Unassociated Document
As
filed with the Securities and Exchange Commission on June 9,
2005.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
AMENDMENT
NO. 4 FORM SB-2
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
___________
Advaxis,
Inc.
(Name
of small business issuer in our charter)
Colorado
(State
or other jurisdiction
of
incorporation or organization) |
2836
(Primary
Standard Industrial
Classification
Code Number) |
841521955
(I.R.S.
Employer
Identification
No.) |
212
Carnegie Center
Suite
206
Princeton,
NJ 08540
(609)
895-7150
(Address,
including zip code, and telephone number, including area code, of registrant’s
principal place of business)
___________________________
Mr.
Todd Derbin, Chief Executive Officer
212
Carnegie Center
Suite
206
Princeton,
NJ 08540
(609)
895-7150
(Name,
address, including zip code, and telephone number, including area code, of
registrant’s agent for service)
___________________________
Copies
to:
Gary
A. Schonwald, Esq.
Reitler
Brown & Rosenblatt LLC
800
Third Avenue
21st
Floor
New
York, New York 10022
(212)
209-3050 / (212) 371-5500 (Telecopy)
Approximate
date of commencement of proposed sale to the public. From
time to time 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, as
amended, 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 of 1933, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering: o
If this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act of 1933, check the following box and list the Securities Act of
1933 registration statement number of the earlier effective registration
statement for the same offering: o
If
delivery of the prospectus is expected to be made pursuant to Rule 434, please
check the following box: o
CALCULATION
OF
REGISTRATION FEE
Title
of each class of
securities
to be registered |
Amount
to be Registered
(1)
|
Proposed maximum
offering
price per unit
(2) |
Proposed maximum
aggregate offering
price
(2) |
Amount
of
registration
fee |
|
|
|
|
|
common
stock par value $0.001 per share(3) |
|
$1.00 |
$4,366.61 |
$4,366.61 |
common
stock par value $0.001 per share(4) |
19,630,588 |
$1.00 |
$2,310.52 |
$2,310.52 |
THE
REGISTRANT HEREBY AMENDS THIS REGISTRATION SATEMENT ON SUCH DATE OR DATES AS MAY
BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A
FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SECTION8(A) MAY
DETERMINE.
(1)
|
In
accordance with Rule 416(a), the Registrant is also registering hereunder
an indeterminate number of shares that may be issued and resold to prevent
dilution resulting from stock splits, stock dividends or similar
transactions as well as anti-dilution provisions applicable to shares
underlying the warrants.
|
(2)
|
Estimated
pursuant to Rule 457(c) of the Securities Act of 1933 solely for the
purpose of computing the amount of the registration fee.
|
(3)
|
Represents
shares of the Registrant’s common stock being registered for resale that
have been issued to the selling stockholders named in the prospectus or a
prospectus supplement.
|
(4)
|
Represents
shares of the Registrant’s common stock being registered for resale that
have been or may be acquired upon the exercise of warrants issued to the
selling stockholders named in the prospectus or a prospectus
supplement. |
Subject
to completion
Dated
June 9, 2005
PRELIMINARY
PROSPECTUS
56,730,045
Shares
Advaxis,
Inc.
This
prospectus relates to the resale of up to 36,690,056 shares of common stock and
19,630,588 shares of common stock underlying warrants of Advaxis, Inc. by
certain selling stockholders identified in this prospectus. This
prospectus also relates to the resale of 409,401 shares of common stock
(representing penalty shares issuable to certain selling stockholders). All of
the shares, when sold will be sold by these selling
stockholders. The selling stockholders may sell their common stock
from time to time at prevailing market prices. We will
not receive any proceeds from the sales by the Selling Stockholders, but we will
receive funds from the exercise of warrants held by selling stockholders, if
exercised and if payment is made by means other than cashless
exercise.
We have
applied for our common stock to be quoted on the Over The Counter Bulletin
Board, which is commonly referred to as the “OTC Bulletin Board” maintained by
various broker dealers. There is no “public market” for shares of our common
stock.
No
underwriter or person has been engaged to facilitate the sale of shares of
common stock in this offering. None of the proceeds from the sale of common
stock by the selling stockholders will be placed in escrow, trust or any similar
account. There are no underwriting commissions involved in this offering. We
have agreed to pay all the costs of this offering. Selling stockholders will pay
no offering expenses.
This
offering is highly speculative and these securities involve a high degree of
risk. You should purchase shares only if you can afford a complete loss. See
“Risk Factors” beginning on page 9.
_________________________
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 is __________, 2005.
The
information in this prospectus is not complete and may be changed without
notice. The selling stockholders may not sell these securities
until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to
sell these securities, and it is not soliciting offers to buy these
securities, in any state where the offer or sale of these securities is
not permitted. |
TABLE
OF CONTENTS
|
|
Item
Description |
Page
No. |
|
|
PROSPECTUS
SUMMARY |
3 |
|
|
THE
OFFERING |
8 |
|
|
RISK
FACTORS |
9 |
|
|
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS |
24 |
|
|
USE
OF PROCEEDS |
25 |
|
|
MARKET
FOR COMMON STOCK AND RELATED STOCKHOLDER MATTERS |
25 |
|
|
DIVIDEND
POLICY |
25 |
|
|
DILUTION |
25 |
|
|
CAPITALIZATION |
26 |
|
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
AND PLAN OF OPERATIONS |
28 |
|
|
BUSINESS |
40 |
|
|
MANAGEMENT |
57 |
|
|
PRINCIPAL
AND MANAGEMENT STOCKHOLDERS |
66 |
|
|
CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS |
69 |
|
|
SELLING
STOCKHOLDERS |
71 |
|
|
DESCRIPTION
OF CAPITAL STOCK OF THE COMPANY |
84 |
|
|
SHARES
OF THE COMPANY ELIGIBLE FOR FUTURE SALE |
86 |
|
|
PLAN
OF DISTRIBUTION |
88 |
|
|
LEGAL
MATTERS |
90 |
|
|
EXPERTS |
90 |
|
|
ADDITIONAL
INFORMATION |
90 |
|
|
FINANCIAL
STATEMENTS |
F-1 |
|
|
INFORMATION
NOT REQUIRED IN PROSPECTUS |
II-1 |
|
|
INDEMNIFICATION
OF DIRECTORS AND OFFICERS |
II-1 |
|
|
OTHER
EXPENSES OF ISSUANCE AND DISTRIBUTION |
II-1 |
|
|
RECENT
SALES OF UNREGISTERED SECURITIES |
II-1 |
|
|
EXHIBITS |
II-2 |
|
|
UNDERTAKINGS |
II-5 |
Please
read this prospectus carefully. It describes our business, our financial
condition and results of operations. We have prepared this prospectus so that
you will have the information necessary to make an informed investment
decision.
You
should rely on the information contained in this prospectus. We have not
authorized anyone to provide you with information different from that contained
in this prospectus. The selling stockholders are offering to sell shares of our
common stock and seeking offers to buy shares of our common stock only in
jurisdictions where offers and sales are pemitted. The information contained in
this prospectus is accurate only as of the date of the prospectus, regardless of
the time the prospectus is delivered or the common stock is sold.
PROSPECTUS
SUMMARY
This
summary highlights some information from this prospectus, and it may not contain
all of the information that is important to you. You should read the following
summary together with the more detailed information regarding our company and
the common stock being sold in this offering, including “Risk Factors” and our
consolidated financial statements and related notes, included elsewhere in this
prospectus.
General
We are a
development stage biotechnology company utilizing multiple mechanisms of
immunity with the intent to develop cancer vaccines that are more effective and
safer than existing vaccines. To that end, we have licensed rights from the
University of Pennsylvania (“Penn”) to use a patented system to engineer a live
attenuated Listeria monocytogenes bacteria (the “Listeria System”) to secrete a
protein sequence containing a tumor-specific antigen. Using the Listeria System,
we believe we will force the body’s immune system to process and recognize the
antigen as if it were foreign, creating the immune response needed to attack the
cancer. Our licensed Listeria System, developed at Penn over the past 10 years,
provides a scientific basis for believing that this therapeutic approach induces
a significant immune response to a tumor. Accordingly, we believe that the
Listeria System is a broadly enabling platform technology that can be applied to
many types of cancers. In addition, we believe there may be useful applications
in infectious diseases and auto-immune disorders.
The
therapeutic approach that comprises the Listeria System is based upon the
innovative work of Yvonne Paterson, Ph.D., Professor of Microbiology at Penn,
involving the creation of genetically engineered Listeria that stimulate the
innate immune system and induce an antigen-specific immune response involving
humoral and cellular components. We have obtained an exclusive 20-year license
from Penn to exploit the Listeria System, subject to meeting various royalty and
other obligations (the “Penn License”).
We have
focused our initial development efforts upon cancer vaccines targeting cervical,
breast, melanoma, ovarian, lung and other cancers. Our lead products in
development are as follows:
Product |
|
Indication |
|
Stage |
Lovaxin
C
|
|
Cervical
and head and neck cancers
|
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in the first half
of 2005*
|
Lovaxin
B
|
|
Breast
cancer and melanoma
|
|
Pre-clinical;
Phase I study anticipated to commence in 2006
|
Lovaxin
NY
|
|
Ovarian,
melanoma and lung cancer
|
|
Pre-clinical;
Phase I study anticipated to commence in 2006
|
Lovaxin
W
|
|
Wilms
tumor and leukemia
|
|
Pre-clinical;
Phase I study anticipated to commence in 2006
|
Lovaxin
T
|
|
Cancer
through control of telomerase
|
|
Pre-clincial
|
Lovaxin
H
|
|
Prophylactic
vaccine for HIV (AIDS)
|
|
Pre-clincial
|
*
Possible delays of up to three months may occur based on the production schedule
of Cobra Biomanufacturing PLC of material, the length of time for Pharm Olam to
complete toxicology studies and the issuance of required regulatory
approval.
See
“Business - Research and Development Programs”.
Since our
formation, we have had a history of losses which, as of January 31, 2005
aggregate ($1,903,996), and because of the long development period for new
drugs, we expect to continue to incur losses for several years. Our business
plan to date has been realized by substantial outsourcing of virtually all major
functions of drug development including scaling up for manufacturing, research
and development, grant applications and others. The expenses of these outsourced
services account for most of our accumulated loss. We cannot predict when, if
ever, any of our product candidates will become commercially viable or FDA
approved. Even if one or more of our products becomes commercially viable and
receives FDA approval, we are not certain that we will ever become a profitable
business.
Strategy
During
the next 12 to 24 months our strategic focus will be to achieve several
objectives. The foremost of these objectives are as follows:
· |
Initiate
and complete Phase I clinical study of Lovaxin C; |
· |
Continue
the pre-clinical development of our product candidates, as well as
continue research to expand our technology platform;
and |
· |
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies. |
There are
many potential obstacles to the implementation of our proposed strategy. Among
the potential obstacles we may encounter with respect to the Phase I clinical
study of Lovaxin C are: difficulty in recruiting patients for the study; a
material, adverse medical result in a patient during the study; and extended
time for FDA approval of the IND (or foreign regulatory authority approval)
required to proceed with the test.
Among the
potential obstacles which we may encounter with respect to continuing
preclinical development of our product candidates such as Lovaxin B or T are
ambiguous animal data not sufficient to establish a proof of concept;
insufficient or adverse preclinical data on future products; and unexpected
higher costs or preclinical studies.
Among the
potential obstacles which we may encounter in establishing strategic
collaborations are: we may be perceived by desirable potential partners as too
early stage; we may need to demonstrate more human safety or efficicacy data; or
our technology may be perceived as high risk for patients or to the
environment.
History
of the Company
We were
originally incorporated in the State of Colorado on June 5, 1987 under the name
Great Expectations, Inc. We were administratively dissolved January 1, 1997 and
reinstated June 18, 1998 under the name Great Expectations and Associates, Inc.
In 1999, we became a reporting company under the Securities Exchange of 1934
(the “Exchange Act’). Until November 2004, we were a
shell company without any business. On November 12, 2004, we acquired Advaxis,
Inc., a Delaware corporation (“Advaxis”), through a Share Exchange and
Reorganization Agreement, dated as of August 25, 2004 (the “Share Exchange”), by
and among Advaxis, the stockholders of Advaxis and us. As a result of such
acquisition, Advaxis become our wholly-owned subsidiary and our sole operating
company. On
December 23, 2004, we amended and restated our articles of incorporation and
changed our name to Advaxis, Inc. Our principal executive offices are located at
212 Carnegie Center, Suite 206, Princeton, NJ 08540 and our
telephone number is (609) 895-7150.
_______________
Recent
Developments
In
November 2004, we acquired 100% of the stock of Advaxis. Advaxis was organized
in 2002 to develop the Listeria System under patents licensed from Penn which
are described above under “General” and later in this prospectus under
“Business.”
The
acquisition of Advaxis was pursuant to the Share Exchange. In connection with
the Share Exchange (i) our existing stockholders entered into a Surrender and
Cancellation Agreement whereby such stockholders contributed to us 199 shares of
every 200 shares of common stock beneficially
owned by them so that their ownership was reduced to 752,600 shares of common
stock and (ii) we issued to the existing stockholders of Advaxis and others
16,350,323 shares of common stock, warrants to purchase 584,885 shares of common
stock and options to purchase 2,381,525 shares of common stock. Upon the closing
of the Share Exchange, the total number of shares of our common stock
outstanding was 20,069,333 shares on a fully-diluted basis. The transaction is
being accounted for as a recapitalization. The historical financial statements
of Advaxis are our financial statements for reporting purposes.
On
November 12, 2004, we completed an initial closing of a private placement
offering (the “Private Placement”), whereby we sold an aggregate of $2.925
million worth of
units to accredited investors. Each unit was sold for $25,000 (the “Unit Price”)
and consisted of (a) 87,108 shares of common stock and (b) a warrant to
purchase, at any time prior to the fifth anniversary following the date of
issuance of the warrant, 87,108 shares of common stock included at a price equal
to $0.40 per share of common stock (a “Unit”). In consideration of the
investment, we granted to each investor certain registration rights and
anti-dilution rights. Also, in November 2004, we converted approximately
$618,000 aggregate principal of promissory notes and accrued interest
outstanding into Units.
On
December 8, 2004, we completed a second closing of the Private Placement,
whereby we sold an aggregate of $200,000 of Units to accredited
investors.
On
January 4, 2005, we completed a third and final closing of the Private
Placement, whereby we sold an aggregate of $128,000 of Units to accredited
investors.
The
aggregate sale of the Units in the Private Placement was
$3,253,000.
Pursuant
to the terms of a investment banking agreement, dated March 19, 2004, by and
between us and Sunrise Securities, Corp. (the “Placement Agent”), we issued to
the Placement Agent and its designees an aggregate of 2,283,445 shares of common
stock and warrants to purchase up to an aggregate of 2,666,900 shares of common
stock. The shares were issued as part consideration for the services of the
Placement Agent, as our placement agent in the Private Placement. In addition,
we paid the Placement Agent a total cash fee of $50,530.
On
January 12, 2005, we completed a second private sale of Units whereby we sold an
aggregate of $1,100,000 of Units to a single investor. As with the Private
Placement, each Unit issued and sold in this subsequent private placement was
sold at $25,000 per Unit and is comprised of (i) 87,108 shares of our common
stock, and (ii) a five-year warrant to purchase 87,108 shares of our common
stock at an exercise price of $0.40 per share.
Pursuant
to the terms of a certain Registration Rights Agreement, dated as of November
12, 2004, by and among us and certain of our stockholders and a Registration
Rights Agreement, dated as of January 12, 2005, by and between us and one of our
stockholders, we are obligated to issue shares of our common stock to certain
stockholders on a monthly basis if this registration statement is not declared
effective by a certain date. As of May 10, 2005, we were obligated to issue an
aggregate of 409,401 shares (the “Penalty
Shares”) to
such stockholders.
Our
auditors, in their report on our financial statements as of December 31, 2002
and 2003, indicated that the Company has incurred losses from operations, has a
working capital deficiency, and a shareholder’s deficiency, which raise
substantial doubt about the Company’s ability to continue as a going concern.
Subsequent to the issuance of those financial statements the Company has raised
additional equity financing in the Private Placement and intends to raise
additional funds. As a result of raising such funds our ability to continue as a
going concern is no longer an issue for our accountants. See further discussion
in “Management’s Discussion and Analysis of Financial Condition and Results of
Operations and Plan of Operations - Liquidity and Capital
Resources”.
Our
Website
We
maintain a website at www.advaxis.com which
contains descriptions of our technology, our drugs and the trial status of each
drug.
SUMMARY
CONSOLIDATED FINANCIAL DATA OF ADVAXIS
On
November 12, 2004, we acquired Advaxis, Inc., a Delaware corporation through the
Share Exchange. The transaction was accounted for as a recapitalization. The
historical financial statements of Advaxis will be our financial statements for
reporting purposes. Advaxis, Inc has changed its fiscal year to October
31st and as a
result is providing herein its audited financial statements for the years ended
December 31, 2002 and 2003 and for the ten months ended October 31,
2004.
The
following condensed statement of operations data for the period from March 1,
2002 (inception) to December 31, 2002, the year ended December 31, 2003, the ten
months ended October 31, 2004 and the selected balance sheet data at December
31, 2002 and 2003, and at October 31, 2004 are derived from Advaxis’ financial
statements and the related notes, audited by Goldstein
Golub Kessler LLP, Certified Public Accountants, 1185 Avenue of the Americas,
Suite 500, New York, NY 10036-2602,
Advaxis’ independent registered public accounting firm. The financial statements
and the related notes as of December 31, 2002 and 2003 and for period ended
December 31, 2002, the year ended December 31, and 2003 and the ten months ended
October 31, 2004 are included elsewhere herein. The selected unaudited statement
of operations data for the ten months ended October 31, 2003, and the unaudited
selected statement of operations data for the three months ended January 31,
2004 and 2005, and the unaudited consolidated selected balance sheet data at
January 31, 2005, are derived from Advaxis’ unaudited financial statements,
which have been prepared on a basis consistent with Advaxis’ audited financial
statements and, in the opinion of management, include all adjustments,
consisting of normal recurring adjustments, necessary for a fair presentation of
Advaxis’ financial position and results of operations. The results of operations
for any interim period are not necessarily indicative of results to be expected
for the entire year. The following data should be read in conjunction with
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations and Plan of Operations” and our financial statements and the related
notes included elsewhere in this prospectus.
|
|
|
Period
from March 1, 2002 (inception) to
December
31, |
|
|
Year
ended December 31, |
|
|
Ten Months Ended October
31, |
|
|
Three Months Ended January
31, (unaudited) |
|
Statement
of Operations Data: |
|
|
2002 |
|
|
2003 |
|
|
Unaudited 2003 |
|
|
2004 |
|
|
2004 |
|
|
2005 |
|
Income |
|
|
|
|
$ |
4,000 |
|
$ |
3,600 |
|
$
|
116,406 |
|
$ |
400 |
|
|
|
|
Total
operating expenses |
|
$ |
167,902 |
|
$ |
897,076 |
|
|
821,725 |
|
|
650,310 |
|
$ |
132,241 |
|
$ |
245,126 |
|
Interest
expense (income) |
|
|
-- |
|
|
17,190 |
|
|
7288 |
|
|
4229 |
|
|
10,655
|
|
|
2,968 |
|
Other
income |
|
|
966 |
|
|
521 |
|
|
106 |
|
|
56 |
|
|
(30 |
) |
|
(2,739 |
) |
Provision
for income taxes |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(166,936 |
) |
$ |
(909,745 |
) |
|
(825,907 |
) |
|
(538,076 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) |
Loss
per Share Information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
|
$ |
(0.01 |
) |
$ |
(0.05 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
Balance
Sheet Data: |
|
|
December
31, |
|
|
December
31, |
|
|
October
31 |
|
|
January
31, (unaudited) |
|
|
|
|
2002 |
|
|
2003 |
|
|
2004 |
|
|
2005 |
|
Cash
and cash equivalents |
|
$ |
204,382 |
|
$ |
47,160 |
|
$ |
32,279 |
|
$ |
3,217,430 |
|
Intangible
assets |
|
|
-- |
|
$ |
277,243 |
|
$ |
469,803 |
|
$ |
666,447 |
|
Total
assets |
|
$ |
204,382 |
|
$ |
324,403 |
|
$ |
502,083 |
|
$ |
3,886,327 |
|
Total
liabilities |
|
$ |
125,825 |
|
$ |
1,131,138 |
|
$ |
1,841,579 |
|
$ |
923,517 |
|
Stockholders’
equity (deficiency) |
|
|
78,557 |
|
|
(806,735 |
) |
$ |
(1,339,496 |
) |
|
2,962,810 |
|
THE
OFFERING
Common
stock offered by selling stockholders |
56,730,045(1) |
Common
stock outstanding |
36,690,056
(2) |
Use
of proceeds |
We
will not receive any proceeds from the sale of the common stock, but we
will receive funds from the exercise of warrants by selling stockholders,
if exercised for cash. |
“OTC
Bulletin Board Quote” |
None |
-------------------------
(1) |
Represents
36,690,056 shares
of common stock that were issued to selling stockholders and
19,630,588 shares
of common stock underlying warrants that were issued to selling
stockholders and
409,401 shares of common stock issuable to certain selling stockholders as
Penalty Shares. |
(2)
|
The
number of shares of common stock outstanding as of January 31, 2005 listed
above excludes |
· |
2,182,894
shares of common stock issuable upon exercise of
options; |
· |
20,302,582
shares of common stock issuable upon exercise of warrants with exercise
prices ranging from $0.1952 to $0.40 per
share; |
· |
Commitments
to issue stock, options or warrants. |
ADDITIONAL
INFORMATION
In this
prospectus, the terms “we”, “us”, and “our” refer to Advaxis,
Inc., a Colorado corporation, and its consolidated subsidiary, Advaxis,
as appropriate in the context, and, unless the context otherwise requires,
“common stock” refers to the common stock, par value $0.001 per share,
of Advaxis,
Inc.
RISK
FACTORS
An
investment in the common stock is highly speculative, involves a high degree of
risk, and should be made only by investors who can afford a complete loss. You
should carefully consider, together with the other matters referred to in this
prospectus, the following risk factors before you decide whether to buy our
common stock.
Risks
Specific to Us
We
are a development stage company.
We are a
development stage company with a history of losses and can provide no assurance
as to future operating results. As a result of losses which will continue
throughout our development stage, we may exhaust our financial resources and be
unable to complete the development of our production. Our deficit will continue
to grow during our drug development period.
We have
sustained losses from operations in each fiscal year since our inception and
losses are expected to continue, due to the substantial investment in research
and development, for the next several years. At January 31, 2005, we had an
accumulated deficit of $1,903,996 and stockholders’ equity of $2,962,810. We
expect to spend substantial additional sums on the continued research and
development of proprietary products and technologies with no certainty that
losses will not increase or that we will ever become profitable as a result of
these expenditures.
We
will require substantial additional financing in order to meet our business
objectives.
Although
we believe that the net proceeds received from the sale of Units will be
sufficient to finance our currently planned operations for the near-term
(approximately 12 to 24 months), such amounts will not be sufficient to meet our
longer-term cash requirements or cash requirements for the commercialization of
certain products currently in development. We will be required to issue equity
or debt securities or enter into other financial arrangements, including
relationships with corporate and other partners, in order to raise substantial
additional capital during the five to ten year period of product development and
the United States Food and Drug Administration (“FDA”) testing through Phase III
testing. Depending upon market conditions, we may not be successful in raising
sufficient additional capital for our long-term requirements. If we fail to
raise sufficient additional financing we will not be able to develop our product
candidates, we will be required to reduce staff, reduce or eliminate research
and development, slow the development of our product candidates and outsource or
eliminate several business functions. Even if we are successful in raising such
additional financing, we may not be able to successfully complete planned
clinical trials, development, and marketing of all, or of any, of our product
candidates. In such event, our business, prospects, financial condition and
results of operations could be materially adversely affected. We may be required
to reduce our staff, discontinue certain research or development programs of our
future products, and cease to operate. We may not be able to conduct clinical
trial in Lovaxin C. See “Management’s Discussion and Analysis of Financial
Condition and Results of Operations and Plan of Operations”.
Our
limited operating history does not afford investors a sufficient history on
which to base an investment decision.
We
commenced our Listeria System vaccine development business in February 2002 and
have existed as a development stage company since such time. Prior thereto we
conducted no business. Accordingly, we have a limited operating history.
Investors must consider the risks and difficulties we have encountered in the
rapidly evolving vaccine and therapeutic biopharmaceutical industry. Such risks
include the following:
· |
competition
from companies that have substantially greater assets and financial
resources than we have; |
· |
need
for acceptance of products; |
· |
ability
to anticipate and adapt to a competitive market and rapid technological
developments; |
· |
amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure; |
· |
need
to rely on multiple levels of outside funding due to the length of the
product development cycles and governmental approved protocols associated
with the pharmaceutical industry; and |
· |
dependence
upon key personnel including key independent consultants and
advisors. |
We cannot
be certain that our strategy will be successful or that we will successfully
address these risks. In the event that we do not successfully address these
risks, our business, prospects, financial condition and results of operations
could be materially and adversely affected. We may be required to reduce our
staff, discontinue certain research or development programs of our future
products, and cease to operate. We may not be able to conduct clinical trials in
Lovaxin C.
We
can provide no assurance of the successful and timely development of new
products.
Our
products are at various stages of research and development. Further development
and extensive testing will be required to determine their technical feasibility
and commercial viability. Our success will depend on our ability to achieve
scientific and technological advances and to translate such advances into
reliable, commercially competitive products on a timely basis. Vaccine products
that we may develop are not likely to be commercially available until the second
part of this decade. The proposed development schedules for our products may be
affected by a variety of factors, including technological difficulties,
proprietary technology of others, and changes in governmental regulation, many
of which will not be within our control. Any delay in the development,
introduction or marketing of our products could result either in such products
being marketed at a time when their cost and performance characteristics would
not be competitive in the marketplace or in the shortening of their commercial
lives. In light of the long-term nature of our projects, the unproven technology
involved and the other factors described elsewhere in “Risk Factors”, there can
be no assurance that we will be able to complete successfully the development or
marketing of any new products. See “Business - Research and Development
Program”.
Our
research and development expenses are subject to
uncertainty.
Factors
affecting our research and development (or R&D) expenses include, but are
not limited to:
· |
The
number of and the outcome of clinical studies we are planning to conduct.
For example, our R&D expenses may increase based on the number of
late-stage clinical studies which we may be required to
conduct; |
· |
The
number of products entering into development from late-stage research. For
example, there is no guarantee that internal research efforts will succeed
in generating sufficient data for us to make a positive development
decision or that an external candidate will be available on terms
acceptable to us. Some promising candidates may not yield sufficiently
positive pre-clinical results to meet our stringent development
criteria; |
· |
In-licensing
activities, including the timing and amount of related development funding
or milestone payments. For example, we may enter into agreements requiring
us to pay a significant up-front fee for the purchase of in-process
research and development which we may record as an R&D
expense; |
· |
As
part of our strategy, we invest in R&D. R&D as a percent of future
potential revenues can fluctuate with the changes in future levels of
revenue. Lower revenues can lead to more limited spending on R&D
efforts; and |
· |
Future
levels of revenue. |
We
are subject to numerous risks inherent in conducting clinical
trials.
We must
outsource our clinical trials and are in the process of negotiating with third
parties to conduct such trials. We are not certain that we will successfully
conclude agreements for the conduct of our clinical trials. Delay in concluding
such agreements would delay the commencement of the Phase 1 Trial of Lovaxin
C.
Agreements
with clinical investigators and medical institutions for clinical testing and
with other third parties for data management services place substantial
responsibilities on these parties, which could result in delays in, or
termination of, our clinical trials if these parties fail to perform as
expected. For example, if any of our clinical trial sites fail to comply with
FDA-approved good clinical practices, we may be unable to use the data gathered
at those sites. If these clinical investigators, medical institutions or other
third parties do not carry out their contractual duties or obligations or fail
to meet expected deadlines, or if the quality or accuracy of the clinical data
they obtain is compromised due to their failure to adhere to our clinical
protocols or for other reasons, our clinical trials may be extended, delayed or
terminated, and we may be unable to obtain regulatory approval for or
successfully commercialize Lovaxin C.
We or
regulators may suspend or terminate our clinical trials for a number of reasons.
We may voluntarily suspend or terminate our clinical trials if at any time we
believe that they present an unacceptable risk to the patients enrolled in our
clinical trials. In addition, regulatory agencies may order the temporary or
permanent discontinuation of our clinical trials at any time if they believe
that the clinical trials are not being conducted in accordance with applicable
regulatory requirements or that they present an unacceptable safety risk to the
patients enrolled in our clinical trials.
Our
clinical trial operations are subject to regulatory inspections at any time. If
regulatory inspectors conclude that we or our clinical trial sites are not in
compliance with applicable regulatory requirements for conducting clinical
trials, we may receive reports of observations or warning letters detailing
deficiencies, and we will be required to implement corrective actions. If
regulatory agencies deem our responses to be inadequate, or are dissatisfied
with the corrective actions we or our clinical trial sites have implemented, our
clinical trials may be temporarily or permanently discontinued, we may be fined,
we or our investigators may be precluded from conducting any ongoing or any
future clinical trials, the government may refuse to approve our marketing
applications or allow us to manufacture or market our products, and we may be
criminally prosecuted.
The
successful development of biopharmaceuticals is highly
uncertain.
Successful
development of biopharmaceuticals is highly uncertain and is dependent on
numerous factors, many of which are beyond our control. Products that appear
promising in the early phases of development may fail to reach the market for
several reasons including:
· |
Pre-clinical
study results that may show the product to be less effective than desired
(e.g., the study failed to meet its primary objectives) or to have harmful
or problematic side effects; |
· |
Failure
to receive the necessary regulatory approvals or a delay in receiving such
approvals. Among other things, such delays may be caused by slow
enrollment in clinical studies, length of time to achieve study endpoints,
additional time requirements for data analysis, or BLA preparation,
discussions with the FDA, an FDA request for additional pre-clinical or
clinical data, or unexpected safety or manufacturing
issues. |
· |
Manufacturing
costs, pricing or reimbursement issues, or other factors that make the
product uneconomical; and |
· |
The
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized. |
Success
in pre-clinical and early clinical studies does not ensure that large-scale
clinical studies will be successful. Clinical results are frequently susceptible
to varying interpretations that may delay, limit or prevent regulatory
approvals. The length of time necessary to complete clinical studies and to
submit an application for marketing approval for a final decision by a
regulatory authority varies significantly from one product to the next, and may
be difficult to predict.
We
must comply with significant government regulations.
The
research and development, manufacture and marketing of human therapeutic and
diagnostic products are subject to regulation, primarily by the FDA in the
United States and by comparable authorities in other countries. These national
agencies and other federal, state, local and foreign entities regulate, among
other things, research and development activities (including testing in animals
and in humans) and the testing, manufacturing, handling, labeling, storage,
record keeping, approval, advertising and promotion of the products that we are
developing. Noncompliance with applicable requirements can result in various
adverse consequences, including, delay in approving or refusal to approve
product licenses or other applications, suspension or termination of clinical
investigations, revocation of approvals previously granted, fines, criminal
prosecution, recall or seizure of products, injunctions against shipping
products and total or partial suspension of production and/or refusal to allow a
company to enter into governmental supply contracts.
The
process of obtaining requisite FDA approval has historically been costly and
time consuming. Current FDA requirements for a new human drug or biological
product to be marketed in the United States include: (1) the successful
conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain
preliminary information on the product’s safety; (2) filing with the FDA of an
Investigational New Drug Application (“INDA”), to conduct human clinical trials
for drugs or biologics; (3) the successful completion of adequate and
well-controlled human clinical investigations to establish the safety and
efficacy of the product for its recommended use; and (4) filing by a Company and
acceptance and approval by the FDA of a New Drug Application ("NDA") for a drug
product or a Biological License Application ("BLA") for a biological product to
allow commercial distribution of the drug or biologic. A delay in one or more of
the procedural steps outlined above could be harmful to us in terms of getting
our product candidates through clinical testing and to market.
We
can provide no assurance that the Advaxis products will obtain regulatory
approval or that the results of clinical studies will be
favorable.
The
testing, marketing and manufacturing of any product will require the approval of
the FDA. We cannot predict with any certainty the amount of time necessary to
obtain such FDA approval and whether any such approval will ultimately be
granted. Preclinical and clinical trials may reveal that one or more products is
ineffective or unsafe, in which event further development of such products could
be seriously delayed or terminated. Moreover, obtaining approval for certain
products may require the testing on human subjects of substances whose effects
on humans are not fully understood or documented. Delays in obtaining FDA or any
other necessary regulatory approvals of any proposed product and failure to
receive such approvals would have an adverse effect on the product’s potential
commercial success and on our business, prospects, financial condition and
results of operations. In addition, it is possible that a product may be found
to be ineffective or unsafe due to conditions or facts which arise after
development has been completed and regulatory approvals have been obtained. In
this event, we may be required to withdraw such product from the market. To the
extent that our success will depend on any regulatory approvals from
governmental authorities outside of the United States which perform roles
similar to that of the FDA, uncertainties similar to those stated above will
also exist. See “Business - Governmental Regulation”.
We
rely upon patents to protect our technology. We may be unable to protect our
intellectual property rights and we may be liable for infringing the
intellectual property rights of others.
Our
ability to compete effectively will depend on our ability to maintain the
proprietary nature of our technologies, including the Listeria System, and the
proprietary technology of others with which we have entered into licensing
agreements. We have licensed eight patents and 12 patent applications from Penn.
Further, we rely on a combination of trade secrets and nondisclosure, and other
contractual agreements and technical measures to protect our rights in the
technology. We depend upon confidentiality agreements with our officers,
employees, consultants, and subcontractors to maintain the proprietary nature of
the technology. These measures may not afford us sufficient or complete
protection, and others may independently develop technology similar to ours,
otherwise avoid the confidentiality agreements, or produce patents that would
materially and adversely affect our business, prospects, financial condition,
and results of operations. Such competitve events, technologies and patents may
limit our ability to raise funds, prevent other companies from collaborating
with us, and in certain cased prevent us from further developing our technology
due to third party patent blocking right. Such competitive events, technologies
and patents may limit our ability to raise funds, prevent other companies from
collaborating with us, and in certain cases prevent us from further developing
our technology due to third party patent blocking right.
We
believe that our technology and the technology licensed from Penn do not
infringe the rights of others; however, we cannot assure you that the technology
licensed from Penn will not, in the future be found to infringe upon the rights
of others. We have become aware of a public company, Cerus Corporation, which
has issued a press release claiming to have a proprietary Listeria-based
approach to a cancer vaccine. We believe that through our exclusive license with
Penn of U.S. Patent Nos. 5,830,702, 6,051,237 and 6,565,852, we have the
earliest known and dominant patent position for the use of recombinant Listeria
monocytogenes expressing proteins or tumor antigens as a vaccine for the
treatment of infectious diseases and tumors. Based on searches of publicly
available databases, we do not believe that Cerus or The University of
California Berkeley (which is where Cerus’ consulting scientist works) or any
other third party owns any published Listeria patents or has any issued patent
claims that might materially negatively affect our freedom to operate our
business (as currently contemplated to be operated) in the field of Listeria
monocytogenes. For more
information about Cerus Corporation and its claims with respect to
listeria-based technology, you should visit their web site at www.cerus.com or to
view its publicly filed documents, www.sec.gov. Others
may assert infringement claims against us, and should we be found to infringe
upon their patents, or otherwise impermissibly utilize their intellectual
property, our ability to continue to use our technology or the licensed
technology could be materially restricted or prohibited. If this event occurs,
we may be required to obtain licenses from the holders of our intellectual
property, enter into royalty agreements or redesign our products so as not to
utilize this intellectual property, each of which may prove to be uneconomical
or otherwise impossible. Licenses or royalty agreements required in order for us
to use this technology may not be available on acceptable terms, or at all.
These claims could result in litigation, which could materially adversely affect
our business, prospects, financial condition and results of operations. Such
competitive events, technologies and patents may limit our ability to raise
funds, prevent other companies from collaborating with us, and in certain cases
prevent us from further developing our technology due to third party patent
blocking right. See “Business—Patents and Licenses”. See
“Business—Patents and Licenses”.
We
are dependent upon our license agreement with Penn, as well as proprietary
technology of others.
The
manufacture and sale of any products developed by us will involve the use of
processes, products or information, the rights to certain of which are owned by
others. Although we have obtained licenses with regard to the use of Penn’s
patents as described herein and certain of such processes, products and
information of others, we can provide no assurance that such licenses will not
be terminated or expire during critical periods, that we will be able to obtain
licenses for other rights which may be important to us, or, if obtained, that
such licences will be obtained on commercially reasonable terms. If we are
unable to maintain and/or obtain licenses, we may have to develop alternatives
to avoid infringing or the patents of others, potentially causing increased
costs and delays in product development and introduction or preclude the
development, manufacture, or sale of planned products. Some of our licenses
provide for limited periods of exclusivity that require minimum license fees and
payments and/or may be extended only with the consent of the licensor. We can
provide no assurance that we will be able to meet these minimum license fees in
the future or that these third parties will grant extensions on any or all such
licenses. This same restriction may be contained in licenses obtained in the
future. Additionally, we can provide no assurance that the patents underlying
any licenses will be valid and enforceable. Furthermore, we call to your
attention that in 2001 an issue arose regarding the inventorship of U.S. Patent
6,565,852 and U.S. Patent Application No. 09/537,642 of Penn. These patent
rights are included in the patent rights licensed by us from Penn. It is
contemplated by GlaxoSmithKline Biologicals PLC (“GSK”) Penn and us that the
issue will be resolved through: (1) a correction of inventorship to add certain
GSK inventors, (2) where necessary and appropriate, an assignment of GSK’s
possible rights under these patent rights to Penn, and (3) a sublicense from us
to GSK. To date, this arrangement has not been finalized and we cannot assure
that this issue will ultimately be resolved in the manner described above. See
“Business - Patents and Licenses”. To the extent any products developed by us
are based on licensed technology, royalty payments on the licenses will reduce
our gross profit from such product sales and may render the sales of such
products uneconomical. See “Business - Corporate Partnerships and
Agreements”.
We
have no manufacturing, sales, marketing or distribution capability and we must
rely upon third parties for such.
We do not
intend to create facilities to manufacture our products and therefore are
dependent upon third parties to do so. We currently have an agreement with Cobra
Manufacturing for production of our vaccines in small quantities for research
and development purposes. We are negotiating with Cobra to produce large
quantities of our vaccines for trials purposes, but no definitive agreement has
been reached with them. Our reliance on third parties for the manufacture of our
products creates a dependency that could severely disrupt our research and
development, our clinical testing, and ultimately our sales and marketing
efforts if the source of such supply prove to be unreliable or unavailable. If
the contracted manufacturing source is unreliable or unavailable, we may not be
able to replace the development of our product candidates, including the
clinical testing program, could not go forward and our entire business plan
could fail.
If
we are unable to establish or manage strategic collaborations in the future, our
revenue and product development may be limited.
Our
strategy includes eventual substantial reliance upon strategic collaborations
for marketing and commercialization of Lovaxin C, and we may rely even more on
strategic collaborations for research, development, marketing and
commercialization of our other product candidates. To date, we have not entered
into any strategic collaborations with third parties capable of providing these
services although we have been heavily reliant upon third party outsourcing for
our research and development activities. In addition, we have not yet marketed
or sold any of our product candidates or entered into successful collaborations
for these services in order to ultimately commercialize our product candidates.
Establishing strategic collaborations is difficult and time-consuming. Our
discussion with potential collaborators may not lead to the establishment of
collaborations on favorable terms, if at all. For example, potential
collaborators may reject collaborations based upon their assessment of our
financial, regulatory or intellectual property position. If we successfully
establish new collaborations, these relationships may never result in the
successful development or commercialization of our product candidates or the
generation of sales revenue. To the extent that we enter into co-promotion or
other collaborative arrangements, our product revenues are likely to be lower
than if we directly marketed and sold any products that we may
develop.
Management
of our relationships with our collaborators will require:
· |
significant
time and effort from our management team; |
· |
coordination
of our research and development programs with the research and development
priorities of our collaborators; and |
· |
effective
allocation of our resources to multiple
projects. |
If we
continue to enter into research and development collaborations at the early
phases of product development, our success will in part depend on the
performance of our corporate collaborators. We will not directly control the
amount or timing of resources devoted by our corporate collaborators to
activities related to our product candidates. Our corporate collaborators may
not commit sufficient resources to our research and development programs or the
commercialization, marketing or distribution of our product candidates. If any
corporate collaborator fails to commit sufficient resources, our preclinical or
clinical development programs related to this collaboration could be delayed or
terminated. Also, our collaborators may pursue existing or other
development-stage products or alternative technologies in preference to those
being developed in collaboration with us. Finally, if we fail to make required
milestone or royalty payments to our collaborators or to observe other
obligations in our agreements with them, our collaborators may have the right to
terminate those agreements.
We
may incur substantial liabilities from any product liability claims if our
insurance coverage for those claims is inadequate.
We face
an inherent risk of product liability exposure related to the testing of our
product candidates in human clinical trials, and will face an even greater risk
if the product candidates are sold commercially. An individual may bring a
liability claim against us if one of the product candidates causes, or merely
appears to have caused, an injury. If we cannot successfully defend ourselves
against the product liability claim, we will incur substantial liabilities.
Regardless of merit or eventual outcome, liability claims may result in:
· |
decreased
demand for our product candidates, |
· |
injury
to our reputation, |
· |
withdrawal
of clinical trial participants, |
· |
costs
of related litigation, |
· |
substantial
monetary awards to patients or other claimants,
|
· |
the
inability to commercialize product candidates,
and |
· |
increased
difficulty in raising required additional funds in the private and public
capital markets. |
We
currently do not have product liability insurance. We intend to obtain insurance
coverage and to expand such coverage to include the sale of commercial products
if marketing approval is obtained for any of our product candidates. However,
insurance coverage is increasingly expensive. We may not be able to maintain
insurance coverage at a reasonable cost and we may not be able to obtain
insurance coverage that will be adequate to satisfy any liability that may
arise.
We
may incur significant costs complying with environmental laws and regulations.
We will
use hazardous materials, including chemicals and biological agents and compounds
that could be dangerous to human health and safety or the environment. As
appropriate, we will store these materials and wastes resulting from their use
at our or our outsourced laboratory facility pending their ultimate use or
disposal. We will contract with a third party to properly dispose of these
materials and wastes. We will be subject to a variety of federal, state and
local laws and regulations governing the use, generation, manufacture, storage,
handling and disposal of these materials and wastes. We may also incur
significant costs complying with environmental laws and regulations adopted in
the future.
If
we use biological and hazardous materials in a manner that causes injury, we may
be liable for damages.
Our
research and development and manufacturing activities will involve the use of
biological and hazardous materials. Although we believe our safety procedures
for handling and disposing of these materials will comply with federal, state
and local laws and regulations, we cannot entirely eliminate the risk of
accidental injury or contamination from the use, storage, handling or disposal
of these materials. We do not carry specific biological or hazardous waste
insurance coverage, workers compensation or property and casualty and general
liability insurance policies which include coverage for damages and fines
arising from biological or hazardous waste exposure or contamination.
Accordingly, in the event of contamination or injury, we could be held liable
for damages or penalized with fines in an amount exceeding our resources, and
our clinical trials or regulatory approvals could be suspended or terminated.
We
need to attract and retain highly skilled personnel; we may be unable to
effectively manage growth with our limited resources.
At the
date of this prospectus, we have three employees. We intend to expand our
operations and staff materially. Our new employees will include a number of key
managerial, technical, financial, research and development and operations
personnel who will not have been fully integrated into our operations. We expect
the expansion of our business to place a significant strain on our limited
managerial, operational and financial resources. We will be required to expand
our operational and financial systems significantly and to expand, train and
manage our work force in order to manage the expansion of our operations. Our
failure to fully integrate our new employees into our operations could have a
material adverse effect on our business, prospects, financial condition and
results of operations. Our ability to attract and retain highly skilled
personnel is critical to our operations and expansion. We face competition for
these types of personnel from other technology companies and more established
organizations, many of which have significantly larger operations and greater
financial, technical, human and other resources than we have. We may not be
successful in attracting and retaining qualified personnel on a timely basis, on
competitive terms, or at all. If we are not successful in attracting and
retaining these personnel, our business, prospects, financial condition and
results of operations will be materially adversely affected. In such
circumstances we may be unable to conduct certain research and development
programs, unable to adequately manage our clincial trials of Lovaxin C and other
products, and unable to adequately address the management needs of the Company.
See “Management’s Discussion and Analysis of Financial Condition and Results of
Operations and Plan of Operations”, “Business - Strategy”, and
“Business--Employees.”
We
depend upon our senior management and key consultants and their loss or
unavailability could put us at a competitive disadvantage.
We depend
upon the efforts and abilities of our senior executive, as well as the services
of several key consultants, including Yvonne Paterson, Ph.D. The loss or
unavailability of the services of any of these individuals for any significant
period of time could have a material adverse effect on our business, prospects,
financial condition and results of operations. We have not obtained, do not own,
nor are we the beneficiary of, key-person life insurance. See
“Management—Employment Agreements”.
Risks
Related to the Biotechnology / Biopharmaceutical Industry
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. We may be unable to
compete with more substantial enterprises.
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. Competition
in the biopharmaceutical industry is based significantly on scientific and
technological factors. These factors include the availability of patent and
other protection for technology and products, the ability to commercialize
technological developments and the ability to obtain governmental approval for
testing, manufacturing and marketing. We compete with specialized
biopharmaceutical firms in the United States, Europe and elsewhere, as well as a
growing number of large pharmaceutical companies that are applying biotechnology
to their operations. Many biopharmaceutical companies have focused their
development efforts in the human therapeutics area, including cancer. Many major
pharmaceutical companies have developed or acquired internal biotechnology
capabilities or made commercial arrangements with other biopharmaceutical
companies. These companies, as well as academic institutions and governmental
agencies and private research organizations, also compete with us in recruiting
and retaining highly qualified scientific personnel and consultants. Our ability
to compete successfully with other companies in the pharmaceutical field will
also depend to a considerable degree on the continuing availability of capital
to us.
We are
aware of certain products under development or manufactured by competitors that
are used for the prevention, diagnosis, or treatment of certain diseases we have
targeted for product development. Various companies are developing
biopharmaceutical products that potentially directly compete with our product
candidates even though their approach to such treatment is different. Several
companies, such as Cerus Corporation, in particular, Dandreon Corporation and
CancerVax Corporation, are developing cancer vaccines which would be directly
competitive with our product candidates. In addition, numerous other companies,
many of which have greater financial resources than we do, are actively engaged
in the research and development of cancer vaccines, and are in Stage II and
Stage III Testing of such products. Such companies include: Antigenics, Inc.;
Avi BioPharma, Inc.; Biomira, Inc.; Corixa Corporation; Dendreon Corporation;
Epimmune, Inc.; Genzyme Corp.; Progenics Pharmaceuticals, Inc.; Vical
Incorporated; CancerVax Corporation; Genitope Corporation; and Xcyte Therapies,
Inc.
We expect
that our products under development and in clinical trials will address major
markets within the cancer sector. Our competition will be determined in part by
the potential indications for which drugs are developed and ultimately approved
by regulatory authorities. Additionally, the timing of market introduction of
some of our potential products or of competitors’ products may be an important
competitive factor. Accordingly, the relative speed with which we can develop
products, complete pre-clinical testing, clinical trials and approval processes
and supply commercial quantities to market are expected to be important
competitive factors. We expect that competition among products approved for sale
will be based on various factors, including product efficacy, safety,
reliability, availability, price and patent position. See “Business - Research
and Development Programs” and “Business - Competition”.
Risks
Related to the Securities Markets and Investments in our Common
Stock
The
price of our common stock may be volatile.
The
trading price of our common stock may fluctuate substantially. The price of the
common stock that will prevail in the market after the sale of the shares of
common stock by the selling stockholders may be higher or lower than the price
you have paid, depending on many factors, some of which are beyond our control
and may not be related to our operating performance. These fluctuations could
cause you to lose part or all of your investment in our common stock. Those
factors that could cause fluctuations include, but are not limited to, the
following:
· |
price
and volume fluctuations in the overall stock market from time to time;
|
· |
fluctuations
in stock market prices and trading volumes of similar companies;
|
· |
actual
or anticipated changes in our earnings or fluctuations in our operating
results or in the expectations of securities analysts;
|
· |
general
economic conditions and trends; |
· |
major
catastrophic events; |
· |
sales
of large blocks of our stock; |
· |
departures
of key personnel; |
· |
changes
in the regulatory status of our product candidates, including results of
our clinical trials; |
· |
events
affecting Penn or any future collaborators;
|
· |
announcements
of new products or technologies, commercial relationships or other events
by us or our competitors; |
· |
regulatory
developments in the United States and other countries;
|
· |
failure
of our common stock to be listed quoted on the Nasdaq Small Cap Market,
American Stock Exchange, OTC Bulletin Board or other national market
system; |
· |
changes
in accounting principles; and |
· |
discussion
of us or our stock price by the financial and scientific press and in
online investor communities. |
In the
past, following periods of volatility in the market price of a company’s
securities, securities class action litigation has often been brought against
that company. Due to the potential volatility of our stock price, we may
therefore be the target of securities litigation in the future. Securities
litigation could result in substantial costs and divert management’s attention
and resources from our business.
If
additional authorized shares of our common stock available for issuance or
shares eligible for future sale were introduced into the market, it could hurt
our stock price.
We are
authorized to issue 500,000,000 shares of common stock. As of March 31, 2005,
there were an aggregate of 59,374,162 shares of our common stock issued and
outstanding on a fully diluted basis. In addition, 2,341,198 shares of our
common stock may be issued upon the exercise of currently outstanding stock
options and 20,509,220 shares of common stock may be issued upon the exercise of
current outstanding warrants. We are unable to estimate the amount, timing or
nature of future sales of outstanding common stock. Sales of substantial amounts
of the common stock in the public market by these holders or perceptions that
such sales may take place may lower the common stock’s market
price.
Currently,
holders of 15,597,723 shares of our common stock are subject to a standstill
agreement. Pursuant to the standstill agreement, such holders agree not to
effect any sale, transfer or distribution of his, her or its equity securities
in us, or any securities convertible into or exchangeable or exercisable for
such securities, during the period from the November 12, 2004 until the earlier
of (i) the date that this registration statement has been filed with and
declared effective by the Securities and Exchange Commission (“SEC”) and (ii)
the first year anniversary of the Private Placement, unless (a) such sale,
transfer or distribution is approved in writing by a majority of the investors
in the Private Placement, and (b) the transferee of such sold, transferred or
distributed securities agrees in writing to be bound by the terms of the
standstill agreement to the same extent as if they had originally been a party
hereto.
Our
common stock is considered to
be “penny
stock”.
Our
common stock may be deemed to be “penny stock” as that term is defined in Rule
3a51-1, promulgated
under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”).
Penny stocks are stocks:
· |
with
a price of less than $5.00 per share; |
· |
that
are not traded on a “recognized” national exchange;
|
· |
whose
prices are not quoted on the NASDAQ automated quotation system; or
|
· |
of
issuers with net tangible assets less than $2,000,000 (if the issuer has
been in continuous operation for at least three years) or $5,000,000 (if
in continuous operation for less than three years), or with average
revenue of less than $6,000,000 for the last three years.
|
Section
15(g) of the Exchange Act and Rule 15g-2 promulgated thereunder require
broker-dealers dealing in penny stocks to provide potential investors with a
document disclosing the risks of penny stocks and to obtain a manually signed
and dated written receipt of the document before effecting any transaction in a
“penny stock” for the investor’s account. We urge potential investors to obtain
and read this disclosure carefully before purchasing any shares that are deemed
to be “penny stock.”
Rule
15g-9 promulgated under the Exchange Act requires broker-dealers in penny stocks
to approve the account of any investor for transactions in such stocks before
selling any “penny stock” to that investor. This procedure requires the
broker-dealer to:
· |
obtain
from the investor information about his or her financial situation,
investment experience and investment objectives;
|
· |
reasonably
determine, based on that information, that transactions in penny stocks
are suitable for the investor and that the investor has enough knowledge
and experience to be able to evaluate the risks of “penny stock”
transactions; |
· |
provide
the investor with a written statement setting forth the basis on which the
broker-dealer made his or her determination; and
|
· |
receive
a signed and dated copy of the statement from the investor, confirming
that it accurately reflects the investor’s financial situation, investment
experience and investment objectives. |
Compliance
with these requirements may make it harder for investors in our common stock to
resell their shares to third parties. Accordingly, our common stock should only
be purchased by investors, who understand that such investment is a long-term
and illiquid investment, and are capable of and prepared to bear the risk of
holding the common stock for an indefinite period of time.
We
may incur increased costs as a result of recently enacted and proposed changes
in laws and regulations relating to corporate governance matters.
Recently
enacted and proposed changes in the laws and regulations affecting public
companies, including the provisions of the Sarbanes-Oxley Act of 2002 and rules
adopted or proposed by the SEC and by the Nasdaq Stock Market, will result in
increased costs to us as we evaluate the implications of these laws and
regulations and respond to their requirements. These laws and regulations could
make it more difficult or more costly for us to obtain certain types of
insurance, including director and officer liability insurance, and we may be
forced to accept reduced policy limits and coverage or incur substantially
higher costs to obtain the same or similar coverage. The impact of these events
could also make it more difficult for us to attract and retain qualified persons
to serve on our board of directors, our board committees or as executive
officers. We are presently evaluating and monitoring developments with respect
to these laws and regulations and cannot predict or estimate the amount or
timing of additional costs we may incur to respond to their requirements.
A
limited public trading market may cause volatility in the price of our common
stock.
We have
applied to have our common stock quoted on the OTC Bulletin Board. The quotation
of our common stock on the OTC Bulleting Board does not assure that a
meaningful, consistent and liquid trading market currently exists, and in recent
years such market has experience extreme price and volume fluctuations that have
particularly affected the market prices of many smaller companies like us. Our
common stock is thus subject to this volatility. Sales of substantial amounts of
common stock, or the perception that such sales might occur, could adversely
affect prevailing market prices of our common stock and our stock price may
decline substantially in a short time and our shareholders could suffer losses
or be unable to liquidate their holdings.
There
is no assurance of an established public trading market.
A regular
trading market for our common stock may not be established or sustained in the
future. The NASD has enacted recent changes that limit quotation on the OTC
Bulletin Board to securities of issuers that are current in their reports filed
with the SEC. The effect on the OTC Bulletin Board of these rule changes and
other proposed changes cannot be determined at this time. The OTC Bulletin Board
is an inter-dealer, over-the-counter market that provides significantly less
liquidity than the NASDAQ Stock Market. Quotes for stocks included on the OTC
Bulletin Board are not listed in the financial sections of newspapers as are
those for the NASDAQ Stock Market. Therefore, prices for securities traded
solely on the OTC Bulletin Board may be difficult to obtain and holders of
common stock may be unable to resell their securities at or near their originial
offering price or at any price. Market prices for our common stock will be
influenced by a number of factors, including:
· |
The
issuance of new equity securities pursuant to a future
offering; |
· |
Changes
in interest rates; |
· |
Competitive
developments, including announcements by competitors of new products or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital commitments; |
· |
Variations
in quarterly operating results |
· |
Change
in financial estimates by securities
analysts; |
· |
The
depth and liquidity of the market for our common
stock; |
· |
Investor
perceptions of our company and the technologies industires generally;
and |
· |
General
economic and other national conditions. |
We have
applied to have our common stock quoted on the OTC Bulletin Board. In addition
we are subject to a covenant to use our best efforts to apply to be listed on
the American Stock Exchange or quoted on the Nasdaq National Stock Market. We
cannot assure you that we will be successful in obtaining approval for such
applications.
We
may not be able to achieve secondary trading of our stock in certain states
because our common stock is not nationally traded.
Because
our common stock is not approved for trading on the Nasdaq National Market or
listed for trading on a national securities exchange, our common stock is
subject to the securities laws of the various states and jurisdictions of the
United States in addition to federal securities law. This regulation covers any
primary offering we might attempt and all secondary trading by our stockholders.
While we intend to take appropriate steps to register our common stock or
qualify for exemptions for our common stock, in all of the states and
jurisdictions of the United States, if we fail to do so the investors in those
jurisdictions where we have not taken such steps may not be allowed to purchase
our stock or those who presently hold our stock may not be able to resell their
shares without substantial effort and expense. These restrictions and potential
costs could be significant burdens on our stockholders.
Our
executive officers, directors and principal stockholders control our business
and may make decisions that are not in our best interests.
Our
officers, directors and principal stockholders, and their affiliates, in the
aggregate, beneficially own approximately 63.79% of the outstanding shares of
our common stock on a fully diluted basis. As a result, such persons, acting
together, have the ability to substantially influence all maters submitted to
our stockholders for approval, including the election and removal of directors
and any merger, consolidation or sale of all or substantially all of our assets,
and to control our management and affairs. Accordingly, such concentration of
ownership may have the effect of delaying, deferring or preventing a change in
discouraging a potential acquirer from making a tender offer or otherwise
attempting to obtain control of our business, even if such a transaction would
be beneficial to other stockholders.
Sales
of additional equity securities may adversely affect the market price of our
common stock and your rights in us may be reduced.
The
Selling Stockholders hereunder have the right to register securities for resale
that they hold pursuant to registration rights agreements. We expect to continue
to incur product development and selling, general and administrative costs, and
in order to satisfy our funding requirements, we will need to sell additional
equity securities, which may be subject to similar registration rights;
provided, that the Selling Stockholders consent to such registration rights. The
sale or the proposed sale of substantial amounts of our common stock in the
public markets may adversely affect the market price of our common stock and our
stock price may decline substantially. Our stockholders may experience
substantial dilution and a reduction in the price that they are able to obtain
upon sale of their shares. Also, any new equity securities issued may have
greater rights, preferences or privileges than our existing common
stock.
Additional
authorized shares of common stock available for issuance may adversely affect
the market.
We are
authorized to issue 500,000,000 shares of our common stock. As of January 31,
2005, we had 36,690,056 shares of our common stock issued and outstanding,
excluding shares issuable upon exercise of our outstanding warrants and options.
As of January 31, 2005, we had outstanding 2,182,894 options to purchase shares
of our common stock at a weighted exercise price of $0.40 per share and
outstanding warrants to purchase 20,302,582 shares of our common stock, with
exercise prices ranging from $0.1952 to $0.40 per share. Pursuant to our 2004
Stock Option Plan, 2,381,525 shares of common stock are reserved for issuance
under the plan. To the extent the shares of common stock are issued or options
and warrants are exercised, holders of our common stock will experience
dilution. In addition, in the event of any future financing of equity securities
or securities convertible into or exchangeable for, common stock, holders of our
common stock may experience dilution.
Shares
eligible for future sale may adversely affect the market.
From time
to time, certain of our stockholders may be eligible to sell all or some of
their shares of common stock by means of ordinary brokerage transactions in the
open market pursuant to Rule 144 (“Rule 144”) promulgated under the Securities
Act of 1933, as amended (the “Securities Act of 1933”), subject to certain
limitations. In general, pursuant to Rule 144, a stockholder (or stockholders
whose shares are aggregated) who has satisfied a one-year holding period may,
under certain circumstances, sell within any three-month period a number of
securites which does not exceed the greater of 1% of the then outstanding shares
of common stock or the average weekly trading volume of the class during the
four calendar weeks prior to such sale. Rule 144 also permits, under cetain
circumstances, the sale of securities, without any limitations, by a
non-affiliate of our company who has satisfied a two-year holding period. Any
substantial sale of our common stock pursuat to Rule 144 or pursuant ot any
resale prospectus may have an adverse effect on the market price of our
securities.
Holders
of 17,734,165 shares of our common stock and 2,808,434 shares of our common
stock underlying exercisable warrants are subject to a standstill agreement.
Pursuant to the standstill agreement, such holders agree not to effect any sale,
transfer or distribution of his, her or its equity securities in us, or any
securities convertible into or exchangeable or exercisable for such securities,
during the period from the November 12, 2004 until the earlier of (i) the date
that this registration statement has been filed with and declared effective by
the SEC and (ii) the first year anniversary of the Private Placement, unless (a)
such sale, transfer or distribution is approved in writing by a majority of the
investors in the Private Placement, and (b) the transferee of such sold,
transferred or distributed securities agrees in writing to be bound by the terms
of the standstill agreement to the same extent as if they had originally been a
party hereto.
An
aggregate of 56,730,045 shares
of common stock are being registered with the SEC in the registration statement
of which this prospectus forms a part (which amount includes the Penalty
Shares). These shares would otherwise be eligible for future sale under Rule 144
after passage of the minimum one year holding period for holders who are not
officers, directors or affilites of the Company. The registration and subsequent
sales of such shares of common stock will likely have an adverse effect on the
market price of our common stock when it commences to trade.
We
are able to issue shares of preferred stock with rights superior to those of
holders of our common stock. Such issuances can dilute the tangible net book
value of shares of our common stock.
Our
Articles of Incorporation provide for the authorization of 5,000,000 shares of
“blank check” preferred stock. Pursuant to our Articles of Incorporation, our
Board of Directors is authorized to issue such “blank check” preferred stock
with rights that are superior to the rights of stockholders of our common stock,
at a purchase price then approved by our Board of Directors, which purchase
price may be substantially lower than the market price of shares of our common
stock, without stockholder approval.
We
do not intend to pay dividends.
We have
never declared or paid any dividends on our securities. We currently intend to
retain our earnings for funding growth and, therefore, do not expect to pay any
dividends in the foreseeable future.
SPECIAL
NOTE
REGARDING FORWARD-LOOKING
STATEMENTS
This
prospectus
contains forward-looking
statements. We have
based these forward-looking
statements on our
current expectations and projections about future events. These statements
include, but are not limited to:
· |
statements
as
to the anticipated timing of clinical studies and other business
developments; |
· |
statements
as
to the development of new products; |
· |
expectations
as
to the adequacy of our cash balances to
support our operations for specified periods of time and as to the nature
and level of cash expenditures; and |
· |
expectations
as
to the market opportunities for our products, as well as our ability to
take advantage of those opportunities. |
These
statements
may be found in the sections of this prospectus entitled “Prospectus
Summary,”
“Risk
Factors”,
“Management’s
Discussion
and
Analysis
of
Financial
Condition and
Results
of
Operations and Plan
of Operations”, and “Business,” as
well as in this prospectus generally. Actual results could differ materially
from those anticipated in these forward-looking
statements as a
result of various factors, including all the risks discussed in “Risk
Factors”
and
elsewhere in this prospectus.
In
addition,
statements that use the terms “can,” “continue,” “could,” “may,” “potential,”
“predicts,” “should,” “will,” “believe,” “expect,” “plan,” “intend,” “estimate,”
“anticipate,” “scheduled” and similar expressions are intended to identify
forward-looking
statements. All
forward-looking
statements in this
prospectus reflect our current views about future events and are based on
assumptions and are subject to risks and uncertainties that could cause our
actual results to differ materially from future results expressed or implied by
the forward-looking
statements. Many of
these factors are beyond our ability to control or predict. Forward-looking
statements do not guarantee future performance and involve risks and
uncertainties. Actual results will differ, and may differ materially, from
projected results as a result of certain risks and uncertainties. The risks and
uncertainties include, without limitation, those described under “Risk Factors”
and those detailed from time to time in our filings with the SEC, and include,
among others, the following:
· |
Our
limited operating history and ability to continue as a going
concern; |
· |
Our
ability to successfully develop and commercialize products based on our
therapies and the Listeria System; |
· |
A
lengthy approval process and the uncertainty of FDA and other government
regulatory requirements may have a material adverse effect on our ability
to commercialize our aplications; |
· |
Clinical
trials may fail to demonstrate the safety and effectiveness of our
applications or therapies, which could have a material adverse effect on
our ability to obtain government regulatory
approval; |
· |
The
degree and nature of our competition; |
· |
Our
ability to employ and retain qualified employees;
and |
· |
The
other factors referenced in this prospectus, including, without
limitation, under the section entitled “Risk Factors”, “Management’s
Discussion and Analysis of Financial Condition and Results of Operations
and Plan of Operations”, and Business”. |
These
risks are not exhaustive. Other sections of this prospectus may include
additonal factors which could adversely impact our business and financial
performance. Moreover, we operate in a very competitive and rapidly changing
environment. New risk factors emerge from time to time and it is not possible
for our management to predict all risk factors, nor can we assess the impact of
all factors on our business or to the extent to which any factor, or combination
of factors, may cause actual results to differ materially from those contained
in any forward-looking statements. Given these risks and uncertainties,
investors should not place undue reliance on forward-looking statements as a
prediction of actual results. These forward-looking statements are made only as
of the date of this prospectus. Except for our ongoing obligation to disclose
material information as required by federal securities laws, we do not intend to
update you concerning any future revisions to any forward-looking statements to
reflect events or circumstances occurring after the date of this
prospectus.
USE
OF
PROCEEDS
We will
not receive any proceeeds from the sale of the shares of common
stock by the
selling stockholders, but we will receive funds from the exercise of warrants
held by selling stockholders, if exercised for cash.
MARKET
FOR COMMON STOCK AND RELATED STOCKHOLDER MATTERS
Prior to
March 31, 2005, there is no record of any quotes in the Pink Sheets or OTC
Bulletin Board and according to our records no public sales of our securities
have occurred.
At March
31, 2005, there were approximately 84 holders of our common stock.
DIVIDEND
POLICY
We have
not declared nor paid any cash dividend on our common
stock, and we
currently intend to retain future earnings, if any, to finance the expansion of
our business, and we do not expect to pay any cash dividends in the foreseeable
future. The decision whether to pay cash dividends on our common
stock will be made by our Board of Directors, in their discretion, and will
depend on our financial condition, operating results, capital requirements and
other factors that our Board of Directors considers significant.
DILUTION
We are
only registering shares of common stock already outstanding and held by selling
stockholders under this prospectus. As such, purchasers of shares of common
stock sold under this prospectus shall not experience any immediate dilution as
a result of or upon such purchase. Upon
issuance of the Penalty Shares, our outstanding shares increased by 1.01%,
reducing our book value per share (as of January 31, 2005) by $0.00089, and
keeping it at $0.08 per share.
CAPITALIZATION
The
following table sets forth as of January 31, 2005, our actual capitalization.
This table should be read in conjunction with the information contained in
“Management’s
Discussion and Analysis of Financial Condition and Results of Operations and
Plan of Operations” and the
consolidated financial statements and the notes thereto included elsewhere in
this prospectus.
|
|
Actual (Unaudited) |
|
Long-term
debt |
|
$ |
230,000 |
|
|
|
|
|
|
Stockholders’
equity (deficit): |
|
|
|
|
Common
stock |
|
|
36,690 |
|
Additional
paid in capital |
|
|
4,830,116 |
|
Deferred
compensation |
|
|
------ |
|
Retained
earnings (deficit) |
|
|
($1,903,996 |
) |
Total
stockholders equity |
|
$ |
2,962,810 |
|
|
|
|
|
|
Total
capitalization |
|
$ |
3,192,810* |
|
* Not
including short term payables.
SUMMARY
CONSOLIDATED FINANCIAL DATA OF ADVAXIS
On
November 12, 2004, we acquired Advaxis, Inc., a Delaware corporation through the
Share Exchange. The transaction was accounted for recapitalization. Accordingly,
the historical financial statements of Advaxis will be our financial statements
for reporting purposes. Advaxis, Inc has changed its fiscal year to October
31st and as a
result is providing herein
its audited financial statements for the years ended December 31, 2002 and 2003
and for the ten months ended October 31, 2004.
The
following condensed statement of operations data for the period from March 1,
2002 (inception) to December 31, 2002, the year ended December 31, 2003,
the ten
months ended October 31, 2004 and the
selected balance sheet data at December 31, 2002 and 2003, and at
October 31, 2004 are
derived from Advaxis’ financial statements and the related notes, audited by
Goldstein Golub Kessler LLP, Certified Public Accountants, 1185 Avenue of the
Americas, Suite 500, New York, NY 10036-2602, Advaxis’ independent registered
public accounting firm. The financial statements and the related notes as of
December 31, 2002 and 2003 and for periods ended December 31, 2002 and 2003
and the
ten months ended October 31, 2004 are included elsewhere herein. The selected
unaudited statement of operations data for the ten months ended October 31,
2003, and the unaudited
selected statement of operations data for the three months ended
January 31, 2004 and 2005, and the unaudited consolidated selected balance sheet
data at January 31, 2005, are derived from Advaxis’ unaudited financial
statements, which have been prepared on a basis consistent with Advaxis’ audited
financial statements and, in the opinion of management, include all adjustments,
consisting of normal recurring adjustments, necessary for a fair presentation of
Advaxis’ financial position and results of operations. The results of operations
for any interim period are not necessarily indicative of results to be expected
for the entire year. The following data should be read in conjunction with
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations and Plan of Operations” and our financial statements and the related
notes included elsewhere in this prospectus.
|
|
|
Period
from March 1, 2002 (inception) to
December
31, |
|
|
Year
ended December 31, |
|
|
Ten Months Ended October
31, |
|
|
Three Months Ended January
31, (unaudited) |
|
Statement
of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2002 |
|
|
2003 |
|
|
Unaudited
2003 |
|
|
2004 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income |
|
|
|
|
$ |
4,000 |
|
$ |
3,600 |
|
$ |
116,406 |
|
$ |
400 |
|
|
|
|
Total
operating expenses |
|
$ |
167,902 |
|
$ |
897,076 |
|
|
821,725 |
|
|
650,310 |
|
$ |
132,241 |
|
$ |
245,126 |
|
Interest
expense (income) |
|
|
-- |
|
|
17,190 |
|
|
7,288 |
|
|
4,229 |
|
|
10,655
|
|
|
2,968 |
|
Other
income |
|
|
966 |
|
|
521 |
|
|
506 |
|
|
56 |
|
|
(430 |
) |
|
(2,739 |
) |
Provision
for income taxes |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
-- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(166,936 |
) |
$ |
(909,745 |
) |
|
(825,907 |
) |
|
(538,076 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) |
Loss
per Share Information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
|
$ |
(0.01 |
) |
$ |
(0.05 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
|
|
December
31, |
|
|
October
31 |
|
|
January
31, (unaudited) |
|
Balance
Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2002 |
|
|
2003 |
|
|
2004 |
|
|
2005 |
|
Cash
and cash equivalents |
|
$ |
204,382 |
|
$ |
47,160 |
|
$ |
32,279 |
|
$ |
3,217,430 |
|
Intangible
assets |
|
|
-- |
|
$ |
277,243 |
|
$ |
469,803 |
|
$ |
666,447 |
|
Total
assets |
|
$ |
204,382 |
|
$ |
324,403 |
|
$ |
502,083 |
|
$ |
3,886,327 |
|
Total
liabilities |
|
$ |
125,825 |
|
$ |
1,131,138 |
|
$ |
1,841,579 |
|
$ |
923,517 |
|
Stockholders’
equity (deficiency) |
|
|
78,557 |
|
|
(806,735 |
) |
$ |
(1,339,496 |
) |
|
2,962,810 |
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS AND
PLAN OF OPERATIONS
This
Management’s Discussion and Analysis of Financial Condition and Results of
Operations and Plan of Operations and other portions of this prospectus contain
forward-looking information that involve risks and uncertainties. Our actual
results could differ materially from those anticipated by the forward-looking
information. Factors that may cause such differences include, but are not
limited to, availability and cost of financial resources, product demand, market
acceptance and other factors discussed in this prospectus under the heading
“Risk Factors”. This Management’s Discussion and Analysis of Financial Condition
and Results of Operations and Plan of Operations should be read in conjunction
with our financial statements and the related notes included elsewhere in this
prospectus.
Overview
We are a
biotechnology company utilizing multiple mechanisms of immunity with the intent
to develop cancer vaccines that are more effective and safer than existing
vaccines. We believe that by using our licensed Listeria System to engineer a
live attenuated Listeria monocytogenes bacteria to secrete a protein sequence
containing a tumor-specific antigen, we will force the body’s immune system to
process and recognize the antigen as if it were foreign, creating the immune
response needed to attack the cancer. The licensed Listeria System, developed at
Penn over the past 10 years, provides a scientific basis for believing that this
therapeutic approach induces a significant immune response to the tumor.
Accordingly, we believe that the Listeria System is a broadly enabling platform
technology that can be applied in many cancers, infectious diseases and
auto-immune disorders.
Our
therapeutic approach is based upon, and we have obtained an exclusive license
with respect to, the innovative work of Yvonne Paterson, Ph.D., Professor of
Microbiology at Penn involving the creation of genetically engineered Listeria
that stimulate the innate immune system and induce an antigen-specific immune
response involving humoral and cellular components.
We have
focused our initial development efforts on six lead compounds and anticipate
commencing a Phase I clinical study of Lovaxin C, a potential cervical and neck
cancer vaccine, in the first quarter of 2005. See “Business - Research and
Development Program”.
We were
originally incorporated in the state of Colorado on June 5, 1987 under the name
Great Expectations, Inc. We were administratively dissolved January 1, 1997 and
reinstated June 18, 1998 under the name Great Expectations and Associates, Inc.
In 1999, we became a reporting company under the Securities Exchange Act of
1934, as amended. We were a publicly-traded “shell” company in November 2004
without any business. On November 12, 2004, we acquired Advaxis through the
Share Exchange, as a result of which Advaxis become our wholly-owned subsidiary
and our sole operating company. For financial reporting purposes, we have
treated the Share Exchange as a recapitalization. As a result of the foregoing
as well as the fact that the Share Exchange is treated as a recapitalization of
Advaxis rather than as a business combination, the historical financial
statements of Advaxis became our historical financial statements after the Share
Exchange.
On
November
12, 2004, December 8, 2004 and January 4, 2005, we
closed a private offering of an aggregate of 11,334,495 shares of our common
stock and warrants to purchase an aggregate of 11,334,495 shares of our common
stock resulting in aggregate net proceeds of approximately $3,253,000. Such
offering was solely to “accredited investors”, as defined in Rule 501(a) of
Regulation D under the Securities Act of 1933, through the Placement Agent. See
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations and Plan of Operations - Liquidity and Capital
Resources”.
On
November 12, 2004 we converted $595,000 of aggregate principal promissory notes
plus accrued interest outstanding into an aggregate of 2,136,441 shares of our
common stock and warrants to purchase 2,223,549 shares of our common
stock.
On
January
12, 2005, we closed
a private offering of 3,832,753 shares of our common stock and warrants to
purchase 3,832,753 shares of our common stock resulting in aggregate net
proceeds of approximately $1,100,000. Such offering was to a single “accredited
investor”, as defined in Rule 501(a) of Regulation D under the Securities Act of
1933. See “Management’s Discussion and Analysis of Financial Condition and
Results of Operations and Plan of Operations - Liquidity and Capital
Resources”.
To date
we have been in the development stage. During the year ended December 31, 2003,
the ten months ended October 31, 2004 and the three months ended January
31, 2005, we had no customers and focused our efforts on research and
development related to our product candidates, capital raising and formation,
and activities relating to the Share Exchange. During these periods, our net
loss was $909,745 and $245,355, respectively. As of December 31, 2003, October
31, 2004 and January 31, 2005, we had a working capital (deficit) of
($997,184), ($1,396,062) and $2,523,913, respectively and an accumulated
deficit of $1,076,861,
$1,658,641 and 1,903,996, respectively.
Plan
of Operations
We intend
to use the proceeds of the Private Placement closed on November 12, 2004,
December 8, 2004 and January 4, 2005 and the proceeds of the offering closed on
January 12, 2005 to conduct a Phase I clinical trial in cervical cancer using
Lovaxin C, one of our lead product candidates in development using our Listeria
System. We intend to expand our research and development team and further the
development of the product candidates. We also intend to deploy a portion of the
funds in expanding our manufacturing capabilities and in strategic activities.
Our corporate staff will be responsible for the general and administrative
activities.
During
the next 12 to 24 months, we anticipate that our strategic focus will be to
achieve several objectives. Our foremost objectives are as follows and are
further described under “Business - Strategy”:
· |
Initiate
and complete phase I clinical study of Lovaxin C;
|
· |
Continue
pre-clinical development of our products; |
· |
Continue
research to expand our technology platform. |
Accounting
Policies; Impact of Growth
Below is
a brief description of basic accounting principles which we have adopted in
determining our recognition of expenses, as well as a brief description of the
effects that our management believes that our anticipated growth will have on
our revenues and expenses in the future 12 months.
Revenues. We do
not anticipate
that we will record any material revenues during at least the year ending
December 31, 2005. When we recognize revenues, we anticipate that the
revenue sources will be principally comprised of grants and licensing fees.
Expenses.
We
recorded operating expenses for the year ended December 31, 2003 and the ten
months ended October 31, 2004 of $897,076 and $650,310, respectively.
The
preparation of financial statements requires us to make estimates and judgments
that affect the reported amounts of assets, liabilities, revenue and expenses,
and related disclosure of contingent assets and liabilities. On an on-going
basis, we evaluate our estimates, based on historical experience and on various
other assumptions that we believe to be reasonable under the circumstances.
Actual results may differ from these estimates under different assumptions or
conditions.
We
believe the following critical accounting policy involves significant estimate
and judgment. We
amortize trademark and patent costs over their estimated useful
lives. We may be required to adjust these lives based on advances in science and
competitor actions. We review the recorded amounts of trademarks and patents at
each period end to determine if their carrying amount is still recoverable based
on expectations regarding potential licensing of the intangibles or sales of
related products. Such an assessment, in the future, may result in a conclusion
that the assets are impaired, with a corresponding charge against
earnings.
Due to
the limited nature of our operations, we do not identify any other accounting
policies involving estimates or assumptions that are material due to the levels
of subjectivity and judgment necessary to account for highly uncertain matters
or the susceptibility of such matters to change, and where the impact of the
estimates and assumptions on financial condition or operating performance is
material.
In
accordance with Securities and Exchange Commission Staff Accounting Bulletin
(SAB) No. 104, revenue from license fees and grants is recognized when the
following criteria are met; persuasive evidence of an arrangement exists,
services have been rendered, the contract price is fixed or determinable, and
collectibility is reasonably assured. In licensing arrangements, delivery does
not occur for revenue recognition purposes until the license term begins.
Nonrefundable upfront fees received in exchange for products delivered or
services performed that do not represent the culmination of a separate earnings
process will be deferred and recognized over the term of the agreement using the
straightline method or another method if it better represents the timing and
pattern of performance.
For
revenue contracts that contain multiple elements, we will determine whether the
contract includes multiple units of accounting in accordance with EITF No.
00-21, Revenue Arrangements with Multiple Deliverables. Under that guidance,
revenue arrangements with multiple deliverables are divided into separate units
of accounting if the delivered item has value to the customer on a standalone
basis and there is objective and reliable evidence of the fair value of the
undelivered item.
Research
and Development. During
the year ended December 31, 2003 and the ten months ended October 31, 2004, we
recorded research
and development expenses of $491,508 and $125,942, respectively. Such expenses
were principally comprised of manufacturing scale up and process development,
license fees, sponsored research and consulting. We
recognize research and development expenses as incurred.
During
the year ending December 31, 2005 and beyond, we anticipate that our research
and development expenses will increase as a result of our expanded development
and commercialization efforts related to clinical trials, product development,
and development of strategic and other relationships that will be required
ultimately for the licensing, manufacture and distribution of our product
candidates. We regard four of our product candidates as major research and
development projects. The timing, costs and risks of those projects are as
follows:
Lovaxin
C - Phase I trial Summary Information
· |
Cost
incurred to date: approximately $700,000 |
· |
Estimated
future costs: $1,000,000 |
· |
Anticipated
completion date: second quarter of 2006 |
· |
Risks
and uncertainties: |
– |
the
FDA (or relevant foreign regulatory authority) may not approve the
study |
– |
any
adverse event in a patient in the trial |
– |
difficulty
in recruiting patients |
– |
strong
side effects in patients in the trial |
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to a
marketing collaberation subject to regulatory approval to market and sell
the product. |
Lovaxin
B - Phase I trial Summary Information
· |
Cost
incurred to date: $100,000 |
· |
Estimated
future costs: $1,800,000 |
· |
Anticipate
completion dates: second quarter of 2007 |
· |
Risks
and uncertainties: |
– |
Obtaining
favorable animal data |
– |
Proving
low toxicity in animals and
obtaining favorable animal data |
– |
Manufacturing
scale up to GMP level |
– |
FDA
(or foreign regulatory authority) may not approve the
study |
– |
The
occurrence of an adverse event in a patient |
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage, upon a licensing deal or pursuant to a marketing
collaberation subject to regulatory approval to market and sell the
product. |
Lovaxin
T - Phase I trial Summary Information
· |
Cost
incurred to date: None |
· |
Estimated
future costs: $1,500,000 |
· |
Anticipate
completion dates: third quarter of 2007 |
· |
Risks
and uncertainties: |
– |
Obtaining
favorable animal data |
– |
Proving
low toxicity in animals and obtaining favorable animal
data |
– |
Manufacturing
scale up to GMP levels |
– |
FDA
(or foreign regulatory authority) may not approve the study
initiation |
– |
Adverse
event in a patient in the program |
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to a
maekting collaberation subject to regulatory approval to market and sell
the product. |
Lovaxin
NY - Phase I trial Summary Information
· |
Cost
incurred to date: $100,000 |
· |
Estimated
future costs: Unknown at this stage. |
· |
Anticipated
completion dates: Unknown at this stage. |
· |
Risks
and uncertainties: |
– |
Obtaining
favorable animal data |
– |
Proving
low toxicity in animals and obtaining favorable animal
data |
– |
Manufacturing
scale up to GMP levels |
– |
FDA
(or foreign regulatory authority) may not approve the
study |
– |
The
occurrence of an adverse event in a patient in the
program |
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to a
marketing collaberation subject to regulatory approval to market and sell
the product. |
General
and Administrative Expenses. During
the year ended December 31, 2003 and the ten months ended October 31, 2004,
we
recorded general and administrative expenses of $405,568 and $524,368,
respectively. General and administrative costs primarily include the salaries
for executive, finance, facilities, insurances, accounting and legal assistance,
as well as other corporate and administrative functions that serve to support
Advaxis’ current and our future operations and provide an infrastructure to
support this anticipated future growth. During
the year ending December 31, 2005 and beyond, we anticipate that our
general
and administrative costs will increase due to the increased compliance
requirements, including, without limitation, legal, accounting, and insurance
expenses, arising out of complying with periodic reporting and other regulations
applicable to public companies.
Interest
Expense.
During
the year ended December 31, 2003 and the ten months ended October 31, 2004,
we
recorded interest expense of $17,190 and $4,229, respectively. Interest expense,
relates primarily to our convertible promissory notes which have been converted
into Units at the initial closing of our Private Placement on November 12, 2004.
Each Unit consisting of 87,108 shares of common stock and warrants to purchase
87,108 shares of common stock.
Recently
Issued Accounting Pronouncements. In
December 2004, the Financial Accounting Standards Board issued FASB Statement
No. 123 (revised 2004), share-based payment. This statement requires that
compensation cost relating to share based payment transactions be recognized in
financial statements. The cost will be measured based on the fair value of the
equity or liability instruments issued. At present, we are unable to determine
what effect, if any, the adoption of FASB Statement No. 123 (revised 2004) will
have on our financial statements.
Results
of Operations
Three
Months Ended January 31, 2005 Compared to the Three Months Ended January 31,
2004
Revenue.
Our revenue decreased by $400 or 100% from $400 for the three months ended
January 31, 2004 to $0 for the three months ended January 31, 2005 due to the
decrease in grant money received by the Company in these periods.
Research
and Development Expenses. Research
and development expenses increased by $132,109, or 152.13%, from $86,842 for the
three months ended January 31, 2004 to $218,951 for the three months ended
January 31, 2005. This decrease was principally attributable to the
following:
· |
an
increase in our related manufacturing expenses of $189,947 or 10,629% from
$1,787 to $191,734; such decrease reflects the delay in the manufacturing
program during 2004 because of delays in
funding; |
· |
an
increase in expenses related to toxicology studies from $0 to $27,216;
such increase reflects the initiation of toxicology studies by Pharm Olam
in connection with our Lovaxin C product candidates, and the payment of
deferred license fees to Penn; |
· |
a
decrease in outside research fees and consulting expenses of $85,054 or
100% from $85,054 to $0; such decrease reflects the completion of
sponsored research payment paid by the Company to Penn, and a decrease in
various consulting expenses paid to consultants in connection with our
grant and pre-clinical development program, as well as in other research
expenses. |
General
and Administrative Expenses. General
and administrative expenses decreased by $19,224 or 42.3% from $45,399 for the
three months ended January 31, 2004 to $26,175 for the three months ended
January 31, 2005. This decrease is primarily attributable to the following:
· |
employee
related expenses increased by $18,720, or 43.90%, from $42,670 for the
three months ended January 31, 2004 to $61,390 for the three months ended
January 31, 2005 arising from a bonus to Mr. Derbin, the Chief Executive
Officer, in stock; |
· |
A
decrease in legal fees from $832 for the three-months ended January 31,
2004 to ($166,346) for the three months ended January 31, 2005, as a
result of a settlement with the Company’s Intellectual Property law firm
which resulted in a reduction by approximately $177,000 of accounts
payable previously recorded as legal fee
expense |
· |
Other
General and Administrative expenses increased by $129,234 from $1,897
for the three-months ended January 31, 2004 to $131,131
for the three months ended January 31, 2005 principally
due to an increase in professional, legal and accounting fees, information
technology and internet expenses, insurance cost and
others. |
Interest
Expenses. Interest
expense decreased by $7,687, or 72.14%, from $10,655 for the three months ended
January 31, 2004 to $2,968 for the three months ended January 31, 2005. The
decrease results primarily from a reduction on interest payable on certain notes
which were converted on November 12, 2004.
Other
Income. Other
Income increased by $2,709, or 903%, from $30 for the three months ended January
31, 2004 to $2,739 for the three months ended January 31, 2005. The increase
results primarily from an increase in interest paid to the company on cash
deposits held by the Company.
No
provision for income taxes was made for the three months ended January 31, 2004
or 2005 due to significant tax losses during and prior to such periods.
Ten
Months Ended October 31, 2004 Compared to the Ten Months Ended October 31,
2003
Revenue.
Our revenue increased by $112,806 or 3133.5% from $3,600 for the ten months
ended October 31, 2003 to $116,406 for the ten months ended October 31, 2004 due
to the increase in grant money received by the Company in these
periods.
Research
and Development Expenses. Research
and development expenses decreased by $320,382, or 71.8%, from $446,324 for the
ten months ended October 31, 2003 to $125,942 for the ten months ended October
31, 2004. This decrease was principally attributable to the
following:
· |
A
decrease in our manufacturing expenses of $228,452 or 103.9% from $219,948
to $(8,504); such decrease reflects the delay in the manufacturing program
during 2004 because of delays in funding; |
· |
A
decrease in our License Fees of $110,164 or 196.4% from $56,082 to
$(54,082); such decrease reflects the reclassification of License Fees
from an R&D expense to an investment; |
· |
A
decrease in our outside research fees from $97,306 to $38,382; such
decrease reflects the completion in year 2004 of our expenses resulting
from our sponsored research agreement with
Penn; |
· |
Development
consulting expenses increased from $72,988 to $150,147 or 105.7%. This
increase reflects primarily increased success fees due to DNA Bridges in
connection with two NIH grants awarded to the Company in
2004 |
General
and Administrative Expenses. General
and administrative expenses increased by $148,965 or 39.7% from $375,403 for the
ten months ended October 31, 2003 to $524,368 for the ten months ended October
31, 2004. This decrease was principally attributable to the following:
· |
employee
related expenses increased by $34,790, or 22.5%, from $154,512 for the ten
months ended October 31, 2003 to $189,302 for the ten months ended October
31, 2004 arising from a bonus to Mr. Derbin, the Chief Executive Officer,
in stock; |
· |
professional
fees increased by $14,368 from $204,145 for the ten months ended October
31, 2003 to $218,514 for the ten months ended October 31, 2004 principally
due to (a) an increase in consulting fees from $95,651 to $110,332, and
(b) an increase in accounting fees from $350 to
$23,070; |
· |
Insurance
expense was increased from $1,901 for the ten months ended October 31,
2003 to $9,929 for the ten months ended October 31, 2004;
and |
· |
Other
General and Administrative expenses increased by $66,701 from $14,844 to
$81,545 principally due to an increase in amortization expenses,
information technology and internet expenses, postage, telephone and
travel expenses. |
Interest
Expenses.
Interest
expense decreased by $4,059, or 49%, from $8,288 for the ten months ended
October 31, 2003 to $4,229 for the ten months ended October 31, 2004. The
decrease results primarily from a reduction on interest payable on certain fees
owed to Penn.
Other
Income.
Other
Income increased by $112,357, or 2,736%, from $4,106 for the ten months ended
October 31, 2003 to $116,463_for the ten months ended October 31, 2004. The
increase results primarily from an increase in grants from $3,600 to
$116,406.
Year
ended December 31, 2003 and the period from March 1, 2002 (inception) to
December 31, 2002
Revenue.
Our revenue increased by $4,000 or 100% from $0 for the period from March
1, 2002 (inception) to December 31, 2002 to $4,000 for the year ended December
31, 2003 due to the increase in grant money received by the Company in these
periods.
Research
and Development Expenses. Research
and development expenses increased by $440,609, or 865.6%, from $50,899 for the
period from March 1, 2002 (inception) through December 31, 2002 to $491,508 for
the year ended December 31, 2003. This increase was principally attributable to
the increase in outside research expenses increased by $33,838, or 53%, from
$63,468 for the period from March 1, 2002 (inception) through December 31, 2002
to $97,306 for the year ended December 31, 2003 due to increased research fees
due to Penn relating to an increased research program, the initiation of our
manufacturing scale up program with Cobra Biomanufacturing PLC in year 2003
where such plan did not yet exist in year 2002 as well as the hire of certain
pre clinical and regulatory consultants in early 2003 such as Therrimune
Research Corporation, Dr. Bruce Mackler and AccessBio.
General
and Administrative Expenses. General
and administrative expenses increased by $288,565 or 246.6% from $117,003 for
the period from March 31, 2002 (inception) through December 31, 2002 to $405,568
for the year ended December 31, 2003. This increase is primarily attributable to
the increase in professional fees increased by $316,457, or 328.85%, from
$96,231 for the period from March 1, 2002 (inception) to December 31, 2002 to
$412,688 for the year ended December 31, 2003 due to increased consulting and
legal requirements and increased consulting fees paid to financial advisors in
2003
Other
Income. Other Income decreased by $445, or 46% from $966 for the period
from March 1, 2002 (inception) to December 31, 2002 to $521 for the year ended
December 31, 2003. The decrease results from a decrease in interest paid to the
Companyon cash deposits held by the Company.
Interest
Expenses. Interest
expense increased by $17,190 or 100% from $0 for the period from March 31, 2002
(inception) through December 31, 2002 to $17,190 for the year ended December 31,
2003. The increase results primarily from the interest attributable to notes
issued during such later period.
No
provision for income taxes was made for the period from March 31, 2002
(inception) through December 31, 2002 or the year ended December 31, 2003 due to
significant tax losses incurred.
Liquidity
and capital resources
At
December 31, 2003 and January 31, 2005, our cash was $47,160 and $3,217,430,
respectively, and we had a working capital deficit of $997,184 at December 31,
2003 and working capital of $2,523,913 at January 31, 2005.
To date,
our principal sources of liquidity has been cash provided by private offerings
of our securities. These offering have been structured so as to be exempt from
the prospectus delivery requirements under the Securities Act of 1933. Our
principal uses of cash have been research and development and working capital.
We anticipate these uses will continue to be our principal uses of cash in the
future.
Although
we believe that the net proceeds received by us from the Private Placement and
the private offerings will be sufficient to finance our currently planned
operations for approximately the next 12 to 24 months, we do not believe that
these amounts will be sufficient to meet our longer-term cash requirements or
our cash requirements for the commercialization of any of our existing or future
product candidates. We will be required to issue equity or debt securities or to
enter into other financial arrangements, including relationships with corporate
and other partners, in order to raise additional capital. Depending upon market
conditions, we may not be successful in raising sufficient additional capital
for our long-term requirements. In such event, our business, prospects,
financial condition and results of operations could be materially adversely
affected.
The
following factors, among others, could cause actual results to differ from those
indicated in the above forward-looking statements: increased length and scope of
our clinical trials, increased costs related to intellectual property related
expenses, increased cost of manufacturing and higher consulting costs. These
factors or additional risks and uncertainties not known to us or that we
currently deem immaterial may impair business operations and may cause our
actual results to differ materially from any forward-looking statement.
Although
we believe the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance
or achievements. We are under no duty to update any of the forward-looking
statements after the date of this prospectus to conform them to actual results
or to make changes in our expectations.
We expect
our future sources of liquidity to be primarily equity capital raised from
investors, as well as licensing fees and milestone payments in the event we
enter into licensing agreements with third parties, and research collaboration
fees in the event we enter into research collaborations with third
parties.
On
November 12, 2004, we sold to accredited investors at an initial closing of the
Private Placement 117 Units at $25,000 per unit for an aggregate purchase price
of $2,925,000. Each Unit is comprised of (i) 87,108 shares of our common stock
and (ii) a five-year warrant to purchase 87,108 shares of our common stock at an
exercise price of $0.40 per share. At the initial closing, the accredited
investors received an aggregate of 10,191,638 shares of common stock and
warrants to purchase 10,191,638 shares of common stock. In addition, on November
12, 2004, $595,000 aggregate principal amount of convertible promissory notes of
Advaxis, including accrued interest, were converted into units on the same terms
as those upon which the Units sold. The holders of these notes received an
aggregate of 2,136,441 shares of common stock and warrants to purchase 2,136,441
shares of common stock upon conversion of these notes plus accrued interest
thereon.
On
December 8, 2004, we sold to accredited investors at a second closing of the
Private Placement 8 units for an aggregate purchase price of $200,000. At such
closing, the accredited investors received an aggregate of 696,864 shares of
common stock and warrants to purchase 696,864 shares of Common Stock.
On
January 4, 2005, we sold to accredited investors at a third closing of the
Private Placement 5.12 Units for an aggregate purchase price of $128,000. At
such closing, the accredited investors received an aggregate of 445,993 shares
of common stock and warrants to purchase 445,993 shares of Common Stock.
Pursuant
to the terms of a investment banking agreement, dated March 19, 2004, by and
between us and Sunrise Securities, Corp. (“Sunrise” or the “Placement Agent”),
we issued to the Placement Agent and its designees an aggregate of 2,283,445
shares of common stock and warrants to purchase up to an aggregate of 2,666,900
shares of common stock. The shares were issued as part consideration for the
services of Sunrise, as our placement agent in the Private Placement. In
addition, we paid Sunrise a total cash fee of $50,530.
On
January 12, 2005, we sold to one accredited investor at a closing of a
subsequent private placement offering 44 units for an aggregate purchase price
of $1,100,000. As with the Private Placement, each Unit issued and sold in this
subsequent private placement was sold at $25,000 per unit and is comprised of
(i) 87,108 shares of our common stock, and (ii) a five-year warrant to purchase
87,108 shares of our common stock at an exercise price of $0.40 per share. At
such closing, the accredited investor received an aggregate of 3,832,752 shares
of common stock and warrants to purchase 3,832,752 shares of common stock.
We are
party to a license agreement, dated June 17, 2002, as amended, between Advaxis
and The Trustees of the University of Pennsylvania, pursuant to which Advaxis
has agreed to pay $525,000 over a four-year period as a royalty after the first
commercial sale of our products covered by the license. Advaxis is also
obligated to pay annual license maintenance fees under this agreement ranging
from $25,000 to $125,000 per year after the first commercial sale of a product
under the license, as well as pay up to $482,000 to the licensor upon receiving
financing. The amount due is contingent upon the size of the financing.
For a
description of material employment agreements to which we are party, see
“Certain Relationships and Related Party Transactions”.
Critical
Accounting Policies
The
preparation of financial statements requires the Company to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenue and
expenses, and related disclosure of contingent assets and liabilities. On an
on-going basis, the Company evaluates its estimates, based on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances. Actual results may differ from these estimates under
different assumptions or conditions.
The
Company believes the following critical accounting policy involves significant
estimate and judgment. The Company amortizes trademark and patent costs over
their estimated useful lives. The Company may be required to adjust these lives
based on advances in science and competitor actions. The Company reviews the
recorded amounts of trademarks and patents at each period end to determine if
their carrying amount is still recoverable based on expectations regarding
potential licensing of the intangibles or sales of related products. Such an
assessment, in the future, may result in a conclusion that the assets are
impaired, with a corresponding charge against earnings.
Due to
the limited nature of the Company’s operations, the Company has not identified
any other accounting policies involving estimates or assumptions that are
material due to the levels of subjectivity and judgment necessary to account for
highly uncertain matters or the susceptibility of such matters to change, and
where the impact of the estimates and assumptions on financial condition or
operating performance is material.
Impact
of Inflation
We
believe that our results of operations are not dependent upon moderate changes
in inflation rates.
BUSINESS
General
We are a
development stage biotechnology company utilizing multiple mechanisms of
immunity with the intent to develop cancer vaccines that are more effective and
safer than existing vaccines. To that end, we have licensed rights from Penn to
use the Listeria System to secrete a protein sequence containing a
tumor-specific antigen. Using the Listeria System, we believe we will force the
body’s immune system to process and recognize the antigen as if it were foreign,
creating the immune response needed to attack the cancer. Our licensed Listeria
System, developed at Penn over the past 10 years, provides a scientific basis
for believing that this therapeutic approach induces a significant immune
response to a tumor. Accordingly, we believe that the Listeria System is a
broadly enabling platform technology that can be applied to many types of
cancers. In addition, we believe there may be useful applications in infectious
diseases and auto-immune disorders.
The
therapeutic approach that comprises the Listeria System is based upon the
innovative work of Yvonne Paterson, Ph.D., Professor of Microbiology at Penn,
involving the creation of genetically engineered Listeria that stimulate the
innate immune system and induce an antigen-specific immune response involving
humoral and cellular components. We have obtained the Penn License to exploit
the Listeria System.
We have
focused our initial development efforts upon cancer vaccines targeting cervical,
breast, melanoma, ovarian, lung and other cancers. Our lead products in
development are as follows:
Product |
|
Indication |
|
Stage |
Lovaxin
C
|
|
Cervical
and head and neck cancers
|
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in the first half
of 2005*
|
Lovaxin
B
|
|
Breast
cancer and melanoma
|
|
Pre-clinical;
Phase I study anticipated to commence in 2006
|
Lovaxin
NY
|
|
Ovarian,
melanoma and lung cancer
|
|
Pre-clinical;
Phase I study anticipated to commence in 2006
|
Lovaxin
W
|
|
Wilms
tumor and leukemia
|
|
Pre-clinical;
Phase I study anticipated to commence in 2006
|
Lovaxin
T
|
|
Cancer
through control of telomerase
|
|
Pre-clincial
|
Lovaxin
H
|
|
Prophylactic
vaccine for HIV (AIDS)
|
|
Pre-clincial
|
*
Possible delays of up to three months may occur based on the production schedule
of Cobra Biomanufacturing PLC of material, the length of time for Pharm Olam to
complete toxicology studies and the issuance of required regulatory
approval.
See
“Business - Research and Development Programs”.
Since our
formation, we have had a history of losses which as of January 31, 2005
aggregate $1,903,996, and because of the long development period for new drugs,
we expect to continue to incur losses for several years. Our business plan to
date has been realized by substantial outsourcing of virtually all major
functions of drug development including scaling up for manufacturing, research
and development, grant applications and others. The expenses of these outsourced
services account for most of our accumulated loss. We cannot predict when, if
ever, any of our product candidates will become commercially viable or FDA
approved. Even if one or more of our products becomes commercially viable and
receives FDA approval, we are not certain that we will ever become a profitable
business.
Strategy
During
the next 12 to 24 months our strategic focus will be to achieve several
objectives. The foremost of these objectives are as follows:
· |
Initiate
and complete Phase I clinical study of Lovaxin C; |
· |
Continue
the pre-clinical development of our product candidates, as well as
continue research to expand our technology platform;
and |
· |
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies. |
There are
many potential obstacles to the implementation of our proposed strategy. Among
the potential obstacles we may encounter with respect to the Phase I clinical
study of Lovaxin C are: difficulty in recruiting patients for the study; a
material, adverse medical result in a patient during the study; and extended
time for FDA approval of the IND (or foreign regulatory authority approval)
required to proceed with the test.
Among the
potential obstacles which we may encounter with respect to continuing
preclinical development of our product candidates such as Lovaxin B or T are
ambiguous animal data not sufficient to establish a proof of concept;
insufficient or adverse preclinical data on future products; and unexpected
higher costs or preclinical studies.
Among the
potential obstacles which we may encounter in establishing strategic
collaborations are: we may be perceived by desirable potential partners as too
early stage; we may need to demonstrate more human safety or efficicacy data; or
our technology may be perceived as a high risk for patents or to the
environment.
Initiate
and Complete Phase I Clinical Study of Lovaxin C. We have
had several meetings with the FDA and the Recombinant Advisory Committee of the
National Institutes of Health (the “NIH”) and have designed a Phase I clinical
study, which is primarily a study of the safety of Lovaxin C. We plan to
commence this clinical study in the first quarter 2005 and complete this
clinical study by the first quarter of 2006. We anticipate that the study will
be conducted on 20 to 30 patients with advanced cervical cancer.
We have
demonstrated that the therapeutic response works in concept. In preparation for
the commencement of our Phase I study of Lovaxin C, we have done the
following:
· |
optimized
the Listeria strain to be used; |
· |
identified
and contracted with a manufacturing partner for material manufactured in
accordance with “good manufacturing practices” or “GMP” as established by
the FDA; |
· |
identified
a principal investigator for the trial; |
· |
written
a protocol; and |
· |
commenced
preparing an investigational new drug application, or IND, with an
external consulting group. |
Following
the completion of the Phase I study and assuming that the results of this study
are favorable, we intend to prepare Phase II clinical studies to demonstrate
sufficient induction of immunity and therapeutic efficacy, as well as to
optimize the dosage and dosing regimen for the final vaccine formulation.
Thereafter, and assuming that the results of this study are favorable, we intend
to conduct Phase III clinical studies to demonstrate safety, efficacy and the
potency of the investigational vaccine. Such studies are expected to occur in
the next five to ten years. Throughout this process, we will be meeting with the
FDA prior to and at the conclusion of each phase to reach a consensus before
initiating any studies, in order to minimize regulatory risks during this
clinical development process.
At the
conclusion of the Phase III studies, we intend to prepare and file a BLA with
the FDA. Prior to submission of the BLA, we intend to seek Fast Track
designation from the FDA, which shortens the internal FDA review process for the
BLA to six months. As we accrue clinical data demonstrating the safety, efficacy
and potency of the product in Phase I and II clinical studies we will also
explore other regulatory approval options with the FDA that could expedite the
licensure of the final vaccine.
Continue
Pre-Clinical Development of Our Products, as well as Continued Research to
Expand Our Technology Platform. We intend
to continue to devote a substantial portion of our resources to the continued
pre-clinical development of our product candidates as well as the continued
research to expand our technology platform. Specifically, we intend to focus
upon research relating to combining our Listeria System with new and additional
tumor antigens which, if successful may lead to additional cancer vaccines and
other therapeutic products. These activities will require significant financial
resources, as well as areas of expertise beyond those readily available. In
order to provide additional resources and capital, we may enter into research,
collaborative, or commercial partnerships, joint ventures, or other arrangements
with competitive or complementary companies, including major international
pharmaceutical companies, or with universities, such as its relationship with
Penn and UCLA. See “Business - Partnerships and Agreements - Penn”.
Background
Cancer
Despite
tremendous advances in science, cancer remains a major health problem, and for
many it continues to be the most feared of diseases. Although age-adjusted
mortality rates for all cancer fell during the 1990’s, particularly for the
major cancer sites (lung, colorectal, breast, and prostate), mortality rates are
still increasing in certain sites such as liver and non-Hodgkin’s lymphoma. The
American Cancer Society estimates that more than eight million Americans were
treated for cancer in 1999. According to the HCUP, in 2000, treatment of the top
five cancers resulted in $10.8 billion in hospital costs.
Cancer is
the second largest cause of death in the United States, exceeded only by heart
disease. Approximately 1,268,000 new cases of cancer were expected to be
diagnosed in 2001, and 553,400 Americans were expected to die from the disease.
Since 1990, nearly 15 million new cases have been diagnosed. The NIH estimates
the overall cost for cancer in the year 2000 at $180.3 billion: $60 billion for
direct medical costs, $15 billion for indirect morbidity costs (loss of
productivity due to illness) and, $105.2 billion for indirect mortality costs
(cost of lost productivity due to premature death). (Source: cancer facts &
figures 2001, American Cancer Society).
Immune
System and Normal Antigen Processing
Living
creatures, including humans, are continually confronted with potentially
infectious agents. The immune system has developed multiple mechanisms that
allows the body to recognize these agents as foreign, and to target a variety of
immunological responses, including innate, antibody, and cellular immunity, that
mobilize the body’s natural defenses against these foreign agents that will
eliminate them. In this regard, there are a host of cells involved in the
recognition of and response to antigens, substances, typically proteins, that
are recognized by the body’s immune system and generate an immune response.
Antigens are frequently found on the outside of invading cells like bacteria,
but can also be found on the body’s own cells when they are either infected by a
virus or transformed into a cancer cell.
The
combination of the antibody (also called humoral) system and the cell mediated
system results in the immune response. Different disorders need a different mix
of responses to eliminate the problem, e.g., a streptococcal infection is
typically attacked primarily by the humoral system, and a cancer cell is
typically attacked by the cell mediated system.
The first
step in recognizing a foreign antigen is antigen processing. When cells involved
in the recognition and response encounter an antigen that they do not recognize,
they ingest the antigen. The antigen is then cut into small pieces and the
pieces are combined with proteins called “MHCs” and pushed out to the cell
surface. On the cell surface, the antigen is then able to interact with certain
classes of cells created by the immune system that produce the specialized cells
needed to help in the production of antibodies and the induction of cytotoxic
lymphocytes, primarily with antibodies. This system is called the exogenous
pathway, since it is the prototypical response to an exogenous antigen like a
bacteria.
There
exists another pathway, called the endogenous pathway. In this system, when one
of the body’s cells begins to create unusual proteins, the protein is processed
and expelled to the surface cell and is the cytoplasm into fragments. These are
directed into the endoplasmic reticulum, where they bind major
Historocompatibility Complex proteins, and then traffic to the cell surface.
This signal then calls immune cells to come to the site of the infection and
kill the cell. The endogenous pathway is used by the body to eliminate cells
that are creating unusual proteins (e.g., cancer cells or cells infected with a
virus).
In
clinical cancer, the body does not recognize the cancer cells as foreign. Our
technology forces the body to recognize tumor-associated or tumor-specific
antigens as foreign, thus creating the immune response needed to attack the
cancer. It does this by combining elements of the endogenous and exogenous
pathways utilizing a number of biologic characteristics of the Listeria
bacteria.
Mechanism
of Action
Listeria
is a bacteria well known to medical science because it can cause an infection in
humans. When Listeria enters the body, it is seen as foreign by the antigen
processing cells and ingested into cellular compartments called lysosomes, whose
destructive enzymes kill most of the bacteria. A certain percentage of these
bacteria, however, are able to break out of the lysosomes and enter into the
cytoplasm of the cell, where they are relatively safe from the immune system.
The bacteria multiply in the cell, and the Listeria is able to force the cell to
move the bacteria to its cell surface so it can push into neighboring cells and
spread. In this way, Listeria can cause various clinical conditions, including
sepsis, meningitis and placental infections in pregnant women.
Listeria
produces a substance known as listeriolysin (“LLO”), a protein that cuts a hole
in the membrane of the lysosome and allows the bacteria to escape into the
relatively safe cytoplasm. Once in the cytoplasm, however, LLO is also capable
of cutting a hole in the cell membrane. This would destroy the cell, and spill
the bacteria back out into the space between the cells, where it would be
exposed to more immune cell attacks and destruction. To prevent this, LLO has a
sequence of approximately 30 amino acids attached to it known as the
PEST1 sequence. This PEST sequence is used by normal cells to
force the rapid turnover of proteins that need only have a short life in the
cytoplasm. Listeria has evolved the ability to utilize this PEST sequence itself
as a routing tag that tells the cells to grab the LLO in the cytoplasm and pull
it into the endoplasmic reticulum, where it is processed just like a protein
antigen in the endogenous pathway. The benefit for the Listeria is that the LLO
is neutralized and the bacteria can continue to prosper inside the cell; the
benefit provided by our technology is that we now have a path into the antigen
processing system that causes an immune response of the tumor-specific
antigen.
_______________________
1 PEST is a part of the LLO protein that
is believed to faciliate rapid degradation of LLO in the cytoplasm. It appears
to facilitate movement of the protein into the endoplasmic reticulum of the
cell. In Advaxis’ application, the PEST sequence enhances the cell-mediated
response to an attached antigen, preumely by preferential movement of the
antigen sequence in to the intracellular protein processing system of antigen
processing cells such as macrophages and dendritic cells.
Research
and Development Program
Overview
We use
genetically engineered Listeria monocytogenes as a therapeutic agent. We start
with an attenuated Listeria, and then add to this bacteria a plasmid that
encodes a protein sequence that includes a portion of the LLO molecule
(including the PEST sequence) and the tumor antigen of interest. This protein is
secreted by the Listeria inside the antigen processing cells, which then results
in the immune response as discussed above.
We can
use different tumor antigens (or other antigens) in this system. By varying the
antigen, we create different therapeutic agents. Our lead agent, Lovaxin C, uses
a human papillomavirus derived antigen that is present in cervical cancers.
Lovaxin B uses her2/neu, an antigen found in many breast cancer and melanoma
cells, to induce an immune response that should be useful in treating these
conditions. The table below shows a list of potential products and their current
status:
Product |
|
Indication |
|
Stage |
|
|
|
|
|
Lovaxin
C |
|
Cervical
and neck cancers |
|
Pre-clinincal;
Phase I study in cervical cancer anticipated to commence in the first half
of 2005* |
|
|
|
|
|
Lovaxin
B |
|
Breast
cancer and melanoma |
|
Pre-clinical;
Phase I study anticipated to commence in 2006 |
|
|
|
|
|
Lovaxin
NY |
|
Ovarian
melanoma and lung cancer |
|
Pre-clinical;
Phase I study anticipated to commence in 2006 |
|
|
|
|
|
Lovaxin
W |
|
Wilms
tumor and leukemia |
|
Pre-clinical;
Phase I study anticipated to commence in 2006 |
|
|
|
|
|
Lovaxin
T |
|
Cancer
through control of telomerase |
|
Pre-clinical |
|
|
|
|
|
Lovaxin
H |
|
Prophylactic
vaccine for HIV (AIDS) |
|
Pre-clinical |
|
|
|
|
|
*
Possible delays of up to three months based on the production schedule of Cobra
Biomanufacturing PLC of materials, the length of time for Pharm Olam to complete
toxicology studies, and the issuance of required regulatory
approvals.
Partnerships
and Agreements
Penn
We have
entered into a 20-year exclusive worldwide license, with the right to grant
sublicenses, with Penn with respect to the innovative work of Yvonne Paterson,
Ph.D., Professor of Microbiology in the area of innate immunity, or the immune
response attributable to immune cells, including dentritic cells, macrophages
and natural killer cells, that respond to pathogens non-specifically. The
license provides us with the exclusive rights to the patent portfolio developed
at Penn in connection with Dr. Paterson and requires us to raise capital, pay
various milestone and licensing payments and commercialize the technology. In
exchange for the license, Penn received shares of our common stock currently
representing approximately 10.68% of our common stock on a fully-diluted basis.
In addition, Penn is entitled to receive a non-refundable license initial fee,
license fees, royalty payments and milestone payments based on net sales and
percentages of sublicense fees and certain commercial milestones, as follows:
Under a licensing agreement, Penn is entitled to receive royalties in the
following amounts: 1.5% on NET SALES in countries with pending or issued
patents; and 1.0% on NET SALES in countries without pending or issued patents.
Notwithstanding these royalty rates, we have agreed to pay $525,000 over a
four-year period as a minimum royalty after the first commercial sale of a
product under the license. We are also obligated to pay up to $660,000 to Penn
upon receiving financing or on certain dates on or before December 15, 2007,
whichever is earlier. After the 6th anniversary of the licensing agreement, we
shall pay Penn annual license maintenance fees of $125,000 per year. In
addition, we are obligated to reimburse Penn for all attorneys fees,
expenses, official fees and other charges incurred in the preparation,
prosecution and maintenance of the patents licensed from
Penn.
Furthermore,
upon the achievement of the first sale of a product in certain fields, Penn
shall be entitled to certain milestone payments, as follows: $2,500,000 shall be
due for first commercial sale of the first product in the cancer field (of which
$1,000,000 shall be paid within forty-five (45) days of the date of the first
commercial sale, $1,000,000 shall be paid on the first anniversary of the first
commercial sale; and $500,000 shall be paid on the second anniversary of the
date of the first commercial sale). In addition, $1,000,000 shall be due and
payable within forty-five (45) days following the date of the first commercial
sale of a product in any of the following fields (a) Infectious Disease, (b)
Allergy, (c) Autoimmune Disease, and (d) any other therapeutic indications for
which licensed products are developed. Therefore, the maximum total potential
amount of milestone payments is $6,500,000.
As a
result of the abovementioned payments, we may pay Penn significant amounts. If
over the next 10 years we have net sales in the aggregate amount of $100 million
from our cancer products, our total payments to Penn shall be $5,535,000. If
over the next 10 years our net sales total an aggregate amount of $10 million
from our cancer products, our total payments to Penn shall be $4,560,000.
However,
Penn is not involved in management of our company or in exploitation of the
patent portfolio. Based on the agreements with Penn, we will be responsible for
filing new patents and maintaining the existing patents.
Dr.
Yvonne Paterson
Dr.
Paterson is a Professor in the Department of Microbiology at Penn and the
inventor of our licensed technology. She has been an invited speaker at national
and international health field conferences and leading academic institutions.
She has served on many federal advisory boards, such as the NIH expert panel to
review primate centers, the Office of AIDS Research Planning Fiscal Workshop,
and the Allergy and Immunology NIH Study Section. She has been Section Editor of
the Journal of Immunology since 1994. She has written over 115 publications in
immunology (including a recently published book) with emphasis during the last
several years on the areas of HIV, AIDS and cancer research. Her instruction and
mentorship has trained over 30 post-doctoral and doctoral students in the fields
of Biochemistry and Immunology, many of whom are research leaders in academia
and industry.
Dr.
Paterson is currently the principal investigator on grants from the federal
government and charitable foundations totaling approximately $1.8 million
dollars per year. Her research interests are broad, but her laboratory has been
focused for the past ten years on developing novel approaches for prophylactic
vaccines against infectious disease and immunotherapeutic approaches to cancer.
The approach of the laboratory is based on a long-standing interest in the
properties of proteins that render them immunogenic and how such immunogenicity
may be modulated within the body.
Consulting
Agreement. We
entered into a renewed consulting agreement with Dr. Paterson in January 2005
which expires on January 31, 2006 with automatic renewals for up to six
aditional periods of six months each pursuant to which we have had access to Dr.
Paterson’s consulting services for one full day per week. Dr. Paterson has
advised us on an exclusive basis on various issues related to our technology,
manufacturing issues, establishing our lab, knowledge transfer, and our
long-term research and development program. Pursuant to the agreement, Dr.
Paterson has received options to purchase 169,048 shares of our common stock
subject to vesting. Dr. Paterson is to receive $3,000 per month throughout the
term of the Agreement; provided, that upon the closing of an additonal $3
million in equity capital, Dr. Paterson shall receive $5,000 per month;
provided, further, that upon the closing of an additonal $6 million in equity
capital, Dr. Paterson shall receive $7,000 per month; and provided, further,
that upon the closing of an additional of $9 million in equity capital, Dr.
Pateron shall receive $9,000 per month. In addition, subject to the adoption of
a new stock option plan by our stockholders, Dr. Paterson shall receive options
to purchase 400,000 shares of common stock at an exercise price of $0.28 per
share with 40,000 fully vested when granted and the remaining 360,000 options
vesting equally over 48 months; provided that Dr. Paterson remains a consultant
over the four year period. As of March 31, 2005, Dr. Paterson is being paid
$3,000 per month, and holds options to purchase a total of 169,048 shares of
Common Stock. We intend to grant as options to purchase an additional 400,000
shares of common stock upon adoption of a new stock option plan by the
Company.
Sponsored
Research Agreement. We
entered into a sponsored research agreement which terminates on June 30,
2005 with Penn and Dr. Paterson and have paid approximately $199,000 to sponsor
her continued research in this area. We believe that Dr. Paterson’s continuing
research will serve as a source of ongoing findings and data that both supports
and strengthen the existing patents. Her work will expand the claims of the
patent portfolio (potentially including adding claims for new tumor specific
antigens, the utilization of new vectors to deliver antigens, and applying the
technology to new disease conditions) and create the infrastructure for the
future filing of new patents.
We intend
to enter into additional sponsored research agreements with Penn in the future
with respect to research and development on our produce candidates.
Scientific
Advisory Board. Dr.
Paterson is also the chairman of our Scientific Advisory Board and one of our
stockholders.
Dr.
David Filer
We have
entered a consulting agreement with Dr. David Filer, a biotech consultant. The
Agreement commenced on January 7, 2005 and has a six month term, which may be
extended upon the agreement of both parties. Dr. Filer shall provide to us
for three
days per month during the term of the agreement assistance on its development
efforts, reviewing our scientific technical and business data and materials and
introducing us to industry analysts, institutional investors collaborators and
strategic partners. In
consideration for the consulting services we will pay Dr. Filer $2,000 per
month. In addition, subject
to the adoption of a new stock option plan by our stockholders, Dr.
Filer will receive 40,000 options to purchase shares of common stock, vesting
monthly over 12 months provided that the agreement is not
terminated.
AccessBio,
Inc
(Joy
Cavagnaro, Ph.D.)
We
entered into an agreement with Joy Cavagnaro, Ph.D., to advise us on an on-going
basis in the preparation of our science based regulatory strategy and
submissions with an emphasis on the design and safety of pre-clinical safety
evaluation programs to support initiation of clinical trials and integration of
pre-clinical and clinical research programs to support uninterrupted clinical
development, interpretation of FDA guidelines and development of global
registration strategies. A former expert toxicologist with the FDA, Dr.
Cavagnaro has a distinguished reputation within the industry and the agency.
Pursuant to the terms an agreement between Dr. Cavagnaro and us, in exchange for
its services, AccessBio is entitled to receive cash and accrued compensation
totalling $3,000 per month, as well as options to purchase our common
stock.
The
agreement was to terminate on September 15, 2004 but had been extended until
March 15, 2005 when it was terminated.
DNA
Bridges, Inc. (“DNA”)
We have
entered into an agreement with DNA Bridges, Inc. to develop and manage our grant
writing strategy and application program. Advaxis will pay DNA according to a
fee structure based on achievement of grants awarded to us at the rate of
7% of the grant amount. To date, pursuant to the award of three grants to us,
DNA has earned success fess of $42,000, $14,713 and $17,924. In addition, DNA
has received 16,200 options to purchase shares of our common stock. Either party
may terminate this agreement upon 30 days’ prior notice.
Eileen
Gorman, Ph.D., a principal and owner of DNA, has extensive experience in
accessing public financing opportunites, the national SBIR and related NIH/NCI
programs with approximately 30 years of industry experience.
Under the
DNA Agreement, DNA is compensated on a percentage basis for research grants made
to us through its efforts. We are currently in arbitration with DNA concerning
the timing of payments for the services rendered. See “Legal
Matters.”
UCLA
We have
entereed into a nonexclusive license and bailment agreement with the Regents of
the University of California (“UCLA”) to commercially develop products using the
XFL7 strain of Listeria monoctyogenes in humans and animals. The agreement is
effective for a period of 15 years and renewable by mutual consent of the
parties. Advaxis is to pay UCLA an initial licensee fee and annual maintainence
fees for use of the Listeria. We may not sell products using the XFL7 strain
Listeria other than agreed upon products or sublicense the rights granted under
the license agreement without the prior written consent of UCLA.
David
Carpi
We have
entered into a consulting agreement with David Carpi, whereby Mr. Carpi will
assist us in the prepartation and refinement of our marketing summary and
presentation materials and introduce us to pharmaceutical and biotechnology
companies which may be interested in strategic partnerships. Mr. Carpi will
receive compensation payable in cash and options for our common stock upon
completion of a transaction with a strategic partner introduced by Mr. Carpi.
The agreement was terminated on December 31, 2004 and we chose not to renew it.
No fees were paid and no fees are owed to Mr. Carpi.
We have
also entered into a government funding fee agreement with Mr. Carpi, whereby Mr.
Carpi will assist us in obtaining government funding for clinicial studies for
certain of our products. Mr. Carpi will receive options for our common stock if
he is successful in obtaining government funding for us. The agreement expires
on April 5, 2005 and thereafter continues on a month-to-month basis unless
terminated in writing by either party.
Cobra
Biomanufacturing PLC
In July
2003, we entered into an agreement with Cobra Biomanufacturing PLC for the
purpose of manufacturing our vaccines. Cobra has extensive experience in
manufacturing gene therapy products for investigational studies. Cobra is a full
service manufacturing organization that manufactures and supplies DNA-based
therapeutics for the pharmaceutical and biotech industry. These services include
the GMP manufacturing of DNA, recombinant protein, viruses, mammalian cells
products and cell banking. Cobra’s manufacturing plan for us calls for several
manufacturing stages, including process development, manufacturing of non-GMP
material for toxicology studies and manufacturing of GMP material for the Phase
I trial. The agreement is to expire upon the delivery and completion of
stability testing of the GMP material for the Phase I trial, now estimated to
occur by December 31, 2005. We are currently in negotiations with Cobra to enter
into agreement to manufacture our vaccines for future programs. Cobra has agreed
to convert $300,000 of its existing fees for manufacturing into future royalties
from the sales of Lovaxin C at the rate of 1.5% of net sales, with payments not
to exceed $1,950,000.
Pharm-Olam
International Ltd.
In
January 2005, we entered a consulting agreement with Pharm-Olam International
Ltd. (“POI”), a Texas limited partnership specializing in the management of pre
clinical and toxicology programs. Pursuant to the agreement, POI shall execute
and manage our toxicology studies, with certain third parties. The term of the
agreement is 12 months. In consideration for providing the consulting services,
POI will receive $272,163.
In April
2005, we entered into a consulting agreement with POI, based on which POI shall
execute and manage our Phase 1 clinical trial in Lovaxin C. In consideration for
providing the consulting services, POI will receive $430,000 (50% of which is
contingent on the closing of our next financing) plus certain expenses of
$181,060.
LVEP
Management, LLC
We
entered into a consulting agreement with LVEP Management, LLC (“LVEP”) which is
owned by Scott Flamm, one of our directors and a principal shareholder. LVEP
employs Mr. Flamm and Mr. Roni Appel, our Chief Financial Officer, and a
director and a principal shareholder of the Company. Pursuant to the consulting
agreement, dated as of January 19, 2005, and amended on April 15, 2005, LVEP is
to provide various financial and strategic consulting services to us. The
initial term of the consulting agreement is until December 31, 2005 and
thereafter the term of the consulting agreement shall be automatically extended
for one year periods unless we notify LVEP at least 60 days prior to the end of
term of our intent not to extend. In consideration for providing the consulting
services, LVEP received an initial payment of $4,500, receive $7,000 per month
during January, February and March 2005 and $13,875 per month thereafter for the
term of the consulting agreement plus reimbursement of approved expenses in
connection with providing the consulting services and will receive a payment at
the end of 2005 equal to 60% of the bonus earned by the Chief Executive Officer
of the Company. Additionally, LVEP shall receive options to purchase common
stock equal to 3% of the outstanding shares of the Company as of March 31, 2005.
Strategic
Growth International, Inc.
We
entered into an agreement with Strategic Growth International, Inc.(“SGI”)
whereby SGI will serve as an investor relations consultant. The term of this
agreement is for a period of 18 months commencing on the date of the
effectiveness of this registration statement. In consideration for performing
its services, SGI is to be paid $7,000 per month, provided, that upon the
effective date of this prospectus, SGI is to receive $8,000 per month and $7,000
of common stock with piggyback rights. In addition, SGI is to be issued a
warrant to purchase 240,000 shares of common stock, exercisable for 5 years,
with cashless exercise and piggyback rights. Furthermore, SGI is to be paid a
finder’s fee for any financing by us from an approved institution introduced to
us by SGI.
Patents
and Licenses
Dr.
Paterson and Penn have invested significant resources and time in developing a
broad base of intellectual property around the cancer vaccine platform
technology to which we have a 20-year exclusive worldwide license and a right to
grant sublicenses to pursuant to our license agreement with Penn. Penn currently
has eight issued and 12 pending patents in the United States and other countries
including Japan, Canada, Israel, Australia, and the European Union, through the
Patent Cooperation Treaty (PCT) system pursuant to which we have an exclusive
license to exploit the patents. We believe that these patents will allow us to
take a strong lead in the field of Listeria-based therapy.
The Penn
patent portfolio is currently comprised of the following:
United
States |
|
|
|
Patents |
|
|
|
U.S.
Patent No. 6,051,237, issued April 18, 2000. Patent Application No.
08/336,372, filed November 8, 1994 for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector.” Filed November 8,
1994. Expires April 18, 2017. |
|
|
|
U.S.
Patent No. 6,565,852, issued May 20, 2003, Paterson, et al., CIP Patent
Application No. 09/535,212, filed March 27, 2000 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector.” Filed March 27, 2000. Expires May 20, 2020. |
|
|
|
U.S.
Patent No. 6,099,848, issued August 8, 2000. Frankel et al., Patent
Application No. 08/972,902 “Immunogenic Compositions Comprising DAL/DAT
Double-Mutant, Auxotrophic, Attentuated Strains of Listeria and Their
Methods of Use.” Filed November 18, 1997. Expires November 18,
2017. |
|
|
|
U.S.
Patent No. 6,504,020, issued January 7, 2003 of Divisional Application No.
09/520,207 “Isolated Nucleic Acids Comprising Listeria DAL And DAT Genes”.
Filed March 7, 2000., Frankel et al. Expires March 7,
2020. |
|
U.S.
Patent No. 6,635,749, issued October 21, 2003; Divisional U.S. Patent
Application No. 10/136,253 for “Isolated Nucleic Acids Comprising Listeria
DAL and DAT Genes.” Filed May 1, 2002, Frankel, et al. Filed May 1, 2022.
Expires November 18, 2017. |
|
U.S.
Patent No. 5,830,702, issued November 3, 1998. Patent Application No.
08/366,477, filed December 30, 1994 for “Live, Recombinant Listeria SSP
Vaccines and Productions of Cytotoxic T Cell Response” Portnoy, et al.
Filed December 30, 1997. Expires November 3, 2015. |
|
|
|
US
Patent No. 6,767,542 issued July 27, 2004, Paterson, et al. Patent
Application No. 09/735,450 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed December 13, 2000. Expires March 29,
2020. |
|
Patent
Applications |
|
|
|
U.S.
Patent Application No. 10/441,851, “Methods And Compositions For
Immunotherapy of Cancer,” Filed May 20, 2003, Paterson et
al. |
|
|
|
U.S.
Patent Application No. 10/239,703 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed September 24, 2002, Paterson,
et al. |
|
|
|
Patent
Application No. 09/537,642 for “Fusion of Non-Hemolytic, Truncated Form of
Listeriolysis o to Antigens to Enhance Immunogenicity.” Filed March 29,
2000. Paterson, et al. |
|
|
|
U.S.
Patent Application No. 10/660,194, “Immunogenic Compositions Comprising
DAL/DAT Double Mutant, Auxotrophic Attenuated Strains Of Listeria And
Their Methods Of Use,” Filed September 11, 2003, Frankel et
al. |
|
Australian
Patent No. 730296, Patent Application No. 14108/99 for “Bacterial Vaccines
Comprising Auxotrophic, Attenuated Strains of Listeria Expressing
Heterologous Antigens.” Filed May 18, 2000. Frankel, et al. Expires
November 13, 2018. |
|
Patent
Applications |
|
|
|
Canadian
Patent Application No. 2,204,666, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson et al. |
|
|
|
Canadian
Patent Application No. 2,309,790 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al. |
|
|
|
Canadian
Patent Application No. 2,404,164 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al. |
|
|
|
European
Patent Application No. 95939926.2, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson, et al. |
|
|
|
European
Patent Application No. 01928324.1 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al. |
|
|
|
European
Patent Application No. 98957980.0 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al. |
|
|
|
Israel
Patent Application No. 151942 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al. |
|
|
|
Japanese
Patent Application No. 515534/96, filed November 3, 1995 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector”, Paterson, et al. |
|
|
|
Japanese
Patent Application No. 2001-570290 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al. |
In 2001,
an issue arose regarding the inventorship of U.S. Patent 6,565,852 and U.S.
Patent Application No. 09/537,642. These patent rights are included in the
patent rights licensed by Advaxis from Penn. It is contemplated by GSK, Penn and
us that the issue will be resolved through: (1) a correction of
inventorship to add certain GSK inventors, (2) where necessary and appropriate,
an assignment of GSK’s possible rights under these patent rights to Penn, and
(3) a sublicense from us to GSK of certain subject matter, which is not central
to our business plan. To date, this arrangement has not been finalized and we
cannot assure that this issue will ultimately be resolved in the manner
described above.
Pursuant
to our license with Penn, we have a three year option to license from Penn any
new future invention conceived by either Dr. Yvonne Paterson or by Dr. Fred
Frankel in the vaccine area. We intend to expand our intellectual property base
by exercising this option and gaining access to such future inventions. Further,
our consulting agreement with Dr. Paterson provides, among other things, that,
to the extent that Dr. Paterson’s consulting work results in new inventions,
such inventions will be assigned to Penn, and we will have access to those
inventions under license agreements to be negotiated.
Our
approach to the our intellectual property portfolio is to aggressively create
significant offensive and defensive patent protection for every product and
technology platform that we develop. We work closely with our patent counsel to
maintain a coherent and aggressive strategic approach to building our patent
portfolio with an emphasis in the field of cancer vaccines.
We have
become aware of a public company, Cerus Corporation, which has issued a press
release claiming to have a proprietary Listeria-based approach to a cancer
vaccine. We believe that through our exclusive license with Penn of U.S. Patent
Nos. 5,830,702, 6,051,237 and 6,565,852, we have the earliest known and dominant
patent position for the use of recombinant Listeria monocytogenes expressing
proteins or tumor antigens as a vaccine for the treatment of infectious diseases
and tumors. Based on searches of publicly available databases, we do not believe
that Cerus or The University of California Berkeley (which is where Cerus’
consulting scientist works) or any other third party owns any published Listeria
patents or has any issued patent claims that might materially negatively affect
our freedom to operate our business in the field of Listeria monocytogenes.
For more
information about Cerus Corporation and its claims with respect to
listeria-based technology, you should visit their web site at www.cerus.com or to
view its publicly filed documents, www.sec.gov.
Trademarks
We have
two trademark applications pending in the United States relating to the
trademark of “Advaxis” and ten trademark applications pending relating to the
trademark of “Lovaxin” in the United States and internationally. We work closely
with our trademark counsel to build a brandname for ourself and potential
products. Aventis, Inc. has filed trademark opposition proceedings in the United
States Patent and Trademark Office against our trademark applications Serial
Nos. 78/252527 and 78/252586 related to the trademark of “Advaxis”.
The opposition proceedings are in the early stages and it is impossible to
assess the merits at this point. We will vigorously defend our
trademark applications.
Governmental
Regulation
The
Drug Development Process
The FDA
requires that pharmaceutical and certain other therapeutic products undergo
significant clinical experimentation and clinical testing prior to their
marketing or introduction to the general public. Clinical testing, known as
clinical
trials or
clinical
studies, is
either conducted internally by pharmaceutical or biotechnology companies or is
conducted on behalf of these companies by contract research organizations.
The
process of conducting clinical studies is highly regulated by the FDA, as well
as by other governmental and professional bodies. Below, we describe the
principal framework in which clinical studies are conducted, as well as describe
a number of the parties involved in these studies.
Protocols. Before
commencing human clinical studies, the sponsor of a new drug must submit an
investigational new drug application, or IND, to the FDA. The application
contains what is known in the industry as a protocol. A
protocol is the blueprint for each drug study. The protocol sets forth, among
other things, the following:
· |
who
must be recruited as qualified
participants; |
· |
how
often to administer the drug; |
· |
what
tests to perform on the participants; and |
· |
what
dosage of the drug to give to the
participants. |
Institutional
Review Board. An
institutional review board is an independent committee of professionals and lay
persons which reviews clinical research studies involving human beings and is
required to adhere to guidelines issued by the FDA. The institutional review
board does not report to the FDA, but its records are audited by the FDA. Its
members are not appointed by the FDA. All clinical studies must be approved by
an institutional review board. The institutional review board’s role is to
protect the rights of the participants in the clinical studies. It approves the
protocols to be used, the advertisements which the company or contract research
organization conducting the study proposes to use to recruit participants, and
the form of consent which the participants will be required to sign prior to
their participation in the clinical studies.
Clinical
Trials. Human
clinical studies or testing of a potential product are generally done in three
stages known as Phase I through Phase III testing. The names of the phases are
derived from the regulations of the FDA. Generally, there are multiple studies
conducted in each phase.
Phase
I. Phase I
studies involve testing a drug or product on a limited number of healthy
participants, typically 24 to 100 people at a time. Phase I studies determine a
drug’s basic safety and how the drug is absorbed by, and eliminated from, the
body. This phase lasts an average of six months to a year.
Phase
II. Phase
II trials involve testing up to 200 participants at a time who may suffer from
the targeted disease or condition. Phase II testing typically lasts an average
of one to two years. In Phase II, the drug is tested to determine its safety and
effectiveness for treating a specific illness or condition. Phase II testing
also involves determining acceptable dosage levels of the drug. If Phase II
studies show that a new drug has an acceptable range of safety risks and
probable effectiveness, a company will continue to review the substance in Phase
III studies.
Phase
III. Phase
III studies involve testing large numbers of participants, typically several
hundred to several thousand persons. The purpose is to verify effectiveness and
long-term safety on a large scale. These studies generally last two to three
years. Phase III studies are conducted at multiple locations or sites. Like the
other phases, Phase III requires the site to keep detailed records of data
collected and procedures performed.
New
Drug Approval. The
results of the clinical trials are submitted to the FDA as part of a new drug
application (“NDA”). Following
the completion of Phase III studies, assuming the sponsor of a potential product
in the United States believes it has sufficient information to support the
safety and effectiveness of its product, it submits an NDA to the FDA requesting
that the product be approved for marketing. The application is a comprehensive,
multi-volume filing that includes the results of all clinical studies,
information about the drug’s composition, and the sponsor’s plans for producing,
packaging and labeling the product. The FDA’s review of an application can take
a few months to many years, with the average review lasting 18 months. Once
approved, drugs and other products may be marketed in the United States, subject
to any conditions imposed by the FDA.
Phase
IV. The FDA
may require that the sponsor conduct additional clinical trials following new
drug approval. The purpose of these trials, known as Phase IV studies, is to
monitor long-term risks and benefits, study different dosage levels or evaluate
safety and effectiveness. In recent years, the FDA has increased its reliance on
these trials. Phase IV studies usually involve thousands of participants. Phase
IV studies also may be initiated by the company sponsoring the new drug to gain
broader market value for an approved drug. For example, large-scale trials may
also be used to prove effectiveness and safety of new forms of drug delivery for
approved drugs. Examples may be using an inhalation spray versus taking tablets
or a sustained-release form of medication versus capsules taken multiple times
per day.
The drug
approval process is time-consuming, involves substantial expenditures of
resources, and depends upon a number of factors, including the severity of the
illness in question, the availability of alternative treatments, and the risks
and benefits demonstrated in the clinical trials.
On
November 21, 1997, former President Clinton signed into law the Food and Drug
Administration Modernization Act. That act codified the FDA’s policy of granting
"Fast Track" approval for cancer therapies and other therapies intended to treat
serious or life threatening diseases and that demonstrate the potential to
address unmet medical needs. The Fast Track program emphasizes close, early
communications between FDA and the sponsor to improve the efficiency of
preclinical and clinical development, and to reach agreement on the design of
the major clinical efficacy studies that will be needed to support approval.
Under the Fast Track program, a sponsor also has the option to submit and
receive review of parts of the NDA or BLA on a rolling schedule approved by FDA,
which expedites the review process.
The FDA’s
Guidelines for Industry Fast Track Development Programs require that a clinical
development program must continue to meet the criteria for Fast Track
designation for an application to be reviewed under the Fast Track Program.
Previously, the FDA approved cancer therapies primarily based on patient
survival rates or data on improved quality of life. While the FDA could consider
evidence of partial tumor shrinkage, which is often part of the data relied on
for approval, such information alone was usually insufficient to warrant
approval of a cancer therapy, except in limited situations. Under the FDA’s new
policy, which became effective on February 19, 1998, Fast Track designation
ordinarily allows a product to be considered for accelerated approval through
the use of surrogate endpoints to demonstrate effectiveness. As a result of
these provisions, the FDA has broadened authority to consider evidence of
partial tumor shrinkage or other surrogate endpoints of clinical benefit for
approval. This new policy is intended to facilitate the study of cancer
therapies and shorten the total time for marketing approvals. Under accelerated
approval, the manufacturer must continue with the clinical testing of the
product after marketing approval to validate that the surrogate endpoint did
predict meaningful clinical benefit. To the extent applicable we intend to take
advantage of the Fast Track programs to obtain accelarated approval on our
future products; however, it is too early to tell what effect, if any, these
provisions may have on the approval of our product candidates.
The
Orphan Drug Act provides incentives to develop and market drugs (“Orphan Drugs”)
for rare disease conditions in the United States. A drug that receives Orphan
Drug designation and is the first product to receive FDA marketing approval for
its product claim is entitled to a seven-year exclusive marketing period in the
United States for that product claim. A drug which is considered by the FDA to
be different than such FDA-approved Orphan Drug is not barred from sale in the
United States during such exclusive marketing period even if it receives
approval for the same claim. We can provide no assurance that the Orphan Drug
Act’s provisions will be the same at the time of the approval, if any, of our
products.
Other
Regulations
Various
Federal and state laws, regulations, and recommendations relating to safe
working conditions, laboratory practices, the experimental use of animals, and
the purchase, storage, movements, import, export, use, and disposal of hazardous
or potentially hazardous substances, including radioactive compounds and
infectious disease agents, are used in connection with our research or
applicable to our activities. They include, among others, the United States
Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational
Safety and Health Act, the National Environmental Policy Act, the Toxic
Substances Control Act, and Resources Conservation and Recovery Act, national
restrictions on technology transfer, import, export, and customs regulations,
and other present and possible future local, state, or federal regulation. The
extent of governmental regulation which might result from future legislation or
administrative action cannot be accurately predicted.
Manufacturing
The FDA
requires that any drug or formulation to be tested in humans be manufactured in
accordance with its GMP regulations. This has been extended to include any drug
which will be tested for safety in animals in support of human testing. The GMPs
set certain minimum requirements for procedures, record-keeping, and the
physical characteristics of the laboratories used in the production of these
drugs.
We have
entered into an agreement with Cobra Biomanufacturing PLC for the purpose of
manufacturing our vaccines. Cobra has extensive experience in manufacturing gene
therapy products for investigational studies. Cobra is a full service
manufacturing organization that manufactures and supplies DNA-based therapeutics
for the pharmaceutical and biotech industry. These services include the GMP
manufacturing of DNA, recombinant protein, viruses, mammalian cells products and
cell banking. Cobra’s manufacturing plan for us calls for several manufacturing
stages, including process development, manufacturing of non-GMP material for
toxicology studies and manufacturing of GMP material for the Phase I
trial.
Competition
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. As a
result, our actual or proposed products could become obsolete before we recoup
any portion of our related research and development and commercialization
expenses. The biotechnology and biopharmaceutical industries are highly
competitive, and this competition comes from both from biotechnology firms and
from major pharmaceutical and chemical companies, including Antigenics, Inc.,
Avi BioPharma, Inc., Bachria, Biomira, Inc., Corixa Corporation, Dendreon
Corporation, Epimmune, Inc., Genzyme Corp., Progenics Pharmaceuticals, Inc.,
Vical Incorporated, CancerVax Corporation, Genitope Corporation and Xcyte
Therapies, Inc., each of which is pursuing cancer vaccines. Many of these
companies have substantially greater financial, marketing, and human resources
than we do (including, in some cases, substantially greater experience in
clinical testing, manufacturing, and marketing of pharmaceutical products). We
also experience competition in the development of our products from universities
and other research institutions and compete with others in acquiring technology
from such universities and institutions. In addition, certain of our products
may be subject to competition from products developed using other technologies,
some of which have completed numerous clinical trials.
We expect
that our products under development and in clinical trials will address major
markets within the cancer sector. Our competition will be determined in part by
the potential indications for which drugs are developed and ultimately approved
by regulatory authorities. Additionally, the timing of market introduction of
some of our potential products or of competitors’ products may be an important
competitive factor. Accordingly, the relative speed with which we can develop
products, complete pre-clinical testing, clinical trials and approval processes
and supply commercial quantities to market are expected to be important
competitive factors. We expect that competition among products approved for sale
will be based on various factors, including product efficacy, safety,
reliability, availability, price and patent position. See “Business - Research
and Development Programs” and “Business - Competition”.
We have
become aware of a public company, Cerus Corporation, which has issued a press
release claiming to have a proprietary Listeria-based approach to a cancer
vaccine. We believe that through our exclusive license with Penn of U.S. Patent
Nos. 5,830,702, 6,051,237 and 6,565,852, we have the earliest known and dominant
patent position for the use of recombinant Listeria monocytogenes expressing
proteins or tumor antigens as a vaccine for the treatment of infectious diseases
and tumors. Based on searches of publicly available databases, we do not believe
that Cerus or The University of California Berkeley (which is where Cerus’
consulting scientist works) or any other third party owns any published Listeria
patents or has any issued patent claims that might materially negatively affect
our freedom to operate our business in the field of Listeria monocytogenes.
For more
information about Cerus Corporation and its claims with respect to
listeria-based technology, you should visit their web site at www.cerus.com or to
view its publicly filed documents, www.sec.gov.
Scientific
Advisory Board
We
maintain a scientific advisory board consisting of internationally recognized
scientists who advise us on scientific and technical aspects of our business.
The scientific advisory board meets periodically to review specific projects and
to assess the value of new technologies and developments to us. In addition,
individual members of the scientific advisory board meet with us periodically to
provide advice in particular areas of expertise. The scientific advisory board
consists of the following members, information with respect to whom is set forth
below: Yvonne Paterson, Ph.D.; Carl June, M.D.; Pramod Srivastava, Ph.D; and
Bennett Lorber, M.D.
Dr.
Yvonne Paterson. For a
description of our relationship with Dr. Paterson, please see “Business -
Partnerships and Agreements”.
Carl
June, M.D. Dr. June
is currently Director of Translational Research at the Abramson Cancer Center at
Penn, and is an Investigator of the Abramson Family Cancer Research Institute.
He is a graduate of the Naval Academy in Annapolis, and Baylor College of
Medicine in Houston. He had graduate training in immunology and malaria with Dr.
Paul-Henri Lambert at the World Health Organization, Geneva, Switzerland from
1978 to 1979, and post-doctoral training in transplantation biology with Dr. E.
Donnell Thomas at the Fred Hutchinson Cancer Research Center in Seattle from
1983 to 1986. He is board certified in Internal Medicine and Medical Oncology.
Dr. June founded the Immune Cell Biology Program and was head of the Department
of Immunology at the Naval Medical Research Institute from 1990 to 1995. Dr.
June rose to Professor in the Departments of Medicine and Cell and Molecular
Biology at the Uniformed Services University for the Health Sciences in
Bethesda, Maryland before assuming his current positions as of February 1, 1999.
Dr. June maintains a research laboratory that studies various mechanisms of
lymphocyte activation that relate to immune tolerance and adoptive
immunotherapy.
Pramod
Srivastava, Ph.D. Dr.
Srivastava is Professor of Immunology at the University of Connecticut School of
Medicine, where he is also Director of the Center for Immunotherapy of Cancer
and Infectious Diseases. He holds the Physicians Health Services Chair in Cancer
Immunology at the University. Professor Srivastava is the
Scientific Founder of Antigenics, Inc. He serves on the Scientific Advisory
Council of the Cancer Research Institute, New York, and was a member of the
Experimental Immunology Study Section of the National Institutes of Health of
the U.S. Government (1994 to 1999). He serves presently on the Board of
Directors of two privately held companies: Ikonisys (New Haven, Connecticut) and
CambriaTech (Lugano, Switzerland). In 1997, he was inducted into the Roll of
Honor of the International Union Against Cancer and was listed in Who’s Who in
Science and Engineering. He is among the 20 founding members of the Academy of
Cancer Immunology, New York. Dr. Srivastava obtained his bachelor’s degree in
biology and chemistry and a master’s degree in botany (paleontology) from the
University of Allahabad, India. He then studied yeast genetics at Osaka
University, Japan. He completed his Ph.D. in biochemistry at the Center for
Cellular and Molecular Biology, Hyderabad, India, where he began his work on
tumor immunity, including identification of the first proteins that can mediate
tumor rejection. He trained at Yale University and Sloan-Kettering Institute for
Cancer Research. Dr. Srivastava has held faculty positions at the Mount Sinai
School of Medicine and Fordham University in New York City.
Bennett
Lorber, M.D. Dr.
Lorver attended Swarthmore College where he studied zoology and art history. He
graduated from the University of Pennsylvania School of Medicine and did his
residency in internal medicine and fellowship in infectious diseases at Temple
University, following which he joined the Temple faculty. At Temple he rose
through the ranks to become Professor of Medicine and, in 1988, was named the
first recipient of the Thomas Durant Chair in Medicine. He is also a Professor
of Microbiology and Immunology and serves as the Chief of the Section of
Infectious Diseases. He is a Fellow of the American College of Physicians, a
Fellow of the Infectious Diseases Society of America, and a Fellow of the
College of Physicians of Philadelphia where he serves as College Secretary and
as a member of the Board of Trustees. Dr. Lorber’s major interest in infectious
diseases is in human listeriosis, an area in which he is regarded as an
international authority. He has also been interested in the impact of societal
changes on infectious disease patterns as well the relationship between
infectious agents and chronic illness, and he has authored papers exploring
these associations. He has been repeatedly honored for his teaching; among his
honors are 10 golden apples, the Temple University Great Teacher Award, the
Clinical Practice Award from the Pennsylvania College of Internal Medicine, and
the Bristol Award from the Infectious Diseases Society of America. On two
occasions the graduating medical school class dedicated their yearbook to Dr.
Lorber. In 1996 he was the recipient of an honorary Doctor of Science degree
from Swarthmore College. Dr. Lorber is also a professional painter and an
accomplished guitarist.
Employees
As of
March 31, 2005, we have three employees, all of whom are on a full-time
basis.
Additional
senior employees have been identified and are anticipated to join Advaxis in the
near future.
We
anticipate
increasing the number of employees in the research and development department
significantly during the next two years, as well as increasing the number of
employees in the general and administrative and business development department.
Facilities
Our
corporate offices are currently located at the corporate center at 212 Carnegie
Center, Suite 206, Princeton, New Jersey 08540. We have entered into a
lease effective April 1, 2005, which will continue on a monthly basis, at the
Princeton Corporate Plaza, a biotech industrial park, located at 7 Deer Park
Drive, Monmouth Junction, NJ 08852 for research and development offices and
executive offices. We believe that our facility will be sufficient for our
purposes for the foreseeable future. Our monthly payment on this facility
will be approximately $2,500 per month. In the event that our facility should,
for any reason, become unavailable, we believe that alternative facilities are
available at competitive rates.
Litigation
There are
no material legal proceedings threatened against us. In the ordinary course of
our business we may become subject to litigation regarding our products or our
compliance with applicable laws, rules, and regulations. Aventis,
Inc. has filed trademark opposition proceedings in the United States Patent and
Trademark Office against our trademark applications Serial Nos. 78/252527
and 78/252586 related to the trademark of “Advaxis”. The opposition
proceedings are in the early stages and it is impossible to assess the merits at
this point. We intend to vigorously defend our trademark
applications
MANAGEMENT
Executive
Officers,
Directors, and Key Employees
The
following are our
executive officers and
directors and their respective ages and positions as of January 1, 2005:
|
|
|
|
|
Name |
|
Age |
|
Position |
|
|
|
|
|
J.
Todd Derbin(3) |
|
52 |
|
President,
Chief Executive Officer, and Director |
|
|
|
|
|
Dr.
James Patton(1) |
|
47 |
|
Chairman
of the Board of Directors |
|
|
|
|
|
Roni
A. Appel(3) |
|
38 |
|
Chief
Financial Officer, Secretary and Director |
|
|
|
|
|
Dr.
Thomas McKearn(2) |
|
55 |
|
Director |
|
|
|
|
|
Dr.
Steven Roth |
|
62 |
|
Director |
|
|
|
|
|
Scott
Flamm(1) (2) |
|
50 |
|
Director |
|
(1) |
Member
of the Audit Committee. |
|
(2) |
Member
of the Compensation Committee. |
|
(3) |
Member
of the Nominating and Corporate Governance Committee.
|
J.
Todd Derbin. Mr.
Derbin has served as our President, Chief Executive Officer and a director since
November 2004. Prior thereto he served as the President, Chief Executive Officer
and a director of Advaxis since November 2002. From 1996 until June, 2001, Mr.
Derbin was the founder and Chairman of the Board of Directors, President, and
Chief Executive Officer of Micrus Corporation, a market leader in the design and
development of highly differentiated and proprietary interventional
neuroradiology devices and delivery systems. From 1992 until 1996, he served as
Director of Corporate Business Development, Commercial Director - Cardiovascular
and Director of Strategic Planning, Mergers & Share Exchanges with
Biocompatibles International, plc, a UK biotechnology/biomedical Company. Prior
to this, Mr. Derbin served as Chief Executive Officer of Syncare Corporation,
developers of synthetic wound care products and drug delivery systems. His 20
year tenure in life sciences includes senior management, strategic and
operational positions with CollaTec, Inc., a subsidiary of Marion Merrell Dow,
and American Medical Products Corporation’s domestic and international
divisions. He began his career at Procter & Gamble and American Hospital
Supply Corporation (Baxter) where he held marketing positions. Mr. Derbin is an
alumnus of Wilkes College and the Wharton School of the University of
Pennsylvania.
Dr.
James Patton. Dr.
Patton has served as Chairman of our Board and Directors since November 2004.
Prior thereto, Dr. Patton served as Chairman of Advaxis’ Board of Directors
since February 2002 and as Advaxis’ Chief Executive Officer from February 2002
to November 2002. Additionally, since February 1999, Dr. Patton has served as
the President of Comprehensive Oncology Care, LLC, which owns and operates a
cancer treatment facility in Exton, Pennsylvania and as Vice President of
Millennium Oncology Management, Inc., which provides technical services for
oncology care to four sites. From February 1999 to September 2003, Dr. Patton
served as a consultant to LibertyView Equity Partners SBIC, LP, a venture
capital fund based in Jersey City, New Jersey (“LibertyView”). From July 2000 to
December 2002, Dr. Patton served as a director of Pinpoint Data Corp. From
February 2000 to November 2000, Dr. Patton served as a dirctor of Healthware
Solutions. From June 2000 to June 2003, Dr. Patton served as a director of
LifeStar Response. He earned his B.S. from the University of Michigan, his
Medical Doctorate from Medical College of Pennsylvania, and his M.B.A. from the
University of Pennsylvania’s Wharton School. Dr. Patton was also a Robert Wood
Johnson Foundation Clinical Scholar. He has published papers regarding
scientific research in human genetics, diagnostic test performance and medical
economic analysis.
Roni
A. Appel. Mr.
Appel has served as a member of our Board of Directors and as our Secretary and
Chief Financial Officer since November 2004. Prior thereto he has served as
Advaxis’ Secretary and Chief Finanical Officer since it was formed. Since
January 1999, Mr. Appel has been a partner and managing director in LV Equity
Partners (fka LibertyView Equity Partners). From 1998 until 1999, he was a
founder and the director of business development at Americana Financial
Services, Inc. From 1994 to 1998, he was an attorney and completed his MBA at
Columbia University.
Dr.
Thomas McKearn. Dr.
McKearn has served as a member of our Board of Directors since November 2004.
Prior thereto he served as
an Advaxis director since July 2002. He brings to Advaxis a 20 plus year
experience in the translation of biotechnology science into innovative products
that address unmet medical needs in oncology. First as one of the founders of
Cytogen Corporation, then as an Executive Director of Strategic Science and
Medicine at Bristol-Myers Squibb and now as the VP. Medical Affairs at
GPC-Biotech, McKearn has always worked at bringing the most innovative
scientific findings into the clinic and through the FDA regulatory process for
the ultimate benefit of patients who need better ways to cope with their
afflictions. Prior to entering the then-nascent biotechnology industry in 1981,
McKearn did his medical, graduate and post-graduate training at the University
of Chicago and served on the faculty of the Medical School at the University of
Pennsylvania.
Dr.
Steven Roth. Dr. Roth
has served as a member of our Board of Directors since November, 2004. Prior
thereto he had
served as an Advaxis director since November 2002. He is a co-founder of Neose
Technologies, a publicly traded biotechnology Company, since 1990, and has
served as its chief executive and board chairman since 1994. Between 1980 and
1992 he was a professor of biology at University of Pennsylvania and was
appointed department chairman in 1982, serving in that role until 1987. At the
University of Pennsylvania, Dr. Roth helped form its Plant Science Institute.
Between 1992 and 1994 he was the chief scientific officer and VP, R&D, of
Neose Technologies. From 1970 through 1980, Dr. Roth was assistant and associate
professor of biology at The Johns Hopkins University. His scholarly interests
centered on the roles of complex carbohydrates in embryonic morphogenesis and in
malignancy, topics on which he authored or co-authored nearly 100 articles and
one book. He has received several research awards and prizes, and is an inventor
on 18 patents and six patent applications. Dr. Roth received an A.B. degree from
Johns Hopkins in 1964, a Ph.D. from Case Western Reserve University in 1968, and
did postdoctoral work in carbohydrate chemistry at Hopkins from 1968-1970.
Currently, Dr. Roth is a member of the board of directors of the Philadelphia
Greenhouse Corporation, a member of the board of overseers of the School of Arts
and Sciences of the University of Pennsylvania, a member of the board of
visitors of the School of Arts and Sciences of Case Western Reserve University,
a member of the scientific advisory boards of Quaker BioVentures and Birchmere
Ventures, a member of the editorial board of The Quarterly Review of Biology, a
director of Neose Technologies and a director of Chiral Quest.
Scott
Flamm. Mr. Flamm
has served as a member of our Board of Directors since November, 2004.
Mr. Flamm
is one of Advaxis’ founders and has served as an Advaxis director since its
inception. Since June 1998, Mr. Flamm has been the president and general partner
of LV Equity Partners (fka Liberty View Equity Partners). Among his prior
positions are Senior Managing Director of Trilon Dominion Partners, a $100
million venture fund, and Executive Vice President of Charterhouse Environment
Capital Group, a subsidiary of the private equity investment firm Charterhouse
Group International. From 1988 until January 1993, he was Executive Vice
President, Chief Operating Officer and a Director of Catalyst Energy, a $2
billion independent power producer. He received his masters in public health
from Yale University.
Vafa
Shahabit, Ph.D. Dr.
Shahabit has been Head of Dreictor of Science effective March 1, 2005,
terminable on 30 days notice. Her duties are to work on and/or manage research
and development projects as specified by the Company. The compensation is
$100,000 per annum.
Dr.
John Rothman, Ph.D. Dr.
Rothman has been hired as Vice President of Clinical Development effective March
7, 2005 for a term of one year ending February 28, 2006. His compensation is
$170,000 per annum, to increase to $180,000 upon the closing of a $15 million
equity financing. Upon meeting incentives to be set by the Company, he will
receive a bonus of up to $45,000.
Richard
Berman (Director Nominee). Mr.
Berman has agreed to join the Board by mid May. For the past five years, Mr.
Berman has been Chairman and CEO of Internet Commerce Corporation, an internet
supply chain company. He is also Chairman of a financial services company and
Candidate Resources, Inc., a company which delivers human resources services
over the web. He is a Director of seven public companies, Dyadic International,
Inc., International Microcomputer Software, Inc., Internet Commerce Corporation,
MediaBay, Inc., NexMed, Inc., GVI Security Solutions, Inc., and Financial
Services Co., which he serves as chairman. Previously, Mr. Berman worked at
Goldman Sachs; was Senior Vice President of Bankers Trust Company, where he
started the M&A and Leverage Buyout Departments. He is a past Director of
the Stern School of Business of NYU where he earned a B.S. and an M.B.A. He also
has law degrees from Boston College and The Hague Academy of International Law.
Mr. Berman will receive a director’s fee of $2,000 per month and options for the
purchase of 400,000 shares of Common Stock vesting over four years on a
quarterly basis.
Board
of Directors and Officers
Messrs.
McKearn and Roth have each received an option package of 82,763 options to
purchase shares of our common stock.
Each
director is elected for a period of one year at our annual meeting of
stockholders and serves until the next such meeting and until his or her
successor is duly elected and qualified. Officers are elected by, and serve at
the discretion of, our board of directors. Our directors do not presently
receive any compensation for their services as directors. The board
of directors may also appoint additional directors up to the maximum number
permitted under our by-laws. A director so chosen or appointed will hold office
until the next annual meeting of stockholders.
Each
of
our
executive officers serves at
the discretion of its board of directors and holds office until his or her
successor is elected or until his or her earlier resignation or removal in
accordance with our articles of incorporation and by-laws.
Meetings
and
Committees of the Board of Directors
During
the year ended December 31, 2003, our board of directors held four meetings and
took action by written consent on four occasions. During the year ended December
31, 2004, our board of directors held three meetings and took action by written
consent on 7 occasions.
Audit
Committee
Effective
in November 2004, we established the audit committee of the board of directors
which consists of Messrs. Flamm and Patton.
The audit
committee is responsible
for the following:
· |
reviewing
the
results of the audit engagement with the independent registered public
accounting firm; |
· |
identifying
irregularities
in the management of our
business in consultation with our independent accountants, and suggest an
appropriate course of action; |
· |
reviewing
the
adequacy, scope, and results of the internal accounting controls and
procedures; |
· |
reviewing
the
degree of independence of the auditors, as well as the nature and scope of
our relationship with our independent registered public accounting
firm; |
· |
reviewing
the
auditors’ fees; and |
· |
recommending
the
engagement of auditors to the full board of
directors. |
Compensation
Committee
Effective
on November 2004, we established a compensation committee of the board of
directors which initially consists of Messrs. Flamm and McKearn. The
compensation committee determines the salaries and incentive compensation of our
officers and provides recommendations for the salaries and incentive
compensation of our other employees and consultants.
The
compensation of our executive officers is determined by the compensation
committee of our board of directors, subject to applicable employment
agreements. Our compensation programs will enable us to attract, motivate,
reward and retain the management talent required to achieve corporate objectives
and thereby increase stockholder value. It is our policy to provide incentives
to our senior management to achieve both short-term and long-term objectives and
to reward exceptional performance and contributions to the development of our
business. To attain these objectives, our executive compensation program
includes a competitive base salary, cash incentive bonuses and stock-based
compensation.
Stock
options have been granted to our senior executive officer by the board of
directors or the compensation committee under the 2004 Stock Option Plan. We
believe that stock options provide an incentive that focuses the executive’s
attention on managing us from the perspective of an owner with an equity stake
in the business. Options are awarded with an exercise price equal to the market
value of common stock on the date of grant, have a maximum term of ten years and
generally become exercisable, in whole or in part, starting one year from the
date of grant. Among our executive officers, the number of shares subject to
options granted to each individual generally depends upon the level of that
officer’s responsibility. The largest grants are awarded to the most senior
officers who, in our view, have the greatest potential impact on our
profitability and growth. Previous grants of stock options are reviewed but are
not considered the most important factor in determining the size of any
executive’s stock option award in a particular year.
From time
to time, the compensation committee may utilize the services of independent
consultants to perform analyses and to make recommendations to the committee
relative to executive compensation matters. No compensation consultant has so
far been retained.
Relationship
of Compensation to Performance and Compensation of our executive
officers
The
compensation committee will annually establish, subject to the approval of the
board of directors and any applicable employment agreements, the salaries that
will be paid to our executive officers during the coming year. In setting
salaries, the compensation committee takes into account several factors,
including competitive compensation data, the extent to which an individual may
participate in the stock plans maintained by us, and qualitative factors bearing
on an individual’s experience, responsibilities, management and leadership
abilities and job performance.
Nominating
and Corporate Governance Committee
Effective
on November 2004, we established a nominating and corporate governance committee
of our board of directors which initially consists of Messers. Derbin and Appel.
The functions of the nominating and corporate governance include the
following:
· |
identifying
and recommending to the board of directors individuals qualified to serve
as directors of the Company and on the committees of the board;
|
· |
advising
the board with respect to matters of board composition, procedures and
committees; |
· |
developing
and recommending to the board a set of corporate governance principles
applicable to us and overseeing corporate governance matters generally;
and |
· |
overseeing
the annual evaluation of the board and our management.
|
The
nominating and corporate governance committee shall be governed by a charter,
which we intend to adopt.
Code
of Ethics
We have
adopted a code of ethics that applies to our officers, employees and directors,
including our principal executive officers, principal financial officers and
principal accounting officers. The code of ethics sets forth written standards
that are designated to deter wrongdoing and to promote:
· |
Honest
and ethical conduct, including the ethical handling of actual or apparent
conflicts of interest between personal and professional
relationships; |
· |
Full,
fair, accurate, timely and understandable disclosure in reports and
documents that a we file with, or submit to, the SEC and in other public
communications made by us; |
· |
Compliance
with applicable governmental laws, rules and
regulations; |
· |
The
prompt internal reporting of violations of the code to an appropriate
person or persons identified in our code of ethics;
and |
· |
Accountability
for adherence to our code of ethics. |
A copy of
our code of ethics has been filed with the SEC as an exhibit to our Form 8K
dated November 12, 2004.
Compensation
of
Officers and Directors
The
aggregate
compensation paid to our directors and executive officers, including stock based
compensation, for the
year ended December 31, 2003 and
December 31, 2004 was approximately $183,692 and $238,795, respectively. This
amount includes $0 set aside or accrued to provide pension, severance,
retirement, or similar benefits or expenses, but does not include business
travel, relocation, professional and business association dues and expenses
reimbursed to office holders and other benefits commonly reimbursed or paid by
similarly situated companies. None of our directors has so far received any
compensation for his or her services as a director other than stock options and
reimbursement of expenses.
Compensation
Committee
Interlocks And Insider Participation
There
were no interlocking relationships between us and
other entities that might affect the determination of the compensation of its
directors and executive officers.
Executive
Compensation
The
following
table sets forth the
compensation earned during the years ended
December 31, 2003
and 2004 by our
former and current chief executive officer:
Summary
Compensation
Table For Last Fiscal Year
|
|
|
|
Annual
Compensation |
|
Long
Term
Compensation
Awards |
Name
And Principal Position |
|
Year |
|
Salary($) |
|
Bonus($) |
|
Securities
Underlying Options |
J.
Todd Derbin President,
Chief Executive Officer, and Director |
|
2004
2003 |
|
$168,270
$150,000 |
|
$45,000**
$60,000** |
|
--
1,172,727 |
Dr.
James Patton Chairman
of the Board of Directors |
|
2004
2003 |
|
$-*
$-* |
|
--
-- |
|
29,583
33,810 |
*Dr.
Patton was paid consulting fees by Advaxis of $18,000 in 2003 and $15,750
in 2004.
Mr.
Patton’s compensation related to his consulting agreement which terminated
on November 2004.
**Mr.
Derbin’s stock option award was based in his employment contract. His 2003
bonus of $60,000 was paid in Common Stock of the Company on the basis of a
volume of $0.1452 per share and
was two-third’s of his maximum bonus of $90,000. The basis for this bonus
was the successful conclusion of several matters of great importance to
the Company including: |
-
|
negotiating
and executing an arrangement with GSK in
2003; |
-
|
extending
the patent portfolio and moving it to the care of competent patent
counsel; |
-
|
creating
grant opportunities for the company; |
- |
scaling
up manufacturing; |
-
|
creating
certain collaboration opportunities. |
In
determining Mr. Debin’s bonus, the Board of Directors acted in part on a
discretionary basis.
Option
Grants
In Recent Fiscal Years
The
following
table sets forth each
grant of stock options during the years ended
December 31, 2003 and
2004 to our
current and former Chief Executive Officer under a predecessor stock option
plan. The assumed 5% and 10% rates of stock price appreciation are provided in
accordance with rules of the SEC
and do
not represent our estimate or projection
of our
common stock price.
Actual gains, if any, on stock option exercises are dependent on the future
performance
of our
common stock, overall
market conditions and the option holders’ continued employment through the
vesting period. Unless the market price of
our
common stock appreciates
over the option term, no value will be realized from the option grants made to
these executive officers. The potential realizable values shown in the table are
calculated by assuming that the
estimated fair
market value
of
our
common stock on the
date of grant increases by 5% and 10%, respectively, during each year of the
option term.
The
outstanding stock options described above became options for our common stock
upon the Share Exchange.
|
|
|
|
|
|
|
|
|
|
|
Individual
Grants |
|
|
|
|
|
|
Number
Of Securities Underlying |
|
Percent Of Total Options Granted
To |
|
|
|
|
|
Potential
Realizable Value At Assumed Annual Rates of Stock Price
Appreciation For Option
Term($) |
Name |
|
Year |
|
Options Granted |
|
Employees
In Fiscal
Year) |
|
Exercise Price |
|
Expiration Date |
|
5% |
|
10% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J.
Todd Derbin(1) President,
Chief Executive Officer, and Director |
|
2004 2003 |
|
-- -- |
|
-- -- |
|
-- -- |
|
-- -- |
|
-- -- |
|
-- -- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
James Patton Chairman
of the Board of Directors |
|
2004 2003 |
|
29,583 33,810 |
|
46.6% 53.3% |
|
$0.35 $0.35 |
|
11/1/2012 11/1/2012 |
|
$2,190
$2,503 |
|
$7,845
$8,966 |
____________________
(1) The
initial option grant was in the year 2002.
Aggregate
Option
Exercises In Last Fiscal Year And
Fiscal Year-End
Option Values
The
following
table sets forth information
concerning the options exercised by Advaxis’
current and former Chief Executive Officer in the
years ended
December 31, 2003 and 2004 and the
year-end number and value of unexercised options with respect to each of these
executive officers.
|
|
|
|
|
|
|
|
Number
Of Securities Underlying
Unexercised Options At
Fiscal Year-End(2) |
|
Value
Of Unexercised In-The-Money
Options At
Fiscal Year-End($)(3) |
Name |
|
Year |
|
Shares Acquired On Exercise |
|
Value Realized(1) |
|
Exercisable |
|
Unexercisable |
|
Exercisable |
|
Unexercisable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J.
Todd Derbin President,
Chief Executive Officer, and Director |
|
2004 2003 |
|
0 0 |
|
0 0 |
|
586,382 293,191 |
|
586,382 879,575 |
|
51,015 0 |
|
51,015 0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
James Patton Chairman
of the Board of Directors |
|
2004 2003 |
|
0 0 |
|
0 0 |
|
29,583 33,810 |
|
0 0 |
|
0 0 |
|
0 0 |
__________________
(1) |
Based
on the
fair
market value
of
our
common stock on
the date of exercise, less the exercise price payable for such shares.
|
|
|
(2) |
Certain
of the options are immediately exercisable for all the option shares as of
the date of grant but any shares purchased are subject to repurchase by us
at the original exercise price
paid per share if
the optionee ceases service with us before vesting in such shares.
|
|
|
(3) |
Based
on the
fair
market value
of
our
common stock at
fiscal year end of $0.20
per
share, determined by the board to be equal to our Private Placement price
per share less
the exercise price payable for such shares.
|
2004
Stock Option Plan
In
November
2004, our board of directors and stockholders adopted
the 2004
Stock Option Plan
(“Plan”). The
Plan
provides
for the grant of options to purchase up to 2,381,525
shares of our common stock to
employees,
officers, directors and consultants.
Options
may be
either “incentive
stock options” or
non-qualified options under the Federal tax laws. Incentive
stock options may be
granted only to our employees, while
non-qualified options may be issued to non-employee
directors,
consultants and others, as well as to our employees.
The
Plan
is
administered by “disinterested members” of the board of directors or the
compensation committee, who determine, among other things, the individuals who
shall receive options, the time period during which the options may be partially
or fully exercised, the
number of
shares of
common stock issuable
upon the
exercise of each option and the option exercise price.
Subject
to a
number of exceptions, the exercise price
per
share
of common
stock subject
to an incentive option may not be less than the fair
market value per
share of
common stock on
the date
the option is granted. The per
share exercise price of
the
common stock subject
to a non-qualified option may be established by the board of directors, but
shall not, however, be less than 85% of the fair
market value per
share of
common stock on
the date
the option is granted.
The
aggregate fair
market value of
common
stock for which
any person may be granted incentive
stock options which
first become exercisable in any calendar year may not exceed $100,000 on the
date of grant.
No
stock
option may be transferred by an optionee other than by will or the laws of
descent and distribution, and, during the lifetime of an optionee, the option
will be exercisable only by the optionee. In the event of termination of
employment or engagement other than by death or disability, the optionee will
have no more than three months after such termination during which the optionee
shall be entitled to exercise the option, unless otherwise determined by the
board of directors. Upon termination of employment or engagement of an optionee
by reason of death or permanent and total disability, the optionee’s options
remain exercisable for one year to the extent the options were exercisable on
the date of such termination. No similar limitation applies to non-qualified
options.
We must
grant options under the Plan within ten years from the effective date of the
Plan. The effective date of the Plan was November 12, 2004. Subject to a number
of exceptions, holders of incentive
stock options granted
under the Plan cannot exercise these options more than ten years from the date
of grant. Options
granted
under the Plan generally provide for the payment of the exercise price in cash
and may provide for the payment of the exercise price by delivery to
us
of
shares of
common stock already
owned by
the optionee having a fair market value equal to the exercise price of the
options being exercised, or by a combination of these methods. Therefore, if it
is provided in an optionee’s options, the optionee may be able to tender
shares of
common stock to
purchase
additional
shares of
common stock and
may
theoretically exercise all of his stock options with no additional investment
other than the purchase of his original shares.
Any
unexercised
options that expire or that terminate upon an employee’s ceasing to be employed
by us become
available again for issuance under the Plan.
Employment
Agreements
We have
entered into an amended and restated employment agreement with J. Todd Derbin,
dated December 20, 2004 pursuant to which Mr. Derbin is employed as our
President and Chief Executive Officer. The effective date of the agreement is
January 1, 2005. The term of the agreement is for one year and will be further
renewed if mutually agreed to by Mr. Derbin and us. Mr.
Derbin’s annual base salary shall be $200,000; provided that it shall be
increased to $225,000 or $250,000 based upon certain milestones as set forth in
the agreement. In addition, Mr. Derbin shall be entitled to bonuses in the form
of equity and/or cash as set forth in the agreement and he shall be entitled to
receive non-qualified stock options to purchase our common stock, the amount of
which when added to his existing 1,172,767 options shall equal 5% of the our
total issued and outstanding common stock, as of March 31, 2005. One-half of the
options shall vest on the grant date and one-half of the options shall vest
monthly over four years at a rate of 1/48th per
month. The grant of the options is subject to us adopting a new stock option
plan, which is subject to stockholder approval.
Vafa
Shahabit, Ph.D. Dr.
Shahabit has been Head of Director of Science effective March 1, 2005,
terminable on 30 days. Her duties are to work on and/or manage research and
development projects as specified by the Company. The compensation is $100,000
per annum with a potential bonus of $20,000. In addition, Dr. Shahabi will be
granted 150,000 options.
Dr.
John Rothman, Ph.D. Dr.
Rothman has been hired as Vice President of Clinical Development effective March
7, 2005 for a term of one year ending February 28, 2006 and terminable on 30
days notice. His compensation is $170,000 per annum, to increase to $180,000
upon the closing of a $15 million equity financing. Upon meeting incentives to
be set by the Company, he will receive a bonus of up to $45,000. In addition,
Dr. Rothman will be granted 360,000 stock options.
Compliance
with Section 16(a) of the Securities Exchange Act of 1934
Section
16(a) of the Securities Exchange Act of 1934, as amended, requires our directors
and executive officers and persons who own more than ten percent of a registered
class of our equity securities (collectively, “Reporting Persons”) to file with
the SEC initial reports of ownership and reports of changes in ownership of our
common stock and our other equity securities. Reporting Persons are required by
SEC regulation to furnish us with copies of all Section 16(a) forms that they
file. To our knowledge, based solely on a review of the copies of such reports
furnished to us, we believe that during calendar year ended December 31, 2004,
all of the Reporting Persons complied with all applicable filing requirements,
except for (i) the former officers and directors prior to November 12, 2004 who,
to our knowledge, never filed Form 3s with the SEC, (ii) Messers. Appel and
Flamm who haven’t filed Form 4s with the SEC to reflect new option issuances,
(iii) The Trustees of the University of Pennsylvania who were late in filing
their Form 3 with the SEC and (iv) Harvest Advaxis LLC who has not filed a Form
3 with the SEC.
PRINCIPAL
AND
MANAGEMENT STOCKHOLDERS
The
following
table sets forth,
· |
each
person
who is known by us to be the owner of record or beneficial owner of more
than 5% of our
outstanding common stock; |
· |
each
of
our directors and each of our executive officers;
|
· |
all
of
our directors and executive officers as
a group; and |
· |
the
number
of
shares
of common stock beneficially
owned
by each such person and such group and the percentage of the outstanding
shares owned by each such person and such
group. |
As
used in
the table below and
elsewhere in this prospectus, the
term beneficial
ownership with
respect to a security consists of sole or shared voting power, including the
power to vote or direct the vote and/or sole or shared investment power,
including the power to dispose or direct the disposition, with respect to the
security through any contract, arrangement, understanding, relationship, or
otherwise, including a right to acquire such power(s) during the next 60 days
following the date of this prospectus. Except as otherwise indicated, the
stockholders listed in the table have sole voting and investment powers with
respect to the shares indicated.
Except
as
otherwise noted below, the address of each of the persons in the table is 212
Carnegie Center, Suite 206, Princeton, New Jersey 08540.
|
|
|
|
|
|
Name
and Address |
|
Number
of Shares of Registrant
Common Stock Beneficially Owned |
|
Percentage
of Class Beneficially
Owned(1) |
|
|
|
|
|
|
|
Name
and Address of Beneficial Owner |
|
Shares
of Common Stock Beneficially Owned |
|
Percentage
of Class Beneficially Owned |
|
|
|
|
|
|
|
J.
Todd Derbin(1)(2) |
|
|
1,837,348
(3 |
) |
|
4.81 |
% |
|
|
|
|
|
|
|
|
|
|
Roni
Appel(1)(2) |
|
|
3,041,622
(4 |
) |
|
8.22 |
% |
|
|
|
|
|
|
|
|
|
|
Scott
Flamm(1) |
|
|
2,914,989
(5 |
) |
|
7.90 |
% |
|
|
|
|
|
|
|
|
|
|
Dr.
Steve Roth(1) |
|
|
82,763
(6 |
) |
|
0.02 |
% |
|
|
|
|
|
|
|
|
|
|
Dr.
James Patton(1) |
|
|
2,913,476
(7 |
) |
|
7.92 |
% |
|
|
|
|
|
|
|
|
|
|
Dr.
Thomas McKearn(1) |
|
|
306,601
(8 |
) |
|
0.08 |
% |
|
|
|
|
|
|
|
|
|
|
The
Trustees of the University of Pennsylvania Center
for Technology Transfer,
University of Pennsylvania 3160
Chestnut Street, Suite 200 Philadelphia,
PA 19104-6283 |
|
|
6,339,282
|
|
|
17.2 |
% |
|
Sunrise
Equity Partners, LP 641
Lexington Ave-25fl New
York, NY 10022 |
|
|
1,835,491
(9 |
) |
|
4.99 |
% |
|
Level
Counter, LLC c/o
Sunrise Securities Corp. 641
Lexington Ave-25fl New
York, NY 10022 |
|
|
1,835,491 (10 |
) |
|
4.99 |
% |
|
Marilyn
Adler c/o
Sunrise Securities Corp. 641
Lexington Ave-25fl New
York, NY 10022 |
|
|
1,835,491 (11 |
) |
|
4.99 |
% |
|
Nathan
Low c/o
Sunrise Securities Corp. 641
Lexington Ave-25fl New
York, NY 10022 |
|
|
3,346,311
(12 |
) |
|
9.10 |
% |
|
Amnon
Mandelbaum c/o
Sunrise Securities Corp. 641
Lexington Ave-25fl New
York, NY 10022 |
|
|
2,932,803
(13 |
) |
|
7.97 |
% |
|
Emigrant
Capital Corp. 6
East 43 Street, 8th Fl. New
York, NY 10017 |
|
|
1,838,783
(14 |
) |
|
4.99 |
% |
|
Harvest
Advaxis LLC 30052
Aventura, Suite C Rancho
Santa Margarita, CA 92688 |
|
|
3,832,753(15 |
) |
|
10.4 |
% |
|
All
Directors and Officers as a Group (6 people) |
|
|
11,096,799 |
|
|
28.95 |
% |
|
|
_____________________________________ |
|
* Based on 36,690,056
shares of common stock outstanding as of January 31, 2005. |
|
(1) |
Director |
|
(2) |
Officer |
|
(3) |
Reflects
295,766 shares of common stock, 1,172,767 options to purchase shares of
common stock and 368,815 warrants to purchase shares of common stock.
|
|
(4) |
Reflects
14,449 warrants to purchase shares of common stock and 2,522,166 shares of
common stock owned by Mr. Appel but does not reflect 58,580 warrants to
purchase shares of common stock because such warrants are not under the
current circumstances, exercisable within the next 60 days. Also reflects
355,528 shares of common stock and 149,480 options and warrants to
purchase shares of common stock beneficially owned by Carmel Ventures,
Inc. of which Mr. Appel is a controlling person but does not reflect
355,528 warrants to purchase shares of common stock owned by Carmel
Ventures, Inc. because such warrants are not under the current
circumstances, exercisable within the next 60 days. |
|
(5) |
Reflects
125,772 shares of common stock and 122,751 options and warrants to
purchase shares of common stock owned by Mr. Flamm but does not reflect
125,722 warrants to purchase shares of common stock because such warrants
are not under the current circumstances, exercisable within the next 60
days. Also reflects 2,621,325 shares of common stock and 45,141 warrants
to purchase shares of common stock beneficially owned by Flamm Family
Partners LP of which Mr. Flamm is a partner. |
|
(6) |
Reflects
options to purchase shares of common stock. |
|
(7) |
Reflects
56,349 options to purchase shares of common stock, 36,551 warrants to
purchase shares of common stock and 2,820,576 shares of common stock but
does not reflect 147,716 warrants to purchase shares of common stock
because such warrants are not under the current circumstances, exercisable
within the next 60 days. |
|
(8) |
Reflects
195,586 options and warrants to purchase shares of common stock and
111,015 shares of common stock. |
|
(9) |
Reflects
1,742,160 shares of common stock held by Sunrise Equity Partners, LP
("SEP") and warrants to purchase 93,331 shares of common stock, but does
not include warrants to purchase 1,648,829 shares of common stock issuable
upon exercise of warrants held by SEP because such warrants are not, under
the current circumstances, exercisable within the next 60 days. The
General Partner of SEP is Level Counter, LLC ("LC"), the managers of which
are Nathan Low, Marilyn Adler and Amnon Mandelbaum (the
"Managers"). Decisions regarding voting and disposition require
the unanimous vote of all three managers. The 1,835,491 shares
of common stock benefically held by SEP also does not
include: (1) 1,124,253 shares of common stock directly owned by
Nathan Low or warrants directly owned by Mr. Low to purchase up to 761,971
shares of common stock; (2) 1,094,020 shares of directly owned by Amnon
Mandelbaum or warrants directly owned by Mr. Mandelbaum to purchase up to
672,539 shares of common stock, and (3) shares of common stock held
by limited partners of SEP or LC who may have a direct or indirect
pecuniary interest, but have no authority to vote or dispose of the shares
of common stock held by SEP. Does not reflect the 34,843 shares of common
stock issuable as Penalty
Shares. |
|
(10) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. LC is the general partner of SEP and
as such, is deemed to have beneficial ownership of the securities held by
SEP for purposes of calculating percentage interest. Does not reflect the
34,843 shares of common stock issuable to SEP as Penalty
Shares.
However, LC disclaims beneficial interest in such shares except to the
extent of its pecuniary interest therein. |
|
(11) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the 34,843 shares of
common stock issuable to SEP as Penalty Shares. Ms.
Adler is a manager of LC, the general partner of SEP, and as such, is
deemed to have beneficial ownership of the securities held by SEP for
purposes of calculating percentage interest. However, Ms. Adler disclaims
beneficial interest in such shares except to the extent of her pecuniary
interest therein. |
|
(12) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the 34,843 shares of
common stock issuable to SEP as Penalty Shares. Mr.
Low is a manager of LC, the general partner of SEP, and as such, is deemed
to have beneficial ownership of the securities held by SEP for purposes of
calculating percentage interest. However, Mr. Low disclaims beneficial
interest in such shares except to the extent of his pecuniary interest
therein. Also reflects 1,124,253 shares of common stock owned by Mr. Low
but does not reflect warrants to purchase 761,971 shares of common stock
issuable upon exercise of such warrants because such warrants are not,
under the circumstances, exercisable within the next 60 days nor does it
reflect 37,725 shares of common stock issuable to Mr. Low as Penalty
Shares. Also includes 383,275 shares of common stock held by Sunrise
Securities Corp., a corporation of which Mr. Low is sole stockholder and
director, but does not include warrants to purchase 348,432 shares of
common stock held by Sunrise Securities Corp. because such warrants are
not, under the circumstances, exercisable within the next 60 days nor does
it reflect 14,634 shares of common stock issuable to Sunrise
Securities Corp. as Penalty Shares. Mr. Low’s beneficial ownership does
not include shares of common stock held by Sunrise Foundation Trust, a
charitable trust of which Mr. Low is a trustee. Mr. Low disclaims
beneficial ownership of such shares of common stock held by Sunrise
Foundation Trust. |
|
(13) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the 34,843 shares of
common stock issuable to SEP as Penalty Shares. Mr.
Mandelbaum is a manager of LC, the general partner of SEP, and as such, is
deemed to have beneficial ownership of the securities held by SEP for
purposes of calculating percentage interest. However, Mr. Mandelbaum
disclaims beneficial interest in such shares except to the extent of his
pecuniary interest therein. Also reflects 1,094,020 shares of common stock
owned by Mr. Mandelbaum but does not reflect warrants to purchase 672,539
shares of common stock issuable upon exercise of such warrants because
such warrants are not, under the circumstances, exercisable within the
next 60 days nor does it reflect 35,332 shares of common stock
issuable to Mr. Mandelbaum as Penalty Shares. |
|
(14) |
Reflects
1,742,160 shares of common stock held by Emigrant Capital Corp.
(“Emigrant”) and warrants to purchase 16,623 shares of common stock, but
does not include warrants to purchase 1,645,537 shares of common stock
issuable upon exercise of warrants held by Emigrant because such warrants
are not, under the current circumstances, exercisable within the next 60
days nor does it reflect 34,843 shares of common stock issuable to
Emigrant as Penalty Shares. Mr. Howard Milstern is the Chairman and CEO
and Mr. John Hart is the President of Emigrant. |
|
(15) |
Reflects
3,832,753 shares of common stock but does not reflect warrants to purchase
3,832,753 shares of common stock because such warrants are not currently
exercisable within the next 60 days. Mr. Robert Harvey is the manager of
Harvest Advaxis LLC. It does not reflect 76,655 shares of common
stock issuable to Harvest Advaxis LLC as Penalty
Shares. |
CERTAIN
RELATIONSHIPS
AND RELATED PARTY TRANSACTIONS
Our
policy is
to enter into transactions with related parties on terms that, on the whole, are
no more favorable, or no less favorable, than those available from unaffiliated
third parties. Based on our experience in the business sectors in which we
operate and the terms of our transactions with unaffiliated third parties, we
believe that all of the transactions described below met this policy standard at
the time they occurred.
Consulting
Agreement with Carmel Ventures, Inc.
LVEP is
owned by Scott Flamm, one of our directors and a principal shareholder. LVEP
employs Mr. Flamm and Mr. Roni Appel, our Chief Financial Officer, director and
a principal shareholder. Pursuant to a consulting agreement, dated as of January
19, 2005, and amended on April 15, 2005, LVEP is to provide financial management
and strategic business development consulting services to us. The initial term
of the agreement is until December 31, 2005 and thereafter the term of the
agreement shall be automatically extended for one year periods unless we notify
LVEP at least 60 days prior to the end of term of our intent not to extend. In
consideration for providing the consulting services, LVEP received an initial
payment of $4,500 and shall receive $7,000 per month during January, February
and March 2005 and $13,875 per month thereafter for the term of the agreement
plus reimbursement of approved expenses in connection with providing the
consulting services and will receive a payment at the end of 2005 equal to 60%
of the bonus earned by the Chief Executive Officer of the Company. Additionally,
LVEP shall receive options to purchase common stock equal to 3% of the
outstanding shares of the Company as of March 31, 2005.
Consulting
Agreement with LVEP Management, LLC
LVEP is
owned by Scott Flamm, one of our directors and a principal shareholder. LVEP
employs Mr. Flamm and Mr. Roni Appel, our Chief Financial Officer, director and
a principal shareholder. Pursuant to a consulting agreement, dated as of January
19, 2005, and amended on April 15, 2005 LVEP is to provide financial management
and strategic business development consulting services to us. The initial term
of the agreement is until December 31, 2005 and thereafter the term of the
agreement shall be automatically extended for one year periods unless
we notify LVEP at least 60 days prior to the end of term of our intent not to
extend. In consideration for providing the consulting services, LVEP received an
initial payment of $4,500 and shall receive $7,000 per month during January,
February, and March 2005 and $13,875 per month thereafter for the term of
the agreement plus reimbursement of approved expenses in connection with
providing the consulting services and will receive a payment at the end of 2005
equal to 60% of the bonus earned by the Chief Executive Officer of the Company.
Additionally, LVEP shall receive options to purchase common stock equal to 3% of
the outstanding shares of the Company as of March 31, 2005.
Amended
and Restated Employment Agreement with J. Todd Derbin
J. Todd
Derbin is of Chief Executive Officer and a director. On December 20, 2004, we
entered into an amended and restated employment agreement with J. Todd Derbin,
pursuant to which Mr. Derbin is employed as our President and Chief Executive
Officer. The effective date of the employment agreement is January 1, 2005. The
term of the employment agreement is for one year and will be further renewed if
mutually agreed to by Mr. Derbin and us. Mr. Derbin’s annual base salary shall
be $200,000; provided that it shall be increased to $225,000 or $250,000 based
upon certain milestones as set forth in the employment agreement. In addition,
Mr. Derbin shall be entitled to bonuses in the form of equity and/or cash as set
forth in the employment agreement and he shall be entitled to receive
non-qualified stock options to purchase our common stock, the amount of which
when added to his existing 1,172,767 options shall equal 5% of the our total
issued and outstanding common stock, as of March 31, 2005. One-half of the
options shall vest on the grant date and one-half of the options shall vest
monthly over four years at a rate of 1/48th per
month. The grant of the options is subject to us adopting a new stock option
plan, which is subject to stockholder approval.
Sentinel
Consulting, Inc.
Sentinel
Consulting Inc. is owned by Robert Harvey, an observer to our Board and the
manager of Harvest Advaxis LLC, one of our principal stockholders. Sentinel
provided financial consulting, scientific validation and business strategy
advice to us. The term of the agreement was for six months commencing as of
September 5, 2004 with each party having the right to terminate it after four
months under the agreement. We have paid Sentinel $33,000 for services performed
and we have the obligation to issue to them a warrant to purchase 191,638 shares
of our common stock at an exercise price of an $0.40 per share, plus 287,451
shares of our common stock, a retainer of $5,000, a video preparation fee of
$10,000 and expenses of $6,000 in connection with the preparation of a
scientific review.
SELLING
STOCKHOLDERS
This
prospectus relates to the resale from time to time of up to a total of
56,730,045
shares of common stock by selling stockholders, comprising:
· |
37,099,460
shares of our common stock that were issued to selling stockholders
pursuant to transactions exempt from registration under the Securities Act
of 1933; and |
· |
19,630,588
shares of common stock underlying warrants that were issued to selling
stockholders pursuant to transactions exempt from registration under the
Securities Act of 1933. |
The
following table set forth certain information regarding the beneficial ownership
of our common stock as to the selling stockholders and the shares offered by
them in this prospectus. Beneficial ownership is determined in accordance with
the rules of the SEC. In computing the number of shares beneficially owned by a
selling stockholders and the percentage of ownership of that selling
stockholder, shares of common stock underlying shares of convertible preferred
stock, options or warrants held by that selling stockholder that are convertible
or exercisable, as the case may be, within 60 days of January 31, 2005 are
included. Those shares, however, are not deemed outstanding for the purpose of
computing the percentage ownership of any other selling stockholder. Each
selling stockholder’s percentage of ownership in the following table is based
upon 36,690,056 shares of common stock outstanding as of January 31, 2005 and
not 37,099,460 shares of our common stock. An aggregate of 409,401
shares of common stock are issuable to certain selling stockholders as Penalty
Shares pursuant to the terms of the Registration Rights Agreement, dated as of
November 12, 2004, by and among the Company and certain stockholders and a
Registration Rights Agreement, dated as of January 12, 2005, by and among the
Company and a certan stockholder. Therefore, the following table includes a
column to reflect the additional shares of common stock which certain selling
stockholders are entitled to as Penalty Shares.
However, such amounts are de minimus when calculating such selling stockholders’
percentage ownership in the Company.
Except as
described below, none of the selling stockholders within the past three years
has had any material relationship with us or any of our affiliates:
· |
J.
Todd Derbin has served as our Chief Executive Officer and a director since
November 12, 2004; |
· |
Roni
Appel has served as our Chief Financial Officer and a director since
November 12, 2004; Carmel Ventures, Inc., of which Mr. Appel is the
principal stockholder has provided consulting services to us; LVEP by
which Mr. Appel is employed, is providing consulting services to
us; |
· |
Scott
Flamm has served as a director since November 12, 2004 and LVEP of which
Mr. Flamm is a principal stockholder and an employee of, is providing
consulting services to us; |
· |
Thomas
McKearn has served as a director since November 12,
2004; |
· |
Dr.
James Patton has served as a director since November 12, 2004 and has
served as a consultant to us in the past; |
· |
Dr.
Yvonne Patton has served as a consultant; |
· |
The
Trustees of the University of Pennsylvania own the patents which we have
an exclusive license; |
· |
Sunrise
Securities Corp. acted as placement agent in the Private Placement. Nathan
Low, Amnon Mandelbaum, Marcia Kucher, Derek Caldwell, Richard Stone and
David Goodfriend are all affiliated with or employed by Sunrise Securities
Corp., the placement agent in the Private Placement. Sunrise
Equity Partners, LP and Sunrise Foundation Trust are also affiliates
of Sunrise Securities Corp.; and |
· |
Dr.
David Filer is a consultant for us and provided consulting services to the
Sunrise Securities Corp. |
The term
“selling stockholders” also includes any transferees, pledges, donees, or other
successors in interest to the selling stockholders named in the table below. To
our knowledge, subject to applicable community property laws, each person named
in the table has sole voting and investment power with respect to the shares of
common stock set forth opposite such person’s name.
The
selling stockholders named below are selling the securities. The table assumes
that all of the securities will be sold in this offering. However, any or all of
the securities listed below may be retained by any of the selling stockholders,
and therefore, no accurate forecast can be made as to the number of securities
that will be held by the selling stockholders upon termination of this offering.
These selling stockholders acquired their shares by purchase exempt from
registration under section 4(2) of the Securities Act of 1933 or Regulation D
under the Securities Act of 1933. The selling stockholders acquired their shares
in the ordinary course of business. We believe that the selling stockholders
listed in the table have sole voting and investment powers with respect to the
securities indicated. We will not receive any proceeds from the sale of the
securities by the selling stockholders. No selling stockholders are
broker-dealers or affiliates or employees of broker-dealers other than Sunrise
Securities Corp., David Goodfriend, Amnon Mandelbaum, Marcia Kucher, Derek
Caldwell, Richard Stone Nathan Low, Sunrise Equity Partners LP and Sunrise
Foundation Trust. The securities included in this list include securites which
would otherwise become soleable from time to time pursuant to Rule 144 as
currently in effect.
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
Fees) |
%
After Offering
(not including Penalty
Fees) |
Relationship (if
any) |
|
|
|
|
|
|
|
Adele
Pfenninger
12
Spring Brook Road
Annandale,
NJ 08801 |
79,600
(1) |
70,790
(1) |
-- |
0.22% |
0.02% |
-- |
|
|
|
|
|
|
|
AI
International Corporate (a)
Holdings,
Ltd.
c/o
FCIM Corp.
1
Rockefeller Plaza
Suite
1730
New
York, NY 10020 |
174,216
(2) |
174,216
(2) |
1,742 |
0.
47% |
0.0% |
-- |
|
|
|
|
|
|
|
Alan
Gelband Company (b)
Defined
Contribution Pension Plan and Trust
30
Lincoln Plaza
New
York, NY 10023 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
Alan
Kestenbaum
18
Clover Drive
Great
Neck, NY 11021 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
Beretz
Family Partners LP (c)
48
South Drive
Great
Neck, NY 11021 |
174,216
(2) |
174,216
(2) |
1,742 |
0.47% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
fees) |
%
After Offering
(not including Penalty
Fees) |
Relationship (if
any) |
Bridges
& Pipes, LLC (d)
830
Third Avenue
14th
Floor
New
York, NY 10022 |
1,393,728
(4) |
1,393,728
(4) |
13,937 |
3.73% |
0.0% |
-- |
Bruce
Fogel
218
Everglade Avenue
Palm
Beach, FL 33480 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
C.
Leonard Gordon
551
Fifth Avenue
New
York, NY 10176 |
174,216
(2) |
174,216
(2) |
1,742 |
0.47% |
0.0% |
-- |
Carmel
Ventures, Inc (e)
22
Ruth Lane
Demarest,
NJ 07627 |
860,537
(5) |
711,057
(5)(a) |
-- |
2.32% |
0.41% |
5(b) |
Catherine
Janus
4817
Creak Dr.
Western
Spring, IL 60558 |
118,832
(6) |
105,767
(6) |
-- |
0.32% |
0.04% |
-- |
Chaim
Cymerman
c/o
Tomer Cymerman
Paamoni
10, Apt. 19
Bavli,
Tel Aviv
Israel |
196,371
(7) |
174,593
(7)(a) |
-- |
0.53% |
0.06% |
-- |
Charles
Kwon
834
Monror Street
Evanston,
Il 60202 |
491,233
(8) |
482,322
(8)(a) |
3,484 |
1.33% |
0.02% |
-- |
Cranshire
Capital, LP (f)
666
Dundee Road
Sute
1901
Northbrook,
IL 60602 |
1,045,296
(9) |
1,045,296
(9) |
10,453 |
2.81% |
0.0% |
-- |
Crestwood
Holdings, LLC (g)
c/o
Ran Nizan
109
Boulevard Drive
Danbury,
CT 06810 |
360,253
(10) |
337,978
(10)(a) |
-- |
0.98% |
0.06% |
-- |
David
Stone
228
St. Charles Avenue
Suite
1024
New
Orleans, LA 70130 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
David
Tendler
401
East 60th
Street
New
York, NY 10022 |
696,864
(11) |
696,864
(11) |
6,969 |
1.88% |
0.0% |
-- |
|
|
|
|
|
|
|
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
Fees) |
%
After Offering
(not including Penalty
Fees) |
Relationship (if
any) |
|
|
|
|
|
|
|
Design
Investments, LTD (h)
9
Tanbark Circuit
Suite
1442
Werrington
Downs
NSW
2747
Australia |
696,864
(11) |
696,864
(11) |
6,969 |
1.88% |
0.0% |
-- |
Emigrant
Capital Corp. (i)
6
East 43rd
Street
8th
Floor
New
York, NY 10017 |
3,484,320
(12) |
3,484,320
(12) |
38,843 |
9.07% |
0.0% |
-- |
Eugene
Mancino
Blau
Mancino
12
Roszel Road, Suite C-101
Princeton,
NJ 08540 |
355,099
(13) |
212,544
(13)(a) |
-- |
0.96% |
0.39% |
-- |
Fawdon
Investments Ltd. (j)
4
Ibn Shaprut Street
Jerusalem,
Israel 92478 |
1,393,728
(4) |
1,393,728
(4) |
13,937 |
3.73% |
0.0% |
-- |
Flamm
Family Partners, LP. (k)
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078 |
2,666,466
(14) |
2,657,556
(14)(a) |
-- |
7.26% |
0.02% |
(14)(b) |
Fred
Berdon Co, LP (l)
717
Post Road
Suite
105
Sacrsdale,
NY 10583 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
Gina
Ferarri
36
Stone Run Road
Bedmingter,
NJ 07921 |
79,932
(15) |
71,022
(15)(a) |
-- |
0.22% |
0.2% |
-- |
Hal
H. Beretz
48
South Drive
Great
Neck, NY 11021 |
522,648
(16) |
522,648
(16) |
5,226 |
1.41% |
0.0% |
-- |
Howard
Kaye Family Fund (m)
2
Mohican Trail
Scarsdale,
NY 10583 |
522,648
(16) |
522,648
(16) |
5,226 |
1.41% |
0.0% |
-- |
IRA
FBO / Walter S. Grossman Pershing LLC Custodian (n)
277
North Ave.
Westport,
CT 06880 |
696,864
(11) |
696,864
(11) |
6,969 |
1.88% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
Fees) |
%
After Offering
(not including Penalty
Fees) |
Relationship (if
any) |
Itai
Portnio
26
Yakinton St.
Haifa,
Isreal 34406 |
157,608
(17) |
14,186
(17)(a) |
-- |
0.43% |
0.05% |
-- |
J.
Todd Derbin
840
Pretty Brook Road
Princeton,
NJ 08540 |
1,837,348 (18) |
591,532
(18)(a) |
-- |
4.81% |
3.28% |
(18)(b) |
James
Patton
1937
Swedesford
Malvern,
PA 19355 |
3,061,192
(19) |
2,968,291(19)(a) |
-- |
8.29% |
0.25% |
(19)(b) |
James
Paul
c/o
Fulwider Patton
Howard
Hughes Center
6060
Center Drive, 10th
Floor
Los
Angeles, CA 90045 |
39,215
(20) |
34,861
(20)(a) |
-- |
0.11% |
0.01% |
-- |
Jonas
Grossman
59
Huratio St.
New
York, NY 10014 |
80,640
(21) |
71,731
(21)(a) |
-- |
0.22% |
0.02% |
-- |
Kerry
Propper
59
Huratio St.
New
York, NY 10014 |
201,600
(22) |
179,326
(22)(a) |
-- |
0.55% |
0.06% |
-- |
Lilian
Flamm
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078 |
197,328
(23) |
197,328
(23) |
-- |
0.54% |
0.0% |
-- |
Marilyn
Mendell
1203
River Road,
Apt.
Penthouse 4
Edgewater,
NJ 07020 |
284,500
(24) |
253,316
(24)(a) |
-- |
0.77% |
0.08% |
-- |
Mary
Ann Ryan Francis
1115
Beanaqt Ave.
Seaside
Park, NJ 08752 |
79,071
(25) |
70,360
(25)(a) |
-- |
0.22% |
0.02% |
-- |
MEA
Group, LLC (o)
145
Talmadge Road
Edison,
NJ 08817 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
Mordechai
Mashiach
8
Shlomzion Hamalka
Haifa,
Isreal 34406 |
157,608
(17) |
140,186
(17)(a) |
-- |
0.43% |
0.05% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
Fees) |
%
After Offering
(not including Penalty
Fees) |
Relationship (if
any) |
New
Bank Ltd (p)
Levinstein
Tower #21st
23
Menahem Begin Road
Tel
Aviv, Israel |
1,393,728
(4) |
1,393,728
(4) |
13,937 |
3.73% |
0.0% |
-- |
Open
Ventures LLC (q)
127
West Chestnut Hill Ave.
Philadelphia,
PA 19118 |
17,422 |
17,422 |
-- |
0.05% |
0.0% |
-- |
Peggy
Fern
1548
Herlong Court
Rock
Hill, SC 29732 |
79,712
(26) |
70,081
(26)(a) |
-- |
0.22% |
0.02% |
-- |
Penn
Footware Retirement Trust (r)
Line
& Grove Streets
PO
Box 87
Nanticoke,
PA 18634 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
Richard
Yelovich
603
Milleson Lane
West
Chester, PA 19380 |
151,289
|
151,289 |
-- |
0.41% |
0.0% |
-- |
Roni
Appel
22
Ruth Lane
Demarest,
NJ 07627 |
2,595,193 (27) |
2,580,745
(27)(a) |
-- |
7.06% |
0.04% |
(27)(b) |
RP
Capital, LLC (s)
10900
Wilshire Blvd.
Suite
500
Los
Angeles, CA 90024 |
174,216
(2) |
174,216
(2) |
1,742 |
0.47% |
0.0% |
-- |
Scott
Flamm
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078 |
374,296
(28) |
251,545
(28)(a) |
-- |
1.01% |
0.33% |
(28)(b) |
Shai
Stern
43
Maple Aenue
Cedarhurst,
NY 11516 |
174,216
(2) |
174,216
(2) |
1,742 |
0.47% |
0.0% |
-- |
SRG
Capital, LLC (t)
120
Broadway
40th
Floor
New
York, NY 10271 |
696,864
(11) |
696,864
(11) |
6,969 |
1.88% |
0.0% |
-- |
Sunrise
Equity Partners, LP (u)
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
3,484,320
(12) |
3,484,320
(12) |
34,843 |
9.07% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
Fees) |
%
After Offering
(not including Penalty
Fees) |
Relationship (if
any) |
Thomas
McKearn
6040
Lower Mountain Road
New
Hope, PA 18938 |
374,876
(29) |
269,839
(29)(a) |
-- |
1.02% |
0.29% |
(29)(b) |
Titan
Capital Management, LLC
(TCMP3
Partners) (v)
7
Centure Drive
Suite
201
Parsippany,
NJ 07054 |
696,864
(11) |
696,864
(11) |
6,969 |
1.88% |
0.0% |
-- |
Tracy
Yun
90
LaSalle St., Apt. #13G
New
York, NY 10027 |
60,197
|
60,197 |
-- |
0.16% |
0.0% |
-- |
Trinita,
LLC (w)
c/o
Morten Kielland
22
Painters Lane
Chesterbrook,
PA 19087 |
151,289
|
151,289 |
-- |
0.41% |
0.0% |
-- |
The
Trustees of the
University
of Pennsylvania
Center
for Technology Transfer
University
of Pennsylvania
3160
Chestnut Street
Suite
200
Philadelphia,
PA 19104-6283
Attn:
Managing Director |
6,339,282 |
6,339,282 |
-- |
17.28% |
0.0% |
(41) |
William
Kahn
7903
Longmeadow Road
Baltimore,
MD 21208 |
151,517 |
151,517 |
-- |
0.41% |
0.0% |
-- |
Yair
Talmor
517
Old Chappaqua Road
Briarcliff
Manor, NY 10510 |
174,216
(2) |
174,216
(2) |
1,742 |
0.47% |
0.0% |
-- |
Yoav
Millet
950
Third Avenue
New
York, NY 10022 |
174,216
(2) |
174,216
(2) |
1,742 |
0.47% |
0.0% |
-- |
Yvonne
Paterson
514
South 46 St.
Philadelphia,
PA 19143 |
873,412(30) |
704,365 |
-- |
2.37% |
0.46% |
|
Amnon
Mandelbaum
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
1,766,559
(31) |
1,766,559
(31) |
35,332 |
4.73% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
Fees) |
%
After Offering
(not including Penalty
fees) |
Relationship (if
any) |
David
Goodriend
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
194,193
(32) |
194,193
(32) |
3,884 |
0.53% |
0.0% |
-- |
David
Filer
165
East 32 Street
New
York, NY 10016 |
382,772
(33) |
382,772
(33) |
5,704 |
1.04% |
0.0% |
(32)(a) |
Marcia
Kucher
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
4,140
(34) |
4,140
(34) |
83 |
0.01% |
0.0% |
-- |
Nathan
Low
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
1,886,224
(35) |
1,886,224
(35) |
37,725 |
5.04% |
0.0% |
-- |
Derek
Caldwell
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
153,658
(36) |
153,658
(36) |
3,074 |
0.42% |
0.0% |
-- |
Sunrise
Securities Corp. (x)
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
731,707(37) |
731,707(37) |
14,634 |
1.98% |
0.0% |
(37)(a) |
Richard
Stone
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
307,317(38) |
307,317(38) |
6,146 |
0.83% |
0.0% |
-- |
Sunrise
Foundation Trust (y)
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
71,497(38)(a) |
71,497 |
1,430 |
0.19% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
Penalty Shares |
%
Before Offering
(not including Penalty
Fees) |
%
After Offering
(not including Penalty
Fees) |
Relationship (if
any) |
Martin
Trust Agreement
U/A/
DTD 11/05/01
Peter
L. Martin TTE
3757
Wedbster St, Apt 203
San
Francisco, CA 94123 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
A.
Heifetz Technologies Ltd. (z)
22
Kanfey Nesharim St
Jerusalem,
Israel 95464 |
348,432
(3) |
348,432
(3) |
3,484 |
0.95% |
0.0% |
-- |
Balestra
Spectrum Partners, LLC (aa)
1185
Avenue of the Americas
32nd
Floor
New
York, NY 10036 |
1,045,296
(9) |
1,045,296
(9) |
10,453 |
2.81% |
0.0% |
-- |
Reitler
Brown Holdings, LLC (bb)
800
Third Avenue
21st
Floor
New
York, NY 10022 |
60,000
(39) |
60,000
(39) |
-- |
0.16% |
0.0% |
(39)(a) |
|
|
|
|
|
|
|
Harvest
Advaxis LLC (cc)
30052
Aventura, Suite C
Rancho
Santa Margarita,
CA
92688 |
7,665,506
(40) |
4,665,506
(40) |
76,655 |
18.92% |
0.0% |
-- |
Miles
Wynn
P.O.
Box 440842
Aurora
, CO 80044 |
696,700 |
696,700 |
-- |
1.90% |
0.0% |
-- |
Teresa
Waz
3679
S. Dawson St.
Aurora,
CO 80444 |
26,900 |
26,900 |
-- |
0.07% |
0.0% |
-- |
|
|
|
|
|
|
|
Ormonde
Frew
19996
E. Greenwood Drive Aurora, CO 80013 |
12,000 |
12,000 |
-- |
0.03% |
0.0% |
-- |
|
|
|
|
|
|
|
Ralph
Grills
4042
S. Atchison Way
Aurora,
CO 80014 |
12,000 |
12,000 |
-- |
0.03% |
0.0% |
-- |
Daniel
Unrein
281
S. Leyden St.
Denver,
CO 80220 |
2,500 |
2,500 |
-- |
0.01% |
0.0% |
-- |
Frederick
Malkhe
4105
E. Florida Ave.
Suite
100
Denver,
CO 80222 |
2,500 |
2,500 |
-- |
0.01% |
0.0% |
-- |
---------------------------------------------
(a) |
Rima
Salam has voting and disposition rights on behalf of A1 International
Corporate Holdings, Ltd. |
(b) |
Alan
Gelbard has voting and disposition rights on behalf of Alan Gelband
Company Defined Contribution pension plan and Trust. |
(c) |
Hal
Beretz has voting and disposition rights on behalf of Beretz Family
Partners LLP. |
(d) |
David
Fuchs has voting and disposition rights on behalf of Bridges & Pipes
LLC. |
(e) |
Roni
Appel has voting and disposition rights on behalf of Carmel Ventures,
Inc. |
(f) |
Mitchell
P. Kopin, president of Downsview Capital Inc., the general partner of
Cranshire Captial, L.P, has voting and disposition rights.
|
(g) |
Ran
Nizan has voting and disposition rights on behalf of Crestwood Holdings,
LLC. |
(h) |
Haim
Rolnitsky has voting and disposition rights on behalf of Design
Investments Ltd. |
(i) |
Howard
Milstein and John Hart have voting and disposition rights on behalf of
Emigrant Capital Corp. |
(j) |
Joseph
Franck has voting and disposition rights on behalf of Fawdan Investments
Ltd. |
(k) |
Scott
Flamm has voting and disposition rights on behalf of Flamm Family Partners
LP. |
(l) |
Frederick
Berdon has voting and disposition rights on behalf of Fred Berdon Co.,
LP. |
(m) |
Howard
Kaye, the managing partner, has voting and disposition rights on behalf of
Kay Family Fund. |
(n) |
Pershing
IMS has voting and disposition rights on behalf of IRA FBO / Walter S.
Grossman. |
(o) |
Albert
Chabot has voting and disposition rights on behalf of MEA
Group |
(p) |
Yacov
Reizman and Leon Recanati have voting and disposition rights on behalf of
New Bank Ltd. |
(q) |
Shoshana
Loeb has voting and disposition rights on behalf of Open Venturs,
LLC. |
(r) |
Jeff
Davidowitz has voting and disposition rights on behalf of Penn Footwear
Retirement Trust. |
(s) |
Eric
Richardson has voting and disposition rights on behalf of RP Capital,
LLC. |
(t) |
Edwin
Mecabe and Tai May Lee jointly have voting and disposition rights on
behalf of SRB Capital LLC. |
(u) |
Nathan
Low, Marilyn Adler and Amnon Mandelbaum are the managers of Level Counter,
LLC, the general partner of Sunrise Equity Partners, L.P. The unanimous
vote of such managers is required for voting and disposition
rights. |
(v) |
Walter
Schenker and Steven Slawson have voting and disposition rights on behalf
of Titan Capital Management LLC. |
(w) |
Morten
Kiellan has voting and disposition rights on behalf of Trinita,
LLC. |
(x) |
Nathan
Low has voting and disposition rights on behalf of Sunrise Securities
Corp. |
(y) |
Nathan
Low is a trustee. |
(z) |
Avit
Heifetz has voting and disposition rights on behalf of A. Heifetz
Technologies Ltd. |
(aa) |
James
L. Melcher has voting and disposition rights on behalf of Balestra
Spectrum Partners, LLC. |
(bb) |
Robert
Brown, Scott Rosenblatt, Edward G. Reitler and John Watkins have voting
and disposition rights on behalf of Reitler Brown Holdings,
LLC. |
(cc) |
Robert
Harvey has voting and disposition rights on behalf of Harvest Advaxis,,
LLC. |
(1) |
Reflects
35,395 shares of common stock 44,205 warrants to purchase shares of common
stock. |
(2) |
Reflects
87,108 shares of common stock and 87,108 warrants to purchase shares of
common stock. |
(3) |
Reflects
174,216 shares of common stock and 174,216 warrants to purchase shares of
common stock. |
(4) |
Reflects
696,864 shares of common stock and 696,864 warrants to purchase shares of
common stock. |
(5) |
Reflects
355,528 shares of common stock, 413,441 warrants to purchase shares of
common stock and 91,567 options exercisable for shares of common
stock. |
(5)(a) |
Reflects
355,528 shares of common stock and 355,528 warrants to purchase shares of
common stock |
(5)(b) |
Carmel
Ventures, Inc. has performed consulting services for us and is owned by
Roni Appel, our chief financial officer, director and principal
shareholder. |
(6) |
Reflects
52,833 shares of common stock and 52.883 warrants to purchase shares of
common stock. |
(7) |
Reflects
87,297 shares of common stock and 109,074 warrants to purchase shares of
common stock. |
(7)(a) |
Reflects
87,297 shares of common stock and 87,297 warrants to purchase shares of
common stock. |
(8) |
Reflects
271,260 shares of common stock and 219,973 warrants to purchase shares of
common stock. |
(8)(a) |
Reflects
271,260 shares of common stock and 211,063 warrants to purchase shares of
common stock. |
(9) |
Reflects
522,648 shares of common stock and 522,648 warrants to purchase shares of
common stock. |
(10) |
Reflects
244,933 shares of common stock and 115,320 warrants to purchase shares of
common stock. |
(10)(a) |
Reflects
266,933.shares of common stock and 93,046 warrants to purchase shares of
common stock. |
(11) |
Reflects
348,432 shares of common stock and 348,432 warrants to purchase shares of
common stock. |
(12) |
Reflects
1,742,160 shares of common stock and 1,742,160 warrants to purchase shares
of common stock. |
(13) |
Reflects
106,272 shares of common stock and 248,827 warrants to purchase shares of
common stock. |
(13)(a) |
Reflects
106,272 shares of common stock and 106,272 warrants to purchase shares of
common stock. |
(14) |
Reflects
2,585,094 shares of common stock and 45,141 warrants to purchase shares of
common stock. |
(14)(a) |
Reflects
2,621,325 shares of common stock and 36,231 warrants to purchase shares of
common stock. |
(14)(b) |
The
general partner of Flamm Family Partners is Scott Flamm a director and
principal shareholder. |
(15) |
Reflects
35,511 shares of common stock and 44,421 warrants to purchase shares of
common stock. |
(15)(a) |
Reflects
35,511 shares of common stock and 35,511 warrants to purchase shares of
common stock. |
(16) |
Reflects
261,324 shares of common stock and 261,324 warrants to purchase shares of
common stock. |
(17) |
Reflects
70,093 shares of common stock and 87,515 warrants to purchase shares of
common stock. |
(17)(a) |
Reflects
70,093 shares of common stock and 70,093 warrants to purchase shares of
common stock. |
(18) |
Reflects
295,766 shares of common stock and 1,172,767 options to purchase shares of
common stock and 368,815 shares of common stock issuable upon exercise of
warrants. |
(18)(a) |
Reflects
295,766 shares of common stock and 295,766 warrants to purchase shares of
common stock. |
(18)(b) |
Mr.
Derbin is one of our directors and the chief executive
officer. |
(19) |
Reflects
56,349 options to purchase shares of common stock, 36,551 warrants to
purchase shares of common stock and 2,820,576 shares of common stock but
does not reflect 147,716 warrants to purchase shares of common stock
because such warrants are not currently exercisable within the next 60
days. |
(19)(a) |
Reflects
2,820,576 shares of common stock and 14,7716 warrants to purchase shares
of common stock. |
(19)(b |
Dr.
Patton is one of our directors. |
(20) |
Reflects
17,430 shares of common stock and 21,785 warrants to purchase shares of
common stock. |
(20)(a) |
Reflects
17,430 shares of common stock and 17,430 warrants to purchase shares of
common stock. |
(21) |
Reflects
35,865 shares of common stock and 44,775 warrants to purchase shares of
common stock. |
(21)(a) |
Reflects
35,865 shares of common stock and 35,865 warrants to purchase shares of
common stock. |
(22) |
Reflects
89,663 shares of common stock and 111,937 warrants to purchase shares of
common stock. |
(22)(a) |
Reflects
89,663 shares of common stock and 89,663 warrants to purchase shares of
common stock. |
(23) |
Reflects
98,664 shares of common stock and 98,664 warrants to purchase shares of
common stock. |
(24) |
Reflects
126,658 shares of common stock and 157,842 warrants to purchase shares of
common stock. |
(24)(a) |
Reflects
126,658 shares of common stock and 126,658 warrants to purchase shares of
common stock. |
(25) |
Reflects
35,180 shares of common stock and 43,981 warrants to purchase shares of
common stock. |
(25)(a) |
Reflects
35,180 shares of common stock and 35,180 warrants to purchase shares of
common stock. |
(26) |
Reflects
35,401 shares of common stock and 44,311 warrants to purchase shares of
common stock. |
(26)(a) |
Reflects
35,401 shares of common stock and 35,401 warrants to purchase shares of
common stock. |
(27) |
Reflects
2,522,164 shares of common stock and 73,029 warrants to purchase shares of
common stock.. |
(27)(a) |
Reflects
2,522,164 shares of common stock and 58,580 warrants to purchase shares of
common stock |
(27)(b) |
Mr.
Appel is one of our directors and our chief financial officer and owner of
Carmel Ventures, Inc., one of our stockholders and is employed by LVEP
Management, LLC one of our consultants. |
(28) |
Reflects
125,772 shares of common stock, 156,956 warrants to purchase shares of
common stock and 91,567 options. |
(28)(a) |
Reflects
125,772 shares of common stock and 125,772 warrants to purchase shares of
common stock. |
(28)(b) |
Mr.
Flamm is one of our directors and also the general partner of Flamm Family
Partners, one of our stockholders and is the beneficial owner of LVEP
Management, LLC one of our consultants. |
(29) |
Reflects
179,290 shares of common stock, 82,763 options and 112,823 warrants to
purchase shares of common stock. |
(29)(a) |
Reflects
179,290 shares of common stock and 90,549 warrants to purchase shares of
common stock. |
(29)(b) |
Mr.
McKearn is one of our directors. |
(30) |
Refelcts
704,365 shares of common stock and 169,048 options to purchase shares of
common stock. |
(31) |
Reflects
1,094,020 shares of common stock warrants to purchase 672,539 shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the
selling Stockholder’s employer, Sunrise Securities Corp. as
Placement Agent. |
(32) |
Reflects
119,466 shares of common stock and 74,727 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(33) |
Reflects
97,561 shares of common stock and 97,561 warrants to purchase shares
of common stock, which securities were purchased in the private placement.
In addition, includes 187,650 warrants to purchase common stock, which
securities were received as compensation for consulting services
rendered to Sunrise Securities Corp., the Company's Placement
Agent. |
(34) |
Reflects
2,070 shares of common stock and 2,070 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of Sunrise Securities Corp. as Placement
Agent. Dr.
Filer is a consultant to Sunrise Securities
Corp. |
(35) |
Reflects
1,124,253 shares of common stock owned by Mr. Low and warrants to purchase
761,971 shares of common stock owned by Mr. Low, all of which securities
were received as compensation in the ordinary course of selling
Stockholder’s employer, business of Sunrise Capital as Placement
Agent. |
(36) |
Reflects
80,488 shares of common stock and 73,170 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(37) |
Reflects
383,275 shares of common stock and 348,432 warrants to purchase shares of
common stock. Nathan Low is the sole director and stockholder, with 100%
beneficial ownership and voting and disposition rights. |
(37)(a) |
Our
placement agent in connection with the Private Placement discussed in this
prospectus. |
(38) |
Reflects
160,976 shares of common stock and 146,341 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(38)(a) |
Sunrise
Foundation Trust is a charitable trust of which Nathan Low, owner of
Sunrise Securities Corp., is a trustee. |
(39) |
Reflects
60,000 warrants to purchase shares of common stock. |
(39)(a) |
Reitler
Brown Holdings, LLC is an affiliate of our legal counsel in connection
with this prospectus. |
(40) |
Reflects
3,832,753 shares of common stock and warrant to purchase 3,832,753 shares
of common stock. |
(41) |
We
license our intellectual property from Penn through an exclusive
license. |
(32) |
Reflects
119,466 shares of common stock and 74,727 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(33) |
Reflects
97,561 shares of common stock and 285,211 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of Sunrise Securities Corp. as Placement
Agent. |
(34) |
Reflects
2,070 shares of common stock and 2,070 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of Sunrise Securities Corp. as Placement
Agent. Dr.
Filer is a consultant to Sunrise Securities
Corp. |
(35) |
Reflects
1,124,253 shares of common stock owned by Mr. Low and warrants to purchase
761,971 shares of common stock owned by Mr. Low, all of which securities
were received as compensation in the ordinary course of business of
Sunrise Capital as Placement Agent. |
(36) |
Reflects
80,488 shares of common stock and 73,170 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(37) |
Reflects
383,275 shares of common stock and 348,432 warrants to purchase shares of
common stock. Nathan Low is the sole director and stockholder, with 100%
beneficial ownership and voting and disposition rights. |
(37)(a) |
Our
placement agent in connection with the Private Placement discussed in this
prospectus. |
(38) |
Reflects
160,976 shares of common stock and 146,341 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(38)(a) |
Sunrise
Foundation Trust is a charitable trust of which Nathan Low, owner of
Sunrise Securities Corp., is a trustee. |
(39) |
Reflects
60,000 warrants to purchase shares of common stock. |
(39)(a) |
Reitler
Brown Holdings, LLC is an affiliate of our legal counsel in connection
with this prospectus. |
(40) |
Reflects
3,832,753 shares of common stock and warrant to purchase 3,832,753 shares
of common stock. |
Blue
Sky
Thirty-five
states have what is commonly referred to as the “standard manual exemption” for
secondary trading of securities such as those to be resold by selling
stockholders under this registration statement. In these states, so long as we
obtain and maintain a listing in one of the commonly accepted standard manuals
e.g. Standard and Poor’s Corporate Manual, and the manual sets forth certain
information: (1) the names of our officers and directors, (2) our balance sheet,
and (3) our profit and loss statement for either the fiscal year preceding the
balance sheet or for the most recent fiscal year of operations, secondary
trading can occur without any filing, review or approval by state regulatory
authorities in these states. These states are: Alaska, Arizona, Arkansas,
Colorado, Connecticut, Delaware, District of Columbia, Delaware, Hawaii, Idaho,
Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Mississippi,
Missouri, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North
Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Texas, Utah,
Washington, West Virginia, and Wyoming. We cannot secure this listing, and thus
this qualification, until after this registration statement is declared
effective. Once we secure this listing, secondary trading can occur in these
states without further
action.
We
currently do not intend to and may not be able to qualify securities for resale
in other states which require shares to be qualified before they can be resold
by our stockholders; provided however that we intend to take appropriate action
to qualify securities for resale in the State of New York.
We are
required to pay certain fees and expenses incurred by us incident to the
registration of the shares. We have agreed to indemnify the selling stockholders
against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act of 1933.
Because
selling stockholders may be deemed to be “underwriters” within the meaning of
the Securities Act of 1933, they will be subject to the prospectus delivery
requirements of the Securities Act of 1933. In addition, any securities covered
by this prospectus which qualify for sale pursuant to Rule 144 under the
Securities Act of 1933 may be sold under Rule 144 rather than under this
prospectus. Each selling stockholder has advised us that they have not entered
into any agreements, understandings or arrangements with any underwriter or
broker-dealer regarding the sale of the resale shares. There is no underwriter
or coordinating broker acting in connection with the proposed sale of the resale
shares by the selling stockholders.
We agreed
to keep this prospectus effective until the earlier of the date which is three
years after this registration has been declared effective by the SEC, or such
earlier date as of which all of the common stock registered for resale hereunder
has been sold. The resale shares will be sold only through registered or
licensed brokers or dealers if required under applicable state securities laws.
In addition, in certain states, the resale shares may not be sold unless they
have been registered or qualified for sale in the applicable state or an
exemption from the registration or qualification requirement is available and is
complied with.
Under
applicable rules and regulations under the Securities Exchange Act of 1934, any
person engaged in the distribution of the resale shares may not simultaneously
engage in market making activities with respect to our common stock for a period
of two business days prior to the commencement of the distribution. In addition,
the selling stockholders will be subject to applicable provisions of the
Exchange Act and the rules and regulations thereunder, including Regulation M,
which may limit the timing of purchases and sales of shares of our common stock
by the selling stockholder or any other person. We will make copies of this
prospectus available to the selling stockholders and have informed them of the
need to deliver a copy of this prospectus to each purchaser at or prior to the
time of the sale.
DESCRIPTION
OF
CAPITAL STOCK
OF THE COMPANY
General
At the
date hereof we are authorized by our articles of incorporation to issue an
aggregate of 500,000,000 shares of common stock, par value $0.001 per share and
5,000,000 shares of “blank
check” preferred stock, par
value $0.001 per share. 36,690,056
shares of
common stock are
outstanding
and held of record by 83
stockholders
and no shares of convertible
preferred stock will be
outstanding.
Common
Stock
Holders
of common
stock are
entitled
to one vote for each share held of record on each matter submitted to a vote of
stockholders. There is no cumulative voting for the election of directors.
Subject to the prior rights of any class or series of preferred stock which may
from time to time be outstanding, if any, holders
of common stock are
entitled
to receive ratably, dividends when, as, and if declared by our board of
directors out of funds legally available for that purpose and, upon our
liquidation, dissolution, or winding up, are
entitled to share ratably in all assets remaining after payment of liabilities
and payment of accrued dividends and liquidation preferences on the
preferred stock, if any.
Holders of common
stock have no
preemptive rights and have no rights to convert their
common stock into any
other securities. The outstanding common stock is
validly authorized and issued, fully-paid and nonassessable.
The
shares of
common stock offered
in this
prospectus
have been fully paid and not liable for further call or assessment. Holders
of
the
common stock do not
have cumulative voting rights, which means that the holders of more than one
half of the
outstanding
shares of
common stock,
subject
to the
rights of the holders of the
preferred stock, if any,
can elect all of our directors, if they choose to do so. In this event, the
holders of the
remaining
shares of
common stock would
not be
able to elect any directors. Except as otherwise required by Colorado law, and
subject to the rights of the holders of preferred stock, if any, all stockholder
action is taken by the vote of a majority of the
outstanding
shares of
common stock voting
as a
single class present at a meeting of stockholders at which a quorum consisting
of a majority of the
outstanding
shares of
common stock is
present
in person or proxy.
Preferred
Stock
We are
authorized to issue up to 5,000,000 shares of “blank check” preferred stock.
Preferred stock may
be issued in one or more series and having the rights, privileges and
limitations, including voting rights, conversion privileges and redemption
rights, as may, from time to time, be determined by the board of directors.
Preferred stock may be issued in the future in connection with acquisitions,
financings, or other matters as the board of directors deems appropriate. In the
event that any shares of
preferred stock are to be
issued, a certificate of designation containing the rights, privileges and
limitations of such series of preferred stock shall be filed with the Secretary
of State of the State of Colorado. The effect of such preferred stock is that,
subject to Federal securities laws and Colorado law, the board of directors
alone, may be able to authorize the issuance of preferred stock which could have
the effect of delaying, deferring, or preventing a change in control of
the
Company without
further action by the stockholders, and may adversely affect the voting and
other rights of the holders of the
common stock. The
issuance of preferred stock with voting and conversion rights may also adversely
affect the voting power of the
holders
of common stock,
including the loss of voting control to others.
Stock
Symbol;
No Trading of common stock
Currently
there is no market for our securities, however Vfinance Investment has filed a
form 15c2ll with NASD to become a market maker.
We have
applied for trading on the OTC Bulletin Board. At this time there is no
symbol.
Transfer
Agent
and Registrar
The
transfer
agent and registrar for the
common stock is
Securities Transfer Corporation, 2591 Dallas Parkway, Suite 102, Frisco, TX
75034.
Directors’
Limitation of Liability
Our
articles
of incorporation and by-laws include provisions to (1)
indemnify
the directors and officers to the fullest extent permitted by the Colorado
Revised Statutes, including circumstances under which indemnification is
otherwise discretionary and (2)
eliminate
the personal liability of directors and officers for monetary damages resulting
from breaches of their fiduciary duty, except for liability for breaches of the
duty of loyalty, acts, or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law, violations under Section
7-108-704 of
Colorado Law, or for any transaction from which the director derived an improper
personal benefit. We believe that these provisions are necessary to attract and
retain qualified persons as directors and officers.
We
will
enter into an indemnification agreement with each of our directors which
provides that we will indemnify our directors and advance expenses to our
directors, to the extent permitted by the laws of the State of
Colorado.
We
have
directors and officers liability insurance in an amount of $1 million.
Insofar
as
indemnification for liability arising under the Securities
Act of 1933 may be
permitted to our directors, officers and controlling persons as stated
in the foregoing provisions or otherwise, we have
been advised that, in the opinion of the SEC, this
indemnification is
against public policy as expressed in the Act
and is,
therefore, unenforceable.
SHARES
OF
THE COMPANY ELIGIBLE FOR FUTURE SALE
Prior to
the date of this prospectus, there has been a limited public market for our
common stock. Sales of
substantial numbers of
shares of
our
common stock in the
public market following this Offering, or the perception that such sales may
occur, could adversely affect prevailing market prices of our shares.
Assuming
no exercise of options outstanding, or up 671,994 warrants to purchase shares of
our common stock, and assuming exercise of 19,630,588 warrants to purchase
shares of our common stock, there are 56,730,045 shares of our common stock
issued and outstanding as of the date of this prospectus. These
shares of common stock will be deemed to be “restricted
securities” under
Rule
144.
Restricted securities may only be sold in the public market pursuant to an
effective registration statement under the Act
or
pursuant to an exemption from registration under Rule
144,
Rule 701
or
Rule 904
under the
Act. These
rules are summarized below.
Eligibility
of
Restricted Shares for Sale in the Public Market
As of the
date of this prospectus no shares may be eligible for resale, 46,586,560 shares
of common stock may become eligible for resale under Rule 144 on November 12,
2005, 1,671,080 shares of common stock may be eligible for resale under Rule 144
on December 8, 2005, 1,069,491 shares of common stock may be eligible for resale
under Rule 144 on January 4, 2006, 7,665,606 shares of common stock may be
eligible for resale under Rule 144 on January 12, 2006, and 409,401 shares of
common stock may be eligible for resale under Rule 144 on May 10, 2006, in
each case subject to volume, manner of sale and other limitations under
Rule
144.
All
shares of Common Stock of shareholders whose shares are included in the
foregoing calculations are included in the shares of Common Stock being
registered in this Registration Statement.
Rule
144
In
general,
under Rule
144 as
currently in effect, a person who has beneficially owned
shares of
common stock for
at least
one year is entitled to sell within any three-month period a number of shares
that does not exceed the greater of:
· |
1.0%
of the
number of
shares
of common stock outstanding,
which is approximately 366,900
shares of common stock; or |
· |
the
average
weekly trading volume of the
shares
of common stock during
the four calendar weeks preceding the filing of a notice on Form 144 in
connection with the sale. |
Sales
under
Rule
144 are
also subject to manner of sale provisions and notice requirements and to the
availability of current public information about us. In addition, under
Rule
144(k) as
currently in effect, a person:
· |
who
is
not considered to have been one of our affiliates at any time during the
90 days preceding a sale; and |
· |
who
has
beneficially owned the shares proposed to be sold for at least two years,
including the holding period of any prior owner other than an
affiliate, |
is
entitled
to sell his shares without complying with the manner of sale, public
information, volume limitation or notice provisions of Rule
144.
Rule
701
In
general,
under Rule
701, any
of our employees, directors, officers, consultants, or advisors (other than
affiliates) who purchased
shares of
common stock from
us under
a compensatory stock
option plan or other
written agreement before the closing of the Share Exchange is entitled to resell
these shares. These shares can be resold 90 days after the effective date of the
Share Exchange in reliance on Rule
144,
without having to comply with restrictions, including the holding period,
contained in Rule
144.
However, the 2004 Plan has a lock-up provision and shares issued under it are
not eligible for resale at this time. Pursuant to such lock-up provision any
common stock or other equity securities issued or issuable upon exercise of an
option may not be sold, transferred or disposed of until the earlier of
(i) the
date that this registration statement has been filed with and declared effective
by the SEC, and (ii) November 12, 2005, unless (a) such sale, transfer or
distribution is approved in writing by a majority of the investors in the
Private Placement, and (b) the transferee of such sold, transferred or
distributed securities agrees in writing to be bound by the terms of such
lock-up provision to the same extent as if they had originally been a party
hereto.
The
Securities
and Exchange Commission has
indicated that Rule
701 will
apply to typical share options granted by an issuer before it becomes subject to
the reporting requirements of the Securities
Exchange Act of 1934, along
with the shares acquired upon exercise of these options, including exercises
after the date of this prospectus. Securities
issued in
reliance on Rule
701 are
restricted securities and, subject to the contractual restrictions described
above, beginning 90 days after the date of this prospectus, may be sold:
· |
by
persons
other than affiliates subject only to the manner of sale provisions of
Rule
144;
and |
· |
by
affiliates
under Rule
144
without compliance with its one year minimum holding period requirement.
|
Options
We intend
to file one or more registration statements on Form S-8 under the Act
to
register 2,381,525
shares of
common stock reserved
for
issuance under our
stock
option
plans. The
registration statement on Form S-8 will become effective automatically upon
filing. As of the date of this prospectus, options to purchase 2,182,894
shares of
common stock were
issued
and outstanding, of which options to purchase approximately
1,400,988 shares of
common stock had
vested
and had not been exercised. Shares
of common
stock issued
upon
exercise of a share option and registered under the Form S-8 registration
statement will, subject to vesting provisions and Rule
144
volume limitations applicable to our affiliates and the lock-up provision
described above, be available for sale in the open market
immediately.
Lock
Up of Certain Shares
We have
secured the agreement of all persons who received their shares of common stock
by reason of securities ownership in Advaxis prior to the Share Exchange to not
sell, transfer, pledge or otherwise dispose of such shares during
the period from November 12, 2004 until the earlier of (i) the date that this
registration statement has been filed with and declared effective by the SEC,
and (ii) the first year anniversary of the date hereof, unless (a) such sale,
transfer or distribution is approved in writing by a majority of the investors
in the Private Placement, and (b) the transferee of such sold, transferred or
distributed securities agrees in writing to be bound by the terms of the
standstill agreement to the same extent as if they had originally been a party
hereto. A total of 17,734,163 shares of Common Stock and 2,808,434 shares of
Common Stock underlying exercisable warrants are subject to such agreement.
PLAN
OF DISTRIBUTION
The
selling
stockholders, and any of their pledgees, asignees and successors-in-interest,
may from time to time, sell any or all of their shares of our common
stock on any stock exchange, market or trading facility on which the shares are
traded or in private transactions. These sales may be at fixed or negotiated
prices. The selling stockholders may use any one or more of the following
methods when selling shares:
· |
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits Investors; |
· |
block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction; |
· |
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account; |
· |
an
exchange distribution in accordance with the rules of the applicable
exchange; |
· |
privately
negotiated transactions; |
· |
short
sales (other than short sales established prior to the effectiveness of
the Registration Statement to which this Prospectus is a part)
|
· |
broker-dealers
may agree with the Selling Stockholders to sell a specified number of such
shares at a stipulated price per share; |
· |
a
combination of any such methods of sale;
and |
· |
any
other method permitted pursuant to applicable
law. |
The
selling stockholders may also sell shares under Rule 144 under the Securities
Act of 1933, if available, rather than under this prospectus.
Broker-dealers
engaged by selling stockholders may arrange for other broker-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from
the selling stockholders (or, if any broker-dealer acts as agent for the
purchaser of shares, from the purchaser) in amounts to be negotiated. Each
selling stockholder does not expect these commissions and discounts relating to
its sales of shares to exceed what is customary in the types of transactions
involved.
The
selling stockholders may from time to time pledge or grant a security interest
in some or all of the registrable securities owned by them and, if they default
in the performance of their secured obligations, the pledgees or secured parties
may offer and sell shares of common Stock from time to time under this
prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or
other applicable provision of the Securities Act of 1933 amending the list of
selling stockholders to include the pledgee, transferee or other successors in
interest as selling stockholders under this prospectus.
Upon us
being notified in writing by a selling stockholder that any material arrangement
has been entered into with a broker-dealer for the sale of common stock through
a block trade, special offering, exchange distribution or secondary distribution
or a purchase by a broker or dealer, a supplement to this prospectus will be
filed, if required, pursuant to Rule 424(b) under the Securities Act of 1933,
disclosing (i) the name of each such selling stockholder and of the
participating broker-dealer(s), (ii) the number of shares involved, (iii) the
price at which such the shares of common stock were sold, (iv) the commissions
paid or discounts or concessions allowed to such broker-dealer(s), where
applicable, (v) that such broker-dealer(s) did not conduct any investigation to
verify the information set out in this
prospectus, and (vi) other facts material to the transaction. In addition, upon
us being notified in writing by a selling stockholder that a donee or pledge
intends to sell more than 500 shares of common stock, a supplement to this
prospectus will be filed if then required in accordance with applicable
securities law.
The
selling stockholders also may transfer the shares of common stock in other
circumstances, in which case the transferees, pledgees or other successors in
interest will be the selling beneficial owners for purposes of this
prospectus.
The
selling stockholders and any broker-dealers or agents that are involved in
selling the shares may be deemed to be "underwriters" within the meaning of the
Securities Act of 1933 in connection with such sales. In such event, any
commissions received by such broker-dealers or agents and any profit on the
resale of the shares purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act of 1933. Each selling
stockholder has represented and warranted to us that it does not have any
agreement or understanding, directly or indirectly, with any person to
distribute the common stock.
We are
required to pay all fees and expenses incident to the registration of the
shares. We have agreed to indemnify the selling stockholders against certain
losses, claims, damages and liabilities, including liabilities under the
Securities Act of 1933.
LEGAL
MATTERS
The
validity of the common stock offered by this prospectus will be passed upon for
us by Frascona, Joiner, Goodman and Greenstein, PC.
EXPERTS
The
financial statements appearing in this prospectus and registration statement
have been audited by Goldstein Golub Kessler LLP, independent accountants; to
the extent and for the periods indicated in their report appearing elsewhere
herein, and are included in reliance upon such report and upon the authority of
such firms as experts in accounting and auditing.
ADDITIONAL
INFORMATION
We filed
with the SEC a registration statement on Form SB-2 under the Securities Act of
1933 for the shares of common stock in this offering. This prospectus does not
contain all of the information in the registration statement and the exhibits
and schedule that were filed with the registration statement. For further
information with respect to us and our common stock, we refer you to the
registration statement and the exhibits that were filed with the registration
statement. Statements contained in this prospectus about the contents or any
contract or any other document that is filed as an exhibit to the registration
statement are not necessarily complete, and we refer you to the full text of the
contract or other document filed as an exhibit to the registration statement. A
copy of the registration statement and the exhibits and schedules that were
filed with the registration statement may be inspected without charge at the
Public Reference Room maintained by the SEC at 450 Fifth Street, N.W.,
Washington, DC 20549, and copies of all or any part of the registration
statement may be obtained from the SEC upon payment of the prescribed fee.
Information regarding the operation of the Public Reference Room may be obtained
by calling the SEC at 800-SEC-0330. The SEC maintains a web site that contains
reports, proxy and information statements and other information regarding
registrants that file electronically with the SEC. The address of the site is
www.sec.gov.
We are
subject to the information and periodic reporting requirements of the Securities
Exchange Act of 1934, and in accordance with the Securities Exchange Act of
1934, we file annual, quarterly and special reports, and other information with
the SEC. These periodic reports, and other information are available for
inspection and copying at the regional offices, public reference facilities and
website of the SEC referred to above.
FINANCIAL
STATEMENTS
Report
of Independent Registered Public Accounting Firm |
F-2 |
|
|
|
|
Financial
Statements: |
|
|
|
Balance
Sheet |
F-3 |
Statement
of Operations |
F-4 |
Statement
of Shareholders' Equity (Deficiency) |
F-5 |
Statement
of Cash Flows |
F-7 |
Notes
to Financial Statements |
F-8
- F-20 |
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors of
Advaxis,
Inc.
We have
audited the accompanying balance sheets of Advaxis, Inc. (a development stage
company) as of December 31, 2002 and 2003 and October 31, 2004, and the related
statements of operations, shareholders' equity (deficiency), and cash flows for
the period from March 1, 2002 (inception) to December 31, 2002, the year
ended December 31, 2003, the period from January 1, 2004 to October 31, 2004,
and the period from March 1, 2002 (inception) to October 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 audits.
We
conducted our audits 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 audits provide a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Advaxis, Inc. as of December 31,
2002 and 2003 and October 31,2004, and the results of its operations and its
cash flows for the period from March 1, 2002 (inception) to December 31,
2002, the year ended December 31, 2003, the period from January 1, 2004 to
October 31, 2004 and the period from March 1, 2002 (inception) to October 31,
2004 in conformity with United States generally accepted accounting
principles.
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 has incurred losses from operations, has a working
capital deficiency and has a shareholders' deficiency that raise substantial
doubt about its ability to continue as a going concern. Management's plan in
regard to these matters is also described in Note 1. These financial statements
do not include any adjustments that may result from the outcome of this
uncertainty.
GOLDSTEIN
GOLUB KESSLER LLP
New York,
New York
April 21,
2005
ADVAXIS,
INC. |
|
(a
development stage company) |
|
BALANCE
SHEET |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
|
October
31, |
|
January
31, |
|
|
|
2002
|
|
2003
|
|
2004 |
|
2005 |
|
|
|
|
|
|
|
|
|
(unaudited) |
|
ASSETS |
|
|
|
|
|
|
|
|
|
Current
Asset - cash |
|
$ |
204,382 |
|
$ |
47,160 |
|
$
|
32,279
|
|
$ |
3,217,430 |
|
Intangible
Assets |
|
|
|
|
|
277,243
|
|
|
469,804
|
|
|
666,447 |
|
Other
Assets |
|
|
|
|
|
|
|
|
|
|
|
2,450 |
|
Total
Assets |
|
$ |
204,382 |
|
$ |
324,403 |
|
$
|
502,083
|
|
$ |
3,886,327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' EQUITY (DEFICIENCY) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
85,825 |
|
$ |
1,018,936 |
|
$
|
823,152
|
|
$ |
435,280 |
|
Notes
payable, current portion |
|
|
|
|
|
25,408
|
|
$
|
605,190 |
|
|
258,237 |
|
Total
current liabilities |
|
|
85,825
|
|
|
1,044,344
|
|
|
1,428,342 |
|
|
693,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes
Payable, net of current portion |
|
|
40,000
|
|
|
86,794
|
|
|
413,237 |
|
|
230,000 |
|
Total
liabilities |
|
|
125,825
|
|
|
1,131,138
|
|
|
1,841,579 |
|
|
923,517
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
Equity (Deficiency): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock - $0.001 par value; authorized 500,000,000 shares,
issued and outstanding 15,557,723 at December 31, 2002 and 2003 and
October 31, 2004 and 36,690,046 shares at January 31,
2005 |
|
|
15,598
|
|
|
15,598 |
|
|
15,598 |
|
|
36,690
|
|
Additional
paid-in capital |
|
|
229,895 |
|
|
254,348 |
|
|
303,547 |
|
|
4,830,116
|
|
Deficit
accumulated during the development stage |
|
|
(166,936 |
) |
|
(1,076,681 |
) |
|
(1,658,641
|
)
|
|
(1,903,996 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity (deficiency) |
|
|
78,557
|
|
|
(806,735 |
) |
|
(1,339,496
|
)
|
|
2,962,810
|
|
Total
Liabilities and Shareholders' Equity (Deficiency) |
|
$ |
204,382 |
|
$ |
324,403 |
|
$
|
502,083
|
|
$ |
3,886,327 |
|
The
accompanying notes and the report of independent registered public accounting
firm should be read in conjunction with the financial statements.
ADVAXIS,
INC. |
(a
development stage company) |
STATEMENT
OF OPERATIONS |
|
|
|
Period
from
March
1,
2002
(inception)
to
December
31, |
|
|
Year
ended
December
31, |
|
|
Ten
Month Period ended October 31, |
|
|
Ten
Month Period ended October 31, |
|
|
Period
from
March
1,
2002
(inception)
to
October
31, |
|
|
Three-month
period
ended
January
31, |
|
|
Three-month
period
ended
January
31, |
|
|
Period
from
March
1,
2002
(inception)
to
January
31, |
|
|
|
|
2002 |
|
|
2003 |
|
|
2003 |
|
|
2004 |
|
|
2004 |
|
|
2004 |
|
|
2005 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
$ |
4,000 |
|
$ |
3,600 |
|
$ |
116,406 |
|
$ |
120,406 |
|
$ |
400 |
|
|
|
|
$ |
120,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development expenses |
|
$ |
50,899 |
|
|
491,508 |
|
|
446,324 |
|
|
125,942 |
|
|
668,349 |
|
|
86,842 |
|
$ |
218,951 |
|
|
887,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative expenses |
|
|
117,003 |
|
|
405,568 |
|
|
375,403 |
|
|
524,368 |
|
|
1,046,939 |
|
|
45,399 |
|
|
26,175 |
|
|
1,073,114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
|
|
|
|
17,190 |
|
|
8,288 |
|
|
4,229 |
|
|
21,419 |
|
|
10,655 |
|
|
2,968 |
|
|
24,387 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income |
|
|
966 |
|
|
521 |
|
|
506 |
|
|
57 |
|
|
1,544 |
|
|
30 |
|
|
2,739 |
|
|
4,283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
(166,936 |
) |
|
(909,745 |
) |
|
(825,907 |
) |
|
(538,076 |
) |
|
(1,614,757 |
) |
|
(142,466 |
) |
|
(245,355 |
) |
|
(1,860,112 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends
attributed to preferred stock |
|
|
|
|
|
|
|
|
|
|
|
43,884 |
|
|
43,884 |
|
|
|
|
|
|
|
|
43,884
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss applicable to common stock |
|
$ |
(166,936 |
) |
$ |
(909,745 |
) |
|
(825,907 |
) |
$ |
(581,960 |
) |
$ |
(1,658,641 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) |
$ |
(1,903,996 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share |
|
$ |
(0.01 |
) |
$ |
(0.06 |
) |
$ |
(0.05 |
) |
|
($0.04 |
) |
|
($0.11 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares, baseic and diluted |
|
|
15,597,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31,181,332 |
|
|
16,941,389 |
|
The
accompanying notes and the report of independent registered public accounting
firm should be read in conjunction with the financial
statements.
ADVAXIS,
INC. (a
development stage company) |
|
STATEMENT
OF SHAREHOLDERS' EQUITY (DEFICIENCY) |
|
Period
from March 1, 2002 (inception) to January 31,
2005 |
|
|
Preferred
Stock |
|
Common
Stock |
|
|
|
|
|
|
|
|
|
Number
of Shares Outstanding |
|
Amount |
|
Number
of Shares Outstanding |
|
Amount |
|
Additional
Paid-in Capital |
|
Deficit
Accumulated During the Development Stage |
|
Shareholders'
Equity (Deficiency) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock issued |
|
|
3,418.18
|
|
$ |
235,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
235,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued |
|
|
|
|
|
|
|
|
40,000
|
|
$ |
40 |
|
$ |
(40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
granted to consultants and professionals |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,493
|
|
|
|
|
|
10,493
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(166,936 |
) |
|
(166,936 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retroactive
restatement to reflect recapitalization on November 12,
2004 |
|
|
(3,418.18 |
) |
|
(235,000 |
) |
|
|
|
|
15,558 |
|
|
219,442 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2002 |
|
|
-
0 - |
|
|
-
0 - |
|
|
|
|
|
15,598 |
|
|
229,895 |
|
|
(166,936 |
) |
|
78,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
payable converted into preferred stock |
|
|
232.27 |
|
|
15,969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,969 |
|
The accompanying notes and the report of independent
registered public accounting firm should be read in conjunction with the
financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
granted to consultants and professionals |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,484 |
|
|
|
|
|
8,484 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(909,745 |
) |
|
(909,745 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retroactive
restatement to reflect recapitalization on November 12,
2004 |
|
|
(232.27 |
) |
|
(15,969 |
) |
|
|
|
|
|
|
|
15,969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2003 |
|
|
-
0 - |
|
|
-
0 - |
|
|
|
|
|
15,598 |
|
|
254,348 |
|
|
(1,076,681 |
) |
|
(806,735 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
dividend on preferred stock |
|
|
638.31
|
|
|
43,884
|
|
|
|
|
|
|
|
|
|
|
|
(43,884 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(538,076 |
) |
|
(538,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
granted to consultants and professionals |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,315 |
|
|
|
|
|
5,315
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retroactive
restatement to reflect recapitalization on November 12,
2004 |
|
|
(638.31 |
) |
|
(43,884 |
) |
|
|
|
|
|
|
|
43,884 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at October 31, 2004 |
|
|
- 0
- |
|
|
- 0
- |
|
|
|
|
|
15,598 |
|
|
303,547 |
|
|
(1,658,641 |
) |
|
(1,339,496 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock issued to Placement Agent on recapitalization |
|
|
|
|
|
|
|
|
752,600 |
|
|
753 |
|
|
(753 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect
of recapitalization |
|
|
|
|
|
|
|
|
752,600 |
|
|
752 |
|
|
(752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
granted to consultants and professionals |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion
of Note payable to Common Stock |
|
|
|
|
|
|
|
|
2,136,441 |
|
|
2,136 |
|
|
611,022 |
|
|
|
|
|
613,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issance
of Common Stock for cash, net of shares to Placement Agent |
|
|
|
|
|
|
|
|
17,450,693 |
|
|
17,451 |
|
|
4,335,549 |
|
|
|
|
|
4,353,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
Costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(329,673 |
) |
|
|
|
|
(329,673 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(245,355 |
) |
|
(245,355 |
) |
The accompanying notes and the report of independent
registered public accounting firm should be read in conjunction with the
financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restatement
to reflect recapitalization on November 12, 2004 including cash paid of
$44,940 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(88,824
|
) |
|
|
|
|
(88,824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at January 31, 2005 |
|
$ |
-
0 - |
|
$ |
-
0 - |
|
|
36,690,057 |
|
$ |
36,690 |
|
$ |
4,830,116 |
|
$ |
(1,903,996 |
) |
$ |
2,962,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes and the report of independent
registered public accounting firm should be read in conjunction with the
financial statements.
ADVAXIS,
INC. (a
development stage company) |
STATEMENT
OF CASH FLOWS |
|
|
Period
from March 1, 2002 (inception) to December 31, |
|
Year
ended December 31, |
|
Tenth
Month Period ended October 31 |
|
Tenth
Month Period ended October 31 |
|
Period
from March 1, 2002 (inception) to October 31, |
|
Three-month
period ended January 31, |
|
Three-month
period ended January 31, |
|
Period
from March 1, 2002 (inception) to January 31, |
|
|
|
|
2002 |
|
|
2003 |
|
|
2003 |
|
|
2004 |
|
|
2004 |
|
|
2004 |
|
|
2005 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(unaudited) |
|
Cash
flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(166,936 |
) |
$
|
(909,745 |
) |
|
(825,907 |
) |
|
|
|
|
(1,614,757 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) |
$ |
(1,860,112 |
) |
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value
assigned to options given as payment to consultants and
professionals |
|
|
10,493 |
|
|
8,484 |
|
|
|
|
|
5,315 |
|
|
24,292 |
|
|
8,484 |
|
|
|
|
|
24,292 |
|
Amortization
expense |
|
|
|
|
|
3,171 |
|
|
|
|
|
15,818 |
|
|
18,989 |
|
|
800 |
|
|
6,817 |
|
|
25,806 |
|
Accrued
interest on notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,968 |
|
|
7,968 |
|
Increase
in Other Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,450 |
) |
|
(2,450 |
) |
Increase
(decrease) in accounts payable |
|
|
85,825 |
|
|
933,111 |
|
|
840,037 |
|
|
80,307 |
|
|
1,099,243 |
|
|
102,910 |
|
|
(356,756 |
) |
|
742,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by (used in) operating activities |
|
|
(70,618 |
) |
|
35,021 |
|
|
14,130 |
|
|
(436,636 |
) |
|
(472,233 |
) |
|
(30,272 |
) |
|
(589,776 |
) |
|
(1,062,009 |
) |
CASH
FLOWS USED IN INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid on acquisition of Great Expectations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(44,940 |
) |
|
(44,940 |
) |
Cost
of Intangible Assets |
|
|
|
|
|
(277,243 |
) |
|
(217,133 |
) |
|
(124,469 |
) |
|
(401,712 |
) |
|
(30,228 |
) |
|
(203,460 |
) |
|
(605,172 |
) |
Net
cash used in Investing Activities |
|
|
|
|
|
(277,243 |
) |
|
(217,133 |
) |
|
(124,469 |
) |
|
(401,712 |
) |
|
(30,228 |
) |
|
(248,400 |
) |
|
(650,112 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from notes payable |
|
|
40,000 |
|
|
85,000 |
|
|
|
|
|
546,224 |
|
|
671,224 |
|
|
87,203 |
|
|
|
|
|
671,224 |
|
Net
proceeds on issuance of preferred stock |
|
|
235,000 |
|
|
|
|
|
|
|
|
|
|
|
235,000 |
|
|
|
|
|
|
|
|
235,000 |
|
Net
Proceeds on Issuance of Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,023,327 |
|
|
4,023,327 |
|
Cash
provided by financing activities |
|
|
275,000 |
|
|
85,000 |
|
|
|
|
|
546,224 |
|
|
906,224 |
|
|
87,203 |
|
|
4,023,327 |
|
|
4,929,551 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash |
|
|
204,382 |
|
|
(157,222 |
) |
|
(203,003 |
) |
|
(14,881 |
) |
|
32,279 |
|
|
26,703 |
|
|
3,185,151 |
|
|
3,217,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
at beginning of period |
|
|
|
|
|
204,382 |
|
|
204,382 |
|
|
47,160 |
|
|
|
|
|
1,379 |
|
|
32,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
at end of period |
|
$ |
204,382 |
|
$ |
47,160 |
|
$ |
1,379 |
|
$ |
32,279 |
|
$ |
32,279 |
|
$ |
28,082 |
|
$ |
3,217,430 |
|
$ |
3,217,430 |
|
The accompanying notes and the report of independent
registered public accounting firm should be read in conjunction with the
financial statements.
|
|
Period
from March 1, 2002 (inception) to December 31,
2002 |
|
Year
ended December 31, 2003 |
|
Tenth
Month Period ended October 31, 2003 |
|
Tenth
Month Period ended October 31, 2004 |
|
Period
from March 1, 2002 (inception) to December 31,
2003 |
|
Three
months ended January 31, 2005 |
|
Three
months ended January 31, 2004 |
|
Period
from March 1, 2002 (Inception) January 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
SCHEDULE OF NONCASH INVESTING AND FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock issued to founders |
|
$ |
40 |
|
|
|
|
|
|
|
|
|
|
$ |
40 |
|
|
|
|
|
|
|
$ |
40 |
|
Notes
Payable and Accrued Interest Converted to Preferred Stock |
|
|
|
|
$ |
15,969 |
|
$ |
15,969 |
|
|
|
|
$ |
15,969 |
|
|
|
|
|
|
|
$ |
15,969 |
|
Stock
Dividend on Preferred Stock |
|
|
|
|
|
|
|
|
|
|
$ |
43,884 |
|
$ |
43,884 |
|
|
|
|
|
|
|
$ |
43,884 |
|
Notes
Payable and Accrued Interest Converted to Common |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
631,158 |
|
$ |
613,158 |
|
Intangible
Assets Acquired with Notes Payable |
|
|
|
|
|
|
|
|
|
|
$ |
360,000 |
|
$ |
360,000 |
|
|
|
|
|
|
|
$ |
360,000 |
|
The accompanying notes and the report of independent
registered public accounting firm should be read in conjunction with the
financial statements.
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month periods
ended January 31, 2005 and 2004 is
unaudited) |
1.
PRINCIPAL BUSINESS ACTIVITY
AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES: |
Advaxis,
Inc. (the "Company") was incorporated in 2002 and is a biotechnology
company researching and developing new cancer-fighting
techniques.
The
Company is in the development stage and its operations are subject to all
of the risks inherent in an emerging business enterprise. The accompanying
financial statements have been prepared assuming the Company will continue
as a going concern. As shown in the financial statements, the Company has
incurred losses from operations, and has a working capital deficit of
$971,776 and $1,396,063, and a shareholders' deficiency of $806,735 , and
$1,339,496 at December 31, 2003 and October 31, 2004 , respectively.
Management has raised (see Note 8) and will continue to raise additional
funds through equity and is working to develop technologies that will
generate revenue that will allow the Company to continue as a going
concern. These financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
In
accordance with Securities and Exchange Commission (SEC) Staff Accounting
Bulletin (SAB) No. 104, revenue from license fees and grants is recognized
when the following criteria are met; persuasive evidence of an arrangement
exists, services have been rendered, the contract price is fixed or
determinable, and collectibility is reasonably assured. In licensing
arrangements, delivery does not occur for revenue recognition purposes
until the license term begins. Nonrefundable upfront fees received in
exchange for products delivered or services performed that do not
represent the culmination of a separate earnings process will be deferred
and recognized over the term of the agreement
using the straightline method or another method if it better represents
the timing and pattern of performance.
For
revenue contracts that contain multiple elements, the Company will
determine whether the contract includes multiple units of accounting in
accordance with EITF No. 00-21, Revenue
Arrangements with Multiple Deliverables.
Under that guidance, revenue arrangements with multiple deliverables are
divided into separate units of accounting if the delivered item has value
to the customer on a standalone basis and there is objective and reliable
evidence of the fair value of the undelivered item.
The
Company maintains its cash in bank deposit accounts which, at times, may
exceed federally insured limits.
Intangible
assets, which consist primarily of legal costs in obtaining trademarks and
patents, are being amortized on a straight-line basis over 15 and 17
years, respectively.
The
Company reviews long-lived assets for impairment whenever events or
changes in circumstances indicate that the carrying amount of an asset may
not be recoverable. An asset is considered to be impaired when the sum of
the undiscounted future net cash flows expected to result from the use of
the asset and its eventual disposition exceeds its carrying amount. The
amount of impairment loss, if any, is measured as the difference between
the net book value of the asset and its estimated fair
value. |
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
|
Basic
loss per share is computed by dividing net loss by the weighted-average
number of shares of common stock outstanding during the periods. Diluted
earnings per share gives effect to dilutive options, warrants and other
potential common stock outstanding during the period. Potential common
stock has not been included in the computation of diluted loss per share,
as the effect would be antidilutive.
Deferred
income taxes are provided for the differences between the bases of assets
and liabilities for financial reporting and income tax purposes. A
valuation allowance is established when necessary to reduce deferred tax
assets to the amount expected to be realized.
The
preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires the
use of estimates by management. Actual results could differ from these
estimates.
The
estimated fair value of the notes payable approximates the carrying amount
based on the rates available to the Company for similar debt.
Accounts
payable consists entirely of trade accounts payable.
Research
and development costs are charged to expense as incurred.
Management
does not believe that any recently issued, but not yet effective,
accounting standards if currently adopted would have a material effect on
the accompanying financial
statements. |
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
|
|
|
The
Company has elected to apply APB Opinion No. 25 and related
interpretations in accounting for its stock options granted to employees
and has adopted the disclosure-only provisions of SFAS No. 123. Had the
Company elected to recognize compensation cost based on the fair value of
the options granted at the grant date as prescribed by SFAS No. 123, the
Company's net loss would have been as
follows: |
|
|
March
1, 2002 (date of inception) to December
31, 2002 |
|
Year
ended
December
31, 2003 |
|
10
months ended October 31, 2003 |
|
10
months ended October 31, 2004 |
|
3
months ended
January
31
2004 |
|
3
months ended
January
31,
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss as reported |
|
$ |
(166,936 |
) |
$ |
(909,745 |
) |
$ |
(825,907 |
) |
$ |
(538,076 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) |
Deduct
stock option compensation expense determined under fair value based
method |
|
|
(8,566 |
) |
|
(32,923 |
) |
$ |
(30,199 |
) |
$ |
(70,019 |
) |
|
(22,612 |
) |
|
(18,573 |
) |
Adjusted
Net Loss |
|
$ |
(175,502 |
) |
$ |
(942,668 |
) |
$ |
(856,106 |
) |
$ |
(608,095 |
) |
$ |
(165,078 |
) |
$ |
(263,928 |
) |
Net
Loss per share as reported |
|
$ |
(0.01 |
) |
$ |
(0.06 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
Net
Loss per share pro forma |
|
$ |
(0.01 |
) |
$ |
(0.06 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
|
|
|
|
|
The
Company accounts for nonemployee stock-based awards in which goods or
services are the consideration received for the equity instruments issued
based on the fair value of the equity instruments in accordance with the
guidance provided in the consensus opinion of the Emerging Issues Task
Force ("EITF") Issue 96-18, Accounting
for Equity Instruments that Are Issued to Other than Employees for
Acquiring, or in Conjunction With Selling Goods or
Services. |
|
|
|
The
accompanying unaudited interim financial statements have been prepared in
accordance with generally accepted accounting principles for interim
financial information and the requirements of item 310(b) of Regulation
S-B. Accordingly, certain information and footnote disclosures normally
included in financial statements prepared in accordance with generally
accepted accounting principles have been condensed or omitted pursuant to
the rules and regulations of the Securities and Exchange Commission. The
results of operations for the three-month period ended January 31, 2005
are not necessarily indicative of the results of operations expected for
the year ended October 31, 2005. |
|
|
|
In
the opinion of management, the accompanying unaudited interim financial
statements for the nine-month periods ended September 30, 2004 and 2003
include all adjustments (consisting only of those of a normal recurring
nature) necessary for a fair statement of the results of the interim
period. |
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
2.
INTANGIBLE ASSETS: |
Intangible
assets consist of the following:
|
|
|
December
31, 2003 |
|
|
October
31, 2004 |
|
Trademarks |
$ |
8,243 |
|
$ |
8,243 |
|
Patents |
|
|
|
|
117,377 |
|
License |
|
269,000 |
|
|
360,000 |
|
Less:Accumulated
Amortization |
|
|
|
|
(15,818 |
) |
|
$ |
277,243 |
|
$ |
469,804 |
|
|
|
|
|
|
|
|
During
the ten-month period ended October 31, 2004, the Company renegotiated
certain payables with its attorney which reduced intangible assets by
$98,090. |
|
|
|
|
|
|
|
|
Estimated
amortization expense is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ending October
31, |
|
|
|
|
|
|
2005 |
|
$ |
24,281 |
|
2006 |
|
|
24,281 |
|
2007 |
|
|
24,281 |
|
2008 |
|
|
24,281 |
|
2009 |
|
|
24,281 |
|
|
|
|
|
|
|
|
|
|
|
During
the three-month period ended January 31, 2005, the Company acquired
$203,460 of new patents. Amortization expense during the period amounted
to $6,817. |
|
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month periods
ended January 31, 2005 and 2004 is
unaudited) |
Notes
payable consist of the following: |
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
|
|
October
31 |
|
|
|
|
2003 |
|
|
2002 |
|
|
2004 |
|
Note
payable with interest at 6% per annum, due on December 31, 2005. The
amount is mandatorily convertible at the time of the closing of the
Company's contemplated $2,000,000 equity financing into the same class of
shares issued at the equity financing at a conversion price per share
equivalent to the price per share in the equity financing. Upon closing of
an equity financing which is less than $2,000,000, the holder has the
right to convert, at the holder's option, into the same class of shares
issued at the equity financing at a conversion price per share equivalent
to the price per share in the equity financing. |
|
$ |
10,060 |
|
|
|
|
$ |
605,190 |
|
|
|
|
|
|
|
|
|
|
|
|
Note
payable with interest at 8% per annum, due on November 10,
2008. |
|
|
10,112 |
|
|
|
|
|
10,647 |
|
|
|
|
|
|
|
|
|
|
|
|
Note
payable with interest at 8% per annum, due on December 17,
2008. |
|
|
40,122 |
|
|
|
|
|
42,590 |
|
|
|
|
|
|
|
|
|
|
|
|
Note
payable with interest at 6% per annum, due on December 31, 2004. The
amount is mandatorily convertible at the time of the closing of the
Company's contemplated $2,000,000 equity financing into the same class of
shares issued at the equity financing at a conversion price per share
equivalent to the price per share in the equity financing. Upon closing of
an equity financing which is less than $2,000,000, the holder has the
right to convert, at the holder's option, into the same class of shares
issued at the equity financing at a conversion price per share equivalent
to the price per share in the equity financing. |
|
|
25,408 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes
payable with no interest, due on December 15, 2006. |
|
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Notes
payable with no interest, due on December 15, 2007. |
|
|
|
|
|
|
|
|
230,000 |
|
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month periods
ended January 31, 2005 and 2004 is
unaudited) |
(continued) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
|
|
October
31 |
|
|
|
|
2003 |
|
|
2002 |
|
|
2004 |
|
|
|
|
|
|
|
|
|
|
|
|
Note
payable with interest at 6% per annum, due on June 30, 2005. The amount is
convertible at the holder's option into Series A convertible preferred
stock at a price per share of $68.75. |
|
$ |
26,500 |
|
$ |
25,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
payable with interest at 6% per annum, due and payable on June 30, 2005.
The amount is convertible at the holder's option into Series A convertible
preferred stock at a price per share of $68.75. The full amount of this
note plus accrued interest of $969 was converted into 232.27 shares of
Series A preferred stock on September 22, 2003. |
|
|
|
|
|
15,000 |
|
|
|
|
|
|
|
112,202
|
|
|
40,000
|
|
|
1,018,427
|
|
Less
current portion |
|
|
25,408 |
|
|
|
|
|
605,190 |
|
|
|
$ |
86,794 |
|
$ |
40,000 |
|
$ |
413,237 |
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate
maturities of notes payable at October 31, 2004 are as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
ending December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
605,190 |
|
|
|
|
|
|
|
2006 |
|
|
130,000 |
|
|
|
|
|
|
|
2007 |
|
|
230,000 |
|
|
|
|
|
|
|
2008 |
|
|
53,237 |
|
|
|
|
|
|
|
|
|
$ |
1,018,427 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
|
|
|
|
|
|
|
4. |
STOCK
OPTIONS: |
The
Company has adopted the Advaxis, Inc. 2002 Stock Option Plan (the "Plan"),
which allows for grants up to 8,000 shares of the Company's common stock.
The Plan shall be administered and interpreted by the Company's board of
directors. |
|
|
|
Stock
option activity during the periods indicated is as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options |
|
Exercise |
|
|
|
Granted |
|
Price |
|
|
|
|
|
|
|
Granted
from the period March 1, 2002 (inception) to December 31,
2002 |
|
|
4,351 |
|
$ |
73.63 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2002 |
|
|
4,351 |
|
|
73.63 |
|
Granted |
|
|
1,777 |
|
|
97.47 |
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2003 |
|
|
6,464 |
|
$ |
78.91 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
350 |
|
$ |
117.32 |
|
Forfeited |
|
|
(750 |
) |
$ |
68.75 |
|
|
|
|
|
|
|
|
|
Outstanding
at October 31, 2004 |
|
|
6,064 |
|
$ |
80.95 |
|
Vested
and exercisable at October 31, 2004 |
|
|
3,917 |
|
$ |
87.63 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At
October 31, 2004, the weighted exercise prices and weighted-average
remaining contractual life of outstanding options were $80.95 and 7.70
years, respectively. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
fair value of each option is estimated on the date of grant using the
Black-Scholes option-pricing model with the following assumptions used for
grants in 2004, 2003 and 2002: dividend yield of 0%; average risk-free
interest rates of 6%; volatility of 0%; and an expected life of 10 years
in each year. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Also
under the Plan, the Company has granted 3,430 options to purchase the
Company's common stock that are being accounted for under variable plan
accounting because these options have an exercise price that is subject to
a one-time price adjustment following the next round of equity financing.
Accordingly, each period, increases in the stock price of the Company will
result in a charge to operations for the increase in the Company's stock
price multiplied by the number of these options still outstanding.
However, there has been no fluctuation in the Company's stock price from
inception to December 31, 2003 and, as such, no charge has been taken on
the accompanying statement of operations. |
|
|
|
|
|
|
|
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
|
On
November 12, 2004, in connection with the recapitalization (see Note 8),
the above options were canceled, and employees and consultants were
granted options of Great Expectations. The pro forma disclosures in Note 1
are presented for the options outstanding prior to the recapitalization.
The cancellation and replacement had no accounting consequence since the
aggregate intrinsic value of the options immediately after the
cancellation and replacement was not greater than the aggregate intrinsic
value immediately before the cancellation and replacement, and the ratio
of the exercise price per share to the fair value per share was not
reduced. Additionally, the original options were not modified to
accelerate vesting or extend the life of the new
options. |
|
|
|
5. |
SHAREHOLDERS'
EQUITY: |
Prior
to the recapitalization (see Note 8), the Company had convertible
preferred stock with $.001 par value and 50,000 shares authorized. 6,000
of those shares were designated as Series A and 3,418.18, 3,650.45, and
3.640.45 were issued and outstanding at December 31, 2002, December 31,
2003 and October 31, 2004, respectively. The Company also had 100,000
shares authorized of $.001
par value common stock with 40,000 shares issued and outstanding at
December 31, 2002 and 2003, and at October 31,
2004. |
|
|
|
The
preferred stock and common stock amounts were retroactively restated to
reflect the effects of the recapitalization on November 12, 2004 (see Note
8). |
|
|
|
6. |
COMMITMENTS
AND CONTINGENCIES: |
Pursuant
to multiple consulting agreements and a licensing agreement, the Company
is contingently liable for the following: |
|
The
Company is obligated to pay $35,500 to two consultants upon receiving
financing of $1,000,000 or greater. |
|
The
Company is obligated to pay $20,000 to two consultants upon receiving
financing of $500,000 or greater and an additional $20,000 upon receiving
financing of $2,000,000 or greater. |
|
The
Company is obligated to pay $91,000 to two consultants upon receiving
financing of $4,000,000 or greater. |
|
Under
a licensing agreement, the Company has agreed to pay $525,000 over a
four-year period as a royalty after the first commercial sale of a product
under the license. The Company is also obligated to pay annual license
maintenance fees ranging from $25,000 to $125,000 per year after the first
commercial sale of a product under the license. The Company is also
obligated to pay up to $660,000 to the licensor upon receiving financing.
The amount due is contingent upon the size of the
financing. |
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month periods
ended January 31, 2005 and 2004 is
unaudited) |
|
As
of October 31, 2004, the Company has an employment agreement with a key
executive through December 31, 2004. The agreement shall be automatically
renewed for one-year periods unless the Company or the key executive gives
the other party written consent of its intent not to renew at least 30
days prior to the end of the term of the contract. The agreement provides
for an annual base salary of $150,000, which will be adjusted to $225,000
to $250,000 per annum once the Company closes on its next round of equity
financing. |
|
The
Company is also obligated under two employment agreements to pay
approximately $220,000 per annum upon the closing of the next round of
equity financing. |
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
7. |
INCOME
TAXES: |
The
Company has a net operating loss carryforward of approximately $1,800,000
at October 31, 2004 available to offset taxable income through
2023. |
|
|
|
|
|
|
The
tax effects of loss carryforwards give rise to a deferred tax asset and a
related valuation allowance as follows: |
|
|
|
|
|
|
|
December
31, 2003 |
|
October
31, 2004 |
|
Net
operating losses |
$ |
640,000 |
|
$ |
720,000 |
|
Less
valuation allowance |
|
(640,000 |
) |
|
(720,000 |
) |
Deferred
tax asset |
$ |
- 0
- |
|
$ |
- 0
- |
|
|
|
|
|
|
|
|
The
difference between income taxes computed at the statutory federal rate of
34% and the provision for income taxes relates to the
following: |
|
|
|
|
Period
from |
|
|
|
|
|
|
|
|
|
|
|
1-Mar-02 |
|
|
|
Ten-month |
|
three-month |
|
|
|
(inception)
to |
|
Year
ended |
|
period
ended |
|
period
ended |
|
|
|
December
31, |
|
December
31, |
|
October
31, |
|
January
31, |
|
|
|
2002 |
|
2003 |
|
2004 |
|
2004 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision
at federal statutory rate |
|
|
34 |
% |
|
34 |
% |
|
34 |
% |
|
34 |
% |
|
34 |
% |
Valuation
allowance |
|
|
(34 |
) |
|
(34 |
) |
|
(34 |
) |
|
(34 |
) |
|
(34 |
) |
|
|
|
-0- |
% |
|
-0- |
% |
|
-0- |
% |
|
-0- |
% |
|
-0- |
% |
|
|
|
8. |
SUBSEQUENT
EVENTS: |
On
November 12, 2004, Great Expectations and Associates, Inc. ("Great
Expectations") acquired the Company through a share exchange and
reorganization (the "Recapitalization"), pursuant to which the Company
became a wholly owned subsidiary of Great Expectations. Great Expectations
acquired (i) all of the issued and outstanding shares of common stock of
the Company and the Series A preferred stock of the Company in exchange
for an aggregate of 15,597,723 shares of authorized, but theretofore
unissued, shares of common stock, no par value, of Great Expectations;
(ii) all of the issued and outstanding warrants to purchase the Company's
common stock, in exchange for warrants to purchase 584,885 shares of Great
Expectations; and (iii) all of the issued and outstanding options to
purchase the Company's common stock in exchange for an aggregate of
2,381,525 options to purchase common stock of Great Expectations,
constituting approximately 96% of the common stock of Great Expectations
prior to the issuance of shares of common stock of Great Expectations in
the private placement described below. Prior to the closing of the
Recapitalization, Great Expectations performed a 200-for-1 reverse stock
split, thus reducing the issued and outstanding shares of common stock of
Great Expectations from 150,520,000 shares to 752,600 shares.
Additionally, 752,600 shares of common stock of Great Expectations were
issued to the financial advisor in connection with the Recapitalization.
Pursuant to the Recapitalization, there are 17,102,923 common shares
outstanding in Great Expectations. |
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
|
As
a result of the transaction, the former shareholders of Advaxis are the
controlling shareholders of the Company. Additionally, prior to the
transaction, Great Expectations had no substantial assets. Accordingly,
the transaction is treated as a recapitalization of a public shell, rather
than a business combination. The historical financial statements of
Advaxis are now the historical financial statements of the Company.
Historical shareholders' equity (deficiency) of Advaxis has been restated
to reflect the recapitalization, and include the shares received in the
transaction. |
|
Pro
forma information has not been presented since the transaction is not a
business combination. |
|
November
12, 2004, the Company completed an initial closing of a private placement
offering (the “Private Placement”), whereby it sold an aggregate of $2.925
million worth
of units to accredited investors. Each unit was sold for $25,000 (the
“Unit Price”) and consisted of (a) 87,108 shares of common stock and (b) a
warrant to purchase, at any time prior to the fifth anniversary following
the date of issuance of the warrant, to purchase 87,108 shares of common
stock included at a price equal to $0.40 per share of common stock (a
“Unit”). In consideration of the investment, the Company granted to each
investor certain registration rights and anti-dilution rights. Also, in
November 2004, the Company converted approximately $618,000 of aggregate
principal promissory notes and accrued interest outstanding into
Units.
|
On
December 8, 2004, the Company completed a second closing of the Private
Placement, whereby it sold an aggregate of $200,000 of Units to accredited
investors.
|
On
January 4, 2005, the Company completed a third and final closing of the
Private Placement, whereby it sold an aggregate of $128,000 of Units to
accredited investors.
|
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
Pursuant
to the terms of a investment banking agreement, dated March 19, 2004, by
and between the Company and Sunrise Securities, Corp. (the “Placement
Agent”), the Company issued to the Placement Agent and its designees an
aggregate of 2,283,445 shares of common stock and warrants to purchase up
to an aggregate of 2,666,900 shares of common stock. The shares were
issued as part consideration for the services of the Placement Agent, as
placement agent for the Company in the Private Placement. In addition, the
Company paid the Placement Agent a total cash fee of $50,530.
|
On
January 12, 2005, the Company completed a second private placement
offering whereby it sold an aggregate of $1,100,000 of units to a single
investor. As with the Private Placement, each unit issued and sold in this
subsequent private placement was sold at $25,000 per unit and is comprised
of (i) 87,108 shares of common stock, and (ii) a five-year warrant to
purchase 87,108 shares of our common stock at an exercise price of $0.40
per share. Upon the closing of this second private placement offering the
Company issued to the investor 3,832,753 shares of common stock and
warrants to purchase up to an aggregate of 3,832,753 shares of common
stock. |
|
The
aggregate sale from the four private placements was $4,353,000, which was
netted against transaction costs of $329,673 for net proceeds of
$4,023,327. |
|
Pursuant
to the Recapitalization and the first closing of the private placement,
there are 2,381,525 options to purchase the Company's common stock
outstanding. These options have a 10-year life and vest ratably over a
four-year period. A summary of the options outstanding are as
follows: |
|
|
|
|
Options |
|
Exercise
Price |
|
|
|
|
|
1,966,939 |
|
$ |
0.1952 |
|
14,087 |
|
$ |
0.2839 |
|
35,639 |
|
$ |
0.2870 |
|
227,509 |
|
$ |
0.3549 |
|
137,351 |
|
$ |
0.4259 |
|
2,381,525 |
|
|
|
|
|
Pursuant
to the Recapitalization and the first closing of the private placement,
there are 14,951,292 warrants to purchase the Company's common stock
outstanding. A summary of the warrants outstanding are as
follows: |
ADVAXIS, INC. (a development stage
company) |
|
NOTES TO FINANCIAL STATEMENTS (information related
to the ten-month period ended October 31, 2003 and the three-month
periods ended January 31, 2005 and 2004 is
unaudited) |
|
|
|
|
Expiration |
|
|
|
|
|
|
|
2,543,553 |
|
$ |
0.20 |
|
|
2009 |
|
35,218 |
|
$ |
0.28 |
|
|
2011 |
|
142,555 |
|
$ |
0.29 |
|
|
2007 |
|
2,038,328 |
|
$ |
0.29 |
|
|
2009 |
|
10,191,638 |
|
$ |
0.40 |
|
|
2009 |
|
14,951,292 |
|
|
|
|
|
|
|
On
December 20, 2004, the Company entered into an Amended and Restated
Employment Agreement with J. Todd Derbin, its current chief executive
officer and president ("Employment Agreement"). Pursuant to the terms of
the Employment Agreement, Mr. Derbin shall serve as the Company's chief
executive officer and president for a period of one year commencing on
January 1, 2005. The Employment Agreement may be extended, in writing, by
the Company and Mr. Derbin. Mr. Derbin's salary shall be $200,000,
provided that it shall be increased to $225,000 or $250,000 based upon
certain milestones of the Company as set forth in the Employment
Agreement. In addition, Mr. Derbin shall be entitled to bonuses in the
form of equity and/or cash as set forth in the Employment Agreement and he
shall be entitled to receive non-qualified stock options to purchase
common stock of the Company (the "Options"), the amount of which when
added to his existing 1,172,767 options shall equal 5% of the total issued
and outstanding common stock of the Company, as of March 31, 2005.
One-half of the Options shall vest on the grant date and one-half of the
Options shall vest monthly over four years at a rate of 1/48th
per month. The grant of the Options is subject to the Company adopting a
2005 Stock Option Plan, which is subject to stockholder
approval. |
|
The
Company entered into an employment agreement with Dr. Vafa Shahabi PhD to
become Head of Director of Science effective March 1, 2005, terminable on
30 days notice. The compensation is $100,000 per annum with a potential
bonus of $20,000. In addition, Dr. Shahabi will be granted 150,000
options. |
|
The
Company entered into an employment agreement with Dr. John Rothman, Ph.D
to become Vice President of Clinical Development effective March 7, 2005
for a term of one year ending February 28, 2006 and terminable on 30 days
notice. His compensation is $170,000 per annum, to increase to $180,000
upon the closing of a $15 million equity financing. Upon meeting
incentives to be set by the Company, he will receive a bonus of up to
$45,000. In addition, Dr. Rothman will be granted 360,000 stock
options. |
|
56,320,114
Shares
ADVAXIS,
INC.
Common
Stock
__________________
PROSPECTUS
____________,
2005
__________________
Until
[__________], 2005, all dealers that buy, sell, or trade the common stock, may
be required to deliver a prospectus, regardless of whether they are
participating in this offering. This is in addition to the dealers’ obligation
to deliver a prospectus when acting as underwriters and with respect to their
unsold allotments or subscriptions.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
INDEMNIFICATION
OF DIRECTORS AND OFFICERS
Our
articles of incorporation and by-laws include provisions to (1) indemnify the
directors and officers to the fullest extent permitted by the Colorado Revised
Statutes, including circumstances under which indemnification is otherwise
discretionary and (2) eliminate the personal liability of directors and officers
for monetary damages resulting from breaches of their fiduciary duty, except for
liability for breaches of the duty of loyalty, acts, or omissions not in good
faith or which involve intentional misconduct or a knowing violation of law,
violations under Section 7-108-704 of Colorado Law, or for any transaction from
which the director derived an improper personal benefit. We believe that these
provisions are necessary to attract and retain qualified persons as directors
and officers.
We will
enter into an indemnification agreement with each of our directors which
provides that we will indemnify our directors and advance expenses to our
directors, to the extent permitted by the laws of the State of Colorado.
We have
directors and officers liability insurance in an amount not less than $1
million.
Insofar
as indemnification for liability arising under the Act may be permitted to our
directors, officers and controlling persons as stated in the foregoing
provisions or otherwise, we have been advised that, in the opinion of the SEC,
this indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable.
OTHER
EXPENSES OF ISSUANCE AND DISTRIBUTION
The
following table sets forth the costs and expenses, other than underwriting
discounts and commissions, if any, payable by the Registrant relating to the
sale of common stock being registered. All amounts are estimates except the SEC
registration fee.
SEC
registration fee |
|
$ |
6,628.94* |
|
Printing
and engraving expenses |
|
$ |
10,000* |
|
Legal
fees and expenses |
|
$ |
25,000* |
|
Accounting
fees and expenses |
|
$ |
5,000* |
|
Transfer
agent and registrar’s fees and expenses |
|
$ |
10,000* |
|
Miscellaneous
expense |
|
$ |
3,371.06* |
|
Total |
|
$ |
60,000* |
|
_________________
*
Estimates only.
RECENT
SALES OF UNREGISTERED SECURITIES
During
the last three years, we have issued unregistered securities to the persons, as
described below. None of these transactions involved any underwriters,
underwriting discounts or commissions, except as specified below, or any public
offering, and we believe that each transaction was exempt from the registration
requirements of the Securities Act of 1933 by virtue of Section 4(2) thereof
and/or Regulation D promulgated thereunder. All recipients had adequate access,
though their relationships with us, to information about us.
We issued
on November 12, 2004 pursuant to the Share Exchange, 16,350,323 shares of our
common stock, 2,381,525 options to purchase shares of common stock and 584,885
warrants to purchase shares of common stock.
We issued
on November 12 ,2004 pursuant to the conversion of $595,000 principal amount of
outstanding promissory notes, 2,136,441 shares of our common stock and warrants
to purchase 2,136,441 shares of our common stock.
On
November 12, 2004 in connection with the first closing of the Private Placement
we issued 12,248,798 shares of our common stock and 12,229,966 warrants to
purchase shares of our common stock.
On
November 12, 2004 we issued a warrant to purchase 60,000 shares of common stock
to RB Holdings, LLC, an affilate of Reitler Brown & Rosenblatt LLC in
connection with legal services rendered.
On
December 8, 2004, in connection with the second closing of the Private Placement
we issued 834,843 shares of our common stock and 836,237 warrants to purchase
shares of our common stock.
On
January 4, 2005, in connection with the third and final closing of the Private
Placement we issued 534,299 shares of our common stock and 535,192 warrants to
purchase shares of our common stock.
On
January 12, 2005, in connection with the closing of a second private placement
offering, we issued 3,832,752 shares of our common stock and 3,832,752 warrants
to purchase shares of our common stock.
EXHIBITS |
|
|
EXHIBIT
NUMBER |
DESCRIPTION
OF EXHIBIT |
|
|
|
|
Exhibit
3.1 |
Amended
and Restated Articles of Incorporation. Incorporated by reference to
Exhibit 3.1 to Report on Form 8K filed with the SEC on December 27,
2004. |
|
|
|
|
Exhibit
3.2 |
Amended
and Restated Bylaws. Incorporated by reference to |
|
|
Exhibit
3.1 to Report on Form 8K filed with the SEC on December 27,
2004. |
|
|
|
|
Exhibit
4.1 |
Form
of Warrant issued to purchasers. Incorporated by reference to Exhibit 4.1
to Report on Form 8K filed with the SEC on November 18,
2004. |
|
|
|
|
Exhibit
4.2 |
Form
of Warrant issued to Placement Agent. Incorporated by reference to Exhibit
4.2 to Report on Form 8K filed with the SEC on November 18,
2004. |
|
|
|
|
Exhibit
5.1 |
Opinion
of Frascona, Joiner, Goodman and Greenstein, PC |
|
|
|
|
Exhibit
10.1 |
Share
and Exchange Agreement, dated as of August 25, 2004, by and among the
Company, Advaxis and the shareholders of Advaxis. Incorporated by
reference to Exhibit 10.1 to Report on Form 8K filed with the SEC on
November 18, 2004. |
|
|
|
|
Exhibit
10.2 |
Form
of Securities Purchase Agreement, by and among the Company and the
purchasers listed as signatories thereto. Incorporated by reference to
Exhibit 10.2 to Report on Form 8K filed with the SEC on November 18,
2004. |
|
|
|
|
Exhibit
10.3 |
Form
of Registration Rights Agreement, by and among the Company and the persons
listed as signatories thereto. Incorporated by reference to Exhibit 10.3
to Report on Form 8K filed with the SEC on November 18,
2004. |
|
|
|
|
Exhibit
10.4 |
Form
of Standstill Agreement, by and among the Company and persons listed on
Schedule 1 attached thereto. Incorporated by reference to Exhibit 10.4 to
Report on Form 8K filed with the SEC on November 18,
2004. |
|
|
|
|
Exhibit
10.5 |
Amended
and Restated Employment Agreement, dated December 20, 2004, by and between
the Company and J.Todd Derbin. Incorporated by reference to Exhibit 10.1
to Report on Form 8K filed with the SEC on December 23,
2004. |
|
|
|
|
Exhibit
10.6 |
2004
Stock Option Plan of the Company. Incorporated by reference to Exhibit
10.1 to Report on Form 8K filed with the SEC on December 27,
2004. |
|
|
|
|
Exhibit
10.7 |
License
Agreement, dated as of June 17, 2002, by and between Advaxis and The
Trustees of the University of Pennsylvania*. |
|
|
|
|
Exhibit
10.8 |
Non-Exclusive
License and Bailment, dated as of March 17, 2004, betweeen The Regents of
the University of California and Advaxis, Inc. |
|
|
|
|
Exhibit
10.9 |
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP Management,
LLC. and the Company. |
|
|
|
|
Exhibit
10.10 |
Government
Funding Agreement, dated as of April 5, 2004, by and between David Carpi
and Advaxis, Inc. |
|
|
|
|
Exhibit
10.11 |
Amended
and Restated Consulting and Placement Agreement, dated as of May 28, 2003,
by and between David Carpi and Advaxis, Inc., as
amended |
|
|
|
|
Exhibit
10.12 |
Consultancy
Agreement, dated as of January 22, 2005, by and between Dr. Yvonne
Paterson and Advaxis, Inc. |
|
|
|
|
Exhibit
10.13 |
Consultancy
Agreement, dated as of March 15, 2003, by and between Dr. Joy A. Cavagnaro
and Advaxis, Inc. |
|
|
|
|
Exhibit
10.14 |
Grant
Writing Agreement, dated June 19, 2003, by and between DNA Bridges, Inc.
and Adavaxis, Inc. |
|
|
|
|
Exhibit
10.15 |
Consulting
Agreement, dated as of July 2, 2004, by and between Sentinel Consulting
Corporation and Advaxis, Inc. |
|
|
|
|
Exhibit
10.16 |
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and Advaxis,
Inc.* |
|
|
|
|
Exhibit
10.17 |
Securities
Purchase Agreement, dated as of January 12, 2005, by and between the
Company and Harvest Advaxis LLC. Incorporated by reference to Exhibit 10.1
to Report on Form 8K filed with the SEC on January 18,
2005. |
|
|
|
|
Exhibit
10.18 |
Registration
Rights Agreement, dated as of January 12, 2005, by and between the Company
and Harvest Advaxis LLC. Incorporated by reference to Exhibit 10.2 to
Report on Form 8K filed with the SEC on January 18,
2005. |
|
|
|
|
Exhibit
10.19 |
Letter
Agreement, dated as of January 12, 2005 by and between the Company and
Robert T. Harvey. Incorporated by reference to Exhibit 10.3 to Report on
Form 8K filed with the SEC on January 18, 2005. |
|
|
|
|
Exhibit
10.20 |
Consultantcy
Agreement, dated as of January 15, 2005, by and between Dr. David Filer
and the Company. |
|
|
|
|
Exhibit
10.21 |
Consultancy
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the Company. |
|
|
|
|
Exhibit
10.22 |
Agreement,
dated February 1, 2004, by and between Strategic Growth International Inc.
and the Company. |
|
|
|
|
Exhibit
10.23 |
Letter
Agreement, dated February 10, 2005, by and between Richard Berman and the
Company. |
|
|
|
|
Exhibit
10.24 |
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi and the
Company. |
|
|
|
|
Exhibit
10.25 |
Employment
Agreement, dated March 1, 2005, by and between John Rothman and the
Company. |
|
|
|
|
Exhibit
10.26 |
Clinical
Research Services Agreement, dated April 6, 2005, between Pharm-Olam
International Ltd. and the Company.* |
|
|
|
|
Exhibit
10.27 |
Amendment
to Consultancy Agreement, dated as of April 4, 2005, between LVEP
Management LLC and the Company. |
|
|
|
|
|
|
|
Exhibit
10.28 |
Royalty
Agreement, dated as of May 11, 2003, by and between Cobra
Manufacturing PLC and the Company. |
|
|
|
|
|
|
|
Exhibit
14.1 |
Code
of Ethics. Incorporated by reference to Exhibit 14.1 to Report on Form 8K
filed with the SEC on November 18, 2004. |
|
|
|
|
Exhibit
21.1 |
Advaxis,
Inc., a Delaware corporation |
|
|
|
|
Exhibit
23.1 |
Consent
of Goldstein Golub Kessler LLP |
|
|
|
|
Exhibit
23.2 |
Consent
of Frascona, Joiner, Goodman and Greenstein, PC (included in Exhibit 5.1
above) |
|
|
|
|
Exhibit
24.1 |
Power
of Attorney (Included on the signature page) |
|
---------------------- |
|
|
*
Confidential Treatment sought. |
UNDERTAKINGS
The
undersigned small business issuer hereby undertakes to:
(1) For
determining any liability under the Securities Act of 1933, treat the
information omitted from this form of prospectus
filed as part of this registration statement in reliance upon Rule 430A and
contained in a form of prospectus filed by the small business issuer under Rule
424(b) (1), or (4) or 497(h) under the Securities
Act of 1933 as part of this registration
statement as of the time the SEC declared it effective.
(2) For
determining any liability under the Securities Act of 1933, treat each
post-effective amendment that contains a form of prospectus as a new
registration
statement for the securities offered in this registration statement, and that
offering of the securities at that time as the initial BONA FIDE offering of
those securities.
The
undersigned small business issuer hereby undertakes with respect to the
securities being offered and sold in this offering:
(1) To file,
during any period in which it offers or sells securities, a post-effective
amendment to this Registration
Statement to:
(a) Include
any prospectus
required by Section 10(a)(3) of the Securities
Act of 1933;
(b) Reflect
in the prospectus
any facts or events which, individually or together, represent a fundamental
change in the information in this 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 percent change in
the maximum aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration statement; and
(c) Include
any additional or changed material information on the plan of
distribution.
(2) For
determining liability under the Securities
Act of 1933, treat each post-effective amendment as a new registration
statement of the securities offered, and the offering of the securities at that
time to be the initial bona fide offering.
(3) File a
post-effective amendment to remove from registration any of the securities that
remain unsold at the end of the offering.
Insofar
as indemnification by the undersigned small business issuer for liabilities
arising under the Securities Act of 1933 may be permitted to directors, officers
and controlling persons of the small business issuer pursuant to the foregoing
provisions, or otherwise, the small business issuer has been advised that in the
opinion of the SEC such
indemnification is against public policy as expressed in the Securities
Act of 1933, and is, therefore, unenforceable.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the Registrant has duly
caused this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in Princeton, Mercer County, State of
New Jersey, on the 9th day of June, 2005.
|
|
|
|
ADVAXIS, INC.
|
|
|
|
|
By: |
/s/ J. Todd
Derbin |
|
J. Todd Derbin |
|
Chief Executive Officer
|
POWER
OF ATTORNEY
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration
Statement has been signed by the following persons in the capacities and on the
dates indicated:
SIGNATURE |
|
TITLE |
|
DATE |
/s/
J. Todd Derbin |
|
Chief
Executive Officer and Director |
|
June
9, 2005 |
J.
Todd Derbin |
|
(Principal
Executive Officer |
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Chief
Financial Officer and Director |
|
June
9, 2005 |
Roni
Appel |
|
(Principal
Financial and Accounting Officer) |
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
June
9, 2005 |
Scott
Flamm |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
June
9, 2005 |
Thomas
McKearn |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
June
9, 2005 |
James
Patton |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Director |
|
June
9, 2005 |
Steven
Roth |
|
|
|
|
|
|
|
|
|
*by:
/s/ J. Todd Derbin |
|
|
|
|
J.
Todd Derbin |
|
|
|
|
Attorney-in-fact |
|
|
|
|
Unassociated Document
CONFIDENTIAL
TREATMENT REDACTED VERSION
LICENSE
AGREEMENT
BETWEEN
ADVAXIS,
INC.
(COMPANY)
AND
THE
TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
(PENN)
_____
EFFECTIVE
DATE: JUNE 17, 2002
Table
of Contents
1.
Definitions |
|
|
|
2.
License Grant |
|
|
|
3.
Fees and Royalties |
|
|
|
4.
Confidentiality |
|
|
|
5.
Term and Termination |
|
|
|
6.
Patent Maintenance and Reimbursement |
|
|
|
7.
Infringement And Litigation |
|
|
|
8.
Disclaimer Of Warranties; Indemnification |
|
|
|
9.
Use Of PENN's Name |
|
|
|
10.
Additional Provisions |
|
Attachment
1 - List
of Intellectual Property
Attachment
2 -
Joinder Agreement
Attachment
3 -
Development Plan
Attachment
4 - Stock
Purchase Agreement
Attachment
5 -
Shareholders Agreement
Attachment
6 - Form
NDA
Attachment
7 - Client
and Billing Agreement
Attachment
8 -
Required Territories
LICENSE
AGREEMENT
This
License Agreement ("AGREEMENT") is between The Trustees of the University of
Pennsylvania, a Pennsylvania nonprofit corporation, with offices located at 3700
Market Street, Suite 300, Philadelphia, Pennsylvania 19104-3147 ("PENN") and
Advaxis, Inc., a corporation organized and existing under the laws of Delaware
("COMPANY"), having a place of business at 250 West Lancaster Avenue, Ste 100,
Paoli, PA 19301.
This
AGREEMENT shall be and become effective on the date (the “EFFECTIVE DATE”) on
which COMPANY raises two-hundred fifty thousand dollars ($250,000) of equity
capital or convertible debt, whereupon the COMPANY shall be deemed to have
exercised its rights under the Option (as defined below).
BACKGROUND
A. PENN
owns issued and pending U.S. and foreign patent applications based upon
information in PENN Dockets D751, H1219, H1219 - CIP, J1598, M2244, M2244 - CIP,
N2483 (which was joined with M2244), O2876 and O2883 naming Dr. Yvonne Paterson
and colleagues of PENN’s School of Medicine, as inventors; and,
B. PENN
and COMPANY have entered into a Exclusive Negotiation and Option Agreement (the
“Option”) with an effective date of March 15, 2002 and extendable upon agreement
of the parties, which grants COMPANY exclusive rights to negotiate for a license
to such pending U.S. and foreign patents and patent applications;
and,
C.
COMPANY desires to fund further research by Dr. Paterson relating to therapeutic
vaccines based on LLO-antigen fusion proteins under a sponsored research
agreement between PENN and COMPANY; and,
D.
COMPANY desires to obtain the exclusive right and license to use and exploit the
intellectual property developed by Dr. Paterson, et al, as described in
Attachment 1,
in
accordance with the DEVELOPMENT PLAN (as defined below); and,
E. PENN
has determined that commercial exploitation of the intellectual property
developed by Dr. Paterson in accordance with the terms of this AGREEMENT is in
the best interest of PENN and is consistent with its educational and research
missions; and,
NOW,
THEREFORE, in consideration of the promises and covenants contained in this
AGREEMENT and intending to be legally bound, the parties agree as
follows:
1.
DEFINITIONS
1.1 AFFILIATE
means, any
legal entity directly or indirectly controlling, controlled by or under common
control with COMPANY that has executed a Joinder Agreement substantially in the
form of Attachment 2 or such other form as PENN and COMPANY may hereafter agree
in writing. For purposes of this AGREEMENT, "control" means the direct or
indirect ownership of more than fifty percent (50%) of the outstanding voting
securities of a legal entity, or the right to receive more than fifty percent
(50%) of the profits or earnings of a legal entity, or the right to control the
policy decisions of a legal entity.
1.2 CALENDAR
QUARTER means each three calendar month period beginning on January 1, April 1,
July 1 and October 1, or any portion thereof, arising during the term of this
AGREEMENT.
1.3 DEVELOPMENT
PLAN means a plan for the development and/or marketing of the PENN PATENT RIGHTS
and/or PENN LICENSED PRODUCTS that reasonably demonstrates COMPANY's capability
to bring such patent rights, technical information and/or products to practical
application, as more fully described in the
Attachment 3, consisting of the following:
1.3.1 development
activities to be undertaken, including proposed dates of completion of all major
milestones to develop and commercialize PENN LICENSED PRODUCTS;
1.3.2 a list of
all government regulatory approvals, including the nature of submissions and
government agencies involved in pre-market clearance;
1.3.3 a list of
current competitors and their competitive products, including competitors' known
plans for further development of competing technologies; and
1.3.4 anticipated
dates of first SALE of each PENN LICENSED PRODUCT described in the DEVELOPMENT
PLAN.
1.4 FAIR
MARKET VALUE means the cash consideration which COMPANY, an AFFILIATE, or any
sublicensee would realize from an unaffiliated, unrelated buyer in an arm's
length sale of an identical item sold in the same quantity and at the same time
and place of the transaction.
1.5 FIELD OF
USE means therapeutic use in humans and other mammals.
1.6 NET SALES
means the consideration or FAIR MARKET VALUE attributable to the SALE of any
PENN LICENSED PRODUCT(S), less the qualifying costs set forth below that are
directly attributable to such SALE and actually identified on the invoice and
borne by COMPANY, an AFFILIATE, or any sublicensee. Such qualifying costs shall
be limited to the following:
1.6.1
Discounts, in amounts customary in the trade, for quantity purchases, prompt
payments and for wholesalers and distributors.
1.6.2
Credits or refunds, not exceeding the original invoice amount, for claims or
returns.
1.6.3
Prepaid outbound transportation expenses and transportation insurance
premiums.
1.6.4
Sales and use taxes and other fees, duties, and imports imposed by any
governmental agency.
1.7 PENN
LICENSED PRODUCT(S) means products which are made, made for, used or sold by
COMPANY, an AFFILIATE, or any sublicensees and which: (1) in the absence of this
AGREEMENT would infringe at least one Valid Claim or (2) use a process or
machine covered by a Valid Claim.
1.8 PENN
PATENT RIGHTS means all patents represented by or issuing from those United
States patent applications listed in Attachment 1, including continuation,
divisional and re-issue applications and any foreign counterparts and extensions
of the foregoing.
1.9 PRIMARY
STRATEGIC FIELD shall be
Cancer, including Cancer caused by infection.
1.10 SALE
means any bona fide transaction for which consideration is in fact received by
COMPANY or AFFILIATE or any sublicensee hereunder or expected for the sale, use,
lease, transfer or other disposition of PENN LICENSED PRODUCT(S). A SALE shall
be deemed completed at the time COMPANY, an AFFILIATE, or any sublicensee
invoices, ships, or receives payment for such PENN LICENSED PRODUCT(S),
whichever occurs first.
1.11 SECONDARY
STRATEGIC FIELDS includes
(a) Infectious Disease, (b) Allergy, (c) Autoimmune Disease, and (d) any other
therapeutic indications for which PENN LICENSED PRODUCT(S) are
developed.
1.12 SPONSORED
RESEARCH AGREEMENT means a sponsored research agreement between PENN and COMPANY
providing for the conduct of certain research consistent with this AGREEMENT,
all on terms and conditions acceptable to PENN and COMPANY.
1.13 VALID
CLAIM means any pending, issued or granted claim of the PENN PATENT RIGHTS that
has not been surrendered, abandoned or declared invalid or unenforceable by an
unappealed and unappealable decision of a court of competent
jurisdiction.
2.
LICENSE GRANT
2.1 PENN
grants to COMPANY for the term of this AGREEMENT an exclusive, world-wide right
and license, with the right to grant sublicenses, to make, have made, use,
import, sell and offer for sale PENN LICENSED PRODUCT(S) in the FIELD OF USE.
Except for Section 2.6, no other rights or licenses are granted. Intellectual
property created or conceived during the performance of the SPONSORED RESEACH
AGREEMENT shall be governed by the SPONSORED RESEARCH AGREEMENT.
2.2 This
license grant is exclusive except that PENN may use and permit other not-for
profit organizations to use the PENN PATENT RIGHTS for educational and research
purposes.
2.3 COMPANY
acknowledges that pursuant to Public Laws 96-517, 97-256 and 98-620, codified at
35 U.S.C. 200-212, the United States government retains certain rights in
intellectual property funded in whole or part under any contract, grant or
similar agreement with a Federal agency. Pursuant to these laws, the government
may impose certain requirements regarding such intellectual property, including
but not limited to the requirement that products resulting from such
intellectual property sold in the United States must be substantially
manufactured in the United States. This license grant is expressly subject to
all applicable United States government rights as provided in the
above-mentioned laws and any regulations issued under those laws, as those laws
or regulations may be amended from time to time.
2.4 The right
to sublicense granted to COMPANY under this AGREEMENT is subject to the
following conditions:
2.4.1 In
each such sublicense, COMPANY must prohibit the sublicense from further
sublicensing and require that the sublicensee is subject to the terms and
conditions of the license granted to COMPANY pursuant to Section 2.1 of this
AGREEMENT, the limitations thereon set forth in Sections 2.2 , 2.3 and 2.4 as
well as sublicensee’s compliance with Sections 3.4.4, 5.5, 5.9 and 9, and
COMPANY shall impose upon its sublicensees obligations comparable to those
obligations imposed upon COMPANY pursuant to Sections 8.2 and 8.4 of this
Agreement. COMPANY may submit a written request to PENN to obtain the right to
allow a sublicensee to further sublicense on a case by case basis. Such right to
allow a sublicensee to further sublicense PENN PATENT RIGHTS shall not be
unreasonably withheld provided that COMPANY can validate to PENN’s satisfaction
that such sublicensee has the financial and resource capabilities to develop and
commercialize PENN PATENT RIGHTS and further, such sublicensee agrees that any
sub-sublicense shall be subject to the terms and conditions of the license
granted to COMPANY under this AGREEMENT.
2.4.2
Within thirty (30) days after COMPANY enters into any sublicense, COMPANY shall
deliver to PENN a complete copy of the sublicense written in the English
language. PENN's receipt of the sublicense shall not constitute an approval of
the sublicense or a waiver of any of PENN's rights or COMPANY's obligations
under this AGREEMENT.
2.4.3 In
the event of a DEFAULT under Section 5.3 hereunder all payments then or
thereafter due to COMPANY from its AFFILIATES or sublicensees in connection with
rights granted to such third party pursuant to this Agreement shall upon notice
from PENN to any such AFFILIATE or sublicensee become owed directly to PENN for
the account of COMPANY; provided however, that PENN shall remit to COMPANY the
amount by which such payments exceed the amounts owed by COMPANY to
PENN.
2.4.4 In
the event that COMPANY enters into sublicenses, COMPANY remains primarily liable
to PENN for all of COMPANY'S duties and obligations contained in this AGREEMENT,
and any act or omission of a sublicensee which would be a breach of this
AGREEMENT if performed by COMPANY shall be deemed to be a breach by COMPANY of
this AGREEMENT.
2.5 Promptly
after the date of execution of this AGREEMENT, PENN and COMPANY shall in good
faith negotiate the terms of, and enter into, the SPONSORED RESEARCH AGREEMENT;
provided, however, that neither PENN nor COMPANY shall be obligated to enter
into the SPONSORED RESEARCH AGREEMENT on terms that are not acceptable to such
party in all respects.
2.6 PENN
grants to COMPANY a series of exclusive options during [ * ] following the
EFFECTIVE DATE of this AGREEMENT to obtain exclusive licenses to new inventions
on therapeutic vaccines: (1) involving the use of listeria vectors and/or
listeria antigen and/or PEST-containing fusion proteins in the FIELD OF USE and
(2) developed by, under the supervision of, or in collaboration with Dr. Yvonne
Paterson; to the extent of PENN's ownership interest in any resulting
intellectual property. Each option shall be granted at [ * ] to COMPANY by PENN,
and shall extend for a period of (a) [ * ] from the date of disclosure of such
new inventions if the disclosure was made on or before 12.31.2004, or (b)[ * ]
from the date of disclosure of such new inventions if the disclosure was made
after 12.31.2004 but before the [ * ] anniversary of the EFFECTIVE
DATE. Such
license agreement shall include a license initiation fee of [ * ], shall be
substantially similar in form to this AGREEMENT and shall include no financial
terms that [ * ] in this AGREEMENT. All fees, excluding the license initiation
fee and royalty payments, shall be fully creditable against payments made by
COMPANY to PENN under this AGREEMENT.
2.7 PENN
grants to COMPANY a series of exclusive options during [ * ] following the
EFFECTIVE DATE of this AGREEMENT to obtain exclusive licenses to new inventions
on therapeutic vaccines: (1) involving the use of listeria vectors and/or
listeria antigen and/or PEST-containing fusion proteins in the FIELD OF USE; and
(2) developed by, under the supervision of, or in collaboration with Dr. Fred
Frankel; to the extent of PENN's ownership interest in any resulting
intellectual property. Each option shall be granted at [ * ] to COMPANY by PENN,
and shall extend for a period of (a) [ * ] from the date of disclosure of such
new inventions if the disclosure was made on or before 12.31.2004, or (b) [ * ]
from the date of disclosure of such new inventions if the disclosure was made
after 12.31.2004 but before the [ * ] anniversary of the EFFECTIVE
DATE. Upon
exercise of option by COMPANY, PENN and COMPANY agree to negotiate in good faith
a comprehensive license agreement within ninety (90) days of COMPANY's exercise
of its option. Such license agreement shall include a license initiation fee of
[ * ] fully creditable against license maintenance fees and shall be
substantially similar in form to this AGREEMENT, with financial terms not to
exceed those in this AGREEMENT.
3.
FEES AND ROYALTIES
3.1 LICENSE
INITIATION FEE AND ROYALTIES
3.1.1 In
partial consideration of the exclusive license granted to COMPANY, COMPANY shall
pay to PENN a non-refundable license initiation fee of [ * ] within thirty (30)
days of the date COMPANY receives in the aggregate [ * ] in equity financing.
The initiation fee paid to PENN pursuant to this Section shall be [ *
].
3.1.2 In
further consideration of the License, COMPANY shall perform its obligations
under that certain Stock Purchase Agreement dated April 19, 2002, between
COMPANY and PENN (“STOCK
PURCHASE AGREEMENT”), a
copy of which is attached as Attachment 4.
3.1.3. In
further consideration of the exclusive license granted to COMPANY, COMPANY must
pay to PENN, on a quarterly basis, royalties on the annual, worldwide NET SALES
of PENN LICENSED PRODUCTS as follows:
|
|
[ *
]% on NET SALES in countries with pending or issued patents;
and |
|
|
[ *
]% on NET SALES in countries without pending or issued
patents. |
However,
in the event that the PENN royalty rates represent greater than [ * ] of any
royalty payable to COMPANY by a sublicensee (on a country-by-country basis in
regard to patent status), PENN’s royalty rate shall be reduced to [ * ]of such
sublicense royalties; provided, however, that at no time will the aggregate
royalty due to PENN for any Calendar Quarter be less than [ * ]of worldwide NET
SALES of PENN LICENSED PRODUCTS.
3.1.4.
Following the first commercial SALE of a each
PENN LICENSED PRODUCT, COMPANY must pay to PENN non-refundable minimum royalties
in advance on the following dates and in the corresponding amounts:
|
Date
Payment Becomes Due |
Amount |
|
|
|
|
|
|
the
first January 1st
arising after the first commercial SALE |
$[
* ] |
|
|
|
|
|
|
the
second January 1s
arising
after the first commercial SALE |
$[
* ] |
|
|
|
|
|
|
the
third and fourth January 1st
arising after the first commercial SALE |
$[
* ] |
The
obligation to pay such Minimum Royalties will not, in respect of each PENN
LICENSED PRODUCT, extend beyond January 1st of the [
* ] year following the first commercial sale of that PENN LICENSED PRODUCT. A
minimum royalty payment paid under this Section 3.1.5 shall serve as an advance
payment against royalties due under Section 3.1.3 during the period for which
such minimum royalty payment was paid.
3.1.5
COMPANY will pay PENN, on a quarterly basis, a percentage of any sublicense
initiation fee or any other non-royalty payments received by COMPANY from
sublicensees of PENN PATENT RIGHTS as follows:
|
If
Sublicense Becomes Effective Anytime: |
Percent
of Sublicense Fees |
|
|
|
|
On
or before the 1st
Anniversary of the EFFECTIVE DATE |
[ *
]% |
|
|
|
|
After
the 1st
and on or before the 2nd
Anniversary of the EFFECTIVE DATE |
[ *
]% |
|
|
|
|
After
the 2nd
and on or before 3rd
Anniversary of the EFFECTIVE DATE |
[ *
]% |
|
|
|
|
After
the 3rd
and on or before the 4th
Anniversary of the EFFECTIVE DATE |
[ *
]% |
|
|
|
|
After
the 4th
Anniversary of the EFFECTIVE DATE |
[ *
]% |
Such
sublicense payments include but are not limited to: i) upfront cash payments
made to COMPANY in consideration of the sublicense, but excluding funds paid to
COMPANY for research and development purposes and equity investments in COMPANY
at FAIR MARKET VALUE, and excluding equity received by COMPANY in affiliates,
joint venture partners and sublicensees; ii) "premium" over the fair market
value of equity investments in COMPANY, where "premium" is defined as the amount
by which cash amounts received by COMPANY for a particular equity security
exceed the fair market value of such security and, notwithstanding the
definition of FAIR MARKET VALUE set forth in Section 1.4 above, the fair market
value of securities shall, for purposes of this Section 3.1.5(ii), be the
average of the final “bid” and “ask” price of COMPANY's securities as of the
close of business on the last business day prior to the date such securities are
transferred to COMPANY if such securities are publicly traded or, in the event
that such securities are not traded in the public market, the fair market value,
as of the date of such securities are issued to the sublicensee, shall be
established in good faith by the COMPANY Board of Directors; and iii) the fair
market value of non-cash consideration received by COMPANY from a sublicensee
(excluding equity received by COMPANY in sublicensee), where such fair market
value, notwithstanding the definition of FAIR MARKET VALUE set forth in Section
1.4 above, is determined as of the date such consideration is received by
COMPANY and equals the fair market value determined in good faith by the COMPANY
Board of Directors
3.1.6 NET
SALES of any PENN LICENSED PRODUCT shall not be subject to more than one
assessment of the scheduled royalty; such assessment shall be the highest
applicable royalty. Where any PENN LICENSED PRODUCT is the subject of a SALE by
the COMPANY or any AFFILIATE but the COMPANY concludes in good faith that, in
the ordinary course of business, the same PENN LICENSED PRODUCT will be the
subject of a subsequent SALE by the COMPANY or any AFFILIATE for an amount
greater than the consideration paid for the previous SALE, the COMPANY may
exclude consideration paid for the previous SALE from NET SALES until the date
arising ninety (90) days after the date of the previous SALE;. If a
subsequent SALE for an amount greater than the consideration paid for the
previous SALE arises prior to such date, then the consideration paid for the
previous SALE shall be permanently excluded from NET SALES; if there is no
subsequent SALE for an amount greater than the consideration paid for the
previous SALE prior to such date, then the consideration paid for the previous
SALE shall be included in NET SALES, but shall still be credited against any
subsequent SALE of the same PENN LICENSED PRODUCT for a higher
price.
3.2 MILESTONE
PAYMENTS
The
following milestone payments are non-refundable, non-creditable, and payable to
PENN by COMPANY within forty-five (45) days following the achievement of the
following milestones as follows:
3.2.1 [ * ]
shall be due for first commercial SALE of the first PENN LICENSED PRODUCT in the
PRIMARY STRATEGIC FIELD. Such payment shall be payable as follows: [ * ] shall
be paid within forty-five (45) days of the date of the first commercial SALE, [
* ] shall be paid on the first Anniversary of the first commercial SALE; and [ *
] shall be paid on the second Anniversary of the date of the first commercial
SALE.
3.2.2 [ * ]
shall be due and payable within forty-five (45) days following the date of the
first commercial SALE of a PENN LICENSED PRODUCT in a SECONDARY STRATEGIC FIELD;
provided,
however, that
this fee shall [ * ] for each of the SECONDARY STRATEGIC FIELDS in which PENN
LICENSED PRODUCTS are sold.
3.3 DILIGENCE
AND MAINTENANCE FEES
3.3.1
Financial Due Diligence
3.3.1.1 COMPANY
shall, within twelve (12) months of the EFFECTIVE DATE, raise at least [ * ] in
equity financing or convertible debt from reputable investors.
3.3.1.2
COMPANY shall, within thirty-six (36) months of the EFFECTIVE
DATE, raise
at least an additional [ * ] in equity financing or convertible debt from
reputable investors.
3.3.3
Developmental Due Diligence.
3.3.3.1 COMPANY
will use commercially reasonable efforts to develop, commercialize, and market
PENN LICENSED PRODUCTS as soon as practical, consistent with the terms of the
DEVELOPMENT PLAN and any DEVELOPMENT PLAN PROGRESS REPORTS provided pursuant to
Section 3.6.1 of this AGREEMENT. The DEVELOPMENT PLAN will be prepared by
COMPANY and delivered to PENN prior to the EFFECTIVE DATE.
3.3.3.2 COMPANY
agrees to commit resources (including relevant resources dedicated by
sublicensees and strategic or collaboration partners and including research
grants for Dr. Paterson) during the term of this AGREEMENT to the development
and commercialization of PENN LICENSED PRODUCTS in the PRIMARY STRATEGIC FIELD
in amounts not less than the following:
Anniversary
of |
Required
Diligence |
EFFECTIVE
DATE |
Expenditure
|
|
|
First
|
$[
* ] |
Second
|
$[
* ] |
Third |
$[
* ] |
Fourth |
$[
* ] |
Fifth
and thereafter |
$[
* ] |
Notwithstanding
the above, COMPANY shall be not be obligated to make any due diligence
expenditures at any time after the date the COMPANY first becomes obligated to
pay minimum royalties pursuant to Section 3.1.5. In the event that total
expenditures for the development and commercialization of PENN LICENSED PRODUCTS
do not meet or exceed the amounts set forth above, COMPANY must pay to PENN the
difference between the mandated amount listed above and the actual amount
expended by COMPANY and/or its sublicensees, strategic or collaboration
partner(s). Funds invested in development in a given year that are in excess of
the above amounts shall be creditable up to $[ * ] against the diligence
requirements of the following year.
3.3.3.3 SECONDARY
STRATEGIC FIELDS: By [ * ] of the EFFECTIVE DATE, COMPANY must either (i)
initiate research and development programs for the SECONDARY STRATEGIC FIELDS of
infectious disease, allergy, and autoimmune disease, at an initial annual
expense level of at least [ * ] per field, or (ii) partner with or grant one or
more third parties rights for the commercial development of PENN LICENSED
PRODUCTS in one or more of such SECONDARY STRATEGIC FIELDS.
3.3.3.4 In the
event COMPANY develops PENN LICENSED PRODUCTS in any SECONDARY STRATEGIC FIELDS
pursuant to Section 3.3.3.3, part (i), the parties will negotiate in good faith
due diligence requirements for subsequent years for such SECONDARY STRATEGIC
FIELD under development at that time. If COMPANY fails to complete either part
(i) or (ii) as described in Section 3.3.3.3 above for such SECONDARY STRATEGIC
FIELD(S) by [ * ] anniversary of the EFFECTIVE DATE, COMPANY will forfeit all
rights for development of commercial products in such SECONDARY STRATEGIC
FIELDS, and rights will return to PENN for such SECONDARY STRATEGIC FIELD(S).
PENN will thereafter be free to enter into agreements for such forfeited rights
with any third party for commercial development in the respective SECONDARY
STRATEGIC FIELD(S).
3.3.6 COMPANY
must pay to PENN annual license maintenance fees, according to the following
schedule:
Due
Date: |
Amount: |
|
|
1st
anniversary of EFFECTIVE DATE |
$[
* ] |
2nd
anniversary of EFFECTIVE DATE |
$[
* ] |
3rd
anniversary of EFFECTIVE DATE |
$[
* ] |
4th
anniversary of EFFECTIVE DATE |
$[
* ] |
5th
anniversary of EFFECTIVE DATE |
$[
* ] |
6th
anniversary of EFFECTIVE DATE and each anniversary
thereafter |
$[
* ] |
provided,
however, that
such fees shall not be payable on any anniversary of the EFFECTIVE DATE arising
at any time after the first commercial SALE of a PENN LICENSED
PRODUCT.
3.4 REPORTS
AND RECORDS
3.4.1 On each
December 1 arising during the term of this AGREEMENT, COMPANY must provide PENN
with written progress reports,
(each a
“DEVELOPMENT PLAN PROGRESS REPORT”), setting forth COMPANY'S progress regarding
its efforts to develop and commercialize PENN LICENSED PRODUCTS, including
activities of AFFILIATES and sublicensees, for the preceding year. COMPANY shall
also notify PENN within thirty (30) days of the first commercial SALE by the
COMPANY, an AFFILIATE, or any sublicensee of each PENN LICENSED PRODUCT. Each
DEVELOPMENT PLAN PROGRESS REPORT shall include, without limitation:
3.4.1.1 The date
of the DEVELOPMENT PLAN PROGRESS REPORT and the time covered by such
report.
3.4.1.2 Major
activities and accomplishments completed by COMPANY, any AFFILIATE or any
sublicensee since the last DEVELOPMENT PLAN PROGRESS REPORT.
3.4.1.3
Significant research and development projects currently being performed by
COMPANY, any AFFILIATE, or any sublicensee and projected dates of
completion.
3.4.1.4
Future development activities expected to be undertaken by COMPANY, any
AFFILIATE, or any sublicensee during the next reporting period.
3.4.1.5
Current development stage (e.g., pre-clinical, Phase I, Phase II or Phase II) of
each PENN LICENSED PRODUCT and targeted date of NDA approval, if
any.
3.4.1.6
Significant changes to the DEVELOPMENT PLAN, including the reasons for the
changes.
3.4.1.7
Summary of development efforts related to PENN PATENT RIGHTS being performed by
third parties including the nature of the relationship between the COMPANY
and such third parties.
3.4.2
COMPANY
must deliver to PENN within forty-five (45) days after the end of each CALENDAR
QUARTER a report, certified by the chief financial officer of COMPANY, setting
forth the calculation of the royalties due to PENN for such CALENDAR QUARTER,
including, without limitation:
3.4.2.1 Number of
PENN LICENSED PRODUCTS involved in SALES, listed by country.
3.4.2.2 Gross
consideration for SALES of PENN LICENSED PRODUCTS, including all amounts
invoiced, billed, or received.
3.4.2.3 Qualifying
costs, as defined in Section 1.5, listed by category of cost.
3.4.2.4 NET SALES
of PENN LICENSED PRODUCTS listed by country.
3.4.2.5 Royalties
owed to PENN, listed by category, including without limitation earned,
sublicensee-derived, and minimum royalty categories.
3.4.2.6 Earned
royalty amounts credited against minimum royalty payments.
3.4.3 COMPANY
must pay the royalties due under Sections 3.1 and 3.3 within forty-five (45)
days following the last day of the CALENDAR QUARTER in which the royalties
accrue. COMPANY must send with the royalties the report described in Section
3.4.1.
3.4.4 COMPANY
must maintain and cause its AFFILIATES and any sublicensees to maintain,
complete and accurate books and records which enable the royalties, fees, and
payments payable under this AGREEMENT to be verified. The records for each
CALENDAR QUARTER must be maintained for five (5) years after the submission of
each report provided pursuant to Section 3.4.2. Upon reasonable prior notice to
COMPANY, COMPANY must provide an independent auditor appointed by PENN and
reasonably acceptable to COMPANY with access to all books and records relating
to the SALES of PENN LICENSED PRODUCTS by COMPANY and its AFFILIATES or any
sublicensees in order to conduct a review or audit of those books and records.
Access to these books and records pertaining to NET SALES must be made available
following the date of the first product sale and then no more than once every
three (3) years following each audit during the term of this AGREEMENT, during
normal business hours, and on two (2) occasions during the three (3) year period
immediately following expiration or termination of this AGREEMENT. If a review
or audit of the [ * ] or more, COMPANY must reimburse to PENN its actual
out-of-pocket costs of employing its auditors in connection with such review or
audit. Notwithstanding the foregoing, COMPANY agrees to conduct, at its expense,
an independent audit of SALES and royalties at least every five (5) years once
annual SALES of a PENN LICENSED PRODUCT are greater than [ * ]. The audit shall
address, at a minimum, the amount of gross sales by or on behalf of COMPANY
during the audit period, the amount of funds owed to PENN under this AGREEMENT,
and whether the amount owed has been paid to PENN and is reflected in the
records of the COMPANY. A report by the auditors shall be submitted promptly to
PENN upon completion.
3.4.5 COMPANY
shall provide to PENN, at
least as frequently as they are distributed to the Board of Directors and/or
management of COMPANY, copies of: all Board and managerial reports that relate
to the PENN
PATENT RIGHTS and
PENN
LICENSED PRODUCTS; and all
business plans, projections and financial statements that are distributed to the
Board of Directors and/or management.
3.5 CURRENCY,
PLACE OF PAYMENT, INTEREST, PAYMENT OF EXPENSES
3.5.1 All
dollar amounts referred to in this AGREEMENT are expressed in United States
dollars. All payments to PENN under this AGREEMENT must be made in United States
dollars by check payable to "The Trustees of the University of Pennsylvania" and
sent to the following address:
The
Trustees of the University of Pennsylvania
[ *
]
For
electronic transfer, all payments should be sent to the following
address:
[ *
]
3.5.2 If
COMPANY receives revenues from SALES of PENN LICENSED PRODUCTS in currency other
than United States dollars, such revenues shall, for purposes of calculating NET
SALES, be converted into United States dollars at the conversion rate for the
foreign currency as published in the eastern edition of The Wall Street Journal
as of the last business day of the CALENDAR QUARTER in which such NET SALES were
accrued.
3.5.3 Amounts
that are not paid when due shall accrue interest from the due date until paid,
at a rate equal to [ * ] per month (or the maximum allowed by law, if
less).
4.
CONFIDENTIALITY
4.1 CONFIDENTIAL
INFORMATION means and includes all technical information, inventions,
developments, discoveries, software, know-how, methods, techniques, formulae,
data, processes and other proprietary ideas, whether or not patentable or
copyrightable, that PENN identifies as confidential or proprietary at the time
it is delivered or communicated to COMPANY.
4.2 COMPANY agrees to
maintain in confidence and not to disclose to any third party any CONFIDENTIAL
INFORMATION of PENN. COMPANY agrees to ensure that its employees have access to
CONFIDENTIAL INFORMATION only on a need-to-know basis and are obligated in
writing to abide by COMPANY's obligations under this AGREEMENT. The foregoing
obligation shall not apply to:
4.2.1
information that is known to COMPANY or independently developed by COMPANY prior
to the time of disclosure, in each case, to the extent evidenced by written
records promptly disclosed to PENN upon receipt of the CONFIDENTIAL
INFORMATION;
4.2.2
information disclosed to COMPANY by a third party that has a right to make such
disclosure;
4.2.3
information that becomes patented, published or otherwise part of the public
domain as a result of acts by PENN or a third person obtaining such information
as a matter of right; or
4.2.4 information
that is required to be disclosed by order of United States governmental
authority or a court of competent jurisdiction; provided that COMPANY must use
best efforts to obtain confidential treatment of such information by the agency
or court.
4.2.5
information
disclosed by COMPANY to a third party under the normal course of business,
provided that COMPANY discloses such information under confidentiality
agreements that are substantially in the form of Attachment 6 or such other form
as PENN may from time-to-time approve.
4.3 PENN
shall not be obligated to accept any confidential information from COMPANY. PENN
shall use best efforts not to disclose confidential information of COMPANY that
is received by PENN’s Center for Technology Transfer from COMPANY to any third
party (subject to the exceptions analogous to those in Section 4.2). PENN bears
no institutional responsibility for maintaining the confidentiality of any
CONFIDENTIAL INFORMATION other than (i) reports provided pursuant to Sections
3.4.1. and 3.4.2 and (ii)
any information disclosed to PENN's auditor pursuant to Section
3.4.4.
4.4 PENN
acknowledges that COMPANY is free to enter into confidentiality agreements with
any faculty members or other employees or students of PENN provided such
agreements are acceptable to the relevant faculty members, employees or students
and are substantially in the form of Attachment 6 or such other form as PENN may
from time-to-time approve.
5.
TERM AND TERMINATION
5.1 This
AGREEMENT, unless sooner terminated as provided in this AGREEMENT, terminates
upon the later of: (a) expiration of the last to expire or become abandoned of
the PENN PATENT RIGHTS; or (b) twenty (20) years after the EFFECTIVE
DATE.
5.2 COMPANY
may, upon sixty (60) days written notice to PENN, terminate this AGREEMENT by
doing all of the following:
5.2.1
ceasing to make, have made, use, import, sell and offer for sale all PENN
LICENSED PRODUCTS; and
5.2.2
terminating all sublicenses, and causing all AFFILIATES and sublicensees to
cease making, having made, using, importing, selling and offering for sale all
PENN LICENSED PRODUCTS; and
5.2.3
paying all monies owed to PENN under this AGREEMENT and the SPONSORED RESEARCH
AGREEMENT, if any.
5.3 PENN may
terminate this AGREEMENT if any of the following events of default (“DEFAULT”)
occur:
5.3.1
COMPANY is late in paying to PENN royalties, expenses, or any other monies due
under this AGREEMENT and COMPANY does not pay PENN in full within ninety (90)
days of written demand for such payment; or
5.3.2
COMPANY, experiences a Trigger Event (as defined below); or
5.3.3
COMPANY, or any AUTHORIZED AFFILIATE is in material breach of this AGREEMENT and
such breach is not cured within ninety
(90) sixty
(60) days after written notice of the breach is provided to
COMPANY.
5.4 Trigger
Event means any of the following:
5.4.1.1
becomes insolvent, bankrupt or generally fails to pay its debts as such debts
become due;
5.4.1.2
is adjudicated insolvent or bankrupt; admits in writing its inability to pay its
debts; or shall suffer a custodian, receiver or trustee for it or substantially
all of its property to be appointed and, if appointed without its consent, not
be discharged within thirty (30) days; or
5.4.1.3
makes an assignment for the benefit of creditors; or suffers proceedings under
any law related to bankruptcy, insolvency, liquidation or the reorganization,
readjustment or the release of debtors to be instituted against it and, if
contested by it, not dismissed or stayed within ten (10) days;
5.4.2 If
proceedings under any law related to bankruptcy, insolvency, liquidation, or the
reorganization, readjustment or the release of debtors are instituted or
commenced by COMPANY;
5.4.3 If any
order for relief is entered relating to any of the proceedings described in
Sections 5.4.1 or 5.4.;
5.4.4 If
COMPANY shall call a meeting of its creditors with a view to arranging a
composition or adjustment of its debts;
5.4.5 If any
sublicensee experiences an event comparable to a TRIGGER EVENT or is in material
breach of its sublicense and fails to cure such material breach within sixty
(60) days of COMPANY's written notice thereof, and (i) such sublicensee is
either (x) responsible for a material amount of NET SALES or (y) primarily
responsible for research and/or development activities relating to any
contemplated PENN LICENSED PRODUCT described in the DEVELOPMENT PLAN and
anticipated to result in commercial SALES having a positive material effect on
NET SALES, and (ii) COMPANY fails to use commercially reasonable efforts to
exercise its termination rights under the relevant sublicense;
5.4.6 If any
AFFILIATE experiences an event comparable to a TRIGGER EVENT and (i) such
AFFILIATE is either (x) responsible for a material amount of NET SALES or (y)
primarily responsible for research and/or development activities relating to any
contemplated PENN LICENSED PRODUCT described in the DEVELOPMENT PLAN and
anticipated to result in commercial SALES having a positive material effect on
NET SALES, and (ii) COMPANY fails to use commercially reasonable efforts to
exercise its termination rights under any applicable agreements between COMPANY
and such AFFILIATE implicating the rights granted to COMPANY under this
AGREEMENT or otherwise deprive such AFFILIATE of any responsibility for the
development or commercialization of PENN LICENSED PRODUCTS; or
5.4.7 If,
without PENN's express prior written consent, COMPANY grants a sublicense to. or
otherwise subsequently conducts material business implicating COMPANY's rights,
duties and obligations under this AGREEMENT with, any Affiliate or sublicensee
whose agreement or commercial relationship with COMPANY was previously
terminated by COMPANY as contemplated in Sections 5.4.5 or 5.4.6 above.
5.5 In the
event of a termination under Section 5.3 above, all duties of PENN and all
rights (but not duties) of COMPANY under this AGREEMENT immediately terminate
without the necessity of any action being taken either by PENN or by COMPANY.
Upon and after any termination of this Agreement, COMPANY, any AFFILIATE, and
any sublicensee shall refrain from further manufacture, sale, marketing,
importation and/or distribution of PENN
LICENSED PRODUCT(s). If,
upon a termination of this agreement by PENN, a sublicensee is not in breach of
its sublicense agreement and did not cause the Trigger Event, than PENN shall
agree to negotiate in good faith with sublicensee a license agreement having
commercially-reasonable terms.
5.6 Upon
termination of this AGREEMENT, COMPANY must, at PENN's request, return to PENN
all CONFIDENTIAL INFORMATION in respect of which COMPANY is RECIPIENT, together
with any data generated by COMPANY during the term of this AGREEMENT which will
facilitate the further development of the Technology licensed to COMPANY
hereunder (the “NEW COMPANY DATA”). Upon termination of this AGREEMENT, COMPANY
agrees to negotiate in good faith a license granting to potential licensees
identified by PENN rights in the NEW COMPANY DATA on commercially reasonable
terms.
5.7 COMPANY's
obligation to pay all monies owed but not yet paid under this AGREEMENT shall
survive termination of this AGREEMENT. In addition, the provisions of Sections
3.4.2, 3.4.3, 3.4.4 and 3.5, Articles 4 - Confidentiality, Article 5 - Term and
Termination, Article 8 - Disclaimer of Warranties; Indemnification, Article 9 -
Use of PENN's Name; and Article 10 - Additional Provisions shall survive such
termination in accordance with their respective terms.
5.8 Upon
termination of this AGREEMENT, COMPANY shall cause physical inventories to be
taken immediately of: (a) all completed PENN
LICENSED PRODUCT(s) on
hand under the control of COMPANY, any AFFILIATES, or any sublicensees; and (b)
such PENN
LICENSED PRODUCT(s) as
are in the process of manufacture and component parts thereof as of the date of
termination of this AGREEMENT, which inventories shall be reduced to writing.
COMPANY shall deliver copies of such written inventories, verified by an officer
of COMPANY forthwith to PENN.
PENN shall
have 45
forty-five (45) days after receipt of such verified inventories within which to
challenge the inventory and request an audit. Upon five (5) days written notice
to COMPANY, PENN and its
agents shall be given access during business hours to the premises of COMPANY
and/or AFFILIATES or sublicensees for the purpose of conducting an audit. Upon
the termination of this AGREEMENT, COMPANY shall, at its own expense forthwith
remove and promptly upon PENN’s request, efface or destroy all references to
PENN from all
advertising or other materials used in the promotion of COMPANY’s business or
the business of any AFFILIATE or sublicensee and COMPANY, its AFFILIATES, and
any sublicensee shall not thereafter represent in any manner that it has rights
in or to the PENN
PATENT RIGHTS or
PENN
LICENSED PRODUCT(s).
5.9 Notwithstanding
the foregoing, if this AGREEMENT terminates other than pursuant to Section 5.4.1
or 5.4.2, COMPANY shall have a period of six (6) months to sell off its
inventory of PENN
LICENSED PRODUCT(s)
existing on the date of termination of this AGREEMENT and shall pay royalties to
PENN with
respect to such PENN
LICENSED PRODUCT(s)
within thirty (30) days following the expiration of such six-month period (“Sell
Off Right”).
6.
PATENT MAINTENANCE AND REIMBURSEMENT
6.1 Subject
to this Article 6, PENN controls the prosecution and maintenance of PENN PATENT
RIGHTS. COMPANY must reimburse PENN for all documented attorneys fees, expenses,
official fees and other charges incurred after the EFFECTIVE DATE of the option
and incident to the preparation, prosecution maintenance and licensing of PENN
PATENT RIGHTS. COMPANY's obligation to reimburse such costs shall commence as of
the date COMPANY closes an initial [ * ] or greater financing round;
reimbursements shall be paid within thirty (30) days after COMPANY’S receipt of
invoices for such fees, expenses and charges
6.2 COMPANY
shall reimburse PENN for all historically accrued patent and licensing expenses,
attorneys fees, official fees and all other charges incident to the preparation,
prosecution and maintenance of the PENN PATENT RIGHTS that were incurred before
the EFFECTIVE DATE of the Option (March 15, 2002) within thirty (30) days after
the date of closing of an initial [ * ] or greater financing round. Such
historically accrued expenses are estimated by PENN at approximately [ * ] but
will not be greater than [ * ].
6.3 Notwithstanding
Section 6.1, COMPANY [ * ]. In that event, PENN shall be the client of the
attorney, and COMPANY may directly manage the prosecution of the PENN PATENT
RIGHTS through a Client and Billing Agreement attached hereto as Attachment 7
(the "CLIENT AND BILLING AGREEMENT");. COMPANY
shall bear all costs of prosecution of the PENN PATENT RIGHTS. PENN shall be
copied on all correspondence related to the prosecution of the PENN PATENT
RIGHTS between COMPANY and the selected attorney, and retains the right to
advise COMPANY regarding patent prosecution. PENN and COMPANY shall in good
faith cooperate to implement the prosecution and maintenance of PENN PATENT
RIGHTS in accordance with the CLIENT AND BILLING AGREEMENT and COMPANY must
promptly pay for all ongoing attorneys fees, expenses, official fees and all
other charges incident to the preparation, prosecution and maintenance of the
PENN PATENT RIGHTS after the EFFECTIVE DATE of this AGREEMENT in accordance with
such CLIENT AND BILLING AGREEMENT.
6.4 COMPANY
hereby covenants and agrees that it shall in good faith prosecute PENN PATENT
RIGHTS in all countries set forth in Attachment 7 (the “REQUIRED TERRITORIES”);
[ * ]; If COMPANY refuses such expenditures under the CLIENT AND BILLING
AGREEMENT, or does not reimburse PENN for expenses related to PENN PATENT
RIGHTS, COMPANY’S rights in the relevant PENN PATENT RIGHTS granted under
Section 2.1 of this AGREEMENT shall,
thereafter terminate on a patent-by-patent basis. Thereafter, (i) PENN
will, be free,
at its discretion and expense, to either abandon such applications or patents or
to continue such preparation, prosecution and/or maintenance activities; and
(ii) PENN may,, license
such PENN PATENT RIGHTS to any third party upon such terms and conditions as
PENN deems appropriate.
6.5 If COMPANY should
desire to abandon any of the PENN PATENT RIGHTS (whether an already issued
patent or an application therefor) in any countries other than those countries
in the REQUIRED TERRITORIES, COMPANY shall give PENN at least [ * ] advance
written notice of its intention and, upon the written request of the PENN within
said [ * ], shall alternatively consent to termination of the license granted
pursuant to Section 2.1 in respect only of those PENN PATENT RIGHTS COMPANY
desires to abandon. Upon such limited termination of the license, the other
provisions of this Agreement shall be deemed terminated with regard to such PENN
PATENT RIGHTS only and COMPANY shall have no further rights or obligations in
respect of the same or subsequently accrued proceeds thereof; provided, however,
that (i) PENN covenants that it shall not assert such PENN PATENT RIGHTS
(whether by way of infringement or otherwise) against COMPANY, or any AFFILIATES
or sub-licensees of the PENN PATENT RIGHTS without COMPANY's express prior
written consent; and (ii) if any third parties continue to hold rights in such
PENN PATENT RIGHTS under any license or other binding agreement previously
entered into by or under the authority of COMPANY, its AFFILIATES or
sublicensees, then both of COMPANY's and PENN's rights and obligations under
this Agreement and in respect of proceeds from such third party agreements shall
survive such termination, but PENN shall be under no obligation to COMPANY or
any third parties to file, prosecute, maintain, defend or enforce PENN PATENT
RIGHTS in respect of which the license has been terminated pursuant to this
Section 6.5.
6.6 Nothing
in Sections 6.4 or 6.5 above, shall
prevent COMPANY from abandoning or surrendering any of the PENN PATENT RIGHTS,
or from canceling or amending any claim of any of the PENN PATENT RIGHTS,
without giving rise to any rights under Sections 6.4 or 6.5, provided that such
abandonment, surrender, cancellation or amendment is, in COMPANY's sole
reasonable discretion, necessary or appropriate in the ordinary course of the
prosecution, maintenance and enforcement of the PENN PATENT RIGHTS. For the
purposes of Sections 6.4 and 6.5, COMPANY's election not to pursue applications
for patents or other rights in respect of the PENN PATENT RIGHTS in any
countries, territories and regions in which, or in accordance with any treaties,
conventions or other multi-national agreements under which, any applications for
patents or other rights in respect of the PENN PATENT RIGHTS could in good faith
lawfully be applied for or otherwise prosecuted, shall not constitute or be
construed to constitute abandonment of any PENN PATENT RIGHTS.
6.7 COMPANY
may at its sole discretion (i) apply for and obtain such extension, term
restoration or comparable addition to the life of the affected PENN PATENT
RIGHTS and (ii) apply for and obtain such supplemental protection certificates
for the approved product or process covered by the PENN PATENT RIGHTS, all to
the extent the same are available pursuant to the applicable laws and
regulations of the jurisdiction where such regulatory approval is given. Nothing
herein shall be construed to obligate COMPANY to in fact seek extension or
restoration of any PENN PATENT RIGHTS or supplemental protection for any PENN
LICENSED PRODUCTS. Where COMPANY applies for and obtains supplemental protection
or comparable treatment for any PENN LICENSED PRODUCT, then, subject to
continued payment by COMPANY of its royalty obligations under this AGREEMENT,
this AGREEMENT shall not expire pursuant to Section 5.1(a) prior to the date of
termination of such supplemental protection or comparable
treatment.
6.8 Notwithstanding
the other provisions of this Article 6, COMPANY shall in good faith confer with,
and regularly keep PENN apprised of, its patent prosecution, maintenance,
enforcement and defense strategy and plans and shall in good faith consider
PENN's comments regarding such strategy and plans including, without limitation,
the following:
6.8.1 Providing
to PENN, promptly upon PENN's request, copies of any office actions or proposed
responses to office actions affecting PENN PATENT RIGHTS.
6.8.2 Providing
to PENN, promptly upon PENN's request, copies of any written communications
alleging infringement of, or responding to allegations of infringement of, the
PENN PATENT RIGHTS by third parties and any pleadings, motions, briefs or other
substantive papers filed by COMPANY or any third parties or proposed to be filed
by COMPANY, in connection with any litigation, arbitration or regulatory
proceedings (including interference and opposition proceedings).
7.
INFRINGEMENT AND LITIGATION
7.1 PENN and
COMPANY are responsible for notifying each other promptly of any infringement of
PENN PATENT RIGHTS which may come to their attention. PENN and COMPANY shall
consult one another in a timely manner concerning any appropriate response to
the infringement.
7.2 COMPANY
may prosecute such infringement at its own expense. COMPANY must not settle or
compromise any such suit in a manner that imposes any obligations or
restrictions on PENN or grants any rights to the or the PENN PATENT RIGHTS,
without PENN's prior written permission. Financial recoveries from any such
litigation will first be applied to reimburse COMPANY for its litigation
expenditures with additional recoveries being paid to COMPANY, subject to a
royalty due PENN based on the provisions of Article 3.
7.3 COMPANY's
rights under Section 7.2 are subject to the continuing right of PENN to
intervene at PENN's own expense and join COMPANY in any claim or suit for
infringement of the PENN PATENT RIGHTS. Any consideration received by COMPANY in
settlement of any claim or suit shall be shared between PENN and COMPANY in
proportion with their share of the litigation expenses in such infringement
action.
7.4 Subject
to COMPANY’S obligations under Section 6.7 above, COMPANY shall be free to
determine at its sole discretion when, if at all, and how to assert and
prosecute infringement claims relating to PENN PATENT RIGHTS where such
determinations are based upon bona
fide
strategic issues such as COMPANY’S concerns regarding challenges to the validity
of the PENN PATENT RIGHTS. If COMPANY elects at its sole discretion not to
prosecute or otherwise abate any infringement for non-strategic reasons, COMPANY
shall so notify PENN, and PENN may thereafter prosecute such infringement at its
own expense. In such event, financial recoveries will be entirely retained by
PENN.
7.5 In any
action to enforce any of the PENN PATENT RIGHTS, either party, at the request
and expense of the other party shall cooperate to the fullest extent reasonably
possible. This provision shall not be construed to require either party to
undertake any activities, including legal discovery, at the request of any third
party except as may be required by lawful process of a court of competent
jurisdiction.
7.6 For so
long as this Agreement is effective, PENN may not itself assert, or authorize
others to assert, claims of infringement of the PENN PATENT RIGHTS against third
parties without COMPANY’S express prior written consent.
8.
DISCLAIMER OF WARRANTIES; INDEMNIFICATION
8.1 THE PENN
PATENT RIGHTS, PENN LICENSED PRODUCTS AND ALL OTHER TECHNOLOGY LICENSED UNDER
THIS AGREEMENT ARE PROVIDED ON AN "AS IS" BASIS AND PENN MAKES NO
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO. BY WAY
OF EXAMPLE BUT NOT OF LIMITATION, PENN MAKES NO REPRESENTATIONS OR WARRANTIES
(i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE; OR (iii) THAT THE USE OF THE PENN PATENT RIGHTS, PENN LICENSED PRODUCTS
AND ALL TECHNOLOGY LICENSED UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT,
COPYRIGHT OR TRADEMARK OR OTHER PROPRIETARY RIGHTS OF OTHERS. PENN SHALL NOT BE
LIABLE TO COMPANY, COMPANY'S SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH
RESPECT TO: ANY CLAIM ARISING FROM COMPANY'S USE OF THE PENN PATENT RIGHTS, PENN
LICENSED PRODUCTS AND ALL TECHNOLOGY LICENSED UNDER THIS AGREEMENT OR FROM THE
MANUFACTURE, USE OR SALE OF PENN LICENSED PRODUCTS. NEITHER PARTY SHALL BE
LIABLE TO THE OTHER FOR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF
BUSINESS, OR FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND
REGARDLESS OF THE CAUSE OF ACTION OR THEORY OF LIABILITY UPON WHICH SUCH CLAIM
IS BASED, AND WHETHER OR NOT THE PARTY AGAINST WHOM SUCH CLAIM IS MADE WAS AWARE
OF THE POSSIBILITY OF SUCH DAMAGES.
8.2 COMPANY
must defend, indemnify and hold harmless PENN, its trustees, officers, agents
and employees (individually, an "Indemnified Party", and collectively, the
"Indemnified Parties"), from and against any and all liability, loss, damage,
action, claim or expense suffered or incurred by the Indemnified Parties
(including attorney's fees) (individually, a "Liability", and collectively, the
"Liabilities") that results from or arises out of third-party claims made in
connection with: (a) the development, use, manufacture, promotion, sale or other
disposition of any PENN PATENT RIGHTS or PENN LICENSED PRODUCTS by COMPANY, its
assignees, AFFILIATES, sublicensees, vendors or other third parties; (b) any
breach by COMPANY of this AGREEMENT, as well as any Liabilities resulting from
the enforcement by an Indemnified Party of this Section. Without limiting the
foregoing, COMPANY must defend, indemnify and hold harmless the Indemnified
Parties from and against any Liabilities resulting from:
8.2.1 any
product liability or other claim of any kind made by a third party and related
to the use by a third party of a PENN LICENSED PRODUCT that was manufactured,
sold or otherwise disposed by COMPANY, its assignees, AFFILIATES, sublicensees,
vendors or other third parties;
8.2.2 a
claim by a third party that the PENN PATENT RIGHTS or the design, composition,
manufacture, use, sale or other disposition of any PENN LICENSED PRODUCT
infringes or violates any patent, copyright, trademark or other intellectual
property rights of such third party; and
8.2.3
claims made by third parties (including governmental agencies) in connection
with clinical trials or studies conducted by or on behalf of COMPANY relating to
the PENN PATENT RIGHTS or PENN LICENSED PRODUCTS, including, without limitation,
any claim by or on behalf of a human subject of any such clinical trial or
study.
8.3 COMPANY
is not permitted to settle or compromise any claim or action giving rise to
Liabilities in a manner that imposes any restrictions or obligations on PENN or
grants any rights to the PENN PATENT RIGHTS or PENN LICENSED PRODUCTS
without PENN’s
prior written consent. If COMPANY fails or declines to assume the defense of any
such claim or action within thirty (30) days after notice thereof, PENN may
assume the defense of such claim or action for the account and at the risk of
COMPANY for indemnification, and any Liabilities related thereto shall be
conclusively deemed a liability of the party responsible for indemnification.
The indemnification rights of PENN or any other Indemnified Parties are in
addition to all other rights which such Indemnified Party may have at law or in
equity or otherwise.
8.4 INSURANCE
8.4.1
Within 90 days of the EFFECTIVE DATE of this AGREEMENT, COMPANY must procure and
maintain a policy or policies of comprehensive general liability insurance,
including broad form and contractual liability, in a minimum amount of
$2,000,000 combined single limit per occurrence and in the aggregate as respects
personal injury, bodily injury and property damage arising out of COMPANY's
performance under this AGREEMENT.
8.4.2
COMPANY must, upon commencement of clinical trials involving PENN LICENSED
PRODUCTS, procure and maintain a policy or policies of product liability
insurance in a minimum amount of $3,000,000 combined single limit per occurrence
and in the aggregate as respects bodily injury and property damage arising out
of COMPANY's performance under this AGREEMENT.
8.4.3 The
policy or policies of insurance described in this Section 8.4 [must be issued by
an insurance carrier with an AM Best rating of “A” or better and] must name PENN
as an additional insured with respect to COMPANY's performance of this
AGREEMENT. COMPANY must provide PENN within thirty (30) days of the EFFECTIVE
DATE with certificates evidencing the insurance coverage required herein. Such
certificates must provide that COMPANY's insurance carrier(s) notify PENN in
writing at least 30 days prior to cancellation or material change in
coverage.
8.4.4
PENN may periodically review the adequacy of the minimum limits specified above
and reserves the right to require COMPANY to adjust the liability coverages,
provided such adjustments do not require COMPANY to obtain coverages in excess
of those customarily obtained by entities incurring comparable risks in
comparable industries. The specified minimum insurance amounts do not constitute
a limitation on COMPANY's obligation to indemnify PENN under this
AGREEMENT.
9.
USE OF PENN'S NAME
COMPANY
and its employees and agents must not use and COMPANY must not permit its
AFFILIATES or sublicensees to use PENN's name or any adaptation thereof, or any
PENN seal, logotype, trademark, or service mark, or the name, mark, or logotype
of any PENN representative or organization in any way without the prior written
consent of PENN.
10.
ADDITIONAL PROVISIONS
10.1 Nothing
in this AGREEMENT shall be deemed to establish a relationship of principal and
agent between PENN and COMPANY, nor any of their agents or employees for any
purpose whatsoever, nor shall this AGREEMENT be construed as creating any other
form of legal association or arrangement which would impose liability upon one
party for the act or failure to act of the other party.
10.2 COMPANY
is not permitted to assign this AGREEMENT or any part of it, either directly or
by merger or other operation of law, without the prior written consent of PENN,
which consent shall not be unreasonably withheld. A withholding of PENN’s
consent shall be considered as reasonable in the event that the acquiring party
of the assignee of this license is not reputable or is not capable of developing
the PENN PATENT RIGHTS in the FIELD OF USE. Any prohibited assignment of this
AGREEMENT or the rights hereunder shall be null and void. No assignment relieves
COMPANY of responsibility for the performance of any accrued obligations which
it has prior to such assignment.
10.3 A waiver
by either party of a breach of any provision of this AGREEMENT will only be
valid if express, in writing and signed by an authorized representative of the
waiving party and will not constitute a waiver of any subsequent breach of that
provision or a waiver of any breach of any other provision of this
AGREEMENT.
10.4 Notices,
payments, statements, reports and other communications under this AGREEMENT
shall be in writing and shall be deemed to have been received as of the date
sent if sent by public courier (e.g. Federal Express) or by Express Mail,
receipt requested, and addressed as follows:
|
If
for PENN: |
with
a copy to: |
|
|
|
|
University
of Pennsylvania |
Office
of General Counsel |
|
Center
for Technology Transfer |
University
of Pennsylvania |
|
[ *
] |
|
|
|
|
|
If
for COMPANY: |
with
a copy to: |
|
|
|
|
Advaxis,
Inc. |
Pryor
Cashman Sherman & Flynn |
|
250
West Lancaster Ave., Ste. 100 |
410
Park Avenue, 10th Floor |
|
Paoli,
PA 19301 |
New
York, NY 10022 |
|
Attn:
Mr. James P. Patton |
Attn:
Selig D. Sacks, Esq. |
Either
party may change its official address upon written notice to the other
party.
10.5 This
AGREEMENT shall be construed and governed in accordance with the laws of the
Commonwealth of Pennsylvania, without giving effect to conflict of law
provisions. In the event that a party to this AGREEMENT perceives the existence
of a dispute with the other party concerning any right or duty provided for
herein, the parties will, as soon as practicable, confer in an attempt to
resolve the dispute. If the parties are unable to resolve such dispute amicably,
then the parties hereby submit to the exclusive jurisdiction of and venue in the
courts located in the Eastern District of the Commonwealth of Pennsylvania with
respect to any and all disputes concerning the subject of this
AGREEMENT.
10.6 PENN and COMPANY
shall not discriminate against any employee or applicant for employment because
of race, color, sex, sexual or affectional preference, age, religion, national
or ethnic origin, handicap, or because he or she is a disabled veteran or a
veteran of the Vietnam Era.
10.7 COMPANY
must comply with all prevailing laws, rules and regulations that apply to its
activities or obligations under this AGREEMENT. Without limiting the foregoing,
it is understood that this AGREEMENT may be subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities, articles and information, including
the Arms Export Control Act as amended in the Export Administration Act of 1979,
and that the parties’ obligations are contingent upon compliance with applicable
United States export laws and regulations. The transfer of certain technical
data and commodities may require a license from the cognizant agency of the
United States Government and/or written assurances by COMPANY that COMPANY shall
not export data or commodities to certain foreign countries without prior
approval of such agency. PENN neither represents that a license is not required
nor that, if required, it will issue.
10.8 If any
provision of this AGREEMENT shall be
held to be illegal, invalid or unenforceable, then such illegality, invalidity
or unenforceability shall attach only to such provision and shall not in any
manner affect or render illegal, invalid or unenforceable any other provision of
this AGREEMENT, and
this AGREEMENT shall be
carried out as if any such illegal, invalid or unenforceable provision were not
contained herein.
10.9 This
AGREEMENT embodies
the entire agreement of the parties with respect to the matters herein
contained, and supercedes all prior oral or written agreements relating thereto
except to the extent expressly addressed in the STOCK
PURCHASE AGREEMENT or the
STOCKHOLDER’S
AGREEMENT. Any
modification of this AGREEMENT must be in writing and signed by an authorized
representative of each party.
IN
WITNESS WHEREOF, the parties, intending to be legally bound, have caused this
AGREEMENT to be executed by their duly authorized representatives.
THE TRUSTEES OF THE UNIVERSITY
OF PENNSYLVANIA |
|
|
ADVAXIS,
INC. |
|
|
|
|
|
|
|
|
/s/ Louis P.
Berneman |
|
|
/s/ J. Todd
Derbin |
|
|
|
|
TYPED NAME: Louis P.
Berneman TITLE:
Managing Director
Center
for Technology Transfer |
|
|
TYPED
NAME: J.
Todd Derbin TITLE:
|
|
|
|
|
DATE: |
|
|
DATE: |
ATTACHMENT
1 - List of Intellectual Property
[
* ]
ATTACHMENT 2
- - Required Territories
[
* ]
Unassociated Document
CONFIDENTIAL
TREATMENT REDACTED VERSION
Cobra
Biomanufacturing Plc
The
Science Park,
Keele,
U.K.
ST5
5SP
|
Executive
Summary
Advaxis
has developed a recombinant attenuated L.
monocytogenes for
vaccination against HPV E7 expressing tumors. Advaxis will require the
production of approximately [ * ] cfu of
L.
monocytogenes non-cGMP
preclinical material and [ * ] cfu for
clinical trial use produced following cGMP guidelines. The program will involve
the following phases:
Phase
I
· |
Transfer
of current Listeria
culture and analysis methods |
· |
Two
month feasibility study and process development
program |
· |
Animal
component free growth media recommendation |
· |
Analytical
methods development and host characterization methods
|
Phase
II
· |
cGMP
Master Cell Bank production |
· |
Manufacture
of clinical material |
· |
Development
of product stability tests |
· |
Quality
assurance review |
· |
Bulk
product release for fill/finish |
To
achieve these goals, Advaxis will require the collaboration of a partner
with:
· |
Specialized
facilities for plasmid DNA manufacture |
· |
Experience
in plasmid DNA manufacture according to cGMP
|
· |
Successful
track record producing material for clinical trials in the
USA |
· |
Experience
in meeting regulatory requirements in facilities and
documentation |
Cobra
has both the expertise and the facilities available to meet the project
deliverables required by Advaxis in the timescales attached.
Cobra
Biomanufacturing Plc
Cobra is
a full
service, world class Contract Manufacturing Organization that manufactures and
supplies DNA-based therapeutics for the pharmaceutical and biotechnology
industries. Cobra provides contract services spanning pre-clinical to early
Phase III scale production and supply of biological products. These services
include the cGMP manufacture of DNA, recombinant protein, viruses, mammalian
cell products and cell banking.
Currently,
four clinical trials in the USA are being conducted using products manufactured
at Cobra. Additionally, there are clinical trials in Europe, Africa, China, and
Australia using products manufactured at Cobra.
Cobra has
a Type II Drug Master File (DMF) lodged with the FDA covering DNA manufacture.
We were last inspected by the MCA in August 2002 and found to be cGMP compliant.
Cobra provides a comprehensive analytical and documentation package for
regulatory filing.
Confidential
Document |
July
7, 2003 |
Introduction
Cobra
Biomanufacturing
is a full service, world class Contract Manufacturing Organization that
manufactures and supplies DNA-based therapeutics for the pharmaceutical and
biotechnology industries. Cobra provides contract services spanning pre-clinical
to early Phase III scale production and supply of biological products. These
services include the cGMP manufacture of DNA, recombinant protein, viruses,
mammalian cell products and cell banking. The company also undertakes process
development programs for recombinant protein and gene therapy products.
Company
History
Cobra was
founded in 1992 as a start up biotechnology company specializing in gene therapy
and has been operating from facilities at the Keele Science Park for the past 8
years. The manufacturing division was originally established in order to
expedite Cobra Therapeutics own R & D programs. Investments were made in
cGMP manufacturing facilities and the development of technology for scaleable
manufacture of DNA and protein based pharmaceuticals. In 1998 the manufacturing
division began to offer cGMP manufacturing services to the pharmaceutical
industry. Cobra Therapeutics became a wholly owned subsidiary of ML Laboratories
in 2000.
In June
2002, following a successful IPO on London’s AIM, Cobra Biomanufacturing was
established as an independent company
with an exclusive focus on custom manufacturing of bio
therapeutics.
Cobra’s
corporate objective is to continue to grow as a major contract supplier of DNA,
virus and protein based therapeutics for clinical trials and of licensed
biopharmaceutical products for commercial sale.
Manufacture
of DNA Therapeutics for Clinical Trials
Cobra has
established a worldwide reputation in the manufacture of plasmid DNA
therapeutics and is supporting clinical trials in the USA, Europe, Africa,
China, and Australia.
Every
project undergoes a technology transfer of your existing expression system to
utilize our scale-up expertise before initiating the cGMP manufacturing program.
During the evaluation stage genetic stability and relative productivity will be
determined in shake flask experiments. The fermenter productivity of the
transformed host strain will then be evaluated in a scale down (5L)
evaluation.
This
initial optimisation is to achieve the maximum productivity in the fermentation,
ensure yield and product purity throughout the purification process. It is
essential for the identification
of potential difficulties with your plasmid. The process development work is
necessary because in our experience there can
often be a 5-10 fold difference in productivity between strains (even with
similar plasmid backbones) and genetic instability is observed with some
plasmids. By assessing the plasmid at the beginning of the program, we can
accurately estimate the yields of clinical material that you will
obtain.
Confidential
Document |
July
7, 2003 |
Cobra has
substantial experience working with Kanamycin and Tetracycline resistant
plasmids and has also developed and been granted patents covering an
antibiotic-free plasmid DNA manufacturing process, the Operator Repressor
Titration (ORT) System. A Type II
DMF (Drug Master File) has been lodged with the FDA covering DNA
manufacture.
Facilities
Cobra has
over 11,000 square feet of space used for a process development facility,
separate QA/QC laboratories, and dedicated cGMP manufacturing facilities. The
existing cGMP manufacturing facility includes 4,500 square feet of EU Grade C
Clean Room space required for key stages in the manufacture of biopharmaceutical
products. The cGMP facility has two microbial production suites. The [ * ]
fermenter suite ([ * ] working volume) is for Phase I and II clinical trial
material. There is a [ * ] fermenter ([ * ] working volume) that is used to
provide an inoculum for the larger fermenter. The [ * ]fermenter suite ([ * ]
working volume) is for Phase II and III clinical trial material.
Additionally,
there are two virus production suites with [ * ] and [ * ] fermenters ([ * ] and
[ * ] working volume) utilising adenovirus and baculovirus expression systems
for manufacture of Phase I and II clinical trial material.
Quality
Cobra is
committed to conducting its manufacturing activities in accordance with
appropriate current Good Manufacturing Practice (cGMP) and Good Control
Laboratory Practice (GLP) regulations and/or guidelines. The latest inspection
from the UK Medicines Control Agency (MCA) was in August 2002 with a compliance
statement received several weeks later. Cobra’s QA group ensures that the
products manufactured by the division meet appropriate standards of safety,
quality, and efficacy. The QA group oversees manufacture at all stages and is
responsible for testing, release, storage, and arranges shipment of the drug
product. Overseas shipping and safe passage
through
Customs is easily co-ordinated and sub-contracted to BioCair, Inc or World
Courier.
Key
Personnel
Cobra’s
belief that quality individuals result in quality products is reflected in the
key personnel that will be involved in the manufacture of Advaxis’ L.
monocytogenes for
clinical trials.
Confidential
Document |
July
7, 2003 |
Julian
Hanak B.Sc.
(Hons), MSc.,
Director
of Production
After
gaining an honours degree in Biochemistry at University College London, Julian
obtained an MSc at the University College of North Wales and then trained in
cell culture and microbial fermentation at the National Institute of Medical
Research. He then moved to the Bioproducts Laboratory (Elstree) where his duties
involved the pilot scale production of human monoclonal antibodies for clinical
trials. He was also responsible for running a sterile fill operation and
supervising the commissioning of a new cGMP production suite.
In 1992,
Julian moved to Zeneca Pharmaceuticals where he was involved with the process
development of several immunotherapy products and the development of virus
expression systems for protein production. He joined Cobra in 1994 and took over
responsibility for production in 1995.
Geoff
Sharpe BSc.,
PhD., CChem, MRSC.,
Director
of Quality
Assurance
Geoff has
over 25 years experience in pharmaceutical biotechnology with over 12 years
experience in Quality Assurance. After having gained a degree in Applied
Chemistry at Liverpool, Geoff trained as a research chemist working for ICI
Corporate Laboratory. He later worked at the ICI Corporate Bioscience Group and
went on to complete a PhD in molecular biology at Leicester University.
In 1991
he transferred to ICI Pharmaceuticals (now AstraZeneca) where he was involved
with the cloning and expression of recombinant proteins and managed the
corporate DNA sequencing laboratory. In 1993, he moved to Zeneca
Pharmaceuticals. In the pharmaceutical department Geoff managed a team involved
in the development, manufacture, and release of both small molecule and
biotechnology based therapeutics. In 1996 he joined Cobra as their Quality
Assurance Manager and has been trained as a Qualified Person under Article 23 of
Directive 75/319/EEC.
Amanda
Weiss BSc.,
MSc.,
Section
Head Fermentation
Amanda
was trained at the University of Birmingham, Centre for Biochemical Engineering
before joining Cobra in 1996 as a fermentation scientist. Amanda has expertise
in microbial and mammalian cell culture, scale-up design and large-scale
manufacture
of biopharmaceuticals. She was also involved with the exemplification and
publication of Cobra’s ORT technology. Amanda has successfully managed the
fermentation aspect of Cobra’s manufacturing operations for over 5
years.
Tony
Hitchcock BSc,
Section
Head Microbial Products
Tony has
over 19 years’ experience in the large-scale manufacture of biopharmaceuticals.
Tony has held positions in the Blood Products Laboratory (Elstree) and at Zeneca
Pharmaceuticals in the protein process development department. Tony was a
founding staff
member of Cobra and has been responsible for the development of much of Cobra’s
DNA manufacturing technology. Tony has published several papers in the field and
is an inventor on two families of Cobra’s process patents.
Confidential
Document |
July
7, 2003 |
Roy
Cowell BSc.
(Hons), CChem, MRSC,
Section
Head Quality
Control
Roy has
16 years’ experience of analytical development and quality control of
pharmaceuticals within the associated regulatory framework. Ten years employed
by Zeneca (now AstraZeneca) Pharmaceuticals working on new chemical entities and
candidate biotherapeutics and six years employed at Cobra working on candidate
DNA products. Roy is currently undergoing training leading to eligibility for
Qualified Person status.
Joy
Manley BSc, Senior
QA Microbiologist
Joy is
currently responsible for developing, validating, and applying suitable testing
regimes that help to assure clean room suitability and equipment cleanliness.
New test methods are designed and validated for plant systems and for cleaning
as required. Both standard and novel microbiological methods are developed and
used to characterize cell banks. She has experience in working with
microorganisms from both pharmaceutical and clinical backgrounds, previously
working for Fisons and The Public Health Laboratory.
David
Thatcher, Chief Executive
David was
trained as a protein chemist at the Universities of Newcastle on Tyne and
Edinburgh. In 1981 he moved to Biogen SA in Geneva where he worked on the
isolation of recombinant cytokines. In 1985 he became Director of Process
Development of Biogen, Inc. in Cambridge, MA, where he was responsible for the
development of large-scale processes for the production of gamma interferon,
GM-CSF and several other products.
In 1988
he left Biogen and joined Zeneca Pharmaceuticals as head of their Protein
Production Lab where he was responsible for the production of a number of
biopharmaceutical products for clinical evaluation. In 1994 he joined Cobra and
has been responsible for managing the evolution of Cobra’s manufacturing
technology and developing the contract manufacturing business into an
independent company with a successful initial public offering.
Confidential
Document |
July
7, 2003 |
Quotation
O422
Description Price
Phase
I
[
* ]
Phase
II
[
* ]
Notes:
Stage
I
1. |
Execution
of Material Transfer Agreement. Advaxis methods for recombinant
Listeria
culture and analysis will be transferred to Cobra. This will include
plasmid isolation, plasmid and host identity, plasmid and host stability,
cryopreservation, and protocol for plasmid
isolation. |
2. |
Characterization and strain history of the
untransformed L.
monocytogenes
will be addressed by Advaxis. Advaxis will also be responsible for plasmid
sequence and/or detailed restriction maps. Host and plasmid information is
required for the GMO risk assessment. A letter from Dr. Paterson
addressing the mobility of L.
monocytogenes is
requested. |
3. |
Advaxis
will supply [ * ] vials of a transformed research cell bank (mid log
phase) of L.
monocytogenes
with documentation sufficient to make the research bank suitable for
generation of the cGMP Master Cell Bank. |
4. |
A
two-month feasibility study will be undertaken to determine the growth
kinetics of Listeria
(latest
harvest point) in various growth media. The study will also involve
bioreactor growth, analysis of log phase, determination of yield, and
number of cell doublings in vivo before maintenance of virulence is lost.
We suggest running Stage II at the same time as Stage I to reduce the
timeline to cGMP manufacture. |
Stage
II
4. |
An
animal component free growth media will be recommended following
evaluation
of the existing media formulations with suitable alternatives. The media
evaluated will be from published references for media used in Listeria
culture. |
Confidential
Document |
July
7, 2003 |
5. |
Development
of a cryopreservation media suitable for administration to
patients. |
6. |
Analytical
methods will be developed to meet FDA regulatory requirements for a
live
attenuated bacterial vaccine. Methods developed will include:
|
o |
plasmid
identity (restriction mapping or
sequencing) |
o |
culture
purity (monosepsis) |
7. |
Host
characterization methods will be developed for the
following: |
o |
phenotype
auxotrophies and markers |
o |
specific
media for identification |
8. |
Cobra
will supply Dr. Paterson with [ * ] of log phase culture for a hemolysin
assay. Additionally, Cobra will supply Dr. Paterson with three samples of
[ * ] for a mouse tumor challenge to study maintenance of
virulence. |
9. |
The
following documentation will be provided: |
Technical
Report
10. |
Confirmation
of price estimates for cGMP manufacture at this point, dependent upon
successful technology transfer, feasibility study and process development.
|
Stage
III
11. |
Cell
banking will only proceed based upon the feasibility study achieving cell
densities of at least [ * ] viable
cells per litre of culture. The Master Cell Bank will be manufactured
under cGMP in accordance with the latest CPMP guidelines and MCA guidance.
A Type II Drug Master File has been lodged with the FDA covering these
procedures. Cells will be cryopreserved in mid log growth at a density of
between [ * ] to [ * ] cfu/ml. |
Pricing
for the Working Cell Bank is based on production immediately following the
Master Cell Bank. Characterization for the Working Cell Bank is free of charge
if concurrent with Master Cell Bank testing.
12. |
A [
* ]-vial cGMP Master Cell Bank and Working Cell Bank will be released
according to the agreed program. |
Confidential
Document |
July
7, 2003 |
13. |
The
Master Cell Bank and Working Cell Bank will be characterised using the
following range of tests: |
· |
Confirmation
of species (API Listeria) |
· |
Confirmation
of strain by partial genotyping |
· |
Plasmid
stability by serial sub-culture |
· |
Counter
selection for monosepsis |
· |
Plasmid
identity by restriction digest |
· |
DNA
sequence of the plasmid (to be invoiced
separately). |
14. |
The
non-cGMP material for use in toxicology studies, stability testing, and
quality control
lot release will produced at the [ * ] scale with a yield of [ * ]
based
upon the feasibility study achieving cell densities of at least [ * ]
viable cells per litre of culture. |
15. |
The
following documentation will be provided to support a Regulatory
filing: |
Certificates
of Analysis
Analytical
Reports
Stage
IV
16. |
cGMP
Manufacture:
Prices are estimates without knowledge of the results of the Phase I
Feasibility Program and may require variances to this proposal. If the
productivity of the strain cannot be developed to achieve cell densities
of at least [ * ] viable cells per litre of culture the delivery of [ * ]%
of final bulk material cannot be guaranteed. The expected quantity of bulk
and scale required will be advised as soon as it is determined during the
Phase I Feasibility and Development Program and prior to initiation of the
Phase II cGMP manufacturing program. If cell densities of [ *
] cells
per litre are obtained in the feasibility study then a [ * ] fermentation
should yield the requested [ * ] clinical material. If the desired cell
densities of [ * ] cells per litre are not achieved, then the cGMP
manufacturing program will be renegotiated. |
Stage
V
17. |
Product
Stability Testing will be required, but will be negotiated as a separate
contract once the methods have been developed and the protocol agreed by
Advaxis after FDA discussions. Stability tests for genetic stability; cell
bank stability and bulk drug stability will be developed once a program is
agreed upon. The figure provided is for budgetary
purposes. |
Stage
VI
18.
Documentation.
Confidential
Document |
July
7, 2003 |
The
following documentation will be provided:
Certificate
of Analysis
Technical
Summary to support regulatory filing
A copy of
the completed BMR will be provided.
Cobra
warrants that upon delivery of the Product to Advaxis, Inc. the Product
shall:
· |
Have
been manufactured in accordance with cGMP. |
· |
Be
in conformity with the provisional draft specifications as attached to
this document. |
· |
That
Cobra will provide Product of sufficient quality for human clinical
use. |
· |
In
the event the Product fails to meet any of the specification described
above, the final determination as to the suitability of the product for
human clinical use shall be determined by Advaxis, Inc., who may consult
with the appropriate offices of the US FDA or other regulatory
agencies. |
Stage
VII
20. |
Fill/Finish
will be subcontracted to BioReliance. A quote cannot be provided until the
type of container, number of vials and other variables have been
determined. The figure provided is for budgetary purposes.
|
20. |
The
costs of consumables have not been included in this quotation and will be
billed directly to the customer without additional charge.
|
21. |
The
cost of subcontracted work has not been included in this quotation and
will be billed
directly to the customer (plus a [ * ]% handling
charge). |
22. |
Cobra
will take responsibility for shipment. The price of shipment of bulk,
dosage forms and samples and insurance thereof is excluded from this
contract. Shipping will be arranged in consultation with the customer and
will be billed directly to the customer (plus a [ * ]% handling
charge). |
23. |
Cobra
and/or Advaxis, Inc. may wish to issue a press release relating to this
contract. However, prior to any information being disclosed written
approval must be obtained from the other party. |
24. |
The
Customer agrees to pay reasonable travel expenses connected with Cobra
staff attending
meetings, other than those on Company premises and requested by the
Customer.
|
Confidential
Document |
July
7, 2003 |
25. |
Cobra
Bio-Manufacturing plc’s O422 Phase I Terms and Conditions and O422 Phase
II Terms and Conditions apply to this work and acceptance of this
quotation implies acceptance of these Terms and Conditions.
|
How
to Proceed
Please
return a signed copy of the enclosed contract with your formal Purchase Order to
Cobra Biomanufacturing.
Cobra
Biomanufacturing Plc
The
Science Park
Keele,
United Kingdom ST5 5SP
Phone:
011 44 1782 714181
Fax: 011
44 1782 714168
When
timing is critical a faxed version is acceptable, but an original must be signed
and returned within fourteen days. Upon receipt Cobra will notify the client of
acceptance within 72 hours.
Confidential
Document |
July
7, 2003 |
Advaxis,
Inc.
212
Carnegie Center, Suite 206
Princeton,
NJ 08540 USA
July 7,
2003
Contract
O422
Determination
of Manufacturing Parameters, Process Development and cGMP Manufacture
of L.
monocytogenes
(a)
Phase I: Two-month Feasibility Study and Development
Program
Price
(Line
items: a + b + c):
Total: $[
* ]
Terms
of Payment
The
following payment terms will apply: On receipt of a signed copy of the Contract,
Cobra Biomanufacturing Plc. will begin Phase I. Upon commencement of the work
program, Advaxis will be invoiced for $[ * ] net 30 days and will be invoiced
the remaining $[ * ] appropriately on a monthly basis for the length of the
program. The final invoice will be sent before [ * ].
This
phase of the program is governed by the Terms and Conditions set out in the
attached document “ O422 Phase I Terms and Conditions”.
Phase
II: Pre-Clinical and GMP Manufacture
Price
Estimate is based on [ * ] cGMP manufacture:
(Line
items: d + e + f + g + i +k + l + m + n + o)
Total: $[
* ] (excluding Fill/Finish)
Terms
of Payment
The
following payment terms will apply: On receipt of a signed copy of the Contract,
Cobra Biomanufacturing Plc. will hold a slot for Advaxis without a deposit.
Advaxis will be notified of any request for the slot and may reserve the slot
with a [ * ]% deposit. Receipt of this payment will reserve the production slots
as per the agreed program. On commencement of the work program, [ * ]% of the
cost will be appropriately invoiced on a monthly
basis for the length of the program, with the remaining [ * ]% due upon the
delivery and acceptance of the Certificate of Analysis by the Customer’s QA
Department (less
deposit if required). There is an intention by Advaxis and Cobra to agree on %
royalties of final commercial products utilizing the current Listeria
monocytogenes platform and variations thereof for various indications in
exchange for a reduction in price of the Phase II cGMP manufacturing campaign of
proposal 0422.
Confidential
Document |
July
7, 2003 |
This
phase of the program is governed by the Terms and Conditions set out in the
attached document “ O422 Phase II Terms and Conditions”.
Contract
O422
Determination
of Manufacturing Parameters, Process Development and cGMP Manufacture
of L.
monocytogenes
For Advaxis, Inc. |
|
|
For Cobra Biomanufacturing Plc |
|
|
|
|
Accepted by: J. Todd
Derbin |
|
|
David R. Thatcher |
|
|
|
|
Signature: /s/ J. Todd Derbin |
|
|
/s/
David R. Thatcher |
|
|
|
|
Date: 7/7/03 |
|
|
8th
July 2003 |
Confidential
Document |
July
7, 2003 |
CTL.0422.S.1.1
Provisional
Draft Specification
Test Method Specification
[ *
]
Identity
API
Listeria Profile
number conforms, typically >0.95
Growth on
selective media Good
growth
Gram
strain Gram
positive
Colony
morphology Complies
with that for L.
monocytogenes
Quantity
[ *
]
Purity
[ *
]
Confidential
Document |
July
7, 2003 |
COBRA
BIO-MANUFACTURING PLC
O422
PHASE II - TERMS AND CONDITIONS
In these
conditions the following words have the following meanings unless the context
requires otherwise:
|
“Agreement” |
means
these conditions of business; |
|
“Background” |
means all Intellectual Property Rights
belonging to Cobra existing prior to the date of this Agreement or which,
if created subsequent to the date of this Agreement, are created outside
of any work with Advaxis under this Agreement or the scope of any
Contract; |
|
“Cobra” |
means
Cobra Biomanufacturing Plc, a corporation located at The Science Park,
Keele, United Kingdom ST5 5SP; |
|
“Confidential
Information” |
means, in relation to a party to the Contract,
any and all confidential and/or proprietary information relating its
business methods, customers, suppliers, finances, ideas, strategies,
concepts, methodologies, protocols, inventions, processes, specifications,
materials, marketing plans, formulae, products, software and other
matters, including but not limited to its Intellectual Property Rights,
and, in the case of Advaxis, including the Results, but excluding all
information described in clause 15.8; |
|
“Contract” |
means any contract relating to Phase II of
Proposal 0422 dated 7th July 2003 by and between Cobra and Advaxis
incorporating the conditions of business set forth in this Agreement for
the sale of Products and/or the provision of the Services and agreed to in
writing by an authorized representative of each of Advaxis and
Cobra; |
|
“Contract
Price” |
means, with respect to a Contract, the total
sums payable to Cobra by Advaxis under the Contract for Phase II of
Proposal 0422 dated 7th July 2003; |
|
“Deposit” |
means, with respect to a Contract, the sum of
10% of the Contract Price; |
|
“Foreground” |
means all Intellectual Property Rights
conceived or made by or on behalf of either Cobra or Advaxis, or jointly
by Cobra and Advaxis, as a result of work under any letter of intent
executed by the parties or under this Agreement or the performance of any
Contract, other than general laboratory or manufacturing know-how that is
not specifically related to any Materials; |
|
“GMP” |
means
the current good manufacturing practices (under U.S. 21 CFR Part 211, as
amended and supplemented from time to time, or the equivalent EU good
manufacturing practices as confirmed at inspection by the UK Medicines
Control Agency) for the methods to be used in, and the facilities and
controls to be used for, the manufacture, processing, packing and holding
of Products, as applicable under a
Contract; |
|
“Intellectual
Property Rights” |
means any or all intellectual property rights
including, without limitation, patents, registered and/or unregistered
design rights, registered and/or unregistered trade marks and/or trade
names, logos, copyright, know-how and any other similar industrial or
intellectual property rights subsisting anywhere in the world together
with any application for such rights and/or the right to make any such
application; |
|
“Liability” |
means liability for damages, claims,
proceedings, actions, awards, expenses, costs (including reasonable
attorneys’ fees and expenses) and any other losses and/or liabilities in
any way related to this Agreement or any
Contract; |
Confidential
Document |
July
7, 2003 |
|
“Materials” |
means any products, DNA, protein, cell lines,
biological matter and/or other materials which are supplied by Advaxis and
used by Cobra in performing its obligations under a
Contract; |
|
“Products” |
means any protein, DNA, biological matter,
cell lines, materials, products, goods and/or other matter ordered from
Cobra by Advaxis or to be supplied by Cobra to Advaxis and/or such items
which are to be provided to Advaxis in the performance of the
Services; |
|
“Results” |
means any results from any Services carried
out by Cobra for Advaxis; |
|
“Services” |
means the research, evaluation, development,
scale up, manufacturing services and/or any other services to be performed
by Cobra for Advaxis; |
|
“Specification” |
means the manufacturing procedures specified
for a Product and/or the acceptance criteria for such Product;
|
|
“Advaxis” |
Means Advaxis, Inc., located at 212 Carnegie
Center, Princeton, NJ
08540; |
2.1 |
This
Agreement shall govern each Contract “Phase II” of the Quotation detailed
in proposal O422 between Cobra and Advaxis and shall supersede and replace
any conflicting terms or conditions included therein.
|
2.2 |
No
order placed by Advaxis shall be accepted by Cobra unless it is a Contract
which incorporates these conditions. |
2.3 |
This
Agreement supersedes all previous terms and conditions relating to Phase
II of Proposal O422 and shall replace any terms and conditions previously
notified to Advaxis. |
Confidential
Document |
July
7, 2003 |
2.4 |
No
variation to this Agreement shall be binding on Cobra or Advaxis unless
agreed to in writing between an authorised representative of each of
Advaxis and Cobra. |
2.5 |
Cobra’s
employees, sub-contractors and/or agents are not authorised to make any
representations or warranties concerning the Products and/or Services
unless confirmed by Cobra in writing. |
2.6 |
Advaxis
acknowledges that Advaxis does not rely on any representation and/or
warranty which has not been made in this Agreement or a Contract or other
writing signed by an authorized representative of
Cobra. |
3.1 |
Quotations
(unless stated otherwise) are not binding or capable of acceptance and are
estimates only. A binding quotation issued by Cobra shall be binding for
10 business days unless withdrawn by Cobra by oral or written notice given
to Advaxis at any time before the expiry of the 10-business-day period.
Advaxis may place an order based on a binding quotation issued to Advaxis
at any time before the expiry of the 10-business-day period or earlier
withdrawal of the quotation by Cobra (whichever is the first to
occur). |
3.2 |
A
Contract between Cobra and Advaxis shall come into effect when it has been
executed and delivered (whether in one or more counterparts) by an
authorized representative of each party. |
4. |
Samples
and Additional Work |
4.1 |
The
production of any additional samples or test work not detailed in a
Contract shall, unless otherwise agreed to in writing, be delayed until
such production is covered by a Contract or Contract amendment entered
into in accordance with this Agreement. |
4.2 |
If
Advaxis approves in writing any sample Product produced or test Services
performed by Cobra under a Contract, then, unless and until Advaxis
withdraws such approval in writing, Advaxis shall have no claim in respect
of, nor any right to reject, Products or Services provided under the
Contract if the Products and/or the Services in question are of the same
description, Specification, quality and fitness for purpose as the
approved sample and/or test work as appropriate. If Advaxis withdraws its
approval of any sample Product or test Services, then from and after
receipt by Cobra of such written withdrawal by Advaxis, Advaxis shall not
be required to accept any additional Products or Services of the same
description, and the parties shall promptly amend the terms of the
applicable Contract reflect mutually agreed upon changes resulting from
such withdrawal (e.g., designation of such withdrawal as a production
variation under Section 8, a cancellation under Section 9 or otherwise,
provision of alternate supply and pricing terms).
|
Confidential
Document |
July
7, 2003 |
5.1 |
Any
Materials supplied by or on behalf of Advaxis to Cobra in respect of any
Contract shall at all times remain Advaxis’s
property. |
5.2 |
Risk
in the Materials shall pass to Cobra whilst such Materials are in the
power, possession and/or control of Cobra. |
5.3 |
Cobra
shall not transfer, or permit the transfer of any Materials to a third
party except to a sub-contractor of Cobra. Cobra shall limit access to the
Materials to employees or sub-contractors of Cobra who have a need to
access the Materials in connection with the production of Products and/or
the provision of Services for Advaxis, and shall take all other reasonable
measures to protect the Materials from destruction, theft or loss whilst
in the possession and/or control of Cobra. |
5.4 |
Cobra
shall use the Materials only for the production of Products and/or the
provision of Services for Advaxis under a Contract, and for no other
purpose, except with the specific written consent of
Advaxis. |
5.5 |
Advaxis
shall ensure that Cobra has the right to use in the performance of the
Services and/or production of the Products any Materials provided by
Advaxis |
5.6 |
Advaxis
shall provide to Cobra storage, handling, health and safety and/or
utilisation information regarding any Materials, to the extent known to
Advaxis, at the time of delivery of the Materials to Cobra, or upon
request by Cobra in writing, in advance of such
delivery. |
5.7 |
If
any Materials are lost, damaged and/or destroyed, Cobra shall promptly
inform Advaxis and shall re-imburse Advaxis for (or Advaxis, at its
option, may credit against any amounts due to Cobra) the cost of replacing
any Materials lost, damaged and/or destroyed. This shall not apply to any
Materials which are properly utilised in and/or natural wastage arising
from the performance of the Services and/or production of the Products.
|
6.1 |
Cobra
may not sub-contract all or any part of a Contract to a third party
without the prior written approval of Advaxis (such consent not to be
unreasonably refused or delayed). In the event that Advaxis allows any
such sub-contracting, Cobra shall remain liable for any non-performance of
the Contract due to the acts and/or omissions of a third party
sub-contractor. |
Confidential
Document |
July
7, 2003 |
6.2 |
If
Cobra sub-contracts work to a sub-contractor, Cobra shall ensure that,
prior to entering into the sub-contract, the sub-contractor enters into a
separate agreement with Cobra obligating the sub-contractor to protect
Advaxis’s Confidential Information and Materials at least to the same
degree as they are protected by the obligations of Cobra under this
Agreement, and Cobra shall not disclose to the sub-contractor any Advaxis
Confidential Information and shall not provide to the sub-contractor any
Materials except as required to permit the sub-contractor to perform the
sub-contract approved by Advaxis. |
7. |
Production
Slot Timetable and Deposit |
7.1 |
In
any quotation for the provision of Products and/or Services submitted by
Cobra to Advaxis, Cobra shall provisionally allocate to Advaxis a
production slot. |
7.2 |
No
order for Products and/or Services placed by Advaxis shall become binding
until a Contract has been entered into by the parties
therefor. |
7.3 |
Upon
the execution and delivery of a Contract for Products and/or Services and
the receipt of the Deposit by Cobra from Advaxis, Cobra shall firmly
allocate the production slot(s) for the Products and/or Services specified
in the Contract. |
8. |
Production
Variations and
Deposit |
8.1 |
Cobra
has agreed to hold a production slot without requiring pre-payment of a
deposit from Advaxis providing no other customers compete for that slot.
If another customer requests the same production slot agreed upon with
Advaxis, then Advaxis will be required to secure the slot with a deposit
of 10% ($51,100) of the Phase II portion of Proposal 0422. If Advaxis has
secured the production slot and requests any change to a production slot
for Products to be manufactured under this Contract less than 30 calendar
days prior to the commencement of such production slot, Advaxis shall pay
Cobra an amount of $50,000. |
8.2 |
If
Advaxis requests a change to a secured production slot for Products to be
manufactured under this Contract and the change is requested 30 to 60 days
prior to the commencement of such production slot, then Advaxis shall
forfeit an amount of $20,000, |
8.3 |
If
Advaxis requests a change of more than one month to a secured production
slot for Products to be manufactured under this Contract and the change is
requested more than 90 days prior to the commencement of such production
slot, then Advaxis shall forfeit 25% of the Deposit allocable to the
production slot (calculated as provided in clause 8.1) with the remaining
75% being carried forward and allocated to the alternative production
slot. Cobra shall firmly allocate to Advaxis the requested rescheduled
production slot, unless that slot has been filled prior to receipt of 25%
of the Deposit allocable to the production slot from Advaxis under this
clause 8.3, in which case Cobra will secure for Advaxis the next available
production slot. |
Confidential
Document |
July
7, 2003 |
8.4 |
Cobra
shall use its reasonable endeavours to accept any request to change to a
production slot for Products provided that the requested new production
slot is available. All such requests will be considered in good
faith. |
8.5 |
Cobra
shall consider in good faith any request by Advaxis for Cobra to waive
Cobra’s right to treat all or any portion of the Deposit allocated to the
production slot as forfeited under this Section
8. |
9.1 |
If
Advaxis cancels or terminates a Contract without cause, or refuses to
accept delivery of conforming Products and/or performance of Services
rendered in accordance with a Contract: |
|
9.1.1 |
The
Deposit paid by Advaxis under the Contract shall be forfeited and shall
not be refundable to Advaxis. Under circumstances where cancellation
occurs after commencement of the programme and the Deposit has been
waived, Advaxis will pay an equivalent sum to the value of the Deposit;
and |
|
9.1.2 |
Advaxis
will pay Cobra for all Services rendered in accordance with the Contract
and conforming Products attempted to be delivered in accordance with the
Contract through the date of cancellation, on a percentage of completion
basis, if and to the extent that their value exceeds the Deposit and the
Deposit paid by Advaxis shall be creditable against any payment due for
such Services. |
10. |
Delivery
and Performance |
10.1 |
Cobra
will use its reasonable commercial efforts to ensure delivery and/or
performance on the dates specified in each Contract and shall keep Advaxis
promptly informed of any delivery and/or performance that may be delayed.
The delivery and/or performance dates specified in a Contract are Cobra’s
best estimates only and are not guaranteed. Time is not of the essence in
relation to such dates. They are also subject to clause
24.4. |
10.2 |
Advaxis
shall have no right to rescind or terminate a Contract for late delivery
and/or performance, or to reject Products and/or Services as
non-conforming unless the due date for delivery and/or performance has
passed and Advaxis shall have provided notice to Cobra requiring the
delivery to be made, the Services to be performed and/or delivery of
conforming Products and giving Cobra not less than 14 days in which to do
so and the notice shall not have been complied
with. |
Confidential
Document |
July
7, 2003 |
10.3 |
Cobra
shall arrange for the delivery of the Products to Advaxis’s premises or to
an agreed delivery address provided that Advaxis confirms that such a
location is appropriately equipped to store and handle the Products,
otherwise Cobra shall keep and store the Products at its own expense for
45 days. Cobra shall consult with Advaxis as to any and all delivery
arrangements. Delivery generally will be made between 9.00am and 5.00pm on
days when Advaxis is open for business. |
10.4 |
Advaxis
shall procure during normal working hours that Cobra and/or its appointed
representatives have free right of access to the address for delivery for
the purpose of delivering the Products between 9.00am and 5.00pm on any
working day for Advaxis. |
10.5 |
If
the parties agree that the Products are to be collected from Cobra’s
premises, then Advaxis shall collect the Products within 30 working days
of being notified that the Products are ready for collection. If the
Products are not collected by Advaxis or its agent within the specified
period, Cobra shall provide notice thereof to Advaxis and at any time
commencing three business days after Advaxis receives such notice, the
parties will negotiate in good faith as to the appropriate steps to be
taken. |
10.6 |
If
Advaxis refuses to take delivery of any Products and/or to allow
performance of the Services without cause, then after providing a notice
to Cobra in writing 45 days in advance. Cobra shall be entitled to
withhold delivery and/or performance of any other Products and/or Services
and to treat this Agreement or any Contract as repudiated by Advaxis and
Cobra shall have the right to rescind this
Contract. |
11.1 |
The
price of the Products and/or the Services shall be as set forth in the
applicable Contract. |
11.2 |
Unless
expressly stated in a Contract, Cobra’s prices are exclusive of costs of
importation, transport, insurance, packaging and/or freight of Products
and/or Materials which shall be payable by Advaxis in
addition. |
11.3 |
The
parties will negotiate in good faith an increase a Contract Price to take
into account of any changes in methodology and/or additional work that are
requested by Advaxis or are reasonably deemed necessary by Cobra in light
of any Results or are required to comply with changes in
GMP. |
11.4 |
Advaxis
will be informed in writing by Cobra of any increases in a Contract Price
to be made pursuant to clause 11.3 or 11.4, not less than 30 days before
such increase takes effect. |
Confidential
Document |
July
7, 2003 |
11.5 |
If
the increase in Contract Price cannot be agreed between Cobra and Advaxis,
Cobra may cease working on the Contract, and Advaxis may cease making
payments on the Contract (except as required under clause 11.7), until any
increase is agreed. |
11.6 |
Advaxis
may cancel without Liability any Contract in relation to which the price
is to be increased and such increase cannot be agreed provided that Cobra
receives notice of cancellation from Advaxis within 30 days after receipt
by Advaxis of Cobra’s notice of the price increase. In such cases, Advaxis
will pay Cobra for all Services rendered and conforming Products produced
in accordance with the Contract up to the date of cancellation, on a
percentage of completion basis, if and to the extent that their value
exceeds the Deposit. |
11.7 |
If
the Contract Price is to be increased as provided in clause 11.3 or 11.4
and Advaxis does not cancel the Contract within the 30-day period
specified in clause 11.6, then the price increase shall take effect for
the Products and/or Services provided by Cobra under the Contract after
the end of the 30-day period unless Advaxis has notified Cobra that it
does not agree with such increase. |
11.8 |
Advaxis
shall reimburse Cobra for its out-of-pocket costs in connection with
reasonable travel and accommodation expenses involved in the provision of
the Services, provided that such travel is specified in the Contract or
otherwise approved in advance by Advaxis in writing.
|
12.1 |
The
balance of the Contract Price shall be
payable: |
|
12.1.1 |
85%
paid as equal monthly payments over the length of the Contract as detailed
in the Contract; and |
|
12.1.2 |
15%
on receipt of the certificate of analysis and/or acceptance/deemed
acceptance by Advaxis of the Products and/or Services under the
Contract. |
12.2 |
Cobra’s
terms of payment are net cash within 30 days after Advaxis receives
Cobra’s duly issued invoice, except as otherwise provided in clauses 12.1
and 12.8. Cobra shall have no right to terminate a Contract for failure by
Advaxis to make timely payment of any amount due thereunder unless Cobra
provides Advaxis a written notice specifying the unpaid amount and
requiring such payment and giving Advaxis not less than three business
days in which to make such payment and the notice shall not have been
complied with. |
12.3 |
If
Advaxis fails to make any undisputed payment in full on the due date,
Advaxis will be extended 90 days free of interest, after 90 days Cobra may
charge Advaxis interest (both before and after judgment) on the amount
unpaid at the annual rate of 2% above the prime, compounded monthly.
|
Confidential
Document |
July
7, 2003 |
12.4 |
Any
monies received by Cobra from Advaxis may be applied by Cobra at its
option against any interest charged prior to application against any
principal sums due from Advaxis against which it may be applied in any
order. |
12.5 |
Payment
shall not be deemed to be made until Cobra has received either cash or
cleared funds in respect of the full amount outstanding.
|
12.6 |
If
any undisputed payment is not made in full to Cobra when due, then Cobra
may withhold or suspend future or current deliveries of the Products
and/or performance of the Services and delivery and/or performance under
any other Contract. |
12.7 |
If
any Contract is cancelled or terminated under clause 9.1, Cobra shall
invoice Advaxis for all amounts due in accordance with clause 9.1, and
Advaxis shall pay the amount of such invoice within 15 days after
receipt. |
13.1 |
Any
Specification for Products supplied by Cobra to Advaxis shall only be
approximate unless the Specification applies to the production of Products
under GMP, the Specification is marked “Final” and signed by authorized
representatives of Cobra and Advaxis, or the Contract provides
otherwise. |
13.2 |
The
quantity, quality, description and/or Specification for the Products
and/or the Services shall be that set out in the Contract unless otherwise
agreed in writing by the parties. |
13.3 |
It
is the responsibility of Advaxis to verify and check any Specification for
the Products. |
13.4 |
Cobra
shall have no Liability for errors in any Specification unless Cobra has
been negligent and/or in breach in relation to the Specification.
|
13.5 |
Advaxis
shall indemnify and keep indemnified Cobra against any and all liability,
loss, costs and expenses arising out of or in any way connected with any
third party claim relating to Cobra’s use of Materials and/or information
supplied by Advaxis under a Contract or any Specification approved in
writing by Advaxis, subject to the limitations set forth in clause 21.6.
|
13.6 |
Subject
to Advaxis’ written approval Cobra reserves the right to make changes to
the Specification of any Products and/or Services as required from time to
time by good laboratory practice, GMP, law, and/or applicable safety
requirements, provided that they do not have a material adverse effect on
the quality and/or performance of the Products and/or the Services and
that they shall not be put into effect until 5 business days after receipt
by Advaxis of a description and explanation of any such
changes. |
Confidential
Document |
July
7, 2003 |
13.7 |
If
Cobra does make changes to the Specification of any Products and/or
Services in violation of clause 13.6, then Advaxis shall have the right to
cancel the Contract without Liability. |
14. |
Intellectual
Property Rights |
14.1 |
The
Background shall remain the absolute and unencumbered property of Cobra.
Advaxis shall not obtain any license in respect of Cobra’s Background.
Advaxis shall not be obligated to pay any royalties in respect of the use
of the Background in connection with the performance of any Contract by
Cobra or for any use of Background to the extent it is embedded in the
Advaxis products. It is understood that any consideration for the use of
the Background in connection with the performance of any Contract by Cobra
is already included in Contract O422. |
14.2 |
All
Foreground relating to process and manufacturing technology shall belong
to Advaxis. Cobra will promptly make full written disclosure to Advaxis in
the form of summary reports, will hold in trust for the sole right and
benefit of Advaxis, and hereby assigns, transfers and conveys to Advaxis,
or its designee, all use Foreground covered by this clause.
|
14.3 |
All
Foreground not covered by clause 14.2 shall belong to Advaxis. Cobra shall
provide regular reports to Advaxis describing the Foreground and shall
promptly reply to Advaxis’s reasonable requests for information regarding
the Foreground. Cobra hereby assigns and agrees to assign to Advaxis all
of its rights, title and interest in and to the Foreground not covered by
clause 14.2, and upon request by Advaxis, Cobra shall promptly execute
such documents and perform such other acts as may be reasonably requested
by Advaxis, at Advaxis’s expense, to obtain, perfect and enforce the
rights of Advaxis under this clause 14.3 and the assignment
thereof. |
14.4 |
Advaxis
grants to Cobra a licence to use such of Advaxis’s Intellectual Property
Rights (including, without limitation, any Foreground) as are necessary to
enable Cobra to carry out its obligations under a Contract, and Cobra may
sub-licence such Intellectual Property Rights to any sub-contractors
approved by Advaxis in accordance with Section 6, solely for the purpose
of performing the Contract. |
14.5 |
Advaxis
agrees to indemnify and keep Cobra indemnified against any and all
Liability suffered by Cobra arising from and/or due to any claim that the
use by Cobra of any or all of Advaxis’s Intellectual Property Rights in
performing a Contract infringes any third party’s Intellectual Property
Rights. |
Confidential
Document |
July
7, 2003 |
14.6 |
Cobra
warrants that Cobra has the right to use the Background to perform its
obligations in accordance with this Agreement and any
Contract. |
14.7 |
Cobra
agrees to indemnify and keep Advaxis indemnified against any and all
Liability suffered by Advaxis arising from or due to any claim that the
use of any or all of the Background in performing a Contract infringes any
third party’s Intellectual Property Rights. |
14.8 |
Advaxis
warrants that Advaxis has the right to grant the license and any permitted
sub-license of the Intellectual Property Rights required under clause 14.4
above. |
15.1 |
Each
party shall use the other party’s Confidential Information disclosed to
and/or acquired by it only for the purposes of this Agreement, any
Contract, and any other purpose for which the other party gives its prior
written consent. |
15.2 |
Each
party shall maintain as confidential all of the other party’s Confidential
Information which has come into and/or may come into its possession under
this Agreement or any Contract. |
15.3 |
Each
party shall not directly and/or indirectly use and/or disclose any of the
other party’s Confidential Information in whole or in part except in
accordance with this Agreement. |
15.4 |
Each
party shall at the other party’s request made at any time deliver up to
the other party all documents, material and/or other media which may be in
its possession, power or control which comprises or contains any part of
the other party’s Confidential Information except that it may retain one
complete copy solely for archive purposes. |
15.5 |
Each
party shall allow access to the other party’s Confidential Information
only to those employees who need to see and use such Confidential
Information in order to perform their obligations under this
Agreement. |
15.6 |
Each
party shall be responsible for the acts and/or omissions of its employees
and/or representatives (whether or not they remain its employees and/or
representatives) as if they were its own acts and/or omissions under this
Agreement. |
15.7 |
The
obligations of confidentiality and non-use in relation to the other
party’s Confidential Information and/or Materials shall have retrospective
force and effect and apply to any of the other party’s Confidential
Information disclosed prior to the date of this Agreement and shall
continue indefinitely. |
Confidential
Document |
July
7, 2003 |
15.8 |
A
party’s Confidential Information shall not include any information which:
|
|
15.8.1 |
the
receiving party can prove by documentary evidence was information already
in its possession and at its free disposal when received by it under this
Agreement or any Contract; |
|
15.8.2 |
is
after the date of this Agreement disclosed to the receiving party in
writing without any obligations of confidentiality by a third party who is
not in breach of any duty of confidentiality in doing so;
|
|
15.8.3 |
is
or becomes generally available to the public in printed publications in
general circulation through no act or default on the part of the receiving
party; or |
|
15.8.4 |
is
required to be disclosed by law, provided that the party required to make
such disclosure gives the other party prompt notice of such requirement so
that the other party may seek a protective order or other appropriate
remedy or waive compliance with the provisions of this Agreement, and
provided, further, that the party required to make such disclosure
cooperates with all reasonable efforts of the other party to obtain
confidential treatment of, or to otherwise limit, the required
disclosure. |
15.9 |
The
exceptions in clause 15.8 above shall not apply
to: |
|
15.9.1 |
Confidential
Information merely because it is embraced by more general information
which falls within any one or more of such exceptions;
and/or |
|
15.9.2 |
any
combination of features merely because individual features (but not the
combination itself) fall within any one or more of such
exceptions. |
16.1 |
Risk
in and title to the Products shall pass to Advaxis at the time of delivery
to Advaxis. Delivery shall be deemed to
occur:- |
|
16.1.1 |
at
the time when the Products arrive at the place of delivery if Cobra
delivers the Products by its own transport and/or it arranges transport
for Advaxis; or |
|
16.1.2 |
after
the expiration of 10 working days after Advaxis has been notified of that
the Products are available for collection from Cobra in accordance with
clause 10.6. |
Confidential
Document |
July
7, 2003 |
16.2 |
If
any Products are to be utilised in the Services, risk of damage to or loss
of such Products shall pass to Advaxis once utilised in the performance of
the Services. Cobra will replace free of charge any Products in which risk
has passed to Advaxis if it can be shown that they were damaged or lost
due to the neglect or default of Cobra, its employees or other
representatives. |
|
17.1.1 |
fails
to make any payment to Cobra 30 days after due
date; |
|
17.1.2 |
breaches
the terms of this Agreement or any Contract and, if the breach is capable
of remedy, has not remedied the breach within 14 days of receiving notice
requiring the breach to be remedied; |
|
17.1.3 |
persistently
breach any one or more terms of this Agreement;
or |
|
17.1.4 |
pledges
any Products which remain the property of Cobra, or ceases or threatens to
cease to carry on business, applies for an interim order under Section 252
Insolvency Act 1986 or has a Bankruptcy Petition presented against
Advaxis, enters into voluntary or compulsory liquidation, has a receiver,
administrator or administrative receiver appointed over all or any of its
assets, or takes or suffers any similar action in any jurisdiction;
|
then
Cobra shall have the right, without prejudice to any other remedies, to exercise
any or all of the rights set out in clause 17.2 below.
17.2 |
If
any of the events set out in clause 17.1 above occurs in relation to
Advaxis then:- |
|
17.2.1 |
Cobra
may withhold delivery of any undelivered Products and stop any Products in
transit; |
|
17.2.2 |
Cobra
may withhold the performance of any Services and cease any Services in
progress; |
|
17.2.3 |
Cobra
may cancel, terminate and/or suspend any Contract with Advaxis without
Liability to Advaxis for such cancellation, termination or suspension;
and/or |
|
17.2.4 |
All
monies owed by Advaxis to Cobra shall immediately become due and
payable. |
18.1 |
On
termination or completion of a Contract, Cobra shall, within 30 days of
Advaxis’s written request, either return and/or destroy any and all
Materials in Cobra’s possession supplied by or on behalf of Advaxis under
this Agreement together with any Results provided that Advaxis has paid to
Cobra all monies due and payable to Cobra under the Contract, except that
Cobra shall be entitled to retain in its archive one copy of such
Materials, Results and/or other information to enable it to comply with
GMP and/or Good Laboratory Practice and any and all other applicable
legislation, regulations and/or best practice from time to time in force.
No charge is made for such archive storage. |
Confidential
Document |
July
7, 2003 |
18.2 |
If
Cobra does not receive a request from Advaxis in accordance with clause
18.1 above, Cobra shall retain in its archives for a period of 10 years
(or such other period as Cobra determines based on the quality of the
matters to be archived) following either the date of termination of the
Contract or from the date of completion of the Contract all of the
Materials, Results and other information arising out of that Contract
whether or not Cobra is obliged to archive such matters under clause 18.1.
At the end of the ten-year period Cobra shall contact Advaxis for further
instructions as to the disposal and/or storage of the archived information
held by Cobra. If Advaxis does not respond within 30 days of such
notification, Cobra may either return the archived matter to Advaxis at
Advaxis’s own expense or destroy the archived
matter. |
19.1 |
Cobra
warrants that the Products and/or
Services:- |
|
19.1.1 |
will
be free from substantial defects in materials and/or
workmanship; |
|
19.1.2 |
are
manufactured and/or performed with all proper and reasonable skill,
competence, care and attention; |
|
19.1.3 |
are
produced and/or performed in accordance with GMP and Medicines Control
Agency and/or FDA guidelines where specified or
appropriate; |
|
19.1.4 |
will
at the time of delivery and/or performance conform with any final
Specification (for the avoidance of doubt this warranty does not extend to
draft or provisional Specification); |
|
19.1.5 |
comply
with all applicable legal and regulatory standards from time to time;
and |
|
19.1.6 |
are
manufactured, packaged, handled and stored in accordance with the terms of
the applicable Contract and all appropriate legislation rules and other
requirements of the appropriate regulatory authorities in force at the
time of the Contract. |
Confidential
Document |
July
7, 2003 |
19.2 |
The
warranties in clause 19.1 above are given by Cobra subject to the
following conditions:- |
|
19.2.1 |
Cobra
shall be under no Liability in respect of any defect in the Products
and/or Services arising directly from any information and/or
specifications supplied to Cobra by
Advaxis; |
|
19.2.2 |
Cobra
shall have no Liability in respect of any faults arising after risk in the
Products has passed to Advaxis that are caused by any subsequent
mechanical, chemical, biological, electrolytic or other damage not due to
a defect in the Products and/or Services or the neglect or default of
Cobra; and/or |
|
19.2.3 |
Cobra
shall be under no Liability in respect of any faults or defects caused by
wilful damage, abnormal working or operating conditions, failure to follow
Cobra’s instructions, misuse or alteration of Products and/or Services
without Cobra’s approval, improper maintenance, storage or negligence on
Advaxis’s part and/or by a third party. |
19.3 |
Cobra
does not guarantee that the Services to be carried out by Cobra under this
Agreement or any Contract will be successful and/or will achieve any
objectives outlined by Advaxis in Advaxis’s
order. |
19.4 |
If
Cobra is in breach of any of the warranties given in clause 19.1 with
respect to a Contract, Advaxis may suspend the due date for payment of any
unpaid amounts under the Contract until Cobra
promptly: |
|
19.4.1 |
replaces
the defective Products; and/or |
|
19.4.2 |
re-performs
the Services; |
and
thereafter all outstanding amounts shall become due and payable.
19.5 |
Cobra
shall have no liability under the warranties given in clause 19.1 unless
it has received written notification of non-conformance from Advaxis
within 21 days of discovery by Advaxis of the
non-conformance. |
20. |
Repairs
And Replacements |
20.1 |
Cobra
will at its option, promptly, either refund the price or re-perform any
defective Services and/or replace any defective Products where the defect
is apparent on inspection, provided that the defect is notified to Cobra
within 21 working days of delivery of such Products or performance of the
Services. |
20.2 |
If
Advaxis fails to notify Cobra of any defect in the Products and/or
Services under clause 20.1 within 21 working days of delivery and/or
performance, Advaxis will be deemed to have accepted the Products and/or
Services. |
Confidential
Document |
July
7, 2003 |
20.3 |
A
sample of any defective Products must where reasonable be returned to
Cobra for inspection if requested by Cobra before Cobra will have any
Liability for defective Products. If the sample proves to be defective,
then Cobra shall reimburse Advaxis for the cost of returning the sample of
the defective Products to Cobra. |
20.4 |
Cobra,
if it requests and where reasonable, shall have the right to inspect the
subject-matter of any allegedly defective Services at a mutually
convenient time, and Cobra will not have any Liability for any such
defective Services until it has been allowed to make such
inspection. |
20.5 |
Cobra
will replace and/or re-perform defective Products and/or Services which
are not notified to Cobra within the time limit specified in clause 20.1
where the defect would not have been ascertainable on inspection and has
been notified to Cobra as soon as reasonably practicable after discovery
by Advaxis. |
20.6 |
Cobra
will at its option either refund the price of or replace free of charge
any Products missing from a delivery of Products provided that the missing
items are notified to Cobra within five working days after receipt of the
shipment or, in the event of total non-delivery, this fact is notified to
Cobra within five working days after receipt by Advaxis of Cobra’s invoice
for such Products. |
20.7 |
If,
on investigation, it is found that any claimed defects in the Products
and/or Services are not the responsibility of Cobra under this Agreement
or the applicable Contract, Cobra may charge Advaxis for all reasonable
costs and expenses it has incurred in the course of and/or in consequence
of the investigation. |
21. |
Limitations
On Liability |
21.1 |
Cobra
shall have no Liability for defective Products and/or Services where the
defect has been caused by Advaxis. |
21.2 |
Cobra
shall have no Liability to Advaxis for defective Products and/or Services,
Products not despatched or Products damaged or lost in transit unless the
event is notified to Cobra within the appropriate time limit set out in
this Contract. |
21.3 |
Cobra
shall have no Liability for additional damage, loss, liability, claims,
costs or expenses caused by Advaxis’s continued use of defective Products
and/or Services after a defect has become apparent to
Advaxis. |
21.4 |
Advaxis
shall where reasonable give Cobra a reasonable opportunity to remedy any
matter for which Cobra is liable before Advaxis incurs any costs and/or
expenses in attempting to remedy the matter independently. If Advaxis does
not do so, Cobra shall have no liability to Advaxis for any damages caused
by Advaxis, which could have been avoided if Advaxis had permitted Cobra
the opportunity to remedy the matter first. |
Confidential
Document |
July
7, 2003 |
21.5 |
Neither
party shall have any Liability to the other party for
any:- |
|
21.5.1 |
consequential
losses; |
|
21.5.2 |
loss
of profits (other than direct loss of profit under a Contract in relation
to work to be and/or already performed by Cobra under that Contract)
and/or damage to goodwill; |
|
21.5.3 |
economic
and/or other similar losses; |
|
21.5.4 |
special
damages and indirect losses; and/or |
|
21.5.5 |
business
interruption, loss of business, contracts, opportunity and/or
production; |
suffered
by the other party, and this shall apply whether or not it has been informed by
the other party of the possibility of such matters.
21.6 |
Each
party shall be under a duty to mitigate any loss, damage, costs or
expenses that it may suffer. |
21.7 |
Cobra’s
total Liability to Advaxis in relation to any Contract shall not exceed
the
amount paid by Advaxis to Cobra in relation to that
Contract. |
21.8 |
Each
of the limitations and/or exclusions in this Agreement shall be deemed to
be repeated and apply as a separate provision for each of:
|
|
21.8.1 |
Liability
for breach under any Contract and/or under this Agreement;
|
|
21.8.2 |
Liability
in tort (including negligence); |
|
21.8.3 |
Liability
for breach of statutory duty; and |
|
21.8.4 |
Liability
for breach of Common Law. |
except
clause 21.8 which shall apply once only as to any Contract in respect of all the
said types of Liability under the Contract.
21.9 |
Nothing
in this Agreement or any Contract shall exclude or limit the Liability of
Cobra for death or personal injury due to its negligence or any Liability
which is due to Cobra’s fraud or any other liability which it is not
permitted to exclude or limit as a matter of
law. |
22.1 |
Cobra
shall provide prompt and regular updates to Advaxis as the progression of
work under each Contract and shall disclose all Results to Advaxis on a
regular basis. |
Confidential
Document |
July
7, 2003 |
22.2 |
All
Results and any and all Intellectual Property Rights in the Results shall
belong to Advaxis and shall form part of Advaxis’s Confidential
Information under the Contract. Cobra may only use the Results with
Advaxis’s prior written consent. |
22.3 |
Cobra
shall provide Advaxis with a final report within 30 working days of
completion of the Services under any Contract, the contents of which
include but will not be limited to the Results. Further copies of the
final report shall be made available to Advaxis on Advaxis’s request and
at Advaxis’s own expense. |
23.1 |
Advaxis
shall not, during the term of any Contract and for a period of 12 months
immediately following the termination of the Contract, whether on
Advaxis’s own behalf or in conjunction with or on behalf of any person,
firm, company, business entity or other organisation and whether as
employee, director, principal, agent, consultant, shareholder or in any
other capacity whatsoever, directly or
indirectly:- |
|
23.1.1 |
solicit
or procure any person who is or was an employee, agent and/or
representative of Cobra to cease working for Cobra or accept into
employment or otherwise engage or use the services of any person where
that person:- |
|
23.1.1.1 |
is
an employee, agent and/or representative of Cobra at that time;
and/or |
|
23.1.1.2 |
has
been an employee, agent and/or representative of Cobra at any time during
the immediately preceding three months. |
23.2 |
Whilst
each of the restrictions in clause 23.1 are considered by the parties to
be reasonable in all the circumstances as at the date of this Contract, it
is agreed and declared that if any one or more of such restrictions shall
be judged to be void as going beyond what is reasonable in all the
circumstances for the protection of the interests of Cobra but would be
valid if the restrictions were reduced in scope, the restrictions shall be
deemed to apply with such modification. |
23.3 |
Any
restriction or part of a restriction found in any event to be void shall
not affect the validity of any other restriction contained in this
Agreement. |
23.4 |
Cobra
may by written notice at any time reduce the duration and/or scope of any
of the restrictions in clause 23.1 above. |
Confidential
Document |
July
7, 2003 |
24.1 |
Advaxis
agrees to indemnify and keep indemnified Cobra against any and all
liability, loss, costs and expenses arising out of (i) any third party
claim relating to this Agreement, (ii) any third party claim relating to
the use of Products by Advaxis or by any third party, or (iii) the breach
by Advaxis of any of its obligation or covenants under any Contract, in
each case, subject to the limitations set forth in clause 21.6.
|
24.2 |
Cobra
agrees to indemnify and keep indemnified Advaxis against any and all
liability, loss, costs and expenses arising out of (i) any third party
claim relating to this Agreement, (ii) any third party claim relating to
the use of Products by Cobra or by any third party, or (iii) the breach by
Cobra of any of its obligation or covenants under any Contract, in each
case, subject to the limitations set forth in clause 21.6.
|
24.4 |
No
waiver by a party of any breach of this Agreement or any Contract shall be
considered as a waiver of any subsequent breach of the same provision or
any other provision. |
24.5 |
If
any provision of this Agreement or any Contract is held by any competent
authority to be invalid or unenforceable in whole or in part, the validity
of the other provisions thereof and the remainder of the affected
provision shall be unaffected and shall remain in full force and
effect. |
24.6 |
Neither
party shall have any Liability to the other party for any delay in
performance of any Contract to the extent that such delay is due to any
events outside its reasonable control including but not limited to acts of
God, war, flood, fire, labour disputes, subcontractor delays, strikes,
lock-outs, riots, civil commotion, malicious damage, explosion,
governmental actions and any other similar events. If a party is affected
by any such event, then time for performance shall be extended for a
period equal to the period that such event or events delayed such
performance, provided that the party uses all reasonable efforts to
minimize the duration of such effect. This shall not apply to any decision
by the Medicines Control Agency that the Products have, where required,
been produced without appropriate GMP and/or Good Laboratory Practice
controls and/or documentation. |
24.7 |
Neither
party may assign this Agreement or any Contract without the written
consent of the other party, except to a wholly owned subsidiary or to any
successor in interest by merger or purchase of all or substantially all of
its assets. |
Confidential
Document |
July
7, 2003 |
24.8 |
All
third party rights are excluded and no third party shall have any right to
enforce this Agreement or any Contract. |
24.9 |
Any
dispute arising out of or in connection with the Contract shall be
referred to the arbitration in London of a single arbitrator appointed by
agreement between the parties or, in default of agreement, nominated on
the application of either party by the President for the time being of The
Law Society. The arbitration shall be carried out in accordance with the
Rules of Arbitration of the International Chamber of Commerce in force as
at the date of the dispute. This Agreement shall be governed by and
construed in all respects in accordance with the Laws of England. This
shall not prevent either party seeking interim injunctive relief from any
court of law. |
24.10 |
Ongoing
Relationship and Commercial Supply |
|
24.10.1 |
Cobra
acknowledges that drug development is a lengthy and risky process and
accordingly: |
|
24.10.2 |
Advaxis
may wish to amend or terminate the Development Program at any time it
reasonably considers the manufacture and/or marketing to the public at
large of Formulated Product or Listeria monocytogenes ceases to be
commercially viable; or |
|
24.10.3 |
Advaxis
may require Cobra to be a long-term collaborator in the production of
Formulated Product or Listeria monocytogenes suitable for toxicological
studies, stability studies, human clinical trials and marketing to the
public at large. |
|
24.10.4 |
Upon
Advaxis’s written request, the Parties will negotiate in good faith an
agreement on the terms under which Cobra will manufacture and supply to
Advaxis quantities of Formulated Product or Listeria monocytogenes
required by Advaxis on a commercial scale for marketing to the public at
large. |
|
24.10.5 |
Notwithstanding
clause 24.8.4, Cobra acknowledges that Advaxis has made no representation
that Advaxis will, intends to or is likely to, issue a request to Cobra
for the manufacture and supply of Formulated Product or Listeria
monocytogenes in quantities on a commercial scale for marketing to the
public at large. |
Confidential
Document |
July
7, 2003 |
Redacted
Version
Confidential
Treatment Sought
with
respect to certain portions of the Agreement indicated
by a [ *
]
CLINICAL
RESEARCH SERVICES AGREEMENT
BETWEEN
ADVAXIS,
INC
AND
PHARM-OLAM
INTERNATIONAL LTD.
TABLE
OF CONTENTS
RECITALS |
1 |
|
|
1. |
DEFINITIONS |
1 |
|
|
|
2. |
INTERPRETATION |
5 |
|
|
|
3. |
APPOINTMENT
& RELATIONSHIP OF PARTIES |
5 |
|
|
|
4. |
REPRESENTATIONS
& WARRANTIES |
6 |
|
|
|
5. |
POI's
OBLIGATIONS |
6 |
|
|
|
6. |
THE
COMPANY's
OBLIGATIONS |
7 |
|
|
|
7.
|
CRO
COMPENSATION |
8 |
|
|
|
8. |
INSURANCE |
9 |
|
|
|
9. |
CONFIDENTIALITY |
9 |
|
|
|
10. |
INTELLECTUAL
PROPERTY |
10 |
|
|
|
11. |
ARBITRATION |
10 |
|
|
|
12. |
NON-SOLICITATION
OF STAFF |
11 |
|
|
|
13. |
TERM
& TERMINATION |
11 |
|
|
|
14 |
CONSEQUENCES
OF TERMINATION |
13 |
|
|
|
15. |
GENERAL
PROVISIONS |
13 |
|
|
|
16. |
APPLICABLE
LAW |
15 |
Attachment
I and IA |
Payment
Schedule, Budget, pass through and Timelines Schedule |
|
|
Attachment
II |
POI
Clinical Research Services and POI deliverables |
|
|
Attachment
III |
Protocol
and Schedule of Procedures |
Advaxis
Clinical Research Agreement
April 6,
2005
This
Clinical Research Services Agreement (this Agreement) is made and entered into
effective as of April 4, 2005, by and between Advaxis, Inc. (hereafter “THE
COMPANY”), a Colorado Company with its principal office at 212 Carnegie Center,
Suite 206, Princeton, New Jersey 08540, and PHARM-OLAM INTERNATIONAL LTD.
(hereafter “POI”), a Texas limited partnership, with its principal office at 450
N Sam Houston Pkwy, Suite 450, Houston, TX 77060, United States.
RECITALS
WHEREAS,
THE COMPANY is a biotech company that develops biological vaccines to cure
cancer; and
WHEREAS,
POI is a contract research organization that plans, implements, and manages
clinical trials; and
WHEREAS,
THE COMPANY desires to engage POI to assist THE COMPANY in planning,
implementing, and managing regulatory and conduct of a phase I clinical trial on
an Investigational Biological Product Lovaxin C, as hereafter defined;
and
WHEREAS,
POI is willing to accept such engagement on the terms and conditions set forth
herein;
NOW,
THEREFORE, in consideration of the premises and the mutual covenants and
obligations set forth herein, and for other good and valuable consideration, the
receipt and sufficiency of which are acknowledged, the parties agree as
follows:
1. DEFINITIONS
For
purposes of this Agreement and the Protocol Synopsis, each capitalized term
shall have the meaning ascribed to it in this Agreement. Each capitalized term
not defined in this Agreement shall have the meaning ascribed to that term in
the Protocol. In the event of a discrepancy in the meaning ascribed to a term in
the body of this Agreement and the meaning ascribed to that term in the
Protocol, the definition utilized in the body of this Agreement shall
control.
1.1 “Case
Report Form” or “CRF” means the record of pertinent information collected on
each subject who participates in the Study;
1.2 “Clinical
Laboratory Agreement” means the Agreement between THE COMPANY and the clinical
laboratory or laboratories that will provide clinical laboratory services for
the Study.
1.3 “Clinical
Research Associate” or “CRA” means the person assigned by POI to monitor one or
more Study Sites.
Advaxis
Clinical Research Agreement
April 6,
2005
1.4 “Clinical
Trial Agreement” means the agreement between POI and an Investigator that
details the respective rights and obligations of both parties in relation to the
Study;
1.5 “Clinical
Trial Materials” means the Investigational Product, printed Case Report Forms,
competitor substances, CRF monitoring conventions, the Protocol, the
investigational drug brochure, informed consent form, guidelines for use of the
Investigational Product, and all other materials provided by THE COMPANY to
conduct the Study.
1.6 “Closeout
Services” means those services described in Section 14 to be performed by POI
upon termination of this Agreement.
1.7 “Company
Obligations” means the obligations of THE COMPANY under this
Agreement.
1.8 “Confidential
Information” means any information, whether written or oral, including all
notes, studies, customer lists, forms, business or management methods, marketing
data, fee schedules, or trade secrets of any member of the POI Group or of THE
COMPANY, as appropriate, disclosed or otherwise made available to one party by
the other party pursuant to this Agreement. Confidential Information shall also
include the terms and provisions of this Agreement and any transaction or
documents executed by the parties pursuant to this Agreement. In
addition, Confidential Information shall include any data or information
developed or generated in the course of performance of this Agreement.
Publication of the fact that THE COMPANY and POI have entered into a clinical
trials agreement, without disclosing the terms and provisions of this Agreement,
shall not be construed as unauthorized disclosure of Confidential
Information.
Confidential
Information does not include any information that (i) is or becomes generally
available to and known by the public, other than as a result of an unauthorized
disclosure directly or indirectly by the receiving party or its affiliates,
advisors, or representatives; (ii) is or becomes available to the receiving
party on a non-confidential basis from a source other than the furnishing party
or its affiliates, advisors, or representatives, provided that such source is
not and was not bound by a confidentiality agreement with or other obligation of
secrecy to the furnishing party of which the receiving party has knowledge at
the time of such disclosure; or (iii) has already been or is hereafter
independently developed by the receiving party by persons not having access to
the Confidential Information of the furnishing party.
The
parties acknowledge that they have already executed a confidentiality agreement.
(“CDA”) In the event of a conflict or a contradiction between this Agreement and
the CDA, the terms of the CDA shall control.
1.9 “CRO
Compensation” means the compensation to be paid by THE COMPANY to POI as set out
in Attachment 1.
1.10 “Effective
Date” means the effective date of this Agreement as set forth in the initial
paragraph of this Agreement.
Advaxis
Clinical Research Agreement
April 6,
2005
1.11 “Food and
Drug Administration” means the United States government agency responsible for
ensuring compliance with the Food, Drug, and Cosmetics Act of 1938.
1.12 “Force
Majeure Event” means an event beyond the reasonable control of the relevant
party including, but not limited to, acts of God, a public enemy, or a civil or
military authority; fires or other catastrophes; strikes, lockouts, or other
industrial action taken by the employees of any party or any third party; delays
in transportation; riots; or invasions, wars, or threats of war.
1.13 “Good
Clinical Practice” means the clinical standards established by the FDA and
counterpart agencies of each country in which the Study will take place,
designed to regulate the activities of THE COMPANY’s investigators, monitors,
and Institutional Review Boards (“IRBs”) involved in clinical drug
testing.
1.14 “Institutional
Review Board” means the independent group of professionals designated to ensure
that the Study is safe and effective for human participation and that the Study
adheres to the regulations issued by the FDA and any
other applicable country-specific laws, regulations or guidelines.
1.15 “Investigational
New Drug Application” or “IND” means the petition filed by THE COMPANY with the
FDA requesting the FDA to allow human testing on the Investigational
Product.
1.16 “Investigational
Product” means the product (drug, device, or biologic) described in the Protocol
that will be evaluated in this Study.
1.17 “Investigator”
means an
individual who actually conducts a clinical investigation, i.e., under whose
immediate direction the Investigational Product is administered or dispensed to,
or used involving a subject, or, in the event of an investigation conducted by a
team of individuals, is the responsible leader of that team.
1.18 “POI
Group” means the following persons and entities, as constituted at the date of
this Agreement or subsequently: (i) POI; and (ii) any person or entity that
directly, or indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with POI.
1.19 “POI’s
Obligations” means the obligations of POI under this Agreement.
1.20 “Project
Manager” means the manager assigned by POI to be the primary contact person
between POI and THE COMPANY during the Study.
1.21 “Protocol”
means the plan that describes the objectives, study design, and methodology and
any approved amendments thereto, which is attached as Attachment
III, and
which is herein incorporated by reference.
Advaxis
Clinical Research Agreement
April 6,
2005
1.22 “Regulatory
Requirements” means those laws, regulations, and professional and ethical
standards and guidelines then in effect in the countries in which the Study is
conducted that apply to the Investigational Product or clinical trials in
general.
1.23 “Related
Products” means any product (drug, device, or biologic), other than the
Investigational Product, administered or utilized as part of this
Study.
1.24 “Serious
Adverse Event” shall take the meaning given this term in the
Protocol.
1.25 “Services”
means the services to be furnished by POI in connection with the Study as set
out in this Agreement and the list of deliverable specified in Attachment
II.
1.26 “Staff”
means the staff assigned to the Study by THE COMPANY either directly or
indirectly through the Clinical Trial Agreement.
1.27 “Standard
Operating Procedures” or “SOP’s” means internal procedures for the management of
a clinical trial designed to ensure that the trial is carried out in a
consistent, controlled, and effective manner.
1.28 “Study”
means the clinical trial of the Investigational Product, the details of which
are set out in the Attachments I, II and III and the Protocol..
1.29 “Study
Documents” means the documents produced by POI in connection with the Study that
are, in the sole discretion of POI, necessary for the production of the Final
Study Report.
1.30 “Term”
means the duration of this Agreement as set out in Section 13.
2. INTERPRETATION
2.1 Words of
any gender used in this Agreement shall be held and construed to include any
other gender, and words in the singular number shall be held to include the
plural, and the plural to include the singular, unless the context requires
otherwise.
2.2 The
headings of the sections of this Agreement are inserted for convenience only and
in no way define, limit, or prescribe the intent of this Agreement.
2.3 Unless
otherwise specified, references in this Agreement to Sections and Attachment I
are to the sections of, and Attachment I to, this Agreement. Attachment I is
deemed to be
incorporated into, and form part of, this Agreement, and the term “Agreement”
shall be construed accordingly.
2.4 Unless
otherwise specified, any reference to a statute, rule, or regulation shall be to
that statute, rule, or regulation as amended from time to time.
Advaxis
Clinical Research Agreement
April 6,
2005
3. APPOINTMENT
AND RELATIONSHIP OF PARTIES
3.1 THE
COMPANY hereby engages the services of POI, and POI accepts such engagement, to
perform the Study and the Services, under the terms and conditions contained in
this Agreement.
3.2 During
the Term, POI shall at all times be the independent contractor of THE COMPANY,
and nothing in this Agreement is intended, nor shall be construed, to create
between THE COMPANY and POI the relationship of principal and agent, employer
and employee, partnership, or joint venture, and the parties shall not represent
themselves otherwise.
3.3 THE
COMPANY shall be liable for its own debts, obligations, acts or omissions,
including but not limited to the payment of all required compensation,
withholding, social security and other taxes or benefits for THE COMPANYs
employees. Likewise, POI shall be liable for its own debts, obligations, acts or
omissions, including but not limited to the payment of all required
compensation, withholding, social security and other taxes or benefits for
POI’s
employees.
3.4 If the
Internal Revenue Service or any other government authority shall, at any time,
question or challenge the independent contractor status of POI, upon receipt by
either party of notice from the Internal Revenue Service or any other
governmental authority, the receiving party shall promptly notify the other
party and afford the other party the opportunity to participate in any
discussion or negotiation with the Internal Revenue Service or other government
authority, regardless as to who initiates such discussions or
negotiations.
4. REPRESENTATIONS
AND WARRANTIES
4.1 POI
warrants to THE COMPANY that it has the authority to enter into this
Agreement.
4.2 THE
COMPANY warrants to POI that (i) it has the authority to enter into this
Agreement; and (ii) all consents and approvals required for the Study (except
for the consent of the individuals who will participate in the Study) have been,
or will be obtained prior to initiation of the Study.
5. POI'S
OBLIGATIONS
In
addition to POI's
Obligations set forth in Attachment I and II and elsewhere in this Agreement,
POI shall have the following obligations:
5.1 Before
commencement of the Study, POI shall assign to the Study a Project Manager and
sufficient personnel, including CRAs, with suitable experience and training to
fulfill POI's
obligations under this Agreement. Any
change in the Project Manager thereafter must be reasonably acceptable to THE
COMPANY.
Advaxis
Clinical Research Agreement
April 6,
2005
5.2 POI shall
apply to the Study systems of quality control designed to ensure that, as far as
is reasonably practicable, THE COMPANY and the Investigators conduct the Study;
generate data; and record and report data, all in compliance with the Regulatory
Requirements, Good Clinical Practice, the Protocol, and this Agreement, in that
order.
5.3 POI shall
use its best efforts to perform the Services and deliverables within the time
frames specified in Attachment
I.
5.4 POI shall
procure and maintain consents, approvals, licenses, and operating certificates
as required.
5.5 POI shall
retain all material Study Documents, as determined by POI in its sole
discretion, until this Agreement has terminated and all Closeout Services has
been performed. All Study
Documents and CRF’s will be forwarded to THE COMPANY after the Study is
completed.
5.6 Company
shall have the right to visit and co-monitor a Study Site or inspect and audit
any of the Study Documents maintained by POI. All such visits and inspections
must be conducted during normal working hours on regular business days, unless
otherwise agreed. POI shall
arrange access to the Study Site as soon as reasonably practicable following
notification by THE COMPANY.
5.7 POI will
provide THE COMPANY with written status reports in accordance with either THE
COMPANY or POI SOP’s.
5.8 POI shall
notify THE COMPANY by phone immediately after becoming aware of a Serious
Adverse Event and shall submit an initial written report to THE COMPANY
regarding that Serious Adverse Event via facsimile within 24 hours after POI
becomes aware of any such event.
5.9 POI shall
indemnify and save harmless THE COMPANY, its officers, agents, and employees
from all suits, actions, losses, damages, claims, or liability of any character,
types, or description, including without limiting the generality of the
foregoing, all expenses of litigation, court costs, and reasonable attorney’s
fees for injury or death to any person, or injury to property, received or
sustained by any person or persons or property, arising out of, or occasioned by
POI (or its agents or employees), in connection with its execution or
performance of this Agreement. The Investigators are not and shall not be deemed
the agents of POI for purposes of this Section 5.9. THE COMPANY will notify POI
of any claim or suit which may be subject to the provisions of this Section 5.9
as soon as reasonably practicable after receiving notice of the claim. POI shall
have the sole right to control and settle any such claim or suits, and THE
COMPANY shall make all reasonable efforts to cooperate (at POI’s expense) as
requested by POI in handling any such claim or suit.
Advaxis
Clinical Research Agreement
April 6,
2005
5.10 For the
removal of any doubt, subject to the Company providing POI with the materials
necessary for POI to complete and write the Investigational Product, POI shall
be responsible to obtain all approvals, construct all the necessary written
materials submit any and all applications as necessary, and cause the Phase I
clinical trial to be conducted and completed in accordance with the Protocol (a
draft of which is attached hereto as Attachment
III) and in
a form and manner acceptable to the US Food and Drug
Administration.
5.11 In the
event the Phase I study is conducted out of the US, POI shall follow the Special
Protocol Assessment procedure of the US Food and Drug Administration and seek
the feedback or approval of the US Food and Drug Administration to the
Protocol.
5.12 Outside
regulatory consultant: POI
will work with a third party regulatory consultant pre approved by THE
COMPANY.
5.13 POI shall
be responsible for the list of services and deliverables specified in
Attachment
II. POI as
the contracted research organization agrees to conduct the proposed phase 1b
trial for Advaxis with the highest quality of care and in compliance with
accepted standards of Good Research Practice and Good Laboratory Practice.
Without derogating from the generality of the foregoing statement, the standards
of management mentioned in Attachment
II shall
apply.
6. THE
COMPANY'S
OBLIGATIONS
In
addition to THE COMPANY's
Obligations set forth in the Attachment I and elsewhere in this Agreement, THE
COMPANY shall have the following obligations:
6.1 THE
COMPANY shall provide POI, at no expense to POI (i) with all information and
documentation reasonably necessary for POI to perform its duties hereunder,
including but not limited to, all Clinical Trial Materials; and (ii) with all
advice, guidance, and assistance reasonably requested by POI to fulfill it
duties under this Agreement.
6.2 Except
for the POI obligations in Paragraph 5.4, or as otherwise specifically provided
herein, THE COMPANY shall procure and maintain all consents, approvals,
licenses, and operating certificates required to conduct the Study. THE COMPANY
shall also develop, comply with, and require Staff to comply with, policies and
procedures designed to assure, at all times, that such consents, approvals,
licenses, and operating certificates remain in effect throughout the
Term.
6.3 THE
COMPANY shall indemnify and save harmless POI, its officers,
agents, and employees from all suits, actions, losses, damages, claims, or
liability of any character, types, or description, including without limiting
the generality of the foregoing, all expenses of litigation, court costs, and
attorneys’ fees for injury or death to any person, or injury to property,
received or sustained by any person or persons or property, arising out of, or
occasioned by the Investigational Product or the acts or omissions of the Staff
or THE COMPANY (or its agents or employees), in connection with the Study or
their execution or performance of this Agreement. POI will notify THE COMPANY of
any claim or suit which may be subject to the provisions of this Section 6.3 as
soon as reasonably practicable after receiving notice of the claim. THE COMPANY
shall have the sole right to control and settle any such claims or suits, and
POI shall make all reasonable efforts to cooperate (at THE COMPANY’s expense) as
requested by THE COMPANY in handling any such claim or suit.
Advaxis
Clinical Research Agreement
April 6,
2005
7. CRO
COMPENSATION
7.1 THE
COMPANY shall pay POI the amounts set forth in Attachment I for all services
provided and expenses incurred by POI pursuant to this Agreement, according to
the payment schedule set forth in Attachment I. Upon early termination of this
Agreement pursuant to Sections 13.2, 13.3, or 13.4, THE COMPANY shall continue
to pay POI the amounts set forth in Attachment I for all services provided by
POI prior to the termination of this Agreement and for the Closeout Services
furnished by POI after the termination of this Agreement, provided that in no
event will the amount owed to POI exceed the maximum amounts specified in
Attachment
I.
7.2 POI shall
submit invoices to THE COMPANY upon the completion of each payment milestone
event set forth in Attachment I. THE COMPANY shall make full payment of such
sums by check or in cleared funds to such bank account in the United States as
POI may reasonably specify from time to time, upon receipt of invoice (“Due
Date”), without any deduction, set off or withholding except any tax which THE
COMPANY is required by law to deduct or withhold. Any amounts which remain
unpaid for thirty (30) days or more after the Due Date shall bear interest at
the rate equal to 8% per annum. Interest shall be computed on the basis of a 365
or 366-day year, as the case may be, subject to the provisions hereof limiting
interest to the maximum rate of interest allowed by applicable law. If any
amounts remain unpaid for ninety (90) days or more after the Due Date, POI shall
have the right to discontinue all work and services under this Agreement until
such amounts are paid in full.
7.3 If THE
COMPANY is required by law to make any tax deduction or withholding, THE COMPANY
shall provide reasonable assistance as requested by POI to assist POI to claim
exemption from, or if that is not possible a credit for, the deduction or
withholding under any applicable double taxation or similar agreement. THE
COMPANY shall also supply POI from time to time with proper evidence as to the
deduction or withholding and payment over of the tax deducted or
withheld.
8. INSURANCE
8.1 THE
COMPANY and POI shall each maintain, at its sole cost and expense, insurance
coverage with a reputable insurer (which shall be either occurrence based or
claims made coverage) in an amount usual and customary for companies engaged in
activities as contemplated by this Agreement. All such insurance shall be in
place before the first patient is enrolled in the Study. Each shall designate
the other party as an additional named insured on all such policies, and an
endorsement shall be made on each such policy prohibiting the insurer from
canceling the policy for any reason or substantially modifying its terms without
first giving the other party at least twenty-eight (28) days written notice of
its intention to do so.
Advaxis
Clinical Research Agreement
April 6,
2005
8.2 Upon
request by either party, the other party shall provide evidence of that party’s
compliance with this Section.
9. CONFIDENTIALITY
9.1 Except as
specified in the following Section, each of the parties agrees (i) that it shall
not disclose any Confidential Information of the other party to other persons
without the express written authorization of the other party; (ii) that such
Confidential Information shall not be used in any way detrimental to the other
party; and (iii) that the parties will keep such Confidential Information
confidential and will ensure that its affiliates and advisors who have access to
such Confidential Information comply with these non-disclosure
obligations.
9.2 Notwithstanding
the foregoing, the parties may disclose Confidential Information to (i) those of
its representatives, including, but not limited to the other party’s legal,
financial and accounting advisors, who need to know Confidential Information for
the purpose of conducting this Study, it being understood and agreed by the
parties that such representatives will be informed of the confidential nature of
the Confidential Information, will agree to be bound by this Section, and will
be directed by the respective party not to disclose to any other person any
Confidential Information; and (ii) the FDA, an IRB, or comparable governmental
or professional body with jurisdiction over the Study provided such disclosure
is requested by the respective governmental or professional body or is required
in order to satisfy Section 6.1.
In the
event that either party determines that it is required by law to disclose the
other party’s Confidential Information, or such disclosure is in response to a
subpoena or a similar legal process, such disclosure shall be permitted provided
that the other party required to make such disclosure promptly notifies the
other party and assists the other party in obtaining a protective order or other
appropriate remedy.
10. INTELLECTUAL
PROPERTY
10.1 POI
acknowledges that, as between THE COMPANY and POI, any and all intellectual
property rights that may arise in the Study itself shall belong solely to THE
COMPANY, including without limitation all data generated in the course of the
Study, and all Clinical Trial Materials.
10.2 THE
COMPANY acknowledges that, as between POI and THE COMPANY, any and all
intellectual property rights in works authored by POI before the Effective Date
of this Agreement and works authored by POI independent of the Study shall
belong to POI.
11. ARBITRATION
11.1 Any
controversy or claim between the parties arising out of or relating to this
Agreement, shall be finally determined and settled pursuant to arbitration in
Princeton, NJ, by three disinterested arbitrators each of whom (i) shall have at
least 5 years of experience as an arbitrator and (ii) shall be associated with
the American Health Lawyers Association ADR Service or the American Arbitration
Association. One arbitrator shall be appointed by THE COMPANY, one arbitrator
shall be appointed by POI, and one arbitrator shall be appointed by such
party-appointed arbitrators. The third arbitrator shall be an attorney and shall
act as chairman. Should either party fail to appoint an arbitrator as
contemplated in this Section within 10 days after that party has received such
written request, or if the two arbitrators appointed by or on behalf of the
parties as contemplated in this Section fail to appoint a third arbitrator, then
upon application by either party, the remaining arbitrator(s) shall be appointed
pursuant to the Commercial Arbitration Rules of the American Arbitration
Association, which arbitrator(s) shall fill such position with the same force
and effect as though such arbitrator(s) had been appointed as contemplated in
this Section.
Advaxis
Clinical Research Agreement
April 6,
2005
11.2 The
arbitration proceedings shall be conducted in accordance with the Commercial
Arbitration Rules of the American Arbitration Association. A determination,
award, or other action shall be considered the valid action of the arbitrators
if supported by the affirmative vote of two or three of the three arbitrators.
The costs of arbitration (exclusive of a party’s own
costs incurred in attending the arbitration, and of the fees and expenses of
legal counsel to such party, all of which shall be borne by such party) shall,
in the discretion of the arbitrators, be ordered to be paid by the one or both
of the parties either equally or in such proportions as may be decided by the
arbitrators. The arbitration award shall be final and binding, and judgment upon
such award may be entered in any court having jurisdiction.
Notwithstanding any other
provision hereof, no party shall be awarded punitive or exemplary damages in any
arbitration hereunder.
12. NON-SOLICITATION
OF STAFF
During
the term of this Agreement and for a period of twelve months following its
termination or expiration, THE COMPANY shall not directly or indirectly (i)
solicit or entice any employee or contractor of POI with whom it comes into
contact as a result of participation in the Study, to be employed by it or any
other person or entity; or (ii) approach any such employee or contractor for
such purpose or authorize or approve the taking of such action by any other
person.
13. TERM AND
TERMINATION
13.1 This
Agreement shall commence on the Effective Date and, unless terminated pursuant
to this Section 13, shall
continue until such time as the Services and Closeout Services have been
completed.
13.2 This
Agreement may be terminated upon the mutual, written consent of both
parties. This
Agreement may also be terminated by THE COMPANY without cause upon thirty (30)
days prior written notice to the other party.
13.3 Either
party may immediately terminate this Agreement for cause, upon written notice to
the other party stating the date of termination, pursuant to the
following:
13.3.1
Termination
by POI. POI may
terminate this Agreement for cause upon the occurrence of any of the following
events:
Advaxis
Clinical Research Agreement
April 6,
2005
(i) THE
COMPANY fails to maintain the insurance coverage required by Section
8.1;
(ii) The FDA,
IRB, or any regulatory authority with jurisdiction over the Study suspends or
revokes any consent, approval, license, or operating certificate required to
conduct the Study;
(iii) If THE
COMPANY enters into a Clinical Trial Agreement with an Investigator relating to
the Study, and the Investigator or any member of the Investigator’s staff fails
to possess all qualifications, training, and licenses necessary to perform the
duties and obligations of that individual under that agreement or fails in any
material manner to abide by the provisions of the Regulatory Requirements or
this Agreement; provided, however, that THE COMPANY may cure any such deficiency
by removing the affected individual from providing services under this
Agreement;
(iv) THE
COMPANY breaches any material provision of this Agreement, other than those
specifically referenced in this Section 13.3.1, and fails to remedy that breach
within 30 days after receiving notice of such breach; or
(v) THE
COMPANY files a petition for the appointment of a receiver in liquidation or a
trustee with respect to itself or any of its property; or any person other than
THE COMPANY files a petition for the appointment of a receiver in liquidation or
a trustee with respect to THE COMPANY in bankruptcy, insolvency, or
reorganization, compromise, adjustment or other relief relating to the relief of
debtors, and such involuntary petition is not vacated or set aside or stayed
within 60 days from THE COMPANY’s receiving notice of such
petition.
13.3.2
Termination
by THE COMPANY. THE
COMPANY may terminate this Agreement for cause upon the occurrence of any of the
following events:
(i) The FDA,
IRB, or any regulatory authority with jurisdiction over the Study suspends or
revokes any consent, approval, license, or operating certificate required to
conduct the Study;
(ii) The
occurrence of a Serious Adverse Event which should cause the Study to be
terminated due to safety concerns
(iii) POI
breaches any material provision of this Agreement, other than those specifically
referred to in this Section 13.3.2, and fails to remedy that breach within 30
days after receiving notice of such breach; or
(iv) POI files
a petition for the appointment of a receiver in liquidation or a trustee with
respect to itself or any of its property; any entity POI controls makes a
voluntary assignment for the benefit of creditors or files a petition in
bankruptcy or insolvency or for reorganization, compromise, adjustment, or other
relief; or if any person other than POI files a petition for the appointment of
a receiver in liquidation or a trustee with respect to POI or any entity it
controls in bankruptcy, insolvency, or reorganization, compromise, adjustment or
other relief relating to the relief of debtors, and such involuntary petition is
not vacated or set aside or stayed within 60 days from POI’s receiving notice of
the petition.
Advaxis
Clinical Research Agreement
April 6,
2005
13.4 In the
event of any change or reinterpretation of a Regulatory Requirement, the
adoption of any new law or regulation, or the initiation of an enforcement
action with response to laws, regulations, or guidelines applicable to this
Agreement, any of which shall affect the legality of this Agreement, the parties
agree to negotiate in good faith to amend this Agreement to comply with the
offended law or regulation. If the parties do not agree to such amendment within
30 days prior to the effective date of the offended law or regulation (or such
earlier time as may be required to comply), then either party may terminate this
Agreement immediately by giving written notice to such effect to the other
party.
14. CONSEQUENCES
OF TERMINATION
14.1 The
termination of this Agreement for any reason shall not affect any right or
remedy existing hereunder prior to the effective date of
termination.
14.2 Without
limiting the foregoing, upon termination of this Agreement, THE COMPANY shall,
in addition to all CRO Compensation then due, compensate POI, as specified in
Attachment I, for all Closeout Services required to terminate and closeout the
Study, including but not limited to, any activities necessary to satisfy the
requirements of any governmental, regulatory, or professional authority with
jurisdiction over the Study
15. GENERAL
PROVISIONS
15.1 This
Agreement sets forth the entire agreement and understanding among the parties as
to the matters contained therein, and merges and supersedes any prior
discussions, agreements, and understanding of every kind and nature relating
thereto.
15.2 Any
amendment of or modification to this Agreement shall become effective only if it
is in writing and executed by the parties.
15.3 This
Agreement shall be binding upon, and inure to the benefit of, the parties and
their respective legal representatives, trustees, receivers, successors and
permitted assigns.
15.4 Except as
otherwise specified in this Agreement or otherwise agreed to by the parties in
writing, all notices, requests, demands, and other communications provided for
in this Agreement shall be in writing in English and shall be deemed to have
been given at the time when personally delivered, or mailed by registered or
certified mail, return receipt requested, to the address of the other party
stated below or to such other address as any such party may have fixed by
notice, provided, however, that any notice of change of address shall be
effective only upon receipt by addressee.
Advaxis
Clinical Research Agreement
April 6,
2005
All
notices to THE COMPANY shall be addressed to:
Mr. Todd
Durbin
Advaxis,
Inc.
212
Carnegie Center, Suite 206
Princeton,
N.J. 08540
If
notices or communications by telephone or facsimile are specifically authorized
in this Agreement or otherwise agreed to by the parties in writing, calls to THE
COMPANY shall be placed and facsimiles to THE COMPANY shall be sent to the
following numbers:
Phone: 609 895
7150 Fax: 801 459 3596.
All
notices to POI shall be addressed to:
John
Hovre
Executive
Vice President
Pharm-Olam
International Ltd.
450 N.
Sam Houston Pkyw. Ste 250
Houston,
TX 77060
If
notices or communications by telephone or facsimile are specifically authorized
in this Agreement or otherwise agreed to by the parties in writing, calls to POI
shall be placed and facsimiles to POI shall be sent to the following
numbers:
Phone: (713)
463-8075
Fax:
(713)
463-8281
The
parties shall give notice to each other of any change of their address or
telephone, facsimile, or similar number at the earliest possible
opportunity.
15.5 All
agreements of the parties, as well as any rights or benefits accruing to them,
pertaining to a period of time following the termination or expiration of this
Agreement or any of its provisions, including but not limited to Paragraph 6.3,
and Sections 7 through 12, and 14, shall survive such termination or expiration
hereof and shall not be merged.
15.6 The
waiver by any party of a breach or default by any other party shall not operate
as a waiver of a continuing or subsequent breach or default of the same or a
different nature or kind.
15.7 If any
provision of this Agreement or the application of any such provision to any
person or circumstance is held invalid, the remainder of this Agreement and the
application of such provision to other persons or circumstances shall not be
affected unless the invalid provision substantially impairs the benefits of the
remaining provisions of this Agreement.
Advaxis
Clinical Research Agreement
April 6,
2005
15.8 No party
may assign this Agreement or its rights and duties hereunder, without the prior
written consent of the other party, except
that THE COMPANY may assign this Agreement to a purchaser or acquirer of
substantially all of the business to which this Agreement relates.
15.9 The
provisions of this Agreement shall be self-executing and shall not require
further agreement by the parties except as may otherwise be specifically
provided in this Agreement; provided, however, that, at the request of a party,
the other party shall execute such additional instruments and perform such
additional acts as may be reasonably necessary to effectuate this
Agreement.
15.10 This
Agreement may be executed in counterpart originals, with each counterpart to be
deemed an original, but all counterparts together shall constitute a single
instrument.
15.11 In the
event that performance by a party of any of its obligations under the terms of
this Agreement shall be interrupted or delayed by a Force Majeure, that party
shall be excused from such performance for the same amount of time as such
occurrence shall have lasted or such period of time as is reasonably necessary
after such occurrence abates for the effects thereof to have
dissipated.
16. APPLICABLE
LAW
This
Agreement shall be governed by and be construed under the laws of the State of
New Jersey, without giving effect to its choice-of-law rules, and exclusive
venue of any action or other proceeding that may be brought or arise out of, in
connection with, or by reason of this Agreement shall be in NJ, United
States.
IN
WITNESS WHEREOF, this Agreement is executed by the parties hereto and is
effective as of the day and year first above written.
Adavaxis,
Inc.
By: ____________________________________
Pharm-Olam,
Int'l.
By: ____________________________________
John
Hovre, its Executive Vice President
Advaxis
Clinical Research Agreement
April 6,
2005
Attachment
I
Timelines
and Payment Schedule
Timelines:
Event |
Date |
|
|
Protocol
Completion and Investigator Brochure |
Completed
and attached |
Submitting
request for Special |
|
Protocol
Assessment meeting with FDA |
[ *
] |
Special
Protocol Assessment meeting with FDA |
[ *
] |
Submit
to Ethics Committee and RA, [ * ] |
[ *
] |
Submit
IND with FDA |
[ *
] |
Approval
[ * ] |
[ *
] |
Approval
[ * ] |
[ *
] |
First
patient in to study [ * ] |
[ *
] |
Last
patient in to study |
[ *
] |
Interim
report |
[ *
] |
Last
patient out of study |
[ *
] |
Close
database |
[ *
] |
Statistical
analysis complete |
[ *
] |
Study
draft Final Report |
[ *
] |
Excluding
pass-through costs
Payment
Schedule for Services:
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
* these
payments are subject to the closing of an equity financing equal or greater to
$[ * ]
Advaxis
Clinical Research Agreement
April 6,
2005
Pass-throughs:
Invoices
will be sent to Advaxis, Inc for all pass-through cost.
The
parties agree that the pass-through costs shall not exceed the cost structure
detailed in Attachment
IA:
Attachment
IA
Pass-throughs
Item |
Cost
($) |
Notes |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
[ *
] |
Total |
$181,080
|
|
[ *
]
Advaxis
Clinical Research Agreement
April 6,
2005
Attachment
II
Clinical
Research Services and POI’s deliverables
POI
Deliverables
2. |
Investigator
Brochure completion |
3. |
Submitting
request for Special Protocol Assessment meeting with
FDA |
4. |
Special
Protocol Assessment meeting with FDA |
5. |
Submit
to Ethics Committee and RA, [ * ] |
7. |
Obtain
Approval for Phase I in Lovaxin C in [ * ] |
8. |
Obtain
Approval for Phase I in Lovaxin C in [ * ] |
9. |
Recruit
2 Phase I study sites In [ * ] |
10. |
Recruit
2 Phase I study sites In [ * ] |
11. |
Provide
an Interim study report after 10 patients have completed the
treatment |
12. |
Create
and manage a database accessible to Advaxis at all
times. |
13. |
Perform
and complete statistical analysis |
14. |
Study
draft Final Report |
Quality
of Study Management
1. |
A
site screening visit that assures each site has the appropriate facilities
and personnel to conduct the proposed study. This includes approved and
certified physicians, a dedicated study nurse, and adequate clerical
personnel necessary facilities for patient visits, diagnostic devices, and
so forth. |
2. |
A
study initiation visit for previously screened sites in which the specific
details of the protocol are reviewed in detail and instruction is given to
the site personnel as to the correct methods for conducting the study.
Specific attention is paid to following the study plan and schedule,
collecting information, completing case report forms (CRF) and assuring
their veracity when compared with the patient
charts. |
3. |
A
monitoring schedule which assures that CRFs are audited on a timely basis.
Weekly calls to the site to track patient enrollment and visits at least
once per month to assure adequate patient enrollment, enrolled patients
are being treated in compliance with the protocol as written, auditing of
CRF against original documents (patient charts, scans, X-rays, lab
reports, etc). The retrieval of all CRF, or portions of CRF, which are
completed, audited, and ready for data
entry. |
4. |
Verification
of data entered into the analytic database against the CRF data forms to
assure the reliability of the data to be
analyzed. |
Advaxis
Clinical Research Agreement
April 6,
2005
Attachment
III
Protocol
Not yet
finalized.
Advaxis
Clinical Research Agreement
April 6,
2005
Unassociated Document
June 9,
2005
Securities
and Exchange Commission
460 Fifth
Street, N.W.
Washington,
D.C. 20549
Re: |
Advaxis,
Inc.
Registration
Statement on Form SB-2
Application for Confidential Treatment, filed
April 7th
and June 1st
2005
File No.
333-122504 |
Ladies
and Gentlemen:
On behalf
of our client, Advaxis, Inc., a Colorado corporation (the “Company”), we
attach for filing under the Securities Act of 1933, as amended (the
“Act”), by
means of the Electronic Data Gathering, Analysis, and Retrieval system,
Amendment No. 4 to Registration Statement on Form SB-2 (File No. 0.50621) (the
“Registration
Statement”),
together with certain exhibits thereto.
We are in
receipt of the letter, dated June 9, 2005 (the “Comment
Letter”), from
John Krug, Esq., of the Securities and Exchange Commission (the “Commission”),
addressed
to the Company. Set forth below are the responses of the Company to the comments
set forth in the Comment Letter, numbered to correspond thereto. All capitalized
terms used, but not otherwise defined, herein shall have the respective
definitions assigned thereto in the filing transmitted herewith.
Comment
Number |
Response
|
1.
|
The
Company has revised the application for confidential treatment regarding
proper preparation of a confidential treatment request for information
required to be included in a filing.
|
2.
|
The
Company has revised the application for confidential treatment. The
Company requests confidential treatment until June 9, 2015 with respect to
the redacted portions of the License Agreement with the Trustees of the
University of Pennsylvania.
|
3.
|
The
Company has revised the redactions in Sections 2.6, 2.7, 6.5, 6.6 and 7.6
of the License Agreement with the Trustees of the University of
Pennsylvania.
|
4.
|
The
Company has revised the application for confidential treatment. The
Company requests confidential treatment until June 9, 2008 with respect to
the redacted portion of the Manufacturing Agreement with Cobra
Biomanufacturing PLC. |
Comment
Number |
Response
|
5.
|
The
Company had unintentionally omitted the attached document “0422 Phase II
Terms and Conditions”. The Company has revised the disclosure to include
the attached document.
|
6.
|
The
Company has filed as Exhibit 10.28 the Royalty Agreement, dated as of May
11, 2003, by and between Cobra Bio-Manufacturing PLC and the
Company.
|
7.
|
The
Company has revised the application for confidential treatment. The
Company requests confidential treatment until June 9, 2008 with respect to
the redacted portion of the Clinical Research Services Agreement with
Pharm-Olam International Ltd.
|
Closing
Comments |
The
Company takes notice of the Closing Comments.
|
Please
contact the undersigned at (212) 209-3090 if we may be of
assistance.
|
|
|
|
Sincerely, |
|
|
|
|
/s/ Gary A.
Schonwald |
|
|
|
Gary A. Schonwald |