(Mark One) | |
x |
REGISTRATION
STATEMENT
PURSUANT TO SECTION 12(b) OR (g)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
|
|
o |
ANNUAL REPORT
PURSUANT TO
SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended ______________ | |
OR
|
|
o |
TRANSITIONAL
REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF
1934
|
Page
|
|||
SPECIAL
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
|
2
|
||
PART
I
|
|||
ITEM
1
|
Identity
of Directors, Senior Management and Advisers
|
3
|
|
ITEM
2
|
Offer
Statistics And Expected Timetable
|
3
|
|
ITEM
3
|
Key
Information
|
4
|
|
ITEM
4
|
Information
on the Company
|
19
|
|
ITEM
5
|
Operating
and Financial Review and Prospects
|
34
|
|
ITEM
6
|
Directors,
Senior Management and Employees
|
48
|
|
ITEM
7
|
Major
Shareholders and Related Party Transactions
|
57
|
|
ITEM
8
|
Financial
Information
|
57
|
|
ITEM
9
|
The
Offer and Listing
|
59
|
|
ITEM
10
|
Additional
Information
|
60
|
|
ITEM
11
|
Quantitative
And Qualitative Disclosures About Market Risk
|
79
|
|
ITEM
12
|
Description
of Securities other than Equity Securities
|
80
|
|
PART
II
|
|||
ITEM
13
|
Defaults,
Dividend Arrearages and Delinquencies
|
85
|
|
ITEM
14
|
Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
85
|
|
ITEM
15
|
Controls
and Procedures
|
85
|
|
ITEM
16
|
Reserved
|
85
|
|
ITEM
16A
|
Audit
Committee Financial Expert
|
85
|
|
ITEM
16B
|
Code
of Ethics
|
85
|
|
ITEM
16C
|
Principal
Accountant Fees And Services
|
85
|
|
ITEM
16D
|
Exemptions
From The Listing Standards For Audit Committees
|
85
|
ITEM
16E
|
Purchases
Of Equity Securities By The Issuer And Affiliated Purchasers
|
85
|
PART
III
|
|||
ITEM
17
|
Financial
Statements
|
86
|
|
ITEM
18
|
Financial
Statements
|
86
|
ITEM
19
|
Exhibits
|
86
|
SIGNATURES
|
|
87
|
Name
1
|
Age
|
Position
|
||
Michael
S. Weiss
2
|
39
|
Chairman
of the Board of Directors
|
||
William
J. Kennedy, Ph.D
|
60
|
Non
Executive Director
|
||
Ido
Seltenreich
|
33
|
Non
Executive Director
3
|
||
Vered
Shany, D.M.D
|
40
|
Non
Executive Director
3
|
||
Jonathan
R. Spicehandler, M.D
4
|
56
|
Non
executive Director
|
||
Ben
Zion Weiner, Ph.D
5
|
61
|
Non
executive Director
|
||
Jonathan
Burgin
|
44
|
Chief
Financial Officer
|
||
Shlomo
Dagan, Ph.D
|
54
|
Chief
Scientific Officer
|
1
|
Unless
otherwise indicated, the business address for such director or
officer is
at the Company’s headquarters: XTL Biopharmaceuticals Ltd., Kiryat
Weizmann Science Park, 3 Hasapir Street, Building 3, PO Box 370,
Rehovot
76100, Israel.
|
2
|
Mr.
Weiss’s business address is c/o Keryx Biopharmaceuticals, Inc., 750
Lexington Avenue, 20
th
Floor, New York, New York 10022,
U.S.A.
|
3
|
Designated
as an External Director under the Israeli Companies
Act.
|
4
|
Dr.
Spicehandler’s business address is c/o Schering-Plough Research Institute,
2000 Galloping Hill Road, Kenilworth, NJ 07033,
U.S.A.
|
5
|
Dr.
Weiner’s business address is c/o Teva Pharmaceutical Industries Ltd.,
5
Basel St. Petah-Tikva 49131,
Israel.
|
As
of December
31,
|
||||||||||||||||
2004
|
|
2003
|
|
2002
|
|
2001
|
|
2000
|
||||||||
(in
thousands)
|
||||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank
deposits
and
marketable securities |
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
$
|
52,188
|
$
|
64,969
|
||||||
Working
capital
|
20,240
|
19,967
|
33,396
|
50,433
|
53,752
|
|||||||||||
Total
assets
|
25,624
|
24,853
|
38,423
|
55,106
|
67,876
|
|||||||||||
Long-term
obligations
|
2,489
|
1,244
|
1,017
|
526
|
707
|
|||||||||||
Total
shareholders’ equity
|
19,602
|
20,608
|
34,830
|
51,953
|
64,586
|
December
31, 2004
|
||||
(in
thousands)
|
||||
Shareholders’
equity
|
||||
Ordinary
shares, par value NIS 0.02, 300,000,000 shares authorized,
168,079,196 shares issued and outstanding
|
$
|
841
|
||
Additional
paid-in capital
|
104,537*
|
|||
Deferred
share-based compensation
|
—*
|
|||
Deficit
accumulated during the development stage
|
(85,776
|
)
|
||
Total
shareholders’ equity
|
19,602
|
|||
Total
capitalization
|
$
|
19,602
|
||
* Reclassified |
· |
assist
us in developing, testing and obtaining regulatory approval for
some of
our compounds and technologies;
|
· |
manufacture
our drug candidates; and
|
· |
market
and distribute our products.
|
· |
perceptions
by members of the health care community, including physicians,
of the
safety and efficacy of our products;
|
· |
the
rates of adoption of our products by medical practitioners and
the target
populations for our products;
|
· |
the
potential advantages that our products offer over existing treatment
methods or other products that may be developed;
|
· |
the
cost-effectiveness of our products relative to competing products;
|
· |
the
availability of government or third-party payor reimbursement for
our
products;
|
· |
the
side effects or unfavorable publicity concerning our products or
similar
products; and
|
· |
the
effectiveness of our sales, marketing and distribution efforts.
|
· |
difficulty
and expense of assimilating the operations, technology and personnel
of
the acquired business;
|
· |
our
inability to retain the management, key personnel and other employees
of
the acquired business;
|
· |
our
inability to maintain the acquired company’s relationship with key third
parties, such as alliance partners;
|
· |
exposure
to legal claims for activities of the acquired business prior to
the
acquisition;
|
· |
the
diversion of our management’s attention from our core business; and
|
· |
the
potential impairment of substantial goodwill and write-off of in-process
research and development costs, adversely affecting our reported
results
of operations.
|
· |
decreased
demand for a product;
|
· |
injury
to our reputation;
|
· |
inability
to continue to develop a drug candidate or technology;
|
· |
withdrawal
of clinical trial volunteers; and
|
· |
loss
of revenues.
|
· |
the
progress of our development activities;
|
· |
the
progress of our research activities;
|
· |
the
number and scope of our development programs;
|
· |
our
ability to establish and maintain current and new licensing or
acquisition
arrangements;
|
· |
our
ability to achieve our milestones under our licensing arrangements;
|
· |
the
costs involved in enforcing patent claims and other intellectual
property
rights; and
|
· |
the
costs and timing of regulatory approvals.
|
· |
developments
concerning our drug candidates;
|
· |
announcements
of technological innovations by us or our competitors;
|
· |
introductions
or announcements of new products by us or our competitors;
|
· |
announcements
by us of significant acquisitions, strategic partnerships, joint
ventures
or capital commitments;
|
· |
changes
in financial estimates by securities analysts;
|
· |
actual
or anticipated variations in interim operating results;
|
· |
expiration
or termination of licenses, research contracts or other collaboration
agreements;
|
· |
conditions
or trends in the regulatory climate and the biotechnology and
pharmaceutical industries;
|
· |
changes
in the market valuations of similar companies; and
|
· |
additions
or departures of key personnel.
|
· |
there
is a limitation on acquisition of any level of control of the company;
or
|
· |
the
acquisition of any level of control requires the purchaser to do
so by
means of a tender offer to the
public.
|
· |
HepeX-B
is
being developed to prevent re-infection with hepatitis B, known
as HBV, in
liver transplant patients. HepeX-B is a mixture of two fully human
monoclonal antibodies, which bind to the HBV surface antigen, or
HBsAg.
HepeX-B was recently studied in a Phase IIb trial in liver transplant
patients. In August 2005, we announced that the dosing portion
of the
study ended. Worldwide rights for HepeX-B were licensed to Cubist
in 2004,
in exchange for certain milestone payments and future royalties
on
Cubist’s net sales. Cubist plans to review data from this trial with the
FDA as part of a discussion of design elements of a Phase III clinical
trial.
|
· |
XTL-6865
is
being developed to prevent hepatitis C, known as HCV, re-infection
following a liver transplant and for the treatment of chronic HCV.
XTL-6865 (formerly known as the HepeX-C program) is a combination
of two
fully human monoclonal antibodies (Ab68 and Ab65) against the hepatitis
C
virus E2 envelope protein. A single antibody version of this product
was
tested in a pilot clinical program that included both Phase I and
Phase II
clinical trials. In April 2005, we submitted an IND to the FDA
in order to
commence a Phase Ia/Ib clinical trial later this year for XTL-6865,
the
dual-MAb product. In July 2005, we announced that the FDA granted
XTL-6865
“Fast-Track” designation for the treatment of hepatitis C re-infection
following a liver transplant.
|
· |
Small
Molecule Development Program
.
We currently have a small molecule development program, which is
targeted
at treating chronic hepatitis C utilizing novel non-nucleoside
polymerase
inhibitors. The current program is focused on developing synthetic
small
molecules to be orally-administered to patients for the inhibition
of HCV
viral RNA replication. We have identified two lead candidates from
two
distinct chemical series of compounds, which we licensed from B&C
Biopharm Co., Ltd. XTL-2125, the lead product candidate from our
hepatitis
C small molecule development program, is a small molecule non-nucleoside
polymerase inhibitor for the treatment of chronic hepatitis C.
XTL-2125 is
currently in pre-clinical testing.
|
· |
continue
the clinical development of XTL-6865 and our small molecule development
efforts; and
|
· |
seek
to in-license or acquire additional clinical stage compounds, or
compounds
in advanced pre-clinical
development.
|
· |
A
Phase Ia/Ib Clinical Program in Patients with Chronic
HCV
,
which
demonstrated the safety and tolerability of using single and multi-doses
of Ab 68 up to 120mg for a 28 day dosing period. In terms of efficacy,
eight out of 25 patients had at least a 90% reduction in HCV-RNA
levels
from pre-treatment levels following administration of Ab68. These
trials
provided safety data, as well as a preliminary indication of anti-viral
activity in humans.
|
· |
A
Phase IIa Clinical Trial with Ab68 Following Liver
Transplant
,
which demonstrated the safety and tolerability of Ab68 up to 240mg
for a
12 week dosing period. The study was planned as a blinded,
placebo-controlled, dose-escalating study in a total of 24 liver
transplant patients receiving six different doses of Ab68 (20mg,
40mg,
80mg, 120mg, 240mg, and 480mg). The 480mg dose level was not tested
due to
a clinical hold as a result of an intraoperative death of the first
patient tested at the 480mg dose level (later determined by the
medical
examiner to be related to pulmonary emboli (blood clots in the
lung)). The
FDA later cleared the clinical hold, but we decided to discontinue
the
study and focus further development efforts on the dual anti-body
product,
XTL-6865. No other drug-related serious adverse events were reported
during this study. The 120mg and 240mg dose groups had a greater
reduction
in viral load than the placebo group during the first week when
dosed
daily. This effect was less evident when dosed less frequently
than daily.
This data provided additional evidence of anti-viral activity in
immunosuppressed patients. It should be noted that the small number
of
patients in this pilot study did not allow us to draw statistical
analysis.
|
· |
to
generate humanized monoclonal antibodies, or hMAbs (the “Trimera hMAb
Technology”); and/or
|
· |
as
an animal model of human disease (the “Trimera Model Technology”).
|
· |
NABI,
which develops a hepatitis C immunoglobulin (polyclonal antibody
preparation). This therapeutic did not prevent re-infection in
Phase I/II
trials in liver transplant
patients.
|
· |
GenMab
A/S, which is developing a single MAb against HCV. This antibody
is
presently in pre-clinical
development.
|
· |
is
intended to treat a serious or life-threatening
condition;
|
· |
is
intended to treat a serious aspect of the condition;
and
|
· |
has
the potential to address unmet medical needs, and this potential
is being
evaluated in the planned drug development
program.
|
· |
Phase
I
:
The drug is administered to a small group of humans, either healthy
volunteers or patients, to test for safety, dosage tolerance, absorption,
metabolism, excretion, and clinical pharmacology.
|
· |
Phase
II
:
Studies are conducted on a larger number of patients to assess
the
efficacy of the product, to ascertain dose tolerance and the optimal
dose
range, and to gather additional data relating to safety and potential
adverse events.
|
· |
Phase
III
:
Studies establish safety and efficacy in an expanded patient population.
|
· |
Phase
IV
:
The FDA may require a Phase IV to conduct post-marketing studies
for
purposes of gathering additional evidence of safety and
efficacy.
|
· |
slow
patient enrollment due to the nature of the clinical trial plan,
the
proximity of patients to clinical sites, the eligibility criteria
for
participation in the study or other
factors;
|
· |
inadequately
trained or insufficient personnel at the study site to assist in
overseeing and monitoring clinical trials or delays in approvals
from a
study site’s review board;
|
· |
longer
treatment time required to demonstrate efficacy or determine the
appropriate product dose;
|
· |
insufficient
supply of the drug candidates;
|
· |
adverse
medical events or side effects in treated patients;
and
|
· |
ineffectiveness
of the drug candidates.
|
|
As
of December
31,
|
|||||||||||||||
2004
|
|
|
2003
|
|
|
2002
|
|
|
2001
|
|
|
2000
|
|
|||
|
(in
thousands)
|
|||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||
Cash,
cash equivalents, bank
deposits
and marketable
securities
|
$
|
22,924
|
$
|
22,262
|
$
|
35,706
|
$
|
52,188
|
$
|
64,969
|
||||||
Working
capital
|
20,240
|
19,967
|
33,396
|
50,433
|
53,752
|
|||||||||||
Total
assets
|
25,624
|
24,853
|
38,423
|
55,106
|
67,876
|
|||||||||||
Long-term
obligations
|
2,489
|
1,244
|
1,017
|
526
|
707
|
|||||||||||
Total
shareholders’ equity
|
19,602
|
20,608
|
34,830
|
51,953
|
64,586
|
· |
HepeX-B
is
being developed to prevent re-infection with hepatitis B, known
as HBV, in
liver transplant patients. HepeX-B is a mixture of two fully human
monoclonal antibodies, which binds to the HBV surface antigen,
or HBsAg.
HepeX-B was recently studied in a Phase IIb trial in liver transplant
patients. In August 2005, we announced that the dosing portion
of the
study ended. Worldwide rights for HepeX-B were licensed to Cubist
in 2004,
in exchange for certain milestone payments and future royalties
on
Cubist’s net sales.
Cubist
plans to review data from this trial with the FDA as part of a
discussion
of design elements of a Phase III clinical
trial.
|
· |
XTL-6865
is
being developed to prevent hepatitis C, known as HCV, re-infection
following a liver transplant and for the treatment of chronic HCV.
XTL-6865 (formerly known as the HepeX-C program) is a combination
of two
fully human monoclonal antibodies (Ab68 and Ab65) against the hepatitis
C
virus E2 envelope protein. A single antibody version of this product
was
tested in a pilot clinical program that included both Phase I and
Phase II
clinical trials. In April 2005, we submitted an IND to the FDA
in order to
commence a Phase Ia/Ib clinical trial later this year for XTL-6865,
the
dual-MAb product. In July 2005, we announced that the FDA granted
XTL-6865
“Fast-Track” designation for the treatment of hepatitis C re-infection
following a liver transplant.
|
· |
Small
Molecule Development Program
.
We currently have a small molecule development program, which is
targeted
at treating chronic hepatitis C utilizing novel non-nucleoside
polymerase
inhibitors. The current program is focused on developing synthetic
small
molecules to be orally-administered to patients for the inhibition
of HCV
viral RNA replication. We have identified two lead candidates from
two
distinct chemical series of compounds, which we licensed from B&C.
XTL-2125 is a small molecule non-nucleoside polymerase inhibitor
for the
treatment of chronic hepatitis C and is currently in pre-clinical
testing.
|
· |
the
timing of expenses associated with manufacturing and product development
of the proprietary drug candidates within our portfolio and those
that may
be in-licensed, partnered or acquired;
|
· |
our
ability to achieve our milestones under licensing
arrangements;
|
· |
the
timing of the in-licensing, partnering and acquisition of new product
opportunities; and
|
· |
the
costs involved in prosecuting and enforcing patent claims and other
intellectual property rights.
|
Payment
due by period
|
|||||||||||||
Contractual
obligations
|
Total
|
Less
than
1
year
|
1-3
years
|
More
than
3
years
|
|||||||||
Research
& development agreements
|
$
|
1,129,000
|
$
|
1,129,000
|
$
|
--
|
$
|
--
|
|||||
Operating
leases
|
1,223,000
|
381,000
|
842,000
|
--
|
|||||||||
Total
|
$
|
2,352,000
|
$
|
1,510,000
|
$
|
842,000
|
$
|
--
|
Years
ended December 31,
|
|||||||||||||
2004
|
2003
|
2002
|
Cumulative,
as of December 31, 2004
|
||||||||||
HepeX-B
1
|
|||||||||||||
Research
and development costs
|
$
|
3,301,000
|
$
|
4,036,000
|
$
|
4,284,000
|
$
|
20,973,000
|
|||||
Less
participations
|
--
|
(1,602,000
|
)
|
--
|
(4,161,000
|
)
|
|||||||
3,301,000
|
2,435,000
|
4,284,000
|
16,812,000
|
XTL-6865
|
|||||||||||||
Research
and development costs
|
5,452,000
|
6,287,000
|
3,491,000
|
18,913,000
|
|||||||||
Less
participations
|
--
|
(1,459,000
|
)
|
--
|
(2,540,000
|
)
|
|||||||
5,452,000
|
4,828,000
|
3,491,000
|
16,373,000
|
||||||||||
Small
molecule development program
|
|||||||||||||
Research
and development costs
|
3,232,000
|
1,780,000
|
986,000
|
5,998,000
|
|||||||||
Less
participations
|
--
|
(168,000
|
)
|
--
|
(168,000
|
)
|
|||||||
3,232,000
|
1,612,000
|
986,000
|
5,830,000
|
||||||||||
Other
research and development programs
2
|
|||||||||||||
Research
and development costs
|
--
|
1,565,000
|
4,470,000
|
29,339,000
|
|||||||||
Less
participations
|
--
|
--
|
(75,000
|
)
|
4,081,000
|
||||||||
|
-- |
1,565,000
|
4,395,000
|
25,258,000
|
|||||||||
Research
and development
|
|||||||||||||
Research
and development costs
|
11,985,000
|
13,668,000
|
13,231,000
|
75,223,000
|
|||||||||
Less
participations
|
--
|
(3,229,000
|
)
|
(75,000
|
)
|
10,950,000
|
|||||||
11,985,000
|
10,439,000
|
13,156,000
|
64,273,000
|
· |
a
reduction in headcount of approximately 20 individuals, primarily
in
research and development, as our programs advance into the clinical
stages
of development and our commercialization partner for HepeX-B, Cubist,
takes over more responsibility for its
development;
|
· |
a
streamlining of operations across the business;
and
|
· |
the
deferral of all research and development activity not supporting
the lead
clinical programs until proof of concept has been achieved in at
least one
of the two lead programs.
|
Name
|
Age
|
Position
|
Michael
S. Weiss
|
39
|
Chairman
of the Board of Directors
|
William
J. Kennedy, Ph.D
|
60
|
Non
executive Director
|
Ido
Seltenreich
|
33
|
Non
Executive and External Director
|
Vered
Shany, D.M.D
|
40
|
Non
Executive and External Director
|
Jonathan
R. Spicehandler, M.D
|
56
|
Non
Executive Director
|
Ben
Zion Weiner, Ph.D
|
61
|
Non
Executive Director
|
Jonathan
Burgin
|
44
|
Chief
Financial Officer
|
Shlomo
Dagan, Ph.D
|
54
|
Chief
Scientific Officer
|
· |
first,
our audit committee reviews the proposal for
compensation;
|
· |
second,
provided that the audit committee approves the proposed compensation,
the
proposal is then submitted to our board of directors for review,
except
that a director who is the beneficiary of the proposed compensation
does
not participate in any discussion or voting with respect to such
proposal;
and
|
· |
finally,
if our board of directors approves the proposal, it must then submit
its
recommendation to our shareholders, which is usually done in connection
with our shareholders’ general
meeting.
|
· |
an
employment relationship;
|
· |
a
business or professional relationship maintained on a regular
basis;
|
· |
control;
and
|
· |
service
as an office holder, other than service as an officer for a period
of not
more than three months, during which the company first offered
shares to
the public.
|
· |
the
majority of shares voted at the meeting, including at least one-third
of
the shares held by non-controlling shareholders voted at the meeting,
vote
in favor of election of the director, with abstaining votes not
being
counted in this vote; or
|
· |
the
total number of shares held by non-controlling shareholders voted
against
the election of the director does not exceed one percent of the
aggregate
voting rights in the company.
|
Year
ended December 31,
|
|||
2004
|
2003
|
2002
|
|
Research
and Development
|
|
|
|
Israel
|
44 | 42 | 57 |
U.S.
|
8 | 5 | 4 |
52 | 47 | 65 | |
Financial
and general management
|
|
|
|
Israel
|
7 | 6 | 7 |
U.S.
|
-- | -- | -- |
7 | 6 | 7 | |
Business
development
|
|
|
|
Israel
|
-- | -- | -- |
U.S.
|
1 | 2 | 2 |
1
|
2
|
2
|
|
Total
|
60
|
55
|
74
|
Average
number of full-time employees
|
58
|
68
|
89
|
Amount
and nature of beneficial ownership
|
|||||||||||||
Ordinary
shares beneficially owned excluding options |
Options
exercisable within 60 days after August 1 2005 |
Total
ordinary shares beneficially owned |
Percent
of
ordinary shares beneficially owned |
||||||||||
Michael
S. Weiss
1
Chairman
of the Board
|
--
|
--
|
--
|
*
|
|||||||||
William
Kennedy
Director
|
--
|
--
|
--
|
*
|
|||||||||
Jonathan
Spicehandler
Director
|
--
|
--
|
--
|
*
|
|||||||||
Ben
Zion Weiner
2
Director
|
--
|
--
|
--
|
*
|
|||||||||
Ido
Seltenreich
Director
|
--
|
--
|
--
|
*
|
|||||||||
Vered
Shany
Director
|
--
|
--
|
--
|
*
|
|||||||||
Jonathan
Burgin
Chief
Financial Officer
|
20,000
|
1,382,053
|
1,402,053
|
*
|
|||||||||
Shlomo
Dagan
Chief
Scientific Officer
|
57,000
|
2,031,333
|
2,088,333
|
1.2
|
%
|
||||||||
All
directors and executive officers as a group
(8 persons)
|
77,000
|
3,413,386
|
3,490,386
|
2.0
|
%
|
1
|
Does
not include 9,250,000 options that were granted on August 1, 2005,
pursuant to the achievement of a certain
market
capitalization
milestones.
|
2
|
Does
not include 2,000,000 options that were granted on August 1, 2005,
pursuant to the achievement of a certain
market
capitalization
milestones.
|
Beneficial
owner
|
Number
of ordinary shares beneficially owned
|
Percent
of ownership
|
Bank
Julius Baer
|
19,322,870
|
11.4%
|
Perpetual
Income & Growth Investment Trust Inc.
|
13,624,713
|
8.1%
|
· |
a
reduction in headcount of approximately 20 individuals, primarily
in
research and development, as our programs advance into the clinical
stages
of development, and our commercialization partner for HepeX-B,
Cubist,
takes over more responsibility for its
development;
|
· |
a
streamlining of operations across the business;
and
|
· |
the
deferral of all research and development activity not supporting
the lead
clinical programs until proof of concept has been achieved in at
least one
of the two lead programs.
|
|
British
Pence (p)
|
U.S.
Dollar
|
||
Last
Six Calendar Months
|
High
|
Low
|
High
|
Low
|
July
2005
|
50.25
|
38.00
|
0.88
|
0.67
|
June
2005
|
39.00
|
36.00
|
0.69
|
0.63
|
May
2005
|
40.50
|
37.00
|
0.71
|
0.65
|
April
2005
|
39.75
|
37.00
|
0.70
|
0.65
|
March
2005
|
41.50
|
36.50
|
0.73
|
0.64
|
February
2005
|
43.50
|
30.00
|
0.76
|
0.53
|
Financial
Quarters During the Past Two Full Fiscal Years
|
|
|||
Second
Quarter of 2005
|
40.50
|
36.00
|
0.71
|
0.63
|
First
Quarter of 2005
|
43.50
|
26.00
|
0.76
|
0.46
|
Fourth
Quarter of 2004
|
25.50
|
13.00
|
0.45
|
0.23
|
Third
Quarter 2004
|
19.50
|
13.75
|
0.34
|
0.24
|
Second
Quarter 2004
|
32.25
|
17.00
|
0.57
|
0.30
|
First
Quarter 2004
|
27.25
|
16.25
|
0.48
|
0.29
|
Fourth
Quarter 2003
|
18.75
|
12.00
|
0.33
|
0.21
|
Third
Quarter 2003
|
16.50
|
9.25
|
0.29
|
0.16
|
Last Five Full Financial Years | ||||
2004
|
32.25
|
13.00
|
0.57
|
0.23
|
2003
|
18.75
|
5.75
|
0.33
|
0.10
|
2002
|
64.00
|
11.50
|
1.12
|
0.20
|
2001
|
153.00
|
33.50
|
2.69
|
0.59
|
2000-commencing
September 26, 2000
|
169.50
|
137.50
|
2.98
|
2.42
|
· |
a
breach of the office holder’s duty of care to the company or to another
person;
|
· |
a
breach of the office holder’s fiduciary duty to the company, provided that
he or she acted in good faith and had reasonable cause to believe
that the
act would not prejudice the company;
and
|
· |
a
financial liability imposed upon the office holder in favor of
another
person.
|
· |
monetary
liability imposed upon him or her in favor of a third party by
a judgment,
including a settlement or an arbitral award confirmed by the court;
and
|
· |
reasonable
litigation expenses, including attorneys’ fees, actually incurred by the
office holder or imposed upon him or her by a court, in a proceeding
brought against him or her by or on behalf of the company or by
a third
party, or in a criminal action in which he or she was acquitted,
or in a
criminal action which does not require criminal intent in which
he or she
was convicted; furthermore, a company can, with a limited exception,
exculpate an office holder in advance, in whole or in part, from
liability
for damages sustained by a breach of duty of care to the
company.
|
· |
any
amendment to the Articles of
Association;
|
· |
an
increase of the company's authorized share
capital;
|
· |
a
merger; and
|
· |
approval
of interested party transactions that require shareholders
approval.
|
· |
there
is a limitation on acquisition of any level of control of the company;
or
|
· |
the
acquisition of any level of control requires the purchaser to do
so by
means of a tender offer to the
public.
|
· |
the
judgment was obtained after due process before a court of competent
jurisdiction, that recognizes
and
enforces similar judgments of Israeli courts, and the court had
authority
according to the rules of
private
international law currently prevailing in
Israel;
|
· |
adequate
service of process was effected and the defendant had a reasonable
opportunity to be heard;
|
· |
the
judgment is not contrary to the law, public policy, security or
sovereignty of the State of Israel and
its
enforcement is not contrary to the laws governing enforcement of
judgments;
|
· |
the
judgment was not obtained by fraud and does not conflict with any
other
valid judgment in the same
matter
between the same parties;
|
· |
the
judgment is no longer appealable;
and
|
· |
an
action between the same parties in the same matter is not pending
in any
Israeli court at the time the
lawsuit
is instituted in the foreign court.
|
For
a company with
foreign
investment of
|
Company
tax rate
|
|
More
than 25% and less than 49%
|
25%
|
|
49%
or more and less than 74%
|
20%
|
|
74%
or more and less than 90%
|
15%
|
|
90%
or more
|
10%
|
· |
deduction
of purchase of know-how and patents over an eight-year period;
and
|
· |
the
right to elect, under specified conditions, to file a consolidated
tax
return with additional related Israeli industrial companies and
an
industrial holding company.
|
· |
where
a company's equity, as defined in the law, exceeds the cost of
fixed
assets as defined in the Inflationary Adjustments Law, a deduction
from
taxable income that takes into account the effect of the applicable
annual
rate of inflation on the excess is allowed up to a ceiling of 70%
of
taxable income in any single tax year, with the unused portion
permitted
to be carried forward on a linked basis. If the cost of fixed assets,
as
defined in the Inflationary Adjustments Law, exceeds a company's
equity,
then the excess multiplied by the applicable annual rate of inflation
is
added to taxable income;
|
· |
subject
to specified limitations, depreciation deductions on fixed assets
and
losses carried forward are adjusted for inflation based on the
increase in
the consumer price index; and
|
· |
in
specified circumstances, gains on traded securities, which might
otherwise
be eligible for reduced rates of tax, will be liable to company
tax at the
usual rate in 2005 of 34% (as mentioned above, gradually scheduled
to be
reduced to 25% in 2010).
|
· |
a
citizen or resident of the United
States;
|
· |
a
corporation created or organized under the laws of the United States,
the
District of Columbia, or any state;
or
|
· |
a
trust or estate, treated, for United States federal income tax
purposes,
as a domestic trust or estate.
|
· |
have
elected mark-to-market accounting;
|
· |
hold
our ordinary shares as part of a straddle, hedge or conversion
transaction
with other investments;
|
· |
own
directly, indirectly or by attribution at least 10% of our voting
power;
|
· |
are
tax exempt entities;
|
· |
are
persons who acquire shares in connection with employment or other
performance of services; and
|
· |
have
a functional currency that is not the U.S.
dollar.
|
· |
You
must include the gross amount of the dividend, not reduced by the
amount
of Israeli tax withheld, in your U.S. taxable
income.
|
· |
You
may be able to claim the Israeli tax withheld as a foreign tax
credit
against your U.S. income tax
liability.
|
· |
The
foreign tax credit is subject to significant and complex limitations.
Generally, the credit can offset only the part of your U.S. tax
attributable to your net foreign source passive income. Additional
special
rules apply to taxpayers predominantly engaged in the active conduct
of a
banking, insurance, financing or similar business. Additionally,
if we pay
dividends at a time when 50% or more of our stock is owned by U.S.
persons, you may be required to treat the part of the dividend
attributable to U.S. source earnings and profits as U.S. source
income,
possibly reducing the allowable credit, unless you elect to calculate
your
foreign tax credit separately with respect to XTLbio
dividends.
|
· |
A
U.S. Holder will be denied a foreign tax credit with respect to
Israeli
income tax withheld from dividends received on the ordinary shares
to the
extent the U.S. Holder has not held the ordinary shares for at
least 16
days of the 30-day period beginning on the date which is 15 days
before
the ex-dividend date or to the extent the U.S. Holder is under
an
obligation to make related payments with respect to substantially
similar
or related property. Any days during which a U.S. Holder has substantially
diminished its risk of loss on the ordinary shares are not counted
toward
meeting the 16-day holding period required by the
statute.
|
· |
If
you do not elect to claim foreign taxes as a credit, you will be
entitled
to deduct the Israeli income tax withheld from your XTLbio dividends
in
determining your taxable income.
|
· |
Individuals
who do not claim itemized deductions, but instead utilize the standard
deduction, may not claim a deduction for the amount of the Israeli
income
taxes withheld.
|
· |
If
you are a U.S. corporation holding our stock, you cannot claim
the
dividends-received deduction with respect to our
dividends.
|
· |
gain
recognized by the U.S. Holder upon the disposition of, as well
as income
recognized upon receiving certain dividends on the ordinary shares
and/or
ADRs would be taxable as ordinary
income;
|
· |
the
U.S. Holder would be required to allocate such dividend income
and/or
disposition gain ratably over such U.S. Holder's entire holding
period for
such XTLbio ordinary shares and/or
ADRs;
|
· |
the
amount allocated to each year other than the year of the dividend
payment
or disposition would be subject to tax at the highest applicable
tax rate,
and an interest charge would be imposed with respect to the resulting
tax
liability;
|
· |
the
U.S. Holder would be required to file an annual return on IRS Form
8621
regarding distributions received on, gain recognized on dispositions
of,
our ordinary shares and/or ADRs;
and
|
· |
any
U.S. Holder who acquired the ordinary shares and/or ADRs upon the
death of
the shareholder would not receive a step-up to market value of
his income
tax basis for such ordinary shares and/or ADRs. Instead such U.S.
Holder
beneficiary would have a tax basis equal to the decedent's basis,
if
lower.
|
· |
the
item is effectively connected with the conduct by the Non-U.S.
Holder of a
trade or business in the United States and, in the case of a resident
of a
country which has a tax treaty with the United States, the item
is
attributable to a permanent establishment or, in the case of an
individual, a fixed place of business, in the United States;
|
· |
the
Non-U.S. Holder is subject to tax under the provisions of United
States
tax law applicable to U.S. expatriates;
or
|
· |
the
individual non-U.S. Holder is present in the United States for
183 days or
more in the taxable year of the sale and certain other conditions
are
met.
|
ADR
holders must pay:
|
For:
|
|
$5.00
(or less) per 100 ADSs (or portion thereof)
|
Each
issuance of an ADS, including as a result of a distribution of
shares or
rights or other property.
Each
cancellation of an ADS, including if the agreement terminates
.
|
|
$0.02
(or less) per ADS
|
Any
cash payment
.
|
|
Registration
or Transfer Fees
|
Transfer
and registration of shares on the share register of the Foreign
Registrar
from your name to the name of The Bank of New York or its agent
when you
deposit or withdraw shares
.
|
|
Expenses
of The Bank of New York
|
Conversion
of foreign currency to U.S. dollars.
Cable,
telex and facsimile transmission expenses.
Servicing
of shares or deposited securities
.
|
|
$0.02
(or less) per ADS
per calendar year (if the depositary has not collected any cash
distribution fee during that year)
|
Depositary
services
.
|
|
Taxes
and other governmental charges
|
As
necessary The Bank of New York or the Custodian have to pay on
any ADR or
share underlying an ADR, for example, stock transfer taxes, stamp
duty or
withholding taxes
.
|
|
A
fee equivalent to the fee that would be payable if securities distributed
to you had been ordinary shares and the ordinary shares had been
deposited
for issuance of ADSs
|
Distribution
of securities distributed to holders of deposited securities which
are
distributed by the depositary to ADR holders.
|
If
we:
|
Then:
|
Change
the nominal or par value of our shares
;
Reclassify,
split up or consolidate any of the deposited securities
;
Distribute
securities on the shares that are not distributed to you
;
or
Recapitalize,
reorganize, merge, liquidate, sell all or substantially all
of our assets, or takes any similar action . |
The
cash, shares or other securities received by The Bank of New York
will
become deposited securities. Each ADR will automatically represent
its
equal share of the new deposited securities.
The
Bank of New York may, and will if we ask
it
to, distribute some or all of the cash, shares or other securities
it
received. It may also issue new ADRs or ask you to surrender your
outstanding ADRs in exchange for new ADRs, identifying the new
deposited
securities.
|
· |
are
only obligated to take the actions specifically set forth in the
agreement
without negligence or bad faith;
|
· |
are
not liable if either is prevented or delayed by law or circumstances
beyond their control from performing their obligations under the
agreement;
|
· |
are
not liable if either exercises discretion permitted under the
agreement;
|
· |
have
no obligation to become involved in a lawsuit or other proceeding
related
to the ADRs or the agreement on your behalf or on behalf of any
other
party; and
|
· |
may
rely upon any documents they believe in good faith to be genuine
and to
have been signed or presented by the proper
party.
|
· |
payment
of stock transfer or other taxes or other governmental charges
and
transfer or registration fees charged by third parties for the
transfer of
any shares or other deposited
securities;
|
· |
production
of satisfactory proof of the identity and genuineness of any signature
or
other information it deems necessary,
and
|
· |
compliance
with regulations it may establish, from time to time, consistent
with the
agreement, including presentation of transfer
documents.
|
· |
when
temporary delays arise because: (1) The Bank of New York or we
have closed
its transfer books; (2) the transfer of shares is blocked to permit
voting
at a stockholders' meeting; or (3) we are paying a dividend on
the shares;
or
|
· |
when
it is necessary to prohibit withdrawals in order to comply with
any laws
or governmental regulations that apply to ADRs or to the withdrawal
of
shares or other deposited
securities.
|
Exhibit
Number |
Exhibit
Description
|
|
1
|
*Articles
of Association
|
|
2.1
|
*Form
of Deposit Agreement Between The Bank of New York, XTL Biopharmaceuticals
Ltd. and the Owners and Holders of American Depositary
Receipts
|
|
2.2
|
*
ADR specimen (included in Exhibit 2.1)
|
|
4.1
|
†Research
and License Agreement Between Yeda Research and Development Company
Ltd.
and Xenograft Technologies Ltd. dated April 7, 1993 **
|
|
4.2
|
†Amendment
of Research and License Agreement Between Yeda Research and Development
Company Ltd. and XTL Biopharmaceuticals Ltd. dated August 31, 1995
**
|
|
4.3
|
†Second
Extension Agreement Between Yeda Research and Development Company
Ltd. and
XTL Biopharmaceuticals Ltd. dated August 14, 1996 **
|
|
4.4
|
†Third
Extension Agreement Between Yeda Research and Development Company
Ltd. and
XTL Biopharmaceuticals Ltd. dated November 25, 1997 **
|
|
4.5
|
†Amendment
No. 2 to Research and License Agreement dated April 7, 1993, as
amended on
August 31, 1995, between Yeda Research and Development Company
Ltd. and
XTL Biopharmaceuticals Ltd. dated January 25, 1998 **
|
|
4.6
|
†Amendment
No. 3 to Research and License Agreement dated April 7, 1993 between
Yeda
Research and Development Company Ltd. and XTL Biopharmaceuticals
Ltd.
dated January 26, 2003 **
|
|
4.7
|
†Amendment
No. 4 to Research and License Agreement dated April 7, 1993 between
Yeda
Research and Development Company Ltd. and XTL Biopharmaceuticals
Ltd.
dated June 2, 2004 **
|
|
4.8
|
†License
Agreement Between XTL Biopharmaceuticals Ltd. and Cubist
Biopharmaceuticals, Inc., dated June 2, 2004 **
|
|
4.9
|
†License
Agreement Between XTL Biopharmaceuticals Ltd. and DRK-Blutspendedienst
Baden-Wurttemberg (Ulm University, Germany) dated April 18, 2000
**
|
|
4.10
|
†License
Agreement Between XTL Biopharmaceuticals Ltd. and Stanford University,
dated September 12, 2003 **
|
|
4.11
|
†License
Agreement Between XTL Biopharmaceuticals Ltd. and Applied Immunogenetics
LLC, dated September 12, 2003**
|
|
4.12
|
†1998
Share Option Plan dated October 19, 1998
|
|
4.13
|
†1999
Share Option Plan dated June 1, 1999
|
|
4.14
|
†1999
International Share Option Plan Dated June 1, 1999
|
|
4.14
|
†2000
Share Option Plan dated April 12, 2000
|
|
4.15
|
†2001
Share Option Plan dated February 28, 2001
|
|
4.16
|
*Letter
of Understanding, dated August 5, 2005, relating to the License
Agreement
dated June 2, 2004 between Cubist Pharmaceuticals, Inc. and XTL
Biopharmaceuticals Ltd. **
|
|
4.17
|
*
License
Agreement, dated February 26, 2003, between XTL Biopharmaceuticals
Ltd.
and B&C Biopharm Co., Ltd.**
|
|
4.18
|
*Employment
Agreement, dated August 1, 1999, between XTL Biopharmaceuticals
Ltd. and
Jonathan Burgin
|
|
4.19
|
*Employment
Agreement, dated May 1, 1994, between XTL Biopharmaceuticals Ltd.
and
Shlomo Dagan
|
|
4.20
|
*Agreement,
dated August 1, 2005, between XTL Biopharmaceuticals, Ltd. and
Michael S.
Weiss
|
|
4.21
|
*Form
No. 1 of Director Service Agreement
|
|
4.22
|
*Form
No. 2 of Director Service Agreement
|
|
4.23
|
*Form
No. 3 of Director Service Agreement
|
|
4.24
|
*Form
No. 4 of Director Indemnification Agreement
|
|
15.1
|
†Consent
of PricewaterhouseCoopers, dated July 13, 2005
|
|
15.2
|
†Consent
of KPMG LP, dated July 13, 2005
|
|
XTL
BIOPHARMACEUTICALS LTD.
(Registrant) |
||
|
|
|
Date: August 9, 2005 | By: | /s/ Jonathan Burgin |
Jonathan Burgin Chief Financial Officer |
||
Page
|
|
Reports
of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated
Balance Sheets as of December 31, 2004 and 2003
|
F-4
|
Consolidated
Statements of Operations for the years ended
December
31, 2004, 2003 and 2002, and the period from
March 9, 1993 to December 31, 2004 |
F-5
|
|
|
Consolidated
Statements of Changes in Stockholders’ Equity for the
years
ended December 31, 2004, 2003, and 2002,
and the period from March 9, 1993 to December 31, 2001 |
F-6
|
Consolidated
Statements of Cash Flows for the years ended
December
31, 2004, 2003 and 2002, and the period
from March 9, 1993 to December 31, 2004 |
F-10
|
Notes
to the Consolidated Financial Statements
|
F-12
|
/s/
Rusi K. Kathoke
|
/s/
Jonathan Burgin
|
|
Rusi
K. Kathoke
|
Jonathan
Burgin
|
|
Director
|
Chief
Financial Officer
|
Period
from
|
|||||||||||||
March
9, 1993*
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2004
|
2003
|
2002
|
2004
|
||||||||||
REVENUES
(notes
1j and 2):
|
|||||||||||||
Reimbursed
out-of-pockets expenses
|
3,269
|
—
|
—
|
3,269
|
|||||||||
License
|
185
|
—
|
—
|
185
|
|||||||||
3,454
|
—
|
—
|
3,454
|
||||||||||
COST
OF REVENUES
(notes
1j and 2):
|
|||||||||||||
Reimbursed
out-of-pockets expenses
|
3,269
|
—
|
—
|
3,269
|
|||||||||
License
(with respect to royalties)
|
32
|
—
|
—
|
32
|
|||||||||
3,301
|
—
|
—
|
3,301
|
||||||||||
GROSS
MARGIN
|
153
|
—
|
—
|
153
|
|||||||||
|
|
|
|||||||||||
RESEARCH
AND DEVELOPMENT COSTS
(note
9e)
|
11,985
|
13,668
|
13,231
|
75,223
|
|||||||||
LESS
- PARTICIPATIONS
(note
7a(3))
|
—
|
3,229
|
75
|
10,950
|
|||||||||
11,985
|
10,439
|
13,156
|
64,273
|
||||||||||
|
|||||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
(note
9f)
|
4,134
|
3,105
|
3,638
|
23,555
|
|||||||||
BUSINESS
DEVELOPMENT COSTS
(note
9g)
|
810
|
664
|
916
|
4,286
|
|||||||||
IMPAIRMENT
OF ASSET HELD FOR SALE
(note 4c)
|
—
|
354
|
—
|
354
|
|||||||||
OPERATING
LOSS
|
16,776
|
14,562
|
17,710
|
92,315
|
|||||||||
FINANCIAL
INCOME -
net (note 9h)
|
352
|
352
|
597
|
6,700
|
|||||||||
LOSS
BEFORE TAXES ON INCOME
|
16,424
|
14,210
|
17,113
|
85,615
|
|||||||||
TAXES
ON INCOME
|
49
|
78
|
27
|
161
|
|||||||||
NET
LOSS FOR THE YEAR
|
16,473
|
14,288
|
17,140
|
85,776
|
|||||||||
BASIC
AND DILUTED PER SHARE DATA:
|
|
||||||||||||
Loss
per ordinary share
|
$
|
(
0.12
|
)
|
$
|
(
0.13
|
)
|
$
|
(
0.15
|
)
|
||||
Weighted
average number of shares used to compute loss per ordinary
share
|
134,731,766
|
111,712,916
|
111,149,292
|
Preferred
shares
|
Ordinary
shares
|
|
||||||||||||||
Number
of
shares
|
Amount
|
Number
of
shares
|
Amount
|
Additional
paid-in
capital
|
||||||||||||
CHANGES
DURING THE PERIOD
FROM
MARCH 9, 1993 (DATE OF INCORPORATION) TO DECEMBER 31, 2001: |
||||||||||||||||
Comprehensive
loss:
|
||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Net
unrealized loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Comprehensive
loss
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Deferred
share-based compensation
|
—
|
—
|
—
|
—
|
377
|
|||||||||||
Amortization
of deferred compensation
expenses
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Non-employee
stock option expenses
|
—
|
—
|
—
|
—
|
106
|
|||||||||||
Exercise
of share warrants
|
—
|
—
|
1,707,980
|
8
|
414
|
|||||||||||
Exercise
of employee stock options
|
15,600
|
**
|
221,638
|
1
|
26
|
|||||||||||
Issuance
of share capital, net of share
issue
expenses
|
43,571,850
|
250
|
—
|
—
|
26,187
|
|||||||||||
Bonus
shares
|
7,156,660
|
41
|
19,519,720
|
97
|
(138
|
)
|
||||||||||
Conversion
of preferred shares into
ordinary
shares
|
(50,744,110
|
)
|
(291
|
)
|
50,744,110
|
291
|
—
|
|||||||||
Receipts
in respect of share warrants (expired in 1999)
|
—
|
—
|
—
|
— |
|
89 | ||||||||||
Issuance
of share capital
|
—
|
—
|
15,183,590
|
75
|
16,627
|
|||||||||||
Initial
public offering (“IPO”) of the Company’s shares under a prospectus dated
September 20, 2000 (net of $ 5,199 - issuance
expenses)
|
—
|
—
|
23,750,000
|
118
|
45,595
|
|||||||||||
BALANCE
AT DECEMBER 31, 2001
|
—
|
—
|
111,127,038
|
590
|
89,283
|
* |
Deferred
share-
based
compensation
|
Accumulated
other
comprehensive
income
(loss)
|
Deficit
accumulated
during
the
development
stage
|
Total
|
||||||||||
CHANGES
DURING THE PERIOD
FROM
MARCH 9, 1993 (DATE OF INCORPORATION) TO DECEMBER 31, 2001: |
|||||||||||||
Comprehensive
loss:
|
|||||||||||||
Net
loss
|
—
|
—
|
(37,875
|
)
|
(37,875
|
)
|
|||||||
Net
unrealized loss
|
—
|
(45
|
)
|
—
|
(45
|
)
|
|||||||
Comprehensive
loss
|
—
|
(45
|
)
|
(37,875
|
)
|
(37,920
|
)
|
||||||
Deferred
share-based compensation
|
(377
|
)
|
—
|
—
|
—
|
||||||||
Amortization
of deferred compensation
expenses
|
377
|
—
|
—
|
377
|
|||||||||
Non-employee
stock option expenses
|
—
|
—
|
—
|
106
|
|||||||||
Exercise
of share warrants
|
—
|
—
|
—
|
422
|
|||||||||
Exercise
of employee stock options
|
—
|
—
|
—
|
27
|
|||||||||
Issuance
of share capital, net of share
issue
expenses
|
—
|
—
|
—
|
26,437
|
|||||||||
Bonus
shares
|
—
|
—
|
—
|
—
|
|||||||||
Conversion
of preferred shares into
ordinary
shares
|
—
|
—
|
—
|
—
|
|||||||||
Receipts
in respect of share warrants (expired in 1999)
|
—
|
—
|
—
|
89
|
|||||||||
Issuance
of share capital
|
—
|
—
|
—
|
16,702
|
|||||||||
Initial
public offering (“IPO”) of the Company’s shares under a prospectus dated
September 20, 2000 (net of $ 5,199 - issuance
expenses)
|
—
|
—
|
—
|
45,713
|
|||||||||
BALANCE
AT DECEMBER 31, 2001
|
—
|
* |
(45
|
)
|
(37,875
|
)
|
51,953
|
Ordinary
shares
|
|
|||||||||
Number
of
shares |
Amount
|
Additional
paid in capital |
||||||||
BALANCE AT DECEMBER 31, 2001 - brought forward |
111,127,038
|
590
|
89,283
|
* | ||||||
CHANGES
DURING 2002:
|
|
|
|
|||||||
Comprehensive
loss:
|
||||||||||
Net
loss
|
—
|
—
|
—
|
|||||||
Net
unrealized loss
|
—
|
—
|
—
|
|||||||
Comprehensive
loss
|
—
|
—
|
—
|
|||||||
Exercise
of employee stock options
|
38,326
|
**
|
20
|
|||||||
BALANCE
AT DECEMBER 31, 2002
|
111,165,364
|
590
|
89,303
|
* | ||||||
CHANGES
DURING 2003:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Net
loss
|
—
|
—
|
—
|
|||||||
Net
unrealized gain
|
—
|
—
|
—
|
|||||||
Comprehensive
loss
|
—
|
—
|
—
|
|||||||
Exercise
of employee stock options
|
854,100
|
4
|
—
|
|||||||
BALANCE
AT DECEMBER 31, 2003
|
112,019,464
|
594
|
89,303
|
* | ||||||
CHANGES
DURING 2004:
|
||||||||||
Comprehensive
loss:
|
||||||||||
Net
loss
|
—
|
—
|
—
|
|||||||
Net
unrealized gain
|
—
|
—
|
—
|
|||||||
Comprehensive
loss
|
—
|
—
|
—
|
|||||||
Non-employee
stock option expenses
|
—
|
—
|
32
|
|||||||
Exercise
of employee stock options
|
50,000
|
**
|
19
|
|||||||
Issuance
of shares, net of $2,426 share issuance
expenses
|
56,009,732
|
247
|
15,183
|
|||||||
BALANCE
AT DECEMBER 31, 2004
|
168,079,196
|
841
|
104,537
|
* |
|
Deferred
share- based compensation |
Accumulated
other
comprehensive
income (loss)
|
Deficit
accumulated
during the
development
stage
|
Total
|
|||||||||
BALANCE
AT DECEMBER 31, 2001
-
brought forward
|
—
|
*
|
(45
|
) |
(37,875
|
) |
51,953
|
||||||
CHANGES
DURING 2002:
|
|||||||||||||
Comprehensive
loss:
|
|||||||||||||
Net
loss
|
—
|
—
|
(17,140
|
) |
(17,140
|
) | |||||||
Net
unrealized loss
|
—
|
(3
|
) |
—
|
(3
|
) | |||||||
Comprehensive
loss
|
—
|
(3
|
)
|
(17,140
|
)
|
(17,143
|
)
|
||||||
Exercise
of employee stock options
|
—
|
—
|
—
|
20
|
|||||||||
BALANCE
AT DECEMBER 31, 2002
|
—
|
* |
(48
|
)
|
(55,015
|
)
|
34,830
|
||||||
CHANGES
DURING 2003:
|
|||||||||||||
Comprehensive
loss:
|
|||||||||||||
Net
loss
|
—
|
—
|
(14,288
|
)
|
(14,288
|
)
|
|||||||
Net
unrealized gain
|
—
|
62
|
—
|
62
|
|||||||||
Comprehensive
loss
|
—
|
62
|
(14,288
|
)
|
(14,226
|
)
|
|||||||
Exercise
of employee stock options
|
—
|
—
|
—
|
4
|
|||||||||
BALANCE
AT DECEMBER 31, 2003
|
—
|
* |
14
|
(69,303
|
)
|
20,608
|
|||||||
CHANGES
DURING 2004:
|
|||||||||||||
Comprehensive
loss:
|
|||||||||||||
Net
loss
|
—
|
—
|
(16,473
|
)
|
(16,473
|
)
|
|||||||
Net
unrealized gain
|
—
|
(14
|
)
|
—
|
(14
|
)
|
|||||||
Comprehensive
loss
|
—
|
(14
|
)
|
(16,473
|
)
|
(16,487
|
)
|
||||||
Non-employee
stock option expenses
|
—
|
—
|
—
|
32
|
|||||||||
Exercise
of employee stock options
|
—
|
—
|
—
|
19
|
|||||||||
Issuance
of shares, net of $2,426 share issuance
expenses
|
—
|
—
|
—
|
15,430
|
|||||||||
BALANCE
AT DECEMBER 31, 2004
|
—
|
* |
—
|
(85,776
|
)
|
19,602
|
Year
ended December 31
|
Period
from
March 9, 1993 (b) |
||||||||||||
2004
|
|
|
2003
|
|
|
2002
|
|
|
to
December 31, 2004
|
|
|
Year
ended December 31
|
Period
from
March 9, 1993 (b) |
||||||||||
2004
|
|
|
2003
|
|
|
2002
|
|
to
December 31, 2004
|
|
|
||||||||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||||||||
Issuance
of share capital - net of share issuance expenses
|
15,430
|
—
|
—
|
104,371
|
|||||||||
Exercise
of share warrants and employee stock options
|
19
|
4
|
20
|
492
|
|||||||||
Proceeds
from long-term debt
|
—
|
—
|
—
|
399
|
|||||||||
Proceeds
from short-term debt
|
—
|
—
|
—
|
50
|
|||||||||
Repayment
of long-term debt
|
—
|
—
|
—
|
(399
|
)
|
||||||||
Repayment
of short-term debt
|
—
|
—
|
—
|
(50
|
)
|
||||||||
Net
cash provided by financing activities
|
15,449
|
4
|
20
|
104,863
|
|||||||||
NET
INCREASE (DECREASE) IN CASH
AND
CASH
EQUIVALENTS
|
8,604
|
2,168
|
(15,883
|
)
|
12,788
|
||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD
|
4,184
|
2,016
|
17,899
|
—
|
|||||||||
BALANCE
OF CASH AND CASH
EQUIVALENTS AT
END OF
PERIOD
|
12,788
|
4,184
|
2,016
|
12,788
|
|||||||||
Supplementary
information on financing activity not
involving cash flows - |
|
|
|
|
|
|
|||||||
Conversion
of convertible subordinated debenture into shares
|
—
|
—
|
—
|
1,700 | |||||||||
Supplemental
disclosures of cash flow information:
|
|
||||||||||||
Income
taxes paid (mainly - tax advance in respect of excess
expenses)
|
|
107
|
161
|
79
|
321
|
||||||||
Interest
paid
|
—
|
—
|
—
|
350
|
|||||||||
(a)
Including effect of changes in the exchange rate on
cash
|
(73
|
)
|
(9
|
)
|
(709
|
)
|
(1,839
|
)
|
|||||
(b)
Incorporation date, see note 1a.
|
a. | General: |
1) | XTL Biopharmaceuticals Ltd. (“the Company”) was incorporated under the Israel Companies Ordinance on March 9, 1993. The Company is a development stage company in accordance with Financial Accounting Standard 7 (“FAS”) “Accounting and Reporting by Development Stage Enterprises.” |
2) | Through December 31, 2004, the Company has incurred losses in an aggregate amount of U.S.$86 million. Such losses have resulted from the Company’s activities as a development stage company. It is expected that the Company will be able to finance its operations from its current reserves for the coming year. Continuation of the Company’s current operations after utilizing its current cash reserves during 2006 is dependent upon the generation of additional financial resources either through agreements for the commercialization of its product portfolio or through external financing. |
3) | The consolidated financial statements are prepared in accordance with generally accepted accounting principles (GAAP) in the United States. |
4) | The preparation of the financial statements, in conformity with GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported expenses during the reporting periods. Actual results may vary from these estimates. |
b. | Functional currency |
c. | Principles of consolidation |
d. | Impairment of long-lived assets |
e. | Cash equivalents |
f. | Marketable securities |
g. | Property and equipment |
%
|
|
Laboratory
equipment
|
10-20
(mainly 15) |
Computers
|
33
|
Furniture
and office equipment
|
6-15
|
h. | Deferred income taxes |
i. | Research and development costs and participations |
j. | Revenue Recognition |
k. | Business development costs |
l. | Loss per share (“LPS”) |
m. | Comprehensive loss |
n. | Stock- based compensation |
Year
ended December 31
|
Period
from
March 9, 1993* to December 31, |
|||||||||||||
2004
|
2003
|
2002
|
2004
|
|||||||||||
($
in thousands, except per share amounts)
|
||||||||||||||
Net
loss for the period, as reported
|
16,473
|
14,288
|
17,140
|
85,776
|
||||||||||
Deduct:
stock- based employee
compensation expense, included in reported loss |
--
|
--
|
--
|
(483
|
)
|
|||||||||
Add:
stock- based employee
compensation expense determined under fair value method for all awards |
239
|
821
|
1,297
|
6,355
|
||||||||||
Net
loss - pro-forma
|
16,712
|
15,109
|
18,437
|
91,648
|
||||||||||
Basic
and diluted loss per share:
|
||||||||||||||
As
reported
|
0.12
|
0.13
|
0.15
|
|||||||||||
Pro-forma
|
0.12
|
0.14
|
0.17
|
|||||||||||
* Incorporation date, see note 1a. |
o. | Reclassifications |
p. | Recently issued accounting pronouncements in the United States: |
(1) |
FAS
123 (Revised 2004) Share-based
Payment
|
(2) |
FAS
153 Exchanges of Nonmonetary Assets - An Amendment of APB Opinion
No.
29
|
December
31,
2004
|
|
($
in thousands)
|
Deferred
revenue
|
1,815
|
Less
- Deferred expenses related to Yeda
|
218
|
Deferred
gain
|
1,597
|
a. | Composition of the assets, grouped by major classifications, is as follows: |
December
31
|
|||||||
2004
|
2003
|
||||||
($
in thousands)
|
Cost:
|
|||||||
Laboratory
equipment
|
1,828
|
1,727
|
|||||
Computers
|
517
|
497
|
|||||
Leasehold
improvements
|
698
|
698
|
|||||
Furniture
and office equipment
|
269
|
221
|
|||||
3,312
|
3,143
|
||||||
Accumulated
depreciation and amortization:
|
|||||||
Laboratory
equipment
|
1,120
|
932
|
|||||
Computers
|
488
|
438
|
|||||
Leasehold
improvements
|
691
|
639
|
|||||
Furniture
and office equipment
|
105
|
81
|
|||||
2,404
|
2,090
|
||||||
908
|
1,053
|
b. | Depreciation and amortization totaled $ 319,000, $ 440,000 and $ 470,000 in the years ended December 31, 2004, 2003 and 2002, respectively. |
c. | Asset held for sale |
a. | The Company |
1) | On June 30, 2001 the Company entered into an agreement with each employee implementing Section 14 of the Severance Compensation Act, 1963 (the “Law”) and the General Approval of the Labor Minister issued in accordance to the said Section 14, mandating that upon termination of such employee’s employment, the Company shall release to the employee all the amounts accrued in its Insurance Policies. Accordingly, the Company remits each month to each of its employee’s Insurance Policy, the amounts required by law to cover the severance pay liability. |
2) | Insurance policies for certain employees (senior managers): the policies provide most of the coverage for severance pay and pension liabilities of managerial personnel, the remainder liabilities are covered by the Company. |
b. | The subsidiary |
c. | Severance pay expenses |
d. | Cash flow information regarding the company’s liability for employee rights upon retirement: |
1. | The Company contributed in 2004, 2003 and 2002 to the insurance companies in respect to its severance pay obligations to Israeli employees, $276,000, $348,000 and $327,000, respectively, and expects to contribute, in 2005, $ 290,000 to the insurance companies in respect to its severance pay obligations to Israeli employees. |
2. | The Company expects to pay between 2012 to 2014 future benefits to certain employees who have reached retirement age during these years in the amount of $61,000. |
a. | Share Capital |
b. | Summary of the Company's stock options |
1)
|
The
following table summarizes information about stock options granted
from
the date of incorporation (March 9, 1993) to December 31, 2004:
|
Number
|
Exercise
|
||||||||
Grant
|
The
|
Grant
|
of
|
price
per
|
Vesting
|
||||
number
|
grantees
|
date
|
options
|
option
|
period
|
||||
1
|
Employees
of the Company
|
May
1995
|
900,900
|
NIS
0.02
|
4
year period on a
yearly basis |
||||
2
|
Employees
of the Company
|
February
1997
|
3,955,090
|
$
0.365
|
4
year period on a
yearly basis |
||||
3
|
Employees
of the Company
|
August
1998
|
423,680
|
$
0.497
|
4
year period on
a yearly basis, starting December 3, 1997 |
||||
4
|
Senior
officers of the Company
|
October
1998
|
5,038,360
|
$
0.497
|
4
year period on a
monthly basis |
Grant
number |
The
grantees |
Grant
date
|
Number
of options |
Exercise
price per option |
Vesting
period |
||||
|
5
|
Employees
of the Company and its subsidiary
|
June
1999
|
1,672,500 |
$0.497
|
4
year period on a
yearly basis |
|||
6
|
Senior
officers of the Company
|
August
1999
|
678,720
|
$0.497
|
4
year period on a
monthly basis |
||||
7
|
Employees
of the Company and its subsidiary
|
April
2000
|
1,870,000
|
$1.1
|
4
year period on a monthly or
yearly basis |
||||
|
8
|
Employees
of the Company and its subsidiary
|
May
2001
|
1,942,900
|
$0.931
|
3
year period on a
yearly basis starting May 2003 |
|||
|
9
|
Employees
of the Company and its subsidiary
|
September
2001
|
306,400
|
$0.766
|
3
year period on a
yearly basis starting September 2003 |
|||
|
10
|
Employees
of the Company and its subsidiary
|
March
2002
|
425,800
|
$0.851
|
3
year period on a
yearly basis starting March 2004 |
|||
|
11
|
Employees
of the Company and its subsidiary
|
September
2002
|
877,400
|
$0.482
|
3
year period on a
yearly basis starting September 2004 |
|||
|
12
|
Employees
of the Company and its subsidiary
|
February
2003
|
699,900
|
$0.1055
|
3
year period on a
yearly basis starting February 2005 |
|||
|
13
|
Employees
of the Company and its subsidiary
|
September
2003
|
125,000
|
$0.25
|
3
year period on a
yearly basis starting September 2005 |
|||
|
14
|
Employees
of the Company
|
March
2004
|
103,200
|
$0.486
|
3
year period on a
yearly basis starting March 2006 |
|||
|
15
|
Employees
of the Company
|
September
2004
|
148,800
|
$0.315
|
3
year period on a
yearly basis starting September 2006 |
|||
|
16
|
Senior
officer of the Company
|
October
2004
|
120,000
|
$0.243
|
3
year period on a
yearly basis starting October 2006 |
(1) |
All
options were granted without
consideration.
|
(2) |
The
options are exercisable over a period of 10 years, from the grant
date.
|
Year
ended December 31
|
||||||||||||||||||||
2004
|
2003
|
2002
|
||||||||||||||||||
Weighted
|
Weighted
|
Weighted
|
||||||||||||||||||
average
|
average
|
average
|
||||||||||||||||||
exercise
|
exercise
|
exercise
|
||||||||||||||||||
Number
|
price
|
Number
|
price
|
Number
|
price
|
|||||||||||||||
|
$
|
|
$
|
|
$
|
|||||||||||||||
Balance
outstanding at
beginning of year |
15,552,661
|
0.59
|
|
17,816,823
|
0.61
|
|
17,279,890
|
0.62
|
|
|||||||||||
Changes
during the year:
|
||||||||||||||||||||
Granted
*
|
372,000
|
0.34
|
|
824,900
|
0.13
|
1,303,200
|
0.61
|
|
||||||||||||
Exercised
|
(50,000
|
)
|
0.365
|
|
(854,100
|
)
|
0.01
|
|
(38,326
|
)
|
0.50
|
|
||||||||
Expired
and forfeited
|
(129,000
|
)
|
0.68
|
|
(2,234,962
|
)
|
0.83
|
|
(727,941
|
)
|
0.83
|
|
||||||||
Balance
outstanding at
end of year |
15,745,661
|
0.58
|
|
15,552,661
|
0.59
|
|
17,816,823
|
0.61
|
|
|||||||||||
Balance
exercisable at end
of year
|
|
|
14,059,136
|
0.60
|
|
9,960,260
|
0.45
|
|
12,083,088
|
0.48
|
|
3) |
The
following table summarizes information about stock options outstanding
and
exercisable at December 31, 2004:
|
Options
outstanding
|
Options
exercisable
|
|||||||||||||
Weighted
|
Weighted
|
|||||||||||||
average
|
average
|
|||||||||||||
Balance
at
|
remaining
|
Balance
at
|
remaining
|
|||||||||||
December 31,
|
contractual
|
December 31,
|
contractual
|
|||||||||||
2004
|
life
|
2004
|
life
|
|||||||||||
Number
|
In
years
|
Number
|
In
years
|
|||||||||||
Exercise
prices:
|
||||||||||||||
NIS
0.02
|
2,600
|
0.22
|
2,600
|
0.22
|
|
|||||||||
U.S.$
0.1055
|
537,400
|
8.16
|
—
|
—
|
|
|||||||||
U.S.$
0.243
|
120,000
|
9.20
|
—
|
—
|
|
|||||||||
U.S.$
0.25
|
125,000
|
8.68
|
—
|
—
|
|
|||||||||
U.S.$
0.315
|
148,800
|
9.33
|
—
|
—
|
|
|||||||||
U.S.$
0.365
|
3,511,780
|
2.11
|
3,511,780
|
2.11
|
|
|||||||||
U.S.$
0.482
|
711,400
|
7.68
|
313,016
|
7.68
|
|
|||||||||
U.S.$
0.486
|
103,200
|
9.75
|
—
|
—
|
|
|||||||||
U.S.$
0.497
|
6,395,880
|
3.66
|
6,395,880
|
3.66
|
|
|||||||||
U.S.$
0.766
|
147,600
|
6.71
|
113,652
|
6.71
|
|
|||||||||
U.S.$
0.851
|
167,000
|
7.20
|
101,035
|
7.20
|
|
|||||||||
U.S.$
0.931
|
2,049,701
|
6.38
|
1,895,873
|
6.38
|
||||||||||
U.S.$
1.1
|
1,725,300
|
5.28
|
1,725,300
|
5.28
|
|
|||||||||
|
15,745,661
|
14,059,136
|
c. | Share Purchase Options: |
1) | According to specific agreements signed with consultants, directors and members of the Scientific Advisory Board, the Company has granted them options to purchase ordinary shares as described below. These shares are not part of the plans described in b. above. Each option entitles the holder to purchase one ordinary share of NIS 0.02 par value of the Company. |
December
31
|
||||||||||
2004
|
2003
|
2002
|
||||||||
|
Number
of
options
|
Balance
outstanding at beginning of year
|
2,205,000
|
2,280,000
|
2,430,000
|
||||||||
Changes
during the year:
|
|||||||||||
Granted
|
380,000
|
—
|
—
|
||||||||
Forfeited
|
—
|
(75,000
|
)
|
(150,000
|
)
|
||||||
Total
at end of year (1)
|
2,585,000
|
2,205,000
|
2,280,000
|
||||||||
(1)
Exercise
price:
|
|||||||||||
$
0.497-0.538
|
930,000
|
930,000
|
930,000
|
||||||||
$
2.11
|
1,275,000
|
1,275,000
|
1,350,000
|
||||||||
$
0.238-0.306
|
380,000
|
—
|
—
|
||||||||
2,585,000
|
2,205,000
|
2,280,000
|
|||||||||
Exercisable
by year end:
|
|||||||||||
Exercise
price:
|
|||||||||||
$
0.497-0.538
|
922,188
|
894,063
|
847,188
|
||||||||
$
2.11
|
1,275,000
|
1,275,000
|
1,125,000
|
||||||||
$
0.238-0.306
|
75,901
|
—
|
—
|
||||||||
2,273,089
|
2,169,063
|
1,972,188
|
a. | Royalty Bearing Agreements: |
1) | Under a Research and License agreement with Yeda Research and Development Company Ltd. (“Yeda”), the Company is committed to pay royalty payments at rates determined in the agreement not exceeding 3% of net sales, or royalty rates mainly between 20% to 25% of sublicensing fees, for products in development and research under such an agreement. (See also note 2). |
2) | Although the Company usually conducts its own research and development, it also enters where appropriate into participation agreements with third parties in respect of particular projects. In connection with such agreements the Company may incur royalty and milestone obligations commitments at varying royalty rates not exceeding 5 % of future net sales or 25 % of sublicensing fees of products developed, based on such agreements. |
3) | The Company is committed to pay royalties to the Government of Israel on proceeds from sales of products in the research and development of which the Government participates by way of grants. At the time grants were received, successful development of the related projects was not assured. In the case of failure of a project that was partly financed as above, the Company is not obligated to pay any such royalties. Under the terms of company's funding from the Israeli Government, royalties of 3% - 5% are payable on sales of products developed from projects so funded, up to 100% of the amount of the grant received by the Company (dollar linked); as from January 1, 1999 - with the addition of an annual interest based on Libor. |
4) | The Company entered into a licensing agreement with Cubist, see notes 2 and a(3) above for details. |
b. | Rental Commitments: |
1) | Premises occupied by the Company in Israel are rented under operating lease agreements until 2006, with an option to renew the lease agreements till 2007. |
December
31,
2004
|
||||
|
($
in thousands)
|
In
2005
|
306
|
|||
In
2006
|
355
|
|||
In
2007
|
366
|
|||
1,027
|
2) | The Company leases vehicles under the terms of certain operating lease agreements. These agreements expire in the years 2006 and 2007 . |
December
31,
2004
|
||||
|
($
in thousands)
|
In
2005
|
75
|
|||
In
2006
|
72
|
|||
In
2007
|
49
|
|||
196
|
||||
c. | Other Commitments |
a. | The Company |
|
Tax
rates in Israeli applicable to income from other
sources
|
b.
|
The
subsidiary
|
c.
|
Current
tax losses for tax
purposes:
|
1) | Company |
2) | Subsidiary |
3) | The following table summarizes the taxes on income for the Company and its subsidiary for 2004, 2003 and 2002: |
2004
|
2003
|
2002
|
|||||||||||||||||
($
in thousands)
|
($
in thousands)
|
($
in thousands)
|
|||||||||||||||||
|
Company
|
Subsidiary
|
Company
|
|
|
Subsidiary
|
|
|
Company
|
|
|
Subsidiary
|
Gain
(loss) before taxes on
income |
|
(16,582
|
)
|
158
|
(14,327
|
)
|
117
|
(17,211
|
)
|
98
|
||||||||||
Taxes
on income
|
|
—
|
49
|
—
|
78
|
—
|
27
|
|||||||||||||
Net
gain (loss) for the year
|
|
|
(16,582
|
)
|
109
|
(14,327
|
)
|
39
|
(17,211
|
)
|
71
|
d.
|
Deferred
income taxes
|
e.
|
Reconciliation
of the theoretical tax expense to actual tax
expense
|
f.
|
Tax
assessments
|
a. |
Short-term
bank deposits
|
b. | Marketable securities: |
1) | As of December 31, 2004, there are no marketable securities. The balance as of December 31, 2003 composed as follows: |
December
31, 2003
|
|||||||||||||
|
Amortized
cost |
Unrealized
holding gains |
Unrealized
holding
losses
|
Estimated
fair
market
value
|
|||||||||
|
($
in thousands)
|
Debentures:
|
||||||||||||||
Linked
to the Israeli CPI
|
71
|
—
|
(2
|
)
|
69
|
|||||||||
Unlinked
|
561
|
19
|
(17
|
)
|
563
|
|||||||||
632
|
19
|
(19
|
)
|
632
|
||||||||||
|
||||||||||||||
Short-term
treasury notes and bonds:
|
|
|||||||||||||
Linked
to the U.S. dollar
|
10
|
—
|
—
|
10
|
||||||||||
Unlinked
|
93
|
14
|
—
|
107
|
||||||||||
103
|
14
|
—
|
117
|
|||||||||||
735
|
33
|
(19
|
)
|
749
|
2) | Changes in marketable securities held for sale are as follows: |
2004
|
2003
|
2002
|
||||||||
($
in thousands)
|
Balance
at beginning of year
|
749
|
1,637
|
1,178
|
||||||||
Investments
|
— |
71
|
1,219
|
||||||||
Proceeds
from sales
|
(722
|
)
|
(1,048
|
)
|
(716
|
)
|
|||||
Reclassifications
into earnings (loss) from other
comprehensive income (loss) |
|
(14
|
)
|
62
|
(3
|
)
|
|||||
Realized
gain (loss) from sales
|
(13
|
)
|
27
|
(41
|
)
|
||||||
|
— |
749
|
1,637
|
c. | Accounts receivable - other: |
|
December
31
|
||||||
2004
|
|
|
2003
|
||||
($
in
thousands)
|
Office
of the Chief Scientist of
the Israeli Ministry of Industry (“OCS”) |
—
|
537
|
||||||
Prepaid
expenses
|
165
|
119
|
||||||
Employees
|
24
|
36
|
||||||
Value
Added Tax authorities
|
101
|
6
|
||||||
Sundry
|
16
|
8
|
||||||
306
|
706
|
d. | Accounts payable and accruals: |
Suppliers
|
1,108
|
1,334
|
||||||
Accrued
expenses
|
1,337
|
1,077
|
||||||
Institutions
and employees in respect of salaries
and related benefits |
294
|
280
|
||||||
Provision
for vacation pay and recreation pay
|
385
|
300
|
||||||
Sundry
|
10
|
10
|
||||||
3,134
|
3,001
|
e. | Research and development costs: |
Period
from
|
|||||||||||||
March
9, 1993
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2004
|
|
|
2003
|
|
|
2002
|
|
|
2004
|
||||
|
($
in thousands)
|
Wages,
salaries and related benefits
|
2,776
|
3,450
|
3,958
|
20,945
|
||||||||||
Sub-contractors
expenses
|
6,430
|
6,799
|
5,575
|
33,856
|
||||||||||
Laboratories
supplies
|
754
|
1,128
|
1,653
|
8,406
|
||||||||||
Consulting
|
549
|
494
|
396
|
3,194
|
||||||||||
Rent
and maintenance
|
725
|
866
|
926
|
4,004
|
||||||||||
Depreciation
and amortization
|
277
|
369
|
415
|
2,717
|
||||||||||
Other
|
474
|
562
|
308
|
2,101
|
||||||||||
11,985
|
13,668
|
13,231
|
75,223
|
f. | General and administrative expenses: |
Wages,
salaries and related
benefits
|
1,890
|
1,244
|
1,704
|
11,080
|
||||||||||
Corporate
communications
|
289
|
228
|
598
|
2,210
|
||||||||||
Professional
fees
|
647
|
564
|
662
|
3,515
|
||||||||||
Director
fees
|
243
|
183
|
181
|
1,387
|
||||||||||
Rent
and maintenance
|
90
|
104
|
135
|
865
|
||||||||||
Communication
|
34
|
33
|
43
|
195
|
||||||||||
Depreciation
and amortization
|
42
|
70
|
55
|
589
|
||||||||||
Patent
registration fees
|
271
|
125
|
71
|
1,017
|
||||||||||
Other
|
628
|
554
|
189
|
2,697
|
||||||||||
4,134
|
3,105
|
3,638
|
23,555
|
g. | Business development costs: |
Wages,
salaries and related
benefits
|
410
|
408
|
567
|
2,501
|
||||||||||
Travel
|
36
|
136
|
140
|
742
|
||||||||||
Professional
fees
|
364
|
120
|
209
|
1,043
|
||||||||||
810
|
664
|
916
|
4,286
|
h. | Financial income, net: |
March
9, 1993
|
|||||||||||||
Year
ended December 31
|
to
December 31,
|
||||||||||||
2004
|
|
|
2003
|
|
|
2002
|
|
|
2004
|
||||
|
($
in thousands)
|
Financial
income:
|
|
|||||||||||||
Interest
received
|
297
|
458
|
1,360
|
8,725
|
||||||||||
Foreign
exchange differences
gain
|
67
|
—
|
—
|
203
|
||||||||||
Gain
from available for sale
securities
|
13
|
62
|
—
|
(13
|
)
|
|||||||||
Other
|
—
|
—
|
—
|
156
|
||||||||||
377
|
520
|
1,360
|
9,097
|
|||||||||||
Financial
expenses:
|
||||||||||||||
Foreign
exchange differences
loss
|
—
|
148
|
733
|
1,921
|
||||||||||
Interest
paid
|
—
|
—
|
—
|
374
|
||||||||||
Loss
from available for sale securities
|
—
|
—
|
3
|
14
|
||||||||||
Other
|
25
|
20
|
27
|
88
|
||||||||||
|
25
|
168
|
763
|
2,397
|
||||||||||
Financial
income, net
|
352
|
352
|
597
|
6,700
|
a. | Linkage terms of balances in non-dollars currency: |
1) | As follows: |
December 31,
2004
|
|||||||
Israeli
currency
|
Other
|
||||||
Unlinked
|
|
||||||
($
in thousands)
|
|||||||
Assets
|
837
|
432
|
|||||
Liabilities
|
1,458
|
237
|
2) | Data regarding the changes in the exchange rate of the dollar and the Israeli CPI: |
Year
ended December 31
|
|||||||||||
2004
|
2003
|
2002
|
|||||||||
Devaluation
(evaluation) of the Israeli
currency against the dollar |
(1.6%)
|
|
(7.6%)
|
|
7.3%
|
|
|||||
Changes
in the Israeli CPI
|
1.2%
|
|
(1.9%)
|
|
6.5%
|
|
|||||
Exchange
rate of one dollar (at end of
year)
|
NIS
4.308
|
NIS
4.379
|
NIS
4.737
|
b. |
Fair
value of financial
instruments
|
c. |
Concentration
of credit risks
|
"Alternate
Director"
|
As
defined in Part E below
|
“Auditors”
|
Means
the auditors for the time being of the Company or, in the case
of joint
auditors, anyone of them;
|
"Board
of Directors"
|
The
Board of Directors of the Company elected or properly appointed
in
accordance with the provisions of these Articles of Association
or present
or deemed to be present at a duly/convened meeting of Directors
at which a
quorum is present; any committee of the Board of Directors to
the extent
that any of the authorities of the Board of Directors are delegated
to it;
any person authorised by the Board of Directors, to the extent
so
authorised, for the purposes of any matter or class of
matters;
|
"Business
Day"
|
A
day on which customer services are provided by a majority of
the
commercial banks in Israel and in the United Kingdom;
|
“CA1985”
|
Means
the Companies Act 1985 and where the context requires, every
other statute
from time to time in force concerning companies and affecting
the Company;
(including without limitation, the Regulations)
|
“Chairman”
|
Means
the Chairman (if any) of the Board or, where the context requires,
the
Chairman of a general meeting of the
company
|
"Companies
Law"
|
The
Companies Law, 5759 - 1999, as the same shall be amended from
time to
time, or any other law which shall replace that Law, together
with any
amendments thereto;
|
"Companies
Ordinance"
|
Those
sections of the Companies Ordinance [New Version] 5743 - 1983
that shall
remain in force after the date of the coming into force of
the Companies
Law, as the same shall be amended from time to time thereafter,
or any
other law which shall replace those sections after the date
of entry into
force of the Companies Law;
|
"Company"
|
XTL
Biopharmaceuticals Ltd.
|
"Corporate
Representative"
|
As
defined in Part E below;
|
“Depository”
|
Means
a custodian or other person (or a nominee for such custodian
or other
person) appointed under contractual arrangements with the Company
or other
arrangements approved by the Board of Directors whereby such
custodian or
other person or nominee holds or is interested in shares of
the Company or
rights or interests in shares of the Company and issues securities
or
other documents of title or otherwise evidencing the entitlement
of the
holder thereof to or to receive such shares, rights or interests,
provided
and to the extent that such arrangements have been approved
by the Board
for the purpose of these Articles, and shall include where
approved by the
Board, the trustees (acting in their capacity as such) of any
employees
share scheme established by the Company or any other scheme
or arrangement
principally for the benefit of employees or those in the service
of the
Company and/or its subsidiaries or their respective businesses
and the
managers (acting in their capacity as such) of any investment
or savings
plan, which in each case the Board has
approved.
|
"Director"
or "Directors"
|
A
member or members of the Board of Directors who are elected
or appointed
in accordance with the provisions of these Articles of Association,
including an Alternate Director and a Corporate Representative
serving in
such capacity at the relevant time;
|
"Document"
|
Including
a printed article, photocopy, telegram, facsimile, electronic
mail,
web-site and any other visible of words, and any other graphic
form stored
in a computer or stored in any other form;
|
“execution”
|
Includes
any mode of execution (and “executed” shall be construed
accordingly)
|
"Extraordinary
Transaction"
|
A
Transaction which is not in the ordinary course of business
of the
Company; a Transaction which is not on market terms or a
Transaction
liable to have a material affect on the profitability of
the Company, its
assets or its liabilities; an arrangement between the Company
and an
Officer regarding the terms of his office and engagement,
including the
grant of a release from liability, insurance, and an undertaking
to
indemnify or an indemnity according to the Indemnity
Permit.
|
“General
Meeting”
|
Any
general meeting of the members other than an annual general
meeting in
accordance with Article 22.4
|
“holder”
|
Means
(in relation to any share) the member whose name is entered
in the
Register as the holder or, where the context permits the
members whose
names are entered in the Register as the joint holders of
that
share;
|
"Information"
|
Including
know-how, statistics, financial statements, records of
account, documents
(including drafts), computer files, computer print-outs,
agreements,
protocols (including protocols of meetings of the Board
of Directors and
its committees), registers, business plans, valuations,
forecasts, lists
of clients, price-lists, costs, market surveys and any
other similar
information related directly or indirectly to the activities
of the
Company;
|
“Israeli
Securities Authority”
|
Means
the Israeli Securities Authority as established in accordance
with Section
2 of the Israeli Securities Act - 5728.
|
“London
Stock Exchange”
|
Means
London Stock Exchange plc or other principal stock exchange
in the United
Kingdom for the time being on which the Ordinary Shares
are
listed;
|
"Managing
Director"
|
The
person holding this title and any person having the authority
of a
Managing Director, whatever his title.
|
"Office
"or" the Offices of the Company"
|
The
registered office of the Company at the relevant time;
|
"Officer"
|
a
Director, General Manager, Chief Business Manager, Deputy
General Manager,
Vice General Manager, any person who holds a said position
in the company
even if he has a different title, and also any other manager
who is
directly subject to the authority of the General Manager.
|
“Ordinary
Share”
|
Means
an ordinary share of the Company (as defined in Article
4.1)
|
“Recognised
Person”
|
Means
a recognised clearing house or a nominee of a recognised
investment
exchange which is designated as mentioned in section 185
(4) CA
1985
|
"Reduction
of Capital"
|
A
distribution which is not a permitted distribution under
the provisions of
the Companies Law;
|
"Register"
|
The
shareholders register together with any additional shareholders
register
that the Company may maintain outside Israel in England/pursuant
to
Article 40.3;
|
“Regulations”
|
Means
the Uncertified Securities Regulations 1995 (SI 1995
No.3272) including
any modifications thereof and rules made thereunder or
any regulations in
substitution thereof made under section 207 Companies
Act 1989 for the
time being in force;
|
“Secretary”
|
Means
the secretary for the time being of the Company or any
other person
appointed to perform any of the duties of the secretary
of the Company
including a joint, temporary, assistant or deputy
secretary.
|
"Security"
|
Share,
debenture, capital note, security, certificate or right
entitling
membership or participation in the Company or a claim
from it (if issued
in series), a certificate or right entitling the holder
to acquire a
security of the Company, in each case whether the security
is in name form
or bearer form including a debenture or option convertible
into
shares;
|
"Simple
Majority"
|
A
majority of those present and voting at a general meeting
or meeting of
the Board of Directors. The vote of any person present
at a meeting as
aforesaid who does not vote or abstains from voting with
respect to any
matter on the agenda shall not be included in the number
of votes
cast;
|
"Surplus
Account"
|
The
profits of the Company as appearing in the books of accounts
of the
Company;
|
"These
Articles of Association" or "The Articles of
Association"
|
These
Articles of Association, as they shall be amended from
time to time by the
General Meeting;
|
"Transaction"
|
A
contract or an agreement or a unilateral decision to
bestow a right or
some other benefit;
|
“United
Kingdom”
|
Means
Great Britain and Northern Ireland;
|
“writing”
or “written”
|
Means
and includes printing, typewriting, lithography, photography
and any other
modes or mode or representing or reproducing words in
a legible and
non-transitory form;
|
"Year"
or "Month"
|
According
to the Gregorian
calendar;
|
I,
________ (I.D. Number/Company Number ________) of ____________________,
in
my capacity as shareholder in ______________ Limited, hereby
appoint
________, (I.D. Number/Company Number ______________) of
____________________, or in his/her absence, ______________,
(I.D.
Number/Company Number ______________) of ______________, to vote
on my
behalf and in my name with respect to ________ Class __ shares
held by me
at the (annual/special) meeting of the Company that shall be
held on the
___ day of ________, and at any adjournment of such
meeting.
|
In
witness whereof I have signed hereon this ___ day of
________.
|
____________________
|
Name
and Signature
|
SECTION
2.6
|
Limitations
on Execution and Delivery, Transfer and Surrender of Receipts.
|
19.
|
RESIGNATION
AND REMOVAL OF THE DEPOSITARY; APPOINTMENT OF SUCCESSOR
CUSTODIAN.
|
1. |
By
August 5, 2005, XTL shall:
a)
transfer to Cubist all
physical
materials (including, but not limited to, cell lines, clones,
reference standards, antigens for assay development, retained clinical
samples, and samples from stability testing of formulated
material
);
b) transfer to Cubist all reports (including, but not limited to,
PK
studies in hydrodynamic model, report on media optimization); and
c)
assign to Cubist all contracts and regulatory documents (including,
but
not limited to, the IND application and contracts with *****, *****,
*****, clinical sites and/or clinical investigators, and *****),
including
all rights and obligations thereunder, each to the extent solely
related
to the development of HepeX-B. In addition, XTL shall complete
by August
5, 2005 all ongoing collaboration activities (including, but not
limited
to, *****
).
|
2. |
XTL
shall transfer to Cubist by October 31, 2005, all remaining data
and
original documentation (in any format, including, but not limited
to,
written and electronic formats) related to the development of HepeX-B
(including, but not limited to, electronic files, lab notebooks
and
printouts of raw data, Excel® files, and any data or documentation
relating to: testing of clinical samples, stability testing of
clinical
lots, development of cell-lines, development of reference standards,
or
development of assays used in clinical testing.). For clarification,
XTL
shall provide original documentation only if that documentation
is related
solely to HepeX-B; otherwise, XTL shall provide copies of the information
that is related to HepeX-B. Throughout August, September
and October
of 2005, XTL shall dedicate ***** to perform the activities described
above in this Paragraph 3.
|
3. |
Cubist
shall reimburse XTL for its internal costs reasonably incurred
for
transferring the items referred to in Paragraphs 2 and 3. Such
costs shall
be treated as Designated Costs under Section 7.3 of the Agreement,
except
that such costs shall be reimbursed within fourteen (14) days of
completion to Cubist’s satisfaction of all activities described in
Paragraphs 2 and 3 above.
|
4. |
Cubist’s
reimbursement of XTL for its internal costs reasonably incurred
for
transferring the items referred to in Paragraph 3 shall not exceed
*****
($*****).
|
5. |
Cubist
shall reimburse XTL for Designated Costs paid by XTL to third party
vendors on or after July 1, 2005 within thirty (30) days of Cubist’s
receipt of an invoice from XTL.
|
6. |
Cubist
shall not be required to make any Collaboration Support payments
contemplated by Section 7.1
of
the Agreement for the calendar year
2005.
|
7. |
Cubist
shall be entitled to credit $***** against any future royalties
owed to
XTL on the Net Sales and/or Net Sublicensing Revenues of HepeX-B,
as
contemplated by Section 10 of the
Agreement.
|
Milestone
|
Payment
|
|
*****
|
|
U.S.
$*****
|
|
|
|
*****
|
|
U.S.
$*****
|
|
|
|
*****
|
|
U.S.
$*****
|
|
|
|
*****
|
|
U.S.
$*****
|
XTL
BIOPHARMACEUTICALS LTD.
By:
(Signature)
(Printed
Name)
(Title)
(Date)
|
B&C
BIOPHARM CO., LTD.
By:
(Signature)
(Printed
Name)
(Title)
(Date)
|
*****
|
|||
Territory
|
Rights
to B&C
Compounds
in the Field
|
Responsibility
for Development and Commercialization
|
Financial
Terms
|
|||
World
excluding Asia
|
XTL
receives exclusive license to Licensed Technology
|
XTL
|
XTL
pays B&C according to Article 3
|
|||
Japan
|
XTL
receives exclusive license to Licensed Technology
|
XTL
|
XTL
and B&C equally share all costs and revenues
|
|||
Korea
|
B&C
retains all rights to B&C Compounds
|
B&C
with XTL collaboration on clinical study design
|
B&C
responsible for all costs and receives all revenues
|
|||
Asia
excluding Korea and Japan
|
XTL
and B&C
|
XTL
and B&C
|
XTL
and B&C equally share all costs and
revenues
|
By:
/s/ Jonathan
Burgin
Jonathan Burgin
(the “ Employee ”) |
By:
/s/ Martin
Becker
XTL Biopharmaceuticals Ltd.
Martin Becker Chief Executive Officer |
Dated:
___________________
|
By:
/s/
Jonathan
Burgin
Jonathan Burgin
|
Dated:
___________________
|
By:
/s/ XTL Biopharmaceuticals Ltd.
XTL Biopharmaceuticals Ltd.
|
Dated:
___________________
|
By:
/s/ Shlomo
Dagan
Shlomo Dagan
|
Dated:
___________________
|
By:
/s/ XTL Biopharmaceuticals Ltd.
XTL Biopharmaceuticals Ltd.
|
Private & Confidential
1. |
This
letter records the terms on which you are invited to serve as a
non-Executive director of XTL Biopharmaceuticals Ltd (the "
Company
").
|
2. |
Your
appointment is to continue unless you terminate this arrangement
upon
giving the Company not less than 2 months’ written notice, which may be
given at any time, provided that such notice does not expire before
the
end of the said period. However, your appointment will terminate
forthwith, without any entitlement on your part to compensation,
if:
|
a. |
you
are not reappointed as a director at any Company annual general
meeting
where you are required
to
retire under
the Articles of Association
of
the Company (as amended from time to
time);
|
b. |
you
cease to be a director by reason of your vacating office pursuant
to any
provision of the Articles of Association
of
the Company (as amended from time to time) or the Israeli Companies
Act -
1999 (the “Act”);
|
c. |
you
are convicted of any criminal offence (excluding minor road traffic
offences);
|
d. |
you
breach the terms of this appointment (such breach not being capable
of
remedy) or you fail or refuse to carry out your duties as required
by this
letter; or
|
e. |
you
are guilty of gross misconduct or any act in any way, which may,
in the
opinion of the Board, bring the Company into disrepute or
discredit.
|
3. |
You
will be entitled to a fee for your services as a non-Executive
director,
at the rate of US$20,000 per annum, such fee to be payable quarterly
in
4 equal instalments,
subject to deduction of any tax or other deduction which the Company
is
required to deduct by law
.
In addition, you will be entitled to receive a fee of US$2,000
for each
individual meeting of the Board of Directors of the Company whether
you
attend in person or by telephone, and a fee of US$500 for each
meeting of
a Board Committee, which you attend in your capacity as a non-Executive
Director (whether in person or by telephone). Such additional fees
incurred will be paid in accordance with the payment terms relating
to the
annual fee, above. In addition the Company shall reimburse you
for any
reasonable out of pocket expenses due to your position as a non-Executive
Director of the Company.
|
4. |
You
will be granted 2,000,000 Options to purchase Ordinary Shares,
of nominal
value NIS 0.02 each of the Company (the “Shares”) having an exercise price
equal to $____ (£0.20) per share. The options shall be exercisable for a
period of five (5) years from the date of issuance at the Extraordinary
Shareholders Meeting on 1 August 2005. The Options will be granted
in
accordance with the terms and conditions governing the Company's
2001
Stock Option Plan (the "Plan") and will be subject to the terms
and
conditions thereof; provided, however, that if any provisions hereunder
are inconsistent with the terms and conditions of the Plan, the
terms
hereunder shall control. In accordance with the Plan, should any
change be
made to the Ordinary Shares by reason of any stock split, stock
dividend,
extraordinary cash dividend, recapitalisation, combination of shares,
exchange of shares or other change affecting the outstanding Ordinary
Shares as a class without the Company's receipt of consideration,
appropriate adjustments shall be made to (A) the total number and/or
class
of securities subject to such options and (B) the Exercise Price
in order
to reflect such change and thereby preclude a dilution or enlargement
under such options.
|
5. |
In
the event of termination of this appointment (otherwise than on
termination in accordance with paragraphs 2(a) to (e) inclusive
of this
letter) you will be entitled to that proportion of the fees due
and
unpaid, accrued on a daily basis up to and including the date of
termination of the appointment.
|
6. |
In
the event that you are called on or requested to perform any special
duties or responsibilities outside your ordinary duties as Director
the
Board may agree to pay you special
remuneration.
|
7. |
As
a non-Executive director you will perform the duties normally attendant
on
that office, including (without limitation) using reasonable efforts
to
attend
all
meetings of the
Board of Directors
(you
may attend either in person or through telephone attendance)
.
|
8. |
Both
during the term of your appointment and for three years after its
termination you will observe the obligations of confidentiality,
which are
attendant on the office of director.
In
addition, although they are not specifically mentioned in this
letter, you
will of course be subject to the normal legal duties and responsibilities
of a director of a company incorporated under Israeli
law.
|
9. |
Upon
termination of this appointment you will resign from your office
as a
director of the Company and from all other appointments or offices,
which
you hold as nominee or representative of the
Company.
|
10. |
This
letter shall be governed by Israeli
Law.
|
Private & Confidential
1. |
This
letter records the terms on which you are invited to serve as a
non-Executive director of XTL Biopharmaceuticals Ltd (the "
Company
")
|
2. |
Your
appointment is to continue unless you terminate this arrangement
upon
giving the Company not less than 2 months’ written notice, which may be
given at any time, provided that such notice does not expire before
the
end of the said period. However, your appointment will terminate
forthwith, without any entitlement on your part to compensation,
if:
|
a. |
you
are not reappointed as a director at any Company annual general meeting
where you are required
to
retire under
the Articles of Association
of
the Company (as amended from time to
time);
|
b. |
you
cease to be a director by reason of your vacating office pursuant
to any
provision of the Articles of Association
of
the Company (as amended from time to time) or the Israeli Companies
Act -
1999 (the “Act”);
|
c. |
you
are convicted of any criminal offence (excluding minor road traffic
offences);
|
d. |
you
breach the terms of this appointment (such breach not being capable
of
remedy) or you fail or refuse to carry out your duties as required
by this
letter; or
|
e. |
you
are guilty of gross misconduct or any act in any way, which may,
in the
opinion of the Board, bring the Company into disrepute or
discredit.
|
3. |
You
will be entitled to a fee for your services as a non-Executive director,
at the rate of US$20,000 per annum, such fee to be payable quarterly
in
4 equal instalments,
subject to deduction of any tax or other deduction which the Company
is
required to deduct by law
.
In addition, you will be entitled to receive a fee of US$2,000 for
each
individual meeting of the Board of Directors of the Company whether
you
attend in person or by telephone, and a fee of US$500 for each meeting
of
a Board Committee, which you attend in your capacity as a non-Executive
Director (whether in person or by telephone). Such additional fees
incurred will be paid in accordance with the payment terms relating
to the
annual fee, above.
In
addition, the Company reimburses you for any reasonable out-of-pocket
expenses.
|
4. |
You
will be granted 60,000 options with an exercise price per each option
equal to the average price per share, as derived from the Daily Official
List of the London Stock Exchange, in the three (3) days preceding
the
Extraordinary General Meeting and all such options shall be issued
in
accordance with the Stock Option Plan 2001 and shall vest over three
(3)
years so that upon the first, second and third anniversary of the
Extraordinary General Meeting, they each shall be entitled to exercise
1/3
(one third) of the Options granted, provided that during such time
you are
still members of the Board;
|
5. |
In
the event of termination of this appointment (otherwise than on
termination in accordance with paragraphs 2(a) to (e) inclusive of
this
letter) you will be entitled to that proportion of the fees due and
unpaid, accrued on a daily basis up to and including the date of
termination of the appointment.
|
6. |
In
the event that you are called on or requested to perform any special
duties or responsibilities outside your ordinary duties as Director
the
Board may agree to pay you special
remuneration.
|
7. |
As
a non-Executive director you will perform the duties normally attendant
on
that office, including (without limitation) using reasonable efforts
to
attend
all
meetings of the
Board of Directors
(you may attend either in person or through telephone
attendance)
.
|
8. |
Both
during the term of your appointment and for three years after its
termination you will observe the obligations of confidentiality,
which are
attendant on the office of director.
In
addition, although they are not specifically mentioned in this letter,
you
will of course be subject to the normal legal duties and responsibilities
of a director of a company incorporated under Israeli
law.
|
9. |
Upon
termination of this appointment you will resign from your office
as a
director of the Company and from all other appointments or offices,
which
you hold as nominee or representative of the
Company.
|
10. |
This
letter shall be governed by Israeli
Law.
|
1. |
For
the purpose of the Israeli Companies Act 1999 (the “Act”), each
non-Executive Director who is appointed to the position of any Outside
Director (as such term is defined in the Act) is required to provide
the
Company with a representation as to any related party association
with the
Company. By agreeing to the terms contained herein and signing this
agreement, you hereby confirm,
that:
|
a. |
You,
your relative, your partner, your employee or a corporation you control,
has not, at the date of your appointment or had not in two years
before
the date of your appointment, any relation to the Company, or has
not at
the date of your appointment, any relation to the Controlling Person
(as
defined in the Act), or to “another
corporation”.
|
b. |
Your
other jobs or duties do not cause, and are not likely to cause, any
conflict of interest with your duty as a director of the Company,
or do
not impair your capability to serve as Director of the
Company.
|
c. |
You
are not serving as an Outside Director in any other Company in which
one
of the Directors of the Company is serving as an Outside
Director.
|
2. |
Your
appointment is to continue for a period of 36 months from the date
hereof
and shall continue thereafter until you terminate this arrangement
upon
giving the Company not less than 2 months’ written notice which may be
given at any time, provided that such notice does not expire before
the
end of the said minimum period. However, your appointment will terminate
forthwith, without any entitlement on your part to compensation,
if:
|
a. |
You
are not reappointed as a Director at any Company Annual General Meeting
where you are required to retire under the Articles of Association
of the
Company (as amended from time to
time);
|
b. |
You
cease to be a Director by reason of your vacating office pursuant
to any
provision of the Articles of Association of the Company (as amended
from
time to time) or the Act;
|
c. |
You
are convicted of any criminal offence (excluding minor road traffic
offences);
|
d. |
You
breach the terms of this appointment (such breach not being capable
of
remedy) or you fail or refuse to carry out your duties as required
by this
letter; or
|
e. |
You
are guilty of gross misconduct or any act in any way which may, in
the
opinion of the Board, bring the Company into disrepute or
discredit.
|
3. |
You
will be entitled to a fee for your services as a non-Executive Director,
at the rate of US$20,000 per annum, such fee to be payable quarterly
in 4
equal instalments, subject to restrictions imposed by applicable
law and
to the deduction of any tax or other deduction which the Company
is
required to deduct by law.
In
addition, you will be entitled to receive a fee of US$2,000 for
participating in person in a Board Meeting or a Committee Meeting
occurring in addition to a scheduled Board Meeting, and a fee of
US$500
for participating in a Committee Meeting occurring at the time of
a Board
Meeting or for participating in a Board or a Committee meeting held
via
phone.
Such
additional fees incurred will be paid in accordance with the payment
terms
relating to the annual fee, above.
|
4. |
In
the event of termination of this appointment (otherwise than on
termination in accordance with paragraphs 2(b) to (e) inclusive of
this
letter) you will be entitled to that proportion of the fees due and
unpaid, accrued on a daily basis up to and including the date of
termination of the appointment.
|
5. |
In
the event that you are called on or requested to perform any special
duties or responsibilities outside your ordinary duties as Director
the
Board may agree to pay you special
remuneration.
|
6. |
As
a non-Executive Director you will perform the duties normally attendant
on
that office, including (without limitation) using reasonable efforts
to
attend all meetings of the Board of Directors (you may attend either
in
person or through telephone attendance).
|
7. |
Both
during the term of your appointment and after its termination you
will
observe the obligations of confidentiality which are attendant on
the
Officer of Director. In addition, although they are not specifically
mentioned in this letter, you will of course be subject to the normal
legal duties and responsibilities of a Director of a company incorporated
under Israeli law.
|
8. |
Upon
termination of this appointment you will resign from your office
as a
Director of the Company and from all other appointments or offices
which
you hold as nominee or representative of the
Company.
|
9. |
This
letter shall be governed by Israeli
Law.
|
1.1
|
Expenses
:
includes reasonable costs of litigation, including attorney’s fees,
expended by the Indemnitee or for which the Indemnitee has been
charged by
a court. Expenses shall also include, without limitation and to
the
fullest extent permitted by applicable law, all expenses reasonably
incurred in defending any claim (including investigation and
pre-litigation negotiations) and any security or bond that the
Indemnitee
may be required to post in connection with an Indemnifiable Event
(as
defined below).
|
1.2
|
Office
Holder
:
as such term is defined in the Israeli Companies Law,
5759-1999.
|
2.1
|
The
Company hereby undertakes to indemnify the Indemnitee to the fullest
extent permitted by applicable law, for any liability and Expense
that may
be imposed on Indemnitee, up to an aggregate of $4million, due
to an act
performed or failure to act by him in his capacity as an Office
Holder of
the Company or any subsidiary of the Company or any entity in which
Indemnitee serves as an Office Holder at the request of the Company
either
prior to or after the date hereof for (the following shall be hereinafter
referred to as “Indemnifiable
Events”):
|
2.1.1
|
monetary
liability imposed on
the
Indemnitee
in
favour of a third party in a judgment (which third parties include,
without limitation and to the fullest extent permitted by applicable
law,
any governmental entity), including a settlement or an arbitration
award
confirmed by a court, for an act that
the
Indemnitee
performed by virtue of being an Office Holder of the Company
;
and
|
2.1.2
|
reasonable
costs of litigation, including attorneys’ fees, expended by
the
Indemnitee
or
for which the Indemnitee has been charged by a court, in an action
brought
against the Indemnitee by or on behalf of the Company or a third
party, or
in a criminal action in which the Indemnitee was found innocent,
or in a
criminal offence in which the Indemnitee was convicted and in which
a
proof of criminal intent is not required.
|
2.2.
|
The
indemnification undertaking made by the Company shall be only with
respect
to such events as are described in Schedule A attached hereto.
The maximum
amount payable by the Company under all indemnification agreements
with
all the non-Executive Directors of the Company shall not exceed
four
million dollars measured promptly after receipt by the Indemnitee
of
notice of the commencement of any action, suit or proceeding to
be made
against the Company.
|
2.3
|
If
so requested by the Indemnitee, the Company shall advance an amount
(or
amounts) estimated by it to cover Indemnitee’s reasonable litigation
Expenses with respect to which the Indemnitee is entitled to be
indemnified under Sections 2.1 and 2.2
above.
|
2.4
|
The
Company’s obligation to indemnify the Indemnitee and advance Expenses in
accordance with this Agreement shall be for such period as the
Indemnitee
shall be subject to any possible claim or threatened, pending or
completed
action, suit or proceeding or any inquiry or investigation, whether
civil,
criminal or investigative, arising out of the Indemnitee’s service in the
foregoing positions, whether or not the Indemnitee is still serving
in
such positions.
|
8.1
|
To
the extent that it may wish, the Company jointly with any other
indemnifying party similarly notified will be entitled to assume
the
defence thereof, with counsel reasonably satisfactory to the Indemnitee,
provided, however, that the Company will not be entitled to do
so if
Indemnitee shall have reasonably concluded that there may be a
conflict of
interest between the Company and the Indemnitee in the conduct
of the
defence of such action.
|
8.2
|
The
Indemnitee shall have the right to employ his or her own counsel
in such
action, suit or proceeding at the expense of the
Company.
|
8.3
|
The
Company shall not be liable to indemnify the Indemnitee under this
Agreement for any amounts paid in settlement of any action or claim
effected without its prior written consent - not to be unreasonably
withheld. The Company shall not settle any action or claim in any
manner
that would impose any penalty, liability or limitation on the Indemnitee
without the Indemnitee’s prior written consent. Neither the Company nor
the Indemnitee will unreasonably withhold their consent to any
proposed
settlement.
|
XTL
Biopharmaceuticals Ltd.
Name:
_________________________________
Date:
_________________________________
Signature:
______________________________
|
Non-Executive
Director
Name:
_________________________________
Date:
__________________________________
Signature:
______________________________
|
1.
|
Negotiations,
execution, delivery and performance of agreements on behalf of
the
Company
|
2.
|
Anti-competitive
acts and acts of commercial wrongdoing
|
3.
|
Acts
in regard to invasion of privacy including with respect to databases
and
acts in regard of slander
|
4.
|
Acts
in regard to copyrights, patents, designs and any other intellectual
property rights, and acts in regard to defects in the Company’s products
or services
|
5.
|
Approval
of corporate actions including the approval of the acts of the
Company’s
management, their guidance and their supervision
|
6.
|
Claims
of failure to exercise business judgment and a reasonable level
of
proficiency, expertise and care in regard to the Company’s business
|
7.
|
Claims
relating to the offering of securities, claims relating to violations
of
securities laws of any jurisdiction and claims arising out of the
Company’s status as a publicly-traded company, including, without
limitation, fraudulent disclosure claims, failure to comply with
SEC
disclosure rules and other claims relating to relationships with
investors
and the investment community
|
8.
|
Violations
of securities laws of any jurisdiction, including without limitation,
fraudulent disclosure claims and other claims relating to relationships
with investors and the investment community
|
9.
|
Violations
of laws requiring the Company to obtain regulatory and governmental
licenses, permits and authorizations in any
jurisdiction
|
10.
|
Claims
in connection with publishing or providing any information, including
any
filings with governmental authorities, on behalf of the Company
in the
circumstances required under applicable laws
|
11.
|
Violations
of any law or regulation governing domestic and international
telecommunications in any
jurisdiction
|