United States
Securities Exchange Commission
Washington, D.C. 20549
FORM 10-QSB
[x] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934 For the Period Ended March 31, 1996
or
[ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934 For the Transition Period From ________ to ___________.
Commission file number 0-27436
TITAN PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 94-3171940
- - ------------------------------------------------------------------------------
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
400 Oyster Point, Suite 505 94080
South San Francisco, CA
(Address of principal executive offices) (Zip Code)
(415) 244-4990
(Registrant's telephone number, including area code)
1505 O'Brien Drive, Menlo Park, CA 94025
(Former name, former address and formal fiscal year,
if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required
to filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter periods that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes X No
State the number of shares outstanding of each of the registrant's classes of
common equity, as of the latest practicable date: As of May 8, 1996, there were
10,756,162 shares of Common Stock outstanding, $0.001 par value.
Traditional Small Business Disclosure Format. Yes X No
<PAGE>
Index
Titan Pharmaceuticals, Inc.
PAGE
Part I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets - March 31,
1996 and December 31, 1995...................................... 2
Condensed Consolidated Statements of Operations
- Three months ended March 31, 1996 and 1995
and period from commencement of operations
(July 25, 1991) to March 31, 1996............................... 3
Condensed Consolidated Statements of Cash Flows
- Three months ended March 31, 1996 and 1995
and period form commencement of operations
(July 25, 1991) to March 31, 1996............................... 4
Notes to Condensed Consolidated Financial
Statements - March 31, 1996..................................... 6
Item 2. Management's Discussion and Analysis
or Plan of Operations.......................................... 10
Part II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K................................. 12
SIGNATURES................................................................ 13
1
<PAGE>
Part I. Financial Information
TITAN PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
<TABLE>
March 31, December 31,
1996 1995
----------------- -------------------
(Unaudited) (Note)
<S> <C> <C>
Assets
Current assets:
Cash and cash equivalents $ 304,733 $ 947,805
Short-term investments 8,856,555 -
Prepaid expenses and other current assets 118,516 40,071
Receivable from Ansan, Inc. 66,348 57,791
----------------- -------------------
Total current assets 9,346,152 1,045,667
Furniture and equipment, net 773,387 848,852
Investment in Ansan, Inc. 1,411,150 1,589,826
Deferred stock offering costs 25,000 522,299
Deferred financing costs 142,604 600,183
Other assets 125,344 125,344
$ 11,823,637 $ 4,732,171
================= ===================
Liabilities and Stockholders' Equity (Net Capital Deficiency)
Current liabilities:
Accounts payable $ 787,429 $ 714,896
Notes payable by Ingenex, Inc. - bridge financing - 1,500,000
Notes payable by Titan Pharmaceuticals, Inc. - bridge financing - 2,800,000
Accrued legal fees 255,994 691,368
Accrued sponsored research 94,081 304,202
Other accrued liabilities 465,776 546,057
Current portion of capital lease obligations 235,835 226,709
Current portion of technology financing - Ingenex, Inc. 512,236 494,107
Total current liabilities 2,351,351 7,277,339
Noncurrent portion of capital lease obligation 684,646 747,142
Noncurrent portion of technology financing 1,154,252 1,289,313
Commitments - -
Minority interest - Series B preferred stock of Ingenex, Inc. 1,241,032 1,241,032
Stockholders' Equity (net capital deficiency):
Preferred stock, at amounts paid in - 18,907,772
Common stock, at amounts paid in 35,271,919 745,476
Additional paid-in capital 6,186,353 6,186,353
Subscription receivable (891) -
Deferred compensation (396,000) (418,000)
Deficit accumulated during the development stage (34,669,025) (31,244,256)
----------------- -------------------
Total stockholders' equity (net capital deficiency) 6,392,356 (5,822,655)
----------------- -------------------
$ 11,823,637 $ 4,732,171
================= ===================
</TABLE>
Note: The balance sheet at December 31, 1995 has been derived from the
audited financial statements at that date but does not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements.
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TITAN PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(unaudited)
<TABLE>
Period from
Incorporation
(July 25, 1991) to
THREE MONTHS ENDED MARCH 31, March 31,
1995 1996 1996
----------------- ------------------ -----------------------
<S> <C> <C> <C>
Grant revenue - $ 49,705 $ 189,227
Costs and expenses:
Research and development 1,964,563 827,898 22,841,519
Acquired in-process research and development - - 686,000
General and administrative 677,112 921,193 7,485,575
----------------- ------------------ -----------------------
Total costs and expenses 2,641,675 1,749,091 31,013,094
----------------- ------------------ -----------------------
Loss from operations (2,641,675) (1,699,386) (30,823,867)
Other income (expense):
Equity in loss of Ansan, Inc. - (178,676) (635,790)
Interest income 16,527 76,422 531,180
Interest expense (114,787) (1,623,129) (3,775,467)
Other expense - net (98,260) (1,725,383) (3,880,077)
----------------- ------------------ -----------------------
Loss before minority interest (2,739,935) (3,424,769) (34,703,944)
Minority interest in losses of subsidiaries - - 34,919
Net loss $ (2,739,935) $ (3,424,769) $ (34,669,025)
================= ================== =======================
Net loss per share $ (0.38) $ (0.89)
================= ==================
Shares used in computation 7,229,183 9,916,250
================= ==================
</TABLE>
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TITAN PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(unaudited)
<TABLE>
Period from
Commencement
of Operations
(July 25, 1991) to
THREE MONTHS ENDED MARCH 31, March 31,
1995 1996 1996
------------------ ----------------- --------------------
<S> <C> <C> <C>
Cash flows from operating activities
Net loss $ (2,739,935) $ (3,424,769) $ (34,669,025)
Adjustments to reconcile net loss to net cash used
in operating activities
Amortization and depreciation 81,950 99,024 665,749
Loss on disposal of assets 6,212 - 8,947
Accretion of discount and amortization of
deferred financing costs on bridge financing - 1,407,579 2,290,912
Equity in loss of Ansan, Inc. - 178,676 635,790
Minority interest - - (34,919)
Grant of common stock to employee - - 250
Issuance of common stock to acquire
minority interest of Theracell, Inc. - - 686,000
Changes in operating assets and liabilities:
Prepaid sponsored research 12,207 - -
Prepaid expenses and other current assets 6,383 (78,445) (118,516)
Receivable - Ansan, Inc. - (8,557) (66,348)
Other assets 14,323 - (130,309)
Accounts payable 155,816 72,533 1,021,619
Accrued legal fees (248,477) (435,374) 255,994
Accrued sponsored research 57,509 (210,121) 193,163
Other accrued liabilities 100,019 (80,281) 857,110
Net cash used in operating activities (2,553,994) (2,479,735) (28,403,583)
------------------ ----------------- -------------------
Cash flows from investing activities
Purchase of furniture and equipment (3,757) (1,559) (803,882)
Purchases of short-term investments - (8,856,555) (32,789,048)
Proceeds from sales of short-term investments - - 23,932,493
Effect of deconsolidation of Ansan, Inc. - - (135,934)
Net cash provided by (used in) investing activities (3,757) (8,858,114) (9,796,371)
------------------ ----------------- --------------------
Cash flows from financing activities
Issuance of common stock - 16,115,079 16,174,305
Offering costs (166,752) - (522,299)
Financing costs 98,565 - (810,248)
Issuance of preferred stock 2,450,123 - 17,601,443
Proceeds from notes payable - - 465,000
Repayment of notes payable (1,200,000) - (425,000)
</TABLE>
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TITAN PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(unaudited)
<TABLE>
Period from
Commencement
of Operations
(July 25, 1991) to
THREE MONTHS ENDED MARCH 31, March 31,
1995 1996 1996
----------------- ----------------- --------------------
<S> <C> <C> <C>
Proceeds from notes and advances
payable to related parties - - 2,216,500
Repayment of notes payable to
related parties - - (1,016,500)
Proceeds for Ansan bridge financing - - 1,425,000
Proceeds from Titan and Ingenex bridge financing - - 5,250,000
Repayment of Titan and Ingenex bridge financing - (5,250,000) (5,250,000)
Proceeds from capital lease - - 658,206
Payments of principal under capital lease obligation (61,602) (53,370) (332,961)
Proceeds from Ingenex, Inc. technology financing 2,000,000 - 2,000,000
Principal payments on Ingenex, Inc.
technology financing (26,135) (116,932) (333,512)
Increase in minority interest from issuances of
preferred stock by Ingenex, Inc. - - 1,241,032
Issuance of common stock by subsidiaries - - 163,721
Net cash provided by financing activities 3,094,199 10,694,777 38,504,687
----------------- ----------------- --------------------
Net increase (decrease) in cash and cash equivalents 536,448 (643,072) 304,733
Cash and cash equivalents, beginning of period 1,346,444 947,805 -
Cash and cash equivalents, end of period $ 1,882,892 $ 304,733 $ 304,733
================= ================= ====================
</TABLE>
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<PAGE>
TITAN PHARMACEUTICALS, INC.
(a development stage company)
Notes to Condensed Consolidated Financial Statements
(unaudited)
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
THE COMPANY AND ITS SEVERAL DEVELOPMENT STAGE SUBSIDIARIES
Titan Pharmaceuticals, Inc. (the "Company") was incorporated in
February 1992 in the State of Delaware. It is the holding company for several
development stage biotechnology companies ("the Operating Companies"). The
development stage companies, which rely significantly on third parties to
conduct sponsored research, are Ansan, Inc. ("Ansan"), Ingenex, Inc.
("Ingenex"), Theracell, Inc. ("Theracell"), and ProNeura, Inc. ("ProNeura") each
of which continues in operation, and Geneic Sciences, Inc. ("Geneic"), which
ceased operation in September 1995.
ANSAN, INC.
Ansan was incorporated in November 1992 to engage in the development of
novel analogs of butyric acid for the treatment of cancer and other disorders
characterized by abnormal cellular growth and differentiation. It was a
majority-owned consolidated subsidiary until August 1995. In August 1995, Ansan
completed an initial public offering of its securities. Such offering reduced
the Company's ownership in Ansan from approximately 95% to approximately 44%.
From August 1995, the Company has accounted for its investment in Ansan using
the equity method. Concurrent with the Ansan public offering, Ansan granted the
Company a one-year option to purchase up to 400,000 shares of Ansan common
stock. The exercise price of the option is $6.00 per share until August 1996.
Should the Company exercise its option in full, it may again hold a majority
interest in Ansan.
INGENEX, INC.
Ingenex, a majority-owned consolidated subsidiary was incorporated in
July 1991 and reincorporated in June 1992. It is engaged in the development of
gene-based therapeutics and the discovery of medically important genes for the
treatment of cancer and viral diseases. In September 1994, Ingenex issued shares
of its Series B convertible preferred stock to a third party for $1,241,032, net
of issuance costs. This transaction reduced the Company's ownership of Ingenex
from approximately 82% in the second quarter of fiscal 1994 to approximately 61%
at December 31, 1994 (or from approximately 94% to approximately 72% if
conversion of all Ingenex preferred stock is assumed).
THERACELL, INC.
Theracell was incorporated in November 1992 to engage in the
development of novel treatments for various neurologic disorders through the
transplantation of neural cells and neuron-like cells directly into the brain.
The Company's ownership in Theracell was 85% through November 1995, at which
time the Company entered into an agreement with the minority stockholders of
Theracell pursuant to which 140,000 shares of the Company's stock
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TITAN PHARMACEUTICALS, INC.
(a development stage company)
Notes to Condensed Consolidated Financial Statements
(unaudited)
were issued in exchange for all the outstanding shares of Theracell
common stock held by them. In connection with the issuance of the 140,000
shares, the Company recorded a charge for acquired in-process research and
development of $686,000. In November 1995, the former minority stockholders of
Theracell were granted an option to acquire 5% of the issued and outstanding
capital stock of Theracell. These options can be exercised at a price of $1.59
per share within a period of three (3) years from January 18, 1996. Commencing
thirty (30) days after the date Theracell's shares are first publicly traded,
the Theracell options will be subject to redemption by Theracell on thirty (30)
days' written notice at a redemption price of $0.05 per share if the "Closing
Price"(as defined therein) of Theracell's common stock for any thirty (30)
consecutive trading days ending within fifteen (15) days of the notice of
redemption averages in excess of $3.18 per share.
PRONEURA, INC.
ProNeura was incorporated in October 1995 to engage in the development
of cost effective, long term treatment solutions to neurological and psychiatric
disorders through drug delivery. At March 31, 1996, the Company owned 79% of
ProNeura.
GENEIC SCIENCES, INC.
Geneic Sciences had conducted research and development activities
pursuant to sponsored research and licensing agreements with a university, also
a minority stockholder of Geneic Sciences. In September 1995 the Company and the
university terminated the agreements, at which time all rights in the technology
licensed from the university reverted to the university and the minority
interest in Geneic Sciences held by the university was contributed to the
capital of Geneic Sciences. Geneic Sciences ceased operations at such time.
BASIS OF PRESENTATION
The accompanying unaudited consolidated financial statements have been
prepared in accordance with generally accepted accounting principles for interim
financial information and with the instructions to Form 10- QSB and Article 10
of Regulation S-X. Accordingly, they do not include all of the information and
footnotes required by generally accepted accounting principles for complete
financial statements. In the opinion of management, all adjustments (consisting
of normal recurring accruals) considered necessary for a fair presentation have
been included. Operating results for the three month period ended March 31, 1996
are not necessarily indicative of the results that may be expected for the year
ended December 31, 1996. For further information, refer to the consolidated
financial statements and footnotes thereto included in Titan Pharmaceuticals,
Inc. annual report on Form 10-KSB for the year ended December 31, 1995.
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TITAN PHARMACEUTICALS, INC.
(a development stage company)
Notes to Condensed Consolidated Financial Statements
(unaudited)
PER SHARE DATA
For purposes of computing net share data in the three months ended
March 31, 1996, the net loss has been increased by a $5,431,871 deemed dividend
(see Note 2). Except as noted below, per share data is computed using the
weighted average number of common shares outstanding. Common equivalent shares
are excluded from the computation as their effect is antidilutive, except that,
pursuant to the Securities and Exchange Commission ("SEC") Staff Accounting
Bulletins, common and common equivalent shares (stock options, warrants and
preferred stock) issued during the period commencing 12 months prior to the
initial filing of an initial public offering at prices below the assumed public
offering price have been included in the calculation as if they were outstanding
for all periods presented (using the treasury stock method for stock options and
warrants and the if-converted method for preferred stock). Per share information
calculated on the above noted basis is as follows:
Three Months Ended
March 31,
1996 1995
---- ----
Net loss per share $ (1.19) $ (1.00)
====== ======
Shares used in calculating net
loss per share 2,306,355 8,824,159
========== ==========
Pro forma loss per share has been computed as described above and also
gives effect, pursuant to SEC policy, to common equivalent shares from
convertible preferred stock issued more than 12 months from the proposed initial
public offering that automatically converted upon completion of the Company's
initial public offering (using the if-converted method) from the original date
of issuance.
2. STOCKHOLDERS' EQUITY
UNIT OFFERING
In January 1996, the Company issued 3,200,000 units at $5.00 per unit
in the Initial Public Offering "(IPO)". Each unit consisted of one share of
common stock and one redeemable Class A warrant. The net proceeds (after
underwriter's discount and expenses, and other costs associated with the IPO)
totaled $13,955,079. At the closing of the offering, all of the Company's
outstanding preferred stock automatically converted into common stock. Each
share of Series A and Series B preferred stock was converted into 1.4310444107
and 1.8993878755 shares of common stock, respectively.
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<PAGE>
TITAN PHARMACEUTICALS, INC.
(a development stage company)
Notes to Condensed Consolidated Financial Statements
(unaudited)
In January 1996, the Company repaid the $3,750,000 principal and
accrued interest of $105,083 related to the bridge financing with a portion of
the proceeds of the Offering. The Company also repaid Ingenex's bridge of
$1,500,000 principal and accrued interest of $87,898 at that time.
In February, 1996, the Company issued an additional 480,000 units, at
$5.00 per share, in accordance with the underwriter's over-allotment option. The
net proceeds of the underwriter's over-allotment option totaled $2,160,000.
DEEMED DIVIDEND
The holders of Series A and Series B preferred stock received common
stock in January 1996 with an aggregate fair value (at the $5.00 per share value
of the IPO) which exceeded by $5,431,871 the cost of their initial investment of
Series A and Series B preferred stock. This amount has been deemed to be the
equivalent of a preferred stock dividend. The Company recorded the deemed
dividend at the time of the conversion by offsetting charges and credits to
additional paid in capital, without any effect on total stockholders' equity
(net capital deficiency). There was no effect on net loss from the mandatory
conversion. However, the amount did increase the loss applicable to common
stock, in the calculation of net loss per share in the 1996 period.
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<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
Statements in this report that are not descriptions of historical facts
may be forward-looking statements that are subject to risks and uncertainties.
Actual results could differ materially from those currently anticipated.
Results of Operations
The Company is a development stage company which currently conducts its
operations through four operating companies: Ansan, Inc., Ingenex, Inc.,
Theracell, Inc. and ProNeura, Inc. (collectively, the "Operating Companies").
Since its inception in July 1991, the Company's efforts have been principally
devoted to acquiring licenses and technologies, research and development,
securing patent protection and raising capital. The Company has had no
significant revenue and has incurred an accumulated deficit through March 31,
1996 of approximately $34,669,000. These losses have resulted from expenditures
for research and development and general and administrative activities including
legal and professional activities, and are expected to continue for the
foreseeable future. Approximately $6,553,000 of such expenses were incurred in
connection with the activities of a subsidiary which ceased operations in 1995.
Total revenues for the three months ended March 31, 1996 ("first
quarter 1996") were approximately $50,000 from an NIH grant. There were no
revenues for the three months ended March 31, 1995 ("first quarter 1995").
Research and development expenses for first quarter 1996 were
approximately $828,000 compared with $1,965,000 for first quarter 1995, a
decrease of 58%. The decrease in such expenses reflects the deconsolidation of
Ansan, Inc effective August 1995 and the cessation of operations of Geneic
Sciences, Inc. in September 1995.
General and administrative expenses for first quarter 1996 were
approximately $921,000 compared with $677,000 for first quarter 1995, an
increase of 36%. The increase in such expenses resulted from increased insurance
expenses, rental payments which had previously been charged to Geneic, payments
for public relations and business consulting services and professional fees, the
amortization of deferred compensation expenses associated with stock option
issuances and the hiring of additional personnel.
As a result of the foregoing expenses, the Company incurred an
operating loss of approximately $1,699,000 during first quarter 1996 compared
with $2,642,000 during first quarter 1995. The Company expects to continue to
incur substantial research and development costs in the future as a result of
funding (I) ongoing research and development programs at the Operating
Companies, (ii) manufacturing of products for use in clinical trials, (iii)
patent and regulatory related expenses, and (iv) preclinical and clinical
testing of the Operating Companies' products. The Company also expects that
general and administrative costs necessary to support such research and
development activities will increase. Accordingly, the Company expects to incur
increasing operating losses for the foreseeable future.
Interest expense, net of interest income increased to approximately
$(1,547,000) during first quarter 1996 from $(98,000) during first quarter 1995.
Approximately $950,000 of the increase reflects a non-recurring charge
representing the unamortized portion of the $1,200,000 debt discount and
$458,000 of debt issuance costs relating to the Bridge Financing which was
incurred upon repayment in January 1996 of notes issued in the Bridge Financing
(the "Bridge Notes"). Approximately $179,000 of the increase reflects the
Company's share of Ansan's losses.
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Liquidity and Capital Resources
In January 1996, the Company completed an initial public offering of
its securities (the "IPO") which resulted in net proceeds to the Company of
approximately $8,622,000, after payment of underwriting discounts, a
non-accountable expense allowance to the underwriter and other expenses of the
offering and the repayment of the Bridge Notes and notes issued by Ingenex, Inc.
In February 1996, the underwriter of the Company's IPO exercised its
overallotment option, resulting in net proceeds to the Company, after discounts
and commissions to the underwriter, of $2,160,000.
Upon completion of the IPO, the Company's previously outstanding shares
of preferred stock were converted automatically into shares of Common Stock at
adjusted conversion prices per common share less than the public offering price
per common share. The deemed benefit to the preferred stockholders approximated
$5,400,000 which deemed benefit was recorded by offsetting charges and credits
to additional paid-in capital at the time of conversion. There will be no effect
on net income (loss) per share from the mandatory conversion. However, the
amount would reduce the income allocable to common stock, or increase the loss
allocable to common stock, in the calculation of net income (loss) per share in
the period of the conversion.
The Company expects to continue to incur substantial additional
operating losses from costs related to continuation and expansion of research
and development, including clinical trials, and increased administrative
activities over at least the next several years. The Company believes that the
proceeds of the IPO, together with available cash, will provide the necessary
liquidity and capital resources to sustain its planned operations for the 12 to
18 month period following the IPO. However, the Company's capital requirements
may change depending on numerous factors including, but not limited to, the
progress of the Operating Companies' research and development programs, the
results of clinical studies, the timing of regulatory approvals, technological
advances, determinations as to the commercial potential of the Company's
products, and the status of competitive products.
It is not anticipated that the Company or any of the Operating
Companies will have the resources necessary to conduct the several phases of
clinical testing in human subjects necessary to complete development and to
commercialize any products. The Company's strategy will continue to be to seek
public or private financing for the Operating Companies through the sale of
securities or corporate partnering arrangements at such time as their stage of
development and working capital requirements permit such outside financing in
order to reduce their financial dependence on the Company and enable the Company
to continue to expand its product portfolio through acquisitions. There can be
no assurance that financing from such sources or others will be available to any
of the Operating Companies. In the event that the Company fails to raise any
funds it requires, it may be necessary for the Company to outlicense rights it
would prefer to retain or significantly curtail its activities or cease
operations.
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<PAGE>
PART II
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
3.1* -- Restated Certificate of Incorporation of the Registrant
3.2* -- Form of Amendment to Restated Certificate of Incorporation of the
Registrant
3.3* -- By-laws of the Registrant
4.3* -- Form of Warrant Agreement
4.4* -- Form of Underwriter's Unit Purchase Option
4.5* -- Amended and Restated Investor Rights Agreement between the
Registrant and the holders of Series and Series A and Series B
Preferred Stock
+10.19 -- License Agreement between Theracell, Inc. and the University of
South Florida dated March 15, 1996
11 -- Computation of net loss per share
- - ---------------------------
+ Confidential treatment has been requested with respect to portions of this
exhibit.
* Incorporated by reference from the Company's Registration Statement on
Form SB-2 (File No.33-99386)
(b) No reports on Form 8-K were filed during the three months ended
March 31, 1996.
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<PAGE>
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
TITAN PHARMACEUTICALS, INC.
May 15, 1996 By: /S/ LOUIS R. BUCALO
-----------------------------
Louis R. Bucalo, President
May 15, 1995 By: /S/ CAROL DARBY
-----------------------------
Carol Darby, Chief Accounting
Officer
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EXHIBIT INDEX
3.1* -- Restated Certificate of Incorporation of the Registrant
3.2* -- Form of Amendment to Restated Certificate of Incorporation of the
Registrant
3.3* -- By-laws of the Registrant
4.3* -- Form of Warrant Agreement
4.4* -- Form of Underwriter's Unit Purchase Option
4.5* -- Amended and Restated Investor Rights Agreement between the
Registrant and the holders of Series and Series A and Series B
Preferred Stock
+10.19 -- License Agreement between Theracell, Inc. and the University of
South Florida dated March 15, 1996
11 -- Computation of net loss per share
- - ---------------------------
+ Confidential treatment has been requested with respect to portions of this
exhibit.
* Incorporated by reference from the Company's Registration Statement on
Form SB-2 (File No.33-99386)
EX. 10.19
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by * and [ ], have been
separately filed with the Commission.
LICENSE AGREEMENT
This License Agreement, effective the 15th day of March, 1996, is between
Theracell, Inc., a Delaware corporation, having a principal place of business at
1505 O'Brien Drive, Suite B., Menlo Park, CA 94025 ("THERACELL"), the University
of South Florida, acting for and on behalf of the Board of Regents, a public
corporation of the State of Florida, of 4202 E. Fowler Ave., Tampa, FL 33620
("USF"), and the University of South Florida Research Foundation, Inc., a
university direct-support not for profit organization under Florida law, of 4202
E. Fowler Ave., FAO 126, Tampa, FL 33620 ("USFRF").
INTRODUCTION
WHEREAS, USF has developed, and is continuing to develop USF SERTOLI
TECHNOLOGY, as defined herein;
WHEREAS, THERACELL desires to support USF's continued development of USF SERTOLI
TECHNOLOGY, and to commercially exploit USF SERTOLI TECHNOLOGY; and
WHEREAS, THERACELL, USF, and USFRF believe it is in the public interest for USF
SERTOLI TECHNOLOGY to be further developed and commercially exploited in the
manner provided herein;
NOW, THEREFORE, in consideration of the premises and mutual covenants set forth
herein, and intending to be legally bound, the parties agree as follows:
I. Definitions
A. USF Sertoli Patent Rights ("PATENT RIGHTS") shall mean:
1. USF Patent Applications listed in Appendix A and any
successor applications, domestic or foreign resulting
therefrom, as well as any US or foreign patents
issuing therefrom.
2. All subsequent USF patent applications and issued US
and foreign patents involving Sertoli cells filed
and/or issued during the term of this License
Agreement on which one or more of the following USF
researchers is also an inventor:
(a) Paul R. Sanberg
(b) Don F. Cameron
(c) Cesario F. Borlongon
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B. "FIELD" shall mean extra-testicular cell and tissue
transplantation or administration for therapeutic medical
purposes.
C. "USF SERTOLI TECHNOLOGY" shall mean USF PATENT RIGHTS or
know-how related to the use of Sertoli cells in the FIELD. It
is further understood that "know how" means the know how of
USF researchers whose work in developing USF SERTOLI
TECHNOLOGY has been supported by funds from THERACELL or its
sublicensees.
D. "LICENSED PRODUCT" shall mean any product or process for a
defined medical condition covered in whole or in part by USF
SERTOLI TECHNOLOGY
E. "NET SALES" for a LICENSED PRODUCT shall mean THERACELL's and
its sublicensees' billings for LICENSED PRODUCT less the sum
of the following:
(i) discounts allowed in amounts customary in the trade for
quantity purchases, samples, prompt payments' wholesalers'
and distributors;
(ii) sales, tariff duties and/or use taxes directly imposed and
with reference to particular sales;
(iii) outbound transportation prepaid or allowed; and
(iv) amounts allowed or credited on returns.
F. "TERRITORY" shall mean worldwide.
II. Grant
A. Subject to USF's and USFRF's retained rights and covenants
(Section VlIl herein) USF and USFRF grant THERACELL the right
and license in the TERRITORY to practice under USF SERTOLI
TECHNOLOGY, and exclusively to the extent not prohibited by
patent rights of others, or retained by USF and USFRF pursuant
to Section VlIl herein, to make, have made, use, lease, sell,
export and import LICENSED PRODUCTS until the termination of
this Agreement.
B. Subject to USF's and USFRF's retained rights and covenants
(Section VlIl herein) THERACELL shall have the right to enter
into sublicensing agreements for LICENSED PRODUCTS, provided
however, that in no case shall a sublicense be at rates which
are lower than set forth herein below,
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except by prior written consent of USF and USFRF, which
consent shall not be unreasonably withheld.
In each sublicense agreement, THERACELL shall use its best
efforts to secure, as part of the sublicense terms, (i)
unrestricted basic research funds for USF researchers to
further USF SERTOLI TECHNOLOGY, (ii) USF most favored research
and development collaborator status (as defined in Section
IV.B.), and (iii) USF most favored clinical research
collaborator status (as defined in Section IV.C.).
Further, in all sublicense agreements, THERACELL shall advise
its sublicensee of all terms and conditions of this License
Agreement that could effect the sublicensee's rights in and to
USF Sertoli Technology.
III. DILIGENCE
A. THERACELL shall use its best efforts to commercialize multiple
LICENSED PRODUCTS through vigorous research and development
and/or sublicensing efforts, and to continue active, diligent
marketing efforts for one or more LICENSED PRODUCTS throughout
the life of this agreement. In this regard, THERACELL shall:
1. Develop and introduce into clinical trials at least one
LICENSED PRODUCT within three years from the effective date
of this license agreement.
2. Continue to exploit USF SERTOLI TECHNOLOGY through its own
efforts and/or those of its sublicensees such that a second
LICENSED PRODUCT is introduced into clinical trials or
analogous precommercialization trials (the parties
understand this latter term to encompass analogous
regulatory trials required where a LICENSED PRODUCT is a
process or derived from a process in which Sertoli cells are
employed) within five years, and successive LICENSED
PRODUCTS are introduced into clinical trials or analogous
precommercialization trials at an average rate of one every
two years, until the commercialization of at least one
LICENSED PRODUCT.
3. Invest not less than $1.5 MM in connection with activities
described in this agreement over the course of two years
from the effective date of this agreement.
B. If THERACELL has not developed at least one LICENSED PRODUCT
to the stage of entering clinical trials within three years
from the effective date of this License Agreement, USF and
USFRF may convert this license
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The information below marked by * and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.
agreement into a product specific license by terminating this
license as to all LICENSED PRODUCTS, except for any LICENSED
PRODUCTS which THERACELL or a sublicensee is then using its
best efforts to bring to clinical trials and for which
THERACELL continues to use its best efforts pursuant to this
Section to develop and commercialize, provided however,
1. that USF and/or USFRF shall not grant licenses to
others (ALTERNATE LICENSEES) for remaining LICENSED
PRODUCTS that would compete with use of THERACELL's
LICENSED PRODUCTS for their defined medical
condition.
C. If THERACELL fails to maintain the development progress set
forth in Section III.A.2., USF and USFRF may convert this
license agreement into a product specific license by
terminating this license as to all LICENSED PRODUCTS, except
for any LICENSED PRODUCTS which THERACELL or a sublicensee is
then using its best efforts to bring to clinical trials and
for which THERACELL continues to use its best efforts pursuant
to this Section to develop and commercialize, provided
however,
1. that USF and/or USFRF shall not grant licenses to others
(ALTERNATE LICENSEES) for remaining LICENSED PRODUCTS that
would compete with use of THERACELL's LICENSED PRODUCTS for
their defined medical condition, and
2. that if THERACELL or its sublicensees have advanced at least
two products into clinical trials or analogous
precommercialization trials (The parties understand this
latter term to encompass analogous regulatory trials
required where a LICENSED PRODUCT is a process or derived
from a process in which Sertoli cells are employed), USFRF
will rebate to THERACELL up to [********] of the royalties
received from ALTERNATE LICENSEES, not to exceed [*******
******] of NET SALES.
D. In the event USF and USFRF seek ALTERNATE LICENSEES, pursuant
to this Section III, until ALTERNATE LICENSEES for remaining
LICENSED PRODUCTS are found, THERACELL shall have the right to
negotiate with USF and USFRF to regain rights to said
remaining LICENSED PRODUCTS.
IV. USF/THERACELL Research and Development Relationship
A. THERACELL will provide USF researchers with $110,000 per annum
for unrestricted basic research in furtherance of USF SERTOLI
TECHNOLOGY for two years beginning on the effective date of
this agreement. To the extent consistent with USF Rules and
Policy, and Florida Law, said funds
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The information below marked by * and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.
shall be placed in a Sertoli Cell Research Fund and disbursed
to said researchers by mutual agreement with Dr. Paul Sanberg.
B. THERACELL will afford USF most favored research and
development collaborator status. THERACELL will on a case by
case basis award product research and development contracts
based on the ability of the contractor to deliver the required
services in an FDA acceptable manner, in accord with
development timelines, and at a competitive cost, consistent
with the THERACELL's obligations under Section III of this
agreement. To the extent that THERACELL determines that USF
research proposals meet these criteria, THERACELL will give
USF researchers priority in the awarding of such contracts.
C. THERACELL will afford USF most favored clinical research
collaborator status. THERACELL will on a case by case basis
award product clinical research contracts based on ability of
the contractor to deliver the required services in an FDA
acceptable manner, in accord with development times lines, and
at a competitive cost, consistent with THERACELL's obligations
under Section lIl of this agreement. To the extent that
THERACELL determines that USF clinical research proposals meet
these criteria, THERACELL will give USF clinical researchers
priority in the awarding of such contracts.
D. THERACELL will use its best efforts, consistent with economic
feasibility, good business practices, and its obligations
under Section III of this agreement to establish Research and
Development facility adjacent to the campus of USF for the
purpose, among others, of furthering the goals of this
agreement in collaboration with USF researchers.
V. THERACELL Fees and Royalties
THERACELL agrees to pay license fees and royalties (all payable to
USFRF) as follows:
A. An initial License Fee of [******] to which is creditable all
option fees and patent attorney fees paid to USFRF by
THERACELL prior to February 1, 1996, in connection with USF
SERTOLI CELL TECHNOLOGY.
B. Annual License Maintenance Fees of [*****] in 1996, [*****] in
1997, [*****] in 1998, [*****] in 1999, and [******] for each
year after 1999, providing, however,
1. that Running Royalties due on NET SALES for each year, if
any, shall be creditable against the License Maintenance Fee
for said year.
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The information below marked by * and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.
C. Running Royalties on NET SALES of LICENSED PRODUCTS by
THERACELL or its sublicensees, shall be as follows:
1. [******] in countries where neither patent protection for
LICENSED PRODUCT exists nor a competitive, Sertoli based
transplant product is marketed, or
2. [*****] in countries in which patent protection to LICENSED
PRODUCT exists.
Should THERACELL receive sublicensing royalties that are not
conditioned on lack of competition or existence of a patent,
THERACELL will rebate [********] of sublicensing royalties
not to exceed [***********] of NET SALES by sublicensees.
D. THERACELL shall rebate to USFRF [****] of the value of Initial
License Fees and License Maintenance Fees, or any other
consideration other than running royalties (as set forth
above), received from third parties in connection with the
grant of a sublicense on a LICENSED PRODUCT; provided that
this rebate shall not include research and development monies
received from third parties. It is agreed that THERACELL will
in good faith spend any such research and development monies
for that purpose, and USF's most favored research and
development collaborator and most favored clinical research
collaborator status will apply.
E. No multiple Royalties shall be payable to USFRF on any
LICENSED PRODUCT.
F. Royalties shall be payable on LICENSED PRODUCT for the greater
of 15 years from marketing in a commercial territory or until
the expiration (or determination of invalidity by Court of
last resort) of a patent covering said product in that
commercial territory.
VI. Patent Prosecution
A. The filing, prosecution and maintenance of all PATENT RIGHTS
applications and patents shall be the primary responsibility
of USF; provided, however, that THERACELL shall have
reasonable opportunities to advise and consult with USF
thereon and shall cooperate with USF in such filing,
prosecution and maintenance.
B. Paragraph VI.A not withstanding, THERACELL may elect to assume
from USF primary responsibility for filing, prosecution and
maintenance of all PATENT RIGHTS, in the name of USF as owner
and assignee, and pursuant
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to a retainer agreement between THERACELL and outside patent
counsel, to be secured in consultation with USF. In the event
of such election, USF shall have reasonable opportunity to
advise THERACELL in such filing, prosecution and maintenance,
and THERACELL shall use its best efforts to obtain strong and
broad claims under PATENT RIGHTS and shall not abandon
prosecution of any patent application or any of the claims of
patent rights without written consent of USF, which consent
shall not be unreasonably withheld. If THERACELL decides to
abandon any such application or patent, it shall give USF
reasonable notice and opportunity to assume prosecution.
C. THERACELL shall assume financial responsibility for all fees
related to filing, prosecution and maintenance of PATENT
RIGHTS incurred subsequent to February 1, 1996. In the event
Section Vl.A. is operative, USF shall verify the accuracy of
attorney fees and disbursements, and submit invoices to
THERACELL within one month of receipt. In the event Section
Vl.B. is operative, attorney invoices shall be submitted
directly to THERACELL. In the event of a conversion of this
license to a product specific license, pursuant to Section
II.B.3, the parties, will, in good faith, negotiate an
equitable reduction in THERACELL's obligation to pay the fees
set forth in this Section Vl.C.
VlI. Assignability
This license may NOT be assigned to any person or entity without USF's
and USFRF's advance written permission.
VlIl. USF and USFRF Retained Rights and Covenants
USF and USFRF retain the right to do all things granted to THERACELL
under Section II, and USF and USFRF covenant not to commercially
exploit USF Sertoli Technology unless
(i) authorized by this License Agreement, or
(ii) THERACELL becomes insolvent, or
(iii) anyone files a lien against this License Agreement, or
(iv) THERACELL takes any action, or fails to take any action, the
result of which gives a third party the right to file such a
lien, or
(v) THERACELL files for bankruptcy or a receiver is appointed, or
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(vi) THERACELL ceases to carry on its business, or
(vii) THERACELL materially breaches this License Agreement in a
manner which causes this License Agreement to terminate or
gives USF or USFRF the right to terminate under Section Xll.
IX. Product Liability/Insurance
THERACELL shall, at all times during the term of this License Agreement
and thereafter, be solely responsible for, and defend, hold harmless
and indemnify USF, USFRF, their trustees, officers, employees, agents
and other representatives, against any claims and expenses, including
legal expenses and reasonable attorneys' fees, arising out of the death
of or injury to any person or property based upon products produced or
developed for, or by, THERACELL, or commercially exploited by THERACELL
or a sublicensee of THERACELL pursuant to its rights under this
Agreement. THERACELL shall obtain and carry in full force and effect
product liability insurance, in amounts customary in the biotech
industry which shall protect USF, USFRF, their trustees, officers,
employees, agents and other representatives in regard to the foregoing
events.
X. Record Keeping
A. THERACELL shall keep full, true and accurate books of account
containing all particulars that may be necessary for the
purpose of showing the amounts payable to USFRF hereunder.
Said books of account shall be kept at THERACELL's principal
place of business. Said books and the supporting data shall be
open at all reasonable times for five (5) years following the
end of the calendar year to which they pertain, to the
inspection of USFRF or its agents for the purpose of verifying
THERACELL's royalty statement of compliance in other respects
with this Agreement.
B. THERACELL, within ninety (90) days after March 31, June 30,
September 30 and December 31, of each year, shall deliver to
USFRF true and accurate reports, giving such particulars of
the business conducted by THERACELL and its sublicensees
during the preceding three-month period under this Agreement
as shall be pertinent to a royalty accounting hereunder. These
shall include at least the following:
(i) number of LICENSED PRODUCTS manufactured and sold by
THERACELL and its sublicensees, if any,
(ii) total billings for LICENSED PRODUCTS sold,
(iii) deductions applicable as provided in Paragraph
Section l.H.,
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(iv) total royalty due,
(v) after a first sublicense is granted names and addresses of
all sublicensees of THERACELL (and copies of all sublicensee
agreements then effect), and
(vi) if Section Vl.B. is operative progress report on patent
filings in each country, including the serial number, name
of patent application, name of inventors and status of each
patent application covering LICENSED PRODUCT. [If Section
Vl.A. is operative, USF will provide THERACELL with such
information at least semi-annually.]
With each such report submitted, THERACELL shall pay the
royalties, fees and any other consideration due and payable
under this Agreement. If no royalties, fees or other
consideration shall be due, THERACELL shall so report.
C. On or before the ninetieth (9Oth) days following the close of
THERACELL's fiscal year, THERACELL shall provide USF and USFRF
with THERACELL's certified financial statements for the
preceding fiscal year including, at a minimum, a Balance Sheet
and an Opening Statement.
D. The payments for royalties, fees or other consideration set
forth in this Agreement shall, if overdue, bear interest until
payment at the monthly rate of one percent (1%). The payment
of such interest shall not foreclose USF and USFRF from
exercising any other rights either may have as a consequence
of the lateness of any payment.
E. THERACELL hereby agrees that it shall not sell, transfer,
export or reexport any LICENSED PRODUCTS or related
information in any form, or any direct products of such
information, except in compliance with all applicable laws,
including the export laws of any U.S. government agency and
any regulations thereunder, and will not sell, transfer,
export or reexport any such LICENSED PRODUCTS or information
to any persons or any entities with regard to which there
exist grounds to suspect or believe that they are violating
such laws. THERACELL shall be solely responsible for obtaining
all licenses, permits or authorizations required from the U.S.
and any other government for any such export or reexport. To
the extent not inconsistent with this Agreement, USF and USFRF
agree to provide THERACELL with such assistance as it may
reasonably request in obtaining such licenses, permits or
authorization.
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Xl. Non-Use of Names
THERACELL shall not use the names of the USF or USFRF, nor any adaptation of
either, in any advertising, promotional or sales literature without prior
written consent obtained from USF and/or USFRF in each case, except that
THERACELL may state that it is licensed under one or more of the patents and/or
applications comprising the Patent Rights. The parties agree to issue a mutually
agreed press release on or after the Effective Date.
Xll. Term and Termination
A. Unless sooner terminated as provided herein, this License
Agreement will expire with respect to a given LICENSED PRODUCT
on the later of the date of the last to expire of the PATENT
RIGHTS or fifteen (15) years from the first bona fide
commercial sale of said LICENSED PRODUCT. Upon such expiration
of this License Agreement, THERACELL shall have a fully
paid-up worldwide right and license to continue to
commercially exploit said LICENSED PRODUCT.
B. If THERACELL assigns this License Agreement without USF's and
USFRF's written permission, in violation of Section Vll, this
License Agreement shall terminate automatically.
C. If THERACELL shall cease to carry on its business, this
License Agreement shall terminate upon notice by USF and/or
USFRF.
D. In the event either party files for bankruptcy or a receiver
is appointed, this License Agreement may immediately
thereafter be terminated at the option of the other party.
E. Should THERACELL fail to pay the royalties, fees and/or other
consideration due and payable hereunder, USFRF and/or USF
shall have the right to terminate this License Agreement on
forty-five (45) days notice, unless THERACELL shall pay,
within the forty-five (45) day period, all such royalties,
fees and other consideration, and interest due and payable.
Upon the expiration of the forty-five (45) day period, if
THERACELL shall not have paid all such royalties, fees and
other consideration, and interest due and payable, the rights,
privileges and license granted hereunder shall terminate.
F. Upon any material breach or default this License Agreement by
THERACELL. other than those occurrences set out hereinabove
which shall always take precedence in that order over any
material breach or default referred to in this Section, USFRF
and/or USF shall have the right to terminate this License
Agreement and the rights, privileges and license granted
hereunder upon thirty (30) days' written notice to THERACELL.
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Such termination shall become effective unless (i) Licensee
shall have cured any such breach or default prior to the
expiration of thirty (30) days from the date THERACELL
receives notice of the breach or default, or (ii) THERACELL
shall have demonstrated substantial efforts to cure such
breach or default, which efforts shall be reasonably
satisfactory to USF and/or USFRF.
G. THERACELL shall have the right to terminate this License
Agreement at any time on six (6) months' written notice to
USFRF and USF, and upon payment of all amounts due USFRF
through the effective date of the termination.
H. Upon termination of this License Agreement for any reason,
nothing herein shall be construed to release either party from
any obligation that matured prior to the effective date of
such termination. THERACELL and any sublicensee thereof may,
however, after the effective date of such termination, sell
all LICENSED PRODUCTS, and complete LICENSED PRODUCTS in the
process of manufacture at the time of such termination and
sell the same, provided that THERACELL shall pay to USF and/or
USFRF the royalties thereon as required by Article IV of this
License Agreement and shall submit the reports required by
Article V hereof on the sales of the LICENSED PRODUCTS.
1. Upon termination of this License Agreement for any reason,
any sublicensee not then in default under its sublicense
agreement with THERACELL shall automatically have a license
under this License Agreement as a direct THERACELL of USF
and/or USFRF, on economic terms no less favorable than those
set forth in the sublicense agreement, and otherwise with
the same rights and obligations as THERACELL hereunder,
provided, however, that such automatic license is granted
only, to the extent that it does not conflict with any other
rights lawfully granted to anyone else, and further provided
that such automatic license shall terminate unless
sublicensee, within thirty (30) days from notice by USF
and/or USFRF that this License Agreement has terminated,
shall:
(i) state to USF and USFRF in writing that to the best of its
knowledge and belief, it is capable of performing to such an
automatic sublicense;
(ii) pay any royalties, fees and other consideration (including
interest) due and payable, or cure any such breach or
default in any manner which preserves the value to USFRF and
USF of this License Agreement, or demonstrate substantial
efforts
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to cure such breach or default, which efforts shall be
reasonably satisfactory to USFRF and USF;
or the license hereunder to sublicense shall terminate.
J. Upon termination of this Agreement for any reason, all
intellectual property rights licensed hereunder, including
without limitation all PATENT RIGHTS and all USF Sertoli
Technology shall revert to USF and/or USFRF and THERACELL
shall have no further right to or continuing interest
herein.
XlIl. Payments, Notices and Other Communications
Any payment, notice or other communication pursuant to this License Agreement
shall be sufficiently made or given on the date of mailing if sent to such party
by certified first class mail or air courier, postage prepaid, addressed to it
at its address below or it shall designate by written notice given to the other
party:
In the case of USFRF:
USF Research Foundation, Inc.
P. O. Box 30445
Tampa, FL 33620-3044
In the case of THERACELL:
Theracell, Inc.
1505 O'Brien Drive, Ste. B
Menlo Park, CA 94025
All Payments to:
USF Research Foundation, Inc.
P.O. Box 20445
Tampa, FL 33620-30440
In the case of USF:
Director, Sponsored Research
4202 E. Fowler Ave., FAO 126
Tampa, FL 33620
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XIV. Infringement
The parties consider infringement (either of the Patent Rights or of a third
party patent) to be a different matter from the patent and other legal fees
referred to in this License Agreement, and the parties therefore agree that it
is in their mutual interests to confer when a question of infringement (either
of the Patent Rights or of a third party patent) arises before taking legal
action which may result in substantial expense. It is the intent of the parties
to evaluate the infringement-related situations on a case-by-case basis in order
to determine the best course of action.
XV. Miscellaneous Provisions
A. Each party represents and warrants that it has the authority
to enter into this License Agreement and that the execution,
delivery and performance of this Agreement do not conflict
with any agreement or understanding, either written or oral,
to which it is a party or to which it is otherwise bound.
B. This License Agreement shall be construed, governed,
interpreted and applied in accordance with the laws of the
State of Florida, U.S.A., except that questions affecting the
construction and effect of any Patent Rights shall be
determined by the law of the country in which the patent was
granted.
C. The parties hereto acknowledge that this License Agreement
sets forth the entire agreement and understanding of the
parties hereto as to the subject matter hereof, and shall not
be subject to any change or modification except by the
execution of a written instrument subscribed to by the parties
hereto.
D. If any term, covenant or condition of this License Agreement
or the application thereof to any party or circumstance shall,
to any extent be held to be invalid or unenforceable,
(i) the remainder of this License Agreement, or the
application of such term, covenant or condition to
the parties or circumstances other than those as to
which it is held invalid or unenforceable, shall not
be affected thereby and each term, covenant or
condition of this Agreement shall be valid and be
enforced to the fullest extent permitted by law; and
(ii) the parties hereto covenant and agree to renegotiate
any such term, covenant or application thereof in
good faith in order to provide a reasonably
acceptable alternative to the term, covenant or
condition of this License Agreement or the
application thereof that is invalid or unenforceable,
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it being the intent of the parties that the basic purposes of
this License Agreement are to be effectuated.
E. THERACELL agrees to mark the containers or packages of
LICENSED PRODUCTS sold in the United States with all
applicable United States patent numbers. All LICENSED PRODUCTS
shipped to or sold in other countries shall be marked in such
a manner as to confirm with the patent laws and practice of
the country of manufacture or sale.
F. The failure of any party to assert a right hereunder or to
insist upon compliance with any term or condition of this
License Agreement shall not constitute a waiver of that right
or excuse a similar subsequent failure to perform any such
term of condition by the other party.
G. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS LICENSE
AGREEMENT, USF and/or USFRF MAKE NO REPRESENTATION AND EXTEND
NO WARRANTIES OF ANY KIND, EITHER EXPRESS OF IMPLIED,
INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, NON INFRINGEMENT, AND
VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING.
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IN WITNESS WHEREOF, the parties have hereunto set their hands and seals and duly
executed this License Agreement the day and year set forth below.
UNIVERSITY OF SOUTH FLORIDA
RESEARCH FOUNDATION, INC.
By /S/ KENNETH G. PRESTON /S/ DEANNA BONDOC
---------------------------- ---------------------------
Kenneth G. Preston Witness
Executive Director
Date:
UNIVERSITY OF SOUTH FLORIDA
By /S/ GEORGE R. NEWKOME /S/ AMY COMBAST
---------------------------- ----------------------------
George R. Newkome Witness
Vice President
Date:
THERACELL INC.
By /S/ RICHARD ALLEN /S/ DEANNA BONDOC
----------------------------- ----------------------------
Richard Allen, Ph.D. Witness
President and CEO
Date:
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<PAGE>
APPENDIX A TO LICENSE AGREEMENT EFFECTIVE
MARCH 15,1996
BETWEEN USF, USFRF, AND THERACELL
Patent Applications
TITLE: Purified and Isolated Sertoli Cell Aggregate
Filing Date: 4/20/95
Serial No.: 08/425,868
Inventors: Richard Heller, Don F. Cameron, Paul R. Sanberg, and Mark J.
Jaroszeski
TITLE: Sertoli Cells as Transplantation Facilitor for Cell
Transplantation
Filing Date: 3/13/95
Serial No.: 08/402,387
Inventors: Paul R. Sanberg, Don F. Cameron, Cesario V. Borlongan, and
Richard Heller (note: based upon information from Inventors,
inventorship may need to be changed to delete Richard Heller)
TITLE: Sertoli Cells as Neurorecovery Inducing Cells for
Neurodegenerative Disorders Filing Date: 3/13/95
Serial No.: 08/402,389
Inventors: Paul R. Sanberg, Don F. Cameron, and Cesario V. Borlongan
TITLE: Method and Media for Enhancing Cryopreservation of Cells
Filing Date: 3/12/96
Serial No.: 08/615,039
Inventors: Don F. Cameron, Paul R. Sanberg, Cesario V. Borlongan and
Samuel Saporta
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<PAGE>
PCT/CIP Applications
TITLE: Sertoli Cells as Neurorecovery Inducing Cells for
Neurodegenerative Disorders - CIP which was filed through the
PCT designating the US
Filing Date: 3/12/96
Serial No.:
Inventors: Paul R. Sanberg, Don F. Cameron; and Cesario V. Borlongan
TITLE: Sertoli Cells as Transplantation Facilitator for Cell
Transplantation - CIP which was filed through the PCT
designating the US
Filing Date: 3/12/96
Serial No.:
Inventors: Paul R. Sanberg, Don F. Cameron, Cesario V. Borlongan, and
Richard Heller (note: based upon information from Inventors,
inventorship may need to be changed to delete Richard Heller)
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EXHIBIT 11
TITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENT OF COMPUTATION OF NET LOSS PER SHARE
<TABLE>
THREE MONTHS ENDED MARCH 31,
1995 1996
------------------ -------------------
<S> <C> <C>
NET LOSS $ (2,739,935) $ (3,424,769)
DEEMED DIVIDEND UPON CONVERSION OF PREFERRED STOCK - (5,431,871)
NET LOSS APPLICABLE TO COMMON STOCK (2,739,935) (8,856,640)
================== ===================
WEIGHTED AVERAGE SHARES OF
COMMON STOCK OUTSTANDING 1,408,519 8,824,159
SHARES RELATED TO STAFF ACCOUNTING
BULLETIN TOPIC 4D:
STOCK OPTIONS AND WARRANTS 897,836 -
SHARES USED IN COMPUTING NET LOSS PER SHARE 2,306,355 8,824,159
================== ===================
NET LOSS PER SHARE $ (1.19) $ (1.00)
================== ===================
PRO FORMA
NET LOSS APPLICABLE TO COMMON STOCK $ (2,739,935) $ (8,856,640)
================== ===================
CALCULATION OF SHARES OUTSTANDING FOR
COMPUTING PRO FORMA NET LOSS PER SHARE:
SHARES USED IN COMPUTING NET LOSS PER SHARE 2,306,355 8,824,159
ADJUSTED TO REFLECT THE EFFECT OF THE
assumed conversion of preferred stock 4,922,183 9,916,250
------------------ -------------------
SHARES USED IN COMPUTING PRO FORMA NET
LOSS PER SHARE 7,229,183 9,916,250
================== ===================
PRO FORMA NET LOSS PER SHARE $ (0.38) $ (0.89)
================== ===================
</TABLE>
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE
SHEET AND STATEMENT OF OPERATIONS AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE
TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-END> MAR-31-1996
<CASH> 304,733
<SECURITIES> 8,856,555
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 9,346,152
<PP&E> 1,389,407
<DEPRECIATION> 616,020
<TOTAL-ASSETS> 11,823,637
<CURRENT-LIABILITIES> 2,351,351
<BONDS> 0
0
0
<COMMON> 35,271,919
<OTHER-SE> (28,879,563)
<TOTAL-LIABILITY-AND-EQUITY> 11,823,637
<SALES> 0
<TOTAL-REVENUES> 49,705
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 1,747,091
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 1,623,129
<INCOME-PRETAX> (3,424,769)
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (3,424,769)
<EPS-PRIMARY> (1.00)
<EPS-DILUTED> (0.89)
</TABLE>
