Delaware
|
|
98-0178636
|
(State of other jurisdiction of
incorporation or
organization)
|
|
(IRS Employer Identification No.)
|
Large
accelerated filer o
|
Accelerated
filer o
|
|
Non-accelerated
filer o
|
|
Smaller
reporting company x
|
PART
I. FINANCIAL INFORMATION
|
|
Item
1. Financial Statements (unaudited)
|
|
Consolidated
Balance Sheets - January 31, 2010 (unaudited) and July 31,
2009
|
1
|
Consolidated
Statements of Operations — For the three and six-month periods ended
January 31, 2010 and 2009, and cumulative from November 2, 1995 to January
31, 2010 (unaudited)
|
2
|
Consolidated
Statements of Cash Flows — For the six month periods ended January 31,
2010 and 2009, and cumulative from November 2, 1995 to January 31, 2010
(unaudited)
|
3
|
Notes
to Consolidated Financial Statements (unaudited)
|
5
|
Item
2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
|
14
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
27
|
Item
4. Controls and Procedures
|
27
|
PART
II: OTHER INFORMATION
|
|
Item
1. Legal Proceedings
|
27
|
Item
1A. Risk Factors
|
27
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
29
|
Item
3. Defaults Upon Senior Securities
|
30
|
Item
4. Reserved.
|
-
|
Item
5. Other Information
|
30
|
Item
6. Exhibits
|
30
|
Signatures
|
31
|
January
31,
|
July
31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
(Audited)
|
|||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$ | 22,624,666 | $ | 14,197,048 | ||||
Accounts
receivable
|
142,301 | 57,792 | ||||||
Inventory
(see Note 5)
|
2,103,098 | 1,271,456 | ||||||
Other
current assets
|
575,687 | 766,741 | ||||||
Total
Current Assets
|
25,445,752 | 16,293,037 | ||||||
Property
and Equipment, Net
|
1,381,778 | 1,444,770 | ||||||
Assets
Held for Investment, Net
|
3,444,899 | 3,373,564 | ||||||
Patents,
Net
|
3,586,784 | 3,702,386 | ||||||
TOTAL
ASSETS
|
$ | 33,859,213 | $ | 24,813,757 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable and accrued expenses (see Note 6)
|
$ | 9,485,196 | $ | 7,486,155 | ||||
Deferred
revenue and rebate liability
|
394,886 | 140,883 | ||||||
Current
maturities of long-term debt
|
1,068,725 | 1,060,788 | ||||||
Current
maturities of obligations under capital lease
|
26,600 | 43,836 | ||||||
Total
Current Liabilities
|
10,975,407 | 8,731,662 | ||||||
Obligations
Under Capital Lease, Net
|
— | 3,932 | ||||||
Long-Term
Debt, Net
|
1,842,500 | 1,854,421 | ||||||
Commitments
and Contingencies (see Note 8)
|
||||||||
Total
Liabilities
|
12,817,907 | 10,590,015 | ||||||
Stockholders’
Equity (see Note 10):
|
||||||||
Special
Voting Rights Preferred Stock, $.001 par value; authorized 1,000 shares at
January 31, 2010 and July 31, 2009; -0- shares issued and outstanding at
January 31, 2010 and July 31, 2009
|
— | — | ||||||
Common
stock, $.001 par value; authorized 750,000,000 shares at January 31, 2010
and July 31, 2009; 251,025,190 and 212,628,818 shares issued and
outstanding at January 31, 2010 and July 31, 2009,
respectively
|
251,024 | 212,628 | ||||||
Additional
paid-in capital
|
329,577,557 | 307,401,016 | ||||||
Deficit
accumulated during the development stage
|
(309,495,607 | ) | (294,041,489 | ) | ||||
Accumulated
other comprehensive income
|
708,332 | 651,587 | ||||||
Total
Stockholders’ Equity
|
21,041,306 | 14,223,742 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 33,859,213 | $ | 24,813,757 |
Cumulative From
|
||||||||||||||||||||
November 2, 1995
|
||||||||||||||||||||
For the Six Months Ended
|
For the Three Months
|
(Date of Inception)
|
||||||||||||||||||
January 31,
|
Ended January 31,
|
to January 31,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
||||||||||||||||
Revenues,
net
|
$ | 528,886 | $ | 972,982 | $ | 431,344 | $ | 434,636 | $ | 4,146,780 | ||||||||||
Cost
of Goods Sold
|
367,125 | 349,390 | 287,888 | 327,198 | 1,008,506 | |||||||||||||||
Gross
profit
|
161,761 | 623,592 | 143,456 | 107,438 | 3,138,274 | |||||||||||||||
Operating
Expenses:
|
||||||||||||||||||||
Research
and development
|
6,476,290 | 7,596,130 | 3,400,521 | 3,240,441 | 109,853,465 | |||||||||||||||
Research
and development - related party
|
— | — | — | — | 220,218 | |||||||||||||||
Selling
and marketing
|
2,646,772 | 1,446,905 | 1,348,068 | 609,707 | 7,079,270 | |||||||||||||||
General
and administrative
|
6,559,222 | 4,912,435 | 2,733,957 | 2,064,522 | 123,360,040 | |||||||||||||||
General
and administrative - related party
|
— | — | — | — | 314,328 | |||||||||||||||
Total
Operating Expenses
|
15,682,284 | 13,955,470 | 7,482,546 | 5,914,670 | 240,827,321 | |||||||||||||||
Operating
Loss
|
(15,520,523 | ) | (13,331,878 | ) | (7,339,090 | ) | (5,807,232 | ) | (237,689,047 | ) | ||||||||||
Other
Income (Expense):
|
||||||||||||||||||||
Miscellaneous
income (expense)
|
750 | 3 | 250 | (2 | ) | 197,011 | ||||||||||||||
Income
from rental operations, net
|
154,659 | 167,739 | 70,066 | 79,359 | 1,726,667 | |||||||||||||||
Interest
income
|
16,426 | 221,097 | 6,341 | 52,632 | 7,763,300 | |||||||||||||||
Interest
expense
|
(105,430 | ) | (10,792,585 | ) | (53,029 | ) | (6,363,197 | ) | (68,102,598 | ) | ||||||||||
Loss
on extinguishment of debt
|
— | — | — | — | (14,134,068 | ) | ||||||||||||||
Net
Loss Before Undernoted
|
(15,454,118 | ) | (23,735,624 | ) | (7,315,462 | ) | (12,038,440 | ) | (310,238,735 | ) | ||||||||||
Minority
Interest Share of Loss
|
— | — | — | — | 3,038,185 | |||||||||||||||
Net
Loss
|
(15,454,118 | ) | (23,735,624 | ) | (7,315,462 | ) | (12,038,440 | ) | (307,200,550 | ) | ||||||||||
Preferred
Stock Dividend
|
— | — | — | — | 2,295,057 | |||||||||||||||
Net
Loss Available to Common Stockholders
|
$ | (15,454,118 | ) | $ | (23,735,624 | ) | $ | (7,315,462 | ) | $ | (12,038,440 | ) | $ | (309,495,607 | ) | |||||
Basic
and Diluted Net Loss Per Common Share (see Note 9)
|
$ | (.06 | ) | $ | (.20 | ) | $ | (.03 | ) | $ | (.10 | ) | ||||||||
Weighted
Average Number of Shares of Common Stock Outstanding
|
241,522,176 | 121,454,322 | 249,053,034 | 124,799,620 |
Cumulative From
|
||||||||||||
November 2, 1995
|
||||||||||||
For the Six Months
|
(Date of Inception)
|
|||||||||||
Ended January 31,
|
to January 31,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
||||||||||
Cash
Flows From Operating Activities:
|
||||||||||||
Net
loss
|
$ | (15,454,118 | ) | $ | (23,735,624 | ) | $ | (307,200,550 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
393,958 | 413,793 | 8,166,629 | |||||||||
Minority
interest share of loss
|
— | — | (3,038,185 | ) | ||||||||
Reduction
of notes receivable - common stock in exchange for services
rendered
|
— | — | 423,882 | |||||||||
Write-off
of uncollectible notes receivable - common stock
|
— | — | 391,103 | |||||||||
Write-off
of deferred offering costs
|
— | — | 3,406,196 | |||||||||
Write-off
of abandoned patents
|
— | — | 913,196 | |||||||||
Loss
on disposal of property and equipment
|
— | — | 911 | |||||||||
Loss
on extinguishment of debt
|
— | — | 14,134,069 | |||||||||
Common
stock issued as employee compensation
|
50,500 | 102,800 | 3,729,893 | |||||||||
Amortization
of options and option modifications as employee
compensation
|
916,381 | 19,360 | 1,023,377 | |||||||||
Common
stock issued for services rendered
|
832,605 | 124,166 | 10,895,234 | |||||||||
Amortization
of prepaid services in conjunction with common stock
issuance
|
— | — | 138,375 | |||||||||
Non-cash
compensation expense
|
— | — | 45,390 | |||||||||
Stock
options and warrants issued for services rendered
|
505,000 | — | 7,870,723 | |||||||||
Issuance
of warrants as additional exercise right inducement
|
— | — | 21,437,909 | |||||||||
Preferred
stock issued for services rendered
|
— | — | 100 | |||||||||
Treasury
stock redeemed for non-performance of services
|
— | — | (138,000 | ) | ||||||||
Amortization
of deferred debt issuance costs and loan origination fees
|
— | 307,583 | 2,405,629 | |||||||||
Amortization
of discount on convertible debentures
|
— | 8,459,007 | 38,345,592 | |||||||||
Common
stock issued as interest payment on convertible debentures
|
— | 252,083 | 757,514 | |||||||||
Interest
on short-term advance
|
— | — | 22,190 | |||||||||
Founders’
shares transferred for services rendered
|
— | — | 353,506 | |||||||||
Fees
in connection with refinancing of debt
|
— | — | 113,274 | |||||||||
Warrant
repricing costs
|
— | 1,589,988 | 3,198,604 | |||||||||
Changes
in operating assets and liabilities (excluding the effects of
acquisition):
|
||||||||||||
Accounts
receivable
|
(84,392 | ) | (428,276 | ) | (157,627 | ) | ||||||
Miscellaneous
receivables
|
— | — | 43,812 | |||||||||
Inventory
|
(820,673 | ) | 172,810 | (2,136,523 | ) | |||||||
Other
current assets
|
350,775 | (1,291,294 | ) | (570,405 | ) | |||||||
Accounts
payable and accrued expenses
|
3,822,306 | (1,204,834 | ) | 16,375,446 | ||||||||
Deferred
revenue
|
252,534 | 27,446 | 391,371 | |||||||||
Other,
net
|
— | — | 110,317 | |||||||||
Net
Cash Used in Operating Activities
|
(9,235,124 | ) | (15,190,992 | ) | (178,547,048 | ) | ||||||
Cash
Flows From Investing Activities:
|
||||||||||||
Purchase
of property and equipment
|
(134,312 | ) | (1,385 | ) | (4,729,244 | ) | ||||||
Costs
incurred for patents
|
(81,922 | ) | (66,503 | ) | (2,284,432 | ) | ||||||
Change
in restricted cash
|
— | — | 512,539 | |||||||||
Proceeds
from maturity of short term investments
|
— | 8,852,214 | 195,242,918 | |||||||||
Purchases
of short-term investments
|
— | — | (195,242,918 | ) | ||||||||
Cash
received in conjunction with merger
|
— | — | 82,232 | |||||||||
Advances
to Antigen Express, Inc.
|
— | — | (32,000 | ) | ||||||||
Increase
in officers’ loans receivable
|
— | — | (1,126,157 | ) | ||||||||
Change
in deposits
|
— | — | (652,071 | ) | ||||||||
Change
in notes receivable - common stock
|
— | — | (91,103 | ) | ||||||||
Change
in due from related parties
|
— | — | (2,222,390 | ) | ||||||||
Other,
net
|
— | — | 89,683 | |||||||||
Net
Cash Provided By (Used in) Investing Activities
|
(216,234 | ) | 8,784,326 | (10,452,943 | ) |
Cumulative From
|
||||||||||||
November 2, 1995
|
||||||||||||
For the Six Months
|
(Date of Inception)
|
|||||||||||
Ended January 31,
|
to January 31,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Cash
Flows From Financing Activities:
|
||||||||||||
Proceeds
from short-term advance
|
— | — | 325,179 | |||||||||
Repayment
of short-term advance
|
— | — | (347,369 | ) | ||||||||
Proceeds
from issuance of long-term debt
|
— | — | 2,005,609 | |||||||||
Repayment
of long-term debt
|
(47,950 | ) | (41,095 | ) | (2,072,476 | ) | ||||||
Repayment
of obligations under capital lease
|
(21,168 | ) | (12,304 | ) | (56,402 | ) | ||||||
Change
in due to related parties
|
— | — | 154,541 | |||||||||
Proceeds
from exercise of warrants
|
1,517,940 | — | 45,642,159 | |||||||||
Proceeds
from exercise of stock options
|
— | 56,000 | 5,001,916 | |||||||||
Proceeds
from minority interest investment
|
— | — | 3,038,185 | |||||||||
Proceeds
from issuance of preferred stock
|
— | — | 12,015,000 | |||||||||
Redemption
of SVR preferred stock
|
— | — | (100 | ) | ||||||||
Proceeds
from issuance of convertible debentures, net
|
— | — | 40,704,930 | |||||||||
Payment
of costs associated with convertible debentures
|
— | — | (722,750 | ) | ||||||||
Repayments
of convertible debentures
|
— | (3,130,000 | ) | (5,142,424 | ) | |||||||
Purchase
of treasury stock
|
— | — | (483,869 | ) | ||||||||
Proceeds
from issuance of common stock, net
|
16,400,671 | — | 112,137,624 | |||||||||
Purchase
and retirement of common stock
|
— | — | (497,522 | ) | ||||||||
Net
Cash Provided by (Used in) Financing Activities
|
17,849,493 | (3,127,399 | ) | 211,702,231 | ||||||||
Effect
of Exchange Rates on Cash
|
29,483 | (23,613 | ) | (77,574 | ) | |||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
8,427,618 | (9,557,678 | ) | 22,624,666 | ||||||||
Cash
and Cash Equivalents, Beginning of Period
|
14,197,048 | 17,237,510 | — | |||||||||
Cash
and Cash Equivalents, End of Period
|
$ | 22,624,666 | $ | 7,679,832 | $ | 22,624,666 | ||||||
Supplemental
Disclosure of Cash Flow Information:
|
||||||||||||
Cash
paid during the period for:
|
||||||||||||
Interest
|
$ | 105,430 | $ | 976,706 | ||||||||
Income
taxes
|
$ | — | $ | — | ||||||||
Disclosure
of non-cash investing and financing activities:
|
||||||||||||
Issuance
of common stock as satisfaction of accounts payable and accrued
expenses
|
$ | 1,991,838 | $ | — | ||||||||
Par
value of common stock issued in conjunction with cashless exercise of
warrants
|
$ | 5,245 | $ | — | ||||||||
Issuance
of common stock as repayment of convertible debentures and advance
payments
|
$ | — | $ | 6,506,668 | ||||||||
Purchase
of property and equipment through the issuance of obligations under
capital lease
|
$ | — | $ | 83,002 |
1.
|
Basis
of Presentation
|
2.
|
Effects
of Recent Accounting Pronouncements
|
3.
|
Stock-Based
Compensation
|
Weighted
|
Weighted
|
|||||||||||||||
Average
|
Average
|
|||||||||||||||
Exercise
|
Remaining
|
Aggregate
|
||||||||||||||
Price
|
Contractual
|
Intrinsic
|
||||||||||||||
Options
|
Share
|
Term (Years)
|
Value
|
|||||||||||||
Outstanding,
August 1, 2009
|
5,067,138 | $ | 0.44 | |||||||||||||
Granted
|
855,000 | 0.64 | ||||||||||||||
Forfeited
or expired
|
(270,000 | ) | 0.92 | |||||||||||||
Exercised
|
— | — | ||||||||||||||
Outstanding,
January 31, 2010
|
5,652,138 | 0.44 | 4.65 | $ | 1,456,715 | |||||||||||
Exercisable,
January 31, 2010
|
4,753,388 | 1,456,715 | ||||||||||||||
Grant
Date Fair Value of Options Granted
|
$ | 0.46 | ||||||||||||||
Grant
Date Fair Value of Options Forfeited or Expired
|
0.70 | |||||||||||||||
Total
Intrinsic Value of Options Exercised
|
n/a |
Weighted Average
|
||||||||
Grant Date
|
||||||||
Options
|
Fair Value
|
|||||||
Outstanding,
August 1, 2009
|
43,750 | $ | 0.59 | |||||
Granted
|
855,000 | 0.46 | ||||||
Vested
|
— | n/a | ||||||
Forfeited
|
— | n/a | ||||||
Outstanding,
January 31, 2010
|
898,750 | 0.47 |
Weighted
|
||||||||
Average
|
||||||||
Grant Date
|
||||||||
Number of
|
Fair
|
|||||||
Shares
|
Value
|
|||||||
Non-vested
restricted stock, August 1, 2009
|
14,844 | $ | 1.51 | |||||
Granted
|
— | n/a | ||||||
Vested
|
(14,844 | ) | 1.51 | |||||
Forfeited
|
— | n/a | ||||||
Non-vested
restricted stock, January 31, 2010
|
— | n/a |
4.
|
Comprehensive
Loss
|
5.
|
Inventory
|
January 31,
|
July 31,
|
|||||||
2010
|
2009
|
|||||||
Raw
materials
|
$ | 1,255,436 | $ | 728,919 | ||||
Finished
goods
|
847,662 | 542,537 | ||||||
Total
|
$ | 2,103,098 | $ | 1,271,456 |
6.
|
Accounts
Payable and Accrued Expenses
|
January 31,
|
July 31,
|
|||||||
2010
|
2009
|
|||||||
Accounts
Payable
|
$ | 3,765,183 | $ | 2,983,037 | ||||
Research
and Development
|
3,065,806 | 1,629,293 | ||||||
Executive
Compensation
|
2,654,207 | 2,873,825 | ||||||
Total
|
$ | 9,485,196 | $ | 7,486,155 |
7.
|
Pending
Litigation
|
8.
|
Commitments
|
9.
|
Net
Loss Per Share
|
10.
|
Stockholders’
Equity
|
Warrants
|
||||
Outstanding,
August 1, 2009
|
46,478,276 | |||
Issued
|
10,595,622 | |||
Forfeited
or expired
|
(500,001 | ) | ||
Exercised
|
(13,944,612 | ) | ||
Outstanding,
January 31, 2010
|
42,629,285 |
Additional
|
Total
|
|||||||||||||||
Common Stock
|
Paid-In
|
Stockholders’
|
||||||||||||||
Shares
|
Amount
|
Capital
|
Equity
|
|||||||||||||
Issuance
of common stock in private placement
|
23,870,513 | $ | 23,870 | $ | 16,376,801 | $ | 16,400,671 | |||||||||
Issuance
of common stock for services
|
1,300,659 | 1,301 | 831,304 | 832,605 | ||||||||||||
Issuance
of common stock as employee compensation
|
84,258 | 84 | 50,416 | 50,500 | ||||||||||||
Stock-based
executive compensation
|
— | — | 10,189 | 10,189 | ||||||||||||
Warrants
exercised for cash
|
4,599,817 | 4,600 | 1,513,340 | 1,517,940 | ||||||||||||
Issuance
of common stock as satisfaction of accounts payable and accrued
expenses
|
3,295,670 | 3,296 | 1,988,543 | 1,991,839 | ||||||||||||
Issuance
of warrants for services
|
— | — | 505,000 | 505,000 | ||||||||||||
Issuance
of common stock in conjunction with cashless exercise of
warrants
|
5,245,459 | 5,245 | (5,245 | ) | — | |||||||||||
Amortization
of stock options as employee compensation
|
— | — | 30,419 | 30,419 | ||||||||||||
Option
re-pricing costs
|
— | — | 875,773 | 875,773 | ||||||||||||
Total
|
38,396,376 | $ | 38,396 | $ | 22,176,540 | $ | 22,214,936 |
11.
|
Subsequent
Events
|
|
·
|
our expectations concerning
product candidates for our
technologies;
|
|
·
|
our expectations concerning
existing or potential development and license agreements for third-party
collaborations and joint
ventures;
|
|
·
|
our expectations of when
different phases of clinical activity may commence and
conclude;
|
|
·
|
our expectations of when
regulatory submissions may be filed or when regulatory approvals may be
received; and
|
|
·
|
our expectations of when
commercial sales of our products may commence and when actual revenue from
the product sales may be
received.
|
|
·
|
the inherent uncertainties of
product development based on our new and as yet not fully proven
technologies;
|
|
·
|
the risks and uncertainties
regarding the actual effect on humans of seemingly safe and efficacious
formulations and treatments when tested
clinically;
|
|
·
|
the inherent uncertainties
associated with clinical trials of product
candidates;
|
|
·
|
the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product
candidates;
|
|
·
|
the inherent uncertainties
associated with commercialization of products that have received
regulatory approval;
|
|
·
|
the volatility of, and recent
decline in, our stock price and the impact on our ability to pay
installments due on our outstanding senior secured notes in stock rather
than cash; and
|
|
·
|
our ability to obtain the
necessary financing to fund our
operations.
|
Date Issued
|
Aggregate No. of
Shares
Unexercised
|
Exercise
Price*
|
Expiration Date
|
|||
June
15, 2009
|
8,844,926
|
0.76
|
December
15, 2014
|
|||
August
6, 2009
|
3,572,971
|
0.79
|
February
4, 2015
|
|||
September
14, 2009
|
6,022,651
|
1.00
|
March
15, 2015
|
Date Issued
|
Aggregate No. of
Shares Unexercised
|
Exercise
Price*
|
Expiration Date
|
||||||
March
31, 2008
|
14,330,603 | $ | 0.33 |
March
31, 2016
|
|||||
March
31, 2008
|
4,591,735 | $ | 0.33 |
September
30, 2016
|
|
·
|
the timing and amount of expense
incurred to complete our clinical
trials;
|
|
·
|
the costs and timing of the
regulatory process as we seek approval of our products in
development;
|
|
·
|
the advancement of our products
in development;
|
|
·
|
Our ability to generate new
relationships with industry partners throughout the world that will
provide us with regulatory assistance and long-term commercialization
opportunities;
|
|
·
|
the timing, receipt and amount of
sales, if any, from Generex Oral-lyn™ in India, Lebanon, Algeria and
Ecuador;
|
|
·
|
the timing, receipt and amount of
sales, if any, from our over-the-counter
products;
|
|
·
|
the cost of manufacturing (paid
to third parties) of our licensed products, and the cost of marketing and
sales activities of those
products;
|
|
·
|
the costs of prosecuting,
maintaining, and enforcing patent claims, if any claims are
made;
|
|
·
|
Our ability to maintain existing
collaborative relationships and establish new relationships as we advance
our products in development;
and
|
|
·
|
the receptivity of the financial
market to biopharmaceutical
companies.
|
GENEREX BIOTECHNOLOGY CORPORATION
|
||
(Registrant)
|
||
Date: March
10, 2010
|
By:
|
/s/ Anna E. Gluskin
|
Anna E. Gluskin
|
||
President and Chief Executive Officer
|
||
Date: March
10, 2010
|
By:
|
/s/ Rose C. Perri
|
Rose C. Perri
|
||
Chief Financial Officer
|
Exhibit
Number
|
Description of Exhibit(1)
|
|
2
|
Agreement
and Plan of Merger among Generex Biotechnology Corporation, Antigen
Express, Inc. and AGEXP Acquisition Inc. (incorporated by reference to
Exhibit 2.1 to Generex Biotechnology Corporation’s Current Report on Form
8-K filed on August 15, 2003)
|
|
3(i)
|
Restated
Certificate of Incorporation of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Post-Effective Amendment No. 1 to the Registration Statement
on Form S-8 filed on October 26, 2009)
|
|
3(ii)
|
Amended
and Restated By-Laws of Generex Biotechnology Corporation (incorporated by
reference to Exhibit 3.2(ii) to Generex Biotechnology Corporation’s Report
on Form 8-K filed December 5, 2007)
|
|
4.1
|
Form
of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
|
4.2.1
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended October 31, 2003 filed on August 13,
2003)
|
|
4.2.2
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended October 31, 2003 filed on August 13,
2003)
|
|
4.2.3
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners, L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures, LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
October 31, 2003 filed on August 13, 2003)
|
|
4.3
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|
4.4.1
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24,
2004)
|
4.4.2
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
4.4.3
|
Form
of Warrant issued in connection with Exhibit 4.4.1 (incorporated by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
4.4.4
|
Form
of Additional Investment Right issued in connection with Exhibit 4.4.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
4.5.1
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.5.2
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.5.3
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
4.5.4
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.6.1
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.6.2
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.6.3
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
4.6.4
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.7.1
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
4.7.2
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
4.7.3
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
4.7.4
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.7.5
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
4.8.1
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
4.8.2
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
4.8.3
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.9.1
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.9.2
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.9.3
|
Warrant
issued in connection with Exhibit 4.9.1 (incorporated by reference to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
4.9.4
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
4.10.1
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
4.10.2
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit 4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
4.10.3
|
Form
of Warrant issued in connection with Exhibit 4.10.1 (incorporated by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
4.10.4
|
Form
of Additional Investment Right issued in connection Exhibit 4.10.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
4.11.1
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
4.11.2
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
4.11.3
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
4.11.4
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
4.12
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|
4.13.1
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
|
4.13.2
|
Form
of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
|
4.14
|
Form
of Warrant issued by Generex Biotechnology Corporation on January 23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|
4.15.1
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
4.15.2
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
4.15.3
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
4.15.4
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
4.15.5
|
Form
of Warrant issued by Generex Biotechnology Corporation on February 27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006)
|
4.16.1
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2006).
|
|
4.16.2
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
4.16.3
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
4.16.4
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2006).
|
|
4.16.5
|
Form
of Additional AIR Debenture issued by Generex Biotechnology Corporation on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
4.16.6
|
Form
of Additional AIR Warrant issued by Generex Biotechnology Corporation on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
4.17.1
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
|
4.17.2
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
|
|
4.18
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to Zapfe
Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006)
|
|
4.19
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17, 2006
to certain employees (incorporated by reference to Exhibit 4.34 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
|
4.20.1
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
|
|
4.20.2
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
|
|
4.21.1
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
4.21.2
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1, 2006 in
connection with Exhibit 4.39 (incorporated by reference to Exhibit 4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
|
4.22.1
|
Securities
Purchase Agreement, dated as of March 31, 2008 among the Registrant and
each of the purchasers named therein (incorporated by reference to Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
April 2, 2008)
|
|
4.22.2
|
Form
of 8% Secured Convertible Note, as amended (incorporated by reference to
Exhibit 4.2 to Generex Biotechnology Corporation’s Registration Statement
(333-150562) on Form S-3 filed on October 31, 2008)
|
|
4.22.3
|
Form
of Series A Warrant, as amended (incorporated by reference to Exhibit 4.3
to Generex Biotechnology Corporation’s Registration Statement on Form S-3
(333-150562) filed on October 31, 2008)
|
|
4.22.4
|
Form
of Series A-1 Warrant, as amended (incorporated by reference to Exhibit
4.4 to Generex Biotechnology Corporation’s Registration Statement on Form
S-3 (333-150562) filed on October 31, 2008)
|
|
4.22.5
|
Form
of Series B Warrant, as amended (incorporated by reference to Exhibit 4.5
to Generex Biotechnology Corporation’s Registration Statement on Form S-3
(333-150562) filed on October 31, 2008)
|
|
4.22.6
|
Form
of Series C Warrant, as amended (incorporated by reference to Exhibit 4.6
to Generex Biotechnology Corporation’s Registration Statement on Form S-3
(333-150562) filed on October 31, 2008)
|
|
4.22.7
|
Registration
Rights Agreement, dated March 31, 2008, among Registrant and each of the
purchasers under Securities Purchase Agreement (incorporated by reference
to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on April 2, 2008)
|
|
4.22.8
|
Security
Agreement (incorporated by reference to Exhibit 4.8 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on April 2,
2008)
|
|
4.22.9
|
Form
of Guaranty (incorporated by reference to Exhibit 4.9 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on April 2,
2008)
|
|
4.23.1
|
Form
of Securities Purchase Agreement, dated May 15, 2009, entered into between
Generex Biotechnology Corporation and each investor in the offering
(incorporated by reference to Exhibit 1.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on May 18, 2009)
|
|
4.24.1
|
Form
of Securities Purchase Agreement, dated June 15, 2009, entered into
between Generex Biotechnology Corporation and each investor in the
offering (incorporated by reference to Exhibit 10.1 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on June 16,
2009)
|
|
4.24.2
|
Form
of Warrant issued in connection with Exhibit 4.24.1 (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on June 16, 2009)
|
|
4.24.3
|
Form
of Warrant issued to Midtown Partners & Co., LLC in connection with
Exhibit 4.24.1 (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on June 16,
2009)
|
4.25.1
|
Form
of Securities Purchase Agreement, dated August 6, 2009, entered into
between Generex Biotechnology Corporation and each investor in the
offering (incorporated by reference to Exhibit 10.1 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 6,
2009)
|
|
4.25.2
|
Form
of Warrant issued in connection with Exhibit 4.25.1 (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on August 6, 2009)
|
|
4.25.3
|
Form
of Warrant issued to Midtown Partners & Co., LLC in connection with
Exhibit 4.25.1 (incorporated by reference to Exhibit 4.28 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 6,
2009)
|
|
4.26.1
|
Form
of Securities Purchase Agreement, dated September 11, 2009, entered into
between Generex Biotechnology Corporation and each investor in the
offering (incorporated by reference to Exhibit 10.1 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on September 15,
2009)
|
|
4.26.2
|
Form
of Warrant issued in connection with Exhibit 4.26.1 (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 15, 2009)
|
|
4.26.3
|
Form
of Warrant issued to Midtown Partners & Co., LLC in connection with
Exhibit 4.26.1 (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on September 15,
2009)
|
|
10.1
|
Recombinant
Human Insulin Active Ingredient Manufacturing and Supply Agreement entered
into on December 7, 2009 by and between Generex Biotechnology
Corporation and Sanofi-Aventis Deutschland GmbH (incorporated by reference
to Exhibit 10.2 to Generex Biotechnology Corporation’s Report on Form 10-Q
filed on December 11, 2009) (subject to confidential
treatment)
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
32
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to Section
906 of the Sarbanes-Oxley Act of
2002
|
(1)
|
In the case of incorporation by
reference to documents filed by the Registrant under the Exchange Act, the
Registrant’s file number under the Exchange Act is
000-25169.
|