<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 June 30, 1998, 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
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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 August 11, 1998, 23,366,658 shares of the registrant's
Common Stock were outstanding.
<PAGE> 2
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
<TABLE>
<CAPTION>
Page
----
<S> <C>
Condensed Consolidated Balance Sheets -- June 30, 1998
and December 31, 1997 ....................................... 3
Condensed Consolidated Statements of Operations -- Six
Months Ended June 30, 1998 and 1997 ......................... 4
Condensed Consolidated Statements of Operations -- Three
Months Ended June 30, 1998 and 1997 ......................... 4
Consolidated Statements of Cash Flows -- Six
Months Ended June 30, 1998 and 1997 ......................... 5
Notes to Condensed Consolidated Financial Statements .......... 6
</TABLE>
2
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THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
<TABLE>
<CAPTION>
June 30, 1998 December 31, 1997
------------- -----------------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 2,268,914 $ 4,915,077
Restricted cash 1,000,000 --
Short-term investments -- 1,997,240
Trade receivables 141,980 594,267
Value added tax receivable 123,769 179,629
Inventories 160,497 489,138
Other current assets 216,779 409,929
------------ ------------
Total current assets 3,911,939 8,585,280
Property and equipment, net 11,287,699 11,456,690
Patent and trademark costs, net 620,224 598,924
Other assets, net 126,013 159,171
------------ ------------
Total assets $ 15,945,875 $ 20,800,065
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 1,216,693 $ 1,457,121
Accrued interest 206,502 146,326
Current portion of notes payable 5,299,410 2,545,701
------------ ------------
Total current liabilities 6,722,605 4,149,148
Notes payable, net of current portion 5,625,043 6,059,072
Deferred revenue 364,496 559,467
Other liabilities 276,839 274,033
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Total liabilities 12,988,983 11,041,720
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Stockholders' equity:
Preferred stock - par value $.01 per share; 1,000,000 shares authorized;
issued and outstanding, none -- --
Common stock - par value $.001 per share; 39,000,000 shares authorized,
23,366,658 issued and outstanding June 30, 1998; 30,000,000 shares authorized, -- --
23,252,825 issued and outstanding December 31, 1997 23,366 23,253
Additional paid-in capital 69,325,631 68,927,203
Deficit accumulated during the development stage (1984-1998) (66,647,248) (59,412,383)
Cumulative translation adjustment 255,143 220,272
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Total stockholders' equity 2,956,892 9,758,345
------------ ------------
Total liabilities and stockholders' equity $ 15,945,875 $ 20,800,065
============ ============
</TABLE>
The accompanying notes are an integral part of the condensed consolidated
financial statements.
3
<PAGE> 4
THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
For the Cumulative
For the Six Months Ended For the Three Months Ended Development Stage
June 30 June 30 from August 10, 1984
----------------------------- --------------------------- (inception) Through
1998 1997 1998 1997 June 30, 1998
---- ---- ---- ---- -------------
<S> <C> <C> <C> <C> <C>
Revenues:
Sales and contract revenue $ 489,768 $ 219,195 $ 400,077 $ 131,780 $ 3,280,885
Licensing revenue 1,543,925 62,305 1,400,000 -- 2,900,380
Interest income 144,295 488,230 57,446 204,372 2,066,981
Grant income 20,623 20,432 10,336 10,226 753,142
Foreign currency gains 24,115 -- -- 28,297 1,810,099
Value-added tax and insurance recoveries -- -- -- -- 577,170
Other 31,758 32,636 23,544 17,479 252,572
----------- ----------- ----------- ----------- ------------
2,254,484 822,798 1,891,403 392,154 11,641,229
----------- ----------- ----------- ----------- ------------
Expenses:
Cost of sales and contract revenue 384,032 73,453 365,028 20,793 929,189
Research and development 5,551,426 5,474,934 2,985,756 2,884,248 47,593,883
General and administrative 2,022,880 1,630,240 1,041,751 988,568 14,966,047
Marketing and distribution 259,236 246,935 123,300 159,281 2,235,789
Depreciation and amortization 801,651 771,414 427,683 403,662 6,313,321
Interest 470,124 535,359 257,240 252,992 4,200,707
Foreign currency losses -- 715,691 22,361 -- 913,119
Debt conversion expense -- -- -- -- 801,597
Other -- 10,496 -- 10,496 334,825
----------- ----------- ----------- ----------- ------------
9,489,349 9,458,522 5,223,119 4,720,040 78,288,477
----------- ----------- ----------- ----------- ------------
Net loss $(7,234,865) $(8,635,724) $(3,331,716) $(4,327,886) $(66,647,248)
=========== =========== =========== =========== ============
Basic and diluted net loss per share $ (0.31) $ (0.38) $ (0.14) $ (0.19) $ (6.40)
=========== =========== =========== =========== ============
Weighted average shares used in
computing basic and diluted net loss
per share 23,257,950 22,569,850 23,263,075 22,776,008 10,416,239
=========== ============ =========== ============ ============
</TABLE>
The accompanying notes are an integral part of the condensed consolidated
financial statements.
4
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THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
For the Cumulative
For the Six Months Ended Development Stage
June 30, From August 10, 1984
----------------------------- (Inception) Through
1998 1997 June 30, 1998
---- ---- ------------
<S> <C> <C> <C>
Cash flow from operating activities:
Net loss $(7,234,865) $ (8,635,724) $(66,647,248)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 801,651 771,414 6,313,321
Disposal of property and equipment -- -- 927,238
Foreign currency (gain) loss (24,115) 715,691 (896,980)
Warrant expense 48,820 -- 242,814
Stock-based compensation expense 54,372 5,001 604,771
Debt conversion expense -- -- 801,597
Changes in:
Trade receivable 483,712 2,737 (25,520)
Inventories 328,640 (85,663) (46,324)
Other current assets 194,587 (102,348) (213,520)
Accounts payable and accrued expenses (208,910) 22,883 1,344,472
Accrued interest 65,620 105,405 841,845
Deferred revenue (197,711) (47,179) 31,896
Other -- -- (43,489)
----------- ------------ ------------
Net cash used in operating activities (5,688,199) (7,247,783) (56,765,127)
----------- ------------ ------------
Cash flows from investing activities:
(Increase) in restricted cash (1,000,000) -- (1,000,000)
Purchase of property and equipment (555,382) (544,758) (14,443,705)
Patent and trademark costs (41,700) (107,802) (702,697)
Purchase of short-term investments -- (8,155,045) (13,933,294)
Maturity of short-term investments 2,094,508 1,000,000 13,933,293
Other -- -- 69,750
----------- ------------ ------------
Net cash provided by (used in) investing activities 497,425 (7,807,605) (16,076,653)
----------- ------------ ------------
Cash flows from financing activities:
Proceeds from notes payable 3,331,412 42,200 19,140,417
Payments on notes payable (590,331) (556,461) (6,767,801)
Proceeds from line of credit -- 8,143 3,371,278
Payments on line of credit (43,836) (100,296) (3,371,278)
Proceeds from convertible debt, net -- -- 9,655,000
Payments on convertible debt -- -- (4,320,325)
Proceeds from issuance of stock, net 51,250 1,145,373 57,062,830
Proceeds from issuance of warrants -- -- 65,000
Other (1,937) -- (149,535)
----------- ------------ ------------
Net cash provided by financing activities 2,746,558 538,959 74,685,585
----------- ------------ ------------
Effect of exchange rate changes on cash and cash equivalents (201,948) (288,015) 425,109
----------- ------------ ------------
Net (decrease) increase in cash and cash equivalents (2,646,164) (14,804,444) 2,268,914
Cash and cash equivalents, beginning of period 4,915,077 20,502,536 --
----------- ------------ ------------
Cash and cash equivalents, end of period $ 2,268,914 $ 5,698,092 $ 2,268,914
=========== ============ ============
</TABLE>
The accompanying notes are an integral part of the condensed consolidated
financial statements
5
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THERAPEUTIC ANTIBODIES INC. AND SUBSIDIARIES
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
JUNE 30, 1998
NOTE 1 - BASIS OF PRESENTATION
The accompanying interim condensed consolidated 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 interim consolidated financial statements should be read in
conjunction with the audited December 31, 1997 consolidated financial statements
of Therapeutic Antibodies Inc. ("TAb" or the "Company"). The December 31, 1997
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, 1998.
Since its inception, the Company has been in the development stage, 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 licensing
agreements with corporate partners, contract agreements, 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, process development,
preclinical and clinical testing, regulatory affairs, initial manufacturing
activities and administration. Management anticipates that additional financing
will be necessary to fund the Company's operations until product sales are of
sufficient volume to generate positive cash flows from operations. The Company
is currently pursuing such financing which includes a private placement of debt
and an equity offering. There can be no assurances that the Company will be
successful in obtaining financing on terms acceptable to it.
NOTE 2 - RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
During June 1997, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 131 "Disclosures about Segments of an
Enterprise and Related Information" ("SFAS No. 131"). The Company will adopt
SFAS No. 131 in 1998 as required. Because this standard requires only disclosure
of certain additional information, the effect of adoption will not have a
significant impact on the Company's financial position and results of
operations.
During 1998, Statement of Position No. 98-1 "Accounting for the Costs of
Computer Software Developed or Obtained for Internal Use" ("SOP No. 98-1") and
Statement of Position No. 98-5 "Reporting on the Costs of Start-Up Activities"
("SOP No. 98-5") were issued. The Company will adopt SOP No. 98-1 and SOP No.
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98-5 in 1999 as required. However, the effect of the adoption will not have a
significant impact on the Company's financial position and results of
operations.
NOTE 3 - COMPREHENSIVE INCOME
Effective January 1, 1998, the Company adopted Statement of Financial Accounting
Standards No. 130, "Reporting Comprehensive Income" ("SFAS No. 130") which
requires that all items that are required to be recognized under accounting
standards as components of comprehensive income be reported in the financial
statements. Adoption of SFAS No. 130 did not impact the Company's consolidated
financial position, results of operations or cash flows. The reconciliation of
net loss to comprehensive net loss is as follows:
<TABLE>
<CAPTION>
Six months ended June 30, Three months ended June 30,
------------------------- ---------------------------
1998 1997 1998 1997
---- ---- ---- ----
(unaudited) (unaudited) (unaudited) (unaudited)
<S> <C> <C> <C> <C>
Net loss ($7,234,865) ($8,635,724) ($3,331,715) ($4,327,886)
Other comprehensive income (loss):
Change in equity due to foreign currency
translation adjustments (34,872) 274,307 49,777 (112,158)
----------- ----------- ----------- -----------
Total comprehensive loss ($7,269,737) ($8,361,417) ($3,281,938) ($4,440,044)
=========== =========== =========== ===========
</TABLE>
NOTE 4 - BASIC AND DILUTED EARNINGS PER COMMON SHARE
The basic and diluted earnings per common share calculation was based on
Statement of Financial Accounting Standards No. 128, "Earnings per Share" ("SFAS
No. 128"), which the Company adopted during the fourth quarter of 1997.
Application of SFAS No. 128 to previous periods did not change the previously
disclosed per share amounts.
The calculations are based upon the weighted average number of shares of common
stock outstanding during each period as disclosed in the condensed consolidated
statements of operation. Common equivalent shares from stock options, warrants
and other dilutive securities are excluded from the computations as their effect
is antidilutive.
NOTE 5 - FINANCING ACTIVITIES
At June 30, 1998, the Company had raised $3,150,000 in a private placement of
the Company's 15% Subordinated Promissory Notes (the "15% Notes"). The notes
mature in the fourth quarter of 1998 and interest is payable quarterly. Warrants
to purchase 315,000 shares of the Company's common stock were issued in
connection with the 15% Notes. As of August 11, 1998, total principal raised and
warrants issued were $3,525,000 and 352,500 shares, respectively. A portion of
the proceeds of the Company's proposed financing will be used to repay the 15%
Notes at or before maturity.
In April 1998, the Company received a loan of $162,000 from the Department of
Primary Industries and Resources of the South Australian Government. The loan is
for the construction of transportable buildings at the Company's Australian
location. The interest rate is currently 6.5% annually and is variable at the
discretion of the Minister for Primary Industries. Principal and interest
payments are due semi-annually beginning October 1998 through April 2008.
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In June 1998, the Company received the final installment of a loan from the
Department of Industry and Trade ("DIT") of the South Australian Government. In
April, 1996, the DIT agreed to loan the Company up to $62,000 based upon the
number of local citizens employed by the Company through April 1998. The Company
borrowed a total of $50,000 at June 30, 1998. The loan is provided interest free
and is due in full on April 29, 2006.
8
<PAGE> 9
REPORT OF INDEPENDENT ACCOUNTANTS
TO THE BOARD OF DIRECTORS
THERAPEUTIC ANTIBODIES INC.
We have reviewed the condensed consolidated balance sheet of Therapeutic
Antibodies Inc. and Subsidiaries at June 30, 1998 and the related condensed
consolidated statements of operations and condensed consolidated statements of
cash flows for the three-month and six-month periods ended June 30, 1998 and
June 30, 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, 1997 and the related
consolidated statements of operations, stockholders' equity and cash flows for
the year then ended (not presented herein); and in our report dated March 5,
1998, 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, 1997, is fairly stated,
in all material respects, in relation to the consolidated balance sheet from
which it has been derived.
/s/ PricewaterhouseCoopers LLP
PRICEWATERHOUSECOOPERS LLP
Louisville, Kentucky
August 10, 1998
9
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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 Therapeutic Antibodies Inc. (the "Company") should be
read in conjunction with the condensed consolidated financial statements and
notes thereto. Statements made in this Quarterly Report on Form 10-Q which are
not historical fact are forward-looking statements. In addition, the Company,
through its senior management, from time to time makes forward-looking public
statements concerning its expected future operations and performance and other
developments. Such forward-looking statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995 and
are necessarily estimates reflecting the Company's best judgment based on
current information and involve a number of 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 in 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, the Company's
ability to appropriately address the Year 2000 computer system issue, 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
Since its inception, the Company has been in the development stage,
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
licensing agreements with corporate partners, contract agreements, 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, process
development, preclinical and clinical testing, regulatory affairs, initial
manufacturing activities and administration. Additional financing will be
necessary to fund the Company's operations until product sales are of sufficient
volume to generate positive cash flows from operations. The Company is currently
pursuing a financing plan, the first phase of which includes a private placement
of debt securities. There can be no assurances that the Company will be
successful in obtaining financing on terms acceptable to it.
The Company conducts its operations from its headquarters in the United
States and through subsidiaries located in the United Kingdom, Australia and New
Zealand.
RESULTS OF OPERATIONS
Three Months Ended June 30, 1998 Compared to Three Months Ended June 30, 1997
The Company's total revenues for the second quarter of 1998 increased
by 382% to $1,891,000 from $392,000 for the same period in 1997 due primarily to
increases in licensing revenue and in sales and contract revenue. As described
under "Liquidity and Capital Resources", licensing revenue of $1,400,000 was
recorded for the quarter ended June 30, 1998 due to milestone payments of
$900,000 and $500,000 received under agreements with G. D. Searle & Co. and
Altana, Inc., respectively. The Company received no milestone payments during
the quarter ended June 30, 1997. Sales and contract revenue increased 203%
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during the three months ended June 30, 1998 to $400,000 from $132,000 during the
same period in 1997 due to sales of the Company's African antivenom, EchiTAb(TM)
and to higher sales of the Company's European antivenom, ViperaTAb(R). Interest
income during the second quarter of 1998 was $57,000, a decrease of 72% from
$204,000 in the second quarter of 1997 reflecting lower cash resources in 1998.
The Company recorded a foreign currency transaction gain of $28,000 during the
second quarter of 1997 as a result of the U.S. dollar's improvement against the
British pound and the Australian dollar. Foreign currency losses of $22,000 were
recorded during the same period of 1998.
Total expenses for the quarter ended June 30, 1998 increased by 11% to
$5,223,000 from $4,720,000 for the same period in 1997 due primarily to the cost
of sales related to the African antivenom, EchiTAb(TM). Research and development
expenses during the same periods increased slightly by 4% to $2,986,000 from
$2,884,000 due to efforts to contain costs at 1997 levels.
General and administrative expenses for the quarter ended June 30, 1998
increased by 5% to $1,042,000 from $989,000 for the quarter ended June 30, 1997.
This increase relates primarily to the establishment of a new information
systems department in early 1998 and associated staffing costs, and to the
hiring of a new Chief Executive Officer in February 1998.
Marketing and distribution expenses decreased for the three months
ended June 30, 1998 by 23% to $123,000 from $159,000 for the three months ended
June 30, 1997, reflecting the Company's efforts to reduce expenses.
Depreciation and amortization expense for the quarter ended June 30,
1998 remained relatively stable, increasing by 6% to $428,000 from $404,000 for
the quarter ended June 30, 1997.
The Company's net loss for the quarter ended June 30, 1998, was
$3,332,000 compared to a net loss of $4,328,000 for the quarter ended June 30,
1997.
Six Months Ended June 30, 1998 Compared to Six Months Ended June 30, 1997
The Company's revenues for the first six months of 1998 increased by
174% to $2,254,000 from $823,000 for the same period of 1997. The increase in
revenues in the first six months of 1998 is attributable to increases in
licensing fees and product sales. These increases were partially offset by a
decrease in interest income to $144,000 in the first six months of 1998 from
$488,000 in the first six months of 1997. The Company received milestone
payments totalling $1,000,000 in the first six months of 1998 from G. D. Searle
& Co. for the signing of a research collaboration agreement. The Company also
received a milestone payment of $500,000 in May 1998 for the submission of its
Product License Application and Establishment Licensing Application for the
Company's North American snake antivenom, CroTAb(R), to the United States Food
and Drug Administration. Sales and contract revenue increased 124% to $490,000
for the six months ended June 30, 1998 from $219,000 for the six months ended
June 30, 1997. This increase resulted from higher sales of EchiTAb(TM) and
ViperaTAb(R).
Total expenses for the six months ended June 30, 1998 remained
relatively unchanged compared to the same period in 1997. Research and
development expenses during the same periods increased by only 1.4% to
$5,551,000 from $5,475,000 as a result of management's efforts to streamline and
sharpen the focus of the Company's research and development efforts. Research
and development costs are related to manufacturing the Company's products for
clinical trials, conducting clinical trials and ensuring that the necessary
quality control and assurance procedures are in place, as well as costs
associated with regulatory compliance.
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General and administrative expenses for the first half of 1998
increased by 24% to $2,023,000 from $1,630,000 for the first half of 1997. This
increase relates to one-time staffing costs incurred in early 1998 and the
development of a new information systems department in 1998.
Marketing and distribution expenses increased slightly by 5% to
$259,000 in the first half of 1998 from $247,000 in the first half of 1997 due
to costs incurred for market research and increased distribution charges related
to product sales.
Interest expense in the six months ending June 30, 1998, decreased by
12% to $470,000 from $535,000 in the first six months of 1997 due to continued
repayment of debt obligations. Interest expense is expected to increase over the
remainder of 1998 as a result of the Company's sale of additional debt
securities commencing in June 1998.
In the six months ended June 30, 1998, the Company recorded foreign
currency gains of $24,000. In the six months ended June 30, 1997, the Company
recorded foreign currency losses of $716,000. These gains and losses were the
result of changes in the UK and Australian exchange rates from December 31, 1997
to June 30, 1998 on the Company's holdings of cash in British pounds sterling
and Australian dollars.
The Company's net loss for the six months ended June 30, 1998 decreased
16% from $7.2 million compared to a net loss of $8.6 million for the six months
ended June 30, 1997.
LIQUIDITY AND CAPITAL RESOURCES
Since its inception, the Company 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, for product research and development activities, for
clinical testing and to meet the Company's overall increased working capital
requirements. Although revenue from initial product sales has increased,
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. Funds for the Company's operating and capital
requirements historically have been provided by the sale of equity and debt and
from collaboration agreements and other financing arrangements. With the arrival
of a new Chief Executive Officer in early 1998, management began to implement
measures to conserve cash resources while at the same time sustaining the
progress of clinical trials for products with the greatest likelihood of
near-term commercial success. Additional financing will be necessary for the
Company to fund operations for at least the next 18 months. Management is
currently preparing for an additional financing which is expected to be
completed in 1998. As of August 11, 1998, the Company had received $3,525,000 in
interim financing as discussed below. There can be no assurances that the
Company will be successful in obtaining additional financing on terms acceptable
to it.
At June 30, 1998, the Company had cash and cash equivalents totaling
$3,269,000, of which approximately $15,000 was denominated in British pounds and
$4,000 in Australian dollars. The Company's net cash used in operating
activities during the six months ended June 30, 1998, totaled $5,688,000, a
decrease of 22% from the six months ended June 30, 1997. Capital expenditures
increased 2% to $555,000 in the first six months of 1998 from $545,000 in the
first six months of 1997. The Company anticipates that total capital
expenditures for 1998 will be approximately $2,300,000. During the second half
of 1998, the Company intends to add additional capacity to its production
facilities in Wales and continue expanding the Australian facility with the
necessary laboratory equipment in anticipation of increased
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commercial production. The Company believes capital expenditures for the
remainder of 1998 and for 1999 will be funded from proceeds of the additional
financing discussed above.
According to the Company's agreement with Altana, Inc., the Company may
receive additional payments upon the achievement of certain milestones expected
in 1998. During the second quarter of 1998 the Company received a milestone
payment of $500,000 upon the United States Food and Drug Administration's
("FDA") acceptance of the submission of the Company's Product License
Application and Establishment License Application for the Company's North
American antivenom, CroTAb(R). The Company is entitled to receive additional
payments under the agreement based on achievement of certain milestones relating
to CroTAb(R) and the Company's DigiTAb(R) and TriTAb(R) products, culminating
with FDA approvals of the product lines. In addition, the Company will receive
bonus payments tied to the first three years of each product's sales.
In May of 1998, the Company entered into an agreement with G. D. Searle
& Co. ("Searle") for the identification, development and commercialization of a
new antibody based drug specified by Searle. Searle forecasts it will pay the
Company up to $8,000,000 under the agreement for research and development and
product supplies based on achieving certain milestones. The Company received a
milestone payment of $1,000,000 upon execution of the agreement in May 1998.
At June 30, 1998, the Company had raised $3,150,000 in a private
placement of the Company's 15% Subordinated Promissory Notes (the "15% Notes").
The 15% Notes mature in the fourth quarter of 1998 and interest is payable
quarterly. Warrants to purchase 25,000 shares of the Company's common stock were
issued to each purchaser of $250,000 principal amount of 15% Notes. Total
principal raised and warrants issued in the offering as of August 11, 1998, were
$3,525,000 and 352,500 shares, respectively. A portion of the proceeds of the
Company's proposed financing will be used to repay the 15% Notes at or before
maturity.
In April 1998, the Company received a loan of $162,000 from the
Department of Primary Industries and Resources of the South Australian
Government. The loan is for the construction of transportable buildings at the
Company's Australian location. The interest rate is currently 6.5% annually and
is variable at the discretion of the Minister for Primary Industries. Principal
on the loan is payable in 20 equal semi-annual installments, together with
interest accrued thereon, beginning October 1998 through April 2008.
In June 1998, the Company received the final installment of a loan from
the Department of Industry and Trade ("DIT") of the South Australian Government.
In April, 1996, the DIT agreed to loan the Company up to $62,000 based upon the
number of local citizens employed by the Company through April 1998. Borrowing
on the loan totalled $50,000 at June 30, 1998. The loan is provided interest-
free and is due in full on April 29, 2006.
The Company has completed a preliminary evaluation of its computerized
systems for its laboratory, business and manufacturing processes. An inventory
of equipment has been developed, identifying all components and processes that
have a date element issue. The Company has performed a preliminary risk
assessment of all inventoried equipment. Dependent on an item's risk assessment,
the Company will seek Year 2000 assurances from the relevant suppliers by
letters, questionnaire or full supplier audit, as appropriate. The Company
believes that the Year 2000 issue will not impose significant operational
problems and that the compliance costs will not be material. The Year 2000
Compliance Project is scheduled to be completed June 1999.
13
<PAGE> 14
RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
During June 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 131 "Disclosures about Segments
of an Enterprise and Related Information" ("SFAS No. 131"). The Company will
adopt SFAS No. 131 in 1998 as required. Because this standard requires only
disclosure of certain additional information, the effect of adoption will not
have a significant impact on the Company's financial position.
During 1998, Statement of Position No. 98-1 "Accounting for the Costs
of Computer Software Developed or Obtained for Internal Use" ("SOP No. 98-1")
and Statement of Position No. 98-5 "Reporting on the Costs of Start-Up
Activities" ("SOP No. 98-5") were issued. The Company will adopt SOP No. 98-1
and SOP No. 98-5 in 1999 as required. However, the effect of the adoption will
not have a significant impact on the Company's financial position.
OTHER FINANCIAL INFORMATION
PricewaterhouseCoopers, LLP, the Company's independent 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, PricewaterhouseCoopers, LLP
did not express an opinion on the aforementioned data.
14
<PAGE> 15
PART II
OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Annual Meeting of Shareholders of the Company was held on April
27, 1998. At the meeting, shareholders were asked to vote upon the election of
the Company's directors and an amendment to the Company's Amended and Restated
Certificate of Incorporation. Proxies for the meeting were solicited pursuant to
Regulation 14 under the Securities and Exchange Act of 1934, as amended. There
was no solicitation in opposition to management's recommendations as stated in
the proxy statement. All nominees to the board of directors were elected and
each OTHER matter to come before the meeting was approved in accordance with
management's recommendations.
The following persons were elected to serve as directors of the
Company until the next annual meeting of shareholders or until their respective
successors are elected and qualified. The vote was as follows:
<TABLE>
<CAPTION>
VOTES CAST VOTES CAST BROKER NON-VOTES/
NAME IN FAVOR AGAINST ABSTENTIONS
- ---- -------- ------- -----------
<S> <C> <C> <C>
Martin S. Brown 14,468,711 1,250 8,782,864
Andrew J. Heath, M.D. 14,463,711 6,250 8,782,864
Harry G. Browne, M.D. 14,410,211 59,750 8,782,864
A. J. Kazimi 14,339,376 130,585 8,782,864
John Landon, M.D. 14,447,045 22,916 8,782,864
Timothy Chard, M.D. 14,447,045 22,916 8,782,864
Thomas G. Andrews 14,410,211 59,750 8,782,864
Robert C. Hilton 14,393,450 76,511 8,782,864
Steven L. Stroup, M.D. 14,387,200 82,761 8,782,864
Joseph D. Williams 14,469,866 95 8,782,864
</TABLE>
At the Annual Meeting, the shareholders also approved an amendment
to the Company's Amended and Restated Certificate of Incorporation, increasing
the number of authorized shares of Common Stock to 39,000,000 and authorizing
the addition of a class of Preferred Stock, the rights and preferences of which
may be determined from time to time by the Board of Directors. The vote on the
amendment was 12,688,838 in favor and 83,634 against, with 10,480,353 broker
non-votes or abstentions.
ITEM 5. OTHER INFORMATION
The deadline for delivering to the Company notice of shareholder
proposals, other than proposals to be included in the proxy statement, for the
1999 Annual Meeting of Shareholders will be February 15,1999, pursuant to Rule
14a-4 under the Securities Exchange Act of 1934. The persons named as proxies in
the proxy statement may exercise discretionary authority to vote on any
proposals received after such date.
15
<PAGE> 16
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits.
<TABLE>
<CAPTION>
Exhibit
Number Description of Exhibits
- ------ -----------------------
<S> <C>
3.1 Certificate of Amendment to Amended and Restated Certificate of
Incorporation of Therapeutic Antibodies Inc., filed May 13, 1998
10.1 Antibody Development and Supply Agreement, dated May 14, 1998,
between G. D. Searle & Co. and Therapeutic Antibodies Inc.
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 three months ended June 30, 1998.
</TABLE>
16
<PAGE> 17
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: August 14, 1998 /s/ A.J. Kazimi
---------------------------------------
A.J. Kazimi
President and Chief Operating Officer
(senior financial and accounting officer)
17
<PAGE> 1
Exhibit 3.1
CERTIFICATE OF AMENDMENT
OF THE
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
THERAPEUTIC ANTIBODIES INC.
In accordance with the provisions of Sections 103 and 242 of
the Delaware General Corporation Law (the "Act"), Therapeutic Antibodies Inc., a
Delaware corporation (the "Corporation"), organized and existing under and by
virtue of the provisions of the Act and all amendments thereto, does hereby
certify as follows:
1. The Amended and Restated Certificate of Incorporation of
the Corporation, as heretofore filed, shall, upon the filing and recording of
this Certificate of Amendment, be amended as follows:
Paragraph THIRD, subsection 4, of the Amended and
Restated Certificate of Incorporation is deleted in its entirety, and
the following text is substituted in its place and stead:
"4. (a) The Corporation shall have authority, acting by
its Board of Directors, to issue not more than forty million
(40,000,000) shares of capital stock, consisting of thirty-nine
million (39,000,000) shares of common stock, par value one tenth of
one cent ($.001) per share ("Common Stock") and one million
(1,000,000) shares of preferred stock, par value one cent ($.01) per
share ("Preferred Stock").
(b) All shares of Common Stock shall be one and the
same class and when issued shall have equal rights of participation in
dividends and assets of the Corporation and shall be non-assessable.
Each outstanding share of Common Stock shall be entitled to one vote on
each matter submitted to a vote at a meeting of stockholders.
(c) Shares of Preferred Stock may be issued from time
to time in one or more series as may from time to time be determined by
the Board of Directors, each of said series to be distinctly
designated. All shares of any one series of Preferred Stock shall be
alike in every particular, except that there may be different dates
from which dividends, if any, thereon shall be cumulative, if made
cumulative. The voting powers and the preferences and relative,
participating, optional and other special rights of each such series,
and the qualifications, limitations or restrictions thereof, if any,
may differ from those of any and all other series at any time
outstanding; and the Board of Directors of the Corporation is hereby
expressly granted authority to fix by resolution or resolutions adopted
prior to the issuance of any shares of a particular series of Preferred
Stock, the voting powers and the designations, preferences and
relative, optional and other special rights, and the qualifications,
limitations and restrictions of such series."
<PAGE> 2
2. Except as otherwise set forth in paragraph 1 above, all
other provisions of the Corporation's Amended and Restated Certificate of
Incorporation shall remain as set forth in the Amended and Restated Certificate
of Incorporation as it now exists.
3. The foregoing amendment has been duly adopted in accordance
with the provisions of Section 242 of the Act.
IN WITNESS WHEREOF, Therapeutic Antibodies Inc. has caused
this Certificate to be signed by its President and Secretary this 29th day of
April, 1998.
THERAPEUTIC ANTIBODIES INC.
By: /s/ A.J. Kazimi
-----------------------
A.J. Kazimi, President
ATTEST:
By: /s/ Harry G. Browne, M.D.
--------------------------------
Harry G. Browne, M.D., Secretary
2
<PAGE> 1
Exhibit 10.1
G.D. SEARLE & CO.
THERAPEUTIC ANTIBODIES INC
ANTIBODY DEVELOPMENT AND SUPPLY AGREEMENT
MAY 20, 1998
<PAGE> 2
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
1. Definitions...............................................................1
2. Preclinical Development of Antidote.......................................5
3. Clinical Trials of Antidote...............................................6
4. Regulatory Approvals......................................................6
5. Manufacturing and Supply..................................................8
6. Distribution License.....................................................10
7. Marketing of Antidote....................................................11
8. Payments.................................................................11
9. Audit Rights, Records, and Reporting.....................................12
10. Order Procedure..........................................................13
11. Shipment, Risk of Loss, and Delivery.....................................14
12. Compliance...............................................................15
13. Trademarks and Proprietary Rights........................................18
14. Duration and Termination of Agreement....................................19
15. Indemnification..........................................................21
16. Representation and Warranties............................................22
17. Disclaimer of Warranties; Limited Liability..............................23
18. Confidentiality..........................................................24
19. Enforcement..............................................................25
20. Noncompete...............................................................25
21. General..................................................................25
</TABLE>
<PAGE> 3
SCHEDULES
<TABLE>
<CAPTION>
Page
----
<S> <C>
2.2 Global Development Plan...............................................30
5.1 Specifications........................................................31
8.1 Payments..............................................................32
16.4 Patents...............................................................33
</TABLE>
<PAGE> 4
ANTIBODY DEVELOPMENT AND SUPPLY AGREEMENT
This Antibody Development and Supply Agreement is made and entered into
this 20th day of May 1998 (the "Effective Date"), among G.D. SEARLE & CO., a
Delaware corporation having its principal offices in Skokie, Illinois
("Searle"), and THERAPEUTIC ANTIBODIES INC, a Delaware corporation having its
principal offices in Nashville, Tennessee ("TAb"). Searle and TAb may be
referred to herein as a "Party" or collectively as "Parties."
W I T N E S S E T H:
WHEREAS, TAb has developed and is the sole owner of all worldwide
right, title, and interest in and to certain antibody products.
WHEREAS, Searle desires to enter into a collaborative relationship to
support the preclinical and clinical development of * .
WHEREAS, the parties desire to enter into an agreement establishing
terms under which the parties will develop the Antidote (as defined herein),
conduct preclinical and clinical trials of the Antidote, seek regulatory
approval to market the Antidote, and provide Searle with exclusive, worldwide
rights to manufacture (subject to the conditions set forth herein), use, market
and sell the Antidote for use in * .
NOW, THEREFORE, in consideration of the mutual promises and covenants
herein contained, and intending to be legally bound hereby, the Parties agree as
follows:
1. Definitions.
1.1 "Antidote" means a certain polyclonal-antibodies product
derived only from * (" * Antibody"), which excludes human
sequence antibodies derived from genetically engineered manufacturing or
sources, and solely owned by TAb and developed pursuant to this Agreement in
order to * .
1.2 "Batch" means one (1) production lot of the Antidote
consisting of 500 to 1,000 units.
1.3 "Certificate of Analysis" means a certificate issued by
TAb which states the Specifications, indicates the final release test results
and includes documentation of any Batch deviations.
1.4 "Certificate of Compliance" means a certificate issued by
TAb stating that a Batch has been Processed and Packaged in accordance with the
Specifications and with GMPs (as defined herein).
* Confidential treatment requested. Omitted material filed separately.
<PAGE> 5
1.5 "Clinical Trials" shall mean any and all investigations,
evaluations, or experiments conducted on human beings in relation to the
Antidote.
1.6 "Commencement Date" means the date on which TAb receives
its first Regulatory Approval (as defined herein) for the Antidote.
1.7 "Confidential Information" means, with respect to a Party,
all information obtained or developed which relates to the business of the other
Party or the Antidote or Material, regardless of the form in which such
information is transmitted, including, without limitation, all such information
previously obtained by a Party pursuant to the Confidentiality Agreement dated
January 6, 1998, between TAb and Searle (the "Confidentiality Agreement"), all
information furnished to a Party by another Party in relation to the Antidote or
Material pursuant to this Agreement, all Results, and all Trade Secrets. The
following shall not be considered Confidential Information for purposes hereof:
(a) Information that is already in the possession of the
receiving Party, other than under an obligation of confidentiality, at the time
of disclosure, so long as the receiving Party promptly notifies the disclosing
Party of its belief that the information is excepted under the terms of this
subsection;
(b) Information received from a Person which has the right to
disclose the same, so long as the receiving Party promptly notifies the
disclosing Party of its belief that the information is excepted under the terms
of this subsection;
(c) Information that is or becomes publicly available without
the fault of the receiving Party; or
(d) Information that the receiving Party is obligated to
produce pursuant to an order of a court of competent jurisdiction or a valid
administrative order; provided that if the receiving Party is subject to such an
order, it must promptly notify the disclosing Party and cooperate with the
disclosing Party's efforts to contest or limit the scope of such order.
In the event of a dispute regarding the applicability of the above exceptions to
the definition of Confidential Information, the receiving Party shall have the
burden of producing clear and convincing proof that the information should be
excepted from the definition of Confidential Information.
1.8 "Documentation" means any and all labels, instructions
(including without limitation instructions for storage and handling), manuals,
analytical and all other specifications, testing methods, warnings and similar
documentation relating to the Antidote prepared by or for TAb other than
documentation relating to the Material (as defined herein).
5
<PAGE> 6
1.9 "End User" means a Person who purchases the Antidote for
such Person's own use or for administration to patients, and not for
redistribution.
1.10 "FDA" means the United States Food and Drug
Administration, or the successor thereto.
1.11 "Gross Profit" means Net Sales Revenue less Supply Price.
1.12 "IND" means the Investigational New Drug application,
together with all documents, data and other information concerning the Antidote
that are required to be included in such application, filed or submitted with
the FDA in the U.S.A., or the equivalent application to the appropriate
governing health authority of any other country or group of countries in the
Territory, for the purpose of obtaining approval or authority to commence or to
continue human clinical trials in such country for the purpose of seeking
general marketing approval.
1.13 "Manufacturing Costs" means TAb's costs of manufacturing
the Antidote, including without limitation TAb's costs of raw materials, labor,
manufacturing and packaging costs and expenses, overhead amounts applicable to
such manufacturing (including without limitation appropriately amortized capital
equipment costs and excluding non-manufacturing overhead and allocations),
calculated in accordance with generally accepted accounting principles
consistently applied.
1.14 "Material" means any chemical compound samples and
structures of * and * supplied by Searle to TAb.
1.15 "Net Sales Revenue" means the aggregate amount billed by
Searle, directly or indirectly, for the sale of the Antidote, less (a) trade,
cash and quantity and promotional discounts, (b) excise, sales, value added or
other taxes imposed upon and paid by Searle with respect to such sales
(excluding taxes based on income), (c) freight, insurance and other
transportation charges included in the amount billed, (d) amounts repaid or
credited by reason of rejections, defects, recalls, or returns for failure to
meet Specifications (e) the total of (i) the amount billed by Searle to its
customers for Antidote that was later returned for reasons other than failure to
meet Specifications (including Antidote returned as a result of expired shelf
life), less (ii) Supply Price for such returned Antidote and (f) rebates,
chargebacks or discounts pursuant to agreements with customers or applicable
laws.
1.16 "Packaging" means the procedures of filling, inspecting,
labeling, packaging and packing of the Antidote (either in bulk or finished
form) or any part thereof in accordance with the Specifications. The terms
"Package," "Packaged" and "Packaging" in this Agreement shall have the identical
meaning.
1.17 "Person" means an individual, corporation, company,
partnership, trust, association, governmental authority or other entity.
* Confidential treatment requested. Omitted material filed separately.
6
<PAGE> 7
1.18 "Processing" means the compounding, component
preparation, testing, and other procedures, or any part thereof, involved in
manufacturing the Antidote in accordance with the Specifications. The terms
"Process," "Processed" and "Processing" in this Agreement shall have the
identical meaning.
1.19 "Proprietary Rights" means the rights and properties
described in Section 13.3.
1.20 "Raw Materials" means the active ingredients, excipients,
components, labels, labeling, packaging boxes, and shipping containers necessary
for the Processing and Packaging of the Antidote as listed in the master batch
records other than the Material.
1.21 "Regulatory Approval" means, with respect to a country,
all approvals (including price and reimbursement approvals), licenses,
registrations, or authorizations of any federal, state or local regulatory
agency, department, bureau or other government entity, necessary for the
manufacture, use, storage, import, transport, and sale of the Antidote in such
country for use in * .
1.22 "Regulatory Authorities" means the FDA, as well as the
national regulatory authorities of the countries within the Territory with
responsibility for regulating the testing, manufacture, distribution, sales or
specific use of the Antidote.
1.23 "Regulatory Filing" shall mean an application for
Regulatory Approval and any other filing pursuant to the regulations and
procedures required by any Regulatory Authority in the Territory for the
testing, manufacture, distribution, sale, or specific use of the Antidote.
1.24 "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 Searle in connection with the
Global Development Plan (as defined herein), and Regulatory Approvals
contemplated by Sections 2, 3, and 4, or otherwise in connection with this
Agreement that relate to the Antidote per-se, use of the Antidote, or
manufacture of the Antidote, and Searle expressly disclaims any ownership in the
Antidote or in any intellectual property related to the manufacture, use, or
sale of the Antidote. Any technology, ideas (whether or not copyrightable),
know-how, data, improvements, modifications, innovations, inventions,
methodology, processes, techniques, and results, tangible and intangible, which
are developed or discovered by Searle or TAb in relation to the Material and do
not relate to the Antidote, are expressly excluded from the foregoing, and TAb
expressly disclaims any ownership in the Material or in any intellectual
property, related to the manufacture, use or sale of the Material, discovered,
developed, or created pursuant or incident to this Agreement other than that
relating to the Antidote per-se, use of the Antidote, or manufacture of the
Antidote.
* Confidential treatment requested. Omitted material filed separately.
7
<PAGE> 8
1.25 "Supply Price" means the price to be paid by Searle to
TAb for orders of the Antidote for all purposes other than for preclinical
development and Clinical Trials in accordance with the Global Development Plan
(as defined herein). Such purposes shall include, without limitation, for
treatment, compassionate use, or distribution. Subject to the adjustments set
forth in Section 5.3, the Supply Price per unit of the Antidote shall be equal
to the greater of (a) * or (b) * ; provided that so long as
the unit size is less than or equal to 1.5 grams, the Supply Price per unit
shall not exceed * . In the event that the size of any unit of Antidote
supplied to Searle is greater than 1.5 grams, then the Parties shall negotiate
in good faith to adjust such Supply Price.
1.26 "Territory" means all of the countries and territories
of the world.
1.27 "Trademarks" means all trademarks, trade names, and other
designations of origin under which the Antidote is marketed. Each Trademark
shall be chosen, owned and maintained by Searle; provided each such Trademark
shall be one to which TAb has no reasonable objection.
1.28 "Trade Secrets" means all techniques, technology,
processes, and know-how related to production and purification of polyclonal
antibodies developed by TAb or any agent thereof, including (a) the design and
syntheses of immunogens which can produce high affinity antibodies in large
quantities, (b) the selection, immunization, and handling of * 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.
2. Preclinical Development of Antidote.
2.1 The Parties intend to work cooperatively to pursue
development of the Antidote in order to obtain Regulatory Approval of the
Antidote for use in * as soon as practicable using commercially
reasonable efforts in accordance with the terms of this Agreement.
2.2 Within seventy-five (75) days of the Effective Date, the
Parties shall prepare a "Global Development Plan", including budgets and listing
planned countries of clinical trials and registrations, pursuant to which the
parties shall allocate responsibilities for development matters, including
without limitation the following:
(i) selecting and designing the immunogen(s) that
will be used to develop the Antidote,
* Confidential treatment requested. Omitted material filed separately.
8
<PAGE> 9
(ii) identifying the studies anticipated to be
conducted,
(iii) specifying the steps involved in producing and
evaluating the antisera and in completing the preclinical studies,
(iv) identifying the method of formulating and
packaging the preclinical and clinical supplies of the Antidote, and
(v) identifying the required manufacturing
investments.
TAb responsibilities under the Global Development Plan
include, but are not limited to, delivery of the formulated Antidote to Searle
for * testing for efficacy, and performing toxicology studies; provided
that TAb is entitled to reimbursement from Searle of the Manufacturing Costs of
the Antidote so delivered. The Global Development Plan shall also specify the
criteria for the commencement and continuation of preclinical studies at mutual
and synchronized decision points. After the Parties agree in writing to the
contents of the Global Development Plan, it shall be attached hereto as Schedule
2.2, and may only be modified by written agreement of the Parties. If the Global
Development Plan is not adopted and agreed to in writing within seventy-five
(75) days of the Effective Date, then this Agreement shall terminate
automatically, and each Party shall immediately return the Confidential
Information of the other Party to such other Party. Upon termination of this
Agreement pursuant to this Section 2.2, TAb shall immediately refund to Searle
(i) the amount of the Signing Payment less any expenditures incurred by TAb for
its funding requirements under Section 2.3; and (ii) any advance payments by
Searle of a portion of the Supply Price for any unfilled Purchase Orders, less
documented Manufacturing Costs corresponding to unfilled Purchase Orders.
2.3 TAb shall be responsible for providing all funding
required to support the conduct of TAb's activities in meeting its
responsibilities under this Agreement and as set forth in the Global Development
Plan. The Signing Payment (as defined in Schedule 8.1) shall be used solely for
expenditures incurred by TAb in meeting its funding requirements hereunder.
2.4 Searle shall be responsible for providing all funding
required to support the conduct of Searle's activities in meeting its
responsibilities under this Agreement and as set forth in the Global Development
Plan.
2.5 The Parties will each use all commercially reasonable
efforts to meet their respective obligations under the Global Development Plan
as soon as practicable, subject to applicable regulatory and legal requirements.
3. Clinical Trials of Antidote.
3.1 TAb shall manufacture and supply Searle with preclinical
and clinical
* Confidential treatment requested. Omitted material filed separately.
9
<PAGE> 10
requirements of the Antidote for conducting clinical trials in amounts set forth
in the Global Development Plan as soon as practicable upon request by Searle.
Within thirty (30) days of submission of invoice or receipt of the Antidote,
whichever is later, Searle shall reimburse TAb for the Manufacturing Costs of
the Antidote supplied for preclinical requirements or use in Clinical Trials;
provided that in no event other than when the unit size of the Antidote at issue
exceeds 1.5 grams, shall Manufacturing Costs per unit of Antidote exceed
* .
3.2 Searle shall be responsible for preparation, with TAb's
advice and assistance, of a clinical plan and study reports for Clinical Trials
for the Antidote as well as implementation thereof, including paying for,
conducting, monitoring and using commercially reasonable efforts to
expeditiously complete all Clinical Trials necessary for Regulatory Approval for
the Antidote in the Territory in accordance with the Global Development Plan.
TAb shall advise Searle on the preparation for and implementation of Clinical
Trials in accordance with the Global Development Plan.
3.3 The Parties shall cooperate and provide access and
reference to their respective Regulatory Filings as may be necessary for
obtaining Regulatory Approvals for the Antidote and Material. The Parties shall
also coordinate and exchange such information as may be necessary or useful in
the conduct of Clinical Trials under the Global Development Plan regarding the
FDA center for drug evaluation and review and the FDA center for biologic
evaluation and review.
4. Regulatory Approvals.
4.1 Regulatory Approval in the United States of America
(a) TAb shall use all commercially reasonable efforts to
expeditiously obtain Regulatory Approval in the United States of America ("U.S.
Regulatory Approval") for the Antidote in accordance with the Global Development
Plan and in collaboration with Searle. TAb shall be responsible for the
preparation and filing of all required Regulatory Filings in the United States
("U.S. Regulatory Filings") for the Antidote. TAb shall provide Searle with
written certification that the Antidote has obtained U.S. Regulatory Approval
promptly upon receipt thereof.
(b) Searle shall assist TAb in the preparation and submission
of all U.S. Regulatory Filings in accordance with the Global Development Plan
and shall reimburse TAb for all reasonable direct out-of-pocket costs and
expenses incurred in the preparation and submission of U.S. Regulatory Filings
in accordance with the Global Development Plan and pre-approved by Searle,
including without limitation, payments to contract research organizations, and
all fees associated with obtaining or maintaining U.S. Regulatory Approval of
the Antidote.
(c) TAb shall have the sole responsibility for communicating
with the FDA with respect to the Antidote, provided that TAb shall provide
Searle with a reasonable
* Confidential treatment requested. Omitted material filed separately.
10
<PAGE> 11
opportunity to review and comment upon all U.S. Regulatory Filings and U.S.
Regulatory Approval concerning the Antidote, except as provided herein, prior to
submissions of such documentation to the FDA. TAb shall provide Searle with an
opportunity to review and comment upon any correspondence or other formal
communication with the FDA concerning the Antidote or any U.S. Regulatory Filing
for the Antidote. Searle agrees to identify non-material, routine, U.S.
Regulatory Filings which TAb will not have to provide to Searle for review and
comment.
(d) TAb shall use its best efforts to provide Searle with
prior notice of all meetings, conferences and discussions scheduled with the FDA
concerning any U.S. Regulatory Filings or U.S. Regulatory Approval for the
Antidote. At all such meetings, conferences or discussions, Searle shall have
the right to attend and participate, either in person or by telephone. TAb and
Searle shall use their best efforts to agree in advance on the objectives to be
accomplished at such meetings, conferences, and discussions and the agenda for
the meetings, conferences, and discussions with the FDA.
(e) TAb shall provide to Searle, within twenty-four (24) hours
after its receipt of such information, copies of any and all communications with
or from the FDA about the manufacture, sale, promotion, distribution, or
clinical investigation of the Antidote and any review of or inquiry about the
Antidote by the FDA, the need for a remedial action related to one or more
Batches of the Antidote (including a recall or withdrawal), or the initiation of
any investigation, detention, seizure of or injunction against distribution of
the Antidote by the FDA.
4.2 Regulatory Approvals Outside of the United States of
America
(a) In collaboration with TAb, Searle shall use all
commercially reasonable efforts to expeditiously obtain Regulatory Approvals
outside of the United States of America ("Non-U.S. Regulatory Approvals") for
the Antidote in Searle's name to be held for the benefit of TAb in accordance
with the Global Development Plan. Searle shall be responsible for the
preparation and filing of all Regulatory Filings required outside of the United
States ("Non-U.S. Regulatory Filings") for distribution of the Antidote in the
Territory. Searle shall provide TAb with written certification that the Antidote
has obtained a Non-U.S. Regulatory Approval, promptly upon receipt of the
respective Non-U.S. Regulatory Approval.
(b) TAb shall assist Searle in the preparation and submission
of all Non-U.S. Regulatory Filings in accordance with the Global Development
Plan. Searle is responsible for all costs and expenses incurred in the
preparation and submission of Non-U.S. Regulatory Filings in accordance with the
Global Development Plan, including without limitation, payments to contract
research organizations, and all fees associated with obtaining or maintaining
Non-U.S. Regulatory Approvals of the Antidote.
(c) Searle shall have the sole responsibility for
communicating with all Regulatory Authorities outside of the United States with
respect to the Antidote, provided that
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Searle shall provide TAb with a reasonable opportunity to review and comment
upon the basic dossier prepared by Searle and provided to its affiliates for all
Non-U.S. Regulatory Filings and Non-U.S. Regulatory Approvals concerning the
Antidote prior to submissions of such dossier to Searle's affiliates. Searle
shall provide TAb with an opportunity to review and comment upon any
correspondence or other formal communication with any Regulatory Authorities
outside of the United States concerning the Antidote or any Non-U.S. Regulatory
Filing for the Antidote. Searle shall not make any material change in any
non-U.S. Regulatory Filing without notifying TAb prior to submission of such
documentation to the relevant Regulatory Authorities.
(d) Searle shall use its best efforts to provide TAb with
prior notice of all meetings, conferences and discussions scheduled with any
Regulatory Authorities concerning any Non-U.S. Regulatory Filings or Non-U.S.
Regulatory Approval for the Antidote which involve major countries and are
significant to such Regulatory Filings or Regulatory Approvals. At all such
meetings, conferences or discussions, TAb shall have the right to attend and
participate, either in person or by telephone. Searle and TAb shall use their
best efforts to agree in advance on the objectives to be accomplished at such
meetings, conferences, and discussions and the agenda for the meetings,
conferences, and discussions with such Regulatory Authorities.
(e) Searle shall provide to TAb, within twenty-four (24) hours
after its receipt of such information, copies of any and all communications with
or from any Regulatory Authorities about the manufacture, sale, promotion,
distribution, or clinical investigation of the Antidote outside of the U.S. and
any review of or inquiry about the Antidote by all Regulatory Authorities
outside of the U.S., the need for a remedial action related to one or more
Batches of the Antidote (including a recall or withdrawal), or the initiation of
any investigation, detention, seizure of or injunction against distribution of
the Antidote outside of the U.S. by any Regulatory Authority.
4.3 Except as otherwise provided in this Agreement, all
authorizations obtained for the Antidote hereunder shall be the sole and
exclusive property of TAb and shall be held in the name of TAb. All Results
shall be the sole and exclusive property of TAb, and Searle hereby assigns to
TAb any and all right, title, and interest it may now or in the future have in
the Results.
4.4 Each Party shall notify the other party within twenty-four
(24) hours after receiving information about the initiation of any
investigation, review, or inquiry by any Regulatory Authority concerning the
need for a remedial action related to one or more Batches of the Antidote
(including a recall or withdrawal), the initiation of an investigation,
detention, seizure of or injunction against distribution of the Antidote, or the
initiation of an inspection of the facilities used in conjunction with the
manufacturing or distribution of the Antidote by a Regulatory Authority.
4.5 Searle shall be solely responsible for making
representations, responding to inquiries, and providing information to the FDA
with respect to the Material.
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5. Manufacturing and Supply.
5.1 The Antidote supplied by TAb to Searle shall be
manufactured in compliance with (i) current Good Manufacturing Practices as
promulgated by the FDA ("GMPs"), (ii) specifications developed by TAb and agreed
to by Searle (the "Specifications") to be attached hereto as Schedule 5.1 after
review by applicable Regulatory Authorities, and (iii) the Regulatory Approvals.
The Antidote will be manufactured, packaged, and labeled entirely by TAb and/or
a third party designated by TAb, to which Searle has no reasonable objection.
5.2 TAb shall have the exclusive supply rights to supply
Searle and all of its affiliates and marketing collaborators with any and all
* Antibodies used by Searle as an antidote for the Material;
provided, however, that if TAb is unable to fill an order made pursuant to
Section 10.2 or Section 10.4 within six (6) months of the Agreed Delivery Date,
Searle shall have the right to terminate the exclusive supply rights by written
notice unless TAb provides a commercially reasonable explanation for the delay
and a proposal to resolve the shortfall in supply for Searle's consent, which
shall not be unreasonably withheld.
5.3 TAb shall provide Searle with regular updates with respect
to production capacity for the Antidote so that the Parties may make good faith
efforts to avoid or mitigate shortages in supply of Antidote and may encourage
prompt or early delivery of the Antidote. Price adjustments for delivery of
orders at times other than Agreed Delivery Dates shall be as follows:
(a) In the event that TAb fails to fill an order made pursuant
to Section 10.2 or Section 10.4 by the Agreed Delivery Date, then Searle may
give notice of such shortfall in supply to TAb. If TAb does not cover the
shortfall in supply of the Antidote within thirty (30) days from the date of
receipt of the notice (a "Notice of Supply Interruption"), then the Supply Price
for the amount of the shortfall shall be reduced by * . The Supply
Price for the amount of any respective shortfall for such order shall thereafter
be reduced by an additional * per month, subject to a maximum price
reduction of * after six (6) months.
(b) If, upon Searle's request, TAb fills an order for Antidote
more than thirty (30) days and less than sixty (60) days before the delivery
date agreed upon pursuant to Section 10.2 or Section 10.4 (the "Agreed Delivery
Date"), then the Supply Price for the amount of Antidote delivered early shall
be increased by * . If, upon Searle's request, TAb fills an order sixty
(60) or more days prior to the Agreed Delivery Date, then TAb may increase the
Supply Price for the amount of Antidote delivered early at a rate of *
for each month occurring between (i) the actual delivery date and (ii) the date
that is sixty (60) days before the Agreed Delivery Date, subject to a maximum
price increase of * for delivery more than six (6) months prior to the
Agreed Delivery Date.
* Confidential treatment requested. Omitted material filed separately.
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5.4 In the event that TAb's exclusive supply rights are
terminated pursuant to Section 5.2, Searle and its designated third party
supplier are hereby granted the right and license to manufacture the Antidote
and use the Documentation, Proprietary Rights, Regulatory Approvals, Results,
and Trade Secrets in connection therewith during the term hereof, subject to
Sections 13.3, 15.1 and 18 of this Agreement; provided, that such right and
license shall not be granted if:
(a) TAb has delivered more than fifty percent (50%) of the
amount of Antidote ordered in the partially unfilled Purchase Order and has
provided reasonable assurance that the balance of the order will be delivered
without undue delay; and
(b) TAb has undertaken efforts to cure the shortage in supply
which are reasonably satisfactory to Searle.
After Searle or a third party supplier has been granted a
license to manufacture the Antidote, should TAb reasonably demonstrate to Searle
TAb's ability to discharge and fulfill its production and supply obligations
hereunder, the license to manufacture and all rights granted in connection
therewith shall revert to TAb.
TAb and Searle shall take any and all actions, and execute and
deliver such documents and communications, as may be necessary to implement and
effect the foregoing. In the event that Searle or a third party supplier
exercise the right and license to manufacture the Antidote, (i) all of Searle's
obligations hereunder, including, without limitation, payment obligations
pursuant to Section 8.1 shall remain in full force and effect, and (ii) all of
TAb's obligations set forth herein with respect to manufacturing the Antidote,
including without limitation, compliance in manufacturing and recordkeeping,
shall apply to Searle and such third party suppliers instead of to TAb. Should
the license to manufacture revert to TAb, TAb shall credit direct out-of-pocket
expenses incurred by Searle (including such commitments to incur future direct
out-of-pocket expenses as Searle reasonably may incur) to develop an alternative
source of supply for the Antidote towards Searle's payment obligations
hereunder; provided that such expenses are reasonable and that Searle provides
TAb prior written notice of the anticipated type and estimated amount of any
such expense for which it shall seek credit.
If TAb is in Bankruptcy (as defined herein), Searle may
exercise the above manufacturing rights regardless of partial delivery or
efforts to cure.
5.5 To the extent that the creation, development or
manufacture of Antidote by TAb for Searle would otherwise infringe a claim of a
patent issued to, owned or controlled by Searle or a Searle affiliate now or
during the term of this Agreement, Searle hereby grants to TAb a personal,
non-transferable, non-assignable, non-exclusive, royalty-free, license under
such claim in the Territory. Such license shall continue only for such period or
periods in which TAb is manufacturing Antidote for Searle and is not otherwise
in breach of this Agreement, and shall be limited to the creation, development
and manufacture of Antidote for Searle.
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6. Distribution License.
6.1 Subject to compliance with the terms of this Agreement,
TAb hereby grants Searle the exclusive license, with the right to sublicense, to
manufacture (but solely pursuant to the provisions of Section 5.4) and use,
market, advertise, promote, distribute, import, export and sell the Antidote in
such countries as Searle shall determine in accordance with Section 7.5 below.
6.2 The rights and licenses granted to Searle under this
Agreement are personal, non-transferable, non-assignable, are limited solely to
the Antidote, and in all cases are granted without the right to assign, except
as expressly set forth in this Agreement. Searle's appointment only grants to
Searle and its sublicensee(s)a right to manufacture (but solely pursuant to the
provisions of Section 5.4) and use, market, advertise, promote, sell and
distribute Antidote in such countries as Searle shall determine in accordance
with Section 7.5 below and does not transfer any right, title, or interest in
the Proprietary Rights to Searle.
6.3 Searle may utilize sublicensees for distribution of the
Antidote in the Territory so long as pricing arrangements between Searle and
such sublicensees result from arms-length negotiations and so long as Searle
uses reasonable care in the selection of such sublicensees to insure their
compliance with the terms hereof.
7. Marketing of Antidote.
7.1 Searle shall provide its sales force with training,
technical support and other assistance appropriate in promoting the Antidote
based upon the Documentation.
7.2 Searle shall not make representations, warranties, or
guarantees with respect to the Specifications, features or efficacy of the
Antidote that are inconsistent with the Documentation, including all warranties
and disclaimers contained in the Documentation.
7.3 Searle shall transport and store the Antidote in
accordance with the Documentation and Specifications and all applicable laws and
regulations.
7.4 Searle agrees not to advertise, promote, sell, distribute,
or use for any purpose whatsoever any Antidote which Searle knows is
adulterated, misbranded, damaged, spoiled, or otherwise fails to meet the
requirements of this Agreement. Searle shall not jeopardize the integrity of the
container closure system for the Antidote.
7.5 Searle agrees to use commercially reasonable best efforts
to promote, detail, sell, and distribute the Antidote in the Territory in
connection with the marketing and sale of the Material for the Antidote's
indicated use on a basis no less favorable than provided for its own products of
similar scope and market potential.
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7.6 Searle shall be the primary contact for adverse events and
shall prepare reports of adverse drug experiences associated with the Antidote
for filing by TAb with the FDA. Searle shall file reports of adverse drug
experiences with Regulatory Authorities outside of the United States. TAb shall
provide to Searle copies of all complaints and reports of adverse drug
experiences associated with the use of the Antidote promptly after TAb's receipt
of same. Detailed reports of adverse events shall be reported to Searle within
twenty-four (24) hours with respect to serious adverse drug experiences, and
within seven (7) days with respect to non-serious adverse drug experiences, of
receipt of such information by TAb. TAb shall cooperate with and assist Searle
at Searle's expense in the investigation of complaints and adverse events with
respect to the Antidote and the preparation of applicable reports and filings
with Regulatory Authorities, and Searle shall submit a copy of each such report
and filing outside the United States to TAb.
7.7 Searle shall consult with TAb regarding Antidote pricing
but shall be free to set prices at any level deemed appropriate by Searle.
8. Payments.
Searle shall make payments as specified on Schedule 8.1.
9. Audit Rights, Records, and Reporting.
9.1 TAb agrees that at all times during the existence of this
Agreement and for a period of seven (7) years thereafter, it will keep full and
accurate books and records of its costs related to development, Clinical Trials,
Regulatory Filings, Regulatory Approvals, manufacture and supply for the
Antidote and determination thereof. Searle shall have the right to have an
independent audit conducted by any national firm of independent public
accountants as to which TAb has no reasonable objection ("Independent
Auditors"), under appropriate confidentiality provisions, for the sole purpose
of ascertaining or confirming the accuracy of the statements rendered hereunder.
Any such audit shall be conducted no more than once each twelve (12) months
during the term of this Agreement, and for twelve (12) months thereafter, and
upon at least thirty (30) days' advance notice during normal business hours. If
an inspection by Independent Auditors reveals that the corresponding payments by
Searle have been overstated, then TAb shall pay to Searle the amount overstated,
immediately upon demand, plus interest accrued thereon from the date due at a
rate equal to the prime rate announced by Citibank, N.A., New York, New York or
its successors and assigns, on the date that the Independent Auditors inform
Searle the amount has been overstated. The cost of inspections by the
Independent Auditors shall be borne by Searle; provided, however, that if an
inspection reveals that a statement rendered hereunder has overstated
corresponding payments by greater than five percent (5%), then the costs of such
inspection shall be borne by TAb.
9.2 Searle agrees that at all times during the existence of
this Agreement, and
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for a period of seven (7) years thereafter, it will keep full and accurate books
of account and other records containing all details relating to the distribution
and sale of Antidote, and the calculation of Gross Profit. TAb shall have the
right to have an independent audit conducted by any Independent Auditors as to
which Searle has no reasonable objection, under appropriate confidentiality
provisions, for the sole purpose of ascertaining or confirming the accuracy of
the statements rendered hereunder. Any such audit shall be conducted no more
than once each twelve (12) months during the term of this Agreement, and for
twelve (12) months thereafter, and upon at least thirty (30) days' advance
notice during normal business hours. If an inspection by Independent Auditors
reveals that Gross Profit and/or corresponding payments have been understated,
then Searle shall pay to TAb the amount understated, immediately upon demand,
plus interest accrued thereon from the date due at a rate equal to the prime
rate announced by Citibank, N.A., New York, New York or its successors and
assigns, on the date that the Independent Auditors inform TAb the amount has
been understated. The cost of inspections by the Independent Auditors shall be
borne by TAb; provided, however, that if an inspection reveals that a statement
rendered hereunder has understated Gross Profit and/or corresponding payments by
greater than five percent (5%), then the costs of such inspection shall be borne
by Searle.
9.3 Searle shall furnish TAb within forty-five (45) 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, to include the following information: (a) total Gross Profit on an
aggregate basis; (b) number and gross selling price of Antidote sold; (c)
information as to returns actually credited; (d) calculation of Net Sales
Revenue and (e) current inventory levels for Antidote; and (f) purchase price
paid by any sublicensees. All amounts shall be stated in U.S. dollars.
9.4 TAb shall furnish Searle within forty-five (45) 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 setting forth TAb's expenditures incurred during such quarterly period
for its funding requirements under Section 2.3, together with the Account
Statement (as defined in Schedule 8.1). TAb's obligation to furnish the
foregoing statement and Account Statement shall terminate upon depletion of all
funds represented by the Account Statement.
10. Order Procedure.
10.1 Commercial Supply Orders. Searle hereby agrees to
purchase a total of at least * units of Antidote during the first
seven (7) years of the initial term hereof on the terms and conditions set forth
hereinafter. Searle may purchase the Antidote in round lots of one or more
Batches of Antidote. Purchases of the Antidote shall not be any fraction of such
Batches.
10.2 Purchase Orders in the First Two Years of Distribution.
The order procedure for the first two years following the Effective Date shall
be as follows: Searle shall
* Confidential treatment requested. Omitted material filed separately.
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submit a written order (a "Purchase Order") for the amount of the corresponding
Antidote that it commits to purchase within two (2) years from the Effective
Date. The Purchase Order shall indicate the requested delivery schedule, and
shall be accompanied by payment of * . Such payment shall be
nonrefundable except as set forth in Section 14.6, Section 2.2, and Section
14.4. TAb shall use its commercially reasonable best efforts to accept orders
and to supply Antidote in accordance with the Purchase Orders. Because of supply
variables, including the lead time required to manufacture Antidote, TAb cannot
guarantee supply during the first two years, and Searle acknowledges that no
Purchase Order shall be binding upon TAb unless and until accepted by TAb in
writing. Should TAb not accept all or any portion of a Purchase Order, TAb shall
credit or promptly refund the payment accompanying the Purchase Order on a pro
rata basis, as directed by Searle. After TAb has accepted such Purchase Order
and the Parties have agreed to a delivery date, Searle shall provide TAb with a
payment of * for such Purchase Order not less than six (6) months
prior to the agreed delivery date; provided that TAb has warranted that it has
production capacity to fill such Purchase Order. Such payment shall be
nonrefundable except as set forth in Section 14.4 and Section 14.6. Such
Purchase Orders and any acknowledgment thereof, whether printed, stamped, typed,
or written shall be governed by the terms of this Agreement, and none of the
provisions of such Purchase Orders or acknowledgments shall be enforceable
except those specifying quantity ordered, delivery dates, and invoice
information, and only if such provisions do not conflict with the terms hereof.
10.3 Forecasts for Subsequent Purchase Orders. Searle shall
provide TAb with a good-faith estimate of the amount of the Antidote which
Searle expects to purchase from TAb in the first calendar quarter beginning
after the second anniversary of the Effective Date (the "Forecasts") and,
immediately upon receipt of TAb's written acceptance of such Forecast, a payment
of * for the Forecast. Such payment shall be nonrefundable except as
set forth in Section 14.4, Section 14.6 and Section 2.2. Within ninety (90) days
after such Forecast is given and on the first day of each calendar quarter
thereafter, Searle shall provide TAb with a Forecast for the quarter that
follows the last month of the preceding Forecast and, immediately upon receipt
of TAb's written acceptance of such Forecast, a payment of * for such
Forecast. Each such payment shall be nonrefundable except as set forth in
Section 14.4, Section 14.6 and Section 2.2. Each "acceptance" of a Forecast by
TAb pursuant to this Section 10.3 shall contain TAb's commitment to supply the
quantity of Antidote specified therein.
10.4 Subsequent Purchase Orders. Searle may revise the amount
of Antidote estimated in any Forecast, until one year prior to the start of the
calendar quarter in which the forecast purchases are to be made (the "Purchase
Period"). One year prior to the start of the Purchase Period, Searle shall
submit a Purchase Order indicating the amount of Antidote which it thereby
commits to purchase from TAb within one (1) year from the start of such Purchase
Period. The quantity of Antidote to be ordered pursuant to a Purchase Order
shall not be less than seventy-five percent (75%), nor greater than one hundred
twenty-five percent (125%) of the quantity indicated in the Forecast; provided,
however, that TAb shall use its commercially reasonable best efforts to increase
TAb's production capacity and its best efforts to supply the Antidote for orders
by Searle in excess of such amounts. In order to address any order in excess
* Confidential treatment requested. Omitted material filed separately.
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of one hundred twenty-five percent (125%) of the amount indicated in the
Forecast, the Parties shall discuss in good faith methods and the cost of
increasing TAb's production capacity. TAb shall consent to undertake such
commercially reasonable measures as are agreed upon by the Parties in order to
increase production capacity. Any such agreed measures will be set forth in a
writing executed by both parties. Each Purchase Order shall be accompanied by a
payment of * , and a requested delivery schedule for such Antidote,
which shall not commence sooner than one (1) year from the date of such Purchase
Order. Each such payment shall be nonrefundable except as set forth in Section
14.4, Section 14.6, and Section 2.2. Such purchase orders and any acknowledgment
thereof, whether printed, stamped, typed, or written shall be governed by the
terms of this Agreement, and none of the provisions of such purchase orders or
acknowledgments shall be enforceable except those specifying quantity ordered,
delivery dates, and invoice information, and only if such provisions do not
conflict with the terms hereof.
10.5 Reconciliation. The Manufacturing Costs under Section 3.1
and with respect to the Supply Price under Section 10 shall be initially based
on TAb's good faith estimate of Manufacturing Costs; provided that in no event
other than when the unit of Antidote at issue exceeds 1.5 grams, shall
Manufacturing Costs per unit of Antidote exceed * . Within thirty (30)
days following the end of each calendar quarter, TAb shall provide Searle with a
detailed statement of actual Manufacturing Costs used in the manufacture of
Antidote delivered to Searle during the prior calendar quarter, together with
the amount by which such actual Manufacturing Costs exceeded or were less than
the estimated Manufacturing Costs used in the supply of such Antidote. Within
thirty (30) days following receipt of such statement, TAb shall, at Searle's
option, pay to Searle or credit towards subsequent payment obligations of Searle
the amount of the shortfall, if any, subject to a minimum Supply Price of
* per unit of Antidote, or Searle shall pay to TAb the amount of the
excess, if any, subject in all cases other than when the unit of Antidote at
issue exceeds 1.5 grams, to a maximum Supply Price of * per unit of
Antidote.
10.6. Supply Priority. TAb shall use its best efforts to
provide Searle's supply requirements on a priority basis, but no less favorable
than provided to other customers of TAb.
11. Shipment, Risk of Loss, and Delivery.
11.1 Searle shall take delivery of all Antidote FOB TAb's
Welsh facility or FOB such other TAb facility as the parties may agree. Delivery
will be made to carrier or freight forwarder identified by Searle. Searle will
be responsible for and pay all shipping, freight, and insurance charges, as well
as all customs, duties, and similar tariffs and fees.
11.2 All risk of loss, spoilage, or damage shall pass to
Searle upon delivery by TAb to the carrier, freight forwarder, or Searle,
whichever first occurs; provided, however, that TAb shall retain all risk of
loss, spoilage or damage due to failure of the Antidote to meet the
Specifications or delivery by TAb to Searle of Antidote having a shelf life of
less than the amount required by Section 11.4. Unless Searle advises TAb to the
contrary in writing, TAb
* Confidential treatment requested. Omitted material filed separately.
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may make partial shipments of Searle's orders, to be separately invoiced and
paid for when due.
11.3 Except as set forth otherwise in this Agreement, TAb
shall not accept returns of the Antidote.
11.4 Beginning on the first anniversary of the first shipment
by TAb of the Antidote for commercial sale by Searle, Searle shall have the
right to reject any units of the Antidote shipped by TAb with an approved shelf
life of less than eighteen (18) months from date of delivery to Searle (as
indicated on the corresponding FDA-approved label) and, upon such rejection, TAb
shall credit or, at Searle's election, promptly refund any payment made by
Searle for the supply of such Antidote. TAb shall use its best efforts to
provide Antidote with an approved shelf life of not less than twenty-four (24)
months.
12. Compliance.
12.1 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. and foreign governments (and political
subdivisions thereof).
12.2 TAb agrees to comply with its document change control
management system which may be reviewed by Searle upon request.
12.3 Searle, at its option and sole expense, may inspect and
make a quality control evaluation of each shipment of Antidote. In the event any
shipment fails to conform to the Specifications or shall have been Processed or
Packaged under conditions which do not comply with the provisions of this
Agreement, Searle may reject the same by giving prompt written notice to TAb.
Searle shall destroy or return nonconforming Antidote in compliance with Section
17.4. TAb shall not re-Process such rejected Antidote without the express
written direction of Searle.
12.4 TAb shall perform in-process quality control tests and
all testing for the release of Raw Materials and the Antidote in accordance with
the release Specifications and GMPs. Within five (5) days following each
shipment, TAb shall ship to the destination(s) specified by Searle a Certificate
of Analysis of chemical, physical, and microbiological attributes from each
Batch of Antidote contained in such shipment, a Certificate of Compliance from
such Batch(es) and, if requested by Searle, representative samples from such
Batch(es); provided that any such representative samples shall be supplied to
Searle at Searle's sole cost.
12.5 Any dispute as to whether any shipment of Antidote fails
in whole or part to conform to the Specifications or shall have been Processed,
Packaged or shipped under conditions which do not comply with the provisions of
this Agreement, such dispute shall be promptly resolved by an independent
testing organization of recognized repute within the pharmaceutical industry
mutually agreed upon by the Parties, the appointment of which shall not
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be unreasonably withheld by either party. The fees and costs of such testing
organization and related shipping costs shall be borne by the Party whose
position is not sustained by the testing organization.
12.6 TAb shall retain samples from each Batch of Antidote
Processed or Packaged hereunder in accordance with TAb's Quality Assurance
Policy, Document and Sample Retention, the details of which have been made
available to Searle. In-process sample quantities and testing of such samples by
TAb will comply with procedures specified in the Specifications.
12.7 TAb will conduct stability quality control tests for the
Antidote following the protocol(s) and related documentation listed in the
Specifications. Test results indicating any Antidote which does not conform to
the Specifications must be investigated by TAb in accordance with TAb's
Procedure for Investigation of Out-of-Specification Results. Within thirty (30)
days after commencing such investigation, TAb must notify Searle in writing of
the results of such investigation.
12.8 TAb shall maintain all production Batch and control
records and Batch related documentation as required by regulations, and if
requested by Searle, TAb shall provide Searle access to and copy of all such
records. Such records shall be retained according to TAb's Quality Assurance
Policy, Document and Sample Retention, the details of which have been made
available to Searle.
12.9 Any Batch deviations shall be recorded in TAb's
production Batch records, investigated by TAb and reported to Searle. TAb shall
obtain Searle's approval prior to releasing for shipment Batches affected by any
process deviations outside validated and registered parameters. TAb agrees to
comply with its material review management system, the details of which have
been made available to Searle.
12.10 TAb shall (a) perform and prepare an annual GMP quality
assurance product review ("AQAPR") for the Antidote each year, (b) report to
Searle any adverse findings within a AQAPR within thirty (30) days of the
completion of the respective AQAPR, and (c) upon Searle's request, make
available to Searle a summary AQAPR.
12.11 TAb will not make any changes in the layout or structure
of the equipment in or the operation and structure of the facility in which the
Antidote is Processed or Packaged, which TAb reasonably anticipates will require
approval by the FDA or other Regulatory Authorities unless TAb has Searle's
prior written approval, not to be unreasonably withheld or delayed. TAb shall
not be obligated to obtain Searle's prior consent for any changes required as a
result of the FDA's order, provided TAb promptly notifies Searle of any such
proposed change and consults with Searle regarding such proposed change.
12.12 Should TAb become aware, or Searle discover, that TAb's
methods and procedures for Processing Antidote are not in compliance with the
Specifications, GMPs, the
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Regulatory Approvals or any of the provisions of this
Agreement, TAb shall correct any such deficiencies immediately after obtaining
knowledge thereof.
12.13 TAb warrants to Searle that any information relating to
the Products or their manufacture which is submitted to Regulatory Authorities
by TAb during the term hereof will be prepared with reasonable care and due
diligence customary in the pharmaceutical industry and as required by the
Regulatory Authorities.
12.14 TAb shall utilize a lot numbering system for the
Antidote, the details of which have been made available to Searle. Each Batch
will be assigned a lot number which will appear on all production Batch records.
The release of each Batch of Antidote will be identified by the lot number.
12.15 TAb shall utilize a vendor approval program for vendors
of all Raw Materials to be used in the Processing and Packaging of Products. TAb
will not make any changes to vendors identified in the Regulatory Filings or
Regulatory Approvals without complying with existing regulatory constraints.
12.16 Prior to shipping the Antidote, TAb shall Process and
Package as far as is necessary the appropriate number of Batches for the purpose
of validation. In connection therewith, TAb shall validate all other systems and
procedures used to Process and Package the Antidote. TAb shall conduct such
analyses as are necessary or appropriate for validation and shall make copies of
the analyses and all documents associated therewith available to Searle at
Searle's expense. Searle may, at its option, review and approve TAb's validation
protocols.
12.17 TAb agrees to permit Searle's designated representatives
to whom TAb has no reasonable objection to inspect facilities at which the
Products are Processed, Packaged, stored or tested for the purpose of
determining compliance with applicable regulations and the Specifications at
reasonable times after reasonable notice during regular business hours. Searle's
exercise of these rights shall in no way waive, modify or diminish TAb's
obligations under this Agreement.
12.18 Except as otherwise required by law or Regulatory
Authorities, any recall of the Antidote shall be determined by mutual agreement
of the Parties as a result of good faith discussions. Any dispute as to whether
a recall is necessary shall be promptly resolved by an independent testing
organization of recognized repute within the pharmaceutical industry mutually
agreed upon by the Parties, the appointment of which shall not be unreasonably
withheld by either Party. The fees and costs of such testing organization shall
be borne by the Party whose position is not sustained by the testing
organization. The Parties shall cooperate fully with each other in the conduct
of any recall and provide such assistance in connection therewith as the other
Party hereto may reasonably request. The costs of any recall shall be borne (a)
by the Party whose negligence, breach of this Agreement or other conduct
resulted in such recall, or (b) equally by the Parties if neither Party's
negligence, breach of this Agreement or
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<PAGE> 23
other conduct resulted in such recall. TAb shall notify Searle promptly if any
product (other than the Antidote) manufactured at the facility at which the
Antidote is Processed or Packaged is recalled due to causes which may have an
adverse effect on the Antidote and provide Searle with any information it may
reasonably request to evaluate such possible adverse effect.
12.19 Searle will be responsible for coordinating Antidote
quality complaints. Searle will promptly forward any Antidote quality complaint
received to TAb. TAb will promptly forward any Antidote quality complaint
received to Searle. TAb will investigate all complaints. Searle will promptly
provide TAb such assistance in investigating such complaints as reasonably
requested and in compliance with GMPs. Each Party shall designate a
representative who will handle Antidote quality complaint activities for the
respective Party and coordinate such activities with the other Party. In the
event that either Party determines that a physical, chemical, biological, or
other evaluation should be made in relation to an Antidote quality complaint,
its designated representative will advise the other Party representative of the
basic information. The Parties will make arrangements for TAb to receive samples
of the Antidote or Antidote components to be evaluated. TAb shall promptly
conduct the necessary evaluations and advise Searle of the results of its
evaluation. In the event that either Party requires additional assistance from
the other Party they shall be promptly advised. Searle shall coordinate any
subsequent follow-up and shall close each complaint file. Searle shall provide
TAb with written documentation confirming closure of each complaint.
12.20 Searle 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. and foreign governments (and
political subdivisions thereof).
12.21 TAb shall make best efforts to receive an Establishment
License (as such term is defined by the FDA) for the manufacturing facility at
which the Antidote is manufactured and shall promptly provide Searle with a copy
thereof upon obtaining such approval.
12.22 Neither Party nor their respective agents shall use any
person debarred by the FDA in any capacity in connection with the performance of
their activities in meeting their respective obligations under this Agreement.
13. Trademarks and Proprietary Rights.
13.1 The Antidote will be marketed by Searle under the
Trademarks. Searle shall not use any alternative trademark or other designation
of origin on or in connection with Antidote unless and until Searle has given at
least ninety (90) days' prior written notice to TAb and TAb has approved the use
of such trademark in writing, which approval shall not be unreasonably withheld.
13.2 Searle 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
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<PAGE> 24
labels, designs, cartons, containers, or other packaging or wrapping, and all
related advertising, promotional, and display material which include TAb's
tradename, logo or otherwise make reference to TAb (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
for the Antidote. TAb shall respond to all requests for approval required by
this Section 13.2 within fifteen (15) days of receipt of Searle's written
request and accompanying materials with respect to Packaging and Promotional
Material to be used for the initial distribution of the Antidote and within
seven (7) days thereafter. No approval shall be effective unless in writing and
signed by a TAb officer.
13.3 Searle acknowledges that TAb is the sole and exclusive
owner of all present and future right, title, and interest in and to the
Antidote, including, without limitation, (a) all worldwide patent rights,
including registrations and applications, Regulatory Approvals, Regulatory
Filings, copyrights, and related rights, in or primarily and directly related to
the Antidote 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 Antidote and the Packaging and Promotional
Materials directly related to the Antidote, (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 Antidote. The rights and properties
described in this Section 13.3 are referred to collectively as the "Proprietary
Rights."
13.4 Searle agrees it will not challenge, oppose or cancel, or
permit any act or thing that would endanger any right of TAb in the Proprietary
Rights, nor will Searle claim any proprietary interest in the Proprietary
Rights. Searle shall not apply to register rights in the Proprietary Rights with
any governmental authority.
13.5 During the term of this Agreement, each Party shall
promptly give the other notice of:
(a) any claim or allegation that the exercise of the rights
under this Agreement constitutes an infringement of the rights of any third
party; and
(b) any third party's infringement or threatened infringement
of any of the Proprietary Rights of which it becomes aware.
13.6 TAb will cooperate with Searle at Searle's expense in any
actions taken against any Person infringing any Trademarks. Searle shall have
control over any related prosecution or proceeding and shall bear all costs in
connection with such prosecution or proceeding.
13.7 Nothing in this Agreement shall be construed as an
agreement by TAb to bring actions or suits against third parties for
infringement of any Proprietary Rights, or as a
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<PAGE> 25
representation or warranty as to the nature or incontestability of the
Proprietary Rights.
13.8 Should TAb determine not to pursue any action within
sixty (60) days following any notice of infringement of any Proprietary Rights,
Searle shall have the right (but not the obligation) to pursue any such action,
in which case TAb shall use all reasonable efforts to cooperate in Searle's
handling and prosecution.
13.9 As both a covenant by Searle and a condition of TAb's
authorization of Searle's distribution, Searle will include on all Packaging and
Promotional Material for the Antidote, all patent, and other notices of
Proprietary Rights reasonably required by TAb. Searle agrees not to alter,
erase, deface or overprint any such notice on any item provided by TAb. Searle
agrees that all such packaging and promotional material for the Antidote shall
identify TAb as the source of the Antidote, and agrees to comply with TAb's
reasonable instructions in this regard.
13.10 Upon termination of this Agreement for any reason other
than uncured material breach by TAb, Searle shall assign the Trademarks to TAb
at no cost; provided that TAb shall be responsible for any out-of-pocket costs
with respect to such assignment and transfer.
14. Duration and Termination of Agreement.
14.1 The initial term of this Agreement is ten (10) years from
the Effective Date, unless earlier terminated in accordance with the provisions
hereof, and shall automatically renew for consecutive twenty-four (24) month
periods thereafter unless terminated by either Party upon not less than
twenty-four (24) months written notice.
14.2 If either Party materially breaches any of its
obligations under this Agreement, the other Party may give notice of such
material breach in accordance with the provisions of Section 21.2 hereof. If the
breaching Party does not cure the material breach within thirty (30) days from
the date of receipt of the notice, then the notifying Party may terminate this
Agreement.
14.3 Either Party hereto shall have the right to terminate
this Agreement immediately and without prior notice:
(a) 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 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 (each event constitutes
"Bankruptcy"); or
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<PAGE> 26
(b) if the manufacture, use, sale, distribution, importation
or exportation of the Antidote is enjoined permanently and unavoidably by a
court or administrative agency of competent jurisdiction as infringing the
patent rights of any third party in any country of the Territory; or if it
reasonably determines, on advice of competent patent counsel, that the
manufacture, use, sale, distribution, importation or exportation of the Antidote
unavoidably infringes the patent rights of any third party in any country of the
Territory. Such termination shall be on a country-by-country basis within the
Territory, or at either Party's option the termination shall apply to the whole
of the Territory if the affected country is the United States.
14.4 In the event that the FDA has not accepted for filing the
IND for the Antidote within sixty (60) days of the date on which TAb submits the
IND for the Antidote to the FDA, Searle shall have the right, by written notice
to be sent at any time within thirty (30) days following such date to terminate
this Agreement. If the FDA has not granted a Product License Application
("PLA"), as defined by the Federal Food, Drug and Cosmetics Act and all
regulations promulgated thereunder, for use of the Antidote to *
within ninety (90) days of the date on which TAb submits the PLA to the FDA,
Searle shall have the right, by written notice to be sent at any time within
thirty (30) days following such date to terminate this Agreement, except in the
event that the Material does not have all FDA approvals necessary for the sale
of the Material in the U.S. On the date TAb receives Searle's notice of
termination, all rights and licenses granted to Searle with respect to the
Antidote, including without limitation, the right to distribute and sell the
Antidote, shall terminate and revert to TAb; Searle shall cease all use of all
Proprietary Rights, and each Party shall return the Confidential Information of
the other Party; provided, however, that Searle may keep one copy of all
preclinical and clinical data for the Antidote that it possesses. Upon
termination of this Agreement by Searle pursuant to Section 14.4, TAb shall
promptly reimburse Searle any advance payments by Searle of a portion of the
Supply Price for any unfilled Purchase Orders, less documented Manufacturing
Costs corresponding to unfilled Purchase Orders; provided that in no event other
than when a unit of Antidote in the unfilled Purchase Order exceeds 1.5 grams,
shall Manufacturing Costs per unit of Antidote exceed * .
14.5 The obligations of both parties under Sections 8, 9, 11,
12, 13, 14, 15, 17, 18, 19, 20, and 21 hereof shall survive the expiration or
termination of this Agreement.
14.6 In addition to other remedies available to Searle at law
or in equity, upon termination of this Agreement as a result of an uncured
breach by TAb of its obligations as set forth in Section 14.2, TAb shall
promptly reimburse Searle any advance payments by Searle of a portion of the
Supply Price for any unfilled Purchase Orders, less documented Manufacturing
Costs corresponding to unfilled Purchase Orders; provided that in no event other
than when a unit of Antidote in the unfilled Purchase Order exceeds 1.5 grams
shall Manufacturing Costs per unit of Antidote exceed * .
14.7 Upon expiration or termination of this Agreement (a)
Searle may continue to sell and distribute the Antidote to the extent necessary
to fulfill all orders placed by End Users
* Confidential treatment requested. Omitted material filed separately.
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<PAGE> 27
prior to the date of such termination, and (b) if Searle has existing inventory
of the Antidote in excess of orders placed prior to the date of such
termination, Searle 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.
Except as provided in Sections 5.2 and 5.3, immediately upon such expiration or
termination or, if applicable, upon the expiration of the Sell-Off Period, (i)
Searle shall cease all use of the Antidote, the Packaging and Promotional
Materials, the Trademarks, and all Proprietary Rights, including all
advertisement, promotion, sale, and distribution of the Antidote, (ii) all
rights granted by TAb herein shall revert to TAb, (iii) Searle shall destroy all
Packaging and Promotional Material and certify the same to TAb, provided that
Searle may keep one copy of all Packaging and Promotional Material for archival
purposes , and (iv) Searle shall prepare and deliver to TAb 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.
14.8 Notwithstanding the above, should TAb terminate this
Agreement pursuant to Section 14.2 or 14.3, Searle shall not be entitled to a
Sell-Off Period, the provisions of subparts (i)-(iv) of Section 14.7 shall be
effective immediately, and TAb shall have the right, in its sole discretion,
subject to applicable bankruptcy law in the event of termination pursuant to
Section 14.3, to either (a) purchase all or a portion of the Antidote in
Searle's possession at the Purchase Price paid by Searle, which inventory shall
be returned to TAb or destroyed by Searle at TAb's direction, or (b) permit
Searle to sell such Antidote in Searle's possession.
14.9 Searle shall have the right, upon written notice to TAb,
to terminate this Agreement:
(a) at any time that Searle determines in good faith that
further development or use of the Antidote would be detrimental to the marketing
or commercial viability of the Material; or
(b) in the event Searle terminates pursuing Regulatory
Approval of the Material in the United States.
Upon termination of this Agreement pursuant to Section 14.9, TAb shall
reimburse Searle any advance payment by Searle made within six (6) months of
such termination date in an amount equal to up to * for any unfilled
Purchase Order for at least three thousand (3,000) units, less documented
Manufacturing Costs corresponding to such unfilled Purchase Order; provided that
in no event other than when a unit of Antidote in the unfilled Purchase Order
exceeds 1.5 grams, shall Manufacturing Costs per unit of Antidote exceed
* .
* Confidential treatment requested. Omitted material filed separately.
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15. Indemnification.
15.1 Searle 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 or breach of any provision of the Agreement
or the Global Development Plan by Searle;
(b) any alleged negligence, gross negligence, or intentional
misconduct of Searle;
(c) subject to Section 15.2(c), promotion, distribution, and
sale of the Antidote by Searle; or
(d) defective or negligent manufacture of the Material or of
the Antidote pursuant to Section 5.4;
provided that upon receipt of notice by TAb of any such claims, TAb shall
promptly notify Searle. TAb shall permit Searle to handle such claims at
Searle's sole cost, and TAb shall give Searle all reasonable assistance (except
financial assistance) in the conduct of any such claims. In no event is Searle
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.
15.2 TAb shall indemnify and hold harmless Searle, its
subsidiaries and affiliates, and their officers, directors, employees, agents,
and shareholders, notwithstanding termination of this Agreement from all
liability, damage, cost, or expense (including reasonable attorneys' fees)
relating to any third party claims arising from:
(a) default under or breach of any provision of the Agreement
or the Global Development Plan by TAb; or
(b) any alleged negligence, gross negligence, or intentional
misconduct of TAb;
(c) defective or negligent manufacture of the Antidote by TAb
or any third party designated by TAb; or
(d) any use of the Proprietary Rights, Results, Documentation,
Results or Promotional Materials by TAb or any third party designated by TAb
after termination of the Agreement;
provided that upon receipt of notice by Searle of any such claims, Searle shall
promptly notify TAb. Searle shall permit TAb to handle such claims at TAb's sole
cost, and Searle shall give
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<PAGE> 29
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 Searle.
16. Representations and Warranties.
16.1 Searle represents and warrants that (a) it is a company
duly organized and validly existing under the laws of Delaware; (b) the
execution and delivery by Searle of this Agreement, the performance by Searle 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 Searle, enforceable in
accordance with its terms; (d) this Agreement and the execution and delivery
thereof by Searle, 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 Searle, (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 Searle, or (iii) conflict with, result in a
breach of, or constitute a default under, any material agreement or obligation
to which Searle is a party.
16.2 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.
16.3 Searle represents and warrants that to the best of its
knowledge, use of the Material will not infringe any patent or proprietary
rights of third parties.
16.4 TAb represents and warrants that to the best of its
knowledge use of the Antidote to * will not infringe any patent or
proprietary rights of third parties. TAb
* Confidential treatment requested. Omitted material filed separately.
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has not carried out, nor instructed to be carried out, any searches for any
patent or proprietary rights of third parties which may be relevant. Schedule
16.4 contains a correct and complete list of all patents which (a) are pending,
applied for, granted or registered in any country or jurisdiction, (b) are
either owned by or licensed to TAb or any of its Affiliates, and (c) relate to
the Antidote. It is understood and recognized that such patents listed thereon
may relate to the Antidote only to the extent that the Antidote may be made
using the method described in the patents located in Schedule 16.4. To the best
of its knowledge, TAb owns or possesses, or will own or possess, adequate
licenses or other valid rights to use all patents, patent rights, and Trade
Secrets as necessary to manufacture, distribute, use and sell the Antidote. All
of the patents listed in Schedule 16.4 are, to the best knowledge of TAb, valid
and in full force and effect as of the date of this Agreement, are held of
record in the name of TAb, free and clear of all liens, encumbrances and other
claims, and are not subject to any pending cancellation or reexamination
proceeding or any other pending proceeding challenging their extent or validity.
TAb is the applicant or assignee of record in all patent applications listed in
Schedule 16.4, and no notice of opposition, interference or refusal to register
has been received in connection with any such application.
17. Disclaimer of Warranties; Limited Liability.
17.1 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, even if the other
party has been advised of the possibility of such damages.
17.2 TAb disclaims all implied warranties for the Antidote,
including, without limitation, any warranty of merchantability or fitness for a
particular purpose.
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.
17.3 Searle disclaims all implied warranties for the Material,
including without limitation any warranty of merchantability or fitness for a
particular purpose.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, SEARLE 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.
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17.4 Subject to Section 15.2, TAb's sole liability to Searle
for breach of warranty or for negligence or otherwise shall be, at Searle's
election, to credit, refund or replace promptly, free of charge, any
nonconforming Antidote (i.e. any Antidote that do not conform to the
Specifications at the time of delivery to Searle). Searle shall destroy or
return to TAb all such nonconforming Antidote, as instructed by TAb.
18. Confidentiality.
18.1 In consideration of the disclosure of Confidential
Information, each Party undertakes:
(a) to treat the Confidential Information as strictly
confidential and not permit Confidential Information to be disclosed to third
persons, except as provided herein;
(b) to use the Confidential Information only for the purposes
of this Agreement;
(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
appropriate 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 Party 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 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.
18.2 Upon termination or expiration of this Agreement, the
receiving Party shall deliver to the disclosing Party (a) all Confidential
Information, all copies thereof, and all documents and storage media containing
Confidential Information, providing that the receiving Party may keep one copy
of such Confidential Information for the purpose of demonstrating
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compliance with this Agreement, (b) the names and addresses of all recipients of
Confidential Information, and (c) a written certification that the receiving
Party has complied with its obligations under this Section 18.2.
19. Enforcement.
Each Party acknowledges that in the event of breach of its covenants
under this Agreement, actual damages will be impossible to calculate, that
remedies at law will be inadequate, and the other Party will suffer irreparable
harm. Therefore, the Parties agrees that the foregoing covenants may be
specifically enforced through injunctive relief, but such right to injunctive
relief shall not preclude either Party from other remedies which may be
available to it.
20. Non-Compete.
During the term of this Agreement and in the event that this Agreement
is terminated by Searle as a result of an uncured material breach by TAb, for a
period of five (5) years thereafter, TAb shall, directly or indirectly, not use
or authorize any third party to use the Antidote in connection with any product
which competes with the Material.
21. General.
21.1 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.
21.2 All notices and demands hereunder shall be in writing and
shall be served by personal delivery, by registered mail, by recognized national
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: Searle:
Therapeutic Antibodies Inc. G.D. Searle & Co.
1207 17th Avenue South, Suite 103 5200 Old Orchard Road
Nashville, Tennessee 37212 Skokie, Illinois 60077
Attention: President Attention: President, Research and Development
Fax: 1-615-320-1212 Fax: 1-847-982-8701
with a copy to: Stokes & Bartholomew, P.A.
General Counsel
</TABLE>
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SunTrust Center
c/o G.D. Searle & Co.
424 Church Street, Suite 2800
Fax: (847) 967-2045
Nashville, TN 37219-2386
Attn: Martin S. Brown, Esq.
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
national courier, or upon receipt of fax-back confirmation if sent by facsimile.
21.3 In the event 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 documented expenses incurred by such prevailing party in the litigation.
21.4 This Agreement shall be governed by and construed in
accordance with the laws of the State of New York. The parties agree that any
claims 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
or Chicago, Illinois. 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.
21.5 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.
21.6 Neither party shall be responsible for any failure or
delay in performing its obligations under this Agreement due to unforeseen
circumstances or to causes beyond such party's control, including but not
limited to acts of God, war, riot, embargoes, acts of civil or military
authorities, governmental decrees or regulations, fire, floods, accidents,
strikes, or shortages of transportation facilities, fuel, energy, or materials.
21.7 This Agreement and the Schedules are fully incorporated
herein by this reference hereto and constitute the entire agreement between the
parties pertaining to the subject matter hereof, and supersedes in their
entirety 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.
21.8 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
33
<PAGE> 34
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.
21.9 This Agreement shall not be assigned by either party
without the prior written consent of the other party, and the performance of its
duties shall not be delegated, except as provided in this Agreement; provided,
however, that either party may assign this Agreement to any entity which
acquires substantially all of its assets and business.
21.10 The parties expressly acknowledge and agree that Searle
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 Searle. Nothing in this Agreement shall be
construed as a grant of authority to Searle 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. 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 Searle. Except as
expressly set forth herein, the parties agree that TAb shall neither exercise
control over Searle's method of operations nor provide assistance to Searle.
21.11 Neither party hereto shall solicit any employee of the
other party hereto without the prior written consent of the other party for a
period of at least one year after termination of such employee's employment
agreement with the other party.
21.12 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 Searle, including those related to Searle's performance of this Agreement,
are subject to the sole management and control of Searle.
21.13 This Agreement may be executed in one or more
counterparts, each of which shall constitute an original.
21.14 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.
34
<PAGE> 35
IN WITNESS WHEREOF, each of the parties has caused this Agreement to be
executed in duplicate originals by its duly authorized representative effective
on the date first set forth above.
G.D. SEARLE & CO. THERAPEUTIC ANTIBODIES INC
By: /s/ Phillip Needleman By: /s/ Andrew J. Heath
------------------------------ -------------------------------
Name: Phillip Needleman, Ph.D. Name: Andrew J. Heath
---------------------------- ------------------------------
Title: President, CEO Title: CEO
--------------------------- -----------------------------
35
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