Delaware
|
2834
|
36-3898269
|
(State
or other jurisdiction of incorporation
or
organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer Identification
Number)
|
Anthony
O. Pergola, Esq.
Lowenstein
Sandler PC
65
Livingston Avenue
Roseland,
New Jersey 07068
Telephone:
(973) 597-2500
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
(Do
not check if a smaller reporting company)
|
Smaller
reporting company x
|
Title of Each Class of
Securities to be Registered
|
Amount to
be Registered (1)(2)
|
Proposed
Maximum
Offering Price
Per Share(3)
|
Proposed
Maximum
Aggregate
Offering
Price(3)
|
Amount of
Registration
Fee
|
|||||||||
Common
Stock, par value $0.001 per share
|
33,928,571
|
$
|
0.13
|
$
|
4,410,715
|
$
|
174(4
|
)
|
(1)
|
Pursuant
to Rule 416 under the Securities Act of 1933, as amended, this
registration statement also covers such indeterminate number of shares
of
common stock as may be required to prevent dilution resulting from
stock
splits, stock dividends or similar
events.
|
(2)
|
Includes
(i) 26,785,714 shares of common stock issuable upon exercise of
a put
right and (ii) 7,142,857 shares of common stock issuable upon exercise
of
an outstanding warrant.
|
(3)
|
Estimated
solely for the purpose of calculating the amount of the registration
fee
pursuant to Rule 457(c) under the Securities Act of 1933, as amended,
based upon the average of the high and low sales prices of the
registrant’s common stock on April 28, 2008, as reported on the Over the
Counter Bulletin Board.
|
(4)
|
The
registration fee has been paid
previously.
|
Preliminary
Prospectus
|
|
Subject to
completion, dated October 3,
2008
|
|
Page
|
|
|
Prospectus
Summary
|
1
|
Risk
Factors
|
7
|
Special
Note Regarding Forward-Looking Statements
|
17
|
Use
of Proceeds
|
17
|
Price
Range for our Common Stock
|
18
|
Dividend
Policy
|
18
|
Selected
Financial Information
|
19
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
20
|
Business
|
37
|
Management
|
54
|
Security
Ownership of Certain Beneficial Owners and Management
|
62
|
Certain
Relationships and Related Transactions
|
64
|
Description
of Securities to be Registered
|
67
|
Shares
Eligible for Future Sale
|
71
|
Selling
Securityholder
|
72
|
Plan
of Distribution
|
75
|
Legal
Matters
|
76
|
Experts
|
76
|
Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
|
76
|
Where
You Can Find Additional Information
|
76
|
Financial
Statements
|
F-1
|
Common
Stock Offered by Selling Securityholder (1):
|
|
33,928,571
shares
|
|
|
|
Common
Stock Issued and Outstanding as of September 15, 2008(2):
|
70,624,232
shares
|
|
|
||
Common
Stock Issued and Outstanding after this Offering (3):
|
104,552,803
shares
|
|
Use
of Proceeds:
|
|
We
will not receive cash proceeds from the exercise of all or any
portion of
the put right exercisable for shares of common stock being registered
in
this offering; however, in the event of any such exercise, we will
receive
all or a portion of the selling securityholder's equity interest
in Hedrin
Pharmaceuticals K/S, a Danish limited partnership of which we and
the
selling securityholder are partners. We also will receive the proceeds
of
any cash exercise of the
warrant.
|
Over
the Counter Bulletin Board Symbol:
|
|
MHAN
|
Includes
(i)
26,785,714 shares of our common stock which are issuable upon exercise
of
the selling securityholder’s right to put all or a portion of the selling
securityholder’s equity interest in Hedrin Pharmaceuticals K/S and (ii)
7,142,857 shares of our common stock issuable upon exercise of
an
outstanding warrant held by the selling securityholder.
|
(2)
|
Excludes
approximately 19,590,189 shares of our common stock issuable upon
exercise
of outstanding warrants and options to purchase shares of our common
stock
and up to 42,857,143 shares issuable, or which may become issuable,
upon
exercise of the selling securityholder's right to put, and our
right to
call, all
or a portion of the selling securityholder’s equity interest in Hedrin
Pharmaceuticals K/S and the warrant held by the selling securityholder.
|
(3)
|
Based
on the number of shares of our common stock outstanding as of September
15, 2008. Excludes approximately 19,590,189 shares issuable upon
exercise
of outstanding warrants and options to purchase shares of our common
stock.
|
Year Ended December 31,
|
Six Months Ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
June 30,
|
||||||||||||||
2007
|
2006
|
2008
|
2007
|
2008
|
||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenue
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
||||||
Research
and development expense
|
$
|
8,535,687
|
$
|
6,172,845
|
$
|
1,365,799
|
$
|
5,551,082
|
$
|
27,854,842
|
||||||
General
and administrative expense
|
$
|
3,608,270
|
$
|
3,827,482
|
$
|
1,715,598
|
$
|
1,967,098
|
$
|
15,567,961
|
||||||
Stock-based
compensation
|
$
|
1,440,956
|
$
|
1,675,499
|
$
|
295,664
|
$
|
706,549
|
$
|
3,660,647
|
||||||
Net
loss attributable to common shares
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(58,000,631
|
)
|
|
Net
loss per common share
|
$
|
(0.18
|
)
|
$
|
(0.16
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
N/A
|
|||
Statements
of Cash Flows Data:
|
||||||||||||||||
Net
cash used in operating activities
|
$
|
(10,229,711
|
)
|
$
|
(7,750,738
|
)
|
(2,903,970
|
)
|
(6,090,775
|
)
|
$
|
(37,064,526
|
)
|
|||
Net
cash provided by (used in) financing activities
|
$
|
7,859,413
|
$
|
(15,257
|
)
|
$
|
2,853,230
|
$
|
7,861,381
|
$
|
37,284,199
|
|||||
Cash
dividends declared
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
At
December 31,
2007
|
At
June 30, 2008
|
||||||
(unaudited)
|
|||||||
Balance
Sheets Data:
|
|||||||
Total
assets
|
$
|
980,577
|
$
|
973,340
|
|||
Total
liabilities
|
$
|
1,871,662
|
$
|
4,420,322
|
|||
Total
stockholders’ deficiency
|
$
|
(891,085
|
)
|
$
|
(3,446,982
|
)
|
· |
the
results of any clinical trials;
|
· |
the
scope and results of our research and development
programs;
|
· |
the
time required to obtain regulatory
approvals;
|
· |
our
ability to establish and maintain marketing alliances and collaborative
agreements; and
|
· |
the
cost of our internal marketing
activities.
|
· |
continue
to undertake nonclinical development and clinical trials for our
product
candidates;
|
· |
seek
regulatory approvals for our product
candidates;
|
· |
implement
additional internal systems and infrastructure;
|
· |
lease
additional or alternative office facilities;
and
|
· |
hire
additional personnel.
|
· |
continuing
to undertake nonclinical development and clinical
trials;
|
· |
participating
in regulatory approval processes;
|
· |
formulating
and manufacturing products; and
|
· |
conducting
sales and marketing activities.
|
· |
delay
commercialization of, and our ability to derive product revenues
from, our
product candidates;
|
· |
impose
costly procedures on us; and
|
· |
diminish
any competitive advantages that we may otherwise
enjoy.
|
· |
unforeseen
safety issues;
|
· |
determination
of dosing issues;
|
· |
lack
of effectiveness during clinical
trials;
|
· |
slower
than expected rates of patient
recruitment;
|
· |
inability
to monitor patients adequately during or after treatment;
and
|
· |
inability
or unwillingness of medical investigators to follow our clinical
protocols.
|
· |
perceptions
by members of the health care community, including physicians,
about the
safety and effectiveness of our
products;
|
· |
cost-effectiveness
of our product relative to competing
products;
|
· |
availability
of reimbursement for our products from government or other healthcare
payers; and
|
· |
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
|
· |
We
may be unable to identify manufacturers on acceptable terms or at
all
because the number of potential manufacturers is limited and the
FDA must
approve any replacement contractor. This approval would require new
testing and compliance inspections. In addition, a new manufacturer
would
have to be educated in, or develop substantially equivalent processes
for,
production of our products after receipt of FDA approval, if
any.
|
· |
Our
third-party manufacturers might be unable to formulate and manufacture
our
products in the volume and of the quality required to meet our
clinical
needs and commercial needs, if
any.
|
· |
Our
future contract manufacturers may not perform as agreed or may not
remain
in the contract manufacturing business for the time required to supply
our
clinical trials or to successfully produce, store and distribute
our
products.
|
· |
Manufacturers
of drug and medical devices are subject to ongoing periodic unannounced
inspection by the FDA, the Drug Enforcement Agency, and corresponding
state agencies to ensure strict compliance with good manufacturing
practice and other government regulations and corresponding foreign
standards. We do not have control over third-party manufacturers’
compliance with these regulations and
standards.
|
· |
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the
innovation.
|
· |
developing
drugs;
|
· |
undertaking
nonclinical testing and human clinical
trials;
|
· |
obtaining
FDA and other regulatory approvals of
drugs;
|
· |
formulating
and manufacturing drugs; and
|
· |
launching,
marketing and selling drugs.
|
· |
the
degree and range of protection any patents will afford us against
competitors including whether third parties will find ways to invalidate
or otherwise circumvent our
patents;
|
· |
if
and when patents will issue;
|
· |
whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications;
or
|
· |
whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
|
· |
obtain
licenses, which may not be available on commercially reasonable terms,
if
at all;
|
· |
redesign
our products or processes to avoid
infringement;
|
· |
stop
using the subject matter claimed in the patents held by
others;
|
· |
pay
damages; or
|
· |
defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion of
our
valuable management resources.
|
· |
government
and health administration
authorities;
|
· |
private
health maintenance organizations and health insurers;
and
|
· |
other
healthcare payers.
|
· |
publicity
regarding actual or potential clinical results relating to products
under
development by our competitors or
us;
|
· |
delay
or failure in initiating, completing or analyzing nonclinical or
clinical
trials or the unsatisfactory design or results of these
trials;
|
· |
achievement
or rejection of regulatory approvals by our competitors or
us;
|
· |
announcements
of technological innovations or new commercial products by our competitors
or us;
|
· |
developments
concerning proprietary rights, including
patents;
|
· |
developments
concerning our collaborations;
|
· |
regulatory
developments in the United States and foreign
countries;
|
· |
economic
or other crises and other external factors;
|
· |
period-to-period
fluctuations in our revenues and other results of
operations;
|
· |
changes
in financial estimates by securities analysts;
and
|
· |
sales
of our common stock.
|
·
|
that
a broker or dealer approve a person’s account for transactions in penny
stocks; and
|
·
|
the
broker or dealer receive from the investor a written agreement to
the
transaction, setting forth the identity and quantity of the penny
stock to
be purchased.
|
·
|
obtain
financial information and investment experience objectives of the
person;
and
|
·
|
make
a reasonable determination that the transactions in penny stocks
are
suitable for that person and the person has sufficient knowledge
and
experience in financial matters to be capable of evaluating the risks
of
transactions in penny stocks.
|
·
|
sets
forth the basis on which the broker or dealer made the suitability
determination; and
|
·
|
that
the broker or dealer received a signed, written agreement from the
investor prior to the transaction.
|
High
|
Low
|
||||||
2006
|
|||||||
First
Quarter
|
$
|
1.640
|
$
|
1.160
|
|||
Second
Quarter
|
$
|
1.360
|
$
|
0.075
|
|||
Third
Quarter
|
$
|
0.880
|
$
|
0.620
|
|||
Fourth
Quarter
|
$
|
0.920
|
$
|
0.620
|
|||
2007
|
|||||||
First
Quarter
|
$
|
0.960
|
$
|
0.700
|
|||
Second
Quarter
|
$
|
1.100
|
$
|
0.690
|
|||
Third
Quarter
|
$
|
0.780
|
$
|
0.220
|
|||
Fourth
Quarter
|
$
|
0.230
|
$
|
0.090
|
|||
2008
|
|||||||
First
Quarter
|
$
|
0.230
|
$
|
0.110
|
|||
Second
Quarter
|
$
|
0.180
|
$
|
0.100
|
|||
Third
Quarter (through August 28, 2008)
|
$
|
0.200
|
$
|
0.100
|
Year Ended December 31,
|
Six Months Ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
August 6, 2001
(inception) to
June 30,
|
||||||||||||||
2007
|
2006
|
2008
|
2007
|
2008
|
||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenue
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
||||||
Research
and development expense
|
$
|
8,535,687
|
$
|
6,172,845
|
$
|
1,365,799
|
$
|
5,551,082
|
$
|
27,854,842
|
||||||
General
and administrative expense
|
$
|
3,608,270
|
$
|
3,827,482
|
$
|
1,715,598
|
$
|
1,967,098
|
$
|
15,567,961
|
||||||
Stock-based
compensation
|
$
|
1,440,956
|
$
|
1,675,499
|
$
|
295,664
|
$
|
706,549
|
$
|
3,660,647
|
||||||
Net
loss attributable to common shares
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(58,000,631
|
)
|
|
Net
loss per common share
|
$
|
(0.18
|
)
|
$
|
(0.16
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
N/A
|
|||
Statements
of Cash Flows Data:
|
||||||||||||||||
Net
cash used in operating activities
|
$
|
(10,229,711
|
)
|
$
|
(7,750,738
|
)
|
(2,903,970
|
)
|
(6,090,775
|
)
|
$
|
(37,064,526
|
)
|
|||
Net
cash provided by (used in) financing activities
|
$
|
7,859,413
|
$
|
(15,257
|
)
|
$
|
2,853,230
|
$
|
7,861,381
|
$
|
37,284,199
|
|||||
Cash
dividends declared
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
At
December 31,
2007
|
At
June 30, 2008
|
||||||
(unaudited)
|
|||||||
Balance
Sheets Data:
|
|||||||
Total
assets
|
$
|
980,577
|
$
|
973,340
|
|||
Total
liabilities
|
$
|
1,871,662
|
$
|
4,420,322
|
|||
Total
stockholders’ deficiency
|
$
|
(891,085
|
)
|
$
|
(3,446,982
|
)
|
|
·
|
Topical
PTH (1-34) for the treatment of
psoriasis;
|
·
|
Altoderm,
a proprietary formulation of topical cromolyn sodium for the treatment
of
atopic dermatitis;
|
·
|
Hedrin,
a novel, non-insecticide treatment for head lice, through Hedrin
Pharmaceuticals K/S, a joint venture between the Company Nordic
Biotech
Fund II K/S; and
|
·
|
Altolyn,
a proprietary site specific tablet formulation of oral cromolyn
sodium for
the treatment of
mastocytosis.
|
Six Months ended June 30,
|
Increase
|
% Increase
|
|||||||||||
2008
|
2007
|
(decrease)
|
(decrease)
|
||||||||||
COSTS
AND EXPENSES
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
80,000
|
$
|
224,000
|
$ |
(144,000
|
)
|
(64
|
)%
|
||||
Other
research and development expense
|
$
|
1,286,000
|
$
|
5,327,000
|
$ |
(4,041,000
|
)
|
(76
|
)%
|
||||
Total
research and development expense
|
$
|
1,366,000
|
$
|
5,551,000
|
$ |
(4,185,000
|
)
|
(75
|
)%
|
||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
$
|
215,000
|
$
|
482,000
|
$ |
(267,000
|
)
|
(55
|
)%
|
||||
Other
general and administrative expense
|
$
|
1,500,000
|
$
|
1,485,000
|
$
|
15,000
|
1
|
%
|
|||||
Total
general and administrative expense
|
$
|
1,715,000
|
$
|
1,967,000
|
$
|
(252,000
|
)
|
(13
|
)%
|
||||
Other
income
|
$
|
79,000
|
$
|
59,000
|
$
|
20,000
|
34
|
%
|
|||||
NET
LOSS
|
$ |
(3,002,000
|
)
|
$ |
(7,459,000
|
)
|
$
|
(4,457,000
|
)
|
(60
|
)%
|
Three Months ended June 30,
|
Increase
|
% Increase
|
|||||||||||
2008
|
2007
|
(decrease)
|
(decrease)
|
||||||||||
COSTS
AND EXPENSES
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
27,000
|
$
|
122,000
|
$ |
(95,000
|
)
|
(77
|
)%
|
||||
Other
research and development expense
|
$
|
539,000
|
$
|
3,750,000
|
$ |
(3,211,000
|
)
|
(86
|
)%
|
||||
Total
research and development expense
|
$
|
566,000
|
$
|
3,872,000
|
$ |
(3,306,000
|
)
|
(85
|
)%
|
||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
$
|
75,000
|
$
|
250,000
|
$ |
(175,000
|
)
|
(70
|
)%
|
||||
Other
general and administrative expense
|
$
|
826,000
|
$
|
803,000
|
$
|
23,000
|
3
|
%
|
|||||
Total
general and administrative expense
|
$
|
901,000
|
$
|
1,053,000
|
$
|
(152,000
|
)
|
(14
|
)%
|
||||
Other
income
|
$
|
45,000
|
$
|
30,000
|
$
|
15,000
|
50
|
%
|
|||||
NET
LOSS
|
$ |
(1,442,000
|
)
|
$ |
(4,895,000
|
)
|
$ |
(3,473,000
|
)
|
(71
|
)%
|
|
Years ended December 31,
|
Increase
|
% Increase
|
||||||||||
|
2007
|
2006
|
(decrease)
|
(decrease)
|
|||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
539,000
|
$
|
529,000
|
$
|
10,000
|
1.89
|
%
|
|||||
In-license,
milestone and related fees
|
2,245,000
|
250,000
|
1,995,000
|
798.00
|
%
|
||||||||
Other
research and development expenses
|
5,752,000
|
5,394,000
|
358,000
|
6.64
|
%
|
||||||||
Total
research and development expenses
|
8,536,000
|
6,173,000
|
2,363,000
|
38.28
|
%
|
||||||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
902,000
|
1,147,000
|
(245,000
|
)
|
(21.36
|
)%
|
|||||||
Other
general and administrative expenses
|
2,706,000
|
2,680,000
|
26,000
|
0.97
|
%
|
||||||||
Total
general and administrative expenses
|
3,608,000
|
3,827,000
|
(219,000
|
)
|
(5.72
|
)%
|
|||||||
|
|||||||||||||
Other
income
|
112,000
|
305,000
|
(193,000
|
)
|
(63.28
|
)%
|
|||||||
Net
loss
|
$
|
12,032,000
|
$
|
9,695,000
|
$
|
2,337,000
|
24.11
|
%
|
|
U.S.
Patent Application No. 2007/0142330, entitled, “Method and composition for
the control of arthropods.” Jayne Ansell, Inventor. Application filed
February 12, 2007. This application is a divisional of U.S. application
Ser. No. 10/097,615, filed Mar. 15, 2002, which is a continuation
of
International Application No. PCT/GB00/03540, which designated
the United
States and was filed on Sep. 14, 2000. This application has not
yet issued
as a patent. Any patent that issues will expire on September14,
2020.
|
1. |
U.S.
Patent No. 5,527,772, entitled “Regulation of cell proliferation and
differentiation using peptides.” M.F. Holick, Inventor. Application filed
July, 28, 1994. Patent issued June 18, 1996. This patent expires
June 18,
2013.
|
2. |
U.S.
Patent No. 5,840,690, entitled “Regulation of cell proliferation and
differentation using peptides.” M.F. Holick, Inventor. Application filed
June 6, 1995. Patent issued November 24, 1998. This patent expires
June
18, 2013.
|
3. |
U.S.
Provisional application No. US60/940,509, entitled “Topical Compositions
comprising a macromolecule and methods of using same.” Application was
filed on May 29, 2007.
|
1. |
U.S.
Patent No. 7,109,246, entitled “Pharmaceutical compositions comprising an
amphoteric surfactant an alkoxylated cetyl alcohol and a polar
drug.”
Brian Hawtin, Inventor. Application filed May 20, 1999. Patent
issued
September 19, 2006. This patent expires on May 20,
2019.
|
|
2.
|
U.S.
Application Publication No. 2007/0036860, entitled “Treatment of allergic
conditions.” Alexander James Wigmore, Inventor. Any patent that issues
will expire on November 9, 2019. This patent covers both Altoderm
and
Altolyn.
|
|
1.
|
U.S.
Patent No. 7,258,872, entitled “Chromone enteric release formulation.”
Alexander James Wigmore, Inventor. Application filed November 9,
1999,
claiming the benefit of a GB application filed November 11, 1998.
Patent
issued August 21, 2007. The expected date of expiration, which
was
November 9, 2019, has been extended by 793 days (expiration date
Jan 10,
2022).
|
|
2.
|
U.S.
Application Publication No. 2007/0036860, entitled “Treatment of allergic
conditions.” Alexander James Wigmore, Inventor. Application filed October
13, 2006, claiming the benefit of a prior U.S. application, which
claimed
the benefit of a PCT application filed November 9, 1999. This application
has not yet issued as a patent. Any patent that issues is expected
to
expire on November 9, 2019. This patent covers both Altoderm and
Altolyn.
|
·
|
nonclinical
laboratory tests, animal studies, and formulation
studies,
|
·
|
submission
to the FDA of an IND for human clinical testing, which must become
effective before human clinical trials may
begin,
|
·
|
adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the drug for each
indication,
|
·
|
submission
to the FDA of an NDA,
|
·
|
satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities at which the drug is produced to assess compliance with
current
good manufacturing practices, or cGMPs,
and
|
·
|
FDA
review and approval of the NDA.
|
Name
|
|
Age
|
|
Position(s)
Held
|
|
Director
Since
|
|
|||
Douglas
Abel
|
|
|
47
|
|
|
President,
Chief Executive Officer and Director
|
|
|
2005
|
|
Neil
Herskowitz
|
|
|
51
|
|
|
Director
|
|
|
2004
|
|
Malcolm
Hoenlein
|
|
|
64
|
|
|
Director
|
|
|
2004
|
|
Timothy
McInerney
|
|
|
47
|
|
|
Director
|
|
|
2004
|
|
Richard
I. Steinhart
|
|
|
51
|
|
|
Director
|
|
|
2004
|
|
Michael
Weiser, M.D.
|
|
|
45
|
|
|
Director
|
|
|
2003
|
|
Name
of Committee
|
|
Membership
|
Audit
|
|
Messrs.
Herskowitz, Hoenlein and Steinhart (Chair)
|
|
|
|
Compensation
|
|
Messrs.
Herskowitz, Hoenlein, Steinhart and Weiser (Chair)
|
|
|
|
Nominating
and Governance
|
|
Messrs.
Herskowitz, Hoenlein and Steinhart
(Chair)
|
Name
|
|
Age
|
|
Position
|
Douglas
Abel
|
|
47
|
|
President
& Chief Executive Officer and Director
|
Michael
G. McGuinness
|
|
54
|
|
Chief
Operating and Financial Officer &
Secretary
|
Name and
Principal
Position
|
Year
|
Salary
|
Bonus
|
Option
Awards
|
Non-Equity
Incentive Plan
Compensation
|
Nonqualified
Deferred
Compensation
Earnings
|
All Other
Compensation
|
Total
|
|||||||||||||||||
Douglas Abel
Chief
Executive
Officer
and
President
|
2007
2006
|
$
$
|
345,000
325,000
|
$
$
|
180,000
150,000
|
(3)
|
$
$
|
910,224
1,156,065
|
(5)
(5)
|
$
$
|
0
0
|
$
$
|
0
0
|
$
$
|
42,333
116,776
|
(4)
(4)
|
$
$
|
1,477,557
1,748,841
|
|||||||
Alan
G. Harris (1)
Chief
Medical
Officer
|
2007
2006
|
$
$
|
288,333
252,083
|
$
$
|
0
107,500
|
$
$
|
292,530
98,837
|
(5)
(5)
|
$
$
|
0
0
|
$
$
|
0
0
|
$
$
|
9,000
8,800
|
(6)
(6)
|
$
$
|
589,863
467,220
|
||||||||
Michael
McGuinness(2)
Chief
Operating
and
Financial
Officer,
Secretary
|
2007
2006
|
$
$
|
238,333
98,229
|
$
$
|
100,000
60,000
|
(3) |
$
$
|
95,528
23,622
|
(5)
(5)
|
$
$
|
0
0
|
$
$
|
0
0
|
$
$
|
9,000
0
|
(6)
|
$
$
|
442,861
181,851
|
(1)
|
Dr.
Harris was appointed our Chief Medical Officer on February 1, 2006.
Dr.
Harris’ employment with us ended effective December 31,
2007.
|
(2)
|
Mr.
McGuinness was appointed our Chief Financial Officer on July 10,
2006 and
Chief Operating Officer on April 1,
2008.
|
(3)
|
The
Company has accrued for such bonuses but has not paid such bonuses.
Payment of such bonuses are contingent upon our raising additional
financing and shall be paid as follows: (i) 50% will be paid
when we have
consummated a financing transaction with gross proceeds (net
of
commissions) to the Company of at least $1,000,000 and (ii) the
remaining
50% will be paid when we have consummated a financing transaction
with
gross proceeds (net of commissions) to us of at least $2.5 million
(cumulative, including the $1 million financing transaction referred
to
above).
|
(4)
|
For
2007 represents a payment in the amount of $33,333, which represents
the
approximate amount of additional expense incurred by Mr. Abel relating
to
his commuting between Boston and New York and a tax “gross up” to cover
the additional tax liability to Mr. Abel from such payment, and
a matching
contributions by us pursuant to our company’s 401(k) retirement plan of
$9,000. For 2006 represents a payment in the amount of $83,333,
which
represents the approximate amount of additional expense incurred
by Mr.
Abel relating to his commuting between Boston and New York and
a tax
“gross up” to cover the additional tax liability to Mr. Abel from such
payment, reimbursement of certain commuting expenses of $24,643
and a
matching contributions by us pursuant to our company’s 401(k) retirement
plan of $8,800.
|
(5)
|
Represents
the amount of share-based costs recognized by us during 2007 under
SFAS
No. 123(R). See Note 3 to our Consolidated Financial Statements
included
in our annual report for 2007 on Form 10-K and for 2006 on Form
10-KSB for
the assumptions made in the valuation.
|
(6)
|
Represents
matching contributions by us pursuant to our company’s 401(k) retirement
plan.
|
Option
Awards
|
|||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option Exercise
Price ($)
|
Option
Expiration Date
|
|||||||||
Douglas
Abel
|
2,923,900
0
|
0
250,000
|
$
$
|
1.50
0.95
|
04/01/2015
04/25/2017
|
||||||||
Alan
Harris
|
300,000
100,000
|
0
0
|
$
$
|
1.35
0.95
|
12/31/2009
12/31/2009
|
||||||||
Michael
McGuinness
|
73,333
20,000
0
|
146,667
40,000
320,000
|
$
$
$
|
0.70
1.35
0.95
|
07/10/2016
07/10/2016
04/25/2017
|
Name
|
Fees Earned or
Paid in
Cash
|
Option
Awards (1)
|
All Other
Compensation
|
Total
|
|||||||||
Neil Herskowitz
|
$
|
27,500
|
$
|
7,948
|
(3)
|
$
|
0
|
$
|
35,448
|
||||
Malcolm
Hoenlein
|
$
|
25,000
|
$
|
7,948
|
(4)
|
$
|
0
|
$
|
32,948
|
||||
Timothy
McInerney
|
$
|
24,000
|
$
|
7,948
|
(5)
|
$
|
0
|
$
|
31,948
|
||||
Joan
Pons Gimbert (2)
|
$
|
12,000
|
$
|
7,948
|
(6)
|
$
|
0
|
$
|
19,948
|
||||
Richard
I. Steinhart
|
$
|
27,000
|
$
|
7,948
|
(7)
|
$
|
0
|
$
|
34,948
|
||||
Michael
Weiser
|
$
|
24,500
|
$
|
7,948
|
(8)
|
$
|
0
|
$
|
32,448
|
(1)
|
Represents
the amount of share-based costs recognized by us during 2006 under
SFAS
No. 123(R). See Note 3 to our Consolidated Financial Statements
included
in our annual report for 2006 on Form 10-KSB for the assumptions
made in
the valuation.
|
(2)
|
Joan
Pons Gimbert resigned from the Board in July
2007.
|
(3)
|
As
of September 15, 2008, Mr. Herskowitz had options to purchase
an aggregate
of 216,010 shares of our common
stock.
|
(4)
|
As
of September 15, 2008, Mr. Hoenlein had options to purchase an
aggregate
of 216,010 shares of our common
stock.
|
(5)
|
As
of September 15, 2008, Mr. McInerney had options to purchase
an aggregate
of 236,010 shares of our common
stock.
|
(6)
|
As
of September 15, 2008, Mr. Pons Gimbert had options to purchase
an
aggregate of 133,334 shares of our common
stock.
|
(7)
|
As
of September 15, 2008, Mr. Steinhart had options to purchase
an aggregate
of 216,010 shares of our common
stock.
|
(8)
|
As
of September 15, 2008, Mr. Weiser had options to purchase an
aggregate of
230,000 shares of our common
stock.
|
of
our common stock;
|
Name of Beneficial Owners, Officers and Directors
|
Number of
Shares
Beneficially
Owned (#)
|
|
Percentage
Beneficially
Owned (%)
|
||||
Douglas
Abel (1)
|
3,519,566
|
4.8
|
|||||
Michael
McGuinness (2)
|
694,000
|
1.0
|
|||||
Michael
Weiser (3)
|
2,562,651
|
3.6
|
|||||
Timothy
McInerney (4)
|
990,857
|
1.4
|
|||||
Neil
Herskowitz (5)
|
347,128
|
*
|
|||||
Richard
I. Steinhart (6)
|
154,967
|
*
|
|||||
Malcolm
Hoenlien (7)
|
150,525
|
*
|
|||||
All
directors and officers as a group (8)(7
persons)
|
8,419,694
|
11.1
|
|||||
Lester
Lipschutz (9)
1650
Arch Street, Philadelphia, PA 19103
|
8,941,873
|
12.7
|
|||||
Lindsay
Rosenwald (10)
787
Seventh Avenue
New
York, NY 10019
|
4,224,268
|
5.9
|
|||||
Nordic
Biotech Venture Fund II K/S(11)
Ostergrade
5, 3rd floor, DK-1100
Copenhagen
K, Denmark
|
33,928,571
|
32.5
|
|
(1)
|
Includes
3,440,566 shares issuable upon exercise of vested portions of
options and
24,000 shares issuable upon exercise of warrants.
|
|
(2)
|
Includes
660,000 shares issuable upon exercise of vested portions of options
and
24,000 shares issuable upon exercise of warrants.
|
|
(3)
|
Includes
163,334 shares issuable upon the exercise of vested portions
of options,
and 151,754 shares issuable upon exercise of
warrants.
|
|
(4)
|
Includes
183,334 shares issuable upon exercise of vested portions of options;
and
139,863 shares issuable upon exercise of
warrants.
|
|
(5)
|
Includes
149,344 shares issuable upon exercise of vested portions of options,
and
43,444 shares issuance upon exercise of warrants; 77,288 shares
held by
Riverside Contracting, LLC, a limited liability company of which
Mr.
Herskowitz is a member holding 50% ownership and 44,168 shares
held by
ReGen Capital II, LLC, a limited liability company of which Mr.
Herskowitz
is a member holding 50% ownership.
|
|
(6)
|
Includes
149,344 shares issuable upon exercise of vested portions of
options.
|
|
(7)
|
Includes
149,344 shares issuable upon exercise of vested portions of
options.
|
|
(8)
|
Includes
4,895,246 shares issuable upon exercise of vested portions of
options;
383,061 shares issuable upon the exercise of warrants; 77,288
shares held
by Riverside Contracting, LLC, a limited liability company of
which Mr.
Herskowitz is a member holding 50% ownership and 44,168 shares
held by
ReGen Capital II, LLC, a limited liability company of which Mr.
Herskowitz
is a member holding 50% ownership.
|
|
(9)
|
Includes
8,941,873 shares of Common Stock held by separate trusts for
the benefit
of Dr. Rosenwald or his family with respect to which Mr. Lipschutz
is
either trustee or investment manager and in either case has investment
and
voting power. Mr. Lipschutz disclaims beneficial ownership of
these
shares, except to the extent of his pecuniary interest therein,
if
any. The foregoing information is derived from a Schedule 13G filed
on behalf of the reporting person on August 1, 2007
|
|
(10)
|
Includes
3,183,497 shares held directly by Dr. Rosenwald, 1,040,658 shares
issuable
upon the exercise of warrants, 80 shares held by the Dr. Rosenwald's
wife,
over which Dr. Rosenwald may be deemed to have sole voting and
dispositive
power, although he disclaims beneficial ownership of such shares
except
with regard to his pecuniary interest therein, if any, and 33
shares held
by Dr. Rosenwald’s children, over which Dr. Rosenwald may be deemed to
have sole voting and dispositive power, although he disclaims
beneficial
ownership of such shares except with regard to his pecuniary
interest
therein, if any. The foregoing information is derived from a
Schedule
13G/A filed on behalf of the reporting person on February 13,
2008.
|
(11)
|
Includes
(i) 26,785,714 shares issuable upon exercise of Nordic's right
to put all
or a portion of Nordic Biotech Venture Fund II K/S' equity interest
in
Hedrin Pharmaceuticals K/S, a Danish limited partnership, of
which we and
Nordic are partners and (ii) 7,142,857 shares issuable upon exercise
of an
outstanding warrant held by Nordic. Does not include (i) 26,785,714
shares
issuable upon exercise of our right to call all or a portion
of Nordic’s
equity interest in Hedrin Pharmaceuticals K/S to the extent such
shares
are not issued upon exercise of Nordic’s put right, which call right is
subject to the satisfaction of certain conditions with respect
to the
closing price of our common stock and Nordic's right to refuse
such call
upon payment of cash or forfeiture of equity interests in Hedrin
Pharmaceuticals K/S, or (ii) 8,928,572 additional shares which
may become
issuable upon exercise of Nordic's right to put, or subject to
the
satisfaction of certain conditions and to certain exceptions
discussed
above, our right to call, all or a portion of selling securityholder's
equity interest in Hedrin Pharmaceuticals K/S upon classification
of
Hedrin by the FDA, as a Class II or Class III medical device
and selling
securityholder's investment of an additional $1.25 million in
Hedrin
Pharmaceuticals K/S. Florian Schonharting and Christian Hansen
have voting
and investment control over such
securities.
|
|
·
|
any
breach of his or her duty of loyalty to us or our
stockholders;
|
|
·
|
acts
or omissions not in good faith which involve intentional misconduct
or a
knowing violation of law;
|
|
·
|
the
payment of dividends or the redemption or purchase of stock in
violation
of Delaware law; or
|
|
·
|
any
transaction from which the director derived an improper personal
benefit.
|
• |
1.0%
of the number of ordinary shares then outstanding, which will equal
706,242 shares immediately after this offering;
or
|
• |
the
average weekly trading volume of the ordinary shares during the
four
calendar weeks preceding the filing of a notice on Form 144 with
respect
to the sale.
|
Number of
Shares
|
Common Stock Beneficially
Owned After this Offering
|
||||||||||||
Selling Securityholder
|
of Common
Stock
Beneficially
Owned Prior
to the Offering
|
Shares
Being
Offered
|
Number of
Shares
Outstanding
|
Percent
of Shares
Outstanding
|
|||||||||
Nordic
Biotech Venture Fund II K/S
|
33,928,571
|
(1)
|
33,928,571
|
(1)
|
0
|
0
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares
as agent
but may position and resell a portion of the block as principal
to
facilitate the transaction;
|
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer
for its
account;
|
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
·
|
privately
negotiated transactions;
|
|
·
|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a part;
|
|
·
|
broker-dealers
may agree with the selling securityholder to sell a specified number
of
such shares at a stipulated price per share;
|
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
|
|
·
|
a
combination of any such methods of sale; or
|
|
·
|
any
other method permitted pursuant to applicable
law.
|
Page
|
|
Unaudited
Condensed Consolidated Financial Statements as of June 30, 2008
and
2007
|
|
Unaudited
Condensed Consolidated Balance Sheets as of June 30, 2008 and
December 31,
2007
|
F-2
|
Unaudited
Condensed Consolidated Statements of Operations For the Three
and Six
Months Ended June 30, 2008 and 2007 and the cumulative period
from August
6, 2001 (inception) to June 30, 2008
|
F-3
|
Unaudited
Condensed Consolidated Statement of Stockholders’ Equity (Deficiency) from
August 6, 2001 (inception) to June 30, 2008
|
F-4
|
Unaudited
Condensed Consolidated Statements of Cash Flows For the Six Months
Ended
June 30, 2008 and 2007 and the cumulative period from August
6, 2001
(inception) to June 30, 2008
|
F-6
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
F-7
|
Financial
Statements as of December 31, 2007 and 2006
|
|
Report
of Independent Registered Public Accounting Firm
|
F-20
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-21
|
Consolidated
Statements of Operations for the Years Ended December 31, 2007
and 2006
and the cumulative period from August 6, 2001 (inception) to
December 31,
2007
|
F-22
|
Consolidated
Statement of Stockholders’ Equity (Deficiency) for the Years
Ended
December
31, 2007 and 2006 and the cumulative period from August 6, 2001
(inception) to December 31, 2007
|
F-23
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2007
and 2006
and the cumulative period from August 6, 2001 (inception) to
December 31,
2007
|
F-25
|
Notes
to Consolidated Financial Statements
|
F-26
|
|
June 30,
2008
|
|
December 31,
2007
|
|
|||
|
|
(Unaudited)
|
|
(See Note 1)
|
|||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
576,354
|
$
|
649,686
|
|||
Prepaid
expenses and other current assets
|
135,540
|
215,852
|
|||||
Total
current assets
|
711,894
|
865,538
|
|||||
|
|||||||
Investment
in Hedrin JV
|
142,408
|
-
|
|||||
Property
and equipment, net
|
34,912
|
44,533
|
|||||
Other
assets
|
84,126
|
70,506
|
|||||
Total
assets
|
$
|
973,340
|
$
|
980,577
|
|||
|
|||||||
Liabilities
and Stockholders’ Deficiency
|
|||||||
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
617,346
|
$
|
1,279,485
|
|||
Accrued
expenses
|
849,746
|
592,177
|
|||||
Total
current liabilities
|
1,467,092
|
1,871,662
|
|||||
Exchange
obligation
|
2,953,230
|
-
|
|||||
Total
liabilities
|
4,420,322
|
1,871,662
|
|||||
Commitments
and contingencies
|
|||||||
|
|||||||
Stockholders’
deficiency:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued and
outstanding at June 30, 2008 and December 31, 2007
|
|||||||
Common
stock, $.001 par value. Authorized 300,000,000 shares; 70,624,232
shares
issued and outstanding at June 30, 2008 and December 31, 2007
|
70,624
|
70,624
|
|||||
Additional
paid-in capital
|
54,483,025
|
54,037,361
|
|||||
Deficit
accumulated during the development stage
|
(58,000,631
|
)
|
(54,999,070
|
)
|
|||
Total
stockholders’ deficiency
|
(3,446,982
|
)
|
(891,085
|
)
|
|||
|
|||||||
Total
liabilities and stockholders' deficiency
|
$
|
973,340
|
$
|
980,577
|
Three months ended June 30,
|
Six months ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
June 30
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
2008
|
||||||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
$
|
565,728
|
$
|
3,871,634
|
$
|
1,365,799
|
$
|
5,551,082
|
$
|
27,854,842
|
||||||
General
and administrative
|
901,538
|
1,052,374
|
1,715,598
|
1,967,098
|
15,567,961
|
|||||||||||
In-process
research and development charge
|
—
|
—
|
—
|
—
|
11,887,807
|
|||||||||||
Impairment
of intangible assets
|
—
|
—
|
—
|
—
|
1,248,230
|
|||||||||||
Loss
on disposition of intangible assets
|
—
|
—
|
—
|
—
|
1,213,878
|
|||||||||||
Total
operating expenses
|
1,467,266
|
4,924,008
|
3,081,397
|
7,518,180
|
57,772,718
|
|||||||||||
Operating
loss
|
(1,467,266
|
)
|
(4,924,008
|
)
|
(3,081,397
|
)
|
(7,518,180
|
)
|
(57,772,718
|
)
|
||||||
Other
(income) expense:
|
||||||||||||||||
Equity
in loss of Hedrin JV
|
87,718
|
—
|
107,593
|
—
|
107,593
|
|||||||||||
Interest
and other income
|
(132,772
|
)
|
(29,608
|
)
|
(187,429
|
)
|
(59,998
|
)
|
(1,009,327
|
)
|
||||||
Interest
expense
|
—
|
—
|
—
|
475
|
26,034
|
|||||||||||
Realized
gain on sale of marketable equity securities
|
—
|
—
|
—
|
—
|
(76,032
|
)
|
||||||||||
Total
other income
|
(45,054
|
)
|
(29,608
|
)
|
(79,836
|
)
|
(59,523
|
)
|
(951,731
|
)
|
||||||
Net
loss
|
(1,422,212
|
)
|
(4,894,400
|
)
|
(3,001,561
|
)
|
(7,458,657
|
)
|
(56,820,987
|
)
|
||||||
Preferred
stock dividends (including imputed amounts)
|
—
|
—
|
—
|
—
|
(1,179,644
|
)
|
||||||||||
Net
loss applicable to common shares
|
$
|
(1,422,212
|
)
|
$
|
(4,894,400
|
)
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(58,000,631
|
)
|
|
Net
loss per common share:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.02
|
)
|
$
|
(0.07
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||
Basic
and diluted
|
70,624,232
|
70,463,543
|
70,624,232
|
65,377,865
|
Series
A convertible preferred
stock
|
Series
A convertible preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in
capital
|
Subscription
receivable
|
Deficit
accumulated during development
stage
|
Dividends
payable
in
Series
A
preferred
stock
|
Accumulated
other comprehensive income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity
(deficiency)
|
||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for subscription receivable
|
—
|
$
|
—
|
10,167,741
|
$
|
10,168
|
$
|
(6,168
|
)
|
$
|
(4,000
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2001
|
—
|
—
|
10,167,741
|
10,168
|
(6,168
|
)
|
(4,000
|
)
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Proceeds
from subscription receivable
|
—
|
—
|
—
|
—
|
—
|
4,000
|
—
|
—
|
—
|
—
|
4,000
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
—
|
—
|
2,541,935
|
2,542
|
(1,542
|
)
|
—
|
—
|
—
|
—
|
—
|
1,000
|
||||||||||||||||||||||
Stock
options issued for consulting services
|
—
|
—
|
—
|
—
|
60,589
|
—
|
—
|
—
|
—
|
(60,589
|
)
|
—
|
||||||||||||||||||||||
Amortization
of unearned consulting services
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22,721
|
22,721
|
|||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
3,043,332
|
3,043
|
1,701,275
|
—
|
—
|
—
|
—
|
—
|
1,704,318
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
|
—
|
(1,037,320
|
)
|
—
|
—
|
—
|
(1,037,320
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2002
|
—
|
—
|
15,753,008
|
15,753
|
1,754,154
|
—
|
(1,094,116
|
)
|
—
|
—
|
(37,868
|
)
|
637,923
|
|||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
1,321,806
|
1,322
|
742,369
|
—
|
—
|
—
|
—
|
—
|
743,691
|
|||||||||||||||||||||||
Effect
of reverse acquisition
|
—
|
—
|
6,287,582
|
6,287
|
2,329,954
|
—
|
—
|
—
|
—
|
—
|
2,336,241
|
|||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
37,868
|
37,868
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(7,760
|
)
|
—
|
(7,760
|
)
|
|||||||||||||||||||||
Payment
for fractional shares for stock combination
|
—
|
—
|
—
|
—
|
(300
|
)
|
—
|
—
|
—
|
—
|
—
|
(300
|
)
|
|||||||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
1,000,000
|
1,000
|
—
|
—
|
9,045,176
|
—
|
—
|
—
|
—
|
—
|
9,046,176
|
|||||||||||||||||||||||
Imputed
preferred stock dividend
|
|
|
|
|
418,182
|
—
|
(418,182
|
)
|
—
|
|
|
—
|
||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,960,907
|
)
|
—
|
—
|
—
|
(5,960,907
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000
|
1,000
|
23,362,396
|
23,362
|
14,289,535
|
—
|
(7,473,205
|
)
|
—
|
(7,760
|
)
|
—
|
6,832,932
|
|||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
27,600
|
27
|
30,073
|
—
|
—
|
—
|
—
|
—
|
30,100
|
|||||||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
—
|
—
|
3,368,952
|
3,369
|
3,358,349
|
—
|
—
|
—
|
—
|
—
|
3,361,718
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(585,799
|
)
|
585,799
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
24,901
|
25
|
—
|
—
|
281,073
|
—
|
—
|
(282,388
|
)
|
—
|
—
|
(1,290
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528
|
)
|
(171
|
)
|
1,550,239
|
1,551
|
(1,380
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Warrants
issued for consulting services
|
—
|
—
|
—
|
—
|
125,558
|
—
|
—
|
—
|
—
|
(120,968
|
)
|
4,590
|
||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100,800
|
100,800
|
|||||||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss
on
short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20,997
|
—
|
20,997
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,896,031
|
)
|
—
|
—
|
—
|
(5,896,031
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2004
|
854,373
|
854
|
28,309,187
|
28,309
|
18,083,208
|
—
|
(13,955,035
|
)
|
303,411
|
13,237
|
(20,168
|
)
|
4,453,816
|
Series
A convertible preferred
stock
|
Series
A convertible preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in
capital
|
Subscription
receivable
|
Deficit
accumulated during development
stage
|
Dividends
payable in
Series
A
preferred
stock
|
Accumulated
other comprehensive income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity
(deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||
Common
stock issued at $1.11 and $1.15, net of expenses
|
—
|
—
|
11,917,680
|
11,918
|
12,238,291
|
—
|
—
|
—
|
—
|
—
|
12,250,209
|
|||||||||||||||||||||||
Common
stock issued to vendor at $1.11 per share in satisfaction of
accounts
payable
|
—
|
—
|
675,675
|
676
|
749,324
|
—
|
—
|
—
|
—
|
—
|
750,000
|
|||||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
32,400
|
33
|
32,367
|
—
|
—
|
—
|
—
|
—
|
32,400
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
279,845
|
279
|
68,212
|
—
|
—
|
—
|
—
|
—
|
68,491
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(175,663
|
)
|
175,663
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
41,781
|
42
|
—
|
—
|
477,736
|
—
|
—
|
(479,074
|
)
|
—
|
—
|
(1,296
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(896,154
|
)
|
(896
|
)
|
8,146,858
|
8,147
|
(7,251
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
66,971
|
—
|
—
|
—
|
—
|
20,168
|
87,139
|
|||||||||||||||||||||||
Reversal
of unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,250
|
)
|
—
|
(12,250
|
)
|
|||||||||||||||||||||
Stock
issued in connection with acquisition of Tarpan Therapeutics,
Inc.
|
—
|
—
|
10,731,052
|
10,731
|
11,042,253
|
—
|
—
|
—
|
—
|
—
|
11,052,984
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(19,140,997
|
)
|
—
|
—
|
—
|
(19,140,997
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2005
|
—
|
—
|
60,092,697
|
60,093
|
42,751,111
|
—
|
(33,271,695
|
)
|
—
|
987
|
—
|
9,540,496
|
||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
27,341
|
27
|
(27
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,675,499
|
—
|
—
|
—
|
—
|
—
|
1,675,499
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(987
|
)
|
—
|
(987
|
)
|
|||||||||||||||||||||
Costs
associated with private placement
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
—
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(9,695,123
|
)
|
—
|
—
|
—
|
(9,695,123
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2006
|
—
|
—
|
60,120,038
|
60,120
|
$
|
44,411,326
|
—
|
(42,966,818
|
)
|
—
|
—
|
—
|
1,504,628
|
|||||||||||||||||||||
Common
stock issued at $0.84 and $0.90 per shares, net of
expenses
|
—
|
—
|
10,185,502
|
10,186
|
7,841,999
|
—
|
—
|
—
|
—
|
—
|
7,852,185
|
|||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction
of accounts
payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
—
|
20,000
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at
$0.90 per
share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at
$0.80 per
share
|
—
|
—
|
150,000
|
150
|
119,850
|
—
|
—
|
—
|
—
|
—
|
120,000
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,440,956
|
—
|
—
|
—
|
—
|
—
|
1,440,956
|
|||||||||||||||||||||||
Warrants
issued for consulting
|
83,670
|
83,670
|
||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,032,252
|
)
|
—
|
—
|
—
|
(12,032,252
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2007
|
—
|
—
|
70,624,232
|
70,624
|
54,037,361
|
—
|
(54,999,070
|
)
|
—
|
—
|
—
|
(891,085
|
)
|
|||||||||||||||||||||
Sale
of warrant
|
150,000
|
150,000
|
||||||||||||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
295,664
|
—
|
—
|
—
|
—
|
—
|
295,664
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(3,001,561
|
)
|
—
|
—
|
—
|
(3,001,561
|
)
|
|||||||||||||||||||||
Balance
at June 30, 2008
|
—
|
$
|
—
|
70,624,232
|
$
|
70,624
|
$
|
54,483,025
|
$
|
—
|
$
|
(58,000,631)
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(3,446,982
|
)
|
|
|
Six
months ended June 30,
|
|
Cumulative
period
from
August
6, 2001
(inception)
to
|
|
|||||
|
|
2008
|
|
2007
|
|
June
30, 2008
|
||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(56,820,987
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Equity
in loss of Hedrin JV
|
107,593
|
—
|
107,593
|
|||||||
Share-based
compensation
|
295,664
|
706,549
|
3,660,647
|
|||||||
Shares
issued in connection with in-licensing agreement
|
—
|
112,500
|
232,500
|
|||||||
Warrants
issued to consultant
|
—
|
—
|
83,670
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
—
|
(76,032
|
)
|
|||||||
Depreciation
|
15,631
|
29,974
|
211,456
|
|||||||
Non
cash portion of in-process research and development charge
|
—
|
—
|
11,721,623
|
|||||||
Loss
on impairment and disposition of intangible assets
|
—
|
—
|
2,462,108
|
|||||||
Other
|
2,962
|
—
|
8,552
|
|||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||
(Increase)/decrease
in prepaid expenses and other current assets
|
80,311
|
(88,071
|
)
|
(77,296
|
)
|
|||||
Increase
in other assets
|
—
|
-
|
(70,506
|
)
|
||||||
Increase
/(decrease) in accounts payable
|
(662,139
|
)
|
(371,447
|
)
|
1,037,559
|
|||||
Increase
in accrued expenses
|
257,569
|
978,377
|
309,425
|
|||||||
Net
cash used in operating activities
|
(2,903,970
|
)
|
(6,090,775
|
)
|
(37,064,526
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(8,972
|
)
|
(9,135
|
)
|
(239,607
|
)
|
||||
Cash
paid in connection with acquisitions
|
—
|
—
|
(26,031
|
)
|
||||||
Net
cash provided from the purchase and sale of short-term investments,
net
|
—
|
—
|
435,938
|
|||||||
Proceeds
from the sale of license
|
—
|
—
|
200,001
|
|||||||
Investment
in Hedrin JV’s general partner
|
(13,620
|
)
|
—
|
(13,620
|
)
|
|||||
Net
cash (used in) provided by investing activities
|
(22,592
|
)
|
(9,135
|
)
|
356,681
|
|||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Proceeds
related to sale of common stock, net
|
—
|
7,854,153
|
25,896,262
|
|||||||
Proceeds
from sale of preferred stock, net
|
—
|
—
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
—
|
7,228
|
138,219
|
|||||||
Proceeds
from the Hedrin JV Agreement, net
|
2,703,230
|
—
|
2,703,230
|
|||||||
Sale
of warrant
|
150,000
|
—
|
150,000
|
|||||||
Other,
net
|
—
|
—
|
235,214
|
|||||||
Net
cash provided by financing activities
|
2,853,230
|
7,861,381
|
37,284,199
|
|||||||
Net
(decrease) increase in cash and cash equivalents
|
(73,332
|
)
|
1,761,471
|
576,354
|
||||||
Cash
and cash equivalents at beginning of period
|
649,686
|
3,029,118
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
576,354
|
$
|
4,790,589
|
$
|
576,354
|
||||
|
||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
—
|
$
|
475
|
$
|
26,033
|
||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
—
|
$
|
20,000
|
$
|
750,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
9,046,176
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
—
|
112,500
|
232,500
|
|||||||
Marketable
equity securities received in connection with sale of
license
|
—
|
—
|
359,907
|
|||||||
Warrants
issued to consultant
|
—
|
—
|
83,670
|
|||||||
Net
liabilities assumed over assets acquired in business
combination
|
—
|
—
|
(675,416
|
)
|
||||||
Investment
in Hedrin JV
|
250,000
|
—
|
250,000
|
|||||||
Cashless
exercise of warrants
|
—
|
6
|
33
|
Three months ended June 30,
|
Six months ended June 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
General
and administrative expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
75,362
|
$
|
249,623
|
$
|
215,405
|
$
|
471,544
|
|||||
Share-based
consultant and non-employee (credit) cost
|
—
|
—
|
—
|
10,550
|
|||||||||
$
|
75,362
|
$
|
249,623
|
$
|
215,405
|
$
|
482,094
|
||||||
Research
and development expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
27,735
|
$
|
121,531
|
$
|
80,000
|
$
|
231,449
|
|||||
Share-based
consultant and non-employee (credit) cost
|
(287
|
)
|
185
|
259
|
(6,994
|
)
|
|||||||
$
|
27,448
|
$
|
121,716
|
$
|
80,259
|
$
|
224,455
|
||||||
Total
share-based cost
|
$
|
102,810
|
$
|
371,339
|
$
|
295,664
|
$
|
706,549
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
|
||||||||
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|||||
Expected
Volatility
|
92.3
|
%
|
79.7
- 93.2
|
%
|
92.3
|
%
|
79.7
- 93.2
|
%
|
|||||
Dividend
yield
|
-
|
-
|
-
|
-
|
|||||||||
Expected
term (in years)
|
6
|
6
- 8
|
6
|
6
- 8
|
|||||||||
Risk-free
interest rate
|
2.81
|
%
|
4.56%
- 4.96
|
%
|
2.81
|
%
|
4.56%
- 4.96
|
%
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at December 31, 2007
|
8,033,808
|
$
|
1.25
|
||||||||||
Granted:
|
|||||||||||||
Officers
|
2,400,000
|
||||||||||||
Directors
|
375,000
|
||||||||||||
Employees
|
192,500
|
||||||||||||
Total
granted
|
2,967,500
|
0.17
|
|||||||||||
Exercised
|
-
|
||||||||||||
Cancelled
|
(224,972
|
)
|
0.17
|
||||||||||
Outstanding
at June 30, 2008
|
10,766,336
|
$
|
0.93
|
7.46
|
$
|
-
|
|||||||
Exercisable
at June 30, 2008
|
8,004,692
|
$
|
1.12
|
6.80
|
|||||||||
Weighted
average fair value of options granted during the six months ended
June 30,
2008
|
$
|
0.13
|
December 31,
2007
|
|
December 31,
2006
|
|||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
649,686
|
$
|
3,029,118
|
|||
Prepaid
expenses
|
215,852
|
264,586
|
|||||
|
|||||||
Total
current assets
|
865,538
|
3,293,704
|
|||||
|
|||||||
Property
and equipment, net
|
44,533
|
83,743
|
|||||
Other
assets
|
70,506
|
70,506
|
|||||
|
|||||||
Total
assets
|
$
|
980,577
|
$
|
3,447,953
|
|||
|
|||||||
Liabilities
and Stockholders’ Equity (Deficiency)
|
|||||||
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,279,485
|
$
|
1,393,296
|
|||
Accrued
expenses
|
592,177
|
550,029
|
|||||
|
|||||||
Total
liabilities
|
1,871,662
|
1,943,325
|
|||||
|
|||||||
Commitments
and contingencies
|
|||||||
|
|||||||
Stockholders’
equity (deficiency):
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued and
outstanding at December 31, 2007 and 2006
|
|||||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,624,232
and
60,120,038 shares issued and outstanding at December 31, 2007
and December
31, 2006, respectively
|
70,624
|
60,120
|
|||||
Additional
paid-in capital
|
54,037,361
|
44,411,326
|
|||||
Deficit
accumulated during the development stage
|
(54,999,070
|
)
|
(42,966,818
|
)
|
|||
|
|||||||
Total
stockholders’ equity (deficiency)
|
(891,085
|
)
|
1,504,628
|
||||
|
|||||||
Total
liabilities and stockholders' equity (deficiency)
|
$
|
980,577
|
$
|
3,447,953
|
|
Years ended December 31,
|
Cumulative
period from
August 6, 2001 (inception) to
December 31,
|
||||||||
|
2007
|
2006
|
2007
|
|||||||
Revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
|
|
|
|
|||||||
Costs
and expenses:
|
|
|
|
|||||||
Research
and development
|
8,535,687
|
6,172,845
|
26,489,043
|
|||||||
General
and administrative
|
3,608,270
|
3,827,482
|
13,852,363
|
|||||||
In-process
research and development charge
|
—
|
—
|
11,887,807
|
|||||||
Impairment
of intangible assets
|
—
|
—
|
1,248,230
|
|||||||
Loss
on disposition of intangible assets
|
—
|
—
|
1,213,878
|
|||||||
|
|
|
|
|||||||
Total
operating expenses
|
12,143,957
|
10,000,327
|
54,691,321
|
|||||||
|
|
|
|
|||||||
Operating
loss
|
(12,143,957
|
)
|
(10,000,327
|
)
|
(54,691,321
|
)
|
||||
|
|
|
|
|||||||
Other
(income) expense:
|
|
|
|
|||||||
Interest
and other income
|
(112,181
|
)
|
(307,871
|
)
|
(821,897
|
)
|
||||
Interest
expense
|
476
|
1,665
|
26,034
|
|||||||
Realized
(gain)/loss on sale of marketable equity securities
|
—
|
1,002
|
(76,032
|
)
|
||||||
|
|
|
|
|||||||
Total
other income
|
(111,705
|
)
|
(305,204
|
)
|
(871,895
|
)
|
||||
|
|
|
|
|||||||
Net
loss
|
(12,032,252
|
)
|
(9,695,123
|
)
|
(53,819,426
|
)
|
||||
|
|
|
|
|||||||
Preferred
stock dividends (including imputed amounts)
|
—
|
—
|
(1,179,644
|
)
|
||||||
|
|
|
|
|||||||
Net
loss applicable to common shares
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(54,999,070
|
)
|
|
|
|
|
|
|||||||
Net
loss per common share:
|
|
|
|
|||||||
Basic
and diluted
|
$
|
(0.18
|
)
|
$
|
(0.16
|
)
|
|
|||
|
|
|
|
|||||||
Weighted
average shares of common stock outstanding:
|
|
|
|
|||||||
Basic
and diluted
|
68,015,075
|
60,112,333
|
|
Series A
convertible
preferred
stock
|
Series A
convertible
preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in capital
|
Subscription
receivable
|
Deficit
accumulated
during
development
stage
|
Dividends
payable in
Series A
preferred
stock
|
Accumulated
other
comprehensive
income (loss)
|
Unearned
consulting
services
|
Total
stockholders’
equity
(deficiency)
|
||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for subscription receivable
|
—
|
$
|
—
|
10,167,741
|
$
|
10,168
|
$
|
(6,168
|
)
|
$
|
(4,000
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2001
|
—
|
—
|
10,167,741
|
10,168
|
(6,168
|
)
|
(4,000
|
)
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Proceeds
from subscription receivable
|
—
|
—
|
—
|
—
|
—
|
4,000
|
—
|
—
|
—
|
—
|
4,000
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
—
|
—
|
2,541,935
|
2,542
|
(1,542
|
)
|
—
|
—
|
—
|
—
|
—
|
1,000
|
||||||||||||||||||||||
Stock
options issued for consulting services
|
—
|
—
|
—
|
—
|
60,589
|
—
|
—
|
—
|
—
|
(60,589
|
)
|
—
|
||||||||||||||||||||||
Amortization
of unearned consulting services
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22,721
|
22,721
|
|||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
3,043,332
|
3,043
|
1,701,275
|
—
|
—
|
—
|
—
|
—
|
1,704,318
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
|
—
|
(1,037,320
|
)
|
—
|
—
|
—
|
(1,037,320
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2002
|
—
|
—
|
15,753,008
|
15,753
|
1,754,154
|
—
|
(1,094,116
|
)
|
—
|
—
|
(37,868
|
)
|
637,923
|
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
1,321,806
|
1,322
|
742,369
|
—
|
—
|
—
|
—
|
—
|
743,691
|
|||||||||||||||||||||||
Effect
of reverse acquisition
|
—
|
—
|
6,287,582
|
6,287
|
2,329,954
|
—
|
—
|
—
|
—
|
—
|
2,336,241
|
|||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
37,868
|
37,868
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(7,760
|
)
|
—
|
(7,760
|
)
|
|||||||||||||||||||||
Payment
for fractional shares for stock combination
|
—
|
—
|
—
|
—
|
(300
|
)
|
—
|
—
|
—
|
—
|
—
|
(300
|
)
|
|||||||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
1,000,000
|
1,000
|
—
|
—
|
9,045,176
|
—
|
—
|
—
|
—
|
—
|
9,046,176
|
|||||||||||||||||||||||
Imputed
preferred stock dividend
|
|
|
|
|
418,182
|
—
|
(418,182
|
)
|
—
|
|
|
—
|
||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,960,907
|
)
|
—
|
—
|
—
|
(5,960,907
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000
|
1,000
|
23,362,396
|
23,362
|
14,289,535
|
—
|
(7,473,205
|
)
|
—
|
(7,760
|
)
|
—
|
6,832,932
|
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
27,600
|
27
|
30,073
|
—
|
—
|
—
|
—
|
—
|
30,100
|
|||||||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
—
|
—
|
3,368,952
|
3,369
|
3,358,349
|
—
|
—
|
—
|
—
|
—
|
3,361,718
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(585,799
|
)
|
585,799
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
24,901
|
25
|
—
|
—
|
281,073
|
—
|
—
|
(282,388
|
)
|
—
|
—
|
(1,290
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528
|
)
|
(171
|
)
|
1,550,239
|
1,551
|
(1,380
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Warrants
issued for consulting services
|
—
|
—
|
—
|
—
|
125,558
|
—
|
—
|
—
|
—
|
(120,968
|
)
|
4,590
|
||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100,800
|
100,800
|
|||||||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss on
short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20,997
|
—
|
20,997
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,896,031
|
)
|
—
|
—
|
—
|
(5,896,031
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2004
|
854,373
|
854
|
28,309,187
|
28,309
|
18,083,208
|
—
|
(13,955,035
|
)
|
303,411
|
13,237
|
(20,168
|
)
|
4,453,816
|
Series A
convertible
preferred
stock
|
Series A
convertible
preferred
stock
|
Common
stock
|
Common
stock
|
Additional
paid-in
capital
|
Subscription
receivable
|
Deficit
accumulated
during
development
stage
|
Dividends
payable in
Series A
preferred
stock
|
Accumulated
other
comprehensive
income (loss)
|
Unearned
consulting
services
|
Total
stockholders’
equity
(deficiency)
|
||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
|||||||||||||||||||||||
Common
stock issued at $1.11 and $1.15, net of expenses
|
—
|
—
|
11,917,680
|
11,918
|
12,238,291
|
—
|
—
|
—
|
—
|
—
|
12,250,209
|
|||||||||||||||||||||||
Common
stock issued to vendor at $1.11 per share in satisfaction of accounts
payable
|
—
|
—
|
675,675
|
676
|
749,324
|
—
|
—
|
—
|
—
|
—
|
750,000
|
|||||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
32,400
|
33
|
32,367
|
—
|
—
|
—
|
—
|
—
|
32,400
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
279,845
|
279
|
68,212
|
—
|
—
|
—
|
—
|
—
|
68,491
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(175,663
|
)
|
175,663
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
41,781
|
42
|
—
|
—
|
477,736
|
—
|
—
|
(479,074
|
)
|
—
|
—
|
(1,296
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(896,154
|
)
|
(896
|
)
|
8,146,858
|
8,147
|
(7,251
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
66,971
|
—
|
—
|
—
|
—
|
20,168
|
87,139
|
|||||||||||||||||||||||
Reversal
of unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,250
|
)
|
—
|
(12,250
|
)
|
|||||||||||||||||||||
Stock
issued in connection with acquisition of Tarpan Therapeutics,
Inc.
|
—
|
—
|
10,731,052
|
10,731
|
11,042,253
|
—
|
—
|
—
|
—
|
—
|
11,052,984
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(19,140,997
|
)
|
—
|
—
|
—
|
(19,140,997
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2005
|
—
|
—
|
60,092,697
|
60,093
|
42,751,111
|
—
|
(33,271,695
|
)
|
—
|
987
|
—
|
9,540,496
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
27,341
|
27
|
(27
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,675,499
|
—
|
—
|
—
|
—
|
—
|
1,675,499
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(987
|
)
|
—
|
(987
|
)
|
|||||||||||||||||||||
Costs
associated with private placement
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
—
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(9,695,123
|
)
|
—
|
—
|
—
|
(9,695,123
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2006
|
—
|
—
|
60,120,038
|
60,120
|
44,411,326
|
—
|
(42,966,818
|
)
|
—
|
—
|
—
|
1,504,628
|
||||||||||||||||||||||
Common
stock issued at $0.84 and $0.90 per shares, net of
expenses
|
—
|
—
|
10,185,502
|
10,186
|
7,841,999
|
—
|
—
|
—
|
—
|
—
|
7,852,185
|
|||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction of accounts
payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
—
|
20,000
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.90
per
share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.80
per
share
|
—
|
—
|
150,000
|
150
|
119,850
|
—
|
—
|
—
|
—
|
—
|
120,000
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,440,956
|
—
|
—
|
—
|
—
|
—
|
1,440,956
|
|||||||||||||||||||||||
Warrants
issued for consulting
|
83,670
|
83,670
|
||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,032,252
|
)
|
—
|
—
|
—
|
(12,032,252
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2007
|
—
|
$
|
—
|
70,624,232
|
$
|
70,624
|
$
|
54,037,361
|
$
|
—
|
$
|
(54,999,070
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(891,085
|
)
|
|
Years ended December 31,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
|
||||||||
|
2007
|
2006
|
2007
|
|||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(53,819,426
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Share-based
compensation
|
1,440,956
|
1,675,499
|
3,364,983
|
|||||||
Shares
issued in connection with in-licensing agreement
|
232,500
|
—
|
232,500
|
|||||||
Warrants
issued to consultant
|
83,670
|
—
|
83,670
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
(Gain)/loss
on sale of marketable equity securities
|
—
|
1,002
|
(76,032
|
)
|
||||||
Depreciation
|
48,345
|
60,186
|
195,825
|
|||||||
Non
cash portion of in-process research and development charge
|
—
|
—
|
11,721,623
|
|||||||
Loss
on impairment and disposition of intangible assets
|
—
|
—
|
2,462,108
|
|||||||
Other
|
—
|
—
|
5,590
|
|||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||
Decrease
(increase) in prepaid expenses and other current assets
|
48,734
|
(69,810
|
)
|
(157,607
|
)
|
|||||
Increase
in other assets
|
—
|
—
|
(70,506
|
)
|
||||||
Increase
(decrease) in accounts payable
|
(93,812
|
)
|
(224,193
|
)
|
1,699,698
|
|||||
Increase
in accrued expenses
|
42,148
|
501,701
|
51,856
|
|||||||
Net
cash used in operating activities
|
(10,229,711
|
)
|
(7,750,738
|
)
|
(34,160,556
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(9,134
|
)
|
(37,052
|
)
|
(230,635
|
)
|
||||
Cash
paid in connection with acquisitions
|
—
|
—
|
(26,031
|
)
|
||||||
Net
cash provided from the purchase and sale of short-term
investments
|
—
|
1,005,829
|
435,938
|
|||||||
Proceeds
from sale of license
|
—
|
—
|
200,001
|
|||||||
Net
cash (used in) provided by investing activities
|
(9,134
|
)
|
968,777
|
379,273
|
||||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Proceeds
(costs) related to sale of common stock, net
|
7,852,185
|
(15,257
|
)
|
25,896,262
|
||||||
Proceeds
from sale of preferred stock, net
|
—
|
—
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
7,228
|
—
|
138,219
|
|||||||
Other,
net
|
—
|
—
|
235,214
|
|||||||
Net
cash provided by (used in) financing activities
|
7,859,413
|
(15,257
|
)
|
34,430,969
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
(2,379,432
|
)
|
(6,797,218
|
)
|
649,686
|
|||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
649,686
|
$
|
3,029,118
|
$
|
649,686
|
||||
|
||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
475
|
$
|
1,665
|
$
|
26,033
|
||||
|
||||||||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
20,000
|
$
|
—
|
$
|
770,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
1,067
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
232,500
|
232,500
|
||||||||
Marketable
equity securities received in connection with sale of
license
|
—
|
—
|
359,907
|
|||||||
Warrants
issued to consultant
|
83,670
|
—
|
83,670
|
|||||||
Net
liabilities assumed over assets acquired in business
combination
|
—
|
—
|
(675,416
|
)
|
||||||
Cashless
exercise of warrants
|
6
|
27
|
33
|
2007
|
2006
|
||||||
General
and administrative expense:
|
|||||||
Share-based
employee compensation cost
|
$
|
891,897
|
$
|
1,176,618
|
|||
Share-based
consultant and non-employee cost
|
10,550
|
(29,842
|
)
|
||||
$
|
902,447
|
$
|
1,146,776
|
||||
Research
and development expense
|
|||||||
Share-based
employee compensation cost
|
$
|
555,663
|
$
|
494,043
|
|||
Share-based
consultant and non-employee cost
|
(17,154
|
)
|
34,680
|
||||
$
|
538,509
|
$
|
528,723
|
||||
Total
share-based cost
|
$
|
1,440,956
|
$
|
1,675,499
|
2007
|
2006
|
||||||
Expected
volatility
|
93
|
%
|
84%
- 98
|
%
|
|||
Dividend
yield
|
—
|
—
|
|||||
Expected
term (in years)
|
5
- 10
|
5
- 10
|
|||||
Risk-free
interest rate
|
3.6%
- 4.9
|
%
|
4.45%
- 5.1
|
%
|
|||
Forfeiture
rate
|
7
|
%
|
4
|
%
|
2007
|
2006
|
||||||
Property
and equipment
|
$
|
226,010
|
$
|
244,040
|
|||
Less
accumulated depreciation
|
(181,477
|
)
|
(160,297
|
)
|
|||
Net
property and equipment
|
$
|
44,533
|
$
|
83,743
|
2007
|
|||||||||||||
Shares
|
Weighted
average
exercise
price
|
Weighted
Average Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at beginning of year
|
|
7,000,504
|
$
|
1.310
|
|||||||||
Granted
|
1,342,500
|
$
|
0.875
|
||||||||||
Exercised
|
-
|
||||||||||||
Cancelled
|
(309,166
|
)
|
$
|
0.336
|
|||||||||
8,033,838
|
$
|
1.253
|
6.887
|
$
|
|||||||||
Options
exercisable at year-end
|
5,601,714
|
$
|
1.263
|
6.625
|
$
|
||||||||
Weighted-average
fair value of
|
|||||||||||||
options
granted during the year
|
$
|
0.63
|
Number
|
Remaining
|
Number of
|
||||||||
Exercise
|
of Options
|
Contractual
|
Options
|
|||||||
Price
|
Outstanding
|
Life (years)
|
Exercisable
|
|||||||
$ 0.40
|
876,090
|
5.16
|
876,090
|
|||||||
0.43
|
400
|
5.15
|
400
|
|||||||
0.70
|
220,000
|
8.53
|
73,333
|
|||||||
0.72
|
365,000
|
9.09
|
32,500
|
|||||||
0.82
|
75,000
|
9.08
|
-
|
|||||||
0.89
|
16,667
|
8.38
|
16,667
|
|||||||
0.95
|
670,000
|
9.32
|
100,000
|
|||||||
0.97
|
440,000
|
6.75
|
440,000
|
|||||||
1.00
|
65,000
|
4.24
|
65,000
|
|||||||
1.00
|
290,698
|
7.04
|
290,698
|
|||||||
1.25
|
12,000
|
4.08
|
12,000
|
|||||||
1.25
|
163,750
|
4.14
|
163,750
|
|||||||
1.35
|
108,333
|
8.08
|
64,999
|
|||||||
1.35
|
300,000
|
8.09
|
300,000
|
|||||||
1.35
|
60,000
|
8.53
|
20,000
|
|||||||
1.50
|
2,923,900
|
7.25
|
1,949,277
|
|||||||
1.50
|
250,000
|
2.58
|
25,000
|
|||||||
1.60
|
100,000
|
7.46
|
75,000
|
|||||||
1.65
|
1,077,000
|
6.08
|
1,077,000
|
|||||||
4.38
|
10,000
|
3.14
|
10,000
|
|||||||
20.94
|
10,000
|
2.28
|
10,000
|
|||||||
Total
|
8,033,838
|
5,601,714
|
Number of
|
Remaining
|
Number of
|
||||||||
Exercise
price
|
Warrants
outstanding
|
contractual life
(years)
|
warrants
exercisable
|
|||||||
$ 0.28
|
150,000
|
4.64
|
150,000
|
|||||||
0.78
|
10,000
|
1.98
|
10,000
|
|||||||
1.00
|
3,564,897
|
4.25
|
3,564,897
|
|||||||
1.00
|
509,275
|
4.25
|
509,275
|
|||||||
1.10
|
909,090
|
.85
|
909,090
|
|||||||
1.10
|
326,499
|
1.04
|
326,499
|
|||||||
1.44
|
2,161,767
|
2.65
|
2,161,767
|
|||||||
1.44
|
540,449
|
2.65
|
540,449
|
|||||||
1.44
|
135,135
|
2.65
|
135,135
|
|||||||
1.49
|
221,741
|
2.67
|
221,741
|
|||||||
1.49
|
55,000
|
2.67
|
55,000
|
|||||||
1.90
|
10,000
|
1.21
|
10,000
|
|||||||
1.90
|
90,000
|
1.21
|
90,000
|
|||||||
6.69
|
185,601
|
.10
|
185,601
|
|||||||
Total
|
8,869,454
|
8,869,454
|
(9) |
Income
Taxes
|
2007
|
2006
|
||||||
Deferred
tax assets:
|
|||||||
Tax
loss carryforwards
|
$
|
22,513,000
|
$
|
18,265,000
|
|||
Research
and development credit
|
1,769,000
|
1,374,000
|
|||||
In-process
research and development charge
|
4,850,000
|
4,850,000
|
|||||
Stock
based compensation
|
1,270,000
|
682,000
|
|||||
Other
|
85,000
|
29,000
|
|||||
Gross
deferred tax assets
|
30,487,000
|
25,200,000
|
|||||
Less
valuation allowance
|
(30,487,000
|
)
|
(25,200,000
|
)
|
|||
Net
deferred tax assets
|
$
|
—
|
$
|
—
|
2007
|
2006
|
||||||||||||
%
of
|
%
of
|
||||||||||||
pretax
|
pretax
|
||||||||||||
Amount
|
loss
|
Amount
|
loss
|
||||||||||
Federal
income tax benefit at statutory rate
|
$
|
(4,102,000
|
)
|
(34.0
|
)%
|
$
|
(3,296,000
|
)
|
(34.0
|
)%
|
|||
State
income taxes, net of federal tax
|
(820,000
|
)
|
(6.8
|
)%
|
(659,000
|
)
|
(6.8
|
)%
|
|||||
Research
and development credits
|
(366,000
|
)
|
(3.0
|
)%
|
(200,000
|
)
|
(1.7
|
)%
|
|||||
Other
|
1,000
|
0.0
|
%
|
(166,000
|
)
|
(2.1
|
)%
|
||||||
Change
in valuation allowance
|
5,287,000
|
43.8
|
%
|
4,321,000
|
44.6
|
%
|
|||||||
|
— |
—
|
%
|
—
|
—
|
%
|
(10) |
License
and Consulting Agreements
|
(11) |
Commitments
and Contingencies
|
Years Ending December 31,
|
Commitment
|
|||
2008
|
$
|
100,000
|
||
2009
and subsequent
|
$
|
0
|
12. |
Subsequent
events
|
$
|
175.00
|
|||
Legal
fees and expenses
|
10,000.00
|
|||
Printing
fees and expenses
|
1,000.00
|
|||
Accounting
fees and expenses
|
10,000.00
|
|||
Miscellaneous
fees and expenses
|
2,000.00
|
|||
Total
|
Exhibits.
|
Exhibit No.
|
|
Description
|
|
|
|
2.1
|
|
Agreement
and Plan of Merger among the Company, Manhattan Pharmaceuticals
Acquisition Corp. and Manhattan Research Development, Inc. (formerly
Manhattan Pharmaceuticals, Inc.) dated December 17, 2002 (incorporated
by
reference to Exhibit 2.1 from Form 8-K filed March 5,
2003).
|
|
|
|
2.2
|
|
Agreement
and Plan of Merger among the Registrant, Tarpan Therapeutics, Inc.
and
Tarpan Acquisition Corp., dated April 1, 2005 (incorporated by
reference
to Exhibit 2.1 of the Registrant’s Form 8-K/A filed June 15,
2005).
|
|
|
|
3.1
|
|
Certificate
of incorporation, as amended through September 25, 2003 (incorporated
by
reference to Exhibit 3.1 to the Registrant’s Form 10-QSB for the quarter
ended September 30, 2003).
|
|
|
|
3.2
|
|
Bylaws,
as amended to date (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
|
|
|
4.1
|
|
Specimen
common stock certificate (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
|
|
|
4.2
|
|
Form
of warrant issued by Manhattan Research Development, Inc., which
automatically converted into warrants to purchase shares of the
Registrant’s common stock upon the merger transaction with such company
(incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-QSB
for the quarter ended March 31, 2003).
|
|
|
|
4.3
|
|
Form
of warrant issued to placement agents in connection with the Registrant’s
November 2003 private placement of Series A Convertible Preferred
Stock
and the Registrant’s January 2004 private placement (incorporated by
reference to Exhibit 4.18 to the Registrant’s Registration Statement on
Form SB-2 filed January 13, 2004 (File No.
333-111897)).
|
|
|
|
4.4
|
|
Form
of warrant issued to investors in the Registrant’s August 2005 private
placement (incorporated by reference to Exhibit 4.1 of the Registrant’s
Form 8-K filed September 1, 2005).
|
|
|
|
4.5
|
|
Form
of warrant issued to placement agents in the Registrant’s August 2005
private placement (incorporated by reference to Exhibit 4.2 of
the
Registrant’s Form 8-K filed September 1,
2005).
|
4.6
|
Warrant,
dated April 30, 2008, issued to Nordic Biotech Venture Fund II
K/S
(incorporated by reference to Exhibit 4.6 of the Registrant’s Registration
Statement on Form S-1 filed on May 1, 2008 (File No.
333-150580).
|
4.7
|
Form
of Warrant issued to Noteholders on September 11, 2008 (Incorporated
by
reference to Exhibit 10.2 to the Current Report on Form 8-K filed
on
September 15, 2008)
|
|
5.1
|
Opinion
of Lowenstein Sandler PC
|
|
10.1
|
|
1995
Stock Option Plan, as amended (incorporated by reference to Exhibit
10.18
to the Registrant’s Form 10-QSB for the quarter ended September 30,
1996).
|
10.2
|
|
Form
of Notice of Stock Option Grant issued to employees of the Registrant
from
April 12, 2000 to February 21, 2003 (incorporated by reference
to Exhibit
99.2 of the Registrant’s Registration Statement non Form S-8 filed March
24, 1998 (File 333-48531)).
|
10.3
|
|
Schedule
of Notices of Stock Option Grants, the form of which is attached
hereto as
Exhibit 4.2.
|
|
|
|
10.4
|
|
Form
of Stock Option Agreement issued to employees of the Registrant
from April
12, 2000 to February 21, 2003 (incorporated by reference to Exhibit
99.3
to the Registrant’s Registration Statement on Form S-8 filed March 24,
1998 (File 333-48531)).
|
|
|
|
10.5
|
|
License
Agreement dated on or about February 28, 2002 between Manhattan
Research
Development, Inc. (f/k/a Manhattan Pharmaceuticals, Inc.) and
Oleoyl-Estrone Developments SL (incorporated by reference to Exhibit
10.6
to the Registrant’s Amendment No. 2 to Form 10-QSB/A for the quarter ended
March 31, 2003 filed on March 12, 2004).
|
|
|
|
10.6
|
|
License
Agreement dated April 4, 2003 between the Registrant and NovaDel
Pharma,
Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s
Amendment No. 1 to Form 10-QSB/A for the quarter ended June 30,
2003 filed
on March 12, 2004).++
|
|
|
|
10.7
|
|
2003
Stock Option Plan (incorporated by reference to Exhibit 4.1 to
Registrant’s Registration Statement on Form S-8 filed February 17,
2004).
|
|
|
|
10.8
|
|
Employment
Agreement dated April 1, 2005, between the Registrant and Douglas
Abel
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K/A
filed June 15, 2005).
|
|
|
|
10.9
|
|
Sublicense
Agreement dated April 14, 2004 between Tarpan Therapeutics, Inc.,
the
Registrant’s wholly-owned subsidiary, and IGI, Inc. (incorporated by
reference to Exhibit 10.109 to IGI Inc.’s Form 10-Q for the quarter ended
March 31, 2004 (File No. 001-08568).
|
|
|
|
10.10
|
|
Form
of subscription agreement between the Registrant and the investors
in the
Registrant’s August 2005 private placement (incorporated by reference as
Exhibit 10.1 to the Registrant’s Form 8-K filed September 1,
2005).
|
10.11
|
|
Separation
Agreement between the Registrant and Alan G. Harris December
21, 2007
(incorporated by reference to Exhibit 10.11 to the Registrant's
Form 10-K
filed March 31, 2008.)
|
|
|
|
10.12
|
|
Employment
Agreement dated July 7, 2006 between the Registrant and Michael
G.
McGuinness (incorporated by reference to Exhibit 10.1 of the
Registrant’s
Form 8-K filed July 12,
2006.)
|
10.13
|
|
Summary
terms of compensation plan for Registrant’s non-employee directors
(incorporated by reference to Exhibit 10.1 of Registrant’s Form 8-K filed
February 5, 2007).
|
|
|
|
10.14
|
|
Form
of Stock Option Agreement issued under the Registrant’s 2003 Stock Option
Plan (Incorporated by reference to Exhibit 10.15 to the Registrant's
Form
10-KSB filed April 2, 2078.)
|
|
|
|
10.15
|
|
Exclusive
License Agreement for “Altoderm” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dates April 3, 2007. (Incorporated
by
reference to Exhibit 10.3 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14,
2007.)
|
10.16
|
|
Exclusive
License Agreement for “Altolyn” between Thornton &Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3, 2007. (Incorporated
by
reference to Exhibit 10.4 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14, 2007.)
|
|
|
|
10.17
|
|
Exclusive
License Agreement for “Hedrin” between Thornton &Ross Ltd. , Kerris,
S.A. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007.
(Incorporated by reference to Exhibit 10.5 of the registrant’s form 10-Q
for the quarter ended June 30, 2007 filed on August 14,
2007.)
|
|
|
|
10.18
|
|
Supply
Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan
Pharmaceuticals, Inc. dated June 26, 2007. (Incorporated by reference
to
Exhibit 10.6 of the registrant’s form 10-Q for the quarter ended June 30,
2007 filed on August 14, 2007.)
|
|
|
|
10.19
|
|
Joint
Venture Agreement between Nordic Biotech Fund II K/S and Manhattan
Pharmaceuticals, Inc. to develop and commercialize “Hedrin” dated January
31, 2008.
|
|
|
|
10.20
|
|
Amendment
No. 1, dated February 25, 2008, to the Joint Venture Agreement
between
Nordic Biotech Fund II K/S and Manhattan Pharmaceuticals, Inc.
to develop
and commercialize “Hedrin” dated January 31, 2008 (Incorporated by
reference to Exhibit 10.20 to the Registrant's Form 10-K filed
March 31,
2008).
|
|
|
|
10.21
|
Omnibus
Amendment to Joint Venture Agreement and Additional Agreements,
dated June
9, 2008, among Manhattan Pharmaceuticals, Inc., Hedrin Pharmaceuticals
K/S, Hedrin Pharmaceuticals General Partner ApS and Nordic Biotech
Venture
Fund II K/S.
|
|
10.22
|
|
Assignment
and Contribution Agreement between Hedrin Pharmaceuticals K/S
and
Manhattan Pharmaceuticals, Inc. dated February 25, 2008. (Incorporated
by
reference to Exhibit 10.21 to the Registrant's Form 10-K filed
March 31,
2008.)
|
|
|
|
10.23
|
|
Registration
Rights Agreement between Nordic Biotech Venture Fund II K/S and
Manhattan
Pharmaceuticals, Inc. dated February 25, 2008. (Incorporated
by reference
to Exhibit 10.22 to the Registrant's Form 10-K filed March 31,
2008.)
|
|
|
|
10.24
|
Letter
Agreement, dated September 17, 2008, between Nordic Biotech Venture
Fund
II K/S and Manhattan Pharmaceuticals, Inc.
|
|
10.25
|
|
Amendment
to Employment Agreement by and between Manhattan Pharmaceuticals,
Inc. and
Douglas Abel (Incorporated by reference to Exhibit 10.23 to the
Registrant's Form 10-K filed March 31, 2008.)
|
10.26
|
Form
of Secured Promissory Note, dated September 11, 2008 (Incorporated
by
reference to Exhibit 10.1 to the Current Report on Form 8-K filed
on
September 15, 2008)
|
|
23.1
|
|
Consent
of J.H. Cohn LLP.
|
|
|
|
23.2
|
Consent
of Lowenstein Sandler PC (incorporated by reference to Exhibit
5.1)
|
|
24.1
|
Powers
of Attorney (Included in Signature Page of this Registration
Statement)
|
++
|
Confidential
treatment has been granted as to certain portions of this exhibit
pursuant
to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
|
|
(1)
|
To
file, during any period in which offers or sales are being made,
a
post-effective amendment to this registration
statement:
|
||
|
(i)
|
To
include any prospectus required by Section 10(a)(3) of the Securities
Act
of 1933, as amended;
|
||
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the
effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent
a
fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease
in
volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation
from
the low or high end of the estimated maximum offering range may
be
reflected in the form of prospectus filed with the Commission pursuant
to
Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than 20 percent change in the maximum aggregate
offering
price set forth in the “Calculation of Registration Fee” table in the
effective registration statement; and
|
||
|
(iii)
|
To
include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material
change to such information in the registration
statement;
|
||
|
provided,
however
,
that subparagraphs (i) and (ii) above do not apply if the information
required to be included in a post-effective amendment by these
subparagraphs is contained in periodic reports filed with or furnished
to
the Commission by the Registrant pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934 that are incorporated by reference
in
this registration statement.
|
|||
|
(2)
|
That,
for the purpose of determining any liability under the Securities
Act of
1933, as amended, each such post-effective amendment shall be deemed
to be
a new registration statement relating to the securities offered
therein,
and the offering of such securities at that time shall be deemed
to be the
initial bona fide offering thereof.
|
||
(3)
|
To
remove from registration by means of a post-effective amendment
any of the
securities being registered which remain unsold at the termination
of the
offering.
|
|
Manhattan
Pharmaceuticals, Inc.
|
|
|
||
By:
|
/s/ Michael
G. McGuinness
|
|
|
|
Mr.
Michael G. McGuinness
Chief
Operating and Financial Officer
|
/s/
Douglas Abel
|
Chief
Executive Officer, President and
|
October
3, 2008
|
|
Douglas
Abel
|
Director
(principal executive officer)
|
|
|
|
|
|
|
/s/
Michael G. McGuinness
|
Chief
Operating and Financial
|
October
3, 2008
|
|
Michael
G. McGuinness
|
Officer
& Secretary (principal financial and accounting and officer)
|
|
|
|
|
|
|
/s/
Neil Herskowitz
|
Director
|
October
3, 2008
|
|
Neil
Herskowitz
|
|
|
|
|
|
|
|
Director
|
October
3, 2008
|
||
Malcolm
Hoenlein
|
|
|
|
|
|
|
|
/s/
Timothy McInerney
|
|
|
|
Timothy
McInerney
|
Director
|
October
3, 2008
|
|
|
|
|
|
/s/
Richard Steinhart
|
|
|
|
Richard
Steinhart
|
Director
|
October
3, 2008
|
|
|
|
|
|
/s/
Michael Weiser
|
|
|
|
Michael
Weiser
|
Director
|
October
3, 2008
|
October
3,
2008
|
If
to MHA:
|
Manhattan
Pharmaceuticals, Inc.
|
|
810
Seventh Avenue, 4th
Floor
|
|
New
York, NY 10019
|
|
Fax:
(212) 582-3957
|
|
Attn:
Chief Financial Officer
|
|
Email:
mgmcguinness@manhattanpharma.com
|
|
|
with
a copy to:
|
Lowenstein
Sandler PC
|
|
65
Livingston Avenue
|
|
Roseland,
New Jersey 07068
|
|
Telephone:
(973) 597-2500
|
|
Fax:
(973) 597-2400
|
|
Attn:
Anthony O. Pergola
|
|
Email:
apergola@lowenstein.com
|
If
to Nordic:
|
Nordic
Biotech Advisors
|
|
Østergade
5, 3rd floor
|
|
DK-1100
Copenhagen K
|
|
Denmark
|
|
Attn:
Florian Schönharting
|
|
Fax:
(978) 448-3145
|
|
Email:
fs@nordicbiotech.com
|
|
With
a copy to: John M. Barberich
|
|
Email:
jmb@nordicbiotech.com
|
|
|
with
a copy to:
|
Nutter,
McClennen & Fish LLP
|
|
World
Trade Center West
|
|
155
Seaport Boulevard
|
|
Boston,
MA 02210
|
|
Fax:
(617) 310-9000
|
|
Attn:
James E. Dawson, Esq.
|
|
Email:
jdawson@nutter.com
|
|
|
MANHATTAN
PHARMACEUTICALS, INC.
|
|
|
|
By:
|
/s/
Michael McGuinness
|
Name:
|
|
Title:
|
CFO
|
|
|
NORDIC:
|
|
|
|
NORDIC
BIOTECH VENTURE FUND II K/S
|
|
|
|
By:
|
/s/
Florian Schonharting
|
Name:
|
|
Title:
|
Partner
|
|
|
By:
|
/s/
Christian Hansen
|
Name:
|
|
Title:
|
Partner
|
|
|
Address:
|
Østergade 5, 3rd floor
|
|
DK-1100 Copenhagen K
|
|
Denmark
|
Hedrin
Pharmaceuticals K/S
|
1.
|
Definitions
|
4
|
2.
|
Background
and purpose
|
5
|
3.
|
The
Partnership Shares
|
6
|
4.
|
Capital
Increases
|
7
|
5.
|
Liability
|
9
|
6.
|
Administration
of the Partnership
|
9
|
7.
|
The
General Partner
|
10
|
8.
|
Management
Fee
|
11
|
9.
|
Meetings
of the Partnership
|
11
|
10.
|
Power
to bind the Partnership
|
13
|
11.
|
Liquidation
and Trade Sale preferences
|
13
|
12.
|
Pledge
and assignment of Partnership Shares
|
14
|
13.
|
Dividends
|
17
|
14.
|
Auditor
|
18
|
15.
|
Non-competition
|
18
|
16.
|
Confidentiality
|
19
|
17.
|
Value
added tax - taxes
|
19
|
18.
|
Exculpation
and indemnities
|
20
|
19.
|
Amendment
of the Agreement
|
20
|
20.
|
Notices
|
20
|
21.
|
Governing
law and jurisdiction
|
21
|
1.
|
DEFINITIONS
|
A.
|
In
this Agreement the following words and expressions shall have the
following meanings, unless the context otherwise
requires:
|
Agreement
|
This
limited partnership agreement between MHA, Nordic and the General
Partner
as amended from time to time.
|
Assets
|
As
defined in the Joint Venture
Agreement.
|
Business
Day
|
A
day when banks are generally open for business in New York City,
New
York.
|
Call
Option
|
As
defined in the Joint Venture Agreement.
|
Closing
|
The
date on which the Partnership is established by the signatures of
the
parties to this Agreement or if there be several dates the latest
thereof.
|
Connected
Transferee
|
Any
entity holding Partnership Shares in consequence of a transfer of
Partnership Shares pursuant to clause 12.3.
|
Contribution
Agreement
|
As
defined in the Joint Venture Agreement.
|
Joint
Venture Agreement
|
The
joint venture agreement between MHA and Nordic defined in clause
2.1.
|
License
Agreement
|
As
defined in Section 13.1.
|
License
Payment
|
As
defined in Section 22.1.
|
Limited
Partner
|
Any
holder of Partnership Shares.
|
MHA
Partnership Shares
|
The
Partnership shares owned by MHA.
|
Nordic
Partnership Shares
|
The
Partnership shares owned by Nordic.
|
Partnership
|
The
Danish limited liability partnership Hedrin Pharmaceuticals K/S
established and governed by this Agreement.
|
Partnership
Shares
|
The
partnership shares described in clause 3.1 as well as any additional
partnership shares issued under clause 4 of the
Agreement.
|
Parties
|
The
General Partner and the Limited Partners
|
Payment
Milestone
|
As
defined in the Joint Venture Agreement.
|
Put
Option
|
As
defined in the Joint Venture Agreement.
|
Services
Agreement
|
As
defined in the Joint Venture
Agreement.
|
Shareholders'
Agreement
|
The
shareholders' agreement between the holders' of Partnership Shares
concerning their holdings of shares in the General Partner as amended
from
time to time (at Closing the shareholders' agreement attached hereto
as
Appendix 8.3).
|
Trade
Sale
|
The
sale of 100 percent of the Partnership Shares to a bona fide third
party
or related parties, or a sale or
exclusive license of all or substantially all assets of the Partnership
against consideration in stock or cash or
similar.
|
2.
|
BACKGROUND
AND PURPOSE
|
B.
|
As
of
January 31 2008 MHA and Nordic have entered into a joint venture
agreement
(the "Joint Venture Agreement") according to which Nordic shall contribute
capital to a newly formed limited partnership (the "Partnership")
and MHA
shall assign and contribute the Assets to the Partnership.
|
C.
|
The
Partnership is founded as a Danish limited liability partnership
by the
Parties' signatures to this Agreement with the General Partner as
general
partner and the Limited Partners as limited
partners.
|
D.
|
It
is the purpose of the Partnership to acquire, develop and commercialize
the Assets and to perform all activities necessary and convenient
to
accomplish the foregoing purpose. The Partnership shall carry out
no other
activities.
|
E.
|
The
articles of association of the Partnership are attached hereto as
Appendix
2.4.
In
the event that there is any discrepancy between the Agreement and
the
articles of association the provisions of the Agreement shall prevail
in
the internal relationship of the
Parties.
|
3.
|
THE
PARTNERSHIP SHARES
|
F.
|
The
Partnership is established with a nominal share capital of DKK 1,000,000
divided into 1,000
Partnership Shares of nominally DKK
1,000.
|
G.
|
At
Closing the Partnership Shares are distributed among the Parties
as
follows (all amounts in DKK):
|
Number of Partnership Shares
|
|
Nordic
|
500
|
MHA
|
500
|
General Partner
|
0
|
Total
|
1,000
|
H.
|
None
of the Partnership Shares have been paid in to the Partnership at
Closing.
|
I.
|
The
payment
for the MHA Closing
Partnership Shares
shall be paid in to the Partnership at the Closing upon the Partnership's
execution of the Contribution Agreement and MHA’s consummation of the
assignment of the Assets to the Partnership as contemplated thereunder.
Thus, the value of the Assets exceeds the cash payments payable under
the
Contribution Agreement and the excess value is contributed to the
Partnership in return for the MHA Partnership
Shares.
|
J.
|
The
payment for the Nordic Closing Partnership Shares shall be paid in
to the
Partnership at
the Closing upon the payment by Nordic to
the Partnership
of
$2,500,000 by wire transfer to a bank account designated by the
Partnership.
|
K.
|
No
later than 15 Business Days after satisfaction, if any, of the Payment
Milestone, Nordic shall pay to the Partnership an additional $2,500,000
by
wire transfer to a bank account designated by the Partnership as
payment
for an additional 500 Partnership Shares. The satisfaction of the
Payment
Milestone shall constitute payment by MHA for an additional 500
Partnership Shares. Accordingly, after satisfaction of the Payment
Milestone, the Partnership Shares shall be distributed among the
Parties
as follows (all amounts in DKK):
|
Number of Partnership Shares
|
|
Nordic
|
1,000
|
MHA
|
1,000
|
General
Partner
|
0
|
Total
|
2,000
|
II.
|
CAPITAL
INCREASES
|
A.
|
Except
as provided herein, the number of Partnership Shares may not be increased
without the express unanimous written consent of the Parties.
|
B.
|
Notwithstanding
Section 4.1, in the event that either Party determines, in its reasonable
good faith discretion, that the Partnership requires additional capital
for the proper and efficient conduct of its business and to avoid
insolvency (other than additional capital obtained through indebtedness
for borrowed money from a bank), such Party shall provide each Limited
Partner with a written request for contribution of such Limited Partner’s
proportionate share of such requested additional capital amount
(i.e.,
pro rata according to the Limited Partners’ then respective equity
ownership in the Partnership) in exchange for the Partnership’s issuance
of Partnership Shares in the Partnership to such Limited Partner
so that,
after giving effect to such issuance, each Limited Partner will continue
to maintain its same proportionate equity interest in the Partnership
(assuming all Limited Partners elect to so contribute their proportionate
shares of such requested additional capital amount) as of the date
of such
request. The Limited Partners shall have fifteen (15) days to make
such
election to contribute all or part of their proportionate share of
the
requested additional capital amount by the delivery of written notice
to
the Partnership of such election and, if such written notice is timely
delivered, fifteen (15) days after delivery of such written notice
to
contribute the requested additional capital amount to the Partnership.
If
a Limited Partner declines to so contribute, elects to so contribute
but
thereafter fails to do so timely, or elects to contribute and timely
does
contribute some, but not all of, its proportionate share of the requested
additional capital amount, the other Limited Partners shall have
the
option, for a period of fifteen (15) days next following the expiration
of
the applicable fifteen (15) day period, to contribute the remaining
balance of such requested additional capital amount on the terms
and
conditions set forth in the written notice, which option shall be
exercised by the delivery of written notice to the Partnership within
such
fifteen (15) day period, and to receive in exchange therefor the
Partnership Shares in the Partnership that otherwise would have been
issuable to the Limited Partner so declining or failing to contribute,
or
contributing less than all of, its proportionate share of the requested
additional capital amount. The General Partner shall determine the
fair
market value of the shares for purposes of determining how to allocate
the
number of Partnership Shares issuable to each Limited Partner in
consideration for its contribution of capital. If the General Partner
is
unable to determine the fair market value of the shares
(because, among other reasons, the members of the board of directors
of
the General Partner cannot agree on the fair market value of the
shares,
as that decision is not a decision over which the chairman of the
board
has a casting vote), the fair market value of the shares shall be
equal to
the amount determined in good faith by the contributing Limited Partner
if
such amount is equal to or greater than the most recent valuation
of such
Partnership Shares calculated by or on behalf of the Partnership
(the
“Most Recent Valuation”), or, if such amount is lower than the Most Recent
Valuation, then the fair market value shall be fixed as the average
of two
valuations made by impartial valuators (the “Independent Valuation”)
appointed by the Institute of State-Authorised Public Accountants
(in
Danish: Foreningen af Statsautoriserede Revisorer). Both valuators
shall
be recommended experts in valuation of biotech companies. The Independent
Valuation need not precede the contributions of capital, but shall
in any
case be initiated promptly following any contribution. Upon receipt
of any
additional capital from time to time contributed to it by a Limited
Partner pursuant to this Section 4.2, the General Partner is authorized
and directed,
if requested by such Limited Partner, to deliver a certificate, executed
on behalf of the Partnership by the General Partner, to such Limited
Partner evidencing the Partnership Shares acquired by such Limited
Partner
hereunder.
|
4.
|
LIABILITY
|
4.1
|
The
liability of the General Partner shall be personal and unlimited.
|
C.
|
The
liability of each Limited Partner shall be limited to such Limited
Partner's contribution to the Partnership. Thus, the liability of
MHA in
respect of the MHA Partnership Shares shall be limited to the contribution
described in clause 3.4 and the liability of Nordic in respect of
the
Nordic Partnership Shares shall be limited to the contribution described
in clause 3.5.
|
5.
|
ADMINISTRATION
OF THE PARTNERSHIP
|
D.
|
The
General Partner shall in its capacity as general partner be responsible
for the management and administration of the Partnership. In particular
the General Partner shall monitor and oversee the development and
commercialization activities with respect to the Assets.
|
E.
|
The
Partnership shall delegate the execution of certain of the General
Partner's obligations pursuant to this Agreement to MHA to the extent
set
out in the Services Agreement. For the avoidance of doubt, the General
Partner shall retain final power and authority in respect of all
decisions
regarding the Assets, including in respect of final development,
partnering and marketing decisions, and such authority shall not
be
limited by the previous sentence.
|
F.
|
The
General Partner shall at all times act in good faith and in the best
interest of the Partnership, shall use its best endeavours to ensure
the
safekeeping of the Partnership's assets and shall provide such services
and support to the Partnership as will ensure that the Partnership
is in
compliance with all applicable laws from time to
time.
|
III.
|
THE
GENERAL PARTNER
|
A.
|
The
General Partner is a Danish limited liability company, which has
been
established prior to Closing with the articles of association attached
hereto as Appendix
7.1.
|
B.
|
At
Closing the share capital of the General Partner is distributed between
the Limited Partners as follows (all amounts in
DKK):
|
Number of shares in the General Partner
|
|
Nordic
|
62,500
|
MHA
|
62,500
|
Total
|
125,000
|
C.
|
At
Closing the rights and obligations of the Limited Partners regarding
their
holdings of shares in the General Partner are set out in the shareholders'
agreement attached hereto as Appendix
7.3.
|
D.
|
The
share capital of the General Partner shall at all times be owned
by the
Limited Partners pro rata to their holdings of Partnership Shares.
At any
time that the relative
ownership of Partnership Shares by MHA and Nordic changes, including,
without limitation in accordance with the Put Option or the Call
Option,
the share capital of the General Partner shall be redistributed in
accordance with the previous sentence. Each of Nordic and MHA agrees
to
deliver any certificates evidencing its share capital in the General
Partner to the General Partner in furtherance of any such
redistribution.
|
IV.
|
MANAGEMENT
FEE
|
A.
|
In
consideration of the services to be provided under this Agreement
and the
liability as a general partner of the Partnership, the General Partner
shall receive a management fee of DKK 50,000
per year, payable in arrears in quarterly instalments beginning on
March
31, 2008 (prorated for the period from the Closing through March
31,
2008).
|
B.
|
If
the General Partner undertakes any of the services described in the
Services Agreement (as a result of termination of the Services Agreement),
the management fee shall be renegotiated and fixed at an amount which
covers the reasonable expenses of the General Partner related to
the
provision of its services to the Partnership after the termination
of the
Services Agreement
plus a reasonable profit.
|
V.
|
MEETINGS
OF THE PARTNERSHIP
|
A.
|
Every
year the General Partner shall convene an ordinary general meeting
in the
Partnership.
|
B.
|
Extraordinary
general meeting shall be held when deemed appropriate by the General
Partner. Furthermore an extraordinary general meeting shall be held
when
it is requested in writing by a Limited Partner for consideration
of a
specified proposal.
|
C.
|
The
notice convening general meetings shall be forwarded not earlier
than 20
Business Days and not later than 5 Business Days before the general
meeting and shall include the agenda for the general
meeting.
|
D.
|
At
the general meeting resolutions may exclusively be passed as to matters
which according to the Agreement or the articles of association of
the
Partnership are not under the purview of the General
Partner.
|
E.
|
The
ordinary general meeting shall be held in time for the audited and
approved annual report to be filed with the Danish Commerce and Companies
Agency no later than 5 months after the expiry of each accounting
year.
|
F.
|
The
agenda for the ordinary general meeting shall
include:
|
(i)
|
The
General Partner's presentation of the Partnership's activities during
the
past year.
|
(ii)
|
Presentation
of the audited annual report for
approval.
|
(iii)
|
Proposals,
if any, from the General Partner and/or the Limited
Partners.
|
G.
|
Each
Partnership Share of DKK 1,000 confers one vote at the general meeting.
|
H.
|
All
matters being dealt with at the general meeting shall be decided
by simple
majority. However, any amendment of the articles of association of
the
Partnership can only be made with the consent of the General Partner.
Resolutions may be passed or matters dealt with by written consent
in lieu
of votes taken at a meeting.
|
I.
|
The
General Partner shall elect the chairman of the general meeting.
The
chairman leads the discussions and decides on all questions relating
to
the procedure of the matters tried at the general meeting, the voting
and
its results.
|
J.
|
The
discussions at the general meeting shall be kept in a minute book
signed
by the chairman and the General
Partner.
|
6.
|
POWER
TO BIND THE PARTNERSHIP
|
K.
|
The
Partnership shall be bound by the signature of the General Partner,
such
signature to include the signatures of one member of the board of
directors of the General Partner appointed by Nordic, if any, and
one
member of the board of directors of the General Partner appointed
by MHA,
if any. No board member of the General Partner may refuse to sign
anything
authorized and directed by the board of directors of the General
Partner,
in accordance with the Shareholders Agreement, to be signed by the
General
Partner.
|
VI.
|
LIQUIDATION
AND TRADE SALE PREFERENCES
|
A.
|
In
the event of a dissolution of the Partnership whether in the form
of a
liquidation, bankruptcy or any other form of dissolution of the
Partnership the following shall apply as regards the respective rights
of
the Limited Partners to receive distribution of
proceeds:
|
(i)
|
Before
any distribution is made to Limited Partners other than the holder(s)
of
the Nordic Partnership Shares, an amount corresponding to (a) the
total
amount contributed to the Partnership by Nordic pursuant to clauses 3.5
and
3.6 with the addition of a compounded return calculated at the rate
of 10
percent per annum as from the time each such capital contribution
to the
Partnership has been made through the date of payment of distribution,
minus (b) distributions or
payments received by the holder(s) of the Nordic Partnership Shares
pursuant to clauses 13.1 and 13.2 hereof, shall be made to the holders
of
the Nordic Partnership Shares.
|
(ii)
|
From
any amount available for distribution in excess of the amount referred
to
under sub-clause 11.1 (i) the holder(s) of the MHA Partnership Shares
shall before any distribution is made to other Limited Partners be
entitled to receive an amount corresponding to the proceeds distributed
to
the holders of the Nordic Partnership Shares under sub-clause 11.1
(i).
|
(iii)
|
Any
amount available for distribution in excess of the amounts referred
to
under sub-clauses 11.1 (i) and (ii) shall be distributed among Limited
Partners on a pro rata basis according to their respective nominal
holdings of Partnership Shares.
|
B.
|
In
the event of a Trade Sale based on a sale of 100 percent of the
Partnership Shares the proceeds from such Trade Sale shall be distributed
among the Limited Partners in accordance with clause 11.1. In the
event of
a Trade Sale based on the sale or
license of all or substantially all assets of the Partnership,
each
Limited Partner shall be entitled to require that the Partnership
be
liquidated and the proceeds from such liquidation be distributed
among the
Limited Partners in accordance with clause
11.1.
|
C.
|
Except
as set forth in clause 11.2, the Partnership shall not be liquidated,
dissolved or wound up without the unanimous consent of the Limited
Partners and the General Partner. The proceeds from any liquidation,
dissolution, winding up or sale of all Partnership Shares shall be
distributed pursuant to clause
11.1.
|
VII.
|
PLEDGE
AND ASSIGNMENT OF PARTNERSHIP SHARES
|
A.
|
A
Party may not pledge or otherwise create or suffer the creation of
any
encumbrance or lien over all or any part of its Partnership Shares,
without the prior written consent of the General
Partner.
|
B.
|
Except
for a conversion of Partnership Shares taking place by exercise of
the
Call Option and/or the Put Option as described in the Joint Venture
Agreement, a Party may not sell, assign, issue put- or call-options,
transfer or otherwise dispose of all or any part of its Partnership
Shares
without observing the rules set out in clauses
12.3-12.5
|
C.
|
Permitted
Transfers
|
1.
|
The
transfer or other transmission of the Partnership Shares is subject
to the
rules set out in clauses 12.4-12.5,
provided that the Limited Partners shall be allowed to transfer their
Partnership Shares without observing these rules in the following
situations:
|
(i)
|
Each
Limited Partner shall be entitled to transfer its Partnership Shares
wholly or partly to an entity which is 100 percent owned and controlled
by
such Limited Partner, provided that the original Limited Partner
shall
remain liable for the assignee's performance of all of the original
Limited Partner's obligations under this Agreement and that the original
Limited Partner shall maintain a 100 percent direct ownership and
control
of such company as long as it owns Partnership
Shares.
|
(ii)
|
Nordic
shall be entitled to transfer its Partnership Shares to another investment
entity advised by its management company, Nordic Biotech Advisors
ApS
(company registration No 26123925), as well as to one or more of
the
limited partners in Nordic.
|
D.
|
Rights
of First Refusal
|
1.
|
Upon
any transfer of a Limited Partner's (referred to as the "Proposing
Transferor") Partnership Shares or any part thereof (referred to
as the
"Sale Shares"), whether by sale, gift, enforcement by creditors or
division of an estate, the other Limited Partner(s) shall have a
pre-emptive right to the Sale Shares offered for sale by the Proposing
Transferor – failing amicable agreement as to the price and
conditions for the transfer of such shares – at the price and on the
conditions at which the Proposing Transferor proposes to sell the
Sale
Shares to a independent third party (referred to as the "Proposing
Transferee"). The Proposing Transferee may not whether directly or
indirectly have any community of interests with the Proposing
Transferor.
|
2.
|
The
Proposing Transferor that wishes to dispose of Sale Shares in accordance
with clause 12.4.1 must offer such shares to the other Limited Partner(s)
by giving written notice (referred to as the "Transfer Notice") to
the
General Partner, who shall without undue delay and in any event within
5
Business Days pass on the Transfer Notice to the other Limited Partner(s).
The Transfer Notice shall include information as to the identity
of the
Proposing Transferee and must be accompanied by the offer from the
Proposing Transferee, including documentation to the effect that
the
Proposing Transferee is able to pay the purchase price and fulfil
any
other conditions of such offer.
|
3.
|
In
the event that the other Limited Partner(s) is(are) desirous of accepting
the offer, such Limited Partner(s) shall submit its(their) acceptance
in
writing addressed to the General Partner and such acceptance must
reach
the General Partner within 10 Business Days after the General Partner
having submitted the Transfer Notice to the other Limited
Partner(s).
|
4.
|
In
the event that an offer made in pursuance hereof is accepted by several
other Limited Partners in respect of a total share amount exceeding
the
share amount comprised in the Transfer Notice, the General Partner
shall
allot shares to each such Limited Partners in proportion as nearly
as may
be to the number of shares already held by the respective participating
Limited Partner. Not later than 5 Business Days after the expiry
of the
above-mentioned 10 Business Days time limit, the General Partner
shall
give notice to the Proposing Transferor stating whether the shares
comprised in the Transfer Notice have been taken up by the other
Limited
Partner(s) having a pre-emptive
right.
|
5.
|
Failing
the other Limited Partner's(s') acceptance to take up all of the
Sale
Shares proposed to be disposed of in the Transfer Notice, all the
Sale
Shares may be transferred to the Proposing Transferee at a price,
which is
not lower and on conditions not less strict than those offered to
the
other Limited Partner(s), provided that the transfer is executed
within 40
Business Days following expiry of the period, in which the offer
from the
Proposing Transferor may be accepted by the other Limited Partner(s).
After expiry of such 40 Business Days period, the Proposing Transferor
may
not sell such shares to the Proposing Transferee or any other third
party
without having offered such shares to the other Limited Partner(s)
according to the provisions of this clause
12.4.
|
E.
|
Tag-along
Right
|
F.
|
General
conditions
|
1.
|
A
transfer of Partnership Shares pursuant to clauses 12.3 or 12.4,
including
by way of enforcement by creditors or in any other way, as well as
a
transfer of Partnership Shares by exercise of part of the Call Option
or
Put Option, is conditional upon that simultaneously with such transfer
the
transferring party shall transfer such number of shares in the General
Partner to the transferee(s) that subsequent to the transfer of
Partnership Shares the share capital of the General Partner is owned
by
the holders of Partnership Shares pro rata to their holdings of
Partnership Shares.
|
2.
|
A
transfer of Partnership Shares pursuant to clause 12.3 or 12.4, including
by way of enforcement by creditors or in any other way, as well as
a
transfer of Partnership Shares by exercise of part of the Call Option
or
Put Option, is conditional upon the transferee(s) signing and adhering
to
this Agreement and the Shareholders' Agreement.
|
VIII.
|
DIVIDENDS
AND DISTRIBUTIONS
|
A.
|
Minimum
Distribution.
Within 45 days of the end of each fiscal year of the Partnership,
the
General Partner shall determine
the amount of available cash from operations to be distributed (the
“Distributable Amount”). The General Partner shall authorize and
distribute
(1) a “Minimum Distribution” to Nordic equal to
the greater of (i) 6% of Net Sales (as such term is defined in that
certain Exclusive License Agreement for “Hedrin” among Thornton &
Ross, Ltd., Kerris, S.A. and Manhattan Pharmaceuticals, Inc., dated
June
26, 2007, as such Exclusive License Agreement may be amended and/or
restated from time to time (the “License Agreement”)) for such fiscal
year, as such amount may be reduced in accordance with clause 13.3
(the
“Nordic Royalty”), and (ii) Nordic’s pro rata share of the Distributable
Amount, and (2) an amount to MHA equal to the Distributable Amount
minus
the Minimum Distribution. To the extent Nordic has received one or
more
License Payments for such fiscal year, the Minimum Distribution shall
be
reduced by the amount of such License
Payments.
|
B.
|
In
all events, the General Partner shall, to the extent not prohibited
by
law, authorize and distribute a distribution,
allocated among the Limited Partners pro
rata in accordance with their Partnership Shares, that will at least
cover
the tax liability of each Limited Partner arising from the net income
of
the Partnership.
|
C.
|
To
the extent Nordic’s percentage ownership of Partnership Shares changes,
the percentage set forth in clause 13.1(1)(i) shall be changed in
the same
proportion as the amount of the change of Nordic’s percentage ownership.
For the avoidance of doubt, if Nordic’s percentage ownership of
Partnership Shares decreases from 50% to 20%, the Nordic Royalty
shall be
reduced from 6% to 2.4% of Net
Sales.
|
7.
|
AUDITOR
|
D.
|
The
auditor of the Partnership shall be a Danish member of an internationally
recognised accounting group.
|
E.
|
The
auditor is elected by
the General Partner for 1 year at a time.
Re-election may take place.
|
8.
|
NON-COMPETITION
|
F.
|
During
the term of this Agreement none of the Limited Partners are entitled
to
start up, acquire, engage in, or in any other way directly or indirectly
participate in any activity or business which competes fully or partly
with the activities of the Partnership relating to the development
or
commercialization of the Assets within North America, in the field
of
treating lice infestations in human beings, unless written consent
thereto
is granted by the other Limited
Partner(s).
|
9.
|
CONFIDENTIALITY
|
9.1
|
The
Parties shall keep as confidential any information they may obtain
on the
business and activities of the Partnership as a consequence of the
Limited
Partners' joint ownership of the Partnership and neither the conditions
for any of the Limited Partners' investment in the Partnership nor
the
conditions included in this Agreement shall be disclosed publicly
or
privately, except (i) otherwise agreed between the Parties, (ii)
where
such disclosure is required to be given by law, a court of competent
jurisdiction, a stock ex-change or any administrative, regulatory
or
governmental authority or body, (iii) where the information was available
in the public at the time of disclosure, (iv) becomes available to
the
general public other than as a result of any non-compliance with
this
clause 16.1, (v) is provided to the disclosing Party by a third party
who
is lawfully in possession of such information and has a lawful right
to
disclose it, or (vi) was independently developed by the disclosing
Party.
|
9.2
|
Notwithstanding
clause 16.1, Nordic shall always be entitled to provide such information
to its limited partners about the Partnership as required from time
to
time by Nordic under its limited partnership
agreement.
|
IX.
|
VALUE
ADDED TAX - TAXES
|
A.
|
All
amounts payable pursuant to this Agreement shall, unless otherwise
stated,
be exclusive of any VAT.
|
B.
|
The
Partnership shall be responsible for any VAT and other taxes which
may be
payable on services acquired by the Partnership.
|
C.
|
The
Parties shall fully account for their own taxes and VAT (if any)
arising
out of distributions from the
Partnership.
|
10.
|
EXCULPATION
AND INDEMNITIES
|
D.
|
No
director, officer, employee, agent, advisor or shareholder of the
General
Partner shall have any liability for any loss to the Partnership
or to the
Limited Partners arising in connection with services or duties performed
or to be performed by the General Partner pursuant to or resulting
from
this Agreement, except in respect of any matter resulting from such
person's gross negligence or willful misconduct towards any obligation
or
duty such person has or may have in relation to the services performed
or
to be performed by the General Partner pursuant to or resulting from
this
Agreement.
|
E.
|
The
Partnership shall indemnify any director, officer, employee, agent,
advisor or shareholder of the General Partner against any claim raised
by
a third party in connection with services or duties performed or
to be
performed by the General Partner pursuant to or resulting from this
Agreement, except in respect of any matter resulting from such person’s
gross negligence or willful misconduct towards any obligation or
duty such
person has or may have in relation to the services performed or to
be
performed by the General Partner pursuant to or resulting from this
Agreement.
|
X.
|
AMENDMENT
OF THE AGREEMENT
|
A.
|
The
Agreement can only be amended with the written consent of all
Parties.
|
B.
|
The
Agreement is non-terminable, except as agreed to by all
Parties.
|
XI.
|
NOTICES
|
A.
|
All
notices between the Parties under this Agreement shall be sent by
(i)
registered mail, or (ii) email or fax to be confirmed by ordinary
letter
within 48 hours after transmission to the following addresses,
email and
fax numbers, unless these subsequently are changed to another address,
email of fax with a notice of at least 3 Business
Days:
|
Nordic:
|
Nordic
Biotech Venture Fund II K/S
|
c/o
Nordic Biotech Advisors ApS
|
|
Østergade
5, 3rd floor
|
|
DK-1100
Copenhagen K
|
|
Denmark
|
|
Fax
+45 70 20 12 64
|
|
E-mail:
fs@nordic-biotech.com
|
|
Attn.:
Florian Schönharting
|
|
With
a copy to: John M. Barberich
|
|
Email:
jmb@nordicbiotech.com
|
|
MHA:
|
Manhattan
Pharmaceuticals, Inc.
|
810
Seventh Avenue, 4th Floor
|
|
New
York, NY 10019
|
|
Fax:
(212) 582-3957
|
|
Attn:
Chief Financial Officer
|
|
Email:
mgmcguinness@manhattanpharma.com
|
|
General
Partner:
|
Hedrin
Pharmaceuticals General Partner ApS
|
Østergade
5, 3rd floor
|
|
DK-1100
Copenhagen K
|
|
Denmark
|
|
Fax
+45 70 20 12 64
|
|
E-mail:
fs@nordic-biotech.com
|
|
Attn.:
Florian Schönharting
|
|
and
|
|
810
Seventh Avenue, 4th Floor
|
|
New
York, NY 10019
|
|
Fax:
(212) 582-3957
|
|
Attn:
Chief Financial Officer
|
|
Email:
mgmcguinness@manhattanpharma.com
|
11.
|
GOVERNING
LAW AND JURISDICTION
|
B.
|
This
Agreement shall be governed by and construed in accordance with Danish
law.
|
C.
|
Each
Party hereby irrevocably submits to the exclusive
jurisdiction of the federal and state courts sitting in the state
of New
York in any action or proceeding arising out of or relating to this
Agreement. Each Party hereby irrevocably agrees, on behalf of itself
and
on behalf of such Party’s successors and permitted assigns, that all
claims in respect of such action or proceeding shall be heard and
determined in any such court and irrevocably waives any objection
such
person may now or hereafter have as to the venue of any such suit,
action
or proceeding brought in such a court or that such court is an
inconvenient forum.
|
XII.
|
LICENSE
|
A.
|
The
General Partner and the Parties agree that any agreement entered
into by
the Partnership with respect to the Assets or the License Agreement,
including, without limitation, a sublicense agreement or other agreement
by which a third party (a “Licensee”) contracts to sell or otherwise
commercialize the Assets, shall include, at Nordic’s option, a provision
by which the Licensee agrees to pay a portion of the consideration
payable
by such Licensee equal to the Nordic Royalty directly to Nordic (the
“License Payment”). Nordic shall agree in any such agreement to provide
notice of changes to the Nordic Royalty to any Licensee promptly
as they
occur.
|
/s/
Christian Hansen
|
||
/s/
Florian Schonharting
|
||
Name:
Christian Hansen
|
Name:
Florian Schonharting
|
|
Title:
Partner
|
VEDTÆGTER
for
[Hedrin
Pharmaceuticals K/S]
|
ARTICLES
OF ASSOCIATION
of
[Hedrin
Pharmaceuticals K/S]
(Translation
of official Danish language version in left-hand
column)
|
||
1.
|
SELSKABETS
NAVN
|
NAME
|
|
1.1
|
Selskabets
navn er [Hedrin
Pharmaceuticals K/S].
|
The
name of the company is [Hedrin Pharmaceuticals K/S].
|
|
2.
|
HJEMSTED
|
REGISTERED
OFFICE
|
|
2.1
|
Selskabets
hjemsted er Københavns Kommune.
|
The
registered office of the company is in the municipality of
Copenhagen.
|
|
3.
|
FORMÅL
|
OBJECTS
|
|
3.1
|
Det
er selskabets formål at eje, udvikle og kommercialisere medicinske
produkter.
|
The
object of the company is to acquire,
develop and commercialize medical products.
|
|
4
|
SELSKABETS
KAPITAL
|
SHARE
CAPITAL
|
|
4.1
|
Selskabets
kapital udgør DKK 2.000.000 fordelt på 2.000 kommandit-anparter a DKK
1.000.
|
The
capital of the company is DKK 2,000,000 divided into 2,000 limited
partnership shares of DKK 1,000.
|
|
4.2
|
Ved
tegning eller anden erhvervelse af kommanditanparter skal enhver
kommanditist underskrive eller på anden måde tiltræde den gældende
kommanditselskabsaftale.
|
At
subscription or any other acquisition of limited partnership
shares any
limited partner shall sign or in other ways accede to the applicable
limited partnership agreement.
|
|
4.3
|
Selskabets
kapital er ikke indbetalt ved stiftelsen, men skal under visse
betingelser
som nærmere beskrevet i kommanditselskabsaftalen indbetales af
kommanditisterne. Indbetalingen kan foretages som kontantindskud
og som
apportindskud.
|
The
share capital of the company has not been paid in at the foundation,
but
shall under certain conditions specified in the limited partnership
agreement be paid in by the limited partners. The payment may
take place
in cash and by contribution in kind.
|
|
4.4
|
Komplementaren
har ingen ejerandel i selskabet.
|
The
general partner has no ownership share in the
company.
|
5.
|
HÆFTELSE
|
LIABILITY
|
|
5.1
|
Komplementaren
hæfter personligt og ubegrænset for selskabets
forpligtelser.
|
The
general partner is subject to personal and unlimited liability
for all
obligations of the company.
|
|
5.2
|
Selskabets
øvrige deltagere er kommanditister, som hæfter indirekte og solidarisk for
selskabets forpligtelser, dog således at den enkelte kommanditists
hæftelse er begrænset til dennes til enhver tid værende indskud i
selskabet.
|
The
other participants of the company are limited partners, who shall
have
indirect, joint and several liability for the obligations of
the company,
however the liability of the individual limited partner shall
be limited
to such
limited partner's contribution to the company at the time in
question.
|
|
6.
|
GENERALFORSAMLINGER
|
GENERAL
MEETINGS
|
|
6.1
|
Komplementaren
skal hvert år indkalde til en ordinær generalforsamling i
selskabet.
|
Every
year the general partner shall convene an ordinary general meeting
in the
company.
|
|
6.2
|
Ekstraordinær
generalforsamling skal afholdes, når komplementaren finder anledning
hertil. Endvidere skal komplementaren indkalde til ekstraordinær
generalforsamling, såfremt en af kommanditister fremsætter skriftlig
anmodning herom med angivelse af de forslag, som de pågældende
kommanditister ønsker behandlet.
|
Extraordinary
general meeting shall be held when deemed appropriate by the
general
partner. Furthermore extraordinary general meeting shall be held
when it
is requested in writing by a limited partner for consideration
of a
specified proposal.
|
|
6.3
|
Skriftlig
indkaldelse til såvel ekstraordinær som ordinær generalforsamling skal ske
med mindst 5 hverdages og højst 20 hverdages varsel. Indkaldelsen skal
indeholde dagsordenen for generalforsamlingen og en beskrivelse
af
dagsordenens væsentlige punkter.
|
The
notice convening general meetings shall be forwarded not earlier
than 20
business days and not later than 5 business days before the general
meeting and shall include the agenda for the general meeting
and
particulars of important items on the agenda.
|
|
6.4
|
På
generalforsamlingen kan alene træffes beslutning om forhold, som ikke
ifølge den for selskabet gældende kommanditselskabsaftale eller selskabets
vedtægter henhører under komplementaren.
|
At
the general meeting resolutions may exclusively be passed as
to matters
which according to the applicable limited partnership agreement
or the
company’s articles of association are not under the purview of the general
partner.
|
|
6.5
|
Den
ordinære generalforsamling skal afholdes i så god tid, at selskabets
reviderede og godkendte årsrapport kan indsendes til Erhvervs- og
Selskabsstyrelsen, så den er modtaget i styrelsen inden 5 måneder efter
udløbet af hvert regnskabsår.
|
The
ordinary general meeting shall be held in time for the audited
and
approved annual accounts to be filed with the Danish Commerce
and
Companies Agency no later than 5 months after the expiry of each
accounting year.
|
6.6
|
Dagsordenen
for den ordinære generalforsamling skal omfatte:
1. Komplementarens
beretning om selskabets
virksomhed i det forløbne år.
2. Fremlæggelse
af revideret årsrapport til
godkendelse.
3. Eventuelle
forslag fremsat af komplementaren
og/eller kommanditisterne.
|
The
agenda for the ordinary general meeting shall include:
1. The
general partner's presentation of the
company's
activities during the past year.
2. Presentation
of the audited annual accounts
for approval.
3. Proposals,
if any, from the general partner
and/or the limited partners.
|
|
6.7
|
Ved
afstemninger på generalforsamlingen giver hvert kommanditandel, én stemme.
|
Each
Share confers one vote at the general meeting.
|
|
6.8
|
Alle
beslutninger på generalforsamlingen vedtages med simpelt stemmeflertal,
idet beslutning om ændring af selskabets vedtægter dog kun er gyldig,
såfremt den tiltrædes af komplementaren.
|
All
matters being dealt with at the general meeting shall be decided
by simple
majority. However, any amendment of the company's articles of
association
can only be made with the consent of the general
partner.
|
|
6.9
|
Generalforsamlingen
ledes af en dirigent valgt af komplementaren.
|
The
general partner shall elect the chairman of the general meeting.
|
|
6.10
|
Dirigenten
leder forhandlingerne og afgør alle spørgsmål vedrørende sagernes
behandlingsmåde, stemmeafgivningen og dennes resultater.
|
The
chairman leads the discussions and decides on all questions relating
to
the procedure of the matters tried at the general meeting, the
voting and
its results.
|
|
6.11
|
Over
forhandlingerne på generalforsamlingen føres en protokol, der underskrives
af dirigenten og komplementaren.
|
The
discussions at the general meeting shall be kept in a minute
book signed
by the chairman and the general partner.
|
|
7.
|
ANPARTSOVERGANG
|
TRANSFER
OF SHARES
|
|
7.1
|
Overdragelse
og anden retsovergang af kommanditanparter er kun gyldig, når dette sker i
overensstemmelse med kommanditselskabsaftalen, og når selskabet efter
anmeldelse af ejerskiftet har bekræftet dets gyldighed.
|
Any
transfer of limited partnership shares shall only be valid when
such
transfer takes place in accordance with the limited partnership
agreement,
and when the company after receipt of notification of the change
of
ownership has confirmed its
validity.
|
8.
|
SELSKABETS
LEDELSE
|
MANAGEMENT
OF THE COMPANY
|
|
8.1
|
Selskabet
ledes af komplementaren, der dog er berettiget til at lade tredjemand
udføre drifts- og ledelsesmæssige opgaver på komplementarens vegne og på
komplementarens ansvar, i det omfang dette er tilladt efter
kommanditselskabsaftalen.
|
The
company is managed by the general partner who shall, however,
be entitled
to appoint a third party to perform its operational and management
tasks
on behalf of the general partner and on the general partner's
responsibility to the extent permitted by the limited partnership
agreement.
|
|
Som
vederlag for de ydelser, som skal leveres i henhold til
kommanditselskabsaftalen og hæftelsen som komplementar, skal
komplementaren modtage et årligt management fee på 50.000 eller et sådant
andet beløb, som måtte blive besluttet i henhold til
kommanditselskabsaftalen.
|
In
consideration of the services to be provided under the limited
partnership
agreement and the liability as a general partner of the company,
the
general partner shall receive a management fee of DKK 50,000
per year or
such other amount as may be decided pursuant to the limited partnership
agreement.
|
||
9.
|
FORDELING
OG UDLODNING AF SELSKABETS RESULTAT
|
DISTRIBUTION
AND ALLOCATION OF THE COMPANY’S RESULT
|
|
9.1
|
Fordeling
og udlodning af selskabets resultat sker som bestemt i
kommanditselskabsaftalen.
|
Distribution
and allocation of the company’s result shall take place as set out in the
limited partnership agreement.
|
|
10.
|
TEGNINGSREGEL
|
POWER
TO BIND THE COMPANY
|
|
10.1
|
Selskabet
tegnes af komplementaren. Komplementarens
tegningsregel skal kræve underskrift af mindst to medlemmer af
komplementarens bestyrelse.
|
The
company shall be bound by the signature of the general partner.
The rules
of signature of the general partner shall require signature by
at least
two members of the board of directors of the general partner.
|
|
11.
|
REVISOR
|
AUDITOR
|
|
11.1
|
Selskabets
regnskaber revideres af en statsautoriseret revisor. Revisor
vælges af
komplementaren på den ordinære generalforsamling for ét år ad gangen med
mulighed for genvalg.
|
The
company’s accounts shall be audited by a state-authorised public
accountant. The auditor shall be elected by the general partner
at the
ordinary general meeting for 1 year at a time. Re-election may
take
place.
|
12.
|
REGNSKABSÅR
|
FINANCIAL
YEAR
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12.1
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Selskabets
regnskabsår løber fra 1. januar til 31. december.
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The
financial year of the company is 1 January to 31
December.
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12.2
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Selskabets
første regnskabsår løber fra stiftelsen til den 31. december
2008.
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The
first accounting year of the company is from the foundation until
31
December 2008.
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*
*
*
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*
*
*
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||
Således
vedtaget ved selskabets stiftelse den 2008
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As
adopted at the foundation of the company on
2008
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VEDTÆGTER
for
[Hedrin
Pharmaceuticals General
Partner ApS]
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ARTICLES
OF ASSOCIATION
of
[Hedrin
Pharmaceuticals General
Partner ApS]
(Translation
of official Danish language version in left-hand
column)
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1.
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NAVN
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NAME
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1.1
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Selskabets
navn er [Hedrin Pharmaceuticals General Partner ApS].
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The
name of the company is [Hedrin
Pharmaceuticals General Partner ApS].
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2.
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HJEMSTED
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REGISTERED
OFFICE
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2.1
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Selskabets
hjemsted er i Københavns Kommune.
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The
registered office of the company
is in the municipality of Copenhagen.
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3.
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FORMÅL
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OBJECTS
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3.1
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Selskabets
formål er at være komplementar i [Hedrin Pharmaceuticals
K/S].
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The
object of the company is to be general partner of [Hedrin
Pharmaceuticals K/S].
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4.
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ANPARTSKAPITAL
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SHARE
CAPITAL
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4.1
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Selskabets
anpartskapital udgør DKK 125.000 fordelt på anparter à DKK
1.
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The
share capital of the company is DKK 125,000 divided into shares
of DKK
1.
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4.2
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Anparterne
er undergivet visse begrænsninger i den indgåede
anpartshaveroverenskomst.
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The
shares are subject to and comprised
by certain restrictions in the entered into shareholders'
agreement.
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5.
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ANPARTSOVERGANG
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TRANSFER
OF SHARES
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Overdragelse
og anden retsovergang af selskabets anparter kan alene ske i
overensstemmelse med den indgåede
anpartshaveroverenskomst.
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Any
transfer and other assignment of the company's shares may only
take place
be in accordance with the shareholders' agreement entered
into.
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6.
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GENERALFORSAMLINGER
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GENERAL
MEETINGS
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6.1
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Generalforsamlingen
har den højeste myndighed i alle selskabets anliggender inden for de i
lovgivningen og nærværende vedtægter fastsatte grænser.
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The
general meeting of shareholders
has the supreme authority in all matters pertaining to the company
subject
to the limitations established by law and these articles of
association.
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6.2
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Selskabets
generalforsamling skal afholdes på selskabets hjemsted eller andetsteds i
Region Hovedstaden. Den ordinære generalforsamling skal afholdes hvert år
i så god tid, at den reviderede og godkendte årsrapport kan indsendes til
Erhvervs- og Selskabsstyrelsen, så den er modtaget i styrelsen inden 5
måneder efter udløbet af hvert regnskabsår.
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General
meetings shall be held at the registered office of the company
or elsewhere in the Capital Region of Denmark. The annual general
meeting
shall be held in time for the audited and adopted annual report
to be
received by the Danish Commerce and Companies Agency (Erhvervs-
og
Selskabsstyrelsen) within five months after expiry of the financial
year.
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6.3
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Dagsordenen
for den ordinære generalforsamling skal omfatte:
1. Valg
af dirigent.
2. Forelæggelse
af årsrapport med revisionspåtegning
til godkendelse.
3. Beslutning
om anvendelse af overskud eller
dækning af tab i henhold til den godkendte
årsrapport
4. Eventuelle
forslag fra bestyrelse eller anpartshavere.
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The
agenda for the ordinary general
meeting shall include:
1. Election
of chairman of the meeting.
2. Presentation
of the annual report with the
auditor's
report for approval.
3. Decision
on allocation of profit or the cover
of losses according to the approved annual
report.
4. Proposals,
if any, from the board of
directors or the shareholders.
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6.4
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På
generalforsamlingen giver hver anpart én stemme.
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Each
share carries one vote at the general meeting.
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7.
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SELSKABETS
LEDELSE
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MANAGEMENT
OF THE COMPANY
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7.1
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Selskabet
ledes af en bestyrelse på én til fem medlemmer valgt af
generalforsamlingen.
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The
board of directors shall consist
of one to five directors appointed by the general meeting in
accordance
with the shareholders agreement.
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7.2
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Selskabet
har ingen direktion.
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The
company has no board of management.
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8.
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TEGNINGSREGEL
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POWER
TO BIND THE COMPANY
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Selskabet
tegnes af 2 bestyrelsesmedlemmer i forening.
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The
company is bound by the joint signatures
of 2 directors.
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9.
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REVISOR
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AUDITOR
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9.1
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Selskabets
regnskaber revideres af en af generalforsamlingen valgt statsautoriseret
revisor.
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The
company’s accounts shall be audited by a state-authorised public
accountant elected by the general meeting.
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10.
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REGNSKABSÅR
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FINANCIAL
YEAR
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10.1
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Selskabets
regnskabsår løber fra 1. januar til 31. december.
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The
financial year of the company is 1 January to 31
December.
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10.2
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Selskabets
første regnskabsår løber fra stiftelsen til den 31. december
2008.
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The
first accounting year of the company is from the foundation until
31
December 2008.
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11.
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BEMYNDIGELSE
TIL EKSTRAORDINÆR UDBYTTEUDDELING
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AUTHORIZATION
FOR PAYMENT
OF EXTRAORDINARY DIVIDENS
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11.1
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Bestyrelsen
er bemyndiget til efter aflæggelsen af selskabets første årsrapport at
træffe beslutning om uddeling af ekstraordinært udbytte, jf.
anpartsselskabslovens § 44a. Bemyndigelsen er ikke tidsbegrænset.
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The
board of directors is authorized
to pay extraordinary dividends after the submission of the company's
first
annual report, cf. Section 44a of the Danish Private Companies
Act. The
authorization is not limited in time.
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Således
vedtaget i forbindelse med stiftelsen.
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As
adopted at the foundation.
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Dato:
[*.] 2008
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Date:
[*] 2008
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Number of Partnership Shares
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Nordic
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700
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MHA
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700
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General
Partner
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0
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Total
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1,400
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Number of Partnership Shares
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||||
Nordic
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1,000
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MHA
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1,000
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General
Partner
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0
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Total
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2,000
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Number of Partnership Shares
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||||
Nordic
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700
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MHA
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300
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General
Partner
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0
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Total
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1,000
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MANHATTAN
PHARMACEUTICALS, INC.
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By:
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/s/
Douglas Abel
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Name:
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/s/
Douglas Abel
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Title:
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President
and Chief Executive Officer
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NORDIC:
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NORDIC
BIOTECH VENTURE FUND II K/S
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By:
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/s/
Florian Schonharting
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Florian
Schonharting, Partner
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/s/
Christian Hansen
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Christian
Hansen, Partner
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By:
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/s/
Florian Schonharting
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By:
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/s/
Douglas Abel
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Florian Schonharting, Director |
Douglas
Abel, Director
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By:
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Florian
Schonharting
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By:
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/s/
Douglas Abel
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Florian
Schonharting, Director
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Douglas
Abel, Director
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Re: |
Registration
Rights Agreement Issues
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Very
truly yours,
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MANHATTAN
PHARMACEUTICALS, INC.
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By:
/s/ Michael McGuinness
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Its:
Chief Operating and Financial
Officer
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ACCEPTED
AND AGREED TO:
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NORDIC
BIOTECH VENTURE FUND II K/S
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By:
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/s/
Christian Hansen
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Name:
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Christian
Hansen
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Title:
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Partner
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By:
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/s/
Florian Schonharting
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Name:
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Florian
Schonharting
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Title:
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Partner
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cc: |
Jennifer
Riegel
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1.
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It
appears that you have not filed copies of all of the exhibits to
the joint
venture agreement. Please be aware that when you file an agreement
pursuant to Item 601(b)(10) of Regulation S-K, you are required to
file
the entire agreement, including all exhibits, schedules, appendices
and
any document which is incorporated in the agreement. Please amend
your
registration statement to provide a copy of the full and complete
joint
venture agreement, including any exhibits, schedules and appendices
which
are included in the agreement. We may have further comments upon
reviewing
the full and complete
agreement.
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2.
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In
connection with the put right, please revise your registration statement
throughout to register only the resale of up to 17,857,143 shares
underlying the put of Nordic’s current investment in the joint venture
which appears to be $2.5 million. Given the contingency regarding
FDA
approval occurring as to the second $2.5 million investment by Nordic
in
the joint venture, and that the put right as to those shares does
not
currently and may never actually exist, it is premature to register
the
resale of shares underlying that put
right.
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The
Company has revised the Registration Statement to register the resale
of
shares of common stock, par value $.001 per share, of the Company
(the
"Common Stock") underlying the put, and not the call, of the current
investment of Nordic in Hedrin K/S, as more particularly described
herein.
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3.
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In
connection with the call right, we note that Nordic has the right
to
refuse the call and pay a cash amount to you. Since the call right
provides that Nordic has a decision to either pay cash or exchange
its
interest in the joint venture for shares of your common stock, it
appears
that the registration of the common shares underlying the call option
is
premature. Please amend your registration statement to remove these
shares.
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The
Company has revised the Registration Statement to remove from registration
the resale of all of the shares of Common Stock underlying the Company's
right to call all or any portion of Nordic's equity interest in Hedrin
K/S.
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