x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
|
For
the quarterly period ended
|
September 30,
2010
|
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
|
Commission File Number:
333-45241
|
ELITE PHARMACEUTICALS,
INC.
|
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
22-3542636
|
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
|
165 Ludlow Avenue, Northvale, New
Jersey
|
07647
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(201) 750-2646
|
(Registrant's
telephone number, including area code)
|
(Former
name, former address and former fiscal year, if changed since last
report)
|
Large
Accelerated filer ¨
|
Accelerated
Filer ¨
|
Non-Accelerated
Filer ¨
|
Smaller
Reporting Company x
|
Page No.
|
|||
PART
I - FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements
|
||
Condensed
Consolidated Balance Sheets as of September 30, 2010 (unaudited) and March
31, 2010 (audited)
|
F-1 – F-2
|
||
Condensed
Consolidated Statements of Operations for the three and six months ended
September 30, 2010 (unaudited) and September 30, 2009
(unaudited)
|
F-3
|
||
Condensed
Consolidated Statement of Changes in Stockholders’ Equity for the six
months ended September 30, 2010 (unaudited)
|
F-4
|
||
Condensed
Consolidated Statements of Cash Flows for the six months ended September
30, 2010 (unaudited) and September 30, 2009 (unaudited)
|
F-5
|
||
Notes
to Condensed Consolidated Financial Statements
|
F-6
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
1
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
8
|
|
Item
4
|
Controls
and Procedures
|
8
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
9
|
|
Item 1A.
|
Risk
Factors
|
9
|
|
Item
2
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
9
|
|
Item
3.
|
Defaults
upon Senior Securities
|
10
|
|
Item
4.
|
Removed
and reserved
|
10
|
|
Item
5.
|
Other
Information
|
10
|
|
Item
6.
|
Exhibits
|
11
|
|
SIGNATURES
|
15 |
September 30,
2010
(Unaudited)
|
March 31,
2010
(Audited)
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
and cash equivalents
|
$ | 593,853 | $ | 578,187 | ||||
Accounts
receivable (net of allowance for doubtful accounts of -0-)
|
441,330 | 404,961 | ||||||
Inventories
(net of reserve of $494,425 and $494,425, respectively)
|
1,331,173 | 1,371,292 | ||||||
Prepaid
expenses and other current assets
|
100,639 | 131,507 | ||||||
Total
Current Assets
|
2,466,995 | 2,485,947 | ||||||
PROPERTY
AND EQUIPMENT, net of accumulated depreciation of $3,954,837 and
$3,840,279, respectively
|
3,910,418 | 4,095,814 | ||||||
INTANGIBLE
ASSETS – net of accumulated amortization of $-0- and $76,434,
respectively
|
554,872 | 96,407 | ||||||
OTHER
ASSETS
|
||||||||
Investment
in Novel Laboratories, Inc.
|
3,329,322 | 3,329,322 | ||||||
Security
deposits
|
28,377 | 14,652 | ||||||
Restricted
cash – debt service for EDA bonds
|
292,416 | 294,836 | ||||||
EDA
bond offering costs, net of accumulated amortization of 71,832 and 64,767,
respectively
|
282,619 | 289,685 | ||||||
Total
Other Assets
|
3,932,734 | 4,024,902 | ||||||
TOTAL
ASSETS
|
$ | 10,865,019 | $ | 10,606,663 |
September 30,
2010
(Unaudited)
|
March 31,
2010
(Audited)
|
|||||||
LIABILITIES
AND STOCKHOLDERS DEFICIT
|
||||||||
CURRENT
LIABILITIES
|
||||||||
EDA
bonds payable
|
$ | 3,385,000 | $ | 3,385,000 | ||||
Short
term loans and current portion of long-term debt
|
12,335 | 82,302 | ||||||
Accounts
payable and accrued expenses
|
1,342,094 | 986,777 | ||||||
Preferred
share derivative interest payable
|
306,439 | 306,440 | ||||||
Total
Current Liabilities
|
5,045,868 | 4,760,519 | ||||||
LONG
TERM LIABILITIES
|
||||||||
Deferred
revenues
|
198,889 | — | ||||||
Long
term debt, less current portion
|
56,173 | 19,823 | ||||||
Derivative
liability - preferred shares
|
12,595,402 | 7,924,763 | ||||||
Derivative
liability – warrants
|
5,775,676 | 8,499,423 | ||||||
Total
Long Term Liabilities
|
18,626,140 | 16,444,009 | ||||||
TOTAL
LIABILITIES
|
23,672,008 | 21,204,528 | ||||||
STOCKHOLDERS
DEFICIT
|
||||||||
Common
stock – par value $0.001, Authorized
355,516,558 Issued and outstanding – 92,656,745
shares and 83,950,168 shares, respectively
|
92,657 | 83,950 | ||||||
Additional
paid-in-capital
|
91,591,236 | 90,903,896 | ||||||
Accumulated
deficit
|
(104,184,041 | ) | (101,278,870 | ) | ||||
Treasury
stock at cost (100,000 common shares)
|
(306,841 | ) | (306,841 | ) | ||||
TOTAL
STOCKHOLDERS DEFICIT
|
(12,806,989 | ) | (10,597,865 | ) | ||||
TOTAL
LIABILITIES AND STOCKHOLDERS DEFICIT
|
$ | 10,865,019 | $ | 10,606,663 |
THREE
MONTHS ENDED
|
SIX
MONTHS ENDED
|
|||||||||||||||
SEPTEMBER
30,
|
SEPTEMBER
30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
REVENUES
|
||||||||||||||||
Manufacturing
Fees
|
$ | 767,341 | $ | 538,941 | $ | 1,334,410 | $ | 1,204,005 | ||||||||
Royalties
|
169,901 | 237,275 | 350,935 | 386,086 | ||||||||||||
Lab
Fee Revenues
|
57,404 | — | 141,221 | — | ||||||||||||
Total
Revenues
|
994,646 | 776,216 | 1,826,566 | 1,590,091 | ||||||||||||
Costs
of Revenues
|
565,624 | 453,029 | 977,295 | 1,315,029 | ||||||||||||
Gross
Profit
|
429,022 | 323,187 | 849,271 | 275,062 | ||||||||||||
OPERATING
EXPENSES
|
||||||||||||||||
Research
and Development
|
150,436 | 259,326 | 315,444 | 510,418 | ||||||||||||
General
and Administrative
|
379,104 | 392,100 | 635,345 | 788,637 | ||||||||||||
Non-cash
compensation through issuance of stock options
|
10,329 | 29,190 | 25,687 | 84,553 | ||||||||||||
Depreciation
and amortization
|
25,960 | 49,230 | 104,291 | 174,772 | ||||||||||||
Total
Operating Expenses
|
565,829 | 729,846 | 1,080,767 | 1,558,380 | ||||||||||||
LOSS
FROM OPERATIONS
|
(136,807 | ) | (406,659 | ) | (231,496 | ) | (1,283,318 | ) | ||||||||
OTHER
INCOME (EXPENSES)
|
||||||||||||||||
Interest
expense, net
|
(57,737 | ) | (61,208 | ) | (115,806 | ) | (131,188 | ) | ||||||||
Change
in fair value of warrant derivatives
|
900,047 | (1,520,822 | ) | 2,723,747 | (1,366,496 | ) | ||||||||||
Change
in fair value of preferred share derivatives
|
1,505,333 | (1,383,231 | ) | (4,569,005 | ) | 1,178,296 | ||||||||||
Interest
expense attributable to preferred share derivatives
|
(306,440 | ) | (299,352 | ) | (670,359 | ) | (658,373 | ) | ||||||||
Discount
in Series E issuance attributable to beneficial conversion
features
|
(39,132 | ) | — | (39,132 | ) | (258,700 | ) | |||||||||
Total
Other Income (Expense)
|
2,002,071 | (3,264,613 | ) | (2,670,555 | ) | (1,236,461 | ) | |||||||||
INCOME
(LOSS) BEFORE PROVISION FOR INCOME TAXES
|
1,865,264 | (3,671,272 | ) | (2,902,051 | ) | (2,519,779 | ) | |||||||||
Provision
for income taxes
|
1,040 | 1,040 | 3,120 | 1,040 | ||||||||||||
NET
INCOME (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
$ | 1,864,224 | $ | (3,672,312 | ) | $ | (2,905,171 | ) | $ | (2,520,819 | ) | |||||
NET
INCOME (LOSS) PER SHARE
|
||||||||||||||||
Basic
|
$ | 0.02 | $ | (0.05 | ) | $ | (0.03 | ) | $ | (0.04 | ) | |||||
Diluted
|
$ | 0.01 | $ | (0.05 | ) | $ | (0.03 | ) | $ | (0.04 | ) | |||||
WEIGHTED
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
|
||||||||||||||||
Basic
|
92,367,680 | 74,075,307 | 89,760,532 | 70,232,854 | ||||||||||||
Diluted
|
299,999,783 | 74,075,307 | 89,760,532 | 70,232,854 |
Common
Stock
|
Treasury
Stock
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Additional
Paid-In
Capital
|
Shares
|
Amount
|
Accumulated
Deficit
|
Stockholders’
Deficit
|
||||||||||||||||||||||
Balance
at March 31, 2010
|
83,950,168 | $ | 83,950 | $ | 90,903,896 | 100,000 | $ | (306,841 | ) | $ | (101,278,870 | ) | $ | (10,597,865 | ) | |||||||||||||
Net
Income
|
(2,905,171 | ) | (2,905,171 | ) | ||||||||||||||||||||||||
Common
shares issued in lieu of cash in payment of preferred share derivative
interest expense
|
8,706,577 | 8,707 | 661,653 | 670,360 | ||||||||||||||||||||||||
Non-cash
compensation through the issuance of stock options
|
25,687 | 25,687 | ||||||||||||||||||||||||||
Balance
at September 30, 2010
|
92,656,745 | $ | 92,657 | $ | 91,591,236 | 100,000 | $ | (306,841 | ) | $ | (104,184,041 | ) | $ | (12,806,989 | ) |
SIX MONTHS ENDED SEPTEMBER 30,
|
||||||||
2010
(Unaudited)
|
2009
(Unaudited)
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net
Loss
|
$ | (2,905,171 | ) | $ | (2,520,819 | ) | ||
Adjustments
to reconcile net loss to cash used in operating activities
:
|
||||||||
Depreciation
and amortization
|
241,626 | 251,936 | ||||||
Inventory
adjustment
|
— | 311,986 | ||||||
Change
in fair value of warrant derivative liability
|
(2,723,747 | ) | 1,366,496 | |||||
Change
in fair value of preferred share derivative liability
|
4,569,005 | (1,178,296 | ) | |||||
Discount
in Series E issuance attributable to embedded beneficial conversion
feature
|
39,132 | 258,700 | ||||||
Preferred
share derivative interest satisfied by the issuance of common
stock
|
670,360 | 658.373 | ||||||
Non-cash
compensation satisfied by the issuance of common stock and
options
|
25,687 | 84,553 | ||||||
Non-cash
lease accretion
|
298 | — | ||||||
Changes
in assets and liabilities :
|
||||||||
Accounts
receivable
|
(36,372 | ) | (357,348 | ) | ||||
Inventories
|
40,120 | (63,109 | ) | |||||
Prepaid
expenses and other current assets
|
30,868 | 12,211 | ||||||
Security
deposit
|
(13,725 | ) | 12,909 | |||||
Accounts
payable, accrued expenses and other current liabilities
|
217,817 | 105,224 | ||||||
Deferred
Revenues
|
198,889 | — | ||||||
NET
CASH PROVIDED BY / (USED IN) OPERATING ACTIVITIES
|
354,788 | (1,057,184 | ) | |||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Purchases
of property and equipment
|
(23,779 | ) | — | |||||
Cost
of capital leasehold improvements
|
(35,610 | ) | — | |||||
Costs
incurred for intellectual property assets
|
(258,464 | ) | — | |||||
Proceeds
from sale of retired equipment
|
30,000 | — | ||||||
Withdrawals
from restricted cash, net
|
2,420 | 214,002 | ||||||
NET
CASH PROVIDED BY / (USED IN) INVESTING ACTIVITIES
|
(285,433 | ) | 214,002 | |||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Other
loan payments
|
(53,689 | ) | (48,953 | ) | ||||
NJEDA
bond principal payments
|
— | (210,000 | ) | |||||
Proceeds
from issuance of Series E Convertible Preferred Stock and
Warrants
|
— | 1,000,000 | ||||||
NET
CASH PROVIDED BY / (USED IN) FINANCING ACTIVITIES
|
(53,869 | ) | 741,047 | |||||
NET
CHANGE IN CASH AND CASH EQUIVALENTS
|
15,666 | (102,135 | ) | |||||
CASH
AND CASH EQUIVALENTS – beginning of period
|
578,187 | 282,578 | ||||||
CASH
AND CASH EQUIVALENTS – end of period
|
$ | 593,853 | $ | 180,443 | ||||
SUPPLEMENTAL
DISCLOSURES OF CASH FLOW INFORMATION
|
||||||||
Cash
paid for interest
|
115,524 | 133,200 | ||||||
Cash
paid for taxes
|
3,120 | 1,040 | ||||||
SCHEDULE
OF NON-CASH INVESTING AND FINANCING ACTIVITIES
|
||||||||
Non-Cash
acquisition of Naltrexone ANDA
|
$ | 200,000 | — |
NOTE 1
|
- BASIS OF PRESENTATION
AND LIQUIDITY
|
|
The
information in this quarterly report on Form 10-Q includes the results of
operations of Elite Pharmaceuticals, Inc. and its consolidated
subsidiaries (collectively the “Company”) for the three and six months
ended September 30, 2010 and 2009. The accompanying unaudited
condensed consolidated financial statements have been prepared pursuant to
rules and regulations of the Securities and Exchange Commission in
accordance with accounting principles generally accepted for interim
financial statement presentation. Accordingly, they do not
include all of the information and footnotes required by accounting
principles generally accepted in the United States of America (“GAAP”) for
complete financial statements. In the opinion of management,
all adjustments (consisting of normal recurring accruals) considered
necessary for a fair presentation of the condensed consolidated financial
position, results of operations and cash flows of the Company for the
periods presented have been
included.
|
|
The
financial results for the interim periods are not necessarily indicative
of the results to be expected for the full year or future interim
periods.
|
|
The
accompanying unaudited condensed consolidated financial statements should
be read in conjunction with the consolidated financial statements and
notes included in the Company’s Annual Report on Form 10-K for the year
ended March 31, 2010. There have been no changes in significant
accounting policies since March 31,
2010.
|
NOTE 2
|
-
CASH AND
CASH EQUIVALENTS
|
NOTE 3
|
- INVENTORIES
|
NOTE 4
|
-
INTANGIBLE
ASSETS
|
Intangible assets at March 31, 2010
(audited)
|
||||
Patent
application costs
|
96,407 | |||
ANDA
acquisitions
|
— | |||
Intangible asset costs capitalized during the six
months ended September 30, 2010
|
||||
Patent
application costs
|
33,465 | |||
ANDA
acquisition costs
|
425,000 | |||
Amortization of intangible assets during the six
months ended September 30, 2010
|
||||
Patent
application costs
|
— | |||
ANDA
acquisition costs
|
— | |||
Intangible assets at September 30, 2010
(unaudited)
|
||||
Patent
application costs
|
129,872 | |||
ANDA
acquisition costs
|
425,000 | |||
Total
|
$ | 554,872 |
NOTE 5
|
- NJEDA
BONDS
|
NOTE 6
|
- DERIVATIVE
LIABILITIES
|
Series B
|
Series C
|
Series D
|
Series E
|
Total
|
||||||||||||||||
Preferred
shares Outstanding
|
896 | 5,418 | 9,008 | 2,062.5 | 17,384.5 | |||||||||||||||
Underlying
common shares into which Preferred may convert
|
574,076 | 3,365,217 | 128,692,014 | 77,292,061 | 209,923,369 | |||||||||||||||
Closing
price on valuation date
|
$ | 0.06 | $ | 0.06 | $ | 0.06 | $ | 0.06 | $ | 0.06 | ||||||||||
Preferred
stock derivative liability at September 30, 2010
|
$ | 34,445 | $ | 201,913 | $ | 7,721,521 | $ | 4,637,524 | $ | 12,595,402 | ||||||||||
Preferred
stock derivative liability at June 30, 2010
|
$ | 39,037 | $ | 228,835 | $ | 8,751,057 | $ | 4,980,172 | $ | 13,999,102 | ||||||||||
Preferred
stock derivative liability at March 31, 2010
|
$ | 48,796 | $ | 286,043 | $ | 3,828,587 | $ | 3,761,761 | $ | 7,925,187 | ||||||||||
Change
in preferred stock derivative liability for the three months ended
September 20, 2010
|
$ | (1,505,333 | ) | |||||||||||||||||
Change
in preferred stock derivative liability for the six months ended September
20, 2010
|
$ | 4,569,005 |
March 31
2010
|
June 30
2010
|
September 30
2010
|
||||||||||
Risk-Free
interest rate
|
2.4% - 3.3 | % | 0.3% - 2.4 | % | 0.3% - 1.6 | % | ||||||
Expected
volatility
|
126% - 214 | % | 120% - 210 | % | 135% - 194 | % | ||||||
Expected
life (in years)
|
0.5 – 6.6 | 0.3 – 6.3 | 0.0 – 6.1 | |||||||||
Expected
dividend yield
|
— | — | — | |||||||||
Number
of warrants
|
125,299,740 | 125,299,740 | 125,116,392 | |||||||||
Fair
value – Warrant Derivative Liability
|
$ | 8,499,423 | $ | 6,675,722 | $ | 5,775,676 | ||||||
Change
in warrant derivative liability for the three months ended
|
$ | (1,823,701 | ) | $ | (900,046 | ) | ||||||
Change
in warrant derivative liability for the six months ended
|
$ | (2,723,747 | ) |
NOTE 7
|
- PREFERRED
SHARE DERIVATIVE INTEREST
PAYABLE
|
NOTE 8
|
- OPERATING
LEASES
|
Fiscal
year ended March 31, 2011
|
$ | 19,689 | ||
Fiscal
year ended March 31, 2012
|
79,248 | |||
Fiscal
year ended March 31, 2013
|
81,228 | |||
Fiscal
year ended March 31, 2014
|
83,259 | |||
Fiscal
year ended March 31, 2015
|
85,344 | |||
Total
Minimum 5 year lease payments
|
$ | 348,768 |
Three Months
Ended
Sept 30, 2010
|
Six Months
Ended
Sept 30, 2010
|
|||||||
Rent
Expense
|
$ | 22,584 | $ | 22,584 | ||||
Change
in deferred rent liability
|
22,584 | 22,584 | ||||||
Balance
of deferred rent liability (long-term liability)
|
22,584 | 22,584 |
NOTE 9
|
- DEFERRED
REVENUES
|
NOTE 10
|
- STOCKHOLDERS’
EQUITY
|
NOTE 11
|
- PER
SHARE INFORMATION
|
For the
Three Months
Ended
September 30, 2010
|
For the
Six months
Ended
September 30, 2010
|
|||||||
Numerator
|
||||||||
Net
Income (loss) attributable to common shareholders
|
$ | 1,864,224 | $ | (2,905,171 | ) | |||
Denominator
|
||||||||
Weighted-average
shares of common stock outstanding
|
92,367,680 | 89,760,532 | ||||||
Dilutive
effect of stock options, warrants and convertible
securities
|
207,632,103 | |||||||
Net
(loss) income per share
|
||||||||
Basic
|
$ | 0.02 | $ | (0.03 | ) | |||
Diluted
|
$ | 0.01 |
NOTE 12
|
- SUBSEQUENT
EVENTS
|
Exhibit
Number
|
Description
|
|
3.1(a)
|
Certificate
of Incorporation of the Company, together with all other amendments
thereto, as filed with the Secretary of State of the State of Delaware,
incorporated by reference to (a) Exhibit 4.1 to the Registration Statement
on Form S-4 (Reg. No. 333-101686), filed with the SEC on December 6, 2002
(the “Form S-4”), (b) Exhibit 3.1 to the Company’s Current Report on Form
8-K dated July 28, 2004 and filed with the SEC on July 29, 2004, (c)
Exhibit 3.1 to the Company’s Current Report on Form 8-K dated June 26,
2008 and filed with the SEC on July 2, 2008, and (d) Exhibit 3.1 to the
Company’s Current Report on Form 8-K dated December 19, 2008 and filed
with the SEC on December 23, 2008.
|
|
3.1(b)
|
Certificate
of Designations, Preferences and Rights of Series A Preferred Stock, as
filed with the Secretary of the State of Delaware, incorporated by
reference to Exhibit 4.5 to the Current Report on Form 8-K dated October
6, 2004, and filed with the SEC on October 12, 2004.
|
|
3.1(c)
|
Certificate
of Retirement with the Secretary of the State of the Delaware to retire
516,558 shares of the Series A Preferred Stock, as filed with the
Secretary of State of Delaware, incorporated by reference to Exhibit 3.1
to the Current Report on Form 8-K dated March 10, 2006, and filed with the
SEC on March 14, 2006.
|
|
|
||
3.1(d)
|
Certificate
of Designations, Preferences and Rights of Series B 8% Convertible
Preferred Stock, as filed with the Secretary of the State of Delaware,
incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K
dated March 15, 2006, and filed with the SEC on March 16,
2006.
|
|
3.1(e)
|
Amended
Certificate of Designations of Preferences, Rights and Limitations of
Series B 8% Convertible Preferred Stock, as filed with the Secretary of
State of the State of Delaware, incorporated by reference to Exhibit 3.1
to the Current Report on Form 8-K dated April 24, 2007, and filed with the
SEC on April 25, 2007.
|
|
3.1(f)
|
Certificate
of Designations, Preferences and Rights of Series C 8% Convertible
Preferred Stock, as filed with the Secretary of the State of Delaware,
incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K
dated April 24, 2007, and filed with the SEC on April 25,
2007.
|
|
3.1(g)
|
Amended
Certificate of Designations, Preferences and Rights of Series C 8%
Convertible Preferred Stock, as filed with the Secretary of the State of
Delaware, incorporated by reference to Exhibit 3.1 to the Current Report
on Form 8-K dated April 24, 2007, and filed with the SEC on April 25,
2007
|
|
3.1(h)
|
Amended
Certificate of Designations of Preferences, Rights and Limitations of
Series B 8% Convertible Preferred Stock, as filed with the Secretary of
State of the State of Delaware, incorporated by reference to Exhibit 3.1
to the Current Report on Form 8-K dated September 15, 2008, and filed with
the SEC on September 16, 2008.
|
|
3.1(i)
|
Amended
Certificate of Designations, Preferences and Rights of Series C 8%
Convertible Preferred Stock, as filed with the Secretary of the State of
Delaware, incorporated by reference to Exhibit 3.2 to the Current Report
on Form 8-K dated September 15, 2008, and filed with the SEC on September
16, 2008.
|
|
3.1(j)
|
Amended
Certificate of Designations of Preferences, Rights and Limitations of
Series D 8% Convertible Preferred Stock, as filed with the Secretary of
State of the State of Delaware, incorporated by reference to Exhibit 3.3
to the Current Report on Form 8-K dated September 15, 2008, and filed with
the SEC on September 16, 2008.
|
|
3.1(k)
|
Certificate
of Designation of Preferences, Rights and Limitations of Series E
Convertible Preferred Stock, as filed with the Secretary of State of the
State of Delaware, incorporated by reference to Exhibit 3.1 to the Current
Report on Form 8-K dated June 1, 2009, and filed with the SEC on June 5,
2009.
|
3.1(l)
|
Amended
Certificate of Designations of the Series D 8% Convertible Preferred Stock
as filed with the Secretary of State of the State of Delaware on June 29,
2010, incorporated by reference to Exhibit 3.1 to the Current Report on
Form 8-K, dated July 1, 2010 and filed with the SEC on July 1,
2010
|
|
3.1(m)
|
Amended
Certificate of Designations of the Series E Convertible Preferred Stock as
filed with the Secretary of State of the State of Delaware on June 29,
2010, incorporated by reference to Exhibit 3.2 to the Current Report on
Form 8-K, dated July 1, 2010 and filed with the SEC on July1,
2010
|
|
3.2
|
By-Laws
of the Company, as amended, incorporated by reference to Exhibit 3.2 to
the Company’s Registration Statement on Form SB-2 (Reg. No. 333-90633)
made effective on February 28, 2000 (the “Form SB-2”).
|
|
4.1
|
Form
of specimen certificate for Common Stock of the Company, incorporated by
reference to Exhibit 4.1 to the Form SB-2.
|
|
4.2
|
Form
of specimen certificate for Series A 8% Convertible Preferred Stock of the
Company, incorporated by reference to Exhibit 4.5 to the Current Report on
Form 8-K, dated October 6, 2004, and filed with the SEC on October 12,
2004.
|
|
4.3
|
Form
of specimen certificate for Series B 8% Convertible Preferred Stock of the
Company, incorporated by reference to Exhibit 4.1 to the Current Report on
Form 8-K, dated March 15, 2006 and filed with the SEC on March 16,
2006.
|
|
4.4
|
Form
of specimen certificate for Series C 8% Convertible Preferred Stock of the
Company, incorporated by reference to Exhibit 4.1 to the Current Report on
Form 8-K, dated April 24, 2007 and filed with the SEC on April 25,
2007.
|
|
4.5
|
Warrant
to purchase 100,000 shares of Common Stock issued to DH Blair Investment
Banking Corp., incorporated by reference to Exhibit 10.2 to the Quarterly
Report on Form 10-Q for the period ended September 30,
2004.
|
|
4.6
|
Warrant
to purchase 50,000 shares of Common Stock issued to Jason Lyons
incorporated by reference to Exhibit 10.3 to the Quarterly Report on Form
10-Q for the period ended June 30, 2004.
|
|
4.7
|
Form
of Warrant to purchase shares of Common Stock issued to designees of
lender with respect to financing of an equipment loan incorporated by
reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q for the
period ended June 30, 2004.
|
|
4.8
|
Form
of Short Term Warrant to purchase shares of Common Stock issued to
purchasers in the private placement which initially closed on October 6,
2004 (the “Series A Financing”), incorporated by reference to Exhibit 4.6
to the Current Report on Form 8-K, dated October 6, 2004, and filed with
the SEC on October 12, 2004
|
|
4.9
|
Form
of Long Term Warrant to purchase shares of Common Stock issued to
purchasers in the Series A Financing, incorporated by reference to Exhibit
4.7 to the Current Report on Form 8-K, dated October 6, 2004, and filed
with the SEC on October 12, 2004.
|
|
4.10
|
Form
of Warrant to purchase shares of Common Stock issued to the Placement
Agent, in connection with the Series A Financing, incorporated by
reference to Exhibit 4.8 to the Current Report on Form 8-K, dated October
6, 2004, and filed with the SEC on October 12, 2004.
|
|
4.11
|
Form
of Replacement Warrant to purchase shares of Common Stock in connection
with the offer to holders of Warrants in the Series A Financing (the
“Warrant Exchange”), incorporated by reference to Exhibit 4.1 to the
Current Report on Form 8-K, dated December 14, 2005, and filed with the
SEC on December 20, 2005.
|
|
4.12
|
Form
of Warrant to purchase shares of Common Stock to the Placement Agent, in
connection with the Warrant Exchange, incorporated by reference to Exhibit
4.2 to the Current Report on Form 8-K, dated December 14, 2005, and filed
with the SEC on December 20,
2005.
|
4.13
|
Form
of Warrant to purchase shares of Common Stock issued to purchasers in the
private placement which closed on March 15, 2006 (the “Series B
Financing”), incorporated by reference to Exhibit 4.2 to the Current
Report on Form 8-K, dated March 15, 2006 and filed with the SEC on March
16, 2006.
|
|
4.14
|
Form
of Warrant to purchase shares of Common Stock issued to purchasers in the
Series B Financing, incorporated by reference to Exhibit 4.3 to the
Current Report on Form 8-K, dated March 15, 2006 and filed with the SEC on
March 16, 2006.
|
|
4.15
|
Form
of Warrant to purchase shares of Common Stock issued to the Placement
Agent, in connection with the Series B Financing, incorporated by
reference to Exhibit 4.4 to the Current Report on Form 8-K, dated March
15, 2006 and filed with the SEC on March 16, 2006.
|
|
4.16
|
Form
of Warrant to purchase 600,000 shares of Common Stock issued to Indigo
Ventures, LLC, incorporated by reference to Exhibit 4.1 to the Current
Report on Form 8-K, dated July 12, 2006 and filed with the SEC on July 18,
2006.
|
|
4.17
|
Form
of Warrant to purchase up to 478,698 shares of Common Stock issued to
VGS PHARMA, LLC, incorporated by reference to
Exhibit 3(a) to the Current Report on Form 8-K, dated December 6, 2006 and
filed with the SEC on December 12, 2006.
|
|
4.18
|
Form
of Non-Qualified Stock Option Agreement for 1,750,000 shares of Common
Stock granted to Veerappan Subramanian, incorporated by reference to
Exhibit 3(b) to the Current Report on Form 8-K, dated December 6, 2006 and
filed with the SEC on December 12, 2006.
|
|
4.19
|
Form
of Warrant to purchase shares of Common Stock issued to purchasers in the
private placement which closed on April 24, 2007 (the “Series C
Financing”), incorporated by reference to Exhibit 4.2 to the Current
Report on Form 8-K, dated April 24, 2007 and filed with the SEC on April
25, 2007.
|
|
4.20
|
Form
of Warrant to purchase shares of Common Stock issued to the placement
agent in the Series C Financing, incorporated by reference to Exhibit 4.3
to the Current Report on Form 8-K, dated April 24, 2007 and filed with the
SEC on April 25, 2007.
|
|
4.21
|
Form
of specimen certificate for Series D 8% Convertible Preferred Stock of the
Company, incorporated by reference to Exhibit 4.1 to the Current Report on
Form 8-K, dated September 15, 2008 and filed with the SEC on September 16,
2008.
|
|
4.22
|
Form
of Warrant to purchase shares of Common Stock issued to purchasers in the
private placement which closed on September 15, 2008 (the “Series D
Financing”), incorporated by reference to Exhibit 4.2 to the Current
Report on Form 8-K, dated September 15, 2008 and filed with the SEC on
September 16, 2008.
|
|
4.23
|
Form
of Warrant to purchase shares of Common Stock issued to the placement
agent in the Series D Financing, incorporated by reference to Exhibit 4.3
to the Current Report on Form 8-K, dated September 15, 2008 and filed with
the SEC on September 16, 2008.
|
|
4.24
|
Form
of specimen certificate for Series E Convertible Preferred Stock of the
Company, incorporated by reference to Exhibit 4.1 to the Current Report on
Form 8-K, dated June 1, 2009, and filed with the SEC on June 5,
2009.
|
|
4.25
|
Warrant
to purchase shares of Common Stock issued to Epic Investments, LLC in the
initial closing of the Strategic Alliance Agreement, dated as of March 18,
2009, by and among the Company, Epic Pharma, LLC and Epic Investments,
LLC, incorporated by reference to Exhibit 4.2 to the Current Report on
Form 8-K, dated June 1, 2009, and filed with the SEC on June 5,
2009.
|
|
10.1
|
Stipulation
of Settlement and Release, dated as of June 25, 2010, by and among the
Company, Midsummer Investment, Ltd., Bushido Capital Master Fund, LP, BCMF
Trustees, LLC, Epic Pharma, LLC and Epic Investments, LLC, incorporated by
reference to Exhibit 10.1 to the Current Report on Form 8-K, dated July 1,
2010 and filed with the SEC on July 1, 2010
|
|
10.2
|
Amendment
Agreement, dated as of June 25, 2010, by and among the Company, and the
investors signatory thereto, incorporated
by reference to Exhibit 10.2 to the Current Report on Form 8-K, dated July
1, 2010 and filed with the SEC on July 1,
2010
|
10.3
|
Amendment
Agreement, dated as of June 2010, by and among the Company, Epic Pharma,
LLC and Epic Investments, LLC, incorporated by reference to Exhibit 10.3
to the Current Report on Form 8-K, dated July 1, 2010 and filed with the
SEC on July 1, 2010
|
|
10.4
|
Asset
Purchase Agreement dated as of May 18, 2010, by and among Mikah Pharma LLC
and the Company
|
|
10.5
|
Asset
Purchase Agreement, dated as of August 27, 2010, by and among Mikah Pharma
LLC and the Company. Confidential portions of this exhibit have been
redacted and filed separately with the Commission pursuant to a
confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended. A description of
this Asset Purchase Agreement is incorporated by reference to Item 2.01 of
the Current Report on Form 8-K, dated August 27, 2010 and filed with SEC
on September 1, 2010
|
|
10.6
|
Master
Development and License Agreement, dated as of August 27, 2010, by and
among Mikah Pharma LLC and the Company. Confidential portions
of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. A description of this Asset Purchase Agreement is
incorporated by reference to Item 1.01 of the Current Report on Form 8-K,
dated August 27, 2010 and filed with SEC on September 1,
2010
|
|
10.7
|
Purchase
Agreement, dated as of September 10, 2010, by and among Epic Pharma LLC
and the Company. Confidential portions of this exhibit have
been redacted and filed separately with the Commission pursuant to a
confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended. A description of
this Asset Purchase Agreement is incorporated by reference to Item 2.01 of
the Current Report on Form 8-K, dated September 10, 2010 and filed with
SEC on September 16, 2010
|
|
10.8
|
License
Agreement, dated as of September 10, 2010, by and among Precision Dose
Inc. and the Company. Confidential portions of this exhibit
have been redacted and filed separately with the Commission pursuant to a
confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended. A description of
this Asset Purchase Agreement is incorporated by reference to Item 1.01 of
the Current Report on Form 8-K, dated September 10, 2010 and filed with
SEC on September 16, 2010
|
|
10.9
|
Manufacturing
and Supply Agreement, dated as of September 10, 2010, by and among
Precision Dose Inc. and the Company. Confidential portions of
this exhibit have been redacted and filed separately with the Commission
pursuant to a confidential treatment request in accordance with Rule 24b-2
of the Securities Exchange Act of 1934, as amended. A
description of this Asset Purchase Agreement is incorporated by reference
to Item 1.01 of the Current Report on Form 8-K, dated September 10, 2010
and filed with SEC on September 16, 2010
|
|
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
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
ELITE
PHARMACEUTICALS, INC.
|
||
Date:
November
15,
2010
|
/s/ Jerry Treppel
|
|
Jerry
Treppel
|
||
Chief
Executive Officer
|
||
(Principal
Executive Officer)
|
||
Date: November
15,
2010
|
/s/ Carter J. Ward
|
|
Carter
J. Ward
|
||
Chief
Financial Officer
|
||
(Principal
Financial and Accounting
Officer)
|