form8k.htm
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
October
1, 2008
Date of
Report (Date of earliest event reported)
HEPALIFE
TECHNOLOGIES, INC.
(Exact
name of registrant as specified in its charter)
Florida
(State or
other jurisdiction of incorporation)
000-29819
(Commission
File Number)
58-2349413
(I.R.S.
Employer Identification No.)
60
State Street, Suite 700, Boston, MA 02109
(Address
of principal executive offices)
(800)
518-4879
(Registrant’s
telephone number, including area code)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
£ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
£ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a
-12)
£
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d -2(b))
£ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e
-4(c))
SECTION
1. Registrant’s Business and Operations
Item
1.01. Entry into a Material Definitive Agreement.
On
October 3, 2008 HepaLife Technologies, Inc. (the “Company”) entered into and
consummated the transactions contemplated by an Asset Purchase Agreement (the
“Purchase Agreement”) between the Company and Arbios Systems, Inc. a Delaware
corporation (“Arbios”).
Pursuant
to the Purchase Agreement, the Company, in order to enhance and strengthen its
current PICM-19 porcine liver cell line based bioartifical liver
technology, purchased certain specified assets of Arbios, relating to the
pig cell based liver device technology which was being developed by
Arbios.
The
acquired assets relate to the bioartificial liver device formerly known as “HepatAssist.” HepatAssist was
evaluated in the largest-ever Phase II/III clinical study (prospective
randomized trial involving over 170 patients) to test safety and efficacy of a
bioartificial liver assist device. The clinical data was published in
2004.
The
Acquired Assets (as defined in the Purchase Agreement) include over 12 patents
and patent licenses, miscellaneous equipment, FDA IND application including
orphan drug and fast track designation, Phase I and Phase II/III clinical
protocols and clinical data as well as standard operating procedures for
manufacturing and quality control.
The
purchase price of the Acquired Assets consisted of (i) $450,000 in cash of which
$250,000 was paid in cash at the closing and $200,000 has been deferred for up
to 18 months, (ii) a Series D warrant to purchase up to 750,000 shares of the
Company’s common stock at an exercise price of $0.35 per share for a period of 5
years (the “Warrant”), and (iii) assumption by the Company of the Assumed
Liabilities (as defined in the Purchase Agreement). The deferred $200,000
payment is due and payable on the earlier of (i) the date on which HepaLife has
consummated one or more debt or equity financings in which the gross proceeds
received in the aggregate equal or exceed $4,000,000, or (ii) the eighteen month
anniversary of the closing date.
The
issuance of the Warrant was deemed to be exempt from registration
under the Securities Act of 1933, as amended (the “Securities Act”), in reliance
on Section 4(2) of the Securities Act in that the issuance did not involve a
public offering. The Company granted Arbios certain registration rights, as more
fully set forth in the Registration Rights Agreement dated October 3, 2008
between the Company and Arbios, a copy of which is attached hereto as Exhibit
10.2, with respect to the shares of the Company’s common stock issuable upon
exercise of the Warrant.
The
foregoing description of the Purchase Agreement is qualified in its entirety by
the full text of the Purchase Agreement which is attached hereto as Exhibit
10.1.
Item
2.01. Completion of Acquisition or Disposition of Assets.
On
October 3, 2008, the Company consummated the transactions contemplated by the
Purchase Agreement. Please refer to the description of the Purchase Agreement
set forth above in “Item 1.01. Entry into a Material Definitive
Agreement.”
As a
result of the abovementiond acquisition, HepaLife initiates a re-organization of
the Company’s bioartificial liver device development activities. The
Company through its
subsidiary, HepaLife
Biosystems, Inc has notified the U.S. Department of Agriculture,
Agricultural Research Service (USDA, ARS) that it has elected to terminate the
Cooperative Research and Development Agreement (the “CRADA”) between the Company
and the USDA, ARS effective November 30, 2008.
The
exclusive license agreement for the PICM-19 liver cell line with the USDA, ARS
for the use of patented liver cell lines in artificial liver devices and
in-vitro toxicological testing platforms remains in force and effect; the
license was recently expanded for the additional use of PICM-19 as in-vitro
infection host system for viral and protozoan agents such as
malaria.
SECTION
2. Financial Information
None
SECTION
3. Securities and Trading Markets
Item
3.02. Unregistered Sale of Equity Securities.
On
October 3, 2008 the Company issued the Warrant to Arbios in connection with the
consummation of the transaction contemplated by the Purchase Agreement. The
Warrant entitles the holder to purchase up to
750,000 shares of the Company’s common stock at an exercise price of $0.35 per
share for a period of 5 year.
The
issuance of the Warrant was deemed to be exempt from registration under the
Securities Act in reliance on Section 4(2) thereof, in that the issuance did not
involve a public offering. The Company granted Arbios certain registration
rights, as more fully set forth in the Registration Rights Agreement dated
October 3, 2008 between the Company and Arbios, a copy of which is attached
hereto as Exhibit 10.2, with respect to the shares of the Company’s common stock
issuable upon exercise of the Warrant.
Please
refer to the description of the Purchase Agreement set forth above in “Item
1.01. Entry into a Material Definitive Agreement.”
SECTION
4. Matters Related to Accountants and Financial Statements
None
SECTION
5. Corporate Governance and Management
On
October 6, 2008 Mr. Frank Fabio, accepted an appointment to
serve, on an interim basis, as the Company’s Chief Financial
Officer.
Mr. Fabio
received a BBA in Accounting from Pace University in June 1973; has been a
certified Public Accountant since 1976; Mr. Fabio received an MS in
Taxation from Long Island University in June 1989. Mr. Fabio was
employed by Ernst & Ernst from 1973 to 1980, attaining the position of
Manager; since 1980 Mr. Fabio has maintained a private practice of
accountancy in New York.
SECTION
6. [Reserved]
N/A
SECTION
7. Regulation FD
Item 7.01
Regulation FD Disclosure
Except
for the historical information presented in this document, the matters discussed
in this Form 8-K, or otherwise incorporated by reference into this document,
contain "forward-looking statements" (as such term is defined in the Private
Securities Litigation Reform Act of 1995). These statements are identified by
the use of forward-looking terminology such as "believes", "plans", "intend",
"scheduled", "potential", "continue", "estimates", "hopes", "goal", "objective",
expects", "may", "will", "should" or "anticipates" or the negative thereof or
other variations thereon or comparable terminology, or by discussions of
strategy that involve risks and uncertainties. The safe harbor provisions of
Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A
of the Securities Act of 1933, as amended, apply to forward-looking statements
made by the Registrant. The reader is cautioned that no statements contained in
this Form 8-K should be construed as a guarantee or assurance of future
performance or results. These forward-looking statements involve risks and
uncertainties, including those identified within this Form 8-K. The actual
results that the Registrant achieves may differ materially from any
forward-looking statements due to such risks and uncertainties. These
forward-looking statements are based on current expectations, and the Registrant
assumes no obligation to update this information. Readers are urged to carefully
review and consider the various disclosures made by the Registrant in this Form
8-K and in the Registrant's other reports filed with the Securities and Exchange
Commission that attempt to advise interested parties of the risks and factors
that may affect the Registrant's business.
Note:
Information in this report furnished pursuant to Item 7 shall not be deemed to
be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, or otherwise subject to the liabilities of that section. The
information in this current report shall not be incorporated by reference into
any registration statement pursuant to the Securities Act of 1933, as amended.
The furnishing of the information in this current report is not intended to, and
does not, constitute a representation that such furnishing is required by
Regulation FD or that the information this current report contains is material
investor information that is not otherwise publicly available.
The
Company issued a press release dated October 7, 2008 pertaining to the
consummation by the company of the transactions contemplated by the Purchase
Agreement. A copy of the press release is attached hereto as Exhibit
99.1.
SECTION
8. Other Events
None
SECTION
9. Financial Statements and Exhibits
Item 9.01
Financial Statements and Exhibits
|
Number
|
Exhibit
Description
|
|
3.1
|
Form
of Series D Warrant
|
|
10.1
|
Asset
Purchase Agreement dated October 3, 2008 between HepaLife Technologies,
Inc. Arbios Systems, Inc.
|
|
10.2
|
Registration
Rights Agreement dated October 3, 2008 between HepaLife Technologies, Inc.
Arbios Systems, Inc.
|
|
10.3
|
Notice
of Termination of the Cooperative Research and Development Agreement
between HepaLife Technologies, Inc. and the U.S. Department of
Agriculture, Agricultural Research Service dated October 1,
2008
|
|
99.1
|
Press
Release dated October 7, 2008.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
HepaLife
Technologies, Inc.
|
Title:
|
President,
Chief Executive Officer and
Chairman
|
HEPALIFE
TECHNOLOGIES, INC.
FORM
8-K
Dated
October 1, 2008
INDEX
TO EXHIBITS
|
Number
|
Exhibit
Description
|
|
|
Asset
Purchase Agreement dated October 3, 2008 between HepaLife Technologies,
Inc. Arbios Systems, Inc.
|
|
|
Registration
Rights Agreement dated October 3, 2008 between HepaLife Technologies, Inc.
Arbios Systems, Inc.
|
|
|
Notice
of Termination of the Cooperative Research and Development Agreement
between HepaLife Technologies, Inc. and the U.S. Department of
Agriculture, Agricultural Research
Service
|
|
|
Press
Release dated October 7, 2008.
|
6