x |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF
1934
|
o |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF
1934
|
Delaware
|
91-2003490
|
|
(State
or Other Jurisdiction of Incorporation or
Organization)
|
(I.R.S.
Employer Identification
No.)
|
|
145
Union Square Drive
|
|
|
New
Hope, PA
|
18938
|
|
(Address
of Principal Executive
Offices)
|
(Zip
Code)
|
February
28, 2007
|
May
31, 2006
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
19,141,242
|
$
|
9,992,545
|
|||
Prepaid
expenses
|
221,153
|
221,187
|
|||||
Total
current assets
|
19,362,395
|
10,213,732
|
|||||
PROPERTY
& EQUIPMENT:
|
|||||||
Lab
equipment
|
692,762
|
327,287
|
|||||
Office
and computer equipment
|
195,986
|
157,787
|
|||||
Furniture
& fixtures
|
40,701
|
40,701
|
|||||
Leasehold
improvements
|
89,967
|
89,967
|
|||||
1,019,416
|
615,742
|
||||||
Less
accumulated depreciation
|
(599,132
|
)
|
(478,785
|
)
|
|||
|
|||||||
420,284
|
136,957
|
||||||
OTHER
ASSETS:
|
|||||||
Deposits
|
7,990
|
7,990
|
|||||
Intellectual
technology property, net of
|
|||||||
accumulated
amortization of $7,458 and $6,693 as
|
|||||||
of
February 28, 2007 and May 31, 2006, respectively
|
12,842
|
13,607
|
|||||
Total
other assets
|
20,832
|
21,597
|
|||||
$
|
19,803,511
|
$
|
10,372,286
|
||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
861,794
|
$
|
744,732
|
|||
Payroll
and related liabilities
|
22,756
|
67,415
|
|||||
Accrued
expenses
|
60,000
|
226,848
|
|||||
Total
current liabilities
|
944,550
|
1,038,995
|
|||||
OTHER
LIABILITIES
|
3,785
|
3,696
|
|||||
|
|||||||
Total
liabilities
|
948,335
|
1,042,691
|
|||||
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
Common
stock, par value $0.00001,
|
|||||||
100,000,000
shares authorized as of
February
28, 2007 and May 31, 2006;
28,600,464
and 22,389,951 shares issued and outstanding as of February 28, 2007
and
May 31, 2006, respectively
|
286
|
224
|
|||||
Additional
paid in capital
|
43,714,692
|
27,740,976
|
|||||
Deficit
accumulated during the development stage
|
(24,859,802
|
)
|
(18,411,605
|
)
|
|||
Total
stockholders’ equity
|
18,855,176
|
9,329,595
|
|||||
|
$
|
19,803,511
|
$
|
10,372,286
|
From
|
||||||||||||||||
Nine
|
Nine
|
Three
|
Three
|
Inception
|
||||||||||||
Months
Ended
|
Months
Ended
|
Months
Ended
|
Months
Ended
|
Through
|
||||||||||||
February
28,
|
February
28,
|
February
28,
|
February
28,
|
February
28,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||
Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Operating
Expenses
|
||||||||||||||||
Research
and development
|
(4,102,055
|
)
|
(2,731,240
|
)
|
(1,757,711
|
)
|
(1,044,226
|
)
|
(15,145,271
|
)
|
||||||
Administrative
|
(2,670,755
|
)
|
(1,569,182
|
)
|
(861,460
|
)
|
(603,798
|
)
|
(8,660,418
|
)
|
||||||
Professional
fees
|
(451,012
|
)
|
(336,688
|
)
|
(147,735
|
)
|
(110,394
|
)
|
(2,166,259
|
)
|
||||||
Depreciation
and amortization
|
(4,009
|
)
|
(3,155
|
)
|
(1,257
|
)
|
(1,050
|
)
|
(154,411
|
)
|
||||||
Operating
Loss
|
(7,227,831
|
)
|
(4,640,265
|
)
|
(2,768,163
|
)
|
(1,759,468
|
)
|
(26,126,359
|
)
|
||||||
Other
income (expense)
|
||||||||||||||||
Interest
income
|
779,634
|
228,860
|
255,168
|
93,419
|
1,347,749
|
|||||||||||
Interest
expense
|
-
|
(741
|
)
|
-
|
(127
|
)
|
(70,612
|
)
|
||||||||
Loss
on disposal of equipment
|
-
|
-
|
-
|
-
|
(10,580
|
)
|
||||||||||
Net
Loss
|
$
|
(6,448,197
|
)
|
$
|
(4,412,146
|
)
|
$
|
(2,512,995
|
)
|
$
|
(1,666,176
|
)
|
$
|
(24,859,802
|
)
|
|
Weighted
average number of common
|
||||||||||||||||
shares
outstanding
|
27,908,754
|
20,013,580
|
28,600,464
|
21,173,309
|
14,902,795
|
|||||||||||
Loss
per common share - basic and diluted
|
$
|
(.23
|
)
|
$
|
(.22
|
)
|
$
|
(.09
|
)
|
$
|
(.08
|
)
|
$
|
(1.67
|
)
|
Nine
|
Nine
|
From
Inception
|
||||||||
Months
Ended
|
Months
Ended
|
Through
|
||||||||
February
28,
|
February
28,
|
February
28,
|
||||||||
2007
|
2006
|
2007
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||
Net
loss
|
$
|
(6,448,197
|
)
|
$
|
(4,412,146
|
)
|
$
|
(24,859,802
|
)
|
|
Adjustments
to reconcile net loss to net cash and cash equivalents used in operating
activities
|
||||||||||
Loss
on disposal of equipment
|
-
|
-
|
10,580
|
|||||||
Depreciation
and amortization
|
121,112
|
53,365
|
629,111
|
|||||||
Non
cash compensation expense
|
1,440,483
|
343,046
|
3,506,008
|
|||||||
Non
cash expenses
|
-
|
-
|
16,644
|
|||||||
(Increase)
decrease in:
|
||||||||||
Prepaid
expenses and deposits
|
34
|
(40,833
|
)
|
(229,143
|
)
|
|||||
Increase
(decrease) in:
|
||||||||||
Accounts
payable and accrued expenses
|
(49,786
|
)
|
(104,712
|
)
|
921,795
|
|||||
Payroll
and related liabilities
|
(44,659
|
)
|
118,966
|
22,756
|
||||||
Other
liabilities
|
89
|
(4,655
|
)
|
3,785
|
||||||
Net
cash and cash equivalents used in operating activities
|
(4,980,924
|
)
|
(4,046,969
|
)
|
(19,978,267
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||
Acquisition
of intellectual technology license - fee portion
|
-
|
-
|
(20,000
|
)
|
||||||
Acquisition
of equipment
|
(403,674
|
)
|
(84,153
|
)
|
(905,936
|
)
|
||||
Excess
of amounts paid for public shell over
|
||||||||||
assets
acquired to be accounted for as a recapitalization
|
-
|
-
|
(250,000
|
)
|
||||||
Proceeds
from disposal of equipment
|
-
|
-
|
6,000
|
|||||||
Net
cash and cash equivalents used in investing activities
|
(403,674
|
)
|
(84,153
|
)
|
(1,169,936
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||
Proceeds
from stock issuance
|
14,533,295
|
5,510,967
|
40,658,458
|
|||||||
Principal
payment on equipment notes payable
|
||||||||||
and
capital leases
|
-
|
(16,308
|
)
|
(295,411
|
)
|
|||||
Contribution
by shareholders
|
-
|
-
|
183,569
|
|||||||
Principal
payment on note payable to individuals
|
-
|
-
|
(225,717
|
)
|
||||||
Issuance
of note payable to individuals
|
-
|
-
|
368,546
|
|||||||
Acquisition
of common stock
|
-
|
-
|
(400,000
|
)
|
||||||
Net
cash and cash equivalents provided by financing activities
|
14,533,295
|
5,494,659
|
40,289,445
|
|||||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
9,148,697
|
1,363,537
|
19,141,242
|
|||||||
Cash
and cash equivalents, beginning
|
9,992,545
|
9,453,367
|
-
|
|||||||
Cash
and cash equivalents, end
|
$
|
19,141,242
|
$
|
10,816,904
|
$
|
19,141,242
|
||||
SUPPLEMENTAL
SCHEDULE OF CASH
|
||||||||||
FLOW
INFORMATION:
|
||||||||||
Interest
paid
|
$
|
-
|
$
|
614
|
$
|
66,770
|
||||
Taxes
paid
|
$
|
-
|
$
|
-
|
$
|
100
|
Nine
|
Three
|
From
Inception
|
||||||||
Months
Ended
|
Months
Ended
|
Through
|
||||||||
February
28,
|
February
28,
|
February
28,
|
||||||||
2006
|
2006
|
2006
|
||||||||
Net
loss, as reported
|
$ | (4,412,146 |
)
|
$ | (1,666,176 |
)
|
$ | (16,719,349 |
)
|
|
Add:
Stock-based
compensation expense
|
||||||||||
included
in reported net loss
|
343,046
|
49,535
|
1,226,068
|
|||||||
|
||||||||||
Deduct:
Stock-based compensation expense
|
||||||||||
determined
under fair value method
|
||||||||||
for
all awards
|
(1,015,133
|
)
|
(196,267
|
)
|
(4,304,782
|
)
|
||||
Pro
forma net loss
|
$
|
(5,084,233
|
)
|
$
|
(1,812,908
|
)
|
(19,798,063
|
)
|
||
Loss
per share, as reported - basic and diluted
|
$
|
(.22
|
)
|
$
|
(.08
|
)
|
$
|
(1.23
|
)
|
|
Pro
forma loss per share basic and diluted
|
$
|
(.25
|
)
|
$
|
(.09
|
)
|
$
|
(1.46
|
)
|
Nine
|
Nine
|
From
Inception
|
||||||||
Months
Ended
|
Months
Ended
|
Through
|
||||||||
February
28,
|
February
28,
|
February
28,
|
||||||||
2007
|
2006
|
2007
|
||||||||
Dividends
per year
|
0
|
0
|
0
|
|||||||
Volatility
percentage
|
94
|
%
|
107-114
|
%
|
90%-131
|
%
|
||||
Risk
free interest rate
|
4.80-4.88
|
%
|
3.85-4.42
|
%
|
2.07%-5.11
|
%
|
||||
Expected
life (years)
|
4
|
4
|
3-5
|
|||||||
Weighted
Average Fair Value
|
$
|
2.08
|
$
|
1.94
|
$
|
2.08
|
Grant | ||||||||||
Options | Prices | Exercisable | ||||||||
Balance,
September 17, 1999
|
—
|
$
|
—
|
—
|
||||||
Granted,
April 28, 2000
|
40,000
|
0.36
|
—
|
|||||||
Granted,
November 26, 2001
|
100,000
|
1.25
|
100,000
|
|||||||
Expired,
April 28, 2002
|
(40,000
|
)
|
0.36
|
—
|
||||||
Granted,
June 1, 2002
|
125,000
|
1.50
|
—
|
|||||||
Granted,
July 18, 2002
|
233,680
|
1.50
|
233,680
|
|||||||
Granted,
October 24, 2002
|
100,000
|
1.45
|
100,000
|
|||||||
Granted,
December 16, 2002
|
863,242
|
1.50
|
863,242
|
|||||||
Granted,
December 16, 2002
|
50,000
|
1.70
|
40,000
|
|||||||
Granted,
March 15, 2003
|
130,000
|
1.50
|
—
|
|||||||
Granted,
April 1, 2003
|
40,000
|
1.50
|
38,332
|
|||||||
Granted,
July 1, 2003
|
40,000
|
1.50
|
30,000
|
|||||||
Granted,
August 13, 2003
|
100,000
|
1.50
|
100,000
|
|||||||
Granted,
September 19, 2003
|
584,333
|
1.50
|
513,694
|
|||||||
Granted,
October 28, 2003
|
60,000
|
1.50
|
60,000
|
|||||||
Granted,
January 22, 2004
|
75,000
|
2.13
|
75,000
|
|||||||
Granted,
January 22, 2004
|
100,000
|
2.13
|
69,372
|
|||||||
Granted,
January 22, 2004
|
50,000
|
2.75
|
—
|
|||||||
Forfeited,
January 22, 2004
|
(130,000
|
)
|
1.50
|
—
|
||||||
Granted,
March 1, 2004
|
150,000
|
2.17
|
—
|
Granted,
July 22, 2004
|
15,000
|
2.60
|
9,687
|
|||||||
Granted,
October 26, 2004
|
30,000
|
2.70
|
5,833
|
|||||||
Granted,
October 26, 2004
|
100,000
|
2.30
|
100,000
|
|||||||
Granted,
January 13, 2005
|
330,000
|
2.55
|
119,694
|
|||||||
Granted,
January 13, 2005
|
125,000
|
2.55
|
125,000
|
|||||||
Forfeited,
January 26, 2005
|
(10,000
|
)
|
1.70
|
—
|
||||||
Forfeited,
January 26, 2005
|
(10,000
|
)
|
2.13
|
—
|
||||||
Granted,
February 15, 2005
|
100,000
|
2.80
|
100,000
|
|||||||
Granted,
April 13, 2005
|
50,000
|
2.60
|
22,916
|
|||||||
Forfeited,
June 1, 2005
|
(125,000
|
)
|
1.50
|
—
|
||||||
Granted,
July 29, 2005
|
51,429
|
2.80
|
17,915
|
|||||||
Granted,
August 23, 2005
|
250,000
|
2.50
|
81,332
|
|||||||
Forfeited,
October 22, 2005
|
(10,000
|
)
|
2.70
|
—
|
||||||
Forfeited,
October 22, 2005
|
(1,000
|
)
|
2.55
|
—
|
||||||
Granted,
October 25, 2005
|
200,714
|
2.65
|
158,570
|
|||||||
Granted,
November 8, 2005
|
121,407
|
2.75
|
121,407
|
|||||||
Granted,
January 11, 2006
|
133,000
|
2.85
|
34,975
|
|||||||
Forfeited,
January 25, 2006
|
(50,000
|
)
|
2.75
|
—
|
||||||
Forfeited,
January 25, 2006
|
(25,000
|
)
|
2.55
|
—
|
||||||
Forfeited,
January 25, 2006
|
(25,000
|
)
|
2.65
|
—
|
||||||
Forfeited,
February 28, 2006
|
(150,000
|
)
|
2.17
|
—
|
||||||
Forfeited,
February 28, 2006
|
(50,000
|
)
|
2.55
|
—
|
||||||
Forfeited,
March 13, 2006
|
(10,000
|
)
|
2.70
|
—
|
||||||
Forfeited,
March 13, 2006
|
(1,500
|
)
|
2.55
|
—
|
||||||
Forfeited,
March 13, 2006
|
(1,429
|
)
|
2.80
|
—
|
||||||
Granted,
March 16, 2006
|
115,000
|
2.90
|
115,000
|
|||||||
Granted,
April 20, 2006
|
27,000
|
4.50
|
5,624
|
|||||||
Forfeited,
April 30, 2006
|
(16,251
|
)
|
2.80
|
—
|
||||||
Exercised,
July 28, 2006
|
(4,000
|
)
|
2.55
|
—
|
||||||
Forfeited,
July 29, 2006
|
(3,749
|
)
|
2.80
|
—
|
||||||
Granted,
August 10, 2006
|
15,000
|
2.35
|
3,750
|
|||||||
Exercised,
August 14, 2006
|
(2,000
|
)
|
2.50
|
—
|
||||||
Granted,
October 24, 2006
|
225,000
|
2.87
|
179,166
|
|||||||
Forfeited,
January 2, 2007
|
(185,939
|
)
|
2.54
|
|||||||
Granted,
January 18, 2007
|
150,000
|
2.30
|
3,124
|
|||||||
Granted,
February 20, 2007
|
68,000
|
2.15
|
35,000
|
|||||||
4,096,937
|
3,462,313
|
Exercise
Price Range |
|
|
Number
|
|
|
Total
Weighted Average Exercise Price |
|
|
Total
Weighted Average Remaining Life |
Number
|
Exercisable
Weighted Average Exercise Price |
Exercisable
Weighted Average Remaining Life |
|||||||
(years)
|
(years)
|
||||||||||||||||||
$0.90
- 1.35
|
100,000
|
$
|
1.25
|
4.7
|
100,000
|
$
|
1.25
|
4.7
|
|||||||||||
$1.36
- 1.80
|
2,061,255
|
$
|
1.50
|
6.0
|
1,978,948
|
$
|
1.50
|
6.0
|
|||||||||||
$1.81
- 2.25
|
233,000
|
$
|
2.14
|
7.8
|
179,372
|
$
|
2.13
|
7.8
|
|||||||||||
$2.26
- 2.70
|
970,546
|
$
|
2.50
|
7.8
|
629,906
|
$
|
2.53
|
7.8
|
|||||||||||
$2.71
- 3.15
|
705,136
|
$
|
2.84
|
8.6
|
568,463
|
$
|
2.83
|
8.6
|
|||||||||||
$3.16
- 4.50
|
27,000
|
$
|
4.50
|
9.1
|
5,624
|
$
|
4.50
|
9.1
|
|||||||||||
4,096,937
|
$
|
2.02
|
7.0
|
3,462,313
|
$
|
1.94
|
7.0
|
·
|
Employee
Agreements-Officers.
To
attract and retain qualified management personnel, we have entered
into
employment agreements with three executive officers: Steven H. Kane,
president and chief executive officer, Marc L. Rose, CPA, vice president
of finance, chief financial officer, treasurer and corporate
secretary.
|
·
|
Directors
Agreements.
To
attract and retain qualified candidates to serve on the board of
directors, we have entered into agreements with G. Kirk Raab, Chairman
of
the Board, Carleton A. Holstrom, Chairman of the Audit Committee,
Eugene
A. Bauer, MD and Peter G. Tombros, under which Messrs. Raab, Holstrom,
Dr.
Bauer and Mr. Tombros receive aggregate annual cash payments aggregating
$150,000, $20,000, $20,000 and $20,000, respectively, as directors’
fees.
|
·
|
Operating
Lease -
Office
Space. We have entered into a three year operating lease in New Hope,
PA
for 3,795 square feet of office and laboratory space. The lease commenced
on January 9, 2004 and was originally to expire on February 28, 2007.
On
November 18, 2005, the company modified the existing lease which
added an
additional 2,147 square feet and extended the lease term to January
31,
2008.
|
·
|
Operating
Lease - Copier.
We
have entered into a sixty-three month operating lease for a multi-function
copier. The lease commenced on December 16, 2004 and will expire
on March
16, 2010.
|
Payments
due by period
|
||||||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1
year |
1-3
years
|
3-5
years
|
More
than 5
years |
|||||||||||
Employment
Agreements-Officers
|
$
|
681,900
|
$
|
681,900
|
$
|
0
|
$
|
0
|
$
|
0
|
||||||
Directors
Agreements
|
210,000
|
210,000
|
0
|
0
|
0
|
|||||||||||
Operating
Lease - Office Space
|
168,500
|
168,500
|
0
|
0
|
0
|
|||||||||||
Operating
Lease - Copier
|
9,213
|
2,490
|
6,723
|
0
|
0
|
|||||||||||
Total
|
$
|
1,069,613
|
$
|
1,062,890
|
$
|
6,723
|
$
|
0
|
$
|
0
|
2.1
|
Stock
Purchase Agreement among the Company, Don Hanosh and Enerdyne Corporation,
dated December 6, 1999
|
Incorporated
by reference, to Exhibit 2.1 to the Company’s 10-SB filing on December 6,
1999
|
|
2.2
|
Merger
Agreement and Plan of Re-organization between the Company and Enerdyne
Corporation
|
Incorporated
by reference, to Exhibit 2.2 to the Company’s 10-SB filing on December 6,
1999
|
|
2.3
|
Plan
of Merger and Agreement between Protalex, Inc., a New Mexico corporation
and Protalex, Inc. a Delaware Corporation
|
Incorporated
by reference, to Exhibit 2.1 to the Company’s 8K filing on December 6,
2004
|
|
3.1
|
Certificate
of Incorporation of the Company
|
Incorporated
by reference, to Exhibit 3.1 to the Company’s 8-K filing on December 6,
2004
|
|
3.2
|
Bylaws
of the Company
|
Incorporated
by reference, to Exhibit 3.2 to the Company’s 8-K filing on December 6,
2004
|
|
3.3
|
State
of Delaware, Certificate of Amendment of Certificate of Incorporation
|
Incorporated
by reference, to Exhibit 3.3 to the Company 10-QSB filed on January
13,
2006
|
|
4.1
|
Letter
Agreement with Pembroke Financial Ltd. Dated July 9, 2001
|
Incorporated
by reference, to Exhibit 10.9 to the Company’s 10-KSB/A filed on September
24, 2003
|
|
4.2
|
Securities
Purchase Agreement dated September 18, 2003 between the Company and
certain of the Selling Stockholders
|
Incorporated
by reference, to Exhibit 4.3 to the Company’s SB-2 filed on October 20,
2003.
|
|
4.3
|
Investor
Rights Agreement dated September 18, 2003 between the Company and
certain
of the Selling Stockholders
|
Incorporated
by reference, to Exhibit 4.3 to the Company’s SB-2 filed on October 20,
2003.
|
|
4.4
|
Form
of Common Stock Purchase Warrant issued by the Company to the Selling
Stockholders
|
Incorporated
by reference, to Exhibit 4.4 to Company’s SB-2 filed on October 20,
2003.
|
|
4.5
|
Warrant
and Common Stock Purchase Agreement dated May 25, 2005 among the
Company
and the several purchasers thereunder
|
Incorporated
by reference to Exhibit 4.5 to the Company’s Form SB-2 filed on June 16,
2005
|
|
4.6
|
Registration
Rights Agreement dated May 25, 2005 among the purchasers under the
Warrant
and Common Stock Purchase Agreement of even date therewith
|
Incorporated
by reference to Exhibit 4.6 to the Company’s Form SB-2 filed on June 16,
2005
|
|
4.7
|
Addendum
1 to Subscription Agreement and Questionnaire of vSpring SBIC, LP
dated
May 25, 2005
|
Incorporated
by reference to Exhibit 4.7 to the Company’s Annual Report on Form 10-KSB
filed on August 26, 2005
|
4.8
|
Warrant
and Common Stock Purchase Agreement dated December 22, 2005 among
the
Company and the several purchasers thereunder
|
Incorporated
by reference, to Exhibit 4.5 to the Company’s SB-2 filed on January 27,
2006
|
|
4.9
|
Registration
Rights Agreement dated December 22, 2005 among the purchasers under
the
Warrant and Common Stock Purchase Agreement of even date therewith
|
Incorporated
by reference, to Exhibit 4.6 to the Company’s SB-2 filed on January 27,
2006
|
|
4.10
|
Form
of Warrant issued by the Company to the Selling Stockholders dated
December 22, 2005 of even date therewith
|
Incorporated
by reference, to Exhibit 4.7 to the Company’s SB-2 filed on January 27,
2006
|
|
4.11
|
Warrant
and Common Stock Purchase Agreement dated June 30, 2006 among the
Company
and the several purchasers thereunder
|
Incorporated
by reference, to Exhibit 10.1 to the Company’s Current Report on Form 8K
filed on July 10, 2006.
|
|
4.12
|
Registration
Rights Agreement dated June 30, 2006 among the purchasers under the
Warrant and Common Stock Purchase Agreement of even date therewith
|
Incorporated
by reference, to Exhibit 10.2 to the Company’s Current Report on Form 8K
filed on July 10, 2006
|
|
4.13
|
Form
of Warrant issued by the Company to the Selling Stockholders dated
June
30, 2006 of even date therewith
|
Incorporated
by reference, to Exhibit 10.3 to the Company’s Current Report on Form 8K
filed on July 10, 2006
|
|
10.1
|
Employment
offer letter executed by Steven H. Kane
|
Incorporated
by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form
10-QSB filed on January 13, 2006.
|
|
10.2
|
Board
appointment executed by G. Kirk Raab
|
Incorporated
by reference, to Exhibit 10.4 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.3
|
Form
of Option Agreement
|
Incorporated
by reference, to Exhibit 10.6 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003
|
|
10.4
|
Frame
Contract between the Company and Eurogentec S.A.
|
Incorporated
by reference, to Exhibit 10.5 to the Company’s 10-KSB/A filed on September
24, 2003
|
|
10.5
|
Assignment
of Intellectual Property from Alex LLC to the Company
|
Incorporated
by reference, to Exhibit 10.8 to the Company’s 10-KSB/A filed on September
24, 2003.
|
|
10.6
|
Assignment
of Intellectual Property from Dr. Paul Mann to the Company
|
Incorporated
by reference, to Exhibit 10.8 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.7
|
Stock
Redemption Agreement dated August 15, 2003, by and between the Company,
Paul L. Mann, Leslie A. McCament-Mann, Gail Stewe and Elizabeth Sarah
Anne
Wiley
|
Incorporated
by reference, to Exhibit 10.10 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.8
|
Letter
dated August 21, 2003 from Paul L. Mann to the Company
|
Incorporated
by reference, to Exhibit 10.11 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.9
|
Technology
License Agreement dated November 17, 1999, between the Company and
Alex,
LLC
|
Incorporated
by reference, to Exhibit 10.4 to the Company’s Registration of Securities
on Form 10-SB filed on December 6, 1999.
|
|
10.10
|
Letter
Agreement, dated March 16, 2005, effective October 26, 2004, between
the Company and Carleton A. Holstrom
|
Incorporated
by reference, to Exhibit 10.3 to the Company’s Quarterly Report on Form
10-QSB/A filed on April 14, 2005.
|
10.11
|
Description
of the verbal agreement between the Company and Eugene A. Bauer,
M.D.
|
Incorporated
by reference to the Company’s Current Report on Form 8K filed on February
22, 2005.
|
|
10.12
|
Protalex,
Inc. 2003 Stock Option Plan Amended and Restated as of July 29, 2005
|
Incorporated
by reference to Appendix B to the Company’s Proxy Statement filed with the
SEC on September 23, 2005.
|
|
10.13
|
Description
of the verbal agreement between the Company and Peter G. Tombros
|
Incorporated
by reference to the Company’s Current Report on Form 8K filed on November
14, 2005.
|
|
10.14
|
Modified
lease agreement with Union Square LP, dated November 18, 2005
|
Incorporate
by reference to Exhibit 99.1 to the Company’s Current Report Form 8-K
filed with the Securities and Exchange Commission on November 22,
2005.
|
|
10.15
|
Employment
offer letter executed by Marc L. Rose
|
Incorporated
by reference, to Exhibit 10.2 to the Company’s Quarterly Report on Form
10-QSB filed on January 14, 2005.
|
|
10.16
|
Employment
offer letter executed by Victor S. Sloan, M.D
|
Incorporated
by reference, to Exhibit 10.1 to the Company’s Quarterly Report on Form
10-QSB filed on October 14, 2005.
|
|
10.17†
|
Clinical
Study Agreement executed October 19, 2005 between the Company and
PAREXEL
International LLC
|
Incorporated
by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form
10-QSB filed on January 13, 2006.
|
|
10.18†
|
Service
Contract with AAIPharma Inc., dated January 29, 2007
|
Filed
herewith
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302(a) of the
Sarbanes-Oxley Act
|
Filed
herewith
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302(a) of the
Sarbanes-Oxley Act
|
Filed
herewith
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act
|
Filed
herewith
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act
|
Filed
herewith
|
Date: April 13, 2007 | PROTALEX, INC. | |
|
|
|
By: | /s/ Steven H. Kane | |
Steven H. Kane, President and Chief Executive Officer |
Date: April 13, 2007 | ||
|
|
|
By: | /s/ Marc L. Rose | |
Marc L. Rose, Vice President of Finance, Chief Financial Officer, Treasurer and Corporate Secretary |
2.1
|
Stock
Purchase Agreement among the Company, Don Hanosh and Enerdyne Corporation,
dated December 6, 1999
|
Incorporated
by reference, to Exhibit 2.1 to the Company’s 10-SB filing on December 6,
1999
|
|
2.2
|
Merger
Agreement and Plan of Re-organization between the Company and Enerdyne
Corporation
|
Incorporated
by reference, to Exhibit 2.2 to the Company’s 10-SB filing on December 6,
1999
|
|
2.3
|
Plan
of Merger and Agreement between Protalex, Inc., a New Mexico corporation
and Protalex, Inc. a Delaware Corporation
|
Incorporated
by reference, to Exhibit 2.1 to the Company’s 8K filing on December 6,
2004
|
|
3.1
|
Certificate
of Incorporation of the Company
|
Incorporated
by reference, to Exhibit 3.1 to the Company’s 8-K filing on December 6,
2004
|
|
3.2
|
Bylaws
of the Company
|
Incorporated
by reference, to Exhibit 3.2 to the Company’s 8-K filing on December 6,
2004
|
|
3.3
|
State
of Delaware, Certificate of Amendment of Certificate of Incorporation
|
Incorporated
by reference, to Exhibit 3.3 to the Company 10-QSB filed on January
13,
2006
|
|
4.1
|
Letter
Agreement with Pembroke Financial Ltd. Dated July 9, 2001
|
Incorporated
by reference, to Exhibit 10.9 to the Company’s 10-KSB/A filed on September
24, 2003
|
|
4.2
|
Securities
Purchase Agreement dated September 18, 2003 between the Company and
certain of the Selling Stockholders
|
Incorporated
by reference, to Exhibit 4.3 to the Company’s SB-2 filed on October 20,
2003.
|
|
4.3
|
Investor
Rights Agreement dated September 18, 2003 between the Company and
certain
of the Selling Stockholders
|
Incorporated
by reference, to Exhibit 4.3 to the Company’s SB-2 filed on October 20,
2003.
|
|
4.4
|
Form
of Common Stock Purchase Warrant issued by the Company to the Selling
Stockholders
|
Incorporated
by reference, to Exhibit 4.4 to Company’s SB-2 filed on October 20,
2003.
|
|
4.5
|
Warrant
and Common Stock Purchase Agreement dated May 25, 2005 among the
Company
and the several purchasers thereunder
|
Incorporated
by reference to Exhibit 4.5 to the Company’s Form SB-2 filed on June 16,
2005
|
|
4.6
|
Registration
Rights Agreement dated May 25, 2005 among the purchasers under the
Warrant
and Common Stock Purchase Agreement of even date therewith
|
Incorporated
by reference to Exhibit 4.6 to the Company’s Form SB-2 filed on June 16,
2005
|
|
4.7
|
Addendum
1 to Subscription Agreement and Questionnaire of vSpring SBIC, LP
dated
May 25, 2005
|
Incorporated
by reference to Exhibit 4.7 to the Company’s Annual Report on Form 10-KSB
filed on August 26, 2005
|
|
4.8
|
Warrant
and Common Stock Purchase Agreement dated December 22, 2005 among
the
Company and the several purchasers thereunder
|
Incorporated
by reference, to Exhibit 4.5 to the Company’s SB-2 filed on January 27,
2006
|
|
4.9
|
Registration
Rights Agreement dated December 22, 2005 among the purchasers under
the
Warrant and Common Stock Purchase Agreement of even date therewith
|
Incorporated
by reference, to Exhibit 4.6 to the Company’s SB-2 filed on January 27,
2006
|
|
4.10
|
Form
of Warrant issued by the Company to the Selling Stockholders dated
December 22, 2005 of even date therewith
|
Incorporated
by reference, to Exhibit 4.7 to the Company’s SB-2 filed on January 27,
2006
|
4.11
|
Warrant
and Common Stock Purchase Agreement dated June 30, 2006 among the
Company
and the several purchasers thereunder
|
Incorporated
by reference, to Exhibit 10.1 to the Company’s Current Report on Form 8K
filed on July 10, 2006.
|
|
4.12
|
Registration
Rights Agreement dated June 30, 2006 among the purchasers under the
Warrant and Common Stock Purchase Agreement of even date therewith
|
Incorporated
by reference, to Exhibit 10.2 to the Company’s Current Report on Form 8K
filed on July 10, 2006
|
|
4.13
|
Form
of Warrant issued by the Company to the Selling Stockholders dated
June
30, 2006 of even date therewith
|
Incorporated
by reference, to Exhibit 10.3 to the Company’s Current Report on Form 8K
filed on July 10, 2006
|
|
10.1
|
Employment
offer letter executed by Steven H. Kane
|
Incorporated
by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form
10-QSB filed on January 13, 2006.
|
|
10.2
|
Board
appointment executed by G. Kirk Raab
|
Incorporated
by reference, to Exhibit 10.4 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.3
|
Form
of Option Agreement
|
Incorporated
by reference, to Exhibit 10.6 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003
|
|
10.4
|
Frame
Contract between the Company and Eurogentec S.A.
|
Incorporated
by reference, to Exhibit 10.5 to the Company’s 10-KSB/A filed on September
24, 2003
|
|
10.5
|
Assignment
of Intellectual Property from Alex LLC to the Company
|
Incorporated
by reference, to Exhibit 10.8 to the Company’s 10-KSB/A filed on September
24, 2003.
|
|
10.6
|
Assignment
of Intellectual Property from Dr. Paul Mann to the Company
|
Incorporated
by reference, to Exhibit 10.8 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.7
|
Stock
Redemption Agreement dated August 15, 2003, by and between the Company,
Paul L. Mann, Leslie A. McCament-Mann, Gail Stewe and Elizabeth Sarah
Anne
Wiley
|
Incorporated
by reference, to Exhibit 10.10 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.8
|
Letter
dated August 21, 2003 from Paul L. Mann to the Company
|
Incorporated
by reference, to Exhibit 10.11 to the Company’s Annual Report on Form
10-KSB/A filed on September 24, 2003.
|
|
10.9
|
Technology
License Agreement dated November 17, 1999, between the Company and
Alex,
LLC
|
Incorporated
by reference, to Exhibit 10.4 to the Company’s Registration of Securities
on Form 10-SB filed on December 6, 1999.
|
|
10.10
|
Letter
Agreement, dated March 16, 2005, effective October 26, 2004, between
the Company and Carleton A. Holstrom
|
Incorporated
by reference, to Exhibit 10.3 to the Company’s Quarterly Report on Form
10-QSB/A filed on April 14, 2005.
|
|
10.11
|
Description
of the verbal agreement between the Company and Eugene A. Bauer,
M.D.
|
Incorporated
by reference to the Company’s Current Report on Form 8K filed on February
22, 2005.
|
|
10.12
|
Protalex,
Inc. 2003 Stock Option Plan Amended and Restated as of July 29, 2005
|
Incorporated
by reference to Appendix B to the Company’s Proxy Statement filed with the
SEC on September 23, 2005.
|
|
10.13
|
Description
of the verbal agreement between the Company and Peter G. Tombros
|
Incorporated
by reference to the Company’s Current Report on Form 8K filed on November
14, 2005.
|
|
10.14
|
Modified
lease agreement with Union Square LP, dated November 18, 2005
|
Incorporate
by reference to Exhibit 99.1 to the Company’s Current Report Form 8-K
filed with the Securities and Exchange Commission on November 22,
2005.
|
10.15
|
Employment
offer letter executed by Marc L. Rose
|
Incorporated
by reference, to Exhibit 10.2 to the Company’s Quarterly Report on Form
10-QSB filed on January 14, 2005.
|
|
10.16
|
Employment
offer letter executed by Victor S. Sloan, M.D
|
Incorporated
by reference, to Exhibit 10.1 to the Company’s Quarterly Report on Form
10-QSB filed on October 14, 2005.
|
|
10.17†
|
Clinical
Study Agreement executed October 19, 2005 between the Company and
PAREXEL
International LLC
|
Incorporated
by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form
10-QSB filed on January 13, 2006.
|
|
10.18†
|
Service
Contract with AAIPharma Inc., dated January 29, 2007
|
Filed
herewith
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302(a) of the
Sarbanes-Oxley Act
|
Filed
herewith
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302(a) of the
Sarbanes-Oxley Act
|
Filed
herewith
|
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act
|
Filed
herewith
|
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act
|
Filed
herewith
|
Process
Transfer and Manufacture of Engineering Batch
|
||||
Manufacture
of Two (2) Clinical Batches
|
||||
Stability
Program for Two (2) Clinical Batches
|
||||
Project
Management
|
||||
Total
Estimated Cost
|
$ | XXXX* |
APPENDIX
I
|
DESCRIPTION OF SERVICES |
APPENDIX
II
|
PAYMENT SCHEDULE AND TERMS |
APPENDIX
III
|
GENERAL TERMS AND CONDITIONS |
AAIPharma Inc. | Protalex, Inc. | |
Reviewed and Approved by: | Printed Name of Authorized Representative | |
Beth Balkcum | ||
Manager, Product Development, | ||
Project Management | ||
Date | Signature | |
Reviewed and Approved by: | Date | |
Lee Karras | ||
Senior Vice President, Pharmaceutical | ||
Operations | ||
Date | Purchase Order Number | |
Please return signed document to: | ||
Baron Bowers | ||
Project Manager, Product Development Group | ||
AAIPharma Inc. | Telephone: 843.746.2513 | |
4221 Faber Place Drive | Facsimile: 843.746.2550 | |
Charleston, SC 29405 | E-mail: baron.bowers@aaipharma.com |
PRTX8000
|
Page
2 of 9
|
01/29/2007
|
I. |
Project
Responsibility
|
A.
|
Client
will supply AAIPharma with sufficient quantities of Active Pharmaceutical
Ingredient (“API”) and a current MSDS.
Note
:
Client will supply the API accompanied by a Certificate of Analysis
(COA)
and a release statement or a COA from an independent laboratory in
order
for AAIPharma to perform limited release testing.
|
B.
|
AAIPharma
will perform the following tests to release the API: identification
and
appearance.
Note
:
A
change order may be necessary if additional release testing is required
by
AAIPharma. AAIPharma will release a single lot of API to be used
in the
engineering and clinical batches.
|
C. |
AAIPharma
will source sufficient amounts of packaging components and materials
on
behalf of Client for use in the activities described herein. The
costs
will be passed-through to Client plus 15% for sourcing and
handling.
|
D. |
AAIPharma
will perform full COA testing per USP or specification for all raw
materials and packaging components.
|
II. |
Process
Transfer and Engineering
Batch
|
·
|
Review
all technical documentation provided by
Protalex.
|
·
|
Generate
appropriate test procedures and specifications for manufacturing
PRTX-100.
|
·
|
Prepare
and issue a batch record to manufacture an engineering batch of
PRTX-100.
|
·
|
Set-up
AAIPharma equipment as appropriate for the Protalex-specified packaging
components and perform trial runs to optimize the operating parameters
of
the filling equipment (
Note
:
If AAIPharma does not purchase the components directly, then Protalex
will
be responsible for sourcing the components in packaging configurations
suitable for AAIPharma gross cleaning
equipment).
|
·
|
Compound,
aseptically fill and lyophilize one full-scale engineering (test)
batch as
outlined in the batch record; if API is limited, AAIPharma will use
surrogate material or placebo to fill the shelves of the
lyophilizer.
|
·
|
Perform
appropriate in-process testing (pH, appearance, bioburden, fill weight
and
concentration via UV 280).
|
·
|
Test
the batch according to specifications agreed upon in writing by Protalex
and AAIPharma. AAIPharma will test the batch for concentration by
UV280,
appearance, pH, isoelectric focusing (IEF), SDS-PAGE, Size Exclusion
Chromatography (SEC), PX1 Binding Affinity (ELISA), concentration
by
m
BCA,
moisture (cKF), completeness, clarity, and color of solution after
reconstitution, reconstitution time, content uniformity, analytical
content (the appropriate method is to be determined) and particulate
matter (via HIAC).
|
·
|
Perform
cleaning verification testing.
|
·
|
Dispose
of any remaining vials (
Note
:
The engineering batch will not be packaged or labeled for clinical
use).
|
·
|
Complete
the batch record (
Note
:
AAIPharma QA approval is not required for master or executed copies
of
engineering batch records).
|
·
|
Prepare
the master batch record - to be approved by
Protalex.
|
·
|
Compound,
aseptically fill and lyophilize two (2) batches of PRTX-100 in a
5-mL vial
(Batch sizes: approximately 2,000
vials).
|
·
|
Perform
appropriate in-process testing during manufacturing (i.e. pH, appearance,
bioburden, fill weight and concentration via UV
280).
|
·
|
Release
the batches according to specifications agreed upon in writing by
Protalex
and AAIPharma. AAIPharma will test the batches for concentration
by UV280,
appearance, pH, isoelectric focusing (IEF), SDS-PAGE, Size Exclusion
Chromatography (SEC), PX1 Binding Affinity (ELISA), concentration
by
m
BCA,
moisture (cKF), completeness, clarity, and color of solution after
reconstitution, reconstitution time, content uniformity, analytical
content (the appropriate method is to be determined), particulate
matter
(via HIAC), endotoxin and sterility.
|
·
|
Perform
cleaning verification testing.
|
·
|
Inspect,
label and package the vials - 100% visual inspection; Protalex to
approve
label copy in writing or provide finished labels with an approved
proof
copy.
|
·
|
Complete
the batch records and issue a copy to
Protalex.
|
·
|
Ship
the batches FOB to Protalex or a designated site as a single shipment.
Each additional shipment will incur an additional
$XXXX
handling charge.
|
Estimated Cost for Section III |
$XXXX
per batch or
$XXXX
|
TESTS
PERFORMED
|
1.
Appearance
|
2.
pH
|
3.
Concentration
by UV280
or
m
BCA
|
4.
Completeness,
clarity and color of solution
|
5.
Moisture
(cKF)
|
6.
PXI
Binding Affinity (ELISA)
|
7.
SEC
|
8.
SDS-PAGE
|
9.
Particulate
matter (HIAC)
|
10.
Sterility
|
Time
(Months)
|
25
°
C/60%
RH
|
30
°
C/65%
RH
|
40
°
C/75%
RH
|
|||||||
0
|
Tests
1-10
|
|||||||||
1
|
Tests
1-9
|
HOLD*
|
Tests
1-9
|
|||||||
3
|
Tests
1-9
|
HOLD*
|
Tests
1-9
|
|||||||
6
|
Tests
1-9
|
HOLD*
|
Tests
1-9
|
|||||||
9
|
Tests
1-9
|
HOLD*
|
N/A
|
|||||||
12
|
Tests
1-10
|
HOLD*
|
N/A
|
|||||||
18
|
Tests
1-9
|
N/A
|
N/A
|
|||||||
24
|
Tests
1-10
|
N/A
|
N/A
|
Estimated Cost for Section IV |
$XXXX
per batch or $XXXX
1
|
V. |
Project
Management
|
Service
Agreement
Section
|
Service
Agreement Description
|
Estimated
Cost
|
Section
I.
|
Project
Responsibility
|
Cost
plus 15%
|
Section
II.
|
Engineering
Batch Manufacture
|
$XXXX
|
Section
III.
|
Clinical
Batch Manufacture (2)
|
$XXXX
|
Section
IV.
|
Stability
Program (2)
|
$XXXX
|
PRTX8000
|
Page 6
of 9
|
01/29/2007
|
Payment
|
Payment
Description
|
Amount
|
||
1
|
Prepayment
Due Upon Signature of Contract
|
$XXXX
|
||
2
|
Engineering
Batch Manufacture
|
$XXXX
|
||
3
|
First
Clinical Batch is Released by AAIPharma Quality Assurance
|
$XXXX
|
||
4
|
Second
Clinical Batch is Released by AAIPharma Quality Assurance
|
$XXXX
|
||
5
|
Stability
Program Initiated for Clinical Batch #1
|
$XXXX
|
||
6
|
6
Month Stability Report is Issued for Clinical Batch #1
|
$XXXX
|
||
7
|
12
Month Stability Report is Issued for Clinical Batch #1
|
$XXXX
|
||
8
|
18
Month Stability Report is Issued for Clinical Batch #1
|
$XXXX
|
||
9
|
24
Month Stability Report is Issued for Clinical Batch #1
|
$XXXX
|
||
10
|
Stability
Program Initiated for Clinical Batch #2
|
$XXXX
|
||
11
|
6
Month Stability Report is Issued for Clinical Batch #2
|
$XXXX
|
||
12
|
12
Month Stability Report is Issued for Clinical Batch #2
|
$XXXX
|
||
13
|
18
Month Stability Report is Issued for Clinical Batch #2
|
$XXXX
|
||
14
|
24
Month Stability Report is Issued for Clinical Batch #2
|
$XXXX
|
a.
Requirements
Client
will supply AAIPharma with this Service Estimate, or a copy of it,
signed
by the appropriate authorized Client representative. Client will
also
supply AAIPharma with a purchase order number and prepayment in the
amount
of $XXXX.
b.
Invoicing
Unless
otherwise agreed, AAIPharma will invoice Client pursuant to the Payment
Schedule and Terms set forth in Appendix II. All invoices are due
and
payable upon receipt and are subject to 1.5% interest monthly after
thirty
(30) days from the date of the respective invoice. In the event of
default
in the payment for services rendered, Client shall be responsible
for all
collection fees and expenses incurred by AAIPharma, including reasonable
attorney’s fees.
c.
Good Manufacturing Practices
AAIPharma
operates its manufacturing facilities in compliance with applicable,
current Good Manufacturing Practices and AAIPharma internal standard
operating procedures, and is registered with the Food and Drug
Administration, Registration Numbers 10-49418, 10-58430, 19-54450
and
10-55790 (Wilmington, NC; Research Triangle Park, NC; Shawnee, Kansas
and
Charleston, SC; respectively).
d.
Amendment
No
addition to or modification of this Service Estimate shall be effective
unless made in writing and signed by both parties, except the parties
may
orally agree to a change order (encompassing a change in project
scope or
definition) for additional services providing the associated fee
for such
additional services does not exceed 10% of the relevant portion of
the
project cost. AAIPharma will confirm in writing any such oral change
order, and Client will be responsible for payment for such additional
services.
e.
Termination
Client
shall be entitled to terminate or cancel the project at any time
on thirty
(30) days' written notice received by AAIPharma prior to the respective
scheduled manufacturing date. In the event of such termination or
cancellation, Client will be obligated to pay only for the cost of
work,
materials and services used for the project through the effective
date of
the cancellation, reasonable project shut down costs, and AAIPharma's
cost
of all materials and services previously acquired or contracted for
and
which cannot be utilized in other day-to-day operations.
In
addition, a cancellation fee in the amount of $XXXX
(50%
of the estimated project cost set forth in Appendix II (the “Project
Cost”)
shall
be due to AAIPharma should Client provide AAIPharma less than thirty
(30)
days and more than ten (10) days notice of such termination or
cancellation in writing. Client shall pay to AAIPharma a cancellation
fee
in the amount of $XXXX
(75%
of the Project Cost)
should it provide AAIPharma ten (10) days or less notice of such
termination or cancellation in writing. Such Project Cost payments
will be
invoiced as provided hereunder. Client shall not be charged a cancellation
fee for any manufacturing orders canceled if a written notice of
cancellation is received by AAIPharma more than thirty (30) days
before
the scheduled clinical supplies manufacturing.
f.
Delivery Schedule
Delivery
dates, if any, in this Service Estimate are approximations. AAIPharma
shall not be liable for, nor shall AAIPharma be in breach of its
obligations to Client because of any delivery made within reasonable
time
of the estimated delivery date.
g.
Safety
information
To
ensure the safe handling, storage, usage, shipment and disposal of
chemicals and other materials provide to AAIPharma by Client, Client
warrants that it will provide AAIPharma with all necessary safety
information (including, without limitation, Material Safety Data
Sheets).
Client is responsible for labeling and all other information relevant
to
the chemicals, materials, drug product and placebo (“Materials”), as
appropriate.
|
PRTX8000
|
Page 9
of 9
|
01/29/2007
|
Dated: April 13, 2007 | By: | /s/ Steven H. Kane |
Steven H. Kane |
||
Chief Executive Officer |
Dated: April 13, 2007 | By: | /s/ Marc L. Rose |
Marc L. Rose |
||
Chief Financial Officer |
Dated: April 13, 2007 | By: | /s/ Steven H. Kane |
Steven H. Kane |
||
Chief Executive Officer |
Dated: April 13, 2007 | By: | /s/ Marc L. Rose |
Marc L. Rose |
||
Chief Financial Officer |