<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
[x] Quarterly Report pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
For the quarterly period ended March 31, 1997, 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 NO.: 0-25978
---------
THERAPEUTIC ANTIBODIES INC.
------------------------------------------------------
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE 62-1212485
------------------------------- ----------------
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
1207 17TH AVENUE SOUTH, SUITE 103
NASHVILLE, TENNESSEE 37212
-------------------- -----
(Address of Principal Executive Offices) (Zip Code)
(615) 327-1027
-------------------------------
(Registrant's Telephone Number,
Including Area Code)
NOT APPLICABLE
----------------------------------------------------
(Former Name, Former Address and Former Fiscal Year,
if Changed Since Last Report)
Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 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
------ -------
As of May 14, 1997, 22,488,221 shares of the registrant's Common Stock
were outstanding. ----------
<PAGE> 2
PART I
FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
ASSETS
<TABLE>
<CAPTION>
March 31, 1997 December 31, 1996
-------------- -----------------
(Unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 12,306,601 $ 20,502,536
Short-term investments 5,398,705 2,002,266
Trade receivables 58,102 101,281
Value added tax receivable 203,860 251,186
Inventories 448,488 400,167
Other current assets 761,356 474,412
------------ ------------
Total current assets 19,177,112 23,731,848
Property and equipment, net 12,082,551 12,682,680
Patent costs, net 562,682 529,228
Other assets, net 218,342 236,234
------------ ------------
Total assets $ 32,040,687 $ 37,179,990
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 935,642 $ 936,591
Accrued interest 177,355 161,367
Current portion of notes payable 1,273,022 1,446,327
------------ ------------
Total current liabilities 2,386,019 2,544,285
Notes payable, net of current portion 8,358,480 8,592,755
Deferred revenue 588,763 656,170
Other liabilities 163,950 171,250
------------ ------------
Total liabilities 11,497,212 11,964,460
------------ ------------
Stockholders' equity:
Common stock - par value $.001 per share;
30,000,000 shares authorized; 22,373,692 -
March 31, 1997 and 22,353,692 - December
31, 1996 issued and outstanding 22,374 22,354
Additional paid-in capital 67,104,278 67,082,048
Deficit accumulated during the development
stage (1984-1997) (46,872,504) (42,564,665)
Cumulative translation adjustment 289,327 675,793
------------ ------------
Total stockholders' equity 20,543,475 25,215,530
------------ ------------
Total liabilities and stockholders' equity $ 32,040,687 $ 37,179,990
============ ============
</TABLE>
The accompanying notes are an integral part of the financial statements.
2
<PAGE> 3
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
For the Cummulative
For the Three Months Ended Development Stage
March 31, from August 10, 1994
------------------------------------ (inception) Through
1997 1996 March 31, 1997
------------ ---------- ------------------
<S> <C> <C> <C>
Revenues:
Sales and contract revenue $ 87,415 $ 36,760 $ 2,485,644
Licensing revenue 62,305 -- 305,805
Interest income 283,858 18,996 1,320,033
Grant income 10,206 9,572 537,156
Value-added tax and insurance recoveries -- -- 577,170
Foreign currency gains -- -- 1,785,984
Other 15,157 14,357 155,963
------------ ------------ ------------
458,941 79,685 7,167,755
------------ ------------ ------------
Expenses:
Cost of sales and contract revenue 52,659 9,672 487,076
Research and development 2,590,687 1,836,995 33,795,749
General and administrative 641,672 447,868 9,398,341
Marketing and distribution 87,654 62,062 1,449,609
Depreciation and amortization 367,753 333,200 4,235,501
Interest 282,367 314,805 3,010,991
Debt conversion expense -- 801,597 801,597
Foreign currency losses 743,988 -- 743,988
Other -- -- 117,407
------------ ------------ ------------
4,766,780 3,806,199 54,040,259
------------ ------------ ------------
Net loss $ (4,307,839) $ (3,726,514) $(46,872,504)
============ ============ ============
Net loss per share $ (0.19) $ (0.22) $ (5.12)
============ ============ ============
Weighted average shares used in
computing net loss per share 22,363,692 16,849,345 9,160,503
============ ============ ============
</TABLE>
The accompanying notes are an integral part of the financial statements.
3
<PAGE> 4
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
For the Cummulative
For the Three Months Ended Development Stage
March 31, from August 10, 1994
------------------------------- (Inception) Through
1997 1996 March 31, 1997
------------ ---------- ------------------
<S> <C> <C> <C>
Cash flows from operating activities:
Net loss $ (4,307,839) (3,726,514) (46,872,504)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 367,753 333,200 4,235,501
Foreign currency (gain) loss 743,988 -- (1,041,996)
Warrant expense -- -- 193,994
Compensation expense 5,000 -- 67,431
Debt conversion expense -- 801,597 801,597
Changes in:
Trade receivable 77,770 34,421 2,678
Inventories (48,321) 68,145 (334,314)
Other current assets (291,931) 55,768 (760,654)
Accounts payable and accrued expenses 18,908 (421,473) 925,740
Accrued interest 16,487 (14,141) 793,489
Deferred revenue (44,601) -- 269,069
Other -- -- (43,489)
------------ ------------ ------------
Net cash used in operating activities (3,462,786) (2,868,997) (41,763,458)
------------ ------------ ------------
Cash flows from investing activities:
Purchase of property and equipment (372,014) (282,165) (12,358,457)
Patent costs (37,379) (58,805) (588,667)
Purchase of short term investments (3,396,439) -- (5,398,705)
Other -- (22,773) 69,750
------------ ------------ ------------
Net cash used in investing activities (3,805,832) (363,743) (18,276,079)
------------ ------------ ------------
Cash flows from financing activities:
Proceeds from notes payable 37,779 51,860 15,829,179
Payments on notes payable (278,285) (707,621) (5,156,545)
Proceeds from line of credit -- 16,426 3,309,381
Payments on line of credit (100,444) (568,581) (3,309,381)
Proceeds from convertible debt, net -- 1,081,732 9,655,000
Payments on convertible debt -- -- (4,320,325)
Proceeds from issuance of stock, net 17,250 654,946 55,670,744
Proceeds from issuance of warrants -- -- 65,000
Other -- -- (186,782)
------------ ------------ ------------
Net cash (used in) provided by financing activities (323,700) 528,762 71,556,271
------------ ------------ ------------
Effect of exchange rate changes on cash and cash equivalents (603,616) 58,625 789,867
------------ ------------ ------------
Net increase in cash and cash equivalents (8,195,934) (2,645,353) 12,306,601
Cash and cash equivalents at beginning of period 20,502,535 3,397,082 --
------------ ------------ ------------
Cash and cash equivalents at end of period $ 12,306,601 751,729 12,306,601
============ ============ ============
</TABLE>
The accompanying notes are an integral part of the financial statements.
4
<PAGE> 5
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
MARCH 31, 1997
NOTE 1 - BASIS OF PRESENTATION
The accompanying first quarter financial statements are unaudited, but include
all adjustments (consisting of normal recurring accruals) which are, in the
opinion of management, necessary for a fair statement of the results for such
periods.
The unaudited first quarter consolidated financial statements should be read in
conjunction with the audited December 31, 1996 consolidated financial statements
of the Company. The December 31, 1996 condensed consolidated balance sheet data
was derived from audited financial statements, but does not include all
disclosures required by generally accepted accounting principles.
The results of operations for the interim periods are not necessarily indicative
of the results to be expected for the full year ending December 31, 1997.
NOTE 2 - RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
During February 1997, the Financial Accounting Standards Board issued Statement
of Financial Accounting Standards No. 128, "Earnings Per Share" ("SFAS No.
128"). The Company will adopt SFAS No. 128 during the fourth quarter of 1997 as
required and does not expect it to have a material impact on the calculation of
net income per share.
5
<PAGE> 6
REPORT OF INDEPENDENT ACCOUNTANTS
BOARD OF DIRECTORS
THERAPEUTIC ANTIBODIES INC.
We have reviewed the condensed consolidated balance sheet of Therapeutic
Antibodies Inc. and Subsidiaries at March 31, 1997 and the related condensed
consolidated statement of income and condensed consolidated statement of cash
flows for the periods set forth in the Quarterly Report on Form 10-Q for the
quarter ended March 31, 1997. These financial statements are the responsibility
of the Company's management.
We conducted our review in accordance with standards established by the American
Institute of Certified Public Accountants. A review of interim financial
information consists principally of applying analytical procedures to financial
data and making inquiries of persons responsible for financial and accounting
matters. It is substantially less in scope than an audit conducted in accordance
with generally accepted accounting standards, the objective of which is the
expression of an opinion regarding the financial statements taken as a whole.
Accordingly, we do not express such an opinion.
Based on our review, we are not aware of any material modifications that should
be made to the financial statements referred to above for them to be in
conformity with generally accepted accounting principles.
We have previously audited, in accordance with generally accepted auditing
standards, the consolidated balance sheet at December 31, 1996 and the related
consolidated statements of income, stockholders' equity and cash flows for the
year then ended (not expressed herein); and in our report dated March 7, 1997,
we expressed an unqualified opinion on those consolidated financial statements.
In our opinion, the information set forth in the accompanying condensed
consolidated balance sheet as of December 31, 1996, is fairly stated, in all
material respects, in relation to the consolidated balance sheet from which it
has been derived.
/s/ COOPERS & LYBRAND L.L.P.
COOPERS & LYBRAND L.L.P.
Louisville, Kentucky
May 12, 1997
6
<PAGE> 7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion and analysis of the financial condition and results of
operations of the Company should be read in conjunction with the financial
statements and notes thereto. This discussion and analysis contains both
historical and forward looking information. The forward looking statements are
made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward looking statements may be significantly impacted by
certain risks and uncertainties, and there can be no assurance that other
factors will not affect the accuracy of such forward-looking statements. While
it is impossible to identify all such factors, factors which could cause actual
results to differ materially from those estimated by the Company include but are
not limited to, changes on the regulation of the pharmaceutical industry, both
in the United States and internationally, changes in pharmaceutical product
testing or approval standards, both in the United States and internationally,
competitive pressures on the pharmaceutical industry and the Company's response
thereto, general conditions in the economy and capital markets, and other
factors which may be identified from time to time in the Company's Securities
and Exchange Commission filings and other public announcements.
GENERAL
Therapeutic Antibodies Inc. ("TAb" or the "Company") has been in the
development stage since inception in 1984, devoting its efforts and resources to
drug discovery and development programs relating to the development of highly
purified, polyclonal antibodies for the treatment of disease. Since inception
the Company's revenues have been from contract agreements with corporate
partners, product sales, grant income, interest income, and insurance and value
added tax recoveries. Net losses have been incurred each year since its
inception and the Company expects to continue to incur operating losses during
at least the next year due to continued spending on research, product
development and increasing requirements for process development, preclinical and
clinical testing, regulatory compliance, manufacturing activities and
administration. The Company may require additional financing until product sales
or licensing fees are sufficient to generate positive cash flows from
operations.
The Company conducts its operations from its headquarters in the United
States and through subsidiaries located in the United Kingdom, Australia and New
Zealand. International operations are primarily located in the United Kingdom.
RESULTS OF OPERATIONS
Three Months Ended March 31, 1997 Compared to Three Months Ended March 31, 1996
Revenues for the three months ended March 31, 1997 increased by 474% to
$459,000 from $80,000 for the three months ending March 31, 1996. The increase
in revenues in the first quarter of 1997 is attributed to increases in interest
income, licensing revenue, and sales and contract revenue. In the first quarter
of 1997, interest income increased to $284,000 from $19,000 in the first quarter
of 1996, reflecting additional cash and short term investment holdings from the
proceeds of the Company's initial public offering of Common Stock in the United
Kingdom in July 1996. TAb received a one-time licensing fee of $62,000 in the
first quarter of 1997 for the execution of a collaboration agreement for
BrownTAb(TM), the Company's Australian Brown snake antivenom. Sales and contract
revenue increased to $87,000 for the quarter ended March 31, 1997 from $37,000
for the quarter ended March 31, 1996 due largely to a $43,000 sale of
EchiTAb(TM), the West African carpet viper antivenom, in March 1997.
7
<PAGE> 8
Expenses increased by 25% to $4,767,000 for the quarter ending March
31, 1997, from $3,806,000 in the first quarter of 1996. Research and development
expenses, the largest component of TAb's expenses, increased by 41% to
$2,591,000 from $1,837,000 in the quarter ending March 31, 1996, as a result of
increased clinical trial activities for DigiTAb(TM) and CytoTAb(TM) for malaria
as well as the progression through the more advanced trial phases for
CytoTAb(TM) for sepsis. These costs are related to manufacturing TAb's products
for clinical trials, conducting clinical trials and ensuring that the necessary
quality control and assurance procedures are in place. Costs associated with
regulatory compliance, a component of research and development expenses, have
also increased as more of the Company's products enter advanced stages of
development.
General and administrative expenses in the first quarter of 1997
increased by 43% to $642,000 from $448,000 in the quarter ending March 31, 1996,
as a result of additional insurance costs (required since the Company's Common
Stock began publicly trading in July 1996), one-time expenses for the relocation
of the corporate headquarters in the first quarter of 1997, increased rent
expense and increases in the number of employees and related expenses.
Marketing expenses in the quarter ended March 31, 1997, increased by
42% to $88,000 compared to $62,000 in the first quarter of 1996 due to increased
personnel and marketing activities.
Interest expense in the quarter ending March 31, 1997, decreased by 10%
to $282,000 from $315,000 in the first quarter of 1996 due to repayment by the
Company of approximately $4,750,000 of debt obligations in the third and fourth
quarters of 1996.
The Company recorded a one-time debt conversion expense in the first
quarter of 1996 of $801,597 relating to the conversion of an aggregate of
$2,565,105 of principal and interest on the Company's 6% Notes into shares of
Common Stock, which represents the difference between the stated conversion
price on the debt of $8.00 per share and the actual conversion price of $5.50.
In the quarter ended March 31, 1997, the Company recorded foreign
currency losses of $744,000. These losses were the result of changes in the UK
and Australian exchange rates from December 31, 1996 to March 31, 1997 on the
Company's holdings of cash in British pounds sterling and Australian dollars.
The Company's net loss for the quarter ending March 31, 1997, was $4.3
million compared to a net loss of $3.7 million for the quarter ending March 31,
1996. This increase was due to the activities described above.
LIQUIDITY AND CAPITAL RESOURCES
Since its inception, TAb has been in the development stage, devoting
its efforts and resources to drug discovery and development programs. Capital
resources have been used for the establishment and expansion of production
facilities, research and development, clinical testing and to meet TAb's
increased working capital needs in connection with such activities. Management
does not expect revenues from product sales to be a significant source of
funding until additional products receive regulatory approval. Future capital
requirements will depend on numerous factors, including the progress of its
research programs and clinical trials, the development of regulatory
submissions, the commercial viability of the Company's products, the development
of sales, distribution and marketing capabilities, and the terms of any new
licensing arrangements. Financing for the Company's operating and capital
requirements historically has been provided by the sale of equity, convertible
debt and through other financings.
8
<PAGE> 9
At March 31, 1997, the Company had cash, cash equivalents and short
term investments totaling $17,706,000 (cash and cash equivalents of $12,306,000
and short term investments of $5,399,900) of which approximately $9,429,000 was
denominated in British pounds and $2,142,000 in Australian dollars. The
Company's net cash used in operating activities during the quarter ending March
31, 1997 totaled $3,463,000, an increase of 21% from the quarter ending March
31, 1996. Capital expenditures of $372,000 in the first quarter of 1997 related
primarily to expansion of production facilities in Wales and Australia. TAb
anticipates that total capital expenditures for 1997 will be approximately $1.5
million.
The Company's holdings of short-term investments increased 170% to
$5,399,000 as of March 31, 1997 from $2,002,000 as of December 31, 1996. This
increase is due to the additional funds available from the Company's initial
public offering in July, 1996.
Between January 1, 1997 and March 31, 1997, certain holders of warrants
for the Company's stock exercised warrants to purchase 20,000 shares of Common
Stock. The exercise prices of the warrants ranged from $.60 to $1.25 per share
and totaled $17,250 in the aggregate.
During the quarter ended March 31, 1997, the Company's subsidiary, TAb
Australia Pty. Ltd., made a $19,000 draw on its collateralized loan agreement
with the South Australian Minister for Primary Industries. To date, TAb
Australia Pty. Ltd. has borrowed a total of $1,578,000 U.S. dollars under this
loan agreement to finance construction and equipping of buildings at its
Turretfield location in South Australia. The loan bears interest at an annual
rate of 11%, payable annually, and principal is payable in ten equal annual
installments.
RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
During February 1997, the Financial Accounting Standards Board issued Statement
of Financial Accounting Standards No. 128, "Earnings Per Share" ("SFAS No.
128"). The Company will adopt SFAS No. 128 during the fourth quarter of 1997 as
required and does not expect it to have a material impact on the calculation of
net income per share.
OTHER FINANCIAL INFORMATION
Coopers & Lybrand, L.L.P., the Company's independent public accountants,
performed a limited review of the financial data presented on pages 2 through 6
inclusive. The review was performed in accordance with standards for such
reviews established by the American Institute of Certified Public Accountants.
The review did not constitute an audit; accordingly, Coopers & Lybrand, L.L.P.
did not express an opinion on the aforementioned data.
9
<PAGE> 10
PART II
OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES
Between January 1, 1997 and March 31, 1997, certain holders of warrants
for the Company's stock exercised warrants to purchase an aggregate of 20,000
shares of Common Stock. The exercise prices of the warrants ranged from $.60 to
$1.25 per share and totaled $17,250 in the aggregate. These shares were issued
pursuant to exemptions from registration contained in Section 4(2) of the
Securities Act of 1933, as amended.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
<TABLE>
<CAPTION>
Exhibit
Number Description of Exhibits
------ -----------------------
<S> <C>
10.1 Clinical Trials, Registration, Manufacturing and
Distribution Agreement dated February 21, 1997,
between the Company and CSL Limited A.C.N.
11.1 Statement re: computation of per share earnings
27 Financial Data Schedule (SEC use only)
(b) Reports on Form 8-K.
The Company did not file any Current Reports on Form
8-K during the first quarter of 1997.
</TABLE>
10
<PAGE> 11
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be filed on its behalf by the
undersigned thereunto duly authorized.
Date: May 15, 1997 /s/ Martin S. Brown
------------------------
Martin S. Brown
Chairman of the Board
Chief Executive Officer
(Principal Executive Officer)
Date: May 15, 1997 /s/ Robert D. Brown
--------------------------
Robert D. Brown, CPA
Vice President & Controller
(Principal Accounting Officer)
11
<PAGE> 1
Exhibit 10.1
CSL LIMITED
THERAPEUTIC ANTIBODIES INC
CLINICAL TRIALS, REGISTRATION, MANUFACTURING,
AND DISTRIBUTION AGREEMENT
FEBRUARY 21, 1997
<PAGE> 2
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C> <C>
1. RECITALS.............................................................. 1
2. DEFINITIONS........................................................... 1
3. CLINICAL TRIALS....................................................... 3
4. OTHER ANTIVENOMS...................................................... 4
5. OTHER OPPORTUNITIES................................................... 5
6. REGISTRATION.......................................................... 5
7. MANUFACTURING......................................................... 6
8. APPOINTMENT OF AUTHORIZED DISTRIBUTOR................................. 6
9. PRODUCT DISTRIBUTION.................................................. 6
10. PAYMENTS.............................................................. 8
11. RECORDS AND REPORTING................................................. 9
12. ORDER PROCEDURE....................................................... 10
13. SHIPMENT, RISK OF LOSS, AND DELIVERY.................................. 10
14. COMPLIANCE............................................................ 10
15. TRADEMARK AND PROPRIETARY RIGHTS...................................... 11
16. DURATION AND TERMINATION OF AGREEMENT................................. 13
17. INDEMNIFICATION....................................................... 15
18. REPRESENTATIONS AND WARRANTIES........................................ 15
19. DISCLAIMER OF WARRANTIES; LIMITED LIABILITY........................... 16
20. FAILURE TO TRADEMARK PRODUCT.......................................... 17
21. CONFIDENTIALITY....................................................... 17
22. ENFORCEMENT........................................................... 18
23. GENERAL............................................................... 18
</TABLE>
10-Feb-97
<PAGE> 3
CLINICAL TRIALS, REGISTRATION, MANUFACTURING
AND DISTRIBUTION AGREEMENT
This Clinical Trials, Registration, and Distribution Agreement is made
and entered into this 21st day of February, 1997, by and between CSL LIMITED
A.C.N. 051588348, located in Parkville, Victoria, Australia ("CSL") and
THERAPEUTIC ANTIBODIES INC, a Delaware corporation located in Nashville,
Tennessee, USA ("TAb").
W I T N E S S E T H:
1. Recitals.
1.1 TAb has developed and is the sole owner of all worldwide
right, title, and interest in and to polyclonal antibody products for treatment
of bites of snakes and other venomous creatures, more particularly described in
Schedule 1.1 attached (the "Products").
1.2 TAb has requested that CSL conduct clinical trials and
obtain registration and marketing approvals for the Products from the relevant
health authorities in Australia and the other territory referred to in Schedule
1.2 attached, and any other countries that the parties may agree upon
(collectively, the "Territory").
1.3 CSL has agreed to conduct clinical trials, obtain
registration and marketing approvals for the Products in the Territory, and
distribute the Products in the Territory on the terms and subject to the
conditions set forth herein.
2. Definitions.
2.1 "Clinical Trials" shall mean any and all investigations,
evaluations, or experiments that are conducted on human beings in relation to
the potential use of the Products.
2.2 "Commencement Date" means, with respect to each Product in
each country within the Territory, the date on which TAb receives CSL's
certification that all necessary registrations and marketing approvals have been
obtained to market and sell the Products in the Territory in accordance with
Section 6.
2.3 "Confidential Information of TAb" means all information
obtained or developed by CSL which relates to TAb's business or the Products,
regardless of the form in which such information is transmitted, including,
without limitation, all such information previously obtained by CSL pursuant to
the Mutual Non-Disclosure Agreement dated December 13, 1995, between TAb and CSL
(the "Confidentiality Agreement"), all information furnished to CSL pursuant to
Section 3 below, all Results, and all Trade Secrets. The following shall not be
considered Confidential Information of TAb for purposes hereof:
(a) Information that is already in the possession of CSL at
the time it is received from TAb or developed on TAb's behalf, so long as the
receiving party promptly notifies TAb of its belief that the information is
excepted under the terms of this subsection;
1 10-Feb-97
<PAGE> 4
(b) Information received by CSL from a Person which has the
right to disclose the same, so long as the receiving party promptly notifies TAb
of its belief that the information is excepted under the terms of this
subsection; or
(c) Information that is or becomes publicly available without
the fault of CSL.
In the event of a dispute regarding the applicability of the above exceptions to
the definition of Confidential Information of TAb, CSL shall have the burden of
producing clear and convincing proof that the information should be excepted
from the definition of Confidential Information of TAb.
2.4 "Confidential Information of CSL" means all information
obtained by TAb which relates to CSL's business, regardless of the form in which
such information is transmitted, including, without limitation, all such
information previously obtained by TAb pursuant to the Confidentiality
Agreement. Neither the Confidential Information of TAb nor the following shall
be considered the Confidential Information of CSL for purposes hereof:
(a) Information that is already in the possession of TAb at
the time it is received from CSL, so long as the receiving party promptly
notifies CSL of its belief that the information is excepted under the terms of
this subsection;
(b) Information received by TAb from a Person which has the
right to disclose the same, so long as the receiving party promptly notifies CSL
of its belief that the information is excepted under the terms of this
subsection; or
(c) Information that is or becomes publicly available without
the fault of TAb.
In the event of a dispute regarding the applicability of the above exceptions to
the definition of Confidential Information of CSL, TAb shall have the burden of
producing clear and convincing proof that the information should be excepted
from the definition of Confidential Information of CSL.
2.5 "Confidential Information" means collectively Confidential
Information of TAb and Confidential Information of CSL.
2.6 "Documentation" means any and all labels, instructions,
manuals, specifications, warnings and similar documentation regarding the
Product prepared by or for TAb.
2.7 "End User" means a Person who purchases the Products for
such Person's own use, and not for redistribution.
2.8 "Gross Profit" means CSL's Net Sales Revenue less the
agreed Product Cost as determined by TAb and CSL pursuant to Section 2.12 below.
2.9 "Net Sales Revenue" means the aggregate amount billed by
CSL, directly or indirectly, for the sale of the Product, provided that Net
Sales Revenue shall not include trade discounts, sales tax, value added tax,
shipping, freight, and insurance charges, and returns actually credited.
2.10 "Person" means an individual, corporation, company,
partnership, trust, association, governmental authority or other entity.
2 10-Feb-97
<PAGE> 5
2.11 "Product" or "Products" means the Products described on
Schedule 1.1 as amended from time to time.
2.12 "Product Cost" means the total cost of manufacturing for
the Product, computed in accordance with generally accepted accounting
principles.
2.13 "Proprietary Rights" means the rights and properties
described in Section 15.9.
2.14 "Regulatory Filing" shall mean any filing outside of the
United States that is equivalent to Notice of Claimed Investigational Exemption
for a New Drug ("IND"), Product License Application("PLA"), Establishment
License Application ("ELA"), or New Drug Application ("NDA") in the United
States pursuant to the regulations and procedures required by any regulatory
authority for any country for the testing, manufacture, distribution, sale, or
specific use of the Product.
2.15 "Results" means all technology, ideas (whether or not
copyrightable), know- how, data, improvements, modifications, innovations,
inventions, methodology, processes, techniques, and results, tangible and
intangible, developed or discovered by TAb or CSL in connection with the
manufacture of Product, the clinical trials, registrations, and approvals
contemplated by Sections 3 and 6, or otherwise in connection with the Product or
this Agreement.
2.16 "Trademarks" means all trademarks, trade names, and other
designations of origin used on or in connection with the Products, including,
without limitation, BrownTAbJ.
2.17 "Trade Secrets" means all techniques, technology,
processes, and know-how related to production and purification of polyclonal
antibodies developed by or on behalf of TAb, including (a) the design and
syntheses of immunogens which can produce high affinity antibodies in large
quantities, (b) the selection, immunization, and handling of animals to produce
therapeutic polyclonal antibodies (including breed comparison studies), (c) the
aseptic collection and handling of antisera, and (d) closed systems for fully
processing and purifying antibodies; types and configuration of processing
equipment; lists of suppliers; development plans; methods of operation and
management; cost control methods; methods of setting prices; reporting methods;
quality assurance programs; information systems; training manuals; databases;
production solutions; financial information; customer and prospective customer
lists; and all other trade secrets of TAb.
3. Clinical Trials.
3.1 TAb shall at its cost promptly supply CSL with the
materials that TAb has assembled for use in preparing a CTX application (i.e.,
the equivalent to an IND in the United States) for the Products before CSL is
required to begin to conduct Clinical Trials.
3.2 TAb shall supply the materials for Clinical Trials using
antisera sourced from Australian sheep in accordance with Section 3.5 hereof.
CSL shall be solely responsible for paying for, conducting, monitoring and
completing all Clinical Trials necessary for the registration of the Products in
the Territory as soon as reasonably possible after receiving the materials TAb
has assembled for use in preparing a CTX application. CSL shall prepare the CTX
application and any other necessary documents for commencement of Clinical
Trials and shall consult with TAb with regard to the final drafts of such
documents before filing any such documents with applicable authorities. CSL
shall file all required documents as soon as reasonably possible after TAb
consents to the content thereof.
3 10-Feb-97
<PAGE> 6
The parties agree that CSL's obligations hereunder in regard to the
commencement of Clinical Trials are contingent upon (i) acceptance by the
Therapeutic Goods Administration of Australia of the existing preclinical data
as being adequate to support the CTX application, and (ii) the premise that a
single clinical trial of BrownTAbJ will be sufficient to achieve marketing
approval for other snake antivenoms that TAb develops for sale in the Territory
as well.
CSL shall assume responsibility as sponsor of clinical trials and
ensure that any clinical material used in such trial is manufactured in
accordance with the regulatory requirements relevant to its Territory. In turn,
TAb shall allow CSL access to its manufacturing operations for audit purposes
during normal office hours upon reasonable notice to ensure compliance with the
relevant regulatory requirements.
3.3 CSL shall assure that Clinical Trials are conducted in
compliance with the schedule set forth on Schedule 6.4 and in accordance with
all applicable governmental requirements in the Territory (e.g., Good Clinical
Practices). It is agreed that Good Clinical Practices shall include, but not be
limited to, the practices referred to in Schedule 3.3. CSL shall consult with
TAb in the selection of the clinical centers to be used for the Clinical Trials.
The Clinical Trials will be implemented according to the dates agreed to by both
parties in Schedule 6.4.
3.4 CSL shall conduct the Clinical Trials with the prior
approval and ongoing review of all appropriate and necessary review authorities
and in accordance with all applicable laws and regulations. CSL shall inform TAb
of any governmental review promptly after such review takes place.
3.5 In the course of the Clinical Trials, TAb shall
manufacture and ship free of charge to the location designated by CSL (by proper
notice as set forth in Section 23.2) partly processed Products for final
finishing prior to use in the Clinical Trials. Careful detailed logs of all the
shipments of Products shall be maintained by CSL. CSL shall be responsible for
and pay for the filling, lyophilization, QC testing, packaging and final
labelling of containers for the Product to be used in the Clinical Trials. CSL
must have the prior written approval of TAb regarding the format and content of
labels before affixing them to the Clinical Trials material. TAb shall only
supply Product derived from Australian sheep for use in the Clinical Trials.
3.6 CSL and TAb shall comply with the GMP Agreement attached
hereto as Schedule 3.6. CSL shall have responsibility for the release of Product
for use in the Clinical Trials at its cost.
3.7 TAb shall at its cost promptly provide CSL with relevant
information in relation to the Products, as it becomes aware of the same from
time to time, including information relating to efficacy, safety, and any
adverse reactions.
3.8 At the completion of the Clinical Trials, CSL shall
prepare and file with the relevant governmental authorities all required
documents. Upon completion or termination of the Clinical Trials and upon TAb's
request, CSL shall return or otherwise dispose of any remaining Products in
accordance with TAb's instructions. CSL shall not use or permit any party to
whom it ships the Product to use the Products for any purpose other than the
Clinical Trials, unless otherwise agreed.
4. Other Antivenoms.
TAb shall grant CSL the right of first refusal to distribute any other
antivenoms that TAb develops for sale in the Territory, and if they reach an
agreement, CSL and TAb shall share equally the product development costs based
upon a mutually agreed budget. Such development costs would not include the
4 10-Feb-97
<PAGE> 7
cost of related clinical trials unless TAb and CSL subsequently reach an
agreement to address such costs. In the event that the parties cannot reach an
agreement for distribution of the other antivenoms within six months after
completion of Clinical Trials for the brown snake antivenom, TAb shall be free
to enter into such an agreement with a third party provided that the commercial
terms agreed to by the third party are no more favorable than the commercial
terms offered by TAb to CSL.
5. Other Opportunities.
CSL and TAb shall explore opportunities to collaborate in other areas,
including:
applying TAb's technology to other CSL antibody-based products;
research and development of new TAb products;
lyophilization and vialing of appropriate TAb products processed in
Australia; and
commercialization of the TAb product range in markets not covered by
existing agreements between TAb and third parties.
6. Registration.
6.1 CSL shall exercise its best efforts, on a continuous
basis, to obtain in a prompt manner and to maintain all required licenses,
permits, and certificates and authorizations for the marketing, distribution,
and sale of the Products within the Territory, at CSL's sole cost and expense.
By the date specified in Schedule 6.4, CSL shall prepare and submit at its cost
all necessary Regulatory Filings and fees for registration of the Products in
the Territory. TAb shall promptly supply CSL with all information and data in
its possession as may be necessary or useful in connection with any
registrations and approvals. CSL shall provide TAb with written certification
that the Product has obtained all registrations and approvals necessary in order
for distribution and sale of the Product in a given country to commence,
promptly upon receipt of the requisite registrations and/or approvals. CSL
agrees that it shall not modify or alter the Product or its Packaging and
Promotional Material, as defined in Section 15.5 in any respect, whether in
relation to design, content, manufacture, use or otherwise, without the prior
written consent of TAb. TAb agrees not to modify or alter the manufacturing of
the Product supplied to CSL in any respect in relation to design, content,
manufacture, use, or otherwise without the prior written consent of CSL.
6.2 All registrations and approvals obtained by CSL hereunder
shall be the sole and exclusive property of TAb. All registrations and approvals
shall be held in the name of TAb or, if required by applicable law or regulatory
authorities, in the name of CSL on TAb's behalf. All Results shall be the sole
and exclusive property of TAb, and CSL hereby assigns to TAb any and all right,
title, and interest it may now or in the future have in the Results. TAb agrees
not to make any changes to the approved registration conditions without
providing prior notice to CSL and without the approval of the regulatory
authorities in the Territory.
6.3 As CSL receives any information relating to the status of
applications for registration and marketing approval and requests for the
Product, it shall promptly provide such information to TAb.
5 10-Feb-97
<PAGE> 8
6.4 Set forth as Schedule 6.4 hereto is the time and events
schedule for the clinical trials, registration, and approval activities
contemplated by this Section 6.4. Both CSL and TAb shall proceed to implement
the agreed work program according to the dates specified in Schedule 6.4.
7. Manufacturing.
7.1 TAb shall manufacture partly processed Product for sale to
CSL. Such partly processed Product shall be derived exclusively from Australian
sheep. The partly processed Product shall be shipped in accordance with Section
13 hereof, and CSL shall fill, lyophilize, package and perform final quality
control on the Product at its cost. CSL shall have responsibility for the final
release of the Product to the market. A GMP Agreement as described in Section
3.6 shall define responsibilities of both TAb and CSL in this regard.
7.2 The GMP Agreement described in Section 3.6 and Schedule
7.2, which shall be attached hereto prior to completion of the Clinical Trials,
shall collectively or separately address all relevant manufacturing issues,
including, but not limited to, price, production schedules, and quality
assurance procedures with respect to the Products.
8. Appointment of Authorized Distributor.
8.1 TAb appoints CSL as an exclusive distributor of the
Product in the Territory. The appointment shall be effective, with respect to
each country within the Territory, on the respective Commencement Dates, and
shall terminate in accordance with the provisions of Section 16 below. Subject
to the provisions of Section 15 below, CSL is authorized by TAb to use any
Trademarks following each Commencement Date and for the term of this Agreement
thereafter solely in connection with CSL's advertisement, marketing, promotion,
distribution and sale of Product in the Territory.
8.2 The rights and licenses granted to CSL under this
Agreement are personal, non-transferable, non-assignable, are limited solely to
the Product, and in all cases are granted without the right to assign or
sublicense. CSL's appointment only grants to CSL a right to market, advertise,
promote, sell, and distribute Product and does not transfer any right, title, or
interest in the Proprietary Rights to CSL.
8.3 CSL agrees that it shall not advertise, promote,
distribute, sell, or otherwise utilize the Product and/or Trademarks outside of
the Territory, and TAb agrees that it will not authorize any of its distributors
to supply the Product into the Territory.
8.4 Nothing herein shall restrict CSL's ability to determine
the price for the Product in the marketplace, provided that CSL shall not take
any action that adversely affects Gross Profit at the same time deriving a
benefit through increased revenues or gross profits from the sale of other
products that CSL sells.
9. Product Distribution.
9.1 CSL agrees that, beginning on the Commencement Date in
each country within the Territory and continuing through the term of this
Agreement, it shall vigorously and diligently, advertise, market, promote, sell
and distribute the Product throughout the Territory in strict accordance and
conformity with the terms of this Agreement. Without limiting the foregoing, the
distribution efforts of CSL hereunder shall be at least as great as the efforts
exerted by CSL to distribute and sell its own products. CSL shall advertise,
promote, sell and distribute the Product in the Territory through all sales
6 10-Feb-97
<PAGE> 9
channels appropriate for pharmaceutical products as chosen by CSL and accepted
by TAb in accordance with Section 9.3.
9.2 For the term of this Agreement, TAb shall not supply the
Product to any Person located within the Territory other than CSL. CSL agrees
that it shall not, within the Territory, develop, manufacture, assemble,
advertise, promote, sell or distribute any products or goods competitive with
the Product or which by reason of their design, or packaging may be reasonably
confused with the Product after the corresponding Commencement Date.
9.3 CSL shall be solely responsible for its marketing plan,
but shall review the plan with TAb on an annual basis during the month of June.
TAb acknowledges that the marketing plan is CSL's property and is confidential
except that TAb shall have unrestricted use of the marketing plan (in other than
its original form and without reference or liability to CSL) in the event of
uncured breach of this Agreement by CSL.
9.4 With respect to each Product, CSL shall deliver to TAb a
forecast of CSL's quantity requirements for such Product for the following
calendar year (the "Annual Forecast") at least ninety (90) days before the
beginning of each calendar year, commencing at least ninety (90) days before the
anticipated corresponding Commencement Date.
9.5 The parties agree that the minimum acceptable Net Sales
Revenue ("Minimums") shall be the percentage of combined Annual Forecasts as
specified in Schedule 9.5. The forecasts in Schedule 9.5 shall initially be
based on the history of CSL's sales of antivenoms in the Territory. If CSL fails
to meet the Minimums for two consecutive calendar years, TAb may, at its option,
terminate CSL's right to sell the Product and to use the Trademarks with respect
to the Product in that country.
9.6 CSL shall insure that its distribution of the Product and
its use of the Trademarks complies with all applicable laws and regulations of
the countries within the Territory, including, but not limited to, applicable
export controls and laws relating to antitrust or unfair competition. If
approval shall be required at any time during the term of this Agreement with
respect to compliance with exchange regulations or other requirements so as to
assure the right of remittance abroad of U.S. dollars, CSL shall immediately
take whatever steps that may be necessary in this respect, and any charges
incurred in connection therewith shall be borne by CSL.
9.7 CSL shall be responsible for translating Documentation at
its cost into the language of non-English speaking countries within the
Territory if Documentation is required by law to be in a language other than
English.
9.8 CSL shall provide its sales force with training, technical
support and other assistance appropriate in promoting the Product, and TAb will
provide CSL with the relevant know-how and training to enable this to occur. TAb
shall provide to CSL one (1) copy of such Documentation and other TAb literature
so that CSL may carry out the request. CSL will be conversant with the technical
language conventional to Product and similar products in general.
9.9 CSL shall not make representations, warranties, or
guarantees with respect to the specifications, features or efficacy of the
Product that are inconsistent with the literature distributed by TAb, including
all warranties and disclaimers contained in the Documentation.
7 10-Feb-97
<PAGE> 10
9.10 TAb will supply CSL with sterile bulk material for
lyophilization, dispensing and packaging. CSL shall insure that all labels and
packaging conform to the requirements of applicable laws and regulations within
the Territory. CSL shall permit TAb to send an authorized representative to
CSL's facilities at any time during normal office hours and on reasonable notice
to ascertain that the Products are packaged, promoted and distributed in
accordance with the requirements of this Agreement. It is understood and agreed
that, despite any such inspections by TAb, CSL remains solely responsible for
its conduct with respect to the Products.
9.11 CSL will advise TAb promptly concerning any market
information that comes to CSL's attention regarding the Products, its market
position or the continued competitiveness of the Products within the Territory.
TAb will advise CSL promptly concerning any market information that comes to
TAb's attention regarding the Products or the continued competitiveness of the
Product in the marketplace outside the Territory.
9.12 CSL shall provide financial assistance to TAb for
establishing animal flocks for commercial purposes in order to build sufficient
inventories of the Products. The level of this financial assistance is set forth
on Schedule 9.12.
10. Payments.
10.1 In consideration for the rights granted to CSL hereunder,
CSL shall pay TAb the following amounts, in cash, upon the conclusion of the
following events:
<TABLE>
<S> <C>
Signing the Clinical Trials, Registration, Manufacturing, and
Distribution Agreement A $______*
First completion of the Clinical Trials in a country in the
Territory, on the date specified in Schedule 6.4 A $______*
First grant of marketing approval in a country in the
Territory, on the date specified in Schedule 6.4 A $______*
Establishment of a government-approved price structure for
Product sales for a country in the Territory A $ *
----------
TOTAL A $ *
==========
</TABLE>
The foregoing payments are fully earned on the date hereof and thereof and are
not refundable; however, such payments shall be creditable against a maximum of
_____ percent (___%)* of TAb's earned proceeds each year pursuant to Section
10.2 during the first three (3) years of marketing the Products in the
Territory.
10.2 On sales of Products in the Territory, CSL and TAb shall
divide Gross Profit equally. Accordingly, TAb's earned proceeds for each
calendar year shall equal __________ percent (___%)* of the Gross Profit for
such period. TAb shall receive its share of Gross Profit through a mark-up on
partly processed Product sales to CSL plus or minus any annual adjustments made
pursuant to
- ------------
*Confidential Treatment Requested.
8 10-Feb-97
<PAGE> 11
Section 10.3. TAb shall set its price for partly processed Product sales to CSL
(the "Purchase Price") from time to time based on a good faith estimate of
Product Cost plus a good faith estimate of _________ percent (____%)* of Gross
Profit. The initial Purchase Price is set forth on Schedule 10.2. Payment of the
Purchase Price shall be due within thirty (30) days of invoice.
10.3 In the event that the cumulative Purchase Price received
by TAb less cumulative Product Cost in any calendar year is more than __________
percent (___%)* of Gross Profit for the corresponding period, then TAb shall
issue a credit against future Product purchases in the amount of the excess. In
the event that the cumulative Purchase Price received by TAb less cumulative
Product Cost in any calendar year is less than _____________ percent (___%)* of
Gross Profit for the corresponding period, then CSL shall pay TAb the amount of
the difference between such cumulative amounts within ninety (90) days of
calendar year end. However, TAb shall not be required to issue a credit or make
any payments to CSL for any amount attributable to the Gross Profit being less
than zero in any calendar year.
10.4 CSL shall be responsible for and shall timely pay and
discharge any and all taxes, whether characterized as sales, value added,
excise, use, manufacturing, receipts, occupation, or otherwise, and any and all
customs, duties, levies, tariffs, or like fees, imposed as a result of sale or
importation of Product in or into the Territory or as a result of existence or
operation of this Agreement. All payments under this Agreement shall be made at
TAb's offices in Nashville, Tennessee, offices, and shall be calculated in local
market currency and paid in United States dollars or such other currency as TAb
shall from time to time require.
10.5 With respect to international shipments of any Products
purchased, sold, distributed, or otherwise transferred hereunder, CSL shall be
responsible for clearing all such Products through customs and shall pay any and
all taxes and/or duties imposed by any governmental authority in connection
therewith.
11. Records and Reporting
11.1 CSL shall furnish TAb within thirty (30) days following
each March 31, June 30, September 30, and December 31 of each calendar year, a
complete and accurate statement for the immediately preceding quarterly period,
said statement to be certified as accurate by the Senior Financial Officer of
the division of CSL which manages distribution of the Product, and to include
the following information: (a) total Net Sales Revenue on an aggregate basis;
(b) number and gross selling price of Products sold; (c) information as to
discounts given and returns actually credited; (d) information as to any
purchaser of Product on a premium basis; (e) current inventory levels for
Product on a country-by-country basis; and (f) such other information as TAb
reasonably may request. All amounts shall be stated in U.S. dollars followed by
the exchange rate applied.
11.2 CSL agrees that at all times during the existence of this
Agreement, and for a period of seven (7) years thereafter, it will keep accurate
books of account and other records containing all details relating to the part
manufacture, distribution and sale of Products, and the calculation of Net Sales
Revenue. CSL agrees that these books of account and other records shall be kept
in accordance with the legal regulations in existence in the Territory and
carefully preserved for at least seven (7) years.
- -----------
*Confidential Treatment Requested.
9 10-Feb-97
<PAGE> 12
11.3 Where TAb is not satisfied that statements made to it by
CSL are accurate, TAb may give CSL written notice requesting CSL to confirm the
accuracy of the statements made to TAb by conducting an internal review. CSL
must provide a written response which confirms or corrects the statements within
thirty (30) days. If CSL fails to provide its response or if TAb is still not
satisfied, CSL agrees that TAb or any representative of TAb, including any
certified public accountant acceptable to CSL, may inspect and make copies of
the books of account of CSL for the purpose of ascertaining or confirming the
accuracy of the statements rendered hereunder. The cost of these inspections
shall be borne by TAb; provided, however, that if an inspection reveals that a
statement rendered hereunder has understated Net Sales Revenue by greater than
five percent (5%), then the costs of such inspection shall be borne by CSL.
12. Order Procedure.
12.1 All orders for the Product shall be deemed accepted as to
quantity, provided the order does not vary from one-fourth of the most recent
Annual Forecast by more than twenty percent (20%). TAb must notify CSL within
thirty (30) days of receipt of such an order whether TAb accepts any portion of
the order varying from one-fourth of the Annual Forecast by more than twenty
percent (20%).
12.2 The terms and conditions of this Agreement will apply to
each order accepted or shipped by TAb hereunder. The provisions of CSL's form of
purchase order or other business forms will not apply to any order
notwithstanding TAb's acceptance of such order.
12.3 Upon receipt of each order for Product, TAb shall inform
CSL of TAb's delivery date for shipment which shall be within one hundred twenty
(120) days of the date of the order in question. TAb shall use its best efforts
consistent with good business practice to meet the delivery date. TAb reserves
the right to cancel any orders placed by CSL and accepted by TAb as set forth
above, or to refuse or delay shipment thereof, if CSL fails to comply with the
terms and conditions of this Agreement.
13. Shipment, Risk of Loss, and Delivery.
13.1 TAb shall deliver all partly processed Product to
Melbourne Tullamarine Airport on a Delivered Duty Unpaid ("DDU") basis
(Incoterms 1990), whereupon CSL shall take delivery. TAb will be responsible for
and pay for all shipping, freight, and insurance charges to effect delivery at
the Melbourne Tullamarine Airport. CSL shall pay all customs, duties, and
similar tariffs and fees.
13.2 All risk of loss, spoilage, or damage shall pass to CSL
upon delivery by TAb to the Melbourne airport. Unless CSL advises TAb to the
contrary in writing, TAb may make partial shipments of CSL's orders, to be
separately invoiced and paid for when due.
14. Compliance.
14.1 TAb agrees that its conduct in performing its obligations
under this Agreement shall conform in all material respects to all applicable
laws and regulations of the U.S., including the Foreign Corrupt Practices Act,
and of foreign governments (and political subdivisions thereof). It is agreed
that compliance with the Foreign Corrupt Practices Act requires that TAb not
make any offer, gift, promise to pay, or authorize payment of anything of value
to any foreign official, political party, or party official for purposes of
influencing or inducing such official to influence any act or decision, to do or
omit
10 10-Feb-97
<PAGE> 13
to do any act in violation of a lawful duty; provided, however, that such
prohibition shall not apply to a foreign official, political party, or party
official for the purpose of expediting or securing the performance of a routine
governmental action by a foreign official, political party, or party official.
14.2 CSL agrees that its conduct in performing its obligations
under this Agreement shall conform in all material respects to all applicable
laws and regulations, including the Foreign Corrupt Practices Act. It is agreed
that compliance with the Foreign Corrupt Practices Act requires that CSL not
make any offer, gift, promise to pay, or authorize payment of anything of value
to any foreign official, political party, or party official for purposes of
influencing or inducing such official to influence any act or decision, to do or
omit to do any act in violation of a lawful duty; provided, however, that such
prohibition shall not apply to a foreign official, political party, or party
official for the purpose of expediting or securing the performance of a routine
governmental action by a foreign official, political party, or party official.
CSL shall not deviate from government-approved or government-required price
structures.
15. Trademark and Proprietary Rights.
15.1 TAb has used or will use its best efforts to register
BrownTAbJ as a trademark in the Territory.
15.2 CSL shall not use any alternative trademark or other
designation of origin in any country of the Territory on or in connection with
Product unless and until CSL has given at least ninety (90) days' prior written
notice to TAb and TAb has approved the use of such trademark in writing.
15.3 For the purpose of protecting its trademark rights and
any registrations of the Trademarks, TAb shall have the right to supervise and
control CSL's use of TAb's Trademarks.
15.4 CSL agrees to use only those labels, imprints, and other
devices, and only the format or formats and design or designs of the Trademarks
which are approved by TAb in writing. TAb shall have the right to restrict the
use of a particular design or format of the Trademarks to a particular use,
within the scope of this Agreement, and require that said format or design of
the Trademarks be put to no other use.
15.5 CSL shall submit to TAb for its written approval, which
shall not be unreasonably withheld or delayed, prior to any use or dissemination
thereof, two (2) copies of all product information, labels, designs, cartons,
containers, or other packaging or wrapping, and all related advertising,
promotional, and display material (collectively, "Packaging and Promotional
Material"). TAb's trade name and relevant Trademarks shall be prominently
displayed on all labels and other Packaging and Promotional Material. CSL shall
make no use whatsoever of any Packaging and Promotional Material prior to
receiving TAb's written approval pursuant hereto. After samples of Packaging and
Promotional Material have been approved as provided herein, CSL shall not depart
therefrom in any material respect without TAb's prior written consent.
15.6 TAb shall respond to all requests for approval required
by this Section 15 within fourteen (14) days of receipt of CSL's written request
and accompanying Products and/or accompanying materials. No approval shall be
effective unless in writing and signed by a TAb officer. If TAb has not
responded within fourteen (14) days, the material will be deemed to have been
approved.
11 10-Feb-97
<PAGE> 14
15.7 CSL agrees that it shall not adopt or use for any purpose
any variation of the Trademarks or any word, design, or mark likely to be
confused with the Trademarks. CSL further agrees not to register during the term
of the Agreement and thereafter, in any country any name, work, design, logo, or
mark resembling or confusingly similar to any of the Trademarks.
15.8 CSL agrees not to advertise, promote, sell, distribute,
or use for any purpose whatsoever any Products or Packaging and Promotional
Material which are damaged or defective, are seconds, or otherwise fail to meet
the requirements of this Agreement.
15.9 CSL acknowledges that all Trademarks and all rights and
goodwill pertaining thereto are the exclusive property of TAb. CSL further
acknowledges that TAb is the sole and exclusive owner of all present and future
right, title, and interest in and to (a) all worldwide patent rights or
applications, registrations and registration rights, copyrights, and related
rights, in or related to the Product and any present and future renewals
thereof, (b) all rights (including copyrights) in the appearance, packaging,
design, trade dress, and other identifying features of the Product and the
Packaging and Promotional Material, (c) the Trade Secrets and the Results, (d)
any adaptations, additions, derivatives, translations, and/or improvements to
any of the foregoing, and (e) all other intangible or intellectual property
rights in the Product. The Trademarks and other rights and properties described
in this Section 15.9 are referred to collectively and the "Proprietary Rights."
15.10 CSL agrees it will not challenge, oppose or cancel, or
permit any act or thing that would endanger any right of TAb in the Products or
the Proprietary Rights, nor will CSL claim any proprietary interest in the
Products or the Proprietary Rights. CSL agrees that its use of Trademarks shall
inure to the benefit of TAb, and that CSL shall not, at any time, acquire any
rights in Trademarks by virtue of any use it may make hereunder. CSL shall not
apply to register rights in the Products or the Proprietary Rights with any
governmental authority, except as may be required pursuant to Section 6.
15.11 During the term of this Agreement, each party shall give
the other notice of:
(a) any claim or allegation that the exercise of the rights
under this Agreement constitute an infringement of the rights of any third
party; and
(b) any third party's infringement or threatened infringement
of any of the Products and the Proprietary Rights as relevant for the purposes
of this Agreement of which it becomes aware.
15.12 The parties will cooperate with each other in any
actions taken against any Person infringing any Proprietary Rights. If only one
of the parties decides to commence legal proceedings, it shall be solely
responsible for legal costs, other costs, damages and expenses incurred
therewith and shall be solely entitled to any damages, profits or other
compensation recovered by such proceedings. The other party shall furnish to it
all reasonable necessary assistance in relation to the proceedings, including
where necessary agreeing to be joined as a party to the proceeding.
12 10-Feb-97
<PAGE> 15
15.13 As both a covenant by CSL and a condition of TAb's
authorization of CSL's distribution, CSL will include on all Packaging and
Promotional Material, all patent, trademark, and other notices of proprietary
rights reasonably required by TAb. CSL, at all times when it uses a Trademark,
shall conspicuously note that the Trademark is used under license from TAb, and
shall indicate TAb's ownership of the Trademark along with the registration
symbol "7" for registered trademarks and service marks (or the designation TM
where applicable as specified by TAb). CSL agrees not to alter, erase, deface or
overprint any such notice on any item provided by TAb. CSL agrees that all
Packaging and Promotional Material shall identify TAb as the Product source, and
agrees to comply with TAb's reasonable instructions in this regard.
15.14 CSL acknowledges that as of the effective date of this
Agreement, TAb has not registered the Trademarks in the Territory. When TAb
provides CSL with the detail of its trademark applications in the Territory, CSL
will acknowledge that it has not attempted to register the trademarks for which
TAb will have applied in the Territory.
16. Duration and Termination of Agreement.
16.1 This Agreement is effective on the date of this Agreement
and, unless earlier terminated in accordance with the provisions hereof, this
Agreement shall terminate five (5) years from the initial Commencement Date. On
the fifth (5th) anniversary of the date thereof, the term of this Agreement
shall be automatically continued for successive periods of two (2) additional
years unless either party provides sixty (60) days' notice prior to expiration
of a term of its intent not to renew.
16.2 Either party may terminate this Agreement by thirty (30)
days' prior written notice (a) if the Therapeutic Goods Administration of
Australia ("TGA") denies the CTX application for TAb's brown snake antivenom in
March of 1997 as a result of inadequate existing pre-clinical data, or (b) if
the TGA notifies either party in March of 1997 in writing or upon receipt by
either party of written confirmation from the TGA thereafter that a single
clinical trial for TAb's brown snake antivenom will be insufficient to achieve
marketing approval for any other antivenoms that TAb develops for sale in the
Territory. TAb may terminate this Agreement on a country-by-country and
Product-by-Product basis upon ninety (90) days prior written notice if CSL fails
to obtain marketing approval and registration for any Products in any country in
the Territory in accordance with the time and events schedule set forth in
Schedule 6.4.
16.3 Either party may terminate this Agreement by six (6)
months' prior written notice to the other party on a country-by-country and
Product-by-Product basis after the first Commencement Date for any Product in a
country in the Territory if (i) the Product is not more effective, as measured
by objective criteria, than existing antivenom products that are competitive
with the Products, and (ii) Net Sales Revenues for the preceding year fall short
of reasonable minimum commercial expectations as set forth in Schedule 9.5.
16.4 If either party breaches any of its obligations under
this Agreement, the other party may give notice of such breach in accordance
with the provisions of Section 23.2 hereof. If the breaching party does not cure
the breach to the satisfaction of the notifying party within thirty (30) days
from the date of receipt of the notice, then the notifying party may terminate
this Agreement.
16.5 Either party hereto shall have the right to terminate
this Agreement immediately and without prior notice in the event that the other
party files a petition for voluntary bankruptcy, has a petition for involuntary
bankruptcy filed against it (which petition is not withdrawn within sixty (60)
days
13 10-Feb-97
<PAGE> 16
of such filing), is adjudicated to be or becomes bankrupt, places any of its
property in liquidation for the purpose of meeting claims of its creditors, is
otherwise unable to pay its debts as such debts become due (including, but not
limited to, payments due hereunder), or ceases to function as a going concern.
16.6 The obligations of CSL under Sections 11, 15, 16, 21, and
22 hereof shall survive the expiration or termination of this Agreement. In the
event that CSL terminates this Agreement for any reason other than provided for
in Section 16.2 hereof, CSL shall not for three years within the Territory
develop, manufacture, assemble, advertise, promote, sell, or distribute any
products or goods competitive with the Product or which by reason of their
design, or packaging may be reasonably confused with the Product; provided,
however, that after the Agreement is terminated by CSL, CSL may service the
market with the equivalent CSL antivenom of equine origin if such equivalent CSL
antivenom is manufactured to CSL's, and not TAb's, specifications.
16.7 Upon termination or expiration of this Agreement for any
reason, neither party shall have any liability for actual or alleged loss of
goodwill, prospective profits or anticipated orders, or on account of any
expenditures, investments, leases, or commitments made by the other party. Each
party acknowledges and agrees that it has no expectation and has received no
assurances that its business relationship with the other party will continue
beyond the stated term of this Agreement or its earlier termination in
accordance with this Section 16, that any payment to support Clinical Trials of
the Product will be recovered or recouped, or that either party shall obtain any
anticipated amount of profit.
16.8 Upon termination or expiration of this Agreement for any
reason, CSL shall immediately return to TAb all Documentation and Confidential
Information of TAb and all copies thereof in the possession of CSL or provided
by CSL to third parties, and TAb shall immediately return to CSL all
Confidential Information of CSL in its possession or provided by TAb to third
parties.
16.9 Upon expiration or termination of this Agreement (a) CSL
may continue to sell and distribute the Products to the extent necessary to
fulfill all orders placed by End Users prior to the date of such termination,
and (b) if CSL has existing inventory of the Products in excess of orders placed
prior to the date of such termination, CSL shall have a period of six (6) months
from the date of such termination (in either case, the "Sell-Off Period") to
advertise, promote, sell and distribute such existing inventory. All terms and
conditions of this Agreement shall remain in full force and effect during any
such Sell-Off Period. Immediately upon such expiration or termination or, if
applicable, upon the expiration of the Sell-Off Period, (i) CSL shall cease (and
shall cause all Third Parties to cease) all use of the Products, the Packaging
and Promotional Material, the Trademarks, and all other Proprietary Rights,
including all advertisement, promotion, sale, and distribution of the Products,
(ii) all rights granted by TAb herein shall revert to TAb, (iii) all
registrations and approvals held in the name of CSL pursuant to Section 6.2
shall be transferred and conveyed to TAb and CSL shall execute and deliver all
documents reasonably required by TAb in this regard, (iv) CSL shall destroy all
Packaging and Promotional Material and certify the same to TAb, and (v) each
party shall prepare and deliver to the other party a final accounting. Any and
all amounts shown on such inventory statement and final accounting shall be due
and payable no later than thirty (30) days following the date of termination or
expiration, or if applicable, the expiration of the Sell-Off Period.
14 10-Feb-97
<PAGE> 17
16.10 Notwithstanding the above, should TAb terminate this
Agreement pursuant to any of Sections 16.4 or 16.5, CSL shall not be entitled to
a Sell-Off Period, the provisions of subparts (i)-(v) of Section 16.9 shall be
effective immediately, and TAb shall have the right, in its sole discretion, to
either (a) purchase all or a portion of the Products in CSL's possession at the
Purchase Price paid by CSL, which inventory shall be returned to TAb or
destroyed by CSL at TAb's direction, or (b) permit CSL to sell such Products in
CSL's possession.
17. Indemnification.
17.1 CSL shall indemnify and hold harmless TAb, its
subsidiaries, and affiliates, and their officers, directors, employees, agents,
and shareholders, notwithstanding termination of this Agreement, against any
liability, damage, loss, cost, or expense (including reasonable attorneys' fees)
relating to any third party claims arising from:
(a) default under any provision of the Agreement by CSL;
(b) any alleged negligence, gross negligence, or intentional
misconduct of CSL; or
(c) promotion, distribution, and sale of the Products by CSL;
provided that upon receipt of notice by TAb of any such claims, TAb shall
promptly notify CSL. TAb shall permit CSL to handle such claims at CSL's sole
cost, and TAb shall give CSL all reasonable assistance (except financial
assistance) in the conduct of any such claims. In no event is CSL authorized to
settle or compromise any claim, or to consent to the entry of any order or
judgment, without the prior written consent of TAb.
17.2 TAb shall indemnify and hold harmless CSL, its
subsidiaries and affiliates, and their officers, directors, employees, agents,
and shareholders, notwithstanding termination of this Agreement, against any
liability, damage, loss, cost, or expense (including reasonable attorneys' fees)
relating to any third party claims arising from:
(a) default under any provision of the Agreement by TAb; or
(b) any alleged negligence, gross negligence, or intentional
misconduct of TAb, provided that if the allegations involve any actual
or alleged defects in the Product manufactured by TAb, the alleged
defect existed when CSL took possession of the partly processed Product
and that the Product was used in accordance with the Documentation;
provided that upon receipt of notice by CSL of any such claims, CSL shall
promptly notify TAb. CSL shall permit TAb to handle such claims at TAb's sole
cost, and CSL shall give TAb all reasonable assistance (except financial
assistance) in the conduct of any such claims. In no event is TAb authorized to
settle or compromise any claim, or to consent to the entry of any order or
judgment, without the prior written consent of CSL.
18. Representations and Warranties.
15 10-Feb-97
<PAGE> 18
18.1 CSL represents and warrants that (a) it is a company duly
organized and validly existing under the laws of Australia; (b) the execution
and delivery by CSL of this Agreement, the performance by CSL of all the terms
and conditions thereof to be performed by it and the consummation of the
transactions contemplated hereby have been duly authorized by all necessary
action, and no other act or approval of any person or entity is required to
authorize such execution, delivery, and performance; (c) the Agreement
constitutes a valid and binding obligation of CSL, enforceable in accordance
with its terms; (d) this Agreement and the execution and delivery thereof by
CSL, does not, and the fulfillment and compliance with the terms and conditions
hereof and the consummation of the transactions contemplated hereby will not,
(i) conflict with any of, or require the consent of any person or entity under,
the terms, conditions, or provisions of the organizational documents of CSL,
(ii) violate any provision of, or require any consent, authorization, or
approval under, any law or administrative regulation or any judicial,
administrative, or arbitration order, award, judgment, writ, injunction, or
decree applicable to CSL, or (iii) conflict with, result in a breach of, or
constitute a default under, any material agreement or obligation to which CSL is
a party; and (e) it shall comply with all applicable manufacturing requirements
set forth herein in final finishing of any Product.
18.2 TAb represents and warrants that (a) it is a corporation
duly organized and validly existing under the laws of the State of Delaware; (b)
the execution and delivery by TAb of this Agreement, the performance by TAb of
all the terms and conditions thereof to be performed by it and the consummation
of the transactions contemplated hereby have been duly authorized by all
necessary action, and no other act or approval of any person or entity is
required to authorize such execution, delivery, and performance; (c) the
Agreement constitutes a valid and binding obligation by TAb, enforceable in
accordance with its terms; (d) this Agreement and the execution and delivery
thereof by TAb, does not, and the fulfillment and compliance with the terms and
conditions hereof and the consummation of the transactions contemplated hereby
will not (i) conflict with any of, or require the consent of any person or
entity under, the terms, conditions, or provisions of the organizational
documents of TAb, (ii) violate any provision of, or require any consent,
authorization, or approval under, any law or administrative regulation or any
judicial, administrative, or arbitration order, award, judgment, writ,
injunction, or decree applicable to TAb, or (iii) conflict with, result in a
breach of, or constitute a default under, any material agreement or obligation
to which TAb is a party; and (e) any partly processed Product supplied by TAb
under the terms of this Agreement shall comply with all applicable manufacturing
requirements set forth herein.
19. Disclaimer of Warranties; Limited Liability.
19.1 Under no circumstances shall either party be liable to
the other party on account of any claim (whether based upon principles of
contract, warranty, negligence or other tort, breach of any statutory duty,
principles of indemnity, the failure of any limited remedy to achieve its
essential purpose, or otherwise) for any special, consequential, incidental or
exemplary damages, including but not limited to lost profits, or for any damages
or sums paid by a party to third parties, even if the other party has been
advised of the possibility of such damages.
19.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, TAB
MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
16 10-Feb-97
<PAGE> 19
TAb represents and warrants that as of the date of this
Agreement, it is not aware that any Product infringes the patent rights of any
third party or that any third party proprietary rights would prevent the sale of
the Products in the Territory.
20. Failure to Trademark Product.
In the event that TAb is unable to secure, or later forfeits, Trademark
registrations within the Territory, this Agreement shall continue to full force
and effect and CSL shall make no claim whatsoever against TAb.
21. Confidentiality.
21.1 In consideration of the mutual exchange and disclosure of
Confidential Information, each party undertakes in relation to the other party's
Confidential Information:
(a) to treat the Confidential Information as strictly
confidential and not permit Confidential Information to be disclosed to third
persons;
(b) to use the Confidential Information only for the purpose
of this Agreement and not to use the Confidential Information for any commercial
purpose other than under a further agreement with the other party;
(c) not to copy or reduce to writing the Confidential
Information except as reasonably necessary for the purposes of this Agreement.
Any copies or reductions to writing so made and data storage media containing
Confidential Information shall be owned by the disclosing party;
(d) to take all reasonable steps to insure that recipients of
Confidential Information comply with the terms of this Agreement, including all
restrictions on use, disclosure, and dissemination of Confidential Information.
Such steps shall include, without limitation, measures to insure that each
recipient has read, understands, and agrees to the provisions hereof. Each party
shall notify the other immediately upon becoming aware of any breach hereof and
shall take all reasonable steps to prevent any further disclosure or
unauthorized use;
(e) only to permit Confidential Information or any part
thereof to be disclosed to those of its employees and Third Parties authorized
by the disclosing party to whom it is strictly necessary to disclose
Confidential Information for the purpose of undertaking and satisfactorily
completing its obligations under this Agreement. The receiving party is
responsible for the performance of the obligations in this Agreement on the part
of its employees; and
(f) to maintain the Confidential Information in a way which
provides adequate protection of such information from unauthorized disclosure,
copying, or use.
21.2 Upon termination or expiration of this Agreement, TAb
shall deliver to CSL (a) all Confidential Information of CSL, all copies
thereof, and all documents and storage media containing Confidential Information
of CSL, (b) the names and addresses of all recipients of Confidential
Information of CSL, and (c) a written certification that TAb has complied with
its obligations under this Section 21.2.
21.3 Upon termination or expiration of this Agreement, CSL
shall deliver to TAb (a) all Confidential Information of TAb, all copies
thereof, and all documents and storage media containing
17 10-Feb-97
<PAGE> 20
Confidential Information of TAb, (b) the names and addresses of all recipients
of Confidential Information of TAb, and (c) a written certification that CSL has
complied with its obligations under this Section 21.3.
21.4 Each recipient of Confidential Information shall keep
confidential and not use, except as provided herein, all Confidential
Information.
22. Enforcement.
Each party acknowledges that in the event of breach of its covenants
under this Agreement, actual damages will be impossible to calculate, the other
party's remedies at law will be inadequate, and the other party will suffer
irreparable harm. Therefore, each party agrees that any of the covenants
contained in this Agreement may be specifically enforced through injunctive
relief, but such right to injunctive relief shall not preclude the other party
from other remedies which may be available to it.
23. General.
23.1 No waiver or modification of the Agreement shall be
effective unless in writing and signed by the party against whom such waiver or
modification is asserted. Waiver by either party in any instance of any breach
of any term or condition of this Agreement shall not be construed as a waiver of
any subsequent breach of the same or of any other term or condition hereof. None
of the terms or conditions of this Agreement shall be deemed to have been waived
by course of dealing or trade usage.
23.2 All notices and demands hereunder shall be in writing and
shall be served by personal delivery, by registered mail, by recognized
international courier, or by facsimile transmission at the address of the
receiving party set forth below (or at such different address as may be
designated by such party by written notice to the other party).
<TABLE>
<S> <C>
TAb: CSL:
Therapeutic Antibodies Inc. CSL Limited
1207 17th Ave. South, St. 103 45 Poplar Road
Nashville, Tennessee 37212 USA Parkville, Victoria 3052 Australia
Attention: President Attention: Company Secretary
Fax: 1-615-320-1212 Fax: + 61 3 9389 1434
</TABLE>
All notices or demands shall be deemed received on the earlier of actual receipt
or seven (7) days after posting if sent by mail, three days after delivery to
international courier, or upon receipt of fax-back confirmation if sent by
facsimile.
23.3 In the event any litigation is brought by either party in
connection with this Agreement, the prevailing party in such litigation shall be
entitled to recover from the other party all the costs, attorneys' fees and
other expenses incurred by such prevailing party in the litigation.
18 10-Feb-97
<PAGE> 21
23.4 This Agreement shall be governed by and construed in
accordance with the laws of the State of Tennessee, United States of America.
The parties agree that any claim asserted in any legal proceeding by one party
against the other shall be commenced and maintained in any state or federal
court in Nashville, Tennessee. Both parties hereby consent to the jurisdiction
of such courts over each of them personally in connection with such litigation,
and waive any objection to venue in such courts and any claim that such forum is
an inconvenient forum.
23.5 In the event that any provision of this Agreement shall
be held by a court or other tribunal of competent jurisdiction to be
unenforceable, such provision will be enforced to the maximum extent permissible
and the remaining portions of this Agreement shall remain in full force and
effect.
23.6 Neither party shall be responsible for any failure to
perform due to unforeseen circumstances or to cause beyond such party's control,
including but not limited to acts of God, war, riot, embargoes, acts of civil or
military authorities, fire, floods, accidents, strikes, or shortages of
transportation facilities, fuel, energy, labor or materials.
23.7 This Agreement constitutes the entire agreement between
the parties pertaining to the subject matter hereof, and supersedes in their
entirety the Heads of Agreement dated March 25, 1996, between the parties and
any and all written or oral agreements previously existing between the parties
with respect to such subject matter. The terms of this Agreement may be modified
only by a writing which is signed by both parties.
23.8 The terms of this Agreement are intended solely for the
benefit of the parties hereto. They are not intended to confer upon any Person
the status of a third party beneficiary. Except as otherwise provided for by
this Agreement, the terms hereto shall inure to the benefit of, and be binding
upon, the respective successors and assigns of the parties hereto.
23.9 This Agreement may be assigned by TAb with CSL's prior
written consent and the performance of its duties delegated. This Agreement may
be assigned by CSL with TAb's prior written consent, and the performance of its
duties delegated.
23.10 The parties expressly acknowledge and agree that CSL
shall act only as an independent contractor of TAb and that this Agreement shall
not be deemed to create an agency, partnership, employment, or joint venture
relationship between TAb and CSL. Nothing in this Agreement shall be construed
as a grant of authority to CSL to accept any order, waive any right, incur any
obligation or liability, enter into any agreement, grant any release or
otherwise purport to act in the name of TAb. Except as expressly set forth
herein, the parties agree that TAb shall neither exercise control over CSL's
method of operations nor provide assistance to CSL. The operations, policies and
procedures of CSL, including those related to CSL's performance of this
Agreement, are subject to the sole management and control of CSL.
23.11 Nothing in this Agreement shall be construed as a grant
of authority to TAb to accept any order, waive any right, incur any obligation
or liability, enter into any agreement, grant any release or otherwise purport
to act in the name of CSL. The operations, policies and procedures of TAb,
including those related to TAb's performance of this Agreement, are subject to
the sole management and control of TAb. The operations, policies, and procedures
of CSL, including those related to CSL's performance of this Agreement, are
subject to the sole management and control of CSL.
19 10-Feb-97
<PAGE> 22
23.12 This Agreement may be executed in one or more
counterparts, each of which shall constitute an original.
23.13 Nothing contained herein shall be construed as
conferring by implication, estoppel, or otherwise any license or right under any
patent, whether or not the exercise of any right herein granted necessarily
employs an invention or any existing or later issued patent.
20 10-Feb-97
<PAGE> 23
IN WITNESS WHEREOF, each of the parties has caused this Agreement to be
executed in duplicate originals by its duly authorized representative on the
date first set forth above.
SIGNED for and on behalf of )
CSL Limited )
by its duly authorised )
representatives ) --------------------------------
) S.R. McLiesh
) General Manager, Pharmaceuticals
)
)
)
)
) --------------------------------
) Peter Tuohy
) Company Secretary
Therapeutic Antibodies Inc
By:
-----------------------------
Name:
---------------------------
Title:
--------------------------
21 10-Feb-97
<PAGE> 24
SCHEDULE 1.1
PRODUCTS
Brown Snake Antivenom
10-Feb-97
<PAGE> 25
SCHEDULE 1.2
TERRITORY
Australia
Papua New Guinea
10-Feb-97
<PAGE> 26
SCHEDULE 3.3
GOOD CLINICAL PRACTICES
(1) All individuals who conduct clinical trials (i.e.,
Investigators) must be qualified in accordance with applicable
laws or regulations.
(2) All patients at the clinical trials must sign a written
informed consent approved by the applicable Institutional
Review Board (IRB) or equivalent prior to enrolling in the
clinical trials.
(3) A duly constituted IRB must review and approve the protocol,
protocol amendments, informed consent, and advertisements for
patients.
(4) Case report forms (CRFs) and other written material shall be
distributed to the various sites of the clinical trials, and
detailed logs shall be maintained for these distributions.
(5) Independent monitors shall be selected to review performance
of clinical trials if such monitors are required. CSL shall be
responsible for the selection of such independent monitors to
audit various clinical sites after consultation with TAb if
applicable laws and regulations contain such a requirement.
10-Feb-97
<PAGE> 27
SCHEDULE 3.6
GMP AGREEMENT
[Schedule not completed at date of filing]
10-Feb-97
<PAGE> 28
SCHEDULE 6.4
TIME AND EVENTS SCHEDULE
[Schedule not completed at date of filing]
10-Feb-97
<PAGE> 29
SCHEDULE 7.2
MANUFACTURING ISSUES
[Schedule not completed at date of filing]
10-Feb-97
<PAGE> 30
SCHEDULE 9.5
MINIMUMS
(1) The minimum acceptable Net Sales Revenue shall be ___________
percent (______%) of the combined Annual Forecasts.
(2) Reasonable minimum commercial expectations for Net Sales
Revenue are $________ per year.
[Schedule not completed at date of filing]
10-Feb-97
<PAGE> 31
SCHEDULE 9.12
FINANCIAL ASSISTANCE
The level of CSL's financial assistance to TAb for establishing flocks for
commercial purposes in order to build sufficient inventories of the Products
shall be _____% of the costs incurred by TAb not to exceed A$_________.
[Schedule not completed at date of filing]
10-Feb-97
<PAGE> 32
SCHEDULE 10.2
PURCHASE PRICE
[Schedule not completed at date of filing]
10-Feb-97
<PAGE> 1
EXHIBIT 11.1
THERAPEUTIC ANTIBODIES INC.
STATEMENT RE: COMPUTATION OF PER SHARE EARNINGS
<TABLE>
<CAPTION>
FOR THE CUMULATIVE
DEVELOPMENT STAGE
FOR THE THREE MONTHS ENDED FROM AUGUST 10, 1984
MARCH 31, (INCEPTION)THROUGH
1997 1996 MARCH 31, 1997
------------ ------------ ------------------
<S> <C> <C> <C>
ACTUAL
Weighted average shares outstanding 22,363,692 16,849,345 9,160,503
============ ============ ============
Net loss $ (4,307,839) $ (3,726,514) $(46,872,504)
============ ============ ============
Net loss per share $ (0.19) $ (0.22) $ (5.12)
============ ============ ============
PRIMARY
Weighted average shares outstanding 22,363,692 16,849,345 9,160,503
Dilutive effect of stock options and warrants 1,331,627 1,974,990 1,331,627
------------ ------------ ------------
23,695,319 18,824,334 10,492,130
============ ============ ============
Net loss $ (4,307,839) $ (3,726,514) $(46,872,504)
============ ============ ============
Net loss per share $ (0.18) $ (0.20) $ (4.47)
============ ============ ============
FULLY DILUTED
Weighted average shares outstanding 22,363,692 16,849,345 9,160,503
Dilutive effect of stock options and warrants 1,378,173 1,974,990 1,378,173
------------ ------------ ------------
23,741,865 18,824,334 10,538,675
============ ============ ============
Net loss $ (4,307,839) $ (3,726,514) $(46,872,504)
============ ============ ============
Net loss per share $ (0.18) $ (0.20) $ (4.45)
============ ============ ============
</TABLE>
The dilutive effect of stock options and warrants is determined under the
treasury stock method utilizing fair values per share of $6.02 and $6.21 for
primary and fully diluted earnings per share in the three months ended March 31,
1997 and $5.50 for both primary and fully diluted earnings per share in the
three months ended March 31, 1996.
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> MAR-31-1997
<CASH> 12,306,601
<SECURITIES> 5,398,705
<RECEIVABLES> 58,102
<ALLOWANCES> 0
<INVENTORY> 448,488
<CURRENT-ASSETS> 19,177,112
<PP&E> 15,908,707
<DEPRECIATION> 3,826,157
<TOTAL-ASSETS> 32,040,687
<CURRENT-LIABILITIES> 2,386,019
<BONDS> 8,358,480
0
0
<COMMON> 22,374
<OTHER-SE> 20,521,101
<TOTAL-LIABILITY-AND-EQUITY> 32,040,687
<SALES> 87,415
<TOTAL-REVENUES> 458,941
<CGS> 52,659
<TOTAL-COSTS> 140,313
<OTHER-EXPENSES> 4,626,467
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 282,367
<INCOME-PRETAX> 0
<INCOME-TAX> 0
<INCOME-CONTINUING> 4,307,839
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 4,307,839
<EPS-PRIMARY> .18
<EPS-DILUTED> .18
</TABLE>
