Colorado
(State
or other jurisdiction
of
incorporation or organization) |
2836
(Primary
Standard Industrial
Classification
Code Number) |
841521955
(I.R.S.
Employer
Identification
No.) |
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) |
36,690,056 |
$1.00 |
$4,318.42 |
$4,318.42 |
common
stock par value $0.001 per share(4) |
19,630,588 |
$1.00 |
$2,310.52 |
$2,310.52 |
(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.
|
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. |
Item
Description |
Page
No. |
PROSPECTUS
SUMMARY |
iii |
THE
OFFERING |
ix |
RISK
FACTORS |
x |
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS |
xxv |
USE
OF PROCEEDS |
xxvi |
MARKET
FOR COMMON STOCK AND RELATED STOCKHOLDER MATTERS |
xxvi |
DIVIDEND
POLICY |
xxvi |
DILUTION |
xxvi |
CAPITALIZATION |
xxvii |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
AND PLAN OF OPERATIONS |
xxix |
BUSINESS |
39 |
MANAGEMENT |
55 |
PRINCIPAL
AND MANAGEMENT STOCKHOLDERS |
64 |
CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS |
67 |
SELLING
STOCKHOLDERS |
69 |
DESCRIPTION
OF CAPITAL STOCK OF THE COMPANY |
81 |
SHARES
OF THE COMPANY ELIGIBLE FOR FUTURE SALE |
83 |
PLAN
OF DISTRIBUTION |
85 |
LEGAL
MATTERS |
87 |
EXPERTS |
87 |
ADDITIONAL
INFORMATION |
87 |
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 |
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
|
· |
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. |
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 |
|||||||||||||||||
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 |
4,521 |
4,106 |
116,462 |
(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 |
) |
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 |
Common
stock offered by selling stockholders |
56,320,644(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. |
(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. |
· |
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. |
· |
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. |
· |
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. |
· |
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. |
· |
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,
|
· |
loss
of revenues, |
· |
the
inability to commercialize product candidates,
and |
· |
increased
difficulty in raising required additional funds in the private and public
capital markets. |
· |
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. |
· |
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.
|
· |
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. |
· |
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. |
· |
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. |
· |
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”. |
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* |
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 |
||||
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 |
4,521 |
4,106 |
116,462 |
(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 |
· |
Initiate
and complete phase I clinical study of Lovaxin C;
|
· |
Continue
pre-clinical development of our products; |
· |
Continue
research to expand our technology platform. |
· |
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 |
– |
delays
in the program |
– |
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. |
· |
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 |
– |
Delays
in the program |
· |
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. |
· |
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 |
– |
Delays
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. |
· |
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 |
– |
Delays
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. |
· |
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; |
· |
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; |
· |
professional
fees decreased by $89,670 from $14,102 for the three-months ended January
31, 2004 to $(75,568) for the three months ended January 31, 2005
principally due to (a) an increase in consulting fees from $13,000 to
$63,259, and (b) 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;
and |
· |
Option
expense was reduced from $8,484 for the three months ended January 31,
2004 to $0 for the three months ended January 31,
2005. |
General
and
Administrative
Expenses |
Three
Months Ended January 31, |
||||||||||||
2005 |
2004 |
Net
Change |
%
Change |
||||||||||
Option
expense |
- |
8,484 |
(8,484 |
) |
-100.00 |
% | |||||||
Accounting |
21,853 |
- |
21,853 |
100.00 |
% | ||||||||
Consulting
Fees |
63,250 |
13,000 |
51,250 |
394.20 |
% | ||||||||
Legal
Fees |
(166,346 |
) |
832 |
(167,178 |
) |
-20093.50 |
% | ||||||
Payroll
Fees |
371 |
271 |
100 |
37.00 |
% | ||||||||
Insurance |
5,398 |
- |
5,398 |
100.00 |
% | ||||||||
Employee
Costs |
61,391 |
42,670 |
18,720 |
43.90 |
% |
· |
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; |
· |
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;
and |
· |
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. |
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
|
· |
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. |
· |
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. |
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 | ||
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. | |
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. |
International | |
Patents | |
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. | |
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. |
· |
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. |
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.
|
· |
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. |
· |
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.
|
· |
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. |
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 $90,000. The basis for this bonus
was the successful conclusion of several matters of great importance to
the Company including: |
-
|
negotiating
and executing an arrangement with GSK in
2003; |
-
|
extending
the patent portfolio and moving it to the care of competent patent
counsel; |
-
|
creating
grant opportunities for the company; |
- |
scaling
up manufacturing; |
-
|
creating
certain collaboration opportunities. |
Individual
Grants |
||||||||||||||
Number
Of Securities Underlying |
Percent Of Total Options Granted To |
Potential
Realizable Value At Assumed Annual Rates of Stock Price Appreciation For Option Term($) | ||||||||||||
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
$8,966 |
Number
Of Securities Underlying Unexercised Options At Fiscal Year-End(2) |
Value
Of Unexercised In-The-Money Options At Fiscal Year-End($)(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.
|
· |
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. |
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, beneficially 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 (which
warrants are not, under the circumstances, exercisable within the next 60
days), 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.
|
(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.
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. 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. 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. 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. 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. 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. |
(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. | |
(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. |
· |
36,690,056
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. |
· |
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. |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
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 Holdings, Ltd.
c/o
FCIM Corp.
1
Rockefeller Plaza
Suite
1730
New
York, NY 10020 |
174,216
(2) |
174,216
(2) |
0.
47% |
0.0% |
-- |
Alan
Gelband Company
Defined
Contribution Pension Plan and Trust
30
Lincoln Plaza
New
York, NY 10023 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Alan
Kestenbaum
18
Clover Drive
Great
Neck, NY 11021 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Beretz
Family Partners LP
48
South Drive
Great
Neck, NY 11021 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Bridges
& Pipes, LLC
830
Third Avenue
14th
Floor
New
York, NY 10022 |
1,393,728
(4) |
1,393,728
(4) |
3.73% |
0.0% |
-- |
Bruce
Fogel
218
Everglade Avenue
Palm
Beach, FL 33480 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
C.
Leonard Gordon
551
Fifth Avenue
New
York, NY 10176 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
Carmel
Ventures, Inc
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) |
1.33% |
0.02% |
-- |
Cranshire
Capital, LP
666
Dundee Road
Sute
1901
Northbrook,
IL 60602 |
1,045,296
(9) |
1,045,296
(9) |
2.81% |
0.0% |
-- |
Crestwood
Holdings, LLC
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) |
0.95% |
0.0% |
-- |
David
Tendler
401
East 60th
Street
New
York, NY 10022 |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Design
Investments, LTD
9
Tanbark Circuit
Suite
1442
Werrington
Downs
NSW
2747
Australia |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Emigrant
Capital Corp.
6
East 43rd
Street
8th
Floor
New
York, NY 10017 |
3,484,320
(12) |
3,484,320
(12) |
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.
4
Ibn Shaprut Street
Jerusalem,
Israel 92478 |
1,393,728
(4) |
1,393,728
(4) |
3.73% |
0.0% |
-- |
Flamm
Family Partners, LP.
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
717
Post Road
Suite
105
Sacrsdale,
NY 10583 |
348,432
(3) |
348,432
(3) |
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) |
1.41% |
0.0% |
-- |
Howard
Kaye Family Fund
2
Mohican Trail
Scarsdale,
NY 10583 |
522,648
(16) |
522,648
(16) |
1.41% |
0.0% |
-- |
IRA
FBO / Walter S. Grossman Pershing LLC Custodian
277
North Ave.
Westport,
CT 06880 |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
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
145
Talmadge Road
Edison,
NJ 08817 |
348,432
(3) |
348,432
(3) |
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 |
%
Before Offering |
%
After Offering |
Relationship (if any) |
New
Bank Ltd
Levinstein
Tower #21st
23
Menahem Begin Road
Tel
Aviv, Israel |
1,393,728
(4) |
1,393,728
(4) |
3.73% |
0.0% |
-- |
Open
Ventures LLC
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
Line
& Grove Streets
PO
Box 87
Nanticoke,
PA 18634 |
348,432
(3) |
348,432
(3) |
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
10900
Wilshire Blvd.
Suite
500
Los
Angeles, CA 90024 |
174,216
(2) |
174,216
(2) |
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) |
0.47% |
0.0% |
-- |
SRG
Capital, LLC
120
Broadway
40th
Floor
New
York, NY 10271 |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Sunrise
Equity Partners, LP
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
3,484,320
(12) |
3,484,320
(12) |
9.07% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
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)
7
Centure Drive
Suite
201
Parsippany,
NJ 07054 |
696,864
(11) |
696,864
(11) |
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
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) |
0.47% |
0.0% |
-- |
Yoav
Millet
950
Third Avenue
New
York, NY 10022 |
174,216
(2) |
174,216
(2) |
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) |
4.73% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
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) |
0.53% |
0.0% |
-- |
David
Filer
165
East 32 Street
New
York, NY 10016 |
382,772
(33) |
382,772
(33) |
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) |
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) |
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) |
0.42% |
0.0% |
-- |
Sunrise
Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
731,707(37)(37A) |
731,707
(37) |
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) |
0.83% |
0.0% |
-- |
Sunrise
Foundation Trust
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
71,497(38)(a) |
71,497 |
0.19% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
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) |
0.95% |
0.0% |
-- |
A.
Heifetz Technologies Ltd
22
Kanfey Nesharim St
Jerusalem,
Israel 95464 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Balestra
Spectrum Partners, LLC
1185
Avenue of the Americas
32nd
Floor
New
York, NY 10036 |
1,045,296
(9) |
1,045,296
(9) |
2.81% |
0.0% |
-- |
Reitler
Brown Holdings, LLC
800
Third Avenue
21st
Floor
New
York, NY 10022 |
60,000
(39) |
60,000
(39) |
0.16% |
0.0% |
(39)(a) |
|
|||||
Harvest
Advaxis LLC
30052
Aventura, Suite C
Rancho
Santa Margarita,
CA
92688 |
7,665,506
(40) |
7,665,506
(40) |
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% |
-- |
(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 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 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. |
(41) |
We
license our intellectual property from Penn through an exclusive
license. |
· |
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. |
· |
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, |
· |
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.
|
· |
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. |
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 |
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 16,350,312 at December 31, 2002 and 2003 and
October 31, 2004 and 36,690,046 shares at January 31,
2005 |
16,350
|
16,350
|
16,350
|
36,690
|
|||||||||
Additional
paid-in capital |
229,143
|
253,596
|
302,795
|
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 |
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) |
||||||||||||||||||||||
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 |
21,420 |
10,655 |
2,968 |
24,387 |
||||||||||||||||||
Other
income |
966 |
4,521 |
4,106 |
116,463 |
121,950 |
430 |
2,739 |
124,689 |
|||||||||||||||||
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 |
) |
($0.10 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
$ |
(0.11 |
) | |||
Weighted-average
number of shares, baseic and diluted |
16,350,312 |
16,350,312 |
16,350,312 |
16,350,312 |
16,350,312 |
16,350,323 |
31,271,317 |
17,636,857 |
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 |
) |
16,310,312 |
16,310 |
218,690
|
|||||||||||||||
|
||||||||||||||||||||||
Balance
at December 31, 2002 |
-
0 - |
-
0 - |
16,350,312 |
16,350 |
229,143 |
(166,936 |
) |
78,557 |
||||||||||||||
Note
payable converted into preferred stock |
232.27 |
15,969 |
15,969 |
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 - |
16,350,312
|
16,350 |
253,596
|
(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
- |
16,350,312 |
16,350 |
302,795 |
(1,658,641 |
) |
(1,339,496 |
) | |||||||||||||
(Unaudited): |
||||||||||||||||||||||
Common
Stock issued to Placement Agent on recapitalization |
752,600 |
753 |
(753 |
) |
||||||||||||||||||
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 |
) |
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 - |
36,690,046
|
$ |
36,690 |
$ |
4,830,116 |
$ |
(1,903,996 |
) |
$ |
2,962,810 |
| |||||||
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 |
) |
(538,076 |
) |
(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 |
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 |
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.
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) |
3. |
NOTES
PAYABLE: |
|
||||||||||
|
|
|
|
|
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: |
|
Weighted- |
||||||
|
|
average |
|||||
|
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) |
Amount |
Exercise
Price |
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. |
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* |
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,
Inc. 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
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. |
ADVAXIS, INC. | ||
|
|
|
By: | /s/ J. Todd Derbin | |
J. Todd Derbin | ||
Chief Executive Officer |
SIGNATURE |
TITLE |
DATE | ||
/s/
J. Todd Derbin |
Chief
Executive Officer and Director |
April
26, 2005 | ||
J.
Todd Derbin |
(Principal
Executive Officer |
|||
* |
Chief
Financial Officer and Director |
April
26, 2005 | ||
Roni
Appel |
(Principal
Financial and Accounting Officer) |
|||
* |
Director |
April
26, 2005 | ||
Scott
Flamm |
||||
* |
Director |
April
26,, 2005 | ||
Thomas
McKearn |
||||
* |
Director |
April
26, 2005 | ||
James Patton | ||||
* |
Director |
April
26, 2005 | ||
Steven
Roth |
||||
*by: /s/ J. Todd Derbin | ||||
J. Todd Derbin | ||||
Attorney-in-fact |
[ *
]% on NET SALES in countries with pending or issued patents;
and |
|
[ *
]% on NET SALES in countries without pending or issued
patents. |
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 |
$[
* ] |
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 |
[ *
]% |
Anniversary
of |
Required
Diligence |
EFFECTIVE
DATE |
Expenditure
|
First |
$[
* ] |
Second |
$[
* ] |
Third |
$[
* ] |
Fourth |
$[
* ] |
Fifth
and thereafter |
$[
* ] |
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. |
THE TRUSTEES OF
THE
UNIVERSITY
OF PENNSYLVANIA |
ADVAXIS, INC. | ||
SIGNATURE: /s/ Louis P. Berneman |
SIGNATURE:
/s/ J. Todd Derbin | ||
|
| ||
TYPED
NAME:
Louis P. Berneman TITLE:
Managing Director
Center
for Technology Transfer |
TYPED
NAME: J.
Todd Derbin TITLE: | ||
DATE: | DATE: |
Exhibit 10.8 |
Exhibit 10.9 CONSULTANCY AGREEMENT THIS CONSULTANCY AGREEMENT (this "Agreement") is made as of this 19th day of January, 2005, by and between Advaxis, Inc, a Colorado corporation, having a principal place of business at 212 Carnegie Center, Princeton, NJ ("Company"), and LVEP Management, LLC with a place of business at 111 River Street, 10th floor, Hoboken, NJ 07030 ("Consultant"). WHEREAS, Consultant and Company desire to enter into an agreement for the performance by Consultant of certain consulting services (the "Services"); and WHEREAS, Consultant has the specific knowledge, experience, and expertise to perform the Services; NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions hereinafter set forth, and intending to be legally bound, Company and Consultant agree as follows: 1. SERVICES AND COMPENSATION 1.1 Services: Consultant shall provide the Services and perform the duties set in Schedule A. The parties may agree at any time to modify Schedule A. Company agrees that Consultant shall have reasonable access to Company's representatives as necessary to perform the Services provided for by this Agreement. Consultant shall report directly to the CEO of the Company. 1.2 Compensation. Consultant shall be paid for performance of the Services as specified in Schedule B. 1.3 Non-Exclusive Arrangement. Consultant may from time to time act as a consultant to, perform services for, or enter into agreements similar to this Agreement with, other persons or entities without the necessity of obtaining approval from Company; provided, however, that in no event shall Consultant provide such other persons or entities with, or incorporate into or provide as part of any services for such other persons or entities, any information or know-how obtained by Consultant through its conduct of the Services (including, without limitation, any Confidential Information (as defined below)). 1.4 Non Competition: Consultant shall not for two years following the termination or non renewal of this agreement for any reason: (a) directly or indirectly compete with the Company, or advise or become a partner, consultant, agent, director, advisor or a 1% shareholder in a business that is substantially similar to or competitive with the business or planned business of the Company. Consultant acknowledges and agrees that the geographic, length of term, and types of activity restrictions contained in this Section 1.4 are reasonable and necessary to protect the legitimate business interests of the Company. 2. CONFIDENTIAL INFORMATION 2.1 Confidentiality. Consultant agrees to maintain in strict confidence all Confidential Information (as defined below) provided to, or learned or developed by, Consultant for a period of five (5) years from the date of termination. Consultant shall not disclose or disseminate any Confidential Information to any person or entity, except with the prior written consent of Company. In addition, Consultant shall not use or copy any Confidential Information for any purpose other than in connection with performance of the Services hereunder. 2.2 Definition of Confidential Information. The term "Confidential Information" shall mean all trade secrets, processes, formulae, data and know-how, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information that has been created, discovered, or developed by Company, or has otherwise 1become known to Company, or which proper rights have been assigned to Company, as well as any other information and materials that are deemed confidential or proprietary to or by Company (including, without limitation, all information and materials of Company's customers and any other third party and their consultants), regardless of whether any of the foregoing are marked "confidential" or "proprietary" or communicated to Consultant by Company in oral, written, graphic or electronic form. 2.3 Exceptions to Confidential Information. Notwithstanding the foregoing paragraph, "Confidential Information" shall not include any information or materials that: (a) are or become known to the general public through no act or omission of Consultant or any other person with an obligation of confidentiality to Company, or (b) are required to be disclosed pursuant to applicable law (provided, however, that prior to any disclosure of Confidential Information as required by applicable law, Consultant shall advise Company of such required disclosure promptly upon learning thereof and shall cooperate with Company in order to afford them a reasonable opportunity to contest or limit such disclosure). 2.4 Consultant-Restricted Information. Consultant agrees that Consultant will not improperly use or disclose to the Company any proprietary or confidential information or trade secrets of any person or entity with whom Consultant has an agreement or duty to keep such information or secrets confidential. 2.5 Use of Third Party Information. Consultant will not use any equipment, supplies, chemicals, molecules, organisms, biological materials, or other physical property, facilities or trade secret information of any present or former employee or consulting client which are not generally available to the public, unless Consultant has obtained prior written authorization for such use and have delivered a copy of such authorization to Company prior to such use. Notwithstanding such authorization, Company shall have the right, at its sole discretion, to exclude the use of any of the foregoing by Consultant. 3. INTELLECTUAL PROPERTY 3.1 Assignment of Inventions. Consultant agrees that Consultant will promptly make full written disclosure to Company, will hold in trust for the sole right and benefit of Company, and hereby assigns, transfers and conveys to Company, or its designee, all of Consultant's worldwide right, title, and interest in and to any and all inventions, original works of authorship, findings, conclusions, data, discoveries, developments, concepts, improvements, trade secrets, techniques, processes and know-how, whether or not patentable or registrable under copyright or similar laws, which Consultant may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or developed or reduced to practice, in the performance of the Services or which result, to any extent, from use of Company's premises or property (collectively, the "Inventions"), including, without limitation, any and all intellectual property rights inherent in the Inventions and appurtenant thereto including, without limitation, all patent rights, copyrights, trademarks, know-how and trade secrets (collectively, "Intellectual Property Rights"). Consultant acknowledges and agrees that certain of the Inventions (whether made solely by Consultant or jointly with others) may be "works made for hire," as that term is defined in the United States Copyright Act, and therefore Company would be deemed the owner of such Inventions. For purposes of clarification, to the extent any Invention is not a "work made for hire," such Invention would be subject to the assignment in the first sentence of this Section 3.1. 3.2 Further Assurances. Upon the request and at the expense of Company, Consultant shall execute and deliver any and all instruments and documents and take such other acts as may be necessary or desirable to document the assignment and transfer described in Section 3.1 or to enable Company to secure its rights in the Inventions and any patents, trademarks, copyrights or other intellectual property rights relating thereto in any and all jurisdictions, or to apply for, prosecute and enforce patents, trademark registrations, copyrights or other intellectual property rights in any and all jurisdictions with respect to any Inventions, or to obtain any extension, validation, re-issue, continuance or renewal of any such intellectual property right. 2 4. REPRESENTATIONS AND WARRANTIES 4.1 Each party represents and warrants that, to the best of its knowledge, it has the right to enter into and to perform its obligations hereunder without thereby breaching any of its obligations to third parties. 4.2 Consultant represents and warrants to Company that: (i) the Services performed by Consultant hereunder will be of professional quality, consistent with generally-accepted industry standards and expectations for work of a similar nature, (ii) all Services provided to Company hereunder shall conform to the agreed-upon specifications therefor, if any, (iii) Consultant's performance under this Agreement and Consultant's retention as a consultant by Company does not and will not breach any obligation or agreement by which Consultant is bound to keep in confidence any information Consultant may acquire, or not to compete with any other person or entity. 5. TERM 5.1 Term. The initial term of this Agreement shall begin on January 1. 2005 and shall end on September 30, 2005 ("Initial Term"). Thereafter, the Term shall be automatically extended by -6-month periods unless Company notifies Consultant no later than 60 days prior to the end of the Initial Term or any extension thereof of its intent not to extend the Agreement. 5.2 Termination. Consultant may terminate this Agreement for any reason during the term hereof upon thirty (30) days prior written notice to the Company. Company may terminate the Agreement upon sixty (60) days prior written notice to the Consultant provided that upon such early termination Company shall continue to pay Consultant the full consulting fee, benefits and expenses for the lesser of: (a) 3 months following the termination date, or (b) the end of the Term (as extended). 5.3 Return of Company Property. All property belonging to Company in Consultant's possession or control, including, without limitation, all Confidential Information (as well as all copies, summaries, or other representations thereof) and all originals and copies of any documents, devices, records, data, notes, reports, proposals, lists, correspondence, specifications, drawings, blueprints, sketches, materials, and equipment shall be and remain the sole property of Company and shall be returned promptly to Company upon the expiration non renewal or termination of this Agreement, and earlier if requested by Company at any time. 5.4 Survival. In the event this Agreement expires or is terminated for any reason, the rights and obligations of Sections 5.2, 5.3 and Articles 2, 3, 4, 6 and 7 shall survive such expiration or termination. 6. NON-SOLICITATION Non-solicitation. Consultant agrees that during the term of this Agreement and for one year thereafter, Consultant shall not for any reason, either directly or indirectly, on Consultant's own behalf or in the service or on behalf of others, (i) solicit, recruit or attempt to persuade any person to terminate employment or a consulting relationship with Company or (ii) interfere in any manner with Company's relationship with, any of Company's co-venturers, vendors, suppliers, licensors or partners. 7. MISCELLANEOUS 7.1 Independent Contractor. For purposes of this Agreement and all Services to be provided hereunder, Consultant shall not be considered a partner, co-venturer, agent, employee or representative of Company, but shall remain in all respects an independent contractor. 7.2 Rules and Policies. While at Company's facilities, Consultant shall observe and follow Company's work rules, policies, and standards as the same are 3 communicated to Consultant from time to time, including, without limitation, those rules, policies and standards of Company relating to security of and access to facilities, telephone systems, electronic mail systems, and computer systems. 7.3 Successors. All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of and be enforceable by the respective heirs, executors, administrators, legal representatives, successors and assigns of the parties hereto, except that the duties and responsibilities of Consultant hereunder are of a personal nature and shall not be assignable or delegable in whole or in part by Consultant. 7.4 Amendments. No change, modification, extension, termination or waiver of this Agreement, or any of the provisions herein contained, shall be valid unless made in writing and signed by Consultant and a duly authorized representative of Company. 7.5 No Waiver. No term or provision of this Agreement will be considered waived and no breach consented to by either party unless such waiver or consent is in writing signed on behalf of the party against whom it is asserted. No consent to or waiver of a breach of this Agreement by either party, whether express or implied, will constitute a consent to, waiver of, or excuse for any other, different, or subsequent breach of this Agreement by such party. 7.6 Severability. Any provisions of this Agreement which are determined to be invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions of this Agreement or affecting the validity or enforceability of such provisions in any other jurisdiction. If a court of competent jurisdiction declares any provision of this Agreement to be invalid or unenforceable, the parties hereto shall request that such court reduce the scope, duration, or area of the provision, delete specific words or phrases from the provision, or to replace the provision with a provision that is valid and enforceable and that comes closest to expressing the original intention of the parties hereto, and this Agreement shall be enforceable as so modified in the jurisdiction in which the provision was declared invalid or unenforceable. 7.7 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of New Jersey without regard to its conflict of law provisions. 7.8 Entire Agreement. This Agreement represents the entire agreement between the parties regarding the Services provided during the term of this Agreement and shall supersede all previous communications, representations, understandings, and agreements, whether oral or written, by or between the parties with respect thereto, whether theretofore or hereafter disclosed to Consultant. Without limitation, this Agreement does not supersede any confidentiality agreement that may have been signed between Company and Consultant. 7.9 Counterparts. This Agreement may be executed in two counterparts, each of which shall be deemed to be an original as against any party whose signature appears thereon, but both of which together shall constitute but one and the same instrument. [SIGNATURE PAGE IMMEDIATELY FOLLOWS] IN WITNESS HEREOF, the parties have read and agree to be bound by the above terms and conditions and have entered into this Agreement effective as of the date set forth above. Company Consultant By: /s/ J. Todd Derbin By: /s/ Roni Appel - ---------------------------------- --------------------------------------- (Signature) (Signature) J. Todd Derbin Roni Appel - ---------------------------------- --------------------------------------- Printed Name Printed Name CEO Manager - ---------------------------------- --------------------------------------- Title Title 19/January 2005 - ---------------------------------- --------------------------------------- Date Date SCHEDULE A Schedule A CONSULTING SERVICES For a Total time commitment of 20 hours per week on average, Consultant shall provide the following services: i. Assisting and advising Company on defining its scientific and business milestones; ii. Reviewing and preparing Company technical and business data and materials; iii. Assisting the company in preparing its financial statements and reports; iv. Assisting the Company in complying with SEC regulation; v. Reviewing and negotiating legal documents and agreements on behalf of Company; vi. Assisting in implementing the Company's commercialization strategy. vii. Providing various financial services to Company. viii. Other services as agreed from time to time. ix. Roni Appel shall serve as Acting CFO of the Company and sign off on various financial statement and representations. Schedule B COMPENSATION AND PAYMENT SCHEDULE. i. Cash: $7,000 per month payment, starting as of January 1, 2004, during the Term of the Agreement. ii. Bonus: Consultant shall receive a payment at year-end equal to 40% of the bonus earned by the CEO of the Company. If Consultant terminated this Agreement prior to the end of the Term, the bonus shall be paid the bonus on a pro rata basis based on the actual number of months this Agreement was in effect. 5 iii. Additional one time payment: Upon the execution of this agreement Company shall pay Consultant a one-time payment of $4,500. iv. Benefits: Company shall reimburse Consultant for individual health insurance expenses. v. Expenses: Company shall reimburse all approved expenses incurred by Consultant in connection with the Services provided herein. Expenses in excess of $1,000.00 shall have prior authorization from the CEO. vi. Equity: Company shall pay Consultant $1004.5 per month payable in 3500 unrestricted common shares of Company priced at $0.287 per share. vii. Vacation: 21 days not including holidays. 6
Exhibit 10.10 Government Funding Fee Agreement This Agreement ("Agreement") is made and entered into as of the 5 day of April, 2004 between David Carpi (the "Finder") and Advaxis, Inc. (the "Company"). 1. Background: Finder believes he may be able to arrange for Company government funded clinical studies for LM LLO E7 or other Advaxis products so as to minimize Advaxis' cash burn rate in demonstrating the potential of the Listeria system with LM LLO E7 or other Advaxis products in human phase I clinical trials and in clinical trials of cervical cancer or other cancers. The parties have agreed that Finder will attempt to assist Company in obtaining such government funding ("Government Clinical Trial Sponsorship") for Clinical Trials to be conducted for the Company (such clinical trials testing Company products or constructs and sponsored by government through the efforts of Finder: " Government Sponsored Clinical Trial"). 2. Equity Compensation: If Finder successfully arranges Government Sponsored Clinical Trial, Company shall grant Finder a non qualified common stock option grant with that number of common stock option equal to (a) 4% (four percent) of the Economic Value of the Government Clinical Trial Sponsorship divided by (b) $100. The options are exercisable at $100 per share. For purpose of this agreement, "Economic Value" of Government Clinical Trial Sponsorship will be determined according to a formula specified in Exhibit A. The grant will be made upon final formal approval of the Government Clinical Trial Sponsorship. The terms of Company's option plan for outside consultants shall apply, however once the options are granted, the Consultant will have no requirement to exercise the options if the Consulting arrangement is terminated and the Consultant will be free to exercise these options at his discretion regardless of any ongoing relationship with Advaxis. For example: if Finder arranges Government Clinical Trial Sponsorship for a Phase II study, with 50 patients with outpatient settings, the Economic Value per Exhibit A shall be $1,100,000. In that case, Finder shall receive 440 options exercisable at $100 per share. On a post 100:1 split basis this will be 44,000 options at $1.00 per share. 3. Exclusion of other transactions: It is hereby agreed and understood that this agreement covers only Government Clinical Trial Sponsorship obtained directly through the efforts of Finder and will not entitle Finder to receive any fees in connection with any other funding or transactions including but not limited to : (a) equity or debt financing of any type, (b) NIH grants obtained by or applied for by Company directly or with its partners, (c) joint ventures, licensing, vendor financing, (d) mergers, acquisition, sale of assets (e) clinical studies conducted by Approved Investors and funded by Company, or (f) sale of securities of any kind by Company (g) government manufacturing process development and pre clinical and toxicology support under the NIH and/or RAID program. 4. Term: This agreement will expire on April 5, 2005 and thereafter will renew on a month-to-month basis unless cancelled in writing by either party. Upon termination or non-renewal of this agreement Consultant will maintain a list of Investigators that will be approached to conduct these trials, provided however that such Investigators are preapproved by Company in writing, in advance. Exhibit B, as amended from time to time, in writing, contains the list of Company approved Investigators ("Approved Investigators"). 5. Post termination government sponsored clinical studies: If any such Approved Investigator agrees to conduct government sponsored clinical studies with an Advaxis product within six months of termination of this Agreement, and such Government Clinical Trial Sponsorship is obtained by Company, then Finder shall be entitled to full compensation as set out in section 2 upon the final written approval of Government Clinical Trial Sponsorship. 6. Subsequent clinical trial sponsorship: If consultant is successful in arranging a phase I Government Clinical Trial Sponsorship as specified in this agreement, then subsequent Government Sponsored Clinical Trials with the same Approved Investigators testing the same product or construct will be subject to the terms of this agreement provided that: (a) such subsequent Government Sponsored Clinical Trial is approved by the government and initiated within 12 months of the completion of any previous clinical trial covered under this agreement, and (b) such subsequent Government Clinical Trial Sponsorship is obtained directly through current or previous efforts of Finder. For the purpose of clarity, this paragraph is designed to enable the Finder to receive fair compensation for obtaining Government Sponsored Clinical Trial for phase I trials and subsequent trials should the phase I trials be completed successfully and subsequent phase I, II, and III trials proceed in a natural progression as a result of the Finders work in establishing initial government funding for the initial phase I program. 7. Entire agreement; dispute: This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof. This Agreement may not be amended, modified or waived, except in writing signed by both parties. This Agreement may be executed in counterparts. Should a dispute arise between the parties under or relating to this Agreement, each party agrees that prior to initiating any formal proceeding against the other (except when injunctive relief is appropriate), the parties will each designate a representative for purposes of resolving the dispute. If the parties' representatives are unable to resolve the dispute within ten business days, the dispute shall be settled by mediation and then, if necessary, by arbitration under the then-current commercial arbitration rules of the American Arbitration Association. The location of the proceeding shall be Princeton, NJ. Judgment upon any award rendered by the arbitrator may be entered by any State or Federal court having jurisdiction thereof. 8. Assignment. This Agreement may not be assigned by any party without written consent 9. Non Exclusive. The Company may from time to time: (i) engage other persons and entities to act as consultants to the Company and perform services for the Company, including services that are similar to the ones described herein; and (ii) enter into agreements similar to this Agreement with other persons or entities, in all cases without the necessity of obtaining approval from Consultant. IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed on the day of the year first above written. ADVAXIS, INC. FINDER By: /s/ J. Todd Derbin By: /s/ David Carpi ------------------------------- ------------------------------- Name: Name: Title: Exhibit A Economic Value of Government Sponsored Clinical Trials Phase I Fixed costs Biostatistic Analyses $300,000 Pharmacokinetic Analyses $150,000 Variable costs Cost per patient if outpatient $ 10,000 Cost per patient if inpatient or extended stay/observation $ 14,000 Total cost 450,000 plus number of enrolled patients X 10,000 or 14,000 dependent on type of study. Phase II trials (about 30 to 50 patients) Fixed costs Biostatistic Analyses $400,000 Pharmacokinetic Analyses $200,000 Variable costs Cost per patient if outpatient $ 10,000 Cost per patient if inpatient or extended stay/observation $ 14,000 Total cost 600,000 plus number of enrolled patients X 10,000 or 14,000 dependent on type of study. Phase III trials (about 300-400 patients) Fixed costs Biostatistic Analyses $700,000 Pharmacokinetic Analyses $400,000 Variable costs Cost per patient if outpatient $ 10,000 Cost per patient if inpatient or extended stay/observation $ 14,000 Total cost 1,100,000 plus number of enrolled patients times $10,000 or $14,000 dependent on type of study. Exhibit B Approved Investigators JEFFERY WEBER UNIVERSITY OF SOUTHERN CALIFORNIA CORNELIA TRIMBLE JOHNS HOPKINS UNIVERSITY PHILIP DISAIA NCI
Exhibit 10.11 Amended and Restated Consulting and Placement Agreement This AMENDED AND RESTATED CONSULTING AND PLACEMENT AGREEMENT (this "Agreement") is entered into this 28 day of May, 2003 (the "Effective Date") by and between David Carpi ("Consultant"), and Advaxis, Inc., (the "Company"). WHEREAS, the Company seeks to enter various business development activities, strategic collaborations and licensing deals (each, a "Transaction"); WHEREAS, Consultant has access to a network of pharmaceutical and biotechnology companies ("Strategic Partners"), one of more of which may be interested in participating in the Transaction and is willing to make introductions to such Strategic Partners on the basis described below. NOW THEREFORE, in consideration of the premises and mutual covenants contained herein, and intending to be legally bound hereby, the parties hereto agree as follows: 1. Consulting and Placement Services. Consultant will: (a) Assist the Company in the preparation and refinement of its marketing summary, financial projections, power point presentation and similar documents and oral presentation (collectively "Offering Materials"). (b) Assist the Company in managing the Strategic Partner solicitation process, including, without limitation: (i) approaching the Approved Partners (as defined below); (ii) disseminating the Offering Materials; and (iii) arranging Introductions between Company and Approved Partners (as defined below). An "Introduction" shall be defined as at least one of (a) a face to face meeting between Company and an Approved Partner (as defined below) or (b) two scientific or business teleconferences or combination of scientific and business teleconference to review Company technology and commercialization possibilities. One executive or scientific level manager from Company and the Approved Partner must attend each teleconference (qualified company personnel include: Yvonne Patterson, Todd Derbin, Jim Patton, Roni Appel). It is hereby agreed and understood that only an Introduction (as defined above) on or before the termination or expiration of this Agreement that will result in a Transaction will result in any fees due to Consultant pursuant to sections 3 and 4 of this Agreement. Following an Introduction (as defined above), Consultant will send Company an e-mail notification of such meetings and Company will respond acknowledging a successful Introduction. Potential partners will qualify as "accredited investors" as that term is defined in Rule 501 of the Securities Act of 1933. 2. Approvals. (a) Pre-approval. Any and all Strategic Partners or individuals approached by Consultant on behalf of the Company must be pre-approved. A list of 28 pre-approved StrategicPartners ("Approved Partners") executed by both parties follows this agreement in Appendix A. The list of Approved Partners may be amended or modified in writing by both parties (each company listed in appendix A: "Approved Partner"). A signed letter from the Company CEO to the Consultant indicating that a company or companies may be added to the Approved Partner list will be sufficient to add an additional company or companies to the Approved Partner list in Appendix A. (b) Final Approval. The final terms of the Transaction will be subject to those terms and conditions negotiated by the Company and any Approved Partner. The Company will be free to reject any proposed transaction with which it is not satisfied for any reason or for no reason. (c) Other Investors. The Company may sell Preferred Stock to or enter a strategic partnership or any other transaction with any person or entity other than an Approved Partner without payment of any Success Fees (as defined below) to Consultant. 3. Compensation. Consultant will receive the following payments (the "Success Fees") to be paid by the Company upon the completion of the Transaction with an Approved Partner pursuant to an Introduction (as defined above) by Consultant: (a) In agreements where the combination of upfront licensing fees, proposed gross proceeds for collaborative research, and milestone payments are greater than $5 million then the following: (i) Cash Fee: A cash fee equal to: (i) five percent (5%) of the gross proceeds received from a Strategic Partners as an upfront licensing fee in any Transaction. (ii) Three percent (3%) of the gross proceeds received from a Strategic Partners for collaborative research; (iii) three percent (3%) of any milestone payment, if and when received by Company (not including royalties). (b) In agreements where the combination of upfront licensing fees, proposed gross proceeds for collaborative research, and milestone payments are less than or equal $5 million then the following: 3% (three percent) of such fees plus 3% of royalties actually received by the company up to a cumulative max of $800,000. (c) Options: That number of non qualified options equal to: (i) five percent (5%) of the gross proceeds received from a Strategic Partners as an upfront licensing fee in any Transaction, divided by $1.50. (ii) Three percent (3%) of the gross proceeds received from a Strategic Partners for collaborative research, divided by $1.50; (iii) 2% (two percent) of any milestone payment, if and when received by Company (not including royalties), divided by $1.50. The number of options and the exercise price assumes a 100:1 split in the Company's shares, currently planned. For purpose of example only, in the event Company receives an upfront license fee of $300,000, Consultant shall receive 10,000 options. The options: (i) shall be immediately exercisable in whole or in part in shares of common stock of the Company; (ii) have a ten (10) year term that does not require an ongoing relationship between the Company and Consultant; (iii) shall have an exercise price equal $150; (vi) shall be -2- non-qualified for tax purpose; (v) shall be subject to the terms and conditions Company's 2003 Stock Option Plan as it applies for consultants and outside advisors. 4. Other Transactions. If the Company enters into a business transaction (other than the Transaction) during the term of this Agreement with an Approved Partner pursuant to an Introduction, the Company agrees to pay Consultant a cash fee of 4% of such proceeds. Such transactions may include, without limitation, a purchase of assets, merger, acquisition, licensing agreement, joint venture, sales contract, an investment of equity, subordinated debt, senior debt or lease facility ("Other Transactions"). Future Transactions. In the event that any Approved Partner enters into a Transaction with the Company pursuant to an Introduction by Consultant within 15 months from the termination of this agreement; or two years from the termination of this agreement for any Approved Partner that enters a material transfer agreement during the term of this agreement pursuant to an Introduction by Consultant, then for such Transactions, Consultant shall be due (i) its full fee as set forth in Section 3 or in section 4, as it may apply. 5. Termination. This Agreement will remain effective until December 31, 2003 and from that point forward will automatically renew on a month to month basis, although both parties may mutually extend this Agreement, and either party reserves the right to terminate this Agreement at any time with a 30-day notice, for any reason or for no reason. Any such termination or extension shall be in writing. Upon the termination or the expiration of this Agreement, Company will send to Consultant a list of Introduction made by Consultants for purpose of section 4. 6. Non Exclusive. The Company may from time to time: (i) engage other persons and entities to act as consultants to the Company and perform services for the Company, including services that are similar to the ones described herein; and (ii) enter into agreements similar to this Agreement with other persons or entities, in all cases without the necessity of obtaining approval from Consultant. 7. Representations and Warranties. Consultant represents and warrants as follows: (a) It shall comply with all applicable laws with respect to the sale of securities in its performance of its obligations under this Agreement. (b) Consultant shall not make any factual statements regarding the Company other than those provided to Consultant by the Company or approved by the Company. 8. Confidentiality. (a) Each party agrees to maintain the confidentiality of the contents of this Agreement. Consultant agrees to maintain the confidentiality of any nonpublic or proprietary information concerning the Company, including without limitation trade secrets, intellectual property, business plans, financial projections, current and potential customer and client lists, business acquisition plans, personnel acquisition plans, all other information pertaining to the business of the Company; provided, however, that confidentiality shall not be required with -3- respect to the following: (i) any information that is, or becomes generally available to the public other than as a result of a disclosure by Consultant; (ii) any information in the possession of Consultant prior to disclosure of such information to Consultant by the Company as evidenced by written records; or (iii) any information that becomes available to Consultant from a source not under a confidentiality obligation to the Company. (b) The Company agrees to hold confidential the names of Approved Partner introduced by Consultant to the Company whether or not such Approved Partner invest in any Transaction. (c) This Section 10 shall survive the termination or expiration of this Agreement. 9. Governing Law. This Agreement shall be interpreted and enforced in accordance with the laws of New Jersey, without giving effect to its conflict of laws rules. 10. Dispute Resolution. Should a dispute arise between the parties under or relating to this Agreement, each party agrees that prior to initiating any formal proceeding against the other (except when injunctive relief is appropriate), the parties will each designate a representative for purposes of resolving the dispute. If the parties' representatives are unable to resolve the dispute within ten business days, the dispute shall be settled by mediation and then, if necessary, by arbitration under the then-current commercial arbitration rules of the American Arbitration Association. The location of the proceeding shall be Princeton, NJ. Judgment upon any award rendered by the arbitrator may be entered by any State or Federal court having jurisdiction thereof. 11. Entire Agreement. This Agreement contains the parties' entire understanding and may not be modified except in writing signed by both parties. 12. Assignment. This Agreement may not be assigned by any party without written consent 13. Travel. Any --expense over $250 will need prior approval from the CEO of Advaxis. -4- IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date. [CONSULTANT] By: /s/ David Carpi ----------------------- Name: ADVAXIS, INC. By: /s/ J. Todd Derbin ------------------------ Name: Title: Appendix A: Approved Partners: 1. Acambis PLC 2. Agensys 3. American Home Products (Wyeth) 4. Amgen 5. Antigenics 6. Aventis (Aventis Pasteur) 7. AVI BioPharma 8. Baxter 9. Bill & Melinda Gates Foundation (Vaccine research foundation) 10. Biomera 11. Cell Genesys 12. Chiron 13. Corixia 14. Dendreon 15. DynPort Vaccine Company LLC 16. Elan 17. Epimmune 18. Genencor 19. Genentech 20. Genezyme 21. GSK 22. Human Genome Sciences 22. Imclone -5- 23. Maxygen 24. Medimmune 25. Merck 26. Shire (Biochem Pharma) 27. Transgene 28. VaxGen -6-
EXHIBIT 10.13 CONSULTANCY AGREEMENT THIS CONSULTANCY AGREEMENT (this "Agreement") is made as of this 15 day of March, 2003, by and between Advaxis, Inc, a Delaware corporation, having a principal place of business at 212 Carnegie Center, Princeton, NJ ("Company"), and the party indicated below ("Consultant"). Name: Joy A. Cavagnaro, PhD, DABT, RAC Address: P.O. Box 1362 Leesburg, VA 20177 Phone: (540) 882-9728 Fax: (540) 882-9729 SS No. -------------------------------------------- WHEREAS, Consultant and Company desire to enter into an agreement for the performance by Consultant of certain consulting services (the "Services"); and WHEREAS, Consultant has the specific knowledge, experience, and expertise to perform the Services; NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions hereinafter set forth, and intending to be legally bound, Company and Consultant agree as follows: 1. SERVICES AND COMPENSATION 1.1 Services. Consultant shall provide the Services and perform all duties as requested by Company, as more particularly set forth in project plans executed in writing by the parties and attached hereto from time to time (each, a "Project Plan"). The initial Project Plan is attached hereto as Schedule A. Each subsequent Project Plan shall be in substantially the same form as the initial Project Plan. Upon execution in writing of each Project Plan by the parties, the provisions of this Agreement shall be incorporated by reference and shall form the entire agreement with respect to such project. The parties may agree at any time to modify a Project Plan; provided, however, that all such modifications must be in writing and signed by both parties. Consultant shall control the manner and means by which it performs the Services, subject to the parameters of the applicable Project Plan and the express provisions of this Agreement. Company agrees that Consultant shall have reasonable access to Company's representatives as necessary to perform the Services provided for by this Agreement. 1.2 Reports. Consultant shall communicate the progress of each Project Plan to Company informally on a regular basis and in written reports to be provided to Company as specified in each Project Plan, and if not specified in a Project Plan, then on a calendar quarterly basis within ten (10) days after the end of such calendar quarter. Each written report shall be subject to acceptance by Company. 1.3 Compensation. Consultant shall be paid for performance of the Services as specified in the applicable Project Plan, subject to completion by Consultant of written reports acceptable to Company pursuant to Section 1.2. Notwithstanding the foregoing, Company may suspend payment if, in Company's reasonable opinion after review of such reports, Consultant has not been performing the Services in the manner and in accordance with the schedule set forth in the applicable Project Plan and pursuant to this Agreement. 1.4 Conflict of Interest; Non-Exclusive Arrangement. Page 1 of 91.4.1 If a conflict of interest should arise during the performance of this Agreement, Consultant shall immediately notify Company thereof and Company shall have the option to pursue any and all remedies, equitable, legal or otherwise, that may be available to Company in connection therewith. Consultant shall ensure that its performance of the Services does not conflict with Consultant's duties with other entiries. 1.4.2 Company may from time to time (i) engage other persons and entities to act as consultants to Company and perform services for Company, including, without limitation, services similar to the Services, and (ii) enter into agreements similar to this Agreement with other persons or entities, in all cases without the necessity of obtaining any approval from Consultant. 1.4.3 Subject to the provisions of Section 6.2, Consultant may from time to time act as a consultant to, perform services for, or enter into agreements similar to this Agreement with, other persons or entities without the necessity of obtaining approval from Company; provided, however, that in no event shall Consultant provide such other persons or entities with, or incorporate into or provide as part of any services for such other persons or entities, any information or know-how obtained by Consultant through its conduct of the Services (including, without limitation, any Confidential Information (as defined below)). 2. CONFIDENTIAL INFORMATION 2.1 Confidentiality. Consultant agrees to maintain in strict confidence all Confidential Information (as defined below) provided to, or learned or developed by, Consultant during the course of Consultant's performance of the Services. Consultant shall not disclose or disseminate any Confidential Information to any person or entity, except with the prior written consent of Company. In addition, Consultant shall not use or copy any Confidential Information for any purpose other than in connection with performance of the Services hereunder. 2.2 Definition of Confidential Information. The term "Confidential Information" shall mean all trade secrets, processes, formulae, data and know-how, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information that has been created, discovered, or developed by Company, or has otherwise become known to Company, or which proper rights have been assigned to Company, as well as any other information and materials that are deemed confidential or proprietary to or by Company (including, without limitation, all information and materials of Company's customers and any other third party and their consultants), regardless of whether any of the foregoing are marked "confidential" or "proprietary" or communicated to Consultant by Company in oral, written, graphic or electronic form. 2.3 Exceptions to Confidential Information. Notwithstanding the foregoing paragraph, "Confidential Information" shall not include any information or materials that: (a) are or become known to the general public through no act or omission of Consultant or any other person with an obligation of confidentiality to Company, or (b) are required to be disclosed pursuant to applicable law (provided, however, that prior to any disclosure of Confidential Information as required by applicable law, Consultant shall advise Company of such required disclosure promptly upon learning thereof and shall cooperate with Company in order to afford them a reasonable opportunity to contest or limit such disclosure). 2.4 Consultant-Restricted Information. Consultant agrees that Consultant will not improperly use or disclose to the Company any proprietary or confidential information or trade secrets of any person or entity with whom Consultant has an agreement or duty to keep such information or secrets confidential. 2.5 Use of Third Party Information. Consultant will not use any equipment, supplies, chemicals, molecules, organisms, biological materials, or other physical property, facilities or trade secret information of any present or former employee or consulting client which are not generally available to the Page 2 of 9 public, unless Consultant has obtained prior written authorization for such use and have delivered a copy of such authorization to Company prior to such use. Notwithstanding such authorization, Company shall have the right, at its sole discretion, to exclude the use of any of the foregoing by Consultant. 3. INTELLECTUAL PROPERTY 3.1 Assignment of Inventions. Consultant agrees that Consultant will promptly make full written disclosure to Company, will hold in trust for the sole right and benefit of Company, and hereby assigns, transfers and conveys to Company, or its designee, all of Consultant's worldwide right, title, and interest in and to any and all inventions, original works of authorship, findings, conclusions, data, discoveries, developments, concepts, improvements, trade secrets, techniques, processes and know-how, whether or not patentable or registrable under copyright or similar laws, which Consultant may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or developed or reduced to practice, in the performance of the Services or which result, to any extent, from use of Company's premises or property (collectively, the "Inventions"), including, without limitation, any and all intellectual property rights inherent in the Inventions and appurtenant thereto including, without limitation, all patent rights, copyrights, trademarks, know-how and trade secrets (collectively, "Intellectual Property Rights"). Consultant acknowledges and agrees that certain of the Inventions (whether made solely by Consultant or jointly with others) may be "works made for hire," as that term is defined in the United States Copyright Act, and therefore Company would be deemed the owner of such Inventions. For purposes of clarification, to the extent any Invention is not a "work made for hire," such Invention would be subject to the assignment in the first sentence of this Section 3.1. 3.2 Further Assurances. Upon the request and at the expense of Company, Consultant shall execute and deliver any and all instruments and documents and take such other acts as may be necessary or desirable to document the assignment and transfer described in Section 3.1 or to enable Company to secure its rights in the Inventions and any patents, trademarks, copyrights or other intellectual property rights relating thereto in any and all jurisdictions, or to apply for, prosecute and enforce patents, trademark registrations, copyrights or other intellectual property rights in any and all jurisdictions with respect to any Inventions, or to obtain any extension, validation, re-issue, continuance or renewal of any such intellectual property right. 4. REPRESENTATIONS AND WARRANTIES 4.1 Each party represents and warrants that, to the best of its knowledge, it has the right to enter into and to perform its obligations hereunder without thereby breaching any of its obligations to third parties. 4.2 Consultant represents and warrants to Company that: (i) the Services performed by Consultant hereunder will be of professional quality, consistent with generally-accepted industry standards and expectations for work of a similar nature, (ii) all Services provided to Company hereunder shall conform to the agreed-upon specifications therefor, if any, (iii) to the best of Consultant's knowledge, all Services, Inventions, and Intellectual Property Rights provided to Company hereunder will not infringe or misappropriate the patent, copyright, trademark, trade secret, or other intellectual property rights of any third party, (iv) Consultant's performance under this Agreement and Consultant's retention as a consultant by Company does not and will not breach any obligation or agreement by which Consultant is bound to keep in confidence any information Consultant may acquire, or not to compete with any other person or entity, and (v) Consultant has not entered into, and will not enter into, any agreement, and is not affected by any policy, either written or oral, that would interfere or be inconsistent with Consultant's performance under this Agreement. Consultant shall indemnify, defend, and hold harmless Company and its officers and employees from and against any and all losses, damages, liabilities, obligations, judgments, penalties, fines, awards, costs, expenses, and disbursements (including without limitation, the costs, expenses and disbursements, as and when incurred, of investigating, preparing or Page 3 of 9 defending any claim, action, suit, proceeding, or investigation) suffered or incurred by Company on account of Consultant's breach of any of the foregoing representations and warranties. 4.3 COMPANY MAKES NO OTHER WARRANTY RELATING TO THE CONFIDENTIAL INFORMATION AND THE USE TO BE MADE THEREOF BY CONSULTANT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES. 5. TERM 5.1 Term. The initial term of this Agreement shall begin on the date set forth above and shall end on September 15th, 2003, or upon termination in accordance with the terms set forth in Section 5.2, whichever date is earlier ("Initial Term"). The Term shall be automatically extended until March 15, 2004 unless Company notifies Consultant no later than August 15th of its intent not to extend the Initial Term. Thereafter, the Term may be extended upon mutual agreement of the parties in writing. 5.2 Termination. Consultant may terminate this Agreement for any reason during the term hereof upon thirty (30) days prior written notice to the Company. Company may terminate the Agreement on September 15, 2003 by providing Consultant with a prior notice as provided in Section 5.1, or at any time with a 10-day prior notice for Cause. Cause shall be defined as any material breach of this agreement which was not cured by Consultant within 5 business days from the Company's written notice of such material breach. Upon the expiration or earlier termination of this Agreement, Company shall only be required to pay Consultant for Services actually completed as of the effective date of such expiration or earlier termination; provided, however, that Company shall not be required to make any payments for Services associated with a milestone or targeted completion date that Consultant has failed to achieve. 5.3 Return of Company Property. All property belonging to Company in Consultant's possession or control, including, without limitation, all Confidential Information (as well as all copies, summaries, or other representations thereof) and all originals and copies of any documents, devices, records, data, notes, reports, proposals, lists, correspondence, specifications, drawings, blueprints, sketches, materials, and equipment shall be and remain the sole property of Company and shall be returned promptly to Company upon the expiration or earlier termination of this Agreement, and earlier if requested by Company at any time. Consultant shall not remove any of Company's property from Company's premises without prior written authorization from Company. 5.4 Survival. In the event this Agreement expires or is terminated for any reason, the rights and obligations of Sections 5.3, 5.4 and Articles 2, 3, 4, 6 and 7 shall survive such expiration or termination. 6. NON-SOLICITATION AND NON-COMPETITION 6.1 Non-solicitation. Consultant agrees that during the term of this Agreement and for one year thereafter, Consultant shall not for any reason, either directly or indirectly, on Consultant's own behalf or in the service or on behalf of others, (i) solicit, recruit or attempt to persuade any person to terminate employment or a consulting relationship with Company or (ii) interfere in any manner with Company's relationship with, any of Company's co-venturers, vendors, suppliers, licensors or partners. 6.2 Non-competition. During the term of this Agreement and for one year thereafter, Consultant shall not, either directly or indirectly, alone or as a consultant, partner, officer, director, employee, joint venturer, lender or stockholder of any entity, accept employment with or provide consulting services to, any business or entity or engage in any business or activity that relates to cancer vaccines. 7. MISCELLANEOUS 7.1 Social Security Number. Consultant certifies that his or her correct Social Security is listed on the first page of this Agreement. Consultant acknowledges that Company will rely upon the foregoing certification in filing certain documents and instruments required by law in connection with this Page 4 of 9 Agreement, including, without limitation, Form 1099 under the Internal Revenue Code of 1986, as amended (or any successor form). 7.2 Independent Contractor. For purposes of this Agreement and all Services to be provided hereunder, Consultant shall not be considered a partner, co-venturer, agent, employee or representative of Company, but shall remain in all respects an independent contractor, and neither party shall have any right or authority to make or undertake any promise, warranty or representation, to execute any contract, or otherwise to assume any obligation or responsibility in the name of or on behalf of the other party. Without limiting the generality of the foregoing, Consultant shall not be considered an employee of Company for purposes of any state or federal laws relating to unemployment insurance, social security, workers compensation or any regulations which may impute an obligation or liability to Company by reason of an employment relationship. Consultant agrees to pay all income, FICA, and other taxes or levies imposed by any governmental authority on any compensation that Consultant receives under this Agreement. Consultant shall indemnify, defend and hold harmless Company and its officers and employees from and against any and all losses, damages, liabilities, obligations, judgments, penalties, fines, awards, costs, expenses and disbursements (including without limitation, the costs, expenses and disbursements, as and when incurred, of investigating, preparing or defending any claim, action, suit, proceeding or investigation) suffered or incurred by Company as a result of any allegation that Consultant is an employee of Company by virtue of performing any work for or on behalf of Company hereunder or otherwise. 7.3 Rules and Policies. While at Company's facilities, Consultant shall observe and follow Company's work rules, policies, and standards as the same are communicated to Consultant from time to time, including, without limitation, those rules, policies and standards of Company relating to security of and access to facilities, telephone systems, electronic mail systems, and computer systems. 7.4 Successors. All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of and be enforceable by the respective heirs, executors, administrators, legal representatives, successors and assigns of the parties hereto, except that the duties and responsibilities of Consultant hereunder are of a personal nature and shall not be assignable or delegable in whole or in part by Consultant. 7.5 Equitable Relief. Consultant hereby acknowledges and agrees that damages at law may be an inadequate remedy for any breach of Consultant's obligations under Article 2 (Confidential Information), Article 3 (Intellectual Property), Article 6 (Non-Solicitation and Non-Competition), and, accordingly, Consultant agrees that Company will be entitled to such temporary, preliminary and permanent injunctive relief as may be necessary to remedy or limit such breach, without the necessity of proving actual damages or posting any bond or other security, and including specific performance of such obligations and an order enjoining Consultant from the continuation of, or from any threatened, breach of such obligations. The rights set forth in this paragraph shall be in addition to, and not in lieu of, any other rights which Company may have at law or in equity. 7.6 Publicity. Consultant shall not disclose to any third party any information about the Services provided or to be provided by Consultant for or on behalf of Company, except as may be required by law or as Company may otherwise agree in writing. 7.7 Assignment. Consultant shall not assign this Agreement or any right hereunder, nor delegate of any Consultant's duties hereunder, without the prior written consent of Company. 7.8 Amendments. No change, modification, extension, termination or waiver of this Agreement, or any of the provisions herein contained, shall be valid unless made in writing and signed by Consultant and a duly authorized representative of Company. 7.9 No Waiver. No term or provision of this Agreement will be considered waived and no breach consented to by either party unless such waiver or consent is in writing signed on behalf of the party against whom it is asserted. No Page 5 of 9 consent to or waiver of a breach of this Agreement by either party, whether express or implied, will constitute a consent to, waiver of, or excuse for any other, different, or subsequent breach of this Agreement by such party. 7.10 Severability. Any provisions of this Agreement which are determined to be invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions of this Agreement or affecting the validity or enforceability of such provisions in any other jurisdiction. If a court of competent jurisdiction declares any provision of this Agreement to be invalid or unenforceable, the parties hereto shall request that such court reduce the scope, duration, or area of the provision, delete specific words or phrases from the provision, or to replace the provision with a provision that is valid and enforceable and that comes closest to expressing the original intention of the parties hereto, and this Agreement shall be enforceable as so modified in the jurisdiction in which the provision was declared invalid or unenforceable. 7.11 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of New Jersey without regard to its conflict of law provisions. 7.12 Entire Agreement. This Agreement represents the entire agreement between the parties regarding the Services provided during the term of this Agreement and shall supersede all previous communications, representations, understandings, and agreements, whether oral or written, by or between the parties with respect thereto, whether theretofore or hereafter disclosed to Consultant. Without limitation, this Agreement does not supersede any confidentiality agreement that may have been signed between Company and Consultant. 7.13 Counterparts. This Agreement may be executed in two counterparts, each of which shall be deemed to be an original as against any party whose signature appears thereon, but both of which together shall constitute but one and the same instrument. [SIGNATURE PAGE IMMEDIATELY FOLLOWS] Page 6 of 9 IN WITNESS HEREOF, the parties have read and agree to be bound by the above terms and conditions and have entered into this Agreement effective as of the date set forth above. Company Consultant By: By: - ---------------------------------------- ------------------------------------ (Signature) (Signature) - ---------------------------------------- ------------------------------------ Printed Name Printed Name - ---------------------------------------- ------------------------------------ Title Title - ---------------------------------------- ------------------------------------ Date Date Page 7 of 9 SCHEDULE A PROJECT PLAN for Project No. 1 I. CONSULTING SERVICES Scope: for two days per month during the term of this agreement and any extension thereof, Consultant shall provide Company with Consulting services and advise the Company on the subjects and tasks detailed below: i. Assisting and advising Company on defining its scientific milestones; ii. Reviewing Company scientific technical and business data and materials; iii. Developing a regulatory strategy to advance the Company's technology to clinical trials. iv. Support Company's effort on obtaining regulatory approval for Phase I clinical trial in cervical cancer ("Phase I"). v. Support the Company's effort to meet RAC submission. vi. Working with the Company's staff and management on designing executing and monitoring pre clinical trials (including all toxicology and bio-distribution studies or additional pre clinical studies if necessary). II. COMPENSATION AND PAYMENT SCHEDULE CASH: a monthly consulting fee of $3,000 which shall be pay as follows: i. Paid in cash: $1,000 monthly. ii. Deferred: $1,000 paid at the closing of any equity financing above $500,000. iii. Deferred: $1,000 at the closing of a subsequent equity financing greater than $1,000,000. EQUITY COMPENSATION. Company has adopted and approved its 2003 Stock Option Plan (the "Plan") and is planning to implement a 100:1 split in its shares. Pursuant to the terms of Plan, Company agrees to grant stock options ("Options") to Consultant (on a post split basis) for 1500 (one thousand five hundred) Shares of Common Stock, at an exercise price of $1.50 per share, per each month while this Agreement is in effect and provided it has not been terminated. The Options shall be non-qualified. The Options shall be fully vested when granted. Other terms and conditions as set forth in the Plan shall apply. Page 8 of 9 The parties intend this Project Plan to be a "Project Plan" under the Consultancy Agreement between the parties dated as of the ___ of March, 2003. The parties have read and agree to be bound by the above terms and conditions and have entered into this Project Plan effective as of the latest date set forth below. Company Consultant By: /s/ J. Todd Derbin By: /s/ Jay Cavagnaro - --------------------------------------- ------------------------------------- (Signature) (Signature) T. Todd Derbin - --------------------------------------- ------------------------------------- Printed Name Printed Name CEO - --------------------------------------- ------------------------------------- Title Title - --------------------------------------- ------------------------------------- Date Date Page 9 of 9
Exhibit 10.14 ADVAXIS, INC 212 CARNEGIE CENTER, SUITE 206 PRINCETON, NJ 08540 PHONE: (609) 497-7555 FAX: (609) 497-9299 Thursday, June 19, 2003 Eileen G. Gorman, PhD DNA Bridges, Inc. ("DNA") 700 Cheltenham Rd. Wilmington, DE 19808-1507 Dear Eileen, RE: GRANT WRITING AGREEMENT This letter summarizes our understanding regarding the terms and conditions of the engagement for the purpose of DNA's implementation and execution of a grant writing strategy for Advaxis, Inc ("Advaxis" or "Company"): 1) Project: a) Implement and execute a grant writing strategy on behalf of Advaxis based on the schedule and grants specified in SCHEDULE A. Specifically: 2) Developing and managing proposal development timeline 3) Gathering relevant background material 4) Writing the grant 5) Editing grant and working with client to fine tune the grant application 6) Preparing budget requirements for grant 7) Prepare forms prior to submission (form review by the company must be completed one week prior to the final submission target date) 8) All other items reasonably necessary to submit the grant 9) Payment schedule: As described in SCHEDULE B. 10) Conflict of interest: If a conflict of interest should arise during the performance of this Agreement, DNA shall immediately notify Company thereof. 11) Confidentiality: the terms of the existing confidentiality agreement between DNA and Advaxis shall apply. 12) Assignment of Inventions. DNA agrees that DNA will promptly make full written disclosure to Company, will hold in trust for the sole right and benefit of Company, and hereby assigns, transfers and conveys to Company, or its designee, all of DNA's worldwide right, title, and interest in and to any and all inventions, original works of authorship, findings, conclusions, data, discoveries, developments, concepts, improvements, trade secrets, techniques, processes and know-how, whether or not patentable or registrable under copyright or similar laws, which DNA may solely or jointly conceive or develop or reduce to practice, or cause tobe conceived or developed or reduced to practice, in the performance of the services under this agreement or which result, to any extent, from use of Company's premises or property. 13) Independent Contractor. For purposes of this Agreement and all Services to be provided hereunder, DNA shall not be considered a partner, co-venturer, agent, employee or representative of Company, but shall remain in all respects an independent contractor, and neither party shall have any right or authority to make or undertake any promise, warranty or representation, to execute any contract, or otherwise to assume any obligation or responsibility in the name of or on behalf of the other party. 14) Termination: Each party may terminate this agreement with a 30 day prior notice. 15) Amendment: This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof. This Agreement may not be amended, modified or waived, except in writing signed by both parties. Both parties may agree in writing to amend this agreement or any of its schedules. 16) Dispute resolution: Any dispute that arises in connection with agreement shall be determined by arbitration conducted in Princeton, New Jersey, in accordance with the Commercial Arbitration Rules of the American Arbitration Association then existing. IN WITNESS HEREOF, the parties have read and agree to be bound by the above terms and conditions and have entered into this Agreement effective as of the date set forth above. ADVAXIS, INC DNA BRIDGES, INC Signature: /s/ J. Todd Derbin Signature: /s/ Eileen Gorman ------------------------- ------------------------- Name Name: Eileen Gorman Title: Title: EIN#: 54-1957384 Date: Date: ------------------------- -------------------------------
EXHIBIT 10.15 CONSULTING AGREEMENT This Consulting Agreement (the "AGREEMENT") is made and entered into this 2nd day of July, 2004 (the "EFFECTIVE DATE"), by and between Advaxis, Inc., a Delaware corporation (the "COMPANY"), and Sentinel Consulting Corporation, a Delaware corporation (the "CONSULTANT"). Each of Company and Consultant shall be referred to as a "PARTY" and collectively as the "PARTIES." RECITALS WHEREAS, Consultant has performed certain services for the Company and the Company desires to compensate Consultant for services performed and to solidify the relationship between the Parties from this point forward; WHEREAS, the Parties hereto have previously discussed the terms of a consulting agreement and desire to finalize all discussions between them into this Agreement; WHEREAS, the Company wishes to engage the consulting services of Consultant on a non-exclusive basis; and WHEREAS, Consultant wishes to provide the Company with consulting services. NOW, THEREFORE, in consideration of the mutual promises herein contained, the Parties hereto hereby agree as follows: 1. CONSULTING SERVICES The Company hereby authorizes, appoints and engages the Consultant to perform the following services in accordance with the terms and conditions set forth in this Agreement: a. The Consultant will consult with the Company concerning its business plan, financial statements, brochures, and other offering materials to be prepared in anticipation of the obtaining one or more rounds of equity financing for the Company. Without limiting the generality of the foregoing, Consultant specifically agrees to: (i) Review all of the Company's books and records, sales materials, business plans, financial statements, projections, and all other materials reasonably necessary in the performance of its duties hereunder; (ii) Suggest and assist in the implementation of changes to any of the above listed materials which will better position the Company to obtain equity financing, including the structure of any private placement which the Company undertakes; Page 1 of 6(iii) Introduce the Company to reasonable sources of accounting, legal, printing, financial statement preparation, public relations and other professional services as needed; (iv) Assist the Company in identifying and engaging, on terms acceptable to the Company, a NASD licensed broker/dealer to assist the Company in raising funds in a private placement; and (v) Submit to the Company, when requested, complete and accurate reports of the status of Consultant's efforts. b. In addition, upon the Company's specific request Consultant shall render the following additional services to the Company upon mutual agreement of Consultant and Company: (i) Drafting of a term sheet for financing; (ii) Drafting of a Private Placement Memorandum or Offering Memorandum; (iii) Drafting of support legal document drafts for review by the Company's legal counsel; (iv) Conducting a patent assessment and intellectual property analysis for investor groups; (v) Conducting a detailed market assessment for a Company's product line; (vi) Conducing or assisting in a technical audit; and (vii) Additional special services to be determined by Consultant and the Company. 2. TERM OF AGREEMENT This Agreement, including all of its terms, conditions and exhibits, shall be in full force and effect as of the date hereof through and including that period which ends six (6) full months from the date of this Agreement (the "Initial Term"). Either Party shall have the right to terminate this Agreement for any reason or for no reason after four (4) months upon delivery of ten (10) days advance written notice. Page 2 of 6 If the Company terminates this Agreement during the first four (4) months of this agreement without cause, a cash fee of Twenty Five Thousand Dollars ($25,000) (the "TERMINATION FEE") shall immediately be due to Consultant. If the Company terminates this Agreement during the fifth or sixth months of this agreement for any reason of for no reason, it shall owe no fees to Consultant and Consultant hereby waives its right to any compensation, in cash, equity or other. 3. COMPENSATION TO CONSULTANT a. Upon execution of this Agreement, the Company shall pay to Consultant an engagement fee of $5,000 (the "ENGAGEMENT FEE"). It is acknowledged by all Parties that the Engagement Fee has been paid by the Company to the Consultant prior to the execution of this Agreement. b. Upon execution of this Agreement, the Company shall pay to Consultant a cash fee of $10,000, plus travel expenses (the "VIDEO FEE"), in connection with the preparation of a video describing the Company. It is acknowledged by all Parties that the Video Fee has been paid by the Company to the Consultant prior to the execution of this Agreement. c. Immediately after the Initial Term, provided that this Agreement has not been terminated by either party during the Initial Term, the Company shall pay to Consultant a cash fee equal to $85,000 (the "CONTINUED CONSULTING FEE"). d. Immediately after the Initial Term, provided that this Agreement has not been terminated by either party during the Initial Term, the Company shall issue to Consultant a warrant to purchase 3.4 Units for an aggregate purchase price of $85,000, exercisable over a five (5) year period (the "WARRANTS"). e. Immediately after the Initial Term, provided that this Agreement has not been terminated by either party during the Initial Term, the Company shall issue to Consultant 444,251 shares of common stock of the Company or any successor thereto (the "SHARES"). 4. EXPENSES; DELEGATION a. The Parties hereto agree that the Company shall not be responsible for any costs or expenses incurred by Consultant in performing his duties hereunder unless Consultant obtains the prior approval of the Company; provided, however, that Company agrees to pay up to (i) $6,000 in connection with the scientific review conducted by Dr. Ferrone, and.(ii) $12,000 in connection with Consultant's legal expenses. b. The Company agrees that Consultant may delegate some of the consulting services under this Agreement to other agents, subject to approval by Company and such compensation or fees due to Consultant pursuant to Page 3 of 6 Section 3 in connection with such services may be payable to such agent in a manner mutually acceptable to the Company and SCI. 5. INDEPENDENT CONTRACTOR Both the Company and the Consultant agree that the Consultant will act as an independent contractor in the performance of his duties under this Agreement. Nothing contained in this Agreement shall be construed to imply that Consultant, or any employee, agent or other authorized representative of Consultant, is a partner, joint venturer, agent, officer or employee of the Company. Neither Party hereto shall have any authority to bind the other in any respect vis a vis any third party, it being intended that each shall remain an independent contractor and responsible only for its own actions. 6. NOTICES Any notice, request, demand, or other communication given pursuant to the terms of this Agreement shall be delivered via hand delivery, facsimile, email, or overnight courier, and shall be deemed delivered upon receipt. All notices shall be delivered to: If to the Company: Advaxis, Inc. 212 Carnegie Center, Suite 206 Princeton, NJ 08540 Attn: J. Todd Derbin, CEO Facsimile (801) 459-3596 If to Consultant: Sentinel Consulting Corporation 30211 Avenida de las Banderas, Suite 121 Rancho Santa Margarita, CA 92688 Attn: Robert Harvey Facsimile (949) 888-2326 7. ASSIGNMENT This contract shall inure to the benefit of the Parties hereto, their heirs, administrators and successors in interest. This Agreement shall not be assignable by either Party hereto without the prior written consent of the other. 8. CHOICE OF LAW AND VENUE This Agreement and the rights of the Parties hereunder shall be governed by and construed in accordance with the laws of the State of California including all matters of construction, validity, performance, and enforcement and without giving effect to the principles of conflict of laws. Any action brought by any Party hereto shall be brought within the State of California, County of Orange. Page 4 of 6 9. NONDISCLOSURE All information which Consultant, its employees, members, officers, directors, representatives or agents ("Consultant Disclosing Party") receives from the Company, (whether communicated orally, by electronic or magnetic media or by visual display and whether prepared or furnished by or on behalf of Company), shall be held in the strictest confidence unless and until Company specifically consents in writing to the disclosure of any confidential information. Consultant agrees to be responsible for any breach of this Section 9 by any Consultant Disclosing Party. Nothing in this Agreement prohibits the disclosure of any confidential information if required by law, rule or regulation. In the event any Consultant Disclosing Party is so required, it will provide Company with prompt written notice so that Company may seek an appropriate protective order and upon the request of Company, it will use its best efforts to cooperate in obtaining such order. It is understood that Company could sustain irreparable injury in the event of a breach of this Section 9. Accordingly, in the event of such breach, Company will be entitled to seek and obtain immediate injunctive relief in addition to any other remedy available at law or equity. Additionally, Company shall not disclose or disseminate Consultant generated information of any sort of form without approval of Consultant. 10. ENTIRE AGREEMENT Except as provided herein, this Agreement, including exhibits, contains the entire agreement of the Parties, and supersedes all existing negotiations, representations, or agreements and all other oral, written, or other communications between them concerning the subject matter of this Agreement. The Parties acknowledge that they have previously executed one or more consulting agreements prior to the date hereof, and those agreement are replaced by this Agreement. There are no representations, agreements, arrangements, or understandings, oral or written, between and among the Parties hereto relating to the subject matter of this Agreement that are not fully expressed herein. 11. SEVERABILITY If any provision of this Agreement is unenforceable, invalid, or violates applicable law, such provision, or unenforceable portion of such provision, shall be deemed stricken and shall not affect the enforceability of any other provisions of this Agreement. 12. CAPTIONS The captions in this Agreement are inserted only as a matter of convenience and for reference and shall not be deemed to define, limit, enlarge, or describe the scope of this Agreement or the relationship of the Parties, and shall not affect this Agreement or the construction of any provisions herein. Page 5 of 6 13. COUNTERPARTS This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which shall together constitute one and the same instrument. 14. MODIFICATION No change, modification, addition, or amendment to this Agreement shall be valid unless in writing and signed by all Parties hereto. 15. DISPUTE RESOLUTION The Parties agree to submit any disputes involving money or damages greater than $5,000 relating to this Agreement and/or transactions, duties, or obligations to be performed under this Agreement to mediation with a mediator approved by the Parties to the dispute. If the Parties resolve their disputes through mediation, the Parties shall share the mediator's fees evenly but pay their own attorney's fees and other expenses related to mediation. If mediation fails to resolve all disputes within thirty (30) days after the Parties submit the dispute to a mediator, then the Parties will submit to binding arbitration. The Parties agree that mediation is a pre-condition to filing an arbitration. The prevailing Party in arbitration relating to transactions contemplated by this Agreement shall be entitled to costs and expenses including reasonable attorneys fees and the attorney's fees and expenses incurred in connection with mediation that failed to resolve the dispute. Claims of $5,000 or less may be submitted to mediation or small claims court. IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed as of the Effective Date. "Company" "Consultant" Advaxis, Inc., Sentinel Consulting Corporation, a Delaware corporation a Delaware corporation /s/ J. Todd Derbin /s/ Robert T. Harvey - ------------------------ ------------------------ By: J. Todd Derbin By: Robert T. Harvey Its: CEO Its: President Page 6 of 6
· |
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
|
· |
cGMP
Master Cell Bank production |
· |
Toxicology
material |
· |
Manufacture
of clinical material |
· |
Development
of product stability tests |
· |
Quality
assurance review |
· |
Bulk
product release for fill/finish |
· |
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 |
Confidential Document |
2 |
July
7, 2003 |
Confidential Document |
3 |
July
7, 2003 |
Confidential Document |
4 |
July
7, 2003 |
Julian Hanak B.Sc. (Hons), MSc., Director of Production
Confidential Document |
5 |
July
7, 2003 |
Confidential Document |
6 |
July
7, 2003 |
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. |
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 |
7 |
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 |
host
identity |
o |
plasmid
identity (restriction mapping or sequencing) |
o |
culture
purity (monosepsis) |
o |
viable
count. |
7. | Host characterization methods will be developed for the following: |
o |
phenotype
auxotrophies and markers |
o |
morphology |
o |
specific
media for identification |
o |
gram
strain |
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: |
10. | Confirmation of price estimates for cGMP manufacture at this point, dependent upon successful technology transfer, feasibility study and process development. |
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. |
12. |
A [
* ]-vial cGMP Master Cell Bank and Working Cell Bank will be released
according to the agreed program. |
Confidential Document |
8 |
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: |
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. |
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. |
18. | Documentation. |
Confidential Document |
9 |
July
7, 2003 |
19. | Specifications |
· |
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. |
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 |
10 |
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.
|
Confidential Document |
11 |
July
7, 2003 |
Confidential Document |
12 |
July
7, 2003 |
Confidential Document |
13 |
July
7, 2003 |
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 |
Confidential Document |
14 |
July
7, 2003 |
EXHIBIT 10.20 CONSULTANCY AGREEMENT THIS CONSULTANCY AGREEMENT (this "Agreement") is made as of this 15th day of January, 2005, by and between Advaxis, Inc, a Colorado corporation, having a principal place of business at 212 Carnegie Center, Princeton, NJ ("Company"), and David Filer, Ph.D. having an address at 165 E. 32nd St. Apt #2F, New York, NY 10016, Phone: 212-689-1373, Fax: 212-581-7010 ("Consultant"). WHEREAS, Consultant and Company desire to enter into an agreement for the performance by Consultant of certain consulting services (the "Services"); and WHEREAS, Consultant has the specific knowledge, experience, and expertise to perform the Services; NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions hereinafter set forth, and intending to be legally bound, Company and Consultant agree as follows: 1. SERVICES AND COMPENSATION 1.1 Services. Consultant shall provide the Services and perform all duties as requested by Company, as more particularly set forth in SCHEDULE A. Company agrees that Consultant shall have reasonable access to Company's representatives as necessary to perform the Services provided for by this Agreement. 1.2 Reports. Consultant shall communicate the progress of each Project Plan to Company informally on a regular basis and in written reports to be provided to Company as specified in each Project Plan, and if not specified in a Project Plan, then on a calendar quarterly basis within ten (10) days after the end of such calendar quarter. Each written report shall be subject to acceptance by Company. 1.3 Compensation. Consultant shall be paid for performance of the Services as specified in SCHEDULE B. Notwithstanding the foregoing, Company may suspend payment if, in Company's reasonable opinion after review of such reports, Consultant has not been performing the Services in the manner and in accordance with the schedule set forth in the applicable Project Plan and pursuant to this Agreement. 1.4 Conflict of Interest; Non-Exclusive Arrangement. 1.4.1 If a conflict of interest should arise during the performance of this Agreement, Consultant shall immediately notify Company thereof and Company shall have the option to pursue any and all remedies, equitable, legal or otherwise, that may be available to Company in connection therewith. Consultant shall ensure that its performance of the Services does not conflict with Consultant's duties with other entiries. 1.4.2 Company may from time to time (i) engage other persons and entities to act as consultants to Company and perform services for Company, including, without limitation, services similar to the Services, and (ii) enter into agreements similar to this Agreement with other persons or entities, in all cases without the necessity of obtaining any approval from Consultant. 1.4.3 Subject to the provisions of Section 6.2, Consultant may from time to time act as a consultant to, perform services for, or enter into agreements similar to this Agreement with, other persons or entities without the necessity of obtaining approval from Company; provided, however, that in no event shall Consultant provide such other persons or entities with, or incorporate into or provide as part of any services for such other persons or entities, any information or know-how obtained by Consultant through its conduct of the Services (including, without limitation, any Confidential Information (as defined below)) and provided further that Consultant shall not provide services to any entity engaged in the research or development or marketing of vaccines. Page 1 of 82. CONFIDENTIAL INFORMATION 2.1 Confidentiality. Consultant agrees to maintain in strict confidence all Confidential Information (as defined below) provided to, or learned or developed by, Consultant during the course of Consultant's performance of the Services. Consultant shall not disclose or disseminate any Confidential Information to any person or entity, except with the prior written consent of Company. In addition, Consultant shall not use or copy any Confidential Information for any purpose other than in connection with performance of the Services hereunder. 2.2 Definition of Confidential Information. The term "Confidential Information" shall mean all trade secrets, processes, formulae, data and know-how, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information that has been created, discovered, or developed by Company, or has otherwise become known to Company, or which proper rights have been assigned to Company, as well as any other information and materials that are deemed confidential or proprietary to or by Company (including, without limitation, all information and materials of Company's customers and any other third party and their consultants), regardless of whether any of the foregoing are marked "confidential" or "proprietary" or communicated to Consultant by Company in oral, written, graphic or electronic form. 2.3 Exceptions to Confidential Information. Notwithstanding the foregoing paragraph, "Confidential Information" shall not include any information or materials that: (a) are or become known to the general public through no act or omission of Consultant or any other person with an obligation of confidentiality to Company, or (b) are required to be disclosed pursuant to applicable law (provided, however, that prior to any disclosure of Confidential Information as required by applicable law, Consultant shall advise Company of such required disclosure promptly upon learning thereof and shall cooperate with Company in order to afford them a reasonable opportunity to contest or limit such disclosure). 2.4 Consultant-Restricted Information. Consultant agrees that Consultant will not improperly use or disclose to the Company any proprietary or confidential information or trade secrets of any person or entity with whom Consultant has an agreement or duty to keep such information or secrets confidential. 2.5 Use of Third Party Information. Consultant will not use any equipment, supplies, chemicals, molecules, organisms, biological materials, or other physical property, facilities or trade secret information of any present or former employee or consulting client which are not generally available to the public, unless Consultant has obtained prior written authorization for such use and have delivered a copy of such authorization to Company prior to such use. Notwithstanding such authorization, Company shall have the right, at its sole discretion, to exclude the use of any of the foregoing by Consultant. 3. INTELLECTUAL PROPERTY 3.1 Assignment of Inventions. Consultant agrees that Consultant will promptly make full written disclosure to Company, will hold in trust for the sole right and benefit of Company, and hereby assigns, transfers and conveys to Company, or its designee, all of Consultant's worldwide right, title, and interest in and to any and all inventions, original works of authorship, findings, conclusions, data, discoveries, developments, concepts, improvements, trade secrets, techniques, processes and know-how, whether or not patentable or registrable under copyright or similar laws, which Consultant may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or developed or reduced to practice, in the performance of the Services or which result, to any extent, from use of Company's premises or property (collectively, the "Inventions"), including, without limitation, any and all intellectual property rights inherent in the Inventions and appurtenant thereto including, without limitation, all patent rights, copyrights, trademarks, know-how and trade secrets (collectively, "Intellectual Property Rights"). Consultant acknowledges and agrees that certain of the Inventions (whether made solely by Consultant or jointly with others) may be "works made for hire," as that term is defined in the United States Copyright Act, and therefore Company would be deemed the owner of such Inventions. For purposes of clarification, to the extent any Invention is not a "work made for hire," such Invention would be subject to the assignment in the first sentence of this Section 3.1. Page 2 of 8 3.2 Further Assurances. Upon the request and at the expense of Company, Consultant shall execute and deliver any and all instruments and documents and take such other acts as may be necessary or desirable to document the assignment and transfer described in Section 3.1 or to enable Company to secure its rights in the Inventions and any patents, trademarks, copyrights or other intellectual property rights relating thereto in any and all jurisdictions, or to apply for, prosecute and enforce patents, trademark registrations, copyrights or other intellectual property rights in any and all jurisdictions with respect to any Inventions, or to obtain any extension, validation, re-issue, continuance or renewal of any such intellectual property right. 4. REPRESENTATIONS AND WARRANTIES 4.1 Each party represents and warrants that, to the best of its knowledge, it has the right to enter into and to perform its obligations hereunder without thereby breaching any of its obligations to third parties. 4.2 Consultant represents and warrants to Company that: (i) the Services performed by Consultant hereunder will be of professional quality, consistent with generally-accepted industry standards and expectations for work of a similar nature, (ii) all Services provided to Company hereunder shall conform to the agreed-upon specifications therefor, if any, (iii) to the best of Consultant's knowledge, all Services, Inventions, and Intellectual Property Rights provided to Company hereunder will not infringe or misappropriate the patent, copyright, trademark, trade secret, or other intellectual property rights of any third party, (iv) Consultant's performance under this Agreement and Consultant's retention as a consultant by Company does not and will not breach any obligation or agreement by which Consultant is bound to keep in confidence any information Consultant may acquire, or not to compete with any other person or entity, and (v) Consultant has not entered into, and will not enter into, any agreement, and is not affected by any policy, either written or oral, that would interfere or be inconsistent with Consultant's performance under this Agreement. Consultant shall indemnify, defend, and hold harmless Company and its officers and employees from and against any and all losses, damages, liabilities, obligations, judgments, penalties, fines, awards, costs, expenses, and disbursements (including without limitation, the costs, expenses and disbursements, as and when incurred, of investigating, preparing or defending any claim, action, suit, proceeding, or investigation) suffered or incurred by Company on account of Consultant's breach of any of the foregoing representations and warranties. 4.3 COMPANY MAKES NO OTHER WARRANTY RELATING TO THE CONFIDENTIAL INFORMATION AND THE USE TO BE MADE THEREOF BY CONSULTANT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES. 5. TERM 5.1 Term. The initial term of this Agreement shall be six months ("Initial Term"). The Term may be extended upon mutual agreement of the parties in writing. 5.2 Termination. Each party may terminate this Agreement upon thirty (30) days prior written notice to the other party. 5.3 Return of Company Property. All property belonging to Company in Consultant's possession or control, including, without limitation, all Confidential Information (as well as all copies, summaries, or other representations thereof) and all originals and copies of any documents, devices, records, data, notes, reports, proposals, lists, correspondence, specifications, drawings, blueprints, sketches, materials, and equipment shall be and remain the sole property of Company and shall be returned promptly to Company upon the expiration or earlier termination of this Agreement, and earlier if requested by Company at any time. Consultant shall not remove any of Company's property from Company's premises without prior written authorization from Company. Page 3 of 8 5.4 Survival. In the event this Agreement expires or is terminated for any reason, the rights and obligations of Sections 5.3, 5.4 and Articles 2, 3, 4, 6 and 7 shall survive such expiration or termination. 6. NON-SOLICITATION AND NON-COMPETITION 6.1 Non-solicitation. Consultant agrees that during the term of this Agreement and for one year thereafter, Consultant shall not for any reason, either directly or indirectly, on Consultant's own behalf or in the service or on behalf of others, (i) solicit, recruit or attempt to persuade any person to terminate employment or a consulting relationship with Company or (ii) interfere in any manner with Company's relationship with, any of Company's co-venturers, vendors, suppliers, licensors or partners. 6.2 Non-competition. During the term of this Agreement and for one year thereafter, Consultant shall not, either directly or indirectly, alone or as a consultant, partner, officer, director, employee, joint venturer, lender or stockholder of any entity, accept employment with or provide consulting services to, any business or entity or engage in any business or activity that relates to cancer vaccines. 7. MISCELLANEOUS 7.1 Social Security Number. Consultant certifies that his or her correct Social Security is listed on the first page of this Agreement. Consultant acknowledges that Company will rely upon the foregoing certification in filing certain documents and instruments required by law in connection with this Agreement, including, without limitation, Form 1099 under the Internal Revenue Code of 1986, as amended (or any successor form). 7.2 Independent Contractor. For purposes of this Agreement and all Services to be provided hereunder, Consultant shall not be considered a partner, co-venturer, agent, employee or representative of Company, but shall remain in all respects an independent contractor, and neither party shall have any right or authority to make or undertake any promise, warranty or representation, to execute any contract, or otherwise to assume any obligation or responsibility in the name of or on behalf of the other party. Without limiting the generality of the foregoing, Consultant shall not be considered an employee of Company for purposes of any state or federal laws relating to unemployment insurance, social security, workers compensation or any regulations which may impute an obligation or liability to Company by reason of an employment relationship. Consultant agrees to pay all income, FICA, and other taxes or levies imposed by any governmental authority on any compensation that Consultant receives under this Agreement. Consultant shall indemnify, defend and hold harmless Company and its officers and employees from and against any and all losses, damages, liabilities, obligations, judgments, penalties, fines, awards, costs, expenses and disbursements (including without limitation, the costs, expenses and disbursements, as and when incurred, of investigating, preparing or defending any claim, action, suit, proceeding or investigation) suffered or incurred by Company as a result of any allegation that Consultant is an employee of Company by virtue of performing any work for or on behalf of Company hereunder or otherwise. 7.3 Rules and Policies. While at Company's facilities, Consultant shall observe and follow Company's work rules, policies, and standards as the same are communicated to Consultant from time to time, including, without limitation, those rules, policies and standards of Company relating to security of and access to facilities, telephone systems, electronic mail systems, and computer systems. Page 4 of 8 7.4 Successors. All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of and be enforceable by the respective heirs, executors, administrators, legal representatives, successors and assigns of the parties hereto, except that the duties and responsibilities of Consultant hereunder are of a personal nature and shall not be assignable or delegable in whole or in part by Consultant. 7.5 Equitable Relief. Consultant hereby acknowledges and agrees that damages at law may be an inadequate remedy for any breach of Consultant's obligations under Article 2 (Confidential Information), Article 3 (Intellectual Property), Article 6 (Non-Solicitation and Non-Competition), and, accordingly, Consultant agrees that Company will be entitled to such temporary, preliminary and permanent injunctive relief as may be necessary to remedy or limit such breach, without the necessity of proving actual damages or posting any bond or other security, and including specific performance of such obligations and an order enjoining Consultant from the continuation of, or from any threatened, breach of such obligations. The rights set forth in this paragraph shall be in addition to, and not in lieu of, any other rights which Company may have at law or in equity. 7.6 Publicity. Consultant shall not disclose to any third party any information about the Services provided or to be provided by Consultant for or on behalf of Company, except as may be required by law or as Company may otherwise agree in writing. 7.7 Assignment. Consultant shall not assign this Agreement or any right hereunder, nor delegate of any Consultant's duties hereunder, without the prior written consent of Company. 7.8 Amendments. No change, modification, extension, termination or waiver of this Agreement, or any of the provisions herein contained, shall be valid unless made in writing and signed by Consultant and a duly authorized representative of Company. 7.9 No Waiver. No term or provision of this Agreement will be considered waived and no breach consented to by either party unless such waiver or consent is in writing signed on behalf of the party against whom it is asserted. No consent to or waiver of a breach of this Agreement by either party, whether express or implied, will constitute a consent to, waiver of, or excuse for any other, different, or subsequent breach of this Agreement by such party. 7.10 Severability. Any provisions of this Agreement which are determined to be invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions of this Agreement or affecting the validity or enforceability of such provisions in any other jurisdiction. If a court of competent jurisdiction declares any provision of this Agreement to be invalid or unenforceable, the parties hereto shall request that such court reduce the scope, duration, or area of the provision, delete specific words or phrases from the provision, or to replace the provision with a provision that is valid and enforceable and that comes closest to expressing the original intention of the parties hereto, and this Agreement shall be enforceable as so modified in the jurisdiction in which the provision was declared invalid or unenforceable. 7.11 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of New Jersey without regard to its conflict of law provisions. 7.12 Entire Agreement. This Agreement represents the entire agreement between the parties regarding the Services provided during the term of this Agreement and shall supersede all previous communications, representations, understandings, and agreements, whether oral or written, by or between the parties with respect thereto, whether theretofore or hereafter disclosed to Consultant. Without limitation, this Agreement does not supersede any confidentiality agreement that may have been signed between Company and Consultant. Page 5 of 8 7.13 Counterparts. This Agreement may be executed in two counterparts, each of which shall be deemed to be an original as against any party whose signature appears thereon, but both of which together shall constitute but one and the same instrument. [SIGNATURE PAGE IMMEDIATELY FOLLOWS] Page 6 of 8 IN WITNESS HEREOF, the parties have read and agree to be bound by the above terms and conditions and have entered into this Agreement effective as of the date set forth above. COMPANY CONSULTANT By: /s/ J. Todd Derbin By: /s/ David Filer - --------------------------------- --------------------------------------- (Signature) (Signature) Dr. J. Todd Derbin David Filer - --------------------------------- --------------------------------------- Printed Name Printed Name CEO Biotech Consultant - --------------------------------- --------------------------------------- Title Title - --------------------------------- --------------------------------------- Date Date Page 7 of 8 SCHEDULE A PROJECT PLAN FOR PROJECT NO. 1 I. CONSULTING SERVICES Scope: for three days per month during the term of this agreement and any extension thereof, Consultant shall provide Company with Consulting services and advise the Company on the subjects and tasks detailed below: i. Assisting and advising Company on its development efforts; ii. Reviewing Company scientific technical and business data and materials; iii. Introducing he Company to industry analysts, institutional investors collaborators and strategic partners. II. COMPENSATION AND PAYMENT SCHEDULE Cash: a monthly consulting fee of $2,000 during the Term. EQUITY COMPENSATION. Company is planning to adopt its 2005 option plan ("Plan"). Pursuant to the terms of Plan, and subject to the approval and establishment of the Plan, Company agrees to grant stock options ("Options") to Consultant for 40,000 (forty thousand) Shares of Common Stock, vesting monthly over 12 months provided that this Agreement has not been terminated. The Options shall be non-qualified. Other terms and conditions as set forth in the Plan shall apply. Page 8 of 8
CONSULTING AGREEMENT EXHIBIT 10.21 This CONSULTING AGREEMENT (the "Agreement") is made by and between Pharm-Olam International Ltd., a Texas limited partnership with an address of 450 North Sam Houston Pkwy., Suite 250, Houston, TX 77060 ("Consultant"), and Advaxis, Inc., with an address of 212 Carnegie Center, Suite 206, Princeton, New Jersey 08540 ("Advaxis") and is effective as of January 15, 2005 ("Effective Date"). RECITALS A. Consultant, a contract research organization, possesses special expertise and knowledge in the field of pre-clinical, clinical and regulatory affairs; and B. Advaxis, a biotechnology company commercializing novel vaccines, has need for Consultant's pre-clinical consultant services; and C. Advaxis and Consultant now desire to enter into this Agreement whereby Consultant shall perform consulting services for Advaxis on the terms and conditions set forth below. AGREEMENT NOW, THEREFORE, Consultant and Advaxis agree as follows: 1. Description of Services. Subject to the terms and conditions of this Agreement, Consultant shall perform management of pre-clinical toxicology studies as defined in Attachment 1 and by cost in Attachment 2. Timelines for pre-clinical toxicology studies milestone payment schedule are outlined in Attachment 3 2. Term and Renewal. This Agreement shall be effective as of the Effective Date and shall remain in effect for a period of Twelve (12) months unless terminated pursuant to this Agreement. This Agreement may only be renewed for additional periods on terms mutually agreed upon in writing by the parties. Neither party shall have any obligation to renew this Agreement. However, the expiration of this Agreement shall not effect the obligations of Consultant to complete the services agreed upon in this Agreement. 3. Fees. a) For return of services as outlined in Attachment 1 and 2, Advaxis will make milestone payments according to payment chart in Attachment 3. The cost for project management, animal studies and DNA assays as outlined in Attachment 2 is $272,163, two hundred seventy two one hundred sixty three dollars. b) Advaxis shall also reimburse Consultant for all reasonable and necessary out-of-scope expenses actually incurred by Consultant in rendering services under this Agreement. In case of meetings, such expenses will include reasonable and necessary travel, lodging and meals. Consultant shall provide Advaxis with a written expense report, complete with receipts or other reasonable documentation, for all such expenses requested for reimbursement. Any expense item greater than $200 shall require Advaxis' prior written or email approval.4. Invoices. Milestone payments due hereunder shall be payable upon Advaxis's receipt ("Due Date") of a written invoice or an expense report and accompanying supporting documentation therefore. Any amounts which remain unpaid for thirty (30) days or more after the Due Date shall bear interest at the rate equal to 8%. Interest shall be computed on the basis of 12 months of 30 days each per year, as the case may be, subject to the provisions hereof limiting interest to the maximum rate of interest allowed by applicable law. 5. Confidentiality; Proprietary Information; Intellectual Property. a) Any and all information which Advaxis or its affiliates may disclose to Consultant under this Agreement will be considered confidential. b) Consultant further agrees that all discussions and negotiations with respect to this Agreement are confidential. c) Consultant understands that Advaxis possesses and will continue to possess information that has been created, discovered or developed, or has otherwise become known to Advaxis or its affiliates and/or in which property rights have been assigned or otherwise conveyed to Advaxis or its affiliates, which information has commercial value in the business in which Advaxis is engaged. All such information, including the information described in Sections 5 (a) and (b) above, and including any other information developed by or on behalf of Consultant pursuant to this Agreement, is hereinafter referred to as "Proprietary Information." By way of illustration, but not limitation, Proprietary Information includes trade secrets, processes, formulae, data and know-how, improvements, inventions, techniques, marketing plans, strategies, forecasts and customer and contact lists. Accordingly, Consultant further agrees as follows: i) All Proprietary Information shall be the sole property of Advaxis or its affiliates and their assigns, as the case may be, and such parties shall be the sole owners of all patents and other rights in connection therewith. At all times during this Agreement and at all times after expiration or termination of this Agreement, Consultant will keep in confidence and trust all Proprietary Information, and will not use or disclose any Proprietary Information without the prior written consent of Advaxis, except as may be necessary in the ordinary course of performing the duties of Consultant hereunder. No announcement, oral presentation or publication of any kind relating to any Proprietary Information shall be made by Consultant without the prior written consent of Advaxis; and ii) All documents, data, records, apparatus, equipment and other physical property, whether or not pertaining to Proprietary Information, furnished to Consultant by or on behalf of Advaxis or developed by or on behalf of Consultant pursuant to this Agreement, shall be and remain the sole property of Advaxis and/or its affiliates and shall be returned promptly as and when requested by Advaxis. Should Advaxis not so request, Consultant agrees to return and deliver all such property upon expiration or termination of this Agreement for any reason and Consultant shall not retain or reproduce any such property upon expiration or termination. iii) Consultant shall promptly disclose to Advaxis or its designee all intellectual property (including, but not limited to any inventions, improvements, formulae, processes, techniques, know-how, data, patents or applications for patents, trade secrets, trademarks, copyrights and confidential information as described in this Section 5), made or conceived or reduced to practice or learned by Consultant (collectively, "Intellectual Property") which (A) result from the tasks assigned to Consultant hereunder; (B) are funded by or on behalf of Advaxis or its affiliates; or (C) result from the use or property or premises owned, leased or contracted for by or on behalf of Advaxis or its affiliates. iv) Consultant agrees to and does hereby sell, assign, transfer and set over to Advaxis, its affiliates, successors or assigns, as the case may be, all right, title and interest in and to all Intellectual Property developed or conceived individually or in conjunction with others in performance of this Agreement, to be held and enjoyed by Advaxis, its affiliates, successor or assigns, as the case may be, to the full extent of the term for which any Letters Patent may be granted and as fully as the Intellectual Property would have been held by Consultant had this Agreement, sale or assignment not be made. v) Consultant shall execute and deliver any and all instruments and documents and perform any and all acts, necessary to obtain, maintain or enforce patents, trademarks, trade secrets and copyrights for such Intellectual Property, and shall make, execute and deliver any and all instruments and documents and perform any and all acts necessary to obtain, maintain or enforce patents, trademarks, trade secrets and copyrights for such Intellectual Property as Advaxis may designate in any and all countries. All costs and expenses of application and prosecution of such patents, trademarks, trade secrets and copyrights shall be paid by Advaxis. vi) Any copyrightable material prepared by Consultant as a result of Consultant's activities with Advaxis, in performance of this Agreement, are prepared as works for hire for the benefit of Advaxis. Consultant hereby assigns to Advaxis any copyright to which Consultant is entitled for any copyrightable material prepared in the course of the performance of this Agreement for Advaxis. Advaxis shall have the right to reproduce, modify and use such material and all results generated as the result of services rendered under this Agreement for any propose related to its lawful business. vii) Upon the written request of Advaxis, Consultant shall make any assignment provided for in this Section 5 directly to, or for the benefit of, an Advaxis affiliate or Advaxis's designee, including Consultant's performance of any related obligations hereunder. 6. Remedies. (a) Consultant acknowledges that Advaxis will have no adequate remedy at law if Consultant breaches the terms of Section 5 hereof. Accordingly, in such event, Advaxis shall have the right, in addition to any other rights it may have at law or equity, to obtain in any tribunal of competent jurisdiction injunctive relief to restrain any breach or threatened breach. (b) If, due to reasons within Consultant's reasonable control, Consultant's products or services fail to meet standards generally accepted in the applicable industry, or if Consultant fails to provide agreed-upon products or services in a timely manner Advaxis shall have the right, in addition to any other remedy it may have at law or equity, to: (i) terminate this Agreement immediately upon written notice to Consultant; (ii) require that defective products or services be replaced or remedied, as the case may be, without charge to Advaxis; and (iii) correct, or have corrected by a third party, the defective product or service and withhold from amounts owing to Consultant hereunder all amounts incurred by Advaxis in taking such corrective measures. 7. Termination. This Agreement may be terminated (a) by Advaxis with or without cause upon thirty (30) day's prior written notice to Consultant, or (b) by Consultant in the event of a material breach by Advaxis, provided that Consultant provides Advaxis with written notice of such breach and Advaxis fails reasonably to cure such breach within thirty (30) days of receipt of such notice. In the event this Agreement is terminated pursuant to this Section prior to completion of the work to be performed, Consultant shall cease work upon Advaxis's request, and shall be entitled to receive its fee for work actually and reasonably performed through the effective date of termination. In addition, Consultant shall promptly return to Advaxis all written materials and biological material provided to Consultant by Advaxis or its partners or affiliates. The provisions of Sections 5-6 and 9-14, inclusive, shall survive expiration or termination of this Agreement. 8. Independent Contractor. Consultant shall be an independent contractor and shall have no authority to enter into contracts on behalf of Advaxis, bind Advaxis to any third parties or act as an agent on behalf of Advaxis in any way. Consultant shall account for and report the payment of all applicable federal and state income taxes, social security taxes, and all other taxes due on payments received by Consultant hereunder. Consultant hereby acknowledges than Advaxis will report as compensation all payments to Consultant hereunder. 9. Consultant's Representation and Warranties. Consultant hereby represents and warrants to Advaxis that (a) Consultant has the authority to enter into and perform this Agreement and (b) performance of Consultant's services as contemplated by this Agreement will not result in the breach or violation of any contract, arrangement or understanding (including without limitation any intellectual property rights or any agreement of confidentiality or non-disclosure, whether written or oral) which Consultant may have with any third party (including with limitation current and former employers of Consultant and any other companies or persons for which Consultant has performed or is performing consulting services). 10. Compliance Standards. During the term of this Agreement and any renewal term, Consultant shall comply with all applicable laws, rules and regulations in the conduct of the services being performed. 11. Severability. If any provision of this Agreement is declared void or unenforceable, such provision shall be deemed modified to the extent necessary to allow enforcement, and all other portions of this Agreement shall remain in full force and effect. 12. Entire Agreement, Amendments. This Agreement contains the entire and complete agreement between the parties with respect to the subject matter hereof, and supersedes all prior oral and/or written agreements with respect to the subject matter hereof, other than any currently effective confidentiality agreement. Any changes to this Agreement must be in writing and signed by both parties. The Parties acknowledge that the confidentiality agreement previously executed beween the parties remain in full force and effect. 13. Successors. This Agreement shall be binding upon and inure to the benefit of the successors, assigns and legal representatives of the parties. 14. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey without regard to its conflicts of laws provisions, and the parties agree to personal jurisdiction and venue in the state and federal courts of New Jersey, in any suit or proceeding arising out of the subject matter of this Agreement. DATED as of the Effective Date written above, and executed by: ADVAXIS, INC.: By: /s/ J. Todd Derbin ------------------------- Name: J. Todd Derbin Title: CEO PHARM-OLAM INTERNATIONAL LTD.: By:___________________________ Name: Title: ATTACHMENT 1 FOUR WEEK TOXICOLOGY STUDY OF LM-LLO-E7 VECTOR IN MICE PURPOSE: To examine the toxicity of Advaxis' Lm-LLO-E7 Vector following four weekly i.v. or s.c. doses to female Balb/C mice. SCOPE: 10 mice/group 70 FEMALE MICE TOTAL REGULATORY STATUS: GLP TEST ARTICLE: Lm-LLO-E7 CONTROL ARTICLES: Control Buffer ROUTES OF ADMINISTRATION: i.v./s.c. OVERALL DESIGN: Wild-Type female Balb/C mice will be administered a single intravenous or subcutaneous injection of Lm-LLO-E7 Vector or control saline once weekly for four weeks on Study Days 1, 8, 15 and 22 as described in the table below.
=========================================================================================================== FOUR WEEK TOXICOLOGY STUDY OF LM-LLO-E7 IN FEMALE MICE - ----------------------------------------------------------------------------------------------------------- Group Treatment Dose Level Route Dosing Days Females ============ ======================= ====================== ========== ==================== =============== 1 Saline 0 i.v. 1,8,15, 22 10 - ------------ ----------------------- ---------------------- ---------- -------------------- --------------- 2 Lm-LLO-E7 Low i.v. 1,8,15, 22 10 - ------------ ----------------------- ---------------------- ---------- -------------------- --------------- 3 Lm-LLO-E7 Mid i.v. 1,8,15, 22 10 - ------------ ----------------------- ---------------------- ---------- -------------------- --------------- 4 Lm-LLO-E7 High i.v. 1,8,15, 22 10 ============ ======================= ====================== ========== ==================== =============== 5 Lm-LLO-E7 Low s.c. 1,8,15, 22 10 - ------------ ----------------------- ---------------------- ---------- -------------------- --------------- 6 Lm-LLO-E7 Mid s.c. 1,8,15, 22 10 - ------------ ----------------------- ---------------------- ---------- -------------------- --------------- 7 Lm-LLO-E7 High s.c. 1,8,15, 22 10 ============ ======================= ====================== ========== ==================== =============== IN-LIFE PROCEDURES: o CLINICAL OBSERVATIONS: Twice Daily cageside observation for signs of mortality, moribundity and/or toxicity. o PHYSICAL EXAMS, BODY WEIGHTS AND FOOD CONSUMPTION: At randomization, prior to treatment on SD1 and weekly thereafter. TERMINAL PROCEDURES: Twenty-four hours following the final dose: o Blood samples are obtained from all surviving mice for clinical pathology and hematological analysis. (5 animals for hematology, 5 for clinical chemistry per group) o Body weights o Necropsy: Full gross necropsy on all main study mice, and will include examination of external surface of body, all orifices, and cranial, thoracic and abdominal cavities and their contents. The following tissues will be obtained at necropsy and preserved in neutral buffered formalin: All Tissues from control and high dose treated animals will be embedded in paraffin, stained with hematoxylin and eosin, and examined microscopically by a board certified veterinary pathologist. Tissues from the mid and low dose group will be retained and evaluated only if findings were noted in corresponding tissues from high dose treated animals. TEST ARTICLE DOSAGE VERIFICATION: INFORMATION TO BE SUPPLIED BY THE SPONSOR. (REQUIRED FOR GLP STUDY)
- ---------------------- -------------- ----------- ---------------- --------------- -------------- ---------- --------------- Adrenals Aorta Bone Brain Cecum Colon Cervix Duodenum - ---------------------- -------------- ----------- ---------------- --------------- -------------- ---------- --------------- epididymides Esophagus Eyes Femur Gallbladder Heart Ileum Jejunum - ---------------------- -------------- ----------- ---------------- --------------- -------------- ---------- --------------- Kidneys Liver Lungs Lymph nodes Salivary gl Mammary Gl Optic Ovaries nerves - ---------------------- -------------- ----------- ---------------- --------------- -------------- ---------- --------------- Pancreas Pituitary Gross Sciatic Nerve Skin Spinal cord Spleen Stomach Lesions - ---------------------- -------------- ----------- ---------------- --------------- -------------- ---------- --------------- Administration Site Thymus Thyroid Parathyroid Trachea Skeletal Vagina Uterus Muscle - ---------------------- -------------- ----------- ---------------- --------------- -------------- ---------- --------------- ACUTE DOSE TOXICITY STUDY OF LM-LLO-E7 IN BALB/C MICE PURPOSE: o To determine the Maximum Tolerated Dose (MTD) of Lm-LLO-E7 Vector via both s.c. and i.v. routes to female Balb/C o To compare the tolerability of Balb/C mice to Lm-LLO-E7 relative to WT Listeria RATIONALE: o 24 Female mice for Dose Range phase. o Only females will be used since the indication for Lm-LLO-E7 is Cervical Cancer o No difference is anticipated between sexes o Balb/c mice will be used since they are more sensitive to Listeria than C57BL/6 Mice. o LD50 for Lm-LLO-E7 in Balb/c mice is reported to be ~108 pfu via ip route. o Sensitivity to i.v. route of administration should be greater. o Dose levels will be adjusted based on results of initial determinations from groups 3 and 6 below. STUDY DESCRIPTION: Test Article: Lm-LLO-E7 Listeria Monocytogenes Bacterial Vector Control Article: WT Listeria Monocytogenes Vector ROUTE OF ADMINISTRATION: Intravenous or subcutaneous (as indicated) A. DOSE RANGE FINDING TOXICITY PHASE: o Groups 1-2 female Balb/c mice will receive a single i.v. or s.c. dose of WT Listeria on study Day 1 and will be monitored for signs of toxicity. This dose will be based on published data on the known toxicity of WT listeria. o Mice in groups 3-5 will be dosed i.v. with increasing doses of LmLLO-E7 starting at 106 pfu. If this dose is well tolerated, a higher dose will be administered until a MTD is established.
========================================================================================================== ACUTE DOSE RANGE FINDING TOXICITY STUDY OF LM-LLO-E7 VECTOR IN BALB/C MICE - ------------ ---------------------------- ------------------------ -------------- ------------------------ GROUP TREATMENT DOSE LEVEL ROUTE NUMBER OF FEMALES (PFU) - ------------ ---------------------------- ------------------------ -------------- ------------------------ 1 WT Listeria MTD i.v. 3 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 2 WT Listeria MTD s.c. 3 ============ ============================ ======================== ============== ======================== 3 Lm-LLO-E7 106 i.v. 3 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 4 Lm-LLO-E7 107* i.v. 3 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 5 Lm-LLO-E7 108* i.v. 3 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 6 Lm-LLO-E7 106 s.c. 3 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 7 Lm-LLO-E7 107* s.c. 3 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 8 Lm-LLO-E7 108* s.c. 3 ============ ============================ ======================== ============== ======================== *Based on results of dosing groups 3 and 6 mice. o Mice in groups of 6-8 will be dosed s.c. with increasing doses of LmLLO-E7 starting at 106 pfu. If this dose is well tolerated, a higher dose will be administered until a MTD is established. B. MAIN PHASE ACUTE TOXICITY STUDY Groups of 5 female mice will be dosed once on Study Day 1 as described in the table below. Mice will be administered a single i.v. or s.c. injection of the Lm-LLO-E7 Vector or WT Listeria (Groups 1-2) on Study Day 1. Mice will be observed for clinical signs and changes in body weight and food consumption during the next 14 days. Surviving mice will be sacrificed on Study day 15, and gross necropsies will be performed. o Mice will be dosed once as described in the table above either i.v. or s.c., and will be monitored for clinical signs of toxicity. o Other assessments will include weekly body weights and food consumption. o Surviving mice will be weighed and sacrificed on SD 15. Gross necropsies only. Only gross lesions to be retained.
========================================================================================================== ACUTE DOSE IV AND SC TOXICITY STUDY OF LM-LLO-E7 VECTOR IN BALB/C MICE - ---------------------------------------------------------------------------------------------------------- GROUP TREATMENT DOSE LEVEL ROUTE NUMBER OF FEMALES (PFU) - ------------ ---------------------------- ------------------------ -------------- ------------------------ 1 WT Listeria MTD (sub LD50) i.v. 5 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 2 WT Listeria MTD (sub LD50) s.c. 5 ============ ============================ ======================== ============== ======================== 3 Lm-LLO-E7 106 i.v. 5 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 4 Lm-LLO-E7 107* i.v. 5 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 5 Lm-LLO-E7 108* i.v. 5 ============ ============================ ======================== ============== ======================== 6 Lm-LLO-E7 106 s.c. 5 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 7 Lm-LLO-E7 107* s.c. 5 - ------------ ---------------------------- ------------------------ -------------- ------------------------ 8 Lm-LLO-E7 108* s.c. 5 ============ ============================ ======================== ============== ======================== PILOT BIODISTRIBUTION STUDY OF LM-LLO-E7 IN FEMALE MICE PURPOSE: The purpose of this pilot study is to determine the biodistribution of Lm-LLO-E7 vector following a single i.v. administration to female Balb/c mice, and to optimize conditions for PCR detection of Lm-LL0-E7 following i.v. administration in mice. CLINICAL OBSERVATIONS: Twice daily cageside observation for signs of mortality, moribundity and/or toxicity PHYSICAL EXAMS: At randomization, prior to treatment on SD1 and weekly thereafter. BODY WEIGHTS: At randomization, prior to treatment on SD1 and weekly thereafter. TERMINAL PROCEDURES: On study day 2, three mice from groups 1 and 2 will be weighed, bled, and sacrificed by CO2 asphyxiation. Blood samples and tissue samples will be obtained and will be analyzed for presence of exogenous Test article DNA using PCR with primers specific for the vector and/or targeted gene. On study days 10 and 30 respectively, three mice per day from group 2 will be weighed, bled and sacrificed and blood and tissue samples obtained and analyzed for exogenous Test article DNA. o Gross necropsies will be performed only to obtain Tissues for PCR analysis. o A portion of the following tissues will be collected using clean sterile instruments (clean sterile set for each individual animal) and placed in vials and frozen at -80(Degree)C: Injection Site Spleen Small Intestine Ovaries Lymph node (1) Lung Heart Brain Bone Marrow Kidney Liver Blood PCR ANALYSIS: PCR analysis will be performed on the tissues using primers specific for genetic sequences of the Listeria monocytogenes vector. TEST ARTICLE DOSAGE VERIFICATION: Information to be supplied by the sponsor.
============================================================================================================= PILOT BIODISTRIBUTION OF LM-LLO-E7 VECTOR IN FEMALE MICE - ------------------------------------------------------------------------------------------------------------- GROUP TREATMENT DOSE LEVEL ROUTE OF FEMALES SCHEDULED SACRIFICES ADMINISTRATION (3 PER TIMEPOINT) ============ ===================== ============== ===================== ============== ====================== 1 Buffer Control 0 Intravenous 4 SD2 - ------------ --------------------- -------------- --------------------- -------------- ---------------------- 2 Lm-LLO-E7 Vector 108 CFU or Intravenous 12 SD 2, 10, 30 MTD ============ ===================== ============== ===================== ============== ====================== BIODISTRIBUTION OF LM-LLO-E7 VECTOR IN MICE PURPOSE: To examine the biodistribution of Lm-LLO-E7 Vector following a single intravenous or s.c. injection to female Balb/C mice. SCOPE: 96 Female Mice REGULATORY STATUS: GLP TEST ARTICLE: Lm-LLO-E7 CONTROL ARTICLES: Control Buffer ROUTES OF ADMINISTRATION: Intravenous and Subcutaneous PURPOSE: To compare overall biodistribution following either i.v. or s.c. administration of Lm-LLO-E7. OVERALL DESIGN: Wild-Type female Balb/c mice will be administered a single intravenous or s.c. injection of Lm-LLO-E7 Vector or control saline on Study Day 1 (SD 1) as described in the table below. Six mice per timepoint will be dosed, but only five per timepoint will be sacrificed for PCR analysis. CLINICAL OBSERVATIONS: Twice Daily cageside observation for signs of mortality, moribundity and/or toxicity PHYSICAL EXAMS: At randomization, prior to treatment on SD1 and weekly thereafter. BODY WEIGHTS: At randomization, prior to treatment on SD1 and weekly thereafter. TERMINAL PROCEDURES: On study days 2, 10 and 30 and 90, five mice per group will be weighed, bled, and sacrificed by CO2 asphyxiation.
============================================================================================================= BIODISTRIBUTION OF LM-LLO-E7 LISTERIA VECTOR IN FEMALE MICE - ------------------------------------------------------------------------------------------------------------- Group Treatment Dose Level Route Dose Volume Females (mL/kg) ============ =================== ================= =================== ================ ===================== 1 Saline 0 i.v. 10 24 - ------------ ------------------- ----------------- ------------------- ---------------- --------------------- 2 Lm-LLO-E7 Low i.v. 10 24 Vector - ------------ ------------------- ----------------- ------------------- ---------------- --------------------- 3 Lm-LLO-E7 High i.v. 10 24 Vector - ------------ ------------------- ----------------- ------------------- ---------------- --------------------- 4 Lm-LLO-E7 High S.C. 10 24 Vector ============ =================== ================= =================== ================ ===================== Blood samples will be analyzed for presence of exogenous Test article DNA using PCR with primers specific for the vector and target gene. Gross necropsies will be performed only to obtain Tissues for PCR analysis. A portion of the following tissues will be collected using clean sterile instruments (clean sterile set for each individual animal) and placed in small microcentrifuge vials and frozen at -80(Degree)C: Injection Site Spleen Blood Ovaries Mesentary lymph node Lung Heart Brain Bone Marrow Kidney Liver Small Intestine PCR ANALYSIS: Quantitative PCR will be performed on DNA extracted from above tissue samples and the presence of the vector sequence will be assessed. TEST ARTICLE DOSAGE VERIFICATION: INFORMATION TO BE SUPPLIED BY THE SPONSOR. (REQUIRED FOR GLP STUDY) ATTACHMENT 2 PRE-CLINICAL TOXICOLOGY STUDIES LM-LLO-E7
- ---------------------------------------------------------------------------------------- -------------------- TASK COST - ---------------------------------------------------------------------------------------- -------------------- Acute Dose Toxicity and Main Phase Includes dose range finding to find MTD (24 mice) and main phase acute toxicity (40 mice), assessments of weekly body weights and food consumption, and gross pathology with necropsy at 15 days, final clinical and GLP reports. $10,632 - ---------------------------------------------------------------------------------------- -------------------- FOUR WEEK TOXICITY STUDY Includes four weekly vaccinations given to 70 mice, sacrifice at 28 days, chemistry and hematology labs. on 50% of mice, gross pathology, final clinical and GLP reports. $31,500 Histology and pathology of 40 tissues per mouse in control and high dose groups (30 mice) by certified veterinary pathologist with histo-pathology report ($25.00 per $30,000 tissue) - ---------------------------------------------------------------------------------------- -------------------- PILOT BIODISTRIBUTION STUDY Includes 16 mice dosed with 12 serial sacrificed out to 30 days, blood and 11 tissues per mouse collected for PCR analysis of vector and targeted gene, clinical and GLP $13,000 reports. - ---------------------------------------------------------------------------------------- -------------------- BIODISTRIBUTION STUDY Includes 96 mice dosed with 80 serial sacrificed out to 90 days, daily clinical observations, weekly physical exams and body weights, blood and 11 tissues taken for $31,700 PCR analysis of vector and targeted gene, clinical and GLP reports. - ---------------------------------------------------------------------------------------- -------------------- PCR ANALYSIS Lark will analyze 11 tissues and one blood from 3 groups of mice (12, 60 and 20) using a targeted assay. Lark will also perform spiking experiments on all samples and extraction efficiency tests. The reactions will be thermal cycled, recorded and analyzed using the ABI PRISM 7700 Sequence Detection System. All work will be $135,831 conducted under Good Laboratory Practices. - ---------------------------------------------------------------------------------------- -------------------- PROJECT MANAGEMENT Pharm-Olam will management all the studies to assure conducted to Good Laboratory Practices and compliant with the protocol, monitor studies at critical points, weekly sponsor updates, oversee development of all protocols and clinical reports and $19,500 maintain study timelines. (130 hours @ $150/hr) - ---------------------------------------------------------------------------------------- -------------------- TOTAL $272,163 - ---------------------------------------------------------------------------------------- -------------------- If the histo-pathology is needed for the medium and low dose (40 mice) in the 4 week study, the cost will be another $40,000. ATTACHMENT 3 TIMELINES FOR PRE-CLINICAL TOXICOLOGY STUDIES February 1 - initiate acute dose toxicity study March 1 - initiate main phase acute dose toxicity study March 1 - initiate pilot bio-distribution study April 1 - initiate 4 week multi-dose study May 1 - initiate 90 day bio-distribution study September 1- Final reports completed for all studies MILESTONE PAYMENT CHART - -------------------------------------------------------------------------------- Milestones Percent Cost - -------------------------------------------------------------------------------- Signing of agreement 10% $27,216.30 - -------------------------------------------------------------------------------- Initiation of pilot acute toxicity 10% $27,216.30 - -------------------------------------------------------------------------------- Initiation of pilot-distribution & 4 main phase studies 20% $54,432.60 - -------------------------------------------------------------------------------- Initiation of 4 week multi-dose study 20% $54,432.60 - -------------------------------------------------------------------------------- Initiation of 90 day bio-distribution study 20% $54,432.60 - -------------------------------------------------------------------------------- Final reports completed for all studies 20% $54,432.60 - -------------------------------------------------------------------------------- Total $272,163 - --------------------------------------------------------------------------------