Nevada
|
|
88-0425691
|
(State or other jurisdiction
of incorporation)
|
|
(IRS Employer Identification
Number)
|
|
|
Page
|
|
|
|
Part I.
FINANCIAL INFORMATION:
|
||
|
Item
1. Financial Statements:
|
|
|
Consolidated
Balance Sheets as of March 31, 2008 (unaudited) and December 31,
2007.
|
F-2
|
|
|
|
|
Consolidated
Statements of Operations (unaudited) for the Three months ended March 31,
2008 and 2007.
|
F-3
|
|
Consolidated
Statements of Cash Flows (unaudited) for the Three months ended March 31,
2008 and 2007.
|
F-4
|
|
|
|
|
Notes
to Consolidated Financial Statements (unaudited)
|
F-5
to F-11
|
|
|
|
|
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
|
1
|
|
|
|
|
Item
4T. Controls and Procedures
|
9
|
|
|
|
Part
II. OTHER INFORMATION:
|
||
|
Item
6. Exhibits
|
10
|
|
|
|
SIGNATURES
|
|
12
|
|
|
|
EXHIBITS
|
|
CHEMBIO DIAGNOSTICS,
INC. AND SUBSIDIARIES
|
||||||||
CONSOLIDATED BALANCE
SHEETS
|
||||||||
AS
OF
|
||||||||
- ASSETS
-
|
||||||||
March 31,
2008
|
December
31, 2007
|
|||||||
(UNAUDITED)
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ |
1,764,735
|
$ |
2,827,369
|
||||
Accounts
receivable, net of allowance for doubtful accounts of $26,052 and $10,045
for 2008 and 2007, respectively
|
952,894
|
946,340
|
||||||
Inventories
|
1,505,451
|
1,453,850
|
||||||
Prepaid
expenses and other current assets
|
315,325
|
243,748
|
||||||
TOTAL CURRENT
ASSETS
|
4,538,405
|
5,471,307
|
||||||
FIXED ASSETS, net of
accumulated depreciation
|
932,750
|
829,332
|
||||||
OTHER
ASSETS:
|
||||||||
License
agreements, net of current portion
|
1,115,754
|
255,948
|
||||||
Deposits
and other assets
|
28,410
|
28,410
|
||||||
$ |
6,615,319
|
$ |
6,584,997
|
|||||
- LIABILITIES AND STOCKHOLDERS’
EQUITY -
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued liabilities
|
$ |
1,991,946
|
$ |
2,175,791
|
||||
Deferred
research and development revenue
|
30,833
|
43,334
|
||||||
Current
portion of license fee payable
|
375,000
|
-
|
||||||
Current
portion of obligations under capital leases
|
18,650
|
23,458
|
||||||
TOTAL CURRENT
LIABILITIES
|
2,416,429
|
2,242,583
|
||||||
OTHER
LIABILITIES:
|
||||||||
Obligations
under capital leases - net of current portion
|
75,131
|
79,588
|
||||||
License
fee payable - net of current portion
|
500,000
|
-
|
||||||
TOTAL
LIABILITIES
|
2,991,560
|
2,322,171
|
||||||
COMMITMENTS AND
CONTINGENCIES
|
||||||||
STOCKHOLDERS’
EQUITY:
|
||||||||
Common
stock - $.01 par value; 100,000,000 shares authorized 60,537,534 shares
issued and outstanding as of 2008 and 2007
|
605,375
|
605,375
|
||||||
Additional
paid-in capital
|
39,162,263
|
39,003,148
|
||||||
Accumulated
deficit
|
(36,143,879 | ) | (35,345,697 | ) | ||||
TOTAL STOCKHOLDERS’
EQUITY
|
3,623,759
|
4,262,826
|
||||||
$ |
6,615,319
|
$ |
6,584,997
|
|||||
See accompanying
notes
|
CHEMBIO DIAGNOSTICS,
INC. AND SUBSIDIARIES
|
||||||||
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
||||||||
FOR THE THREE-MONTHS
ENDED
|
||||||||
(UNAUDITED)
|
||||||||
March 31,
2008
|
March
31, 2007
|
|||||||
REVENUES:
|
||||||||
Net
sales
|
$ |
2,237,971
|
$ |
2,025,322
|
||||
Research
grant income
|
126,757
|
12,998
|
||||||
TOTAL
REVENUES
|
2,364,728
|
2,038,320
|
||||||
Cost
of sales
|
1,302,806
|
1,378,501
|
||||||
GROSS
PROFIT
|
1,061,922
|
659,819
|
||||||
OPERATING
EXPENSES:
|
||||||||
Research
and development expenses
|
626,336
|
318,730
|
||||||
Selling,
general and administrative expenses
|
1,247,154
|
1,252,226
|
||||||
1,873,490
|
1,570,956
|
|||||||
LOSS FROM
OPERATIONS
|
(811,568 | ) | (911,137 | ) | ||||
OTHER INCOME
(EXPENSES):
|
||||||||
Other
income
|
-
|
133,008
|
||||||
Interest
income
|
18,979
|
52,321
|
||||||
Interest
expense
|
(5,593 | ) | (2,997 | ) | ||||
13,386
|
182,332
|
|||||||
LOSS BEFORE INCOME
TAXES
|
(798,182 | ) | (728,805 | ) | ||||
Provision
for income taxes
|
-
|
-
|
||||||
NET LOSS
|
(798,182 | ) | (728,805 | ) | ||||
Dividends
payable in stock to preferred stockholders
|
-
|
353,979
|
||||||
NET LOSS ATTRIBUTABLE TO
COMMON STOCKHOLDERS
|
$ | (798,182 | ) | $ | (1,082,784 | ) | ||
Basic and diluted loss per
share
|
$ | (0.01 | ) | $ | (0.09 | ) | ||
Weighted average number of
shares outstanding, basic and diluted
|
60,537,534
|
11,717,079
|
||||||
See accompanying
notes
|
CHEMBIO DIAGNOSTICS,
INC. AND SUBSIDIARIES
|
||||||||
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
||||||||
FOR THE THREE MONTHS
ENDED
|
||||||||
(UNAUDITED)
|
||||||||
March 31,
2008
|
March
31, 2007
|
|||||||
INCREASE (DECREASE) IN CASH AND
CASH EQUIVALENTS:
|
||||||||
CASH FLOWS FROM OPERATING
ACTIVITIES:
|
||||||||
Cash
received from customers
|
$ |
2,358,174
|
$ |
2,336,931
|
||||
Cash
paid to suppliers and employees
|
(3,245,657 | ) | (2,796,292 | ) | ||||
Interest
received
|
18,979
|
52,321
|
||||||
Interest
paid
|
(5,593 | ) | (2,997 | ) | ||||
Net cash used in operating
activities
|
(874,097 | ) | (410,037 | ) | ||||
CASH FLOWS FROM INVESTING
ACTIVITIES:
|
||||||||
Acquisition
of fixed assets
|
(179,272 | ) | (22,415 | ) | ||||
Net cash used in investing
activities
|
(179,272 | ) | (22,415 | ) | ||||
CASH FLOWS FROM FINANCING
ACTIVITIES:
|
||||||||
Proceeds
from exercise of warrants
|
-
|
31,000
|
||||||
Payment
of accrued interest
|
-
|
(30,000 | ) | |||||
Payment
of capital lease obligation
|
(9,265 | ) | (10,269 | ) | ||||
Net cash utilized by financing
activities
|
(9,265 | ) | (9,269 | ) | ||||
NET (DECREASE) IN
CASH AND CASH EQUIVALENTS
|
(1,062,634 | ) | (441,721 | ) | ||||
Cash
and cash equivalents - beginning of the period
|
2,827,369
|
4,290,386
|
||||||
Cash and cash equivalents - end
of the period
|
$ |
1,764,735
|
$ |
3,848,665
|
||||
RECONCILIATION OF NET INCOME TO
NET CASH FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$ | (798,182 | ) | $ | (728,805 | ) | ||
Adjustments:
|
||||||||
Depreciation
and amortization
|
75,854
|
67,503
|
||||||
Provision
for doubtful accounts
|
16,000
|
10,987
|
||||||
Common
stock, options and warrants issued as compensation
|
174,090
|
16,408
|
||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(22,554 | ) |
287,624
|
|||||
Inventories
|
(51,601 | ) | (192,191 | ) | ||||
Prepaid
expenses and other current assets
|
(86,552 | ) |
9,510
|
|||||
Other
assets and deposits
|
(859,806 | ) |
11,896
|
|||||
License
fee payable
|
875,000
|
-
|
||||||
Deferred
revenue
|
(12,501 | ) |
-
|
|||||
Accounts
payable and accrued expenses
|
(183,845 | ) |
107,031
|
|||||
Net cash used in operating
activities
|
$ | (874,097 | ) | $ | (410,037 | ) | ||
Supplemental disclosures for
non-cash investing and financing activities:
|
||||||||
Value
of warrants issued allocated to additional paid-in capital
|
-
|
20,000
|
||||||
Accreted
dividend to preferred stock
|
-
|
353,979
|
||||||
Value
of Common stock issued as payment of dividend
|
-
|
262,053
|
||||||
Value
of Preferred stock converted to common stock
|
-
|
20,925
|
||||||
See accompanying
notes
|
(a)
|
Basis of
Presentation:
|
(b)
|
Inventories:
|
March 31,
2008
|
December
31, 2007
|
|||||||
Raw
Materials
|
$ |
612,498
|
$ |
705,873
|
||||
Work in
Process
|
390,935
|
234,077
|
||||||
Finished
Goods
|
502,018
|
513,900
|
||||||
$ |
1,505,451
|
$ |
1,453,850
|
(c)
|
Earnings Per
Share
|
For the three months
ended
|
||||||||
March 31,
2008
|
March
31, 2007
|
|||||||
Basic
|
60,537,534
|
11,717,079
|
||||||
Diluted
|
60,537,534
|
11,717,079
|
For the three months
ended
|
||||||||
March 31,
2008
|
March
31, 2007
|
|||||||
1999 Plan Stock
Options
|
2,291,269
|
1,621,750
|
||||||
Other Stock
Options
|
124,625
|
124,625
|
||||||
Warrants
|
19,487,099
|
23,114,990
|
||||||
Convertible Preferred
Stock
|
-
|
17,574,184
|
(d)
|
Employee Stock Option
Plan:
|
For the three months
ended
|
||||
March 31,
2008
|
March
31, 2007
|
|||
Expected term (in
years)
|
1 to
4
|
5
|
||
Expected
volatility
|
109.33%
|
104.80%
|
||
Expected dividend
yield
|
n/a
|
n/a
|
||
Risk-free interest
rate
|
1.91 to
2.46%
|
4.50%
|
Stock
Options
|
Number
of Shares
|
Weighted
Average Exercise Price per Share
|
Weighted
Average Remaining Contractual Term
|
Aggregate
Intrinsic Value
|
|||||||||
Outstanding at December 31,
2007
|
2,201,500
|
$ |
0.64
|
3.52
years
|
$ |
-
|
|||||||
Impact of re-price
(for accounting purposes treated as a cancelation and
re-issue):
|
|||||||||||||
effect
as if cancelled
|
(1,846,500 | ) | $ |
0.64
|
|||||||||
effect
as if re-issiued
|
1,846,500
|
$ |
0.48
|
||||||||||
Granted
|
534,000
|
$ |
0.22
|
||||||||||
Exercised
|
-
|
-
|
|||||||||||
Forfeited/expired
|
(255,000 | ) | $ |
0.73
|
|||||||||
Outstanding at March 31,
2008
|
2,480,500
|
$ |
0.54
|
3.71
years
|
$ |
-
|
|||||||
|
|||||||||||||
Exercisable at March 31,
2008
|
1,836,500
|
$ |
0.42
|
3.55
years
|
$ |
-
|
(e)
|
Geographic
Information:
|
For the three months
ended
|
||||||||
March 31,
2008
|
March
31, 2007
|
|||||||
Africa (excluding
Nigeria)
|
$ |
437,060
|
$ |
166,124
|
||||
Nigeria
|
849,702
|
202,500
|
||||||
Asia
|
101,009
|
41,213
|
||||||
Europe
|
43,940
|
27,011
|
||||||
Middle
East
|
100,841
|
118,959
|
||||||
North
America
|
635,765
|
1,460,925
|
||||||
South
America
|
69,654
|
8,590
|
||||||
$ |
2,237,971
|
$ |
2,025,322
|
(f)
|
Accounts payable and accrued
liabilities
|
March 31,
2008
|
December
31, 2007
|
|||||||
Accounts payable –
suppliers
|
$ |
670,552
|
$ |
726,174
|
||||
Accrued
commissions
|
34,857
|
14,251
|
||||||
Accrued royalties /
licenses
|
752,421
|
852,119
|
||||||
Accrued
payroll
|
146,568
|
279,598
|
||||||
Accrued
vacation
|
133,250
|
155,480
|
||||||
Accrued legal and
accounting
|
135,865
|
10,000
|
||||||
Accrued expenses –
other
|
118,433
|
138,169
|
||||||
TOTAL
|
$ |
1,991,946
|
$ |
2,175,791
|
(g)
|
Recent Accounting
Pronouncements affecting the
Company
|
(h)
|
License
Agreement
|
(a)
|
Economic
Dependency:
|
(b)
|
Governmental
Regulation:
|
(c)
|
Nigeria
Algorithm:
|
(d)
|
Voluntary Component
Recall
|
(e)
|
DPP™
Agreements:
|
a.
|
Bio-Manguinhos:
|
b.
|
Bio-Rad:
|
Selected Product
Categories:
|
For the three months
ended
|
|||||||||||||||
March 31,
2008
|
March 31,
2007
|
$ Change
|
% Change
|
|||||||||||||
HIV
|
$ |
1,920,986
|
$ |
1,811,365
|
$ |
109,621
|
6.05 | % | ||||||||
TB
|
95,155
|
27,300
|
67,855
|
248.55 | % | |||||||||||
Other
|
221,830
|
186,657
|
35,173
|
18.84 | % | |||||||||||
Net
Sales
|
2,237,971
|
2,025,322
|
212,649
|
10.50 | % | |||||||||||
Research grant
income
|
126,757
|
12,998
|
113,759
|
875.20 | % | |||||||||||
Total
Revenues
|
$ |
2,364,728
|
$ |
2,038,320
|
$ |
326,408
|
16.01 | % |
Gross Margin related
to
|
For the three months
ended
|
|||||||||||||||
Net Product
Sales:
|
March 31,
2008
|
March 31,
2007
|
$ Change
|
% Change
|
||||||||||||
Gross Margin per Statement of
Operations
|
$ |
1,061,922
|
$ |
659,819
|
$ |
402,103
|
60.94 | % | ||||||||
Less: Research grant
income
|
126,757
|
12,998
|
113,759
|
875.20 | % | |||||||||||
Gross Margin from Net Product
Sales
|
$ |
935,165
|
$ |
646,821
|
$ |
288,344
|
44.58 | % | ||||||||
Gross Margin
%
|
41.79 | % | 31.94 | % |
Selected expense
lines:
|
For the three months
ended
|
|||||||||||||||
March 31,
2008
|
March 31,
2007
|
$ Change
|
% Change
|
|||||||||||||
Clinical &
Regulatory Affairs:
|
||||||||||||||||
Wages and related
costs
|
$ |
66,836
|
$ |
46,922
|
$ |
19,914
|
42.44 | % | ||||||||
Consulting
|
6,435
|
11,273
|
(4,838 | ) | -42.92 | % | ||||||||||
Clinical
Trials
|
74,180
|
1,500
|
72,680
|
4845.33 | % | |||||||||||
Other
|
21,241
|
1,397
|
19,844
|
1420.47 | % | |||||||||||
Total
Regulatory
|
$ |
168,692
|
$ |
61,092
|
$ |
107,600
|
176.13 | % | ||||||||
R&D Other than
Regulatory:
|
||||||||||||||||
Wages and related
costs
|
$ |
276,180
|
$ |
194,966
|
81,214
|
41.66 | % | |||||||||
Consulting
|
5,000
|
10,084
|
(5,084 | ) | -50.42 | % | ||||||||||
Share-based
compensation
|
53,224
|
708
|
52,516
|
7417.51 | % | |||||||||||
Materials and
supplies
|
90,644
|
24,767
|
65,877
|
265.99 | % | |||||||||||
Other
|
32,596
|
27,113
|
5,483
|
20.22 | % | |||||||||||
Total other than
Regulatory
|
$ |
457,644
|
$ |
257,638
|
$ |
200,006
|
77.63 | % | ||||||||
Total Research and
Development
|
$ |
626,336
|
$ |
318,730
|
$ |
307,606
|
96.51 | % |
Selected expense
lines:
|
For the three months
ended
|
|||||||||||||||
March 31,
2008
|
March 31,
2007
|
$ Change
|
% Change
|
|||||||||||||
Wages and related
costs
|
$ |
345,785
|
$ |
382,177
|
$ | (36,392 | ) | -9.52 | % | |||||||
Consulting
|
44,316
|
34,199
|
10,117
|
29.58 | % | |||||||||||
Commissons, License and
Royalties
|
256,204
|
207,009
|
49,195
|
23.76 | % | |||||||||||
Share-based
compensation
|
72,151
|
456
|
71,695
|
15722.59 | % | |||||||||||
Marketing
Materials
|
8,902
|
17,510
|
(8,608 | ) | -49.16 | % | ||||||||||
Investor
Relations
|
59,080
|
47,827
|
11,253
|
23.53 | % | |||||||||||
Legal, Accounting and Sox 404
compliance
|
259,424
|
248,140
|
11,284
|
4.55 | % | |||||||||||
Travel, Entertainment and
shows
|
20,367
|
37,329
|
(16,962 | ) | -45.44 | % | ||||||||||
Bad Debt
Allowance
|
6,062
|
10,725
|
(4,663 | ) | -43.48 | % | ||||||||||
Other
|
174,863
|
266,854
|
(91,991 | ) | -34.47 | % | ||||||||||
Total S, G
&A
|
$ |
1,247,154
|
$ |
1,252,226
|
$ | (5,072 | ) | -0.41 | % |
Other Income and
Expense
|
For the three months
ended
|
|||||||||||||||
March 31,
2008
|
March 31,
2007
|
$ Change
|
% Change
|
|||||||||||||
Other income
(expense)
|
$ |
-
|
$ |
133,008
|
$ | (133,008 | ) | -100.00 | % | |||||||
Interest
income
|
18,979
|
52,321
|
(33,342 | ) | -63.73 | % | ||||||||||
Interest
expense
|
(5,593 | ) | (2,997 | ) | (2,596 | ) | 86.62 | % | ||||||||
Total Other Income and
Expense
|
$ |
13,386
|
$ |
182,332
|
$ | (168,946 | ) | -92.66 | % |
For the three months
ended
|
||||||||||||||||
March 31,
2008
|
March 31,
2007
|
$ Change
|
% Change
|
|||||||||||||
Net cash used in operating
activities
|
$ | (874,097 | ) | $ | (410,037 | ) | $ | (464,060 | ) | 113.18 | % | |||||
Net cash used in investing
activities
|
(179,272 | ) | (22,415 | ) | (156,857 | ) | 699.79 | % | ||||||||
Net cash utilized by financing
activities
|
(9,265 | ) | (9,269 | ) |
4
|
-0.04 | % | |||||||||
NET (DECREASE) IN
CASH
|
$ | (1,062,634 | ) | $ | (441,721 | ) | $ | (620,913 | ) | 140.57 | % |
OBLIGATIONS
|
Total
|
Less
than
|
1-3
Years
|
4-5
Years
|
Greater
than
|
|||||||||||||||
1 Year
|
5 Years
|
|||||||||||||||||||
Capital Leases
(1)
|
$ |
124,093
|
$ |
30,316
|
$ |
85,716
|
$ |
8,061
|
$ |
-
|
||||||||||
Operating
Leases
|
138,840
|
128,160
|
10,680
|
-
|
-
|
|||||||||||||||
Other Long Term
Obligations(2)
|
1,533,333
|
732,500
|
740,833
|
30,000
|
30,000
|
|||||||||||||||
Total
Obligations
|
$ |
1,796,266
|
$ |
890,976
|
$ |
837,229
|
$ |
38,061
|
$ |
30,000
|
|
(1)
|
This
represents capital leases used to purchase capital equipment. (Obligations
inclusive of interest).
|
|
(2)
|
This
represents contractual obligations for fixed cost licenses and employment
contracts.
|
Number
|
Description
|
3.1
|
Articles
of Incorporation, as amended. (3)
|
3.2
|
Amended
and Restated Bylaws. (1)
|
4.1
|
Second
Amended and Restated Certificate of Designation of the Relative Rights and
Preferences of the Series A Convertible Preferred Stock of the Registrant.
(11)
|
4.2
|
Registration
Rights Agreement, dated as of May 5, 2004, by and among the Registrant and
the Purchasers listed therein. (2)
|
4.3
|
Lock-Up
Agreement, dated as of May 5, 2004, by and among the Registrant and the
shareholders of the Registrant listed therein. (2)
|
4.4
|
Amended
Form of Common Stock Warrant issued pursuant to the May 4, 2004 Stock and
Warrant Purchase Agreement. (11)
|
4.5
|
Form
of $0.90 Warrant issued to Mark L. Baum pursuant to the Consulting
Agreement dated as of May 5, 2004 between the Registrant and Mark L. Baum.
(2)
|
4.6
|
Form
of $0.60 Warrant issued to Mark L. Baum pursuant to the Consulting
Agreement dated as of May 5, 2004 between the Registrant and Mark L. Baum.
(2)
|
4.7
|
Second
Amended and Restated Certificate of Designation of Preferences, Rights,
and Limitations of Series B 9% Convertible Preferred Stock of the
Registrant. (11)
|
4.8
|
Form
of Common Stock Warrant issued pursuant to the January 26, 2005 Securities
Purchase Agreement. (9)
|
4.9
|
Amended
Form of Common Stock Warrant issued pursuant to the January 26, 2005
Securities Purchase Agreement. (11)
|
4.10
|
Registration
Rights Agreement, dated as of January 26, 2005, by and among the
Registrant and the purchasers listed therein. (9)
|
4.11
|
Form
of Warrant, dated June 29, 2006, issued pursuant to Company and purchasers
of the Company’s Secured Debentures. (4)
|
4.12
|
Registration
Rights Agreement, dated June 29, 2006. (4)
|
4.13
|
Second
Amended and Restated Certificate of Designation of Preferences, Rights and
Limitations of Series C 7% Convertible Preferred Stock of the Registrant.
(11)
|
4.14
|
Registration
Rights Agreement, dated as of September 29, 2006, by and among the
Registrant and the Purchasers listed therein. (6)
|
4.15
|
Form
of Common Stock Warrant issued pursuant to the Securities Purchase
Agreements dated September 29, 2006 (6).
|
4.16
|
Amended
Form of Common Stock Warrant issued pursuant to the Securities Purchase
Agreements dated October 5, 2006. (11)
|
4.17
|
Amended
Form of Common Stock Warrant issued to Placement Agents pursuant to the
October 5, 2005 Securities Purchase Agreement. (11)
|
4.18
|
Form
of Employee Option Agreement. (11)
|
4.19
|
Amended
Form of Warrant used for Consultant Services, and in connection with the
Company’s 2004 merger. (11)
|
4.20
|
1999
Equity Incentive Plan (13)
|
10.1
|
Employment
Agreement dated June 15, 2006 with Lawrence A. Siebert.
(5)
|
10.2
|
Employment
Agreement dated April 23, 2007 with Javan Esfandiari.
(12)
|
10.3
|
Series
A Convertible Preferred Stock and Warrant Purchase Agreement (the “Stock
and Warrant Purchase Agreement”), dated as of May 5, 2004, by and among
the Registrant and the purchasers listed therein. (2)
|
10.4
|
Securities
Purchase Agreement (the “Securities Purchase Agreement”), dated as of
January 26, 2005, by and among the Registrant and the purchasers listed
therein. (9)
|
10.5
|
Amendment
No. 1 to Securities Purchase Agreement, dated as of January 28, 2005 by
and among the Registrant and the purchasers listed therein.
(10)
|
10.6
|
Equity
Exchange Agreement, dated as of January 28, 2005, by and between the
Registrant and Kurzman Partners, LP. (10)
|
10.7
|
Security
Purchase Agreement, dated June 29, 2006, among the Company and purchasers
of the Company’s Secured Debentures. (4)
|
10.8
|
Form
of Secured Debenture, dated June 29, 2006. (4)
|
10.9
|
Security
Agreement, dated June 29, 2006, among the Company, Chembio Diagnostic
Systems, Inc., and purchasers of the Company’s Secured Debentures.
(4)
|
10.10
|
Subsidiary
Guarantee, dated June 29, 2006, made by Chembio Diagnostic Systems, Inc.,
in favor of Purchasers of the Company’s Secured Debentures.
(4)
|
10.11
|
Securities
Purchase Agreement (the “Securities Purchase Agreement”), dated as of
September 29, 2006, by and among the Registrant and the Purchasers listed
therein. (6)
|
10.12
|
Letter
of Amendment to Securities Purchase Agreements dated as of September 29,
2006 by and among the Registrant and the Purchasers listed therein.
(6)
|
10.13
|
HIV
Barrel License, Marketing and Distribution Agreement, dated as of
September 29, 2006, by and among the Registrant, Inverness and StatSure.
(6)
|
10.14
|
HIV
Cassette License, Marketing and Distribution Agreement, dated as of
September 29, 2006, between the Registrant and Inverness.
(6)
|
10.15
|
Non-Exclusive
License, Marketing and Distribution Agreement, dated as of September 29,
2006, between the Registrant and Inverness. (6)
|
10.16
|
Joint
HIV Barrel Product Commercialization Agreement, dated as of September 29,
2006, between the Registrant and StatSure. (6)
|
10.17
|
Settlement
Agreement, dated September 29, 2006, between the Registrant and StatSure.
(6)
|
10.18
|
Contract
for Transfer of Technology and Materials with Bio-Manguinhos.
(7)
|
10.19
|
License
and Supply Agreement dated as of August 30, 2002 by and between Chembio
Diagnostic Systems Inc. and Adaltis Inc. (8)
|
31.1
|
Certification
of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
of the 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 18
U.S.C. Section 1350 as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
(1)
|
Incorporated
by reference to the Registrant’s registration statement on Form SB-2 filed
with the Commission on August 23, 1999 and the Registrant's Forms 8-K
filed on May 14, 2004, December 20, 2007 and April 18,
2008.
|
(2)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on May 14, 2004.
|
(3)
|
Incorporated
by reference to the Registrant’s annual report on Form 10-KSB filed with
the Commission on March 31, 2005.
|
(4)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on July 3, 2006.
|
(5)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on June 21, 2006.
|
(6)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on October 5, 2006.
|
(7)
|
Incorporated
by reference to the Registrant’s registration statement on Form SB-2/A
filed with the Commission on August 4,
2004.
|
(8)
|
Incorporated
by reference to the Registrant’s registration statement on Form SB-2 filed
with the Commission on June 7,
2004.
|
(9)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Commission on January 31, 2005.
|
(10)
|
Incorporated
by reference to the Registrant’s registration statement on Form SB-2 filed
with the Commission on March 28,
2005.
|
(11)
|
Incorporated
by reference to the Registrant’s annual report on Form 10-KSB filed with
the Commission on March 12, 2008.
|
(12)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K/A filed with
the Commission on May 3, 2007.
|
(13)
|
Incorporated
by reference to the Registrant’s definitive proxy statement on Schedule
14A filed with the Commission on May 11,
2005.
|
Date:
|
May
12, 2008
|
By:
/s/ Lawrence A. Siebert
|
|
|
Lawrence
A. Siebert
|
|
|
Chief
Executive Officer
(Principal
Executive Officer)
|
|
|
|
Date:
|
May
12, 2008
|
By:
/s / Richard J. Larkin
|
|
|
Richard
J. Larkin
|
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
5.
|
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s
board of directors (or persons performing the equivalent
functions):
|