SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
[x] QUARTERLY REPORT PURSUANT SECTION 13 or 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarter ended June 30, 1996
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from to
-------------- ---------------
Commission File No. 0-26422
ANSAN, INC.
(Exact Name of Small Business Issuer as Specified in Its Charter)
Delaware 94-3171943
(State or Other Jurisdiction of (I.R.S. Employer Identification Number)
Incorporation or Organization)
400 Oyster Point Blvd. Suite 435
South San Francisco, California 94080
(Address of Principal Executive Offices)
(415) 635-0200
(Issuer's Telephone Number, Including Area Code)
Not Applicable
(Former Name, Former Address and Former Fiscal Year,
if Changed Since Last Report)
Check whether the issuer (1) filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
past 12 months (or for such shorter period 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 issuer's
classes of common equity, as of the latest practicable date.
Class Outstanding at July 31, 1996:
Common Stock, $.001
par value 2,786,798 shares
Transitional Small Business Disclosure Format
Yes No X
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INDEX TO FORM 10-QSB
PAGE
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed Financial Statements:
Condensed Balance Sheets as of June 30, 1996
and December 31, 1995.............................................3
Condensed Statements of Operations for the Three- and Six-
Months ended June 30, 1996 and 1995...............................4
Condensed Statements of Cash Flows for the Six
Months ended June 30, 1996 and 1995...............................5
Notes to Condensed Financial Statements.............................6
Item 2. Management's Discussion and Analysis
or Plan of Operation................................................8
PART II. OTHER INFORMATION
Item 1. Legal Proceedings........................................11
Item 2. Changes in Securities....................................11
Item 3. Defaults Upon Senior Securities..........................11
Item 4. Submission of Matters to a
Vote of Security-Holders...........................11
Item 5. Other Information........................................11
Item 6. Exhibits and Reports on Form 8-K.........................11
SIGNATURES ........................................................12
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PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS
ANSAN, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED BALANCE SHEETS
<TABLE>
JUNE 30, DECEMBER 31,
1996 1995
------------------ -------------------
(UNAUDITED) (NOTE A)
<S> <C> <C>
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $69,562 $45,202
Short-term investments 3,002,393 3,809,110
Prepaid expenses and other current assets 28,500 108,089
Total current assets 3,100,455 3,962,401
Furniture and equipment, net 65,778 18,244
$3,166,233 $3,980,645
========== ============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $118,442 $80,276
Payable to Titan Pharmaceuticals, Inc. 82,451 57,791
Accrued sponsored research expense - 32,890
Accrued legal expense 50,730 50,000
Other accrued liabilities 46,792 117,006
---------- ------------
Total current liabilities 298,415 337,963
STOCKHOLDERS' EQUITY
Common stock, at amounts paid in, $0.001 par value; 20,000,000
shares authorized, 2,768,164 and 2,786,798 shares issued and
outstanding at December 31, 1995 and
June 30, 1996, respectively 10,687,037 10,678,061
Deferred compensation (208,339) (236,118)
Deficit accumulated during the development stage (7,610,880) (6,799,261)
Total stockholders' equity 2,867,818 3,642,682
$3,166,233 $3,980,645
============= ===========
</TABLE>
Note A: 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.
See notes to condensed financial statements.
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ANSAN, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
Period from
Three Months Ended Six Months Ended Incorporation
June 30, June 30, (November 6,
------------------------------------- ---------------------------------- 1992) to
June 30,
1996 1995 1996 1995 1996
------------- --------------- ---------------- -------------- -------------
<S> <C> <C> <C> <C> <C>
COSTS AND EXPENSES:
Research and development $205,614 $541,183 $462,976 $834,436 $5,262,429
General and administrative 242,345 528,818 441,926 663,017 2,098,758
Loss from operations (447,959) (1,070,001) (904,902) (1,497,453) (7,361,187)
Other income/(expenses)
Interest income 44,275 13,250 93,283 13,250 185,456
Interest expense - - - - (435,149)
Net loss $(403,684) $(1,083,251) $(811,619) $(1,510,703) $(7,610,880)
============ ============== =========== ============ ============
Net loss per share $(0.17) $(1.90) $(0.34) $(2.65)
============ ============== =========== ============
Shares used in calculating
net loss per share 2,407,885 569,672 2,406,145 569,672
============ ============== =========== ============
Pro forma net loss per share $(1.14) $(1.59)
============= ============
Shares used in calculating
pro forma net loss per share 950,145 950,145
============= ============
</TABLE>
See notes to condensed financial statements.
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ANSAN, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
PERIOD FROM
INCORPORATION
(NOVEMBER 6,
SIX MONTHS ENDED 1992) TO
JUNE 30, MARCH 31,
1996 1995 1996
---------------- -------------- ------------
<S> <C> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $(811,619) $(1,510,703) $(7,610,880)
Adjustments to reconcile net loss to net cash used
by operating activities
Depreciation expense 9,251 - 10,910
Amortization of debt discount - - 400,000
Amortization of deferred compensation 27,779 13,889 69,445
Forgiveness of stockholder receivable - - 205
Issuance of common stock in exchange
for consulting services - - 19,984
Changes in operating assets and liabilities:
Prepaid expenses and sponsored research 79,589 - (28,500)
Accounts payable 38,166 135,284 118,442
Accrued legal 730 - 50,730
Accrued sponsored research (32,890) -
Other accrued liabilities (70,214) 194,934 46,792
Net cash used in operating activities (759,210) (1,166,596) (6,922,872)
----------------- --------------- -------------
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of furniture and fixtures (56,785) - (76,688)
Purchase of short-term investments (93,283) - (3,902,393)
Proceeds from sale of short-term investments 900,000 - 900,000
Net cash provided / (used) by investing activities 749,932 - (3,079,081)
----------------- --------------- -------------
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of series A preferred stock - - 992,592
Proceeds from issuance of common stock, net 8,976 - 5,964,256
Deferred offering costs - (210,065) -
Proceeds from related party notes - - 220,000
Payment on note from related party - - (190,000)
Issuance of notes payable - 1,058,333 1,025,000
Repayment of note payable - - (1,425,000)
Issuance of warrants to purchase common stock - 400,000 400,000
Proceeds from stockholder receivable - - 1,900
Payable to Titan Pharmaceuticals, Inc. 24,660 366,504 3,082,767
Net cash provided by financing activities 33,636 1,614,772 10,071,515
----------------- --------------- -------------
Net increase (decrease) in cash and cash
equivalents 24,360 448,176 69,562
Cash and cash equivalents, beginning of period 45,202 96,704 -
Cash and cash equivalents, end of period $69,562 $544,880 $69,562
================= =============== =============
SUPPLEMENTAL CASH FLOW DISCLOSURE AND NONCASH
FINANCING ACTIVITIES
Forgiveness of note payable to related party $- $- $30,000
================= =============== =============
Interest paid on related party notes $- $- $4,409
================= =============== =============
Conversion of payable to parent into Series A
Preferred Stock $- $- $1,449,064
================= =============== =============
Conversion of payable to parent into Common Stock $- $- $1,551,252
================= =============== =============
</TABLE>
See notes to condensed financial statements.
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ANSAN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company
-----------
Ansan, Inc. (the "Company") was incorporated in the State of Delaware on
November 6, 1992 to engage in the development of analogs of butyric acid
for the treatment of cancer, blood disorders and other serious diseases.
The Company is in the development stage.
Relationship with Titan Pharmaceuticals, Inc.
---------------------------------------------
Titan Pharmaceuticals, Inc. ("Titan"), a biopharmaceutical company engaged,
through the operations of its subsidiaries and affiliates, in the
development of new proprietary therapeutic products for use in the fields
of cancer, immunology, viral diseases, and disorders of the central nervous
system, was the Company's parent until the Company's initial public
offering (the "IPO") in August 1995. Subsequent to the IPO, Titan's
ownership interest was reduced to 44%. In August 1995, the company granted
Titan a one year option to purchase up to 400,000 shares of Common Stock.
In July 1996, the Company extended the option through September 8, 1996, in
order to allow the Company and Titan an opportunity to renegotiate the
terms of such option as well as other possible financing transactions. The
Company had previously contracted with Titan for facilities and equipment,
and certain executive, administrative, financial, regulatory, business
development and human resource services. Subsequent to December 31, 1995
the Company has contracted with Titan only for limited financial and
administrative services. Titan has previously supplied working capital
financing to the Company and may in the future provide such financing. As
part of its affiliation with Titan, the Company and Titan have a number of
members in common of their respective boards of directors.
Basis of Presentation
---------------------
The accompanying unaudited condensed financial statements have been
prepared in accordance with generally accepted accounting principals 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
principals for complete financial statements. In the opinion of management,
all adjustments (consisting of normal recurring accruals) considered for
fair presentation have been included. Operating results for the three- and
six-month periods ended June 30, 1996 are not necessarily indicative of the
results that may expected for the year ending December 31, 1996. For
further information, refer to the consolidated financial statements and
footnotes thereto included in the Company's 1995 Annual Report on Form
10-KSB. The Company's activities since incorporation have consisted
primarily of conducting research and development, performing business and
financial planning and raising capital. Accordingly, the Company is
considered to be in the development stage and expects to incur increasing
losses and require additional financial resources to achieve
commercialization of its products. The Company also depends on third
parties to conduct certain research on the Company's behalf through various
research arrangements. All of the Company's current products under
development are the subject of license agreements that may require the
payment of future royalties.
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ANSAN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
Net Loss Per Share
------------------
Net loss per share for the three- and six-month periods ended June 30, 1996
is computed using the weighted average number of common shares outstanding,
reduced by the number of shares held in escrow (see Note 3 of the Notes to
the Financial Statements included in the Company's 1995 Annual Report on
Form 10-KSB). Common equivalent shares are excluded from the calculation as
their effect is antidilutive. Pro forma net loss per share for the three-
and six-month periods ended June 30, 1995 is computed using the weighted
average number of common shares outstanding, common equivalent shares from
convertible preferred stock which automatically converted upon the closing
of the Company's IPO, and certain other common equivalent shares as
mandated by SEC Staff Accounting Bulletins.
Collaborative Agreements
------------------------
In May of 1996, the Company signed a licensing agreement with Boehringer
Ingelheim GmbH to acquire the rights in the United States and the European
Union to develop a new intravenous formulation of the drug apafant for all
clinical indications. The company intends to proceed with the further
development and, if possible, clinical testing of the drug. Pursuant to the
agreement, the Company may be obligated to make future milestone and
royalty payments to Boehringer Ingelheim GmbH. However, under certain
circumstances, Boehringer Ingelheim GmbH may participate in the further
development and commercialization of apafant and would, in such
circumstances, be obligated to make milestone and royalty payments to
Ansan.
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<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS
Statements in this report may contain forward-looking statements, involving
risks and uncertainties that may or may not be identifiable in advance. Actual
results may differ materially from those anticipated.
RESULTS OF OPERATIONS
The Company is in the development stage. Since its inception in
November 1992, the Company's efforts have been principally devoted to research
and development, securing patent protection and raising capital. From inception
through June 30, 1996, the Company has sustained cumulative losses of
$7,610,880. These losses have resulted from expenditures in connection with
research and development and general and administrative activities, including
legal and professional activities.
Through June 30, 1996, research and development expenses since
inception have been approximately $5,262,000 and general and administrative
expenses since inception have been approximately $2,099,000. Total research and
development expenses were approximately $206,000 and $463,000 during the three-
and six-month periods ended June 30, 1996, respectively, compared with
approximately $541,000 and $834,000 for the three- and six-month periods ended
June 30, 1995, respectively, a decrease of approximately 62% and 44% for the
three- and six-month periods, respectively. The higher level of expenditures in
1995 is attributed to costs incurred in anticipation of the Company's clinical
trial that commenced in the first quarter of 1996. These costs included
expenditures for preparation and compilation of investigational new drug
applications (IND), toxicology studies and manufacturing. Also, during the
second half of 1995 the Company reorganized much of its research and development
activities that are performed by outside vendors by establishing new vendor
relationships, and moving certain functions in-house. This reorganization has
produced a cost savings to the Company.
Total general and administrative expenses were approximately $242,000
and $442,000 during the three- and six-month periods ended June 30, 1996,
respectively, compared with approximately $529,000 and $663,000 for the three-
and six-month periods ended June 30, 1995, respectively, a decrease of
approximately 54% and 33% for the three- and six-month periods, respectively.
The higher level of expenditures in 1995 are associated, in part, with
underwriting commissions and other costs associated with a private placement of
debt. Interest income was approximately $44,000 and $93,000 for the three- and
six-month periods ended June 30, 1996, respectively, compared with approximately
$13,000 for both the three- and six-month periods ended June 30, 1995. This
increase is the result from investment of the remaining proceeds from the
Company's IPO in August 1995.
The Company expects to continue to incur substantial research and
development costs in the future due to ongoing and new research and development
programs, manufacturing of products for use in clinical trials, patent and
regulatory activities, and preclinical and clinical testing of the Company's
products. In May of 1996, the Company signed a licensing agreement with
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<PAGE>
Boehringer Ingelheim GmbH to acquire the rights in the United States and
the European Union to develop a new intravenous formulation of the drug
apafant for all clinical indications. The Company expects to incur
substantial research and development costs related to this acquisition. The
Company also expects that general and administrative costs necessary to
support clinical trials, research and development, manufacturing and the
creation of a marketing and sales organization, if warranted, will increase
in the future. Accordingly, the Company expects to incur increasing
operating losses for the foreseeable future. There can be no assurance that
the Company will ever achieve profitable operations.
LIQUIDITY AND CAPITAL RESOURCES
In August and September 1995, the Company completed an IPO which
resulted in net proceeds to the Company, after deduction of underwriting
discounts and commissions and other expenses of the IPO, of approximately
$5,950,000. As of June 30, 1996, the Company had working capital of
approximately $2,802,000.
In August 1995, the Company granted Titan, the Company's principal
stockholder, a one-year option to purchase up to 400,000 shares of Common Stock.
In July 1996, the Company extended the option through September 8, 1996, in
order to allow the Company and Titan an opportunity to renegotiate the terms of
such option as well as other possible financing transactions.
Titan is a party to a master capital equipment lease, and the Company
and three other majority-owned subsidiaries of Titan have entered into a
sublease and assignment with Titan under such lease for which the Company is
jointly and severally liable. At June 30, 1996, the amount outstanding under the
equipment lease was $864,964 with current monthly payments of $30,459.
The Company believes that the proceeds from the IPO will provide the
necessary liquidity and capital resources to sustain planned operations through
1996. In the event that the Company's internal estimates relating to its planned
expenditures prove materially inaccurate, the Company may be required to
reallocate funds among its planned activities or to curtail certain planned
expenditures. In any event, the Company anticipates that it will require
substantial additional financing after such time in order to continue its
research and development capabilities, fund operating expenses, pursue
regulatory approval, and build production, sales, and marketing activities, as
necessary. There can be no assurance as to the availability or terms of any
additional financing, when and if needed. In the event that the Company fails to
raise any funds it requires, it may be necessary for the Company to curtail its
activities significantly or to cease operations altogether.
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<PAGE>
RELEASE OF ESCROWED SHARES AND OPTIONS
In connection with the IPO, certain stockholders of the Company placed
an aggregate of 363,760 shares of Common Stock (the "Escrow Shares"), and the
current holders of certain options which are exercisable at less than the
initial public offering price of $5.00 placed options to purchase 36,260 shares
(the "Escrow Options"), into escrow pending the Company's attainment of certain
revenue or share price goals. The Securities and Exchange Commission has taken
the position with respect to the release of securities from escrow that in the
event any of the Escrow Shares or Escrow Options are released from escrow to
directors, officers, employees or consultants of the Company, the release will
be treated, for financial reporting purposes, as a compensation expense to the
Company. Accordingly, the Company will, in the event of the release of the
Escrow Shares and Escrow Options, recognize during the period in which the
earnings or market price targets are met what could be a substantial one-time
charge which would substantially increase the Company's loss or reduce or
eliminate earnings, if any, at such time. The amount of compensation expense
recognized by the Company will not affect the Company's total stockholders'
equity.
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<PAGE>
PART II
Item 1. LEGAL PROCEEDINGS
Not Applicable
Item 2. CHANGES IN SECURITIES
Not Applicable
Item 3. DEFAULTS UPON SENIOR SECURITIES
Not Applicable
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not Applicable
Item 5. OTHER INFORMATION
Not Applicable
Item 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) 4.1 -Form of Unit Purchase Option *
4.2 -Form of Warrant Agreement (including forms of Class A
and Class B Warrant Certificates) *
4.3 -Escrow Agreement *
10.11 -License Agreement dated May 31, 1996, between
Boehringer Ingelheim GmbH and the Registrant **
11.0 -Statement re Computation of Earnings of Per Share
27.0 -Financial Data Schedule
* Incorporated by reference to the Company's Registration Statement
on Form SB-2 (file no. 33-92886)
** Confidential treatment has been requested with
respect to portions of this exhibit.
(b) No reports on Form 8-K were filed during the six months ended
June 30, 1996.
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SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the
registrant caused this report to be signed on its behalf by the undersigned,
thereunder duly authorized.
ANSAN, INC.
By: /S/ S. Mark Moran Date: August 13, 1996
--------------------------------------------
S. Mark Moran, President and
Chief Executive Officer
(Principal Executive Officer and
Principal Financial Officer)
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August 14, 1996
VIA EDGAR
Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549
Re: Quarterly Report on Form 10Q-SB
Ansan, Inc.
Ladies and Gentlemen:
On behalf of our client, Ansan, Inc. (the "Company"), enclosed herewith
for filing is one (1) copy of the Company's Quarterly Report on Form 10Q-SB for
its fiscal quarter ended June 30, 1996.
Very truly yours,
Allison G. Godman
AGG/js
Enclosures
cc: Mr. James Ahlers
The Nasdaq Stock Market,
Nasdaq Regulatory Filings
Exhibit (10.11) - License Agreement
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by an * and [ ], have
been separately filed with the Commission.
LICENSE AGREEMENT
This Agreement (the "AGREEMENT") is made and entered into this 31st day
of May, 1996 by and between BOEHRINGER INGELHEIM INTERNATIONAL GMBH, a
corporation with offices at D-55216 Ingelheim/Rhein, Germany ("BI"), and ANSAN,
INC., a Delaware corporation, with offices at 400 Oyster Point Blvd., Suite 435,
South San Francisco, California 94080 ("ANSAN").
WHEREAS, BI is the owner of certain PATENT RIGHTS, KNOW-HOW and the
LICENSED PROCESS (each as hereinafter defined) and has the right to grant the
license set forth herein under said PATENT RIGHTS, KNOW-HOW and LICENSED
PROCESS; and
WHEREAS, BI desires to have ANSAN establish whether LICENSED PRODUCT
(as hereinafter defined) is effective in patients with acute pancreatitis or
whether LICENSED PRODUCT is effective for other indications and is willing to
grant an exclusive license to ANSAN thereunder; and
WHEREAS, ANSAN desires to obtain an exclusive right and license under
the PATENT RIGHTS, LICENSED PROCESS and KNOW-HOW in the TERRITORY (as
hereinafter defined).
NOW, THEREFORE, in consideration of the promises and mutual covenants
contained herein, and other good and valuable consideration, the PARTIES (as
hereinafter defined) hereto agree as follows:
SECTION 1 - DEFINITIONS
For purposes of the AGREEMENT, the following words and phrases shall
have the following meanings:
1.1 "AFFILIATE" shall mean any corporation or business entity
controlled by, controlling or under common control with BI or ANSAN, as the case
may be. For this purpose, control shall mean direct or indirect beneficial
ownership of more than fifty percent (50%) of the voting stock of, or a fifty
percent (50%) or greater interest in the income of such corporation or other
business entity or fifty percent (50%) or greater management control over a
joint venture, or such other relationship as, in fact, constitutes actual
control.
1.2 "CLINICAL TRIAL" shall mean a clinical trial conducted
pursuant to a PROTOCOL.
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1.3 "COMPOUND" shall mean the active ingredient WEB 2086 (i.e.
"Apafant") necessary or useful for the development, manufacture, or use of the
LICENSED PRODUCT in accordance with the R&D PLAN.
1.4 "E.U." shall mean the countries comprising the European Union, as
of the EFFECTIVE DATE, or as hereinafter added to the E.U.
1.5 "EFFECTIVE DATE" shall mean the date of execution of the AGREEMENT.
1.6 "INITIAL PERIOD" shall mean the one hundred and fifty (150)
calendar day period commencing on the EFFECTIVE DATE.
1.7 "KNOW-HOW" shall mean any and all technical data and non-technical
information, expertise, knowledge and the like which relates to the LICENSED
PRODUCT, LICENSED PROCESS and PATENT RIGHTS including, without limitation, all
chemical, pharmacological, toxicological, clinical, assay control, manufacturing
data, marketing and sales information and any other information or designs used
or useful for the development, packaging and/or marketing of the LICENSED
PRODUCT or its manufacture from COMPOUND.
1.8 "LICENSED PROCESS" shall mean any process for manufacturing
LICENSED PRODUCT from COMPOUND which is covered in whole or in part by a claim
contained in the PATENT RIGHTS or by KNOW-HOW.
1.9 "LICENSED PRODUCT(S)" shall mean one or more pharmaceutical
products suitable for the treatment of humans by intravenous administration of
COMPOUND; provided that LICENSED PRODUCT(S) shall not include any pharmaceutical
product whose indication for use is asthma.
1.10 "NET SALES" shall mean the actual gross amount invoiced by a
PARTY, or its AFFILIATES or SUBLICENSEES, for sales of the LICENSED PRODUCT in
the TERRITORY to THIRD PARTIES during a calendar year; provided that:
(a) NET SALES shall not include the following:
(i) direct transportation charges, including insurance;
(ii) any sales, use, value-added and excise taxes
and/or duties or allowances based on the
selling price of the LICENSED PRODUCT which
fall due and are paid as a consequence of
such sales;
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(iii) trade, quantity and cash discounts and
rebates actually allowed and taken to the
extent customary in the trade, including
without limitation governmental rebates such
as Medicaid; and
(iv) allowances or credits, including but not limited
to, allowances or credits to customers on account
of rejection or return of the LICENSED PRODUCT;
(b) A sale or transfer to an AFFILIATE or SUBLICENSEE of
either PARTY for re-sale by such AFFILIATE or
SUBLICENSEE shall not be considered a sale for the
purpose of this provision, but the resale by such
AFFILIATE or SUBLICENSEE shall be a sale for such
purposes, and a "sale" shall include a transfer or
other disposition for consideration, but not such
transfers or dispositions for pre-clinical, clinical,
regulatory, or governmental purposes prior to or
after receiving marketing approval; and
(c) LICENSED PRODUCT shall be considered sold upon
receipt of either PARTY of payment for such LICENSED
PRODUCT.
1.11 "OTHER INTELLECTUAL PROPERTY RIGHTS" shall mean all of the
following intellectual property of ANSAN:
(a) the U.S. or E.U. trademarks, service marks, and tradenames,
or any applications pertaining thereto, as shall be
selected, chosen, created or developed by ANSAN pursuant to
Section 5.2 of the AGREEMENT; and
(b) the U.S. or E.U. trademarks, service marks, and tradenames
issued from any applications submitted pursuant to
Section 1.11(a) of the AGREEMENT.
1.12 "PARTY(IES)" shall mean a person(s) or an entity(ies) who is (are)
a party to the AGREEMENT.
1.13 "PATENT RIGHTS" shall mean all of the following intellectual
property of BI:
(a) the U.S. and E.U. patent and patent applications listed in
Appendix A;
(b) the United States and E.U. patents issued from the
applications listed in Appendix A and from divisionals and
continuations of these applications;
(c) any reissue or extension of patents described in
Sections 1.13(a) or (b) of this AGREEMENT; and
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(d) any improvement patent dominated by the claims of the PATENT
RIGHTS.
1.14 "PHASE II CLINICAL TRIAL" shall mean a CLINICAL TRIAL in patients
having a designated disease or disorder.
1.15 "PROTOCOL" shall mean a protocol for a CLINICAL TRIAL of LICENSED
PRODUCT pursuant to the R&D PLAN or a NEW R&D PLAN (as defined in Section 3.5
herein).
1.16 "R&D PLAN" shall mean a plan for the initial development of
LICENSED PRODUCT for the first indication of pancreatitis.
1.17 "SUBLICENSE" shall mean a sublicense granted by ANSAN pursuant to
the terms of Sections 3.5 or 3.6 of the AGREEMENT or by BI pursuant to the terms
of Section 3.4 of the AGREEMENT.
1.18 "SUBLICENSEE" shall mean any THIRD PARTY licensed by either PARTY
to make, have made, import, export, use or sell any LICENSED PRODUCT.
1.19 "TERRITORY" shall mean the E.U. and the U.S.
1.20 "THIRD PARTY(IES)" shall mean a person(s) or entity(ies) who or
which is (are) neither a PARTY nor an AFFILIATE of a PARTY.
1.21 "U.S." shall mean the United States of America.
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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.
SECTION 2 - GRANT
2.1 Subject to the terms and conditions of the AGREEMENT, and upon
receipt by BI of the payment pursuant to Section 2.2 herein, BI hereby grants to
ANSAN and ANSAN hereby accepts from BI an exclusive, even as to BI,
royalty-bearing right and license (the "LICENSE"), including the right to
sublicense, in accordance with the provisions of Sections 3.5 or 3.6 of the
AGREEMENT, in the TERRITORY, under the PATENT RIGHTS, LICENSED PROCESS and
KNOW-HOW to develop, make or have made LICENSED PRODUCT from COMPOUND, and to
use, manufacture, market, purchase and sell LICENSED PRODUCT in the TERRITORY.
2.2 Upon the EFFECTIVE DATE, and in consideration of the grant of the
LICENSE pursuant to Section 2.1 herein, ANSAN shall pay to BI a fee of [( * )].
Such fee shall be creditable towards any payments due to BI from ANSAN pursuant
to Section 6 hereunder and shall be refunded to ANSAN, within twenty (20)
calendar days, in the event that BI elects to terminate the AGREEMENT in
accordance with Section 3.2 of the AGREEMENT.
SECTION 3 - PROTOCOL, CLINICAL TRIAL AND THE REVERSION OPTION
3.1 At or prior to the expiration of the INITIAL PERIOD, ANSAN shall
provide BI the first PROTOCOL along with the R&D PLAN. The R&D PLAN will include
a PHASE II CLINICAL TRIAL involving at least fifty-eight (58) patients; provided
that such R&D PLAN shall be subject to revision in the event that either : (a)
ANSAN does not receive the necessary regulatory approval to immediately commence
a PHASE II CLINICAL TRIAL of the LICENSED PRODUCT or (b) ANSAN shall determine
that, based upon prudent and reasonable medical judgment, a PHASE II CLINICAL
TRIAL of the LICENSED PRODUCT would not be advisable or that a PHASE II CLINICAL
TRIAL would not be advisable without first conducting additional clinical
trials. To facilitate the design, development and the ultimate approval by BI of
the PROTOCOL and the R&D PLAN, BI shall, during the INITIAL PERIOD and at the
request of ANSAN, consult with ANSAN.
3.2 Upon submission of the PROTOCOL and the R&D PLAN to BI, BI shall
have a period of thirty (30) calendar days for review and approval of the
PROTOCOL and the R&D PLAN, which approval may not be unreasonably withheld. In
the event that BI does withhold approval, BI shall within such thirty (30)
calendar day period provide ANSAN with written notice of its decision to
terminate the AGREEMENT and the reasons therefor.
3.3 In the event the PROTOCOL and the R&D PLAN are approved by BI, or
after approval of a NEW R&D PLAN pursuant to Section 3.5(c), ANSAN shall proceed
with the development of the LICENSED PRODUCT in accordance with the R&D PLAN or
with the NEW R&D PLAN, as the case may be.
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3.4 Following BI's receipt of statistically analyzed data from a PHASE
II CLINICAL TRIAL conducted pursuant to Section 3.3 herein, BI shall have ninety
(90) calendar days (the "REVIEW PERIOD") to review the data from the PHASE II
CLINICAL TRIAL in order to determine whether BI wishes to exercise its option
(the "REVERSION OPTION") to have the LICENSE granted by BI to ANSAN hereunder
revert to BI and to assume the further development of the LICENSED PRODUCT. At
or prior to the expiration of the REVIEW PERIOD, BI shall provide ANSAN with
written notice of either its election to exercise the REVERSION OPTION or its
election to decline such REVERSION OPTION. In the event that BI exercises its
REVERSION OPTION pursuant to Section 3.4 hereof:
(a) all rights granted to ANSAN pursuant to Section 2.1 of the
AGREEMENT shall terminate and revert to BI; and
(b) Ansan shall grant BI an exclusive license, with the
right to sublicense, to use the data and materials
resulting from development activities by ANSAN with
LICENSED PRODUCTS; and
(c) BI shall use its good faith efforts to further develop,
obtain regulatory approvals and commercialize the LICENSED
PRODUCT in the TERRITORY. BI shall take all such actions
as are reasonably necessary and customary to obtain and
maintain the authorization and/or ability to market the
LICENSED PRODUCT in the TERRITORY. BI shall bear sole
responsibility for all expenses of such development,
commercialization and regulatory compliance. In the event
that BI does not make good faith efforts consistent with
good business judgment to pursue the further development
and commercialization of the LICENSED PRODUCT in any country
of the TERRITORY, the REVERSION OPTION for such country
shall immediately expire and all rights granted thereunder
shall terminate and revert to ANSAN; provided that, ANSAN
shall then be required to make good faith efforts to pursue
the further development and commercialization of the
LICENSED PRODUCT. In the event that ANSAN does not make
good faith efforts to pursue the further development and
commercialization of the LICENSED PRODUCT, all rights which
reverted to ANSAN upon the expiration of the REVERSION
OPTION shall once again terminate and revert to BI.
3.5 If BI elects not to exercise the REVERSION OPTION pursuant to
Section 3.4 of the AGREEMENT, and ANSAN shall determine that it is interested in
sublicensing (the "INITIAL POTENTIAL SUBLICENSE(S)") all or any part of the
LICENSE granted to it pursuant to the AGREEMENT to one or more THIRD PARTIES,
then ANSAN shall be free, for a period of twelve (12) months from receipt of
notice of the decision by BI not to exercise the REVERSION OPTION (the
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"INITIAL POTENTIAL SUBLICENSE PERIOD"), to offer an INITIAL POTENTIAL
SUBLICENSE to one or more THIRD PARTIES on whatever commercial terms ANSAN
shall, in its sole discretion (subject to Section 6.7(b) of the AGREEMENT),
decide; provided, however, that such THIRD PARTIES shall be obligated to make
good faith efforts to pursue the further development and commercialization of
LICENSED PRODUCT. In addition, ANSAN agrees that it may not offer an INITIAL
POTENTIAL SUBLICENSE to any THIRD PARTY without first receiving consent from
BI to approach such THIRD PARTY, such consent not to be withheld without good
reason ("GOOD REASON"). GOOD REASONS shall include, but not be limited, to:
1. involvement by the THIRD PARTY with a product substantially
competitive to the LICENSED PRODUCT;
2. past or present activities by the THIRD PARTY that would substantially
prejudice the relationship of BI with recognized regulatory
authorities in the E.U., U.S. or Japan;
3. substantial lack of development and/or marketing capabilities for the
LICENSED PRODUCT on the part of the THIRD PARTY; or
4. substantive litigation between BI and the THIRD PARTY.
If, by the expiration of the INITIAL POTENTIAL SUBLICENSE PERIOD, ANSAN
has not either:(a) granted the INITIAL POTENTIAL SUBLICENSE to a THIRD PARTY;
(b) initiated a clinical trial of the LICENSED PRODUCT in addition to a CLINICAL
TRIAL undertaken pursuant to Section 3.3 herein (the "ADDITIONAL CLINICAL
TRIAL"); or (c) agreed with BI on a new protocol and development plan (a "NEW
R&D PLAN") for the LICENSED PRODUCT, then the AGREEMENT shall terminate and all
rights granted by BI to ANSAN pursuant to the LICENSE shall automatically revert
to BI.
3.6 Notwithstanding the provisions of Section 3.5 herein, in the event
that BI elects not to exercise the REVERSION OPTION pursuant to Section 3.4
herein, and provided further that, after the expiration of the INITIAL POTENTIAL
SUBLICENSE PERIOD: (a) ANSAN has not granted an INITIAL POTENTIAL SUBLICENSE to
a THIRD PARTY, but (b) ANSAN has initiated an ADDITIONAL CLINICAL TRIAL, then,
if ANSAN shall determine that it is interested in sublicensing (the "ADDITIONAL
POTENTIAL SUBLICENSE"), all or any part of the LICENSE granted to it pursuant to
the AGREEMENT to one or more THIRD PARTIES, then ANSAN shall first grant BI a
right of election (the "RIGHT OF ELECTION") to acquire such ADDITIONAL POTENTIAL
SUBLICENSE as follows:
(a) ANSAN shall give notice to BI of the ADDITIONAL
POTENTIAL SUBLICENSE together with the terms of the
ADDITIONAL POTENTIAL SUBLICENSE (the "PROPOSAL"). BI
shall have sixty (60) calendar days after receipt of
such notice and information to provide written notice to
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ANSAN of whether or not it wishes
to exercise its RIGHT OF ELECTION and acquire such
ADDITIONAL POTENTIAL LICENSE pursuant to the terms of
the PROPOSAL.
(b) In the event that BI declines to exercise its RIGHT
OF ELECTION or does not reply to ANSAN's notice
within the sixty (60) calendar day period, ANSAN
shall be free to negotiate the ADDITIONAL POTENTIAL
SUBLICENSE with one or more THIRD PARTIES, subject to
BI's right to withhold consent in accordance with the
provisions of Section 3.5 hereof.
(c) In the event that BI expresses written interest in the
ADDITIONAL POTENTIAL SUBLICENSE, then for an additional
forty (40) calendar day period, ANSAN shall conduct
negotiations on an exclusive basis with BI to reach an
arrangement with BI on substantially the same terms as the
PROPOSAL. At the end of thirty (30) calendar days of the
forty (40) calendar day period provided above, if the PARTIES
have not reached an agreement at such time, BI shall give
ANSAN a written notice setting forth the minimum terms upon
which BI will agree to accept the ADDITIONAL POTENTIAL
SUBLICENSE (the "MINIMUM TERMS"). ANSAN shall then have
ten (10) calendar days to accept or reject the MINIMUM TERMS.
If ANSAN rejects the MINIMUM TERMS or does not reply to BI's
notice within the ten (10) calendar day period, ANSAN shall
be free to negotiate the ADDITIONAL POTENTIAL SUBLICENSE with
one or more THIRD PARTIES. If ANSAN accepts the MINIMUM
TERMS, then the PARTIES shall negotiate on an exclusive
basis for an additional thirty (30) calendar day period to
conclude an agreement incorporating such MINIMUM TERMS.
(d) In the event that ANSAN wishes to enter into an ADDITIONAL
POTENTIAL SUBLICENSE on terms substantially more favorable to
a THIRD PARTY than the MINIMUM TERMS, then ANSAN shall first
reoffer such ADDITIONAL POTENTIAL SUBLICENSE to BI on the
same terms as those offered to such THIRD PARTY. BI shall
then have thirty (30) calendar days to provide ANSAN with
written notice of its interest in such terms. In the event
that BI expresses interest in such terms, then the PARTIES
shall conduct exclusive negotiations and conclude an
agreement incorporating such terms within sixty (60) days
thereafter.
(e) In the event that BI and ANSAN are unable to reach a
final agreement pursuant to the terms specified in
Section 3.6(d) above, ANSAN shall then be free to
conclude an agreement with one or more THIRD PARTIES,
subject to BI's right to withhold consent in accordance with
the provisions of Section 3.5 hereof.
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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.
3.7 The PARTIES agree that, in the event that a SUBLICENSE is granted
to one or more THIRD PARTIES, the THIRD PARTY(IES) shall assume all
responsibilities that would have been the responsibilities of the PARTY granting
the SUBLICENSE in the event that no SUBLICENSE had been granted, except for
those responsibilities that the PARTY granting the SUBLICENSE elects to continue
to perform.
SECTION 4 - DATA AND MATERIALS
4.1 BI shall make available to ANSAN any and all preclinical and
clinical data, formulation data or other data generated from preclinical or
clinical research with regard to the development of the LICENSED PRODUCT, and
shall deliver to ANSAN those documents requested by ANSAN from time to time
during the term of the AGREEMENT within thirty (30) days of such request;
provided, however, that BI shall only be obliged to make available data or
documents already in BI's possession at the EFFECTIVE DATE or which come into
BI's possession as a result of BI's own development activities, and shall not be
required to make any such data available in the event that BI exercises the
REVERSION OPTION, unless rights subsequently revert to ANSAN pursuant to the
terms of Section 9.5 of the AGREEMENT. In the event that BI exercises the
REVERSION OPTION, ANSAN likewise agrees to make available to BI data or
documents generated by ANSAN pursuant to the R&D PLAN. If ANSAN requests
non-U.S. data or reports from BI, ANSAN agrees to be responsible for the
translation of any such data or reports into English if such translation would
not otherwise be performed by BI.
4.2 BI shall, upon ANSAN's reasonable request, deliver to ANSAN, [ * ]
up to one (1) kilogram of COMPOUND, as is necessary or useful for the
manufacture or use of LICENSED PRODUCT and such additional quantity of COMPOUND,
[ * ], as may be reasonably required by ANSAN, to complete the PHASE II CLINICAL
TRIAL in accordance with the R&D PLAN approved by BI under Section 3.2 of the
AGREEMENT.
4.3 In addition to any COMPOUND that BI shall provide ANSAN pursuant to
Section 4.2 herein, BI shall, subject to the final sentence of Section 4.4
herein, provide to ANSAN, its AFFILIATES or SUBLICENSEES, such quantities of
COMPOUND as may be required by the R&D PLAN or a NEW R&D PLAN. The price of such
COMPOUND shall equal [ * ].
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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.
4.4 In addition to any COMPOUND that BI shall provide ANSAN, its
AFFILIATES or SUBLICENSEES, pursuant to Sections 4.2 and 4.3 herein, BI shall
either (a) provide to ANSAN, its AFFILIATES or SUBLICENSEES, such quantities of
COMPOUND as may be requested by such parties for use in the commercialization of
the LICENSED PRODUCT (in which event the price of such COMPOUND shall equal [ *
] or (b) enable ANSAN to have the COMPOUND manufactured by ANSAN or a THIRD
PARTY using BI's manufacturing processes. In the latter case, the PARTIES will
negotiate in good faith any compensation to BI taking into consideration the
value of such manufacturing process and the costs to ANSAN of THIRD PARTY
manufacturing. The conditions of this Section 4.4 shall also apply to batches of
COMPOUND newly manufactured in order to obtain final regulatory approval of the
manufacturing process.
4.5 ANSAN shall during the term of the AGREEMENT provide BI with such
written reports and analyses as BI shall reasonably request regarding the
development, regulatory approval and/or commercialization of LICENSED PRODUCT.
4.6 ANSAN and BI shall comply fully with all applicable medical event
reporting recommendations and requirements in all countries where the PARTIES
intend to carry out clinical trials or to market the LICENSED PRODUCT or to
market other pharmaceutical products containing the COMPOUND. ANSAN and BI agree
to exchange such information as may be necessary to achieve compliance and to
ensure that both PARTIES are appropriately informed regarding medical experience
with LICENSED PRODUCT and other pharmaceutical products containing the COMPOUND.
SECTION 5 - MANUFACTURING AND COMMERCIALIZATION
5.1 ANSAN will be solely responsible as between ANSAN and BI for
manufacturing of the LICENSED PRODUCT from COMPOUND, and for manufacturing
COMPOUND in the event BI elects to enable ANSAN to manufacture under Section
4.4(b), for purposes of conducting clinical trials under THE R&D PLAN or a NEW
R&D PLAN or for sale by ANSAN, in accordance with applicable regulatory
standards.
5.2 ANSAN shall have the exclusive right, but not the obligation, at
its sole option and in its sole discretion, to select, choose, create or develop
OTHER INTELLECTUAL PROPERTY RIGHTS for any and all LICENSED PRODUCTS.
5.3 After the expiration of the INITIAL PERIOD, ANSAN shall use its
good faith efforts to develop, obtain regulatory approval and commercialize the
LICENSED PRODUCT in each country of the TERRITORY where such good faith efforts
would be justified by good business judgment and shall require any AFFILIATES
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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.
and/or SUBLICENSEES to agree to be bound by this obligation. ANSAN shall take
such actions as are reasonably necessary or customary to obtain and maintain
the authorization and/or ability to market the LICENSED PRODUCT in such
countries in the TERRITORY in which ANSAN shall choose to introduce the
LICENSED PRODUCT. ANSAN shall bear responsibility for all expenses of such
development, commercialization and regulatory compliance. In the event that
ANSAN shall not make such good faith efforts to pursue the development and
commercialization of the LICENSED PRODUCT, all rights granted hereunder shall
revert to BI, or in the event that an AFFILIATE or SUBLICENSEE of ANSAN shall
not make good faith efforts to pursue the development and commercialization of
the LICENSED PRODUCT, all rights granted by ANSAN to such AFFILIATE or
SUBLICENSEE shall revert to BI.
SECTION 6 - ROYALTIES AND OTHER COMPENSATION; RECORDS
6.1 ANSAN shall pay to BI a royalty of [ * ].
6.2 The royalties pursuant to Sections 6.1 or 6.5(b)(i) hereof shall be
payable [ * ] in each country in the TERRITORY until: (a) the expiration of the
last-to-expire or become- abandoned of the PATENT RIGHTS in such country, or (b)
for twelve (12) years from the date that LICENSED PRODUCT is first marketed in
such country, whichever is longer.
6.3 In the event that ANSAN, its AFFILIATES and/or SUBLICENSEES, files
a market application for the LICENSED PRODUCT for either the E.U. or U.S., ANSAN
shall pay BI, within forty-five (45) calendar days of each such filing, [ * ].
The aggregate possible total payments due hereunder shall equal [ * ].
6.4 Upon the receipt by ANSAN, its AFFILIATES and/or SUBLICENSEES, of
regulatory approval for the LICENSED PRODUCT for either the E.U. or U.S., ANSAN
shall pay BI, within forty-five (45) calendar days of receipt of each such
regulatory approval, [ * ]. The aggregate possible total payments due hereunder
shall equal [ * ].
6.5 In the event that BI exercises the REVERSION OPTION pursuant to
Section 3.4 of the AGREEMENT:
(a) BI shall pay to ANSAN, within thirty (30) calendar days of
its exercise of the REVERSION OPTION, a sum equal to:
[ * ]; and
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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.
(b) BI shall guarantee, be responsible for and assume the
obligation to pay ANSAN any and all payments due, and
as they shall become due, of BI, its AFFILIATES
and/or SUBLICENSEES as follows:
(i) BI shall pay to ANSAN a royalty of [ * ].
(ii) In the event that BI, its AFFILIATES and/or
SUBLICENSEES, files a market application for the
LICENSED PRODUCT in either the E.U. or U.S., BI shall
pay ANSAN, within forty-five (45) calendar days of
each such filing, [ * ]. The
aggregate possible total payments due hereunder shall
equal [ * ].
(iii) Upon the receipt by BI, its AFFILIATES and/or
SUBLICENSEES, of regulatory approval for the LICENSED
PRODUCT in either the E.U. or U.S., BI shall pay
ANSAN, within forty-five (45) calendar days of receipt
of each such regulatory approval, [ * ].
The aggregate possible total payments due hereunder
shall equal [ * ].
6.6 In the event that BI shall determine it is interested in developing
LICENSED PRODUCT(S) or products containing COMPOUND similar to the LICENSED
PRODUCT in one or more countries or territories outside of the TERRITORY,
including, but not limited to, Japan (the "OPTIONAL TERRITORY"), then, before
BI, its AFFILIATES or SUBLICENSEES may develop any LICENSED PRODUCT in the
OPTIONAL TERRITORY:
(a) BI shall present ANSAN with prior written notice of the
decision to pursue development of LICENSED PRODUCT in such
OPTIONAL TERRITORY; and
(b) BI and ANSAN shall conduct good-faith negotiations to
determine the royalties (the "OPTIONAL ROYALTIES") payable
to ANSAN for any sales of LICENSED PRODUCT in the OPTIONAL
TERRITORY by BI, its AFFILIATES and/or SUBLICENSEES;
provided that such OPTIONAL ROYALTIES shall reflect the
value of ANSAN's development efforts relating to the
LICENSED PRODUCTS, and any data generated therefrom, for
BI's development and commercialization of the LICENSED
PRODUCT in the OPTIONAL TERRITORY.
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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.
6.7 In the event that ANSAN shall sublicense all or any part of the
LICENSE granted hereunder, ANSAN shall pay to BI [ * ]; provided that,
(a) [
*
], and
(b) in the event any remuneration to be received by ANSAN
pursuant to such SUBLICENSE would involve an element
of non-cash consideration, ANSAN and BI shall in good
faith negotiate the cash value of such consideration,
provided that, if the PARTIES are unable to reach an
agreement on such value, ANSAN shall not be permitted
to accept such non-cash consideration from the
SUBLICENSEE.
6.8 Each PARTY marketing a LICENSED PRODUCT in the TERRITORY shall
deliver to the other written reports (consistent with generally accepted
accounting principles and in a format specified by the PARTIES and consistent
with BI's internal accounting policy) within sixty (60) days after the close of
each calendar quarter showing separately for each LICENSED PRODUCT:
[ * ]; (ii) details of the quantities sold in each
country; and (iii) royalties due pursuant to Sections 6.1 or 6.5 (b)(i) hereof.
Concurrently with the making of such report, the PARTY selling LICENSED PRODUCT
shall pay the royalties due [ * ] during the preceding calendar quarter.
6.9 All royalties to be paid under the AGREEMENT will be paid in U.S.
dollars. In the case of royalties due by ANSAN to BI, if any currency
conversions shall be required, such conversion shall be made using the average
monthly exchange rate published regularly by Citibank, New York. In the case of
royalties due by BI to ANSAN, such conversion shall be made by converting the
currency first into German marks and then into U.S. dollars using in both cases
the average monthly exchange rates published regularly by Deutsche Bank,
Frankfurt am Main, and as customarily used by BI in its accounting system.
6.10 If either PARTY shall fail to make a payment when due pursuant to
Section 6 of the AGREEMENT, such PARTY shall have an additional five (5)
business days from the date such payment was due to cure such non-payment.
6.11 The PARTY selling LICENSED PRODUCT shall keep complete and
accurate records in sufficient detail to properly reflect [ * ],
and to enable the royalties payable hereunder to be determined. Upon the
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written request of the non-selling PARTY not more than once in each calendar
year, the selling PARTY shall permit an independent certified public accounting
firm of nationally recognized standing, selected by the non-selling PARTY and
reasonably acceptable to the selling PARTY, and at the non-selling PARTY's
expense (except as provided below), to have access during normal business
hours to such of the records of the selling PARTY as may be reasonably
necessary to verify the accuracy of the royalty reports hereunder for any year
ending not more than twenty-four (24) months prior to the date of such request.
The accounting firm shall disclose all information gathered or concluded to the
selling PARTY. The accounting firm shall disclose to the non-selling PARTY only
whether the records are correct or not and the specific details concerning any
discrepancies. No other information shall be shared with the non-selling PARTY.
If the accounting firm concludes that additional royalties were owed during
such period (exceeding five percent (5%) of royalties paid during the period),
the selling PARTY shall pay all costs associated with the audit and the unpaid
royalties within thirty (30) days of the date the accounting firm delivers the
firm's written report to the PARTIES, with interest thereon at the prime rate
reported by the Deutsche Bank, Frankfurt am Main, on the last calendar day of
the quarter in which such payments were due. Should the accounting firm
conclude that the selling PARTY has overpaid any royalties, the non-selling
PARTY shall credit any overpayment to the selling PARTY against amounts later
due the non-selling PARTY.
6.12 Each PARTY shall deduct any withholding taxes from the payments
due under the AGREEMENT and pay them to the proper tax authorities as required
by the laws of Germany or the U.S. applicable at the date of payment. Neither
PARTY shall deduct any other withholding or any other governmental charges from
the payments due under the AGREEMENT. Each PARTY shall annually provide the
other PARTY with official receipts of payment of any withholding taxes and
forward these receipts to such other PARTY. The PARTIES shall use their best
efforts to ensure that any withholding taxes imposed are reduced or eliminated
as far as possible under the terms of the current or any future double taxation
agreement between the U.S. and Germany.
6.13 In accordance with the tax laws of Germany as of the EFFECTIVE
DATE, a reduction of withholding tax requires that the German Bundesamt fuer
Finanzen issue a Certificate of Tax Exemption. In order to achieve such a
reduction, ANSAN shall provide BI with a completed Application for Tax Exemption
and a Certificate of Filing a Tax Return, which forms shall have been provided
by BI to ANSAN prior to the EFFECTIVE DATE. Payments due to ANSAN under the
terms of the AGREEMENT are not payable to ANSAN until the pertinent Applications
for Tax Exemption are provided by ANSAN to BI. Notwithstanding the above, BI
shall make the payments due to ANSAN under the terms of the AGREEMENT, net of
any applicable withholding. BI shall notify ANSAN as soon as reasonably
practicable of any changes regarding the procedure for claiming withholding tax
exemptions.
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SECTION 7 - CONFIDENTIALITY
7.1 Any information which is transmitted by one PARTY to the other
PARTY in connection with the entering into or the performance of the AGREEMENT,
shall be kept confidential by the receiving PARTY and its AFFILIATES and/or
SUBLICENSEES prior to the expiration or termination of the AGREEMENT and for a
period of five (5) years after its expiration. The foregoing obligation shall
not apply to:
(a) any information which at the time of disclosure or
acquisition is part of the public knowledge or
literature, or thereafter becomes part of the public
knowledge or literature otherwise than by
unauthorized disclosure by the recipient;
(b) any disclosure of information to the United States
Food and Drug Administration ("FDA") or other similar
governmental authorities for the purpose of complying
with regulatory requirements with respect to the
LICENSED PROCESSES or LICENSED PRODUCT;
(c) any information which at the time of disclosure or
acquisition was in the recipient's possession as evidenced
by its written records;
(d) any information which became available to the recipient
from another source not bound to secrecy to the disclosing
PARTY with respect to such information;
(e) disclosure by the recipient to THIRD PARTIES under
provisions of confidentiality similar to those contained in
the AGREEMENT for the purposes of development or marketing
of the LICENSED PRODUCT; and
(f) any disclosure of information required by law;
provided; however, that BI shall have the right to
review press releases relating to the AGREEMENT prior
to dissemination by ANSAN.
7.2 Notwithstanding the provisions of Section 7.1 herein, in the event
that either PARTY, its AFFILIATES and/or SUBLICENSEES shall determine that it
wishes to disclose any information, the disclosure of which would be prohibited
by Section 7.1 herein, such PARTY shall present the other PARTY with a written
request to disclose such information. The other PARTY shall have a period of
five (5) calendar days to approve the disclosure contained in such written
request, which approval shall not be unreasonably withheld.
SECTION 8 - COMPETITION
8.1 Unless BI exercises the REVERSION OPTION or obtains an ADDITIONAL
POTENTIAL SUBLICENSE, BI shall not, during the term of the AGREEMENT, develop,
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manufacture or market within the TERRITORY any product or substance
incorporating COMPOUND for use in the treatment of pancreatitis or any other
indication provided for in any R&D PLAN or NEW R&D PLAN approved by BI in
accordance with Section 3 of the AGREEMENT.
8.2 Notwithstanding the provisions of Section 8.1 herein, if BI elects
to develop a product which contains WEB 2086 and is intended for the treatment
of asthma by intravenous administration of such product (the "ASTHMA PRODUCT
DEVELOPMENT EFFORTS"), BI shall, prior to commencement of the ASTHMA PRODUCT
DEVELOPMENT EFFORTS (a) provide ANSAN with written notice thirty (30) days in
advance of the date BI intends to commence the ASTHMA PRODUCT DEVELOPMENT
EFFORTS, and (b) conduct good faith negotiations with ANSAN to determine the
compensation to ANSAN, if any, to ensure that the ASTHMA PRODUCT DEVELOPMENT
EFFORTS shall not result in commercial harm to ANSAN.
SECTION 9 - PATENT MATTERS
9.1 BI shall, subject to good business judgment, at its sole cost and
expense: (a) maintain the PATENT RIGHTS in Appendix A and (b) prosecute and/or
defend any infringement of and/or challenge to the PATENT RIGHTS.
9.2 Provided that BI shall not have exercised the REVERSION OPTION or
not have obtained an additional SUBLICENSE from ANSAN pursuant to Section 3 of
the AGREEMENT, or in the event that BI shall determine not to maintain the
PATENT RIGHTS in Appendix A in accordance with the provisions of Section 9.1,
ANSAN shall, at ANSAN's sole expense, have the right, but not the obligation,
to: (a) apply for, seek prompt issuance of, or maintain, the PATENT RIGHTS in
Appendix A, in such countries in the TERRITORY as ANSAN in its sole discretion
may elect; provided that, in the event an extension of a patent is available
pursuant to Title II of the Drug Price Competition and Patent Term Restoration
Act of 1984 (or any successor or related statute in the U.S. or outside the
U.S.), ANSAN shall have the right to designate the patent for which such
extension will be applied for, and (b) prosecute and/or defend at its own
expense any infringement of and/or challenge to the PATENT RIGHTS. If ANSAN
elects to prosecute any alleged infringement, BI hereby agrees that BI, at the
request of ANSAN, shall join ANSAN as a party plaintiff in any such suit. ANSAN
alone shall retain any recovery or damages for past infringement derived from
any such infringement action.
9.3 Each of the PARTIES shall notify the other promptly in the event
that it becomes aware of any alleged infringement of the PATENT RIGHTS by a
THIRD PARTY and of any available evidence thereof.
9.4 In the event that ANSAN shall undertake the enforcement or defense
of the PATENT RIGHTS in any country in the TERRITORY by litigation pursuant to
Section 9.2 of the AGREEMENT or otherwise, ANSAN may withhold, until ANSAN is
reimbursed under the AGREEMENT any payments or royalties due BI
-16-
<PAGE>
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.
[ * ] in such country hereunder, pursuant to Section 6 of the AGREEMENT, and
apply the same toward reimbursement of its expenses, including attorney's
fees, in connection therewith.
9.5 In the event BI exercises its REVERSION OPTION or obtains an
additional SUBLICENSE from ANSAN pursuant to Section 3 of the AGREEMENT, all
rights granted to ANSAN pursuant to this Section 9 shall terminate and revert to
BI; provided that, in the event that BI does not, subject to good business
judgment, diligently pursue the further development and commercialization of the
LICENSED PRODUCT, all rights granted to BI, upon its exercise of the REVERSION
OPTION and pursuant to this Section 9.5, shall terminate and revert to ANSAN.
9.6 (a) In any infringement suit either PARTY may institute to
enforce the PATENT RIGHTS pursuant to the AGREEMENT, or in
any suit brought by a THIRD PARTY in which either PARTY is
defending the PATENT RIGHTS, the other PARTY hereto shall,
at the request and expense of the PARTY initiating or
defending such suit, as the case may be, cooperate in
all reasonable respects and, to the extent practicable,
have its employees and, if practicable, former employees,
testify when requested and make available relevant records,
papers, information, samples, specimens and the like.
(b) If, as a result of any such suit, the PATENT RIGHTS
are held in any country to be not enforceable or
invalid pursuant to a judgment rendered by a court of
final determination and not subject to appeal, then,
from and after the date of the filing of the action
which resulted in such judgment, [ * ].
9.7 In the event BI exercises the REVERSION OPTION or obtains an
additional SUBLICENSE from ANSAN, patent rights for COMPOUND obtained by ANSAN
after the EFFECTIVE DATE of the AGREEMENT and pursuant to the R&D PLAN or a NEW
R&D PLAN shall be assigned to BI.
SECTION 10 - REPRESENTATIONS AND WARRANTIES
10.1 Each PARTY represents and warrants to the other PARTY that: (i) it
is free to enter into the AGREEMENT and has the full right and authority to do
so; (ii) it has taken all corporate action necessary to authorize the execution
and delivery of the AGREEMENT and the performance of its obligations under the
AGREEMENT; (iii) it is not aware of any impediment that would inhibit its
-17-
<PAGE>
ability to perform in all material respects its obligations under the
AGREEMENT; and (iv) the execution, delivery and performance of the AGREEMENT
will not violate any provision of, conflict with or result in any breach of any
of the terms of, or constitute a default under either PARTY's respective
certificate of incorporation, by-laws, or any material indenture, lease,
agreement or other material instrument to which it is a party, or any decree,
judgment or order applicable to such party or any law, statute, rule or
regulation applicable to such party.
10.2 BI hereby represents and warrants to ANSAN that:
(a) It is the assignee of the PATENT RIGHTS covered by
Sections 1.13(a), (b), (c) and (d) of the AGREEMENT;
(b) It has the legal power to convey the rights granted to ANSAN
in the AGREEMENT;
(c) It has no knowledge of any facts which would rebut
the presumption of validity accorded any issued
patents within the PATENT RIGHTS and it has disclosed
to the United States Patent and Trademark office all
information "material to patentability," as such is
defined in 37 C.F.R.
ss.1.56;
(d) It has no knowledge of any adverse claims to the PATENT
RIGHTS;
(e) All patent applications included in the PATENT RIGHTS are
pending and have not been abandoned and are enforceable
pursuant to a valid assignment;
(f) To its best knowledge and belief, as of the EFFECTIVE DATE,
there are no asserted or unasserted claim or demand which
may be enforced against any of the PATENT RIGHTS;
(g) To its best knowledge and belief, on the EFFECTIVE
DATE the practice of any processes and/or products
disclosed in the PATENT RIGHTS do not infringe upon
any THIRD PARTY patents; and
(h) BI has not entered into any agreement with any THIRD
PARTY which is in conflict with the rights granted to
ANSAN pursuant to the AGREEMENT.
-18-
<PAGE>
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.
SECTION 11 - ASSIGNMENT; CHANGE -IN-CONTROL
11.1 The AGREEMENT shall not be assignable by ANSAN without the prior
written consent of BI (which consent shall not be unreasonably withheld). BI
shall provide ANSAN with written notice of its decision within thirty (30) days
of a request from ANSAN to assign.
11.2 In the event that BI does withhold consent for GOOD REASON and:
(a) ANSAN has not initiated a CLINICAL TRIAL, then BI owes
[ * ]; or
(b) ANSAN has initiated a CLINICAL TRIAL and BI has not yet had
the opportunity to exercise the REVERSION OPTION, then BI
shall pay ANSAN, within forty-five (45) calendar days of
notice of its decision to withhold consent, a sum equal to:
[ * ]; or
(c) BI has rejected the REVERSION OPTION and ANSAN has
not granted a SUBLICENSE, then BI shall pay ANSAN,
within forty-five (45) calendar days of notice of its
decision to withhold consent as follows:
1. In the event that ANSAN has not yet initiated a CLINICAL
TRIAL in addition to the CLINICAL TRIAL (Section 3.4), BI
shall pay ANSAN a sum equal to: [ * ];
2. In the event that ANSAN has initiated a CLINICAL TRIAL in
addition to the CLINICAL TRIAL (Section 3.4), BI shall
pay ANSAN a sum equal to: [ * ];
3. In the event ANSAN has filed a marketing application in
the U.S. or the E.U., BI shall pay ANSAN a sum equal to:
[ * ].
11.3 Notwithstanding Sections 11.1 and 11.2 herein, BI agrees to waive
its rights to withhold consent for assignment by ANSAN if a SUBLICENSE has been
granted or if the LICENSED PRODUCT has been approved for marketing in the U.S.
or the E.U.
-19-
<PAGE>
11.4 BI may terminate this AGREEMENT in the event of the acquisition by
a THIRD PARTY or by any one person or persons under common control (other than
by any officer, director or stockholder of ANSAN on the EFFECTIVE DATE or any
affiliate of any such person) of more than fifty percent (50%) of the capital
stock or voting interest of ANSAN whether by sale, transfer, merger, operation
of law or otherwise (such an acquisition being a CHANGE-IN-CONTROL); provided,
however, that a CHANGE-IN-CONTROL shall not be deemed to have occurred if it
results from a public offering of ANSAN's securities or from the exercise of any
options or warrants to purchase ANSAN's securities outstanding on the date of
the AGREEMENT. In the event BI exercises its right to terminate the AGREEMENT
under this Section 11.4, BI will compensate ANSAN as if BI had withheld consent
for an assignment in accordance with the provisions of Sections 11.1 through
11.3 of the AGREEMENT. Furthermore, after said termination, if BI, its
AFFILIATE(S) and/or SUBLICENSEE(S) continue development or commercialization of
LICENSED PRODUCT substantially according to the R&D PLAN, NEW R&D PLAN, or other
terms of the AGREEMENT, then such continuation of development or
commercialization shall constitute an exercise (the "DE FACTO EXERCISE") by BI
of the REVERSION OPTION pursuant to Section 3.4 of the AGREEMENT and all
obligations of BI attendant to the exercise of said REVERSION OPTION shall
apply. In the event of the DE FACTO EXERCISE, any payments to ANSAN made
according to the provisions of Section 11.2 and 11.4 of the AGREEMENT shall be
credited towards any payments due to ANSAN from BI according to the provisions
of Section 6 of the AGREEMENT.
SECTION 12 - TERM AND TERMINATION
12.1 Except as otherwise specifically provided herein and unless sooner
terminated pursuant to Sections 3.2, 3.5 or 11.4 of the AGREEMENT, the AGREEMENT
and the licenses and rights granted hereunder shall remain in full force and
effect for as long as royalties are payable under Section 6 of the AGREEMENT in
any country of the TERRITORY.
12.2 Following expiration of the AGREEMENT pursuant to Section 12.1
hereof each PARTY shall have a perpetual fully paid up non-exclusive license
under the rights granted, as of the date of expiration, by the other PARTY
pursuant to Sections 2.1 and 3.4 of the AGREEMENT.
12.3 Either PARTY shall have the right to terminate the AGREEMENT with
thirty (30) days notice in written form to the other PARTY in the event that the
other PARTY fails to remedy any material failure to fulfill its obligations
under the AGREEMENT or is in material breach of the terms of conditions hereof
within sixty (60) days after receipt of notice in written form specifying the
circumstances giving rise to failure or breach.
12.4 Either PARTY may terminate the AGREEMENT with immediate effect by
notice in written form in the event that the other PARTY becomes insolvent, is
declared bankrupt or adopts a plan of liquidation and dissolution.
-20-
<PAGE>
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.
12.5 Upon termination of the AGREEMENT pursuant to Sections 12.3 or
12.4 herein, any licenses or sublicenses granted under Sections 2.1, 3.4, 3.5
and/or 3.6 of the AGREEMENT may continue in effect at the option of the
non-breaching or non-bankrupt PARTY, as long as the non-breaching or
non-bankrupt PARTY abides by the terms of the license and the surviving
provisions of the AGREEMENT including but not limited to the obligation to pay
milestone payments and royalties under Section 6, and subject to later
expiration under this Section 12. Any court awarded damages granted to one PARTY
arising from material breach or bankruptcy of the other PARTY may be deducted
from milestone and/or royalty payments which may be subsequently due to the
other PARTY.
12.6 Upon termination of the AGREEMENT pursuant to Sections 12.3 or
12.4 herein, nothing herein shall be construed to release either PARTY from any
obligation that matured prior to the effective date of such termination. Either
PARTY or any AFFILIATE or SUBLICENSEE thereof may after the effective date of
such termination sell all LICENSED PRODUCTS manufactured or in process of
manufacture on the effective date of such termination.
12.7 Upon termination of the AGREEMENT by BI pursuant to Section 12.3
herein, ANSAN will transfer or have transferred to BI any authorizations for
clinical trials or sale of LICENSED PRODUCT owned by ANSAN, its AFFILIATES or
SUBLICENSEES [ * ] with the free (subject to the provisions of Section 12.5
herein) right to use the same and ANSAN will refrain from using any rights
granted under Section 2.1 of the AGREEMENT.
12.8 Upon termination of the AGREEMENT by BI pursuant to Section 12.4
herein, ANSAN will transfer or have transferred to BI any authorizations for
clinical trials or sale of LICENSED PRODUCT owned by ANSAN, its AFFILIATES or
SUBLICENSEES upon payment to ANSAN in cash of an amount [ * ] to be transferred
upon which BI shall have the right to use the same and ANSAN will refrain from
using any rights granted under Section 2.1 of the AGREEMENT.
SECTION 13 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
13.1 Any payment, notice or other communication pursuant to the
AGREEMENT shall be sufficiently made or given on the date of mailing if sent to
such PARTY by certified or registered first class mail, postage prepaid, or by
recognized public courier (e.g. Federal Express) addressed to it at its address
below or as it shall designate by written notice given to the other PARTY:
-21-
<PAGE>
In the case of BI:
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
D-55216
Ingelheim/Rhein, Germany
Attention: Corporate Licensing
with a copy to: Legal Department
In the case of ANSAN:
ANSAN, INC.
400 Oyster Point Blvd.
Suite 435
South San Francisco, California 94080
with a copy to:
Fran Stoller, Esq.
Bachner, Tally, Polevoy & Misher LLP
380 Madison Avenue
New York, New York 10017
SECTION 14 - MISCELLANEOUS PROVISIONS
14.1 The AGREEMENT shall be construed, governed, interpreted and
applied in accordance with the laws of GERMANY, except that questions affecting
the construction and effect of any patent shall be determined by the law of the
country in which the patent was granted and disputes arising out of the
AGREEMENT which cannot be settled between the PARTIES will be brought before the
courts of Germany.
14.2 The PARTIES hereto acknowledge that the AGREEMENT sets forth the
entire agreement and understanding of the PARTIES hereto as to the subject
matter hereof, and no oral or written communications between the PARTIES with
respect to the LICENSE granted hereunder shall be of any force or effect, nor
shall the AGREEMENT be subject to any change or modification, except by the
execution of a subsequent written instrument subscribed to by the PARTIES
hereto.
14.3 The provisions of the AGREEMENT are severable, and in the event
that any provisions of the AGREEMENT shall be determined to be invalid or
unenforceable under any controlling body of the law, such invalidity or
unenforceability shall not in any way affect the validity or enforceability of
the remaining provisions hereof.
-22-
<PAGE>
14.4 The failure of either PARTY to assert a right hereunder or to
insist upon compliance with any term or condition of the AGREEMENT shall not
constitute a waiver of that right or excuse a subsequent failure to perform any
term or condition by the other PARTY.
14.5 Except as required by U.S. regulatory authorities, no press
releases, publicity, announcements or other disclosures of the AGREEMENT shall
be made by either PARTY without the prior written consent of the other PARTY.
14.6 The AGREEMENT may be executed in any number of counterparts, each
of which shall be deemed an original but all of which together shall constitute
one and the same instrument.
IN WITNESS WHEREOF, the PARTIES have hereunto duly executed
the AGREEMENT as of the day and year set forth above.
ANSAN, INC.
By:
------------------------------
Name: S. MARK MORAN, M.D.
------------------------------
Title: PRESIDENT AND CEO
------------------------------
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
By:
------------------------------
Name: MUELLER AND DR. MITCHARD
------------------------------
Title: AUTHORISED SIGNATORIES
------------------------------
-23-
<PAGE>
APPENDIX A
1. Record 2702 in
Database PATL
Case Number: 1-733-EU
Land: Austria
Date of filing: 1/20/1986
File Number: 86100656.7
Date of issue: 4/26/1989
Patent Number: 0194416
Date of expiration: 1/20/2006
2. Record 2558 in
Database PATL
Case Number: 1-728-EU
Land: Austria
Date of filing: 9/24/1985
File Number: 85112074.1
Date of issue: 8/8/1993
Patent Number; 0176927
Date of expiration: 9/24/2005
3. Record 2704 in
Database PATL
Case Number: 1-733-EU
Land: Belgium
Date of filing: 1/20/1986
File Number: 86100656.7
Date of issue: 4/26/1989
Patent Number: 0194416
Date of expiration: 1/20/2006
4. Record 2716 in
Database PATL
Case Number: 1-733
Land: Denmark
Date of filing: 1/24/1986
File Number: 860367
Date of issue: 3/29/1993
Patent Number: 165323
Date of expiration: 1/24/2006
-24-
<PAGE>
5. Record 2720 in
Database PATL
Case Number: 1-733
Land: Finland
Date of filing: 1/22/1986
File Number: 860296
Date of issue: 10/26/1992
Patent Number: 86851
Date of expiration: 1/22/2006
6. Record 2721 in
Database PATL
Case Number: 1-733-EU
Land: France
Date of filing: 1/20/1986
File Number: 86100656.7
Date or issue: 4/26/1989
Patent Number: 0194416
Date of expiration: 1/20/2006
7. Record 2593 in
Database PATL
Case Number: 1-728-EU
Land: France
Date of filing: 9/24/1985
File Number: 85112074.1
Date of issue: 9/8/1993
Patent Number: 0176927
Date of expiration: 9/24/2005
8. Record 2715 in
Database PATL
Case Number: 1-733-EU
Land: Germany
Date of filing: 1/20/1986
File Number: 86100656.7
Date of issue: 4/26/1989
Patent Number: P 36 63 028.4-08,
0194416
Date of expiration: 1/20/2006
-25-
<PAGE>
9. Record 2591 in
Database PATL
Case Number: 1-728-EU
Land: Germany
Date of filing: 9/24/1985
File Number: 85112074.1
Date of issue: 9/8/1993
Patent Number: P 35 87 568.2-08,
0176927
Date of expiration: 9/24/2005
10. Record 2722 in
Database PATL
Case Number: 1-733-EU
Land: Great Britain
Date of filing: 1/20/1986
File Number: 86100656.7
Date of issue: 4/26/1989
Patent Number: 0194416
Date of expiration: 1/20/2006
11. Record 2594 in
Database PATL
Case Number: 1-728-EU
Land: Great Britain
Date of filing: 9/24/1985
File Number: 85112074.1
Date of issue: 9/8/1993
Patent Number: 0176927
Date of expiration: 9/24/2005
12. Record 2723 in
Database PATL
Case Number: 1-733
Land: Greece
Date of filing: 1/23/1986
File Number: 860189
Date of issue: 5/26/1986
Patent Number: 860189
Date of expiration: 1/23/2006
-26-
<PAGE>
13. Record 2726 in
Database PATL
Case Number: 1-733
Land: Ireland
Dating of filing: 1/24/1986
File Number: 209/86
Date of issue: 10/21/1993
Patent Number: 58728
Date of Expiration: 1/24/2006
14. Record 2728 in
Database PATL
Case Number: 1-733-EU
Land: Italy
Date of filing: 1/20/1986
File Number: 86100656.7
Date of issue: 4/26/1989
Patent Number: 0194416,
49211/BE/89
Date of expiration: 1/20/2006
15. Record 2595 in
Database PATL
Case Number: 1-728-EU
Land: Italy
Date of filing: 9/24/1985
File Number: 85112074.1
Date of issue: 9/8/1993
Patent Number: 0176927,
51388/BE/93
Date of expiration: 9/24/2005
16. Record 2731 in
Database PATL
Case Number: 1-733-EU
Land: Luxembourg
Date of filing: 1/20/1986
File Number: 86100656.7
Date of issue: 4/26/1989
Patent Number: 0194416
Date of expiration: 1/20/2006
-27-
<PAGE>
17. Record 2734 in
Database PATL
Case Number: 1-733-EU
Land: Netherlands
Date of filing: 1/20/1986
File Number: 86100656.7
Date of issue: 4/26/1989
Patent Number: 0194416
Date of expiration: 1/20/2006
18. Record 2740 in
Database PATL:
Case Number: 1-733
Land: Portugal
Date of filing: 1/24/1986
File Number: 81898
Date of issue: 11/12/1987
Patent Number: 81898
Date of expiration 11/12/2002
19. Record 2718 in
Database PATL
Case Number: 1-733
Land: Spain
Date of filing: 1/24/1986
File Number: 551198
Date of issue: 3/4/1987
Patent Number: 551198
Date of expiration: 3/4/2007
20. Record 17478 in
Database PATL
Case Number: 1-733-I
Land: Spain
Date of filing: 1/24/1986
File Number: 557343
Date of issue: 4/8/1988
Patent Number: 557343
Date of expiration: 4/8/2008
-28-
<PAGE>
21. Record 17479 in
Database PATL
Case Number: 1-733-II
Land: Spain
Date of filing: 1/24/1986
File Number: 557344
Date of issue 4/8/1988
Patent Number: 557344
Date of expiration: 4/8/2008
22. Record 2742 in
Data PATL
Case Number: 1733 EU
Land: Sweden
Date of filing: 1/20/1986
File Number 86100656.7
Date of issue: 0194416
Date of expiration: 1/20/2006
23. Record 2746 in
Database PATL
Case Number: 1-733-Cip-1
Land: USA
Date of filing: 10/3/1988
File Number: 252725
Date of issue: 11/6/1990
Patent Number: 4968794
Date of expiration: 11/6/2007
24. Record 17547 in
Database PATL
Case Number 1-733-I
Land: USA
Date of filing: 6/15/1990
File Number: 539416
Date of issue: 1/21/1992
Patent Number: 5082839
Date of expiration: 1/21/2009
-29-
<PAGE>
25. Record 17548 in
Database PATL
Case Number: 1-733-II
Land: USA
Date of filing: 10/11/1991
File Number: 774683
Date of issue: 10/13/1992
Patent Number: 5155103
Date of expiration: 10/13/2009
26. Record 2598 in
Database PATL
Case Number: 1-728
Land: USA
Date of filing: 10/1/1985
File Number: 782632
Date of issue: 11/4/1986
Patent Number: 4621083
Date of expiration: 11/4/2003
-30-
EXHIBIT (11) -- STATEMENT RE: COMPUTATION OF NET LOSS PER SHARE
<TABLE>
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
---------------------------------- ----------------------------------
1996 1995 1996 1995
<S> <C> <C> <C> <C>
Net Loss $(403,684) $(1,083,251) $(811,619) $(1,510,703)
=============== ================= ============== =================
Weighted average shares of
Common Stock outstanding 2,771,645 387,956 2,769,905 387,956
Shares related to staff accounting bulletin topic 4D:
Stock Options 57,012 57,012
Conversion of payable to parent 352,557 352,557
Escrow Shares (363,760) (227,853) (363,760) (227,853)
Shares used in calculating net loss per share 2,407,885 569,672 2,406,145 569,672
=============== ================= ============== =================
Net loss per share $(0.17) $(1.90) $(0.34) $(2.65)
=============== ================= ============== =================
Pro forma net loss per share information:
Shares used in calculating net loss per share 569,672 569,672
Adjusted to reflect the effect of the assumed
conversion of Preferred Stock 532,651 532,651
Escrow Shares (152,178) (152,178)
----------------- -----------------
Shares used in computing pro forma
net loss per share 950,415 950,415
================= =================
Pro forma net loss per share $(1.14) $(1.59)
================= =================
</TABLE>
Exhibit 11
<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 statement.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> DEC-13-1996
<PERIOD-END> JUN-30-1996
<CASH> 69,562
<SECURITIES> 3,002,393
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 3,100,455
<PP&E> 76,688
<DEPRECIATION> 10,910
<TOTAL-ASSETS> 3,166,233
<CURRENT-LIABILITIES> 298,415
<BONDS> 0
0
0
<COMMON> 10,687,037
<OTHER-SE> (7,819,219)
<TOTAL-LIABILITY-AND-EQUITY> 3,166,233
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 904,902
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (811,619)
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (811,619)
<EPS-PRIMARY> (0.34)
<EPS-DILUTED> (.08)
</TABLE>
