   Purchase of Property and Equipment

0

(545)

(4,560)

   

   

Net Cash Flows Used in Investing Activities

0

(545)

(4,560)

    

Cash Flows From Financing Activities

   

   Proceed From Issuance of Common Stock

597,700

483,150

2,945,420

   Proceed (Repayment) From Promissory Notes

 (50,000)

             0

950,000

Net Cash Flows Provided By Financing Activities

547,700

483,150

3,895,420

    

Increase (Decrease) in Cash

(359,246)

(67,833)

254,277

Cash, Beginning of Period

    613,523   

312,201   

             0

Cash, End of Period

$254,277

$244,368

$254,277

    

Supplemental Information

   

   Cash Paid For:

   

      Interest

$9,432

$0

$61,341

      Income Taxes

$0

$0

$0

 

 

  

   Noncash Investing and Financing Activities:

   

      Conversion of debt to equity

$20

$0

$0

$338,020

      Common Stock Issued For Services

$0

$523,100



The accompanying notes are an integral part of these financial statements.

F-8








HEPALIFE TECHNOLOGIES, INC.

(A Development Stage Company)

NOTES TO INTERIM FINANCIAL STATEMENTS

JUNE 30, 2005

(Unaudited)

(Expressed in US Dollars)



NOTE 1 – BASIS OF PRESENTATION – GOING CONCERN UNCERTAINITIES


The Company has incurred net operating losses since inception. The Company faces all the risks common to companies in their early stages of development, including under capitalization and uncertainty of funding sources, high initial expenditure levels, uncertain revenue streams, and difficulties in managing growth. The Company’s recurring losses raise substantial doubt about its ability to continue as a going concern.  The Company’s financial statements do not reflect any adjustments that might result from the outcome of this uncertainty. The Company expects to incur losses from its business operations and will require additional funding during 2005. The satisfaction of our cash hereafter will depend in large part on the Company’s ability to successfully raise capital from external sources to pay for planned expenditures and to fund operations.


In view of these conditions, the ability of the Company to continue as a going concern is in substantial doubt and dependent upon achieving a profitable level of operations and on the ability of the Company to obtain necessary financing to fund ongoing operations.  Management believes that its current and future plans enable it to continue as a going concern.  These financial statements do not give effect to any adjustments which would be necessary should the Company be unable to continue as a going concern and therefore be required to realize its assets and discharge its liabilities in other than the normal course of business and at amounts different from those reflected in the accompanying financial statements.


NOTE 2 – STATEMENT OF INFORMATION FURNISHED


The accompanying unaudited interim financial statements have been prepared in accordance with Form 10-Q instructions and in the opinion of management contains all adjustments necessary to present fairly the financial position as of June 30, 2005 and December 31, 2004, and the results of operations for three and six months ended June 30, 2005 and June 30, 2004 and cash flows for the six months ended June 30, 2005 and for the same period in 2004.  These results have been determined on the basis of generally accepted accounting principles and practices in the United States and applied consistently with those used in the preparation of the Company's 2004 Annual Report on Form 10-KSB.


Certain information and footnote disclosure normally included in the financial statements presented in accordance with generally accepted accounting principles in the United States have been condensed or omitted.  It is suggested that the accompanying financial statements be read in conjunction with the accompanying financial statements and notes thereto incorporated by reference in the Company's 2004 Annual Report on Form 10-KSB.


NOTE 3 – EARNINGS (LOSS) PER SHARE


Basic earnings or loss per share is based on the weighted average number of common shares outstanding.  Diluted earnings or loss per share is based on the weighted average number of common shares outstanding and dilutive common stock equivalents.  The computation of earnings (loss) per share is net loss available to common stockholders (numerator) divided by the weighted average number of common shares outstanding (denominator) during the periods presented.  All earnings or loss per share amounts in the financial statements are basic earnings or loss per share, as defined by SFAS No. 128, “Earnings Per Share.”  Diluted earnings or loss per share does not differ materially from basic earnings or loss per share for all periods presented.  Convertible securities that could potentially dilute basic earnings or loss per share in the future are not included in the computation of diluted earnings or loss per share because to do so would be antidilutive.  All per share and per share information are adjusted retroactively to reflect stock splits and changes in par value, when applicable.

F-9


The computation of basic and diluted loss per share is as follows:





Three months ended
June 30, 2005



Three months ended
June 30, 2004



Six months

 ended
June 30, 2005



Six months

 ended
June 30, 2004



Inception (October 21, 1997) to

June 30, 2005

Numerator-net loss available to common stockholders


$ (292,098)


$ (142,767)


$ (969,112)


$ (238,931)


$(4,716,883)

Denominator-weighted average number of common shares outstanding

69,214,041

64,540,832

67,841,064

64,540,832

45,073,047

Basic and diluted loss per common share


$(0.004)


$(0.002)


$(0.014)


$(0.004)


$(0.105)



NOTE 4 – RELATED PARTY TRANSACTIONS


Management Fees or Consulting Fees:  During the three months ended June 30, 2005 and 2004, the Company charged $5,098 and $0 to directors, officers and consultants.  During the six months ended June 30, 2005 and 2004, the Company charged $11,051 and $0 to directors, officers and consultants.    As of June 30, 2005, the Company owed $27,000 for outstanding management fees to Mr. Harmel S. Rayat, which is included in accounts payable and accrued liabilities, related party.  There is no management or consulting agreement in effect nor is there an agreement in place to convert debt to equity.


Notes Payable and Accrued Interest:  Notes payable total $950,000 as at June 30, 2005, and represents unsecured loans of $250,000 and $700,000 (both bearing an interest rate of 8.50%) due to Mr. Harmel S. Rayat, a Director, President and majority shareholder of the Company.  The entire principal and accrued interest is due and payable on demand.  Accrued and unpaid interest on these notes during the three and six month period ended June 30, 2005, amounted to $20,187 and $35,062, respectively (2004-$23,738).


Properties:  The Company's office is located at Suite 216, 1628 West 1st Avenue, Vancouver, BC, V6J 1G1.  These premises are owned by a private corporation controlled by a director and majority shareholder of the Company.  At present, the Company pays no rent.  The fair value of the rent has not been included in the financial statements because the amount is immaterial.


NOTE 5 – COOPERATIVE AGREEMENT


On November 1, 2002, the Company entered into a Cooperative Research and Development Agreement (the “agreement”) with the United States Department of Agriculture’s (USDA) Agricultural Research Service (ARS), and committed a total payment of $292,727 to ARS over two year period, ending February 19, 2005.


On May 24, 2004, the Agreement was extended to September 30, 2007 and required total payments to ARS was amended to $807,828 with a revised schedule of repayment as follows:

F-10


-  $65,422.80 on or before 8/1/04 (paid in 2004);

-  $65,422.80 on or before 11/1/04 (paid in 2005);

-  $65,422.80 on or before 2/1/05 (included in accounts payable);

-  $65,422.80 on or before 5/1/05 (included in accounts payable);

-  $65,422.80 on or before 8/1/05;

-  $65,422.80 on or before 11/1/05;

-  $65,422.80 on or before 2/1/06;

-  $65,422.80 on or before 5/1/06;

-  $65,422.80 on or before 8/1/06; and

-  $65,422.80 on or before 11/1/06.


As at June 30, 2005, total payments of $415,292 have been paid/accrued.  

As amended, the Company, instead of ARS as in the original agreement, has the first option to prepare and prosecute patent or Plant Variety Protection Certificate applications, foreign and domestic, on subject invention owned or co-owned by the U.S Government, subject to certain conditions.

The agreement is for the purpose of funding salaries, equipment, travel and other indirect costs of one post-doctoral researcher, one support scientist, and one technician. The terms of the agreement require the interaction of the Company with ARS personnel on the technical details involved with pig liver cell culture development, providing the necessary funds for the purpose above, preparing and filing any patent applications, and reviewing reports and implementing procedures for the development of an artificial liver device utilizing the pig liver cell line.  ARS’s responsibilities include hiring the post-doctoral research associate for a two-year period, providing laboratory and office space for the research associate, providing experimental animals (pigs) and slaughter facilities, conducting the research, preparing progress reports on project objectives, and preparing and submitting technical reports for publication.

All rights, title, and interest in any subject invention made solely by ARS employees are owned by ARS, solely by the Company are owned by the Company, and owned jointly between the Company and ARS if made jointly by ARS and the Company. The Company is granted an option to negotiate an exclusive license in each subject invention owned or co-owned by ARS for one or more field (s) of use encompassed by the agreement. The option terminates when the Company fails to (1) submit a complete application for an exclusive license within sixty days of being notified by ARS of an inventions availability for licensing or (2) submit a good faith written response to a written proposal of licensing terms within forty five days of such proposal.

The agreement, or parts thereof, is subject to termination at any time by mutual consent.  Either party may unilaterally terminate the entire agreement at any time by giving the other party written notice not less than sixty calendar days prior to the desired termination date.

F-11

NOTE 6 – EQUIPMENT


 

June 30, 2005

December 31, 2004

Computer equipment

$3,471

$3,471

Furniture and fixtures

$1,089

$1,089

 

$4,560

$4,560

Less: Accumulated depreciation

($3,994)

($3,732)

 

$566

$828

 




Depreciation expense charged to operations as of June 30, 2005 was $261 (2004 – $0).



NOTE 7 – SUBSEQUENT EVENTS


On July 8, 2005, HepaLife Technologies, Inc. (the “Company”) entered into a Common Stock Purchase Agreement (“Purchase Agreement”) and a Registration Rights Agreement (“Registration Agreement”) with Fusion Capital Fund II, LLC (“Fusion Capital”). Pursuant to the terms of the Purchase Agreement, the Company agreed to issue to Fusion 711,598 (subject to possible adjustment) of its common stock, which Fusion has agreed to hold for thirty (30) months, and Fusion Capital has agreed to purchase from the Company up to $15,000,000 of the Company’s common stock over a thirty (30) month period. Pursuant to the terms of the Registration Agreement, the Company has agreed to file a registration statement (the “Registration Statement”) with the Securities and Exchange Commission covering shares which may be purchased by Fusion Capital under the Purchase Agreement.


Once the Registration Statement has been declared effective, each trading day during the term of the Purchase Agreement the Company has the right to sell to Fusion Capital $25,000 of the Company’s common stock at a purchase price equal to the lower of (a) the lowest sale price of the common stock on such trading day and (b) the arithmetic average of the three (3) lowest closing sale prices for the common stock during the twelve (12) consecutive trading days immediately preceding the date of purchase. At the Company’s option, Fusion Capital can be required to purchase fewer or greater amounts of common stock each month. The company has the right to control the timing and the number of shares sold to Fusion Capital. This offering was made pursuant to an exemption from registration provided by Section 4(2) of the Securities Act, 1933, as amended.


On August 12, 2005, the Company announced the appointment of Mr. Harmel S. Rayat, a current director, to the position of president and chief executive officer. Mr. Rayat will also assume the position of Chief Financial Officer and Principal Accounting Officer.  Mr. Arian Soheili, the Company's former president and CEO, remains with HepaLife as a director, secretary and treasurer.

F-12







REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM



To the Board of Directors and Stockholders of


HEPALIFE TECHNOLOGIES, INC.

(formerly Zeta Corporation)

(A development stage company)


We have audited the balance sheet of Hepalife Technologies, Inc. (formerly Zeta Corporation) (A development stage company) (“the Company”) as at December 31, 2004 and the related statements of stockholders’ equity (deficiency), operations and cash flows for the years ended December 31, 2004 and 2003 and the cumulative data from October 21, 1997 (inception) to December 31, 2004.  These financial statements are the responsibility of the Company's management.  Our responsibility is to express an opinion on these financial statements based on our audit.  The Company’s financial statements for the period from October 21, 1997 (inception) to December 31, 2002 were audited by other auditors whose report, dated March 3, 2003, expressed an unqualified opinion, has been furnished to us.  Our opinion, insofar as it relates to the amounts included for cumulative data from October 21, 1997 (inception) to December 31, 2002, is based solely on the report of the other auditors.


We conducted our audit in accordance with standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform an audit to obtain reasonable assurance whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audit provide a reasonable basis for our opinion.


In our opinion, these financial statements present fairly, in all material respects, the financial position of the Company as at December 31, 2004 and the results of its operations and its cash flows for the years ended December 31, 2004 and 2003 and the cumulative data from October 21, 1997 (inception) to December 31, 2004 in conformity with generally accepted accounting principles in the United States of America.  


The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.  As discussed in Note 1 to the financial statements, the Company is a development stage company since inception on October 21, 1997, and has incurred significant recurring net losses since then resulting in a substantial accumulated deficit, which raise substantial doubt about its ability to continue as a going concern.  The Company is devoting substantially all of its present efforts in establishing its business.  Management’s plans regarding these matters are also disclosed in Note 1 to the financial statements.  The ability to meet its future financing requirements and the success of future operations cannot be determined at this time. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.




Vancouver, Canada

MOORE STEPHENS ELLIS FOSTER LTD.”


March 15, 2005

Chartered Accountants

F-13










REPORT OF INDEPENDENT AUDITORS


To the Board of Directors and Stockholders of


HEPALIFE TECHNOLOGIES, INC.

(formerly Zeta Corporation)

(A development stage company)



We have audited the balance sheet of Hepalife Technologies, Inc. (formerly Zeta Corporation) (A development stage company) (“the Company”) as at December 31, 2003 and the related statements of stockholders’ equity (deficiency), operations and deficit and cash flows for the year ended December 31, 2003.  These financial statements are the responsibility of the company's management.  Our responsibility is to express an opinion on these financial statements based on our audit.  We did not audit the cumulative data from October 21, 1997 (inception) to December 31, 2002 in the statements of stockholders’ equity, operations and cash flows, which were audited by other auditors whose report, dated March 3, 2003, which expressed an unqualified opinion, has been furnished to us.  Our opinion, insofar as it relates to the amounts included for cumulative data from October 21, 1997 (inception) to December 31, 2002, is based solely on the report of the other auditors.


We conducted our audit in accordance with auditing standards generally accepted in the United States of America.  Those standards require that we plan and perform an audit to obtain reasonable assurance whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audit provide a reasonable basis for our opinion.


In our opinion, these financial statements present fairly, in all material respects, the financial position of the Company as at December 31, 2003 and the results of its operations and its cash flows for the year then ended in conformity with generally accepted accounting principles in the United States of America.  


The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.  As discussed in Note 1 to the financial statements, the Company is a development stage company since inception on October 21, 1997, and has incurred significant recurring net losses since then resulting in a substantial accumulated deficit, which raise substantial doubt about its ability to continue as a going concern.  The Company is devoting substantially all of its present efforts in establishing its business.  Management’s plans regarding the matters that raise substantial doubt about the Company’s ability to continue as a going concern are also disclosed in Note 1 to the financial statements.  The ability to meet its future financing requirements and the success of future operations cannot be determined at this time. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.




Vancouver, Canada

MOORE STEPHENS ELLIS FOSTER LTD.”


March 15, 2004

Chartered Accountants

F-14








2002 AUDITOR LETTER


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM



To the Board of Directors and Stockholders of  

Hepalife Technologies, Inc. (formerly Zeta Corporation)


We have audited the accompanying statements of operations, changes in stockholders’ equity, and cash flows for the year ended December 31, 2002 and the cumulative data from October 21, 1997 (inception) to December 31, 2002, of Hepalife Technologies, Inc. (formerly Zeta Corporation) (a development stage company, the “Company”), a Florida Corporation. These financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these statements based on our audit.


We conducted our audit, in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audit provides a reasonable basis for our opinion.


In our opinion the financial statements referred to above present fairly, in all material respects, the Company’s results of operations and its cash flows for the year ended December 31, 2002, and the cumulative data from October 21, 1997 (inception) to December 31, 2002, in conformity with generally accepted accounting principles in the United States.


The accompanying financial statements have been prepared assuming the Company will continue as a going concern.  As discussed in Note 2 to the financial statements, the Company is a development stage company since inception on October 21, 1997, and has incurred significant recurring net losses since inception resulting in a substantial accumulated deficit.  The Company is devoting substantially all of its present efforts in establishing its business.  Management’s plans regarding the matters that raise substantial doubt about the Company’s ability to continue as a going concern are also disclosed in Note 2 to the financial statements.  The ability to meet its future financing requirements and the success of future operations cannot be determined at this time.  These factors raise substantial doubt about its ability to continue as a going concern.  These financial statements do not include any adjustments that might result from the outcome of this uncertainty.  



Clancy and Co., P.L.L.C.

Phoenix, Arizona


March 3, 2003

F-15










HEPALIFE TECHNOLOGIES, INC.


BALANCE SHEET

DECEMBER 31, 2004 and 2003


 

Years Ended December 31

 

2003

2004

ASSETS

  
   

Current Assets      

  

   Cash

$312,201

$613,523

Total Current Assets

312,201

613,523

   

Equipment , net

-

828

Total Assets

$312,201

$614,351

   

LIABILITIES AND STOCKHOLDERS' (DEFICIENCY)

  
   

Current Liabilities

  

   Accounts Payable and Accrued Liabilities

$82,159

$100,243

   Accounts Payable and Accrued Liabilities – Related Party

-

53,059

   Notes Payable – Related Party

725,000

1,000,000

Total Current Liabilities

807,159

1,153,302

   

Stockholders' Equity (Deficiency)

  

   Preferred Stock: $0.10 Par Value; Authorized Shares,                                1,000,000 shares; Issued and Outstanding, None            


-


-

   Common Stock: $0.001 Par Value; Authorized Shares, 300,000,000; Issued and Outstanding, 69,167,832 Shares


64,196


67,818

   Additional Paid In Capital

1,753,004

3,141,002

   Loss Accumulated During the Development Stage

(2,312,158)

(3,747,771)

Total Stockholders' Equity (Deficiency)

(494,958)

(538,951)

   

Total Liabilities and Stockholders’ Equity (Deficiency)

$312,201

$614,351



The accompanying notes are an integral part of these financial statements.

F-16










 HEPALIFE TECHNOLOGIES, INC.


STATEMENTS OF OPERATIONS

FOR THE YEARS ENDED DECEMBER 31, 2004, 2003 AND 2002



  

Years Ended December 31

  

2002

2003

2004

Revenues

 

$0

$0

$0

     

General and administrative

    

   Management fees and consulting fees – Related party

 

144,600

28,500

9,500

   Investor Relations

 

119,500

960,003

1,016,916

   Other operating expense

 

21,823

73,767

259,572

   Research and Development

 

91,500

41,400

151,546

     

Total General and Administrative Expenses

 

377,423

1,103,670

1,437,534

     

Other Income

    

   Interest Income

 

(1,951)

(947)

(1,921)

     

Provision for Income Taxes

 

-

-

-

     

Net Loss Available to Common Stockholders

 

($375,472)

($1,102,723)

($1,435,613)

     

Basic and Diluted Loss Per Common Share

 

($0.007)

($0.019)

($0.020)

     

Weighted Average Common Shares Outstanding

 

52,723,277

57,817,305

64,610,777


The accompanying notes are an integral part of these financial statements.

F-17







HEPALIFE TECHNOLOGIES, INC.


STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIENCY)



       

Loss

 

Total

       

accumulated

 

stock-

    

Additional

 

during

 

holders'

 

Common shares

 

paid-in

development

 

equity

 

Shares

Amount

 

capital

 

stage

 

(deficiency)

          

Common stock issued for services rendered

         

  at $0.00025 per share, October 21, 1997

12,000,000

$

12,000

$

(9,000)

$

-

$

3,000

     


 


 


Common stock issued for cash at

    


 


 


$0.0625 per share during 1997

1,200,000

 

1,200

 

73,800

 

-

 

75,000

     


 


 


Comprehensive income

    


 


 


  Income from inception (October 21,

    


 


 


    1997) to December 31, 1997

-

 

-

 

-

 

42

 

42

     


 


 


Balance, December 31, 1997

13,200,000

 

13,200

 

64,800

 

42

 

78,042

     


 


 


Common stock issued for services rendered

    


 


 


  at $0. 025 per share, December 15, 1998

16,000,000

 

16,000

 

384,000

 

-

 

400,000

     


 


 


Comprehensive income (loss)

    


 


 


  Loss, year ended December 31, 1998

-

 

-

 

-

 

(471,988)

 

(471,988)

     


 


 


Balance, December 31, 1998

29,200,000

 

29,200

 

448,800

 

(471,946)

 

6,054

     


 


 


Common stock issued for cash at

    


 


 


  $0. 025 per share, March 1999

12,000,000

 

12,000

 

288,000

 

-

 

300,000

     


 


 


Comprehensive income (loss)

    


 


 


  Loss, year ended December 31, 1999

-

 

-

 

-

 

(121,045)

 

(121,045)

     


 


 


Balance, December 31, 1999

41,200,000

 

41,200

 

736,800

 

(592,991)

 

185,009

     


 


 


Comprehensive income (loss)

    


 


 


  Loss, year ended December 31, 2000

-

 

-

 

-

 

(80,608)

 

(80,608)

     


 


 


Balance, December 31, 2000

41,200,000

 

41,200

 

736,800

 

(673,599)

 

104,401

          


F-18






Conversion of debt to equity at $0.015

      


 


  per share, July 13, 2001

8,933,332

 

8,933

 

125,067

 

-

 

134,000

Comprehensive income (loss)

      


 


  Loss, year ended December 31, 2001

-

 

-

 

-

 

(160,364)

 

(160,364)

       


 


Balance, December 31, 2001

50,133,332

 

50,133

 

861,867

 

(833,963)

 

78,037

       


 


Common stock issued for services at

      


 


  $0.06 per share, April 23, 2002

10,000

 

10

 

590

 

-

 

600

       


 


Conversion of debt to equity at $0.05

      


 


  per share, April 26, 2002

2,160,000

 

2,160

 

105,840

 

-

 

108,000

       


 


Common stock issued for investor relations

      


 


  services at $0.05 per share, July 25 , 2002

2,390,000

 

2,390

 

117,110

 

-

 

119,500

       


 


Conversion of debt to equity at $0.05 per

      


 


  share, December 18, 2002

1,920,000

 

1,920

 

94,080

 

-

 

96,000

       


 


Comprehensive income (loss)

      


 


  Loss, year ended December 31, 2002

-

 

-

 

-

 

(375,472)

 

(375,472)

       


 


Balance, December 31, 2002

56,613,332

 

56,613

 

1,179,487

 

(1,209,435)

 

26,665

       


 


Common stock issued pursuant to

      


 


  exercise of stock options during the year

      


 


  at between $0.07 to $2.11 per share

282,500

 

283

 

398,317

 

-

 

398,600

       


 


Common stock issued pursuant to

      


 


  exercise of share purchase warrants in

      


 


  November 2003 at $0.025 per share

7,300,000

 

7,300

 

175,200

 

-

 

182,500

       


 


Comprehensive income (loss)

      


 


  Loss, year ended December 31, 2003

-

 

-

 

-

 

(1,102,723)

 

(1,102,723)

         


Balance, December 31, 2003

64,195,832

$

64,196

$

1,753,004

$

(2,312,158)

$

(494,958)

         


Common stock issued pursuant to exercise of

        


  stock options during the year

        


  at between $0.07 to $2.11 per share

1,622,000

 

1,622

 

1,339,998

   

1,341,620

         


Common stock issued pursuant to exercise of

        


  share purchase warrants in December 2004

        


  at $0.025 per share

2,000,000

 

2,000

 

48,000

   

50,000

         


Comprehensive income (loss)

        


  Loss, year ended December 31, 2004

      

(1,435,613)

 

(1,435,613)

         


Balance, December 31, 2004

67,817,832

$

67,818

$

3,141,002

$

(3,747,771)

$

(538,951)



The accompanying notes are an integral part of these financial statements

F-20










HEPALIFE TECHNOLOGIES, INC.

(A Development Stage Company)

STATEMENTS OF CASH FLOWS

FOR THE YEARS ENDED DECEMBER 31, 2004, 2003 AND 2002




 

Years Ended December 31

 

2002

2003

2004

Cash Flows From (Used In) Operating Activities

   

   Net Loss for the Period

($375,472)

($1,102,723)

($1,435,613)

   Adjustments to Reconcile Net Loss to Net Cash Used                    

   

   In  Operating Activities

   

      Common Stock Issued For Services

120,100

-

-

      Depreciation

1,153

583

261

      Conversion of Debt to Equity

204,000

-

-

   Changes in Assets and Liabilities

   

       Increase (Decrease) in Accounts Payable

(57,910)

79,639

18,084

      Increase (Decrease) in Accounts Payable – Related Parties

-

-

53,059

Net Cash Flows Used In Operating Activities

(108,129)

(1,022,501)

(1,364,209)

            

   

Cash Flows From Investing Activities

   

   Purchase of Property and Equipment

-

-

(1,089)

Net Cash Flows Used In Investing Activities

-

-

(1,089)

Cash Flows From (Used In) Financing Activities

   

   Net Proceed From Notes Payable

-

725,000

275,000

   Proceed From Issuance of Common Stock

-

581,100

1,391,620

Net Cash Flows Provided By Financing Activities

-

1,306,100

1,666,620

    

Increase (Decrease) in Cash and Cash Equivalents

(108,129)

283,599

301,322

Cash and Cash Equivalents, Beginning of Period

136,731

28,602

312,201

Cash and Cash Equivalents, End of Period

$28,602

$312,201

$613,523

    

Supplemental Information

   

Cash paid for:

   

      Interest

$-

$-

$51,909

      Income Taxes

$-

$-

$-

Noncash investing and financing activities:

   

      Conversion of debt to equity

$204,000

$-

$-

      Common Stock Issued For Services

$120,100

$-

$-


The accompanying notes are an integral part of these financial statements.

F-21






#







HEPALIFE TECHNOLOGIES, INC.


NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2004


1.  Organization and Nature of Operations

Hepalife Technologies, Inc. (formerly Zeta Corporation) (the “Company”) was incorporated under the laws of the State of Florida on October 21, 1997, with an authorized capital of 100,000,000 shares of common stock, par value of $0.001 per share, and 1,000,000 shares of $0.10 par value preferred stock, which may be divided into series with the rights and preferences of the preferred stock to be determined by the Board of Directors. On August 12, 2001, Articles of Amendment to the Articles of Incorporation were filed in the State of Florida to increase the authorized capital stock of the Company to 300,000,000 shares of $0.001 par value common stock.

The Company’s current business includes a Cooperative Research and Development Agreement entered into with the United States Department of Agriculture’s Agricultural Research Service to fund the research and development involving optimizing the function of a patented cell line and applying this technology to the development of extra corporeal liver assist device.

The accompanying financial statements have been prepared in conformity with generally accepted accounting principles, which contemplates continuation of the Company as a going concern. However, the Company has sustained substantial operating losses since inception resulting in a substantial accumulated deficit and has used substantial amounts of working capital in its operations. In view of these matters, the continued operations of the Company is dependent upon the Company’s ability to meet its financing requirements, and the success of its future operations. The Company expects to incur losses as it expands its business and will require additional funding during 2005.

To meet these objectives, the Company plans to seek additional equity and expects to raise funds through a private or public equity investment in order to support existing operations and expand the range and scope of its business. There is no assurance that such additional funds will be available for the Company on acceptable terms, if at all. The Company anticipates that its major stockholder will contribute sufficient funds to satisfy the cash needs of the Company through calendar year ending December 31, 2005, however, there can be no assurances to that effect. If adequate funds are not available or not available on acceptable terms, the Company may be (i) unable to fund further research and operating plans, (ii) required to scale back or abandon our research and product development activities, (iii) reduce our workforce, and (iv) license to others products or technologies we would otherwise seek to commercialize ourselves, all of which could have a material adverse effect on our business, results of operations and financial condition. Management believes that actions presently taken to revise the Company’s operating and financial requirements provide the opportunity for the Company to continue as a going concern. The Company’s ability to achieve these objectives cannot be determined at this time.

 

2.  Summary of Significant Accounting Policies


(a)  Principles of Accounting


These financial statements are stated in U.S. Dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America.

F-22


(b)  Use of Estimates


The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management makes its best estimate of the ultimate outcome for these items based on historical trends and other information available when the financial statements are prepared. Changes in estimates are recognized in accordance with the accounting rules for the estimate, which is typically in the period when new information becomes available to management. Actual results could differ from those estimates.

(c)  Cash and Cash Equivalents

The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents for the year ended December 31, 2004.

(d)  Equipment and Depreciation

Property and equipment, stated at cost and are depreciated under the straight-line method over their estimated useful lives.  Repairs and maintenance are charged to operations as incurred.

(e)  Research and Development Costs

Research and development costs are expensed as incurred.

(f)  Start-up Costs

The Company accounts for start-up costs in accordance with Statement of Position (SOP) 98-5, “Reporting on the Costs of Start-up Activities.”, where they are expensed as incurred. For income tax purposes, the Company has elected to treat its organizational costs as deferred expenses and amortize them over a period of sixty months, beginning in the first month the Company is actively in business.

(g)  Income Taxes

The Company accounts for income taxes under the provisions of SFAS No. 109, “Accounting for Income Taxes.” Under SFAS No. 109, deferred income tax assets and liabilities are computed for differences between the financial statements and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future, based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary, to reduce deferred income tax assets to the amount expected to be realized.

(h)  Earnings (Loss) Per Share

Basic earnings (loss) per share is based on the weighted average number of common shares outstanding. Diluted earnings (loss) per share is based on the weighted average number of common shares outstanding and dilutive common stock equivalents. Basic earnings (loss) per share is computed by dividing income/loss (numerator) applicable to common stockholders by the weighted average number of common shares outstanding (denominator) for the period. All earnings (loss) per share amounts in the financial statements are basic earnings or loss per share, as defined by SFAS No. 128, “Earnings Per Share.” Diluted earnings (loss) per share does not differ materially from basic earnings (loss) per share for all periods presented. Convertible securities that could potentially dilute basic earnings per share in the future, such as options and warrants, are not included in the computation of diluted earnings or loss per share because to do so would be antidilutive. All per share and per share information are adjusted retroactively to reflect stock splits and changes in par value.

(i)  Advertising Expenses

The Company expensed advertising costs as incurred. The Company did not incur any advertising costs during the years ended December 31, 2004 and 2003.

F-23


(j)  Stock-Based Compensation


The Company accounts for stock-based compensation using the intrinsic value method prescribed in Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees.” Compensation cost for stock options, if any, is measured as the excess of the quoted market price of the Company’s stock at the date of grant over the amount an employee must pay to acquire the stock. SFAS No.123, “Accounting for Stock-Based Compensation,” established accounting and disclosure requirements using a fair-value-based method of accounting for stock-based employee compensation plans. The Company has elected to remain on its current method of accounting as described above, and has adopted the disclosure requirements of SFAS No. 123.

(k)  Comprehensive Income

The Company adopted Statement of Financial Accounting Standards No. 130 (SFAS No. 130), "Reporting Comprehensive Income", which establishes standards for reporting and display of comprehensive income, its components and accumulated balances.  The Company is disclosing this information on its Statements of Stockholders' Equity (Deficiency).  Comprehensive income comprises equity except those resulting from investments by owners and distributions to owners.  

(l)  Foreign Currency Translation

The Company maintains both U.S. Dollar and Canadian Dollar bank accounts at a financial institution in Canada. Foreign currency transactions are translated into their functional currency, which is U.S. Dollar, in the following manner:

At the transaction date, each asset, liability, revenue and expense is translated into the functional currency by the use of the exchange rate in effect at that date. At the period end, monetary assets and liabilities are translated into U.S. Dollars by using the exchange rate in effect at that date. Transaction gains and losses that arise from exchange rate fluctuations are included in the results of operations.

(m)  Intangible Assets

The Company adopted SFAS No. 142, “Goodwill and Other Intangible Assets” as of January 1, 2002, which presumes that goodwill and certain intangible assets have indefinite useful lives. Accordingly, goodwill and certain intangibles will not be amortized but rather will be tested at least annually for impairment. SFAS No. 142 also addresses accounting and reporting for goodwill and other intangible assets subsequent to their acquisition.

The Company did not have any goodwill or intangible assets with indefinite or definite life since its inception.

(n)  Impairment of Long-Lived Assets

Long-lived assets of the Company are reviewed for impairment when changes circumstances require as to whether their carrying value has become impaired, pursuant to guidance established in the Statement of Fianncial Accounting Standards No 144 (SFAS 144), Accounting for the Impairment or Disposal of Long-Lived Assets.  Management considers assets to be impaired if the carrying amount of an asset exceeds the future projected cash flows from related operations (undiscounted and without interest charges).  If impairment is deemed to exist, the asset will be written down to fair value, and a loss is recorded as the difference between the carrying value and the fair value. Fair values are determined based on quoted market values, discounted cash flows or internal and external appraisals, as applicable. Assets to be disposed of are carried at the lower of carrying value or estimated net realizable value.

(o)  Fair Value of Financial Instruments

Fair value of financial instruments is made at a specific point in time, based on relevant information about financial markets and specific financial instruments.  As these estimates are subjective in nature, involving uncertainties and matters of significant judgement, they cannot be determined with precision.  Changes in assumptions can significantly affect estimated fair values.

F-24

The carrying value of cash and cash equivalents and accounts payable and accrued liabilities approximate their fair value because of the short-term nature of these instruments. The Company places its cash and cash equivalents with high credit quality financial institutions.

The Company operates outside of the United States of America and is exposed to foreign currency risk due to the fluctuation between the currency in which the Company operates in and the U.S. dollar.

(p)  Accounting for Derivative Instruments and Hedging Activities

The Company adopted Statement of Financial Accounting Standards Board No. 133 (SFAS 133), Accounting for Derivative Instruments and Hedging Activities, which requires companies to recognize all derivatives contracts as either assets or liabilities in the balance sheet and to measure them at fair value.  If certain conditions are met, a derivative may be specifically designated as a hedge, the objective of which is to match the timing of gain or loss recognition on the hedging derivative with the recognition of (i) the changes in the fair value of the hedged asset or liability that are attributable to the hedged risk or (ii) the earnings effect of the hedged forecasted transaction.  For a derivative not designated as a hedging instrument, the gain or loss is recognized in income in the period of change.

The Company has not entered into derivative contracts either to hedge existing risks or for speculative purposes.  The adoption of this pronouncement does not have an impact on the Company’s financial statements.

(q)  Related Party Transactions

A related party is generally defined as (i) any person that holds 10% or more of the Company’s securities and their immediate families, (ii) the Company’s management, (iii) someone that directly or indirectly controls, is controlled by or is under common control with the Company, or (iv) anyone who can significantly influence the financial and operating decisions of the Company. A transaction is considered to be a related party transaction when there is a transfer of resources or obligations between related parties. (See Note 4).

(r)  New Accounting Pronouncements

In November 2004, the FASB issued SFAS No. 151, “Inventory Costs-an amendment of ARB No. 43, Chapter 4”, which is the result of the FASB’s project to reduce differences between U.S. and international accounting standards. SFAS No. 151 requires idle facility costs, abnormal freight, handling costs, and amounts of wasted materials (spoilage) be treated as current-period costs. Under this concept, if the costs associated with the actual level of spoilage or production defects are greater than the costs associated with the range of normal spoilage or defects, the difference would be charged to current-period expense, not included in inventory costs. SFAS No. 151 will be effective for inventory costs incurred during fiscal years beginning after June 15, 2005.  The adoption of SFAS No. 151 will not have a material impact on the Company’s financial statements.


In December 2004, the FASB issued SFAS No. 153, Exchanges of Nonmonetary Assets, an amendment of APB No. 29, Accounting for Nonmonetary Transactions. SFAS No. 153 requires exchanges of productive assets to be accounted for at fair value, rather than at carryover basis, unless (1) neither the asset received nor the asset surrendered has a fair value that is determinable within reasonable limits or (2) the transactions lack commercial substance. SFAS 153 is effective for nonmonetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. The adoption of FASB No. 153 will not have a material impact on the Company’s financial statements.


In December 2004, the FASB issued SFAS No. 123(R), "Accounting for Stock-Based Compensation". SFAS 123(R) establishes standards for the accounting for transactions in which an entity exchanges its equity instruments for goods or services. This Statement focuses primarily on accounting for transactions in which an entity obtains employee services in share-based payment transactions. SFAS 123(R) requires that the fair value of such equity instruments be recognized as expense in the historical financial statements as services are performed. Prior to SFAS 123(R), only certain pro-forma disclosures of fair value were required. SFAS 123(R) shall be effective for the Company as of the beginning of the first interim or annual reporting period that begins after December 15, 2005. The adoption of FASB No. 123(R), will not have a material impact on the Company’s financial statements.

F-25


3.  Equipment

2004

Computer equipment

            $3,471

Furniture and fixtures

1,089

4,560

Less: Accumulated depreciation

             (3,732)

 

 $828


Depreciation expense charged to operations during 2004 was $261 (2003 – $583; 2002-$1,153).

4.  Related Party Transactions

(a)  Management fees

During 2004, the Company incurred $9,500 (2003 – $28,500; 2002-$144,600) in management fees to directors of the Company.  Included in accounts payable – related parties at December 31, 2004 is management and consulting fees of $1,600 incurred in 2004 and $27,000 incurred in previous years.

(b)  Notes Payable

At a Board of Directors meeting held on May 28, 2003, the Company’s Board of Directors agreed to accept a loan of up to $750,000 from a director and major stockholder of the Company.  Proceeds from the loan, which will be drawn down on a “as needed basis”, will be used to fund the Company’s research and development commitments, legal and audit fees, investor and public relations costs and other ongoing working capital requirements.

Total unsecured promissory notes issued in 2003 of $725,000 bearing interest at rates ranging from 7.00% to 7.25% were repaid in 2004 including accrued interest of $51,500.  

On August 27, 2004, the Company drew down $300,000 from the loan commitment and issued an unsecured promissory note bearing an interest rate of 7.50%, due on August 27, 2005.  

Accrued interest as at December 31, 2004 of $7,187 is included in accounts payable – related parties.

In December 2004, the same director and major stockholder of the Company paid $700,000 in investor relation fees on behalf of the Company.  For reimbursement, the Company issued an unsecured promissory note bearing interest at a rate of prime plus 3% per annum and due on September 1, 2006.

(c)  Amounts payable to related parties

Included in accounts payable – related parties is $17,272 (2003 - $nil) payable to various stockholders for expenses incurred on behalf of the Company, of which $12,595 is payable to the same director and majority stockholder in note 4b.

(d)  Rent Expenses

The Company's office is located at Suite 216, 1628 West 1st Avenue, Vancouver, British Columbia, Canada. These premises are owned by a private corporation of the same director and officer of the Company in note 4b. At present, the Company pays no rent. The fair value of the rent has not been included in the financial statements because the amount is immaterial.

F-26

(e)  Warrants

All 2,700,000 warrants outstanding as at December 31, 2004 (2003 – 4,700,000) (see Note 7), are held by family members of the same director and majority stockholder in note 4b.  


5.  Cooperative Agreement


On November 1, 2002, the Company entered into a Cooperative Research and Development Agreement (the “Agreement”) with the United States Department of Agriculture’s Agricultural Research Service (ARS), and committed a total payment of $292,727 to ARS  over two year period ending February 19, 2005.


On May 24, 2004, the Agreement was extended to September 30, 2007 and required total payments to ARS was amended to $807,828 with a revised schedule of repayment as follows:


-  $65,422.80 on or before 8/1/04 (paid in 2004);

-  $65,422.80 on or before 11/1/04 ( included in accounts payable);

-  $65,422.80 on or before 2/1/05;

-  $65,422.80 on or before 5/1/05;

-  $65,422.80 on or before 8/1/05;

-  $65,422.80 on or before 11/1/05;

-  $65,422.80 on or before 2/1/06;

-  $65,422.80 on or before 5/1/06;

-  $65,422.80 on or before 8/1/06; and

-  $65,422.80 on or before 8/1/06; and

-  $65,422.80 on or before 11/1/06.


As at December 31, 2004, total payments of $284,446 have been paid/accrued.  

As amended, the Company, instead of ARS as in the original agreement, has the first option to prepare and prosecute patent or Plant Variety Protection Certificate applications, foreign and domestic, on subject invention owned or co-owned by the U.S Government, subject to certain conditions.

The agreement is for the purpose of funding salaries, equipment, travel and other indirect costs of a post-doctoral research associate.  The terms of the agreement require the interaction of the Company with ARS personnel on the technical details involved with pig liver cell culture development, providing the necessary funds for the purpose above, preparing and filing any patent applications, and reviewing reports and implementing procedures for the development of an artificial liver device utilizing the pig liver cell line.  ARS’s responsibilities include hiring the post-doctoral research associate for a two-year period, providing laboratory and office space for the research associate, providing experimental animals (pigs) and slaughter facilities, conducting the research, preparing progress reports on project objectives, and preparing and submitting technical reports for publication.

All rights, title, and interest in any subject invention made solely by ARS employees are owned by ARS, solely by the Company are owned by the Company, and owned jointly between the Company and ARS if made jointly by ARS and the Company. The Company is granted an option to negotiate an exclusive license in each subject invention owned or co-owned by ARS for one or more field (s) of use encompassed by the agreement. The option terminates when the Company fails to (1) submit a complete application for an exclusive license within sixty days of being notified by ARS of an Inventions availability for licensing or (2) submit a good faith written response to a written proposal of licensing terms within forty five days of such proposal.

The agreement, or parts thereof, is subject to termination at any time by mutual consent. Either party may unilaterally terminate the entire agreement at any time by giving the other party written notice not less than sixty calendar days prior to the desired termination date.

F-27

6.  Warrants


In November 2003, 7,300,000 of these warrants were exercised into common share for total proceeds of $182,500.

In December 2004, 2,000,000 warrants were exercised into common share for total proceeds of $50,000.

Share purchase warrants outstanding as at December 31, 2004:

Number of Warrants

Exercise Price

      Expiry Date

          2,700,000

      $0.025

    March 22, 2005


Each warrant entitles the holder to acquire one common share of the Company.


7.  Stock Option Plan


On July 12, 2001, the stockholders of Hepalife Technologies, Inc. approved the Company’s 2001 Stock Option Plan which has 40,000,000 shares reserved for issuance thereunder, all of which were registered under Form S8 on May 8, 2003.  The objective of this plan is to attract and retain the best personnel, providing for additional  performance incentives, and promoting the success of the Company by providing individuals the opportunity to acquire common stock.

The Company did not grant any stock options in 2004.  

On December 18, 2002, the Company’s Board of Directors agreed to grant 10,000,000 Non-Statutory Stock Options out of the 40,000,000 common shares available for issuance under the Company’s 2001 Stock Option Plan at $0.07 per share being the market price at the time of the grant. The terms and conditions, such as expiration dates and vesting periods are defined in the individual stock option agreements finalized on February 10, 2003. The options are exercisable in three (3) equal installments of thirty-three and one-third percent (33 1/3%), the first installment being exercisable immediately, with an additional of thirty-three and one-third percent (33 1/3%) of the shares becoming exercisable on each of the two (2) successive anniversary dates. The options expire on February 10, 2013.  

On February 12, 2003, the Board of Directors authorized the Company to grant 75,000 options to purchase common stock to a director at $0.38 per share, being the approximate fair value at the date of grant and expiring ten (10) years from the grant date. The options become exercisable in two equal installments of fifty percent (50%), with the first installment becoming exercisable immediately and the balance becoming exercisable in 180 days from issuance.  On September 22, 2003, 37,500 of these options were cancelled due to the resignation of the director from the Board of Directors.

On August 27, 2003, the Board of Directors authorized the Company to grant 3,000,000 options to purchase common stock to directors and employees of the Company at $2.11 per share.  The option price was based on the closing price of the Company’s common shares on August 27, 2003. The options become exercisable in two equal installments of fifty percent (50%), with the first installment becoming exercisable immediately and the balance becoming exercisable in 180 days from issuance.

Summary of employee stock options information for the years ended on December 31, 2004 and 2003 is as follows:

Weighted Average

    

   Shares

    Exercise Price

Options outstanding at December 31, 2002

                 -

        $-

Granted

 13,075,000

        $ 0.54

Exercised

    (282,500)

        $(1.41)

Cancelled

      (37,500)

        $(0.38)

Options outstanding at December 31, 2003

12,755,000

        $ 0.52

Exercised

 (1,622,000)

        $(0.83)

Options outstanding at December 31, 2004

11,133,000

        $ 0.48

F-28


Options Outstanding and Exercisable


Weighted

Average

Weighted

Range of

Remaining

Average

Exercise

 Number

Contractual

Exercise

Prices

Outstanding

Number exercisable

Life (yr.)

Price


$0.01 - $1.00

  8,915,000

    5,581,666

8.10

$0.07

$2.00 - $3.00

  2,218,000

    2,218,000

8.70

$2.11

11,133,000

    7,799,666

8.63

$0.48



Had compensation expense for the Company's stock-based compensation plans been determined under SFAS No. 123, based on the fair market value at the grant dates, the Company's pro-forma net loss and pro-forma net loss per share would have been reflected as follows:

     2004

      

     2003

                  2002


Net income (loss) as reported:

$(1,435,613)

$(1,102,723)

$(375,472)

    Stock-based employee compensation


      expense as determined under the


      fair value based method

     (901,242)

  (5,591,425)

              -

  Pro-forma, net (loss)

$(2,336,855)

$(6,694,148)

$(375,472)


Net (loss) per share

  – basic and diluted:


  As reported

      

        $(0.02)

         $(0.02)

    $(0.007)

  Pro-forma

       

        $(0.04)

         $(0.12)

    $(0.007)


The weighted average fair value of the options granted in2003 was estimated at $0.50 by using the Black-Scholes Option Pricing Model with the following weighted average assumptions: dividend yield of 0%, expected volatility of 81.29%, risk-free interest rates of 3.5%, and expected lives of five years.


8.  Income Taxes


There is no current or deferred tax expense for the years ended December 31, 2004 and 2003 due to the Company’s loss position. The benefits of timing differences have not been previously recorded. The deferred tax consequences of temporary differences in reporting items for financial statement and income tax purposes are recognized, as appropriate. Realization of the future tax benefits related to the deferred tax assets is dependent on many factors, including the Company’s ability to generate taxable income. Management has considered these factors in reaching its conclusion as to the valuation allowance for financial reporting purposes and has recorded a full valuation allowance against the deferred tax asset.

F-29


The income tax effect of temporary differences comprising the deferred tax assets on the accompanying balance sheet is primarily a result of start-up expenses, which are capitalized for income tax purposes. Applying a federal statutory rate of 34% to the pretax loss results in a deferred tax benefit with a full valuation allowance recorded against the benefit as follows at December 31:

   

   2004

  2003

2002

NOL carryforwards

 $194,000

$57,000

 $171

Start-up costs

1,138,000

788,000

          410,610

Organizational costs

       1,020

    1,020

              1,020

1,333,020

846,020

          411,801

Valuation allowance

(1,333,020)          (846,020)           (411,801)

Net deferred tax assets

            $-

         $-

     $-


The Company has available net operating loss carryforwards of approximately $570,000 (2003 – $169,000) for tax purposes to offset future taxable income which expire commencing 2008 to 2024. Additionally, the estimated effect of the charge-off of start-up expenses in 2004 is a reduction in estimated income taxes of approximately $1,035,000 (2003 – $1,026,000), assuming normal operations have commenced.

 

9.  Subsequent Events


On January 10, 2005, the Company extended an Investor and media relations agreement with Thornhill Advisors for another 12 months ending December 31, 2005, with monthly payments of CDN$7,000 (US$5,385).

F-30






#






PART II


INFORMATION NOT REQUIRED IN PROSPECTUS


ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION


The following table sets forth estimated expenses expected to be incurred in connection with the issuance and distribution of the securities being registered.


Securities and Exchange Commission Registration Fee

$2,144

Accounting Fees and Expenses

$10,000

Legal Fees and Expenses

$50,000

Other

$7,500

TOTAL

  

$69,644


All amounts except the Securities and Exchange Commission registration fee are estimated. No portion of the expenses associated with this offering will be borne by the selling stockholders.


ITEM 14. INDEMNIFICATION OF OFFICERS AND DIRECTORS


The Florida Business Corporation Act, or FBCA, permits a Florida corporation to indemnify any person who may be a party to any third party proceeding by reason of the fact that such person 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 entity, against liability incurred in connection with such proceeding (including any appeal thereof) if he or she acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.

 

The FBCA permits a Florida corporation to indemnify any person who may be a party to a derivative action if such person acted in any of the capacities set forth in the preceding paragraph, against expenses and amounts paid in settlement not exceeding, in the judgment of the board of directors, the estimated expenses of litigating the proceeding to conclusion, actually and reasonably incurred in connection with the defense or settlement of such proceeding (including appeals), provided that the person acted under the standards set forth in the preceding paragraph. However, no indemnification shall be made for any claim, issue, or matter for which such person is found to be liable unless, and only to the extent that, the court determines that, despite the adjudication of liability, but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnification for such expenses which the court deems proper.

II-1


The FBCA provides that any indemnification made under the above provisions, unless pursuant to a court determination, may be made only after a determination that the person to be indemnified has met the standard of conduct described above. This determination is to be made by a majority vote of a quorum consisting of the disinterested directors of the board of directors, by duly selected independent legal counsel, or by a majority vote of the disinterested stockholders. The board of directors also may designate a special committee of disinterested directors to make this determination. Notwithstanding the foregoing, the FBCA provides that a Florida corporation must indemnify any director, officer, employee or agent of a corporation who has been successful in the defense of any proceeding referred to above.

 

Notwithstanding the foregoing, the FBCA provides, in general, that no director shall be personally liable for monetary damages to our company or any other person for any statement, vote, decision, or failure to act, regarding corporate management or policy, unless: (a) the director breached or failed to perform his duties as a director; and (b) the director’s breach of, or failure to perform, those duties constitutes (i) a violation of criminal law, unless the director had reasonable cause to believe his conduct was lawful or had no reasonable cause to believe his conduct was unlawful, (ii) a transaction from which the director derived an improper personal benefit, either directly or indirectly, (iii) an approval of an unlawful distribution, (iv) with respect to a proceeding by or in the right of the company to procure a judgment in its favor or by or in the right of a stockholder, conscious disregard for the best interest of the company, or willful misconduct, or (v) with respect to a proceeding by or in the right of someone other than the company or a stockholder, recklessness or an act or omission which was committed in bad faith or with malicious purpose or in a manner exhibiting wanton and willful disregard of human rights, safety, or property. The term “recklessness,” as used above, means the action, or omission to act, in conscious disregard of a risk: (a) known, or so obvious that it should have been known, to the directors; and (b) known to the director, or so obvious that it should have been known, to be so great as to make it highly probable that harm would follow from such action or omission.

 

The FBCA further provides that the indemnification and advancement of payment provisions contained therein are not exclusive and it specifically empowers a corporation to make any other further indemnification or advancement of expenses of any of its directors, officers, employees or agents under any bylaw, agreement, vote of stockholders or disinterested directors, or otherwise, both for actions taken in an official capacity and for actions taken in other capacities while holding such office. However, a corporation cannot indemnify or advance expenses if a judgment or other final adjudication establishes that the actions of the director, officer, employee, or agent were material to the adjudicated cause of action and the director, officer, employee, or agent (a) violated criminal law, unless the director, officer, employee, or agent had reasonable cause to believe his or her conduct was unlawful, (b) derived an improper personal benefit from a transaction, (c) was or is a director in a circumstance where the liability for unlawful distributions applies, or (d) engaged in willful misconduct or conscious disregard for the best interests of the corporation in a proceeding by or in right of the corporation to procure a judgment in its favor or in a proceeding by or in right of a stockholder.

II-2


We have adopted provisions in our articles of incorporation and bylaws providing that our directors, officers, employees, and agents shall be indemnified to the fullest extent permitted by Florida law. Additionally, our bylaws permit us to secure insurance on behalf of any officer, director, employee, or other agent for any liability arising out of his or her actions in connection with their services to us, regardless of whether our articles or incorporation or bylaws permit such indemnification. We intend to obtain such insurance.


Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to our directors or officers pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities Exchange Commission, this indemnification is against public policy as expressed in the Securities Act of 1933, and is therefore unenforceable.

 

There is no pending litigation or proceeding involving any of our directors, officers, employees, or other agents as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director, officer, employee, or other agent.


ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES


Except as otherwise noted, all of the following shares were issued and options and warrants granted pursuant to the exemption provided for under Section 4(2) of the Securities Act of 1933, as amended, as a “transaction not involving a public offering,”  and/or Regulations D and S as promulgated under said act.  Except as noted, no commissions or finders fees were paid, and no underwriter participated, in connection with any of these transactions. Each such issuance was made pursuant to individual contracts which are discrete from one another and are made only with persons who were sophisticated in such transactions and who had knowledge of and access to sufficient information about us to make an informed investment decision. Among this information was the fact that the securities were restricted securities.


On April 26, 2002, our Board of Directors authorized the issuance of 2,160,000 restricted common shares at a price of $0.05 per share in exchange for the satisfaction of $108,000 due for management fees owed to Mr. Harmel S. Rayat, a director and majority stockholder. The registrant believes that the offer and sale of these shares were exempt from the registration requirements of the Securities Act by virtue of Section 4(2) thereof and Regulation S as promulgated under the Securities Act.


On July 25, 2002, our Board of Directors agreed to issue 2,390,000 restricted shares of our common stock at a price of $0.05 per share in exchange for investor relations services valued at $119,500 to EquityAlert.com, Inc., a wholly owned subsidiary of Innotech Corporation. Mr. Rayat was at the time, also a Director and majority stockholder of Innotech Corporation. The registrant believes that the offer and sale of these shares were exempt from the registration requirements of the Securities Act by virtue of Section 4(2) thereof.

II-3


On December 18, 2002, the Board of Directors authorized the issuance of 1,920,000 restricted common shares at a price of $0.05 per share in exchange for the satisfaction of $84,000 due for management fees due to Mr. Rayat. The registrant believes that the offer and sale of these shares were exempt from the registration requirements of the Securities Act by virtue of Section 4(2) thereof and Regulation S as promulgated under the Securities Act.


On June 20, 2005 we issued 20,000 restricted shares of common stock to Fusion Capital Fund II, LLC pursuant to a confidential term sheet; and, on July 8, 2005, we issued an additional 691,598 restricted shares of common stock to Fusion Capital Fund II, LLC pursuant to the terms of a common stock purchase agreement. The registrant believes that the offer and sale of these securities (and the delivery of the common stock purchase agreement) were exempt from the registration requirements of the Securities Act by virtue of Section 4(2) thereof and Regulation D as promulgated under the Securities Act.


ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.


 The following exhibits are filed as part of this registration statement:

 

Exhibit No.

Description

3.1

Amended and Restated Articles of Incorporation, filed March 7, 2000 (1)


3.2

By-laws, filed March 7, 2000 (1)


4.1

Promissory Note between the Company and Harmel S. Rayat, filed March 2, 2005 (2)


4.2

Promissory Note between the Company and Harmel S. Rayat, filed March 8, 2005 (3)


4.3

Common Stock Purchase Agreement with Fusion Capital Fund II, LLC, filed July 13, 2005 (4)


4.4

Registration Rights Agreement with Fusion Capital Fund II, LLC, filed July 13, 2005 (4)


10.1

Cooperative Research and Development Agreement between the Company and the USDA’s Agricultural Research Service



10.2

Amendment and Extension of the Cooperative Research and Development Agreement between the Company and the USDA’s Agricultural Research Service


10.3

Market Access Services Agreement between the Company and National InfoSystems Inc., filed March 2, 2005 (5)


10.4

2001 Incentive Stock Option Plan, filed May 8, 2003 (6)



10.5

Restated Finder Agreement dated as of August 1, 2005 with Pacific Capsource, Inc.


10.6

Grant of $0.07 stock options to employees, directors, officers and consultants (7)


10.7

Grant of $2.11 stock options to employees, directors, officers and consultants (8)


10.8

Grant of $3.10 stock options to employees, directors, officers and consultants (9)


10.9

Grant of $2.38 stock options to employees, directors, officers and consultants (10)


23.1

Consent of Sierchio Greco & Greco, LLP

(Included in Exhibit 5 hereto)


23.2

Consent of Moore Stephens Ellis Foster Ltd.


23.3

Consent of Clancy and Co. PLLC


NOTES


(1)

The documents identified are incorporated by reference from the Company's Registration Statement on Form 10-SB12G (No. 000-29819).


(2)

Incorporated by reference from the Company’s Form 8-K filed on March 2, 2005.


(3)

Incorporated by reference from the Company’s Form 8-K filed on March 8, 2005.


(4)

Incorporated by reference from the Company’s Form 8-K filed on July 13, 2005.


(5)

Incorporated by reference from the Company’s Form 8-K filed on March 2, 2005.


(6)

Incorporated by reference from the Company's Registration Statement on Form S-8 (No. 333-105083).


(7)

Incorporated by reference from the Company’s Form 8-K/A filed on February 11, 2003.


(8)

Incorporated by reference from the Company’s Form 8-K filed on August 28, 2003.


(9)

Incorporated by reference from the Company’s Form 8-K filed on March 7, 2005.


(10)

Incorporated by reference from the Company’s Form 8-K filed on March 18, 2005.



ITEM 17. UNDERTAKINGS


The undersigned registrant hereby undertakes:


(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:


(i) to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended;

II-4


(ii) to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and


(iii) to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;


(2) That, for the purpose of determining any liability under the Securities Act of 1933, as amended, each such post-effective amendment 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.


(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.


Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described under Item 24 above, 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 of 1933 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 of 1933 and will be governed by the final adjudication of such issue.

 

II-5













SIGNATURES



Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Registration Statement to be signed on our behalf by the undersigned, thereunto duly authorized, in Vancouver, British Columbia, Canada, on this 17th day of August, 2005.


Hepalife Technologies, Inc.



By: /s/ Harmel S. Rayat

Harmel S. Rayat

President, Chief Executive Officer,

Chief Financial Officer and Principal Accounting Officer



Pursuant to the requirements of the Securities Act of 1933, the following persons in the capacities and on the dates indicated have signed this Form S-1 Registration Statement:



Signature                         

Title                           

Date




/s/ Harmel S. Rayat

Director, President,   

August 17, 2005

Harmel S. Rayat

Chief Executive Officer,

Chief Financial Officer and

Principal Accounting Officer



/s/ Arian Soheili

Director , Secretary and

August 17, 2005

Arian Soheili

Treasurer




/s/ Jasvir Kheleh

Director

August 17, 2005

Jasvir Kheleh

II-6









POWER OF ATTORNEY


KNOW ALL MEN BY THESE PRESENTS that each individual whose signature appears below constitutes and appoint Harmel S. Rayat, as his true and lawful attorneys-in-fact and agents for the undersigned, with full power of substitution, for and in the name, place and stead of the undersigned, to sign and file with the Securities and Exchange Commission under the Securities Act any registration statement relating to this offering that is to become effective upon filing pursuant to Rule 462 under the Securities Act (a “462 Registration Statement”), any and all amendments and exhibits to this Registration Statement or any 462 Registration Statement, and any and all applications and other documents to be filed with the Securities and Exchange Commission pertaining to the registration of the securities covered hereby or thereby, with full power and authority to do and perform any and all acts and things whatsoever requests and necessary or desirable.

 



Signature                         

Title                           

Date




/s/ Arian Soheili

Director , Secretary and

August 17, 2005

Arian Soheili

Treasurer




/s/ Jasvir Kheleh

Director

August 17, 2005

Jasvir Kheleh

II-7









Hepalife Technologies, Inc.

Registration Statement on Form S-1

Index to Exhibits Filed as Part of This Registration Statement


Exhibit No.

Description

3.1

Amended and Restated Articles of Incorporation, filed March 7, 2000 (1)


3.2

By-laws, filed March 7, 2000 (1)


4.1

Promissory Note between the Company and Harmel S. Rayat, filed March 2, 2005 (2)


4.2

Promissory Note between the Company and Harmel S. Rayat, filed March 8, 2005 (3)


4.3

Common Stock Purchase Agreement with Fusion Capital Fund II, LLC, filed July 13, 2005 (4)


4.4

Registration Rights Agreement with Fusion Capital Fund II, LLC, filed July 13, 2005 (4)


10.1

Cooperative Research and Development Agreement between the Company and the USDA’s Agricultural Research Service



10.2

Amendment and Extension of the Cooperative Research and Development Agreement between the Company and the USDA’s Agricultural Research Service


10.3

Market Access Services Agreement between the Company and National InfoSystems Inc., filed March 2, 2005 (5)


10.4

2001 Incentive Stock Option Plan, filed May 8, 2003 (6)



10.5

Restated Finder Agreement dated as of August 1, 2005 with Pacific Capsource, Inc.


10.6

Grant of $0.07 stock options to employees, directors, officers and consultants (7)


10.7

Grant of $2.11 stock options to employees, directors, officers and consultants (8)


10.8

Grant of $3.10 stock options to employees, directors, officers and consultants (9)


10.9

Grant of $2.38 stock options to employees, directors, officers and consultants (10)


23.1

Consent of Sierchio Greco & Greco, LLP

(Included in Exhibit 5 hereto)


23.2

Consent of Moore Stephens Ellis Foster Ltd.


23.3

Consent of Clancy and Co. PLLC


NOTES


(1)

The documents identified are incorporated by reference from the Company's Registration Statement on Form 10-SB12G (No. 000-29819).


(2)

Incorporated by reference from the Company’s Form 8-K filed on March 2, 2005.


(3)

Incorporated by reference from the Company’s Form 8-K filed on March 8, 2005.


(4)

Incorporated by reference from the Company’s Form 8-K filed on July 13, 2005.


(5)

Incorporated by reference from the Company’s Form 8-K filed on March 2, 2005.


(6)

Incorporated by reference from the Company's Registration Statement on Form S-8 (No. 333-105083).


(7)

Incorporated by reference from the Company’s Form 8-K/A filed on February 11, 2003.


(8)

Incorporated by reference from the Company’s Form 8-K filed on August 28, 2003.


(9)

Incorporated by reference from the Company’s Form 8-K filed on March 7, 2005.


(10)

Incorporated by reference from the Company’s Form 8-K filed on March 18, 2005.











Exhibit 5 Opinion of Counsel



SIERCHIO GRECO & GRECO, LLP

720 Fifth Avenue

New York, New York 10019

Telephone: (212) 246-3030

Facsimile: (212) 246-2225



August 18, 2005


HepaLife Technologies, Inc.

Suite 216 – 1628 West 1st Avenue

Vancouver, BC, V6J 1G1


Re:          Form S-1 Registration Statement


Ladies and Gentlemen:


You have requested our opinion with respect to certain matters in connection with the filing by HepaLife Technologies, Inc., a Florida corporation (the “Company”) of a Registration Statement on Form S-1 (the “Registration Statement”) filed with the Securities and Exchange Commission (the “Commission”) pursuant to the Securities Act of 1933, as amended (the “Act”) regarding the registration of 10,911,598 shares (the “Registered Shares”) of the Company’s common stock, $0.001 par value per share, for sale by the selling stockholders named in the registration statement.


All capitalized terms herein that are not otherwise defined shall have the meaning ascribed thereto in the Registration Statement. In connection with this opinion, we have examined and relied upon the Company’s Articles of Incorporation, as amended, the Company’s Bylaws, and Registration Statement and related prospectus originals or copies certified or otherwise identified to our satisfaction of all such corporate records of the Company and such other instruments and other certificates of public officials, officers and representatives of the Company and such other persons, and we have made such investigations of law, as we have deemed appropriate as a basis for the opinions expressed below. In addition, we have assumed and have not independently verified the accuracy as to factual matters of each document we have reviewed.


In arriving at the opinions expressed below, we have assumed the authenticity of all documents submitted to us as originals and the conformity to the originals of all documents submitted to us as copies.  We have also assumed that the Company will receive full payment from the selling stockholder for all shares registered and resold by them.


Based on the foregoing, and in reliance thereon, subject to the further assumptions and qualifications set forth below, we are of the opinion that the Registered Shares, when issued and paid for in accordance with the terms set forth in the prospectus constituting a part of the Registration Statement, will be validly issued, fully paid and non-assessable,


The foregoing opinion is limited to the laws of the State of Florida. 


We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and to the reference to this firm under the heading “Legal Matters” in the Registration Statement and the related prospectus included in the Registration Statement. In giving such consent, we do not thereby admit that we are “experts” within the meaning of the Act or the rules and regulations of the Commission issued thereunder with respect to any part of the Registration Statement, including this exhibit.


Very truly yours,

 

Sierchio Greco & Greco, LLP.



By:

/s/ Sierchio Greco & Greco, LLP.


Exhibit 10.1






UNITED STATES DEPARTMENT OF AGRICULTURE



TYPE OF RESEARCH AGREEMENT

RESEARCH AGREEMENT

Cooperative Research and Development Agreement


AGREEMENT NO.

58-3K95-3-967


TYPE OF ACTION

NEW


AGENCY (Name and Address)





Agricultural Research Service

1400 Independence Avenue SW

Washington DC 20250-0302


PERIOD OF AGREEMENT


11/1/02 through 10/31/04


FEDERAL OBLIGATION


$ -0-


CHANGE IN FEDERAL OBLIGATION


             N/A


CRIS NO.


AUTHORITY


PERFORMING ORGANIZATION (Name and Address)


Zeta Corporation

1025 - 11811 N. Tatum Blvd.

Phoenix, AZ 85028-1699


1265-31000-087-01T


15 USC 3710a, et seq.


OBLIGATION DISTRIBUTION

Accounting Code

$Amount


X91-1265-356


$292,727.00


PRINCIPAL INVESTIGATOR (Name and Address)


Harmel Rayat

(Same as Above)




FINANCE OFFICE (Complete Mailing Address)


USDA, ARS, BA, Budget and Fiscal Office

10300 Baltimore Ave.

Bldg. 003, Rm. 206, BARC-West

Beltsville, MD  20705-2350


TITLE OF PROJECT


Development and Application of an In Vitro Model

of the Pig Liver


AUTHORIZED DEPARTMENTAL OFFICER'S DESIGNATED REPRESENTATIVE (Name and Address)


Neil C. Talbot

USDA, ARS, BA, ANRI, GEML

10300 Baltimore Ave.

Bldg. 200, Rm. 13A, BARC-E

Beltsville, MD 20705-2350


LOG #22659

Incorporated into this Agreement are the following:


1.  General Provisions.

2.  Schedule 1 - Certifications.

3.  Schedule 2 - Statement of Work.

4.  Schedule 3 - Estimated Budget.







FOR THE UNITED STATES DEPARTMENT OF AGRICULTURE


AUTHORIZED DEPARTMENTAL OFFICER


TYPED NAME


DATE


October 22, 2002

/s/ Richard Brenner

RICHARD J. BRENNER






FOR THE PERFORMING ORGANIZATION

(Signature of person authorized by the governing body of the performing organization to incur contractual obligations.)


SIGNATURE


TYPED NAME AND TITLE


Harmel Rayat


DATE


November 1, 2002

/s/ Harmel S. Rayat

 



SIGNATURE


TYPED NAME AND TITLE


DATE



  




58-3K95-3-967



GENERAL PROVISIONS


1.

Definitions


ARS means the United States Department of Agriculture=s Agricultural Research Service.


Zeta means Zeta Corporation


Agreement means this Cooperative Research and Development Agreement.


Confidential Information means trade secrets or commercial or financial information that is privileged or confidential, under the meaning of 5 USC 552(b)(4).


Subject Inventions means any invention or other intellectual property conceived or first reduced to practice under this Agreement which is patentable or otherwise protectable under Title 35 of the United States Code, under 7 USC 2321, et seq., or under the patent laws of a foreign country.  Specifically not included in the definition of Subject Inventions are inventions made outside The Scope of Agreement or prior to the execution of this Agreement.


Scope of Agreement means those activities set forth in Schedule 2, Statement of Work.


2.

Publications


a.

Subject to the requirements of confidentiality and preservation of rights in Subject Inventions, either party may publish the results of this Agreement, PROVIDED:


(1)

The other party is allowed to review the manuscript at least sixty (60) days prior to submission for publication.


(2)

The publication shall acknowledge this Agreement and the contributions of each party's personnel.


b.

The final decision as to the publication content rests with the party that writes the publication.


c.

Publication and/or other disclosure of the results of this Agreement shall be delayed as necessary to preserve both United States of America and foreign patent rights in a Subject Invention.


(1)

Such a delay will only be granted if requested in writing; and


(2)

The requesting party demonstrates promptness and diligence in seeking patent protection on the Subject Invention.


3.

Meetings, Reports and Records


a.

Frequent and effective communication is essential to the successful accomplishment of the objectives of this Agreement.  To this end, the scientific representatives of ARS and Zeta shall meet at least once every six (6) months to exchange results, perform critiques, and make plans and recommendations.  Written progress reports shall be supplied by each party to the other at least fifteen (15) calendar days prior to each semiannual meeting.


b.

Any such plan or recommendation that is outside the Scope of Agreement shall be reduced to writing and referred to the management of each party for appropriate action.  Any such plan or recommendation so referred shall not be binding upon either party unless incorporated into this Agreement by amendment.


c.

Each party shall keep complete records relating to this research.  All such records shall be available for inspection by either party at reasonable times.  The records, or true copies of them, shall be delivered to either party upon request.


d.

The results of this Agreement and research data which are collected, compiled, and evaluated under this Agreement shall be shared and mutually interchanged by Zeta and ARS.


e.

A final report summarizing all data shall be submitted by each party to the other within sixty (60) days of the completion of this Agreement.  


4.

Confidentiality


a.

Confidential Information which is owned by one party to this Agreement and given to the other shall not be disclosed by the recipient without the written permission of the owner.


b.

Confidential Information given by one party to the other  under this Agreement shall be labeled "CONFIDENTIAL" by the submitter.


c.

To the extent either party orally submits its Confidential Information to the other party, the submitting party will prepare a document marked "CONFIDENTIAL" embodying or identifying in reasonable detail such orally submitted Confidential Information and provide the document to the other party.


d.

Any Confidential Information created under this Agreement which normally would be included in scientific publications describing the results under this Agreement may be included in such publications after an one (1) year delay after creation of the information unless Zeta waives delay.


(1)

Such publications may be delayed an additional year upon justifiable request from the non-publishing party; and


(2)

The preparation and filing of a patent application on a Subject Invention is sufficient justification.


e.

Neither party shall be bound by confidentiality if the Confidential Information received from the other party:


(1)

Already is available to the public or known to the recipient;


(2)

Becomes available to the public through no fault of the recipient; or


(3)

Is nonconfidentially received from another party legally entitled to it.


5.

Research Exclusion


a.

The results of this Agreement owned or co-owned by the US Government may be made available to others by ARS for bona fide noncommercial research purposes if:


(1)

Confidentiality is not breached; or


(2)

Patent or Plant Variety Protection Certificate rights are not compromised.


b.

Plants and animals, their genetic materials or information relating thereto, or reproducing parts thereof, covered by Plant Variety Protection Certificates, Plant Patents, or Utility Patents, owned or co-owned by ARS, may be made available by ARS to third parties for bona fide research purposes including the development of new animals or plants.


6.

Ownership of Inventions


a.

All rights, title, and interest in any Subject Invention made solely by employee(s) of ARS shall be owned by ARS.  


b.

All rights, title, and interest in any Subject Invention made jointly by at least one (1) employee of ARS and at least one (1) employee of Zeta shall be jointly owned by ARS and Zeta.  


c.

All rights, title, and interest in any Subject Invention made solely by employees of Zeta shall be owned by Zeta.


7.

Subject Invention Licenses


a.

Zeta is granted an option to negotiate an exclusive license in each Subject Invention owned or co-owned by ARS for one or more field(s) of use encompassed by the Scope of Agreement.  This license shall be consistent with the requirements of 35 USC 209(a), 209(b), and 209(f) and other such terms and conditions as may be reasonable under the circumstances, as agreed upon through good faith negotiations between Zeta and ARS.


b.

The option shall terminate whenever Zeta fails to:

(1)

Submit a complete application for an exclusive license within sixty (60) days of being notified by ARS of an Inventions availability for licensing; or


(2)

Submit a good faith written response to a written proposal of licensing terms within forty five (45) days of such proposal.


c.

Zeta grants ARS, on behalf of the US Government, a royalty free, nonexclusive, worldwide, irrevocable, nontransferable license for any Zeta solely owned Subject Invention.  The purpose of this license shall be to practice the Subject Invention or have it practiced, by or on behalf of the US Government, for research or other US Government purposes.  15 USC 3710a(b)(2).


8.

Subject Invention Information


a.

The Authorized Agents or designees of each party shall promptly make written disclosure to each other of each Subject Invention.  


b.

This information shall be treated in confidence by the receiving party, EXCEPT: it may be shared with those having a need to know.


c.

Each party shall provide, when requested by the other, all information in its possession, or true copies thereof, pertaining to a Subject Invention which may be necessary or useful in the preparation, filing, and prosecution of patent or Plant  Variety Protection Certificate applications covering the Subject Invention.


9.

Intellectual Property Protection Applications


a.

ARS and Zeta agree to cooperate with the other in the preparation, filing, and prosecution of Patent or Plant Variety Protection Certificate applications on Subject Inventions in the United States of America and any other country.


b.

The Authorized Agents of each party or their designees shall provide the other party with a copy of any such application on a Subject Invention within fourteen (14) calendar days after filing.


c.

ARS shall have the first option to prepare and prosecute patent or Plant Variety Protection Certificate applications on Subject Inventions that are owned or co-owned by the U.S. Government, which option may be waived in whole or in part.


10.

Copyrights


a.

Any work copyrightable under 17 USC 101, et seq., produced in whole or in part by Zeta's employees under this Agreement shall be owned by Zeta.


b.

Zeta shall mark any such works with a copyright notice showing Zeta as an owner and shall have the option to register the copyright at Zeta's expense.


c.

Zeta hereby grants in advance to the U.S. Government, as represented by ARS, a worldwide, royalty-free, and nonexclusive license to use such copyrightable work for U.S. Governmental purposes.


d.

Examples of Governmental purposes are:


(1)

The right to reproduce the work in copies, phonograph or electronic records;


(2)

The right to perform or display the work publicly;


(3)

The right to prepare derivative works based on the work; and


(4)

The right to have others do so for U.S. Governmental purposes.


e.

Zeta will prominently mark each such copyrighted work subject to the U.S. Government purpose license with the words:





"This work was created in the performance of a Cooperative Research and Development Agreement with the U.S. Department of Agriculture.  The Government of the United States has a royalty-free government purpose license to use, duplicate or disclose the work, in whole or in part and in any manner, and to have or permit others to do so, for government purposes."


f.

Zeta shall furnish to ARS, at no cost to ARS, three (3) copies of each such work created in whole or in part by Zeta under this Agreement.


11.

Use of Name or Endorsements


Zeta shall not in any way state or imply that this Agreement or the results of this Agreement is an endorsement of its organizational units, employees, products, or services except to the extent permission is specifically granted by ARS' Authorized Agent (Authorized Departmental Officer).


12.

Regulatory Approvals


a.

Zeta is responsible for obtaining appropriate opinions, permits, or licenses from Federal or State agencies which regulate research materials or


commercial products that may arise from the research work performed within the Scope of Agreement.


b.

In carrying out its responsibilities under this clause, Zeta shall:


(1)

Consult and coordinate regulatory approval actions with ARS; and


(2)

Give ARS= Authorized Agent or designee a copy of any applications and opinions, permits, or licenses issued.


13.

Indemnity and Liability


a.

Zeta agrees to indemnify and hold harmless ARS from any liability arising from the negligent acts or omissions of an employee, agent, or officer of Zeta, EXCEPT:  to the extent aforesaid liability arises from the negligent acts or omissions of ARS, its employees, agents, or contractors and employees or agents of the contractor.



b.

ARS will hold Zeta harmless from any liability arising from the negligent act or omission of a Federal Government officer or employee acting within the scope of his or her employment, EXCEPT:  to the extent aforesaid liability arises from the negligent acts or omissions of Zeta, its employees, agents, or contractors and employees or agents of the contractor.


c.

ARS' liability is limited to that available pursuant to the Federal Tort Claims Act, 28 USC 2671, et seq.


14.

Termination


a.

This Agreement, or parts thereof, is subject to termination at any time by mutual consent.


b.

Either party may unilaterally terminate this entire Agreement at any time by giving the other party written notice not less than sixty (60) calendar days prior to the desired termination date.


c.

Pledges of confidentiality shall survive such termination.


d.

If either party unilaterally terminates this Agreement pursuant to this Clause, each party shall return to the other or destroy, as shall be then agreed, any and all data and materials originated or provided by one party to the other that is still in the receiving party=s possession.


15.

Availability of Appropriations


The continuance of this Agreement is subject to the passage by the Congress of the United States of an appropriation of funds from which expenditures may legally be made to cover ARS' contributions.


16.

Disputes


a.

Any dispute arising under this Agreement which cannot be readily resolved shall be submitted jointly to the Authorized Agents, identified in Clause 17 of these General Provisions.


b.

Each party agrees to seek in good faith to resolve the issue through negotiation or other forms of nonbinding dispute resolution processes mutually acceptable to the parties.


c

A joint decision of the Authorized Agents, or their designees, shall be dispositive of such dispute.


d.

Pending the resolution of any dispute or claim pursuant to this Clause, the parties agree that performance of all obligations shall be pursued diligently.


17.

Notices and Authorized Agents


Notices between the parties and copies of correspondence among the scientific and/or technical representatives of each party that interpret or may have a bearing on the legal effect of this Agreement's terms and conditions shall be sent to the Authorized Agents.  Referencing Agreement Number 58-3K95-3-XXX thereon, send copies to:


ARS' Authorized Agent:

Zeta's Authorized Agent


Richard J. Brenner

Harmel Rayat

USDA-ARS-OTT

Zeta Corporation

5601 Sunnyside Ave.

1025 - 11811 N. Tatum Blvd.

Beltsville MD 20705-5131

Phoenix, AZ 85028-1699

Tel.  (301) 504-6905

Tel. 604-659-5000

FAX:  (301) 504-5060

FAX: 604-659-5029

Email: crada.ott@

Email: rayat@simbra.net

nps.ars.usda.gov.


18.

Limitation on ARS' Scientific Representative's Authority


ARS' Scientific Representative, also known as the Authorized Departmental Officer's Designated Representative (AADODR@), is authorized to perform the research and development falling within the Scope of Agreement.  This individual is not authorized to change or interpret with authority the terms and conditions of this Agreement.


19.

Export Control


a.

Both ARS and Zeta understand that materials resulting from the performance of this Agreement may be subject of export control laws and regulations.


b.

Each party is separately responsible for compliance with such laws.


20.

Assignments


a.

Neither this Agreement nor any rights or obligations of the parties hereto shall be assigned or otherwise transferred by either party without the prior written consent of the other party, which consent shall not be unreasonably withheld.


b.

In no case shall Zeta assign or transfer this Agreement to a party not a citizen or resident of the United States.


c.

ARS is an agency of the U.S. Government and any rights or obligations created under this Agreement are freely transferrable within the Government and shall not be deemed an "assignment" as contemplated by this Clause.


21.

Relationship of Parties


a.

ARS and Zeta act in their independent capacities in the performance of their respective functions under this Agreement and neither party is to be considered the officer, agent, or employee of the other.


b.

Each party shall permit the other entrance and exit from each=s facilities, as needed.


c.

Each party shall separately assign personnel, equipment, supplies, transportation, and facilities, as needed and available to meet each=s it responsibilities hereunder, such resources to remain the property of the assignor.


22.

Force Majeure


a.

Neither party shall be liable for any unforeseeable event beyond its reasonable control not caused by the fault or negligence of such party:


(1)

Which causes the party to be unable to perform its obligations under this Agreement; and


(2)

Which it has been unable to overcome by the exercise of due diligence.


(3)

This includes, but is not limited to, flood, drought, earthquake, storm, fire, pestilence, lightning and other natural catastrophes, epidemic, war, riot, civil disturbance or disobedience, strikes, labor dispute, failure, or sabotage of either party's facilities or any order or injunction made by a court or public agency.


b.

In the event of the occurrence of such force majeure event, the party unable to perform shall promptly notify the other party.  It shall also:


(1)

Use its best efforts to resume performance as quickly as possible;


(2)

Suspend performance only for such period of time as is necessary as a result of the force majeure event.


23.

Amendment


a.

If either party desires a modification in this Agreement, the parties shall confer in good faith to determine the desirability of such modification.


b.

Such modification shall not be effective until a written amendment is signed by the Authorized Agents of both parties.


24.

Severability


The illegality or invalidity of any provision of this Agreement shall not impair, affect, or invalidate the other provisions of this Agreement.


25.

Headings and Titles


The headings and titles to the articles and paragraphs in this Agreement are intended solely for convenience and shall be given no effect in the construction or interpretation of this Agreement.


26.

Ambiguities


ARS and Zeta agree that each party has reviewed this Agreement and that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not apply to the interpretation of this Agreement.


27.

Officials Not To Benefit


a.

No Delegate to or Member of the Congress of the United States of America shall have a part of or benefit from this Agreement.


b.

This requirement does not include corporations if this Agreement is entered into for the corporation's general benefit.


28.

Subcontracting Approval


a.

A party hereto desiring to obtain and use the services of a third party via contract or otherwise shall give prior notice to the other party, including details of the contract or other arrangement.


b.

This requirement is to assure that confidentiality is not breached and rights in Subject Inventions are not compromised.


29.

Governing Law


The construction, validity, performance, and effect of this entire Agreement shall be governed by the laws applicable to the Government of the United States of America as practiced in the Federal Courts located in the District of Columbia.


30.

US Competitiveness


US Government policy is that the results of a Cooperative Research and Development Agreement are to be used primarily to enhance the competitiveness of US industry and commerce.  15 USC 3710a(c)(4)(B).   Accordingly, Zeta agrees to use the results of this Agreement substantially in the United States prior to use in foreign countries.


31.

Entire Agreement


This Agreement constitutes the entire agreement between Zeta and ARS and supersedes all prior agreements and understandings between them with respect to its subject matter.


a.

Any representation, promise, or condition in connection with such subject matter which is not incorporated in this Agreement shall not be binding upon either party.


b.

No modification, renewal, extension, waiver, or termination of this Agreement or any of its provisions shall be binding upon the party against whom enforcement of such modification, renewal, extension, waiver, or termination is sought, unless made in writing and signed on behalf of such party by that party=s Authorized Agent.


c.

As used herein, the word "termination" includes any and all means of bringing to an end prior to its expiration by its own terms of this Agreement, or any provision thereof, whether by release, discharge, abandonment, or otherwise.




58-3K95-3-967

Schedule 1


CERTIFICATIONS


Zeta certifies that it:


1.

 X   is,     is not, a small business concern.


2.

    is, X   is not, a minority business.


3.

operates as:


    an individual

    a partnership

 X  a corporation

__ limited liability corporation

__ public institution

__ private institution

__ educational institution;

and is incorporated in the State of Florida.


4.

has not paid or agreed to pay any company or person (other than a bona fide employee working solely for Zeta) any fee, commission, percentage, or brokerage fee, contingent upon the award of this Agreement, and if so, agrees to furnish information relating thereto, as requested, by the Authorized Departmental Officer.


5.

has not employed or retained any company or person (other than a full-time bona fide employee working solely for Zeta) to solicit or secure this Agreement.


6.

its Principal Officers are not listed on the U.S. Government's list of debarred and suspended organizations and individuals; shall notify the Authorized Departmental Officer if so listed; and shall not subcontract or otherwise award to any organization or individual so listed.


7.

agrees to comply with the provisions of the Civil Rights Act of 1964, as amended, and Executive Order 11246, addressing equal opportunity and affirmative action.


8.

agrees to comply with the provisions of Title IX of the Education Amendment of 1972, 20 USC 1681, et seq.; Section 504 of the Rehabilitation Act of 1973, as amended, 29 USC 794; Age Discrimination Act of 1975, 42 USC 6101-6107; Clean Air Act, 42 USC 7401, et seq.; and Drug-Free Workplace Act of 1988, 41 USC 701, et seq.


9.

is in a position to undertake, perform, and complete this Agreement and will diligently perform work in accordance with its provisions.



58-3K95-3-967

Schedule 2


STATEMENT OF WORK


A.

Introduction/Background


ARS has developed several in vitro model systems to investigate various aspects of hepatic gene expression and metabolic regulation.  These systems encompass both established cell lines and primary liver cell cultures.  One stem-like cell line, derived from porcine epiblast (embryonic) tissue is the ARS PICM-19 cell line (ARS patent #5,532,156), has been partially characterized and is a non-transformed immortal cell line that possesses many characteristics similar to that of intact liver parenchymal cells.  ARS interests would be greatly enhanced by further characterization and improvements in the culture technology that would ultimately result in the cell line not requiring feeder cell support and growth in a completely serum-free defined medium. These advancements would facilitate our understanding of regulatory events in pig liver gene/proteome expression and in regulation of nutrient metabolism.  Further, it has already been demonstrated that the unique hepatic characteristics of the ARS-PICM-19 cell line would have potential application for use in the production of a rescue device for human patients in liver failure (ARS patent # 5,866,420; AArtificial Liver Device@, granted to ARS on 2/2/1999).  To date, the cellular components of artificial liver devices that are being tested by other institutions are based on freshly isolated porcine hepatocytes, human transformed tumor cells, or poorly defined stem-like cells prepared from fresh human adult liver tissue.  It is widely recognized that the greatest hindrance to the development of a completely functional artificial liver rescue device is the lack of an appropriate defined cell line that will provide the functions of an intact liver.  The primary interest of Zeta is to explore the possibility that the ARS PICM-19 cell line is indeed the most appropriate cell line to use in such a device.


B.

Objective


The overall objective of the work is to optimize the patented ARS-PICM-19 cell line as an in vitro model of the pig liver. The first objective is to investigate and discover culture conditions for the ARS-PICM-19 cell line, or modifications of the ARS-PICM-19 cell line technology itself, that will optimize function, i.e., culture conditions or cell line modifications that will enable, as closely as possible, the reproduction of normal pig liver functions in an in vitro environment.  Directly related to the first objective will be the second objective of adapting and applying the optimized ARS-PICM-19 cell line technology to the development of an extracorporeal liver assist device as described in patent #5,866,420.


C.

Approach and Methodology


ARS will study experimental culture conditions for the ARS-PICM-19 cell or other pig epiblast-derived liver cell lines (as described under ARS patent #5,532,156, AHepatocyte Cell Line Derived from the Epiblast of Pig Blastocysts@) so as to optimize their hepatocyte functions for use as an in vitro liver model and for their use in an artificial liver device.  


Specific project objectives are the following:


1.

Develop cell culture system allowing the growth and differentiation of ARS-PICM-19 cells without STO feeder cell support.


2.

Develop serum-free, defined or semi-defined medium cell culture system for growth and differentiation of ARS-PICM-19 cells.


3

Develop spheroid cultures of PICM-19 cells without STO feeder cells and testing of rotating cell culture system (RCCS) for production and maintenance of spheroids.


4.

Investigate effects of accessory cells obtained from pig liver on spheroid form and function.


5.

Assay ARS-PICM-19 cells and spheroids for liver specific functions by measuring P450 activity, γ-glutamyltranspeptidase activity, urea production, and ammonia clearance.


6.

Assay ARS-PICM-19 liver specific protein synthesis and secretion by electrophoretic and immunochemical techniques.


7.

Assay liver specific markers in ARS-PICM-19 by immunocytochemistry.


8.

Document ARS-PICM-19 spheroid morphology by  electron microscopy.


9.

Zeta will provide funds for the salary of one post-doctoral researcher for a  period two years and funds for the associated laboratory supplies and professional activities involved with conducting the CRADA objectives.


D.

ARS’  Responsibilities


1.

Conduct these portions of the research project or perform the following tasks:


a.

Hire one post-doctoral research associate for a 2 year period.


b.

Provide laboratory and office space for the research associate.


c.

Provide fully equipped cell culture laboratory and protein chemistry laboratory.


d.

Provide experimental animals (pigs) and slaughter facilities.


e.

Acquire specific laboratory equipment, i.e., RCCS, and  supplies to conduct the CRADA objectives.


f.

Conduct research on the optimization of the ARS-PICM-19 cell line (or related pig epiblast-derived cell lines) as an in vitro pig liver cell model and the adaptation of the ARS-PICM-19 liver cell technology to an extracorporeal liver assist device.


g.

Prepare progress reports on project objectives.


h.

Prepare and submit technical reports for publication.


2.

a.

Provide access to 1850 square feet of laboratory space in Building 200, Room 13, 202, 204, and 212, at the Beltsville Agricultural Research Center for those Zeta personnel assigned to this project.


b.

Provide utilities, services, and general support to Zeta's personnel, as needed and available.


E.

Zeta’s Responsibilities


1.

Perform these portions of the research effort:


a.

Interact with ARS personnel on the technical details involved with pig liver cell culture development.


b.

Provide funds for post-doctoral research associate for two years.


c.

Provide funds for project related laboratory equipment, supplies, and off site research services such as electron microscopy.


d.

Provide funds for position advertisement and travel expenses for position interviews.


e.

Provide funds for professional activities of research associate such as travel to meetings and project specific training activities.


f.

Prepare and file patent applications.


g.

Review reports and implement procedures for the development of an artificial liver device utilizing the ARS-PICM-19 cell line (or related pig liver epiblast-derived cell lines).


2.

Pay $ 292,727 to ARS.

  

a.

The payment schedule is:


(1)

$ 91,500 within 30 days of signing this agreement;

(2)

$ 20,700 on or before 1/31/03;

(3)

$20,700 on or before 4/30/03;

(4)

$20,700 on or before 7/31/03;

(5)

$91,500 on or before 10/31/03;

(6)

$15,875 on or before 1/31/04;

(7)

$15,876 on or before 4/30/04; and

(8)

$15,876 on or before 8/1/04


b.

Make checks or money orders out to the "Agricultural Research Service," cite Agreement No. 58-3K95-3-XXX thereon, and send to:


USDA, ARS, BA, Budget and Fiscal Office

10300 Baltimore Ave.

Bldg. 003, Rm. 306, BARC-West

Beltsville, Maryland 20705-2350


3.

Zeta may pay the travel and per diem of ARS scientific representatives traveling pursuant to this Agreement if such payment receives the prior approval of the appropriate ARS Area Director.


4.

ZETA will not furnish any personnel and/or equipment to ARS.


F.

ARS & Zeta’s Joint or Mutual Responsibilities


1.

Perform these portions of the effort jointly:


a.

Develop strategy for design of a support system matrix to grow and maintain established ARS-PICM-19 or related pig liver epiblast-derived cell lines.


b.

Evaluate efficacy of ARS-PICM-19 or related pig liver epiblast-derived cell lines in an in vitro pig liver model system for potential use in an extracorporeal liver assist device.






ESTIMATED BUDGET


TOTAL YEARS


ARS

  ARS

Zeta

to Receive    In-House

In-House

Funds For


A.

Salaries and Wages.......

$150,000

$ 46,440

$144,000

B.

Equipment................

$ 13,025

$100,000

$ 12,000

C.

Materials and Supplies...

$ 91,000

$ -0-

$ -0-

D.

Travel

1.  Domestic.............

$  4,000

$  4,000

$ 16,000

2.  Foreign..............

$ -0-

$ -0-

$ -0-

E.

Facilities...............

$ -0-

$112,000

$ 24,000

F.

Other Direct Costs.......

$  5,430

$ 52,488

$ -0-

G.

TOTAL DIRECT COSTS.......

$263,455

$314,928

$196,000

H.

Indirect Costs...........

$ 29,272

$  -0-

$ -0-

I.

TOTAL COSTS (G+H)........

$292,727

$314,928

$196,000


YEAR 1


A.

Salaries and Wages.......

$ 75,000

$ 23,220

$ 72,000

B.

Equipment................

$ 13,025

$ 50,000

$  6,000

C.

Materials and Supplies...

$ 45,500

$  -0-

$ -0-

D.

Travel

1.  Domestic.............

$  2,000

$  2,000

$  8,000

2.  Foreign..............

$  -0-

$  -0-

$ -0-

E.

Facilities...............

$  -0-

$ 56,000

$ 12,000

F.

Other Direct Costs.......

$  2,715

$ 26,244

$ -0-

G.

TOTAL DIRECT COSTS.......

$138,240

$157,464

$ 98,000

H.

Indirect Costs...........

$ 15,360

$  -0-

$ -0-

I.

TOTAL COSTS (G+H)........

$153,600

$157,464

$ 98,000


YEAR 2


A.

Salaries and Wages.......

$ 75,000

$ 23,220

$ 72,000

B.

Equipment................

$  -0-

$ 50,000

$  6,000

C.

Materials and Supplies...

$ 45,500

$  -0-

$ -0-

D.

Travel

1.  Domestic.............

$  2,000

$  2,000

$  8,000

2.  Foreign..............

$  -0-

$  -0-

$ -0-

E.

Facilities...............

$  -0-

$ 56,000

$ 12,000

F.

Other Direct Costs.......

$  2,715

$ 26,244

$ -0-

G.

TOTAL DIRECT COSTS.......

$125,215

$157,464

$ 98,000

H.

Indirect Costs...........

$ 13,912

$  -0-

$ -0-

I.

TOTAL COSTS (G+H)........

$139,127

$157,464

$ 98,000










EXHIBIT 10.2


UNITED STATES DEPARTMENT OF AGRICULTURE


RESEARCH AGREEMENT

TYPE OF RESEARCH AGREEMENT

Cooperative Research and Development Agreement

AGREEMENT NO.

58-3K95-3-0967

TYPE OF ACTION

Amendment No. 3

AGENCY (Name and Address)


Agricultural Research Service

1400 Independence Avenue SW

Washington, D.C. 20250-0302

PERIOD OF AGREEMENT


10/01/02 through 9/30/07

FEDERAL OBLIGATION


$ 0

CHANGE IN FEDERAL OBLIGATION

This Agreement is authorized by the Federal Technology Transfer Act, 15 USC 3710a, et seq., and is governed by its terms.

Items

2                                                                                                                                                

Descriptions

1.  Technology Transfer Coordinator

Harry D. Danforth

2.  Cooperator

Hepalife Technologies, Inc.

Suite 216 - 1628 West 1st Ave,

Vancouver, BC, V6J 1G1

Tax ID #  

3.  Principal Investigator

Harmel Rayat, Director

4.  USDA Laboratory

Growth Biology Laboratory

10300 Baltimore Ave.

Beltsville, MD  20705-2350

5.  USDA Researcher (ADODR)

Neil Talbott, Thomas Caperna

6.  National Program Leader & Area

First & Last Name of NPL

7.  Accounting Code

X91-1265-356

8.  Amount

$807,828.00 (total for 5 years)

9.  Finance Office

Budget & Fiscal Office

USDA-ARS-BA

Bldg. 003, Room 306, BARC-West

Beltsville, MD  20705-2350

10.  Cris No.

1365-31000-087-01T

11.  Title of Project

OPTIMIZATION OF THE ARS-PICM-19 CELL LINE FOR AN IN VITRO MODEL OF PIG LIVER FUNCTION AND APPLICATION TO AN EXTRACORPOREAL LIVER ASSIST DEVICE

12.  Log #

22659


This Agreement is amended, as follows:

The duration of the Agreement is extended for three (3) years through September 30, 2007.  ARS will receive a total of  $807,828.00 in funds of which $153,600.00 has been paid. The Statement of Work and Clause 9 have been changed and are incorporated herein. The Title of Project has been changed.  ALL OTHER TERMS AND CONDITIONS REMAIN THE SAME.  

FOR THE UNITED STATES DEPARTEMENT OF AGRICULTURE

SIGNATURE

/s/ Richard Brenner

TYPED NAME

RICHARD J. BRENNER

Authorized Departmental Officer

DATE

May 19, 2004

FOR THE COOPERATOR

(Signature of person(s) authorized by the governing body of the COOPERATOR to incur contractual obligations)

SIGNATURE

/s/ Harmel Rayat

TYPED NAME AND TITLE

HARMEL RAYAT

DATE

May 24, 2004

OTT COVER FORM













Clause 9



9.1

HEPALIFE shall have the first option to prepare and prosecute patent or Plant Variety Protection Certificate applications, foreign and domestic, on Subject Inventions owned or co-owned by the U.S. Government, subject to the following conditions:


a.

All documents shall be submitted to ARS sufficiently in advance of filing to allow ARS a reasonable opportunity to review and make recommendations thereon;


b.

Copies of all correspondence from the U.S. Patent and Trademark Office or Plant Variety Protection Office and foreign equivalent offices shall be provided promptly to ARS;


c.

The following USDA personnel shall be given an associate power of attorney or be listed as an attorney of record:


Patent Advisor

Patent Attorney


Evelyn Rabin

John Fado

USDA-ARS-OTT

USDA-OGC Rm. 3311

5601 Sunnyside Avenue

South Agriculture Bldg.

Beltsville MD

Washington, D.C. 20250-1415

Registration Number

Registration No. 27876

Tel: 301-504-4781

Tel.: 202-720-2421

Fax: 301-504-5060

Fax: 202-720-8706


9.2

The act of preparing and/or filing documents, per se, shall not entitle HEPALIFE to any rights in such Inventions or the reimbursement of costs incident to patent prosecution.


9.3

ARS shall have the right at any time, at its sole discretion, concerning Inventions solely owned by the U.S. Government, to: (1) assume responsibility for prosecuting any such application; and (2) permit any application to become abandoned or issued patent/certificate to expire, subject to the provisions of any license agreement relating to the subject matter.


9.4

ARS agrees to provide HEPALIFE consultation and advice in the preparation, filing, and prosecution of patent or Plant Variety Protection Certificate applications on Subject Inventions.












STATEMENT OF WORK


A.

Introduction/Background


ARS has developed several in vitro model systems to investigate various aspects of hepatic gene expression and metabolic regulation. These systems encompass both established cell lines and primary liver cell cultures. One stem-like cell line, derived from porcine epiblast (embryonic) tissue is the ARS PICM-19 cell line (ARS patent #5,532,156), has been partially characterized and is a non-transformed immortal cell line that possesses many characteristics similar to that of intact liver parenchymal cells. ARS interests would be greatly enhanced by further characterization and improvements in the culture technology that would ultimately result in the cell line not requiring feeder cell support and growth in a completely serum-free defined medium. These advancements would facilitate our understanding of regulatory events in pig liver gene/proteome expression and in regulation of nutrient metabolism. Further, it has already been demonstrated that the unique hepatic characteristics of the ARS-PICM-19 cell line would have potential application for use in the production of a rescue device for human patients in liver failure (ARS patent # 5,866,420; “Artificial Liver Device”, granted to ARS on 2/2/1999). To date, the cellular components of artificial liver devices that are being tested by other institutions are based on freshly isolated porcine hepatocytes, human transformed tumor cells, or poorly defined stem-like cells prepared from fresh human adult liver tissue. It is widely recognized that the greatest hindrance to the development of a completely functional artificial liver rescue device is the lack of an appropriate defined cell line that will provide the functions of an intact liver. The primary interest of Hepalife is to explore the possibility that the ARS PICM-19 cell line is indeed the most appropriate cell line to use in such a device.


B.

Objective


The overall objective of the work is to optimize the patented ARS-PICM-19 cell line as an in vitro model of the pig liver. The first objective is to investigate and discover culture conditions for the ARS-PICM-19 cell line, or modifications of the ARS-PICM-19 cell line technology itself, that will optimize function, i.e., culture conditions or cell line modifications that will enable, as closely as possible, the reproduction of normal pig liver functions in an in vitro environment.  Directly related to the first objective will be the second and third objectives.  The second objective is adapting and applying the optimized ARS-PICM-19 cell line technology to the development of an extracorporeal liver assist device as described in patent #5,866,420.  The third objective is to use the ARS-PICM-19 cell line in the development of in vitro assay formats for testing, a.) cell metabolism and toxicity responses, b.)  hepatocyte and bile duct epithelium cell function responses, and c.) cell transformation responses, i.e., loss of normal differentiation.


C.

Approach and Methodology


ARS will study experimental culture conditions for the ARS-PICM-19 cell line, its derivative cell lines, or other pig epiblast-derived liver cell lines (as described under ARS patent #5,532,156, “Hepatocyte Cell Line Derived from the Epiblast of Pig Blastocysts”) so as to optimize their hepatocyte functions for use as an in vitro liver model, for their use in an artificial liver device, and for their use in the in vitro assay of metabolic, toxic, or carcinogenic responses.  Specific project objectives are the following:


1)  Develop feeder-cell-independent and serum-free medium cell culture systems allowing the growth and differentiation of ARS-PICM-19 cells, or subclones or subpopulations of the ARS-PICM-19 cells, under defined conditions.


2)  Develop spheroid cultures of PICM-19 cells without STO feeder cells and testing of rotating cell culture system (RCCS) for production and maintenance of spheroids.


3)  Investigate effects of accessory cells obtained from pig liver on ARS-PICM-19 growth, differentiation, and metabolic function.


4)  Assay ARS-PICM-19 cells and spheroids for liver specific functions by measuring  P450 activity, γ-glutamyltranspeptidase activity, urea production, and ammonia clearance.


5)  Assay ARS-PICM-19 liver specific protein synthesis and secretion by electrophoretic, immunochemical, or mass spectrophotometric techniques.


6)  Develop and test, by in vitro assay, flow-through bioreactors that enable the growth, differentiation, and  maintenance of metabolic function of the ARS-PICM-19 cell line, or its derivative cell lines, over long term culture (1-3 months).


 7)  Develop and test multi-well cell culture formats for the in vitro assay of the effects of

various test compounds on the metabolism and viability of ARS-PICM-19-derived hepatocytes or bile ductules.


8)  Genetically engineer ARS-PICM-19 cells to create derivative cell lines containing gene reporter constructs, e.g., green fluorescent protein (GFP) based constructs, so that GFP expression is linked to various cell metabolic responses or stimulation of various cell signal transduction pathways.


9)  Develop cell transformation assay formats to demonstrate and enable the utilization of the ARS-PICM-19 cell line for the study of  mutagenic or carcinogenic processes.


Hepalife will provide funds for the salary of one post-doctoral researcher, one support scientist, and one technician for a period of three years and funds for the associated laboratory supplies and professional activities involved with conducting the CRADA objectives.


D.

ARS’ Responsibilities


1.

Conduct these portions of the research project or perform the following tasks:


a. Hire one post-doctoral research associate, one support scientist, and one technician for a  2-3 year period.


b. Provide laboratory and office space for the research associate.


c. Provide fully equipped cell culture laboratory and protein chemistry laboratory.


d. Provide experimental animals (pigs) and slaughter facilities.


e. Acquire specific laboratory equipment, e.g.., RCCS, and  supplies to conduct the CRADA objectives.


f. Conduct research on the optimization of the ARS-PICM-19 cell line, or its derivative cell lines (or related pig epiblast-derived cell lines), as an in vitro pig liver cell model, and adapt the ARS-PICM-19 liver cell technology to an extracorporeal liver assist device and to in vitro formats for metabolic, toxicological, and carcinogenicity assay.


g. Prepare progress reports on project objectives.


h. Prepare and submit technical reports for publication.


2.

a. Provide access to 1850 square feet of laboratory space in Building 200, Rooms 13, 202, 204 and 212, at the Beltsville Agricultural Research Center for those Hepalife personnel assigned to this project.


b. Provide utilities, services, and general support to Hepalife's personnel, as needed and available.


E.

Hepalife’s Responsibilities


1.

Perform these portions of the research effort:


a. Provide funds for one post-doctoral research associate, one support scientist, and one technician for a 2-3 year period.


b. Provide funds for project related laboratory equipment, supplies, and off site research services such as electron microscopy and bioreactor component manufacturing.


c. Provide funds for position advertisement and travel expenses for position interviews.

 

d. Provide funds for professional activities of research associate such as travel to meetings and project specific training activities.


e. Prepare and file patent applications.


2.

Pay a total of $807,828.00 to ARS for the 5-year life of the CRADA.  


a.

The payment schedule for the funds which remain to be paid is:


(1)

$65,422.80 on or before August 1, 2004;


(2)

$65,422.80 on or before November 1, 2004;


(3)

$65,422.80 on or before February 1, 2005;


(4)

$65,422.80 on or before May 1, 2005;


(5)

$65,422.80 on or before August 1, 2005;


(6)

$65,422.80 on or before November 1, 2005;


(7)

$65,422.80 on or before February 1, 2006;


(8)

$65,422.80 on or before May 1, 2006;


(9)

$65,422.80 on or before August 1, 2006;


(10)

$65,422.80 on or before November 1, 2006;



Total: $654.228.00


Second year funding arrangements as negotiated in the original CRADA are superseded by this amendment.  No additional funds are owed for Year 2.


b.

Make checks or money orders out to the "Agricultural Research Service," cite Agreement No. 58-3K95-3-0967 thereon, and send to:


USDA, ARS, BA, Budget and Fiscal Office

10300 Baltimore Ave.

Bldg. 003, Rm. 306, BARC-West

Beltsville, Maryland 20705-2350



3.

Hepalife may pay the travel and per diem of ARS scientific representatives traveling pursuant to this Agreement if such payment receives the prior approval of the appropriate ARS Area Director.


4.

Describe any personnel and/or equipment Hepalife will furnish ARS.


Hepalife will provide funds for the hiring and laboratory research support of a post-doctoral research associate.


F.

ARS & Hepalife’s Joint or Mutual Responsibilities


1.

Perform these portions of the effort jointly:


a. Develop strategy for design of a support system matrix to grow and maintain established ARS-PICM-19, or its derivative cell lines, or related pig liver epiblast-derived cell lines.


b. Evaluate efficacy of ARS-PICM-19,  its derivative cell lines, or related epiblast-derived pig liver cell lines, in an in vitro pig liver model system for potential use in an extracorporeal liver assist device and in the development and testing of in vitro formats for assaying metabolic, toxicological, and carcinogenic responses in pig hepatocytes and bile ductules.












SCHEDULE 3 ESTIMATED BUDGET



TOTAL YEARS

 

ARS Receive

Funds for

ARS In-House

Hepalife

In-House

A.  Salaries and Wages

408,400.00

99,628.00

360,000.00

B.  Equipment

28,025.00

200,000.00

33,000.00

C.  Materials and Supplies

265,500.00

  

D.   Travel

1.  Domestic

2.  Foreign


14,000.00


8,000.00


80,000.00

E. Facilities

 

224,000.00

84,000.00

F.  Other Direct Costs

11,126.00

105,144.00

 


G.  TOTAL DIRECT COSTS


727,051.00


636,722.00


557,000.00

H.  Indirect Costs

80,777.00

  

I. TOTAL COSTS…….…$

807,828.00

636,722.00

557,000.00


YEAR 1

 

ARS Receive

Funds for

ARS In-House

Hepalife

In-House

A.  Salaries and Wages

75,000.00

23,200.00

72,000.00

B.  Equipment

13,025.00

50,000.00

6,000.00

C.  Materials and Supplies

45,500.00

  

D.   Travel

1.  Domestic

2.  Foreign


2,000.00


2,000.00


8,000.00

E. Facilities

 

56,000.00

12,000.00

F.  Other Direct Costs

2,715.00

26,244.00

 


G.  TOTAL DIRECT COSTS


138,240.00


157,444.00


98,000.00

H.  Indirect Costs

15,360.00

  

I. TOTAL COSTS…….…$

153,600.00

157,444.00

98,000.00


Year 2

 

ARS Receive

Funds for

ARS In-House

Hepalife

In-House

A.  Salaries and Wages

   

B.  Equipment

   

C.  Materials and Supplies

   

D.   Travel

1.  Domestic

2.  Foreign

   

E. Facilities

   

F.  Other Direct Costs

   

G.  TOTAL DIRECT COSTS

   

H.  Indirect Costs

   

I. TOTAL COSTS…….…$

0.00

0.00

0.00




Year 3

 

ARS Receive

Funds for

ARS In-House

Hepalife

In-House

A.  Salaries and Wages

125,900.00

24,244.00

96,000.00

B.  Equipment

5,000.00

50,000.00

9,000.00

C.  Materials and Supplies

80,000.00

  

D.   Travel

1.  Domestic

2.  Foreign


4,000.00


2,000.00


24,000.00

E. Facilities

 

56,000.00

24,000.00

F.  Other Direct Costs

2,800.00

26,300.00

 


G.  TOTAL DIRECT COSTS


217,700.00


158,544.00


153,000.00

H.  Indirect Costs

24,187.00

  

I. TOTAL COSTS…….…$

241,887.00

158,544.00

153,000.00



Year 4

 

ARS Receive

Funds for

ARS In-House

Hepalife

In-House

A.  Salaries and Wages

135,500.00

25,456.00

96,000.00

B.  Equipment

5,000.00

50,000.00

9,000.00

C.  Materials and Supplies

80,000.00

  

D.   Travel

1.  Domestic

2.  Foreign


4,000.00


2,000.00


24,000.00

E. Facilities

 

56,000.00

24,000.00

F.  Other Direct Costs

2,800.00

26,300.00

 


G.  TOTAL DIRECT COSTS


225,300.00


159,756.00


153,000.00

H.  Indirect Costs

25,030.00

  

I. TOTAL COSTS…….…$

250,330.00

159,756.00

153,000.00


Year 5

 

ARS Receive

Funds for

ARS In-House

Hepalife

In-House

A.  Salaries and Wages

74,000.00

26,728.00

96,000.00

B.  Equipment

5,000.00

50,000.00

9,000.00

C.  Materials and Supplies

60,000.00

  

D.   Travel

1.  Domestic

2.  Foreign


4,000.00


2,000.00


24,000.00

E. Facilities

 

56,000.00

24,000.00

F.  Other Direct Costs

2,811.00

26,300.00

 


G.  TOTAL DIRECT COSTS


145,800.00


161,028.00


153,000.00

H.  Indirect Costs

16,200.00

  

I. TOTAL COSTS…….…$

162,011.00

161,028.00

153,000.00













Exhibit 10.5



RESTATED FINDER AGREEMENT


Restated Finder And Agreement , dated as of the 1st  day of August, 2005 (the “Restated Agreement”), between Pacific Capsource, Inc., (“Finder”), a Nevada Corporation, with offices located at 1751 Greenwich, San Francisco, CA 94123, and HepaLife Technologies, Inc. (“Client”), a Florida Corporation, with offices located at Suite 216, 1628 West 1st Avenue, Vancouver, B.C., V6J 1G1.


Finder and Client are parties to a Finder Agreement dated as of the 15th day of June, 2005 (the “Finder Agreement”) as amended on the 8th day of July, 2005 (the “Amendment”); the Finder Agreement as amended and modified by, and together with the Amendment, is referred to herein as the “Original Finder Agreement;” and


Finder and Client deem it to be in their respective best interest to terminate, in its entirety, the Original Finder Agreement and to restate their understanding with respect to the subject matter thereof all on the terms and conditions set forth herein.


Accordingly, in consideration of the mutual promises made herein and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:


1.  Purpose: This agreement applies specifically to:


(i)

the termination of the Original Finder Agreement;


(ii)

compensation related to the relationship between Client and Fusion Capital Partners, LLC (“Fusion”), which was introduced previously by Finder to Client;  


(iii)

Finder’s engagement, on a non-exclusive basis, by Client, to obtain financing from various other funding resources that Finder has association or relationships with to be used for various Companies controlled by or affiliated with Client (collectively, an “Affiliated Company”).


2.  Term: The term of this Restated Agreement shall be for a period of 48 calendar months commencing on the date hereof and terminating on August 1, 2009 (the “Engagement Term”). Except as otherwise specified in Section 4 hereof, any funding resource introduced by Finder to Client or to an Affiliated Company, without a previous relationship having existed between and/or among Client, Affiliated Company and such funding resource, shall be protected as to payment of fees under this Restated Agreement.


3.  Duties of Finder:  During the term of this Restated Agreement, Finder and Finder’s affiliates shall seek to provide introductions to various funds resources and institutions that may have interest in providing Client or the various Companies controlled by or affiliated with Client with various forms of financing.  Finder shall not be obligated to spend any specific amount of time in so doing.  It is agreed and understood that Client may accept or reject any proposed funding source or financing, in its sole discretion, for any reason or no reason whatsoever.


4.  Compensation:  (a) Subject to the provisions of Section 4 (d) hereof, upon Client’s, or an Affiliated Company’s obtainment of financing from Fusion during the period commencing on the date hereof and continuing until the 4th anniversary date of this Restated Agreement (the “Compensation Term”), Client shall be obligated to pay Finder a diligence fee of 3% of all funds initially and subsequently actually obtained and received by Client (or any such Affiliated Company) from Fusion.   Any fee due and payable hereunder will be paid in arrears, on a monthly basis, based on the actual funds received from Fusion during the prior 30 day period. Client agrees to provide Finder full disclosure of all Fusion stock purchases each month at Finder’s request. No fee is due and payable with respect to amounts received from Fusion, and any financing arrangement entered into with Fusion, after the Compensation Term.


(b) In addition, and subject to Section 4(d) hereof, Finder shall be issued a one time warrant compensation for 200,000 warrants exercisable  over a 4 year term at a fixed price of  110% of the current share price (for example if the shares were trading at $1.00 per share, then warrants would be exercisable at $1.10 per share) based on the average of the closing price per share for the 5 trading days immediately prior to the original filing date of the registration statement for the Fusion capital investment. Finder’s will have piggy back registration rights exclusive, however, of any registration statement filed in connection with any financing arrangement entered into between or among, Client, an Affiliated Company and Fusion, or any registration statement filed on Form S-8 and S-4.


(c) There are no additional fees or compensation beyond these fees and warrants outlined.  Fees for any additional funding resources will be negotiated separate and apart from this Restated Agreement and will be reflected in a separate written agreement.


(d) Finder has represented to Client that it is not a registered broker/dealer.  Accordingly, no fee due and payable under this Restated Agreement to Finder shall actually be paid unless and until Finder can reasonably demonstrate that it or an entity affiliated with the principals of Finder is a registered broker dealer (a “Registered Entity”) or otherwise lawfully entitled to receive such fee(s) in compliance with applicable state and federal securities laws.  If such fee is to be paid to an entity other than a Registered Entity, Client, in its sole discretion, may require Finder to deliver to Client an opinion of counsel, reasonably satisfactory to Client, to the affect that the payment of such fee will not constitute a violation of the Securities Laws and that no third party rights or claims against Client may arise from such payment.  If Finder has not complied with the conditions of this Section 4(d) on or prior to the expiration of the Engagement Term, all fees due Finder hereunder shall be forfeited as of such date, and Finder shall not be entitled to any compensation whatsoever hereunder.


5.  Finder Introductions and Meeting Coordination:   The Client acknowledges that all introductions and meeting coordination (written or oral) provided by Finder to the Client or its named affiliates in connection with Finder’s engagement are intended solely for the benefit and use of the Client or its named affiliates in considering the transaction to which they relate, and the Client agrees that no person or Affiliated Company shall be entitled to make use of the introductions provided by Finder hereunder.  Company shall not make any public references to Finder, or use the Finder’s name in any annual reports or any reports or public releases of the Client, or Affiliated Company without Finder’s prior written consent.


6.  Confidentiality:    Finder will hold in confidence any confidential information which the Client or an Affiliated Company provide to Finder pursuant to this Agreement which is designated by an appropriate stamp or legend as being confidential.  Notwithstanding the foregoing, Finder shall not be required to maintain confidentiality with respect to information (i) which is or becomes part of the public domain not due to the breach of this Agreement by Finder, (ii) of which it had independent knowledge prior to disclosure, (iii) which comes into the possession of Finder in the normal and routine course of its own business from and through independent non-confidential sources; or (iv) which is required to be disclosed by Finder by laws, rules or regulators.  If Finder is requested or required to disclose any confidential information supplied to it by the Client or one or more or Affiliated Company, Finder shall, unless prohibited by law, promptly notify the Client and any such Affiliated Company of such request(s) so that the Client and/or any such Affiliated Company may seek an appropriate protective order.


The Client acknowledges that all introductions (written or oral) provided by Finder to Client or an Affiliated Company in connection with Finder’s engagement are intended solely for the benefit and use of the Client or an Affiliated Company in considering the transaction to which they relate, and the Client agrees that no person or entity other than the Client or  an Affiliated Company, shall be entitled to make use of the introductions to be given hereunder, and no such related information shall be used for any other purpose or reproduced, disseminated, quoted or referred to at any time, in any manner or for any purpose without Finder’s  prior written consent.


7. Finder’s Services to Others:  The Client acknowledges that Finder or its affiliates are in the business of providing funding resource introductions to others.  Nothing herein contained shall be construed to limit or restrict Finder in conducting such business with others.


8.  Company Information:   Finder shall rely on Client to check properly beforehand that any information supplied to an introduced funding resource be true, fair and accurate and not misleading.  This includes checking any expressions of opinion and any possible omissions.  Before sending any business plan or financial data to potential funding sources, Finder shall require Client’s confirmation that any information contained within the submitted documentation is accurate and not misleading and that nothing likely to be material has been omitted.  If, during the Engagement Period, Client subsequently discovers something which renders any such information inaccurate, incomplete or misleading, Client shall notify Finder immediately.


9.  Termination of the Original Finder Agreement And Mutual Releases.


(a) The Original Finder Agreement is terminated, and deemed null and void, as of August 1, 2005


(b) Finder individually and on behalf of its successors and assigns, does hereby fully release, remise and forever discharge Client and any Affiliated Company and their respective officers, directors, shareholders, employees, subsidiaries, attorneys, representatives and agents from any and all debts, obligations, liabilities, accountings, promises, covenants, agreements, contracts, controversies, suits, actions, causes of actions, judgments, damages, claims, demands, in law or in equity, which Finder ever had, now has, or hereafter can, shall or may have against them for, upon or by reason of any matter, cause or thing whatsoever, from the beginning of the world to the date hereof, including all claims for any share of income, any return of capital or any compensation for services from any of such parties arising from or otherwise related to the Original Finder Agreement.


(c) Client (or any Affiliated Company) individually and on behalf of its successors and assigns, does hereby fully release, remise and forever discharge Finder and their respective officers, directors, shareholders, employees, subsidiaries, attorneys, representatives and agents from any and all debts, obligations, liabilities, accountings, promises, covenants, agreements, contracts, controversies, suits, actions, causes of actions, judgments, damages, claims, demands, in law or in equity, which Finder ever had, now has, or hereafter can, shall or may have against them for, upon or by reason of any matter, cause or thing whatsoever, from the beginning of the world to the date hereof, including all claims for any share of income, any return of capital or any compensation for services from any of such parties arising from or otherwise related to the Original Finder Agreement .


(d) The releases set forth in this Restated Agreement are intended by the parties to release all claims, whether known, unknown, foreseen, unforeseen, patent or latent, which one party may have against the other as of the date of this Restated Agreement.  Each party understands and acknowledges the significance and consequence of such specific intention to release all claims related to the Original Finder Agreement.  


10.  Indemnification:  (a)The Client (or an Affiliated Company) as the case may be, severally and not jointly, agree to indemnify and hold harmless Finder, its employees, agents, representatives and controlling persons from and against any and all losses, claims, damages, liabilities, suits, actions, proceedings, costs and expenses (collectively, “Damages”), including, without limitation, reasonable attorney fees and expenses, as and when incurred, if such Damages were directly or indirectly caused by, relating to, based upon or arising out of the rendering by Finder of services pursuant to this Agreement, so long as Finder shall not have engaged in intentional or willful misconduct, or shall have acted grossly negligently in connection with the services provided which form the basis of the claim for indemnification.  This paragraph shall remain in effect during the Compensation Term of this Restated Agreement.


(b) Finder agrees to agree to indemnify and hold harmless Client (or Affiliated Company) as the case may be, and their respective employees, agents, representatives and controlling persons from and against any and all Damages, including, without limitation, reasonable attorney fees and expenses, as and when incurred, if such Damages were directly or indirectly caused by, relating to, based upon or arising out of the rendering by Finder of services pursuant to this Restated Agreement. This paragraph shall remain in effect during the Compensation Term of this Restated Agreement.


10.  Employment:  Finder shall perform its services hereunder as an independent contractor and not as an employee, agent or an affiliate of the Client or Affiliated Company.  Finder shall have no authority to act on behalf of, represent or bind the Client or Affiliated Company in any manner, except as may be expressly agreed to by the Client or the various Companies controlled by or affiliated with Client in writing from time to time.


11.  Claims Under This Agreement:  Any claim or controversy arising out of or related to this agreement or breach thereof, which cannot be reconciled by the parties herein shall be subject to mediation, and if no resolution is reached, then the dispute will be subject to binding arbitration in the city of San Francisco in the state of California.  Such arbitration shall be conducted by the American Arbitration Association, by a three member panel.  Judgment rendered by the arbitrator(s) may be entered in a court having jurisdiction thereof.

 

12.  Notices:  Any notice required to be served herein may be done by registered mail to the address first listed above or to any future address designated by either party, and shall be deemed to be delivered as of the date of mailing of such notice.


13.  Authorization: The parties hereby acknowledge that they are authorized to commit themselves and/or their corporation, partnership or group to the terms of this agreement and do attest that there are no contracts, agreements, understandings or otherwise, either written or oral, that will make this Agreement void or unenforceable.


14.  Assignment:  If any party shall transfer his business to another entity, such transfer shall include the transfer of this agreement which shall remain in full force and effect.  Finder shall have the right to transfer their interest to one or more entities in which they are principals of.


15.  Miscellaneous:


(1)  This Agreement between Finder and Client constitutes the entire agreement and understanding of the parties hereto, and supersedes any and all previous agreements and understandings, whether oral or written, including, but not limited to the Original Finder Agreement, between the parties with respect to the matters set forth herein.


(2) The invalidity of any clause of this document shall not affect the enforceability of the balance of this agreement, and the contract shall be read as if such clause was not included herein.


(3) This Agreement may be executed in any number of counterparts, each of which together shall constitute one and the same original document.


(4)  No provision of this Agreement may be amended, modified or waived, except in a writing signed by all of the parties hereto.  


16.   Facsimile:   Should this Agreement be transmitted by facsimile, the facsimile document or copy thereof shall be considered as an original document, both binding and enforceable.


IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed, as of the day and year first above written.



Pacific Capsource, Inc.

HepaLife Technologies, Inc.



By:/s/ Gary Little

By: /s/ Harmel S. Rayat

Name: Gary Little

Name:  Harmel S. Rayat

Title:  

Title:

 Director














Exhibit 23.1



Consent of Sierchio Greco & Greco, LLP



Included in Exhibit 5.











Exhibit 23.2



Consent of Independent Registered Public Accounting Firm



We consent to the reference to our firm under the caption “Experts” and to the use of our reports dated March 15, 2005 and March 15, 2004in the Registration Statement and the related Prospectus of HepaLife Technologies, Inc. for the registration of up to 10,711,598 shares of its common stock.



/s/ Moore Stephens Ellis Factor

Moore Stephens Ellis Foster Ltd.

Certified Public Accountants

Vancouver, British Columbia, Canada

August 16, 2005










Exhibit 23.3



Consent of Independent Registered Public Accounting Firm


We consent to the reference to our firm under the caption “Experts” and to the use of our report dated March 3, 2003 in the Registration Statement (Form S-1 No. 333-______) and the related Prospectus of HepaLife Technologies, Inc. for the registration of up to 10,711,598 shares of its common stock.



/s/ Clancy and Co.

Clancy and Co. P.L.L.C.

Certified Public Accountants

Phoenix, AZ

August 16, 2005