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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 September 30,
1998.
[ ] Transition report pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934. For the transition period from
__________________ to ___________ .
Commission File Number
0-19290
COR THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware 94-3060271
(State or other jurisdiction of (I.R.S. employer
incorporation or organization) identification no.)
256 East Grand Avenue,
South San Francisco, California 94080
(Address of principal executive offices and zip code)
(650) 244-6800
(Registrant's telephone number, including area code)
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 ____
Indicate the number of shares outstanding of each of the issuer's
classes of common stock, as of the latest practicable date.
Common Stock $.0001 par value 24,319,173
Outstanding at October 31, 1998
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COR THERAPEUTICS, INC.
INDEX
<TABLE>
<CAPTION>
PART I. FINANCIAL INFORMATION PAGE NO.
- ------- --------------------- --------
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Item 1. Financial Statements and Notes
Condensed Balance Sheets - September 30, 1998 3
and December 31, 1997
Statements of Operations - for the three and nine months 4
ended September 30, 1998 and 1997
Statements of Cash Flows - for the nine months 5
ended September 30, 1998 and 1997
Notes to Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial Condition 7
and Results of Operations
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K 11
SIGNATURES 12
COR(TM) and INTEGRILIN(TM) are trademarks of COR THERAPEUTICS, INC.
</TABLE>
2
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements and Notes
COR THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
ASSETS
<TABLE>
<CAPTION>
September 30, December 31,
------------- ------------
1998 1997
--------- ---------
(Unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 15,671 $ 22,209
Short-term investments 65,200 60,360
Contract receivables 1,952 422
Prepaid copromotion expenses 15,001 6,422
Other current assets 1,113 564
--------- ---------
Total current assets 98,937 89,977
Property and equipment, net 5,495 5,408
--------- ---------
$ 104,432 $ 95,385
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 3,493 $ 2,446
Accrued compensation 3,504 2,510
Accrued development costs 906 3,155
Accrued pre-commercial costs 3,108 1,256
Deferred revenue 15,794 886
Other accrued liabilities 3,083 1,345
Long-term debt--current portion 841 873
Capital lease obligations--current portion 1,533 1,699
--------- ---------
Total current liabilities 32,262 14,170
Long-term debt--noncurrent portion 2,244 1,014
Capital lease obligations--noncurrent portion 783 1,803
Stockholders' equity 243,015 239,948
Accumulated deficit (173,872) (161,550)
--------- ---------
Total stockholders' equity 69,143 78,398
--------- ---------
$ 104,432 $ 95,385
========= =========
</TABLE>
See accompanying notes.
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COR THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
---------------------- ----------------------
1998 1997 1998 1997
-------- -------- -------- --------
<S> <C> <C> <C> <C>
Contract revenues:
Copromotion revenue $ 1,812 $ -- $ 1,812 $ --
Milestone payments -- -- 32,000 3,000
Development contract revenue 1,040 2,911 1,963 12,816
-------- -------- -------- --------
Total contract revenues 2,852 2,911 35,775 15,816
-------- -------- -------- --------
Expenses:
Cost of copromotion revenue 4,704 -- 4,733 --
Research and development 9,274 11,417 27,964 37,256
Marketing, general and administrative 6,159 2,644 18,169 7,246
-------- -------- -------- --------
Total expenses 20,137 14,061 50,866 44,502
-------- -------- -------- --------
Loss from operations (17,285) (11,150) (15,091) (28,686)
Interest income 1,126 437 3,347 1,684
Interest expense (116) (148) (578) (496)
-------- -------- -------- --------
Net loss $(16,275) $(10,861) $(12,322) $(27,498)
======== ======== ======== ========
Basic and diluted net loss per share $ (0.67) $ (0.54) $ (0.51) $ (1.37)
======== ======== ======== ========
Shares used in computing basic and diluted net loss per share 24,194 20,171 24,056 20,099
======== ======== ======== ========
</TABLE>
See accompanying notes.
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COR THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
Increase (decrease) in cash and cash equivalents
(unaudited, in thousands)
<TABLE>
<CAPTION>
Nine Months Ended
September 30,
----------------------
1998 1997
-------- --------
<S> <C> <C>
Cash flows provided by (used in) operating activities:
Net loss $(12,322) $(27,498)
Adjustments to reconcile net loss to net cash
provided by (used in) operating activities:
Depreciation and amortization 2,511 2,723
Amortization of deferred compensation 359 186
Changes in assets and liabilities:
Contract receivables (1,530) 1,088
Prepaid copromotion expenses (8,579) (2,106)
Other current assets (549) 2,555
Accounts payable 1,047 1,328
Accrued compensation 994 971
Accrued development costs (2,249) (3,420)
Accrued pre-commercial costs 1,852 764
Deferred revenue 14,908 (1,414)
Other accrued liabilities 1,738 (269)
-------- --------
Total adjustments 10,502 2,406
-------- --------
Net cash used in operating activities (1,820) (25,092)
-------- --------
Cash flows provided by (used in) investing activities:
Purchases of short-term investments (88,287) (18,546)
Sales of short-term investments 15,724 40,612
Maturities of short-term investments 68,000 7,500
Additions to property and equipment (2,598) (681)
-------- --------
Net cash provided by (used in) investing activities (7,161) 28,885
-------- --------
Cash flows provided by (used in) financing activities:
Proceeds from long-term debt 1,951 --
Principal payments on long-term debt (753) (943)
Proceeds from capital lease obligations 83 701
Principal payments under capital lease obligations (1,269) (1,193)
Issuance of common stock 2,431 695
-------- --------
Net cash provided by (used in) financing activities 2,443 (740)
-------- --------
Net increase (decrease) in cash and cash equivalents (6,538) 3,053
Cash and cash equivalents at the beginning of the period 22,209 2,615
-------- --------
Cash and cash equivalents at the end of the period $ 15,671 $ 5,668
======== ========
</TABLE>
See accompanying notes.
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COR THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
COR Therapeutics, Inc. ("COR" or the "Company") was incorporated in Delaware on
February 4, 1988. The Company is focused on the discovery, development and
commercialization of novel pharmaceutical products for the treatment and
prevention of severe cardiovascular diseases.
Interim financial information
The accompanying unaudited condensed financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and with the instructions for Form 10-Q and Article 10 of Regulation
S-X. In the Company's opinion, the financial statements include all adjustments,
consisting only of normal recurring adjustments, which the Company considers
necessary to fairly state the Company's financial position and the results of
its operations and its cash flows. The balance sheet at December 31, 1997 has
been derived from the audited financial statements at that date but does not
include all of the information and footnotes required by generally accepted
accounting principles for complete financial statements. The accompanying
financial statements should be read in conjunction with the financial statements
and notes thereto included in the Company's Annual Report on Form 10-K for the
year ended December 31, 1997. The results of the Company's operations for any
interim period are not necessarily indicative of the results of the Company's
operations for any other interim period or for a full fiscal year.
Revenues
Revenues consist of contract revenues and license fees. Contract revenues
include milestone payments, development-related revenues and copromotion-related
revenues. Milestone payments and development contract revenues are recorded as
earned based on the performance requirements of the contracts, while related
costs are expensed as incurred. Copromotion-related contract revenues are
generally recognized at the time of shipment of related product by
Schering-Plough Corporation ("Schering") to wholesalers and are recorded net of
allowances which management believes are sufficient to cover future
requirements. Copromotion-related contract revenues for INTEGRILIN(TM) include
the Company's share of profits, as defined, from the sales of product, as well
as the reimbursement of certain manufacturing-related and marketing expenses
which increase the amount of copromotion-related contract revenue included in
the financial statements. Certain manufacturing-related copromotion expenses are
deferred until the time of shipment of related product by Schering to
wholesalers. Deferred revenue includes payments from Schering received prior to
the period in which the related contract revenues are earned.
Prepaid contract expenses
Prepaid contract expenses represent materials on-hand and deposits associated
with manufacturing-related copromotion expenses.
2. EARNINGS PER SHARE
The Company adopted Statement of Financial Accounting Standard No. 128
("Statement 128"), Earnings Per Share, ("EPS"), for the year ended December 31,
1997. The adoption of Statement 128 had no effect on amounts previously
reported. Basic and diluted net loss per share was calculated using the weighted
average number of shares of common stock outstanding of 24,194,000 and
24,056,000 for, respectively, the three and nine months ended September 30, 1998
and 20,171,000 and 20,099,000, respectively, for the same periods in 1997.
Potentially dilutive securities, such as stock options, are excluded from the
computation as their effect is antidilutive.
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COR THERAPEUTICS, INC.
3. RECENT ACCOUNTING PRONOUNCEMENTS
Effective January 1, 1998, the Company adopted Financial Accounting Standard No.
130 ("Statement 130"), Reporting Comprehensive Income. Statement 130 establishes
new rules for the reporting and display of comprehensive income and its
components; however, the adoption of Statement 130 had no impact on the
Company's financial condition or results of operations. Statement 130 requires
unrealized gains or losses on the Company's available-for-sale securities, which
are recorded separately in stockholders' equity, to be included in other
comprehensive income. Prior period financial statements have been reclassified
to conform to the requirements of Statement 130.
For all periods presented, the differences between the Company's loss as
reported and comprehensive income (loss) were immaterial.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
In addition to the historical information contained herein, this document
includes forward-looking statements which involve risks and uncertainties.
Actual results of the Company's activities may differ significantly from the
potential results discussed in such forward-looking statements. These
forward-looking statements are based on current expectations, and the Company
assumes no obligation to update this information. Risk factors that might cause
such differences include, but are not limited to, those factors identified below
and in the sections titled "Business" and "Business-Additional Risk Factors" in
the Company's Annual Report on Form 10-K for the fiscal year ended December 31,
1997.
The Company's business is subject to significant risks including, but not
limited to, market acceptance of INTEGRILIN(TM), the success of its research and
development efforts, lack of marketing and sales experience, the lengthy and
expensive regulatory process, intense competition, uncertainties related to
clinical trials, and the prosecution and enforcement of patents important to the
Company's business. Even if the Company's potential products appear promising at
various stages of development, they may not reach the market for a number of
reasons. Such reasons include, but are not limited to, the possibilities that
the potential products will be found ineffective during clinical trials, fail to
receive necessary regulatory approvals, be difficult to manufacture on a large
scale, be uneconomical to market or be precluded from commercialization by
proprietary rights of third parties. Additionally, when a product is approved
for commercialization, such as INTEGRILIN(TM), it may not be successful for a
number of reasons, including, but not limited to, competition from competing
products, pharmaceutical pricing and reimbursement practices, risk of product
recalls and potential supply shortages. Additional expenses, delays and losses
of opportunities that may arise out of these and other risks could have a
material adverse effect on the Company's business, financial condition and
results of operations.
OVERVIEW
Since its inception, COR has focused on the discovery and development of novel
pharmaceutical products for the treatment and prevention of severe
cardiovascular diseases. The Company has incurred a cumulative net loss of
$173.9 million during the period from inception to September 30, 1998. The
Company's principal sources of working capital have been primarily public equity
financings and proceeds from collaboration research and development agreements,
as well as private equity financings, interest income and property and equipment
financings.
The Company's lead product is INTEGRILIN(TM) (eptifibatide). INTEGRILIN(TM) has
received marketing approval for the treatment of patients with Acute Coronary
Syndrome ("ACS"), a leading cause of hospitalization in the United States,
including patients who are to be managed medically and those undergoing
Percutaneous Coronary Intervention ("PCI"). INTEGRILIN(TM) is also approved for
the treatment of patients undergoing PCI who do not present with ACS.
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COR THERAPEUTICS, INC.
The Company and Schering-Plough Corporation ("Schering") are worldwide partners
for INTEGRILIN(TM). The Company and Schering co-promote the drug in the United
States and share profits, if any. The Company and Schering launched
INTEGRILIN(TM) in June 1998 in the United States.
Sales of INTEGRILIN(TM) to wholesalers, as reported to COR by Schering, were
$2,300,000 for the quarter ended September 30, 1998, and $3,700,000 from launch
through September 30, 1998. Product sales as reported by Schering for the period
from launch to June 30, 1998 or for the quarter ended September 30, 1998 are not
necessarily indicative of product sales for any other interim period, for a full
fiscal quarter or for a full fiscal year.
In February 1998, the European Union's ("EU") European Medicines Evaluation
Agency accepted for review a centralized Marketing Authorization application for
INTEGRILIN(TM) submitted by Schering. This application seeks European marketing
approval of INTEGRILIN(TM) in the EU for the treatment of patients with unstable
angina and Non-Q-wave Myocardial Infarction and as an adjunct to PCI. Schering
has the right to launch INTEGRILIN(TM) in the EU as an exclusive licensee on a
royalty-bearing basis for a period of time.
In addition to the collaboration agreement with Schering for INTEGRILIN(TM), the
Company has collaboration agreements with Ortho Pharmaceutical Corporation, a
subsidiary of Johnson & Johnson, and Kyowa Hakko Kogyo Co., Ltd.
RESULTS OF OPERATIONS
Three and nine months ended September 30, 1998
Contract revenues of $2.9 million for the three months ended September 30, 1998
were approximately equal to the corresponding period in 1997. The Company
recorded $1.8 million in copromotion revenue during the three months ended
September 30, 1998 resulting from the launch of INTEGRILIN(TM) in June 1998.
Development contract revenues decreased to $1.0 million for the three months
ended September 30, 1998 compared to $2.9 million for the corresponding period
in 1997, primarily due to the completion of PURSUIT, a large Phase III clinical
trail for INTEGRILIN(TM), in the first half of 1997.
Total revenues increased to $35.8 million for the nine months ended September
30, 1998, compared to $15.8 million for the corresponding period in 1997.
Contract revenues for the nine months ended September 30, 1998 included a $24.0
million milestone payment from Schering received in connection with regulatory
approval of INTEGRILIN(TM) in the United States for certain indications and an
$8.0 million milestone payment from Schering received in connection with the
acceptance for review of the centralized Marketing Authorization application
seeking marketing approval for INTEGRILIN(TM) in the EU. The increase in
contract revenues from milestone payments was offset in part by a decrease in
development contract revenues related to INTEGRILIN(TM). Development activities
for INTEGRILIN(TM) in the nine months ended September 30, 1998 were lower than
the corresponding periods of 1997, primarily due to the completion of the
PURSUIT trial.
Cost of copromotion revenue was $4.7 million for the three and nine months ended
September 30, 1998. Cost of copromotion revenue includes certain
manufacturing-related and marketing expenses incurred in connection with the
collaboration with Schering.
Research and development expenses decreased 19% and 25% for the three and nine
months ended September 30, 1998, compared to the corresponding periods in 1997,
primarily due to expenses associated with the completion of the PURSUIT trial in
the first half of 1997. These decreases were offset in part by increased costs
associated with increases in headcount and other research, development and
clinical activities associated with other potential products. The Company
expects research and development expenses to increase over the next several
years, although the timing of certain of these expenses may depend on the timing
and phase of, and indications pursued in, additional clinical trials of
INTEGRILIN(TM) and clinical trials of product candidates in development.
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COR THERAPEUTICS, INC.
Marketing, general and administrative expenses increased 133% and 151% for the
three and nine months ended September 30, 1998, compared to the corresponding
periods in 1997. These increases were primarily due to expenses associated with
increased marketing and sales personnel and the launch of INTEGRILIN(TM), as
well as increases in staffing and administrative expenses associated with
general corporate activities.
LIQUIDITY AND CAPITAL RESOURCES
The Company had available cash, cash equivalents and short-term investments of
$80.9 million at September 30, 1998. Cash in excess of immediate requirements is
invested according to the Company's investment policy, which provides guidelines
with regard to liquidity and return and, wherever possible, seeks to minimize
the potential effects of concentration and credit risk. The Company has funded
its operations to date primarily through public equity financings and proceeds
from collaboration research and development agreements, as well as private
equity financings, interest income and property and equipment financings.
Net cash used in operating activities, offset by additions to capital equipment,
was $4.4 million for the nine months ended September 30, 1998, compared to net
cash used by operating activities and additions to capital equipment of $25.8
million for the corresponding period in 1997. This change was primarily due to
the recognition of milestone revenues related to the collaboration agreement
with Schering. The Company expects that its expenditures for operating
activities and additions to capital equipment will increase in future periods.
The timing of these expenditures may vary from period to period depending on the
timing and phase of, and indications pursued in, clinical trials of
INTEGRILIN(TM) and product candidates in development.
The Company expects that its cash requirements will increase in future periods
due to costs related to continuation and expansion of research and development,
including clinical trials, and increased marketing, sales, general and
administrative activities. The Company anticipates that its existing capital
resources and interest earned thereon will enable it to maintain its operations
at least through 1999. However, the Company's capital requirements may change
depending on numerous factors including, but not limited to, the commercial
success of INTEGRILIN(TM), the progress of the Company's research and
development programs, the scope and results of preclinical studies and clinical
trials, the number and nature of the indications the Company pursues in clinical
trials, the timing of regulatory approvals, technological advances,
determinations as to the commercial potential of the Company's potential
products and the status of competitive products. In addition, expenditures may
be dependent on the establishment and maintenance of collaboration relationships
with other companies, the availability of financing and other factors. The
Company may need to raise substantial additional funds in the future, and there
can be no assurance that such funds will be available on favorable terms, if at
all. If such funds are unavailable, the Company may need to delay or curtail its
research and development activities to a significant extent, which could have a
material adverse effect on the Company's business, financial condition and
results of operations.
YEAR 2000 ISSUE
The Company uses and relies on a wide variety of information technologies,
computer systems and scientific equipment containing computer-related
components. Some of the Company's older computer software programs and equipment
may use two digit fields rather than four digit fields to define the applicable
year (i.e., "98" in the computer code refers to the year "1998"). As a result,
time-sensitive functions of those software programs and equipment may
misinterpret dates after January 1, 2000 to refer to the twentieth century
rather than to the twenty-first century (i.e., "02" could be interpreted as
"1902" rather than "2002"). This condition is commonly referred to as the Year
2000 Issue. The Year 2000 Issue could have a material adverse effect on the
Company's business, financial condition or results of operations.
The Company has developed a strategy to address the potential exposures related
to the Year 2000 Issue on its operations for the Year 2000 and beyond. A review
of key financial, informational and operational
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COR THERAPEUTICS, INC.
systems has been completed. Plans for implementation and testing of any
necessary modifications to these key computer systems and equipment to ensure
that they are Year 2000 compliant have been or are in the final stages of being
developed to address computer system and equipment problems as required by
December 31, 1999. The Company believes that with these plans and completed
modifications, the Year 2000 Issue will not have a material adverse effect on
its business, financial condition or results of operations. However, there can
be no assurance that if these modifications are made in a timely fashion that
they will prevent a material adverse effect on the Company's business, financial
condition or results of operations. If such a material adverse effect were to
occur, the magnitude of it cannot be known at this time. The Company currently
has no contingency plans to deal with major Year 2000 failures, although such
plans will be developed over the coming quarters if they are deemed necessary.
In addition to risks associated with the Company's own computer systems and
equipment, the Company has relationships with, and is to varying degrees
dependent upon, a large number of third parties that provide information, goods
and services to the Company. These include corporate partners, suppliers,
vendors, financial institutions and governmental entities. There can be no
assurance that the systems of other organizations on which the Company may rely
will adequately address the Year 2000 Issue, or that the failure of other
organizations to address the Year 2000 Issue will not have a material adverse
effect on the Company's business, financial condition or results of operations.
The Company has instituted a review of key third parties to assess their
readiness to address the Year 2000 Issue.
The total cost of systems assessments and modifications related to the Year 2000
Issue is funded through operating cash flows and has not been material to date.
The Company is expensing these costs as incurred. The Company has identified
resources to address the Year 2000 Issue. The financial impact of making the
required systems changes cannot be known precisely at this time, but it is
currently expected to be less than $2.0 million. The actual financial impact
could, however, exceed this estimate. These costs are not expected to have a
material adverse effect on the Company's business, financial condition or
results of operations.
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PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
<TABLE>
<S> <C> <C>
10.22 * Long Term Supply Agreement between Registrant and Solvay, Societe Anonyme,
dated September 28, 1995.
10.23 * Amendment No. 1 to the Long Term Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated April 1, 1997.
10.24 * License and Supply Agreement between the Registrant and Solvay, Societe Anonyme,
dated July 27, 1994.
10.25 * First Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated March 13, 1995.
10.26 * Second Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated June 1, 1995.
10.27 * Third Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated September 5, 1995.
10.28 * Letter Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated June 6, 1996.
10.29 * Fourth Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated April 1, 1997.
27.1 Financial Data Schedule
* Confidential treatment requested.
</TABLE>
(a) Reports
There were no reports on Form 8-K filed for the quarter
ended September 30, 1998.
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COR THERAPEUTICS, INC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Date: November 12, 1998
COR THERAPEUTICS, INC.
By: /s/ VAUGHN M. KAILIAN By: /s/ LAURA A. BREGE
-------------------------- ----------------------------------
Vaughn M. Kailian Laura A. Brege
President and Chief Senior Vice President, Finance and
Executive Officer Chief Financial Officer
By: /s/ PETER S. RODDY
----------------------------------
Peter S. Roddy
Director, Finance and Controller
12
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EXHIBIT INDEX
<TABLE>
<S> <C>
10.22 * Long Term Supply Agreement between Registrant and Solvay, Societe Anonyme,
dated September 28, 1995.
10.23 * Amendment No. 1 to the Long Term Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated April 1, 1997.
10.24 * License and Supply Agreement between the Registrant and Solvay, Societe Anonyme,
dated July 27, 1994.
10.25 * First Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated March 13, 1995.
10.26 * Second Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated June 1, 1995.
10.27 * Third Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated September 5, 1995.
10.28 * Letter Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated June 6, 1996.
10.29 * Fourth Amendment to the License and Supply Agreement between Registrant and
Solvay, Societe Anonyme, as amended, dated April 1, 1997.
27.1 Financial Data Schedule
* Confidential treatment requested.
</TABLE>
<PAGE> 1
EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
LONG TERM SUPPLY AGREEMENT
THIS Agreement is entered into effective as of 28 September 1995,
between COR Therapeutics, Inc. ("COR"), a Delaware corporation, with its
principal offices at 256 East Grand Avenue, South San Francisco, California USA
94080, and Solvay, Societe Anonyme ("Solvay"), a Belgian corporation, with its
principal offices at 33, rue du Prince Albert - 1050 Bruxelles, Belgium, each on
behalf of itself and its Affiliates. COR and Solvay are sometimes referred to
herein individually as a "Party" and collectively as the "Parties", and
references to "COR" and "Solvay" shall include their respective Affiliates.
WHEREAS:
COR and Solvay are Parties to a certain License and Supply
Agreement dated 27 July 1994 (the "License Agreement") and a Supply Agreement
dated 27 July 1994 (the "Supply Agreement"); and
COR and Solvay wish to enter into a further agreement for the
long term production and supply of bulk peptide products containing
Integrelin(TM).
NOW, THEREFORE, COR and Solvay agree as follows:
1.0 CERTAIN DEFINITIONS.
1.1 "AFFILIATES" shall mean any entity or person which controls,
is controlled by or is under common control with either Party. For purposes of
this Article 1.1, "control" shall mean (a) in the case of corporate entities,
the direct or indirect ownership of at least one-half of the stock or
participating shares entitled to vote for the election of directors, and (b) in
the case of a partnership, the power to direct the management and policies of
such partnership. Without limitation of the foregoing and for purposes of this
Agreement, Peptisyntha & Cie, Societe en Nom Collectif ("Peptisyntha"), which is
fully owned subsidiary of Solvay and an entity existing under the laws of
Belgium and having its principal offices at 310, rue de Ransbeek - 1210
Bruxelles, Belgium, and also Solvay Duphar B.V., a Dutch corporation having its
main office at C.J. van Houtenlaan, 36, Weesp, The Netherlands, are deemed
Affiliates of Solvay.
1.2 "BULK PRODUCT" shall mean a bulk peptide product which
contains Integrelin(TM), is produced by the Licensed Process (as defined in the
License Agreement) and is intended to undergo further processing, formulation
and/or vialing and packaging.
1.3 "BULK PRODUCT INTERMEDIATES" shall mean [*] used to
manufacture Bulk Product which have been partially processed.
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 2
1.4 "INTEGRELIN(TM)" shall mean a specific peptide designated by
COR and known as Integrelin(TM), the chemical structure of which is known to
Solvay because of the prior business relationship between COR and Solvay.
1.5 "KEY RAW MATERIALS" shall mean [*] reasonably required for
the production of Bulk Product [*].
1.6 "PRODUCTION CAPACITY" shall refer to Solvay's capacity for
manufacturing Bulk Product during a given period of time, considering the
available plant, equipment, personnel and other staff and physical assets.
Production Capacity shall be measured in [*] of Bulk Product per year.
1.7 "PRODUCTION FORECASTS" shall mean the estimates of future
requirements for Bulk Product to be manufactured by Solvay that are prepared by
COR pursuant to Article 3.2.
1.8 "PRODUCTION SUITE" shall mean the plant, equipment, and
other physical assets of Solvay sufficient for the manufacture of an annual unit
amount [*] of Bulk Product through a complete production cycle. A complete
production cycle is considered to start with [*] and end with [*]. A Production
Suite shall be considered "New" until, for the first two New Production Suites,
the [*] and for additional New Production Suites, the end of the [*] following a
request by COR, duly accepted by Solvay, for the establishment of such New
Production Suite pursuant to Article 2.3.
1.9 "PURCHASE ORDER" shall mean a binding order placed by COR
for the production and supply by Solvay of Bulk Product.
1.10 "SPECIFICATION" shall mean the specification for Bulk
Product as agreed to by the Parties and as may thereafter be amended in writing
from time to time by mutual consent to reflect changes in such specifications.
The current Specification is contained in Appendix D.
Unless otherwise defined herein, other capitalized terms used
herein shall have the meaning specified in the License or Supply Agreement. For
convenience, this Agreement may refer to specific provisions or appendices of
the License or the Supply Agreement. Defined terms may be used in their singular
or plural forms.
2.0 ESTABLISHMENT AND RESERVATION OF PRODUCTION CAPACITY.
2.1 INITIAL PRODUCTION CAPACITY. The parties agree that,
pursuant to Section 2.2 of the Supply Agreement, COR has ordered and Solvay has
agreed to supply the [*] of Bulk Product for delivery in 1997, and that COR
shall pay to Solvay [*] of the purchase price for that order within [*] days of
the execution of this Agreement. Solvay represents and COR acknowledges that for
1997, Solvay's Production Capacity will be [*] per year pursuant to this
Agreement, in addition to the capacity required to manufacture the quantity of
Bulk Product already ordered for delivery in 1997 pursuant to the Supply
Agreement.
2.2 PRODUCTION CAPACITY INCREASE. Solvay represents and COR
acknowledges that decisions regarding the establishment of any New Production
Suite(s) will
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 3
need to be made approximately [*] before the [*] in which COR would like to have
the New Production Suite(s) established to allow time for construction and
validation. Therefore, on a timely basis, the Parties shall discuss the
Production Forecasts and the implication of these forecasts on the need for New
Production Suites.
2.3 TIMING OF NEW PRODUCTION CAPACITY COMMITMENTS. Solvay shall
establish [*] New Production Suites before the beginning of 1998 and shall be
able to complete production of Bulk Product in those suites [*]. On [*] and on
[*] during the term of this Agreement, COR may request that Solvay establish
additional New Production Suites capable of complete production of Bulk Product
therein [*] following the request. Within [*] from each [*] when such request
has been made, Solvay shall notify COR whether or not it will establish part or
all of the requested New Production Suites.
2.4 FEE FOR FACILITATION OF NEW PRODUCTION SUITES. In order to
facilitate the establishment by Solvay of New Production Suites, COR shall pay
to Solvay a fee intended to be applicable to the future manufacture of Bulk
Product in the amount of [*] for [*] New Production Suites, and [*] for [*] New
Production Suite whose establishment is agreed upon by Solvay and COR. For each
New Production Suite, such fee payments shall be made in [*] installments:
(a) [*] for the [*] New Production Suites, and for [*]
New Production Suite, within [*] from the receipt by COR of notice by Solvay
that it will establish such additional New Production Suite;
(b) [*] within [*] from delivery of the major equipment
for each New Production Suite, as certified by Solvay; and
(c) [*] within [*] from validation of each New
Production Suite in accordance with Good Manufacturing Practice requirements as
prescribed from time to time by appropriate regulatory agencies, as certified by
Solvay and agreed by COR. In the event COR does not agree with Solvay's
certification of validation, and provided that COR so notifies Solvay within [*]
of COR's receipt of Solvay's certification, COR shall pay to Solvay the [*]
installment subject to return of such installment on demand forthwith in the
event that an independent auditor, agreeable to both COR and Solvay, find that
the facility is not appropriately validated.
2.5 CREDIT FOR FEE PAYMENT. The fee payments made to Solvay
pursuant to Article 2.4 coincident with the establishment of a New Production
Suite shall be credited against future installment payments made pursuant to
Article 8.3(d) for Bulk Product in an amount equal to (i) [*] of the total
purchase price of quantities of Bulk Product produced in the New Production
Suite up to the first [*] per calendar year, and (ii) [*] of the total purchase
price of quantities of Bulk Product produced in the New Production Suite over
[*] per calendar year, until this Agreement is terminated. The fee payments made
to Solvay pursuant to Article 2.4 coincident with the establishment of a New
Production Suite shall not be refundable to COR except in the event of a
material breach by Solvay of its obligations under this Agreement to establish
that particular New Production Suite.
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 4
2.6 RESERVATION OF PRODUCTION CAPACITY. Solvay shall reserve a
Production Capacity of [*] for 1997, in addition to the capacity required to
manufacture the quantity of Bulk Product already ordered for [*]. For 1998,
Solvay shall reserve a Production Capacity of [*] per year. For 1999 and
subsequent years, Solvay shall reserve a Production capacity equal to [*] (a)
the quantity of Bulk Product ordered for manufacture in the previous year [*] or
(b) [*] Production Capacity of all New Production Suite(s). In the event that
the reserved Production Capacity for 1999 or subsequent years is [*], Solvay may
utilize the unreserved capacity for manufacturing activities unrelated to this
Agreement, so long as such activities do not adversely effect the ability of
Solvay to produce Bulk Product in the amounts ordered by COR or the regulatory
status of Integrelin(TM).
3.0 PRODUCTION PLANNING AND FORECASTS.
3.1 PRODUCTION SCHEME. Solvay represents and COR acknowledges
that certain manufacturing steps (described in terms of their timing and yields)
are to be utilized by Solvay in the production of Bulk Product from Bulk Product
Intermediates and certain Bulk Product Intermediates from other Bulk Product
Intermediates or from raw materials at various levels of production. This
production scheme is set forth in Appendix A. Solvay shall provide COR with a
prompt written update of this production scheme whenever the information
provided in Appendix A differs substantially from actual performance.
3.2 PRODUCTION FORECASTS. COR shall provide Solvay with
forecasts of its expected requirements for Bulk Product in accordance with
Section 2.2 of the License Agreement that are prepared in good faith and to the
best of COR's knowledge at the time they are prepared. The Production Forecasts
shall be consistent with the forecasts made by COR for requirements for
Integrelin(TM) worldwide, including [*]. The first Production Forecast is
appended hereto as Appendix B. Subsequent Production Forecasts shall be provided
to Solvay on [*] of each year during the term of this Agreement, but COR may
elect to provide such Production Forecasts more frequently. The Production
Forecasts are provided for the purpose of programming, are not to be construed
as Purchase Orders, and are not binding on COR or Solvay.
3.3 CHANGES TO THE SPECIFICATION. In the event that COR notifies
Solvay of requested changes to the Specification, Solvay shall acknowledge
receipt of such notice within a reasonable time, but in any event no later than
[*]. The Specification shall not be changed without the agreement of both
Parties. To the extent that changes to the Specification accomplish a change in
Production Capacity, Solvay shall so notify COR, and any increases in Production
Capacity created in this fashion shall not require any additional payment by COR
under Article 2.4. Both parties acknowledge that such changes may have an effect
on Appendices A and C.
4.0 PURCHASE ORDERS.
4.1 PURCHASE COMMITMENT. COR agrees to purchase and Solvay
agrees to manufacture and supply an amount of Bulk Product through Purchase
Orders to Solvay. Any Purchase Orders placed under this Agreement do not replace
or supersede the quantities of Bulk Product specified for purchase by COR in
Section 2.2 of the Supply Agreement.
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 5
4.2 ADDITIONAL PURCHASE COMMITMENT. COR shall order from Solvay
a minimum quantity of [*] of Bulk Product to be manufactured in the calendar
years [*]. In the event that COR does not order [*] of Bulk Product for any such
calendar year, COR shall pay a capacity reservation fee for such [*] calculated
as follows: [*]. Such capacity reservation fee shall be paid in [*]
installments, within [*] days of the end of each calendar quarter during the
affected year. The capacity reservation fee may be satisfied (i) in cash or (ii)
by the value of other research, development or manufacturing contracts placed
with Solvay in the field of [*] by COR or by third parties whose arrangements
with Solvay are facilitated by COR, or (iii) a combination of (i) and (ii).
4.3 TIMING OF PURCHASE ORDERS. On [*], COR shall provide Solvay
with a Purchase Order specifying the amount of Bulk Product that COR is ordering
for calendar year 1997. On [*] and on each anniversary thereof during the term
of this Agreement, COR shall provide Solvay with a Purchase Order specifying the
amount of Bulk Product that COR is ordering for the following calendar year.
Solvay shall accept such Purchase Orders as long as the amount ordered does not
exceed the Production Capacity reserved for COR pursuant to Article 2.6 for such
year. Further, COR may elect to increase the amount COR has ordered for a
calendar year by providing Solvay with a supplemental Purchase Order no later
than [*] of the relevant ordering year, which increase Solvay shall accept, as
long as the total amount does not exceed either the Production Capacity reserved
for COR pursuant to Article 2.6 for such year or [*] of the amount of the
Purchase Order placed on [*] for such year.
4.4 SIZE OF ORDERS. For [*] and any subsequent calendar year
during the term of this Agreement, an order for Bulk Product shall be at least
equal to [*] and the total amount of Bulk Product ordered by COR shall not
exceed [*] or [*] of the amount of the Purchase Order placed on [*] for such
year. However, COR may request that Solvay produce [*] and Solvay agrees to use
reasonable efforts to accommodate such request. [*] Solvay shall be entitled to
utilize for manufacturing activities unrelated to this Agreement any unused
Production Capacity as long as such activities do not affect the ability of
Solvay to produce Bulk Product in the quantities ordered by COR or the
regulatory status of Integrelin(TM).
4.5 ACCEPTANCE OF PURCHASE ORDERS. Solvay shall acknowledge in
writing its receipt of and acceptance of a Purchase Order or increased Purchase
Order placed pursuant to this Article within [*] of receipt.
4.6 PRODUCTION SCHEDULING. During the term of this Agreement,
COR may request that Solvay modify the production schedule pertaining to an
outstanding Purchase Order by [*] or more steps of the production scheme of
Appendix A, subject only to the payment to Solvay of a price adjustment
described in Article 4.8, provided that such [*] of the production schedule [*]
does not result in orders for Bulk Product manufacture for that [*] which exceed
the Production Capacity reserved for COR pursuant to Article 2.6. Bulk Product
manufactured only through [*] shall be put into inventory by Solvay pursuant to
Article 5.2, however Solvay represents and COR acknowledges that Bulk Product
manufactured only through [*] of the manufacturing steps in Appendix A and put
into inventory pursuant to this Article 4.6 cannot be kept in inventory for a
period exceeding [*].
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 6
4.7 PRODUCTION CAPACITY REALLOCATION. For 1998 and each
subsequent calendar year, COR may request that Solvay reallocate the use of the
Production Capacity planned by Solvay for Bulk Product manufacture in that year
by rearranging the production schedule pursuant to Article 4.6, according to the
production scheme of Appendix A, subject to the agreement of Solvay which shall
not be unreasonably withheld, provided that the Production Capacity is used [*].
4.8 PRODUCTION POSTPONEMENT AND ORDER CANCELLATION BY COR. Any
[*] pursuant to Article 4.6 shall be subject to the [*]. For Purchase Orders
placed in a given year, such [*] for Purchase Orders [*] of the given year, [*]
for Purchase Orders [*] of the given year, [*] for Purchase Orders [*] of the
following year, [*] for Purchase Orders [*] of the following year, or [*] for
Purchase Orders [*] of the following year. Following a modification of the
production scheme pursuant to Article 4.6, COR may elect to cancel, by notice
given to Solvay within [*] of any such modification, an outstanding Purchase
Order for Bulk Product manufactured only through [*] and retained in inventory
without paying any [*]. After such cancellation, Solvay shall [*] and provide
COR certification [*].
5.0 INVENTORIES, STORAGE AND OWNERSHIP OF RAW MATERIALS AND BULK
PRODUCT INTERMEDIATES.
5.1 RAW MATERIALS INVENTORY. In addition to having available the
amounts of Key Raw Materials required to accomplish the manufacture of the
specific quantities of Bulk Products or Bulk Product Intermediates ordered by
COR for each calendar year during the term of this Agreement, Solvay will
maintain an inventory of Key Raw Materials of not less than the amount necessary
to meet [*] of the production scheduled for that calendar year. The inventory
will be maintained at a facility [*] Such inventory shall be rotated [*].
5.2 INVENTORY OF BULK PRODUCT INTERMEDIATES. During the term of
this Agreement, Solvay will maintain in inventory Bulk Product Intermediates
manufactured up through certain manufacturing steps, as defined in Appendix A,
pursuant to Articles 4.6, 4.7 or 4.8. To the extent possible, such inventory
shall be rotated on a [*] basis, with Bulk Product Intermediates subsequently
manufactured and scheduled for production through to final Bulk Product. Solvay
shall retain samples of lots of each Bulk Product Intermediate to be used in the
manufacture of Bulk Product until such Bulk Product ha been manufactured,
shipped to and accepted by COR.
5.3 BULK PRODUCT INVENTORY. During the term of this Agreement,
Solvay shall notify COR of the completion of the manufacture of each lot of
final, [*] Bulk Product and shall put such lot into inventory at a facility [*]
and for a period not to exceed [*]. Solvay shall deliver all completed Bulk
Product to its inventory facility, and shipments shall be delivered to COR from
that inventory facility.
5.4 STORAGE COST. No separate storage or inventorying costs
pursuant to Solvay's obligations under this Article shall be charged to COR.
5.5 OWNERSHIP. Upon full payment by COR for Bulk Product
pursuant to Article 8.3, COR shall own such Bulk Product. Upon payment by COR
for completion of Bulk
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 7
Product through a particular manufacturing step pursuant to Article 8.0, COR
shall also own those materials and shall be entitled to take possession of them
in the event of material breach of this Agreement by Solvay, or in the event
that Solvay indicates that it will not be able to deliver Bulk Product within
[*] of an agreed shipping date, and such possession shall be COR's only remedy
with respect to these materials in such events.
6.0 QUALITY CONTROL AND REGULATORY MATTERS.
6.1 SOLVAY'S MANUFACTURING COMMITMENT. Solvay shall manufacture
Bulk Product under this Agreement in conformity with the Specification, in a
duly licensed facility as required by the United States Food and Drug
Administration and equivalent European Union regulatory agencies, and in
compliance with applicable laws and regulations and Good Manufacturing
Practices, as prescribed from time to time by these appropriate regulatory
agencies. Each shipment of Bulk Product hereunder shall have been subjected to a
quality control inspection by Solvay in accordance with the Specification and
with Solvay's then-current quality control standards and systems, which shall be
consistent with those agreed between COR and Solvay. Solvay shall number each
shipment with a vendor lot number that is traceable to Key Raw Materials, Bulk
Product Intermediates and/or other components used to manufacture such Bulk
Product and shall maintain all appropriate validation documentation as
reasonably specified by COR and agreed by Solvay, or as required by appropriate
regulatory authorities. Such manufacturing and validation information shall be
communicated to COR pursuant to Section 3.4 of the License Agreement. Solvay
shall permit COR and/or representatives of appropriate regulatory agencies to
review periodically Solvay's Bulk Product manufacturing facilities and testing
procedures at reasonable times with a Solvay representative present, and to
obtain copies of batch records for Bulk Product in order to assure compliance
with the requirements of this Article 6.0.
6.2 COMPLIANCE WITH LAW. Solvay shall be responsible for
complying with all applicable regulatory requirements of the United States, the
European Union, and to the extent applicable, of Member States of the European
Union, for the manufacture, importation and shipment of the Bulk Product
supplied hereunder. Solvay shall give COR prompt written notice of any impending
inspections by a governmental agency of the facility used for or processes
involved in the manufacture of Bulk Product, and provide COR an opportunity to
observe such inspection. Each Party shall promptly notify the other in writing
of new instructions or specifications of which it becomes aware and governmental
inspection reports which are relevant to the manufacture of Bulk Product under
this Agreement and which are required by the United States Food and Drug
Administration, equivalent European Union regulatory agencies, or other
applicable laws or governmental regulations and shall confer with each other
with respect to the best means to comply with such requirements. Solvay shall
assist COR in obtaining and maintaining all approvals and authorizations of any
governmental agencies necessary for the use, sale or distribution of
Integrelin(TM) products, and will notify COR within [*] of any comments,
responses or notices received from any governmental authorities which relate to
the regulatory status of Integrelin(TM). These actions by Solvay shall not be
construed as an admission that Solvay is doing business in the United States.
6.3 NOTIFICATION OF ISSUES. Solvay shall notify COR in writing
within [*] of any issue related to manufacturing or raw material supply, or
other information relating to
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 8
Solvay or the site of manufacture which may affect the regulatory status of
Integrelin(TM) or the ability of Solvay to supply Bulk Product.
7.0 SHIPPING AND ACCEPTANCE OF PRODUCT.
7.1 SHIPPING INSTRUCTIONS. COR shall send to Solvay a request
for shipment of Bulk Product at least [*] prior to a requested date of delivery,
the exact date of delivery to be agreed between COR and Solvay. Solvay shall
acknowledge in writing its receipt of and acceptance of a shipping request
within [*] of receipt and shall use its best efforts to:
(a) ship Bulk Product at the agreed delivery date with
the proper identification on the packaging as required by applicable
authorities; and
(b) fill the entirety of each shipping request from the
same production lot.
7.2 PRODUCT SHIPPING PROCEDURES. Solvay shall ship to a
destination specified by COR all Bulk Product owned by COR pursuant to Article
5.5 and requested to be delivered, by the delivery dates provided in an accepted
shipping request. Bulk Product will be labeled and packaged according to the
Specification. In the event that COR specifies that the Bulk Product be shipped
to a location other than COR's principal offices (e.g., to a different location
[*]), or in the event that COR's shipping request requires that the Bulk Product
by placed into inventory for a period longer than [*], and upon COR's request,
Solvay shall ship a quality control sample to COR's principal offices (or such
other place as COR may designate) in advance of or not later than concurrently
with the shipment of the Bulk Product. Except as provided herein with respect to
non-conforming product, title and risk of loss as to all materials shipped shall
pass [*]. Solvay shall provide a packing list and a certificate of analysis to
COR for every shipment.
7.3 NON-CONFORMING PRODUCT. Bulk Product supplied hereunder
shall be produced by Solvay in accordance with applicable laws and regulations,
including current Good Manufacturing Practices as set forth in the United States
Code of Federal Regulations, in conformance with the Specification. COR may
reject any shipment of Bulk Product which (a) does not conform with the
Specification or (b) is adulterated or misbranded within the meaning of the
United States Federal Food, Drug and Cosmetic Act, equivalent European Union
regulatory agency requirements, or other applicable laws or governmental
regulations. Any notice of rejection of non-conforming product or notice that
the product is adulterated or misbranded must be submitted to Solvay within [*]
after shipment, accompanied by a report of analysis (including a product sample
from the lot analyzed) prepared according to the Specification. If no such
notice of rejection of non-conforming product is submitted, COR shall be deemed
to have accepted such delivery of the product. Product may be rejected as
non-conforming based on analysis of a product sample shipped in advance of or
concurrently with the full lot.
7.4 PROCEDURES AFTER NOTICE OF REJECTION. After notice of
rejection of non-conforming product is given, COR shall cooperate with Solvay in
determining whether rejection is necessary or justified. Solvay shall notify COR
promptly whether or not it accepts COR's
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 9
basis for any rejection. If Solvay disagrees with COR's determination that a
certain product does not meet the Specification, such product shall be submitted
to a mutually acceptable third party laboratory; the fees and expenses of such
laboratory testing shall be borne entirely by the Party against whom such
findings are made. Such third party laboratory shall determine whether such
product meets the Specification and the Parties agree that such laboratory's
determination shall be final and determinative. Whether or not Solvay accepts
COR's basis for rejection, promptly on receipt of a notice of rejection of
non-conforming product, Solvay shall, at COR's request, use its best efforts to
replace such rejected product. In the event that the rejected lot is determined
to not meet the Specification, any moneys paid for the rejected lot shall be
credited against the cost of a replacement lot or returned to COR in the event
Solvay is unable to manufacture a replacement lot. Bulk Product may only be
reprocessed in accordance with validated reprocessing procedures described in
the drug master file, as agreed by the Parties.
Unless Solvay requests the destruction of rejected Bulk Product
within [*] of receipt of COR's notice of rejection of non-conforming product,
COR shall promptly return said Bulk Product to Solvay, at Solvay's cost [*] and
according to shipping instructions in the Specification. COR shall, upon receipt
of a request for destruction of the material, destroy such product promptly,
properly and at Solvay's expense, and provide Solvay with certification of such
destruction. In the event the Bulk Product is rejected by COR on the basis of
analysis of a product sample, Solvay shall retain the relevant lot of Bulk
Product and treat it in the same fashion provided above.
7.5 GOVERNING TERMS. All sales hereunder shall be subject to the
provisions hereof (including the Specification) and shall not be subject to the
terms and conditions contained on any shipping request of COR or confirmation of
Solvay, except insofar as any such shipping request or confirmation establishes:
(a) the quantity of any Bulk Product to be shipped; (b) the agreed delivery
date; (c) the shipment route and destination; or (d) the carrier.
8.0 PRICE AND PAYMENTS.
8.1 PRICES. COR agrees to pay to Solvay the prices for the
manufacture of Bulk Product set forth in Appendix C. Applicable pricing shall be
determined based on the total quantity of Bulk Product ordered in a particular
calendar year.
8.2 PRICE COMPUTATION. The payments to be made by COR to Solvay
for the quantity of Bulk Product stated in a Purchase Order shall be computed by
[*] in Appendix C. COR shall be entitled to a credit pursuant to Article 2.5 for
previous payments made pursuant to Article 2.4.
8.3 INVOICING AND PAYMENT. Payment for Bulk Product shall be
made in the following increments:
(a) Before [*] of each year for Purchase Orders placed
during that year, [*] of the Bulk Product price specified in Appendix C [*] in
the applicable Purchase Order;
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 10
(b) Within [*] of receipt of Solvay's written
certification of the completion of the manufacture of Bulk Product through [*]
as described in Appendix A, [*] of the Bulk Product price specified in Appendix
C [*] stated in the applicable Purchase Order;
(c) Within [*] of receipt of Solvay's written
certification of the completion of the manufacture of Bulk Product through [*]
as described in Appendix A, [*] of the Bulk Product price specified in Appendix
C [*] in the applicable Purchase Order; and
(d) Within [*] of receipt of Solvay's written
certification of the completion of the manufacture of Bulk Product through [*]
as described in Appendix A, [*] of the Bulk Product price specified in Appendix
C [*] in the applicable Purchase Order.
8.4 METHOD OF PAYMENT. All payments shall be made in United
States Dollars by wire transfer to the bank account of [*] or to such account of
Solvay in such bank as Solvay may from time to time designate by notice to COR.
8.5 TAXES. Solvay shall be responsible for all value added
taxes, property taxes, sales tax or any other such tax resulting from sales of
Bulk Product to COR from Solvay or production of Bulk Product or purchase of any
raw materials.
8.6 PROCESS MODIFICATION. It is understood by both parties that
significant manufacturing cost reductions may be possible by negotiating with
regulatory authorities to achieve cost effective product specifications. The
parties shall discuss and agree on a mechanism by which the benefits of process
modifications to which COR contributed are equitably allocated to the parties
according to their relative contribution to a cost reduction.
8.7 COR'S RIGHT TO VERIFY MANUFACTURE CERTIFICATION. COR shall
have the right at its own expense to have an independent third party, acceptable
to Solvay, audit Solvay's production records, during normal business hours and
upon reasonable notice, for the purpose of verifying the manufacture of Bulk
Product in accordance with this Agreement as certified pursuant to Article 8.3.
Solvay's acceptance of the independent third party shall not be unreasonably
withheld.
8.8 OVERDUE PAYMENT. Payments provided for in this Article 8.0,
when overdue, shall bear interest at a rate per annum equal to [*] effective [*]
and for the time period until payment is made by COR.
8.9 [*] Without prejudice to any of Solvay's rights hereunder,
in the event that [*].
8.10 SHORT-TERM DELAY IN SUPPLY FROM NEW PRODUCTION CAPACITY.
Royalties payable to Solvay under the License Agreement will change in the event
that Bulk Product supply is delayed because the FDA or other regulatory
authority deems the New Production Capacity, environmental assessment, or any
other procedure or process followed by Solvay in the manufacture of Bulk Product
unacceptable and the problems cannot be remedied by the reasonable efforts of
Solvay prior to the intended commencement date of manufacture in the New
Production Capacity, resulting in either: i) a delay of less than [*] in the
supply of Bulk
10.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 11
Product; or ii) COR's seeking, for a period of time, the Secondary Source to
produce the quantities that would have been produced by Solvay, if COR and
Solvay nonetheless believe the problems can be remedied in a timely manner. In
either of these circumstances i) or ii), royalties payable to Solvay on Net Bulk
Sales by the Secondary Source as specified in the License Agreement will
decrease by [*] during the time period in question, until all necessary
regulatory approvals are achieved and the Production Capacity can produce the
ordered quantities.
8.11 OTHER DELAY IN SUPPLY. In recognition of the fact that long
term supply disruptions will affect the commercial viability of COR and
Integrelin(TM), in the event that Solvay is unable to consistently supply
conforming Bulk Product according to agreed schedules, then COR may elect to
obtain [*] of its Bulk Product supply needs from the Secondary Source for as
long as Solvay remains unable to supply. Additionally, no royalties shall be
paid during such time period on Net Bulk Sales to COR from a Secondary Source.
9.0 TERM AND TERMINATION.
9.1 TERM. The term of this Agreement shall commence on 28
September 1995 and will continue subject to the provisions of Article 9.2 (a) or
(b) until 31 December 2000. This Agreement shall automatically renew thereafter
in one (1) year increments until terminated pursuant to Article 9.2.
9.2 TERMINATION. This Agreement may be terminated: (a) upon
mutual written agreement between the Parties, (b) by either Party as a result of
a material breach or default in the performance of any obligation, condition or
covenant of this Agreement, if such default or noncompliance shall not have been
remedied, or steps initiated to remedy the same to the other Party's reasonable
satisfaction, within ninety (90) days after receipt by the defaulting Party of a
notice thereof from the other Party, or (c) by either Party on notice of its
intention to terminate, provided that such notice is served on the other Party
at least two (2) years before the termination becomes effective and further
provided that such termination shall not become effective at a time when a
Production Suite is considered "New".
9.3 EFFECT OF TERMINATION. The termination of this Agreement
shall not relieve Solvay from its obligation to deliver Bulk Product, or Bulk
Product Intermediates pursuant to Article 5.5, ordered by Purchase Orders
received and accepted by Solvay prior to the effective date of such termination,
nor shall termination relieve COR from accepting and, upon acceptance, paying
for any such Bulk Product and/or Bulk Product Intermediates. Termination shall
not limit COR's right to sell Integrelin(TM) produced from Bulk Product in its
possession or delivered to it after such termination. The provisions of Articles
6.0, 7.0, 8.0, 10.0 and 11.0 shall survive the termination of this Agreement.
Termination of this Agreement shall not affect the License Agreement or the
Supply Agreement.
10.0 INDEMNIFICATION, LIABILITY AND RECALLS
10.1 COR INDEMNIFICATION. COR shall indemnify, defend and hold
harmless Solvay and Solvay Affiliates from and against all costs, claims, suits,
expenses (including reasonable attorneys' fees) and damages arising out of or
resulting from:
11.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 12
(a) the use by or administration to any person of
Integrelin(TM) (except where such cost, claim, suit, expense or damage arose or
resulted from Solvay's negligence or willful misconduct, or an event specified
in Article 10.2); or
(b) infringement of any third party intellectual
property rights relating to Integrelin(TM) but not to the manufacture of Bulk
Product;
provided that Solvay gives prompt notice in writing to COR of any such claim or
action, tenders the defense of such claim or action to COR, assists COR if
requested by COR, at COR's expense in defending such claim or action and does
not compromise or settle such claim or action without COR's prior written
consent.
10.2 SOLVAY INDEMNIFICATION. Solvay shall indemnify, defend and
hold COR harmless from and against all costs, claims, suits, expenses (including
reasonable attorneys' fees) and damages arising out of or resulting from:
(a) any failure of the Bulk Product supplied by Solvay
under this Agreement to meet the Specification;
(b) any failure of Solvay to manufacture the Bulk
Product in accordance with Good Manufacturing Practices or any other applicable
government law or regulation; and
(c) infringement of any third party intellectual
property right relating to the manufacture, use or sale of Bulk Product but not
to Integrelin(TM) independent of its manufacture;
provided that COR gives prompt notice to Solvay of any such claim or action,
offers to tender the defense of such claim or action to Solvay, assists Solvay
if requested by Solvay, at Solvay's expense in defending such claim or action,
and does not compromise or settle such claim or action without Solvay's prior
written consent.
10.3 LIMITATION OF LIABILITY. Subject to Solvay's obligations
under Articles 10.2(c) and 10.4 and other than for death or personal injury
caused by Solvay's negligent or willful acts, Solvay's liability to COR under
this Agreement shall be limited to the free (to COR) replacement of Bulk Product
within a reasonable time, or the value thereof, provided that the information
Solvay originally submitted to COR about the batch of Bulk Product and the
manufacture of same was accurate. Neither Party shall be liable to the other for
indirect, incidental or consequential damages arising out of any of the terms or
conditions of this Agreement or with respect to its performance.
10.4 RECALLS. Solvay will indemnify and hold COR harmless from
the costs of Bulk Product recalled and up to [*] for any out-of-pocket expense
relating to implementation of a recall of any batch of Bulk Product supplied by
Solvay due to failure to meet the warranties set forth in Article 11.1 below.
For purposes of this Agreement, the expenses of recall shall be the expenses of
notification and destruction or return of the recalled Bulk Product, and any
costs directly associated with the distribution of replacement Bulk Product. COR
shall have the right
12.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 13
to control the arrangement of any recall, and the Parties will cooperate with
each other in implementing such recall.
11.0 WARRANTIES
11.1 WARRANTIES. Solvay warrants:
(a) that it will comply with all manufacturing
instructions and the Specification, including quality control standards provided
in accordance with this Agreement;
(b) that Bulk Product will be produced in accordance
with such instructions and specifications and with Good Manufacturing Practices
and other applicable laws, rules and regulations of the United States, the
European Union, and to the extent applicable, of European Union Member States;
and
(c) that, upon delivery of Bulk Product to [*] Bulk
Product will be in conformity with the Specification and with the United States
Food, Drug and Cosmetic Act, providing, inter alia, that the Bulk Product shall
not be adulterated or misbranded or otherwise of a nature which may not be
introduced into United States interstate commerce.
11.2 NO OTHER WARRANTIES. THE EXPRESS WARRANTIES MADE IN THIS
AGREEMENT, THE LICENSE AGREEMENT AND THE SUPPLY AGREEMENT ARE IN LIEU OF ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
12.0 GENERAL PROVISIONS.
12.1 COMPLAINTS. Solvay will report to COR in writing any
complaints and any information that it may receive relating to Integrelin(TM).
12.2 NOTICES. All notices and demands required or permitted to
be given or made pursuant to this Agreement shall be in writing and shall be
deemed given if delivered personally or be given by facsimile transmission
(receipt verified), telexed, mailed by registered or certified mail (return
receipt requested), postage prepaid, or sent by express courier service (receipt
verified), properly addressed to the address of the Party to be notified as
shown below:
If to Solvay:
Peptisyntha & Cie, SNC
General Manager
310, rue de Ransbeek
B-1210 Bruxelles, Belgium
If to COR:
COR Therapeutics, Inc.
President
13.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 14
256 East Grand Avenue
South San Francisco, California, 94080 U.S.A.
or to such other address as to which either Party may notify the other. Any
notice sent by facsimile transmission or telex shall be followed within
twenty-four (24) hours by a signed notice sent by first class mail, postage
prepaid.
12.3 ASSIGNMENT AND DELEGATION. Solvay may not assign its rights
and/or delegate its obligations under this Supply Agreement to any third party
without the prior written consent of COR, such consent not to be unreasonably
withheld, except in connection with the sale, merger or transfer of
substantially all of the stock or assets of Solvay or the sale, merger or
transfer of substantially all of the interests in or the assets of Peptisyntha
to any party who meets financial and ethical standards generally acceptable
within the pharmaceutical industry, providing that such assignee or delegatee
agrees to be bound by the terms of this Agreement, in which case the consent of
COR is not required. COR may assign its rights hereunder in whole or part, or
delegate any of its obligations hereunder to any party who meets financial and
ethical standards generally acceptable within the pharmaceutical industry,
except without such requirement of standards in connection with the sale, merger
or transfer of all or substantially all of the assets of COR relating to
Integrelin(TM), provided such assignee or delegatee agrees to be bound by the
terms of this Agreement.
12.4 PERFORMANCE BY AFFILIATES. The Parties recognize that each
may perform some or all of its obligations under this Agreement through
Affiliates as specified in this Agreement, provided however, that each Party
shall remain responsible and be guarantor of the performance by its Affiliates
and shall cause its Affiliates to comply with the provisions of this Agreement
in connection with such performance.
12.5 PERFORMANCE BY THIRD PARTIES. The Parties recognize that
Solvay may perform some or all of its manufacture and storage obligations under
this Agreement through a third party, with the prior written consent of COR,
such consent not to be unreasonably withheld. [*] Solvay shall remain
responsible and be guarantor of the performance by third parties performing its
obligations hereunder and shall cause such third parties to comply with the
provisions of this Agreement in connection with such performance.
12.6 GOVERNING LAW. This Agreement shall be governed by and
construed in accordance with the laws of England. Solvay and COR submit
irrevocably to the exclusive jurisdiction and venue of the English courts.
12.7 FORCE MAJEURE. Neither Party shall be liable to the other
for loss or damage, or, except as provided herein, have any right to terminate
this Agreement by virtue of an occurrence which prevents, delays or interferes
with the performance by a Party of any of its obligations hereunder, if such
occurs by reason of any Act of God, flood, fire, explosion, casualty or
accident, or war, revolution, civil commotion, acts of public enemies, blockage
or embargo, or any law, order or proclamation of any government, strike or other
labor trouble, failure of suppliers to deliver materials, equipment or
machinery, interruption of or delay in transportation, or any other cause
whatsoever, whether similar or dissimilar to those above enumerated, beyond the
reasonable control of such Party, if, and only if, the Party affected shall
14.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 15
have used its best efforts to avoid such occurrence. In such an event, the Party
affected shall notify the other and shall attempt to perform its obligations as
soon as possible.
12.8 ENTIRE AGREEMENT. This Agreement, together with the License
Agreement and the Supply Agreement, is the entire agreement between the Parties
with respect to the production of Bulk Product for 1997 and thereafter, and
shall terminate and supersede any prior written or oral promises or
representations with respect to the production of Bulk Product by Solvay for
1997 and thereafter between the Parties not incorporated herein. In the event of
conflict between this Agreement and the License Agreement, the terms of the
License Agreement shall control, except for the provisions of Articles 8.10 and
8.11 of this Agreement which shall be governed by the terms of this Agreement.
No amendment or modification of the terms of this Agreement shall be binding on
either Party unless reduced to writing and signed by the respective authorized
officers of the Parties.
12.9 SEVERABILITY. If any provision of this Agreement is
determined to be illegal or unenforceable by any Court of law or any competent
governmental or other authority, the remaining provisions shall be severable and
enforceable in accordance with their terms so long as this Agreement without
such terms or provisions does not fail of its essential purpose. The Parties
shall negotiate in good faith to replace any such illegal or unenforceable
provisions with suitable substitute provisions which will maintain as far as
possible the purposes and the effect of this Agreement.
12.10 RELATIONSHIP OF THE PARTIES. Nothing in this Supply
Agreement is intended or shall be deemed to constitute a partnership, agency,
employer-employee or joint venture relationship between the Parties. All
activities by the Parties hereunder shall be performed by them as independent
contractors. Neither Party shall incur any debts or make any commitments for the
other Party, except to the extent, if at all, specifically provided herein. No
right, express or implied, is granted by this Agreement to either Party to use
in any manner the name of the other or any other trade name or trade mark of the
other in connection with the performance of this Supply Agreement. Solvay shall
not, without first obtaining the written consent of COR, in any manner disclose
or publish the terms of this Agreement and/or the fact that Solvay has
contracted to furnish COR the goods and services which are the subject of this
Agreement.
12.11 WAIVER. Failure of either Party to insist upon strict
observance of or compliance with any of the terms of this Supply Agreement in
one or more instances shall not be deemed to be a waiver of its rights to insist
upon such observance or compliance with the other terms hereof, at that point in
time or in the future.
12.12 HEADINGS. All headings, titles and captions in this
Agreement are for convenience only and shall not be of any force or substance.
12.13 COUNTERPARTS. This Supply Agreement may be executed in
multiple counterparts, each of which shall be an original, but all of which
shall constitute but one agreement.
15.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 16
IN WITNESS WHEREOF, the Parties hereto have executed this Supply
Agreement to be effective on the date first set forth above.
COR THERAPEUTICS, INC. SOLVAY S.A.
By: By:
-------------------------------- --------------------------------------
Title: Title:
----------------------------- -----------------------------------
Appendix A: Production Scheme
Appendix B: Production Forecast
Appendix C: Bulk Product Price
Appendix D: Bulk Product Specification
16.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 17
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX A
PRODUCTION SCHEME
[*]
17.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 18
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX B
PRODUCTION FORECAST
[*]
18.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 19
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX C
BULK PRODUCT PRICE
The reference price for Bulk Product at the Specification, [*] shall be:
[*]
The unit price for Bulk Product shall be computed by [*].
19.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 20
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX D
BULK PRODUCT SPECIFICATION
I. BULK PRODUCT CONTENT AND TESTING
[*]
- -----------------------------
[*]
20.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 21
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
[*]
[*]
21.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 22
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
[*]
22.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 1
EXHIBIT 10.23
CONFIDENTIAL TREATMENT REQUESTED = [*]
CERTAIN CONFIDENTIAL INFORMATION CONTAINED
IN THIS DOCUMENT, MARKED BY BRACKETS, IS
FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
AMENDMENT NO. 1 TO
THE LONG TERM SUPPLY AGREEMENT
BETWEEN COR THERAPEUTICS, INC.
AND
SOLVAY, S. A.
THIS AMENDMENT NO. 1 to the Long Term Supply Agreement (the
"Amendment") is entered into between COR Therapeutics, Inc. ("COR"), a Delaware
corporation, with its principal offices at 256 East Grand Avenue, South San
Francisco, California, USA 94080, and Solvay, Societe Anonyme ("Solvay"), a
Belgian corporation, with its principal offices at 33, rue du Prince Albert,
1050 Bruxelles, Belgium, each on behalf of itself and its Affiliates. This
Amendment shall be effective on April 1, 1997 (the "Amendment Effective Date").
RECITALS
WHEREAS, COR and Solvay entered into a License and Supply Agreement
dated 27 July 1994 (the "License and Supply Agreement") and a Long Term Supply
Agreement dated 28 September 1995 (the "Long Term Supply Agreement"), to provide
for the manufacture of a bulk peptide product and for the supply of that product
to COR for commercial and clinical use; and
WHEREAS, the Long Term Supply Agreement provided, in Article 2.3, for
the establishment by Solvay of [*] New Production Suites before the beginning of
[*] and it is Solvay's present intention to increase its capacity through a
Facility Expansion according to the Expansion Plan; and
WHEREAS, under this Amendment, the parties confirm their approval and
support of the Expansion Plan according to the terms herein.
NOW, THEREFORE, in consideration of the foregoing and the covenants and
promises contained in this Amendment, COR and Solvay hereby amend the Long Term
Supply Agreement as follows.
In this Amendment, capitalized terms shall have the meanings provided
herein or otherwise provided by the License and Supply Agreement or the Long
Term Supply Agreement. Headings are for the convenience of the Parties only, and
shall not be of any force or substance.
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 2
1. Article 1.3a shall be inserted after Article 1.3 as follows:
1.3a "DILIGENT EFFORTS" means the carrying out of activities in a
sustained manner consistent with the efforts a Party devotes to a product of
similar market potential, profit potential or other value resulting from its own
research efforts, based on conditions then prevailing. Diligent Efforts requires
that (i) the Party promptly assign responsibility for such activities to
specific employee(s) who are held accountable for progress and monitor such
progress on an ongoing basis, (ii) the Party set and consistently seek to
achieve specific and meaningful objectives for carrying out such obligations,
and (iii) the Party consistently make and implement decisions and allocate
resources designed to advance progress with respect to such objectives.
2. Article 1.3b shall be inserted after Article 1.3a as follows:
1.3b "EXPANSION PLAN" shall refer to the plan and timeline for the
design, construction and validation of new Production Capacity, current as of
the Amendment Effective Date, provided to COR as the "Peptisyntha Facility
Expansion Summary Description Prepared for the [*] Meeting" dated [*] together
with the Amendment to that document attached hereto as Appendix H. The Expansion
Plan shall include the ordering, installation and validation of [*] identified
in that plan and specified in the Equipment List attached as Appendix E.
3. Article 1.3c shall be inserted after Article 1.3b as follows:
1.3c "1997 FACILITY EXPANSION" shall refer to Solvay's new
Production Capacity established according to the Expansion Plan.
4. Article 1.4 shall be deleted and replaced with the following:
1.4 "INTEGRILIN" shall refer to a specific peptide designated by
COR and known as INTEGRILIN(TM), which same peptide was known previously as
"Integrelin", the chemical structure of which is known to Solvay because of the
prior business relationship between COR and Solvay. Any references herein to
Integrelin shall be deemed to refer to Integrilin.
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 3
5. Article 1.11 shall be inserted after Article 1.10 as follows:
1.11 "STEP ONE INTERMEDIATES" shall refer to those Bulk Product
Intermediates which exist upon completion of the manufacture of Bulk Product
through [*] as described in Appendix A, namely Bulk Product Intermediates [*].
6. Article 2.3 shall be deleted in its entirety and shall be replaced with
the following:
2.3 TIMING OF NEW PRODUCTION SUITE COMMITMENTS. On [*] and on [*]
during the term of this Agreement, COR may request that Solvay establish
additional New Production Suites capable of complete production of Bulk Product
therein [*] following the request. Within [*] from each [*] when such request
has been made, Solvay shall notify COR whether or not it will establish part or
all of the requested New Production Suites.
7. Article 2.3a shall be inserted following Article 2.3 as follows:
2.3a 1997 FACILITY EXPANSION. Solvay shall proceed with Diligent
Efforts to complete its planned 1997 Facility Expansion according to the
Expansion Plan and the timelines set forth therein. Solvay's progress on the
1997 Facility Expansion shall be monitored by [*] a [*] company having an
address at [*] in accordance with the provisions of the Confidentiality
Agreement between COR, Solvay and [*] has been retained by COR which shall be
solely responsible for compensation of [*] under this contract. [*] shall
monitor the 1997 Facility Expansion (including the design, construction and
validation plans) and report to COR and Solvay on an ongoing basis until the
1997 Facility Expansion is completed [*]. In the event [*] is not able or
willing to perform the tasks identified in this Article, COR shall have the
right to appoint another comparable firm to perform these tasks.
8. Article 2.3b shall be inserted following Article 2.3a as follows:
2.3b APPLICATION OF FEES PAID FOR NEW PRODUCTION SUITES. The
Parties acknowledge the payment by COR to Solvay of [*] in [*] for the
facilitation of New Production Suites according to Article 2.4(a), and also [*]
in [*] for the 1997 Facility Expansion according to Article 2.3c(a). Upon
execution of this Amendment, Solvay may apply this money to its 1997 Facility
Expansion activities. The parties further acknowledge the accrued interest on
this payment, in the agreed amount of [*]. For their mutual convenience, the
parties hereby confirm
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 4
that the credits available to COR according to Article 2.5 by reason of payments
made through the Amendment Effective Date consist of [*].
9. Article 2.3c shall be inserted following Article 2.3b as follows:
2.3c FEE FOR FACILITATION OF 1997 FACILITY EXPANSION. In addition
to the payment referred to in Article 2.3b above, COR will facilitate the 1997
Facility Expansion with [*] additional milestone payments:
(a) [*] which was paid to Solvay in [*] upon receipt of
notification by Solvay of:
(i) delivery of all major equipment (list attached as Appendix
E to this Amendment), and
(ii) certification by Solvay of completion of the new
construction according to the Expansion Plan, including [*].
If there is a good faith dispute between the Parties about the
milestone being met, then the issues will be put before an
independent auditor agreeable to both COR and Solvay, and the
milestone payment will not be made unless the auditor finds
that it is due; and
(b) [*] to be paid for [*] according to the activities lists and
Plan provided to COR by [*] as the "Solvay Commissioning and Validation Schedule
Overall Project" dated [*] (Appendix I) as well as the Master Validation Plan
already agreed to by COR and Solvay [*] within [*] of Solvay's certification of
completion of [*] and [*] within [*] of Solvay's certification of completion of
all [*]. In the event COR does not agree with Solvay's certification of [*] and
provided that COR so notifies Solvay within [*] of COR's receipt of Solvay's
certification, COR shall pay the appropriate portion of this milestone payment
subject to return of such payment on demand forthwith in the event that an
independent auditor, agreeable to both COR and Solvay, finds that [*] was not
appropriately [*]. In the event COR's 1997 Purchase Order is [*] as a result of
the rescheduling procedure provided in Article 4.6 such that [*] of the 1997
Facility Expansion [*] using material manufactured under CORs 1997 Purchase
Order [*] then the payment provided in this Paragraph (b) of Article 2.3c shall
be made upon Solvay's certification of completion of all [*] subject to audit as
above.
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 5
10. Article 2.5 shall be deleted in its entirety and shall be replaced with
the following:
2.5 CREDIT FOR FEE PAYMENT. The fee payments made to Solvay
pursuant to Article 2.4 coincident with the establishment of New Production
Suites, if any, and pursuant to Article 2.3b and Paragraph (b) of Article 2.3c
coincident with the 1997 Facility Expansion, shall be credited against future
installment payments made pursuant to Article 8.3(c) for Bulk Product in an
amount equal to (i) [*] of the total purchase price of quantities of Bulk
Product produced in the New Production Suite or 1997 Facility Expansion up to
the first [*] per calendar year, and (ii) [*] of the total purchase price of
quantities of Bulk Product produced in the New Production Suite or 1997 Facility
Expansion over [*] per calendar year, until this Agreement is terminated. The
fee payments made to Solvay pursuant to Article 2.4 coincident with the
establishment of a New Production Suite, and pursuant to Articles 2.3b and 2.3c
coincident with the 1997 Facility Expansion, shall not be refundable to COR
except in the event of a material breach by Solvay of its obligations under this
Agreement to establish that particular New Production Suite or 1997 Facility
Expansion.
11. Article 2.6 shall be deleted in its entirety and shall be replaced with
the following:
2.6 RESERVATION OF PRODUCTION CAPACITY. Solvay shall reserve a
Production Capacity of [*] for 1997, in addition to the capacity required to
manufacture the quantity of Bulk Product already ordered for [*]. For 1998,
Solvay shall reserve a Production Capacity of [*] per year. For 1999 and
subsequent years, Solvay shall reserve a Production Capacity equal to [*](a)
the quantity of Bulk Product ordered for manufacture [*] Production Capacity of
the 1997 Facility Expansion [*], or (b)[*] Production Capacity of the 1997
Facility Expansion [*]. In the event that the reserved Production Capacity for
1999 or subsequent years is [*] Solvay may utilize the unreserved capacity for
manufacturing activities unrelated to this Agreement, so long as such activities
do not adversely effect the ability of Solvay to produce Bulk Product in the
amounts ordered by COR or the regulatory status of Integrilin(TM).
12. Article 3.4 shall be inserted following article 3.3 as follows:
3.4 PRODUCTION AND COMPLIANCE TEAM. The Parties acknowledge that
they have previously established and hereby agree to maintain a Production and
Compliance Team (PCT), composed of members appointed by COR and appointed by
Solvay. The role of the PCT will be to review Solvay and its subcontractors'
planned and actual manufacturing of Bulk Product
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 6
Intermediates and Bulk Product, including, [*]. The PCT shall not have the
authority to amend this or any other Agreements between COR and Solvay.
13. Section 3.5 shall be inserted after Section 3.4 as follows:
3.5 PERSONNE DE CONFIANCE. Solvay agrees that COR may designate a
"Personne de confiance", who will be a COR employee or COR consultant. He or she
shall have the mission to improve communications between SOLVAY and COR and to
identify issues and facilitate their prompt resolution. Such mission shall
consist of the following activities:
[*]
Any additional activity is subject to Solvay's approval.
Under appropriate confidentiality arrangements with Solvay, the Personne de
confiance will have access to the same information that could be communicated to
any other COR personnel, except technology transfer agents (also referred to by
the parties as TTAs). However, the Personne de confiance shall not have the
power to make contractual commitments on behalf of COR, amend this Amendment or
any other agreements between COR and Solvay or enter into any other agreements
on behalf of COR without specific written authorization from COR. COR may change
its designated Personne de confiance as necessary, provided he or she signs a
confidentiality agreement in substantially similar form to that signed by [*] (a
copy of which is attached hereto as Appendix F).
14. Article 5.1a shall be inserted following Article 5.1 as follows:
5.1a AVAILABILITY OF PRODUCTION OF BULK PRODUCT INTERMEDIATES [*]
On an ongoing basis for each year during the term of this Long Term Supply
Agreement, Solvay guarantees the availability of the [*] for the production of
sufficient Bulk Product Intermediate [*] to satisfy all of Solvay's Bulk Product
production commitments, up to a level of each which is equivalent to that
quantity required to manufacture [*] of Bulk Product until the time when Solvay
has qualified (through [*]) and guarantees the availability of [*] having at
least the same capacity.
15. Article 5.1b shall be inserted following Article 5.1 as follows:
5.1b AVAILABILITY OF PRODUCTION OF BULK PRODUCT INTERMEDIATE [*] On
an ongoing basis for each year during the term of this Long Term Supply
Agreement, Solvay guarantees the production of Bulk Product Intermediate [*] up
to a level equivalent to that quantity which is
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 7
required to manufacture [*] of Bulk Product until the time when Solvay has
qualified (through [*]) and guarantees the availability of [*] having at least
the same capacity. In the event of a sale, merger or transfer of substantially
all of the stock or assets of the [*] Long Term Supply Agreement.
16. Article 5.1c shall be inserted following Article 5.1 as follows:
5.1c Solvay commits to the establishment of [*] agreements with [*]
for the manufacture of sufficient quantities of the Bulk Product [*] to satisfy
[*] of Solvay's production commitments up to a maximum of [*] of Bulk Product
per year. Such agreements shall be entered into by the [*] the first product
regulatory approval from the U.S. Food and Drug Administration ("U.S. FDA") or
the European Agency for the Evaluation of Medicinal Products ("EMEA"). COR will
be given copies of all such supply agreements promptly [*].
17. Article 5.2 shall be deleted in its entirety and shall be replaced with
the following:
5.2 INVENTORY OF BULK PRODUCT INTERMEDIATES. During the term of
this Agreement, Solvay will maintain in inventory Bulk Product Intermediates
manufactured up through certain manufacturing steps, as defined in Appendix A,
pursuant to Articles 4.6, 4.7 or 4.8. To the extent possible, such inventory
shall be rotated [*] with Bulk Product Intermediates subsequently manufactured
and scheduled for production through to final Bulk Product. Solvay shall retain
samples of lots of each Bulk Product Intermediate to be used in the manufacture
of Bulk Product until such Bulk Product has been manufactured, shipped to and
accepted by COR. COR will be informed by Solvay at least [*] on the level of
inventories of all Bulk Product Intermediates and on the scheduled production of
Bulk Product Intermediates.
18. Article 5.2a shall be inserted following Article 5.2 as follows:
5.2a INVENTORY OF BULK PRODUCT INTERMEDIATES [*] In addition to the
provisions of Article 5.2, commencing [*] the first regulatory approval from the
U.S. FDA or the EMEA, for that calendar year and each subsequent year, Solvay
shall have and maintain at all times an inventory of Bulk Product [*] at a level
that is at least [*] greater than that required to satisfy the Purchase Orders
in effect for that calendar year. If COR requests that Solvay maintain an
inventory of Bulk Product Intermediates at a higher level, then Solvay shall
produce the higher quantities of inventories, [*](i)[*] a Purchase Order that
would utilize these higher quantities of
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 8
inventories, (ii) they may be purchased by COR for use by another authorized
manufacturer, and will be purchased for this purpose [*] according to Article
5.2b below, or (iii) COR may purchase them from Solvay [*].
19. Article 5.2b shall be inserted following Article 5.2a as follows:
5.2b SUPPLY OF [*] TO OTHER MANUFACTURERS. Solvay agrees to supply
the Secondary Source [*] with the [*] according to the terms described in
Appendix G provided reasonable delivery schedules can be agreed. If COR wants to
deliver to the Secondary Source [*] higher quantities of inventories ordered
under Article 5.2a above, they will be provided by Solvay [*] in amounts of each
intermediate sufficient to produce designated quantities of Bulk Product.
20. Article 5.2c shall be inserted following Article 5.2b as follows:
5.2c ADDITIONAL BULK PRODUCT INTERMEDIATE SUPPLIERS. In the event
COR orders [*] of Bulk Product in a particular year, then Solvay shall promptly
qualify an additional supplier [*] for each subcontracted Bulk Product
Intermediate. This additional supplier may be either a third party or a Solvay
facility (including the 1997 Facility Expansion).
21. Article 5.3 shall be deleted in its entirety and shall be replaced with
the following:
5.3 BULK PRODUCT INVENTORY. During the term of this Agreement,
Solvay shall notify COR of the completion of the manufacture of each lot of
final, [*] Bulk Product and shall ship such lot promptly to COR or COR's
designee according to the Shipping Procedures described in Article 7.2. COR may
however request that such shipment be postponed for a period not to exceed [*].
In such event, Solvay shall put such lot into inventory at a facility [*] until
it is shipped.
22. Article 5.5 shall be deleted in its entirety and shall be replaced with
the following:
5.5 OWNERSHIP OF [*] Upon payment by COR for completion of the
Manufacture of [*] pursuant to Article 8.3, COR shall own such [*] and shall be
entitled to take possession of such paid-for [*] in the event of material breach
of this Agreement by Solvay, or in the event that Solvay indicates that it will
not be able to deliver Bulk Product within [*] after an agreed shipping date,
and such possession shall be COR's only remedy with respect to these materials
in such events.
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 9
23. Article 7.2 shall be deleted in its entirety and shall be replaced with
the following:
7.2 PRODUCT SHIPPING PROCEDURES. Solvay shall ship to a
destination specified by COR all Bulk Product requested to be delivered, by the
delivery dates provided in an accepted shipping request. Bulk Product will be
labeled and packaged according to the Specification. Notwithstanding contrary
provisions in the Specification, however, Bulk Product shall be packaged in a
shipping container approved by COR and supplied by Solvay. Solvay shall invoice
such shipping containers to COR at Solvay's direct cost. In the event that COR
specifies that the Bulk Product be shipped to a location other than COR's
principal offices (e.g., to a different location [*], or in the event that COR's
shipping request requires that the Bulk Product be placed into inventory for a
period longer than [*] and upon COR's request, Solvay shall ship a quality
control sample to COR's principal offices (or such other place as COR may
designate) in advance of or not later than concurrently with the shipment of the
Bulk Product. Except as provided herein with respect to non-conforming product,
title and risk of loss as to all Bulk Product shipped shall pass to [*]. In the
event that, upon COR's request pursuant to Article 5.3, shipment of a lot of
Bulk Product is not made promptly after the completion of manufacture of such
lot and therefore such lot is placed into inventory, title shall pass to [*].
Solvay shall provide a packing list and a certificate of analysis to COR for
every shipment.
24. Article 7.3 shall be deleted in its entirety and shall be replaced with
the following:
7.3 NON-CONFORMING PRODUCT. Bulk Product supplied hereunder shall
be produced by Solvay in accordance with applicable laws and regulations,
including current Good Manufacturing Practices as set forth in the United States
Code of Federal Regulations, in conformance with the Specification. COR may
reject any shipment of Bulk Product which (a) does not conform with the
Specification or (b) is adulterated or misbranded within the meaning of the
United States Federal Food, Drug and Cosmetic Act, equivalent European Union
regulatory agency requirements, or other applicable laws or governmental
regulations. Any notice of rejection of non-conforming product or notice that
the product is adulterated or misbranded must be submitted to Solvay within [*]
after shipment, accompanied by a report of analysis (including a product sample
from the lot analyzed) prepared according to the Specification. If no such
notice of rejection of non-conforming product is submitted, COR shall be deemed
to have accepted such delivery of the product. Product may be rejected as
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 10
nonconforming based on analysis of a product sample shipped in advance of or
concurrently with the full lot.
25. Article 8.3 shall be deleted in its entirety and shall be replaced with
the following:
8.3 INVOICING AND PAYMENT. Payment for Bulk Product shall be made
in the following increments:
(a) Before the [*] for Purchase Orders placed during that year,
[*] of the Bulk Product price specified in Appendix C [*] in the applicable
Purchase Order;
(b) Within [*] of receipt of Solvay's written certification of the
completion of the manufacture of Bulk Product through [*] as described in
Appendix A, [*] of the Bulk Product price specified in Appendix C [*] stated in
the applicable Purchase Order; and
(c) Within [*] of receipt of Solvay's written certification of the
completion of the manufacture and delivery to Solvay's inventory of a lot of
Bulk Product (if upon COR's request pursuant to Article 5.3 shipment is not made
promptly after completion of the manufacture), or within [*] of receipt of
Solvay's written certification of the completion of the manufacture and shipment
of a lot of Bulk Product to COR or COR's designee, [*] of the Bulk Product price
specified in Appendix C [*] in that lot.
26. Except as otherwise amended herein, the Long Term Supply Agreement
shall remain in full force and effect.
10.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 11
IN WITNESS WHEREOF, the Parties hereto have executed this Amendment.
COR THERAPEUTICS, INC. SOLVAY, S.A.
By: By:
-------------------------------- --------------------------------
General Manager Research
and Development
Title:
-----------------------------
Appendix E: List of Major Equipment
Appendix F: Personne de Confiance Confidentiality Agreement
Appendix G: Sample Purchase Order [*]
Appendix H: Amendment to Facility Expansion Summary Document
Appendix I [*] Report
11.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 12
CERTAIN CONFIDENTIAL INFORMATION CONTAINED
IN THIS DOCUMENT, MARKED BY BRACKETS, IS
FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
LIST OF MAJOR EQUIPMENT
APPENDIX E
NO. ITEM
[*]
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 13
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
CONFIDENTIALITY AGREEMENT
THIS AGREEMENT is entered into effective as of October 10, 1996 among:
SOLVAY, Societe Anonyme ("SOLVAY"), a Belgian corporation, with its
principal offices at 33, rue du Prince Albert, 1050 Brussels, Belgium, on behalf
of itself and its Affiliates; and
COR THERAPEUTICS, INC. ("COR"), a Delaware corporation, with its
principal offices at 256 East Grand Avenue, South San Francisco, California
94080, USA, on behalf of itself and its Affiliates; and
[*] a designee of COR with an address at [*].
WITNESSETH:
WHEREAS, COR owns certain patent rights, trademarks and know-how
relating to a product called INTEGRILIN(TM).
WHEREAS, SOLVAY has developed a unique and valuable patented and
proprietary process useful for the manufacture of peptides, and is practising
the said process for the manufacture of bulk peptide products containing
INTEGRILIN sold to COR, pursuant to several Agreements entered into between
SOLVAY and COR.
WHEREAS, SOLVAY has agreed to disclose confidential information to the
RECIPIENT who has been duly appointed as "Homme de Confiance" by COR with
responsibility for coordination of certain communications between COR and
PEPTISYNTHA, an Affiliate of SOLVAY, such mission being described in the
APPENDIX hereof and being subject to updating from time to time by SOLVAY and
COR.
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 14
NOW, THEREFORE, in consideration of the foregoing and the mutual promises
contained herein, the parties agree as follows:
1.0. CERTAIN DEFINITIONS
For the purposes of this Agreement, the following terms shall have the
following meanings:
1.1 "AFFILIATES" shall mean any entity or person which controls, is
controlled by or is under common control with either Party. For
purposes of this section 1.1., "control" shall mean:
(a) in the case of corporate entities, the direct or indirect
ownership of at least one-half of the stock or participating
shares entitled to vote for the election of directors, and
(b) in the case of a partnership, the power to direct the
management and policies of such partnership.
Without limitation on the foregoing and for purposed of this Agreement,
PEPTISYNTHA & Cie, Societe en Nom Collectif ("PEPTISYNTHA"), which is a
fully owned subsidiary of SOLVAY and an entity existing under the laws
of Belgium and having its principal offices at 310, rue de Ransbeek,
1120 Brussels, Belgium, is deemed an Affiliate of SOLVAY.
1.2 "AGREEMENT PURPOSE" shall mean the fulfilment by RECIPIENT of the
mission of "Homme de Confiance" he has been entrusted with and which is
described in the APPENDIX hereof.
1.3 "SOLVAY CONFIDENTIAL INFORMATION" shall mean any or all information
disclosed by SOLVAY to RECIPIENT in order to enable him to fulfil the
Agreement Purpose as well as any and all information that RECIPIENT may
learn or have access to, due to his presence in SOLVAY's or
PEPTISYNTHA's facilities, relating to SOLVAY's or PEPTISYNTHA's
business or technology.
1.4 "EFFECTIVE DATE" shall mean October 10, 1996.
1.5 "INTEGRILIN" shall mean a specific peptide designated by COR and known
as INTEGRILIN(TM), the chemical structure of which is known to
RECIPIENT pursuant to the terms of separate agreements entered into
with COR.
1.6 "PARTY" shall mean SOLVAY, COR or RECIPIENT.
2.0. DISCLOSURE OF SOLVAY CONFIDENTIAL INFORMATION
2.1 SOLVAY shall disclose to RECIPIENT SOLVAY Confidential Information
sufficient to enable RECIPIENT to fulfil the Agreement Purpose.
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 15
2.2 SOLVAY Confidential Information disclosed under paragraph 2.1 hereabove
may be disclosed in tangible form, such as in writing and marked
"Confidential", or provided orally.
3.0. CONFIDENTIALITY AND EXCEPTIONS
3.1 RECIPIENT hereby agrees, regarding SOLVAY Confidential Information
disclosed to him by SOLVAY under the terms of Article 2 hereof, that he
shall
(a) make no use of said information, except for the Agreement
Purpose;
(b) not disclose said information to any party or person, except
to COR's employees duly appointed to receive it;
(c) not disclose to any party or person either the existence of
this Agreement or its underlying discussions except for the
Agreement Purpose;
(d) take the same steps to protect said information as he takes to
protect the proprietary and confidential information of COR.
3.2 RECIPIENT hereby agrees, regarding SOLVAY Confidential Information he
may learn or have access to due to his presence in SOLVAY's
PEPTISYNTHA's facilities and which is not comprised in the Confidential
Information referred to in Article 2 hereof, that he shall:
(a) make no use of said information, except for the Agreement
Purpose;
(b) not disclose said information to any party or person;
(c) not disclose to any party or person either the existence of
this Agreement or its underlying discussions except for the
Agreement Purpose;
(d) take the same steps to protect said information as he takes to
protect the proprietary and confidential information of COR.
3.3 The obligations under paragraph 3.1 and 3.2 hereabove shall not,
however, apply to any SOLVAY Confidential Information which:
(a) RECIPIENT can prove is at the time of disclosure or thereafter
becomes public knowledge through no fault or negligence of
RECIPIENT, OR
(b) RECIPIENT can prove was known to him, prior to the receipt of
such Confidential Information from SOLVAY, or
(c) is lawfully obtained by RECIPIENT from any party not bound by
a secrecy obligation towards SOLVAY relating to the
Confidential Information.
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 16
For the purposes of this paragraph 3.3, information shall not be deemed to be
public knowledge or known on the ground only that:
(i) the general principle is public knowledge or known to RECIPIENT if the
particular practice is not itself public knowledge or so known, or
(ii) it constitutes a combination of or is drawn from information which is
public knowledge or known to RECIPIENT unless the combination itself
and its principle and mode of operation is also public knowledge or
known to the RECIPEINT.
4.0. DOCUMENTS DELIVERY OR DESTRUCTION
Upon the written request of SOLVAY, RECIPIENT undertakes to promptly deliver it,
or destroy if so instructed by it, all documents furnished by SOLVAY to
RECIPIENT and constituting Confidential Information, as well as all copies
thereof which might be in his possession.
5.0. NO IMPLIED LICENSE
Nothing in this Agreement shall be construed as to grant RECIPIENT any title or
right or license to own or use at any time the SOLVAY Confidential Information,
except as expressly set forth herein.
6.0. COR'S RESPONSIBILITY
COR shall guarantee the performance of this Agreement by RECIPIENT.
7.0. TERM
This Agreement shall become effective on the Effective Date and shall remain in
effect until terminated by any Party. The provisions of Article 3 shall however
survive until the [*].
8.0. GENERAL PROVISIONS
8.1 Notices
All notices and demands required or permitted to be given or made
pursuant to this Agreement shall be in writing and shall be deemed
given if delivered personally or by given facsimile transmission
(receipt verified), telexed, mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by express courier
service, properly addressed to the address of the Party to be notified
as shown below:
If to SOLVAY:
SOLVAY S.A.
DCR-LC
310, rue de Ransbeek
B - 1120 Brussels, Belgium
Attention : General Manager Research and Development
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 17
If to COR:
President, COR Therapeutics, Inc.
256 East Grant Avenue
South San Francisco, California 94080, USA
If to RECIPIENT:
[*]
or to such other address as to which any Party may notify the others.
Any notice sent by facsimile transmission or telex shall be followed
within twenty-four (24) hours by a signed notice sent by first class
mail, postage prepaid.
8.2 Assignment and Delegation
RECIPIENT may not assign his rights and/or delegate his obligations
under this Agreement to any third party without the prior consent of
SOLVAY and COR.
8.3 Amendment
No amendment or modification of the terms of this Agreement shall be
binding on any Party unless reduced to writing and signed by the
respective authorised officers of SOLVAY and COR and by RECIPIENT.
8.4 Publicity
The Parties agree that, except as may otherwise be required by
applicable laws, regulations, rules or orders, no information
concerning this Agreement and the transactions contemplated herein
shall be made public by any Party without the prior written consent of
the others.
8.5 Waiver
Failure of any Party to insist upon strict observance of or compliance
with any of the terms of this Agreement in one or more instances shall
not be deemed to be a waiver of its rights to insist upon such
observance or compliance with the other terms hereof, at that point in
time or in the future.
8.6 Counterparts
This Agreement may be executed in multiple counterparts, each of which
shall be an original, but all of which shall constitute but one
agreement.
8.7 Governing Law
This Agreement shall be governed by the laws of England. SOLVAY, COR
and RECIPIENT consent to the exclusive jurisdiction and venue of the
Courts of England.
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 18
IN WITNESS THEREOF, the parties hereto have executed this Agreement, in
three original copies.
SOLVAY S.A. COR THERAPEUTICS, INC.
By: By:
-------------------------------- --------------------------------
Title: Title:
----------------------------- -----------------------------
RECIPIENT
[*]
APPENDIX: Mission of the "Homme de Confiance"
APPENDIX F (PG 7)
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 19
APPENDIX F (PG 8)
MISSION OF THE "HOMME DE CONFIANCE"
The mission of the "Homme de Confiance" aims at improving communications between
SOLVAY and COR and at facilitating prompt resolution of issues between them.
The mission will include the following activities:
[*]
Any additional activity, within the scope of COR's letter dated October 6, 1996
attached, is subject to SOLVAY's approval.
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 20
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
October 6, 1996
Mr. Alfred Hoffait
General Manager, Research & Development
Solvay, S.A.
Rue de Ransbeek 310
B-1120 Brussels, Belgium
Dear Alfred:
This letter serves to clarify any issues regarding [*] level of confidentiality
and access to information from COR's perspective. As "homme de confiance", COR
views [*] as a COR representative in frequent attendance at Solvay, and as such,
we would like him to have access to the same information that could be
communicated to any other COR personnel.
[*] has entered into a confidentiality arrangement with COR, and therefore this
letter specifically authorizes you to show [*] confidential COR information that
may be in your files, and to discuss with him any issues regarding the
relationship between COR and Solvay.
It is our hope that involving [*] in COR/Solvay issues on a regular basis will
improve communications between our companies and facilitate prompt resolution of
issues. However, you understand that [*] is not COR's general agent and he does
not have the power to commit COR or enter into agreements on behalf of COR
without specific instructions from COR.
We appreciate your willingness to include [*] as a representative of COR.
Regards,
Mark D. Perrin
Executive Vice President, Commercial Operations
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 21
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
APPENDIX G (P 1)
[*]
* The unit price for such a complete set of all [*] shall be computed by [*].
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 22
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
APPENDIX H (PG 1)
PEPTISYNTHA FACILITY EXPANSION
SUMMARY DESCRIPTION PREPARED FOR THE 10 OCTOBER 1996
PCT MEETING
The purpose of this document is to provide an overview of the proposed
PEPTISYNTHA expansion project as it is currently defined and to highlight any
proposed process changes which may be introduced concurrent with the expansion.
The tentative timeline for execution of the project is also provided. As we are
still in the early stages of the project, certain aspects are not yet fully
defined and are still under evaluation. It is envisioned that as the project
progresses, updates will be provided to COR Therapeutics at each PCT meeting.
1. PROJECT ORGANIZATION
[*]
2. PROJECT OBJECTIVE
[*]
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 23
APPENDIX H (PG 2)
[*] The building design and equipment will be thoroughly reviewed to
facilitate possible future expansions in a later stage to accommodate [*].
[*]
[*]
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 24
APPENDIX H (PG 3)
[*]
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 25
APPENDIX H (PG 4)
[*]
3. PROJECT DESCRIPTION
[*]
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 26
APPENDIX H (PG 5)
[*]
4. EQUIPMENT
[*]
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 27
APPENDIX H (PG 6)
[*]
6. GMP ISSUES
[*]
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 28
APPENDIX H (PG 7)
[*]
7. PROJECT TIMELINES
The project timeline is provided in annex to this summary document.
8. ATTACHMENTS
8.1. PROCESS FLOW DIAGRAMS
8.2. [*] CHART SHOWING ORGANIZATION OF PRODUCTION CAMPAIGNS
8.3. EQUIPMENT LIST
8.4. PROPOSED LAYOUT
8.5. TIMELINE
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 29
APPENDIX H (PG 8)
8.1 PROCESS FLOW DIAGRAMS
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 30
APPENDIX H (PG 9)
[*]
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 31
APPENDIX H (PG 10)
[*]
10.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 32
APPENDIX H (PG 11)
[*]
11.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 33
APPENDIX H (PG 12)
[*]
12.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 34
APPENDIX H (PG 13)
[*]
13.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 35
APPENDIX H (PG 14)
[*]
14.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 36
APPENDIX H (PG 15)
8.2 [*] CHART - PRODUCTION CAMPAIGNS
15.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 37
APPENDIX H (PG 16)
[*]
16.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 38
APPENDIX H (PG 17)
8.3 EQUIPMENT LIST
17.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 39
APPENDIX H (PG 18)
EQUIPMENT NUMBERING SYSTEM
[*]
18.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 40
APPENDIX H (PG 19)
EQUIPMENT LIST
[*]
19.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 41
APPENDIX H (PG 20)
EQUIPMENT LIST (CONTINUED)
[*]
20.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 42
APPENDIX H (PG 21)
EQUIPMENT LIST (CONTINUED)
[*]
21.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 43
APPENDIX H (PG 22)
8.4 PROPOSED LAYOUT
22.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 44
APPENDIX H (PG 23)
[*]
23.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 45
APPENDIX H (PG 24)
8.5 TIMELINE
24.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 46
APPENDIX H (PG 25)
[*]
25.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 47
APPENDIX H (PG 26)
Amendment to the PEPTISYNTHA FACILITY EXPANSION document
[*]
26.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 48
APPENDIX H (PG 27)
[*]
27.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 49
APPENDIX H (PG 28)
[*]
28.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 50
APPENDIX H (PG 29)
COMMISSIONING AND VALIDATION TIMETABLE
[*]
29.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 51
APPENDIX I (PG 1)
[*]
30.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 52
APPENDIX I (PG 2)
[*]
31.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 53
APPENDIX I (PG 3)
[*]
32.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 54
APPENDIX I (PG 4)
[*]
33.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 55
APPENDIX I (PG 5)
[*]
34.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 56
APPENDIX I (PG 6)
[*]
35.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 57
APPENDIX I (PG 7)
[*]
36.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 58
APPENDIX I (PG 8)
[*]
37.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 59
APPENDIX I (PG 9)
[*]
38.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 1
EXHIBIT 10.24
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
LICENSE AND SUPPLY AGREEMENT
THIS Agreement is entered into effective as of 27 July 1994, between COR
Therapeutics, Inc. ("COR"), a Delaware corporation, with its principal offices
at 256 East Grand Avenue, South San Francisco, California USA 94080, and Solvay,
Societe Anonyme ("Solvay"), a Belgian corporation, with its principal offices at
33, rue du Prince Albert - 105 Bruxelles, Belgium each on behalf of itself and
its Affiliates. COR and Solvay are sometimes referred to herein individually as
a "Party" and collectively as the "Parties", and references to "COR" and
"Solvay" shall include their respective Affiliates.
WlTNESSETH:
WHEREAS, COR owns certain patent rights, trademarks and know-how
relating to a product called Integrelin(TM);
WHEREAS Solvay has developed a unique and valuable patented and
proprietary process useful for the manufacture of bulk peptide products
containing Integrelin(TM);
WHEREAS COR has entered into a Confidentiality Agreement as of 24 July
1990 with the Solvay Affiliate Peptisyntha & Cie, Societe en Nom Collectif;
WHEREAS Peptisyntha and COR have entered into a Process Development
Agreement dated 11 October 1990 and amended as of 10 March 1993 for the
development by Solvay of a process for the manufacture of a bulk peptide product
containing Integrelin and for the supply of the same to COR;
WHEREAS COR is willing to purchase from Solvay and Solvay is willing to
manufacture for and to sell to COR additional quantities of a bulk peptide
product containing Integrelin; and
WHEREAS Solvay is willing to provide access to and a license of certain
technology developed by Solvay for the manufacture by a Secondary Source of bulk
peptide products
1
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 2
containing Integrelin using the process developed by Solvay on the terms and
conditions herein set forth;
NOW THEREFORE, in consideration of the foregoing and the mutual promises
contained herein, the Parties agree as follows:
1.0 Certain Definitions. For the purposes of this Agreement, the
following terms shall have the following meanings:
1.1 "Affiliates" shall mean any entity or person which controls,
is controlled by or is under common control with either Party. For purposes of
this section 1.1, "control" shall mean (a) in the case of corporate entities,
the direct or indirect ownership of at least one-half of the stock or
participating shares entitled to vote for the election of directors, and (b) in
the case of a partnership, the power to direct the management and policies of
such partnership. Without limitation on the foregoing and for purposes of this
Agreement, Peptisyntha & Cie, Societe en Nom Collectif ("Peptisyntha"), which is
a fully owned subsidiary of Solvay and an entity existing under the laws of
Belgium and having its principal offices at 310, rue de Ransbeek - 1210
Bruxelles, Belgium, and also Solvay Duphar B.V., a Dutch corporation having its
main office at C.J. van Houtenlaan, 36, Weesp, The Netherlands, are deemed
Affiliates of Solvay.
1.2 "Bulk Product" shall mean a bulk peptide product which
contains Integrelin, is produced by the Licensed Process and is intended to
undergo further processing, formulation and/or vialing and packaging.
1.3 "Bulk Product Intermediates" shall mean [*] used to
manufacture Bulk Product which have been partially processed.
1.4 "Effective Date" shall mean 27 July 1994.
1.5 "Force Majeure" shall mean an occurrence which prevents,
delays or interferes with the performance by a Party of any of its obligations
hereunder, if such occurs by reason of any Act of God, flood, fire, explosion,
casualty or accident, or war, revolution, civil commotion, acts of public
enemies, blockage or embargo, or any law, order or proclamation of any
government, strike or other labor trouble, failure of suppliers to deliver
materials, equipment
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 3
or machinery, interruption of or delay in transportation, or any other cause
whatsoever, whether similar or dissimilar to those above enumerated, beyond the
reasonable control of such Party, if, and only if, the Party affected shall have
used its reasonable best efforts to avoid such occurrence.
1.6 "Good Manufacturing Practices" shall mean the good
manufacturing practices required by the U.S. Food and Drug Administration for
the manufacture and testing of pharmaceutical materials including bulk peptide
products, and the corresponding requirements of the European Union and, to the
extent they are applicable, of Member States of the European Union.
1.7 "Integrelin" shall mean a specific peptide designated by COR
and known as Integrelin(TM), the chemical structure of which is known to Solvay
because of the prior business relationship between COR and Solvay.
1.8 "Licensed Process" shall mean any process or process(es)
developed or acquired by Solvay presently or in the future and used commercially
for making bulk peptide products containing Integrelin according to COR's
specifications, during the term of any supply arrangements between COR and
Solvay or a Secondary Source.
1.9 "Net Bulk Sales" shall mean as to each calendar quarter the
gross invoiced sales price charged for all Bulk Products sold to COR by a
Secondary Source, after deducting the following items paid by COR during such
calendar quarter with respect to sales of Bulk Product hereunder regardless of
the calendar quarter in which such sales were made, provided and to the extent
that such items are incurred, and are included in the price charged:
(a) trade, quantity and case discounts or rebates:
(b) credits or allowances given or made for rejection or
return of previously sold Bulk Product;
(c) any tax or government charge (other than an income
tax) levied on the sale, transportation or delivery of Bulk Product and borne by
the seller thereof; and
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 4
(d) any charges for freight or insurance in a CIF sale.
1.10 "Secondary Source" shall mean the party established
hereunder for the manufacture and supply of Bulk Product for COR.
1.11 "Solvay Know-how" shall mean all information now or
hereafter in the possession of Solvay, whether or not patentable or disclosed
within the Solvay Patents, constituting materials, methods, processes,
techniques and data which are useful [*] for the manufacture of Bulk Product and
which relate to the Licensed Process which Solvay has the right to license or
disclose without violating existing contractual obligations to third parties.
1.12 "Solvay Patents" shall mean all patents (including
inventor's certificates) and applications therefor throughout the world and
substitutions, extensions, reissues, renewals, divisions, continuations or
continuations-in-part thereof or therefor, which Solvay presently or hereafter
owns or controls, or under which Solvay now or hereafter shall have the right to
grant a sublicense, to the extent they cover the Licensed Process, or to the
extent that they cover Integrelin manufactured by the Licensed Process. A list
of such Solvay Patents is attached hereto as Exhibit A.
2.0 Supply of Integrelin
2.1 Supply of Bulk Product. Solvay agrees to supply Bulk Product
to COR, and COR agrees to purchase Bulk Product from Solvay, pursuant to the
terms of the Supply Agreement attached as Exhibit B. Solvay and COR agree to
continue to negotiate in good faith an agreement for the long-term supply of
Bulk Product. It is contemplated that Solvay may fulfill its obligation to
supply Bulk Product to COR under the long-term supply agreement by having a
third party manufacture on its behalf part or all of the Bulk Product
Intermediates or the Bulk Product required by COR provided that such
manufacturing activities would not affect the regulatory status of Integrelin.
2.2 Secondary Supply. COR shall have the right to establish a
Secondary Source for the manufacture of Bulk Product by the Licensed Process for
COR. The Secondary Source shall be [*]. COR and Solvay agree that a [*], would
be acceptable as the Secondary Source. COR will notify Solvay of the
establishment of the Secondary Source. In the event
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 5
COR terminates a supply arrangement with a Secondary Source, COR may establish
an alternate Secondary Source. COR shall notify Solvay within [*] of such a
termination of supply arrangements with a Secondary Source. COR's future
requirements for Bulk Product [*] COR wants to entertain certain [*]. Therefore,
after the Secondary Source is established, COR shall be [*] of its total,
worldwide requirements for Bulk Product on a year-to-year basis (to the extent
that such [*] does not exceed the manufacturing capacity planned by Solvay to
product Bulk Product) for the time period during which royalties are payable
under this Agreement. For purposes of the preceding sentence, such planned
capacity shall be determined for a particular calendar year X on [*].
Notwithstanding the above however, COR may purchase from such Secondary Source
[*] in the event of any breach or default of Solvay of any supply arrangement
between COR and Solvay, [*]. If by 15 March 1995, Solvay and COR have not
completed an agreement for the long-term supply of Bulk Product, provided that
COR and Solvay have been negotiating in good faith an agreement for the
long-term supply of Bulk Product, [*], COR may establish an additional,
"Back-up" Secondary Source for the manufacture of Bulk Product. In the event
that COR wishes to establish [*], then COR and Solvay shall negotiate in good
faith, before [*].
3.0 Licenses
3.1 Grant by Solvay. Solvay hereby grants to COR under the
Solvay Patents and Solvay Know-how an irrevocable (subject to Section 5.2), sole
- - with Solvay and Solvay Affiliates - worldwide license, with right to
sublicense to the Secondary Source and the Back-up Secondary Source, to develop,
use for regulatory or legal purposes, sell, have sold, and either manufacture
[*], or have manufactured by the Secondary Source and/or Back-up Secondary
Source [*]. Integrelin and products containing Integrelin produced practicing
the Solvay Know-how or the Licensed Process. No other rights than those
expressly provided in this Agreement and the Supply Agreement are granted by
Solvay to COR or any Secondary Source by implication or otherwise. COR [*]. Any
rights sublicensed to the Secondary Source or Back-up Secondary Source, pursuant
to this Section 3.1 shall not be further transferred without the prior written
consent of Solvay. For the purpose of this Section 3.1, "sole" license shall
mean that Solvay shall not grant to any third party any right during the term of
this Agreement under the
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 6
Solvay Patents and Solvay Know-how to manufacture bulk peptide products
containing Integrelin or to use or sell Bulk Products manufactured thereby.
3.2 Grant by COR. COR hereby grants to Solvay a non-exclusive,
worldwide license, without right to sublicense, under COR's patents and know-how
covering Integrelin, for the sole purpose of manufacturing Bulk Product for COR
during the term of any Bulk Product supply arrangement between COR and Solvay.
This license shall not be assigned or transferred without the prior written
consent of COR.
3.3 Process Improvements. The Parties acknowledge that Solvay or
COR may develop or acquire improvements to the manufacturing materials,
equipment, procedure, Solvay Know-how or Licensed Process in the course of
fulfilling its obligations under this Agreement and the Supply Agreement. Solvay
agrees to obtain COR's consent prior to implementing such improvements, or any
changes in the Licensed Process or [*]. Any such improvements developed or
acquired by Solvay which are used commercially by Solvay or the Secondary Source
and/or Back-up Secondary Source for making bulk peptide products containing
Integrelin shall be deemed to be within the definition of Licensed Process or
Solvay Know-how as licensed in Section 3.1.
Except as provided below, COR hereby agrees to establish only a
Secondary Source (and/or Back-up Secondary Source) which agrees to grant back to
COR a non-exclusive, worldwide, royalty-free license, sublicenseable by COR to
entities entitled to practice the Licensed Process, to use any improvements to
the manufacturing materials, equipment, procedure, Solvay Know-how or the
Licensed Process related to this Agreement which are developed or acquired by
such Secondary Source, to develop, use, sell, have sold, [*] or have
manufactured by the Secondary Source (and/or Back-up Secondary Source) [*] of
this Agreement, Integrelin and products containing Integrelin. COR hereby agrees
to sublicense the rights granted to it pursuant to this Section 3.3 by a
Secondary Source (and/or Back-up Secondary Source) to Solvay, for use by Solvay
during any time period wherein Solvay is supplying COR with Bulk Product,
pursuant to the terms of any supply arrangement between COR and Solvay. COR
agrees that it will use any such Secondary Source improvements to
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 7
manufacture Bulk Product [*] is the Secondary Source, [*] COR [*] such Secondary
Source improvements to manufacture Bulk Product [*] Secondary Source when COR
[*].
For purposes of this Section 3.3, COR, Solvay and any Secondary Source
shall exchange rights to the improvements specified in this Section 3.3 which
are developed or acquired by any of them during the time period between the
Effective Date and [*] at which time COR and Solvay agree to consider in good
faith, in consultation with any Secondary Source, whether or not the exchange of
improvements should be continued beyond [*].
In the event that COR establishes itself as the Secondary Source (and/or
Back-up Secondary Source), COR hereby agrees to grant to Solvay a worldwide,
royalty-free license, without right to sublicense, to use any improvements to
the manufacturing materials, equipment, procedure, Solvay Know-hew or the
Licensed Process related to this Agreement which are owned or developed by COR,
to develop, manufacture, have made, use, sell and have sold Integrelin and
products containing Integrelin, according to the terms of this Agreement, and
for use by Solvay during any time period wherein Solvay is supplying COR with
Bulk Product, pursuant to the terms of any supply arrangement between COR and
Solvay.
In the event that, despite good faith negotiations, a potential
Secondary Source with whom COR desires to contract is unable or refuses to grant
rights to its improvements to COR for further sublicense, then COR agrees that
any [*] or [*] by Solvay upon or after the establishment of that Secondary
Source shall [*] that Secondary Source, to be [*].
3.4 Technology Transfer to COR. Promptly upon execution of this
Agreement and updated at least quarterly, Solvay shall provide to COR in a
written form, [*] the Solvay Know-how which is useful [*] for supporting COR's
efforts to obtain appropriate regulatory approvals needed to market products
containing Integrelin, including by way of example, [*] and any documents which
result from inspection by governmental agencies [*]. COR agrees that such Solvay
Know-how shall be distributed by COR only to those employees designated by COR
as having a need to know such information (e.g., in COR's regulatory,
development and manufacturing, and legal departments) who sign personal
obligations of confidentiality with Solvay with respect to Solvay Confidential
Information; COR further agrees to guarantee such personal obligations of
confidentiality made by COR employees.
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 8
3.5 Technology Transfer to the Secondary Source. Promptly upon
the notification by COR to Solvay of the establishment of the Secondary Source
or the Back-up Secondary Source pursuant to Sections 2.2, 3.3 and 3.5 of this
Agreement, and updated at least quarterly, Solvay shall provide to the Secondary
Source in a written form, [*] Solvay Know-how useful for the manufacture of Bulk
Product, including by way of example, [*] and any documents which result from
inspection by governmental agencies [*]. Solvay shall disclose [*]. During the
term of this Agreement, Solvay shall continue to provide such technical
assistance and access to information, as may be useful for the Secondary Source
to manufacture Bulk Product by the Licensed Process and to obtain appropriate
regulatory approvals for the sale of products containing Integrelin.
COR shall require the Secondary Source to agree that such Solvay
Know-how shall be distributed by the Secondary Source only to those employees
designated by the Secondary Source as having a need to know such information,
and who sign personal obligations of confidentiality with Solvay with respect to
Solvay Confidential Information. COR shall require the Secondary Source to
further agrees to guarantee such personal obligations of confidentiality made by
employees of the Secondary Source.
3.6 Escrow of Technology. [*] Solvay shall deposit to a third
party escrow acceptable to COR and Solvay, all such technical information in
English language written form. Such escrow of [*] technical information shall be
updated at least quarterly by Solvay. Access to this escrowed information may be
made by COR upon [*] or [*] or [*], or [*] or [*] or [*]:
(a) failure by Solvay to transfer relevant technology
to a Secondary Source under Section 3.5 of this
Agreement, within [*] of notice by COR to Solvay
of the establishment of that Secondary Source or
on an ongoing basis [*] of a request from the
Secondary Source (or from COR on behalf of the
Secondary Source) for applicable information
within Solvay's possession, unless Solvay is in
the process of attempting in good faith to remedy
such failure, in which case [*];
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 9
(b) failure by Solvay to transfer relevant technology
to COR under Section 3.4 of this Agreement, on an
ongoing basis within [*] of a request from COR to
Solvay for applicable information within Solvay's
possession, unless Solvay is in the process of
attempting in good faith to remedy such failure,
in which case [*];
(c) in the event that Solvay assigns or transfers to a
third party the Licensed Process, or any of its
rights or obligations under this Agreement or the
Supply Agreement inconsistently with the
provisions of Section 10.2 of this Agreement or
Section 6.6 of the Supply Agreement;
(d) in the event of any assignment by Solvay or
Peptisyntha of substantially all of its assets for
the benefit or creditors, or the placement of
substantially all of Solvay or Peptisyntha's
assets in the hands of a receiver unless the
receivership is dissolved within [*] thereafter,
or
(e) upon judicial order.
4.0 Payments and Royalties.
4.1 License Issue Fee. Within [*] of the Effective Date, COR
shall pay to Solvay a license issue fee of [*].
4.2 Royalty Payments. COR shall pay Solvay a running royalty
computed at the following rates:
(a) until the [*] anniversary of the first commercial
launch by COR of a product containing Integrelin,
[*] of Net Bulk Sales, and
(b) after the [*] anniversary of the first commercial
launch by COR of a product containing Integrelin
and until [*] of Net Bulk Sales of Bulk Product
manufactured, used or sold in any country or
territory where valid and enforceable patent
claims covering the Licensed Process or products
manufactured by the Licensed Process exist. The
period for payment of royalties [*].
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 10
4.3 Minimum Annual Royalty. Before the [*] the first commercial
launch by COR of a product containing Integrelin and before the [*] until and
including the [*] anniversary of such first commercial launch, COR shall make to
Solvay an advance payment of [*] of which each such payment shall be refundable
either as a credit against all payments to be made by COR to Solvay under
Section 4.2 during the following year, or as a credit against [*] of the gross
invoiced sales price for all Bulk Product sold to COR by Solvay during the
following year, after deducting the following items provided and to the extent
that such items are incurred, and are included in the price charged:
(a) trade, quantity and case discounts or rebates;
(b) credits or allowances given or made for rejection
or return of previously sold Bulk Product;
(c) any tax or government charge (other than an income
tax) levied on the sale, transportation or
delivery of Bulk Product and borne by the seller
thereof; and
(d) any charges for freight or insurance in a CIF
sale.
4.4 Payment Dates. COR shall pay royalties to Solvay within [*]
of the end of each calendar quarter for that calendar quarter. Such payment
shall be accompanied by a statement showing the amount of Bulk Product sold, on
a country-by-country, currency-by-currency basis.
4.5 Records and Accounting. COR shall keep complete and accurate
records of the latest [*] calendar years of Net Bulk Sales with respect to which
a royalty is payable under this Agreement. Solvay shall have the right at its
own expense to have an independent, certified public accountant, reasonably
acceptable to COR and acting on a confidential basis, review COR's business
records upon reasonable notice and during reasonable business hours for the
purposes of verifying the payments provided for in this Agreement. This right
may not be exercised more than once in any calendar year. In the event such
review reveals a willful misstatement of royalties owed, in which instance the
expense of such independent review shall be paid by COR.
10.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 11
4.7 Currency of Payments. All payments to Solvay by COR under
this Agreement shall be made in United States Dollars by wire transfer (or such
other reasonable means as Solvay may direct) to the bank account of [*] or such
bank account as Solvay may designate from time to time. Any payments clue
hereunder on sales outside of the United States shall by payable in United
States Dollars at the prevailing rate of exchange of the currency of the country
or collective of countries in which the sales are made in accordance with each
Party's customary and usual translation procedures (which are in accord with
generally accepted accounting principles consistently applied).
4.8 Taxes. Solvay shall pay any and all taxes levied on account
of royalties it receives under this Agreement. If laws or regulations require
that taxes be withheld, COR will (a) deduct those taxes from the remittable
royalty, (b) timely pay the taxes to the proper taxing authority, and (c) send
proof by certificate or other evidence of payment as required by the tax
authorities to Solvay promptly following receipt of such proof.
4.9 Expenses for Training and Technology Transfer. COR shall pay
to Solvay, as compensation for technical assistance to COR or the Secondary
Source in the transfer of information including the Solvay Know-how and the
Licensed Process, and for training to personnel of the Secondary Source [*] the
amount of [*] any Solvay employee is providing such technical assistance or
training. From the [*] this amount shall be [*] for the [*]. COR shall also bear
all actually incurred [*] for Solvay personnel working for the benefit of COR or
the Secondary Source [*] upon invoice, with supporting documentation, from
Solvay.
4.10 Overdue Payment. Payments provided for in this Section 4.0,
when overdue, shall bear interest at a rate per annum equal to [*] effective [*]
and for the time period until such payment is received by Solvay, without
prejudice of any other available remedies.
5.0 Termination
5.1 Term. This Agreement shall become effective on the Effective
Date and shall remain in effect until the thirty-first (31st) day of December
2020, unless earlier terminated as provided in this Section 5.0.
11.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 12
5.2 Early Termination.
(a) If either Party shall default in a material manner
with respect to any material provision of this
Agreement and the other Party shall have given the
defaulting Party notice of such default, the
defaulting Party shall have ninety (90) days to
cure such default. If such default is not cured
within such ninety (90) day period, the
nondefaulting Party shall have the right, upon
notice to the defaulting Party and without
prejudice to any other rights it may have, to
terminate this Agreement unless the defaulting
Party is in the process of attempting in good
faith to remedy such default, in which case the
ninety (90) day cure period shall be extended by
an additional sixty (60) days;
(b) If the other Party (the "Troubled Party") makes
any assignment of substantially all of its assets
for the benefit of creditors, or places
substantially all of its assets in the hands of a
receiver or judicial manager unless the
receivership or judicial management is dissolved
within thirty (30) days thereafter, goes into
liquidation, or is dissolved, wound up,
confiscated, sequestered or in any other way
transferred into state ownership, then the
non-Troubled Party may terminate this Agreement
forthwith upon ten (10) days written notice to the
Troubled Party.
5.3 Effects of Expiration or Termination. After expiration of
this Agreement, the provisions of Sections 4.0 and 8.0 shall survive, and the
Parties shall be free to practice the Licensed Process and the Improvements as
of the year 2000. In the event of early termination by COR due to default by
Solvay, or if Solvay is the Troubled Party, the provisions of Sections 3.1, [*]
4.0 and 8.0 shall survive, and COR shall be free, within the context of the
obligations of the surviving Sections, to practice the Licensed Process and any
Solvay Improvements incorporated into the Licensed Process prior to the
termination. In the event of early termination by Solvay due to default of COR
or if COR is the Troubled Party, the provisions of Sections 4.0 and 8.0 of this
Agreement shall survive.
12.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 13
6.0 Representations and Warranties.
6.1 Mutual Representations and Warranties. Each Party hereby
represents and warrants to the other Party that to the best of its knowledge
this Agreement and the Supply Agreement are legal and valid obligations binding
upon such Party and enforceable in accordance with their terms. The execution,
delivery and performance of this Agreement and the Supply Agreement by such
Party does not conflict with any agreement, instrument or understanding, oral or
written, to which it is a party or by which it is bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.
6.2 Solvay Representations and Warranties. Solvay represents and
warrants that it is entitled to grant the rights granted under Section 3.0
hereof, and that Solvay has not, and during the term of this Agreement and the
Supply Agreement will not, grant any right to any third party relating to the
Solvay Patents and Solvay Know-how which would conflict with the rights granted
hereunder. Solvay further represents that to the best of its present knowledge
the Solvay Patents cover patentable inventions and are valid and enforceable.
Solvay represents that to the best of its present knowledge the Licensed Process
and Solvay Know-how can be practiced without infringing the rights of any third
party.
6.3 COR Representations and Warranties. COR represents and
warrants that it has not, and during the term of this Agreement and the Supply
Agreement will not, grant any right to any third party relating to the Solvay
Patents and Solvay Know-how which would conflict with this Agreement.
6.4 No Representation of Approvability. Nothing in this
Agreement or the Supply Agreement shall be construed as a representation or
warranty that the manufacture, sale or use of Integrelin or products containing
Integrelin shall be approved by any appropriate governmental agency.
6.5 No Other Warranties. The express warranties made in this
Agreement and the Supply Agreement are in lieu of all other warranties, express
or implied, including, without limitation, the warranties of merchantability and
fitness for a particular purpose.
13.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 14
6.6 Performance by Affiliates. The Parties recognize that each
may perform some or all of its obligations under this Agreement through
Affiliates as specified in this Agreement and the Supply Agreement, provided
however, that each Party shall remain responsible and be guarantor of the
performance by its Affiliates and shall cause its Affiliates to comply with the
provisions of this Agreement and the Supply Agreement in connection with such
performance.
6.7 Performance by Secondary Source. COR shall remain
responsible and be guarantor of the performance by its Secondary Source under
this Agreement and the Supply Agreement and shall cause its Secondary Source to
comply with the provisions of this Agreement and the Supply Agreement in
connection with such performance.
6.8 Limitation of Liability. Neither Party shall be liable to
the other for indirect, incidental or consequential damages arising out of any
of the terms or conditions of this Agreement or with respect to its performance.
7.0 Patent Rights. The Parties recognize that in the course of work
under this Agreement, either Party may independently make or come to control
inventions (including without limitation, processes and methods) respecting Bulk
Product. In such event, the Party making the invention shall be the sole owner
of that invention. With respect to any inventions that are jointly made by the
Parties including also any inventions made by one obliged to assign an invention
to a Party (i.e., inventions in which one or more inventors from each Party have
made an inventive contribution as determined by English laws of inventorship)
concerning Bulk Product or processes or methods relating to Bulk Product, the
Parties shall own such inventions (and any patent applications filed on such
inventions and any patents issued on such inventions) jointly as co-owners of
equal, undivided shares without right of accounting for any act carried out in
accordance with the invention, and agree to cooperate in filing any patent
applications and undertaking all other reasonable and appropriate protection for
such patentable joint inventions. Solvay shall have the first right, but no
obligation, to undertake such filings and prosecutions respecting jointly held
inventions, subject to reimbursement from COR for one-half of any reasonable
out-of-pocket expenses Solvay incurs in such filing and prosecution. In the
event Solvay fails to undertake the filing of such a patent application within
[*] of a notice by COR to
14.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 15
Solvay that it believes the filing of such an application is appropriate, COR
may undertake such a filing at its own expense in which event any subsequently
issued patent application shall be owned solely by COR. As to the enforcement of
jointly owned patents, including actions against an infringer, the Parties shall
consult with each other in good faith as to the best manner in which to proceed.
The Parties agree as a basic principle that in the case of such actions against
infringers, the expenses incurred and damages awarded shall be for the account
of the Party or Parties undertaking such actions to the extent of their
financial participation therein. Either Party may assign its rights to any
jointly owned invention, application or subsequently issued patent on notice to
the other Party, which other Party shall then have the right to assume the
prosecution and/or maintenance as the sole owner thereof.
8.0 Confidentiality.
8.1 Confidentiality and Exceptions. In the course of the
performance of this Agreement, one Party may disclose to the other or receive
information from the other relating to the subject matter of this Agreement and
of the Supply Agreement which information, if so identified upon disclosure,
shall be considered to be the disclosing party's Confidential Information.
Confidential Information shall include in the case of COR, information relating
to the structure of Integrelin. Each Party agrees that it will take the same
steps to protect the confidentiality of the other Party's Confidential
Information as it takes to protect its own proprietary and confidential
information. Each Party shall protect and keep confidential and shaft not use,
publish or otherwise disclose to any third party, except as permitted by this
Agreement, the Supply Agreement, or with the other Party's written consent, the
other Party's Confidential Information. For the purposes of this Agreement,
Confidential Information shall not include such information that:
(a) was already known to the receiving Party, other
than under an obligation of confidentiality, at
the time of disclosure by the other Party;
(b) was generally available to the public or was
otherwise part of the public domain at the time of
disclosure or became generally available to the
public or otherwise part of the public domain
after
15.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 16
disclosure other than through any act or omission
of the receiving party in breach of this
Agreement; or
(c) was lawfully disclosed to the receiving Party,
other than under an obligation of confidentiality,
by a third party who had no obligation to the
disclosing Party not to disclose such information
to others.
8.2 Authorized Disclosure. Each Party may disclose Confidential
Information hereunder to the extent such disclosure is reasonably necessary for
prosecuting or defending litigation, complying with applicable governmental
regulations or conducting preclinical or clinical trials, provided that if a
Party is required by law or regulation to make any such disclosure of the other
Party's Confidential Information it will, except where impracticable for
necessary disclosures, for example in the event of medical emergency, give
reasonable advance notice to the other Party of such disclosure requirement and
will use its reasonable efforts to secure confidential treatment of such
Confidential Information required to be disclosed. In addition, COR shall be
entitled to disclose, under a binder of confidentiality containing provisions as
protective as those of this Section 8.0, Solvay Confidential Information to any
Secondary Source permitted under Sections 2.2 and 3.0 of this Agreement. Nothing
in this Section 8.0 shall restrict any Party from using for any purpose any
information developed by it during the course of this Agreement. Neither Party
shall disclose Confidential Information of the other Party in any patent filings
without the prior written consent of the disclosing Party.
8.3 Survival. All obligations of confidentiality and non-use
imposed upon the Parties under this Agreement shall expire on [*].
8.4 Termination of Prior Agreement. This Agreement supersedes
all confidentiality arrangements previously entered into between the Parties.
Any disclosures between COR and Solvay or Solvay Affiliates made prior to the
Effective Date of this Agreement of confidential information related to the
Licensed Process, Bulk Product or to Integrelin shall be considered Confidential
Information covered by Section 8.0.
16.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 17
8.5 Confidentiality and Limitation on Use. COR agrees, and shall
require any Secondary Source to agree, to not disclose Solvay Know-how to any
third party and not to use Solvay Know-how for any purpose other than the
production of Bulk Product, except for necessary disclosures to governmental
agencies such as the U.S. Food and Drug Agency and its equivalents, according to
the provisions of Section 8.0. COR shall require the Secondary Source to sign a
three-way confidentiality agreement (with COR and Solvay) in the form of Exhibit
D or in a form substantially similar to that of Exhibit D hereto but having
changes agreed to by COR and Solvay.
9.0 Patent Infringement.
9.1 Notification of Infringement. COR shall promptly notify
Solvay of any violation by a third party of any Solvay Patent of which it is
aware, and shall provide Solvay with available evidence of such violation.
9.2 Enforcement of Solvay Patents. Upon reasonable notice and
evidence of infringement, the Parties agree to consult with each other as to the
best manner in which to abate the infringement, considering the best interest of
both Parties. Solvay shall have the right to bring any suit or action for
infringement of Solvay Patents in force covering the Licensed Process. The costs
of such action shall be borne by Solvay, and any amount recovered shall be owned
by Solvay.
9.3 Defense and Settlement of Third Party Claims. If a third
party asserts that a patent or other right owned by it is infringed by the
manufacture, use or sale of Integrelin manufactured by the Licensed Process in
accordance with this Agreement or the Supply Agreement, by reason of such
manufacture, the Party first obtaining knowledge of such a claim shall
immediately provide the other Party notice of such claim and the related facts
in reasonable detail. Solvay agrees to investigate the situation fully in
collaboration with COR, and the Parties agree to discuss how best to control the
defense of any such claim. In the event the Parties cannot agree on the defense
of any such claim, Solvay shall have the right, but not the obligation, to
control such defense. COR shall have the right to be represented separately by
counsel of its own choice.
17.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 18
10.0 General Provisions.
10.1 Notices. All notices and demands required or permitted to
be given or made pursuant to this Agreement shall be in writing and shall be
deemed given if delivered personally or by given by facsimile transmission
(receipt verified), telexed, mailed by registered or certified mail (return
receipt requested), postage prepaid, or sent by express courier service,
properly addressed to the address of the Party to be notified as shown below:
If to Solvay:
Solvay, S.A.
Head of Licensing Department
Rue du Prince Albert, 33
B-1050 Bruxelles, Belgium
If to COR:
President, COR Therapeutics, Inc.
258 East Grand Avenue
South San Francisco, California, 94080 U.S.A.,
or to such other address as to which either Party may notify the other. Any
notice sent by facsimile transmission or telex shall be followed within
twenty-four (24) hours by a signed notice sent by first class mail, postage
prepaid.
10.2 Assignment and Delegation. Solvay may not assign its rights
and/or delegate its obligations under this Agreement or any three-way
confidentiality agreement pursuant to Section 8.5, to any third party without
the prior consent of COR, such consent not to be unreasonably withheld, except
in connection with the sale, merger or transfer of substantially all of the
stock or assets of Solvay or the sale, merger or transfer of substantially all
of the interests in or assets of Peptisyntha, providing such assignee or
delegatee agrees to be bound by the terms of this Agreement, in which case the
consent of COR is not required. COR may assign its rights in whole or in part,
or delegate any of its obligations, under this Agreement or any three-way
confidentiality agreement pursuant to Section 8.5, to any party who meets
financial and ethical standards generally acceptable within the pharmaceutical
industry, except without such requirement of standards in connection with the
sale, merger, or transfer of all or substantially all of the rights of COR
relating to Integrelin, provided such assignee or delegatee agrees to be bound
by the terms of this Agreement.
18.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 19
10.3 Exclusivity. Solvay shall not engage in, or enable any
third party to engage in, any commercialization, licensing, manufacturing,
marketing or sales activity with respect to the application of Solvay Know-how
or the Licensed Process to Integrelin with or on behalf of any third party
without COR's prior written consent, except as expressly provided in this
Agreement.
10.4 Governing Law. This Agreement shall be governed by the laws
of England. Solvay and COR consent to the exclusive jurisdiction and venue of
the courts of England.
10.5 Force Majeure. Neither Party shall be liable to the other
for loss or damage, or, except as provided herein, have any right to terminate
this Agreement by virtue of Force Majeure. In the event of Force Majeure, the
Party affected shall notify the other and shall attempt to perform its
obligations as soon as possible.
10.6 Entire Agreement. This Agreement (including the Supply
Agreement attached as Exhibit B hereto) is the entire agreement between the
Parties and shall terminate and supersede any prior written or oral promises or
representations between the Parties not incorporated herein. No amendment or
modification of the terms of this Agreement shall be binding on either Party
unless reduced to writing and signed by the respective authorized officers of
the Parties.
10.7 Binding Effect. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their respective successors and
permitted assigns.
10.8 Severability. If any provision of this agreement is
determined to be illegal or unenforceable by any Court of law or any competent
governmental or other authority, the remaining provisions shall be severable and
enforceable in accordance with their terms so long as this Agreement without
such terms or provisions does not fail of its essential purpose. The parties
shall negotiate in good faith to replace any such illegal or unenforceable
provisions with suitable substitute provisions which will maintain as far as
possible the purposes and the effect of this agreement.
19.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 20
10.9 Publicity. Solvay and COR agree that, except as may
otherwise be required by applicable laws, regulations, rules, or orders, no
information concerning this Agreement and the transactions contemplated herein
shall be made public by either Party without the prior written consent of the
other.
10.10 Waiver. Failure of either Party to insist upon strict
observance of or compliance with any of the terms of this Agreement in one or
more instances shall not be deemed to be a waiver of its rights to insist upon
such observance or compliance with the other terms hereof, at that point in time
or in the future.
10.11 Headings. All headings, titles and captions in this
Agreement are for convenience only and shall not be of any force or substance.
10.12 Counterparts. This Agreement may be executed in multiple
counterparts, each of which shall be an original, but all of which shall
constitute but one agreement.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement to
be effective on the date first set forth above.
COR THERAPEUTICS, INC. SOLVAY S.A.
BY: BY:
-------------------------------- --------------------------------------
TITLE: TITLE:
----------------------------- -----------------------------------
Exhibit A: Solvay Patents
Exhibit B: Supply Agreement
Exhibit C: Secondary Sources
Exhibit D: Three-way confidentiality agreement
20.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 21
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
EXHIBIT A
SOLVAY PATENTS
[*]
[*]
21.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 22
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
[*]
[*]
22.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 23
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
[*]
[*]
23.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 24
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
[*]
[*]
24.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 25
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
EXHIBIT B
SUPPLY AGREEMENT
THIS Agreement is entered into effective as of 27 July 1994, between COR
Therapeutics, Inc. ("COR"), a Delaware corporation, with its principal offices
at 256 East Grand Avenue, South San Francisco, California USA 94080, and Solvay,
Societe Anonyme ("Solvay"), a Belgian corporation, with its principal offices at
33, rue du Prince Albert - 10 Bruxelles, Belgium each on behalf of itself and
its Affiliates. COR and Solvay are sometimes referred to herein individually as
a "Party" and collectively as the "Parties", and references to "COR" and
"Solvay" shall include their respective Affiliates.
WHEREAS:
COR and Solvay are Parties to a certain License and Supply Agreement
made and entered into as of 27 July 1994 (the "License Agreement"); and
Pursuant to the terms and conditions of the License Agreement, Solvay
has agreed to supply COR with bulk peptide products containing Integrelin for
the preparation, use and sale of discrete products containing Integrelin;
NOW, THEREFORE, COR and Solvay agree as follows:
1.0 Certain Definitions. For the purposes of this Agreement, the
following terms shall have the following meanings:
1.1 "Specification" shall mean the specification for Bulk
Product as agreed to by the Parties and as may thereafter be amended from time
to time to reflect changes in such Specifications. The current Specification is
contained in Appendix 1 to this Supply Agreement.
Unless otherwise defined herein, other capitalized terms used herein shall have
the meaning specified in the License Agreement.
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 26
2.0 Supply of Products.
2.1 Purchase and Sale of Products. During the term of this
Supply Agreement, Solvay agrees to supply Bulk Product to COR, and COR agrees to
purchase Bulk Product from Solvay.
2.2 Purchase Commitment. Notwithstanding COR's right to purchase
from a Secondary Source as provided in the License Agreement, COR agrees to
purchase, and Solvay agrees to supply, an amount of Bulk Product equivalent to
[*] according to the agreed Specification and to use its best efforts to ship
according to the shipping schedule in Appendix 2. In the event that COR wishes
to purchase more than these amounts during [*]. Solvay agrees to use its
reasonable efforts to supply additional amounts ordered by COR at the price in
Appendix 3 and according to the delivery schedule in Appendix 2.
2.3 Inventory. It is contemplated that a long-term supply
agreement between the Parties will involve an obligation by Solvay to maintain,
on agreed terms and conditions, an inventory of Bulk Product of not less than
[*]. The inventory will be maintained at a warehouse [*]. Such inventory shall
be rotated to maintain an average time in inventory of [*].
2.4 Intermediates. It is contemplated that a long-term supply
agreement between the Parties will involve an obligation by Solvay to maintain,
on agreed terms and conditions, an inventory of certain Bulk Product
Intermediates of not less than [*]. Such inventory shall be rotated to maintain
an average time in inventory of [*]. For Bulk Product Intermediates utilized
pursuant to this Supply Agreement and any long term Supply Agreement between the
Parties, Solvay shall retain samples of lots of Bulk Product Intermediates used
in the manufacture of Bulk Product until such Bulk Product has been shipped to
and accepted by COR.
2.5 Product Estimates and Shipping Requests. With respect to
COR's administrative effectuation of its orders of Bulk Product, COR shall send
firm shipping requests for Bulk Product to Solvay at least [*] prior to the
dates for delivery agreed between COR and Solvay according to Appendix 2 and
further specifying the delivery destination, which shall be noncancellable
except as provided in Section 2.8 below.
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 27
Solvay shall acknowledge in writing its receipt of and acceptance of a
shipping request placed pursuant to this Section 2.5 within [*] of receipt and
shall use its best efforts to:
(a) ship Bulk Product at the agreed delivery date with
the proper identification on the packaging as
required by applicable authorities; and
(b) fill the entirety of each individual shipping
request from the same production lot.
2.6 Non-Conforming Product. Bulk Product supplied hereunder
shall be produced by Solvay in accordance with applicable laws and regulations
and Good Manufacturing Practices, to meet the Specification. COR may reject any
shipment of Bulk Product which is (a) not conforming with the Specification or
(b) adulterated or misbranded within the meaning of the United States Federal
Food, Drug and Cosmetic Act. Any notice of rejection of non-conforming Bulk
Product must be submitted to Solvay within [*] after shipment, accompanied by a
report of analysis (including a product sample from the lot analyzed) prepared
according to the Specification. If no such notice of rejection of non-conforming
Bulk Product is received, COR shall be deemed to have accepted such delivery of
Bulk Product.
After notice of rejection of non-conforming Bulk Product is given, COR
shall cooperate with Solvay in determining whether rejection is necessary or
justified. Solvay shall notify COR as promptly as reasonably possible whether or
not it accepts COR's basis for any rejection. If Solvay disagrees with COR's
determination that certain Bulk Product does not meet the Specification, such
Bulk Product shall be submitted to a mutually acceptable third party laboratory;
the fees and expenses of such laboratory testing shall be borne entirely by the
Party against whom such findings are made. Such third party laboratory shall
determine whether such Bulk Product meets the Specifications and the Parties
agree that such laboratory's determination shall be final and determinative.
Whether or not Solvay accepts COR's basis for rejection, promptly on receipt of
a notice of rejection of non-conforming Bulk Product, Solvay shall, at COR's
request, use its best efforts to replace such rejected Bulk Product. Bulk
Product can only be reprocessed in accordance with validated reprocessing
procedures described in the drug master file, as agreed by the Parties.
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 28
Unless Solvay requests the destruction of rejected Bulk Product within
[*] of receipt of COR's notice of rejection of non-conforming Bulk Product, COR
shall promptly return said Bulk Product to Solvay, at Solvay's cost, and
according to shipping instructions in the Specification. COR shall, upon receipt
of a request for destruction of the material, destroy such Bulk Product promptly
and provide Solvay with certification of such destruction.
2.7 Shipment. Solvay shall ship to a destination specified by
COR air Bulk Product ordered by COR by the agreed delivery dates. Bulk Product
will be labeled and packed according to the Specification. In the event that COR
specifies that the Bulk Product shall be shipped to a location other than COR's
principal offices (e.g., to a different location [*]) and upon COR's request,
Solvay shall ship a quality control sample to COR's principal offices (or such
other place as COR may designate) in advance or not later than concurrently with
the shipment of the Bulk Product. Except as provided herein with respect to
non-conforming Bulk Product, title and risk of loss as to all materials shipped
shall pass [*]. Solvay shall assist COR in arranging [*]. A packing list and a
certificate of analysis will be provided to COR for every shipment.
2.8 Purchase Cancellation. COR, on notice to Solvay, may cancel
any or all outstanding shipments only to the extent materials have not been
produced for such shipments. At any time, should COR cancel all outstanding
shipments other than by termination of this Agreement pursuant to Section 4.2,
COR agrees [*]. In the event that cancellation occurs after COR has paid Solvay
for Bulk Product Intermediates or for finished Bulk Product, COR shall be the
owner of such already-paid-for Bulk Product Intermediates and such finished Bulk
Product.
2.9 Governing Terms. All sales hereunder shall be subject to the
provisions hereof (including the Specification) and shall not be subject to the
terms and conditions contained on any shipping request of COR or confirmation of
Solvay, except insofar as any such shipping request or confirmation establishes:
(a) the quantity of any Bulk Product to be shipped; (b) the agreed delivery
date; (c) the shipment route and destination; or (d) the carrier.
2.10 Quality Control. Solvay shall manufacture Bulk Product
under this Agreement in conformity with the Specification, in a duly licensed
Peptisyntha facility as required by the United States Food and Drug
Administration or equivalent European Union
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 29
regulatory agencies, and in compliance with applicable laws and regulations and
Good Manufacturing Practices, as prescribed from time to time by these
appropriate regulatory agencies. Each shipment of Bulk Product hereunder shall
have been subjected to a quality control inspection by Solvay in accordance with
the Specification and with Solvay's then-current quality control standards and
systems, which shall be consistent with those agreed between COR and Solvay.
Solvay shall number each shipment with a vendor lot number that is traceable to
raw materials and/or components used to manufacture such Bulk Product and shall
maintain all appropriate validation documentation. Solvay shall permit COR
and/or representatives of appropriate regulatory agencies to review periodically
Solvay's Bulk Product manufacturing facilities and testing procedures at
reasonable times with a Solvay representative present, and to obtain copies of
batch records for Bulk Product in order to assure compliance with the
requirements of this Section 2.10.
2.11 Compliance With Law. Solvay shall be responsible for
complying with all applicable regulatory requirements of the United States, the
European Union, and to the extent applicable, of Member States of the European
Union, for the manufacture and shipment of the Bulk Product supplied hereunder.
Solvay shall give COR prompt notice of any impending inspections by a
governmental agency of the facility used for or processed involved in the
manufacture of Bulk Product, and provide COR an opportunity to observe such
inspection. Each Party shall promptly notify the other of new instructions or
specifications of which it becomes aware which are relevant to the manufacture
of Bulk Product under this Supply Agreement and which are required by the United
States Food and Drug Administration, equivalent European Union regulatory
agencies, or other applicable laws or governmental regulations and shall confer
with each other with respect to the best means to comply with such requirements.
Solvay shall assist COR in obtaining and maintaining all approvals and
authorizations of any governmental agencies necessary for the use or
distribution of Integrelin products, and will promptly notify COR of any
comments, responses or notices received from any governmental authorities which
relate to the regulatory status of Integrelin.
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 30
3.0 Price and Payments.
3.1 Price. COR shall pay to Solvay for the Bulk Product
purchased hereunder the amount set forth in Appendix 3, for Bulk Product in
accordance with the Specification of Appendix 1.
3.2 Initial and Intermediate Payments. Within thirty (30) days
of the Effective Date, COR shall pay to Solvay [*] which amount Solvay has
agreed will be committed to the purchase of raw materials for use in the
preparation of Bulk Product. Additionally, COR shall pay to Solvay [*] within
[*] days of the date on which Solvay notifies COR that Solvay has produced all
of the following intermediates fit for further processing into Bulk Product (or
such other level of production agreed in the Specification):
[*]
Ownership of such Bulk Product Intermediates shall pass to COR upon [*] by COR
to Solvay.
3.3 Method of Payment for Finished Bulk Product. Within [*]
after a shipment of Bulk Product pursuant to Section 2.7 above, Solvay shall
submit an invoice for the balance of payments attributable to that shipment of
Bulk Product to COR. All payments due hereunder to Solvay shall be paid to
Solvay in United States Dollars not later than [*] days following the acceptance
date of the applicable shipment, to such account of Solvay in such bank as
Solvay may from time to time designate by notice to COR, as provided in the
License Agreement.
3.4 Taxes. Solvay shall be responsible for all value added
taxes, property taxes, sales tax or any other such tax resulting from sales of
Bulk Product to COR from Solvay or production of bulk product or purchase of any
raw materials.
3.5 Process Improvement. It is understood by both Parties that
significant manufacturing cost reductions may be possible. The parties shall
discuss and agree on a mechanism by which the benefits of process improvements
to which COR contributed are equitably allocated to the Parties according to
their relative contribution to the improvements.
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 31
3.6 Overdue Payment. Payments provided for in this Section 3.0,
when overdue, shall bear an interest at a rate per annum equal to [*] effective
[*] and for the time period until payment is received by Solvay.
3.7 [*]. Without prejudice to any of Solvay's rights hereunder,
in the event that [*] COR agrees to [*] and [*].
4.0 Term and Termination.
4.1 Term. The term of this Supply Agreement shall commence on
the Effective Date and will continue, unless sooner terminated, for a period of
three (3) years.
4.2 Termination. This Supply Agreement may be terminated: (a)
upon mutual written agreement between the Parties; or (b) by either Party as a
result of a material default in the performance of any material agreement,
condition or covenant of this Agreement, if such default or noncompliance shall
not have been remedied, or steps initiated to remedy the same to the other
Party's reasonable satisfaction, within ninety (90) days after receipt by the
defaulting Party of a notice thereof from the other Party.
4.3 Effect of Termination. The expiration or termination of this
Supply Agreement shall not relieve Solvay from its obligation to deliver Bulk
Product ordered by purchase orders received and accepted by Solvay prior to the
effective date of such expiration or termination, nor shall expiration or
termination relieve COR from accepting and, upon acceptance, paying for any such
Bulk Product. Expiration or termination shall not limit COR's right to sell
Integrelin produced from Bulk Product in its possession or delivered to it after
such expiration or termination. Unless expressly provided to the contrary, the
provisions of Sections 3.0, 4.3, 5.0, 6.1,6.6 and 6.10 shall survive the
expiration or termination of this Agreement.
5.0 Indemnification and Liability.
5.1 COR Indemnification. COR shall indemnify, defend and hold
harmless Solvay and Solvay Affiliates from and against all costs, claims, suits,
expenses (including reasonable attorneys' fees) and damages arising out of or
resulting from:
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 32
(a) the use by or administration to any person of
Integrelin (except where such cost, claim, suit,
expense or damage arose or resulted from Solvay's
negligence or willful misconduct, or an event
specified in Section 5.2); or
(b) infringement of any third party intellectual
property rights relating to Integrelin;
provided that Solvay gives prompt notice to COR of any such claim or action,
tenders the defense of such claim or action to COR, assists COR if requested by
COR, at COR's expense in defending such claim or action and does not compromise
or settle such claim or action without COR's prior written consent.
5.2 Solvay Indemnification. Solvay shall indemnify COR for:
(a) any failure of the Bulk Product supplied by Solvay
under the Supply Agreement to meet the
Specification:
(b) any failure of Solvay to manufacture the Bulk
Product in accordance with Good Manufacturing
Practices or any other applicable government law
or regulation; and
(c) infringement of any third party intellectual
property right relating to the manufacture use or
sale of Bulk Product;
provided that COR gives prompt notice to Solvay of any such claim or action,
offers to tender the defense of such claim or action to Solvay, assists Solvay
if requested by Solvay, at Solvay's expense in defending such claim or action,
and does not compromise or settle such claim or action without Solvay's prior
written consent.
5.3 Liability Cap. Other than for death or personal injury
caused by Solvay's negligent or willful acts, Solvay's liability to COR under
this Supply Agreement shall be limited to the free (to COR) replacement of Bulk
Product within a reasonable time, or the value thereof, provided that the
information Solvay originally submitted to COR about the batch of Bulk
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 33
Product or Bulk Product Intermediates used to manufacture the batch of Bulk
Product to be replaced and the manufacture of same was accurate.
5.4 Limitation of Liability. Neither Party shall be liable to
the other for indirect, incidental or consequential damages arising out of any
of the terms or conditions of this Agreement or with respect to its performance.
6.0 General Provisions.
6.1 Warranties. Solvay warrants:
(a) that it will comply with all manufacturing
instructions and the Specification, including
quality control standards provided in accordance
with Sections 1.2, 2.10 or 2.11;
(b) that Bulk Product will be produced in accordance
with such instructions and specifications and with
Good Manufacturing Practices and other applicable
laws, rules and regulations of the United States,
the European Union, and to the extent applicable,
of European Union Member States; and
(c) that, upon delivery of Bulk Product to the
carrier, Bulk Product will be in conformity with
the Specification and with the United States Food,
Drug and Cosmetic Act, e.g., shall not be
adulterated or misbranded or otherwise of a nature
which may not be introduced into United States
interstate commerce.
6.2 No Other Warranties. The express warranties made in this
Agreement and the Supply Agreement are in lieu of all other warranties, express
or implied, including, without limitation, the warranties of merchantability and
fitness for a particular purpose.
6.3 Recalls. Solvay will indemnify and hold COR harmless from
any out-of-pocket expense relating to implementation of a recall of any batch of
Bulk Product supplied by Solvay due to failure to meet the warranties set forth
in Section 6.1 above. For purposes of this Agreement, the expenses of recall
shall be the expenses of notification and destruction or return
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 34
of the recalled Bulk Product, the costs of Bulk Product recalled and any costs
directly associated with the distribution of replacement Bulk Product. COR shall
have the right to control the arrangement of any recall, and the Parties will
cooperate with each other in implementing such recall.
6.4 Complaints. Solvay will report to COR in writing any
complaints and any information that it may receive relating to Integrelin.
6.5 Notices. All notices and demands required or permitted to be
given or made pursuant to this Agreement shall be in writing and shall be deemed
given if delivered personally or by given by facsimile transmission (receipt
verified), telexed, mailed by registered or certified mail (return receipt
requested), postage prepaid, or sent by express courier service, properly
addressed to the address of the Party to be notified as shown below:
If to Solvay:
Peptisyntha & Cie, SNC
General Manager
310, rue de Ransbeek
B-1210 Bruxelles, Belgium
If to COR:
President, COR Therapeutics, Inc.
26 East Grand Avenue
South San Francisco, California, 94080 U.S.A.,
or to such other address as to which either Party may notify the other. Any
notice sent by facsimile transmission or telex shall be followed within
twenty-four (24) hours by a signed notice sent by first class mail, postage
prepaid.
6.6 Assignment and Delegation. Solvay may not assign its rights
and/or delegate its obligations under this Supply Agreement to any third party
without the prior written consent of COR, such consent not to be unreasonably
withheld, except in connection with the sale, merger or transfer of
substantially all of the stock or assets of Solvay or the sale, merger or
transfer of substantially all of the interests in or the assets of Peptisyntha,
providing that such assignee or delegatee agrees to be bound by the terms of
this Agreement, in which case the consent of COR is not required. However, in
any event, Solvay agrees that COR's Bulk Product orders for 1995 and 1996 shall
be made in the existing Peptisyntha manufacturing facility. It is
10.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 35
recognized that Solvay may wish to pursue the manufacture of Bulk Product
Intermediates by a manufacturer other than Peptisyntha (such as the Solvay
Affiliate Solvay Duphar B.V.); the Parties agree to discuss in good faith
whether the possibility of such manufacturing activities would affect the
regulatory status of Integrelin. COR may assign its rights hereunder in whole or
part, or delegate any of its obligations hereunder to any party who meets
financial and ethical standards generally acceptable within the pharmaceutical
industry, except without such requirement of standards in connection with the
sale, merger or transfer of all or substantially all of the assets of COR
relating to Integrelin, provided such assignee or delegatee agrees to be bound
by the terms of this Supply Agreement.
6.7 Governing Law. This Agreement shall be governed by the laws
of England. Solvay and COR consent to the exclusive jurisdiction and venue of
the courts of England.
6.8 Force Majeure. Neither Party shall be liable to the other
for loss or damage, or, except as provided herein, have any right to terminate
this Supply Agreement by virtue of Force Majeure. In the event of Force Majeure,
the Party affected shall notify the other and shall attempt to perform its
obligations as soon as possible.
6.9 Severability. If any provision of this agreement is
determined to be illegal or unenforceable by any Court of law or any competent
governmental or other authority, the remaining provisions shall be severable and
enforceable in accordance with their terms so long as this Agreement without
such terms or provisions does not fail of its essential purpose. The parties
shall negotiate in good faith to replace any such illegal or unenforceable
provisions with suitable substitute provisions which will maintain as far as
possible the purposes and the effect of this agreement.
6.10 Relationship Of The Parties. Nothing in this Supply
Agreement is intended or shall be deemed to constitute a partnership, agency,
employer-employee or joint venture relationship between the Parties. All
activities by the Parties hereunder shall be performed by them as independent
contractors. Neither Party shall incur any debts or make any commitments for the
other Party, except to the extent, if at all, specifically provided herein. No
right, express or implied, is granted by this Agreement to either Party to use
in any manner the
11.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 36
name of the other or any other tradename or trademark of the other in connection
with the performance of this Supply Agreement. Solvay shall not, without first
obtaining the written consent of COR, in any manner disclose or publish the fact
that Solvay has contracted to furnish COR the goods and services herein ordered.
6.11 Waiver. Failure of either Party to insist upon strict
observance of or compliance with any of the terms of this Supply Agreement in
one or more instances shall not be deemed to be a waiver of its rights to insist
upon such observance or compliance with the other terms hereof, at that point in
time or in the future.
6.12 Headings. All headings, titles and captions in this
Agreement are for convenience only and shall not be of any force or substance.
6.13 Counterparts. This Supply Agreement may be executed in
multiple counterparts, each of which shall be an original, but all of which
shall constitute but one agreement.
IN WITNESS WHEREOF, the Parties hereto have executed this Supply
Agreement to be effective on the date first set forth above.
COR THERAPEUTICS, INC. SOLVAY S.A.
By: By:
-------------------------------- --------------------------------------
Its: Its:
------------------------------- -------------------------------------
Appendix 1: Product Specification
Appendix 2: Shipping Schedule
Appendix 3: Bulk Product Price
12.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 37
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
APPENDIX 1
BULK PRODUCT SPECIFICATION
I. Bulk Product content and testing
[*]
- -----------------------------
[*]
13.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 38
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
II. Shipping specification for shipment of Bulk Product to COR.
[*]
[*]
[*]
14.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 39
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
APPENDIX 2
BULK PRODUCT SHIPPING SCHEDULE
[*]
- -----------------------
[*]
15.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 40
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
APPENDIX 3
BULK PRODUCT PRICE
COR shall pay to Solvay the amount of [*] for Bulk Product at the Specification.
16.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 41
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
EXHIBIT C
ACCEPTABLE SECONDARY SOURCES
COR
[*]
17.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 42
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
EXHIBIT D
CONFIDENTIALITY AGREEMENT
This Agreement is entered into effective as of ____ between
Solvay, Societe Anonyme ("Solvay"), a Belgian corporation, with its
principal offices at 33, rue du Prince Albert, 1050 Bruxelles, Belgium on behalf
of itself and its Affiliates;
COR Therapeutics, Inc. ("COR"), a Delaware corporation, with its
principal offices at 256 East Grand Avenue, South San Francisco, California,
94080, USA, on behalf of itself and its Affiliates; and
_________________________________________________________ ("Company").
WITNESSETH:
WHEREAS, COR owns certain patent rights, trademarks and know-how
relating to a product called Integrelin(TM);
WHEREAS, Solvay has developed a unique and valuable patented and
proprietary process useful for the manufacture of bulk peptide products
containing Integrelin(TM);
WHEREAS, Solvay is practicing the said process for the manufacture of
bulk peptide products containing Integrelin sold to COR pursuant to a License
and Supply Agreement entered into between Solvay and COR as of 27 July 1994:
WHEREAS, under the said License and Supply Agreement, COR is entitled to
establish, under certain conditions, a secondary source of supply for
manufacturing by practicing the said process and selling to COR bulk peptide
products containing Integrelin;
WHEREAS, under the said License and Supply Agreement, Solvay is
obligated to transfer its know-how and provide technical assistance to the
Company provided that the Company has entered into this confidentiality
agreement;
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 43
NOW THEREFORE, in consideration of the foregoing and the mutual promises
contained herein, the parties agree as follows:
1.0 Certain Definitions
For the purposes of this Confidentiality Agreement, the following terms
shall have the following meanings:
1.1 "Affiliates" shall mean any entity or person which
controls, is controlled by or is under common control
with either Party. For purposes of this section 1.1,
"control" shall mean (a) in the case of corporate
entities, the direct or indirect ownership of at least
one-half of the stock or participating shares entitled
to vote for the election of directors, and (b) in the
case of a partnership, the power to direct the
management and policies of such partnership. Without
limitation on the foregoing and for purposes of this
Agreement, Peptisyntha & Cie, Societe en Nom Collectif
("Peptisyntha"), which is a fully owned subsidiary of
Solvay and an entity existing under the laws of Belgium
and having its principal offices at 310, rue de Ransbeek
- 1210 Bruxelles, Belgium, and also Solvay Duphar B.V.,
a Dutch corporation having its main office at C.J. van
Houtenlaan, 36, Weesp, The Netherlands, are deemed
Affiliates of Solvay.
1.2 "Agreement Purpose" shall mean the manufacture of Bulk
Product by the Company for supply to COR.
1.3 "Bulk Product" shall mean a bulk peptide product which
contains Integrelin, is produced by the Licensed Process
and is intended to undergo further processing,
formulation and/or vialing and packaging.
1.4 "Company Know-how" shall mean all information now or
hereafter in the possession of the Company, whether or
not patentable or disclosed within patents owned or
controlled by the Company, constituting materials,
methods, processes, techniques and data which are useful
or necessary for the manufacture of Bulk Product and
which relate to the Licensed Process
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 44
which the Company has the right to license or disclose
without violating existing contractual obligations to
third parties.
1.5 "Effective Date" shall mean ___________________.
1.6 "Integrelin" shall mean a specific peptide designated by
COR and known as Integrelin(TM), the chemical structure
of which is known to the parties because of prior
business relationships.
1.7 "Licensed Process" shall mean any process or process(es)
developed or acquired by Solvay presently or in the
future and used commercially for making bulk peptide
products containing Integrelin according to COR's
specifications, during the term of any supply
arrangements between COR and Solvay or the Company.
1.8 "Party" shall mean Solvay, COR or the Company.
1.9 "Solvay Know-how" shall mean all information now or
hereafter in the possession of Solvay, whether or not
patentable or disclosed within patents owned or
controlled by Solvay, constituting materials, methods,
processes, techniques and data which are useful [*] for
the manufacture of Bulk Product and which relate to the
Licensed Process which Solvay has the right to license
or disclose without violating existing contractual
obligations to third parties.
2.0 KNOW-HOW AND TECHNICAL ASSISTANCE
2.1 Transfer of Solvay Know-how to the Company. Promptly
upon execution of this Agreement, and updated at least
quarterly, Solvay shall provide to the Company in a
written form, [*] Solvay Know-how useful for the
manufacture of Bulk Product, including by way of
example, [*] and any documents which result from
inspection by governmental agencies [*]. Solvay shall
disclose such [*]. During the term of this Agreement,
Solvay shall continue to provide such technical
assistance and access to
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 45
information, as may be useful for the Company to
manufacture Bulk Product by the Licensed Process and to
support COR's efforts to obtain appropriate regulatory
approvals for the sale of products containing
Integrelin.
The Company agrees that such Solvay Know-how shall be
distributed by the Company only to those employees
designated by the Company as having a need to know such
information, and who sign personal obligations of
confidentiality with Solvay with respect to Solvay
Confidential Information. The Company further agrees to
guarantee such personal obligations of confidentiality
made by its employees
2.2 Transfer of Company Know-how to Solvay. During the term
of this Confidentiality Agreement, the Company shall at
least quarterly and promptly disclose the Company
Know-how to Solvay at a level of detail sufficient to
enable Solvay to practice the Company Know-now and shall
provide such technical assistance and access to
information as may be useful for Solvay to manufacture
Bulk Product and to support COR's efforts to obtain
appropriate regulatory approvals for the sale of
products containing Integrelin.
2.3 Transfer of Solvay Know-how and Company Know-how to COR.
During the term of this Confidentiality Agreement, the
Company may provide to COR in a written form, [*] Solvay
Know-how and [*] Company Know-how [*] useful [*] for
obtaining appropriate regulatory approvals [*] including
by way of example, [*] and any documents which result
from inspection by governmental agencies [*].
Such information shall be deposited by the Company to a
third party escrow acceptable to COR, Solvay and the
Company, in English language written form. Such escrow
of additional technical information shall be updated at
least quarterly by the Company. Access to this escrowed
information may be made by Solvay upon judicial order or
by agreement
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 46
between COR and Solvay. Access to this escrowed
information may be made by [*]. Any information received
by COR from the Company pursuant to this Section 2.3
shall be deemed Solvay Confidential Information for the
purposes of the License and Supply Agreement entered
into between Solvay and COR as of 27 July 1994.
3.0 CONFIDENTIALITY
3.1 Confidentiality and Exceptions. In the course of the
performance of this Confidentiality Agreement, one Party
may disclose to the other or receive information from
another Party relating to the subject matter of this
Agreement which information, if so identified upon
disclosure, shall be considered to be the disclosing
Party's Confidential Information. Each Party agrees that
it will take the same steps to protect the
confidentiality of another Party's Confidential
Information as it takes to protect its own proprietary
and confidential information. Each Party shall protect
and keep confidential and shall not use, publish or
otherwise disclose to another Party or to any third
party, except as permitted by this Agreement, without
the disclosing Party's written consent, the disclosing
Party's Confidential Information. For the purposes of
this Agreement, Confidential Information shall not
include such information that:
(a) was already known to the receiving Party, other
than under an obligation of confidentiality, at
the time of disclosure by the disclosing Party;
(b) was generally available to the public or was
otherwise part of the public domain at the time
of disclosure or became generally available to
the public or otherwise part of the public
domain after disclosure other than through any
act or omission of the receiving Party in breach
of this Agreement; or
(c) was lawfully disclosed to the receiving Party,
other than under an obligation of
confidentiality, by a third party who had no
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 47
obligation to the disclosing Party not to
disclose such information to others.
3.2 Authorized Disclosure. Each Party may disclose
Confidential Information hereunder to the extent such
disclosure is reasonably necessary for prosecuting or
defending litigation, complying with applicable
governmental regulations or conducting preclinical or
clinical trials, provided that if a Party is required by
law or regulation to make any such disclosure of another
Party's Confidential Information it will, except where
impracticable for necessary disclosures, for example in
the event of medical emergency, give reasonable advance
notice to that other Party of such disclosure
requirement and will use its reasonable efforts to
secure confidential treatment of such Confidential
Information required to be disclosed. In addition, COR
and Solvay shall be entitled to disclose, under a binder
of confidentiality containing provisions as protective
as those of this Section 3.0, the Company's confidential
Information to other entity permitted to practice the
License Process. No Party shall disclose Confidential
Information of another Party in any patent filings
without the prior written consent of the disclosing
Party.
3.3 Limitation on use. The Parties shall not use the
Confidentiality Information of any other Party disclosed
herein for any purpose other than the Agreement Purpose.
4.0 TERMINATION.
4.1 Term. This Confidentiality Agreement shall become
effective on the Effective Date and, unless terminated
earlier under Section 4.2 or 4.3, shall remain in effect
until termination of the supply arrangements between COR
and the Company.
4.2 Termination.
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 48
(a) If the Company shall default in a material
manner with respect to any material provision of
this Agreement and Solvay or COR shall have
given the Company and the other Party notice of
such default, the Company shall have ninety (90)
days to cure such default. If such default is
not cured within such ninety (90) day period,
the nondefaulting Parties shall have the right,
upon notice to the Company and without prejudice
to any other rights they may have, to terminate
this Agreement unless the Company is in the
process of attempting in good faith to remedy
such default, in which case the ninety (90) day
cure period shall be extended by an additional
sixty (60) days;
(b) If the Company makes any assignment of
substantially all of its assets for the benefit
of creditors, or places substantially all of its
assets in the hands of a receiver or judicial
manager unless the receivership or judicial
management is dissolved within thirty (30) days
thereafter, goes into liquidation, or is
dissolved, wound up, confiscated, sequestered or
in any other way transferred into state
ownership, then COR or Solvay may terminate this
Agreement forthwith upon ten (10) days written
notice to the Company.
4.3 Survival of Certain Provisions. The provisions of
Section 3.0 shall survive any termination of this
Confidentiality Agreement until [*].
5.0 GENERAL PROVISIONS
5.1 Liability. Solvay makes no representation nor warranty
and, other than for death or personal injury caused by
Solvay's negligent or willful acts, shall have no
liability whatsoever to COR, the Company or any third
party for or on account of any injury, loss or damage,
of any kind or nature, sustained by, or any damage
assessed or asserted against, or any other liability
incurred or imposed upon COR, the Company or any third
party, arising out of or in connection with or resulting
from the execution,
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 49
delivery and performance of this Confidentiality
Agreement and the Company shall hold Solvay and its
officers, agents and employees harmless in the event
Solvay, its officers, agents or employees are held
liable.
5.2 Notices. All notices and demands required or permitted
to be given or made pursuant to this Agreement shall be
in writing and shall be deemed given if delivered
personally or by given by facsimile transmission
(receipt verified), telexed, mailed by registered or
certified mail (return receipt requested), postage
prepaid, or sent by express courier service, properly
addressed to the address of the Party to be notified as
shown below:
If to Solvay:
Solvay, S.A.
Head of Licensing Department
Rue du Prince Albert, 33
B-1050 Bruxelles. Belgium
If to COR:
President, COR Therapeutics, Inc.
256 East Grand Avenue
South San Francisco, California, 94080 U.S.A.,
If to the Company:
or to such other address as to which any Party may notify the
others. Any notice sent by facsimile transmission or telex shall
be followed within twenty-four (24) hours by a signed notice
sent by first class mail, postage prepaid.
5.3 Assignment and Delegation. The Company may not assign
its rights and/or delegate its obligations under this
Agreement to any third party
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 50
without the prior consent of COR and Solvay. Solvay and
COR may assign their rights and/or delegate their
obligations under this Agreement to any third party
without the consent of the Company.
5.4 Governing Law. This Agreement shall be governed by the
laws of England. Solvay, the Company and COR consent to
the exclusive jurisdiction and venue of the courts of
England.
5.5 Amendment. No amendment or modification of the terms of
this Agreement shall be binding any Party unless reduced
to writing and signed by the respective authorized
officers of the Parties.
5.6 Publicity. The Parties agree that, except as may
otherwise be required by applicable laws, regulations,
rules, or orders, no information concerning this
Agreement and the transactions contemplated herein shall
be made public by any Party without the prior written
consent of the others.
5.7 Waiver. Failure of any Party to insist upon strict
observance of or compliance with any of the terms of
this Agreement in one or more instances shall not be
deemed to be a waiver of its rights to insist upon such
observance or compliance with the other terms hereof, at
that point in time or in the future.
5.8 Counterparts. This Agreement may be executed in multiple
counterparts, each of which shall be an original, but
all of which shall constitute but one agreement.
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 1
EXHIBIT 10.25
FIRST AMENDMENT TO THE LICENSE AND SUPPLY AGREEMENT BETWEEN
COR THERAPEUTICS AND SOLVAY
This Amendment is entered into effective as of 13 March 1995 between
COR THERAPEUTICS, INC. ("COR"), a Delaware Corporation, with its principal
offices at 256 East Grand Avenue, South San Francisco, California 94080, U.S.A.
and SOLVAY, SOCIETE ANONYME ("SOLVAY"), a Belgian corporation, with its
principal offices at 33, rue du Prince Albert, 1050 Bruxelles, Belgium.
WITNESSETH
WHEREAS, COR and Solvay have entered into a License and Supply
Agreement effective as of 27 July 1994 (the "Agreement") on their behalf and on
behalf of their Affiliates (as defined in the Agreement);
WHEREAS, COR and Solvay are willing to modify a provision of the
Agreement;
NOW, THEREFORE, in consideration of the foregoing, the parties agree
to amend the Agreement as follows:
In Section 2.2, on page 5, replace line 13 by "(...) as the breach or
default remains uncured. If by 15 June 1995, SOLVAY and COR have not (...)".
All the other provisions of the Agreement shall remain unchanged and
in full force and effect.
IN WITNESS WHEREOF, COR and Solvay have executed this Amendment to be
effective on the date first set forth hereabove.
COR THERAPEUTICS, Inc. SOLVAY S.A.
By: By:
---------------------------------- ----------------------------------
Title: Title:
------------------------------- -------------------------------
1.
<PAGE> 1
EXHIBIT 10.26
SECOND AMENDMENT TO THE LICENSE AND SUPPLY AGREEMENT BETWEEN
COR THERAPEUTICS AND SOLVAY
This Amendment is entered into effective as of the 1st day of June, 1995 between
COR THERAPEUTICS, INC. ("COR"), a Delaware corporation, with its principal
offices at 256 East Grand Avenue, South San Francisco, California 94080, U.S.A.
and SOLVAY, Societe Anonyme ("SOLVAY"), a Belgian corporation, with its
principal offices at 33, rue du Prince Albert, 1050 Bruxelles, Belgium.
WITNESSETH
WHEREAS, COR and SOLVAY have entered into a License and Supply Agreement
effective as of 27 July 1994 (the "Agreement") on their behalf and on behalf of
their Affiliates (as defined in the Agreement);
WHEREAS, COR and SOLVAY have modified a provision of the Agreement by a First
Amendment effective as of 13 March 1995;
WHEREAS, COR and SOLVAY are presently willing to modify the same provision a
second time;
NOW, THEREFORE, in consideration of the foregoing, the parties agree to amend
the Agreement as follows:
In section 2.2, on page 5, replace line 13 by "(...) as the breach or default
remains uncured. If by 15 September 1995, SOLVAY and COR have not (...)".
All the other provisions of the Agreement shall remain unchanged and in full
force and effect.
IN WITNESS WHEREOF, COR and SOLVAY have executed this Amendment to be effective
on the date first set forth hereabove.
COR THERAPEUTICS, Inc. SOLVAY S.A.
By: By:
---------------------------------- ----------------------------------
Title: Title: General Manager
------------------------------- Research and Development
1.
<PAGE> 1
EXHIBIT 10.27
THIRD AMENDMENT TO THE LICENSE AND SUPPLY AGREEMENT BETWEEN
COR THERAPEUTICS AND SOLVAY
This Amendment is entered into effective as of the 5th day of September, 1995
between COR THERAPEUTICS, INC. ("COR"), a Delaware corporation, with its
principal offices at 256 East Grand Avenue, South San Francisco, California
94080, U.S.A. and SOLVAY, Societe Anonyme ("SOLVAY"), a Belgian corporation,
with its principal offices at 33, rue du Prince Albert, 1050 Bruxelles, Belgium.
WITNESSETH
WHEREAS, COR and SOLVAY have entered into a License and Supply Agreement
effective as of 27 July 1994 (the "Agreement") on their behalf and on behalf of
their Affiliates (as defined in the Agreement);
WHEREAS, COR and SOLVAY have modified a provision of the Agreement by two
successive Amendments respectively effective as of 13 March and 1 June, 1995.
WHEREAS, COR and SOLVAY have entered into an ultimate phase of negotiations
relating to the long-term supply of Integrelin;
NOW, THEREFORE, in consideration of the foregoing, the parties agree to amend
the Agreement as follows:
In section 2.2, on page 5, replace line 13 by "(...) as the breach or default
remains uncured. If by 15 October 1995, SOLVAY and COR have not (...)".
All the other provisions of the Agreement shall remain unchanged and in full
force and effect.
IN WITNESS WHEREOF, COR and SOLVAY have executed this Amendment to be effective
on the date first set forth hereabove.
COR THERAPEUTICS, Inc. SOLVAY S.A.
By: By: Alfred Hoffait
---------------------------------- ----------------------------------
Title: Title: General Manager Research and
------------------------------- Development
1.
<PAGE> 1
EXHIBIT 10.28
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
COR COR THERAPEUTICS, INC. 256 E. Grand Avenue
via fax 011-32-2-264-2790 and Federal Express South San Francisco
California 94080
415-244-6800
Fax 415-244-9208
May 16, 1996
Mr. Alfred Hoffait
Solvay S.A.
rue de Ransbeek 310
B-1120 Brussels BELGIUM
Dear Mr. Hoffait:
As you are aware, COR is in the process of locating and qualifying possible
second sources for the supply of Integrilin(TM).
COR notes that our License and Supply Agreement, dated 27 July 1994, includes a
list of possible secondary sources and provides under Article 2.2 for additional
companies to be added to the list from time to time upon the agreement of COR
and Solvay.
To that end, COR would like to amend Exhibit C of our License and Supply
Agreement to include the following companies in addition to those already
listed:
[*]
Thank you for your attention to this matter. To confirm your acknowledgment and
agreement to this addition, could you please sign both original copies of this
letter and return one to COR (attn: Jayne Lange) for our records.
Sincerely,
Mark D. Perrin
Executive Vice President
Commercial Operations
Acknowledged and Agreed:
For Solvay SA:
- -------------------------
Signed
- -------------------------
Name
June 6, 1996
- -------------------------
Date
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 1
EXHIBIT 10.29
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
AMENDMENT NO. 4 TO
THE LICENSE AND SUPPLY AGREEMENT
BETWEEN COR THERAPEUTICS, INC.
AND
SOLVAY, S. A.
THIS AMENDMENT NO. 4 to the License and Supply Agreement (the
"Amendment") is entered into between COR Therapeutics, Inc. ("COR"), a Delaware
corporation, with its principal offices at 256 East Grand Avenue, South San
Francisco, California, USA 94080, and Solvay, Societe Anonyme ("Solvay"), a
Belgian corporation, with its principal offices at 33, rue du Prince Albert,
1050 Bruxelles, Belgium, each on behalf of itself and its Affiliates. This
Amendment shall be effective on April 1, 1997 (the "Amendment Effective Date").
RECITALS
WHEREAS, COR and Solvay entered into a License and Supply Agreement
dated 27 July 1994 (the "License and Supply Agreement") and a Long Term Supply
Agreement dated 28 September 1995 (the "Long Term Supply Agreement") to provide
for the manufacture of a bulk peptide product and for the supply of that product
to COR for commercial and clinical use; and
WHEREAS, Solvay has agreed that COR may utilize [*] on certain terms;
and
WHEREAS, the Parties desire to clarify certain matters related to the
transfer of technology and communications between the Parties.
NOW THEREFORE, in consideration of the foregoing and the covenants and
promises contained in this Amendment, COR and Solvay hereby amend the License
and Supply Agreement as follows.
In this Amendment, capitalized terms shall have the meanings provided
herein or otherwise provided by the License and Supply Agreement. Headings are
for the convenience of the Parties only, and shall not be of any force or
substance.
1. Section 1.7 shall be deleted and replaced with the following:
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 2
1.7 "INTEGRILIN" shall refer to a specific peptide designated by COR and
known as Integrilin(TM), which same peptide was known previously as
"Integrelin", the chemical structure of which is known to Solvay because of the
prior business relationship between COR and Solvay. Any references herein to
Integrelin shall be deemed to refer to Integrilin.
2. Section 1.9 shall be deleted and replaced with the following:
1.9 "NET BULK SALES" shall mean as to each calendar quarter the gross
invoiced sales price charged for all Bulk Products sold to COR [*] or a
Secondary Source, after deducting the following items paid by COR during such
calendar quarter with respect to sales of Bulk Product hereunder regardless of
the calendar quarter in which such sales were made, provided and to the extent
that such items are incurred, and are included in the price charged:
(a) trade, quantity and case discounts or rebates;
(b) credits or allowances given or made for rejection or
return of previously sold Bulk Product;
(c) any tax or government charge (other than an income tax)
levied on the sale, transportation or delivery of Bulk
Product and borne by the seller thereof; and
(d) any charges for freight or insurance in a CIF sale.
3. Section 1.13 shall be inserted after Section 1.12 as follows:
1.13 "STEP ONE INTERMEDIATES" shall refer to those Bulk Product
Intermediates, [*] which exist upon completion of the manufacture of Bulk
Product through a certain step (designated by the Parties as "Step One").
4. Section 2.2 shall be deleted and replaced with the following:
2.2 Secondary Supply. COR shall have the right to establish a Secondary
Source for the manufacture of Bulk Product by the Licensed Process for COR. The
Secondary Source shall be [*] COR and Solvay agree that [*] would be acceptable
as the Secondary Source. COR will notify Solvay of the establishment of the
Secondary Source. In the event COR terminates a supply arrangement with a
Secondary Source, COR may establish an alternate Secondary
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 3
Source. COR shall notify Solvay within [*] of such a termination of supply
arrangements with a Secondary Source. Further, after the Secondary Source is
established, COR may use [*]. COR's future requirements for Bulk Product [*] COR
wants to entertain certain [*]. Therefore, after the Secondary Source is
established, COR shall [*] purchase from Solvay [*] of its total, worldwide
requirements for Bulk Product on a year-to-year basis (to the extent that such
[*] does not exceed the manufacturing capacity planned by Solvay to produce Bulk
Product) for the time period during which royalties are payable under this
Agreement. For purposes of the preceding sentence, such planned capacity shall
be determined for a particular calendar year X on [*]. Notwithstanding the above
however, COR may purchase from such Secondary Source [*] of its requirements in
the event of any breach or default of Solvay of any supply arrangement between
COR and Solvay, for so long as the breach or default remains uncured. [*] COR
may establish an additional, "Back-up" Secondary Source for the manufacture of
Bulk Product. In the event that COR wishes to establish [*] then COR and Solvay
shall negotiate in good faith, before [*].
5. Section 3.1 shall be deleted and replaced with the following:
3.1 Grant by Solvay. Solvay hereby grants to COR under the Solvay
Patents and Solvay Know-how an irrevocable (subject to Section 5.2), sole --
with Solvay and Solvay Affiliates -- worldwide license, with right to sublicense
to the Secondary Source and the Back-up Secondary Source, to develop, use for
regulatory or legal purposes, sell, have sold, and either manufacture if COR is
the Secondary Source and/or Back-up Secondary Source, or have manufactured by
the Secondary Source and/or Back-up Secondary Source [*] Integrilin and products
containing Integrilin produced practicing the Solvay Know-how or the Licensed
Process. In addition, Solvay hereby grants to COR the right, within the
foregoing license, to [*] to have Bulk Product manufactured by [*] for COR
produced by practicing the [*] Solvay Know-how or the Licensed Process, [*]. No
other rights than those expressly provided in this Agreement, the Long Term
Supply Agreement, and the Supply Agreement are granted by Solvay to COR or any
Secondary Source by implication or otherwise. COR [*]. Any rights sublicensed to
the Secondary Source or Back-up Secondary Source, pursuant to this Section 3.1
shall not be further transferred without the prior written consent of Solvay.
For the purpose of this Section 3.1, "sole" license shall mean that Solvay shall
not grant to any third party any right during the
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 4
term of this Agreement under the Solvay Patents and Solvay Know-how to
manufacture bulk peptide products containing Integrilin or to use or sell Bulk
Products manufactured thereby.
6. Section 3.3 shall be deleted and replaced with the following:
3.3 Process Improvements The Parties acknowledge that Solvay or COR
may develop or acquire improvements to the manufacturing materials, equipment,
procedure, Solvay Know-how or Licensed Process in the course of fulfilling its
obligations under this Agreement and the Supply Agreement. Solvay agrees to
obtain COR's consent prior to implementing such improvements, or any changes in
the Licensed Process or in any [*]. Any such improvements developed or acquired
by Solvay which are used commercially by Solvay or [*] and/or the Secondary
Source and/or Back-up Secondary Source for making bulk peptide products
containing Integrilin shall be deemed to be within the definition of Licensed
Process or Solvay Know-how as licensed in Section 3.1.
Except as provided below, COR hereby agrees to use [*] and/or to
establish a Secondary Source (and/or Back-up Secondary Source) only if it agrees
to grant back to COR a non-exclusive, worldwide, royalty-free license,
sublicenseable by COR to entities entitled to practice the Licensed Process, to
use any improvements to the manufacturing materials, equipment, procedure,
Solvay Know-how or the Licensed Process related to this Agreement which are
developed or acquired by [*] or such Secondary Source, to develop, use, sell,
have sold, [*] or have manufactured by [*] and/or the Secondary Source (and/or
Back-up Secondary Source) [*] of this Agreement, Integrilin and products
containing Integrilin.
However, for [*] the Secondary Source established by COR pursuant to
Section 2.2 of this Agreement, any sublicense to [*] those improvements which
are developed or acquired by Solvay upon or after [*] and whose use in the
Licensed Process would have a significant impact on the economics of the
practice of the Licensed Process or on the quality of the products produced
thereby, and such improvements [*].
COR hereby agrees to sublicense the rights granted to it pursuant to
this Section 3.3 by [*] or a Secondary Source (and/or Back-up Secondary Source)
to Solvay, for use by Solvay during any time period wherein Solvay is supplying
COR with Bulk Product, pursuant to the terms of any supply arrangement between
COR and Solvay. COR agrees that it will use any such [*] or Secondary Source
improvements to manufacture Bulk Product [*] is the Secondary
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 5
Source, [*] COR [*] or Secondary Source improvements to manufacture Bulk Product
[*] Secondary Source when COR [*].
For purposes of this Section 3.3, COR, Solvay, [*] and any Secondary
Source shall exchange rights to the improvements specified in this Section 3.3
which are developed or acquired by any of them during the time period between
the Effective Date and [*] at which time COR and Solvay agree to consider in
good faith, in consultation with [*] or any Secondary Source, whether or not the
exchange of improvements should be continued [*].
In the event that COR [*], COR hereby agrees to grant to Solvay a
worldwide, royalty-free license, without right to sublicense, to use any
improvements to the manufacturing materials, equipment, procedure, Solvay
Know-how or the Licensed Process related to this Agreement which are owned or
developed by COR, to develop, manufacture, have made, use, sell and have sold
Integrilin and products containing Integrilin, according to the terms of this
Agreement, and for use by Solvay during any time period wherein Solvay is
supplying COR with Bulk Product, pursuant to the terms of any supply arrangement
between COR and Solvay.
In the event that, despite good faith negotiations, a potential
Secondary Source with whom COR desires to contract is unable or refuses to grant
rights to its improvements to COR for further sublicense, then COR agrees that
any [*] or [*] by Solvay upon or after the establishment of that Secondary
Source shall [*] that Secondary Source, to be [*].
7. Section 3.5 shall be deleted and replaced with the following:
3.5 Technology Transfer to the Secondary Source. Promptly upon the
notification by COR to Solvay of the planned commencement of Bulk Product
manufacture by [*] for COR, or of the establishment of the Secondary Source or
the Back-up Secondary Source pursuant to Sections 2.2, 3.3 and 3.5 of this
Agreement, and updated at least quarterly, Solvay shall provide to the Secondary
Source, and to [*] if applicable, in a written form, [*] Solvay Know-how useful
for the manufacture of Bulk Product, including by way of example, [*] and any
documents which result from inspection by governmental agencies [*]. Solvay
shall disclose [*]. During the term of this Agreement, Solvay shall continue to
provide such technical assistance and access to information as may be useful for
[*] and/or the Secondary Source to manufacture Bulk Product by the Licensed
Process and to obtain appropriate regulatory approvals for the sale of products
containing Integrilin.
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 6
COR shall require [*] and the Secondary Source to agree that such Solvay
Know-how shall be distributed by [*] and/or the Secondary Source only to those
employees designated by [*] and/or the Secondary Source as having a need to know
such information, and who sign personal obligations of confidentiality with
Solvay with respect to Solvay Confidential Information. COR shall require [*]
and the Secondary Source to further agree to guarantee such personal obligations
of confidentiality made by its employees, respectively.
8. Section 3.7 shall be inserted after Section 3.6 as follows:
3.7 TECHNOLOGY TRANSFER AGENTS. Solvay agrees that COR may designate [*]
Technology Transfer Agents ("TTAs"). The mission of the TTAs shall be to
participate in the technology transfer team appointed to transfer the Solvay
Know-How to [*] [*] or a Secondary Source established pursuant to Section 2.2 of
this Agreement (the "Mission"). The Mission shall terminate on the earlier of
either the production under appropriate regulatory approvals related to
manufacturing by [*] and the Secondary Source of an aggregate amount of [*] of
Bulk Product for COR [*] or [*] of the supply, to [*] or to the Secondary Source
pursuant to Section 3.5 of this Agreement, of an initial disclosure package in a
written form which would include:
[*]
In the event that COR entrusts its Secondary Source, [*] with the
manufacture for COR of [*] the Mission shall be reactivated and shall terminate
again on the earlier of either the production under appropriate regulatory
approvals related to manufacturing by [*] of an aggregate amount of [*] of Bulk
Product for COR [*] or [*] of the supply in a written form of the initial
disclosure package described above - to [*] pursuant to Section 3.5 of this
Agreement.
In the event that an alternate Secondary Source is established pursuant
to Section 2.2 of this Agreement, the Mission shall be reactivated and shall
terminate again on the earlier of either the production under appropriate
regulatory approvals related to manufacturing by such Secondary Source of an
aggregate amount of [*] of Bulk Product for COR [*] or [*] of the supply in a
written form of the initial disclosure package described above to such Secondary
Source pursuant to Section 3.5 of this Agreement.
SOLVAY shall disclose promptly to the TTAs all information sufficient to
enable them to complete the Mission. Each TTA will be under confidentiality
obligations to SOLVAY in accordance with the Confidentiality Agreement given in
Exhibit E. The persons utilized as
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 7
TTAs may be changed by COR with the prior written approval of Solvay, such
approval not to be unreasonably delayed or withheld.
9. Section 4.9 shall be deleted and replaced with the following:
4.9 Expenses for Training and Technology Transfer. COR shall pay to
Solvay, as compensation for technical assistance to COR, [*] or the Secondary
Source in the transfer of information including the Solvay Know-how and the
Licensed Process, and for training to personnel of [*] or the Secondary Source
[*] the amount of [*] any Solvay employee is providing such technical assistance
or training. From the [*] this amount shall be [*] for the [*]. COR shall also
bear all actually incurred [*] for Solvay personnel working for the benefit of
COR or [*] or the Secondary Source [*] upon invoice, with supporting
documentation, from Solvay.
10. Section 6.7 shall be deleted and replaced with the following:
6.7 Performance by Secondary Source. COR shall remain responsible
and be guarantor of the performance by [*] or the Secondary Source under this
Agreement and the Supply Agreement and shall cause [*] or the Secondary Source
to comply with the provisions of this Agreement and the Supply Agreement in
connection with such performance.
11. Section 8.2 shall be deleted and replaced with the following:
8.2 Authorized Disclosure. Each Party may disclose Confidential
Information hereunder to the extent such disclosure is reasonably necessary for
prosecuting or defending litigation, complying with applicable governmental
regulations or conducting preclinical or clinical trials, provided that if a
Party is required by law or regulation to make any such disclosure of the other
Party's Confidential Information it will, except where impracticable for
necessary disclosures, for example in the event of medical emergency, give
reasonable advance notice to the other Party of such disclosure requirement and
will use its reasonable efforts to secure confidential treatment of such
Confidential Information required to be disclosed. In addition, COR shall be
entitled to disclose, under a binder of confidentiality containing provisions as
protective as those of this Section 8.0, Solvay Confidential Information to [*]
or any Secondary Source permitted under Sections 2.2 and 3.0 of this Agreement.
Nothing in this
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 8
Section 8.0 shall restrict any Party from using for any purpose any information
developed by it during the course of this Agreement. Neither Party shall
disclose Confidential Information of the other Party in any patent filings
without the prior written consent of the disclosing Party.
12. Section 8.5 shall be deleted and replaced with the following:
8.5 Confidentiality and Limitation on Use COR agrees, and shall
require [*] and the Secondary Source to agree, to not disclose Solvay Know-how
to any third party and not to use Solvay Know-how for any purpose other than the
production of Bulk Product, except for necessary disclosures to governmental
agencies such as the U.S. Food and Drug Agency and its equivalents, according to
the provisions of Section 8.0. COR shall require [*] and the Secondary Source to
sign a three-way confidentiality agreement (with COR and Solvay) in the form of
Exhibit D or in a form substantially similar to that of Exhibit D hereto but
having changes agreed to by COR and Solvay.
13. Except as otherwise amended herein, the License and Supply Agreement
shall remain in full force and effect.
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 9
IN WITNESS WHEREOF, the Parties hereto have executed this Amendment to
be effective on the date set forth above.
COR THERAPEUTICS, INC. SOLVAY, S.A.
By: By:
-------------------------------- --------------------------------
Title: Title:
----------------------------- -----------------------------
Exhibit E: Technology Transfer Agent Confidentiality Agreement
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 10
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
CONFIDENTIALITY AGREEMENT
This Agreement is entered into effective as July 16, 1996
among:
SOLVAY, Societe Anonyme ("SOLVAY"), a Belgian corporation,
with its principal offices at 33, rue du Prince Albert, 1050
Brussels, Belgium, on behalf of itself and its Affiliates; and
COR Therapeutics, Inc. ("COR"), a Delaware corporation, with
its principal offices at 256 East Grand Avenue, South San
Francisco, California 94080, USA, on behalf of itself and its
Affiliates; and
[*] ("RECIPIENT"), a designee of COR with an address at [*]
USA.
WITNESSETH:
WHEREAS, COR owns certain patent rights, trademarks and
know-how relating to a product called INTEGRILIN(TM),
WHEREAS, SOLVAY has developed a unique and valuable patented
and proprietary process useful for the manufacture of
peptides, and is practising the said process for the
manufacture of bulk peptide products containing INTEGRILIN(TM)
sold to COR pursuant to several Agreements entered into
between SOLVAY and COR,
WHEREAS, SOLVAY has agreed to disclose confidential
information relating to its process to RECIPIENT, who has been
duly appointed by COR to participate in technology transfer
team in charge of the transfer of SOLVAY's technology to COR's
Secondary Source of supply of INTEGRILIN(TM) and to [*] the
production of bulk peptide products containing INTEGRILIN(TM)
for the account of SOLVAY.
NOW, THEREFORE, in consideration of the foregoing and the
mutual promises contained herein, the parties agree as
follows:
1.0. CERTAIN DEFINITIONS
For the purposes of this Agreement, the following terms shall
have the following meanings:
EXHIBIT E PG 1
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 11
1.1. "Affiliates" shall mean any entity or person which
controls, is controlled by or is under common control with
either Party. For purposes of this section 1.1., "control"
shall mean:
a) in the case of corporate entities, the direct or indirect
ownership of at least one-half of the stock or participating
shares entitled to vote for the election of directors, and
b) in the case of a partnership, the power to direct the
management and policies of such partnership.
Without limitation on the foregoing and for purposes of this
Agreement, PEPTISYNTHA & Cie, Societe en Nom Collectif
("PEPTISYNTHA"), which is a fully owned subsidiary of SOLVAY
and an entity existing under the laws of Belgium and having
its principal offices at 310, rue de Ransbeek, 1120 Brussels,
Belgium, is deemed an Affiliate of SOLVAY.
1.2. "Agreement Purpose" shall mean the participation of
RECIPIENT in the technology transfer team appointed
to Transfer SOLVAY's technology to COR's Secondary
Source of supply and [*]
1.3 "SOLVAY Confidential Information" shall mean any or
all confidential information relating to the process
developed by SOLVAY for the manufacture of bulk
peptide products containing INTEGRILIN(TM).
1.4. "Effective Date" shall mean 07/16, 1996.
1.5. "INTEGRILIN(TM)" shall mean a specific peptide
designated by COR and known as INTEGRILIN(TM), the
chemical structure of which is known to the Parties
pursuant to the terms of separate agreements entered
into with COR.
1.6. "Party" shall mean SOLVAY, COR or RECIPIENT.
2.0. DISCLOSURE OF SOLVAY CONFIDENTIAL INFORMATION
2.1. SOLVAY shall disclose to RECIPIENT SOLVAY
Confidential Information sufficient to enable
RECIPIENT to fulfil the Agreement Purpose.
2.2 SOLVAY Confidential Information disclosed under
paragraph 2.1 hereabove may be disclosed in tangible
form, such as in writing and marked "Confidential",
or provided
EXHIBIT E PG 2
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 12
orally. SOLVAY confidential Information must be indicated to
be confidential at the time of its first disclosure to
RECIPIENT.
3.0. CONFIDENTIALITY AND EXCEPTIONS
3.1. RECIPIENT hereby agrees, regarding SOLVAY Confidential
Information, that he/she shall:
(a) make no use of said information, except for the Agreement
Purpose;
(b) not disclose said information to any party or person other
than a possible second person appointed by COR to fulfil the
Agreement Purpose and who shall have signed a confidentiality
agreement similar to this Agreement;
(c) not disclose said information to COR;
(d) not disclose to any party or person either the existence
of this Agreement or its underlying discussions except for the
Agreement Purpose;
(e) take the same steps to protect said information as he/she
takes to protect the proprietary and confidential information
of COR.
3.2. The obligations under paragraph 3.1 hereabove shall not,
however, apply to any SOLVAY Confidential Information which:
(a) RECIPIENT can prove is at the time of disclosure or
thereafter becomes public knowledge through no fault or
negligence of RECIPIENT, or
(b) RECIPIENT can prove was known to him/her, prior to the
receipt of such Confidential Information from SOLVAY, or
(c) is lawfully obtained by RECIPIENT from any party not bound
by a secrecy obligation towards SOLVAY relating to the
Confidential Information.
For the purposes of this paragraph 3.2, information shall not be deemed
to be public knowledge or known on the ground only that:
EXHIBIT E PG 3
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 13
(i) the general principle is public knowledge or known to
RECIPIENT if the particular practice is not itself public
knowledge or so known, or
(ii) it constitutes a combination of or is drawn from
information which is public knowledge or known to RECIPIENT
unless the combination itself and its principle and mode of
operation is also public knowledge or known to the RECIPIENT.
4.0. DOCUMENTS DELIVERY OR DESTRUCTION
Upon the written request of SOLVAY, RECIPIENT undertakes to
promptly deliver it, or destroy if so instructed by it, all
documents furnished by SOLVAY to RECIPIENT and constituting
Confidential Information, as well as all copies thereof which
might be in his/her possession.
5.0. NO IMPLIED LICENSE
Nothing in this Agreement shall be construed as to grant
RECIPIENT any title or right or license to own or use at any
time the SOLVAY Confidential Information, except as expressly
set forth herein.
6.0. COR'S RESPONSIBILITY
COR shall guarantee the performance of this Agreement by
RECIPIENT.
7.0. TERM
This Agreement shall become effective on the Effective Date
and shall remain in effect for six (6) months. The provisions
of Article 3 shall however survive until [*].
8.0. GENERAL PROVISIONS
8.1. Notices
All notices and demands required or permitted to be given or
made pursuant to this Agreement shall be in writing and shall
be deemed given if delivered personally or by given facsimile
transmission (receipt verified), telexed, mailed by registered
or certified mail (return receipt requested), postage prepaid,
or sent by express courier service, properly addressed to the
address of the Party to be notified as shown below:
EXHIBIT E PG 4
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 14
If to SOLVAY:
SOLVAY S.A.
DCR-LC
310, rue de Ransbeek
B - 1120 Brussels, Belgium
Attention General Manager Research and Development
If to COR:
President, COR Therapeutics, Inc.
256 East Grand Avenue
South San Francisco, California 94080, USA
If to RECIPIENT:
[*]
or to such other address as to which any Party may notify the
others. Any notice sent by facsimile transmission or telex
shall be followed within twenty-four (24) hours by a signed
notice sent by first class mail, postage prepaid.
8.2. Assignment and Delegation
RECIPIENT may not assign his/her rights and/or delegate
his/her obligations under this Agreement to any third party
without the prior consent of SOLVAY and COR.
8.3. Amendment
No amendment or modification of the terms of this Agreement
shall be binding on any Party unless reduced to writing and
signed by the respective authorised officers of SOLVAY and COR
and by RECIPIENT.
8.4. Publicity
The Parties agree that, except as may otherwise be required by
applicable laws, regulations, rules or orders, no information
concerning this Agreement and the transactions contemplated
herein shall be made public by any Party without the prior
written consent of the others.
8.5. Waiver
EXHIBIT E PG 5
CONFIDENTIAL TREATMENT REQUESTED = [*]
<PAGE> 15
Failure of any Party to insist upon strict observance of or
compliance with any of the terms of this Agreement in one or
more instances shall not be deemed to be a waiver of its
rights to insist upon such observance or compliance with the
other terms hereof, at that point in time or in the future.
8.6. Counterparts
This Agreement may be executed in multiple counterparts, each
of which shall be an original, but all of which shall
constitute but one agreement.
8.7 Governing Law
This Agreement shall be governed by the laws of England.
SOLVAY, COR and RECIPIENT consent to the exclusive
jurisdiction and venue of the Courts of England.
IN WITNESS THEREOF, the parties hereto have executed this
Agreement, in three original copies.
SOLVAY S.A. COR THERAPEUTICS, INC.
By: By:
-------------------------------- --------------------------------
Title: Title:
----------------------------- -----------------------------
RECIPIENT
[*]
EXHIBIT E PG 6
CONFIDENTIAL TREATMENT REQUESTED = [*]
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONDENSED BALANCE SHEETS, STATEMENTS OF OPERATIONS, AND STATEMENTS OF CASH FLOWS
INCLUDED IN THE COMPANY'S FORM 10-Q FOR THE PERIOD ENDED SEPTEMBER 30, 1998 AND
IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS AND THE
NOTES THERETO.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> SEP-30-1998
<CASH> 15,671
<SECURITIES> 65,200
<RECEIVABLES> 1,952
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 98,937
<PP&E> 25,325
<DEPRECIATION> (19,830)
<TOTAL-ASSETS> 104,432
<CURRENT-LIABILITIES> 32,262
<BONDS> 0
0
0
<COMMON> 2
<OTHER-SE> 69,141
<TOTAL-LIABILITY-AND-EQUITY> 104,432
<SALES> 0
<TOTAL-REVENUES> 35,775
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 50,866
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 578
<INCOME-PRETAX> (12,322)
<INCOME-TAX> 0
<INCOME-CONTINUING> (12,322)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (12,322)
<EPS-PRIMARY> (.51)<F1>
<EPS-DILUTED> (.51)
<FN>
<F1>For the Purpose of this Exhibit, Primary means Basic.
</FN>
</TABLE>
