Delaware
|
|
84-1475642
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
|
(IRS
Employer Identification No.)
|
|
|
|
1180
Avenue of the Americas, 19 th
Floor,
New York, NY
|
|
10036
|
(Address
of Principal Executive Offices)
|
|
(Zip
Code)
|
|
|
|
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Page
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PART
I
|
|
FINANCIAL
INFORMATION
|
|
|
|
|
|
|
|
Item
1.
|
|
Financial
Statements
|
|
|
|
|
|
|
|
|
|
Balance
Sheets September 30, 2006 (unaudited) and December 31,
2005
|
|
3
|
|
|
|
|
|
|
|
Statement
of Operations for the three and nine months ended September 30, 2006
and
2005 (unaudited) and for the period from inception (September 9,
2003) to
September 30, 2006 (unaudited)
|
|
4
|
|
|
|
|
|
|
|
Statement
of Cash Flows for the nine months ended September 30, 2006 and 2005
(unaudited) and for the period from inception (September 9, 2003)
to
September 30, 2006 (unaudited)
|
|
5
|
|
|
|
|
|
|
|
Statement
of Changes in Convertible Preferred Stock and Stockholders’
Equity/(Deficit) for the nine months ended September 30, 2006 (unaudited)
and for the year ended December 31, 2005 and 2004 and for the period
from
inception (September 9, 2003) to December 31, 2003
|
|
6
|
|
|
|
|
|
|
|
Notes
to Unaudited Financial Statements
|
|
7
|
|
|
|
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|
Item
2.
|
|
Management’s
Discussion and Analysis or Plan of Operation
|
|
17
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|
|
|
|
|
Item
3.
|
|
Controls
and Procedures
|
|
24
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|
|
|
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PART
II
|
|
OTHER
INFORMATION
|
|
|
|
|
|
|
|
Item
1.
|
|
Legal
Proceedings
|
|
25
|
|
|
|
|
|
Item
2.
|
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
25
|
|
|
|
|
|
Item
3.
|
|
Defaults
Under Senior Securities
|
|
25
|
|
|
|
|
|
Item
4.
|
|
Submission
of Matters to a Vote of Security Holders
|
|
25
|
|
|
|
|
|
Item
5.
|
|
Other
Information
|
|
26
|
|
|
|
|
|
Item
6.
|
|
Exhibits
|
|
26
|
|
|
Signatures
|
|
27
|
|
|
Exhibit
Index
|
|
28
|
September
30, 2006
|
December
31, 2005
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
32,962,230
|
$
|
8,880,717
|
|||
Short-term
investments
|
1,536,357
|
—
|
|||||
Prepaid
expenses and other current assets
|
314,785
|
211,837
|
|||||
Total
current assets
|
34,813,372
|
9,092,554
|
|||||
Property
and equipment, net
|
294,982
|
269,702
|
|||||
Deposits
|
9,367
|
5,700
|
|||||
Other
non current assets
|
177,219
|
124,343
|
|||||
Total
assets
|
$
|
35,294,940
|
$
|
9,492,299
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,143,777
|
$
|
835,997
|
|||
Accrued
expenses
|
2,136,961
|
1,418,819
|
|||||
Total
current liabilities
|
3,280,738
|
2,254,816
|
|||||
Deferred
rent
|
39,972
|
35,557
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value; 280,000,000 shares authorized;
|
|||||||
15,264,248
and 7,247,992 shares issued and outstanding
|
|||||||
at
September 30, 2006 and December 31, 2005, respectively
|
15,264
|
7,248
|
|||||
Additional
paid-in capital
|
59,361,574
|
22,559,034
|
|||||
Deficit
accumulated during the development stage
|
(27,402,608
|
)
|
(15,364,356
|
)
|
|||
Total
stockholders' equity
|
31,974,230
|
7,201,926
|
|||||
Total
liabilities and stockholders' equity
|
$
|
35,294,940
|
$
|
9,492,299
|
|
For
the three
months
ended September 30,
2006
|
For
the three
months
ended September 30,
2005
|
For
the nine
months
ended September 30,
2006
|
For
the nine
months
ended September 30,
2005
|
From
Inception
(Sept.
9, 2003)
through
September
30,
2006
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Research
contract revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
|
||||||||||||||||
Operating
expenses and other income:
|
||||||||||||||||
Research
and development
|
2,097,617
|
1,318,608
|
6,545,986
|
4,279,687
|
14,266,443
|
|||||||||||
General
and administrative
|
1,832,361
|
1,541,740
|
6,345,450
|
2,953,830
|
14,281,596
|
|||||||||||
Total
operating expenses
|
3,929,978
|
2,860,348
|
12,891,436
|
7,233,517
|
28,548,039
|
|||||||||||
|
||||||||||||||||
Loss
from operations
|
(3,929,978
|
)
|
(2,860,348
|
)
|
(12,891,436
|
)
|
(7,233,517
|
)
|
(28,548,039
|
)
|
||||||
|
||||||||||||||||
Interest
income
|
475,476
|
94,231
|
853,184
|
177,710
|
1,145,431
|
|||||||||||
Net
loss
|
$
|
(3,454,502
|
)
|
$
|
(2,766,117
|
)
|
$
|
(12,038,252
|
)
|
$
|
(7,055,807
|
)
|
$
|
(27,402,608
|
)
|
|
|
||||||||||||||||
|
||||||||||||||||
Basic
and diluted net loss per share
|
$
|
(0.23
|
)
|
$
|
(0.77
|
)
|
$
|
(1.03
|
)
|
$
|
(2.32
|
)
|
||||
|
||||||||||||||||
Weighted
average common shares
|
||||||||||||||||
outstanding
used to compute basic
|
||||||||||||||||
and
diluted net loss per share share
|
15,264,368
|
3,593,109
|
11,662,722
|
3,041,829
|
|
For
the nine months
ended
September
30, 2006
|
For
the nine months
ended
September
30, 2005
|
For
the Period
from
Inception
(Sept.
9, 2003)
through
September
30, 2006
|
|||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(12,038,252
|
)
|
$
|
(7,055,807
|
)
|
$
|
(27,402,608
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and amortization
|
117,155
|
72,519
|
252,340
|
|||||||
Non-cash
stock-based compensation
|
2,530,436
|
—
|
3,332,307
|
|||||||
Gain
on disposal of fixed assets
|
(1,165
|
)
|
—
|
(1,165
|
)
|
|||||
Change
in operating assets and liabilites:
|
||||||||||
(Increase)
decrease in:
|
||||||||||
Prepaid
expenses and other current assets
|
(102,948
|
)
|
(92,245
|
)
|
(314,785
|
)
|
||||
Other
noncurrent assets
|
(52,876
|
)
|
(92,812
|
)
|
(177,219
|
)
|
||||
Deposits
|
(3,667
|
)
|
24,014
|
(9,367
|
)
|
|||||
Increase
(decrease) in:
|
||||||||||
Accounts
payable
|
307,780
|
(232,558
|
)
|
1,143,777
|
||||||
Accrued
expenses
|
718,142
|
391,248
|
2,136,961
|
|||||||
Deferred
rent
|
4,415
|
—
|
39,972
|
|||||||
Net
cash used in operating activities
|
(8,520,980
|
)
|
(6,985,641
|
)
|
(20,999,787
|
)
|
||||
|
||||||||||
Cash
flows from investing activities:
|
||||||||||
Purchases
of property and equipment
|
(141,270
|
)
|
(64,648
|
)
|
(546,157
|
)
|
||||
Increase
in short-term investments
|
(1,536,357
|
)
|
—
|
(1,536,357
|
)
|
|||||
Net
cash used in investing activities
|
(1,677,627
|
)
|
(64,648
|
)
|
(2,082,514
|
)
|
||||
|
||||||||||
Cash
flows from financing activities:
|
||||||||||
Stockholders'
capital contribution
|
—
|
—
|
500,000
|
|||||||
Proceeds
from issuance of common stock and warrants, net
|
34,280,120
|
4,676
|
38,784,935
|
|||||||
Proceeds
from issuance of preferred stock, net
|
—
|
16,759,596
|
16,759,596
|
|||||||
Net
cash provided by financing activities
|
34,280,120
|
16,764,272
|
56,044,531
|
|||||||
|
||||||||||
Net
increase in cash and cash equivalents
|
24,081,513
|
9,713,983
|
32,962,230
|
|||||||
|
||||||||||
Cash
and cash equivalents, beginning of period
|
8,880,717
|
1,026,656
|
—
|
|||||||
|
||||||||||
Cash
and cash equivalents, end of period
|
$
|
32,962,230
|
$
|
10,740,639
|
$
|
32,962,230
|
||||
|
||||||||||
Supplementary
disclosure of cash flow information:
|
||||||||||
Cash
paid for interest
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
|
||||||||||
Cash
paid for income taxes
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
|
||||||||||
Supplementary
disclosure of noncash investing and financing activities:
|
||||||||||
Warrants
issued to placement agents and investors, in connection
with
|
||||||||||
with
private placement
|
$
|
13,092,561
|
$
|
—
|
$
|
13,092,561
|
||||
Warrants
issued to placement agent, in connection
|
||||||||||
with
preferred stock issuance
|
$
|
—
|
$
|
1,682,863
|
$
|
1,682,863
|
||||
Preferred stock conversion to common stock |
$
|
—
|
$
|
16,759,596
|
$
|
16,759,596
|
Convertible
Preferred Stock and Warrants
|
Stockholder's
Equity (Deficit)
|
||||||||||||||||||||||||
Series
A Convertible
Preferred Stock |
Warrants
to Purchase
Series
A Convertible
Preferred
Stock
|
Common
Stock
|
|
|
|||||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Warrants
|
|
Shares
|
|
Amount
|
|
Additional
Paid- in
Capital |
|
Deficit
Accumulated
During The
Development
Stage
|
Total
Stockholders'
Equity/(Deficit)
|
||||||||||
Stockholders'
contribution,
|
|||||||||||||||||||||||||
September
9, 2003
|
—
|
$
|
—
|
$
|
—
|
250,487
|
$
|
250.00
|
$
|
499,750.00
|
$
|
—
|
$
|
500,000.00
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(160,136
|
)
|
(160,136
|
)
|
|||||||||||||||
Balance
at December 31, 2003 (audited)
|
0
|
0
|
0
|
250,487
|
250
|
499,750
|
(160,136
|
)
|
339,864
|
||||||||||||||||
Issuance
of common stock
|
—
|
—
|
—
|
2,254,389
|
2,254
|
4,497,746
|
—
|
4,500,000
|
|||||||||||||||||
Issuance
of common stock for services
|
256,749
|
257
|
438,582
|
—
|
438,839
|
||||||||||||||||||||
Fair
value of options/warrants
|
|||||||||||||||||||||||||
issued
for nonemployee services
|
—
|
—
|
—
|
—
|
—
|
264,277
|
—
|
264,277
|
|||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,687,297
|
)
|
(5,687,297
|
)
|
|||||||||||||||
Balance
at December 31, 2004 (audited)
|
—
|
—
|
—
|
2,761,625
|
2,761
|
5,700,355
|
(5,847,433
|
)
|
(144,317
|
)
|
|||||||||||||||
Issuance
of Series A convertible preferred
|
|||||||||||||||||||||||||
stock
(net of expenses of $1,340,263 and
|
|||||||||||||||||||||||||
warrant
cost of $1,682,863)
|
4,197,946
|
15,076,733
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||
Fair
value of warrants to purchase Series
|
|||||||||||||||||||||||||
A
convertible preferred stock
|
—
|
—
|
1,682,863
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||
Issuance
of Common stock to EasyWeb
|
|||||||||||||||||||||||||
Shareholders
|
—
|
—
|
—
|
189,922
|
190
|
(190
|
)
|
—
|
—
|
||||||||||||||||
Conversion
of Series A convertible
|
|||||||||||||||||||||||||
preferred
stock @ $0.001 into $0.001
|
|||||||||||||||||||||||||
common
stock on September 13, 2005
|
|||||||||||||||||||||||||
at
an exchange ratio of .500974
|
(4,197,946
|
)
|
(15,076,733
|
)
|
(1,682,863
|
)
|
4,197,823
|
4,198
|
16,755,398
|
—
|
16,759,596
|
||||||||||||||
Issuance
of common stock for options
|
—
|
—
|
—
|
98,622
|
99
|
4,716
|
—
|
4,815
|
|||||||||||||||||
Fair
value of options/warrants issued for
|
|||||||||||||||||||||||||
nonemployee
services
|
—
|
—
|
—
|
—
|
—
|
98,755
|
—
|
98,755
|
|||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(9,516,923
|
)
|
(9,516,923
|
)
|
|||||||||||||||
Balance
at December 31, 2005 (audited)
|
—
|
—
|
—
|
7,247,992
|
7,248
|
22,559,034
|
(15,364,356
|
)
|
7,201,926
|
||||||||||||||||
Issuance
of common stock in private
|
|||||||||||||||||||||||||
placement,
net of expenses $2,719,395
|
—
|
—
|
—
|
7,991,256
|
7,991
|
21,179,568
|
—
|
21,187,559
|
|||||||||||||||||
Issuance
of warrants
|
—
|
—
|
—
|
—
|
—
|
13,092,561
|
—
|
13,092,561
|
|||||||||||||||||
Issuance
of common stock for
|
|||||||||||||||||||||||||
services
rendered
|
—
|
—
|
—
|
25,000
|
25
|
106,225
|
—
|
106,250
|
|||||||||||||||||
Stock
based compensation for
|
|||||||||||||||||||||||||
employees
|
—
|
—
|
—
|
—
|
—
|
2,424,186
|
—
|
2,424,186
|
|||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,038,252
|
)
|
(12,038,252
|
)
|
|||||||||||||||
Balance
at September 30, 2006 (unaudited)
|
—
|
$
|
—
|
$
|
—
|
15,264,248
|
$
|
15,264
|
$
|
59,361,574
|
$
|
(27,402,608
|
)
|
$
|
31,974,230
|
1.
|
BASIS
OF PRESENTATION AND
OPERATIONS
|
2.
|
STOCK
BASED COMPENSATION
|
|
|
Three
months ended
September 30, 2006 |
|
Nine
months ended
September 30, 2006 |
|||
Research
and development, including costs of research contracts
|
$
|
101,928
|
$
|
266,174
|
|||
General
and administrative
|
228,535
|
2,158,012
|
|||||
Share
based compensation expense before tax
|
330,463
|
2,424,186
|
|||||
Income
tax benefit
|
—
|
—
|
|||||
Net
compensation expense
|
$
|
330,463
|
$
|
2,424,186
|
|
|
Three
months ended
September 30, 2005 |
|
Nine
months ended
September 30, 2005 |
|||
Net
loss:
|
$
|
(2,766,117
|
)
|
$
|
(7,055,807
|
)
|
|
As
reported
|
|||||||
Stock-based
compensation expense included in reported net loss
|
—
|
—
|
|||||
Stock-based
compensation expense under the fair value-based method
|
(176,297
|
)
|
(340,197
|
)
|
|||
Pro
forma net loss
|
$
|
(2,942,414
|
)
|
$
|
(7,396,004
|
)
|
|
Basic
and diluted net loss per share:
|
|||||||
As
reported
|
$
|
(0.77
|
)
|
$
|
(2.32
|
)
|
|
Pro
forma
|
$
|
(0.82
|
)
|
$
|
(2.43
|
)
|
3.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
4.
|
RELATED
PARTY TRANSACTIONS
|
5.
|
STOCK
OPTION PLAN
|
|
Number
of Shares
|
Weighted
Average Exercise
Price |
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate Intrinsic
Value |
|||||||||
Outstanding,
January 1, 2006
|
973,639
|
$ |
2.56
|
||||||||||
Granted
|
705,930
|
5.02
|
|||||||||||
Exercised
|
—
|
—
|
|||||||||||
Canceled
|
22,939
|
4.19
|
|||||||||||
Outstanding,
September 30, 2006
|
1,656,630
|
$ |
3.56
|
8.76
|
$ |
2,679,983
|
|||||||
Options
exercisable, September 30, 2006
|
942,097
|
$ |
3.43
|
8.68
|
$ |
1,622,360
|
6.
|
WARRANTS
|
|
·
|
ZIO-101
is an organic arsenic compound covered by issued U.S. patents and
applications internationally. A form of commercially available inorganic
arsenic (arsenic trioxide (Trisenox®) or ATO) has been approved for the
treatment of acute promyelocytic leukemia (APL), a precancerous condition,
and is on the compendia listing for the therapy of multiple myeloma
as
well as having been studied for the treatment of various other cancers.
Nevertheless, ATO has been shown to be toxic to the heart, liver,
and
brain, limiting its use as an anti-cancer agent. Inorganic arsenic
has
also been shown to cause cancer of the skin and lung in humans. The
toxicity of arsenic generally is correlated to its accumulation in
organs
and tissues. Our preclinical and phase I clinical studies to date
have
demonstrated that ZIO-101 (and organic arsenic in general) is considerably
less toxic than inorganic arsenic, particularly with regard to heart
toxicity. In vitro testing of ZIO-101 using the National Cancer
Institute’s human cancer cell panel detected activity against lung, colon,
brain, melanoma, ovarian and kidney cancer. Moderate activity was
detected
against breast and prostate cancer. In addition to solid tumors,
in vitro
testing in both the National Cancer Institute’s cancer cell panel and in
vivo testing in a leukemia animal model demonstrated substantial
activity
against hematological cancers (cancers of the blood and blood-forming
tissues) such as leukemia, lymphoma, myelodysplastic syndromes and
multiple myeloma.
|
|
|
Phase
I testing of the intravenous (IV) form of ZIO-101 is ongoing with
two
safety and dose finding studies. The Company has seen encouraging
signs of
clinical activity in both of these studies.. The Company has progressed
an
ongoing phase I/II study in advanced multiple myeloma designed to
determine maximum tolerated dose and to assess clinical activity
in this
specific indication. The Company expects to pursue registration in
the
U.S. for the treatment of advanced multiple myeloma with a potentially
pivotal trial to begin in late 2007. The Company also expects to
initiate
additional phase II studies in other hematological and solid tumor
cancers
while also exploring different dosing schedules and to file a U.S.
Investigational New Drug Application for the clinical study of an
oral
form of ZIO-101.
|
|
·
|
ZIO-201,
or isophosphoramide mustard (IPM), is a proprietary stabilized metabolite
of ifosfamide that is also related to cyclophosphamide. A patent
application for pharmaceutical composition has been filed.
Cyclophosphamide and ifosfamide are alkylating agents. The Company
believes cyclophosphamide is the most widely used alkylating agent
in
cancer therapy and is used to treat breast cancer and non-Hodgkin’s
lymphoma. Ifosfamide has been shown to be effective in high dose
by
itself, or in combination in treating sarcoma and lymphoma. Although
ifosfamide-based treatment generally represents the standard of care
for
sarcoma, it is not licensed for this indication by the Food and Drug
Administration. Our preclinical studies have shown that, in animal
and
laboratory models, IPM evidences activity against leukemia and solid
tumors. These studies also indicate that ZIO-201 has a better
pharmacokinetic and safety profile than ifosfamide or cyclophosphamide,
offering the possibility of safer and more efficacious therapy with
ZIO-201. Ifosfamide is metabolized to IPM. In addition to IPM, another
metabolite of ifosfamide is acrolein, which is toxic to the kidneys
and
bladder. The presence of acrolein can mandate the administration
of a
protective agent called mesna, which is inconvenient and expensive.
Chloroacetaldehyde is another metabolite of ifosfamide and is toxic
to the
central nervous system, causing “fuzzy brain” syndrome for which there is
currently no protective measure. Similar toxicity concerns pertain
to
high-dose cyclophosphamide, which is widely used in bone marrow and
blood
cell transplantation. Because ZIO-201 is independently active without
acrolein or chloroacetaldehyde metabolites, the Company believes
that the
administration of ZIO-201 may avoid many of the toxicities of ifosfamide
and cyclophosphamide without compromising efficacy. In addition to
anticipated lower toxicity, ZIO-201 (and without the co-administration
of
mesna) may have other advantages over ifosfamide. In preclinical
studies
ZIO-201 likely cross-links DNA differently than ifosfamide or
cyclophosphamide metabolites, resulting in a different activity profile.
Moreover, in some instances ZIO-201 appears to show activity in
ifosfamide- and/or cyclophosphamide-resistant cancer
cells.
|
|
|
|
|
|
Phase
I testing of the IV form of ZIO-201 is ongoing at two sites in the
U.S.
IPM has been administered without the “uroprotectant” mesna and the
toxicities associated with acrolein and chloroacetaldehyde have not
been
observed. Electrolyte inbalances seen with ifosfamide have occurred
in the
higher dose cohorts. The Company has seen encouraging signs of clinical
activity in the phase I study. The Company initiated a phase I/II
trial in
advanced sarcoma designed to determine maximum tolerated dose and
to
assess clinical activity in this specific indication. The Company
expects
to pursue registration in the U.S. for the treatment of advanced
sarcoma
with a potentialy pivotal trial to begin in late 2007. The Company
also
expects to initiate additional phase II studies in other cancers
and using
different dosing schedules and routes of administration and to file
a U.S.
Investigational New Drug Application for an oral form of
ZIO-201.
|
·
|
Fees
and milestone payments required under the license agreements relating
to
our existing product candidates and additional in-licensed
candidates;
|
·
|
Clinical
trial expenses, including the costs incurred with respect to the
conduct
of clinical trials for ZIO-101 and ZIO-201, ZIO-301, and preclinical
costs
associated with back-up candidates ZIO-102 and ZIO-202;
|
·
|
Costs
related to the scale-up and manufacture of ZIO-101, ZIO-201, and
ZIO-301;
|
·
|
Rent
for our facilities; and
|
·
|
General
corporate and working capital, including general and administrative
expenses.
|
·
|
Changes
in the focus and direction of our research and development programs,
including the acquisition and pursuit of development of new product
candidates;
|
·
|
Competitive
and technical advances;
|
·
|
Costs
of commercializing any of the product candidates;
|
·
|
Costs
of filing, prosecuting, defending and enforcing any patent claims
and any
other intellectual property rights;
|
|
or
other developments.
|
Payments
due by Period
|
||||||||||||||||
Total
|
|
Less
than 1 Year
|
|
1
- 3 Years
|
|
4
- 5 Years
|
|
After
5 Years
|
||||||||
Operating
lease
|
$
|
855,343
|
$
|
275,091
|
$
|
504,220
|
$
|
76,032
|
-
|
Exhibit
No.
|
|
Description
|
|
|
|
10.1
|
Asset Purchase Agreement dated November 3, 2006 by and among Baxter Healthcare S.A., Baxter International, Inc., Baxter Oncology GmbH and ZIOPHARM Oncology, Inc.† | |
10.2
|
License Agreement dated November 3, 2006 by and among Baxter Healthcare S.A., Baxter International, Inc. and ZIOPHARM Oncology, Inc.† | |
31.1
|
|
Certification
of Chief Executive Officer
|
31.2
|
|
Certification
of Chief Financial Officer
|
32.1
|
|
Certifications
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
32.2
|
|
Certifications
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
99.1
|
Press Release dated November 13, 2006. |
|
|
|
|
ZIOPHARM
ONCOLOGY, INC.
|
|
|
|
|
Date: November
13, 2006
|
By:
|
/s/ Jonathan
Lewis
|
|
Jonathan
Lewis
Chief
Executive Officer
(Principal
Executive Officer)
|
|
|
|
|
|
|
|
|
|
|
|
|
Date: November
13, 2006
|
By:
|
/s/ Richard
Bagley
|
|
Richard
Bagley
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
|
|
|
Exhibit
No.
|
|
Description
|
|
|
|
10.1
|
Asset Purchase Agreement dated November 3, 2006 by and among Baxter Healthcare S.A., Baxter International, Inc., Baxter Oncology GmbH and ZIOPHARM Oncology, Inc.† | |
10.2
|
License Agreement dated November 3, 2006 by and among Baxter Healthcare S.A., Baxter International, Inc. and ZIOPHARM Oncology, Inc.† | |
31.1
|
|
Certification
of Chief Executive Officer
|
31.2
|
|
Certification
of Chief Financial Officer
|
32.1
|
|
Certifications
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
32.2
|
|
Certifications
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
99.1
|
Press Release dated November 13, 2006. |
(i) |
Six
Hundred Twenty-Five Thousand Dollars ($625,000) within thirty (30)
days of
the first effectiveness of an IND submitted to the FDA or a CTA submitted
to the EMEA permitting the Buyer to initiate human clinical trials
of
Indibulin or Product in the United States or Europe, whichever comes
first;
|
(ii) |
[**********]
Dollars ($[**********]) within thirty (30) days of the date of
[********************];
|
(iii) |
[**********]
Dollars ($[**********]) within thirty (30) days of the date of
[********************]; and
|
(iv) |
[**********]
Dollars ($[**********]) within thirty (30) days of the date of
[********************].
|
(i) |
[*****]
percent ([*****]%) of worldwide calendar year annual Net Sales less
than
[**********] Dollars
($[**********]);
|
(ii) |
[*****]
percent ([*****]%) of worldwide calendar year annual Net Sales from
[**********] Dollars ($[**********]) up to [**********] Dollars
($[**********]); and
|
(iii) |
[*****]
percent ([*****]%) of worldwide calendar year annual Net Sales in
excess
of [*********] U.S. Dollars
($[*********]).
|
(b) |
Reports,
Audit and Payment Schedule.
|
(i) |
The
Buyer shall keep and maintain detailed records of all sales of Product
worldwide;
|
(ii) |
The
Buyer shall make quarterly payments to the Sellers within forty-five
(45)
days of the close of each calendar quarter (March 31, June 30, September
30 and December 31) based on Net Sales in such quarter, and shall
additionally provide, together with such payment, a sales report
detailing
the Net Sales of Products sold per country and the calculation of
the
amount owed pursuant to Section
2.5(a);
and
|
(iii) |
The
Sellers shall have the right annually, at the Sellers’ expense, to audit
the Buyer’s records, or the Buyer’s subsidiaries, Affiliates, licensees or
licensees’ sublicensees, as the case may be, in order to verify the
calculation of Net Sales of Products. The Buyer shall reasonably
cooperate
with the Sellers to provide Buyer access to such records; provided
that:
|
(c) |
No
Multiple Payments.
For payments pursuant to Section
2.5(a),
only one payment shall be paid for each Product sold, regardless
of the
number of Patents or claims thereof that cover such
Product.
|
(d) |
Sales-Based
Contingent Payment Reduction.
In the event Buyer or its subsidiaries, Affiliates or licensees licenses
Third Party patent rights in order to have freedom to make, have
made or
sell Indibulin without infringing such patent rights, the Buyer shall
be
allowed to deduct from the sales-based contingent payments due pursuant
to
Section
2.5(a),
fifty percent (50%) of any royalties or any other license fees paid
or
incurred in connection with such licensor up to a maximum of fifty
percent
(50%) of the sales-based contingent payments due pursuant to Section
2.5(a)
(with any amount not deducted due to such deduction limitation carried
forward to subsequent calendar quarters for deduction, but subject
to the
fifty percent (50%) maximum deduction limitation provided by this
Section
2.5(d)
for such subsequent calendar quarters).
|
(e) |
Sales-Based
Contingent Payment Credits.
The Buyer shall be allowed to deduct from the sales-based contingent
payments due to the Sellers under Section 2.5(a)
any payments made by it to the Sellers pursuant to Section 2.3.
|
(f) |
Currency
Exchange.
In the event sales are invoiced in a currency other than United States
dollars, Net Sales shall be calculated in the following manner: cumulative
non-United States dollars sales invoiced by month shall be converted
to
United States dollars by multiplying or dividing, whichever is applicable,
this amount by the simple average of the daily NY close rates for
each day
in the month as published by Bloomberg, Reuters or some other generally
accepted source for publishing NY close foreign currency rates. The
rate
source shall be reviewed with the Sellers prior to commencing payment
of
the sales-based contingent payments to the Sellers
|
(g) |
Withholding
Taxes.
The Buyer may withhold taxes in the event that revenue authorities
in any
country require the withholding of taxes on amounts paid hereunder
to the
Sellers. The Buyer will deduct such taxes from such payment and such
taxes
will be paid by the Buyer to the proper taxing authority on behalf
of the
Sellers. In the event such taxing authority routinely provides a
tax
receipt upon payment, the Buyer will procure such tax receipt and
forward
it to the Sellers. The Buyer agrees to assist the Sellers in claiming
exemption from such deductions or withholdings under any applicable
double
taxation or similar agreement or
treaty.
|
(h) |
Value
Added Tax.
The Buyer shall pay to the relevant Governmental Authority, any value
added tax (“VAT”) accruing to any payment by Buyer to Sellers hereunder,
and shall be permitted to deduct such amount from such payment to
Sellers.
Buyer shall cooperate with Sellers in Sellers recovery of such
VAT.
|
If
to the Sellers:
|
Baxter
Healthcare S.A.
Hertistrasse
2, CH-8304
Wallisen,
Switzerland
Attn: General
Manager
Fax:
+41 44 878 64 77
|
Baxter
International Inc.
One
Baxter Parkway
Deerfield,
IL 60015
Attn: Corporate
Vice President & General Counsel
Fax: 847.948.2450
|
|
Baxter
Oncology GmbH
Kantstrasse
2
33790
Halle/Westfalen
Germany
Attn:
Corporate Counsel
Fax:
+49 -5201-711-2546
|
|
If
to the Buyer:
|
ZIOPHARM
Oncology, Inc
1180
Avenue of the Americas
New
York, NY 10036
Attn: Jonathan
Lewis, MD, PhD
Chief Executive Officer and Executive
Chairman
Fax:
203
848 6007
|
With
a copy to:
|
ZIOPHARM
Oncology, Inc
197
Eighth Street, Suite 300
Charlestown,
MA 02129
Attn:
Bob Newman, Senior Vice President,
Business
and Development Operations
Fax:
617
241 2855
|
SELLERS:
BAXTER
HEALTHCARE S.A.
|
|
By:
/s/
Robert J. Hombach
Name: Robert
J. Hombach
Title: VP
Finance Europe
|
|
BAXTER
INTERNATIONAL INC.
|
|
By:
/s/
Rob Burns
Name: Rob
Burns
Title: CVP,
CFO
|
|
BAXTER
ONCOLOGY, INC.
|
|
By:
/s/
Phillip Saame
Name: Philipp
Saame
Title: Senior
Counsel
|
|
BUYER:
ZIOPHARM
ONCOLOGY, INC.
|
|
By:
/s/
Jonathan Lewis
Name: Jonathan
Lewis
Title: Chief
Executive Officer
|
1.1 |
Defined
Terms.
As used in this Agreement, the following terms shall have the following
meanings:
|
2.1 |
Grant.
Subject to the conditions hereunder,
|
(a)
|
Baxter
hereby grants to Licensee a world-wide, royalty bearing (pursuant
to
Article
3)
exclusive right and license, with the right to grant sublicenses,
under
Licensed Patents to use, market, sell,
offer to sell and
import (except
where a product is manufactured in a country where a Valid Claim
relative
to such manufacture does not exist, and such product is imported
in a
country where a Valid Claim relative to the manufacture does exist)
Licensed
Products
in
the Territory; and
|
(b)
|
Baxter
hereby grants to Licensee a world-wide, non-royalty bearing exclusive
right and license, with the right to grant sublicenses, under the
Intangible Property Rights to use, market, sell, offer to sell and
import
Licensed Products in the Territory.
|
2.2 |
Limitation
on License Grants.
Except for the license expressly granted pursuant to Section
2.1,
all right, title and interest in all Licensed Patents, and other
rights
owned by Baxter or in which Baxter has an interest shall remain
the sole
property of Baxter, and nothing herein shall be construed to grant
or
establish any other rights to the contrary.
|
2.3 |
Sublicenses
by Licensee.
Licensee shall notify
Baxter of any sublicense hereunder
and
the identity of each Sublicensee,
and provide Baxter with a copy of the executed agreement involving
such
sublicense
with such redactions of confidential terms as Licensee shall determine
to
be appropriate,
all within thirty (30) days of execution of the Agreement.
Sublicenses shall not contain any provision contrary to, or inconsistent
with, this Agreement and shall provide that all obligations of
Licensee
hereunder shall be binding upon each Sublicensee
as
if the Sublicensee
were a party to this Agreement. Additionally, Licensee shall be
responsible for and liable to Baxter for
Sublicensee’s
compliance with the provisions hereof.
|
2.4 |
Rights
in Bankruptcy.
All rights and licenses granted under or pursuant to this Agreement
by
Baxter are, and will otherwise be deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101 of the U.S. Bankruptcy
Code.
|
3.1
|
Milestone
Fees.
As part of the consideration for the rights granted by Baxter to
Licensee hereunder,
Licensee shall pay to Baxter five hundred thousand United States
dollars
($500,000) within thirty (30) days of the first effectiveness of
an IND
submitted to the FDA or a CTA submitted to the EMEA permitting Licensee
to
initiate human clinical trials of an Indibulin-related Nanosuspension
in
the United States or Europe, whichever comes
first.
|
3.2
|
License
Royalties.
As part of the consideration for the rights granted by Baxter to
Licensee,
Licensee shall pay,
or cause to be paid to Baxter,
the following royalties
based on Net Sales of Licensed Products:
|
a) |
[****]
percent ([****]%) of worldwide calendar year annual Net Sales of
less than
[**********] Dollars
($[**********]);
|
b) |
[****]
percent ([****]%) of worldwide calendar year annual Net Sales from
[**********] Dollars ($[**********]) up to [**********] Dollars
($[**********]); and
|
c) |
[****]
percent ([****]%) of worldwide calendar year annual Net Sales in
excess of
[**********] U.S. Dollars
($[**********]).
|
3.3
|
Reports,
Audit and Payment Schedule. Licensee
shall keep and maintain detailed records of all sales of Licensed
Product
worldwide; and
|
a) |
Licensee
shall make quarterly payments to Baxter within forty-five
(45)
days of the close of each calendar quarter (March 31, June 30, September
30 and December 31) based
on Net
Sales in
such quarter, and shall additionally provide,
together with such payment,
a
sales report detailing Net
Sales of
Licensed Products sold per country and the royalty calculation, pursuant
to Section
3.2;
and
|
b) |
Baxter
shall have the right annually, at Baxter’s expense, to audit
Licensee’s
records, or Licensee’s subsidiaries, Affiliates or Sublicensees in order
to verify the calculation of Net Sales of Licensed Products. Licensee
shall reasonably cooperate with Baxter to provide Licensee access
to such
records; provided that:
|
(i)
|
Such
audit shall be conducted by Baxter’s independent
auditors;
|
(ii)
|
Such
audit shall be conducted during normal business hours, upon reasonable
advance notice and in a manner that does not cause unreasonable disruption
to the conduct of the business of Licensee, its subsidiaries, Affiliates
or Sublicensees;
|
(iii) |
Baxter
shall treat all information reviewed or learned of in the course
of such
audit in accordance with Section
11.13;
and
|
(iv)
|
prior
to such audit, Baxter shall cause its auditors to enter into a reasonably
acceptable confidentiality agreement with Licensee obligating such
auditors to maintain confidentiality of all financial
statements.
|
3.4
|
No
Multiple Payments.
For payments pursuant to Section
3.2,
only one payment shall be paid for each Licensed Product sold, regardless
of the number of Licensed Patents or claims thereof that cover such
Licensed Product. Additionally, in the event Licensee has paid Baxter
a
sales-based
contingent payment
on
the Net Sales of a unit of Licensed Product pursuant to Section
2.4
of
the Asset Purchase Agreement, Licensee shall not pay Baxter a royalty,
pursuant to Section
3.2
of
this Agreement, on the Net Sales of that unit of Licensed Product.
|
3.5
|
Royalty
Reduction.
In the event Licensee or its subsidiaries, Affiliates or Sublicensees
licenses third party patent rights in order to have freedom to make,
have
made or sell Licensed Product without infringing such patent rights,
Licensee shall be allowed to deduct from the royalties due pursuant
to
Section
3.2,
fifty percent (50%) of any royalties or any other license fees paid
or
incurred in connection with such license up to a maximum of fifty
percent
(50%) of the royalties due pursuant to Section 3.2 (with any amount
not
deducted due to such deduction limitation carried forward to subsequent
calendar quarters for deduction, but subject to the fifty percent
(50%)
maximum deduction limitation provided by this Section
3.5
for such subsequent calendar quarters).
|
3.6
|
Royalty
Credits.
Licensee shall be allowed to deduct from the royalty payments due
to
Baxter under Section
3.2
any payments made by it to Baxter pursuant to Section 2.3
of
the Asset Purchase Agreement.
|
3.7
|
Currency
Exchange.
In the event sales are invoiced in a currency other than United States
dollars, Net Sales shall be calculated in the following manner: cumulative
non-United States dollars sales invoiced by month shall be converted
to
United States dollars by multiplying or dividing, whichever is applicable,
this amount by the simple average of the daily NY close rates for
each day
in the month as published by Bloomberg, Reuters or some other generally
accepted source for publishing NY close foreign currency rates. The
rate
source shall be reviewed with Baxter prior to commencing payment
of
royalty payments to Baxter.
|
3.8
|
Withholding
Taxes.
Licensee may withhold taxes in the event that revenue authorities
in any
country require the withholding of taxes on amounts paid hereunder
to
Baxter. Licensee will deduct such taxes from such payment and such
taxes
will be paid by Licensee to the proper taxing authority on behalf
of
Baxter. In the event such taxing authority routinely provides a tax
receipt upon payment, Licensee will procure such tax receipt and
forward
it to Baxter. Licensee agrees to assist Baxter in claiming exemption
from
such deductions or withholdings under any applicable double taxation
or
similar agreement or treaty.
|
3.9
|
Late
Penalty.
Milestone fees and royalties not received within the required timeframe
shall bear interest at the lesser of (a) the maximum rate permitted
by
law, and (b) 1.0%
per month on the outstanding balance compounded monthly. All applicable
sums due herein shall be paid in U.S. Dollars.
|
4.1 |
Baxter
to Supply.
In the event that Licensee desires the supply of Licensed Products
or
Indibulin-related Nanosuspension, Baxter and Licensee shall negotiate
and
enter into a separate supply agreement governing the developmental
and
commercial supply by Baxter of Licensed Product or Indibulin-related
Nanosuspension to Licensee.
|
5.1 |
Prosecution
and Maintenance of Patents.
|
a) |
Patents.
|
5.2 |
Enforcement
of Intellectual Property Rights.
|
a) |
Each
Party shall promptly, but in no event later than thirty (30) days
after
receipt of notice thereof, notify the other Party (i) of any nullity
actions, oppositions, reexaminations, declaratory judgment actions
or any
alleged or threatened infringement affecting any Licensed Patent
or the
misappropriation or violation of any intellectual property rights
relating
to any Licensed Product or any Licensed Patent; or (ii) if it reasonably
believes that any Licensed Patent is being infringed, misappropriated
or
violated by a third party.
|
b) |
Litigation.
|
(i)
|
Except
as provided in Section 5.2(b)(ii), Baxter, in its discretion and
at its
expense, shall pursue all necessary actions,
including initiating a suit, against
any third party that Baxter reasonably believes is infringing,
misappropriating or violating a Licensed
Patent.
|
(ii)
|
Notwithstanding
Section
5.2(b)(i), Licensee,
in its discretion and its expense, shall have the first right and
option
to pursue all necessary actions, including initiating a suit, against
any
third party that Licensee reasonably believes is infringing,
misappropriating or violating or Licensed Patent, if such infringement,
misappropriation or violation relates to the development or
commercialization of a product or product candidate that is competitive
(i.e., the product or product candidate is a tubulin inhibitor particle
suspension) with a Licensed Product being developed or commercialized
by
Licensee. If Licensee fails to take any of the foregoing actions
within a
reasonable period of time after becoming aware of the claimed
infringement, misappropriation or violation (but in no event more
than
ninety (90) days), or otherwise notifies Baxter within such time
period
that it elects to not pursue any such action, then Baxter shall have
the
right to take any such action in accordance with Section
5.2(c).
The ninety (90) day time period in this sub-section shall be shortened
as
reasonably necessary to enable Baxter to initiate a suit or take
other
appropriate action if, in the absence of such shortening, a loss
of rights
with respect to such suit or other action would occur (e.g., if a
generic
pharmaceutical maker files an abbreviated new drug application for
which
the reference listed drug is a Licensed Product and, in order to
obtain an
automatic stay from the FDA with respect to the approval of such
abbreviated new drug application, a patent infringement suit must
be
brought within a shorter period of time). The Party filing any suit
or
taking any such action hereunder shall be responsible for all costs
in
connection therewith.
|
c) |
The
Party initiating suit or action under Section 5.2(b)(ii)
shall have the sole and exclusive right to select counsel for any
suit
initiated by it. If required under applicable law in order for the
initiating Party to initiate and/or maintain such suit or action,
the
other Party shall join as a party to the suit or action. Such other
Party
shall offer reasonable assistance to the initiating Party in connection
therewith at no charge to the initiating Party except for reimbursement
of
reasonable out-of-pocket expenses incurred in rendering such assistance.
The Party filing any such suit or taking any such action shall provide
the
other Party with an opportunity to make suggestions and comments
regarding
such suit or action. Thereafter, the Party filing any such suit or
taking
any such action shall, to the extent permitted by applicable law,
keep the
other Party promptly informed, and shall from time to time consult
with
such other Party regarding the status of any such suit or action
and shall
provide such other Party with copies of all material documents including
complaints, answers, counterclaims, material motions, orders of the
court,
memoranda of law and legal briefs, interrogatory responses, depositions,
material pre-trial filings, expert reports, affidavits filed in court,
transcripts of hearings and trial testimony, trial exhibits and notices
of
appeal filed in, or otherwise relating to, such suit or action. The
Party
not initiating such suit or action shall have the right to participate
and
be represented in any such suit by its own counsel at its own expense.
The
Parties shall not conduct or settle any such suit or action in a
manner
that deprives the non-initiating Party of material consideration
under
this Agreement or materially places at risk the scope or validity
of any
Licensed Patent without the prior written approval of the non-initiating
Party, which approval shall not be unreasonably withheld or
delayed.
|
d) |
With
respect to any suit or action referred to in Section
5.2(b)(ii),
any recovery obtained as a result of any such proceeding, by settlement
or
otherwise, shall be applied in the following order of
priority:
|
5.3
|
Defense
of Infringement Action.
With respect to any and all claims instituted by third parties for
patent
infringement involving the manufacture, use, offer for sale or sale
of a
Licensed Product during the Term (“Third Party Suit”), Licensee shall have
the right, at its sole discretion, to defend and control any action
or
proceeding with respect to such claim. Baxter agrees to be joined
as a
party if necessary to defend the action or proceeding and shall provide
all reasonable cooperation, including any necessary use of its name,
required to defend such litigation. In the event Baxter is joined
as a
party to any Third Party Suit, Baxter shall have the right to be
represented by its own counsel, at its own selection and expense.
Licensee
shall have sole control of any such suit and all negotiations for
its
settlement or compromise, provided that Licensee shall not conduct
or
settle any such suit in a manner that deprives Baxter of material
consideration under this Agreement or materially places at risk the
scope
or validity of any Licensed Patent without the prior written approval
of
Baxter, which approval shall not be unreasonably withheld or
delayed.
|
7.1
|
Licensee’s
Representations And Warranties. Licensee
hereby represents and warrants to Baxter as of the Effective Date
that:
|
(a)
|
Licensee
is duly authorized to enter into this Agreement;
|
(b)
|
no
consents or approvals which Licensee has not previously obtained
are
necessary for Licensee to enter into this Agreement and perform all
of
Licensee's obligations hereunder; and
|
(c)
|
this
Agreement does not conflict with any other Licensee contractual,
statutory
or regulatory obligation.
|
7.2
|
Licensee’s
Covenant.
Licensee hereby covenants during the Term that Licensee shall perform
its
obligations hereunder in accordance with all relevant material applicable
state and federal laws, rules and regulations as they apply.
|
7.3
|
Baxter’s
Representations and Warranties.
Baxter hereby represents and warrants to Licensee, as of the Effective
Date that:
|
(a)
|
Baxter
is duly authorized to enter into this
Agreement;
|
(b)
|
no
consents or approvals which Baxter has not previously obtained are
|
(c) |
this
Agreement does not conflict with any other Baxter contractual, statutory
or regulatory obligation;
|
(d) |
Baxter
is the owner of the Licensed Patents and it is free and clear of
any
encumbrances, and that Baxter has the right to grant the license
hereunder, and such grant does not conflict with any other agreements,
documents or other materials;
|
(e) |
to
Baxter’s knowledge,
the manufacture, sale, offer for sale, importation or use of a Licensed
Product would not infringe any existing, valid intellectual property
right
of any third party throughout the world. Baxter represents that it
has not
received any notice of any claimed infringement (including without
limitation patent infringement) in connection with the manufacture,
sale,
offer for sale, importation or use of a Licensed Product as of the
Effective Date;
|
(f) |
Baxter
has not received and
does not have knowledge of any
information that would suggest the invalidity or unenforceability
of all
of the claims of the Licensed
Patents.
|
7.4
|
Baxter’s
Covenant.
Baxter hereby covenants during the Term that Baxter shall perform
its
obligations hereunder in accordance with all relevant material applicable
state and federal laws, rules and regulations as they
apply.
|
8.1
|
Indemnification.
Each Party’s rights to indemnification with respect to the provisions of
this Agreement and the performance thereof shall be governed by and
set
forth in Section 6.2
and 6.3
of
the Asset Purchase Agreement.
|
8.2
|
Exclusive
Remedy.
Except with respect to claims for fraud or for equitable relief,
and
claims for specific performance of the covenants and obligations
of the
other Party under this Agreement, claims for indemnification pursuant
to
Article VI
of
the Asset Purchase Agreement shall be the sole and exclusive remedy
for
claims and damages available to Baxter and Licensee and their respective
Affiliates arising out of or relating to this Agreement and the licenses
contemplated hereby.
|
8.3 |
Limitation
on Liability.
Notwithstanding Article VI
of
the Asset Purchase Agreement, or any other provision of this Agreement,
no
Party shall be liable under this Agreement for any special, indirect,
consequential or punitive damages except to the extent that the liability
for such damages arises out of a Third Party Action (as defined in
the
Asset Purchase Agreement).
|
10.1
|
Term.
The licenses granted under this Agreement shall come into effect
as of the
Effective Date and, subject to the provisions of this Article
10,
shall expire on the expiration of last to expire of the Licensed
Patents (the
“Term”). Upon expiration of the Term, (i) the licenses granted herein
shall terminate and (ii) no further obligation shall accrue under
Article
3.
|
10.2
|
Termination
of Certain Rights for Material Breach.
Either Party may terminate certain rights of the other Party under
this
Agreement, as more fully described in Section
10.4,
for any material breach by the other Party or if the other Party
has
failed to comply with all laws, regulations or treaties of the United
States of America applicable to its activities under this Agreement,
by
giving sixty (60) days written notice to the other Party specifying
the
nature of such breach or failure. Termination shall become effective
if
such breach or failure remains uncured at the end of such sixty (60)
day
period, provided, however, if such breach or failure is incapable
of cure
within a sixty (60) day period but is otherwise capable of cure,
and the
terminating Party will not be materially prejudiced if the cure is
effected in a reasonable time, and the curing Party is proceeding
to
effect the cure in good faith and with reasonable diligence, then
the
termination shall not become effective until the curing Party has
had a
reasonable time to effect the cure.
|
10.3 |
Licensee
Termination.
Licensee may terminate this Agreement at any time upon sixty (60)
days
prior written notice, at which time (i) the licenses granted herein
shall terminate and (ii) no further obligation shall accrue under
Article III.
|
10.4
|
Effect
of Termination Under Section 10.2.
In
the event Baxter exercises its right of termination pursuant to
Section
10.2,
the license pursuant to Section
2.1
shall, at Baxter’s option, either (i) become non-exclusive, without the
right to sublicense; provided, however, that sublicenses granted
prior to
termination of the other Party’s licenses under this Agreement shall
continue unaffected by termination, except for the substitution of
Baxter
for Licensee as party to such sublicense or (ii) terminate.
|
11. |
1Notices.
All notices, requests, consents and other communications hereunder
shall
be in writing, shall be addressed to the receiving party’s address set
forth below or to such other address as a party may designate
by notice
hereunder, and shall be either (i) delivered by hand, (ii) made
by
telecopy or facsimile transmission, (iii) sent by recognized
overnight
courier, or (iv) sent by registered or certified mail, return
receipt
requested, postage
prepaid:
|
If
to the Sellers:
|
Baxter
Healthcare S.A.
Hertistrasse
2, CH-8304
Wallisen,
Switzerland
Attn: General
Manager
Fax:
+41 44 878 64 77
|
Baxter
International Inc.
One
Baxter Parkway
Deerfield,
IL 60015
Attn: Corporate
Vice President & General Counsel
Fax: 847.948.2450
|
|
If
to the Buyer:
|
ZIOPHARM
Oncology, Inc
1180
Avenue of the Americas
New
York, NY 10036
Attn: Jonathan
Lewis, MD, PhD
Chief
Executive Officer and Executive Chairman
Fax: 203
848 6007
|
With
a copy to:
|
ZIOPHARM
Oncology, Inc
197
Eighth Street, Suite 300
Charlestown,
MA 02129
Attn: Bob
Newman, Senior Vice
President,
Business
and Development Operations
Fax: 617
241 2855
|
11.2 |
Entire
Agreement.
This Agreement, together with the Asset Purchase Agreement, collectively
embodies
the entire agreement and understanding among the Parties with respect
to
the subject matter hereof and supersedes
all prior oral or written agreements and understandings relating
to the
subject matter hereof. No statement, representation, warranty, covenant
or
agreement of any kind not expressly set forth in the Agreement shall
affect, or be used to interpret, change or restrict, the express
terms and
provisions of this Agreement.
|
11.3 |
Modifications
and Amendments.
The terms and provisions of this Agreement may be amended, modified,
supplemented or waived only by written agreement executed by all
Parties.
|
11.4 |
No
Waiver of Rights, Powers and Remedies.
No failure or delay by a Party in exercising any right, power or
remedy
under this Agreement, and no course of dealing between the Parties,
shall
operate as a waiver of any such right, power or remedy of the Party.
No
single or partial exercise of any right, power or remedy under this
Agreement by a Party, nor any abandonment or discontinuance of steps
to
enforce any such right, power or remedy, shall preclude such Party
from
any other or further exercise thereof or the exercise of any other
right,
power or remedy hereunder. The election of any remedy by a Party
shall not
constitute a waiver of the right of such Party to pursue other available
remedies. No notice to or demand on a Party not expressly required
under
this Agreement shall entitle the Party receiving such notice or demand
to
any other or further notice or demand in similar or other circumstances
or
constitute a wavier of the rights of the Party giving such notice
or
demand to any other or further action in any circumstances without
such
notice or demand. The terms and provisions of this Agreement may
be
waived, or consent for the departure therefrom granted, only by written
document executed by the Party entitled to the benefits of such terms
or
provisions. No such waiver or consent shall be deemed to be or shall
constitute a waiver or consent with respect to any other terms or
provisions of this Agreement, whether or not similar. Each such waiver
or
consent shall be effective only in the specific instance and for
the
purpose for which it was given, and shall not constitute a continuing
waiver or consent.
|
11.5 |
Assignment.
Neither Party may assign or transfer this Agreement or any rights
or
obligations hereunder without the prior written consent of the other,
except that a Party may make such an assignment without the other
Party’s
consent to one or more of its Affiliates
or
in connection with a sale or transfer of all or substantially all
of the
stock or assets of the Party or any merger, consolidation or similar
transaction involving the Party.
Any permitted successor or assignee of rights and/or obligations
hereunder
shall, in a writing to the other Party, expressly assume performance
of
such rights and/or obligations. Any permitted assignment shall be
binding
on the successors of the assigning Party. Any assignment or attempted
assignment by either Party in violation of the terms of this Section
shall
be null and void and of no legal
effect.
|
11.6 |
Parties
in Interest.
This Agreement shall be binding upon and inure solely to the benefit
of
each Party and their permitted
successors and
assigns, and nothing in this Agreement, express or implied, (i) is
intended to confer upon any other person or entity any rights or
remedies
of any nature whatsoever under or by reason of this Agreement, or
(ii)
shall be construed to create any rights or obligations except among
the
Parties, and no person or entity shall be regarded as a third-party
beneficiary of this Agreement.
|
11.7 |
Governing
Law.
This Agreement and the rights and obligations of the Parties hereunder
shall be construed in accordance with and governed by the internal
law of
the State of Illinois, without giving effect to the conflicts of
law
principles thereof.
|
11.8 |
Severability.
In the event that any court of competent jurisdiction shall finally
determine that any provision, or any portion thereof, contained in
this
Agreement shall be void or unenforceable in any respect, then such
provision shall be deemed limited to the extent that such court determines
it enforceable, and as so limited shall remain in full force and
effect.
In the event that such court shall determine that any such provision,
or
potion thereof, is wholly unenforceable, the remaining provisions
of this
Agreement shall nevertheless remain in full force and
effect.
|
11.9 |
Interpretation.
The Parties acknowledge and agree that: (i) each Party and its counsel
reviewed and negotiated the terms and provisions of this Agreement
and
have contributed to its revision; (ii) the rule of construction to
the
effect that any ambiguities are resolved against the drafting Party
shall
not be employed in the interpretation of this Agreement; and (iii)
the
terms and provisions of this Agreement shall be construed fairly
as to all
Parties and not in favor of or against any Party, regardless of which
Party was generally responsible for the preparation of this
Agreement.
|
11.10 |
Headings
and Captions.
The headings and captions of the various subdivisions of this Agreement
are for convenience of reference only and shall in no way modify,
or
affect, or be considered in construing or interpreting the meaning
or
construction of any of the terms or provisions
hereof.
|
11.11 |
Enforcement.
Each of the Parties acknowledges and agrees that the rights acquired
by
each Party hereunder are unique and that irreparable damage would
occur in
the event that any of the provisions of this Agreement to be performed
by
the other Party were not performed in accordance with their specific
terms
or were otherwise breached. Accordingly, in addition to any other
remedy
to which the Parties are entitled at law or in equity, each Party
shall be
entitled to an injunction or injunctions to prevent breaches of this
Agreement by the other Party and to enforce specifically the terms
and
provisions hereof in any federal or state court of competent
jurisdiction.
|
11.12 |
Publicity.
Neither Party shall make any public announcement concerning this
Agreement
without the prior written consent of the other Party, unless counsel
to
such Party advises that such announcement or statement is
required by law (including applicable stock exchange rule). In the
case of
an announcement required by law, the other Party shall be advised
in
advance and both Parties shall use good faith efforts to cause a
mutually
agreeable announcement to be issued in a timely basis,
subject to the disclosing party’s legal requirements.
|
11.13 |
Confidentiality.
The Parties acknowledge and agree that any information or data it
has
acquired from the other Parties, not otherwise properly in the public
domain, shall
be subject, in all respects, to Section
7.14
of
the Asset Purchase Agreement.
|
11.14 |
Confidentiality
of This Agreement.
Neither Party nor their representatives, will, without the prior
written
consent of the other Party, other than to its employees, their officers,
its Affiliates and/or its agents, disclose to any person any of the
terms
or conditions of this Agreement; provided, however, that notwithstanding
the foregoing, a Party may disclose the terms or conditions of this
Agreement to the extent such disclosure is reasonably necessary to
(a) comply with or enforce any of the provisions of this Agreement,
(b) comply with applicable laws, or (c) comply with applicable stock
exchange regulation, New York Stock Exchange regulation, Nasdaq regulation
or Securities and Exchange Commission rule or regulation. To the
extent
that either Party determines that it is required to file this Agreement
to
comply with the requirements of an applicable stock exchange regulation,
New York Stock Exchange regulation, Nasdaq regulation or SEC rule
or
regulation, such Party shall give at least three (3) days advance
written
notice of any such required disclosure to the other party, and to
the
extent the other party so requests it within such three (3) day period,
prior to making any such filing shall consult with the other Party
with
respect thereto regarding
confidentiality.
|
11.15 |
Interpretation.
Unless the context otherwise requires, words defined herein in the
singular include the plural and words defined herein in the plural
include
the singular. “Include,” “includes” or “including” shall in all places
mean including, but not limited to. The use of the masculine or any
other
pronoun herein when referring to any person or entity is for convenience
only and shall be deemed to refer to the particular person or entity
intended regardless of the actual gender of such person or whether
such
person is a corporation or other
entity.
|
11.16 |
Counterparts.
This Agreement may be executed in one or more counterparts, each
of which
deemed an original, but all of which together shall constitute one
and the
same instrument.
|
11.17 |
Facsimile/Scanned
Signatures.
For purposes of this Agreement and any other Transaction Documents
required to be delivered pursuant to this Agreement, facsimiles of,
or
scanned, signatures shall be deemed to be original signatures. In
addition, if any of the parties sign facsimile or scanned copies
of this
Agreement or any of the other Transaction Documents, such copies
shall be
deemed originals.
|
BAXTER HEALTHCARE S.A. | ||
By: |
/s/
Robert J. Hombach
|
|
Name: |
Robert J. Hombach
|
|
Title: | VP Finance Europe |
BAXTER
INTERNATIONAL INC.
|
||
|
|
|
By: | /s/ Rob Davis | |
Name: |
Rob Davis |
|
Title: | CVP, CFO |
ZIOPHARM
ONCOLOGY, INC.
|
||
|
|
|
By: | /s/ Jonathan Lewis | |
Name: |
Jonathan Lewis |
|
Title: | Chief Executive Officer |
Date:
November 13, 2006
|
|||
/s/
Jonathan
Lewis
|
|||
Jonathan
Lewis
|
|||
Principal
Executive Officer
|
Date:
November 13, 2006
|
|||
/s/
Richard
E. Bagley
|
|||
Richard
E. Bagley
|
|||
Principal
Financial Officer
|
|
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of
the Securities Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
/s/
Jonathan
Lewis
|
|||
Jonathan
Lewis
Principal
Executive Officer, 2006
November
13, 2006
|
|||
|
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of
the Securities Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
/s/
Richard
E. Bagley
|
|||
Richard
E. Bagley
Principal
Financial Officer
November
13, 2006
|
|||