UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
POST-EFFECTIVE
AMENDMENT NO. 1 TO FORM SB-2
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
___________
Advaxis,
Inc.
(Name
of small business issuer in our
charter)
|
Colorado
(State
or other jurisdiction
of
incorporation or organization)
|
2836
(Primary
Standard Industrial
Classification
Code Number)
|
841521955
(I.R.S.
Employer
Identification
No.)
|
||
212
Carnegie Center
Suite
206
Princeton,
NJ 08540
(609)
895-7150
(Address,
including zip code, and telephone number, including area
code, of
registrant’s principal place of business)
___________________________
Mr.
Roni Appel, Acting Chief Executive Officer
212
Carnegie Center
Suite
206
Princeton,
NJ 08540
(609)
895-7150
(Name,
address, including zip code, and telephone number, including
area code, of
registrant’s agent for service)
___________________________
Copies
to:
|
Gary
A. Schonwald, Esq.
Reitler
Brown & Rosenblatt LLC
800
Third Avenue
21st
Floor
New
York, New York 10022
(212)
209-3050 / (212) 371-5500 (Telecopy)
|
||
Approximate
date of commencement of proposed sale to the public.
From time to time after this Registration Statement becomes
effective.
If
any of the Securities being registered on this Form are to
be offered on a
delayed or continuous basis pursuant to Rule 415 under the
Securities Act
of 1933, as amended, check the following box: S
If
this Form is filed to register additional securities for an
offering
pursuant to Rule 462(b) under the Securities Act of 1933, please
check the
following box and list the Securities Act registration statement
number of
the earlier effective registration statement for the same offering:
o
If
this Form is a post-effective amendment filed pursuant to Rule
462(d)
under the Securities Act of 1933, check the following box and
list the
Securities Act of 1933 registration statement number of the
earlier
effective registration statement for the same offering: o
If
delivery of the prospectus is expected to be made pursuant
to Rule 434,
please check the following box: o
|
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)
|
37,099,457
|
$
|
1.00
|
$
|
4,366.61
|
$
|
4,366.61
|
||||||
common
stock par value $0.001 per share(4)
|
19,630,588
|
$
|
1.00
|
$
|
2,310.52
|
$
|
2,310.52
|
(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.
|
This
prospectus relates to the resale of up to 36,690,056 shares of
common
stock and 19,630,588 shares of common stock underlying warrants
of
Advaxis, Inc. by certain selling stockholders identified in this
prospectus. This prospectus also relates to the resale of 409,401
shares
of common stock (representing penalty shares issuable to certain
selling
stockholders). All of the shares, when sold will be sold by these
selling
stockholders. The selling stockholders may sell their common
stock from
time to time at prevailing market prices. We
will not receive any proceeds from the sales by the Selling Stockholders,
but we will receive funds from the exercise of warrants held
by selling
stockholders, if exercised and if payment is made by means other
than
cashless exercise.
Our
common stock is quoted on the Over The Counter Bulletin
Board, which
is commonly referred to as the “OTC Bulletin Board” maintained by various
broker dealers under the symbol ADXS.
No
underwriter or person has been engaged to facilitate the sale
of shares of
common stock in this offering. None of the proceeds from the
sale of
common stock by the selling stockholders will be placed in escrow,
trust
or any similar account. There are no underwriting commissions
involved in
this offering. We have agreed to pay all the costs of this offering.
Selling stockholders will pay no offering expenses.
This
offering is highly speculative and these securities involve a
high degree
of risk. You should purchase shares only if you can afford a
complete
loss. See “Risk Factors” beginning on page 8.
_________________________
|
Neither
the Securities and Exchange Commission nor any state securities
commission
has approved or disapproved of these securities or determined
if this
prospectus is truthful or complete. Any representation to the
contrary is
a criminal offense.
|
Item Description |
Page
No.
|
PROSPECTUS
SUMMARY
|
|
3
|
|
THE
OFFERING
|
|
9
|
|
RISK
FACTORS
|
|
10
|
|
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
|
24
|
|
USE
OF PROCEEDS
|
|
25
|
|
MARKET
FOR COMMON STOCK AND RELATED STOCKHOLDER MATTERS
|
|
25
|
|
DIVIDEND
POLICY
|
|
25
|
|
DILUTION
|
|
26
|
|
CAPITALIZATION
|
|
27
|
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF
|
|
||
OPERATIONS
AND PLAN OF OPERATIONS
|
|
30
|
|
BUSINESS
|
|
41
|
|
MANAGEMENT
|
|
61
|
|
PRINCIPAL
AND MANAGEMENT STOCKHOLDERS
|
|
72
|
|
CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
|
|
76
|
|
SELLING
STOCKHOLDERS
|
|
78
|
|
DESCRIPTION
OF CAPITAL STOCK OF THE COMPANY
|
|
92
|
|
SHARES
OF THE COMPANY ELIGIBLE FOR FUTURE SALE
|
|
94
|
|
PLAN
OF DISTRIBUTION
|
|
96
|
|
LEGAL
MATTERS
|
|
98
|
|
EXPERTS
|
|
98
|
|
ADDITIONAL
INFORMATION
|
|
98
|
|
FINANCIAL
STATEMENTS
|
|
F-1
|
|
INFORMATION
NOT REQUIRED IN PROSPECTUS
|
|
II-i
|
|
INDEMNIFICATION
OF DIRECTORS AND OFFICERS
|
|
II-i
|
|
OTHER
EXPENSES OF ISSUANCE AND DISTRIBUTION
|
|
II-i
|
|
RECENT
SALES OF UNREGISTERED SECURITIES
|
|
II-i
|
|
EXHIBITS
|
|
II-ii
|
|
UNDERTAKINGS
|
|
II-v
|
Product
|
Indication
|
Stage
|
||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in early
2006
|
||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in late 2006
|
||
Lovaxin
P
|
Prostate
cancer
|
Pre-clinical;
Phase I study anticipated to commence in late 2006
|
||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical;
|
||
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.
|
Year
ended December 31,
|
Ten
Months Ended
October
31,
|
12
Months
Ended
October
31,
|
||||||||||||||
Statement
of Operations Data:
|
||||||||||||||||
2003
|
2003
|
2004
|
2004
|
2005
|
||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Income
|
$
|
4,000
|
$
|
3,600
|
$
|
116,406
|
$
|
116,806
|
$
|
552,868
|
||||||
Total
operating expenses
|
$
|
897,076
|
821,725
|
650,310
|
$
|
715,754
|
2,395,328
|
|||||||||
Interest
expense (income)
|
17,190
|
7,288
|
4,229
|
13,132
|
(36,671
|
)
|
||||||||||
Other
income
|
521
|
106
|
57
|
72
|
--
|
|||||||||||
Provision
for income taxes
|
--
|
--
|
--
|
--
|
--
|
|||||||||||
Net
loss
|
$
|
(909,745
|
)
|
(825,907
|
)
|
(538,076
|
)
|
$
|
(655,892)
|
)
|
$
|
(1,805,789
|
)
|
|||
Loss
per Share Information:
|
||||||||||||||||
Basic
and diluted net loss per share
|
$
|
(0.06
|
)
|
$
|
(0.05
|
)
|
$
|
(0.04
|
)
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
Balance
Sheet Data:
|
December
31,
|
October
31,
|
October
31,
|
||||||||||
2003
|
2004
|
2005
|
|||||||||||
Cash
and cash equivalents
|
$
|
47,160
|
$
|
32,279
|
$
|
2,075,206
|
|||||||
Intangible
assets
|
$
|
277,243
|
$
|
469,803
|
$
|
751,088
|
|||||||
Total
assets
|
$
|
324,403
|
$
|
502,083
|
$
|
2,904,039
|
|||||||
Total
liabilities
|
$
|
1,131,138
|
$
|
1,841,579
|
$
|
1,152,465
|
|||||||
Stockholders’
equity (deficiency)
|
$
|
(806,735
|
)
|
$
|
(1,339,496
|
)
|
$
|
1,751,575
|
Common stock offered by selling stockholders | 56,730,045(1) |
Common stock outstanding | 37,768,932(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”
|
0.20
|
(1)
|
Represents
36,690,056 shares
of common stock that were issued to selling stockholders and
19,630,588 shares
of common stock underlying warrants that were issued to selling
stockholders and 409,401 shares of common stock issuable to
certain
selling stockholders as Penalty
Shares.
|
(2) | The number of shares of common stock outstanding as of December 31, 2005 listed above excludes |
·
|
4,842,534 shares
of common stock issuable upon exercise of
options;
|
·
|
20,509,220
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
|
$
|
443,000
|
||
Stockholders’
equity (deficit):
|
||||
Common
stock
|
37,686
|
|||
Additional
paid in capital
|
5,178,319
|
|||
Deferred
compensation
|
------
|
|||
Retained
earnings (deficit)
|
($3,464,430
|
)
|
||
Total
stockholders equity
|
$
|
1,751,575
|
||
Total
capitalization
|
$
|
2,194,575*
|
Year
ended December 31,
|
Ten
Months Ended
October 31, |
12
Months
Ended
October
31,
|
||||||||||||||
Statement
of Operations Data:
|
||||||||||||||||
2003
|
2003
|
2004
|
2004
|
2005
|
||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Income
|
$
|
4,000
|
$
|
3,600
|
$
|
116,406
|
$
|
116,806
|
$
|
552,868
|
||||||
Total
operating expenses
|
$
|
897,076
|
821,725
|
650,310
|
$
|
715,754
|
2,395,328
|
|||||||||
Interest
expense (income)
|
17,190
|
7,288
|
4,229
|
13,132
|
(36,671
|
)
|
||||||||||
Other
income
|
521
|
106
|
57
|
72
|
--
|
|||||||||||
Provision
for income taxes
|
--
|
--
|
--
|
--
|
--
|
|||||||||||
Net
loss
|
$
|
(909,745
|
)
|
(825,907
|
)
|
(538,076
|
)
|
$
|
(655,892)
|
)
|
$
|
(1,805,789
|
)
|
|||
Loss
per Share Information:
|
||||||||||||||||
Basic
and diluted net loss per share
|
$
|
(0.06
|
)
|
$
|
(0.05
|
)
|
$
|
(0.04
|
)
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
Balance
Sheet Data:
|
December
31,
|
October
31,
|
October
31,
|
|||||||
2003
|
2004
|
2005
|
||||||||
Cash
and cash equivalents
|
$
|
47,160
|
$
|
32,279
|
$
|
2,075,206
|
||||
Intangible
assets
|
$
|
277,243
|
$
|
469,803
|
$
|
751,088
|
||||
Total
assets
|
$
|
324,403
|
$
|
502,083
|
$
|
2,904,039
|
||||
Total
liabilities
|
$
|
1,131,138
|
$
|
1,841,579
|
$
|
1,152,465
|
||||
Stockholders’
equity (deficiency)
|
$
|
(806,735
|
)
|
$
|
(1,339,496
|
)
|
$
|
1,751,575
|
·
|
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
$1,000,000
|
·
|
Estimated
future costs: $700,000
|
·
|
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: $300,000
|
·
|
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: $100,000
|
·
|
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: $200,000
|
·
|
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.
|
Year
Ended October 31, 2005 Compared to the Year Ended October 31,
2004
|
·
|
an
increase in our related manufacturing expenses of $416,842 or 5,710%
from
$(7,300) to $409,542; such increase reflects the delay in the
manufacturing program during 2004 because of delays in funding,
and the
manufacturing of Lovaxin C in 2005 for toxicology and clinical
trials;
|
·
|
an
increase in expenses related to toxicology studies from $0 to $293,105;
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;
|
·
|
an
increase in wages and salaries related to our research and development
program from $0 to $166,346; such increase reflects the recruitment
of our
R&D management team in early
2005.
|
·
|
an
increase in subcontracted work of $141,366 or 100% from $0 to $141,366;
such increase reflects the subcontract work performed by Dr. Paterson
at
Penn, pursuant to certain grants.
|
·
|
employee
related expenses increased by $123,157, or 56.4%, from $218,482
for the
twelve months ended October 31, 2004 to $341,639 for the twelve
months
ended October 31, 2005 arising from a bonus to Mr. Derbin, the
Chief
Executive Officer, in stock, an increase in the salary of Mr. Derbin,
and
the cost of health insurance initiated in 2005;
|
·
|
Offering
expenses increased by $117,498, or 100%, from $0 for the twelve
months
ended October 31, 2004 to $117,498 for the twelve months ended
October 31,
2005 arising from legal and banking expenses relating to the private
placement closed in November 2004;
|
·
|
An
increase in professional fees from $231,686 for the twelve-months
ended
October 31, 2004 to $460,691 for the twelve months ended October
31, 2005,
primarily as a result of an increase in legal fees, public relations
fees,
consulting fees and accounting fees.
|
·
|
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;
and
|
·
|
Development
consulting expenses increased from $72,988 to $150,147 or 105.7%.
This
increase reflects primarily increased success fees due to DNA Bridges
in
connection with two NIH grants awarded to the Company in
2004
|
·
|
employee
related expenses increased by $34,790, or 22.5%, from $154,512
for the ten
months ended October 31, 2003 to $189,302 for the ten months ended
October
31, 2004 arising from a bonus to Mr. Derbin, the Chief Executive
Officer,
in stock;
|
·
|
professional
fees increased by $14,368 from $204,145 for the ten months ended
October
31, 2003 to $218,514 for the ten months ended October 31, 2004
principally
due to (a) an increase in consulting fees from $95,651 to $110,332,
and
(b) an increase in accounting fees from $350 to $23,070;
|
·
|
Insurance
expense was increased from $1,901 for the ten months ended October
31,
2003 to $9,929 for the ten months ended October 31, 2004;
and
|
·
|
Other
General and Administrative expenses increased by $66,701 from $14,844
to
$81,545 principally due to an increase in amortization expenses,
information technology and internet expenses, postage, telephone
and
travel expenses..
|
Product
|
Indication
|
Stage
|
||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in early
2006
|
||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in late 2006
|
||
Lovaxin
P
|
Prostate
cancer
|
Pre-clinical;
Phase I study anticipated to commence in late 2006
|
||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical;
|
||
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 head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in early
2006
|
||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in late 2006
|
||
Lovaxin
P
|
Prostate
cancer
|
Pre-clinical;
Phase I study anticipated to commence in late 2006
|
||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical;
|
||
Lovaxin
T
|
Cancer
through control of telomerase
|
Pre-clincial
|
||
Lovaxin
H
|
Prophylactic
vaccine for HIV (AIDS)
|
Pre-clincial
|
United
States
|
|
Patents
|
|
U.S.
Patent No. 6,051,237, issued April 18, 2000. Patent Application
No.
08/336,372, filed November 8, 1994 for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector.” Filed November 8,
1994. Expires April 18, 2017.
|
|
U.S.
Patent No. 6,565,852, issued May 20, 2003, Paterson, et al.,
CIP Patent
Application No. 09/535,212, filed March 27, 2000 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector.” Filed March 27, 2000. Expires May 20, 2020.
|
|
U.S.
Patent No. 6,099,848, issued August 8, 2000. Frankel et al.,
Patent
Application No. 08/972,902 “Immunogenic Compositions Comprising DAL/DAT
Double-Mutant, Auxotrophic, Attentuated Strains of Listeria and
Their
Methods of Use.” Filed November 18, 1997. Expires November 18,
2017.
|
U.S.
Patent No. 6,504,020, issued January 7, 2003 of Divisional Application
No.
09/520,207 “Isolated Nucleic Acids Comprising Listeria DAL And DAT Genes”.
Filed March 7, 2000., Frankel et al. Expires March 7,
2020.
|
|
U.S.
Patent No. 6,635,749, issued October 21, 2003; Divisional U.S.
Patent
Application No. 10/136,253 for “Isolated Nucleic Acids Comprising Listeria
DAL and DAT Genes.” Filed May 1, 2002, Frankel, et al. Filed May 1, 2022.
Expires Novemer 18, 2017.
|
|
U.S.
Patent No. 5,830,702, issued November 3, 1998. Patent Application
No.
08/366,477, filed December 30, 1994 for “Live, Recombinant Listeria SSP
Vaccines and Productions of Cytotoxic T Cell Response” Portnoy, et al.
Filed December 30, 1997. Expires November 3, 2015.
|
|
US
Patent No. 6,767,542 issued July 27, 2004, Paterson, et al. Patent
Application No. 09/735,450 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed December 13, 2000. Expires March 29,
2020.
|
|
Patent
Applications
|
|
U.S.
Patent Application No. 10/441,851, “Methods And Compositions For
Immunotherapy of Cancer,” Filed May 20, 2003, Paterson et
al.
|
|
U.S.
Patent Application No. 10/239,703 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed September 24, 2002, Paterson,
et al.
|
|
Patent
Application No. 09/537,642 for “Fusion of Non-Hemolytic, Truncated Form of
Listeriolysis o to Antigens to Enhance Immunogenicity.” Filed March 29,
2000. Paterson, et al.
|
|
U.S.
Patent Application No. 10/660,194, “Immunogenic Compositions Comprising
DAL/DAT Double Mutant, Auxotrophic Attenuated Strains Of Listeria
And
Their Methods Of Use,” Filed September 11, 2003, Frankel et
al.
|
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. Expires
November 13, 2018.
|
|
Patent
Applications
|
|
Canadian
Patent Application No. 2,204,666, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson et al.
|
|
Canadian
Patent Application No. 2,309,790 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al.
|
|
Canadian
Patent Application No. 2,404,164 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al.
|
|
European
Patent Application No. 95939926.2, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson, et al.
|
European
Patent Application No. 01928324.1 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al.
|
|
European
Patent Application No. 98957980.0 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al.
|
|
Israel
Patent Application No. 151942 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al.
|
|
Japanese
Patent Application No. 515534/96, filed November 3, 1995 for
“Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector”, Paterson, et al.
|
|
Japanese
Patent Application No. 2001-570290 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al.
|
·
|
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) (4)
|
53
|
Chairman
of the Board of Directors
|
||
Dr.
James Patton(1)
|
48
|
Director
|
||
Roni
A. Appel(3) (4)
|
39
|
President,
Chief Executive Officer, Chief Financial Officer, Secretary and
Director
|
||
Dr.
Thomas McKearn(2)
|
56
|
Director
|
||
Richard
Berman (4)
|
63
|
Director
|
||
Scott
Flamm(1) (2) (4)
|
50
|
Director
|
reviewing
the
auditors’ fees; and
|
·
|
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
|
2005
2004
2003
|
(1)
|
$
$
$
|
225,000
125,000
150,000
|
$
$
|
45,000
60,000
|
(4)
|
684,473
--
1,172,727
|
(6)
(6)
|
||||
Dr.
James Patton
Chairman
of the Board of Directors
|
2005
2004
2003
|
(1)
|
--
$15,000
$15,750
|
(2)
(2)
|
--
--
--
|
28,175
33,810
|
|||||||
Roni
Appel
Secretary,
Chief Financial Officer, and Director
|
2005
2004
2003
|
(1)
|
$
$
$
|
139,250
50,000
60,000
|
(5)
(3)
(3)
|
$
|
35,000
|
1,114,344
35,218
42,262
|
(5)
|
(1) |
Information
for 2004 reflects the ten month period ended October 31,
2004.
|
(2) |
Dr.
Patton was paid consulting fees by the Company of $18,000
in 2003 and
$15,750 in 2004. Dr. Patton’s compensation related to his consulting
agreement which was terminated on November
2004.
|
(3) |
Mr.
Appel was paid consulting fees of $60,000 in 2003 and consulting
fees of
$50,000 in the 10 months ended October 31, 2004 through his
beneficial
ownership of Carmel Ventures, Inc. $35,000 of such fees were
assigned to
Mr. Scott Flamm.
|
(4) |
Mr.
Derbin’s stock option award was based in his employment contract.
His 2003
bonus of $60,000 was paid in 2004 in Common Stock of the Company
on the
basis of a price of $0.1952 per share and
was two-third’s of his maximum bonus of $90,000. The basis for this bonus
was the successful conclusion of several matters of great importance
to
the Company including:
|
- |
extending
the patent portfolio and moving it to the care of competent
patent
counsel;
|
- |
extending
the patent portfolio and moving it to the care of competent
patent
counsel;
|
- |
extending
the patent portfolio and moving it to the care of competent
patent
counsel;
|
- |
creating
grant opportunities for the
company;
|
- |
scaling
up manufacturing; and
|
- |
creating
certain collaboration
opportunities.
|
(5) |
Mr.
Appel’s compensation in year 2005 was paid through a consulting
agreement
between the company and LVEP Management, LLC.
See__________
|
(6) |
Pursuant
to a termination of employment agreement, only 928,441 options
of the
20043 grant vested, and only 427,796 options of the 2005 grant
vested. The
balance of the options were surrenderd to the
company.
|
Individual
Grants
|
Potential
Realizable Value At Assumed Annual Rates of Stock Price Appreciation
For
Option
Term($)
|
|||||||||||||||||||||
Name
|
Year
|
Number
Of Securities Underlying Options
Granted
|
Percent
Of Total Options Granted To Employees In
Fiscal Year)
|
Exercise
Price
|
Expiration
Date
|
5%
|
10%
|
|||||||||||||||
J.
Todd Derbin(1)
|
2005
|
684,473
|
100
|
%
|
$
|
0.29
|
12/15/2014
|
$
|
26,543.13
|
$
|
142,486.07
|
|||||||||||
Director
|
2004
|
--
|
0
|
%
|
--
|
--
|
-
|
-
|
||||||||||||||
|
2003
|
--
|
0
|
%
|
--
|
--
|
-
|
-
|
||||||||||||||
Dr.
James Patton
|
2005
|
5,635
|
8
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
218.52
|
$
|
1,173.03
|
|||||||||||
Chairman
of the Board of Directors
|
2004
|
28,175
|
42
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
1,092.60
|
$
|
5,865.16
|
|||||||||||
|
2003
|
33,810
|
50
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
1,311.12
|
$
|
7,038.19
|
|||||||||||
Roni
Appel
|
2005
|
1,114,344
|
93
|
%
|
$
|
0.29
|
3/31/2015
|
$
|
43,213.06
|
$
|
231,971.89
|
|||||||||||
Chief
Financial Officer, Secretary, and Director
|
2004
|
35,218
|
3
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
1,365.72
|
$
|
7,331.30
|
|||||||||||
|
2003
|
42,262
|
4
|
%
|
$
|
0.35
|
11/1/2012
|
$
|
1,638.87
|
$
|
8,797.64
|
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
|
2005
|
0
|
$
|
-
|
1,273,135
|
584,106
|
$
|
47,033
|
$
|
17,469
|
||||||||||||
President,
Chief Executive Officer, and Director
|
2004
|
0
|
$
|
-
|
586,382
|
586,382
|
$
|
53,947
|
$
|
51,015
|
||||||||||||
|
2003
|
0
|
$
|
-
|
293,191
|
879,575
|
$
|
26,974
|
$
|
80,921
|
||||||||||||
Dr.
James Patton
|
2005
|
0
|
$
|
-
|
73,253
|
-
|
$
|
-
|
$
|
-
|
||||||||||||
Chairman
of the Board of Directors
|
2004
|
0
|
$
|
-
|
29,583
|
-
|
$
|
-
|
$
|
-
|
||||||||||||
|
2003
|
0
|
$
|
-
|
33,810
|
-
|
$
|
-
|
$
|
-
|
||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||
Roni
Appel
|
2005
|
0
|
$
|
-
|
254,075
|
951,835
|
$
|
-
|
$
|
-
|
||||||||||||
Secretary,
Chief Financial Officer, and Director
|
2004
|
0
|
$
|
-
|
91,567
|
-
|
$
|
-
|
$
|
-
|
||||||||||||
|
2003
|
0
|
$
|
-
|
49,305
|
-
|
$
|
-
|
$
|
-
|
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.
|
The
price for end of fiscal year 2005 is based on a price per share
of $0.25.
The price for previous years is based on the
fair
market value
of
our
common stock at
fiscal year end of $0.25
per
share, determined by the board to be equal to our Private Placement
price
per share less
the exercise price payable for such shares.
|
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)
|
2,204,390
|
(3)
|
5.59
|
%
|
|||
Roni
Appel(1)(2)
|
4,016,467
|
(4)
|
10.31
|
%
|
|||
Scott
Flamm(1)
|
2,914,989
|
(5)
|
7.72
|
%
|
|||
Richard
Berman(1)
|
400,000
|
(6)
|
1.05
|
%
|
|||
Dr.
James Patton(1)
|
2,913,476
|
(7)
|
7.71
|
%
|
|||
Dr.
Thomas McKearn(1)
|
306,601
|
(8)
|
0.80
|
%
|
|||
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
|
--
|
(15)
|
--
|
||||
All
Directors and Officers as a Group (6 people)
|
13,215,699
|
35.07
|
%
|
(1)
|
Director
|
(2)
|
Officer
or former officer
|
(3)
|
Reflects
469,338 shares of Common Stock, 1,356,236 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 2,382,666
shares of
Common Stock owned by Mr. Appel and 1,114,344 options to
purchase share of
Common Stock but does not reflect 58,580 warrants to purchase
shares of
Common Stock because such warrants are not under the current
circumstances, exercisable within the next 60 days. Also
reflects 355,528
shares of common stock and 149,480 options and warrants to
purchase shares
of Common Stock beneficially owned by Carmel Ventures, Inc.
of which Mr.
Appel is a controlling person but does not reflect 355,528
warrants to
purchase shares of common stock owned by Carmel Ventures,
Inc. because
such warrants are not under the current circumstances, exercisable
within
the next 60 days.
|
(5)
|
Reflects
125,772 shares of Common Stock and 122,751 options and warrants
to
purchase shares of Common Stock owned by Mr. Flamm but does
not reflect
125,722 warrants to purchase shares of Common Stock because
such warrants
are not under the current circumstances, exercisable within
the next 60
days. Also reflects 2,621,325 shares of Common Stock and
45,141 warrants
to purchase shares of Common Stock beneficially owned by
Flamm Family
Partners LP of which Mr. Flamm is a partner.
|
(6)
|
Reflects
options to purchase shares of Common Stock.
|
(7)
|
Reflects
56,349 options to purchase shares of Common Stock, 36,551
warrants to
purchase shares of Common Stock and 2,820,576 shares of Common
stock but
does not reflect 147,716 warrants to purchase shares of Common
Stock
because such warrants are not under the current circumstances,
exercisable
within the next 60 days.
|
(8)
|
Reflects
195,586 options and warrants to purchase shares of Common
Stock and
111,015 shares of Common
Stock.
|
(9)
|
Reflects
1,742,160 shares of common stock held by Sunrise Equity
Partners, LP
("SEP") and warrants to purchase 93,331 shares of common
stock, but does
not include warrants to purchase 1,648,829 shares of common
stock issuable
upon exercise of warrants held by SEP because such warrants
are not, under
the current circumstances, exercisable within the next
60 days. The
General Partner of SEP is Level Counter, LLC ("LC"), the
managers of which
are Nathan Low, Marilyn Adler and Amnon Mandelbaum
(the
"Managers"). Decisions regarding voting
and disposition require
the unanimous vote of all three managers. The
1,835,491 shares
of common stock benefically held by SEP also does not
include: (1) 1,124,253 shares of common
stock directly owned by
Nathan Low or warrants directly owned by Mr. Low to purchase
up to 761,971
shares of common stock; (2) 1,094,020 shares of directly
owned by Amnon
Mandelbaum or warrants directly owned by Mr. Mandelbaum
to purchase up to
672,539 shares of common stock, and (3) shares of common
stock held
by limited partners of SEP or LC who may have a
direct or indirect
pecuniary interest, but have no authority to vote or dispose
of the shares
of common stock held by SEP. Does not reflect the 34,843
shares of common
stock issuable as Penalty Shares.
|
(10)
|
Reflects
1,742,160 shares of common stock held by SEP and warrants
to purchase
93,331 shares of common stock, but does not include warrants
to purchase
1,648,829 shares of common stock issuable upon exercise
of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. LC is the general
partner of SEP and
as such, is deemed to have beneficial ownership of the
securities held by
SEP for purposes of calculating percentage interest. Does
not reflect the
34,843 shares of common stock issuable to SEP as Penalty
Shares.
However, LC disclaims beneficial interest in such shares
except to the
extent of its pecuniary interest therein.
|
(11)
|
Reflects
1,742,160 shares of common stock held by SEP and warrants
to purchase
93,331 shares of common stock, but does not include warrants
to purchase
1,648,829 shares of common stock issuable upon exercise
of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the
34,843 shares of
common stock issuable to SEP as Penalty Shares. Ms.
Adler is a manager of LC, the general partner of SEP, and
as such, is
deemed to have beneficial ownership of the securities held
by SEP for
purposes of calculating percentage interest. However, Ms.
Adler disclaims
beneficial interest in such shares except to the extent
of her pecuniary
interest therein.
|
(12)
|
Reflects
1,742,160 shares of common stock held by SEP and warrants
to purchase
93,331 shares of common stock, but does not include warrants
to purchase
1,648,829 shares of common stock issuable upon exercise
of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the
34,843 shares of
common stock issuable to SEP as Penalty Shares. Mr.
Low is a manager of LC, the general partner of SEP, and
as such, is deemed
to have beneficial ownership of the securities held by
SEP for purposes of
calculating percentage interest. However, Mr. Low disclaims
beneficial
interest in such shares except to the extent of his pecuniary
interest
therein. Also reflects 1,124,253 shares of common stock
owned by Mr. Low
but does not reflect warrants to purchase 761,971 shares
of common stock
issuable upon exercise of such warrants because such warrants
are not,
under the circumstances, exercisable within the next 60
days nor does it
reflect 37,725 shares of common stock issuable to Mr. Low
as Penalty
Shares. Also includes 383,275 shares of common stock held
by Sunrise
Securities Corp., a corporation of which Mr. Low is sole
stockholder and
director, but does not include warrants to purchase 348,432
shares of
common stock held by Sunrise Securities Corp. because such
warrants are
not, under the circumstances, exercisable within the next
60 days nor does
it reflect 14,634 shares of common stock issuable to Sunrise
Securities
Corp. as Penalty Shares. Mr. Low’s beneficial ownership does not include
shares of common stock held by Sunrise Foundation Trust,
a charitable
trust of which Mr. Low is a trustee. Mr. Low disclaims
beneficial
ownership of such shares of common stock held by Sunrise
Foundation
Trust.
|
(13)
|
Reflects
1,742,160 shares of common stock held by SEP and warrants
to purchase
93,331 shares of common stock, but does not include warrants
to purchase
1,648,829 shares of common stock issuable upon exercise
of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Does not reflect the
34,843 shares of
common stock issuable to SEP as Penalty Shares. Mr.
Mandelbaum is a manager of LC, the general partner of SEP,
and as such, is
deemed to have beneficial ownership of the securities held
by SEP for
purposes of calculating percentage interest. However, Mr.
Mandelbaum
disclaims beneficial interest in such shares except to
the extent of his
pecuniary interest therein. Also reflects 1,094,020 shares
of common stock
owned by Mr. Mandelbaum but does not reflect warrants to
purchase 672,539
shares of common stock issuable upon exercise of such warrants
because
such warrants are not, under the circumstances, exercisable
within the
next 60 days nor does it reflect 35,332 shares of common
stock issuable to
Mr. Mandelbaum as Penalty Shares.
|
(14)
|
Reflects
1,742,160 shares of common stock held by Emigrant Capital
Corp.
(“Emigrant”) and warrants to purchase 16,623 shares of common stock,
but
does not include warrants to purchase 1,645,537 shares
of common stock
issuable upon exercise of warrants held by Emigrant because
such warrants
are not, under the current circumstances, exercisable within
the next 60
days nor does it reflect 34,843 shares of common stock
issuable to
Emigrant as Penalty Shares. Mr. Howard Milstein is the
Chairman and CEO
and Mr. John Hart is the President of Emigrant.
|
(15)
|
Does
not reflect warrants to purchase 3,832,753 shares of common
stock because
such warrants are not currently exercisable within the
next 60 days. Mr.
Robert Harvey is the manager of Harvest Advaxis LLC.
|
·
|
37,099,460
shares of our common stock that were issued to selling stockholders
pursuant to transactions exempt from registration under the Securities
Act
of 1933; and
|
·
|
19,630,588
shares of common stock underlying warrants that were issued to
selling
stockholders pursuant to transactions exempt from registration
under the
Securities Act of 1933.
|
· |
J.
Todd Derbin has served as our Chief Executive Officer and a director
since
November 12, 2004; He will serve as a consultant and our Charirman
of the
board of directors as of January 1,
2006
|
· |
Roni
Appel has served as our Chief Financial Officer and a director
since
November 12, 2004; He will serve as our President and Chief Executive
Officer as of January 1, 2006; 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.
|
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
Adele
Pfenninger
12
Spring Brook Road
Annandale,
NJ 08801
|
79,600
(1
|
)
|
70,790
(1
|
)
|
--
|
0.22
|
%
|
0.02
|
%
|
--
|
|||||||||
AI
International Corporate (a) Holdings, Ltd.
c/o
FCIM Corp.
1
Rockefeller Plaza
Suite
1730
New
York, NY 10020
|
174,216
(2
|
)
|
174,216
(2
|
)
|
1,742
|
0.
47
|
%
|
0.0
|
%
|
--
|
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
Alan
Gelband Company (b)
Defined
Contribution Pension Plan and Trust
30
Lincoln Plaza
New
York, NY 10023
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
Alan
Kestenbaum
18
Clover Drive
Great
Neck, NY 11021
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
Beretz
Family Partners LP (c)
48
South Drive
Great
Neck, NY 11021
|
174,216
(2
|
)
|
174,216
(2
|
)
|
1,742
|
0.47
|
%
|
0.0
|
%
|
--
|
|||||||||
Bridges
& Pipes, LLC (d)
830
Third Avenue
14th
Floor
New
York, NY 10022
|
1,393,728
(4
|
)
|
1,393,728
(4
|
)
|
13,937
|
3.73
|
%
|
0.0
|
%
|
--
|
|||||||||
Bruce
Fogel
218
Everglade Avenue
Palm
Beach, FL 33480
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
C.
Leonard Gordon
551
Fifth Avenue
New
York, NY 10176
|
174,216
(2
|
)
|
174,216
(2
|
)
|
1,742
|
0.47
|
%
|
0.0
|
%
|
--
|
|||||||||
Carmel
Ventures, Inc (e)
22
Ruth Lane
Demarest,
NJ 07627
|
860,537
(5
|
)
|
711,057
(5)(a
|
)
|
--
|
2.32
|
%
|
0.41
|
%
|
5(b
|
)
|
||||||||
Catherine
Janus
4817
Creak Dr.
Western
Spring, IL 60558
|
118,832
(6
|
)
|
105,767
(6
|
)
|
--
|
0.32
|
%
|
0.04
|
%
|
--
|
|||||||||
Chaim
Cymerman
c/o
Tomer Cymerman
Paamoni
10, Apt. 19
Bavli,
Tel Aviv
Israel
|
196,371
(7
|
)
|
174,593
(7)(a
|
)
|
--
|
0.53
|
%
|
0.06
|
%
|
--
|
|||||||||
Charles
Kwon
834
Monror Street
Evanston,
Il 60202
|
491,233
(8
|
)
|
482,322
(8)(a
|
)
|
3,484
|
1.33
|
%
|
0.02
|
%
|
-- |
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
Cranshire
Capital, LP (f)
666
Dundee Road
Sute
1901
Northbrook,
IL 60602
|
1,045,296
(9
|
)
|
1,045,296
(9
|
)
|
10,453
|
2.81
|
%
|
0.0
|
%
|
--
|
|||||||||
Crestwood
Holdings, LLC (g)
c/o
Ran Nizan
109
Boulevard Drive
Danbury,
CT 06810
|
360,253
(10
|
)
|
337,978
(10)(a
|
)
|
--
|
0.98
|
%
|
0.06
|
%
|
--
|
|||||||||
David
Stone
228
St. Charles Avenue
Suite
1024
New
Orleans, LA 70130
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
David
Tendler
401
East 60th
Street
New
York, NY 10022
|
696,864
(11
|
)
|
696,864
(11
|
)
|
6,969
|
1.88
|
%
|
0.0
|
%
|
--
|
|||||||||
Design
Investments, LTD (h)
9
Tanbark Circuit
Suite
1442
Werrington
Downs
NSW
2747
Australia
|
696,864
(11
|
)
|
696,864
(11
|
)
|
6,969
|
1.88
|
%
|
0.0
|
%
|
--
|
|||||||||
Emigrant
Capital Corp. (i)
6
East 43rd
Street
8th
Floor
New
York, NY 10017
|
3,484,320(12
|
)
|
3,484,320
(12
|
)
|
34,843
|
9.07
|
%
|
0.0
|
%
|
--
|
|||||||||
Eugene
Mancino
Blau
Mancino
12
Roszel Road, Suite C-101
Princeton,
NJ 08540
|
355,099
(13
|
)
|
212,544
(13)(a
|
)
|
--
|
0.96
|
%
|
0.39
|
%
|
--
|
|||||||||
Fawdon
Investments Ltd. (j)
4
Ibn Shaprut Street
Jerusalem,
Israel 92478
|
1,393,728
(4
|
)
|
1,393,728
(4
|
)
|
13,937
|
3.73
|
%
|
0.0
|
%
|
--
|
|||||||||
Flamm
Family Partners, LP. (k)
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078
|
2,666,466
(14
|
)
|
2,657,556
(14)(a
|
)
|
--
|
7.26
|
%
|
0.02
|
%
|
(14)(b
|
)
|
||||||||
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
Fred
Berdon Co, LP (l)
717
Post Road
Suite
105
Sacrsdale,
NY 10583
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
Gina
Ferarri
36
Stone Run Road
Bedmingter,
NJ 07921
|
79,932
(15
|
)
|
71,022
(15)(a
|
)
|
--
|
0.22
|
%
|
0.2
|
%
|
--
|
|||||||||
Hal
H. Beretz
48
South Drive
Great
Neck, NY 11021
|
522,648
(16
|
)
|
522,648
(16
|
)
|
5,226
|
1.41
|
%
|
0.0
|
%
|
--
|
|||||||||
Howard
Kaye Family Fund (m)
2
Mohican Trail
Scarsdale,
NY 10583
|
522,648
(16
|
)
|
522,648
(16
|
)
|
5,226
|
1.41
|
%
|
0.0
|
%
|
--
|
|||||||||
IRA
FBO / Walter S. Grossman Pershing LLC Custodian
(n)
277
North Ave.
Westport,
CT 06880
|
696,864
(11
|
)
|
696,864
(11
|
)
|
6,969
|
1.88
|
%
|
0.0
|
%
|
--
|
|||||||||
Itai
Portnoi
26
Yakinton St.
Haifa,
Isreal 34406
|
157,608
(17
|
)
|
140,186
(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
|
%
|
--
|
|||||||||
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
Lilian
Flamm
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078
|
197,328
(23
|
)
|
197,328
(23
|
)
|
--
|
0.54
|
%
|
0.0
|
%
|
--
|
|||||||||
Marilyn
Mendell
1203
River Road,
Apt.
Penthouse 4
Edgewater,
NJ 07020
|
284,500
(24
|
)
|
253,316
(24)(a
|
)
|
--
|
0.77
|
%
|
0.08
|
%
|
--
|
|||||||||
Mary
Ann Ryan Francis
1115
Beanaqt Ave.
Seaside
Park, NJ 08752
|
79,071
(25
|
)
|
70,360
(25)(a
|
)
|
--
|
0.22
|
%
|
0.02
|
%
|
--
|
|||||||||
MEA
Group, LLC (o)
145
Talmadge Road
Edison,
NJ 08817
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
Mordechai
Mashiach
8
Shlomzion Hamalka
Haifa,
Isreal 34406
|
157,608
(17
|
)
|
140,186
(17)(a
|
)
|
--
|
0.43
|
%
|
0.05
|
%
|
--
|
|||||||||
New
Bank Ltd (p)
Levinstein
Tower #21st
23
Menahem Begin Road
Tel
Aviv, Israel
|
1,393,728
(4
|
)
|
1,393,728
(4
|
)
|
13,937
|
3.73
|
%
|
0.0
|
%
|
--
|
|||||||||
Open
Ventures LLC (q)
127
West Chestnut Hill Ave.
Philadelphia,
PA 19118
|
17,422
|
17,422
|
--
|
0.05
|
%
|
0.0
|
%
|
--
|
|||||||||||
Peggy
Fern
1548
Herlong Court
Rock
Hill, SC 29732
|
79,712
(26
|
)
|
70,081
(26)(a
|
)
|
--
|
0.22
|
%
|
0.02
|
%
|
--
|
|||||||||
Penn
Footware Retirement Trust (r)
Line
& Grove Streets
PO
Box 87
Nanticoke,
PA 18634
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
Richard
Yelovich
603
Milleson Lane
West
Chester, PA 19380
|
151,289
|
151,289
|
--
|
0.41
|
%
|
0.0
|
%
|
--
|
|||||||||||
Roni
Appel
22
Ruth Lane
Demarest,
NJ 07627
|
2,595,193(27
|
)
|
2,580,745
(27)(a
|
)
|
--
|
7.06
|
%
|
0.04
|
%
|
(27)(b
|
)
|
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
RP
Capital, LLC (s)
10900
Wilshire Blvd.
Suite
500
Los
Angeles, CA 90024
|
174,216
(2
|
)
|
174,216
(2
|
)
|
1,742
|
0.47
|
%
|
0.0
|
%
|
--
|
|||||||||
Scott
Flamm
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078
|
374,296
(28
|
)
|
251,545
(28)(a
|
)
|
--
|
1.01
|
%
|
0.33
|
%
|
(28)(b
|
)
|
||||||||
Shai
Stern
43
Maple Aenue
Cedarhurst,
NY 11516
|
174,216
(2
|
)
|
174,216
(2
|
)
|
1,742
|
0.47
|
%
|
0.0
|
%
|
--
|
|||||||||
SRG
Capital, LLC (t)
120
Broadway
40th
Floor
New
York, NY 10271
|
696,864
(11
|
)
|
696,864
(11
|
)
|
6,969
|
1.88
|
%
|
0.0
|
%
|
--
|
|||||||||
Sunrise
Equity Partners, LP (u)
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
3,484,320(12
|
)
|
3,484,320
(12
|
)
|
34,843
|
9.07
|
%
|
0.0
|
%
|
--
|
|||||||||
Thomas
McKearn
6040
Lower Mountain Road
New
Hope, PA 18938
|
374,876
(29
|
)
|
269,839
(29)(a
|
)
|
--
|
1.02
|
%
|
0.29
|
%
|
(29)(b
|
)
|
||||||||
Titan
Capital Management, LLC
(TCMP3
Partners) (v)
7
Centure Drive
Suite
201
Parsippany,
NJ 07054
|
696,864
(11
|
)
|
696,864
(11
|
)
|
6,969
|
1.88
|
%
|
0.0
|
%
|
--
|
|||||||||
Tracy
Yun
90
LaSalle St., Apt. #13G
New
York, NY 10027
|
60,197
|
60,197
|
--
|
0.16
|
%
|
0.0
|
%
|
--
|
|||||||||||
Trinita,
LLC (w)
c/o
Morten Kielland
22
Painters Lane
Chesterbrook,
PA 19087
|
151,289
|
151,289
|
--
|
0.41
|
%
|
0.0
|
%
|
--
|
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
The
Trustees of the
University
of Pennsylvania
Center
for Technology Transfer
University
of Pennsylvania
3160
Chestnut Street
Suite
200
Philadelphia,
PA 19104-6283
Attn:
Managing Director
|
6,339,282
|
6,339,282
|
--
|
17.28
|
%
|
0.0
|
%
|
(41
|
)
|
||||||||||
William
Kahn
7903
Longmeadow Road
Baltimore,
MD 21208
|
151,517
|
151,517
|
--
|
0.41
|
%
|
0.0
|
%
|
--
|
|||||||||||
Yair
Talmor
517
Old Chappaqua Road
Briarcliff
Manor, NY 10510
|
174,216
(2
|
)
|
174,216
(2
|
)
|
1,742
|
0.47
|
%
|
0.0
|
%
|
--
|
|||||||||
Yoav
Millet
950
Third Avenue
New
York, NY 10022
|
174,216
(2
|
)
|
174,216
(2
|
)
|
1,742
|
0.47
|
%
|
0.0
|
%
|
--
|
|||||||||
Yvonne
Paterson
514
South 46 St.
Philadelphia,
PA 19143
|
873,412(30
|
)
|
704,365
|
--
|
2.37
|
%
|
0.46
|
%
|
|||||||||||
Amnon
Mandelbaum
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
1,766,559
(31
|
)
|
1,766,559
(31
|
)
|
35,332
|
4.73
|
%
|
0.0
|
%
|
--
|
|||||||||
David
Goodriend
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
194,193
(32
|
)
|
194,193
(32
|
)
|
3,884
|
0.53
|
%
|
0.0
|
%
|
--
|
|||||||||
David
Filer
165
East 32 Street
New
York, NY 10016
|
382,772
(33
|
)
|
382,772
(33
|
)
|
5,704
|
1.04
|
%
|
0.0
|
%
|
(32)(a
|
)
|
||||||||
Marcia
Kucher
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
4,140
(34
|
)
|
4,140
(34
|
)
|
83
|
0.01
|
%
|
0.0
|
%
|
--
|
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
Nathan
Low
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
1,886,224
(35
|
)
|
1,886,224
(35
|
)
|
37,725
|
5.04
|
%
|
0.0
|
%
|
--
|
|||||||||
Derek
Caldwell
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
153,658
(36
|
)
|
153,658
(36
|
)
|
3,074
|
0.42
|
%
|
0.0
|
%
|
--
|
|||||||||
Sunrise
Securities Corp. (x)
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
731,707(37
|
)
|
731,707
(37
|
)
|
14,634
|
1.98
|
%
|
0.0
|
%
|
(37)(a
|
)
|
||||||||
Richard
Stone
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
307,317(38
|
)
|
307,317(38
|
)
|
6,146
|
0.83
|
%
|
0.0
|
%
|
--
|
|||||||||
Sunrise
Foundation Trust (y)
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022
|
71,497(38)(a
|
)
|
71,497
|
1,430
|
0.19
|
%
|
0.0
|
%
|
--
|
||||||||||
Martin
Trust Agreement
U/A/
DTD 11/05/01
Peter
L. Martin TTE
3757
Wedbster St, Apt 203
San
Francisco, CA 94123
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
A.
Heifetz Technologies Ltd. (z)
22
Kanfey Nesharim St
Jerusalem,
Israel 95464
|
348,432
(3
|
)
|
348,432
(3
|
)
|
3,484
|
0.95
|
%
|
0.0
|
%
|
--
|
|||||||||
Balestra
Spectrum Partners, LLC (aa)
1185
Avenue of the Americas
32nd
Floor
New
York, NY 10036
|
1,045,296
(9
|
)
|
1,045,296
(9
|
)
|
10,453
|
2.81
|
%
|
0.0
|
%
|
--
|
Total
Shares
Owned
|
Shares
Registered
|
Penalty
Shares
|
%
Before Offering
(not
including Penalty Shares)
|
%
After Offering
(not
including Penalty Shares)
|
Relationship
(if any)
|
Reitler
Brown Holdings, LLC (bb)
800
Third Avenue
21st
Floor
New
York, NY 10022
|
60,000
(39
|
)
|
60,000
(39
|
)
|
--
|
0.16
|
%
|
0.0
|
%
|
(39)(a
|
)
|
||||||||
Harvest
Advaxis LLC (cc)
30052
Aventura, Suite C
Rancho
Santa Margarita,
CA
92688
|
7,665,506
(40
|
)
|
7,665,506
(40
|
)
|
76,655
|
18.92
|
%
|
0.0
|
%
|
--
|
|||||||||
Miles
Wynn
P.O.
Box 440842
Aurora
, CO 80044
|
696,700
|
696,700
|
--
|
1.90
|
%
|
0.0
|
%
|
--
|
|||||||||||
Teresa
Waz
3679
S. Dawson St.
Aurora,
CO 80444
|
26,900
|
26,900
|
--
|
0.07
|
%
|
0.0
|
%
|
--
|
|||||||||||
Ormonde
Frew
19996
E. Greenwood Drive
Aurora
, CO 80013
|
12,000
|
12,000
|
--
|
0.03
|
%
|
0.0
|
%
|
--
|
|||||||||||
Ralph
Grills
4042
S. Atchison Way
Aurora,
CO 80014
|
12,000
|
12,000
|
--
|
0.03
|
%
|
0.0
|
%
|
--
|
|||||||||||
Daniel
Unrein
281
S. Leyden St.
Denver,
CO 80220
|
2,500
|
2,500
|
--
|
0.01
|
%
|
0.0
|
%
|
--
|
|||||||||||
Frederick
Malkhe
4105
E. Florida Ave.
Suite
100
Denver,
CO 80222
|
2,500
|
2,500
|
--
|
0.01
|
%
|
0.0
|
%
|
--
|
(a) |
Rima
Salam has voting and disposition rights on behalf of AI International
Corporate Holdings, Ltd.
|
(b) |
Alan
Gelband has voting and disposition rights on behalf of Alan
Gelband
Company Defined Contribution Pension Plan and
Trust.
|
(c) |
Hal
Beretz has voting and disposition rights on behalf of Beretz
Family
Partners LLP.
|
(d) |
David
Fuchs has voting and disposition rights on behalf of Bridges
& Pipes
LLC.
|
(e) |
Roni
Appel has voting and disposition rights on behalf of Carmel
Ventures,
Inc.
|
(f) |
Mitchell
P. Kopin, president of Downsview Capital Inc., the general
partner of
Cranshire Captial, L.P, has voting and disposition rights.
|
(g) |
Ran
Nizan has voting and disposition rights on behalf of Crestwood
Holdings,
LLC.
|
(h) |
Haim
Rolnitsky has voting and disposition rights on behalf of Design
Investments Ltd.
|
(i) |
Howard
Milstein and John Hart have voting and disposition rights
on behalf of
Emigrant Capital Corp.
|
(j) |
Joseph
Franck has voting and disposition rights on behalf of Fawdon
Investments,
Ltd.
|
(k) |
Scott
Flamm has voting and disposition rights on behalf of Flamm
Family Partners
LP.
|
(l) |
Frederick
Berdon has voting and disposition rights on behalf of Fred
Berdon Co.,
LP.
|
(m) |
Howard
Kaye, the managing partner, has voting and disposition rights
on behalf of
Kay Family Fund.
|
(n) |
Pershing
IMS has voting and disposition rights on behalf of IRA FBO
/ Walter S.
Grossman.
|
(o) |
Albert
Chabot has voting and disposition rights on behalf of MEA
Group
|
(p) |
Yacov
Reizman and Leon Recanati have voting and disposition rights
on behalf of
New Bank Ltd.
|
(q) |
Shoshana
Loeb has voting and disposition rights on behalf of Open Venturs,
LLC.
|
(r) |
Jeff
Davidowitz has voting and disposition rights on behalf of Penn
Footwear
Retirement Trust.
|
(s) |
Eric
Richardson has voting and disposition rights on behalf of RP
Capital,
LLC.
|
(t) |
Edwin
Mecabe and Tai May Lee jointly have voting and disposition
rights on
behalf of SRB Capital LLC.
|
(u) |
Nathan
Low, Marilyn Adler and Amnon Mandelbaum are the managers of
Level Counter,
LLC, the general partner of Sunrise Equity Partners, L.P. The
unanimous
vote of such managers is required for voting and disposition
rights.
|
(v) |
Walter
Schenker and Steven Slawson have voting and disposition rights
on behalf
of Titan Capital Management LLC.
|
(w) |
Morten
Kiellan has voting and disposition rights on behalf of Trinita,
LLC.
|
(x) |
Nathan
Low has voting and disposition rights on behalf of Sunrise
Securities
Corp.
|
(y) |
Nathan
Low is a trustee.
|
(z) |
Avit
Heifetz has voting and disposition rights on behalf of A. Heifetz
Technologies Ltd.
|
(aa) |
James
L. Melcher has voting and disposition rights on behalf of Balestra
Spectrum Partners, LLC.
|
(bb) |
Robert
Brown, Scott Rosenblatt, Edward G. Reitler and John Watkins
have voting
and disposition rights on behalf of Reitler Brown Holdings,
LLC.
|
(cc) |
Robert
Harvey has voting and disposition rights on behalf of Harvest
Advaxis,,
LLC.
|
(1) |
Reflects
35,395
shares of common stock 44,205 warrants to purchase shares
of common
stock.
|
(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) (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 and warrants to purchase 672,539
shares
of common stock, all of which securities were received as compensation
in
the ordinary course of business of the
Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(32) |
Reflects
119,466 shares of common stock and 74,727 warrants to purchase
shares of
common stock, all of which securities were received as compensation
in the
ordinary course of business of the Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(33) |
Reflects
97,561 shares of common stock and 97,561 warrants to purchase
shares of
common stock which securities were purchased in the private
placement. In
addition, includes 187,650 warrants to purchase common stock,
which
securities were received as compensation for consulting services
rendered
to Sunrise Securities Corp., the Company’s Placement Agent. Dr. Filer is a
consultant to Sunrise Securities
Corp.
|
(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 the Selling Stockholder’s employer, Sunrise
Securities Corp. as Placement
Agent.
|
(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 the
Selling Stockholder’s employer, 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.
|
·
|
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-9
- F-18
|
|
ADVAXIS,
INC.
|
||||
(a
development stage company)
|
||||
BALANCE
SHEET
|
October
31, 2005
|
||||
ASSETS
|
||||
Current
Asset - cash
|
$
|
2,075,206
|
||
Fixed
Assets (net of depreciation)
|
73,145
|
|||
Intangible
Assets (net of amortization)
|
751,088
|
|||
Other
Assets
|
4,600
|
|||
Total
Assets
|
$
|
2,904,039
|
||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
||||
Current
Liabilities:
|
||||
Accounts
payable
|
$
|
651,887
|
||
Notes
payable, current portion
|
57,577
|
|||
Total
current liabilities
|
709,464
|
|||
Notes
Payable, net of current portion
|
443,000
|
|||
Total
liabilities
|
1,152,464
|
|||
Commitments
and Contingencies
|
||||
Shareholders'
Equity (Deficiency):
|
||||
Common
stock - $0.001 par value; authorized 500,000,000 shares,
issued and
outstanding 37,686,427 shares at October 31, 2005
|
37,686
|
|||
Additional
paid-in capital
|
5,178,319
|
|||
Deficit
accumulated during the development stage
|
(3,464,430
|
)
|
||
|
||||
Shareholders'
equity
|
1,751,575
|
|||
Total
Liabilities and Shareholders' Equity
|
$
|
2,904,039
|
ADVAXIS,
INC.
|
||||||||||||||||
(a
development stage company)
|
||||||||||||||||
STATEMENT
OF OPERATIONS
|
|
|
Year
ended December 31,
|
Ten
Month Period ended October 31,
|
Year
ended
October
31,
|
Period
from
March
1,
2002
(inception)
to
October
31,
|
||||||||
2003
|
2004
|
2005
|
2005
|
||||||||||
Revenue
|
$
|
4,000
|
$
|
116,406
|
$
|
552,868
|
$
|
674,297
|
|||||
Research
and development expenses
|
$
|
491,508
|
125,942
|
1,175,536
|
1,843,884
|
||||||||
General
and administrative expenses
|
405,568
|
524,368
|
1,219,792
|
2,266,731
|
|||||||||
Interest
Income (expense)
|
(17,190
|
)
|
(4,229
|
)
|
36,671
|
15,251
|
|||||||
Other
income
|
521
|
57
|
521
|
||||||||||
|
|||||||||||||
Net
loss
|
(909,745
|
)
|
(538,076
|
)
|
(1,805,789
|
)
|
(3,420,546
|
)
|
|||||
Dividends
attributed to preferred stock
|
43,884
|
43,884
|
|||||||||||
Net
loss applicable to common stock
|
$
|
(909,745
|
)
|
$
|
(581,960
|
)
|
$
|
(1,805,789
|
)
|
$
|
(3,464,430
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.06
|
)
|
($0.04
|
)
|
($0.05
|
)
|
||||||
Weighted-average
number of shares; basic and diluted
|
15,597,723
|
15,597,723
|
35,783,666
|
ADVAXIS,
INC.
|
|||||||
(a
development stage company)
|
|||||||
STATEMENT
OF SHAREHOLDERS' EQUITY
(DEFICIENCY)
|
Period
from March 1, 2002 (inception) to October 31,
2005
|
||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in Capital
|
Deficit
Accumulated During the Development Stage
|
Shareholders'
Equity (Deficiency)
|
||||||||||||||||||
Number
of Shares Outstanding
|
Amount
|
Number
of shares outstanding
|
Amount
|
|||||||||||||||||||
Preferred
stock issued
|
3,418.18
|
$
|
235,000
|
$
|
235,000
|
|||||||||||||||||
Common
Stock Issued
|
40,000
|
40
|
(40
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
10,493
|
10,493
|
||||||||||||||||||||
Net
Loss
|
(166,936
|
)
|
(166,936
|
)
|
||||||||||||||||||
Retroactive
restatement to reflect recapitalization on November 12,
2004
|
(-3,418.18
|
)
|
(-235,000
|
)
|
15,557,723
|
15,558
|
219,442
|
|||||||||||||||
Balance
at December 31, 2002
|
15,597,723
|
15,598
|
229,895
|
(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
-
|
15,597,723
|
15,598
|
254,348
|
(1,076,681
|
)
|
(806,735
|
)
|
|||||||||||||
Stock
dividend on preferred stock
|
638.31
|
43,884
|
(43,884
|
)
|
||||||||||||||||||
Net
loss
|
(538,076
|
)
|
(538,076
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
5,315
|
5,315
|
||||||||||||||||||||
Retroactive
restatement to reflect recapitalization on November 12,
2004
|
(638.31
|
)
|
(43,884
|
)
|
43,884
|
|||||||||||||||||
Balance
at October 31, 2004
|
-
0
-
|
-
0
-
|
15,597,723
|
15,598
|
303,547
|
(1,658,641
|
)
|
(1,339,496
|
)
|
ADVAXIS,
INC.
|
|||||||
(a
development stage company)
|
|||||||
STATEMENT
OF SHAREHOLDERS' EQUITY
(DEFICIENCY)
|
Preferred
Stock
|
Common
Stock
|
Additional
Paid-in Capital
|
Deficit
Accumulated During the Development Stage
|
Shareholders'
Equity (Deficiency)
|
||||||||||||||||||
Number
of Shares Outstanding
|
|
Amount
|
Number
of shares outstanding
|
Amount
|
||||||||||||||||||
Common
Stock issued to Placement Agent on recapitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||
Effect
of recapitalization
|
752,600
|
753
|
(753
|
)
|
||||||||||||||||||
Options
granted to consultants and professionals
|
64,924
|
64,924
|
||||||||||||||||||||
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
of common stock to consultants
|
586,970
|
587
|
166,190
|
166,777
|
||||||||||||||||||
Issuance
of common stock in connection with the registration
statement
|
409,401
|
408
|
117,090
|
117,498
|
||||||||||||||||||
Issuance
Costs
|
(329,673
|
)
|
(329,673
|
)
|
||||||||||||||||||
Net
loss
|
(1,805,789
|
)
|
(1,805,789
|
)
|
||||||||||||||||||
Restatement
to reflect recapitalization on November 12, 2004 including
cash paid of
$44,940
|
(88,824
|
)
|
(88,824
|
)
|
||||||||||||||||||
Balance
at October 31, 2005
|
$
|
-
0 -
|
$
|
-
0 -
|
37,686,428
|
37,686
|
5,178,319
|
(3,464,430
|
)
|
1,751,575
|
ADVAXIS,
INC.
(a
development stage company)
|
STATEMENT
OF CASH FLOWS
|
Year
ended December 31,
|
Tenth
Month Period ended October 31
|
Year
ended
October 31, |
Period
from March 1, 2002 (inception) to October 31,
|
||||||||||
2003
|
2004
|
2005
|
2005
|
||||||||||
Cash
flows from operating activities:
|
|||||||||||||
Net
loss
|
$(909,745)
|
$(538,076)
|
$(1,805,789)
|
$(3,420,546)
|
|||||||||
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
|
8,484
|
5,315
|
64,924
|
89,217
|
|||||||||
Amortization
expense
|
3,171
|
15,818
|
33,669
|
52,658
|
|||||||||
Depreciation
expense
|
7,432
|
7,432
|
|||||||||||
Accrued
interest on Notes Payable
|
12,308
|
12,308
|
|||||||||||
Non
cash Charges
|
166,777
|
166,777
|
|||||||||||
Value
of Penalty Shares Issued
|
117,498
|
117,498
|
|||||||||||
Increase
in Other Assets
|
(4,600)
|
(4,600)
|
|||||||||||
Increase
(decrease) in accounts payable
|
933,111
|
80,307
|
(132,149)
|
967,093
|
|||||||||
Net
cash provided by (used in) operating activities
|
35,021
|
(436,636)
|
(1,539,930)
|
(2,012,163)
|
|||||||||
CASH
FLOWS USED IN INVESTING ACTIVITIES:
|
|||||||||||||
Cash
paid on acquisition of Great Expectations
|
(44,940)
|
(44,940)
|
|||||||||||
Cost
of Furniture & Equipment
|
(80,577)
|
(80,577)
|
|||||||||||
Cost
of Intangible Assets
|
(277,243)
|
(124,469)
|
(314,953)
|
(716,665)
|
|||||||||
Net
cash used in Investing Activities
|
(277,243)
|
(124,469)
|
(440,470)
|
(842,182)
|
|||||||||
Cash
flows from financing activities:
|
|||||||||||||
Proceeds
from notes payable
|
85,000
|
546,224
|
671,224
|
||||||||||
Net
proceeds on issuance of preferred stock
|
235,000
|
||||||||||||
Net
Proceeds on Issuance of Common Stock
|
4,023,327
|
4,023,327
|
|||||||||||
Cash
provided by financing activities
|
85,000
|
546,224
|
4,023,327
|
4,896,732
|
|||||||||
Net
increase (decrease) in cash
|
(157,222)
|
(14,881)
|
2,042,927
|
2,075,206
|
|||||||||
Cash
at beginning of period
|
204,382
|
47,160
|
32,279
|
||||||||||
|
|||||||||||||
Cash
at end of period
|
$
|
47,160
|
$
|
32,279
|
$
|
2,075,206
|
$
|
2,075,206
|
|||||
SUPPLEMENTAL
SCHEDULE OF NONCASH INVESTING AND FINANCING ACTIVITIES:
|
|||||||||||||
Common
Stock issued to founders
|
$
|
40
|
|||||||||||
Notes
Payable and Accrued Interest Converted to Preferred Stock
|
$
|
15,969
|
$
|
15,969
|
|||||||||
Stock
Dividend on Preferred Stock
|
$
|
43,884
|
$
|
43,884
|
|||||||||
Notes
Payable and Accrued Interest Converted to Common
|
$
|
613,158
|
$
|
613,158
|
|||||||||
Intangible
Assets Acquired with Notes Payable
|
$
|
360,000
|
$
|
360,000
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
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.
As
shown in the financial statements, the Company has incurred
losses from
operations, which raise doubt as to the ability of the Company
to continue
as a going concern. Although
we believe that the net proceeds received by us from the Private
Placement
and the private offerings will be sufficient to finance our
currently
planned operations for approximately the next 12 to 24 months,
we do not
believe that these amounts will be sufficient to meet our longer-term
cash
requirements or our cash requirements for the commercialization
of any of
our existing or future product candidates. We will be required
to issue
equity or debt securities or to enter into other financial
arrangements,
including relationships with corporate and other partners,
in order to
raise additional capital. Depending upon market conditions,
we may not be
successful in raising sufficient additional capital for our
long-term
requirements. In such event, our business, prospects, financial
condition
and results of operations could be materially adversely affected.
In
accordance with Securities and Exchange Commission (SEC) Staff
Accounting
Bulletin (SAB) No. 104, revenue from license fees and grants
is recognized
when the following criteria are met; persuasive evidence of
an arrangement
exists, services have been rendered, the contract price is
fixed or
determinable, and collectibility is reasonably assured. In
licensing
arrangements, delivery does not occur for revenue recognition
purposes
until the license term begins. Nonrefundable upfront fees received
in
exchange for products delivered or services performed that
do not
represent the culmination of a separate earnings process will
be deferred
and recognized over the term of the agreement using the straightline
method or another method if it better represents the timing
and pattern of
performance. Since its inception and through October 31, 2005,
all of the
Company’s revenues have been from grants. For
the year ended October 31, 2005, 77% and 13% of the Company’s revenues
were received from two grants, respectively. For the ten month
period
ended October 31, 2004, all of the Company’s revenue was received from one
grant.
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
20
years.
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
|
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.
In
December 2004, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 123R,
“Share-Based Payment,” which establishes standards for the Accounting for
transactions in which an entity exchanges its equity instruments
for goods
or services. A Key provision of this statement is the requirement
of a
public entity to measure the cost of employee services received
in
exchange for an award of equity instruments, including stock
options,
based on the grant-Dale fair market value of the award. That
cost will be
recognized over a period during which an employee is required
to provide
services in exchange for the award. This standard becomes
effective in the
Company’s net fiscal quarter. The Company cannot estimate the future
impact on the financial statements from the implementation
SFAS No.
123R.
Management
does not believe that any other 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
|
Year
ended
December
31, 2003
|
10
months ended October
31, 2004
|
Year ended
October
31
2005
|
March
1, 2002 (date of inception) to October
31, 2005
|
||||||||||
Net
Loss as reported
|
$
|
(909,745
|
)
|
$
|
(538,076
|
)
|
$
|
(1,805,789
|
)
|
$
|
(3,20,546
|
)
|
|
Add:
Stock based option expense included in recorded net income
|
8,484
|
5,315
|
64,924
|
89,217
|
|||||||||
Deduct
stock option compensation expense determined under fair value
based
method
|
(41,407
|
)
|
(75,334
|
)
|
(200,942
|
)
|
(328,176
|
)
|
|||||
Adjusted
Net Loss
|
$
|
(942,668
|
)
|
$
|
(608,095
|
)
|
($1,941,807
|
)
|
$
|
(3,659,505
|
)
|
||
Net
Loss per share as reported
|
$
|
(0.06
|
)
|
$
|
(0.04
|
)
|
($0.05
|
)
|
|||||
Net
Loss per share pro forma
|
$
|
(0.06
|
)
|
$
|
(0.04
|
)
|
($0.05
|
)
|
|||||
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
2. INTANGIBLE
ASSETS:
|
Intangible
assets consist of the following at October 31,
2005:
|
Trademarks
|
$
|
51,700
|
||
Patents
|
263,752
|
|||
License
|
485,123
|
|||
Less:
Accumulated Amortization
|
(49,487
|
)
|
||
$
|
751,088
|
|
Estimated
amortization expense is as
follows:
|
Year
ending October 31,
|
||||
2006
|
$
|
40,029
|
||
2007
|
40,029
|
|||
2008
|
40,029
|
|||
2009
|
40,029
|
|||
2010
|
40,029
|
|||
|
Amortization
expense of intangibles amounted to $33,669 and $15,818
for the year ended
October 31, 2005 and the ten-month period ended October
31, 2004,
respectively.
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
3. NOTES
PAYABLE:
|
Notes
payable consist of the following at October 31, 2005:
|
Two
notes payable with interest at 8% per annum, due on December
17, 2008. The
lender has served notice demanding payment pursuant to the
November 2004
recapitalization and financing
|
57,577
|
|||
Note
payable with no interest payable at the time of the closing
of the
Company's contemplated $5,000,000 equity financing
|
75,000
|
|||
Note
payable with no interest payable at the time of the closing
of the
Company's contemplated $5,000,000 equity financing
|
8,000
|
|||
Note
payable with no interest payable at December 15, 2006, or
at the time of
the closing of the Company's contemplated $5,000,000 equity
financing
|
130,000
|
|||
Note
payable with no interest payable at December 15, 2007 or
at the time of
the closing of the Company's contemplated $8,000,000 equity
financing
|
230,000
|
|||
|
500,577
|
|||
Less
current portion
|
57,577
|
|||
$443,000
|
||||
Aggregate
maturities of notes payable at October 31, 2005 are as
follows:
|
||||
Year
ending December 31,
|
||||
2005
|
57,577 | |||
2006
|
213,000 | |||
2007
|
230,000 | |||
$ | 500,577 |
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
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.
This Plan was replaced by the Advaxis 2004 Option Plan, which
allows for
grants up to 2,381,525 shares of the Company's common stock.
The board of
directors adopted the 2005 stock option plan, which allows
for grants up
to 5,600,000 shares of the Company's common stock. The 2005
plan is
subject to the approval of the Company’s shareholders. Both the 2004 plan
and the 2005 plan shall be administered and interpreted by
the Company's
board of directors.
|
Stock
option activity during the periods indicated is as
follows:
|
|
2004
Plan
|
2005
Plan
|
Total
|
||||||||||||||||
|
Options
Granted Under the 2004 plan
|
Weighted
Average Exercise Price
|
Options
Granted Under the 2005 plan
|
Weighted
Average Exercise Price
|
Options
Granted
|
Weighted
Average Exercise Price
|
|||||||||||||
January
1, 2003
|
1,172,767
|
$
|
0.20
|
1,172,767
|
$
|
0.20
|
|||||||||||||
Granted
|
1,084,085
|
1,084,085
|
|||||||||||||||||
Outstanding
at December 31, 2003
|
2,256,852
|
$
|
0.22
|
2,256,852
|
$
|
0.22
|
|||||||||||||
Granted
|
132,419
|
132,419
|
|||||||||||||||||
Outstanding
at October 31, 2004
|
2,389,271
|
$
|
0.23
|
2,389,271
|
$
|
0.23
|
|||||||||||||
Granted
|
283,730
|
$
|
0.20
|
2,958,817
|
$
|
0.29
|
3,242,547
|
$
|
0.29
|
||||||||||
Forfeited
|
532,602
|
$
|
0.20
|
256,677
|
$
|
0.29
|
789,279
|
$
|
0.23
|
||||||||||
Outstanding
at October 31, 2005
|
2,140,399
|
$
|
0.24
|
2,702,140
|
$
|
0.29
|
4,842,539
|
$
|
0.27
|
||||||||||
Vested
and exercisable at October 31, 2005
|
1,715,496
|
$
|
0.24
|
740,501
|
$
|
0.29
|
2,455,997
|
$
|
0.25
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
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 $75,000 to its former patent counsel
upon
receiving financing of $5,000,000 or greater.
The
Company is obligated to pay $8,000 to a consultant upon receiving
financing of $5,000,000 or greater.
|
Under
a license agreement, the Company is obligated to pay (a) $525,000
in
aggregate, divided over a four-year period as a minimum royalty
after the
first commercial sale of a product. Such payments are not anticipated
within the next five years. (b) The Company is also obligated
to pay after
the 6th anniversary of the licensing agreement, annual license
maintenance
fees of $125,000 per year. (c) Upon the achievement of the
first sale of a
product in certain fields, the Company shall be obligated to
pay certain
milestone payments, as follows: $2,500,000 shall be due for
first
commercial sale of the first product in the cancer field (of
which
$1,000,000 shall be paid within forty-five (45) days of the
date of the
first commercial sale, $1,000,000 shall be paid on the first
anniversary
of the first commercial sale; and $500,000 shall be paid on
the second
anniversary of the date of the first commercial sale). In addition,
$1,000,000 shall be due and payable within forty-five (45)
days following
the date of the first commercial sale of a product in any of
the following
fields (a) Infectious Disease, (b) Allergy, (c) Autoimmune
Disease, and
(d) any other therapeutic indications for which licensed products
are
developed. Therefore, the maximum total potential amount of
milestone
payments is $6,500,000. Such milestone payments are not expected
prior to
obtaining a regulatory approval to market and sell the Company’s vaccines,
and such regulatory approval is not expected within the next
5
years.
Under
a consulting agreement with the Company’s scientific inventor, the Company
is obligated to pay $3,000 per month until the Company closes
a $3,000,000
equity financing, $5,000 per month pursuant to a $3,000,000
equity
financing, $7,000 per month pursuant to a $6,000,000 equity
financing, and
$9,000 per month pursuant to a $9,000,000 equity
financing.
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
Pursuant
to a Clinical Research Service Agreement, the Company is
obligated to pay
$430,000 to a vendor, of which $215,000 shall be paid pursuant
to a
$5,000,000 equity financing.
The
Company is obligated under a noncancelable operating lease
for laboratory
and office space expiring in May 2006 with aggregate future
minimum
payments due amounting to $11,500.
J.
Todd Derbin, the President and Chief executive officer of
the Company,
have entered into a Termination of Employment Agreement effective
December
31, 2005 pursuant to which Mr. Derbin’s employment by the Company will end
on December 31, 2005. Pursuant to such agreement Mr. Derbin’s salary for
2005 is set at $225,000 plus a bonus for 2005 of $5,000 in
shares of
Common Stock of the Company valued at $0.287 per share. Following
his
resignation Mr. Derbin shall service as a consultant to the
Company for a
fee of $6,250 per month for 6 months ending June 30, 2006.
Mr. Derbin will
continue to serve as Chairman and a member of the Board of
directors of
the Company until at least September 30, 2006.
The
Company has entered into a consulting agreement with LVEP
Management LLC
(LVEP) dated as of January 19, 2005, and amended on April
15, 2005, and
October 31, 2005, pursuant to which Mr. Roni Appel will serve
as Chief
Executive Officer of the Company. LVEP is owned by Scott
Flamm, one of our
directors and a principal shareholder. LVEP employs Mr. Flamm
and Mr.
Appel. The initial term of the Consulting Agreement as amended
is until
December 31, 2007 and thereafter the term of the agreement
shall be
automatically extended for one year periods unless we notify
LVEP at least
60 days prior to the end of term of our intent not to extend.
In addition,
the Consulting Agreement may be terminated by the Company
for any reason
upon 60 days prior notice or by LVEP upon 45 days prior notice,
Upon such
notice all compensation and bonuses payable under the Consulting
Agreement
shall continue until the later to occur of the end of the
term or twelve
(12) months from such termination. Under the Consulting Agreement
as
amended LVEP shall receive compensation of $250,000 per year
payable at
the rate of $20,833.33 per month for the term of the agreement
plus
reimbursement of approved expenses in connection with providing
the
consulting services. LVEP intends to pay all such compensation
to Mr.
Appel. The Consultant will receive a bonus payment at the
end of 2005 not
to exceed $75,000. In subsequent years the bonus shall equal
40% of the
base consulting compensation. At the election of the Company
up to 50% and
at the election of Consultant up to 100% of the bonus may
be paid in
common stock of the Company. Additionally, LVEP shall receive
additional
options to purchase common stock of the Company bringing
options held by
LVEP to 5% of the outstanding shares and options of the Company
as of
December 31, 2005. The incremental options shall vest monthly
over four
years commencing in April, 2006. LVEP has assigned such options
to Mr.
Appel
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.
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
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.
The
Company is involved in various claims and legal actions
arising in the
ordinary course of business. Management is of the opinion
that the
ultimate outcome of these matters would not have a
material adverse impact
on the financial position of the Company or the results
of its
operations.
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
7. INCOME
TAXES:
|
The
Company has a net operating loss carryforward of approximately
$2,619,000
at October 31, 2005 available to offset taxable income
through
2025.
|
The
tax effects of loss carryforwards give rise to a deferred
tax asset and a
related valuation allowance at October 31, 2005 as
follows:
|
Net
operating losses
|
$
|
1,047,593
|
||
Less
valuation allowance
|
(1,047,593
|
)
|
||
Deferred
tax asset
|
$
|
-0-
|
The
difference between income taxes computed at the statutory
federal rate of
34% and the provision for income taxes relates to the
following:
|
Ten-month
|
Twelve-month
|
Period
from
|
|||||||||||
Year
ended
|
period
ended
|
period
ended
|
1-Mar-02
|
||||||||||
December
31,
|
October
31,
|
October
31,
|
(inception)
to
|
||||||||||
2003
|
2004
|
2005
|
October
31,
|
||||||||||
2005
|
|||||||||||||
Provision
at federal statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
34
|
%
|
|||||
Valuation
allowance
|
(34
|
)
|
(34
|
)
|
(34
|
)
|
(34
|
)
|
|||||
-0-
|
%
|
-0-
|
%
|
-0-
|
%
|
-0-
|
%
|
8.
RECAPITALIZATION:
|
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 were 17,102,923 common
shares
outstanding in Great Expectations.
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
|
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, 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.
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.
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.
|
ADVAXIS,
INC.
(a
development stage company)
|
NOTES
TO FINANCIAL STATEMENTS
|
Amount
|
Exercise
Price
|
Expiration
|
|||||
494,220
|
$
|
0.20
|
2009
|
||||
35,218
|
$
|
0.28
|
2011
|
||||
142,555
|
$
|
0.29
|
2007
|
||||
2,341,900
|
$
|
0.29
|
2009
|
||||
17,495,326*
|
$
|
0.40
|
2009
|
||||
20,509,219
|
|
|
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
|
* |
EXHIBIT
NUMBER
|
DESCRIPTION
OF EXHIBIT
|
Exhibit
3.1
|
Amended
and Restated Articles of Incorporation.Incorporated
by reference to
Exhibit 4.2 to Report on Form S-8 filed with the
SEC on December 1,
2005.
|
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 Jody
M. Walker, Esq.
|
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 4.1
to Report on Form S-8 filed with the SEC on December
1,
2005.
|
Exhibit
10.7
|
License
Agreement, dated as of June 17, 2002, by and between
Advaxis and The
Trustees of the University of Pennsylvania*.
|
Exhibit
10.8
|
Non-Exclusive
License and Bailment, dated as of March 17, 2004,
betweeen The Regents of
the University of California and Advaxis, Inc.
|
Exhibit
10.9
|
Consultancy
Agreement, dated as of January 19, 2005, by and between
LVEP Management,
LLC. and the Company.
|
Exhibit
10.10
|
Government
Funding Agreement, dated as of April 5, 2004, by
and between David Carpi
and Advaxis, Inc.
|
Exhibit
10.11
|
Amended
and Restated Consulting and Placement Agreement,
dated as of May28, 2003,
by and between David Carpi and Advaxis, Inc., as
amended
|
Exhibit
10.12
|
Consultancy
Agreement, dated as of January 22, 2005, by and between
Dr. Yvonne
Paterson and Advaxis, Inc.
|
Exhibit
10.13
|
Consultancy
Agreement, dated as of March 15, 2003, by and between
Dr. Joy A. Cavagnaro
and Advaxis, Inc.
|
Exhibit
10.14
|
Grant
Writing Agreement, dated June 19, 2003, by and
between DNA Bridges, Inc.
and Adavaxis, Inc.
|
Exhibit
10.15
|
Consulting
Agreement, dated as of July 2, 2004, by and between
Sentinel Consulting
Corporation and Advaxis, Inc.
|
Exhibit
10.16
|
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing
PLC and Advaxis,
Inc.*
|
Exhibit
10.17
|
Securities
Purchase Agreement, dated as of January 12, 2005,
by and between the
Company and Harvest Advaxis LLC. Incorporated
by reference to Exhibit 10.1
to Report on Form 8K filed with the SEC on January
18,
2005.
|
Exhibit
10.18
|
Registration
Rights Agreement, dated as of January 12, 2005,
by and between the Company
and Harvest Advaxis LLC. Incorporated by reference
to Exhibit 10.2 to
Report on Form 8K filed with the SEC on January
18,
2005.
|
Exhibit
10.19
|
Letter
Agreement, dated as of January 12, 2005 by and
between the Company and
Robert T. Harvey. Incorporated by reference to
Exhibit 10.3 to Report on
Form 8K filed with the SEC on January 18, 2005.
|
Exhibit
10.20
|
Consultantcy
Agreement, dated as of January 15, 2005, by and
between Dr. David Filer
and the Company.
|
Exhibit
10.21
|
Consultancy
Agreement, dated as of January 15, 2005, by and
between Pharm-Olam
International Ltd. and the Company.
|
Exhibit
10.22
|
Agreement,
dated February 1, 2004, by and between Strategic
Growth International Inc.
and the Company.
|
Exhibit
10.23
|
Letter
Agreement, dated February 10, 2005, by and between
Richard Berman and the
Company.
|
Exhibit
10.24
|
Employment
Agreement, dated February 8, 2005, by and between
Vafa Shahabi and the
Company.
|
Exhibit
10.25
|
Employment
Agreement, dated March 1, 2005, by and between
John Rothman and the
Company.
|
Exhibit
10.26
|
Clinical
Research Services Agreement, dated April 6, 2005,
between Pharm-Olam
International Ltd. and the Company.*
|
Exhibit
10.27
|
Amendment
to Consultancy Agreement, dated as of April 4,
2005, between LVEP
Management LLC and the Company.
|
Exhibit
10.28
|
Royalty
Agreement, dated as of May 11, 2003, by and between
Cobra
Bio-Manufacturing PLC and the Company
|
Exhibit 10.29 | Resignation Agreement between J. Todd Durbin and the Company, dated October 31, 2005. Incorporation by reference to Exhibit 10.1 to report on Form 8-K filed with the SEC on November 9, 2005. |
Exhibit 10.30 | Second Amendment to Consulting Agreement between the Company and LVEP Management LLC, dated October 31, 2005. Incorporation by reference to Exhibit 10.2 to Report on Form 8-K filed with the SEC on November 9, 2005. |
Exhibit 10.31 | Letter of Agreement between the Company and the Investor Relations Group Inc., dated September 27, 2005. |
Exhibit 10.32 | Consulting Agreement between the Company and Freemind Group, LLC dated October 17, 2005. |
Exhibit 10.33 | Strategic Collaboration and Long Term Vaccine Supply Agreement between the Company and Cobra Bio-Manufacturing PLC dated October 31, 2005*. |
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 Jody M. Walker, Esq. (included in Exhibit
5.1 above)
|
Exhibit
24.1
|
Power
of Attorney (Included on the signature
page)
|
ADVAXIS,
INC.
|
||
|
|
|
By: | /s/ Roni Appel | |
Roni
Appel, Chief Financial Officer and Chief Executive
Officer
|
||
SIGNATURE
|
TITLE
|
DATE
|
/s/
Roni Appel
Roni
Appel
|
Chief
Executive Officer and Director
(Principal
Executive Officer
|
January
5, 2006
|
*
/s/ Roni Appel
Roni Appel |
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
January
5, 2006
|
* /s/ J.
Todd Derbin
J.
Todd Derbin
|
Director
|
January
5, 2006
|
*
/s/ Scott Flamm
Scott Flamm |
Director
|
January
5, 2006
|
*
/s/ Thomas McKearn
Thomas McKearn |
Director
|
January
5, 2006
|
*
/s/ James Patton
James Patton |
Director
|
January
5, 2006
|
*
/s/ Richard Berman
Richard Berman |
Director
|
January
5, 2006
|
Very truly yours, | ||
|
|
|
Dian Griesel |
||
Founder & Chairman | ||
The Investor Relations Group, Inc. | ||
ACCEPTED AND AGREED | ||
AS OF THE DATE FIRST ABOVE WRITTEN: |
1.1 |
Consultant's
Duties.
In
performing the Services, Consultant shall have the following duties:
|
1.1.1 |
Advise
and assist in identifying the most suitable NIH Grant applicable for
the
Company and advise on the best alternatives to apply for such grant,
in
the opinion and experience of Consultant;
|
1.1.2 |
Assist
in preparation of a New Application and other NIH Applications, if
required, and in preparation of a Revised Application, where applicable,
following rejection of the original application by NIH; Applications
will
be in agreement with all rules and regulations of the grantor, including,
but not limited to, format and content
requirements.
|
1.2 |
Company's
Duties.
|
1.2.1 |
Company
undertakes to cooperate with Consultant and provide any assistance
or
information required by Consultant in order to provide the
Services.
|
1.2.2 |
Company
and Consultant will mutually agree on a suitable timetable for preparation
and delivery of copies of all materials, documents and correspondence
with
NIH in respect of a project.
|
1.2.3 |
It
is agreed that the first such project shall be a submission of a Phase
II
grant consistent with a filing date of December 1, 2005 via electronic
submission.
|
1.2.4 |
Subsequent
projects shall be consistent with filing dates published by NIH or
other
applicable government or grant agencies.
|
2. |
Consideration.
As consideration for all the Services provided by the Consultant pursuant
to Section 1
above, the Consultant shall be entitled to the following:
|
2.1 |
For
SBIR Phase I Applications:
|
2.1.1 |
Unconditional
Fees: The Company shall pay to Consultant the following unconditional
payments, at the times specified below, against an invoice duly issued
to
Company:
|
2.1.1.1 |
Initial
payment of US$ 2,500 upon receiving positive indication from NIH on
each
summary submitted.
|
2.1.1.2 |
Additional
Payment of US$ 2,500 upon the submission to the NIH of each NIH
Application (except for a Revised Application, which submission shall
not
require additional fees).
|
2.1.2 |
In
the event an SBIR Phase I Project is awarded an NIH Grant, the Company
will be obligated to submit a Phase II application. This Phase II
application will be prepared with the assistance of the Consultant.
Further, If Company does not file a Phase II application within 180
days
of the end of the research period as defined in the Phase I grant,
the
Company shall pay Consultant a conditional success fee of 7% of the
grant
amount.
|
2.1.3 |
There
shall be no obligation of Company to submit a Phase II application
pursuant to the completion of the Phase I research
plan.
|
2.2 |
For
SBIR Phase II Applications:
|
2.2.1 |
Unconditional
Fees: The Company shall pay to Consultant the following unconditional
payments, at the times specified below, against an invoice duly issued
to
Company:
|
2.2.1.1 |
Initial
payment of US$ 2,500 upon initiation of work for each new
application.
|
2.2.1.2 |
Additional
Payment of US$ 3,500 upon the submission to the NIH of each NIH
Application (except for a Revised Application, which submission shall
not
require additional fees).
|
2.2.2 |
Conditional
Fees:
|
2.2.2.1 |
In
the event an SBIR Phase II Project is awarded an NIH Grant, the Company
shall pay Consultant a success fee ("Success Fee The amount of Success
Fee
shall be calculated as 7% - (seven percent) of the Approved Grant (The
"Total Federal Award Amount" plus the "Recommended Future Years Total
Support" as specified in section II of the "Notice of Grant Award"
issued
by the NIH to the Principle Investigator) in the first grant, 6.5%
(six
and a half percent) in the second grant and 6% (six percent) in the
third
or later grant. However, it is hereby clear and acknowledged that such
Success Fee shall in no event be payable out of the funds comprising
a
portion of an NIH Grant.
|
2.3 |
For
SBIR Fast Track Applications:
|
2.3.1 |
Unconditional
Fees. The Company shall pay to Consultant the following unconditional
payments, at the times specified below, against an invoice duly issued
to
Company:
|
2.3.1.1 |
Initial
payment of US$ 2,000 upon receiving positive indication from NIH on
each
summary submitted.
|
2.3.1.2 |
Additional
payment of US$ 5,000 upon the submission to the NIH of each NIH
Application (except for a Revised Application, which submission shall
not
require additional fees).
|
2.3.2 |
Conditional
Fees.
|
2.3.2.1 |
Success
Fee. In the event a Project is awarded an NIH Grant, the Company shall
pay
Consultant a success fee ("Success Fee"). The amount of Success Fee
shall
be calculated as 6% (six percent) of the Approved Grant (The "Total
Federal Award Amount" plus the "Recommended Future Years Total Support"
as
specified in section II of the "Notice of Grant Award" issued by the
NIH
to the Principle Investigator) in the first grant, 6.5% (six and a
half
percent) in the second grant and 6% (six percent) in the third or later
grant. However, it is hereby clear and acknowledged that such Success
Fee
shall in no event be payable out of the funds comprising a portion
of an
NIH Grant.
|
2.4 |
The
Success Fee shall be calculated on a cumulative basis, taking into
account
any funds granted or promised by NIH to the Company and resulting from
any
and all NIH Applications in connection with the
Project.
|
2.4.1 |
For
the purpose of this agreement, non-SBIR Applications will be regarded
as
SBIR Fast Track Applications.
|
2.5 |
Payment
Terms.
Payment of Success Fee will be due for payment in 2 annual installments
for a 2-year grant, or 3 annual installments, for a 3-year grant or
a
longer period grant, each installment payable within 30 days after
first
funds are available for withdrawal by the Company from NIH for the
applicable research year. For example, for a $1,000,000 grant paid
over 2
years at the rate of $500,000/year, the success fee shall be paid in
2
annual installments of $30,000 each. It is hereby clear and agreed
by all
parties that any failure to draw down of funds by the Company will
not
derogate from Consultant's entitlement to the appropriate Success Fee
or
from the payment terms specified
hereunder.
|
2.6 |
Should
the Company decide not to continue with the NIH Grant Application writing
process, after Consultant has already started preparing an application,
or
in any event of termination of this Agreement by the Company for any
reason while Consultant is working on an application, then (i) Company
will pay (a) 100% of the applicable unconditional fee for such application
to Consultant less any amount already paid to Consultant if such grant
or
agreement termination occurred less than 4 weeks from the applicable
grant
deadline, or (b) no additional unconditional fee if such grant or
agreement termination occurred more than 4 weeks from the applicable
grant
deadline; and (ii) in the event Company is eventually entitled to NIH
Grant on this Project or Similar Projects (projects sharing at least
two
of the specific aims with the project which was terminated) at any
time
thereafter, Consultant shall be entitled to the full Success Fees (as
specified above). The payment by the Company of the consideration of
(i)
and (ii) above shall be deemed full and final mutually agreed
compensation
|
3.1 |
This
Agreement shall commence on the date hereof and shall be effective
for a
period of twelve (12) months (the “Term
of the Agreement”).
The Term of the Agreement may be extended by the mutual written consent
of
the parties.
|
3.2 |
Termination
by the Company.
Company may terminate this Agreement at any time by providing Consultant
with a 30 (thirty) days prior written notice. Such voluntary termination
shall be subject to the provisions of Section 3.4
below.
|
3.3 |
Termination
by Consultant.
Consultant may terminate this Agreement by providing Company with a
30
(thirty) days prior written notice. Consultant shall be entitled to
cease
any activity provided by it under this Agreement upon delivery of said
written notice. In the event that the Consultant, at its sole discretion,
decides not to proceed with the New Application preparation and/or
submission for any reason whatsoever, Company shall be entitled to
a
refund of the consideration actually paid to Consultant except for
expenses.
|
3.4 |
Survival.
The termination of this Agreement shall not affect the Company’s
obligation to pay the Consultant fees and commissions due pursuant
to
Section 2,
5.2, and 5.5 including a case where the Company terminates this Agreement
due to a breach or an alleged breach by Consultant of this
Agreement.
|
4. |
LIMITATION
OF LIABILITY.
CONSULTANT WILL IN NO EVENT BE LIABLE TO THE COMPANY FOR ANY SPECIAL,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON BREACH OF CONTRACT,
TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND WHETHER OR NOT CONSULTANT
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE OR
BREACH.
|
5.1 |
NO
GUARANTEE.
The Services rendered hereunder are rendered without any guarantee
or
representation regarding the success or chances of the applications
to be
prepared, submitted and/or approved. Both Parties hereto agree that
Consultant provides the Services hereunder for certain consideration
to be
paid solely by Company, but in no event shall Consultant be liable
for any
unsuccessful applications, competency, quality or fitness to purpose,
losses, claims, punitive damages or any other damages Company may suffer
due to rejection by NIH of any application, failure to comply with
any
applicable regulations or instructions, or otherwise in connection
with
this Agreement.
|
5.2 |
CONFIDENTIAL
INFORMATION
(a) 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. (b) 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. (c) Exceptions
to Confidential Information.
Notwithstanding the foregoing paragraph, “Confidential Information” shall
not include any information or materials that: (i) 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 (ii) 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). (d) 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 (e) Consultant’s
confidentiality obligation under this agreement shall survive termination
for any reason.
|
5.3 |
Non
Exclusive:
This agreement is non exclusive. Company or Consultant at their sole
discretion may enter into similar agreements with one or several third
parties.
|
5.4 |
Omitted.
|
5.5 |
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 registerable 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.
|
5.6 |
Governing
Law.
This agreement shall be governed by and construed under the laws of
the
State of New York. Any dispute arising from this agreement in the amount
of up to $50,000 shall be mediated by the parties in good faith by
a
mediator determined by a mutual agreement of both parties. If such
mediation does not lead to successful resolution within 45 days, or
if the
disputed amount is greater than $50,000, or in any other dispute, then
section 5.7 below shall apply.
|
5.7 |
Notwithstanding
the above, any and all disputes arising out of or in connection with
the
execution, interpretation, performance, or nonperformance of this
Agreement or any other certificate, agreement, or other instrument
between, involving, or affecting the parties (including the validity,
scope, and enforceability of this arbitration agreement) shall be solely
and finally settled by a single arbitrator in accordance with the
Commercial Rules of the American Arbitration Association (the "Rules");
provided, however, that in the event of a conflict between the Rules
and
the terms of this Agreement, the terms of this Agreement shall govern.
The
place of arbitration shall be the City of New York, and the law applicable
to the arbitration procedure shall be the Federal Arbitration Act (9
USC §
2).
|
5.8 |
To
commence arbitration of any such dispute, the party desiring arbitration
shall notify the other party in writing in accordance with the Rules.
In
the event that the parties fail to agree on the selection of an arbitrator
within fifteen (15) days after the delivery of such notice, the
arbitrator, upon request of either party, shall be selected by the
American Arbitration Association.
|
5.9 |
The
failure of either party at any time to require the performance by the
other party of any provision of this Agreement shall not affect in
any way
the right to require such performance at any later time, nor shall
the
waiver by either party of a breach of any provision hereof be taken
or
held to be an implied waiver of that provision.
|
5.10 |
In
the event any provision of this Agreement shall be determined to be
unenforceable, because it is invalid or in conflict with any law of
any
relevant jurisdiction, the validity of the remaining provisions shall
not
be affected, and the rights and obligations of the parties shall be
construed and enforced as if the Agreement did not contain the particular
provision(s) held to be unenforceable.
|
______________________________
|
______________________________
|
FreeMind
Group LLC
|
|
By:
Eyal Schmidt
|
By:
|
Title:
President
|
Title:
|
Confidential |
Page
1
|
Confidential |
Page
2
|
(1)
|
COBRA
BIOLOGICS Ltd (a
wholly owned subsidiary of Cobra Biomanufacturing Plc) whose principal
place of business is at Stephenson Building, The Science Park, University
of Keele, Keele, Staffordshire, ST5 5SP (“Cobra”);
and
|
(2) |
ADVAXIS
INC whose
principal place of business is 212 Carnegie Center Suite 206, Princeton,
NJ 08540 USA (“Advaxis”).
|
(A) |
The
parties have agreed to enter an agreement for Cobra to manufacture
and
supply products in the field of live or dead wild type attenuated
or
recombinant Listeria based vaccines for use in cancer and other
indications to Advaxis and for Advaxis and/or its affiliates to undertake
clinical trials and commercial sales in respect of such
vaccines.
|
(B) |
The
parties have agreed that Cobra will have the right of first refusal
to
manufacture and supply Clinical Product and Bulk Product (as defined
hereinafter) for use in the program of research and development,
clinical
trials and commercial exploitation. If Cobra is unwilling, or unable
to
supply and manufacture either Clinical Product or Bulk Product under
the
terms herein, Cobra will transfer the necessary Vaccine Process (as
defined hereinafter) to enable a third party to manufacture and supply
any
part of the Clinical Product and/or Bulk Product to Advaxis. The
parties
have further agreed that Cobra shall not supply, provide or manufacture
the Bulk Product to or for any third party.
|
(C) |
In
exchange for the rights granted in (B) above Cobra will provide Advaxis
a
discount on the cost of the manufacture and supply by Cobra of all
Clinical Product required by Advaxis for clinical trial purposes.
For the
avoidance of doubt, this provision is not applicable to the supply
of Bulk
Product to Advaxis for commercial
sale.
|
(D) |
The
parties have agreed that Advaxis will have care and conduct of the
exploitation of the Programme Deliverable (as defined
below).
|
Confidential |
Page
3
|
1 |
Definitions
|
1.1 |
In
this Agreement the following words have the following
meanings:
|
“Advaxis
IP”
|
means
any and all existing and/or future Intellectual Property Rights in
the
Programme Deliverable, Vaccine Process and the existing Intellectual
Property Rights set out in Schedule 2 but excluding any Cobra Know
How;
|
Drug
Product
|
Programme
Deliverable
|
“Bulk
Drug Substance ”
|
means
any bulk quantities of Drug Substance required by Advaxis for the
commercial exploitation of the Programme Deliverable;
|
“Bulk
Product”
|
means
any and all Bulk Drug Substance, Drug Product and/or Programme Deliverable
supplied by Cobra to Advaxis under this Agreement for commercial
use;
|
“Clinical
Product”
|
means
the Programme Deliverable which is to be used in the development
phase of
the Programme and/or the Clinical Trials;
|
“Clinical
Trials”
|
means
FDA Phase I, II and III clinical trials, or corresponding regulatory
trials in another jurisdiction to be undertaken by Advaxis (if
commercially viable) to test the safety and/or efficacy of the Programme
Deliverable;
|
“Cobra
Know How”
|
means
any of the Know How of Cobra and Intellectual Property Rights of
Cobra in
the same which can be demonstrated to have been in existence before
this
agreement and any preceeding agreements with Advaxis came into
force.
|
“Cobra
Terms and Conditions”
|
means
the standard terms and conditions of Cobra from time to time, the
current
version of which is set out in Schedule 3;
|
“Confidential
Information”
|
means
in relation to each party, any information about the other party’s
business and/or given by one party to the other party and/or generated
by
one party from the other party’s Confidential Information, including but
not limited to any information relating to the other party’s Intellectual
Property Rights and/or Know How;
|
“Cost”
|
means
the actual and direct aggregate costs and/or expenses (with no non-program
related overhead) associated with the production of Bulk Product
based on
the cost of raw materials plus the cost of project specific equipment
plus
direct costs of labour plus the Facility Occupancy Charge, or in
the
absence of agreement, as determined in accordance with section
21;
|
Confidential |
Page
4
|
“Discount”
|
means
the discount granted by Cobra to Advaxis based on total sales by
Cobra of
the Clinical Product to Advaxis for [ * ] as detailed in Schedule
1. Any
Discount will be applied to orders placed by Advaxis for the Clinical
Product in the following [ * ];
|
“Drug
Substance”
|
means
the active component of the Drug Product as defined in the
“Field”.
|
“Drug
Product”
|
means
any quantities of the formulated dosage form incorporating a defined
quanitity of the “Drug Substance”required by Advaxis for the commercial
exploitation of the vaccine;
|
“Exploit”
|
means
any use, research, development, manufacture, production, distribution,
sale, marketing, licensing, assignment and/or import and the term
“exploitation” and “exploited” shall be interpreted
accordingly;
|
“Facility
Occupancy Charge”
|
means
the cost of running that part of the production line used to produce
the
Bulk Product to be supplied by Cobra under this Agreement as calculated
in
accordance with Schedule 4;
|
“Field”
|
means
in the field of live or dead cell based wild type or attenuated or
recombinant Listeria vaccine(s) with a therapeutic and/or preventative
effect;
|
“First
Commercial Sale”
|
shall
mean, in respect of any Resale Products, the first sale by Advaxis
on a
commercial basis in an arm's length transaction of any Resale Products
for
use in a country where the governing health regulatory authority
of such
country has granted regulatory approval of such Resale Products (to
the
extent such regulatory approval is required in such country). Any
Drug
Product, Drug Substance and/or Programme Deliverable distributed
or used
for clinical trial purposes shall not be considered sold, marketed
or made
publicly available for sale and shall not constitute first commercial
sale;
|
Confidential |
Page
5
|
“Force
Majeure”
|
means
any event outside the reasonable control of either party affecting
its
ability to perform any of its obligations (other than payment) under
this
Agreement including act of God, fire, flood, lightning, war, revolution,
act of terrorism, riot or civil commotion, strikes, lock-outs or
other
industrial action, whether of the affected party’s own employees or
others, failure of supplies of power, fuel, transport, equipment,
raw
materials or other goods or services;
|
“Increased
Order Level”
|
means
any material increase required in the output levels of Bulk Product
for
commercial exploitation of the Programme Deliverable;
|
“Initial
Order Level”
|
means
the initial output levels required of Bulk Product for commercial
exploitation ;
|
“Intellectual
Property Rights”
|
means
all know how, inventions, conceptions, patents, methods, materials,
compositions, formulations, isomers, metabolites, processes, any
copyright, trade marks, design rights and any other intellectual
property
rights and/or industrial property rights (whether registered or
unregistered) anywhere in the world and (a) any applications
for the
protection of any intellectual property rights; (b) any and
all
corresponding foreign intellectual property rights and applications;
(c) provisionals, substitutions, divisionals, reexaminations,
reissues, renewals, extensions, term restorations, continuations,
continuations-in-part, substitute applications and inventors’
certificates, arising from, or based upon, any of such intellectual
property rights, and (d) intellectual property rights issuing
from
any such patent applications;
|
“Know-How”
|
means
any and all data, know-how, methods, process, or experience (whether
patentable or not) including but not limited to manufacturing and/or
production techniques, operating instructions, raw material, intermediate
material, specifications, formulations, and any other technical and
commercial information relating to the research, development, testing,
manufacture and/or production of the Clinical Product, Bulk Product
and/or
the Programme Deliverable; ;
|
Confidential |
Page
6
|
“Manufacture
Specifications”
|
means
the agreed specification for the manufacture of the Clinical Product
and/or the Bulk Product as set forth in the Programme;
|
“Mark
Up”
|
means
the mark up to be applied to the Cost in relation to production of
Bulk
Product being the greater of [
*
] or [ * ];
|
“Net
Sales”
|
means
in relation to any Resale Products :
(a) where
the Resale Products are sold on arm’s length terms, the amount received by
Advaxis less:
(i)
taxes, any value added tax or other sales tax duties or other governmental
tariffs (other than income taxes) and,
(ii)
any packing, freight, warehousing, carriage and insurance
charges,
(iii)
trade discounts, credits or allowances,
(iv)
credits or allowances additionally granted upon returns, rejections
or
recalls, and
(v)
government mandated rebates.
(b) where
the Resale Products are not sold on arm’s length terms, but are
subsequently sold on arm’s length terms, the price charged under the first
such arm’s length sale, calculated in accordance with paragraph (a) above;
and
(c) where
the Resale Products are
not sold on arm’s length terms but are used or otherwise disposed of on a
commercial basis, the price that would have been charged on the first
arm’s length sale, calculated in accordance with paragraph (a)
above;
|
Confidential |
Page
7
|
“Programme”
|
means
the interactions between Cobra and Advaxis in the planning and
implementation of the research and development work, toxicology study
and/or the manufacture, production and exploitation relating to any
Clinical Product, Drug Product, Bulk Drug Substance, Programme
Deliverable, Vaccine Process or any amendment of such collaboration
as may
be agreed in writing between the parties but excluding the conduct
of the
Clinical Trials;
|
“Programme
Data”
|
means
all data, records, analysis, assays, notes regulatory applications,
approvals, certificates, authorizations, letters and documents,
inventions, practices, methods, knowledge, know-how, skill, experience,
test data including pharmacological, manufacture, stability, safety,
toxicological, pre-clinical studies and clinical test data, analytical
and
quality control data, marketing, manufacturing, and compounds,
compositions of matter, assays and biological materials related thereto,
and any other information stored and/or kept in whatever media produced
during the Programme other than Cobra Know How;
|
“Programme
IP”
|
means
any and all Intellectual Property Rights arising under, developed
or
resulting from the Programme other than the Cobra Know How;
|
“Resale
Products”
|
means
any and all Drug Product, Bulk Drug Substance and/or Programme Deliverable
commercially exploited by Advaxis which is produced by any Third
Party
Product Manufacturer;
|
“Technology
Transfer”
|
means
the transfer by Cobra of the Cobra Know-How to a Third Party Product
Manufacturer solely as necessary to enable the Third Party Product
Manufacturer to manufacture the Bulk Product for Advaxis;
|
Confidential |
Page
8
|
“Third
Party Product Manufacturer”
|
means
any third party drug product manufacturer approved in writing by
Cobra
(such approval not to be unreasonably withheld or delayed) and Advaxis
which is to supply Bulk Product to Advaxis instead of or in addition
to
Cobra;
|
“Programme
Deliverable”
|
means
i) the end form vaccine made from the Drug Substance and/or the Drug
Product ; ii) the Master Cell Bank, Working Cell Bank, and Cell Bank
Characterization, any biological material made or developed under
the
Programme; and iii) Vaccine Process.
|
“Vaccine
Process”
|
means
the process, methods, synthesis for making, using or exploiting the
Drug
Substance to produce the Drug Product for inclusion within the Programme
Deliverable; .
|
1.2 |
The
headings to clauses are inserted for convenience only and shall not
affect
the interpretation or construction of this
Agreement.
|
1.3 |
Words
imparting the singular shall include the plural and vice versa. Words
imparting a gender include every gender and references to persons
include
an individual, company, corporation, firm or
partnership.
|
1.4 |
The
words and phrases “other”, “including” and “in particular” shall not limit
the generality of any preceding words or be construed as being limited
to
the same class as any preceding words where a wider construction
is
possible.
|
1.5 |
References
to any statute or statutory provision shall include: any subordinate
legislation made under it; any provision which it has superseded
or
re-enacted (whether with or without modification); and any provision
which
subsequently supersedes it or re-enacts it (whether with or without
modification).
|
2 |
Conduct
of the
Programme and Clinical
Trials
|
2.1 |
Cobra
and Advaxis agree that they shall conduct and undertake the Programme
on
the terms and conditions of this
Agreement.
|
2.2 |
Each
of Cobra and Advaxis shall perform the obligations for which they
are
responsible under this Agreement and the Programme.
|
2.3 |
Cobra
shall manufacture and supply Clinical Product to Advaxis in accordance
with the Manufacture Specifications. Cobra may not change the Manufacture
Specifications without the prior written approval of Advaxis unless
such
change is required in order to comply with any legislative and/or
regulatory requirements. Any such approval is not to be unreasonably
withheld and/or delayed by Advaxis.
|
Confidential |
Page
9
|
2.4 |
For
the avoidance of doubt Advaxis shall be solely responsible for the
planning and conduct of any Clinical Trials and for determining whether
to
proceed with and/or terminate any Clinical
Trials.
|
2.5 |
For
the duration of this Agreement Advaxis grants to Cobra, solely for
use in
the manufacture of Clinical Product and/or Bulk Product, a non-exclusive
royalty free licence in the UK (with the right to sub-licence to
any of
Cobra’s affiliates and/or sub-contractors whether inside or outside the
UK) of any Advaxis IP used in the production of the Clinical Product
and/or Bulk Product to the extent required by Cobra in order to perform
its obligations under this Agreement. Where all Bulk Product is to
be
produced by a third party under section 10, the licence to Cobra
under
this clause shall no longer be required.
|
2.6 |
Cobra
agrees to provide Advaxis within twenty (20) days of a written request
from Advaxis with a cross-reference letter to any Cobra regulatory
applications and approvals relating to the Clinical Product, Bulk
Product
or Vaccine Process. The cross-reference letter shall be without limitation
to clinical phase of the ongoing study. Any such cross-reference
letter
shall remain in effect and may not be revoked by Cobra unless this
Agreement is terminated.
|
3 |
Programme
Data
|
3.1 |
Cobra
shall ensure that all Programme Data created by Cobra:
|
3.1.1 |
is
accurate and complete; and
|
3.1.2 |
complies
with all legal and regulatory
requirements
|
3.2 |
At
the request of Advaxis from time to time, Cobra shall within twenty
days
(20) of Advaxis’ request provide to Advaxis a copy of all Programme Data
and/or Programme Data as may be requested by Advaxis . Any and all
Programme Data shall belong to Advaxis and form part of Advaxis’
Confidential Information.
|
4 |
Supply
of Clinical Product
|
4.1 |
Advaxis
will only use Clinical Product supplied by Cobra for the research
and
development stage of the Programme and any Clinical Trials. Advaxis
shall
place orders for all its requirements for the Clinical Product with
Cobra.
|
4.2 |
The
parties acknowledge that Advaxis has already placed orders for the
Clinical Product with Cobra as at the date of this Agreement. Repeat
orders for any further batches of Clinical Product required for the
Clinical Trials shall be placed by Advaxis with Cobra as soon as
reasonably practicable.
|
Confidential |
Page
10
|
4.3 |
Advaxis
will place further orders for the Clinical Product with Cobra at
least 3
months in advance of the date of commencement of the production slot
of
the relevant Clinical Product.
|
4.4 |
Advaxis
will pay a deposit [ * ] of the gross order value with each order
for
Clinical Product.
|
4.5 |
Cobra
shall, on accepting any further order placed by Advaxis for Clinical
Product, allocate a production slot for the production of such Clinical
Product included within the order and notify Advaxis of the allocated
production slot and anticipated delivery date. Cobra shall use all
reasonable endeavours to obtain for Advaxis the earliest production
slot
for such order of Clinical Product.
|
4.6 |
Cobra
will use its reasonable endeavours to deliver the Clinical Product
within
3 months of the commencement of the allocated production slot(s)
for the
Clinical Product.
|
4.7 |
All
Clinical Product shall be supplied to Advaxis on Cobra’s Terms and
Conditions. If there is any conflict between such terms and the terms
in
the main body of this Agreement then the terms in the main body of
this
Agreement shall prevail.
|
4.8 |
Cobra
warrants and represents that the Clinical Product manufactured by
Cobra,
its affiliates and/or its sub-contractors and delivered to Advaxis
or its
affiliates hereunder for clinical use shall (i) from the date of
shipment
until the end of the specified shelf-life conform to the Manufacturing
Specifications and shall also be manufactured in accordance with
U.S. FDA
Good Manufacturing Practices and Good Laboratory Practices; and (ii)
be
transferred free and clear of any security interests, liens and
encumbrances.
|
4.9 |
Cobra
shall furnish Advaxis with a certificate of analysis, in the form
required
by law for each batch of Clinical Product supplied hereunder with
shipment
of each such batch.
|
4.10 |
Advaxis
shall inspect and analyze a representative sample of the Clinical
Product
from batches supplied by Cobra within thirty days (30) after receipt.
If,
after inspection, Advaxis reasonably believes the shipment does not
meet
the Manufacturing Specifications, Advaxis shall notify Cobra in writing
within forty five (45) days after Advaxis’ receipt of any such Clinical
Product. If Advaxis does not so notify Cobra within the specified
timescales, Advaxis shall be deemed to have accepted the Clinical
Product
and waived all claims against Cobra for said Clinical Product delivered,
except for any latent defects that could not have been reasonably
discovered upon such inspection, which defects must be notified by
Advaxis
to Cobra within fourteen (14) days from discovery of same. Any claims
by
Advaxis regarding any Clinical Product delivered shall specify in
reasonable detail the nature and basis for the claim and cite relevant
Cobra lot numbers or other information to enable specific identification
of the goods involved. Advaxis shall not be required to accept Clinical
Product having a shelf-life of less than ninety percent (90%) of
the
stated expiration dating on the date of shipment by
Cobra.
|
4.11 |
So
long as Advaxis provides Cobra with its forecast for short term
and long
term requirements for the Clinical Product in a regular and timely
fashion
(and in any event at least [once] a month), Cobra shall cooperate
to
anticipate Advaxis’ short term and long-term requirements for Clinical
Product supply and will take reasonable measures to ensure that
Advaxis’
and its sublicensees requirements as set forth in Advaxis’ forecast can be
met. Cobra shall make best efforts to ensure Advaxis is given
the highest
priority for supply of the Clinical Product by Cobra or Cobra’s solo
contractor (as appropriate).
|
Confidential |
Page
11
|
4.12 |
Cobra
shall allow Advaxis and/or representatives of the U.S. FDA and any
other
regulatory agency or authority with jurisdiction over the manufacture,
marketing and distribution of the Clinical Product, at a mutually
agreed
time and date, to tour and inspect all facilities utilized by such
party
in the manufacture, testing, packaging, storage, and shipment of
Clinical
Product sold under this Agreement, and shall co-operate with such
representatives in every reasonable manner. Each party shall also
provide
the other party with a copy of any U.S. FDA Form 483 notices of adverse
findings, regulatory letters or similar notifications it receives
from any
other governmental authority setting forth adverse findings or non
-compliance with any applicable laws, regulations or standards relating
to
the items supplied by it hereunder within five (5) days of its own
receipt
thereof. Each party shall also provide the other party with a copy
of its
proposed written response to such governmental authority before submission
and shall incorporate any changes thereto which the other party may
reasonably request.
|
4.13 |
Clinical
Product sales will be subject to the Discount dependent on the volume
of
orders placed by Advaxis. The level of Discount shall be determined
as set
out in Schedule
1.
Any Discount shall apply to all sales of the Clinical Product to
Advaxis
in the next 12 months.
|
4.14 |
The
prices for the services connected with the manufacture of Clinical
Product
are set out in Schedule 1. These prices will be subject to review
and
Cobra reserves the right to increase these price by up to 2% above
the
rate of inflation current at the time of the price review. The current
rate of inflation is defines as the UK retail price index (RPI) as
published by the UK Office of National
Statistics.
|
4.15 |
The
price review will take place [ * ] providing the RPI [ * ]. Under
those
circumstances where the RPI is greater than [ *
].
|
4.16 |
Advaxis
is allowed to establish or contract with a third party back up
manufacturing source for any Program Deliverable provided that
Advaxis
shall not manufacture more than 1% of the Program Deliverable with
such
third party in the absence of a non Performance Event by
Cobra.
|
Confidential |
Page
12
|
5 |
Change
in Production
Dates for Clinical Product
|
5.1 |
Cobra
has already allocated a production slot for the manufacture of the
first
batch of Clinical Product. Advaxis may request in writing a change
of
production slot for the Clinical Product already ordered at the date
of
this Agreement by giving written notice to Cobra not less than 2
calendar
months before the date of commencement of production under the existing
production slot allocated to the Clinical Product. Cobra will use
its
reasonable endeavours to accept any such request provided that the
requested new production slot is
available.
|
5.2 |
If
Advaxis requests a change or cancellation of a production slot for
Clinical Product already ordered at the date of this Agreement which
is
less than 2 calendar months’ prior to the planned date of commencement of
production under the existing production slot
then:
|
5.2.1 |
Cobra
shall use its reasonable endeavours to accept any such request provided
that the requested new production slot is available;
|
5.2.2 |
Advaxis
shall forfeit the amount of the deposit paid to Cobra and such deposit
shall be unconditionally released to Cobra and not be creditable
against
the price of that Clinical Product;
and
|
5.2.3 |
Advaxis
shall be obliged to pay a further deposit in relation to the rescheduled
production slot for that Clinical Product to which the provisions
of
clauses 5.1 and 5.2 shall again
apply.
|
5.3 |
Advaxis
may request in writing a change of production slot for any further
future
orders of Clinical Product not less than 6 calendar months before
the date
of commencement of production under the production slot allocated
to the
Clinical Product. Cobra will use its reasonable endeavours to accept
any
such request provided that the requested new production slot is
available.
|
5.4 |
If
Advaxis requests a change or cancellation of a production slot for
any
further future orders of Clinical Product and such request is made
fewer
than 6 calendar months’ prior to the planned date of commencement of
production under the production slot allocated to that Clinical Product
then:
|
5.4.1 |
Cobra
shall use its reasonable endeavours to accept any such request provided
that the requested new production slot is available;
|
Confidential |
Page
13
|
5.4.2 |
Advaxis
shall forfeit
|
5.4.2.1 |
20%
of the deposit where the request is made fewer than 6 months but
more than
5 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product;
|
5.4.2.2 |
40%
of the deposit where the request is made fewer than 5 months but
more than
4 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product;
|
5.4.2.3 |
60%
of the deposit where the request is made fewer than 4 months but
more than
3 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product;
|
5.4.2.4 |
80%
of the deposit where the request is made fewer than 3 months but
more than
2 months before the date of commencement of production under the
existing
production slot allocated to that Clinical Product; or
|
5.4.2.5 |
100%
of the deposit where the request is made fewer than 2 months before
the
date of commencement of production under the existing production
slot
allocated to that Clinical Product;
|
5.4.3 |
Advaxis
shall be obliged to pay a further deposit in relation to the rescheduled
production slot for that Clinical Product to which the provisions
of
clauses 5.3 and 5.4 shall again
apply.
|
6 |
Reporting
|
6.1 |
Cobra
shall ensure that regular written reports on the manufacture of the
Clinical Product are provided to
Advaxis.
|
6.2 |
Each
party will promptly notify the other party of any material developments,
progress and/or adverse events which arise in the performance of
its
aspects of the Clinical Trials and/or the
Programme.
|
Confidential |
Page
14
|
6.3 |
Each
party will promptly respond with a full and proper response to any
queries
raised by the other party from time to time in relation to the current
status of the Programme.
|
7 |
Cobra’s
Right of First Refusal for Bulk Drug Substance and Drug
Product
|
7.1 |
Advaxis
will notify Cobra in advance of the anticipated order level for Bulk
Product for each 12 calendar months (commencing each October) by
the end
of the March preceding that period.
|
7.2 |
Cobra
will advise Advaxis in writing within 3 calendar months following
the
determination of the anticipated order level for Bulk Product whether
Cobra will supply:
|
7.2.1 |
all
the Initial Order Level from Cobra’s own production
facilities;
|
7.2.2 |
all
the Initial Order Level from sub-contractors of
Cobra;
|
7.2.3 |
all
the Initial Order Level partly from Cobra’s own production facilities and
partly by sub-contractors of Cobra;
|
7.2.4 |
part
only of the Initial Order Level; or
|
7.2.5 |
none
of the Initial Order Level.
|
7.3 |
Advaxis
will notify Cobra as soon as reasonably practicable of any Increased
Order
Level.
|
7.4 |
Cobra
will confirm in writing within 3 calendar months following notification
of
the anticipated Increased Order Level whether Cobra will
supply:
|
7.4.1 |
all
of the Increased Order Level from Cobra’s own production
facilities;
|
7.4.2 |
all
of the Increased Order Level from sub-contractors of
Cobra;
|
7.4.3 |
all
of the Increased Order Level partly from Cobra’s own production facilities
and partly by sub-contractors of Cobra;
|
7.4.4 |
part
only of the Increased Order Level;
or
|
7.4.5 |
none
of the Increased Order Level.
|
7.5 |
Advaxis
shall ensure that all orders for requirements for Bulk Product are
placed
with Cobra to the extent that Cobra has indicated under clauses 7.2
and
7.4 above that it wishes to supply any Initial Order Level and/or
Increased Order Level by itself and/or in conjunction with its
subcontractors.
|
7.6 |
Advaxis
shall ensure that only its orders for requirements for Bulk Product
which
Cobra has indicated under clauses 7.2 and 7.4 that it does not wish
to
accept will be placed with a Third Party Product
Manufacturer.
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15
|
7.7 |
All
Bulk Product supplied by Cobra to Advaxis (or Advaxis’ nominee) shall be
supplied on Cobra’s Terms and Conditions. If there is any conflict between
such terms and the terms in the main body of this Agreement then
the terms
in the main body of this Agreement shall
prevail.
|
7.8 |
Cobra
shall use its reasonable endeavours to deliver any Bulk Product as
soon as
reasonably possible after firm orders have been placed with
Cobra.
|
8 |
Requirements
for Cobra’s Product
Subcontractors
|
8.1 |
If
Cobra wishes to sub-contract all or any part of the production of
the
Clinical Product and/or the Bulk Product for the Programme, it will
consult with Advaxis and obtain the prior written approval of Advaxis
in
respect of the identity of each sub-contractor. Advaxis shall not
unreasonably refuse and/or delay such approval. Advaxis may also
nominate
a sub-contractor but such sub-contractor shall not be appointed without
the prior written approval of Cobra, which it shall not unreasonable
refuse.
|
8.2 |
Cobra
will use its reasonable endeavours to conclude any sub-contracting
agreements within 9 months of receiving Advaxis’ notification of the
Initial Order Level and/or Increased Order
Level.
|
8.3 |
Any
sub-contract shall conform to the same terms and conditions of this
Agreement. Cobra shall forward to Advaxis any sub-contract for review
by
Advaxis that the terms and conditions of the sub-contract are compatible
with the terms of this Agreement. If material terms are not compatible
or
for other reasonable commercial reasons Advaxis objects to the
sub-contract, Advaxis may refuse approval to Cobra entering into
the
sub-contract. Cobra will ensure that adequate quality control provisions
are included within any of its contracts with sub-contractors, including
a
specification for the production of the Clinical Product and/or the
Bulk
Product (as relevant).
|
8.4 |
The
parties agree that, where Cobra elects to sub-contract all or part
of the
production of Bulk Product and/or Clinical Product, it is Cobra’s
intention to give preference to any eligible sub-contractor on condition
that:
|
8.4.1 |
such
sub-contractor has sufficient capacity, facilities and experience
to
produce the Bulk Product and can demonstrate accreditation for the
manufacture of biological licensed materials;
and
|
8.4.2 |
such
sub-contractor is, as far as Cobra is aware, sufficiently financially
stable, trustworthy and reputable.
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16
|
8.5 |
Cobra
shall be liable for the acts and/or omissions of its sub-contractors
as if
they were its own acts and/or omissions under this Agreement except
where
any such sub-contractor has been nominated by Advaxis as being a
suitable
sub-contractor in which case, as a condition of Cobra’s consent to the
appointment of such sub-contractor, the parties shall agree the
appropriate sharing of risk in relation to the activities of such
sub-contractor.
|
9 |
Price
for Bulk
Product
|
9.1 |
The
price Advaxis will pay Cobra for the supply of Bulk Product is an
amount
equal to the Cost for the Bulk Product plus the Mark Up plus any
freight,
shipping, insurance, packaging and other similar
costs.
|
9.2 |
Cobra
shall use its reasonable endeavours to minimise the Cost of any Bulk
Product which is produced by Cobra’s sub-contractors. Such Cost detailed
and itemized shall be presented to
Advaxis.
|
9.3 |
Sections
4.8- 4.12 above shall also apply to supply of Bulk Product as if
all
references to “Clinical Product” were references to “Bulk
Product”.
|
9.4 |
Recall
Notification: Each Party shall promptly notify the other Party in
writing
of any facts relating to the advisability of the recall, destruction
or
withholding from the market of the Bulk Product anywhere in the world
(collectively, "Recall").
|
9.5 |
Recall
Implementation: If at any time (a) any governmental or regulatory
authority issues a request, directive or order for a Recall; (b)
a court
of competent jurisdiction orders a Recall; or (c) Advaxis reasonably
determines that a Recall is necessary or advisable, Advaxis shall
take all
appropriate corrective actions to effect the Recall and Cobra shall
provide Advaxis with such cooperation in connection with the Recall
as
Advaxis may reasonably request
|
9.6 |
Recall
Costs and Expenses: Advaxis shall bear the costs and expenses of
any
Recall (including any costs and expenses incurred by Cobra in assisting
Advaxis under clause 9.5 above) to the extent such Recall is the
result of
any fault or omission attributable to Advaxis or its affiliates;
and Cobra
shall bear all reasonable costs and expenses of any Recall to the
extent
such Recall is the result of any fault or omission attributable to
Cobra
or its affiliates.
|
10 |
Technology
Transfer
|
10.1 |
If
Cobra:
|
10.1.1 |
confirms
that it will not, either itself or by using sub-contractors, supply
all of
Advaxis’s requirements for Bulk Product;
and/or
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Page
17
|
10.1.2 |
confirms
that it will supply any and/or all of Advaxis’ requirements for Bulk
Product using sub-contractors and Cobra then fails to conclude any
sub-contracting agreement in relation to such supply of such Bulk
Product
within 9 months of the date of Advaxis’s notification in respect of the
Initial Order Requirements and/or Increased Order Requirements (as
the
case may be); and/or
|
10.1.3 |
has
not scaled up for commercial volume production of Bulk Product in
respect
of Advaxis ’s Initial Order Requirements and/or Increased Order
Requirements within 9 months of Advaxis notifying Cobra of Advaxis’
Initial Order Requirements and/or Increased Order Requirements (as
the
case may be);
|
10.2 |
Cobra
and ADVAXIS shall consult in respect of the identity of any Third
Party
Product Manufacturer to which a Technology Transfer is to occur.
|
10.3 |
The
identity of any Third Party Product Manufacturer shall be subject
to
Cobra’s prior written consent (such consent not to be unreasonably
withheld or delayed).
|
10.4 |
The
Technology Transfer will:
|
10.4.1 |
be
negotiated by Cobra in good faith;
|
10.4.2 |
incorporate
such commercial terms as Cobra reasonably requires in order to protect
its
Intellectual Property Rights and/or materials in relation to Cobra
Know
How;
|
10.4.3 |
provide
for Cobra to train the Third Party Product Manufacturer at the then
current market rates for such training to produce Bulk Product.
|
10.5 |
Any
costs and expenses to Cobra associated with the Technology Transfer
shall
be borne and paid for by Advaxis except to the extent that they are
borne
and paid for by the Third Party Product
Manufacturer.
|
10.6 |
Advaxis
at its sole discretion may instruct Cobra to enter into a Technology
Transfer in accordance with this Section 10 as it relates to one
or
several Programme Deliverables, in one or several disease indications,
and
with one or several Third Party Product
Manufacturers.
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18
|
11 |
Royalty
on Technology Transfer
|
11.1 |
Where
a Technology Transfer to cover production of Bulk Product takes place
(except for in a Non Performance Event as defined below), Advaxis
shall
pay to Cobra a [ * ] (three quarters of one percent) of the Net Sales.
Such Royalty shall be capped at a maximum aggregate royalty [ *
].
|
11.2 |
A
“Non
Performance Event”
shall be defined as any of the following: (a) Cobra is unable to
initiate
manufacture of any material required by Advaxis within 90 days due
to
scheduling issues, (b) Cobra is unable or causes unreasonable delays
in
manufacture or development of any product required by Advaxis; and/or
(c)
due to regulatory reasons Cobra cannot manufacture/supply material;
(d)
Cobra is unable to meet the quantities required by Advaxis in relation
to
orders accepted by Cobra.
|
12 |
General
Financial
|
12.1 |
The
payment of all sums payable under this Agreement shall be made in
US
Dollars based on the applicable exchange rate as published from time
to
time by the Wall Street Journal at the day of transfer, by telegraphic
transfer to a bank account nominated from time to time by Cobra.
Any
applicable banking charges on such payments shall be borne by
Advaxis.
|
12.2 |
Where
it is necessary to calculate the exchange rate for the purposes of
payment
of any sums due under this Agreement, the exchange rate used shall
be the
exchange rate at which any monies received by Advaxis are actually
converted to pounds sterling or if they are not so converted during
the
relevant period the exchange rate shall be the spot exchange rate
for
pounds sterling quoted by Advaxis’s bankers at close of business on the
business day preceding the due date for payment of each such
sum.
|
12.3 |
All
sums payable under this Agreement are exclusive of any value added
tax or
other applicable taxes or duties which shall be payable in
addition.
|
12.4 |
All
monies payable under this Agreement shall be paid in cleared funds
without
any set-off, deduction or withholding except any tax which Advaxis
is
required by law to deduct or withhold.
|
12.5 |
If
Advaxis is required by law to make any tax deduction or withholding,
Advaxis shall do all things in its power which may be necessary to
enable
or assist Cobra to claim exemption from or (if that is not possible)
a
credit for the deduction or withholding under any applicable double
taxation or similar agreement from time to time in force, and shall
from
time to time give Cobra proper evidence of the deduction or withholding
and payment over of the tax deducted or withheld.
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|
12.6 |
If
Cobra is not able to obtain a full credit under any applicable double
taxation or similar agreement for any tax deduction or withholding
made
from monies payable to Cobra by Advaxis under this Agreement then
the
amount of monies payable to Cobra shall be grossed up and increased
so
that, after the tax deduction or withholding, Cobra actually receives
the
net amount that would have been due if no tax deduction or withholding
was
being made.
|
12.7 |
If
any party fails to pay in full any monies payable under this Agreement
on
the date specified for payment, the amount outstanding shall bear
interest, both before and after any judgement, from that date until
that
amount is paid in full to Cobra at the rate of 2% above the 6 month
Libor
rate as published in the Wall Street
Journal.
|
12.8 |
Each
party shall:
|
12.8.1 |
keep
(and procure that third parties engaged directly and/or indirectly
by it
keep) true and accurate accounts and records in sufficient detail
to
enable the Net Sales, the Facility Occupancy Charge, the Cost of
supply of
Bulk Product, the Mark Up and the amount of any monies payable under
this
Agreement to be determined and/or verified;
and
|
12.8.2 |
at
the reasonable request of the other party from time to time, allow
(and
procure that third parties engaged directly and/or indirectly by
it allow)
the other party or its auditors (at its expense) to inspect such
accounts
and records referred to in clause 12.8.1 above and, to the extent
that
they relate directly or indirectly to the calculation of any monies
payable under this Agreement, to take copies of them.
|
12.9 |
If,
following any inspection pursuant to clause 12.8.2 above, either
party’s
auditors certify to that party and the other party that the amount
of
monies paid in respect of any period falls short of the amount of
the
monies which were properly payable in respect of that period, the
party
owing the shortfall shall within 7 days of being served with a copy
of the
certificate pay the shortfall plus interest on that sum to the other
party.
|
12.10 |
The
provisions of this Section 12 shall remain in full force and effect
after
the termination of this Agreement for any reason until the settlement
of
all subsisting claims between the parties under this
Agreement.
|
13 |
Confidentiality
|
13.1 |
For
the purposes of this Agreement, any Confidential Information relating
to
Programme Deliverable, Vaccine Process, Bulk Product, Programme,
Programme
Data, Programme IP, or the Clinical Trials shall be treated as Advaxis
Confidential Information.
|
Confidential |
Page
20
|
13.2 |
For
the purposes of this Agreement, any Confidential Information relating
to
the Cobra Know How shall belong to Cobra and shall be treated as
Cobra’s
Confidential Information.
|
13.3 |
Each
of the parties undertakes to the other, in respect of the other party’s
Confidential Information that it (and it will procure that its employees,
ex-employees, consultants, and/or sub-contractors)
shall:-
|
13.3.1 |
only
use the other party’s Confidential Information which is disclosed and/or
acquired by it for the direct purposes of the Programme under this
Agreement;
|
13.3.2 |
not
disclose Confidential Information to any third party and maintain
as
confidential all the other party’s Confidential Information which may come
into its possession in any manner;
|
13.3.3 |
allow
access to the other party’s Confidential Information only to such of its
employees, consultants and/or sub-contractors who need to see and
use it
for the purposes of the Programme under this
Agreement;
|
13.3.4 |
upon
request by the other party made at any time deliver up to the other
party
all documents, material and/or other media which is in its possession,
custody or control which comprises or contains any part of the other
party’s Confidential Information provided that it shall be entitled to
retain one copy of such Confidential Information for archive purposes;
and
|
13.3.5 |
not
incorporate any Confidential Information of the other party in a
patent
application, and may not submit any Confidential Information of the
other
party in any regulatory application without the express prior written
authority of the other party.
|
13.4 |
Confidential
Information shall not include any information
which:-
|
13.4.1 |
the
other party can prove by documentary evidence produced by it was
information already in its possession and at its free
disposal;
|
13.4.2 |
the
other party can prove by documentary evidence produced by it was
information independently developed by it without reference to
Confidential Information of the other
party;
|
13.4.3 |
is
after the date of this Agreement disclosed to the other party without
any
obligations of confidentiality by a third party who has not derived
it
directly or indirectly from the party whose Confidential Information
it
was;
|
Confidential |
Page
21
|
13.4.4 |
is
or becomes available to the public through no act or default on the
part
of the other party; or
|
13.4.5 |
is
required to be disclosed by law or the rules of any stock exchange
and/or
regulatory authority provided where possible the disclosing party
gives
not less than 7 days’ advance notice of any such disclosure to the other
party whose Confidential Information it is and discusses with them
the
form and content of such disclosure.
|
13.5 |
If
a party reasonably requests that any Confidential Information of
the other
party be disclosed because of regulatory purposes, the party making
the
disclosure shall seek confidential treatment of the materials proposed
to
be disclosed and shall use commercially reasonable efforts to request
confidential treatment of such information pursuant to Rule 406 of
the
Securities Act of 1933 or Rule 25b-2 of the Securities Exchange Act
of
1934, as applicable (or any other applicable regulation relating
to the
confidential treatment of information), except to the extent that
the
party making the disclosure receives advice from its legal counsel
that
such Confidential Information is required to be disclosed under applicable
laws or regulations. The party making the disclosure shall give reasonable
advance notice to the other party of such disclosure and use efforts
to
secure confidential treatment of such information at least as diligent
as
such party would use to protect its own confidential information,
but in
no event less than reasonable efforts. In any event, the parties
agree to
take all reasonable action to avoid disclosure of Confidential Information
hereunder. The parties will consult with each other on the provisions
of
this Agreement to be redacted in any filings made by the parties
with the
Securities and Exchange Commission or as otherwise required by law
and on
any disclosure to third parties.
|
13.6 |
Subject
to clause 13.4 and 13.5 above, either party is allowed to disclose
the
other party’s Confidential Information solely for regulatory purposes.
|
13.7 |
Neither
party may disclose the existence of this Agreement or the terms and
conditions of this Agreement without the prior written consent of
another,
except for regulatory purposes as set forth in Section 13. Any press
release shall be coordinated by the parties subject to final review
and
approval by both parties.
|
13.8 |
For
the avoidance of doubt either party shall be entitled to disclose
the
other party’s Confidential Information to any sub-contractor which is
performing all or part of the work under the Programme subject to
it
imposing duties of confidentiality and non use on the sub-contractor
which
are no less onerous than those contained in this
Agreement.
|
13.9 |
Each
party shall be liable to the other for the acts and/or omissions
of its
employees, ex-employees, consultants and/or sub-contractors as if
they
were its own acts and/or omissions under this Agreement.
|
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22
|
13.10 |
The
obligations of confidentiality and non use in this Agreement shall
continue for 10 years after the termination of this
Agreement.
|
13.11 |
Each
party recognizes that violation of confidentiality results in irreparable
harm and agree to injunctive relief and damages.
|
14 |
Intellectual
Property
|
14.1 |
Any
and all Programme Deliverable, Programme IP and Programme Data under
this
Agreement shall be solely owned by Advaxis. Cobra agrees to assign
and
will assign to Advaxis, the sole and exclusive ownership of the Programme
IP.
|
14.2 |
Prosecution
and Maintenance of Programme Intellectual Property
Rights.
Advaxis shall control, prosecute and maintain all Programme IP. Advaxis
shall be responsible for all costs, fees and expenses incurred from
and
after the Effective Date in connection with the filing, prosecution
and
maintenance of such Programme IP.
|
14.3 |
The
disclosure or provision to Cobra of any Confidential Information
of
Advaxis or other information or items shall not be deemed to transfer
or
grant to Cobra, or any other person or entity any right, title, interest,
or license in, to or under any patent or patent application of Advaxis
or
other intellectual property or other right of Advaxis or in or to
any
information, discoveries, knowledge, experience, processes, procedures,
devices, compositions of matter, skills, know-how, samples, trade
secrets,
designs, formulae, specifications, methods, techniques, compilations,
programs, devices, technical information, concepts, developments,
inventions or improvements, whether patentable or not, or other
technology, inventions or property of Advaxis other than any rights
and/or
licence granted under the terms of this
Agreement.
|
14.4 |
Cobra
agrees (and shall ensure that all employees and agents do the same)
that
all information, materials, master cell banks, regulatory reports,
discoveries, knowledge, experience, processes, procedures, devices,
compositions of matter, skills, know-how, samples, trade secrets,
designs,
formulae, specifications, methods, techniques, compilations, programs,
devices, technical information, concepts, developments, inventions
or
improvements, whether patentable or not) arising from Cobra’s performance
of its obligations under this Agreement shall promptly be made known
to
Advaxis in writing (subject to obligations of confidentiality). Cobra
willexecute any and all documents and do any and all things reasonably
requested by to vest and perfect Advaxis interest in the Programme
IP.
|
14.5 |
Cobra
hereby assigns, and shall cause all investigators and clinical sites
to
assign, to Advaxis all right, title and interest, including copyrights
and
other Intellectual Property Rights, in and to all Programme
Data.
|
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23
|
14.6 |
Enforcement
of Licensed Intellectual Property Rights and Missapropriation of
Know-How
and Programme Deliverable.
Each party shall promptly notify the other in writing of any alleged
or
threatened infringement of any Programme IP of which such party becomes
aware.
|
14.6.1 |
With
respect to any infringement in any territory of any Programme IP,
Advaxis
has the sole right to direct, control and bring any action or proceeding
in its own name, with respect to such infringement at its own expense
and
by counsel of its own choice, and Cobra shall have the right, at
its own
expense, to be represented in any such action by counsel of its own
choice. In the event Advaxis brings an infringement action in accordance
with this Section, Cobra shall cooperate fully, including if required
to
bring such action, the furnishing of a power of attorney provided
that
Advaxis pays Cobra’s costs of doing the same.
|
14.6.2 |
With
respect to any misappropriation, conversion or other federal, state,
or
local cause of action in any territory of any Programme Deliverable,
and
Programme Data, Advaxis has the sole right to direct, control and
bring
any action or proceeding in its own name, with respect to such
misappropriation at its own expense and by counsel of its own choice,
and
Cobra shall have the right, at its own expense, to be represented
in any
such action by counsel of its own choice. In the event Advaxis brings
an
misappropriation action in accordance with this Section, Cobra shall
cooperate fully, including if required to bring such action, the
furnishing of a power of attorney provided that Advaxis pays Cobra’s costs
of doing the same.
|
14.7 |
Third
Party Infringement Claims.
Each party shall promptly notify the other in writing of any allegation
by
a third party that the activity of either of the parties pursuant
to this
Agreement infringes or may infringe the Intellectual Property Rights
of
such third party. Advaxis shall have the sole right to control, direct
or
defend in its own name any defense, action, appeal of any such claim,
action, proceeding at its own expense and by counsel of its own choice.
Advaxis shall act in good faith in the conduct of any such third
party
claim. During the pendency of any such proceeding or any appeal thereof
where the proceedings are as a result of any default of Cobra under
this
Agreement, any payment hereunder to Cobra shall be paid by Advaxis
into an
interest-bearing escrow account pending the outcome of such proceeding.
Upon a favorable final resolution of such proceeding or any appeal
thereof
retaining the full rights, Advaxis shall resume paying Cobra the
full
royalties, and all funds in such escrow account shall be paid to
Cobra
plus any interest which has accrued on such sum. Upon an unfavorable
final
resolution of such proceeding or any appeal thereof, the funds in
such
escrow account shall be applied toward the damage award in such action,
if
any, and the balance plus interest, if any, paid to
Cobra.
|
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|
14.8 |
Cooperation
of the Parties.
Each party agrees to cooperate fully in the preparation, filing,
and
prosecution of any Programme IP under this Agreement and in the obtaining
and maintenance of any patent extensions, supplementary protection
certificates and the like with respect to any Intellectual Property
Rights
being developed or commercialized by Advaxis. Such cooperation includes,
but is not limited to, promptly informing the other party of any
matters
coming to such party’s attention that may affect the preparation, filing,
prosecution or maintenance of any Intellectual Property
Rights.
|
14.9 |
Cobra
shall not co-mingle any Programme Deliverable and/or Programme IP
and/or
Programme Data with any compositions, data, information, materials,
and
methods which are proprietary to a third party; and/or with any Cobra
Know- How.
|
15 |
Representations
and Warranties
|
15.1.1 |
Cobra
represents and warrants to Advaxis that:
|
16 |
Indemnities
|
16.1 |
With
respect to any indemnification obligations of either party to the
other
party under this Agreement, the following conditions must be met
for such
indemnification obligations to become applicable where a third party
is
involved: (a) the indemnified party shall notify the indemnifying
party
promptly in writing of any claim which may give rise to an obligation
on
the part of the indemnifying party hereunder; (b) the indemnifying
Party
shall be allowed to timely undertake the sole control of the defense
of
any such action and claim, including all negotiations for the settlement,
or compromise of such claim or action at its sole expense; and (c)
the
indemnified party shall render reasonable assistance, information,
co-operation and authority to permit the indemnifying Party to defend
such
action, it being agreed that any out-of-pocket expenses or other
expenses
incurred by the indemnified party in rendering the same shall be
borne or
reimbursed promptly by the indemnifying party. These conditions shall
not
apply where the claim for which a party may seek indemnification
from the
other party under this section 16 is a claim as between the two
parties.
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25
|
16.2 |
Advaxis
will indemnify and keep indemnified Cobra against any and all claims,
damages, awards, costs (including legal costs on a full indemnity
basis),
compensation, actions, expenses, proceedings and any other losses
and/or
liabilities that may be caused by and/or arise as a result of the
conduct
of the Clinical Trials by Advaxis and/or its employees, sub-contractors
and/or agents, use of the Advaxis IP and/or the Clinical Product
and Bulk
Product (apart from the Cobra Know How) and/or any of the foregoing
infringing and/or being alleged to infringe any third party Intellectual
Property Rights except to the extent that such matters are due to
i)
manufacture or supply of Clinical Product and/or Bulk Product not
in
accordance with Manufacture Specifications; ii) breach of the
representations and warranties of this Agreement; iii) a willfull
or
grossly negligent act by Cobra; or iv) an inherent defect in the
Cobra
Know How and/or a defect in the manufacture of Bulk Product supplied
by
Cobra.
|
16.3 |
Cobra
will indemnify and keep indemnified Advaxis from and against any
and all
claims, damages, awards, costs (including legal costs on a full indemnity
basis), compensation, actions, expenses, proceedings and any other
losses
and/or liabilities that may be caused by and/or arise as a result
of a
defect in the production of the Bulk Product provided by Cobra and/or
its
employees, sub-contractors (except to the extent that risk is agreed
not
to borne by Cobra under clause 8.5) and/or
agents.
|
16.4 |
If
the parties are not able to resolve which party is liable to indemnify
the
other party then the matter shall be determined by an expert in accordance
with section 21.
|
17 |
Force
Majeure
|
17.1 |
If
either party is affected by Force Majeure it shall immediately notify
the
other party of its nature and
extent.
|
17.2 |
Neither
party shall be deemed to be in breach of this Agreement or otherwise
be
liable to the other, by reason of any delay in the performance, or
the
non-performance, of any of its obligations under this Agreement (other
than in respect of payment), to the extent that the delay or
non-performance is due to any Force Majeure of which it has notified
the
other party, and the time for performance of that obligation shall
be
extended by a period equal to the period of the Force
Majeure.
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|
17.3 |
If
the Force Majeure in question prevails for a continuous period in
excess
of 6 months, the party not affected by the Force Majeure shall, for
so
long as the Force Majeure continues, have the right to immediately
terminate this Agreement by written notice served on the other
party.
|
18 |
Duration
and Termination
|
18.1 |
This
Agreement shall come into force on the date of this Agreement and
shall,
unless terminated earlier for any reason, continue in force for as
long as
the Programme continues.
|
18.2 |
Either
party may terminate this Agreement forthwith by giving written notice
to
the other if:
|
18.2.1 |
18.2.2 |
the
other party breaches any of its obligations under this Agreement
(and, if
the party fails to remedy it within 45 days after being given a written
notice containing full particulars of the breach and requiring it
to be
remedied); or
|
18.2.3 |
the
other party persistently breaches its obligations under this Agreement
and
does not cure such breaches after being provided with reasonable
notice
and an opportunity to cure such breaches;
or
|
18.2.4 |
an
encumbrancer takes possession, or a receiver is appointed, of any
of the
property or assets of the other party;
or
|
18.2.5 |
the
other party becomes subject to an administration order, a moratorium
is
declared in respect of its debts or it makes any voluntary arrangement
with its creditors (within the meaning of the Insolvency Act 1986);
or
|
18.2.6 |
the
other party goes into liquidation (except for the purposes of amalgamation
or reconstruction and so that the resulting company effectively agrees
to
be bound by or assume the obligations imposed on that other party
under
this Agreement); or
|
18.2.7 |
the
other party suffers or undergoes any procedure analogous to any event
specified in clauses 18.2.3 to 18.2.5 above or any other procedure
available in the country in which the other party is constituted
or
established against or to an insolvent debtor or available to the
creditors of such a debtor.
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27
|
18.2.8 |
In
the event Advaxis determines that patient safety considerations or
due to
regulatory considerations that the supply/manufacture of the Bulk
Product
or Programme Deliverable should immediately cease and the Bulk Product
or
Programme Deliverable withdrawn from the market, Advaxis shall promptly
inform Cobra of such determination and the reasons therefore and
the
Supply/Manufacture shall terminate.
|
18.3 |
For
the purposes of clause 18.2.2 above, a breach shall be considered
capable
of remedy if the party in breach can comply with the provision in
question
in all respects other than as to the time of performance (provided
that
the time of performance is not of the
essence).
|
18.4 |
[
*
].
|
19 |
Effects
of Termination
|
19.1 |
If
this Agreement is terminated by Cobra under clauses 18.2.1 to 18.2.7,
Cobra shall transfer to Advaxis any and all Programme Deliverable,
Vaccine
Process, Programme IP, Programme Data, and Know-How and any information
and materials reasonably requested by Advaxis so as to allow them
to
continue with the Programme and the development, trials and/or
exploitation of the Programme
Deliverable.
|
19.2 |
The
termination of this Agreement by Advaxis shall not affect any existing
contracts for the supply of Clinical Product and/or Bulk Product
which
shall remain in force unless Advaxis also terminates such contracts
in
accordance with their terms. On termination of this Agreement by
Advaxis ,
Cobra may at its option terminate any outstanding orders for Clinical
Product and/or Bulk Product without any liability to
Cobra.
|
19.3 |
Upon
the termination of this Agreement for any reason any provisions which
expressly and/or impliedly survive the such termination shall continue
in
full force and effect including sections 4 to 14, 16, 17, 18, 19
and
20.
|
19.4 |
Termination
of this Agreement shall not affect any pre-existing claims and/or
rights
of the parties arising and/or in force prior to such
termination.
|
19.5 |
Any
and all payments due as at the date of termination shall immediately
become due and payable.
|
20 |
General
|
20.1 |
Relationship
Between the Parties.
The parties’ relationship, as established by this Agreement, is solely
that of independent contractors. This Agreement does not create any
partnership, joint venture or similar business relationship between
the
parties. Neither party is a legal representative of the other party,
and
neither
party can assume or create any obligation, representation, warranty
or
guarantee, express or implied, on behalf of the other party for any
purpose whatsoever.
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28
|
20.2 |
Any
notice required or provided for by the terms of this Agreement shall
be in
writing, addressed to the address at the head of this Agreement or
such
other address as may be notified in writing, and sent by registered
or
certified mail, return receipt requested, postage prepaid, or by
express
courier service providing evidence of delivery or by facsimile
transmission. The effective date of any notice shall be the date
of
receipt by the Cobra.
|
20.3 |
This
Agreement may be executed in two counterparts, each of which shall
be
deemed an original and both of which together shall constitute one
and the
same instrument.
|
20.4 |
All
rights of any third party to enforce the terms of this Agreement
are
excluded. This shall not apply to members of each party’s group in
relation to which it gives its consent who shall be entitled to enforce
the terms of this Agreement in addition to that party. All rights
of third
parties to enforce the terms of this Agreement may be varied and/or
extinguished by the agreement of the parties to this Agreement without
the
consent of any such third party.
|
20.5 |
This
Agreement shall take effect from the date of the last party to sign
this
Agreement or date upon which signed copies are exchanged by the
parties.
|
20.6 |
Nothing
in this Agreement is intended or will be construed as constituting
a
partnership, agency or joint venture relationship between the parties.
All
activities by the parties under this Agreement will be performed
by them
as independently.
|
20.7 |
Waiver
by either party of a breach of, or failure to comply with, this Agreement
by the other party is of no effect unless it is in writing and signed
by
or on behalf of the first mentioned
party.
|
20.8 |
If
any term or provision of this Agreement can sustain two or more
interpretations, one of which results in the terms or provision being
valid, legal or enforceable, that term or provision will be given
that
interpretation rather than an interpretation which would or be likely
to
result in the term or provision being invalid, illegal or
unenforceable.
|
20.9 |
If
any term or provision of this Agreement is to any extent held to
be
invalid, illegal or unenforceable, the validity, legality, and
enforceability of the remaining terms or provisions (and any application
of the said terms or provisions) will not in any way be affected
or
impaired.
|
20.10 |
If
any term or provision of this Agreement is to any extent held to
be
invalid, illegal or unenforceable, the parties will negotiate in
good
faith and, if legally possible, will agree on an alternate term or
provision having regard to the original intention of the
parties.
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29
|
20.11 |
Advaxis
has the right to assign its rights in this Agreement. Cobra does
not have
the right to assign its right in this
agreement.
|
20.12 |
This
Agreement represents the entire understanding between the parties
and
supersedes any and all previous understandings both written and oral
with
respect to the subject matter of this Agreement with the exception
of the
discount and royalty terms applied to contracts agreed before January
2005.
|
20.13 |
This
Agreement may not be amended, varied, supplemented or otherwise modified
except by an instrument in writing signed by both
parties.
|
20.14 |
Cobra
shall ensure that, in addition to this Agreement between Cobra and
Advaxis, any successor to Cobra is bound by an agreement with Advaxis
on
the same terms as this Agreement as if such successor were Cobra
under
this Agreement
|
20.15 |
Each
party shall from time to time do all such acts and execute all such
documents as may be reasonably necessary in order to give effect
to the
provisions of this Agreement.
|
20.16 |
Except
as otherwise provided in this Agreement, the parties shall bear their
own
costs of and incidental to the preparation, execution and implementation
of this Agreement
|
21 |
Experts
|
21.1 |
If
the parties are unable to agree on the calculation of Cost in relation
to
any matter and/or the calculation of Net Sales from exploitation
of the
Resale Products within 30 days then the calculation shall be determined
by
an independent chartered accountant selected by the agreement of
the
parties. If the parties have not agreed upon the identity of such
accountant within 14 days then, upon the application of either party,
he
shall be selected by the President of the Institute of Chartered
Accountants of England and Wales at the relevant time. Such accountant
shall be appointed on behalf of the parties jointly and each party
shall
initially pay half his professional fees. In determining the relevant
Cost
and/or division of Net Sales such accountant shall act as an expert
and
not as an arbitrator and may make any award as to costs as he sees
fit in
his absolute discretion. His decision shall be final and binding
on the
parties save in the case of manifest
error.
|
21.2 |
If
the parties are unable to agree on the cause of any defect in the
Programme Deliverable for the purposes of the indemnities in section
16
within 30 days then the cause shall be determined by an independent
biological engineering expert selected by the agreement of the parties.
If
the parties have not agreed upon the identity of such expert within
14
days then, upon the application of either party, he shall be selected
by
the President of the Institute of Chemical Engineers in England and
Wales
at the relevant time. Such expert shall be appointed on behalf of
the
parties jointly and each party shall initially pay half his professional
fees. In determining the relevant cause such expert shall act as
an expert
and not as an arbitrator and may make any award as to costs as he
sees fit
in his absolute discretion. His decision shall be final and binding
on the
parties save in the case of manifest
error.
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30
|
22 |
Disputes
|
22.1 |
English
law shall apply to the whole of this Agreement, and each party agrees
to
submit to the non-exclusive jurisdiction of the English
courts.
|
23 |
Intellectual
Property
|
23.1 |
The
terms as agreed in the existing Phase I and II agreements between
Cobra
and Advaxis shall apply and remain in full force and effect. If there
is
any conflict between the terms of this Agreement and the terms of
the
existing Phase I and II agreements, the terms of this Agreement shall
prevail.
|
24 |
Exclusive
supply
|
24.1 |
Cobra
shall not provide, supply, license, transfer, convey, or disclose,
Programme Deliverable, Vaccine Process, Programme Data, Programme
IP, to
any third party for research or development pre-clinical or clinical
trials, importing, distribution, sales or any other commercial purpose,
or
any other purpose, without the prior written consent of Advaxis.
This
section shall survive termination of this Agreement for any reason.
Cobra
shall not manufacture or supply any live or dead, or recombinant
Listeria
product to any third party for any commercial purpose without the
prior
written consent of Advaxis. This section shall survive the termination
of
this agreement for any reason.
|
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31
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32
|
Confidential |
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33
|
1. |
CONFIDENTIALITY
|
1.1 |
to
regard the material, information and results as confidential and
the
property of the Customer;
|
1.2 |
to
take all practical steps possible to ensure that the work, material,
information and results are kept secure and not subject to unauthorised
disclosure;
|
1.3 |
to
disclose the material, information and results only to those of its
employees who need to know the same and Cobra shall take all steps
reasonably practicable to ensure that such employees will comply
with the
requirements and restrictions herein
contained.
|
1.1 |
was
known to it from its own activities prior to disclosure by the Customer
as
evidenced by written records of Cobra predating the date of such
disclosure by the Customer; or
|
1.2 |
was
part of the public domain or the subject to public knowledge at the
date
of disclosure by the Customer; or
|
1.3 |
becomes
part of the public domain or the subject of public knowledge after
the
date of disclosure by the Customer without breach of any obligation
owed
by Cobra to the Customer; or
|
1.4 |
are
furnished to Cobra by a third party without breach of any obligation
of
confidentiality owed by that third party to the Customer;
or
|
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34
|
1.5 |
.
|
2. |
SUB-CONTRACTING
|
3. |
QUALITY
ASSURANCE
|
3.1 |
Cobra
undertakes that it shall conduct the work with all reasonable skill
and
care and where applicable under the prevailing norms for Good
Manufacturing Practice and Good Laboratory Practice as applied to
the
manufacture of biotherapeutic products for Phase I/II clinical trial
purposes.
|
3.2 |
Subject
to clause 3.1 above, Cobra does not give any guarantee or assurance
that
the product in question shall be successfully
produced.
|
4. |
HEALTH
AND SAFETY
|
5. |
VARIATIONS
|
6. |
REPORTS
|
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35
|
7. |
PROTOCOLS
AND CONTRACTS
|
8. |
PAYMENT
|
9. |
INTEREST
|
10. |
PRICES
|
11. |
INTELLECTUAL
PROPERTY RIGHTS AND
INVENTIONS
|
12. |
OWNERSHIP
OF MATERIALS
|
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Page
36
|
13. |
CUSTOMERS
CONFIDENTIALITY
OBLIGATIONS
|
14. |
ARCHIVAL
STORAGE
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37
|
15. |
TERMINATION
|
15.1 |
Subject
to clause 15.2 below, either the Customer or Cobra shall be entitled
to
terminate the contract by giving the other three months written notice.
In
the event of termination by the Customer, for any reason not the
fault of
Cobra, Cobra reserves the right to charge for all costs associated
with
the termination.
|
15.2 |
Either
party may terminate these terms and conditions forthwith by written
notice
to the other party if:
|
15.2.1 |
the
other party shall commit a material breach of any of its obligations
under
these terms and conditions and shall not have remedied such a breach
within thirty days of receiving written notice of the breach;
or
|
15.2.2 |
the
other party shall become bankrupt or enter into liquidation (other
than
the reconstruction of amalgamation) or have a receiver appointed
of its
assets or any part thereof or any administrative order is served
upon
it.
|
15.2.3 |
In
the event Advaxis determines that patient safety considerations or
due to
regulatory considerations that the supply/manufacture should cease,
Advaxis shall promptly inform Cobra of such determination and the
reasons
therefore and the Supply/Manufacture shall terminate.
|
15.3 |
Termination
shall not prejudice or affect any right of action or remedy which
shall
have accrued or shall thereafter accrue to either
party.
|
15.4 |
For
the avoidance of doubt, termination shall not affect any property
or
intellectual property rights vested in the Customer under these terms
and
conditions.
|
16. |
FORCE
MAJEURE
|
16.1 |
Cobra
shall not be liable for any delay in meeting or for failure to meet
any of
its obligations under these terms and conditions due to any cause
outside
of its reasonable control, including without limitation, strikes
and
lock-outs (but excluding strikes and lock-outs of the affected party
and
its subcontractors), acts of God, war, riot, malicious acts of damage
(but
excluding malicious damage involving the employees of the affected
party
or its subcontractors), fire, acts of any government authority or
failure
of the public electricity supply. [The exception being a decision
by the
Medicines Control Agency, which indicates that the material provided,
has
been produced without appropriate GMP or GLP
controls/documentation].
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38
|
16.2 |
If
Cobra is prevented from meeting any of its obligations due to an
event
described in 16.1, it shall promptly notify the Customer in writing
of the
circumstances and if Cobra shall have been so prevented from meeting
its
obligations for more than thirty days following the date of giving
such
notice, then either party may terminate these terms and conditions
forthwith upon written notice.
|
16.3 |
In
the event of termination by either party by reason of Cobra suffering
an
event described in clause 16.1 which prevents Cobra from meeting
its
obligations for more than thirty days from the date which Cobra gave
notice of the event to the Customer, then subject to clause 15.3,
the
Customer shall be under no obligation to pay Cobra any
sum.
|
17. |
LIMITATION
OF LIABILITY AND INDEMNITY - same as Section 16
above
|
18. |
CONTINUING
OBLIGATIONS
|
19. |
NOTICES
|
19.1 |
Any
notice, which expression includes any other communication whatsoever
which
is made in accordance with these terms and conditions, should reference
the Cobra contract shown at the head of these terms and conditions
and
shall, without prejudice to any other method of giving it, be sufficiently
given if it is sent by registered or recorded delivery first class
post to
the other party to the address stated on the signature page of these
terms
and conditions or to such other address as the respective party may
advise
by notice in writing from time to
time.
|
19.2 |
Notices
shall be deemed to have been properly given after three working days
in
the case of notices posted in the United Kingdom to a destination
therein
and eight working days in the case of all other notices posted
internationally.
|
19.3 |
Any
written notices or instructions to make variations under clause 5
shall be
sent to each party’s project
manager.
|
20. |
WAIVER
|
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39
|
21. |
CONSTRUCTION
OF THESE TERMS AND
CONDITIONS
|
21.1 |
If
the scope of any of the provisions of these terms and conditions
is too
broad in any respects to permit enforcement to its full extent, then
the
parties agree that such a provision shall be enforced to the maximum
extent permitted by law and that such provision shall be deemed to
be
varied accordingly.
|
21.2 |
No
purported variations of these terms and conditions shall take effect
unless made in writing and signed by an authorised representative
of each
party.
|
22. |
PROPER
LAW OF CONTRACT
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40
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|