x | ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
¨ | TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware
|
|
20-2903526
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification Number)
|
|
|
|
248 Route 25A, No. 2
East Setauket, New York
|
|
11733
|
(Address of principal executive offices)
|
|
(Zip Code)
|
|
|
Page
Number
|
|
|
|
PART I
|
|
|
|
|
|
ITEM 1.
|
BUSINESS
|
4
|
ITEM 1A
|
RISK FACTORS
|
12
|
ITEM 1B
|
UNRESOLVED STAFF COMMENTS
|
22
|
ITEM 2.
|
PROPERTIES
|
22
|
ITEM 3.
|
LEGAL PROCEEDINGS
|
22
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
22
|
|
|
|
PART II
|
|
|
|
|
|
ITEM 5.
|
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
|
23
|
ITEM 6.
|
SELECTED FINANCIAL DATA
|
24
|
ITEM 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
25
|
ITEM 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
|
36
|
ITEM 8.
|
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
36
|
ITEM 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
36
|
ITEM 9A(T).
|
CONTROLS AND PROCEDURES
|
36
|
ITEM 9B.
|
OTHER INFORMATION
|
37
|
|
|
|
PART III
|
|
|
|
|
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
38
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
41
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
45
|
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
46
|
ITEM 14.
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
48
|
ITEM 15.
|
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
|
48
|
|
|
|
SIGNATURES
|
|
49
|
|
|
|
INDEX TO EXHIBITS
|
50
|
2 | ||
|
3 | ||
|
ITEM 1. | BUSINESS |
4 | ||
|
5 | ||
|
6 | ||
|
Patent
|
|
Priority Date
|
|
Type
|
|
Expiration Date
|
US 7,998,957
|
|
Feb 6, 2008
|
|
Composition and Use in Cancer Treatment
|
|
2/20/2030
|
US 8,227,473
|
|
Aug 1, 2009
|
|
Composition and Use in Cancer Treatment
|
|
2/20/2030
|
US 8,426,444 Divisional
|
|
Feb 6, 2008
|
|
Composition and Use in Cancer Treatment
|
|
2/6/2028
|
7 | ||
|
US 8,143,445
|
|
Oct 1, 2008
|
|
Composition and Use in Cancer Treatment
|
|
8/23/2029
|
US 8,455,688 Divisional
|
|
Oct 1, 2008
|
|
Composition and Use in Cancer Treatment
|
|
10/1/2028
|
US 8,058,268
|
|
Aug 1, 2009
|
|
Use in Treatment of Multiple CNS Diseases
|
|
12/31/2029
|
US 8,329,719 Divisional
|
|
Aug 1, 2009
|
|
Use in Treatment of Multiple CNS Diseases
|
|
7/29/2029
|
8 | ||
|
9 | ||
|
· | the cost-effectiveness of any product that the Company ultimately commercializes relative to competing products; |
· | the ease of use and ready availability of any product that the Company brings to market; |
· | the accuracy of a diagnostic test designed by the Company in detecting cancers, including overcoming the propensity for “false positive” results; and |
· | the relative speed with which the Company is able to bring any product resulting from its research to market in its target markets. |
10 | ||
|
11 | ||
|
ITEM 1B | RISK FACTORS |
· | the research methodology used may not be successful in identifying potential product candidates. However, the Company has identified two promising lead candidate compounds which have activity in animal models, one of which, LB-100, is proceeding with an IND submission to the FDA to conduct a clinical trial; |
· | product candidates for diagnostic tests may on further study be shown to not obtain an acceptable level of accuracy; or |
· | product candidates for drugs may on further study be shown to have harmful side effects or other characteristics that indicate they are unlikely to be effective drugs. |
12 | ||
|
13 | ||
|
· | the cost-effectiveness of any product we ultimately commercialize relative to competing products; |
· | the ease of use and ready availability of any product we bring to market; |
· | the accuracy of a diagnostic test designed by us in detecting cancers, including overcoming the propensity for “false positive” results; and |
· | the relative speed with which we are able to bring any product resulting from our research to market in our target markets. |
14 | ||
|
15 | ||
|
· | our ability to generate revenues and achieve profitability; |
· | the future revenues and profitability of our potential customers, suppliers and collaborators; and |
· | the availability of capital. |
· | our ability to provide acceptable evidence of safety and efficacy; |
· | convenience and ease of administration; |
· | prevalence and severity of adverse side effects; |
· | availability of alternative treatments or diagnostic tests; |
· | cost effectiveness; |
16 | ||
|
· | effectiveness of our marketing strategy and the pricing of any product that we may develop; |
· | publicity concerning our products or competitive products; and |
· | our ability to obtain third-party coverage or reimbursement. |
· | we or our licensors might not have been the first to make the inventions covered by our pending or future patent applications; |
· | we or our licensors might not have been the first to file patent applications for these inventions; |
· | others may independently develop similar or alternative technologies or duplicate any of our technologies; |
· | it is possible that our patent applications will not result in an issued patent or patents, or that the scope of protection granted by any patents arising from our patent applications will be significantly narrower than expected; |
· | any patents under which we hold ultimate rights may not provide us with a basis for commercially-viable products, may not provide us with any competitive advantages or may be challenged by third parties as not infringed, invalid, or unenforceable under United States or foreign laws; |
· | any patent issued to us in the future or under which we hold rights may not be valid or enforceable; or |
· | we may develop additional proprietary technologies that are not patentable and which may not be adequately protected through trade secrets; for example if a competitor independently develops duplicative, similar, or alternative technologies. |
17 | ||
|
· | receiving patent protection for our product candidates; |
18 | ||
|
· | preventing others from infringing our intellectual property rights; and |
· | maintaining our patent rights and trade secrets. |
19 | ||
|
· | the issuance of new equity securities pursuant to a future offering or acquisition; |
· | changes in interest rates; |
· | competitive developments, including announcements by competitors of new products or services or significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments; |
· | variations in quarterly operating results; |
· | changes in financial estimates by securities analysts; |
20 | ||
|
· | the depth and liquidity of the market for our common stock; |
· | investor perceptions of our company and the medical device industry generally; and |
· | general economic and other national conditions. |
21 | ||
|
ITEM 1B | UNRESOLVED STAFF COMMENTS |
ITEM 2. | PROPERTIES |
ITEM 3. | LEGAL PROCEEDINGS |
ITEM 4. | MINE SAFETY DISCLOSURES |
22 | ||
|
ITEM 5. | MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS |
· | Our ability to obtain additional financing and, if available, the terms and conditions of the financing; |
· | Our financial position and results of operations; |
· | Concern as to, or other evidence of, the safety or efficacy of any future proposed products and services or our competitors’ products and services; |
· | Announcements of technological innovations or new products or services by us or our competitors; |
· | U.S. and foreign governmental regulatory actions; |
· | The development of litigation against us; |
· | Period-to-period fluctuations in our operating results; |
· | Changes in estimates of our performance by any securities analysts; |
· | Possible regulatory requirements on our business; |
· | The issuance of new equity securities pursuant to a future offering; |
· | Changes in interest rates; |
· | Competitive developments, including announcements by competitors of new products or services or significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments; |
· | Variations in quarterly operating results; |
· | Change in financial estimates by securities analysts; |
· | The depth and liquidity of the market for our common stock; |
· | Investor perceptions of us; and |
· | General economic and other national conditions. |
23 | ||
|
|
|
High
|
|
Low
|
|
||
Year Ended December 31, 2012
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
0.92
|
|
$
|
0.50
|
|
Second Quarter
|
|
$
|
0.88
|
|
$
|
0.65
|
|
Third Quarter
|
|
$
|
0.25
|
|
$
|
0.25
|
|
Fourth Quarter
|
|
$
|
0.70
|
|
$
|
0.13
|
|
|
|
High
|
|
Low
|
|
||
Year Ended December 31, 2013
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
0.74
|
|
$
|
0.25
|
|
Second Quarter
|
|
$
|
0.35
|
|
$
|
0.20
|
|
Third Quarter
|
|
$
|
0.83
|
|
$
|
0.50
|
|
Fourth Quarter
|
|
$
|
0.71
|
|
$
|
0.20
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
|
|
|
|
|
|
|
|
securities
|
|
|
|
|
|
|
|
|
|
|
remaining
|
|
|
|
|
|
|
|
|
|
|
available for
|
|
|
|
|
Number of
|
|
|
|
|
future issuance
|
|
||
|
|
Securities to be
|
|
|
|
|
under equity
|
|
||
|
|
issued upon
|
|
Weighted
|
|
compensation
|
|
|||
|
|
exercise of
|
|
average price of
|
|
plans (excluding
|
|
|||
|
|
outstanding
|
|
outstanding
|
|
securities
|
|
|||
|
|
options, warrants
|
|
options, warrants
|
|
reflected in
|
|
|||
Plan Category
|
|
and rights
|
|
and rights
|
|
column 2)
|
|
|||
Equity Compensation Plans Approved by Security Holders
|
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Compensation Plans Not Approved by Security Holders (2)
|
|
|
3,150,000
|
|
$
|
0.83
|
|
|
1,550,000
|
(1)
|
(1) | Represents shares available under the Company’s 2007 Stock Option Plan. |
(2) | Includes option for 200,000 shares exercisable by the estate of Dr. Robert B. Royds, a former director, who died on March 23, 2013. |
ITEM 6. | SELECTED FINANCIAL DATA |
24 | ||
|
ITEM 7. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
25 | ||
|
26 | ||
|
27 | ||
|
28 | ||
|
29 | ||
|
30 | ||
|
31 | ||
|
32 | ||
|
33 | ||
|
34 | ||
|
35 | ||
|
|
|
|
|
|
Payments Due By Year
|
|
|||||||||||||
|
|
Total
|
|
2014
|
|
2015
|
|
2016
|
|
2017
|
|
2018
|
|
||||||
Research and development contracts
|
|
$
|
40,385
|
|
$
|
40,385
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Theradex work order agreement
|
|
|
1,746,463
|
|
|
1,346,463
|
|
|
400,000
|
|
|
|
|
|
|
|
|
|
|
Patent license agreement
|
|
|
150,000
|
|
|
30,000
|
|
|
30,000
|
|
|
30,000
|
|
|
30,000
|
|
|
30,000
|
|
Consulting agreement
|
|
|
16,000
|
|
|
16,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liquidated damages payable under registration rights agreement
|
|
|
74,000
|
|
|
74,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to stockholder
|
|
|
92,717
|
|
|
92,717
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
2,119,565
|
|
$
|
1,599,565
|
|
$
|
430,000
|
|
$
|
30,000
|
|
$
|
30,000
|
|
$
|
30,000
|
|
ITEM 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK |
ITEM 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA |
ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
ITEM 9A(T). | CONTROLS AND PROCEDURES |
36 | ||
|
ITEM 9B. | OTHER INFORMATION |
37 | ||
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
Name
|
|
Age
|
|
Position(s) Held with the Registrant
|
Dr. John S. Kovach
|
|
77
|
|
Chief Executive Officer, Chief Financial Officer, Director
|
Dr. Philip F. Palmedo
|
|
80
|
|
Director
|
Dr. Mel Sorensen
|
|
57
|
|
Director
|
Dr. Kathleen P. Mullinix
|
|
69
|
|
Director
|
38 | ||
|
39 | ||
|
40 | ||
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
41 | ||
|
42 | ||
|
43 | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Equity
|
|
Non-Qualified
|
|
|
|
|
|
Name and
|
|
|
|
|
|
|
|
Stock
|
|
Option
|
|
Incentive Plan
|
|
Deferred
|
|
All Other
|
|
|
|
Principal
|
|
|
|
Salary
|
|
Bonus
|
|
Awards
|
|
Awards
|
|
Compensation
|
|
Compensation
|
|
Compensation
|
|
Total
|
|
Position
|
|
Year
|
|
($)
|
|
($)
|
|
($)
|
|
($)(1)
|
|
($)
|
|
Earnings ($)
|
|
($)(2)
|
|
($)
|
|
Philip F. Palmedo
|
|
2013
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
Director
|
|
2012
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
|
|
2011
|
|
0
|
|
0
|
|
0
|
|
196,000
|
|
0
|
|
0
|
|
0
|
|
196,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mel Sorensen
|
|
2013
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
10,417
|
|
10,417
|
|
Director
|
|
2012
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
21,875
|
|
21,875
|
|
|
|
2011
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
25,000
|
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert B. Royds
|
|
2013
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
Director
|
|
2012
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
|
|
2011
|
|
0
|
|
0
|
|
0
|
|
196,000
|
|
0
|
|
0
|
|
0
|
|
196.000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kathleen P. Mullinix
|
|
2013
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
0
|
|
Director
|
|
2012
|
|
0
|
|
0
|
|
0
|
|
118,000
|
|
0
|
|
0
|
|
0
|
|
118,000
|
|
|
(1)
|
Consists of grant date fair value calculated pursuant to Black-Scholes option-pricing model.
|
|
(2)
|
All other compensation was paid in the form of cash.
|
44 | ||
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
|
|
Amount and Nature of
|
|
|
|
|
Name and Address of Beneficial Owner
|
|
Beneficial Ownership
|
|
|
Percent of Class
|
|
|
|
|
|
|
|
|
Officers, Directors and 5% stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. John S. Kovach
|
|
|
|
|
|
|
248 Route 25A, No. 2
|
|
|
|
|
|
|
East Setauket, New York 11733
|
|
17,021,786
|
|
|
40.9
|
%
|
|
|
|
|
|
|
|
Dr. Philip F. Palmedo
|
|
|
|
|
|
|
248 Route 25A, No. 2
|
|
|
|
|
|
|
East Setauket, New York 11733
|
|
1,066,020
|
(1)
|
|
2.5
|
%
|
|
|
|
|
|
|
|
Dr. Mel Sorensen
|
|
|
|
|
|
|
248 Route 25A, No. 2
|
|
|
|
|
|
|
East Setauket, New York 11733
|
|
175,000
|
(2)
|
|
0.4
|
%
|
|
|
|
|
|
|
|
Dr. Kathleen P. Mullinix
|
|
|
|
|
|
|
248 Route 25A, No. 2
|
|
|
|
|
|
|
East Setauket, New York 11733
|
|
175,000
|
(5)
|
|
0.4
|
%
|
|
|
|
|
|
|
|
All officers and directors as a group
|
|
|
|
|
|
|
(four persons)
|
|
18,437,806
|
(1)(2)(5)(8)
|
|
43.6
|
%
|
|
|
|
|
|
|
|
Gil Schwartzberg
|
|
|
|
|
|
|
269 South Beverly Drive, No. 1315
|
|
|
|
|
|
|
Beverly Hills, California 90212
|
|
9,473,397
|
(3)
|
|
21.2
|
%
|
|
|
|
|
|
|
|
Dr. Debbie Schwartzberg
|
|
|
|
|
|
|
269 South Beverly Drive, No. 1315
|
|
|
|
|
|
|
Beverly Hills, California 90212
|
|
6,838,845
|
(4)
|
|
15.5
|
%
|
|
|
|
|
|
|
|
Dr. Arthur and Jane Riggs
|
|
|
|
|
|
|
4852 Saint Andres Avenue
|
|
|
|
|
|
|
La Verne, California 91750
|
|
3,000,000
|
(6)
|
|
7.2
|
%
|
|
|
|
|
|
|
|
Robert and Susan Greenberg
|
|
|
|
|
|
|
228 Manhattan Beach Boulevard
|
|
|
|
|
|
|
Manhattan Beach, California 90266
|
|
3,000,000
|
(7)
|
|
7.0
|
%
|
45 | ||
|
(1) | Consists of 600,000 shares of common stock and warrants to purchase 200,000 shares of common stock owned by the Philip Palmedo Partnership, and 66,020 shares of common stock and options to purchase 200,000 shares of common stock owned by Dr. Palmedo. Dr. Palmedo is the general partner of the Philip Palmedo Partnership and has full voting, disposition and investment control as to such shares. All options and warrants are immediately exercisable or within 60 days. |
(2) | Consists of options to purchase 175,000 shares of common stock, all of which are immediately exercisable. |
(3) | Includes 750,800 shares of common stock, options to purchase 3,500,000 shares of common stock, and warrants to purchase 350,000 shares of common stock owned by Mr. Schwartzberg. Also includes 829,782 shares of common stock and warrants to purchase 150,000 shares of common stock owned by the Gil Schwartzberg IRA; 558,815 shares of common stock owned by Continuum Capital Partners, LP, as to which Mr. Schwartzberg has sole voting, disposition and investment control; 1,184,000 shares of common stock and warrants to purchase 500,000 shares of common stock owned by the Julie Schwartzberg Trust, as to which Mr. Schwartzberg is the co-trustee; and 1,150,000 shares of common stock and warrants to purchase 500,000 shares of common stock owned by the David N. Sterling Trust, as to which Mr. Schwartzberg is the co-trustee. Excludes 1,504,845 shares of common stock and warrants to purchase 1,500,000 shares of common stock owned directly by Debbie Schwartzberg, the wife of Mr. Schwartzberg, as to which Mr. Schwartzberg disclaims beneficial ownership or control; and 500,000 shares of common stock by the Debbie Schwartzberg Family Trust. All options and warrants are immediately exercisable or within 60 days. |
(4) | Includes 1,504,845 shares of common stock and warrants to purchase 1,500,000 shares of common stock owned by Ms. Schwartzberg. Also includes 500,000 shares of common stock owned by the Debbie Schwartzberg Family Trust; 1,184,000 shares of common stock and warrants to purchase 500,000 shares of common stock owned by the Julie Schwartzberg Trust, as to which Ms. Schwartzberg is the co-trustee; and 1,150,000 shares of common stock and warrants to purchase 500,000 shares of common stock owned by the David N. Sterling Trust, as to which Ms. Schwartzberg is the co-trustee. Excludes 750,800 shares of common stock, options to purchase 3,500,000 shares of common stock and warrants to purchase 350,000 shares of common stock owned by Mr. Schwartzberg, the husband of Ms. Schwartzberg. Also excludes 829,782 shares of common stock and warrants to purchase 150,000 shares of common stock owned by the Gil Schwartzberg IRA, and 558,815 shares of common stock owned by Continuum Capital Partners, LP, as to which Mr. Schwartzberg has sole voting, disposition and investment control. All options and warrants are immediately exercisable. |
(5) | Consists of options to purchase 175,000 shares of common stock, all of which are immediately exercisable or within 60 days. |
(6) | Consists of 3,000,000 shares of common stock owned by the Arthur and Jane Riggs 1990 Revocable Trust. |
(7) | Includes 2,000,000 shares of common stock and warrants to purchase 1,000,000 shares of common stock owned by the Robert and Susan Greenberg Family Trust. The warrants are immediately exercisable. |
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
46 | ||
|
47 | ||
|
ITEM 14. | PRINCIPAL ACCOUNTANT FEES AND SERVICES |
|
|
2012
|
|
2013
|
|
||
Audit Fees
(1)
|
|
$
|
53,205
|
|
$
|
49,664
|
|
Audit-Related Fees
(2)
|
|
|
|
|
|
|
|
Tax Fees
(3)
|
|
|
5,804
|
|
|
10,450
|
|
All Other Fees
(4)
|
|
|
|
|
|
|
|
Total
|
|
$
|
59,009
|
|
$
|
60,114
|
|
(1) | Audit fees represent fees for professional services provided in connection with the audit of our annual financial statements and the review of our financial statements included in our Form 10-Q quarterly reports and services that are normally provided in connection with statutory or regulatory filings. |
(2) | Audit-related fees represent fees for assurance and related services that are reasonably related to the performance of the audit or review of our financial statements and not reported above under “Audit Fees.” |
(3) | Tax fees represent fees for professional services related to tax compliance, tax advice and tax planning. |
(4) | All other fees represent fees related to Sarbanes-Oxley compliance work. |
ITEM 15. | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES |
48 | ||
|
|
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
|
|
|
(Registrant)
|
|
|
|
|
Date: March 21, 2014
|
By:
|
/s/ JOHN S. KOVACH
|
|
|
Name: John S. Kovach
|
|
|
Title: Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ JOHN S. KOVACH
|
|
Chief Executive Officer, Chief Financial
|
|
March 21, 2014
|
John S. Kovach
|
|
Officer, Principal Accounting Officer and Director
|
|
|
|
|
|
|
|
/s/ PHILIP F. PALMEDO
|
|
Director
|
|
March 21, 2014
|
Philip F. Palmedo
|
|
|
|
|
|
|
|
|
|
/s/ MEL SORENSEN
|
|
Director
|
|
March 21, 2014
|
Mel Sorensen
|
|
|
|
|
|
|
|
|
|
/s/ KATHLEEN P. MULLINIX
|
|
Director
|
|
March 21, 2014
|
Kathleen P. Mullinix
|
|
|
|
|
49 | ||
|
Exhibit
Number
|
|
Description of Document
|
2.1
|
|
Share Exchange Agreement dated as of June 8, 2006 among the Company, John S. Kovach and Lixte Biotechnology, Inc.
1
|
3.1
|
|
Certificate of Incorporation, as filed with the Delaware Secretary of State on May 24, 2005.
2
|
3.2
|
|
Certificate of Amendment of Certificate of Incorporation.
3
|
3.2
|
|
Bylaws.
2
|
10.1
|
|
Cooperative Research and Development Agreement (CRADA) between the U.S. Department of Health and Human Services, as represented by National Institute of Neurological Disorders and Stroke of the National Institutes of Health and Lixte Inc., as amended.
4
|
10.2
|
|
Amendment No. 6 to CRADA.
5
|
10.3
|
|
Agreement between Lixte Biotechnology Holdings, Inc. and Chem-Master International, Inc. dated as of February 5, 2007.
6
|
10.4
|
|
Amendment dated January 28, 2008 to Agreement with Chem-Master International, Inc.
7
|
10.5
|
|
Stock Option Agreement between Lixte Biotechnology Holdings, Inc. and Stephen K. Carter dated September 12, 2007.
8
|
10.6
|
|
Stock Option Agreement between Lixte Biotechnology Holdings, Inc. and Francis Johnson dated September 12, 2007.
8
|
10.7
|
|
Stock Option Agreement between Lixte Biotechnology Holdings, Inc. and Gil Schwartzberg dated September 12, 2007.
8
|
10.8
|
|
Consulting Agreement between Lixte Biotechnology Holdings, Inc. and Gil Schwartzberg dated September 12, 2007.
8
|
10.9
|
|
Amendment to Consulting Agreement with Gil Schwartzberg dated October 15, 2009.
12
|
10.10
|
|
Consulting Agreement between Lixte Biotechnology Holdings, Inc. and Francis Johnson dated September 12, 2007.
8
|
10.11
|
|
Consulting Agreement between Lixte Biotechnology Holdings, Inc. and Pro-Active Capital Group, LLC dated July 27, 2009.
9
|
10.12
|
|
License Agreement dated as of September 19, 2008 between the Company and the United States Public Health Services.
10
|
10.13
|
|
Stock Option Agreement between the Company and Mel Sorensen dated October 7, 2008.
11
|
10.14
|
|
Consulting Agreement between the Company and Mel Sorensen dated October 7, 2008.
11
|
10.15
|
|
Master Agreement between Lixte Biotechnology Holdings, Inc. and Theradex Systems, Inc. dated January 12, 2010.
12
|
10.16
|
|
Materials Cooperative Research and Development Agreement between Lixte Biotechnology Holdings, Inc. and the National Institute of Neurological Disorders and Stroke dated October 18, 2013.
13
|
10.17
|
|
Scientific Advisory Board Agreement between Lixte Biotechnology Holdings, Inc. and NDA Consulting Corp. dated December 24, 2013.
13
|
10.18
|
|
Advisory Agreement between Lixte Biotechnology Holdings, Inc. and Kathleen P. Mullinix dated January 1, 2014.
13
|
31
|
|
Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
13
|
32
|
|
Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
13
|
1
|
Filed as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 7, 2006 and incorporated herein by reference.
|
|
|
2
|
Filed as an Exhibit to the Company’s Registration Statement on Form 10-SB, as filed with the Securities and Exchange Commission on August 3, 2005 and incorporated herein by reference.
|
|
|
3
|
Filed as Appendix A to the Company’s Information Statement, as filed with the Securities and Exchange Commission on September 20, 2006 and incorporated herein by reference.
|
|
|
4
|
Filed as an Exhibit to the Company’s Registration on Form SB-2 as filed with the Securities and Exchange Commission on March 13, 2007 and incorporated herein by reference.
|
50 | ||
|
5
|
Filed as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August 12, 2009 and incorporated herein by reference.
|
|
|
6
|
Filed as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on February 9, 2007 and incorporated herein by reference.
|
|
|
7
|
Filed as an Exhibit to the Company’s Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission on May 14, 2008 and incorporated herein by reference.
|
|
|
8
|
Filed as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August 12, 2009 and incorporated herein by reference.
|
|
|
9
|
Filed as an Exhibit to the Company’s Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission on November 12, 2009 and incorporated herein by reference.
|
|
|
10
|
Filed as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 31, 2009 and incorporated herein by reference.
|
|
|
11
|
Filed as an Exhibit to the Company’s Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission on November 12, 2008 and incorporated herein by reference.
|
|
|
12
|
Filed as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 15, 2013 and incorporated herein by reference.
|
|
|
13
|
Filed herewith.
|
51 | ||
|
Report of Independent Registered Public Accounting Firm
|
F-2
|
|
|
Consolidated Balance Sheets December 31, 2013 and 2012
|
F-3
|
|
|
Consolidated Statements of Operations - Years Ended December 31, 2013 and 2012, and Period from August 9, 2005 (Inception) to December 31, 2013 (Cumulative)
|
F-4
|
|
|
Consolidated Statement of Stockholders’ Equity (Deficiency) - Period from August 9, 2005 (Inception) to December 31, 2013
|
F-5
|
|
|
Consolidated Statements of Cash Flows - Years Ended December 31, 2013 and 2012, and Period from August 9, 2005 (Inception) to December 31, 2013 (Cumulative)
|
F-7
|
|
|
Notes to Consolidated Financial Statements Years Ended December 31, 2013 and 2012, and Period from August 9, 2005 (Inception) to December 31, 2013 (Cumulative)
|
F-8
|
F-2 | ||
|
|
|
December 31,
|
|
||||
|
|
2013
|
|
2012
|
|
||
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
475,019
|
|
$
|
1,655,122
|
|
Money market funds
|
|
|
6,135
|
|
|
6,134
|
|
Advances on research and development contract services
|
|
|
33,880
|
|
|
51,575
|
|
Prepaid expenses and other current assets
|
|
|
43,006
|
|
|
40,179
|
|
Total current assets
|
|
|
558,040
|
|
|
1,753,010
|
|
Total assets
|
|
$
|
558,040
|
|
$
|
1,753,010
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
107,774
|
|
$
|
80,416
|
|
Research and development contract liabilities, including $34,398 and $9,679
to a related party at December 31, 2013 and 2012, respectively |
|
|
47,283
|
|
|
14,019
|
|
Liquidated damages payable under registration rights agreement
|
|
|
74,000
|
|
|
74,000
|
|
Due to stockholder
|
|
|
92,717
|
|
|
92,717
|
|
Total current liabilities
|
|
|
321,774
|
|
|
261,152
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; authorized 10,000,000 shares; issued none
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; authorized - 100,000,000 shares; issued and
outstanding 41,583,097 shares |
|
|
4,158
|
|
|
4,158
|
|
Additional paid-in capital
|
|
|
13,184,081
|
|
|
13,064,831
|
|
Deficit accumulated during the development stage
|
|
|
(12,951,973)
|
|
|
(11,577,131)
|
|
Total stockholders’ equity
|
|
|
236,266
|
|
|
1,491,858
|
|
Total liabilities and stockholders’ equity
|
|
$
|
558,040
|
|
$
|
1,753,010
|
|
F-3 | ||
|
|
|
|
|
Period from
|
|
|||||
|
|
|
|
August 9,
|
|
|||||
|
|
|
|
2005
|
|
|||||
|
|
|
|
(Inception) to
|
|
|||||
|
|
Years Ended
|
|
December 31,
|
|
|||||
|
|
December 31,
|
|
2013
|
|
|||||
|
|
2013
|
|
2012
|
|
(Cumulative)
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
General and administrative costs, including $115,768
and $724,204 to related parties for the years ended December 31, 2013 and 2012, respectively, and $2,763,909 for the period from August 9, 2005 to December 31, 2013 (cumulative). |
|
|
494,959
|
|
|
1,093,614
|
|
|
5,727,899
|
|
Depreciation
|
|
|
|
|
|
|
|
|
1,909
|
|
Research and development costs, including $304,102
and $185,536 to related parties for the years ended December 31, 2013 and 2012, respectively, and $548,272 for the period from August 9, 2005 to December 31, 2013 (cumulative). |
|
|
879,886
|
|
|
1,012,144
|
|
|
5,449,678
|
|
Reverse merger costs
|
|
|
|
|
|
|
|
|
50,000
|
|
Total costs and expenses
|
|
|
1,374,845
|
|
|
2,105,758
|
|
|
11,229,486
|
|
Loss from operations
|
|
|
(1,374,845)
|
|
|
(2,105,758)
|
|
|
(11,229,486)
|
|
Interest income
|
|
|
3
|
|
|
8
|
|
|
27,437
|
|
Interest expense
|
|
|
|
|
|
|
|
|
(2,469)
|
|
Fair value of warrant extensions
|
|
|
|
|
|
(1,139,592)
|
|
|
(1,339,431)
|
|
Fair value of warrant discount
|
|
|
|
|
|
(334,024)
|
|
|
(334,024)
|
|
Liquidated damages under registration rights agreement
|
|
|
|
|
|
|
|
|
(74,000)
|
|
Net loss
|
|
$
|
(1,374,842)
|
|
$
|
(3,579,366)
|
|
$
|
(12,951,973)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share Basic and diluted
|
|
$
|
(0.03)
|
|
$
|
(0.09)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding Basic and diluted
|
|
|
41,583,097
|
|
|
38,985,832
|
|
|
|
|
F-4 | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Advances
|
|
|
|
|
Accumulated
|
|
Total
|
|
|||
|
|
|
|
|
|
|
|
Under
|
|
Additional
|
|
During the
|
|
Stockholders’
|
|
||||
|
|
Common Stock
|
|
Equity
|
|
Paid-in
|
|
Development
|
|
Equity
|
|
||||||||
|
|
Shares
|
|
Amount
|
|
Financing
|
|
Capital
|
|
Stage
|
|
(Deficiency)
|
|
||||||
Balance, August 9, 2005 (inception)
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Shares issued to founding stockholder
|
|
|
19,021,786
|
|
|
1,902
|
|
|
|
|
|
(402)
|
|
|
|
|
|
1,500
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,124)
|
|
|
(16,124)
|
|
Balance, December 31, 2005
|
|
|
19,021,786
|
|
|
1,902
|
|
|
|
|
|
(402)
|
|
|
(16,124)
|
|
|
(14,624)
|
|
Shares issued in connection with reverse merger transaction
|
|
|
4,005,177
|
|
|
401
|
|
|
|
|
|
62,099
|
|
|
|
|
|
62,500
|
|
Shares issued in private placement, net of offering costs
|
|
|
3,555,220
|
|
|
355
|
|
|
|
|
|
969,017
|
|
|
|
|
|
969,372
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
97,400
|
|
|
|
|
|
97,400
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(562,084)
|
|
|
(562,084)
|
|
Balance, December 31, 2006
|
|
|
26,582,183
|
|
|
2,658
|
|
|
|
|
|
1,128,114
|
|
|
(578,208)
|
|
|
552,564
|
|
Shares issued in private placement, net of offering costs
|
|
|
999,995
|
|
|
100
|
|
|
|
|
|
531,220
|
|
|
|
|
|
531,320
|
|
Stock-based compensation expense
|
|
|
250,000
|
|
|
25
|
|
|
|
|
|
890,669
|
|
|
|
|
|
890,694
|
|
Stock-based research and development expense
|
|
|
|
|
|
|
|
|
|
|
|
50,836
|
|
|
|
|
|
50,836
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,648,488)
|
|
|
(1,648,488)
|
|
Balance, December 31, 2007
|
|
|
27,832,178
|
|
|
2,783
|
|
|
|
|
|
2,600,839
|
|
|
(2,226,696)
|
|
|
376,926
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
357,987
|
|
|
|
|
|
357,987
|
|
Stock-based research and development expense
|
|
|
100,000
|
|
|
10
|
|
|
|
|
|
213,051
|
|
|
|
|
|
213,061
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,271,522)
|
|
|
(1,271,522)
|
|
Balance, December 31, 2008
|
|
|
27,932,178
|
|
|
2,793
|
|
|
|
|
|
3,171,877
|
|
|
(3,498,218)
|
|
|
(323,548)
|
|
Shares issued in private placements, net of offering costs
|
|
|
2,420,000
|
|
|
242
|
|
|
|
|
|
1,096,808
|
|
|
|
|
|
1,097,050
|
|
Advances under equity financing
|
|
|
|
|
|
|
|
|
1,200,000
|
|
|
|
|
|
|
|
|
1,200,000
|
|
Stock-based compensation expense
|
|
|
150,000
|
|
|
15
|
|
|
|
|
|
745,965
|
|
|
|
|
|
745,980
|
|
Stock-based research and development expense
|
|
|
|
|
|
|
|
|
|
|
|
132,933
|
|
|
|
|
|
132,933
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,551,333)
|
|
|
(1,551,333)
|
|
Balance, December 31, 2009
|
|
|
30,502,178
|
|
$
|
3,050
|
|
$
|
1,200,000
|
|
$
|
5,147,583
|
|
$
|
(5,049,551)
|
|
$
|
1,301,082
|
|
F-5 | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Advances
|
|
|
|
|
Accumulated
|
|
Total
|
|
|||
|
|
|
|
|
|
|
|
Under
|
|
Additional
|
|
During the
|
|
Stockholders’
|
|
||||
|
|
Common Stock
|
|
Equity
|
|
Paid-in
|
|
Development
|
|
Equity
|
|
||||||||
|
|
Shares
|
|
Amount
|
|
Financing
|
|
Capital
|
|
Stage
|
|
(Deficiency)
|
|
||||||
Shares issued in private placements, net of offering costs
|
|
|
4,575,000
|
|
$
|
458
|
|
$
|
(1,200,000)
|
|
$
|
2,287,042
|
|
$
|
|
|
$
|
1,087,500
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
160,712
|
|
|
|
|
|
160,712
|
|
Stock-based research and development expense
|
|
|
|
|
|
|
|
|
|
|
|
67,222
|
|
|
|
|
|
67,222
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(880,250)
|
|
|
(880,250
|
|
Balance, December 31, 2010
|
|
|
35,077,178
|
|
|
3,508
|
|
|
|
|
|
7,662,559
|
|
|
(5,929,801)
|
|
|
1,736,266
|
|
Exercise of stock options
|
|
|
181,964
|
|
|
18
|
|
|
|
|
|
4,982
|
|
|
|
|
|
5,000
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
204,898
|
|
|
|
|
|
204,898
|
|
Stock-based research and development expense
|
|
|
|
|
|
|
|
|
|
|
|
982
|
|
|
|
|
|
982
|
|
Fair value of warrant extension
|
|
|
|
|
|
|
|
|
|
|
|
199,839
|
|
|
|
|
|
199,839
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,067,964)
|
|
|
(2,067,964)
|
|
Balance, December 31, 2011
|
|
|
35,259,142
|
|
|
3,526
|
|
|
|
|
|
8,073,260
|
|
|
(7,997,765)
|
|
|
79,021
|
|
Exercise of stock options
|
|
|
241,955
|
|
|
24
|
|
|
|
|
|
33,309
|
|
|
|
|
|
33,333
|
|
Exercise of stock warrants
|
|
|
6,082,000
|
|
|
608
|
|
|
|
|
|
2,467,642
|
|
|
|
|
|
2,468,250
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
723,554
|
|
|
|
|
|
723,554
|
|
Stock-based research and development expense
|
|
|
|
|
|
|
|
|
|
|
|
293,450
|
|
|
|
|
|
293,450
|
|
Fair value of warrant discount
|
|
|
|
|
|
|
|
|
|
|
|
334,024
|
|
|
|
|
|
334,024
|
|
Fair value of warrant extensions
|
|
|
|
|
|
|
|
|
|
|
|
1,139,592
|
|
|
|
|
|
1,139,592
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,579,366)
|
|
|
(3,579,366)
|
|
Balance, December 31, 2012
|
|
|
41,583,097
|
|
|
4,158
|
|
|
|
|
|
13,064,831
|
|
|
(11,577,131)
|
|
|
1,491,858
|
|
Stock-based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
119,250
|
|
|
|
|
|
119,250
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,374,842)
|
|
|
(1,374,842)
|
|
Balance, December 31, 2013
|
|
|
41,583,097
|
|
$
|
4,158
|
|
$
|
|
|
$
|
13,184,081
|
|
$
|
(12,951,973)
|
|
$
|
236,266
|
|
F-6 | ||
|
|
|
|
|
Period from
|
|
|||||
|
|
|
|
August 9,
|
|
|||||
|
|
|
|
2005
|
|
|||||
|
|
|
|
(Inception) to
|
|
|||||
|
|
Years Ended
|
|
December 31,
|
|
|||||
|
|
December 31,
|
|
2013
|
|
|||||
|
|
2013
|
|
2012
|
|
(Cumulative)
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,374,842)
|
|
$
|
(3,579,366)
|
|
$
|
(12,951,973)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
|
|
|
|
|
|
1,909
|
|
Stock-based compensation expense included in general and administrative costs
|
|
|
119,125
|
|
|
723,554
|
|
|
3,300,100
|
|
Stock-based compensation expense included in research and development costs
|
|
|
125
|
|
|
293,450
|
|
|
758,609
|
|
Fair value of warrant extensions
|
|
|
|
|
|
1,139,592
|
|
|
1,339,431
|
|
Fair value of warrant discount
|
|
|
|
|
|
334,024
|
|
|
334,024
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in -
|
|
|
|
|
|
|
|
|
|
|
Advances on research and development contract services
|
|
|
17,695
|
|
|
(22,592)
|
|
|
(33,880)
|
|
Prepaid expenses and other current assets
|
|
|
(2,827)
|
|
|
(4,825)
|
|
|
(43,006)
|
|
Increase (decrease) in -
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
27,358
|
|
|
(28,925)
|
|
|
107,774
|
|
Liquidated damages payable under registration rights agreement
|
|
|
|
|
|
|
|
|
74,000
|
|
Research and development contract liabilities
|
|
|
33,264
|
|
|
(60,669)
|
|
|
47,283
|
|
Net cash used in operating activities
|
|
|
(1,180,102)
|
|
|
(1,205,757)
|
|
|
(7,065,729)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in money market funds
|
|
|
(1)
|
|
|
344,995
|
|
|
(6,135)
|
|
Purchase of office equipment
|
|
|
|
|
|
|
|
|
(1,909)
|
|
Net cash provided by (used in) investing activities
|
|
|
(1)
|
|
|
344,995
|
|
|
(8,044)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options
|
|
|
|
|
|
33,333
|
|
|
38,333
|
|
Proceeds from exercise of warrants
|
|
|
|
|
|
2,468,250
|
|
|
2,468,250
|
|
Proceeds from sale of common stock to consulting firm
|
|
|
|
|
|
|
|
|
250
|
|
Proceeds from sale of common stock to founder
|
|
|
|
|
|
|
|
|
1,500
|
|
Proceeds from issuance of notes payable to consultant
|
|
|
|
|
|
|
|
|
200,000
|
|
Repayment of notes payable to consultant
|
|
|
|
|
|
|
|
|
(200,000)
|
|
Cash acquired in reverse merger transaction
|
|
|
|
|
|
|
|
|
62,500
|
|
Gross proceeds from sale of securities
|
|
|
|
|
|
|
|
|
5,331,389
|
|
Payment of private placement offering costs
|
|
|
|
|
|
|
|
|
(446,147)
|
|
Advances received from stockholder
|
|
|
|
|
|
|
|
|
92,717
|
|
Net cash provided by financing activities
|
|
|
|
|
|
2,501,583
|
|
|
7,548,792
|
|
F-7 | ||
|
|
|
|
|
Period from
|
|
|||||
|
|
|
|
August 9,
|
|
|||||
|
|
|
|
2005
|
|
|||||
|
|
|
|
(Inception) to
|
|
|||||
|
|
Years Ended
|
|
December 31,
|
|
|||||
|
|
December 31,
|
|
2013
|
|
|||||
|
|
2013
|
|
2012
|
|
(Cumulative)
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
Cash:
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease)
|
|
$
|
(1,180,103)
|
|
$
|
1,640,821
|
|
$
|
475,019
|
|
Balance at beginning of period
|
|
|
1,655,122
|
|
|
14,301
|
|
|
|
|
Balance at end of period
|
|
$
|
475,019
|
|
$
|
1,655,122
|
|
$
|
475,019
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
Cash paid for -
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
|
|
$
|
|
|
$
|
2,469
|
|
Income taxes
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash financing activities:
|
|
|
|
|
|
|
|
|
|
|
Decrease in advances under equity financing
|
|
$
|
|
|
$
|
|
|
$
|
1,200,000
|
|
Aggregate exercise price of warrants and options exercised on a cashless basis
|
|
$
|
|
|
$
|
109,391
|
|
$
|
193,598
|
|
F-8 | ||
|
F-9 | ||
|
F-10 | ||
|
F-11 | ||
|
F-12 | ||
|
F-13 | ||
|
|
|
2013
|
|
2012
|
|
||
|
|
|
|
|
|
|
|
Warrants
|
|
|
6,828,800
|
|
|
6,828,800
|
|
Stock options
|
|
|
3,150,000
|
|
|
3,750,000
|
|
Total
|
|
|
9,978,800
|
|
|
10,578,800
|
|
F-14 | ||
|
F-15 | ||
|
F-16 | ||
|
F-17 | ||
|
F-18 | ||
|
F-19 | ||
|
|
|
|
|
|
|
|
Weighted
|
|
||
|
|
|
|
|
|
|
Average
|
|
||
|
|
|
|
|
Weighted
|
|
Remaining
|
|
||
|
|
Number
|
|
Average
|
|
Contractual
|
|
|||
|
|
of
|
|
Exercise
|
|
Life
|
|
|||
|
|
Shares
|
|
Price
|
|
(in Years)
|
|
|||
Warrants outstanding at December 31, 2011
|
|
|
13,454,552
|
|
$
|
0.607
|
|
|
|
|
Issued
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(6,355,752)
|
|
|
0.535
|
|
|
|
|
Expired
|
|
|
(270,000)
|
|
|
0.844
|
|
|
|
|
Warrants outstanding at December 31, 2012
|
|
|
6,828,800
|
|
|
0.667
|
|
|
|
|
Issued
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding at December 31, 2013
|
|
|
6,828,800
|
|
$
|
0.667
|
|
|
0.67
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercisable at December 31, 2012
|
|
|
6,659,840
|
|
$
|
0.672
|
|
|
|
|
Warrants exercisable at December 31, 2013
|
|
|
6,659,840
|
|
$
|
0.672
|
|
|
0.42
|
|
|
|
Warrants
|
|
Warrants
|
|
|
Exercise
|
|
Outstanding
|
|
Exercisable
|
|
|
Prices
|
|
(Shares)
|
|
(Shares)
|
|
|
|
|
|
|
|
|
|
$
|
0.500
|
|
2,253,800
|
|
2,084,840
|
|
$
|
0.750
|
|
4,575,000
|
|
4,575,000
|
|
|
|
|
6,828,800
|
|
6,659,840
|
|
F-20 | ||
|
F-21 | ||
|
F-22 | ||
|
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2013:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
6,135
|
|
$
|
6,135
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2012:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
6,134
|
|
$
|
6,134
|
|
$
|
|
|
$
|
|
|
F-23 | ||
|
F-24 | ||
|
F-25 | ||
|
F-26 | ||
|
F-27 | ||
|
F-28 | ||
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
Weighted
|
|
Remaining
|
|
||
|
|
Number
|
|
Average
|
|
Contractual
|
|
|||
|
|
of
|
|
Exercise
|
|
Life
|
|
|||
|
|
Shares
|
|
Price
|
|
(in Years)
|
|
|||
Options outstanding at December 31, 2011
|
|
|
3,250,000
|
|
$
|
0.884
|
|
|
|
|
Granted
|
|
|
1,200,000
|
|
|
0.796
|
|
|
|
|
Exercised
|
|
|
(100,000)
|
|
|
0.333
|
|
|
|
|
Expired
|
|
|
(600,000)
|
|
|
0.889
|
|
|
|
|
Options outstanding at December 31, 2012
|
|
|
3,750,000
|
|
|
0.870
|
|
|
|
|
Granted
|
|
|
100,000
|
|
|
0.130
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(700,000)
|
|
|
1.045
|
|
|
|
|
Options outstanding at December 31, 2013
|
|
|
3,150,000
|
|
$
|
0.818
|
|
|
2.62
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at December 31, 2012
|
|
|
3,512,500
|
|
$
|
0.876
|
|
|
|
|
Options exercisable at December 31, 2013
|
|
|
3,000,000
|
|
$
|
0.843
|
|
|
2.52
|
|
|
|
|
Options
|
|
Options
|
|
||
Exercise
|
|
Outstanding
|
|
Exercisable
|
|
|||
Prices
|
|
(Shares)
|
|
(Shares)
|
|
|||
|
|
|
|
|
|
|
|
|
$
|
0.130
|
|
|
100,000
|
|
|
|
|
$
|
0.333
|
|
|
200,000
|
|
|
200,000
|
|
$
|
0.500
|
|
|
200,000
|
|
|
200,000
|
|
$
|
0.650
|
|
|
700,000
|
|
|
650,000
|
|
$
|
0.980
|
|
|
450,000
|
|
|
450,000
|
|
$
|
1.000
|
|
|
1,500,000
|
|
|
1,500,000
|
|
|
|
|
|
3,150,000
|
|
|
3,000,000
|
|
F-29 | ||
|
|
|
December 31,
|
|
||||
|
|
2013
|
|
2012
|
|
||
Start-up and organization costs
|
|
$
|
56,000
|
|
$
|
63,000
|
|
Research credits
|
|
|
95,000
|
|
|
68,000
|
|
Contingent liability
|
|
|
31,000
|
|
|
31,000
|
|
Net operating loss carryforwards
|
|
|
2,939,000
|
|
|
2,421,000
|
|
Total deferred tax assets
|
|
|
3,121,000
|
|
|
2,583,000
|
|
Valuation allowance
|
|
|
(3,121,000)
|
|
|
(2,583,000)
|
|
Net deferred tax assets
|
|
$
|
|
|
$
|
|
|
|
|
Years Ended
December 31, |
|
|||||
|
2012
|
|
2012
|
|
||||
|
|
|
|
|
|
|
|
|
U. S. federal statutory tax rate
|
|
|
(34.0)
|
%
|
|
|
(34.0)
|
%
|
Non-deductible stock-based compensation
|
|
|
2.9
|
%
|
|
|
8.6
|
%
|
Non-deductible fair value of warrant extensions
|
|
|
|
%
|
|
|
10.8
|
%
|
Non-deductible fair value of warrant discounts
|
|
|
|
%
|
|
|
3.2
|
%
|
Adjustment to deferred tax asset
|
|
|
(1.3)
|
%
|
|
|
(2.0)
|
%
|
Change in valuation allowance
|
|
|
32.4
|
%
|
|
|
13.4
|
%
|
Effective tax rate
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
F-30 | ||
|
F-31 | ||
|
|
|
|
|
Payments Due By Year
|
|
||||||||||||||
|
|
Total
|
|
2014
|
|
2015
|
|
2016
|
|
2017
|
|
2018
|
|
||||||
Research and development contracts
|
|
$
|
40,385
|
|
$
|
40,385
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Theradex work order agreement
|
|
|
1,746,463
|
|
|
1,346,463
|
|
|
400,000
|
|
|
|
|
|
|
|
|
|
|
Patent license agreement
|
|
|
150,000
|
|
|
30,000
|
|
|
30,000
|
|
|
30,000
|
|
|
30,000
|
|
|
30,000
|
|
Consulting agreement
|
|
|
16,000
|
|
|
16,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liquidated damages payable under registration rights agreement
|
|
|
74,000
|
|
|
74,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to stockholder
|
|
|
92,717
|
|
|
92,717
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
2,119,565
|
|
$
|
1,599,565
|
|
$
|
430,000
|
|
$
|
30,000
|
|
$
|
30,000
|
|
$
|
30,000
|
|
F-32 | ||
|
F-33 | ||
|
NATIONAL INSTITUTES OF HEALTH
MATERIALS COOPERATIVE RESEARCH
AND DEVELOPMENT AGREEMENT
This Materials Cooperative Research and Development Agreement (“M-CRADA”) has been adopted for use by the Institutes and Centers (“ICs”) of the National Institutes of Health (“NIH”) for transfers of essential research material(s) from collaborators (hereinafter “Collaborator Research Material”) not otherwise reasonably available for NIH research. It consists of a copy of the NIH Model M-CRADA, a Signature Page, a Contacts Page, and a Summary Page. The research plan (“Research Plan”) is attached as Appendix A and all changes to this model agreement are collected in Appendix B. Appendices A and B are incorporated herein by reference. This M-CRADA involves no exchange of personnel or of any resources other than as described in Appendix A. This M-CRADA is made under authority of the Federal Technology Transfer Act, 15 U.S.C. § 3710a, and is governed by its terms.
1. | Lixte Biotechnology Holdings, Inc. , hereinafter referred to as “Collaborator”, agrees to transfer to NIH’s investigator, Richard J. Youle, Ph.D. , the following “Collaborator Research Material”: certain compounds proprietary to Collaborator, as listed under Appendix A . |
2. | This Collaborator Research Material will be used solely in connection with the Research Plan by NIH’s investigator in his/her laboratory under suitable containment conditions. |
2(a). | Are the Collaborator Research Materials of human origin? |
¨ Yes
x No
2(b). | If Yes in 2(a), were the Collaborator Research Materials collected according to 45 CFR Part 46, “Protection of Human Subjects?” |
¨ Yes (Please provide Assurance Number: )
¨ No
3. | In all oral presentations or written publications concerning the Research Plan, NIH will acknowledge Collaborator’s contribution of this Collaborator Research Material unless requested otherwise. To the extent permitted by law and unless otherwise directed by a court or administrative body of competent jurisdiction, each Party agrees to treat in confidence, for a period of three (3) years from the date of the disclosure, any of the disclosing Party’s written information about this Collaborator Research Material that is stamped “confidential” or any of the disclosing Party’s oral information about this Collaborator Research Material that is identified in writing as being confidential within ten (10) days of the oral disclosure, except for: |
(a) | information that is publicly known or that becomes publicly available from public sources; |
(b) | information that has been made available by the disclosing Party to others without a confidentiality obligation; |
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 1 of 10 | Confidential | Revised August 1, 2012 |
(c) | information that is already known by the receiving Party, or information that is independently created or compiled by the receiving Party without reference to or use of the provided information; or |
(d) | information that relates to potential hazards or cautionary warnings associated with the production, handling, or use of the subject matter of the Research Plan. |
NIH may publish or otherwise publicly disclose the results of the research, but if Collaborator has given confidential information to NIH such public disclosure may be made only after Collaborator has had thirty (30) days to review the proposed disclosure to determine if it contains any confidential information, except when a shortened time period under court order or the Freedom of Information Act pertains.
4. | This Collaborator Research Material represents a significant investment on the part of Collaborator and is considered proprietary to Collaborator. NIH’s investigator therefore agrees to retain control over this Collaborator Research Material, and further agrees not to transfer the Collaborator Research Material to other people not under her or his direct supervision without advance written approval of Collaborator. Collaborator reserves the right to distribute the Collaborator Research Material to others and to use it for its own purposes. |
5. | This Collaborator Research Material is provided as a service to the research community. IT IS BEING SUPPLIED TO NIH WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Collaborator makes no representations that the use of the Collaborator Research Material will not infringe any patent or proprietary rights of third parties. It is the intention of NIH that Collaborator not be liable for any claims or damages arising from NIH’s use of the Collaborator Research Material; however, no indemnification is provided or intended. |
6. | The NIH shall promptly report to Collaborator in writing each Subject Invention and any patent applications filed thereon resulting from the research conducted under this M-CRADA that is reported to NIH by its employees. Collaborator agrees to keep all information provided to Collaborator confidential until the information is published or the patent issues. “Subject Invention” means any invention, conceived or first actually reduced to practice under this M-CRADA, that is or may be patentable under 35 U.S.C. § 101 or § 161, protectable under 7 U.S.C. § 2321, or otherwise protectable by other types of U.S. or foreign intellectual property rights. |
7. | With respect to Government intellectual property rights to any Subject Invention made solely by an NIH employee(s) or jointly with Collaborator for which a patent or other intellectual property application is filed, NIH hereby grants to the Collaborator an exclusive option to elect an exclusive or nonexclusive commercialization license. The license will be substantially in the form of the appropriate model Public Health Service (PHS) license agreement and will fairly reflect the nature of the Subject Invention, the relative contributions of the Parties to the Subject Invention and the M-CRADA, a plan for the development and marketing of the Subject Invention, the risks incurred by Collaborator, and the costs of subsequent research and development needed to bring the Subject Invention to the marketplace. The field of use of the license will not exceed the scope of the Research Plan. This option does not apply to Subject Inventions conceived prior to the effective date of this M-CRADA that are reduced to practice under this M-CRADA, if prior to that reduction to practice, NIH has filed a patent application on the Subject Invention and has licensed it or offered to license it to a third party. |
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 2 of 10 | Confidential | Revised August 1, 2012 |
8. | To exercise the option of Paragraph 7, Collaborator must submit a written notice to the PHS Patenting and Licensing Contact identified on the Contacts Information Page (and provide a copy to the NIH Contact for M-CRADA Notices) within three (3) months after the Collaborator receives written notice from NIH that the patent application has been filed. The written notice exercising this option will include a completed “Application for License to Public Health Service Inventions” and will initiate a negotiation period that expires nine (9) months after the exercise of the option. If NIH has not responded in writing to the last proposal by Collaborator within this nine (9) month period, the negotiation period will be extended to expire one (1) month after PHS so responds, during which month Collaborator may accept in writing the final license proposal of NIH. In the absence of Collaborator’s exercise of the option, or upon election of a nonexclusive license, NIH will be free to license the Subject Invention to others. These time periods may be extended at the sole discretion of NIH upon good cause shown in writing by Collaborator. |
9. | Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for Subject Inventions made under this M-CRADA by a NIH employee(s) or jointly by such employee(s) and employees of the Collaborator under this M-CRADA, and licensed to Collaborator, the Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention or have the invention practiced throughout the world by or on behalf of the Government. In the exercise of such license, the Government shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. § 552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. |
10. | Pursuant to 15 U.S.C. § 3710a(b)(2), for Subject Inventions made solely by Collaborator employees under this M-CRADA, the Collaborator grants to the Government, a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention or have the invention practiced throughout the world by or on behalf of the Government for research or other Government purposes. |
11. | Pursuant to 15 U.S.C. § 3710a(b)(l)(B), if NIH grants an exclusive license to a Subject Invention made wholly by NIH employees or jointly with a Collaborator under this M-CRADA, the Government shall retain the right to require the Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or if the Collaborator fails to grant such a license, to grant the license itself. The exercise of such rights by the Government shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by Federal regulations, and such requirements are not reasonably satisfied by the Collaborator; or (iii) the Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b). |
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 3 of 10 | Confidential | Revised August 1, 2012 |
12. | Any dispute arising under this M-CRADA that is not disposed of by agreement of the Principal Investigators shall be submitted jointly to the signatories of this M-CRADA. If the signatories are unable to jointly resolve the dispute within thirty (30) days after notification thereof, the Assistant Secretary for Health (or his/her designee or successor) shall propose a resolution. Nothing in this article shall prevent any Party from pursuing any additional administrative remedies that may be available and, after exhaustion of such administrative remedies, pursuing all available judicial remedies. |
13. | The illegality or invalidity of any provisions of this M-CRADA shall not impair, affect or invalidate the other provisions of this M-CRADA. |
14. | Neither this M-CRADA nor any rights or obligations of any Patty hereunder shall be assigned or otherwise transferred by either Party without the prior written consent of the other Party. |
15. | All notices pertaining to or required by this M-CRADA will be in writing, signed by an authorized representative of the notifying Party, and delivered by first class, registered, or certified mail, or by an express/overnight commercial delivery service, prepaid and properly addressed to the other Party at the address designated on the Contacts Information Page, or to any other address designated in writing by the other Party. Notices will be considered timely if received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Notices regarding the exercise of license options will be made pursuant to Paragraph 8. Either Party may change its address by notice given to the other Party in the manner set forth above. |
16. | By entering into this M-CRADA, the Government does not directly or indirectly endorse any product or service that is or will be provided, whether directly or indirectly related to either this M-CRADA or to any patent or other intellectual property license or agreement that implements this M-CRADA by Collaborator, its successors, assignees, or licensees. Collaborator will not in any way state or imply that the Government or any of its organizational units or employees endorses any product or service. Each Party agrees to provide proposed press releases that reference or rely upon the work under this M-CRADA to the other Party for review and comment at least seven (7) days prior to publication. Either Party may disclose the Summary Page to the public without the approval of the other Party. |
17. | Either NIH or Collaborator may unilaterally terminate this M-CRADA at any time by providing written notice at least sixty (60) days before the desired termination date. |
18. | This M-CRADA constitutes the entire agreement between the Parties concerning the subject matter of this M-CRADA and supersedes any prior understanding or written or oral agreement. |
19. | The construction, validity, performance and effect of this M-CRADA will be governed by U.S. federal law, as applied by the federal courts in the District of Columbia. If any provision in this M-CRADA conflicts with or is inconsistent with any U.S. federal law or regulation, then the U.S. federal law or regulation will preempt that provision. |
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 4 of 10 | Confidential | Revised August 1, 2012 |
20. | This M-CRADA shall be effective upon execution by the Parties. The term of this M-CRADA is twelve (12) months from execution. When the Research Plan is completed or twelve (12) months has elapsed, whichever occurs first, or the M-CRADA is terminated, the Collaborator Research Material will be disposed of as directed by Collaborator. |
21. | The provisions of Articles 3, 5-12 and 14 shall survive the termination of this M-CRADA. |
SIGNATURES BEGIN ON THE NEXT PAGE
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 5 of 10 | Confidential | Revised August 1, 2012 |
SIGNATURE PAGE
ACCEPTED AND AGREED
B y executing this M-CRADA, each Party represents that all statements made herein are true, complete, and accurate to the best of its knowledge. Collaborator acknowledges that it may be subject to criminal, civil, or administrative penalties for knowingly making a false, fictitious, or fraudulent statement or claim.
FOR NIH (IC): | ||
/s/ Walter J. Kovoshetz for Dr. S Landis | 9/24/2013 | |
Signature | Date | |
WJ Kovoshetz, Deputy Director/NINDS | ||
Story C. Landis, Ph.D. | ||
Director, National Institute of Neurological Disorders and Stroke | ||
FOR COLLABORATOR: | ||
/s/ John S. Kovach | 10/18/2013 | |
Signature | Date | |
John S. Kovach. M.D. | ||
President, Lixte Biotechnology Holdings, Inc. |
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 6 of 10 | Confidential | Revised August 1, 2012 |
CONTACTS PAGE
M-CRADA Notices
For IC: | For Collaborator: | |
Laurie Arrants | John S. Kovach, M.D. | |
Technology Development Coordinator | 248 Route 25A No. 2 | |
Building 31, Room 8A52 | East Setauket, NY 11733 | |
31 Center Drive, MSC 2540 | Tel: 631-942-7959 | |
Bethesda, MD 20892 | Fax: 631-982-5050 | |
Tel: 301-435-3112 | ||
Fax: 301-496-0296 |
Patenting and Licensing
For NIH: | For Collaborator (if separate from above): | |
Division Director, Division of Technology | ||
Development and Transfer | ||
NIH Office of Technology Transfer | ||
6011 Executive Boulevard, Suite 325 | ||
Rockville, Maryland 20852-3804 | ||
Tel: 301-496-7057 | Tel: | |
Fax: 301-402-0220 | Fax: |
Delivery of Materials Identified In Article 1
For IC:
IC Contact: Richard J. Youle, Ph.D.
IC Address: SNB, Bldg 35, Room 2C-917, 35 Convent Drive, MSC 3704, Bethesda, MD 20892-3704
IC Phone Number: 301-496-6628
IC Fax: 301-402-0380
IC contact e-mail YouleR@ninds.nih.gov
For Collaborator: same as for M-CRADA notices
Collaborator Contact:
Collaborator Address:
Collaborator Phone Number:
Collaborator Fax:
Collaborator contact e-mail:
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 7 of 10 | Confidential | Revised August 1, 2012 |
SUMMARY PAGE
Either party may, without further consultation or permission,
release this summary page to the public.
TITLE OF M-CRADA: | Characterization of Proprietary Compounds from Lixte Biotechnology Holdings, Inc. | |
NIH Institute/Center (IC) IC Principal Investigator: | National Institute of Neurological Disorders and Stroke Richard J. Youle, Ph.D. | |
Collaborator: Collaborator Principal Investigator: |
Lixte Biotechnology Holdings, Inc.
John S. Kovach, M.D. |
|
TERM OF M-CRADA: | Four (4) years from the Effective Date. |
ABSTRACT OF THE RESEARCH PLAN:
The Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke of the National Institutes of Health will conduct research characterizing a variety of compounds proprietary to Lixte Biotechnology Holdings, Inc., under a Materials Cooperative Research and Development Agreement. The research will examine the compounds’ potential for anti-cancer activity, reducing neurologic deficit due to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases.
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 8 of 10 | Confidential | Revised August 1, 2012 |
APPENDIX A
RESEARCH PLAN
Background
Lixte Biotechnology Holdings, Inc.’s primary emphasis is on developing drugs for cancer but its proprietary compounds also have potential for treating a variety of other diseases. The Surgical Neurology Branch (SNB) has experience in researching brain tumors, neurological brain injury, and inborn diseases affecting the brain, such as Gaucher’s disease, von Hippel-Lindau, and neurofibromatosis type II.
Overall Goal . The SNB would like to examine the Collaborator’s compounds’ potential for anti-cancer activity, reduction of neurologic deficit due to ischemia and brain injury, and stabilization of the catalytic function of misfolded proteins for inborn brain diseases.
Research
The SNB will characterize proprietary compounds from the Collaborator, including but not limited to the following seven:
LB-100, LB-102, LB-113, LB-153, LB-157, LB-201, and LB-205.
Collaborator may provide additional proprietary compounds to the SNB if the parties mutually agree in advance and the transfer is documented in writing.
The SNB may study one or more of the above compounds in in vitro and in vivo (animal models) for the following effects:
• | promoting anti-cancer activity alone or in combination with standard anti-cancer drugs and/or radiation for the treatment of primary brain tumors and secondary (metastatic) brain tumors; specific cancers may include astrocytic tumors, oligodendroglial tumors, medulloblastoma, meningeal tumors, hemangioblastomas, and brain mestastic tumors |
• | overcoming or mitigating the physiological phenomenon of multi-drug resistance, particularly of cancer cells to anti-cancer drugs |
• | reducing neurological deficit due to cerebral ischemia and traumatic brain injury |
• | stabilizing the catalytic function of misfolded proteins due to genetic variants responsible for inborn diseases affecting the brain, such as Gaucher’s disease, von Hippel-Lindau diseases and neurofibromatosis 2 |
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 9 of 10 | Confidential | Revised August 1, 2012 |
APPENDIX B
EXCEPTIONS OR MODIFICATIONS TO THIS M-CRADA
Additions are noted as
underline
and deletions are noted as
strikeout
.
Modify Article 20 as follows:
Article 20. |
This M-CRADA shall be effective upon execution by the Parties. The term of this M-CRADA is
forty-eight
|
NIH M-CRADA | Agreement Ref. No. 2013-0167 | MODEL ADOPTED 2006 |
Page 10 of 10 | Confidential | Revised August 1, 2012 |
SCIENTIFIC ADVISORY BOARD AGREEMENT
THIS AGREEMENT (the “ Agreement ”) is made and entered into this 24th day of December, 2013 (the “ Effective Date ”) between Lixte Biotechnology Holdings, Inc., 248 Route 25A No. 2, East Setauket, New York 11733 (hereinafter referred to as the “Company”), and NDA Consulting Corp., an Arizona corporation, with offices at 9977 N. 90th Street, Suite 175, Scottsdale, Arizona 85258 (hereinafter referred to as the “ Consultant ”).
WHEREAS, the Company wishes to engage the Consultant to serve the Company as an Advisor for Clinical Development and provide this service for the compensation and otherwise in accordance with the terms and conditions contained in this Agreement.
NOW, THEREFORE, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, accepted and agreed to, the Company and the Consultant, intending to be legally bound, agree to the terms set forth below.
1. TERM.
(a) The initial term of this Agreement is one (1) year from the Effective Date. The initial term will be extended for successive terms of one (1) year on each anniversary date of the Effective Date, unless the Agreement is terminated as provided below. This Agreement may be renewed or extended for any period as may be mutually agreed by the parties.
(b) This Agreement may be cancelled by either party for any reason by providing written notice to the other party not less than thirty (30) days prior to the end of the initial term or any successive one (1) year term. Upon termination, Consultant shall return to the Company or destroy all Concepts and Ideas and Confidential Information (as defined in Section 5 below) and copies thereof.
(c) In the event Dr. Von Hoff accepts an invitation from the Company to become Principal Investigator in a clinical trial conducted by the Company, this Agreement shall immediately terminate and no further Services will be provided by Consultant pursuant to this Agreement.
2. SERVICES.
(a) Consultant agrees to cause its President, Dr. Von Hoff to be a member of and advise the Company’s SAB in the field of oncology research and drug development under the terms and conditions herein provided (the “ Services ”). The Services shall only be performed by Dr. Von Hoff personally and may not be assigned, subcontracted or otherwise delegated without the prior written consent of the Company
(b) The Consultant represents and warrants to the Company that it is under no contractual or other restrictions or obligations which are inconsistent with the execution of this Agreement, or which will interfere with the performance of its duties. Consultant represents and warrants that the execution and performance of this Agreement will not violate any policies or procedures of any other person or entity for which it performs consulting services concurrently with those performed herein.
3. COMPENSATION.
(a) Subject to the provisions hereof, the Company shall pay the Consultant four thousand dollars ($4,000) per calendar quarter, for providing the Services to the Company (the “ Consulting Fee ”) for up to a cumulative amount of 4 hours per quarter. As additional compensation, the Company shall provide Dr. Von Hoff a grant of options to purchase an aggregate of shares of Lixte with the options vesting as follows: 25,000 options vesting six, eighteen, thirty, and forty two months after the date of this agreement so long as Dr. Von Hoff is continuing as Advisor for Clinical Development on those dates. The options shall be for five years.
(b) The Consulting Fee shall be paid within thirty (30) days of the receipt by the Company of the Consultant’s invoice for Services. The grant of stock or stock options shall be made to Dr. Von Hoff as soon as practicable after the Effective Date.
(c) The Consultant shall be entitled to reimbursement of two hundred fifty dollars ($250) per hour for travel time (not to exceed one thousand five hundred dollars ($1,500) per day) on approved Company business. The Consultant shall also be entitled to prompt reimbursement for preapproved, actual travel and out-of-pocket business expenses incurred in the performance of its Services. The Company shall reimburse Consultant within thirty (30) days of receipt by the Company of the Consultant’s statements or receipts for such expenses. For air travel of three (3) hours or more, Consultant shall be entitled to First Class Airfare.
(d) Unless otherwise notified by the Consultant, the Company shall make payment of the Consulting Fee and reimbursement of travel and out-of-pocket expenses in the name of the Consultant and send the payments directly to:
NDA Consulting Corp.
c/o MCS Biotech Resources, LLC
9977 N. 90th Street, Suite 175
Scottsdale, AZ 85258
Stock or stock options issued in the name of Dr. Von Hoff shall be sent to the same address.
2 |
(e) The Consultant agrees that all Services rendered will be as an independent contractor and that this Agreement does not create an employer-employee, agency, joint venture, or partnership relationship between the Consultant and the Company. The Consultant shall have no right to receive any employee benefits, including, but not limited to, health and accident insurance, retirement, life insurance, sick leave and/or vacation. The Consultant agrees to pay all taxes, including self-employment taxes due in respect of the Consulting Fee and to indemnify the Company in the event the Company is required to pay any such taxes as a direct result of actions taken by the Consultant.
4. COMPANY OBLIGATIONS.
(a) The Company shall provide the Consultant with all information and materials that are necessary to enable Consultant to perform the Services. The Company acknowledges and agrees that such information and materials will be used, and the accuracy and completeness of such information and materials relied upon, by the Consultant as the basis for providing the Services.
(b) Company agrees that Consultant’s services are provided without representation or warranty or any kind. Company acknowledges that drug development carries inherent risks and that no particular work product or business result is guaranteed under this Agreement. Except with respect to Section 5, the Company agrees that Consultant’s monetary liability for any breach of this Agreement shall in no event exceed the amount of cash compensation paid to Consultant under this Agreement. Company hereby releases Consultant from any monetary liability to the extent it may exceed such amount. In addition, Company agrees to indemnify, defend and hold Consultant harmless from and against any losses, costs, claims, damages, liabilities or expense (including reasonable attorneys’ and professional fees and other expenses of litigation) (collectively, “ Liabilities ”) arising directly or indirectly out of or in connection with third party claims, suits, actions, demands or judgments, relating to services provided by Consultant under this Agreement.
(c) The Company agrees not to use the Consultant’s name in any publications or other written material, or otherwise use Consultant’s name in any manner whatsoever unless, in each case, the Company obtains the prior written consent of the Consultant. Unless otherwise notified by Consultant, all such requests should be directed to:
MCS Biotech Resources, LLC
9977 N. 90th Street, Suite 175
Scottsdale, AZ 85258
Telephone number: (480) 268-2000
Facsimile number: (480) 268-2001
5. PROPRIETARY RIGHTS.
(a) Definitions . For the purpose of this Section 5, the terms set forth below shall have the following meanings:
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(i) Concept and Ideas . For the purpose of this Agreement, “Concepts and Ideas” shall mean those concepts and ideas disclosed by the Company to the Consultant or which are first developed by the Consultant during the course of the performance of Services hereunder and which relate to the Company’s past, present, or prospective business activities, services, and products, all of which shall remain the sole and exclusive property of the Company. The Consultant shall have no publication rights and all of the same shall belong exclusively to the Company.
(ii) Confidential Information . For the purposes of this Agreement, “Confidential Information” shall mean and collectively include all information relating to the business, plans and/or technology of the Company including, but not limited to technical information, including inventions, methods, plans, processes, specifications, characteristics, assays, raw data, scientific pre-clinical or clinical data, records, databases, formulations, clinical protocols, equipment design, know-how, experience, and trade secrets.
Notwithstanding the foregoing, the term “Confidential Information” shall not include any information which: (x) can be demonstrated to have already been publicly known or available or generally known in the trade or business of the Company prior to the date of the disclosure to the Consultant, (y) can be demonstrated to have been rightfully in the possession of the Consultant prior to the disclosure of such information to the Consultant, or (z) is required to be disclosed by Consultant as a matter of law or by a judicial or governmental order or requirement.
(b) Non-Disclosure to Third Parties . Except as may be required for the Consultant to perform the Services, the Consultant shall not, at any time now or in the future, directly or indirectly, use, publish, disseminate or otherwise disclose any Confidential Information or Concepts and Ideas to any third party without the prior written consent of the Company.
(c) Patents . The Consultant agrees that the Company is and shall remain the exclusive owner of the Confidential Information and Concepts and Ideas. Any interest in patents, patent applications, inventions, technological innovations, trade names, trademarks, service marks, copyrights, copyrightable works, developments, discoveries, designs, processes, formulas, know-how, data and analysis which the Consultant may develop as a direct result of rendering Services to the Company under this Agreement (collectively the “Developments”), shall: (i) promptly be brought to the attention of the Company by the Consultant and (ii) belong exclusively to the Company. No license or conveyance of any such rights to the Consultant is granted or implied under this Agreement.
(d) Assignment . The Consultant hereby assigns and, to the extent any such assignment cannot be made at present, hereby agrees to assign to the Company any Developments. The Consultant will execute all documents and perform all lawful acts, which the Company considers reasonably necessary or advisable to secure its rights hereunder.
In the event the company is unable for any reason to secure the Consultant’s signature to any document required to apply for or execute any patent, copyright or other application with respect to any Developments, the Consultant hereby irrevocably designates and appoints the Company and its duly authorized officers and agents as the Consultant’s attorneys-in-fact to act for and on behalf of the Consultant, for the sole purpose of executing and filing any such document.
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6. EQUITABLE RELIEF. The Consultant agrees that any breach of Section 5 above by it would cause irreparable damage to the Company and that, in the event of such breach, the Company shall have, in addition to any and all remedies of law, the right to an injunction, specific performance or other equitable relief to prevent the violation or threatened violation of the Consultant’s obligations hereunder.
7. WAIVER. Any waiver by either party of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any subsequent breach of the same or any other provision hereof. All waivers by either party shall be in writing.
8. SEVERABILITY; REFORMATION. If a court or other lawful authority finds any provision of this Agreement to be invalid and unenforceable, the remaining provisions are severable, and will not be affected by that finding. If a court or lawful authority finds any provision of this Agreement to be excessively broad as to duration, geographical scope, activity or subject matter, that provision will be construed to make it enforceable to the extent possible under the applicable law then in effect.
9. ASSIGNMENT. The Company shall have the right to assign its rights and obligations under this Agreement to a related party, which assumes the Company’s obligations hereunder. The Consultant shall not have the right to assign its rights or obligations under this Agreement without the prior written consent of the Company, which consent shall not be unreasonably withheld.
10. HEADINGS. Headings and subheadings are for convenience only and shall not be deemed to be a part of this Agreement.
11. AMENDMENTS. This Agreement may be amended or modified, in whole or in part, only by an instrument in writing signed by all parties hereto.
12. NOTICES. Any notices or other communications required hereunder shall be in writing and shall be deemed effective when (a) hand-delivered with receipt acknowledged, (b) delivered by a nationally recognized overnight delivery service with receipt acknowledged, (c) sent by confirmed facsimile, or (d) three (3) days after mailing, by certified or registered first class mail, postage prepaid, return receipt requested; in each case, addressed to the parties at their addresses specified in the preamble of this Agreement or to such other address as a party hereto shall designate upon written notice to the other party.
13. COUNTERPARTS. This Agreement may be executed in two or more counterparts, each of which shall constitute an original and all of which shall be deemed a single agreement.
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14. GOVERNING LAW. This Agreement shall be construed in accordance with and governed for all purposes by the laws of the State of Arizona.
15. SURVIVAL. The provision of Sections 3, 4, 5, 6, 8 and 14 of this Agreement shall survive the expiration of the Term or the termination of this Agreement. This Agreement supersedes all prior agreements, written or oral, between the Company and the Consultant relating to the subject matter of this Agreement.
EXECUTED, under seal, effective as of the Effective Date.
Lixte Biotechnology Holdings, Inc. | NDA Consulting Corp. | |
/s/ John S. Kovach | ||
John S. Kovach, M.D. | Daniel D. Von Hoff, M.D. | |
President | ||
Federal ID Tax Number 26-0348104 |
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ADVISORY AGREEMENT
This ADVISORY AGREEMENT (this “ Agreement ”), is entered into effective as of January 1, 2014, by and between Lixte Biotechnology Holdings, Inc., a Delaware corporation (the “ Company ”), and Kathleen Mullinix (“ Advisor ”).
RECITALS
WHEREAS, Advisor has certain knowledge, expertise, experience and reputation which the Company desires to avail itself; and
WHEREAS, upon the terms and subject to the conditions of this Agreement, the Company desires to retain Advisor to provide certain advisory services to the Company, and Advisor wishes to render such services.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises and agreements herein contained, Advisor and the Company by this Agreement agree as follows:
1. Engagement . The Company hereby agrees that, commencing on January 1, 2014 (the “ Effective Date ”), the Company shall engage Advisor and Advisor hereby accepts such engagement with the Company, upon the terms and subject to the conditions hereinafter set forth.
2. Term . The initial term of Advisor’s engagement under this Agreement (the “ Initial Term ”) shall commence on the Effective Date and, subject to the provisions of Section 6, shall continue until December 31, 2014. The Initial Term and any subsequent one year term (each a “Term”) shall automatically be extended on an annual basis unless a Notice of Intent to Terminate is given by either party at least 90 days before the end of the applicable Term.
3. Services . Advisor shall advise on business development.
4. No Authority to Bind . Except as directed and authorized by the Chief Executive Officer of the Company in writing, Advisor shall not execute or agree to any contract, agreement or instrument on behalf of the Company.
5. Compensation . The Company shall pay to Advisor the sum of $25,000 payable in two installments of $12,500 with the first installment payable on January 31, 2014 and the second installment payable on July 1, 2014.
6. Termination . The Company may terminate this Agreement at any time “for cause” upon delivery of written notice to Advisor, in which case such termination shall be effective immediately upon Advisor’s receipt of the written notice.
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“Cause” shall mean:
(a) | Advisor is convicted of, or pleas nolo contendere (no contest) to, any crime (whether or not involving the Company) constituting a felony in the jurisdiction involved; or |
(b) | Advisor is in material breach of any provision of this Agreement or any other agreement with the Company, or willfully fails to or refuses to comply with the lawful directives of the Chief Executive Officer or the Board in the performance of her duties under this Agreement (other than a failure caused by temporary disability). |
7. Proprietary Rights and Nondisclosure and Nonuse of Confidential Information .
7.1 It is understood that during the term of this Agreement, Advisor may be exposed to information that is confidential and proprietary to the Company. All such information (hereinafter “Lixte Confidential Information”), whether written or oral, tangible or intangible, that is made available, disclosed, or otherwise made known to Advisor by the Company or its employees under this Agreement shall be considered confidential and shall be considered the sole property of the Company. Lixte Confidential Information shall be (a) marked as confidential, or (b) otherwise represented by the disclosing party as confidential either before or within a reasonable time after its disclosure to the receiving party. This obligation of confidentiality shall remain in effect for a period of five (5) years after the expiration or termination of this Agreement.
7.2 The obligations of confidentiality set forth in Paragraph 7.1 shall not apply to any information that:
(a) | is or hereafter becomes generally available to the public other than by reason of any default with respect to a confidentiality obligation under this Agreement; or |
(b) | was already known to the recipient as evidenced by prior written documents in its possession; or |
(c) | is disclosed to the recipient by a third party who is not in default of any confidentiality obligation to the disclosing party hereunder; or |
(d) | is developed by or on behalf of the receiving party, without reliance on confidential information received hereunder as evidenced by written documents in its possession; or |
(e) | has been approved in writing by one party for publication by the other party; or |
(f) | is required to be disclosed in compliance with applicable laws or regulations. |
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8. Nonsolicitation; Nondisparagement . Advisor acknowledges that during the course of Advisor’s engagement by the Company, Advisor has and will continue to have the opportunity to develop relationships with existing employees, clients, distributors, and prospective clients, and other business associates of the Company, which relationships constitute goodwill of the Company and that the Company would be irreparably damaged if Advisor were to take actions that would damage or misappropriate such goodwill. Advisor accordingly agrees that during the period commencing on the Effective Date and ending on the first anniversary of the conclusion of the Term, Advisor shall not, directly or indirectly, either for the benefit of Advisor or any other person, do any of the following:
(a) | Solicit any employee of the Company to terminate her employment with the Company, or employ any such individual during her employment with the Company and for a period of six months after such individual terminates her employment with the Company; |
(b) | Solicit any distributor or customer, or prospective distributor or customer, of the Company to terminate her relationship with the Company, or accept any business from any such distributor or customer, or prospective distributor or customer, of the Company; or |
(c) | Make any public statement, comment or remark that disparages the integrity or competence of a Company officer, director, employee, or shareholder, that disparages any product or service of the Company, or that is reasonably likely to cause injury to the relationships between the Company and any existing or prospective distributor, client, contractual counterparty, supplier, customer, employee, consultant or other business associate of the Company. Likewise, the Company agrees that it shall not make any public statement, comment or remark that disparages the integrity or competence of Advisor. |
9. Status as Advisor .
9.1 Intention of the Parties . It is mutually understood and agreed that Advisor, while performing all responsibilities under this Agreement, is and shall at all times be, act, function, and perform all services and responsibilities in the legal capacity of an independent contractor. It is mutually understood and agreed that no work, act, commission or omission of any act by Advisor or the Company pursuant to the terms and conditions of this Agreement shall be construed to make or render Advisor an employee of the Company. Furthermore, Advisor shall not, under any circumstances, hold herself out to be an employee of the Company.
9.2 Independent Advisor to Control Performance . The Company shall have no right or authority to direct or control Advisor with respect to the performance of Advisor’s duties under this Agreement, or with respect to any other matter, except as otherwise provided by this Agreement. It is further understood that Advisor is free to contract with other companies to provide professional services, as long as that service does not violate the provisions of Sections 7 or 8.
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9.3 Expenses . Except as provided in this Section 9.3, Advisor shall be fully responsible to pay any and all expenses and disbursements that she incurs in the performance of any services or obligations covered by this Agreement. The Company shall, however, reimburse Advisor for all actual and reasonable travel expenses incurred by Advisor when Advisor is traveling at the request of the Company in connection with its duties; provided , that (i) Advisor shall not be entitled to reimbursement for any individual expenditure in excess of $1,000, unless such expenditure shall have been pre-approved in writing by the Company’s Chief Executive Officer, and (ii) Advisor shall not be entitled to reimbursement for a particular expenditure if Advisor does not submit to the Company sufficient documentation evidencing such expenditure.
9.4 Taxes and Benefit Programs . Advisor shall be liable and responsible to pay any and all taxes relating to all amounts paid to Advisor hereunder. It is understood and agreed that because Advisor is not an employee of the Company, the Company shall not withhold any taxes from amounts paid to Advisor. Advisor shall be fully and solely responsible to report income and expenses. Advisor acknowledges that she is solely responsible for her own tax planning and that the Company has not provided Advisor with any tax advice regarding the tax implications of this Agreement. It is also understood and agreed that Advisor shall not be eligible to participate in any benefits or programs sponsored or financed by the Company for its employees.
10. | Miscellaneous . |
10.1 Notices . All notices, requests, demands and other communications required or permitted to be given hereunder shall be in writing and shall be deemed to have been duly given upon receipt, if delivered personally, upon confirmation of receipt, if given by electronic facsimile and on the third business day following mailing, if mailed first-class, postage prepaid, registered or certified mail addressed as follows:
If to the Company to: | |
Lixte, Inc. 6 Tinker Lane East Setauket, New York 11733 Attn: John Kovach, M.D. |
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Phone: (631) 751-2882 Fax: (631) 982-5050 Email: kovach1329@yahoo.com |
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If to Advisor: | |
1050 Fifth Avenue New York, New York 10028 Phone: Fax: e-mail: |
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Any party may by notice given in accordance with this Section 11.1 to the other parties designate another address or person for receipt of notices hereunder.
10.2 Entire Agreement . This Agreement contains the entire agreement of the parties with respect to the subject matter hereof. This Agreement may be amended, superceded, canceled, renewed or extended, and the terms hereof or thereof may be waived, only by a written instrument signed by each of the parties hereto or thereto or, in the case of a waiver, by the party waiving compliance.
10.3 Attorneys’ Fees . If any legal action or arbitration arises under this Agreement, arises by reason of any asserted breach of it, or arises between the parties and is related in any way to the subject matter of the Agreement, the prevailing party shall be entitled to recover all costs and expenses, including reasonable attorneys’ fees, arbitration costs, investigative costs, reasonable accounting fees and charges for experts.
10.4 Binding Effect; Assignment . This Agreement shall be binding upon and inure to the benefit of the parties and their respective permitted successors and permitted assigns. Neither this Agreement nor any of the rights hereunder may be assigned by any party, nor may any party delegate any obligations hereunder or thereunder, without the written consent of the other party hereto or thereto; provided , however , that the Company may assign its rights hereunder to any subsidiary or to any person or entity that acquires, directly or indirectly, all or substantially all of the Company’s business (whether through acquisition of assets, stock or any other means). Any non-permitted assignment or attempted assignment shall be void, ab initio . Nothing herein is intended or shall be construed to give any person any legal or equitable right, remedy or claim under or in respect of this Agreement or any provision contained herein, except as otherwise provided herein.
10.5 Counterparts . This Agreement may be executed by the parties in separate counterparts, each of which when so executed and delivered shall be an original, but all such counterparts shall together constitute one and the same instrument. Delivery of any counterpart signature page of this Agreement, written communication or notice hereunder by facsimile shall be equally as effective as delivery of a manually executed original of such counterpart signature page, communication or notice.
10.6 Further Assurances . Each party hereto shall execute such documents and other papers and take such further actions as may be reasonably required or desirable to carry out the provisions of this Agreement and the transactions contemplated hereby.
10.7 Agreement Authorized . Advisor hereby represents and warrants that she is free to enter into this Agreement and that she is free to render its services pursuant to this Agreement, and that Advisor is not subject to any obligation or restriction that would prevent him from discharging her duties under this Agreement, and agrees to indemnify and hold harmless the Company from and with respect to any liability, damages or costs, including attorneys’ fees, arising out of any breach by Advisor of this representation and warranty.
10.8 Governing Law . The validity, interpretation and construction of this Agreement and each part thereof will be governed by the laws of the State of New York.
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10.9 Entire Agreement . This Agreement, and any other agreement explicitly mentioned herein, by and between the Company and Advisor, set forth the entire agreement between the Company and Advisor with respect to the subject matter hereof, and supersedes any and all prior agreements between the Company and Advisor, whether written or oral, relating to any or all matters covered by and contained or otherwise dealt with in this Agreement. This Agreement does not constitute a commitment of the Company with regard to Advisor’s engagement, express or implied, other than to the extent expressly provided for herein.
10.10 Survival at Termination . The termination of this Agreement shall not affect the obligations to the parties hereunder which by the nature thereof are intended to survive any such termination including, without limitation, the obligations of Advisor under Sections 7 and 8.
IN WITNESS WHEREOF, the parties hereto have duly executed this Advisory Agreement as of the day and year first above written.
LIXTE BIOTECHNOLOGY HOLDINGS, INC. | ||
By: | ||
Name: John Kovach | ||
Its: President | ||
Kathleen Mullinix |
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CERTIFICATIONS OF THE CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, John S. Kovach, Chief Executive Officer and Chief Financial Officer of Lixte Biotechnology Holdings, Inc. (the “Registrant”), certify that:
1. | I have reviewed this Annual Report on Form 10-K for the fiscal year ended December 31, 2013 of Lixte Biotechnology Holdings, Inc. (the “Annual Report”); |
2. | Based on my knowledge, this Annual Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Annual Report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this Annual Report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this Annual Report; |
4. | I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Registrant and I have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this Annual Report is being prepared; | |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
(c) | Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this Annual Report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this Annual Report based on such evaluation; and | |
(d) | Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and |
5. | I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and | |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting. |
Date: March 21, 2014 | By: | /s/ JOHN S. KOVACH |
Name: John S. Kovach | ||
Title: Chief Executive Officer and Chief Financial Officer |
CERTIFICATIONS OF THE CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
UNDER SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the filing by Lixte Biotechnology Holdings, Inc. (the “Registrant”) of its Annual Report on Form 10-K for the fiscal year ended December 31, 2013 (the “Annual Report”) with the Securities and Exchange Commission, I, John S. Kovach, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(i) The Annual Report fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
A signed original of this written statement required by Section 906 has been provided to the Registrant and will be retained by the Registrant and furnished to the Securities and Exchange Commission or its staff upon request.
Date: March 21, 2014 | By: | /s/ JOHN S. KOVACH |
Name: John S. Kovach | ||
Title: Chief Executive Officer and Chief Financial Officer |